WO2021136460A1 - 止血阀、导管鞘以及介入器械的密封方法 - Google Patents
止血阀、导管鞘以及介入器械的密封方法 Download PDFInfo
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- WO2021136460A1 WO2021136460A1 PCT/CN2020/141817 CN2020141817W WO2021136460A1 WO 2021136460 A1 WO2021136460 A1 WO 2021136460A1 CN 2020141817 W CN2020141817 W CN 2020141817W WO 2021136460 A1 WO2021136460 A1 WO 2021136460A1
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- WIPO (PCT)
- Prior art keywords
- chamber
- energy storage
- hemostatic valve
- valve according
- balance
- Prior art date
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Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/06—Body-piercing guide needles or the like
- A61M25/0662—Guide tubes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
- A61M2039/062—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof used with a catheter
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
- A61M2039/0673—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof comprising means actively pressing on the device passing through the seal, e.g. inflatable seals, diaphragms, clamps
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0097—Catheters; Hollow probes characterised by the hub
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
- A61M39/0613—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof with means for adjusting the seal opening or pressure
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/22—Valves or arrangement of valves
- A61M39/227—Valves actuated by a secondary fluid, e.g. hydraulically or pneumatically actuated valves
- A61M39/228—Valves actuated by a secondary fluid, e.g. hydraulically or pneumatically actuated valves with a tubular diaphragm constrictable by radial fluid force
Definitions
- This application relates to the field of medical devices, in particular to the sealing method of hemostatic valves, catheter sheaths and interventional devices.
- Interventional therapy is a cutting-edge treatment technology developed in recent years between medication and surgical operation.
- Interventional treatment technology usually requires the use of medical imaging equipment such as X-ray fluoroscopy, CT positioning, and B-mode ultrasound equipment as a guide, and the catheter device loaded with interventional devices (such as vascular stents, artificial heart valves) or drugs is reached through human arteries and veins.
- interventional devices such as vascular stents, artificial heart valves
- drugs is reached through human arteries and veins.
- the diseased area in the body so as to achieve the purpose of diagnosis and treatment of diseases.
- the catheter sheath provides a channel for the catheter device to enter the human body, and also creates an outflow outlet for blood or other body fluids.
- it is usually necessary to provide a hemostasis valve with a seal in the catheter sheath.
- the problem in the prior art solution is that there is a contradiction between the sealing function of the hemostatic valve and the passable function of facilitating the passage of interventional instruments.
- it is often necessary to improve the sealing performance, but correspondingly, the penetration of the interventional device in the hemostatic valve will be affected.
- a hemostatic valve includes a housing and a tubular sealing film located in the housing.
- the outer periphery of the tubular sealing film and the housing form a ring-shaped closed cavity, and a filler is injected into the closed cavity.
- a filler is injected into the closed cavity.
- the inventor found that after the sealing film is sealed, it will generate greater friction with the interventional device.
- it is necessary to frequently adjust the pressure of the sealed cavity to adjust the sealing state of the sealing film. , The operation is cumbersome, and the precision control is difficult, which has an impact on the treatment process.
- a hemostatic valve which includes a casing and a sealing film installed in the casing and in a tubular structure.
- the inner cavity of the tubular structure serves as an instrument channel and penetrates the casing.
- the housing is provided with a drive chamber on the periphery of the sealing film for filling fluid, the hemostatic valve further includes an energy storage mechanism that can be linked with the fluid, and the energy storage mechanism changes in the state of the sealing film When the energy is stored or released, the sealing film is driven to seal the instrument channel when the energy is released.
- the hemostatic valve has a working state where the drive chamber is filled with fluid and an initial state where the fluid is not filled, and the fluid is an incompressible liquid.
- the fluid is physiological saline or water.
- the sealing film has a first state of being squeezed by the interventional device to open the device channel, and the energy storage mechanism is driven by the fluid to store energy;
- the sealing membrane has a second state driven by fluid to close the instrument channel, and the energy storage mechanism discharges energy to maintain the fluid pressure that maintains the sealing membrane in the second state.
- the housing is a rigid structure at least on the outer periphery of the driving chamber.
- the housing is a rigid structure as a whole.
- the shell is made of a transparent material.
- a through zone is opened in the housing, the sealing film is arranged in the through zone, and the driving chamber is enclosed between the outer periphery of the sealing film and the wall of the through zone.
- the two open ends of the penetrating area are respectively sealed with a first end cover and a second end cover, each end cover is provided with an escape hole corresponding to the instrument channel, and the axial direction of the sealing film is two The end is clamped and fixed between the shell and the end cover on the corresponding side.
- one end of the instrument channel is an instrument inlet, and the other end is an instrument outlet, and a radially penetrating exhaust hole is opened on the end cover on one side of the instrument outlet.
- an exhaust valve is communicated with the exhaust hole
- the exhaust valve is directly installed in the exhaust hole or communicated with the exhaust hole through an external pipeline.
- each end cover is fixed to the housing by screws.
- a balance chamber is further provided in the housing, the drive chamber and the balance chamber are in communication with each other, and the fluid in the drive chamber is linked with the energy storage mechanism via the balance chamber.
- the balance chamber is located outside the drive chamber.
- the balance chamber surrounds the outer circumference of the driving chamber.
- the drive chamber and the balance chamber are isolated from each other and communicate only through a balance hole.
- one end of the instrument channel is an instrument inlet, and the other end is an instrument outlet, and the balance hole is adjacent to the instrument outlet.
- a first pressure adjustment hole is opened on the wall of the balance chamber or the drive chamber.
- a first regulating valve is communicated with the first pressure regulating hole
- the first regulating valve is directly installed in the first pressure regulating hole or connected to the first pressure regulating hole through an external pipeline.
- the energy storage mechanism includes an energy storage chamber and an energy storage element installed in the energy storage chamber, and the energy storage element correspondingly stores or releases energy when the state of the sealing film changes, so as to drive The sealing film seals and closes the instrument channel.
- the energy storage mechanism includes:
- the energy storage chamber; the housing is also provided with a balance chamber, and the drive chamber and the balance chamber are in communication with each other;
- the energy storage element is a compressible gas and/or an elastic member located in the energy storage chamber and interacting with the piston.
- the wall of the energy storage chamber is provided with a second pressure adjustment hole.
- one end of the instrument channel is an instrument inlet and the other end is an instrument outlet.
- the balance chamber is adjacent to the instrument outlet, and the energy storage chamber is adjacent to the instrument inlet.
- the energy storage chamber has an open structure on the side facing away from the balance chamber and is sealed with a third end cover, and the second pressure adjustment hole is provided on the third end cover.
- a second regulating valve is communicated with the second pressure regulating hole
- the second regulating valve is directly installed in the second pressure regulating hole or connected to the second pressure regulating hole through an external pipeline.
- an adjusting member that abuts against the elastic member is provided in the energy storage chamber, and at least a part of the adjusting member is exposed to the energy storage chamber as an adjustment operation part.
- the energy storage chamber has an open structure on the side facing away from the balance chamber and is sealed with a third end cover, and the adjustment member is provided on the third end cover.
- the adjusting member is an adjusting screw threadedly fitted with the chamber wall of the energy storage chamber, the head of the adjusting screw serves as the adjusting operating part, and the end of the adjusting screw opposite to the head is connected to the adjusting screw.
- the elastic pieces are matched with each other.
- the movement direction of the piston and the extension direction of the instrument channel are mutually parallel or arranged at an angle.
- the energy storage element is an elastic bladder placed in the energy storage chamber.
- the elastic bladder is suspended in the balance chamber or fixed to the wall of the balance chamber.
- the elastic bladder is fixed to the wall of the balance chamber, and a third pressure adjustment hole communicating with the elastic bladder is opened on the wall of the balance chamber.
- a third regulating valve is communicated with the third pressure regulating hole
- the third regulating valve is directly installed in the third pressure regulating hole or connected to the third pressure regulating hole through an external pipeline.
- the elastic bag has a hollow structure and is filled with gas, and the gas stores or releases energy.
- the elastic bladder is made of an elastic material, and energy is stored or released through deformation of the elastic material.
- a hydrophilic lubricating coating is provided on the inner cavity of the sealing film.
- the hemostatic valve further includes a pressurizing mechanism for feeding back changes in blood pressure to the fluid.
- the pressurization mechanism has an input port for collecting blood pressure and an output port after pressurization, and the output of the pressurization mechanism directly or indirectly acts on the fluid in the driving chamber.
- the pressurizing mechanism includes a support body, two cylinder chambers with different cylinder diameters are arranged inside the support body, a sliding part is installed in each cylinder chamber in a sealed sliding manner, and the sliding parts in the two cylinder chambers are linked with each other;
- the input port communicates with a first cylinder chamber with a larger cylinder diameter; the output port communicates with a second cylinder chamber with a smaller cylinder diameter.
- the two cylinder chambers are in communication with each other, and the connecting part is a linkage chamber located between the two sliding parts, and the two sliding parts are linked with each other by the medium pressure in the common linkage chamber.
- the sliding member in the first cylinder chamber is a first sliding member, one side of the first sliding member is an input chamber communicating with the input port, and the other side is the shared linkage chamber;
- the sliding member in the second cylinder chamber is a second sliding member, one side of the second sliding member is an output chamber communicating with the output port, and the other side is the common linkage chamber.
- the two cylinder chambers are isolated from each other, the two sliding parts are directly connected by a connecting part, and both ends of the connecting part are sealed through each cylinder chamber and connected to the corresponding sliding parts.
- the sliding member in the first cylinder chamber is a first sliding member, one side of the first sliding member is an input chamber communicating with the input port, and the other side is a first linkage chamber;
- the sliding member in the second cylinder chamber is a second sliding member, one side of the second sliding member is an output chamber communicating with the output port, and the other side is a second linkage chamber;
- the two ends of the connecting piece are sealed and penetrated into each linkage chamber and connected with the corresponding sliding piece.
- the hemostatic valve is provided with a blood pressure feedback hole that can communicate with the blood vessel in a use state, and the blood pressure feedback hole is connected to the input port through a feedback pipeline.
- one end of the instrument channel is an instrument inlet, and the other end is an instrument outlet, and the blood pressure feedback hole is adjacent to the instrument outlet side.
- the hemostatic valve is provided with an exhaust hole, and the exhaust hole is configured separately from the blood pressure feedback hole.
- the hemostatic valve is provided with an exhaust hole, which doubles as the blood pressure feedback hole, and an exhaust bypass is connected to the feedback pipeline, and an exhaust valve is provided on the exhaust bypass.
- the supporting body and the housing are of integral or separate structure.
- the two cylinder chambers are arranged coaxially, side by side, or nested inside and outside.
- the axes of the two cylinder chambers are parallel or oblique or perpendicular.
- the output port of the pressurizing mechanism is in communication with the driving chamber.
- the pressurizing mechanism includes a support body, two cylinder chambers with different cylinder diameters are arranged inside the support body, a sliding part is installed in each cylinder chamber in a sealed sliding manner, and the sliding parts in the two cylinder chambers are linked with each other;
- the input port communicates with a first cylinder chamber with a larger cylinder diameter; the output port communicates with a second cylinder chamber with a smaller cylinder diameter;
- the two cylinder chambers are in communication with each other, and the connecting part is a linkage chamber located between the two sliding parts, and the two sliding parts are linked with each other by the medium pressure in the linkage chamber.
- the chamber wall of the linkage chamber is provided with a fourth pressure adjustment hole communicating with the linkage chamber; the wall of the cylinder chamber with a smaller cylinder diameter is provided with a fifth pressure adjustment hole communicating with the output port hole.
- the pressurizing mechanism includes a support body, two cylinder chambers with different cylinder diameters are arranged inside the support body, a sliding part is installed in each cylinder chamber in a sealed sliding manner, and the sliding parts in the two cylinder chambers are linked with each other;
- the input port communicates with a first cylinder chamber with a larger cylinder diameter; the output port communicates with a second cylinder chamber with a smaller cylinder diameter;
- the two cylinder chambers are isolated from each other, the two sliding parts are directly connected by a connecting part, and the two ends of the connecting part are sealed through each cylinder chamber and connected to the corresponding sliding parts.
- the chamber wall of the second cylinder chamber is respectively provided with:
- the sixth pressure regulating hole is connected to one side of the sliding member in the second cylinder chamber; the seventh pressure regulating hole is connected to the other side of the sliding member in the second cylinder chamber, and the output port is also connected to this side.
- each pressure regulating hole is connected with a regulating valve; each regulating valve is directly installed in the corresponding pressure regulating hole or connected to the corresponding pressure regulating hole through an external pipeline.
- a balance chamber is further provided in the housing, and the drive chamber and the balance chamber are in communication with each other;
- the output port of the pressurizing mechanism is in communication with the driving chamber and/or the balance chamber.
- the hemostatic valve further includes an energy storage mechanism that can be linked with the fluid, and the energy storage mechanism stores or releases energy correspondingly when the state of the sealing film changes, so as to drive the sealing film Closing the instrument channel;
- the fluid in the driving chamber is linked with the energy storage mechanism via the balance chamber;
- the output of the pressurization mechanism directly acts on the energy storage mechanism, or the output port of the pressurization mechanism is in communication with the drive chamber and/or the balance chamber.
- the energy storage mechanism includes an elastic bag placed in the balance chamber;
- the output port of the pressurizing mechanism communicates with the balance chamber.
- the energy storage mechanism includes an elastic bag placed in the balance chamber;
- the output port of the pressurizing mechanism is in communication with the elastic bladder.
- the energy storage mechanism includes:
- An energy storage chamber connected to the balance chamber
- the compressible gas and/or elastic member located in the energy storage chamber and interacting with the piston;
- the output port of the pressurizing mechanism is in communication with the energy storage chamber.
- the energy storage mechanism includes:
- An energy storage chamber connected to the balance chamber
- the compressible gas and/or elastic member located in the energy storage chamber and interacting with the piston;
- the output port of the pressurizing mechanism communicates with the balance chamber.
- it also includes a blood pressure indicating device connected to the input port.
- the blood pressure indicating device is a separately configured blood pressure meter or integrated into the pressurizing mechanism.
- the pressurizing mechanism has at least a moving part related to blood pressure, and the pressurizing mechanism is provided with a blood pressure mark, and the blood pressure mark is related to the position of the moving part.
- the pressurizing mechanism includes a support body, two cylinder chambers with different cylinder diameters are arranged inside the support body, a sliding part is installed in each cylinder chamber in a sealed sliding manner, and the sliding parts in the two cylinder chambers are linked with each other;
- the input port communicates with a first cylinder chamber with a larger cylinder diameter; the output port communicates with a second cylinder chamber with a smaller cylinder diameter;
- the moving parts are sliding parts in the first cylinder chamber and/or sliding parts in the second cylinder chamber.
- the present application also provides an externally balanced hemostatic valve, including a housing and a sealing film in a tubular structure installed in the housing.
- the inner cavity of the tubular structure is used as an instrument channel, and the housing is provided with a sealing film.
- a peripheral driving chamber is provided with a capsule that interacts with the sealing membrane in the driving chamber, and the capsule is matched with the sealing membrane to close or open the instrument channel.
- the housing has a rigid cylindrical structure and is sleeved on the outer circumference of the sealing film, the two axial ends of the sealing film are in a sealed connection with the housing, and the axial middle of the sealing film
- the driving chamber is enclosed with the inner wall of the casing.
- the housing includes:
- Each end cap is provided with an escape hole corresponding to the position of the instrument channel.
- the position of the balance hole is adjacent to the entrance of the instrument channel.
- connection modes between the two axial ends of the sealing film and the housing are respectively at least one of the following modes:
- the end cap is embedded in the corresponding side and is sealed and fixed by the stuffing piece;
- the elastic bladder includes:
- a hollow structure capsule made of elastic materials
- a second joint connected to and connected to the balloon body, and the second joint is used to infuse a balancing medium that can flow between the elastic balloon and the driving chamber.
- first joint and the second joint are located on two opposite sides of the capsule body, and form an integral or separate structure with the capsule body.
- a sealing plug is installed at the opening of the second joint.
- the second joint is connected with a control valve.
- the application also discloses an internally balanced hemostatic valve, which includes a casing and a sealing membrane mounted in the casing and in a tubular structure.
- the inner cavity of the tubular structure is used as an instrument channel, and the casing is provided with a sealing membrane.
- the driving chamber on the periphery of the membrane is provided with a capsule that interacts with the sealing membrane in the driving chamber, and the capsule is matched with the sealing membrane to close or open the instrument channel.
- the number of the capsule is one, and at least one circle around the instrument channel; or the number of the capsule is multiple, and each capsule is distributed around the instrument channel on the periphery of the sealing membrane, and the distribution mode is It is evenly distributed or non-uniformly distributed in the circumferential direction, and the shape of each capsule is the same or different.
- the number of the capsules is 2, 3 or 4.
- the capsule is a deformed part at least in the middle of itself, and the positions of the deformed parts of the capsules work together. ⁇ The sealing film.
- the balloon has a bulging state maintained by its own elasticity and/or by a filler, and the balloon in the bulging state squeezes the sealing membrane to close the instrument channel; the interventional instrument passes through the instrument channel
- the capsule has a concession state achieved by its own deformation and/or displacement, and the capsule in the concession state allows the sealing membrane to deform to open the instrument channel.
- the housing has a rigid cylindrical structure and is sleeved on the outer periphery of the sealing film, the two axial ends of the sealing film are in a sealed connection with the housing, and the axial middle of the sealing film
- the driving chamber is enclosed with the inner wall of the casing.
- the housing includes:
- a support part, the instrument channel passes through the support part
- Each end cap is provided with an escape hole corresponding to the position of the instrument channel.
- connection modes between the two axial ends of the sealing film and the housing are respectively at least one of the following modes:
- the support portion includes a spherical shell-shaped middle section and a diameter-reducing section butting on both sides of the middle section, the two end caps are respectively inserted and fixed to the corresponding-side diameter-reducing section, and the drive chamber is located at all The interior of the middle section.
- a positioning groove is provided on the casing or each end cover, the capsule body extends along the length direction of the instrument channel, and both ends of the capsule body are respectively inserted and fixed in the corresponding side positioning grooves.
- the support portion or at least one end cover is provided with an injection channel
- at least one end of the capsule has an open structure and is connected to the injection channel
- the support portion or at least one end cover is provided with an injection channel.
- the injection port connected by the channel.
- the injection port is equipped with a sealing plug, or the injection port is sealed with a connecting pipe and a control valve is installed on the connecting pipe.
- the application also discloses a hemostatic valve, which includes a housing and a sealing film installed in the housing and in a tubular structure.
- the inner cavity of the tubular structure serves as an instrument channel and penetrates the housing.
- a drive chamber that can be filled with fluid on the periphery of the sealing membrane, and a balance chamber and an energy storage chamber are also provided in the housing, wherein the balance chamber is in communication with the drive chamber;
- a piston is slidably installed in between, and an energy storage element is arranged in the energy storage chamber, and the energy storage element stores or releases energy through interaction with the piston when the sealing film is deformed.
- the application also discloses a hemostatic valve, which includes a housing and a sealing film mounted in the housing and in a tubular structure.
- the inner cavity of the tubular structure serves as an instrument channel and penetrates the housing.
- a drive chamber that can be filled with fluid on the periphery of the sealing membrane, and a balance chamber and an energy storage chamber are also provided in the housing, wherein the balance chamber is in communication with the drive chamber; the balance chamber and/or the energy storage chamber
- An elastic bag as an energy storage element is arranged in the room, and the elastic bag is subjected to the action of fluid to store or release energy when the sealing membrane is deformed.
- the application also discloses a hemostatic valve, which includes a housing and a sealing film installed in the housing and in a tubular structure.
- the inner cavity of the tubular structure serves as an instrument channel and penetrates the housing.
- a drive chamber filled with fluid on the periphery of the sealing membrane, the hemostatic valve further includes a pressure boosting mechanism having an input port for collecting blood pressure and an output port after pressure, and passing through the output The port feeds back changes in blood pressure to the fluid.
- the application also discloses a hemostatic valve, which includes a housing and a sealing film installed in the housing and in a tubular structure.
- the inner cavity of the tubular structure serves as an instrument channel and penetrates the housing.
- a drive chamber that can be filled with fluid on the periphery of the sealing film, and a balance chamber and an energy storage chamber are also provided in the housing, wherein the balance chamber is in communication with the drive chamber, and the balance chamber and the energy storage chamber
- a piston is slidably installed in between, and an energy storage element is arranged in the energy storage chamber.
- the energy storage element stores or releases energy through the interaction with the piston when the sealing film is deformed;
- the hemostatic valve also includes an increase A pressure mechanism having an input port for collecting blood pressure and an output port after pressurization, the output port communicating with at least one of the drive chamber, the balance chamber, and the energy storage chamber, Used to feed back changes in blood pressure to the fluid.
- the application also discloses a hemostatic valve, which includes a housing and a sealing film installed in the housing and in a tubular structure.
- the inner cavity of the tubular structure serves as an instrument channel and penetrates the housing.
- a drive chamber that can be filled with fluid on the periphery of the sealing film, and a balance chamber and an energy storage chamber are also provided in the housing, wherein the balance chamber is in communication with the drive chamber; the balance chamber and/or the energy storage chamber
- the room is provided with an elastic bladder as an energy storage element, the elastic bladder is stored or released by the action of the fluid when the sealing membrane is deformed;
- the hemostatic valve also includes a pressurizing mechanism, the pressurizing mechanism has a blood pressure collection mechanism An input port and a pressurized output port, the output port communicates with at least one of the drive chamber, the balance chamber, and the energy storage chamber for feeding back changes in blood pressure to the fluid.
- the application also discloses a multi-cavity hemostatic valve, which includes a casing and a sealing film installed in the casing and in a tubular structure.
- the inner cavity of the tubular structure is used as an instrument channel along the radial direction of the instrument channel.
- the housing is provided with a driving chamber on the periphery of the sealing film for filling fluid and a balance chamber located outside the driving chamber.
- the driving chamber and the balance chamber are in communication with each other and the balance chamber surrounds On the outer periphery of the driving chamber;
- the hemostasis valve further includes an energy storage mechanism that can be linked with the fluid, and the fluid in the drive chamber is linked with the energy storage mechanism via the balance chamber; the energy storage mechanism changes when the state of the sealing film changes. Correspondingly, energy is stored or released, and when the energy is released, the sealing film is driven to seal the instrument channel.
- the balance chambers there are a plurality of the balance chambers and they are arranged at intervals of the outer circumference of the driving chamber, and the energy storage mechanism is separately configured for each balance chamber.
- the number of the balance chambers is 2 to 8.
- the balance chambers are arranged at even intervals on the outer periphery of the driving chamber.
- each balance chamber communicates with the drive chamber through an independent balance hole.
- At least two balance chambers share the same balance hole to communicate with the drive chamber.
- each balance chamber communicates with the drive chamber through the same balance hole.
- the energy storage mechanism includes:
- a balance chamber is also provided in the housing, and the drive chamber and the balance chamber are in communication with each other;
- An energy storage element where the energy storage element is a compressible gas and/or an elastic member located in the energy storage chamber and interacting with the piston;
- the housing is provided with at least two cylindrical spaces for the piston to slide, and the cylindrical space is divided into the balance chamber and the energy storage chamber by the piston.
- each piston seals and cooperates with the inner wall of the corresponding cylindrical space through the sealing edge of its outer edge.
- the sealing edge and the inner wall of the cylindrical space are provided with at least two channels. seal.
- the housing is provided with at least two cylindrical spaces for the piston to slide, each cylindrical space is provided with an independent energy storage element, and the energy storage performance of each energy storage element is consistent or Inconsistent.
- the hemostatic valve further includes a pressure adjustment structure provided with a fluid pipeline for supplying the fluid, and the fluid pipeline is directly or indirectly connected to the balance chamber or the drive chamber. Or the balance hole is connected.
- the balance chamber is provided with a plurality of balance chambers distributed circumferentially on the outside of the driving chamber, and each balance chamber communicates with the driving chamber through an independent balancing hole; one side of each balancing hole is linked with the driving chamber, and the other side is It extends radially to the outer peripheral wall of the housing, and each balance hole is closed on the outer peripheral wall or butted with the fluid pipeline.
- the housing is a rigid structure at least on the outer periphery of the driving chamber.
- the driving chamber is also connected with a fluid pipeline, and an external fluid source is connected through the fluid pipeline.
- a control valve is configured on the fluid pipeline.
- the drive chamber is also connected with a balance chamber, and the fluid in the drive chamber is linked with the energy storage mechanism via the balance chamber; the communication between the fluid pipeline and the drive chamber is in the following manner At least one:
- the external fluid source is provided by a pressure regulating structure.
- the driving mode of the pressure adjusting structure is manual, electric or pneumatic.
- the pressure regulating structure has at least one storage chamber, and the fluid pipeline is in communication with the storage chamber.
- a cylindrical space is formed in the housing, and the energy storage mechanism includes:
- a piston is slidably arranged in the cylindrical space and divides the cylindrical space into the balance chamber and the energy storage chamber;
- the energy storage element is located in the energy storage chamber, and the energy storage element is a gas and/or an elastic member that interacts with the piston.
- the housing is annular and has an annular wall, and the cylindrical space is located in the annular wall.
- the cylindrical space is a straight cylindrical structure, and the axis of the straight cylindrical structure and the axis of the housing are parallel to each other.
- the instrument channel passes through the housing along the axis of the housing.
- the number of cylindrical spaces is 2-8.
- the cylindrical space is sequentially distributed along the circumferential direction of the casing.
- the technical solution disclosed in this application stores the deformation energy of the sealing film through the design of the energy storage mechanism, and can adaptively adjust the posture and shape of the sealing film during the relative displacement of the device and the hemostatic valve, so as to realize the passage of different devices. It has good compatibility and good sealing effect; through the setting of the parameters of the sealing film, the parameter setting of the energy storage structure and the matching between the two, the advantages of good drawing operation feeling and small operating force change are realized, and it is for adjusting the drawing.
- the adjustment of the hand feel of the pulling device provides a structural basis.
- the present application also provides a catheter sheath, including an axially extending sheath tube, the sheath tube has an axially penetrating cavity, the sheath tube has a proximal end and a distal end, and the proximal end of the sheath tube is connected with the foregoing Hemostatic valve.
- the distal end of the sheath tube is provided with a developing ring.
- the hemostasis valve is provided with a pipe joint connected with the sheath, the pipe joint is matched with the sheath through a sealing member, and the pipe joint is provided to prevent the sheath from contacting the sheath.
- the tube wall of the sheath tube has a rolled wall structure with a coiled cross section, and the tube wall has an expanded state where the rolled wall structure at the corresponding part is expanded and a predetermined state where the rolled wall structure is automatically restored.
- the tube wall is made of an elastic material that can autonomously switch between an expanded state and a predetermined state.
- the outer diameter of the tube wall in the predetermined state is 4-9 mm.
- the tube wall in the predetermined state is wound more than one circle, and the part beyond the 360-degree circle and the part within the 360-degree overlap each other.
- the overlapping parts have smooth contact surfaces.
- the winding of the tube wall in the predetermined state is less than 720 degrees.
- start side and the end side of the winding wall structure in the circumferential direction are connected by a flexible envelope film.
- a crease line is provided at the turning point of the flexible envelope film.
- the wall thickness of the flexible envelope film is 0.1-1 mm.
- the flexible envelope membrane is a circumferentially closed tubular structure, the section perimeter of the tubular structure of the flexible envelope membrane is greater than the wall length of the tube wall section, and the tube wall is fixedly attached to the flexible envelope membrane. Outer wall.
- the outer periphery of the distal end of the tube wall is wrapped with an elastic sleeve.
- the distal end of the tube wall is connected to the sheath handle, and the connecting part is wrapped by the elastic sleeve.
- the axial length of the elastic sleeve is 5-50 cm.
- the outside of the tube wall is covered with a sheath for confining the tube wall in a predetermined state, and the sheath expands and cracks when the tube wall is in an expanded state.
- the sheath extends from the proximal end of the tube wall in the axial direction of the tube wall, and the extended part is a constricted structure.
- the wall structure is a chamfered structure near the proximal end of the tube wall on the end side of the circumferential winding.
- the present application also provides a method for sealing an interventional device, which includes using a deformable sealing film to construct a device channel, and the outer periphery of the sealing film is deformed by a fluid to drive the sealing film to deform to seal the device channel.
- a fluid to drive the sealing film to deform to seal the device channel.
- the energy storage mechanism linked with the fluid is used to store or release energy correspondingly when the sealing film is deformed to maintain the seal between the interventional device and the device channel.
- the present application also provides a method for sealing an interventional device based on a hemostatic valve.
- the hemostatic valve includes a housing and a sealing film mounted in the housing and having a tubular structure.
- the inner cavity of the tubular structure serves as an instrument channel and penetrates the A housing, which is provided with a drive chamber on the periphery of the sealing film that can be filled with fluid and an energy storage mechanism that can be linked with the fluid.
- the interventional device sealing method includes:
- the fluid drives the sealing membrane to close the instrument channel, and the fluid also acts on the energy storage mechanism to pre-charge the energy storage mechanism to maintain the sealing membrane state;
- the sealing film is squeezed and deformed by the interventional device and the energy storage mechanism is driven by fluid to store energy;
- the energy storage mechanism is released, and the instrument channel is closed by the deformation of the sealing membrane driven by the fluid.
- each interventional device of the present application can be implemented based on the hemostatic valve in the above technical solution.
- the technical solution disclosed in this application stores the deformation energy of the sealing film through the design of the energy storage mechanism, and can adaptively adjust the posture and shape of the sealing film during the relative displacement of the device and the hemostatic valve, so as to realize the passage of different devices. It has good compatibility and good sealing effect; through the setting of the parameters of the sealing film, the parameter setting of the energy storage structure and the matching between the two, the advantages of good drawing operation feeling and small operating force change are realized, and the advantages of The adjustment of the hand feel of the pulling device provides a structural basis.
- Figure 1a is a schematic diagram of the initial state of the hemostatic valve in an embodiment
- Figure 1b is a schematic view of the housing of the hemostatic valve in Figure 1a;
- Fig. 1c is a schematic diagram of the working state of the hemostatic valve in Fig. 1a;
- Figure 1d is a schematic diagram of the device entering the hemostatic valve in Figure 1c;
- Figure 2a is a schematic diagram of the initial state of the hemostatic valve in another embodiment
- Figure 2b is a schematic diagram of the working state of the hemostatic valve in Figure 2a;
- Figure 2c is a schematic diagram of the device entering the hemostatic valve in Figure 2b;
- Fig. 2d is a schematic diagram of the initial state of another embodiment of the hemostatic valve in Fig. 2a;
- Figure 2e is a schematic diagram of the working state of the hemostatic valve in Figure 2d;
- Figure 2f is a schematic diagram of the device entering the hemostatic valve in Figure 2e;
- Figure 3 is a schematic diagram of the adjusting member mechanism
- Figure 4a is a schematic diagram of the initial state of the hemostatic valve in another embodiment
- Figure 4b is a schematic diagram of the working state of the hemostatic valve in Figure 4a;
- Figure 4c is a schematic diagram of the device entering the hemostatic valve in Figure 4b;
- Fig. 5a is a schematic diagram of the working state of another embodiment of the hemostatic valve in Fig. 4a;
- Figure 5b is a schematic diagram of the device entering the hemostatic valve in Figure 5a;
- Fig. 5c is a schematic diagram of the working state of another embodiment of the hemostatic valve in Fig. 4a;
- 6a and 6b are schematic diagrams of the fitting relationship between the sheath of the catheter sheath and the hemostatic valve in an embodiment
- Figure 7a is a schematic diagram of the initial state of the hemostatic valve in an embodiment
- Figure 7b is a schematic diagram of the filling state of the hemostatic valve in Figure 7a;
- Figure 7c is a schematic diagram of the working state of the hemostatic valve in Figure 7a;
- Figure 8 is a schematic diagram of another embodiment of a pressure boosting mechanism in an embodiment
- Fig. 9 is a schematic diagram of another communication mode of the pressurizing mechanism in an embodiment
- Figure 10a is a schematic diagram of an embodiment of the pressurizing mechanism arranged in the hemostatic valve
- Fig. 10b is a schematic diagram of another embodiment of the hemostatic valve in Fig. 10a;
- Figure 11a is a schematic diagram of another energy storage mechanism used by the hemostatic valve in an embodiment
- Fig. 11b is a schematic diagram of another communication mode of the pressurizing mechanism in the hemostatic valve in Fig. 11a;
- Figures 12a and 6b are schematic diagrams of the cooperative relationship between the sheath of the catheter sheath and the hemostatic valve
- Figure 13 is a schematic structural diagram of an externally balanced hemostatic valve in an embodiment when it is not filled with a balancing medium
- Figure 14 is a schematic structural diagram of an externally balanced hemostatic valve in a state of injecting a balanced medium in an embodiment
- Fig. 15 is a schematic structural diagram of the externally balanced hemostatic valve in Fig. 14 when an interventional device passes through;
- Figure 16 is a schematic diagram of the internal structure of Figure 15;
- Figure 17 is a schematic diagram of the structure of the catheter sheath in an embodiment
- FIG. 18 is a schematic structural diagram of an internally balanced hemostatic valve in an embodiment when it is not filled with fillers;
- 19 is a schematic structural diagram of an internally balanced hemostatic valve in a state of injecting fillers in an embodiment
- FIG. 20 is a schematic structural diagram of the internally balanced hemostatic valve in FIG. 19 when no interventional device passes through;
- Figure 21 is a schematic structural diagram of the internally balanced hemostatic valve in Figure 19 when an interventional device passes through;
- Figure 22 is a schematic diagram of the structure of the catheter sheath in an embodiment
- Figures 23a to 23b are structural schematic diagrams of a multi-cavity hemostatic valve in an embodiment
- Figures 24a to 27d are structural schematic diagrams of multi-cavity hemostatic valves in other embodiments.
- Figures 28a to 29f are schematic diagrams of the sheath in an embodiment.
- Pressurizing mechanism 40, support body; 401, first cylinder chamber; 402, second cylinder chamber; 41, input port; 42, output port; 43, first sliding member; 431, input chamber; 432, connection 44, the second sliding member; 441, the output chamber; 442, the shared linkage chamber; 443, the first linkage chamber; 444, the second linkage chamber; 451, the fourth pressure adjustment hole; 452, the fifth pressure adjustment hole; 453.
- Interventional equipment 91. Sheath;
- 100 housing; 110, support part; 120, end cover; 121, escape hole; 122, pipe joint; 130, sealing film; 131, instrument channel; 140, elastic capsule; 141, capsule body; 142, first joint 143, second joint; 150, drive chamber; 151, balance hole; 160, interventional device; 170, sheath; 111, middle section; 112, reduced diameter section; 144, capsule; 145, deformed part; 152, injection Channel; 153, injection port; 154, connecting pipe;
- a component when a component is said to be “connected” with another component, it can be directly connected to the other component or there may also be a central component. When a component is considered to be “installed on” another component, it can be directly installed on another component or a centered component may exist at the same time.
- an embodiment of the present application discloses a hemostatic valve, including a housing 1 and a sealing membrane 2 installed in the housing 1 and having a tubular structure.
- the inner cavity 21 of the tubular structure is used as the instrument channel 11.
- the housing 1 is provided with a drive chamber 12 on the periphery of the sealing membrane 2 for filling fluid.
- the hemostatic valve also includes an energy storage mechanism 3 that can be linked with fluid.
- the energy storage mechanism 3 is located on the sealing membrane 2.
- the function of the sealing film 2 actually separates two mutually independent spaces in the housing 1, that is, the instrument channel 11 and the driving chamber 12, and the two are separated by the sealing film 2.
- the two ends of the instrument channel 11 are open for the interventional instrument 9 to pass through.
- the sealing film 2 itself has a tubular structure, and the inner cavity 21 serves as the instrument channel 11.
- Instrument channel 11 In order to ensure that the interventional instrument 9 passes through the housing 1, the instrument channel 11 needs to penetrate through the housing 1. Therefore, the inner cavity 21 of the sealing film 2 as the instrument channel 11 should be understood as the inner cavity 21 of the sealing film 2 constituting at least a part of the instrument channel 11. .
- the fluid in the driving chamber 12 can drive the sealing membrane 2 to change its state, so as to realize the closing or opening of the instrument channel 11.
- the instrument channel 11 is a channel through which the interventional instrument 9 (such as a catheter, a guide wire, etc.) enters and exits the human body during the interventional treatment process. Therefore, it can be understood that the area surrounded by the tubular structure is at least a part of the instrument channel 11.
- corresponding inlets and outlets connected to the instrument channel 11 are opened on the housing 1, which can also be regarded as the instrument channel 11 passing through the housing 1.
- the function of the driving chamber 12 is to confine the fluid and direct the work of the fluid to the sealing membrane 2.
- the sealing membrane 2 closes the instrument channel 11
- at least a part of the tubular structure of the sealing membrane 2 itself will have a radial shrinking tendency, thereby reducing the cavity diameter of the instrument channel 11 until the instrument channel 11 is closed.
- the sealing film 2 can either close the instrument channel 11 or open the instrument channel 11.
- the inner cavity 21 of the sealing film 2 is radially folded and sealed to wrap the outer periphery of the interventional instrument 9 to close the instrument channel 11; when the interventional instrument 9 is not in the instrument channel 11, the inner cavity of the sealing film 2
- the cavity 21 is collapsed radially until it abuts and closes to each other to close the instrument channel 11.
- the fluid-driven sealing membrane 2 is mainly realized by pressure.
- the driving chamber 12 can drive the sealing membrane 2 to deform itself to change the inner part of the sealing membrane 2. Cavities 21.
- the sealing effect of the instrument channel 11 depends on the fluid pressure in the driving chamber 12.
- Changing the pressure of the fluid in the driving chamber 12 can take many forms, such as connecting a pressure source, changing the temperature of the fluid, changing the physical properties of the fluid, and so on.
- the energy storage mechanism 3 in this embodiment can adaptively adjust the pressure state of the fluid. When the state of the sealing film 2 changes, the energy storage mechanism 3 can store or release energy accordingly, and use the stored energy to drive the sealing film 2 to seal and close the instrument channel 11.
- the technical solution of this embodiment can effectively improve the integration degree of the hemostatic valve, and improve the degree and effect of the sealing membrane 2 transforming form, thereby providing a larger cavity diameter instrument channel 11 and Interventional instruments 9 of different appearance sizes provide a structural basis for the design.
- the tubular structure of the sealing film 2 mentioned in this application is not limited to a round pipe in the strict sense.
- the inner diameter of the inner cavity of the sealing film 2 may vary in the axial direction.
- the inner cavity may have a regular shape such as a rectangle, or an hourglass, pear, or spherical shape with varying edges, or an irregular shape.
- the inner cavity of the sealing film 2 is provided with a hydrophilic lubricating coating (not shown).
- the inner cavity of the sealing film 2 is the part actually in contact with the interventional device 9.
- the hydrophilic lubricating coating can reduce the friction of the inner cavity of the sealing film 2, even if the sealing film 2 tightens the outer periphery of the interventional device 9 under the action of fluid, the intervention The instrument 9 can still travel through the instrument channel 11 smoothly.
- the hydrophilic lubricating coating can also achieve other functions by adjusting the coating material. For example, by adding wear-resistant materials to the coating material to increase the life of the sealing film 2; for another example, adjusting the physical and chemical properties of the coating surface to achieve self-cleaning of the sealing film 2 and so on.
- the hemostatic valve has a working state in which the drive chamber 12 is filled with fluid (for example, FIG. 1c) and an initial state (for example, FIG. 1a) that is not filled with fluid.
- the fluid is an incompressible liquid.
- the air in the driving chamber 12 should be atmospheric pressure; in some products used in special scenes, the driving chamber 12 in the initial state can be set to vacuum.
- the incompressibility of liquid refers to relative to gas, not incompressibility in an absolute sense.
- the incompressibility of the liquid can facilitate medical personnel and other operators to accurately control the degree of deformation of the sealing film 2.
- the fluid is physiological saline or water. The advantage of physiological saline or water as the fluid mentioned above is that it is easy to obtain in the medical field. More importantly, even if the sealing effect of the sealing film 2 fails in an accident, the fluid will not affect the intervention site. Ensure safety.
- the energy storage mechanism 3 can improve the working performance of the sealing film 2.
- the sealing film 2 has a first state in which the interventional device 9 is squeezed to open the device channel 11 (for example, FIG. 1d), and the energy storage mechanism 3 is driven by the fluid to store energy; it is easy to understand that the energy storage When the mechanism 3 is in the energy storage state, the fluid has a higher pressure to ensure the closed state of the instrument channel 11; that is, the energy storage mechanism 3 in the energy storage state still drives the sealing membrane 2 to seal the instrument channel 11.
- the sealing membrane 2 has a second state (for example, FIG. 1c) that is driven by the fluid to close the instrument channel 11, and the energy storage mechanism 3 is discharged to maintain the fluid pressure that maintains the sealing membrane 2 in the second state.
- the sealing membrane 2 When the interventional instrument 9 enters the hemostatic valve, the sealing membrane 2 needs to open the instrument channel 11 to avoid interference with the interventional instrument 9. Therefore, the sealing film 2 will perform work on the fluid in the driving chamber 12. If the preset pressure of the fluid in the driving chamber 12 is too high, the driving force required for the deformation of the sealing membrane 2 will be too high. The interventional instrument 9 needs a relatively large driving force to compress the sealing membrane 2 to open the instrument channel 11. The operation is inconvenient; if the preset pressure of the fluid in the driving chamber 12 is too low, the sealing membrane 2 will have insufficient sealing pressure when the instrument channel 11 is closed, which is likely to cause the sealing failure.
- the energy storage mechanism 3 in this embodiment can well overcome the above-mentioned problems.
- the sealing membrane 2 needs to open the instrument channel 11 to avoid interference with the interventional instrument 9.
- the sealing film 2 will perform work on the fluid in the drive chamber 12, and the energy storage mechanism 3 can store energy to absorb the energy of the fluid to reduce the difficulty of entering the interventional device 9 and provide a good feel for the entry process of the interventional device 9;
- the sealing film 2 needs to close the instrument channel 11 to function as a hemostatic valve.
- the fluid in the driving chamber 12 will perform work on the sealing film 2, and at the same time, the energy storage mechanism 3 can release energy to perform work on the fluid, thereby ensuring the sealing effect of the sealing film 2 on the instrument channel 11.
- the housing 1 is a rigid structure at least on the outer periphery of the driving chamber 12.
- the housing 1 can limit the work done by the driving chamber 12 in other directions, so as to ensure that the energy of the fluid acts on the sealing film 2. With a certain energy, the deformation stroke and sealing effect of the sealing film 2 are improved.
- the rigidity mentioned in this embodiment is relative to the deformable flexible sealing film 2 and is not the rigidity of a rigid body in the physical concept.
- the housing 1 may be made of plastics and other materials, and may be slightly deformed under the action of fluid, but the slight deformation will not affect the working effect of the sealing film 2. The same applies to the description of rigidity below.
- the housing 1 may be common materials such as metal and plastic, or organic materials or inorganic materials, or synthetic materials or natural materials, and so on.
- the housing 1 is a rigid structure as a whole.
- the fluid exerts force on the surrounding components, so when the fluid pressure is high, the housing 1 may be deformed.
- the housing 1 may be deformed to consume the energy of the fluid and affect the working effect of the sealing film 2.
- the technical solution in this embodiment can overcome this problem.
- the housing 1 is made of a transparent material.
- transparent materials are relative to materials that cannot be observed inside. Therefore, as long as the design of the internal structure can be observed and the use requirements in this embodiment can be met, it should also be considered as a transparent expression type in this embodiment. , Such as translucent materials.
- transparency may be partial. For example, it can be realized by setting observation windows at the parts where the internal structure needs to be observed.
- a through zone 13 is opened in the housing 1, and the sealing film 2 is arranged in the through zone 13. The outer circumference of the sealing film 2 and the inner wall of the through zone 13 Drive room 12 is enclosed between.
- the penetrating area 13 contains the sealing film 2, which prevents the external environment from affecting the penetrating area 13 from directions other than the instrument channel 11, and can improve the working stability of the sealing film 2.
- the penetrating area 13 also participates in the formation of the driving chamber 12, which improves the integration of the components of the hemostatic valve, which is beneficial to control the overall volume of the hemostatic valve, and is convenient for use in the treatment process.
- the two open ends of the penetrating area 13 are respectively sealed with a first end cover 14 and a second end cover 15, each end cover is provided with an escape hole corresponding to the instrument channel 11, and the axial direction of the sealing film 2 The two ends are clamped and fixed between the housing 1 and the end cover on the corresponding side.
- the first end cover 14 and the second end cover 15 can fix the sealing film 2 so as to guide the working direction of the sealing film 2.
- the avoidance hole can also play a guiding role in the working process, ensuring the contact position of the interventional instrument 9 with the sealing film 2 when entering the instrument channel 11, and reducing the possibility of the interventional instrument 9 causing damage to the sealing film 2.
- one end of the instrument channel 11 is the entrance of the interventional instrument 9 and the other end is the exit of the interventional instrument 9.
- the end cover on the side of the exit of the interventional instrument 9 is provided with a radially penetrating exhaust hole 16.
- the exhaust hole 16 can overcome the problem of carrying gas before the device is used.
- the operator can remove the gas in the hemostatic valve by injecting physiological saline into the exhaust hole 16 before use.
- the vent 16 itself is also an interface, which can provide a structural basis for special operations in special usage scenarios.
- the exhaust hole 16 is connected with an exhaust valve (not shown);
- the exhaust valve is directly installed in the exhaust hole 16 or communicated with the exhaust hole 16 through an external pipeline.
- the flexible setting of the exhaust valve can be adjusted according to the needs of different cases.
- the design of the exhaust valve directly installed in the exhaust hole 16 can improve the integration of the hemostatic valve and facilitate operation;
- another example is the design of the exhaust valve connected to the exhaust hole 16 through an external pipeline, which can further reduce the external size of the hemostatic valve , Provide adaptability.
- each end cover is fixed to the housing 1 by screws (not shown in the figure).
- the end cover needs to form a relatively closed space in the housing 1, and in some embodiments, the sealing film 2 needs to be fixed. Therefore, the installation stability of the end cover is related to the stable operation of the hemostatic valve.
- the end cover itself can also be installed through its own structure. In order to improve the convenience of installation, screws are a reasonable choice.
- the housing 1 is also provided with a balance chamber 31, the drive chamber 12 and the balance chamber 31 communicate with each other, and the fluid in the drive chamber 12 passes through the balance chamber 31 and the storage chamber 31. Can mechanism 3 linkage.
- the function of the balance chamber 31 is to restrict the movement of the energy storage mechanism 3.
- the balance chamber 31 may also communicate with the drive chamber 12 in a large area. Therefore, the concept of the balance chamber 31 needs to be understood from the principle of the energy storage mechanism 3, rather than a space relatively isolated from the drive chamber 12 in structure.
- the balance chamber 31 and the driving chamber 12 are in open communication (not shown).
- the balance chamber 31 is located outside the drive chamber 12 along the radial direction of the instrument channel 11.
- the driving chamber 12 is a component that directly drives the sealing film 2 to work, and it is a reasonable design to be close to the sealing film 2.
- the design of the balance chamber 31 on the radially outer side of the drive chamber 12 along the instrument channel 11 can reduce the length of the hemostatic valve in the axial direction of the instrument channel 11 and facilitate the operation during treatment.
- the balance chamber 31 surrounds the outer circumference of the driving chamber 12.
- the balance chamber 31 is designed on the outer periphery to accept the diffusion trend of the fluid, and has a good dynamic response.
- the balance chamber 31 has the function of constraining the energy storage mechanism 3.
- the driving chamber 12 and the balance chamber 31 are isolated from each other, and communicate only through the balance hole 311.
- the balance hole 311 is used for the passage of fluid, so as to realize the energy storage or discharge of the fluid in the driving chamber 12 by the energy storage mechanism 3.
- the design in which the drive chamber 12 and the balance chamber 31 are isolated from each other can prevent the fluid in the drive chamber 12 from affecting the operation of the energy storage mechanism 3, thereby improving the stability of the energy storage mechanism 3 in operation.
- one end of the instrument channel 11 is the entrance of the interventional instrument 9 and the other end is the exit of the interventional instrument 9; the balance hole 311 is adjacent to the exit of the interventional instrument 9.
- the instrument channel 11 is a channel through which the interventional instrument 9 enters the hemostatic valve.
- the interventional instrument 9 enters the hemostatic valve, there may be a process in which the interventional instrument 9 first contacts a part of the sealing film 2.
- the fluid in the driving chamber 12 will also be gradually affected by the interventional device 9.
- the balance hole 311 arranged at a position adjacent to the outlet of the interventional device 9 can adapt to the process of the interventional device 9 entering the hemostatic valve, and better reflect the dynamic changes of the fluid into the balance chamber 31 through the balance hole 311.
- a first pressure adjustment hole 32 is opened on the wall of the balance chamber 31 or the drive chamber 12.
- the first pressure adjustment hole 32 can realize the pressure adjustment in the driving chamber 12 from the outside.
- an external pressure source can be set to adjust the pressure of the fluid in the driving chamber 12.
- the first pressure regulating hole 32 itself is also an interface, which can provide a structural basis for special operations in special use scenarios.
- the first pressure regulating hole 32 communicates with a first regulating valve (not shown);
- the first regulating valve is directly installed in the first pressure regulating hole 32 or connected to the first pressure regulating hole 32 through an external pipeline.
- the flexible setting of the first regulating valve can be adjusted according to the needs of different cases.
- the design that the first regulating valve is directly installed in the first pressure regulating hole 32 can improve the integration of the hemostatic valve and facilitate the operation of medical personnel and other operators; for example, the first regulating valve is connected to the first pressure regulating valve through an external pipeline.
- the design of the hole 32 can further reduce the outer size of the hemostatic valve and provide adaptability.
- the energy storage mechanism 3 includes an energy storage chamber 33 and an energy storage element installed in the energy storage chamber 33, the energy storage element correspondingly stores or releases energy when the state of the sealing film 2 changes, And when the energy is released, the sealing film 2 is driven to seal the instrument channel 11.
- the energy storage mechanism 3 includes:
- the housing 1 is also provided with a balance chamber 31, and the drive chamber 12 and the balance chamber 31 communicate with each other;
- Piston 34 sealingly sliding between the balance chamber 31 and the energy storage chamber 33;
- the energy storage element, the energy storage element is a compressible gas and/or an elastic member located in the energy storage chamber 33 and interacting with the piston 34.
- the position change of the piston 34 realizes the energy storage or discharge of the energy storage mechanism 3.
- energy is absorbed by the compressible gas and/or elastic member 341, and in the energy discharging process, the compressible gas and/or elastic member 341 performs work to realize the energy release.
- the energy storage chamber 33 is a functional expression of the energy storage mechanism 3 in the energy storage process.
- the energy storage element is in the energy storage chamber 33, and the actual function is energy discharging.
- the piston 34 seals and slides between the balance chamber 31 and the energy storage chamber 33.
- the body of the piston 34 is the dividing boundary between the balance chamber 31 and the energy storage chamber 33. Therefore, the relative space between the balance chamber 31 and the energy storage chamber 33 changes. .
- the piston 34 moves to the balance chamber 31, and part of the balance chamber 31 becomes the energy storage chamber 33; when the energy storage mechanism 3 stores energy, the piston 34 moves to the energy storage chamber 33, and part of the energy is stored It became room 31 of the balance room.
- the sealing fit of the piston 34 is actually to prevent the fluid in the balance chamber 31 (that is, the fluid in the drive chamber 12) from entering the energy storage chamber 33. This design is very important when the hemostatic valve is not connected to an external pressure source. In some treatment processes, the energy storage mechanism 3 may need to be adjusted accordingly.
- the wall of the energy storage chamber 33 is provided with a second pressure adjustment hole 331.
- the second pressure adjustment hole 331 can adjust the change of the energy storage of the energy storage mechanism 3, so as to make fine adjustments according to different treatment processes and improve the adaptability of the hemostatic valve.
- the second pressure adjustment hole 331 itself is also an interface, which can provide a structural basis for special operations in special usage scenarios.
- one end of the instrument channel 11 is the entrance of the interventional instrument 9 and the other end is the exit of the interventional instrument 9.
- the balance chamber 31 is adjacent to the exit of the interventional instrument 9
- the energy storage chamber 33 is adjacent to the entrance of the interventional instrument 9. .
- the instrument channel 11 is a channel through which the interventional instrument 9 enters the hemostatic valve.
- the interventional instrument 9 enters the hemostatic valve, there may be a process in which the interventional instrument 9 first contacts a part of the sealing film 2.
- the fluid in the driving chamber 12 will also be gradually affected by the interventional device 9.
- the balance chamber 31 is a structure that directly communicates with the drive chamber 12. Therefore, the balance chamber 31 is arranged at a position adjacent to the exit of the interventional device 9 to adapt to the process of the interventional device 9 entering the hemostatic valve, and better reflect the dynamic changes of the fluid through the balance chamber 31 To the energy storage mechanism 3.
- the energy storage chamber 33 has an open structure on the side facing away from the balance chamber 31 and is sealed with a third end cover 332, and the second pressure regulating hole 331 is provided on the third end cover 332.
- the third end cover 332 actually constitutes the side wall of the energy storage chamber 33, so it is the key to maintain the pressure in the energy storage chamber 33 during sealing installation.
- the second pressure adjusting hole 331 is provided on the third end cover 332 to avoid opening the energy storage chamber 33, which reduces the difficulty of the process and avoids the possibility of leakage.
- the second pressure regulating hole 331 is communicated with a second regulating valve (not shown);
- the second regulating valve is directly installed in the second pressure regulating hole 331 or connected to the second pressure regulating hole 331 through an external pipeline.
- the flexible setting of the second regulating valve can be adjusted according to the needs of different cases.
- the design of the second regulating valve directly installed in the second pressure regulating hole 331 can improve the integration of the hemostatic valve and facilitate the operation of medical personnel and other operators; for example, the second regulating valve is connected to the second pressure regulating valve through an external pipeline.
- the design of the hole 331 can further reduce the external size of the hemostatic valve and provide adaptability.
- the energy storage chamber 33 is provided with an adjustment member 342 that is opposed to the elastic member 341, and at least a part of the adjustment member 342 is exposed to the energy storage chamber 33 as an adjustment operation portion 343. .
- the function of the adjusting member 342 is to adjust the parameters such as the preload and the rebound speed of the elastic member 341, so as to facilitate the operator of the medical staff to fine-tune the parameters of the hemostatic valve to adapt to different treatment processes.
- the adjustment operation part 343 is exposed to the energy storage chamber 33 for convenient operation, avoids the disassembly of the hemostatic valve, and can realize fine adjustment during the treatment process.
- the second pressure adjusting hole 331 communicating with the energy storage chamber 33 can also be considered as a deformation of the adjusting member 342.
- the energy storage chamber 33 has an open structure on the side facing away from the balance chamber 31 and is sealed with a third end cover 332, and the adjusting member 342 is provided on the third end cover. 332 on.
- the third end cover 332 is fixed to the housing 1 and has good strength, which can bear the load of the elastic member 341 while facilitating adjustment and assembly.
- the adjusting member 342 is an adjusting screw threaded with the chamber wall of the energy storage chamber 33, and the head of the adjusting screw serves as the adjusting operating portion 343.
- the adjusting screw and the head The opposite end is abuttingly fits with the elastic member 341.
- the form of the adjustment screw is simple and reliable. The most important thing is the high adjustment accuracy, which is convenient for medical staff and other operators to finely adjust the working parameters of the hemostatic valve. At the same time, the threaded fit can conveniently realize the sealed fit under the premise of realizing adjustment.
- the movement direction of the piston 34 and the extending direction of the instrument channel 11 are arranged in parallel or at an angle to each other.
- the function of the piston 34 is to deliver the pressure of the fluid to the energy storage mechanism 3, and the setting of the movement direction does not affect the realization of the function of the piston 34. It is more a consideration of the overall layout structure of the hemostatic valve. In the actual product, it may be set as required.
- the design in which the movement direction of the piston 34 and the extension direction of the instrument channel 11 are parallel to each other can achieve a more regular overall shape; another example is the design where the movement direction of the piston 34 and the extension direction of the instrument channel 11 are set at an angle. Realize a more compact and practical overall shape in the required products.
- the energy storage mechanism 3 can also achieve work effects through other structures.
- the energy storage element is an elastic bladder placed in the energy storage room or outside the energy storage room.
- the function of the energy storage chamber is actually replaced by the balance chamber 31.
- the elastic bladder 35 can jointly realize energy storage or energy release, thereby further increasing the energy storage or energy release of the energy storage technology.
- the elastic bladder 35 is suspended in the balance chamber 31 or fixed to the wall of the balance chamber 31.
- the energy storage and release of the elastic bladder 35 are realized through its own deformation. Therefore, there are many ways of fixing.
- the elastic bladder 35 is suspended in the balance chamber 31, and a plurality of them can be designed.
- This design can fully release the deformation of the elastic bladder 35, and the change of the position of the elastic bladder 35 can also provide a structural basis for exceptional functions in some special scenarios.
- the density change of the fluid in the balance chamber 31 can be indicated.
- the suspension is relative to fixation.
- the specific position of the elastic bladder 35 in the energy storage chamber 33 needs to be determined by the density of the medium stored in the elastic bladder 35 and the density of the medium in the energy storage chamber 33.
- the elastic bladder 35 is fixed to the wall of the balance chamber 31.
- This design can determine the position of the elastic bladder 35 and avoid the friction of the elastic bladder 35 and the balance chamber 31 caused by the friction of the elastic bladder 35 during storage, transportation or use.
- the elastic bladder 35 is fixed to the wall of the balance chamber 31, and a third pressure regulating hole 351 communicating with the elastic bladder 35 is opened on the wall of the balance chamber 31.
- the third pressure adjustment hole 351 can realize the pressure adjustment inside the elastic bladder 35 from the outside.
- an external pressure source can be set to adjust the pressure of the fluid in the elastic bladder 35.
- the third pressure adjustment hole 351 itself is also an interface, which can provide a structural basis for special operations in special use scenarios.
- the third pressure regulating hole 351 communicates with a third regulating valve (not shown);
- the third regulating valve is directly installed in the third pressure regulating hole 351 or connected to the third pressure regulating hole 351 through an external pipeline.
- the flexible setting of the third regulating valve can be adjusted according to the needs of different cases.
- the design of the third regulating valve directly installed in the third pressure regulating hole 351 can improve the integration of the hemostatic valve and facilitate the operation of medical personnel and other operators; for example, the third regulating valve is connected to the third pressure regulating valve through an external pipeline
- the design of the hole 351 can further reduce the external size of the hemostatic valve and provide adaptability.
- the elastic bladder 35 has a hollow structure and is filled with gas, which stores or releases energy through the gas.
- the gas has the advantages of larger deformation and better energy storage or release.
- the elastic bag 35 can restrain the gas and reduce the risk of affecting the intervention operation.
- the elastic bladder 35 is made of an elastic material, which stores or releases energy through deformation of the elastic material.
- the elastic bladder 35 itself is an elastic material, which can avoid the influence of gas on the intervention operation and bring a safer guarantee for the intervention operation. More importantly, through the elasticity of the elastic bladder itself, technical effects different from other solutions can be achieved. For example, a release hole is opened on the shell, and an elastic bladder is covered on the release hole. The fluid enters the elastic bladder under the squeeze of the sealing film and drives the elastic bladder to deform and store energy. Squeeze back into the shell to release energy.
- the energy storage element disposed in the energy storage chamber 33 may be deformed. Therefore, the following several exemplary embodiments should be understood as equivalent solutions of the solutions of this application.
- a release hole is opened on the shell, and the release hole is covered with an elastic member.
- the fluid enters the elastic bag under the squeeze of the sealing film and drives the elastic bag to deform and store energy, similar to the state of blowing a balloon in life.
- the elastic member expands the storage.
- the volume of the energy chamber; in the energy release stage, the elastic bladder deforms itself to squeeze the internal fluid back into the shell, thereby achieving energy release.
- the energy storage element in this solution is located on the boundary of the energy storage chamber 33, which can be understood as the energy storage element itself expands and expands the energy storage chamber during the energy storage process.
- the energy storage element is a tension spring, which is set in the position in the balance chamber marked in the figure.
- the fluid enters the energy storage chamber under the squeeze of the sealing film and drives the tension spring to stretch and store energy.
- the balance chamber actually constitutes the storage
- the concept of energy room and the judgment of the concept of energy storage room should be based on the actual function. In some scenarios, the energy storage room may be shared with the balance room.
- the present application also discloses a catheter sheath, which includes a sheath 91 and a hemostatic valve that are connected to each other, and the hemostatic valve is based on the above technical solution.
- the sheath 91 intervenes with the inside of the human body, the hemostatic valve closes the sheath, and the interventional device 9 enters the sheath 91 through the hemostatic valve, thereby entering the inside of the human body to implement the treatment process.
- the hemostasis valve is provided with a pipe joint connected with the sheath tube 91, the pipe joint is matched with the sheath tube 91 through a seal, and the pipe joint is provided with an engaging structure that prevents the sheath tube 91 from being separated from the pipe joint.
- the pipe joint is formed by extending the second end cover 15.
- the head of the sheath tube 91 is provided with a developing point, which is convenient for medical staff to better complete the operation process with the help of medical equipment.
- the butt-connected sheath tube and the hemostatic valve cooperate to form the instrument channel 11, wherein the sheath tube can be integrated with the end caps on both sides or arranged separately.
- Each end cap extends away from the hemostatic valve, thereby extending in the axial direction of the instrument channel 11, and further wraps and protects the instrument channel 11 for the interventional instrument 9 to pass through.
- This application also discloses a method for sealing an interventional instrument, including the use of a deformable sealing film to construct an instrument channel, and the outer periphery of the sealing membrane is deformed by a fluid to drive the sealing membrane to seal the instrument channel. It is characterized in that when the interventional instrument enters and exits the instrument channel In the process, the energy storage mechanism linked with the fluid is used to store or release energy correspondingly when the sealing film is deformed, so as to maintain the seal between the interventional device and the device channel.
- the interventional device sealing method is implemented according to the hemostatic valve in the above technical solution.
- the specific structure of the hemostatic valve please refer to the description of the hemostatic valve above, which will not be repeated here.
- the present application discloses a hemostatic valve, including a housing 1 and a sealing film 2 mounted in the housing 1 and having a tubular structure.
- the inner cavity 21 of the tubular structure serves as the instrument channel 11 and penetrates the housing 1.
- the housing 1 is provided with a drive chamber 12 on the periphery of the sealing membrane 2 for filling fluid, and the hemostatic valve also includes a pressurizing mechanism 4 for feeding back changes in blood pressure to the fluid.
- the function of the sealing film 2 actually separates two mutually independent spaces in the housing 1, that is, the instrument channel 11 and the driving chamber 12, and the two are separated by the sealing film 2.
- the two ends of the device channel 11 are open for the device to pass through.
- the tubular structure of the sealing film 2 mentioned in this application is not limited to a round pipe in the strict sense.
- the inner diameter of the inner cavity of the sealing film 2 may vary in the axial direction.
- the inner cavity may have a regular shape such as a rectangle, or an hourglass, pear, or spherical shape with varying edges, or an irregular shape.
- the inner cavity of the sealing film 2 is provided with a hydrophilic lubricating coating (not shown).
- the inner cavity of the sealing film 2 is the part that actually comes into contact with the interventional device 9.
- the hydrophilic lubricating coating can reduce the friction of the inner cavity of the sealing film 2, which is convenient for the interventional device 9 in the case of the pressure difference between the inside and outside of the sealing film 2. Walk through passage 11. At the same time, the hydrophilic lubricating coating can also achieve other functions by adjusting the coating material.
- the driving chamber 12 can drive the sealing membrane 2 to change its own state, so as to realize the closing or opening of the instrument channel 11.
- the instrument channel 11 is a channel through which the interventional instrument 9 (such as a catheter, a guide wire, etc.) enters and exits the human body during the interventional treatment. Therefore, it can be understood that the area surrounded by the tubular structure is at least a part of the instrument channel 11.
- corresponding inlets and outlets connected to the instrument channel 11 are opened on the housing 1, which can also be regarded as the instrument channel 11 passing through the housing 1.
- the function of the driving chamber 12 is to confine the fluid and direct the work of the fluid to the sealing membrane 2.
- the sealing membrane 2 closes the instrument channel 11
- at least a part of the tubular structure of the sealing membrane 2 itself will have a radial shrinking tendency, thereby reducing the cavity diameter of the instrument channel 11 until the instrument channel 11 is closed. If the instrument is in the instrument channel 11 or not, the sealing film 2 can either close the instrument channel 11 or open the instrument channel 11.
- the inner cavity 21 of the sealing film 2 is radially collapsed to cooperate with the instrument to close the instrument channel 11.
- the inner cavity 21 of the sealing film 2 is radially collapsed until it abuts against each other and closes to close the instrument channel 11.
- the fluid-driven sealing membrane 2 is mainly realized by pressure.
- the driving chamber 12 can drive the sealing membrane 2 to deform itself to change the inner part of the sealing membrane 2. Cavities 21.
- the sealing effect of the specific instrument channel 11 depends on the fluid pressure in the driving chamber 12.
- Changing the pressure of the fluid in the driving chamber 12 can take many forms, such as connecting a pressure source, changing the temperature of the fluid, changing the physical properties of the fluid, and so on.
- the pressurizing mechanism 4 in this embodiment feeds back the blood pressure at one end of the hemostatic valve to the fluid, thereby changing the fluid pressure in the driving chamber 12, further adjusting the working state of the sealing membrane 2 and adjusting the sealing effect of the instrument channel 11.
- This design can improve the effect of the sealing film 2 closing the device channel 11 during the movement of the interventional device 9 relative to the sealing film 2, improve the operating experience of operators such as medical staff, provide a stable treatment process, and improve the treatment effect.
- the housing 1 can limit the work done by the driving chamber 12 in other directions, so as to ensure that the energy of the fluid acts on the sealing film 2. With a certain energy, the deformation stroke and sealing effect of the sealing film 2 are improved.
- the rigidity mentioned in this embodiment is relative to the deformable flexible sealing film 2 and is not the rigidity of a rigid body in the physical concept.
- the housing 1 may be made of plastics and other materials, and may be slightly deformed under the action of fluid, but the slight deformation will not affect the working effect of the sealing film 2. The same applies to the description of rigidity below.
- the housing 1 may be common materials such as metal and plastic, or organic materials or inorganic materials, or synthetic materials or natural materials, and so on.
- the pressure increasing mechanism 4 has an input port 41 for collecting blood pressure and an output port 42 after pressure.
- the output of the pressure increasing mechanism 4 directly or indirectly acts on Drive the fluid in the chamber 12.
- the energy input to increase the mechanism comes from blood pressure, so it needs to establish a connection with the human body.
- the pressure-increasing mechanism 4 can feed back changes in blood pressure to the fluid through a simple communication relationship.
- the pressurizing mechanism 4 can directly interact with the fluid, or can be indirectly linked through the transmission between the components.
- the pressurizing mechanism 4 includes a support body 40. Two cylinder chambers with different cylinder diameters are arranged inside the support body 40. Each cylinder chamber is sealed and slidably installed with a sliding member, and the two cylinder chambers are sealed and slidably installed. The sliding parts in the cylinder chamber are linked to each other;
- the input port 41 communicates with the first cylinder chamber 401 with a larger bore; the output port 42 communicates with the second cylinder chamber 402 with a smaller bore.
- the support body 40 provides a stable working environment, and the two cylinder chambers can restrict the working stroke of the respective sliding parts.
- the sliding member interacts with the fluid in the corresponding cylinder chamber to achieve energy transfer. It should be explained that the expression larger and smaller in the first cylinder chamber 401 with a larger bore diameter and the second cylinder chamber 402 with a smaller bore diameter means that the first cylinder chamber 401 and the second cylinder chamber 402 want to be compared. the result of. The same goes for the following.
- the cylinder diameters of the two cylinder chambers are different, which can achieve the effect of pressure adjustment. Adjust the feedback relationship between blood pressure and fluid according to actual product needs.
- the linkage between the sliding parts in the two cylinder chambers can be realized in a variety of ways.
- the sliding parts in the two cylinder chambers are connected by physical components; for example, the linkage is realized by filling fluid.
- the two cylinder chambers communicate with each other, and the connecting part is a linkage chamber located between the two sliding parts.
- the two sliding parts are linked to each other by the pressure of the medium in the common linkage chamber 442; for example, through an energy field or a force field.
- the sliding parts in the two cylinder chambers are linked with each other through a magnetic field.
- the sliding member in the first cylinder chamber 401 is the first sliding member 43, and one side of the first sliding member 43 is in communication with the input port 41
- the input room 431, the other side is the shared linkage room 442;
- the sliding part in the second cylinder chamber 402 is the second sliding part 44, one side of the second sliding part 44 is the output chamber 441 communicating with the output port 42, and the other side is the common linkage chamber 442.
- the function of the shared linkage chamber 442 is to provide a movement space for the linkage relationship between the sliding parts in the two cylinder chambers.
- changes may occur among the input chamber 431, the common linkage chamber 442, and the output chamber 441.
- the part originally belonging to the shared interlocking chamber 442 will be compressed and become the space of the input chamber 431.
- the shared linkage room 442 can also be changed in design to become an independent linkage room.
- the two cylinder chambers are isolated from each other, the two sliding parts are directly connected by a connecting part 432, and both ends of the connecting part 432 are sealed through each cylinder chamber and connected to the corresponding sliding parts.
- the sliding part in the first cylinder chamber 401 is the first sliding part 43, one side of the first sliding part 43 is the input chamber 431 communicating with the input port 41, and the other side is the first linkage chamber 443 ;
- the sliding member in the second cylinder chamber 402 is the second sliding member 44, one side of the second sliding member 44 is the output chamber 441 communicating with the output port 42, and the other side is the second linkage chamber 444;
- the two ends of the connecting member 432 seal into each linkage chamber and are connected with the corresponding sliding member.
- the design of the split linkage chamber can facilitate the layout of the pressurizing mechanism 4, so that the hemostasis valve can adjust the overall shape for different treatment cases to provide a structural basis.
- the energy source of the pressurizing mechanism 4 comes from blood pressure.
- the hemostatic valve is provided with a blood pressure feedback hole 161 that can communicate with the blood vessel in use, and the blood pressure feedback hole 161 is connected to the input through the feedback pipeline Port 41 is connected.
- the blood pressure feedback hole 161 can deliver the pressure of the blood pressure to the booster mechanism 4, so as to realize the energy delivery of the blood pressure to the booster mechanism 4.
- the blood pressure feedback hole 161 should be designed on the side of the hemostatic valve close to the human body, so as to meet the requirements of the pressurizing mechanism 4 while hemostasis.
- one end of the instrument channel 11 is an instrument inlet, and the other end is an instrument outlet, and the blood pressure feedback hole 161 is adjacent to the instrument outlet side.
- the exit side of the device is closer to the human body, and the blood pressure feedback hole 161 is close to the exit of the device to facilitate the establishment of connection with human blood.
- the blood pressure and the energy transmission of the pressurizing mechanism 4 can be realized through a shorter pipeline, which improves the working effect of the pressurizing mechanism 4 under dynamic working conditions.
- the hemostatic valve is provided with an exhaust hole (not shown in the figure), and the exhaust hole and the blood pressure feedback hole 161 are arranged separately.
- the vent hole 161 is also an interface, which can provide a structural basis for special operations in special usage scenarios.
- the vent hole and the blood pressure feedback hole 161 are configured separately has different advantages and limitations, and can be set as needed.
- the vent hole and the blood pressure feedback hole 161 are arranged separately to avoid the influence of the gas in the vent hole on blood and improve safety.
- the vent hole and the blood pressure feedback hole 161 can also be configured together.
- the hemostatic valve is provided with an exhaust hole, which doubles as a blood pressure feedback hole 161, and an exhaust bypass is connected to the feedback pipeline, and an exhaust valve is provided on the exhaust bypass.
- the vent hole is also used as the blood pressure feedback hole 161 to improve the integration of the components of the hemostatic valve, while increasing the function and ensuring the overall volume of the hemostatic valve.
- the gas discharged from the exhaust valve can also be used in the pressurizing mechanism 4 to achieve a better sealing effect of the instrument channel 11.
- a structure such as a one-way valve is required to avoid the influence of the gas discharged from the exhaust valve on the blood in the human body.
- the flexible setting of the exhaust valve can be adjusted according to the needs of different cases.
- the design of the exhaust valve directly installed in the exhaust hole can improve the integration of the hemostatic valve and facilitate the operation;
- another example is the design of the exhaust valve connected to the exhaust hole through an external pipeline, which can further reduce the external size of the hemostatic valve and provide Adaptability.
- the support body 40 and the housing 1 are of integral or separate structure.
- the support body 40 and the housing 1 of the separate structure can realize the flexible arrangement of the pressurizing mechanism 4 relative to the housing 1, thereby providing more flexible hemostatic valve performance for the intervention site and improving adaptability; refer to Figures 7a and 7a and Fig. 10a, the integral structure of the support body 40 and the housing 1 can realize the integration of the pressurizing mechanism 4 and the housing 1, reducing the setting of connected pipelines, etc., which is convenient for medical staff and other operators to use experience, and at the same time reduces possible failures The part of the pipeline, especially the part of the pipeline with pressure.
- the two cylinder chambers are arranged coaxially, side by side, or nested inside and outside.
- two-cylinder chambers arranged coaxially can facilitate the linkage setting between the two sliding parts, thereby reducing the difficulty of production and assembly; for example, two-cylinder chambers arranged side by side can effectively control the length of the pressurizing mechanism 4 in the sliding direction of the sliding parts, and improve hemostasis
- the overall space performance of the valve for example, the two-cylinder chambers nested inside and outside can effectively control the size of the pressurizing mechanism 4 in the sliding direction of the sliding part and the radial direction of the sliding part, further improving the overall space performance of the hemostatic valve;
- the setting method can be set as required according to different application scenarios of the hemostatic valve.
- the arrangement of the two-cylinder chambers is viewed from another dimension.
- the axes of the two-cylinder chambers are parallel or obliquely crossing or perpendicular.
- the function of the two-cylinder chamber is to transport the pressure of blood into the fluid.
- the setting of the axial direction does not affect the realization of the function of the two-cylinder chamber. It is more a consideration of the overall layout of the hemostatic valve. In the actual product, it may be set as required.
- the design where the axis directions of the two cylinder chambers are parallel to each other can get a more regular overall shape; another example is the design of the oblique or vertical arrangement of the axis directions of the two cylinder chambers can achieve more compact and practical products in some special needs products. Overall shape.
- the ultimate purpose of the pressurizing mechanism 4 is to transfer the pressure of blood to the fluid.
- the output port 42 of the pressurizing mechanism 4 is in communication with the driving chamber 12.
- the driving chamber 12 is a cavity that directly drives the deformation of the sealing membrane 2. Therefore, the output port 42 of the pressurizing mechanism 4 communicates with the driving chamber 12 to directly react blood pressure changes to the fluid in the driving chamber 12, thereby bringing more sensitivity The effect of the work.
- the pressurizing mechanism 4 can be integrated into the hemostatic valve, in addition to the mutual linkage between the two sliding parts of the pressurizing mechanism 4 through the connecting piece 432, through the medium pressure between the two Realize connectivity.
- the pressurizing mechanism 4 includes a support body 40. Two cylinder chambers with different cylinder diameters are arranged inside the support body 40. Each cylinder chamber is sealed and slidingly installed with sliding parts, and the sliding parts in the two cylinder chambers Mutual linkage
- the input port 41 is connected to the first cylinder chamber 401 with a larger cylinder diameter; the output port 42 is connected to the second cylinder chamber 402 with a smaller cylinder diameter;
- the two cylinder chambers are in communication with each other, and the connecting part is a linkage chamber located between the two sliding parts, and the two sliding parts are linked with each other by the medium pressure in the linkage chamber.
- the two sliding members linked by the medium pressure can release the constraints of the physical size of the connecting member 432, thereby making the arrangement more flexible. More importantly, the media pressure can be flexibly adjusted during the treatment process, which brings more abundant usage methods.
- the wall of the linkage chamber is provided with a fourth pressure adjustment hole 451 that communicates with the linkage chamber; the wall of the cylinder chamber with a smaller cylinder diameter is provided with a fifth pressure adjustment hole 452 that communicates with the output port 42 .
- the fourth pressure adjusting hole 451 can adjust the pressure of the medium in the linkage chamber, thereby changing the linkage relationship between the two sliding parts. For example, when the medium pressure in the linkage room is higher, the linkage relationship between the two sliding parts is closer to the rigid transmission. In scenarios such as rapid changes in blood pressure or a larger range, the pressurizing mechanism 4 has a better dynamic response performance; For another example, when the medium pressure in the linkage chamber is low, the linkage relationship between the two sliding parts is closer to that of flexible transmission. Part of the movement energy of the two sliding parts is absorbed by the medium in the linkage chamber, thereby providing a more flexible booster mechanism 4 The effect of the work.
- the fifth pressure adjustment hole 452 is more direct than the fourth pressure adjustment hole 451, and can directly adjust the pressure of the output port 42, thereby directly adjusting the working result of the pressure boosting mechanism 4 through an external pressure source, and the hemostasis valve provides more abundant Of adjustment options.
- the pressure regulating hole can also be provided on the pressure-increasing mechanism 4 linked by the connecting member 432.
- the pressurizing mechanism 4 includes a support body 40. Two cylinder chambers with different cylinder diameters are arranged inside the support body 40, and sliding parts are installed in each cylinder chamber in a sealed sliding manner, and the sliding parts in the two cylinder chambers are linked with each other;
- the input port 41 is connected to the first cylinder chamber 401 with a larger cylinder diameter; the output port 42 is connected to the second cylinder chamber 402 with a smaller cylinder diameter;
- the two cylinder chambers are isolated from each other, the two sliding parts are directly connected by a connecting piece 432, and the two ends of the connecting piece 432 are sealed through each cylinder chamber and connected to the corresponding sliding parts.
- the walls of the second cylinder chamber 402 are respectively provided with:
- the sixth pressure regulating hole 453 is connected to one side of the sliding member in the second cylinder chamber 402; the seventh pressure regulating hole 454 is connected to the other side of the sliding member in the second cylinder chamber 402, and the output port 42 is also connected to The side.
- the sixth pressure adjustment hole 453 adjusts the pressure of the input port 41
- the seventh pressure adjustment hole 454 adjusts the pressure of the output port 42, which can bring more adjustment options.
- the fourth pressure adjustment hole 451, the fifth pressure adjustment hole 452, the sixth pressure adjustment hole 453, and the seventh pressure adjustment hole 454 themselves are also interfaces, which can provide a structural basis for special operations in special usage scenarios.
- each pressure regulating hole is connected with a regulating valve; each regulating valve is directly installed in the corresponding pressure regulating hole or connected to the corresponding pressure regulating hole through an external pipeline.
- the flexible setting of the regulating valve can be adjusted according to the needs of different cases.
- the design that the regulating valve is directly installed in the pressure regulating hole can improve the integration of the hemostatic valve and facilitate the operation of medical personnel and other operators; for example, the design of the regulating valve connected to the pressure regulating hole through an external pipeline can further reduce the hemostatic valve External dimensions provide adaptability.
- a balance chamber 31 is further provided in the housing 1, and the driving chamber 12 and the balance chamber 31 are in communication with each other;
- the output port 42 of the pressurizing mechanism 4 is in communication with the driving chamber 12 and/or the balance chamber 31.
- the balance chamber 31 is a division of a functional area.
- the balance chamber 31 and the drive chamber 12 can be independent of each other and communicate with each other only through pipelines, or they can share a solid cavity with different functions.
- the hemostatic valve further includes an energy storage mechanism 3 that can be linked with fluid.
- the energy storage mechanism 3 stores or releases energy correspondingly when the state of the sealing membrane 2 changes. Drive the sealing membrane 2 to close the instrument channel 11;
- the fluid in the driving chamber 12 is linked with the energy storage mechanism 3 via the balance chamber 31;
- the output of the booster mechanism 4 directly acts on the energy storage mechanism 3, or the output port 42 of the booster mechanism 4 communicates with the drive chamber 12 and/or the balance chamber 31.
- the sealing membrane 2 When the interventional instrument 9 enters the hemostatic valve, the sealing membrane 2 needs to open the instrument channel 11 to avoid interference with the interventional instrument 9. Therefore, the sealing film 2 will perform work on the fluid in the driving chamber 12. If the preset pressure of the fluid in the driving chamber 12 is too high, the driving force required for the deformation of the sealing membrane 2 is too high, and the interventional device 9 needs a relatively large driving force to squeeze the sealing membrane 2 to open the instrument channel 11. It will affect the use of medical personnel and other operators; if the preset pressure of the fluid in the drive chamber 12 is too low, the sealing membrane 2 will have insufficient sealing pressure when the instrument channel 11 is closed, which is likely to cause sealing failure.
- the energy storage mechanism 3 in this embodiment can well overcome the above-mentioned problems.
- the sealing membrane 2 needs to open the instrument channel 11 to avoid interference with the interventional instrument 9.
- the sealing film 2 will perform work on the fluid in the drive chamber 12, and the energy storage mechanism 3 can store energy to absorb the energy of the fluid to reduce the difficulty of entering the interventional device 9 and provide a good hand feeling for the entry process of the device;
- the sealing film 2 needs to close the instrument channel 11 to function as a hemostatic valve.
- the fluid in the driving chamber 12 will perform work on the sealing film 2, and at the same time, the energy storage mechanism 3 can release energy to perform work on the fluid, thereby ensuring the sealing effect of the sealing film 2 on the instrument channel 11.
- the pressurization mechanism 4 cooperates with the energy storage mechanism 3 to further take into account the sealing effect of the instrument channel 11 and the feel of use when the interventional instrument 9 enters the hemostatic valve.
- the energy storage mechanism 3 includes an elastic bladder 35 placed in the balance chamber 31;
- the output port 42 of the pressurizing mechanism 4 communicates with the balance chamber 31.
- the elastic bladder 35 can realize energy storage or release, and improve the energy storage or release of the energy storage technology.
- the output port 42 of the pressurizing mechanism 4 is in communication with the balance chamber 31. In the process of discharging energy, in addition to the elasticity of the sealing membrane 2 itself, the elastic bladder 35 and the pressurizing mechanism 4 can work together to supplement the energy of the fluid.
- the output port 42 of the pressurizing mechanism 4 can also be arranged in other ways.
- the energy storage mechanism 3 includes an elastic bladder 35 placed in the balance chamber 31; the output port 42 of the pressurizing mechanism 4 is in communication with the elastic bladder 35.
- the elastic bladder 35 can buffer the energy released by the pressurization mechanism 4, thereby providing a smoother performance for fluid pressure changes and improving the overall working effect of the hemostatic valve.
- the energy storage mechanism 3 can also be configured in other ways.
- the energy storage mechanism 3 includes:
- the energy storage chamber 33 connected with the balance chamber 31;
- a piston 34 that seals sliding between the balance chamber 31 and the energy storage chamber 33;
- the compressible gas and/or elastic member located in the energy storage chamber 33 and interacting with the piston 34;
- the output port 42 of the boosting mechanism 4 communicates with the energy storage chamber 33.
- the supercharging mechanism 4 actually shares the structure of the components of the energy storage mechanism 3, the linkage chamber functions as the energy storage chamber 33, and the second cylinder chamber 402 functions as the balance chamber 31.
- the position change of the piston 34 realizes the energy storage or discharge of the energy storage mechanism 3.
- the energy is absorbed by the compressible gas and/or the elastic member, and during the energy release process, the compressible gas and/or the elastic member perform work to realize the energy release.
- the energy storage chamber 33 is a functional expression of the energy storage mechanism 3 during the energy storage process.
- the energy storage chamber 33 is actually a function of discharging energy.
- the output port 42 of the pressurizing mechanism 4 is in communication with the energy storage chamber 33. During the process of discharging energy, the energy output by the pressurizing mechanism 4 is released through the piston 34.
- the piston 34 can buffer the energy released by the pressurizing mechanism 4, thereby providing a smoother performance for the pressure change of the fluid, and improving the overall working effect of the hemostatic valve.
- the output port 42 of the booster mechanism 4 also has other settings,
- the energy storage mechanism 3 includes:
- the energy storage chamber 33 connected with the balance chamber 31;
- a piston 34 that seals sliding between the balance chamber 31 and the energy storage chamber 33;
- the compressible gas and/or elastic member located in the energy storage chamber 33 and interacting with the piston 34;
- the output port 42 of the pressurizing mechanism 4 communicates with the balance chamber 31.
- the output port 42 of the pressurizing mechanism 4 is in communication with the balance chamber 31.
- the elastic bladder 35 and the pressurizing mechanism 4 can work together to supplement the energy of the fluid.
- the output effect of the supercharging mechanism 4 is more direct, which is more suitable in some products that require better dynamic performance.
- the hemostatic valve further includes a blood pressure indicating device (not shown) connected to the input port 41.
- Blood pressure is an important indicator in the treatment process. Compared with monitoring equipment with separate sensors and output devices, the blood pressure indicating device implemented by the pressurizing mechanism 4 has a simple structure, is stable and easy to read, and is easy to implement.
- the blood pressure indicating device is a separately configured blood pressure meter or integrated into the pressure increasing mechanism 4.
- the pressurizing mechanism 4 has at least blood pressure-related moving parts, and the pressurizing mechanism 4 is provided with a blood pressure indicator, and the blood pressure indicator is related to the position of the moving part.
- the pressurizing mechanism 4 includes a support body 40. Two cylinder chambers with different cylinder diameters are arranged inside the support body 40, and sliding parts are installed in each cylinder chamber in a sealed sliding manner, and the sliding parts in the two cylinder chambers are linked with each other;
- the input port 41 is connected to the first cylinder chamber 401 with a larger cylinder diameter; the output port 42 is connected to the second cylinder chamber 402 with a smaller cylinder diameter;
- the moving parts are sliding parts in the first cylinder chamber 401 and/or sliding parts in the second cylinder chamber 402.
- the present application also discloses a catheter sheath, which includes a sheath 91 and a hemostatic valve that are connected to each other, and the hemostatic valve is one of the above technical solutions.
- the sheath 91 intervenes with the inside of the human body, the hemostatic valve closes the sheath, and the interventional device 9 enters the sheath 91 through the hemostatic valve, thereby entering the inside of the human body to implement the treatment process.
- the hemostasis valve is provided with a pipe joint connected with the sheath tube 91, the pipe joint is matched with the sheath tube 91 through a seal, and the pipe joint is provided with an engaging structure that prevents the sheath tube 91 from being separated from the pipe joint.
- the pipe joint is formed by extending the second end cover 15.
- the head of the sheath tube 91 is provided with a developing point, which is convenient for medical staff to better complete the operation process with the help of medical equipment.
- the butt-connected sheath tube 91 and the hemostatic valve cooperate to form the instrument channel 11, wherein the sheath tube 91 can be integrated with the end caps on both sides or arranged separately.
- Each end cap extends away from the hemostatic valve, thereby extending in the axial direction of the instrument channel 11, and further wraps and protects the instrument channel 11 for the interventional instrument 9 to pass through.
- This application also discloses a method for sealing an interventional instrument, including the use of a deformable sealing film to construct an instrument channel, and the outer periphery of the sealing membrane is deformed by a fluid to drive the sealing membrane to seal the instrument channel. It is characterized in that when the interventional instrument enters and exits the instrument channel In the process, the energy storage mechanism linked with the fluid is used to store or release energy correspondingly when the sealing film is deformed, so as to maintain the seal between the interventional device and the device channel.
- the interventional device sealing method is implemented according to the hemostatic valve in the above technical solution.
- the specific structure of the hemostatic valve please refer to the description of the hemostatic valve above, which will not be repeated here.
- the externally balanced hemostatic valve includes a housing 100 and a sealing membrane 130 mounted in the housing 100 and having a tubular structure.
- the inner cavity of the tubular structure is used as an instrument channel 131, and the housing is provided with a In the driving chamber 150 on the periphery of the sealing membrane, a balance hole 151 communicating with the driving chamber is opened on the housing, and an elastic bladder 140 communicating with the balancing hole 151 is provided on the outside of the housing 100, and the elastic bladder 140 adapts to the driving chamber through deformation
- the pressure change in 150 causes the sealing membrane 130 to close or open the instrument channel 131.
- the instrument channel 131 is a channel through which the interventional instrument 160 (such as a catheter, a guide wire, etc.) enters and exits the human body during the interventional treatment. Therefore, it can be understood that the area surrounded by the tubular structure is at least a part of the instrument channel 131.
- the sealing film 130 is made of a non-elastomeric material, such as expanded polytetrafluoroethylene (EPTFE).
- EPTFE expanded polytetrafluoroethylene
- a balance medium such as fluid or hydrogel is injected into the driving chamber 150 through the elastic bladder 140 and the balance hole 151.
- physiological saline can be used as the fluid.
- the hemostatic valve after the balancing medium is injected into the driving chamber 150 is shown in FIG. 14.
- the balancing medium fills the elastic bladder 140, and transmits the pressure generated by the contraction of the elastic bladder 140 into the driving chamber 150, so that the sealing film 130 is close to the interventional instrument and prevents The blood passes through the hemostatic valve.
- the structure when the interventional instrument 160 is inserted into the hemostasis valve is shown in FIG. 15.
- the interventional instrument 160 squeezes the sealing film 130 outward along the radial direction of the sealing film 130, so that the volume of the driving chamber 150 is reduced, and the excess balance medium in the driving chamber 150 It flows into the elastic bladder 140 through the balance hole 151, and the volume of the elastic bladder 140 expands and stores elastic potential energy.
- the balance medium drives the pressure of the sealing membrane 130 to the outer periphery of the interventional instrument 160.
- the elastic bladder 140 generates pressure on the balancing medium through elastic contraction. The two pressures inside and outside the housing are balanced by the balance medium flowing through the balance hole 151.
- the elastic bladder 140 squeezes the balancing medium in the elastic bladder 140 through elastic contraction, so that the balancing medium flows back into the driving chamber 150, and the volume of the elastic bladder 140 is reduced accordingly, and the driving chamber 150 The volume increases accordingly.
- the elastic bladder 140 does not completely return to the natural state as shown in FIG. 13, but maintains a certain elastic deformation and contraction pressure, so that the sealing film 130 always maintains the pressing force on the outer periphery of the interventional instrument 160. The sealing of the instrument channel 131 is maintained.
- the hemostatic valve relies on the elastic potential energy stored in the elastic bladder 140 to return to the initial state as shown in FIG. 14, and the inner surfaces of the sealing membrane 130 are tightly attached to each other to prevent blood from passing through the hemostatic valve.
- a capsule is provided outside the housing, and the pressure balance between the inside and outside of the housing is maintained through the balance medium and the balance hole, and there is no need to connect a special pressure regulating device outside the hemostatic valve, the volume is small, and the carrying and operation are more convenient.
- the housing has a rigid cylindrical structure and is sleeved on the outer periphery of the sealing film.
- the axial ends of the sealing film are in a sealed connection with the housing, and the axial middle part of the sealing film is connected to the housing.
- a drive chamber is enclosed between the inner walls of the body.
- the casing made of rigid material has a better protective effect on the sealing film 130, and can also prevent the casing from being squeezed and deformed by the human body or foreign objects from causing fluctuations in the pressure of the balanced medium in the driving chamber 150.
- the housing includes a supporting portion 110 and two end covers 120.
- the balance hole 151 penetrates the side wall of the support part 110; the two end caps are respectively butted on the axial ends of the support part, and each end cap is provided with an escape hole 121 corresponding to the position of the instrument channel.
- the end cover 120 and the supporting portion 110 adopt an integrated structure or a detachable connection, and the integrated structure has better sealing performance and high safety.
- the detachable connection structure facilitates the assembling of the sealing film 130 and the capsule in the housing, and the cost is lower.
- the position of the balance hole 151 is adjacent to the entrance of the instrument channel 131.
- the balance hole 151 can be extended as far as possible in the radial direction, reducing the difficulty of product processing, and leaving a larger holding space outside the housing to avoid fingers during operation Touch the elastic bladder 140 by mistake.
- the axial ends of the sealing film are connected to the housing in at least one of the following ways: bonding and fixing with the support part 110; bonding and fixing with the end cover 120 on the corresponding side; Clamped and fixed between the supporting part 110 and the end cap 120 on the corresponding side; embedded in the supporting part and sealed and fixed by the plugging member; embedded in the end cap of the corresponding side and sealed and fixed by the plugging member; embedded in the support The part and the end cap on the corresponding side are sealed and fixed by a stuffing piece.
- the end cover 120 Adopting the fixing method of bonding with the supporting part 110, the end cover 120 can be installed without touching the sealing film 130, and the sealing film 130 is not easily damaged.
- the sealing film 130 and the end cap 120 are bonded and fixed, which makes it easier to ensure the sealing performance of the outer periphery of the instrument channel 131.
- By clamping and fixing between the supporting part and the end cap on the corresponding side it is easy to install the sealing film 130 and the capsule body, and better sealing performance can be obtained between the sealing film 130 and the end cap 120.
- an embedding groove may be provided on the support portion 110 or the end cover 120, and the peripheries at both ends of the sealing film 130 may be sealed by the plugs embedded in the embedding groove.
- the elastic bladder 140 includes a bladder body 141, a first joint 142 and a second joint 143.
- the bladder 141 is made of elastic material and has a hollow structure; the first joint 142 is connected to the bladder 141 and communicates with the balance hole 151.
- the second joint 143 is connected to the bladder 141 and is used to infuse the balance medium that can flow between the elastic bladder 140 and the driving chamber 150.
- the first connector 142 is inserted into the balance hole 151 first, and then the balance medium is filled into the capsule 141 through the second connector 143 and the opening at the upper end of the second connector 143 is closed.
- the first joint 142 and the second joint 143 are located on two opposite sides of the capsule 141, which makes it easier to fill the capsule 141 with a balancing medium and reduce air mixing.
- the first joint 142 and the second joint 143 are integrated with the capsule body, which has better sealing performance, and the balancing medium is not easy to leak.
- the first joint 142 and the second joint 143 are separated from the capsule body.
- the two ends of the capsule body 141 form a tubular constricted portion, and the first joint 142 and the second joint 143 are compared with each other.
- the bag body 141 is made of a material with higher rigidity and is inserted into the corresponding constricted portion to ensure the sealing performance between the first joint 142 and the balance hole 151.
- a sealing plug is installed at the opening of the second joint 143. After the capsule 141 is filled with a balancing medium, a sealing plug is used to seal the injection port at the second joint 143.
- the second joint is connected with a control valve (not shown in the figure).
- the control valve can be a complete valve body structure or a corresponding adapting structure, such as a Luer connector.
- the present application also provides a catheter sheath.
- the catheter sheath includes a sheath 170 and a hemostatic valve connected to each other.
- the hemostatic valve is the externally balanced hemostatic valve in the above embodiment.
- the sheath can be extended into the body at the pre-puncture site, and the hemostatic valve of the present application can be used to prevent blood from flowing out through the device channel during the in and out of the interventional device.
- one end of the tube can be covered with an integral or separate tube connector 122, and the sheath tube 170 is sleeved and fixed on the tube connector 122.
- the internally balanced hemostatic valve includes a housing 100 and a sealing film 130 mounted in the housing 100 and having a tubular structure.
- the inner cavity of the tubular structure serves as the instrument channel 131 And it penetrates the housing.
- the housing 100 is provided with a driving chamber surrounding the sealing film.
- In the driving chamber there is a capsule 144 that interacts with the sealing film 130.
- the capsule 144 is matched with the sealing film 130 to close or open. Instrument channel.
- the instrument channel 131 is a channel through which the interventional instrument 160 enters and exits the human body during the interventional treatment. Therefore, it can be understood that the area surrounded by the tubular structure is at least a part of the instrument channel 131.
- corresponding inlets and outlets connected to the instrument channel 3 are opened on the housing 1, which can also be regarded as the instrument channel 3 passing through the housing 1.
- the sealing film 130 is at least partially squeezed by the capsule 144 to close the instrument channel 131.
- the balloon 144 When an interventional instrument passes through the hemostatic valve, the balloon 144 is deformed or moved by being squeezed by the outer periphery of the interventional instrument 160, and the inner hole of the sealing film 130 becomes larger, thereby opening the instrument channel 131.
- the capsule 144 may adopt a solid structure or a hollow structure.
- an elastic material such as silica gel can be used.
- the capsule 144 deforms and stores the elastic potential energy.
- the capsule 144 releases energy and Restore the initial state.
- the capsule 144 When the capsule 144 adopts a hollow structure, the capsule 144 can be made of elastic material, and the capsule 144 is filled with fluid or hydrogel or other water-absorbing swelling materials. In order to improve safety, the fluid can be physiological saline.
- the capsule 144 deforms and stores elastic potential energy. After the interventional device 160 passes through the hemostatic valve, the elastic potential energy stored in the balloon 144 is released, and the sealing film 130 is deformed to shrink the inner hole and close the device channel.
- the balloon 144 always maintains pressure on the sealing membrane 130, so as to ensure that at least one section of the sealing membrane 130 is tightly attached to the outer periphery of the interventional instrument 160 in the length direction of the instrument channel to prevent blood from flowing out. .
- the balloon 144 is disposed inside the housing 100, there is no need to connect a special pressure regulating device outside the hemostatic valve, the volume is small, and the carrying and operation are more convenient.
- the balloon has an inflated state maintained by its own elasticity and/or by a filler.
- the balloon in the inflated state squeezes the sealing membrane to close the instrument channel; when the interventional instrument 160 passes through the instrument channel, the balloon
- the body has a concession state achieved by its own deformation and/or displacement, and the capsule body in the concession state allows the sealing membrane to deform to open the instrument channel.
- the number of the balloon 144 is one, and it goes around the instrument channel at least once.
- the number of capsules is multiple, and the capsules are distributed around the instrument channel on the periphery of the sealing membrane, and the distribution method is uniform or non-uniform in the circumferential direction. Distribution, the shape of each capsule is the same or different.
- each capsule cooperates with the corresponding part of the sealing film to seal a part of the outer circumference of the interventional instrument 160, which can effectively reduce the formation of wrinkles and improve the sealing effect.
- the number of capsules is 2, 3, or 4.
- the capsule 144 is a deformed part 145 at least in the middle of the capsule 144, and the positions of the deformed parts of the capsules act together on the sealing film 130.
- the closing and opening of the instrument channel 131 is realized by the deformation of the sealing film 130. Therefore, the sealing film 130 needs to be made of deformable materials, such as soft and foldable.
- the sealing film 130 is made of a non-elastomeric material. Minimize the elastic deformation.
- the sealing film 130 uses expanded polytetrafluoroethylene (EPTFE). Further, in one embodiment, the thickness of the sealing film 130 is 0.1-0.3 mm.
- EPTFE expanded polytetrafluoroethylene
- the capsule 144 is made of elastomer material, such as rubber.
- the casing 100 has a rigid cylindrical structure and is sleeved on the outer circumference of the sealing film 130.
- the axial ends of the sealing film 130 are in a sealed connection with the casing 100.
- the driving chamber is enclosed between the axial middle part of the sealing film 130 and the inner wall of the housing 100.
- the cylindrical structure does not strictly limit the cross-sectional shape, for example, a circle or an ellipse can be used.
- the cross-sectional area of each part of the housing can be changed appropriately to match the shape change of the capsule 144
- the housing 100 has at least two openings and surrounds the outer periphery of the sealing film 130.
- the housing 100 includes a supporting portion 110 and two end covers 120.
- the instrument channel 131 penetrates the support part 110.
- the two end caps 120 are respectively butted to the two axial ends of the supporting portion 110, and each end cap 120 is provided with an escape hole 121 corresponding to the position of the instrument channel.
- the end cover 120 and the supporting portion 110 adopt an integrated structure or a detachable connection, and the integrated structure has better sealing performance and high safety.
- the detachable connection structure facilitates the assembly of the sealing film 130 and the capsule body 144 in the housing, and the cost is lower.
- the axial ends of the sealing film 130 are connected to the housing 100 in at least one of the following ways: bonding and fixing with the support part 110; bonding and fixing with the end cover of the corresponding side; clamping It is fixed between the support part and the end cover of the corresponding side; is embedded in the support part; is embedded in the end cover of the corresponding side; and is embedded between the support part and the end cover of the corresponding side.
- the end cover 120 Adopting the method of bonding and fixing with the supporting portion 110, the end cover 120 can be installed without touching the sealing film 130, and the sealing film 130 is not easily damaged.
- the sealing film 130 and the end cap 120 are bonded and fixed, which makes it easier to ensure the sealability of the outer periphery of the instrument channel 131.
- By clamping and fixing between the supporting part and the end cap on the corresponding side it is easy to install the sealing film 130 and the capsule 144, and better sealing performance can be obtained between the sealing film 130 and the end cap 120.
- an embedding groove can also be provided on the supporting portion 110 or the end cover 120, and the two ends of the sealing film 130 can be embedded into the supporting portion 110 by using a molding strip or an embedding ring that matches with the embedding groove. Or end cap 120.
- the supporting portion 110 includes a spherical shell-shaped middle section 111 and a diameter-reducing section 112 connected to both sides of the middle section.
- the two end caps 120 are respectively inserted and fixed to the corresponding-side diameter-reducing section 112, and the driving chamber is located in The interior of the middle section.
- the opposite ends of the hemostatic valve swell and form a driving chamber, which provides an accommodation space for the balloon 144. It is more convenient to install the end cap 120 by plugging.
- one end of the sealing film 130 can be sleeved on the outer ring of one of the end caps 120.
- the sealing film 130 extends into the inner hole of the reduced diameter section 112, and the other end cover is inserted into the sealing film 130, so that the sealing film 130 is sandwiched between the reduced diameter section 112 and the end cover 120.
- bolts or screws may be further arranged between the end cover 120 and the reduced diameter section 112.
- the diameter-reducing section 112 and the end cap 120 may also be screwed together.
- two ends of the sealing film 130 are fixed to the supporting portion 110, and the end cap 120 is connected to the diameter-reducing section 112 in a threaded manner.
- the housing 100 and/or each end cover is provided with positioning grooves, the capsule body extends along the length direction of the instrument channel, and the two ends of the capsule body are respectively inserted and fixed in the corresponding side positioning grooves.
- the positioning groove is opened on the inner wall of the housing 100.
- the support part or at least one end cover is provided with an injection channel 152
- at least one end of the capsule is an open structure and is connected to the injection channel 152
- the support part or at least one end cover is provided with an injection port communicating with the injection channel 152 153.
- the inner cavity of the balloon 144 is communicated to the outside of the housing 100 through the injection channel 152 and the injection port 153.
- gas or liquid can be directly injected into or sucked out of the balloon 144 through the injection channel 152 and the injection port 153.
- the injection port 153 is equipped with a sealing plug, or the injection port is sealed with a connecting tube 154, and a control valve (not shown in the figure) is installed on the connecting tube 154.
- the control valve can be a complete valve body structure or a corresponding adapting structure, such as a Luer connector.
- the present application also discloses a multi-cavity hemostatic valve, including a housing 1 and a sealing membrane 2 mounted in the housing 1 and having a tubular structure.
- the inner cavity 21 of the tubular structure is used as an instrument channel 11.
- the housing 1 is provided with a drive chamber 12 on the periphery of the sealing membrane 2 for filling fluid and a balance chamber 31 located outside the drive chamber 12, between the drive chamber 12 and the balance chamber 31 Communicate with each other and the balance chamber 31 surrounds the outer circumference of the driving chamber 12;
- the hemostatic valve also includes an energy storage mechanism 3 that can be linked with fluid.
- the fluid in the drive chamber 12 is linked with the energy storage mechanism 3 through the balance chamber 31; the energy storage mechanism 3 stores or releases energy correspondingly when the state of the sealing membrane 2 changes. , And when the energy is released, the sealing film 2 is forced to seal the instrument channel 11.
- the balance chamber 31 surrounds the outer periphery of the driving chamber 12 and can provide fluid for driving the movement of the sealing membrane 2 to the driving chamber 12 from multiple directions, thereby realizing the sealing of the instrument channel 11.
- the fluid power in the balance chamber 31 is provided by the energy storage mechanism 3, so during the assembly process, energy can be input to the energy storage mechanism 3 in advance to improve the adaptability of the hemostatic valve to interventional instruments 9 with different outer diameters.
- the present application also discloses a multi-cavity hemostatic valve, including a housing 1 and a sealing membrane 2 mounted in the housing 1 and having a tubular structure.
- the inner cavity 21 of the tubular structure is used as an instrument channel.
- the housing 1 is provided with a drive chamber 12 on the periphery of the sealing membrane 2 for filling fluid and a balance chamber 31 located outside the drive chamber 12, between the drive chamber 12 and the balance chamber 31 Communicate with each other and the balance chamber 31 surrounds the outer circumference of the driving chamber 12;
- the hemostatic valve also includes an energy storage mechanism 3 that can be linked with fluid.
- the fluid in the drive chamber 12 is linked with the energy storage mechanism 3 through the balance chamber 31; the energy storage mechanism 3 stores or releases energy correspondingly when the state of the sealing membrane 2 changes. , And when the energy is released, the sealing film 2 is forced to seal the instrument channel 11.
- the balance chamber 31 surrounds the outer periphery of the driving chamber 12 and can provide fluid for driving the movement of the sealing membrane 2 to the driving chamber 12 from multiple directions, thereby realizing the sealing of the instrument channel 11.
- each balance chamber 31 communicates with the drive chamber 12 through an independent balance hole 311 or at least two balance chambers 31 share the same balance hole 311 to communicate with the drive chamber 12, and further, each balance chamber 31 It communicates with the driving chamber 12 through the same balance hole 311.
- the number of balance chambers 31 is 2 to 8.
- the energy storage mechanism 3 includes: an energy storage chamber 33; the housing 1 is also provided with a balance chamber 31, and the drive chamber 12 and the balance chamber 31 communicate with each other; a piston 34 that seals and slides in the balance chamber 31 and the energy storage chamber 33; the energy storage element, the energy storage element is a compressible gas and/or elastic member 341 located in the energy storage chamber 33 and interacting with the piston 34; the housing 1 is provided with at least two The cylindrical space in which the piston 34 slides is divided into a balance chamber 31 and an energy storage chamber 33 by the piston 34.
- each piston 34 is sealed to fit with the inner wall of the corresponding cylindrical space through the sealing edge of its outer edge.
- the sealing edge and the inner wall of the cylindrical space are at least two Road seal.
- the housing 1 is provided with at least two cylindrical spaces for the piston 34 to slide, and each cylindrical space is provided with independent energy storage elements, and the energy storage performance of each energy storage element is consistent or inconsistent.
- the number of balance chambers 31 is preferably three, and each balance chamber 31 is evenly spaced on the outer periphery of the driving chamber 12, and is connected to the driving chamber 12 by independent balancing holes 311, respectively.
- Each balance chamber 31 is equipped with an energy storage mechanism 3, which includes: an energy storage chamber 33; a balance chamber 31 is also provided in the housing 1, and the drive chamber 12 and the balance chamber 31 communicate with each other; a piston 34, a seal Sliding between the balance chamber 31 and the energy storage chamber 33; the energy storage element, the energy storage element is a compressible gas and/or elastic member 341 located in the energy storage chamber 33 and interacting with the piston 34; each piston 34 passes through itself
- the sealing edge of the outer edge is in a sealing fit with the inner wall of the corresponding cylindrical space. In the sliding direction of the piston 34, at least two seals are provided between the sealing edge and the inner wall of the cylindrical space, and a seal is provided between the two seals of the sealing edge. gap.
- the increase in the number of the balance chamber 31 can provide a more uniform and detailed driving effect of the sealing film 2, but if the number is too large, the processing difficulty of the housing 1 will increase; and in the same volume Under the housing 1, the side walls between the adjacent balance chambers 31 will become thinner, which will bring corresponding hidden dangers. Therefore, the number of the balance chambers 31 is preferably 2-8.
- the evenly spaced arrangement of the balance chamber 31 on the outer periphery of the drive chamber 12 can bring a good look and feel, and can also provide a relatively stable force for all directions of the instrument channel 11.
- the balance chamber 31 is also It may be arranged on the outer circumference of the driving chamber 12 at uneven intervals, so as to provide uneven driving force to achieve special effects.
- each balance chamber 31 communicates with the drive chamber 12 through an independent balance hole 311.
- the advantage of this design is that it can avoid the mutual interference between the balance chambers 31 and the working process, and can provide a more detailed adjustment effect.
- each balance chamber 31 can also share a balance hole 311 to communicate with the drive chamber 12.
- the advantage of this design is that it can synchronize the working processes of different balance chambers 31. The specific design can be based on different working conditions and The design needs to be adjusted.
- the piston 34 is the main work component, and the energy storage element is an elastic member 341 in this embodiment, and the two ends respectively press against the piston 34 and the third end cover 332 to realize energy storage and release. . Therefore, the piston 34 needs to be able to ensure a good seal with the cylindrical space to avoid pressure leakage of the fluid. In this embodiment, this is achieved by the two sealing edges of the piston 34 itself. At the same time, in order to avoid the resistance caused by the excessive sealing contact area, a sealing gap is also provided between the sealing edges. The sealing gap can also release the deformation of the sealing edge, thereby improving the sealing effect.
- the diameter and length of each cylindrical space are the same, and the elastic coefficient of the elastic member 341 is the same, so as to obtain a more balanced fluid driving effect.
- the diameter and length of each cylindrical space may be different, and the elastic coefficient of the elastic member 341 may also be different, so that it can be flexibly adjusted according to different working conditions and design requirements.
- the energy storage element is a compressible gas
- the physical and chemical indexes of the compressible gas can also be adjusted.
- the preset working pressure and the preset working temperature of the compressible gas can be changed accordingly.
- the operation can be performed in the following manner: inject a certain amount of liquid from the first pressure regulating hole 32 to move the piston 34 slightly to the left to maintain stability. At this time, the balance chamber 31 and the energy storage chamber 33 The pressure is balanced, and the sealing membrane 2 is squeezed by the liquid in the driving chamber 12 and tightly pressed to seal the instrument channel 11;
- the instrument enters the body from the middle of the sealing film 2 and is tightly wrapped by the sealing film 2, and the blood is always blocked by the sealing film 2 in the body.
- the pressure of the driving chamber 12 increases due to the decrease in volume, so that the piston 34 is pushed to the left by the liquid, the elastic member 341 is compressed and stored energy, the internal pressure reaches a new balance, and it can still be sealed.
- the elastic member 341 releases energy and pushes the piston 34 to move to the right. Back to the initial state.
- the sealing film 2 is always squeezed and continuously sealed.
- the present application also discloses a multi-cavity hemostatic valve, including a housing 1 and a sealing membrane 2 mounted in the housing 1 and having a tubular structure.
- the inner cavity 21 of the tubular structure is used as an instrument channel 11.
- the housing 1 is provided with a drive chamber 12 on the periphery of the sealing film 2 for filling fluid and a balance chamber 31 located outside the drive chamber 12, between the drive chamber 12 and the balance chamber 31 Communicate with each other and the balance chamber 31 surrounds the outer circumference of the driving chamber 12;
- the hemostatic valve also includes an energy storage mechanism 3 that can be linked with fluid.
- the fluid in the drive chamber 12 is linked with the energy storage mechanism 3 through the balance chamber 31; the energy storage mechanism 3 stores or releases energy correspondingly when the state of the sealing membrane 2 changes. , And when the energy is released, the sealing film 2 is forced to seal the instrument channel 11.
- the number of balance chambers 31 is preferably six. Regardless of the product volume, production process and other conditions, theoretically, the greater the number of balance chambers 31, the better. According to the volume of the drive chamber 12 and the balance chamber 31 of the current product, and from structural design, spring selection to mass production, considering function and cost, the optimal number of cavities is currently 5-6.
- the main difference in this embodiment lies in the number of balance chambers 31.
- Six balance chambers 31 can achieve better instrument compatibility, and the resistance performance of the instrument when passing through is less than the balance chamber 31 embodiment.
- the present application also discloses a multi-cavity hemostatic valve, including a housing 1 and a sealing membrane 2 installed in the housing 1 and having a tubular structure.
- the inner cavity 21 of the tubular structure is used as an instrument channel 11.
- the housing 1 is provided with a drive chamber 12 on the periphery of the sealing film 2 for filling fluid and a balance chamber 31 located outside the drive chamber 12, between the drive chamber 12 and the balance chamber 31 Communicate with each other and the balance chamber 31 surrounds the outer circumference of the driving chamber 12;
- the hemostatic valve also includes an energy storage mechanism 3 that can be linked with fluid.
- the fluid in the drive chamber 12 is linked with the energy storage mechanism 3 through the balance chamber 31; the energy storage mechanism 3 stores or releases energy correspondingly when the state of the sealing membrane 2 changes. , And when the energy is released, the sealing film 2 is forced to seal the instrument channel 11.
- the energy storage element includes an elastic member 341 and compressible gas.
- the housing 1 is an entity with a plurality of cylindrical spaces, an instrument channel 11 in the middle, and the cylindrical space around the instrument channel 11 is used to install a plurality of pistons 34 to form an energy storage chamber 33 and a balance chamber 31, wherein the balance
- the chamber 31 is connected to the driving chamber 12, and each energy storage chamber 33 has a built-in spring, and the energy storage chamber 33 has a second pressure adjustment hole 331.
- the second pressure adjustment hole 331 is used to inject gas in this embodiment.
- the housing 1 is connected to the second end cover 15, and a sealing element is built in for sealing.
- the second end cover 15 is provided with a first pressure regulating hole 32; the second end cover 15 and the first end cover 14 seal the membrane 2 Fixed and sealed on the housing 1.
- the exhaust hole 16 is in communication with the blood, and is used to exhaust the gas in the instrument channel 11.
- this embodiment adds gas as a compressed medium to facilitate the adjustment of the resistance of instruments with different diameters, and is more flexible.
- the energy storage chamber 33, The balance chamber 31 and related components have high requirements on the tightness, and the process is relatively complicated.
- each balance chamber 31 can actually be communicated with each other through the drive chamber 12, that is, the sealing membrane 2 is a whole, and the drive chamber 12 is arranged around the sealing membrane 2 and is connected to each balance chamber. 31 Unicom.
- the sealing film 2 may not be a whole, and multiple sealing films 2 are combined together to achieve the closure of the instrument channel 11; in this implementation, the driving chambers 12 between different sealing films 2 may not be connected, correspondingly , The balance chamber 31 between the different driving chambers 12 is also not connected.
- the present application also discloses a multi-cavity hemostatic valve, including a housing 1 and a sealing membrane 2 mounted in the housing 1 and having a tubular structure.
- the inner cavity 21 of the tubular structure is used as an instrument channel 11.
- the housing 1 is provided with a drive chamber 12 on the periphery of the sealing film 2 for filling fluid and a balance chamber 31 located outside the drive chamber 12, between the drive chamber 12 and the balance chamber 31 Communicate with each other and the balance chamber 31 surrounds the outer circumference of the driving chamber 12;
- the hemostatic valve also includes an energy storage mechanism 3 that can be linked with fluid.
- the fluid in the drive chamber 12 is linked with the energy storage mechanism 3 through the balance chamber 31; the energy storage mechanism 3 stores or releases energy correspondingly when the state of the sealing membrane 2 changes. , And when the energy is released, the sealing film 2 is forced to seal the instrument channel 11.
- the energy storage element package is a compressible gas.
- the product of this embodiment can be operated in the following manner during use: exhaust the gas on the side of the instrument channel 11 into the body through the first pressure regulating hole 32, and then insert the blood vessel, at this time, the blood vessel is connected with the catheter sheath to form an instrument
- the instrument channel 11 is entered, and the blood is sealed in the body by the sealing film 2.
- the instrument enters the body from the middle of the sealing film 2 and is tightly wrapped by the sealing film 2, and the blood is always blocked by the sealing film 2 in the body.
- the pressure of the driving chamber 12 increases due to the decrease in volume, thereby pushing the piston 34 to move to the left, the compressible gas is compressed and stored, the internal pressure reaches a new balance, and it can still be sealed.
- the compressible gas is released, pushing the piston 34 to move to the right. Back to the initial state.
- the sealing film 2 is always squeezed and continuously sealed.
- the energy storage element is the combination of the elastic member 341 and the compressible gas
- the resistance to the passage of instruments of different diameters is further flattened; it is convenient for different diameters.
- the resistance adjustment of the device is more flexible.
- the tightness requirements for the energy storage chamber 33, the balance chamber 31, and related components are relatively high, and the process is relatively complicated.
- the multi-cavity structure composed of multiple balance chambers 31 has the following advantages and design starting points compared with the single-cavity structures of other embodiments:
- the structure is simple and reliable, with low requirements for the elastic performance of the spring, and is convenient for mass production;
- the multi-cavity structure is more compatible with different devices, and the passing resistance can be stabilized in a small range, which can be summarized as the passing resistance of the diameter of the device is basically the same;
- the optimal number of cavities needs to be calculated based on the volume of the drive chamber 12 and the volume of the balance chamber 31.
- the largest instrument enters the instrument channel 11 so that the volume of the liquid discharged from the drive chamber 12 makes the pistons 34 in the multiple balance chambers 31 move less than 5mm, the smaller the travel distance, the better.
- the third end cover 332 mentioned above is used to close the energy storage chamber 33.
- the arrangement of multiple balance chambers 31 will increase the number of third end covers 332, and the installation process will be complicated, resulting in unnecessary stability. Therefore, the function of the third end cover 332 is realized by the first end cover 14 in this embodiment.
- the second end cover 15 also has changes in details.
- the second end cover 15 actually has two parts, which are used to realize the connection with the housing.
- the two parts are respectively provided with the first pressure regulating hole 32 and the exhaust hole 16 mentioned above.
- the hemostatic valve also includes a pressure regulating structure (not shown) for conveying fluid.
- the hemostatic valve further includes a pressure regulating structure, and the pressure regulating structure is provided with a fluid pipeline for supplying fluid, and the fluid pipeline is directly or indirectly connected with the balance chamber or the driving chamber or the balance hole.
- the fluid pipeline can directly communicate with any one of the balance chamber, the drive chamber, or the balance hole, or directly communicate with more of them, or it can communicate indirectly through the mutual communication of the balance chamber, the drive chamber, and the balance hole. .
- the fluid in the fluid pipeline is provided by a pressure regulating structure.
- the pressure regulating mechanism can be in the form of a plunger pump or a peristaltic pump commonly used in clinical practice. It can also simplify the design and reduce the production cost. For example, it can be a syringe commonly used in clinical practice.
- the type of conveying cylinder can also be a separate conveying device. The details can be flexibly adjusted according to actual needs.
- the balance chamber is provided with multiple and circumferentially distributed on the outside of the drive chamber, and each balance chamber is connected to the drive chamber through an independent balance hole; one side of each balance hole is linked with the drive chamber, and the other One side extends in the radial direction to the outer peripheral wall of the housing, and each balance hole is closed on the outer peripheral wall or butted with the fluid pipeline.
- the balance hole itself extends to form a channel, which can communicate with the driving chamber and the balance chamber.
- One end of the balance hole extending to the outer peripheral wall of the shell can be closed or opened by a plugging material to be connected to the fluid pipeline for receiving fluid.
- the specific closed quantity and open quantity can be adjusted as needed.
- the invention also discloses a catheter sheath assembly, which includes an axially extending sheath tube, the sheath tube has an axially penetrating cavity, the sheath tube has a proximal end and a distal end, and the proximal end of the sheath tube is connected with the hemostatic valve.
- the distal end of the sheath tube is provided with a visualization ring.
- the present invention also discloses a method for sealing an interventional instrument based on a hemostatic valve.
- the hemostatic valve includes a housing and a sealing film mounted in the housing and in a tubular structure.
- the inner cavity of the tubular structure serves as the instrument channel and penetrates the housing.
- the sealing methods of interventional instruments include:
- the fluid drives the sealing membrane to close the instrument channel, and the fluid also acts on the energy storage mechanism to pre-store energy to maintain the sealing membrane state;
- the sealing membrane When an interventional instrument is inserted into the instrument channel, the sealing membrane is squeezed and deformed by the interventional instrument and the energy storage mechanism is driven by fluid to store energy;
- the energy storage mechanism is released, and the device channel is closed by the deformation of the sealing membrane driven by the fluid.
- the hemostatic valve includes:
- the sealing film has an inner surface and an outer surface, and the inner surface of the sealing film forms an instrument channel for inserting instruments;
- the housing has an inner wall, and the inner wall of the housing and the outer surface of the sealing film form a driving chamber, and the driving chamber is used for filling fluid;
- the hemostatic valve also includes an energy storage mechanism that can be linked with fluid
- the drive chamber and/or is connected with fluid lines.
- the instrument is inserted into the instrument channel, the fluid in the driving chamber is linked with the energy storage mechanism, and the energy storage mechanism further stores energy.
- the design of the energy storage mechanism increases the variation range of the hemostatic valve, which can allow instruments with different outer diameters to pass through the instrument channel while ensuring the sealing effect, which overcomes the hand feel of the interventional instrument and allows the interventional instrument to pass in the related art.
- the contradiction between the size range Thereby, the pressure in the driving chamber is automatically adjusted and the penetration of the equipment is improved.
- the driving chamber is also connected with a fluid pipeline, and the external fluid source is connected through the fluid pipeline.
- the fluid pipeline is equipped with a control valve.
- the control valve can realize functions such as flow adjustment of the fluid pipeline.
- the driving chamber is also connected with a balance chamber, and the fluid in the driving chamber is linked with the energy storage mechanism through the balance chamber; the communication method between the fluid pipeline and the driving chamber is at least One:
- the fluid pipeline When the fluid pipeline provides fluid, it needs a fluid source to provide power support.
- the external fluid source is provided by a pressure regulating structure.
- the pressure adjusting mechanism has multiple setting modes.
- the driving mode of the pressure adjusting structure is manual, electric or pneumatic.
- the pressure adjustment mechanism can be a plunger pump or a peristaltic pump commonly used in clinical practice, which can be flexibly adjusted according to actual needs.
- the pressure adjusting structure has at least one storage chamber, and the fluid pipeline communicates with the storage chamber.
- a cylindrical space is formed in the housing, and the energy storage mechanism includes:
- the piston is slidably arranged in the cylindrical space and divides the cylindrical space into a balance chamber and an energy storage chamber;
- the energy storage element is located in the energy storage chamber, and the energy storage element is a gas and/or elastic member that interacts with the piston.
- the casing is annular and has an annular wall, and the cylindrical space is located in the annular wall.
- the cylindrical space has a variety of design forms, such as a special-shaped tube with a curved axis and a varying cross-section of the cylindrical space.
- the cylindrical space is a straight cylindrical structure.
- the axis of the straight cylinder structure and the axis of the shell are parallel to each other.
- the cylindrical space is sequentially distributed along the circumferential direction of the housing.
- the cylindrical structure provides the actual space provided by the balance chamber and the driving chamber.
- the instrument channel passes through the housing along the axis of the housing.
- the present application also provides a catheter sheath.
- the catheter sheath includes a sheath 170 and a hemostatic valve that are connected to each other, and the hemostatic valve is the internally balanced hemostatic valve in the above embodiment.
- the sheath 170 can be extended into the body at the pre-puncture site, and the hemostatic valve of the present application can be used to prevent blood from flowing out through the device channel when the interventional device 160 is in and out.
- one end of the tube can be covered with an integral or separate tube connector 122, and the sheath tube 170 is sleeved and fixed on the tube connector 122.
- the hemostatic valve in the above embodiments can all be matched with the sheath.
- This application also discloses a sheath tube, including a tube wall 204, which is a rolled-wall structure, and the cross-section is a coiled shape.
- the tube wall 204 has an expanded state of expanding the rolled-wall structure at the corresponding part and a self-recovering rolled-wall structure. Pre-defined state.
- the tube wall 204 is an elastic material that can switch autonomously between the expanded state and the predetermined state.
- the outer diameter of the tube wall 204 in the predetermined state is 4-9 mm.
- the tube wall 204 in the predetermined state is wound more than one circle, and the part beyond the 360-degree circle and the part within the 360-degree overlap each other.
- the overlapping parts have smooth contact surfaces.
- the tube wall 204 in the predetermined state is wound less than 720 degrees.
- start side 209 and the end side 210 of the roll wall structure wound in the circumferential direction are connected by a flexible envelope film.
- a crease line is provided at the turning point of the flexible envelope film.
- the wall thickness of the flexible envelope film is 0.1-1 mm.
- the flexible envelope membrane is a circumferentially closed tubular structure, and the perimeter of the tubular structure of the flexible envelope membrane is greater than the wall length of the section of the tube wall 204, and the tube wall 204 is fixedly attached to the outer wall of the flexible envelope membrane.
- the outer periphery of the distal end of the tube wall 204 is wrapped with an elastic sleeve 206.
- the distal end of the tube wall 204 is connected to the sheath handle, and the connecting part is wrapped by the elastic sleeve 206.
- the axial length of the elastic sleeve 206 is 5-50 cm.
- the outer part of the tube wall 204 is covered with a sleeve for confining the tube wall 204 in a predetermined state, and the sleeve is expanded and cracked when the tube wall 204 is expanded.
- the cuff extends axially along the tube wall 204 beyond the proximal end of the tube wall 204, and the extended part is a constricted structure.
- the rolled wall structure is on the end side 210 wound in the circumferential direction, and is a chamfered structure near the proximal end of the tube wall 204.
- the tube wall 204 of the sheath is a rolled-wall structure, and the cross-section is a coiled shape.
- the tube wall 204 has an expanded state and recovery of the rolled-wall structure at the corresponding position. The pre-defined state of the wall structure.
- the outer diameter of the sheath is 5mm (15Fr) and the inner diameter is 4mm.
- the inner diameter can reach 8mm (24Fr), and the sheath can be transported through the corresponding diameter.
- the distal end of the sheath is equipped with a connector 205 that is matched with the delivery device, and the connection between the sheath and the connector 205 is wrapped by an elastic sleeve 206. It can prevent blood (or body fluid) from escaping from the gap of the overlapped part of the tube wall.
- the elastic sleeve is made of elastic nylon with a thickness of 0.1-0.2mm.
- the wall structure spirally extends from the start side to the end side.
- the end side boundary of the start side can extend along the sheath axis or spirally around the sheath axis.
- Figure 28b shows that the end side boundary 207 is a straight line. And extend along the axial direction of the sheath.
- the interventional device travels from right to left, and the inside of the tube wall will be squeezed where it passes, so that the rolled wall structure of the tube wall will expand accordingly, and the compressed part 208 will turn into an expanded state.
- the interventional device 9 After the interventional device 9 passes through, due to the elasticity of the tube wall 204 itself, it will automatically recover and return to the initial predetermined state.
- the material of the tube wall is selected from HDPE or Pebax.
- the thickness of the tube wall is 0.5 mm.
- Figure 29a is a schematic cross-sectional view of the sheath in the predetermined state (in the initial state) when the device is not implanted.
- the tube wall in the predetermined state is wound more than 360 degrees, That is, from the start side 209 to the end side 210 of the winding, it extends more than 360 degrees in the circumferential direction, and the portion exceeding 360 degrees overlaps the portion not exceeding 360 degrees.
- Fig. 29c is a schematic cross-sectional view of the sheath tube being expanded when the interventional device 9 is implanted. In order to prevent the delivery sheath and the implantation device from being exposed in the expanded state, it can be seen in FIG.
- the overhanging part 211 and the unoverlapping part 212 overlap each other, they are not relatively fixed. They can slide relative to each other to form a gap, so that blood or body fluids may enter and exit the tube wall. Both can form a closed channel of an interventional device.
- the present invention provides another embodiment, which seals the tube wall by arranging a flexible envelope on the start side and the end side of the tube wall.
- the start side 209 and the end side 210 of the tube wall winding are connected by a flexible envelope film 214.
- the flexible envelope mainly acts as a radial supporting force, restraining the implanted device, preventing its exposure, and at the same time preventing blood or body fluids from overflowing the tube wall.
- the flexible envelope 214 Since the flexible envelope 214 has to be buckled or twisted when the tube wall is switched, the wall thickness and rigidity are lower than the tube wall itself.
- the flexible envelope 214 is made of PTFE material, and the wall thickness is 0.25-0.5 mm.
- the flexible envelope 214 can keep the sheath closed, and the flexible envelope 214 can be fixed to the tube wall by welding or the like.
- the flexible envelope film 214 is located in the middle layer of the overlapping part of the pipe wall.
- the flexible envelope 214 can extend for a section in the circumferential direction, that is, there is no 360 cavity that envelops the entire tube wall.
- the flexible envelope 214 is tightened on the starting side of the tube wall 209
- the function of the flexible envelope 214 is to close the gap formed between the start side 209 and the end side 210 to prevent blood or body fluids from entering and exiting the tube wall. Therefore, the fixing points of the flexible envelope 214 and the pipe wall are not strictly required to be on the starting side 209 and the ending side 210, and can also be adjusted appropriately.
- the flexible envelope film 214 is a circumferentially closed tubular structure, the pipe wall is fixedly attached to the outer wall of the flexible envelope film 214, and a part of the flexible envelope film 214 is a circuitous part 215, The roundabout portion 215 is located between the start side 209 and the end side 210 of the tube wall.
- the turning points 216 and 217 of the roundabout part 215 are provided with crease lines.
- the crease lines can be processed by heat setting treatment. In a predetermined shape, the crease lines can make the turning points of the roundabout parts more smooth.
- the roundabout portion 215 is expanded when the tube wall is expanded, which can allow the tube wall to have a larger deformation range.
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Abstract
一种止血阀、导管鞘以及介入器械(9)的密封方法,止血阀包括壳体(1,100)以及安装于壳体(1,100)内且呈管状结构的密封膜(2,130),管状结构的内腔(21)作为器械通道(11,131)且贯通壳体(1,100),壳体(1,100)内设有处在密封膜(2,130)***用于填充流体的驱动室(12,150),止血阀还包括可与流体相联动的储能机构(3),储能机构(3)在密封膜(2,130)状态变化时相应的储能或释能,且在释能时驱使密封膜(2,130)密封器械通道(11,131)。通过储能机构(3)的设计,将密封膜(2,130)形变能量储存起来,从而实现不同器械通过时的兼容性好,密封效果好;通过密封膜(2,130)自身参数的设置、储能结构的参数设置以及两者之间的匹配,实现器械拉拔操作感好,操作力变化小的优点,并且为其他功能提供结构基础。
Description
本申请涉及医疗器械领域,特别是涉及止血阀、导管鞘以及介入器械的密封方法。
介入治疗是近年来发展起来的介于用药和开刀手术之间的前沿治疗技术。介入治疗技术通常需要利用X线透视、CT定位、B型超声仪等医疗影像设备做导向,将装载有介入器械(如血管支架、人工心脏瓣膜)或药物的导管装置经人体动脉、静脉血管抵达体内病变区域,从而达到诊断和治疗疾病的目的。
导管鞘为导管装置进入人体提供了通道,同时也为血液或其它人体体液创造了外流出口。为了防止血液流失,通常需要在导管鞘内设置密封件止血阀。现有技术方案中存在问题在于止血阀密封功能和方便介入器械通过的可穿过功能之间产生了矛盾。为了阻止血液流出,往往需要提高密闭性能,但是相应的会影响介入器械在止血阀内的可穿过性。
相关技术中也公开了针对止血阀的技术改进。例如,在某一相关技术中,止血阀包括壳体以及位于壳体内的管状密封膜,管状密封膜的外周与壳体之间围成环状的密闭腔体,通过朝密闭腔体内注入填充物来调节密闭腔体的大小,从而实现止血阀的开通和关断。发明人发现,密封膜在建立密闭后,会与介入器械之间产生较大的摩擦,为了方便操作介入器械相对于止血阀的位置就需要频繁调整密闭腔体的压力以调整密封膜的密闭状态,操作较为繁琐,精度控制难度较大,对治疗过程产生影响。
发明内容
为了解决上述的技术问题,本申请公开了一种止血阀,包括壳体以及安装于壳体内且呈管状结构的密封膜,所述管状结构的内腔作为器械通道且贯通所述壳体,所述壳体内设有处在所述密封膜***用于填充流体的驱动室,所述止血阀还包括可与所述流体相联动的储能机构,所述储能机构在所述密封膜状态变化时相应的储能或释能,且在释能时驱使所述密封膜密封闭所述器械通道。
以下还提供了若干可选方式,但并不作为对上述总体方案的额外限定,仅仅是进一步的增补或优选,在没有技术或逻辑矛盾的前提下,各可选方式可单独针对上述总体方案进行组合,还可以是多个可选方式之间进行组合。
可选的,所述止血阀具有驱动室填充流体的工作状态,以及未填充流体的初始状态,所述流体为不可压缩的液体。
可选的,所述流体为生理盐水或水。
可选的,所述密封膜具有受介入器械挤压以开放器械通道的第一状态,所述储能机构受流体驱动储能;
所述密封膜具有受流体驱动以关闭器械通道的第二状态,所述储能机构释能以维持将所述密封膜保持在第二状态的流体压力。
可选的,所述壳体至少在所述驱动室的外周为刚性结构。
可选的,所述壳体整体上为刚性结构。
可选的,所述壳体采用透明材料。
可选的,所述壳体内开设有贯通区,所述密封膜布置于该贯通区,所述密封膜的外周与 所在贯通区内壁之间围成所述驱动室。
可选的,所述贯通区的两开放端分别密封安装有第一端盖和第二端盖,各端盖上开设有与所述器械通道相应的避让孔,所述密封膜的轴向两端夹持固定在所述壳体与相应侧的端盖之间。
可选的,所述器械通道一端为器械入口,另一端为器械出口,位于器械出口一侧的端盖上开设有径向贯通的排气孔。
可选的,所述排气孔连通有排气阀;
所述排气阀直接安装于所述排气孔或通过外部管路连通于所述排气孔。
可选的,各端盖通过螺钉固定于所述壳体。
可选的,所述壳体内还设置有平衡室,所述驱动室与所述平衡室之间相互连通,所述驱动室内的流体经由所述平衡室与所述储能机构联动。
可选的,沿所述器械通道的径向,所述平衡室处在所述驱动室的外侧。
可选的,所述平衡室环绕在所述驱动室的外周。
可选的,所述平衡室与所述驱动室之间开放式连通。
可选的,所述驱动室与所述平衡室之间相互隔离,仅通过平衡孔连通。
可选的,所述器械通道一端为器械入口,另一端为器械出口,所述平衡孔邻近所述器械出口。
可选的,所述平衡室或所述驱动室的室壁开设有第一压力调节孔。
可选的,所述第一压力调节孔连通有第一调节阀;
所述第一调节阀直接安装于所述第一压力调节孔或通过外部管路连通于所述第一压力调节孔。
可选的,所述储能机构包括储能室和安装在所述储能室内的储能元件,所述储能元件在所述密封膜状态变化时相应的储能或释能,用以驱使所述密封膜密封闭所述器械通道。
可选的,所述储能机构包括:
所述储能室;所述壳体内还设置有平衡室,所述驱动室与所述平衡室之间相互连通;
活塞,密封滑动在所述平衡室与所述储能室之间;
所述储能元件,所述储能元件为处在所述储能室内且与所述活塞相作用的可压缩气体和/或弹性件。
可选的,所述储能室的室壁开设有第二压力调节孔。
可选的,所述器械通道一端为器械入口,另一端为器械出口,沿所述器械通道的轴向,所述平衡室邻近器械出口,所述储能室邻近器械入口。
可选的,所述储能室在背向所述平衡室的一侧为开放结构且密封安装有第三端盖,所述第二压力调节孔设置在该第三端盖上。
可选的,述第二压力调节孔连通有第二调节阀;
所述第二调节阀直接安装于所述第二压力调节孔或通过外部管路连通于所述第二压力调节孔。
可选的,所述储能室内设有与所述弹性件相抵的调节件,所述调节件的至少一部分暴露于所述储能室作为调节操作部。
可选的,所述储能室在背向所述平衡室的一侧为开放结构且密封安装有第三端盖,所述调节件设置在该第三端盖上。
可选的,所述调节件为与所述储能室的室壁螺纹配合的调节螺杆,所述调节螺杆的头部作为所述调节操作部,所述调节螺杆与头部相对的一端与所述弹性件相抵配合。
可选的,所述活塞的运动方向与所述器械通道的延伸方向相互平行或夹角设置。
可选的,所述储能元件为置于所述储能室内的弹性囊。
可选的,所述弹性囊悬浮于所述平衡室内或固定于所述平衡室的室壁。
可选的,所述弹性囊固定于所述平衡室的室壁,在所述平衡室的室壁上开设有与所述弹性囊连通的第三压力调节孔。
可选的,所述第三压力调节孔连通有第三调节阀;
所述第三调节阀直接安装于所述第三压力调节孔或通过外部管路连通于所述第三压力调节孔。
可选的,所述弹性囊为空心结构,且填充有气体,通过所述气体储能或释能。
可选的,所述弹性囊为弹性材料,通过所述弹性材料的形变储能或释能。
可选的,所述密封膜的内腔上设有亲水润滑涂层。
可选的,所述止血阀还包括增压机构,用于将血压变化反馈于所述流体。
可选的,所述增压机构具有采集血压的输入端口,以及经增压后的输出端口,所述增压机构的输出直接或间接的作用于所述驱动室内的流体。
可选的,所述增压机构包括支撑体,所述支撑体的内部设置有缸径不同的两缸室,各缸室内均密封滑动安装有滑动件,且两缸室内的滑动件相互联动;
所述输入端口连通缸径较大的第一缸室;所述输出端口连通缸径较小的第二缸室。
可选的,所述两缸室相互连通,在连通部位处为位于两滑动件之间的联动室,两滑动件之间通过共用联动室内的介质压力相互联动。
可选的,第一缸室内的滑动件为第一滑动件,第一滑动件的一侧为与所述输入端口连通的输入室,另一侧为所述共用联动室;
第二缸室内的滑动件为第二滑动件,第二滑动件的一侧为与所述输出端口连通的输出室,另一侧为所述共用联动室。
可选的,所述两缸室相互隔离,两滑动件通过连接件直接相连,所述连接件的两端密封穿入各缸室与对应的滑动件相连。
可选的,第一缸室内的滑动件为第一滑动件,第一滑动件的一侧为与所述输入端口连通的输入室,另一侧为第一联动室;
第二缸室内的滑动件为第二滑动件,第二滑动件的一侧为与所述输出端口连通的输出室,另一侧为第二联动室;
所述连接件的两端密封穿入各联动室并与对应的滑动件相连。
可选的,所述止血阀开设有使用状态下可与血管连通的血压反馈孔,所述血压反馈孔通过反馈管路与所述输入端口连通。
可选的,所述器械通道一端为器械入口,另一端为器械出口,所述血压反馈孔邻近位于器械出口一侧。
可选的,所述止血阀开设有排气孔,该排气孔与所述血压反馈孔分别配置。
可选的,所述止血阀开设有排气孔,该排气孔兼做所述血压反馈孔,所述反馈管路上连通有排气旁路,该排气旁路上设置有排气阀。
可选的,所述支撑体与所述壳体为一体或分体结构。
可选的,所述两缸室同轴布置、并排布置或内外嵌套布置。
可选的,所述两缸室的轴线平行或斜交或垂直。
可选的,所述增压机构的输出端口与所述驱动室连通。
可选的,所述增压机构包括支撑体,所述支撑体的内部设置有缸径不同的两缸室,各缸室内均密封滑动安装有滑动件,且两缸室内的滑动件相互联动;
所述输入端口连通缸径较大的第一缸室;所述输出端口连通缸径较小的第二缸室;
所述两缸室相互连通,在连通部位处为位于两滑动件之间的联动室,两滑动件之间通过联动室内的介质压力相互联动。
可选的,所述联动室的室壁上开设有与所述联动室连通的第四压力调节孔;缸径较小的缸室室壁上,开设有与所述输出端口连通的第五压力调节孔。
可选的,所述增压机构包括支撑体,所述支撑体的内部设置有缸径不同的两缸室,各缸室内均密封滑动安装有滑动件,且两缸室内的滑动件相互联动;
所述输入端口连通缸径较大的第一缸室;所述输出端口连通缸径较小的第二缸室;
所述两缸室相互隔离,两滑动件通过连接件直接相连,所述连接件的两端密封穿入各缸室与对应的滑动件相连。
可选的,第二缸室的室壁上分别开设有:
第六压力调节孔,连通至第二缸室内滑动件的一侧;第七压力调节孔,连通至第二缸室内滑动件的另一侧,且所述输出端口也连通于该侧。
可选的,各压力调节孔连通有调节阀;各调节阀直接安装于相应的压力调节孔或通过外部管路连通于相应的压力调节孔。
可选的,所述壳体内还设置有平衡室,所述驱动室与所述平衡室之间相互连通;
所述增压机构的输出端口与驱动室和/或平衡室连通。
可选的,所述止血阀还包括可与所述流体相联动的储能机构,所述储能机构在所述密封膜状态变化时相应的储能或释能,用以驱使所述密封膜关闭所述器械通道;
所述驱动室内的流体经由所述平衡室与所述储能机构联动;
所述增压机构的输出直接作用于所述储能机构,或所述增压机构的输出端口与所述驱动室和/或所述平衡室连通。
可选的,所述储能机构包括置于所述平衡室内的弹性囊;
所述增压机构的输出端口与所述平衡室连通。
可选的,所述储能机构包括置于所述平衡室内的弹性囊;
所述增压机构的输出端口与所述弹性囊连通。
可选的,所述储能机构包括:
与所述平衡室相连通的储能室;
在所述平衡室与所述储能室之间密封滑动的活塞;
处在所述储能室内且与所述活塞相作用的可压缩气体和/或弹性件;
所述增压机构的输出端口与所述储能室连通。
可选的,所述储能机构包括:
与所述平衡室相连通的储能室;
在所述平衡室与所述储能室之间密封滑动的活塞;
处在所述储能室内且与所述活塞相作用的可压缩气体和/或弹性件;
所述增压机构的输出端口与所述平衡室连通。
可选的,还包括与所述输入端口相连的血压指示装置。
可选的,所述血压指示装置为单独配置的血压计或集成至所述增压机构。
可选的,所述增压机构中至少带有与血压相关的运动部件,所述增压机构中设有血压标识,该血压标识与所述运动部件的位置相关。
可选的,所述增压机构包括支撑体,所述支撑体的内部设置有缸径不同的两缸室,各缸室内均密封滑动安装有滑动件,且两缸室内的滑动件相互联动;
所述输入端口连通缸径较大的第一缸室;所述输出端口连通缸径较小的第二缸室;
所述运动部件为第一缸室内的滑动件和/或第二缸室内的滑动件。
本申请还提供一种外平衡式的止血阀,包括壳体以及安装于壳体内且呈管状结构的密封膜,所述管状结构的内腔作为器械通道,所述壳体内设有处在密封膜***的驱动室,在所述驱动室内设有与所述密封膜相作用的囊体,所述囊体与所述密封膜相抵配合用以关闭或开放器械通道。
可选的,所述壳体为刚性的筒状结构且套于所述密封膜的外周,所述密封膜的轴向两端与所述壳体采用密封连接,所述密封膜的轴向中部与所述壳体的内壁之间围成所述驱动室。
可选的,所述壳体包括:
支撑部,所述平衡孔贯穿所述支撑部的侧壁;
两个端盖,分别对接于所述支撑部的轴向两端,各端盖上开设有与所述器械通道位置相应的避让孔。
可选的,所述平衡孔的位置邻近所述器械通道的进口。
可选的,所述密封膜的轴向两端与所述壳体的连接方式分别为以下方式的至少一种:
与所述支撑部粘结固定;
与对应侧的端盖粘结固定;
夹持固定在所述支撑部与对应侧的端盖之间;
嵌装于所述支撑部并通过填塞件封堵固定;
嵌装于对应侧的端盖并通过填塞件封堵固定;
嵌装于所述支撑部与对应侧的端盖之间并通过填塞件封堵固定。
可选的,所述弹性囊包括:
采用弹性材料且为中空结构的囊体;
与所述囊体相对接连通的第一接头,该第一接头与所述平衡孔对接连通;
与所述囊体相对接连通的第二接头,该第二接头用于灌注可在所述弹性囊和所述驱动室之间流动的平衡介质。
可选的,所述第一接头和第二接头位于所述囊体的两相对侧,且与所述囊体之间为一体或分体结构。
可选的,所述第二接头的开口处安装有密封塞。
可选的,所述第二接头连接有控制阀。
本申请还公开了一种内平衡式的止血阀,包括壳体以及安装于壳体内且呈管状结构的密封膜,所述管状结构的内腔作为器械通道,所述壳体内设有处在密封膜***的驱动室,在所述驱动室内设有与所述密封膜相作用的囊体,所述囊体与所述密封膜相抵配合用以关闭或开放器械通道。
可选的,所述囊体的数量为1个,且至少绕所述器械通道一周;或所述囊体的数量为多个,各囊体绕所述器械通道分布在密封膜***,分布方式为周向均匀分布或非均匀分布,各囊体的形状相同或不同。
可选的,所述囊体的数量为2、3或4个,在所述器械通道的长度方向上,所述囊体至少在自身中部为形变部,且各囊体的形变部位置共同作用于所述密封膜。
可选的,所述囊体具有通过自身弹性和/或通过填充物保持的涨鼓状态,涨鼓状态下的囊体挤压所述密封膜以关闭器械通道;介入器械穿过所述器械通道时,所述囊体具有通过自身形变和/或通过位移达到的让位状态,让位状态下的囊体容许所述密封膜形变以开放器械通道。
可选的,所述壳体为刚性的筒状结构且套在所述密封膜的外周,所述密封膜的轴向两端与所述壳体采用密封连接,所述密封膜的轴向中部与所述壳体的内壁之间围成所述驱动室。
可选的,所述壳体包括:
支撑部,所述器械通道贯通所述支撑部;
两个端盖,分别对接于所述支撑部的轴向两端,各端盖上开设有与所述器械通道位置相应的避让孔。
可选的,所述密封膜的轴向两端与所述壳体的连接方式分别为以下方式的至少一种:
与所述支撑部粘结固定;
与对应侧的端盖粘结固定;
夹持固定在所述支撑部与对应侧的端盖之间;
嵌装于所述支撑部;
嵌装于对应侧的端盖;
嵌装于所述支撑部与对应侧的端盖之间。
可选的,所述支撑部包括球壳状的中段以及对接于中段两侧的缩径段,所述两个端盖分别插接固定于对应侧的缩径段,所述驱动室处在所述中段的内部。
可选的,所述壳体或各端盖上设有定位槽,所述囊体沿器械通道的长度方向延伸,且所述囊体的两端分别插接固定在相应侧定位槽内。
可选的,所述支撑部或至少一端盖开设有注射通道,所述囊体的至少一端为开放结构且连通至所述注射通道,所述支撑部或至少一端盖上开设有与所述注射通道连通的注射口。
可选的,所述注射口安装有密封塞,或所述注射口密封插接有连接管,该连接管上安装有控制阀。
本申请还公开了一种止血阀,包括壳体以及安装于壳体内且呈管状结构的密封膜,所述管状结构的内腔作为器械通道且贯通所述壳体,所述壳体内设有处在所述密封膜***可填充流体的驱动室,所述壳体内还设有平衡室和储能室,其中所述平衡室与所述驱动室连通;所述平衡室与所述储能室之间滑动安装有活塞,在储能室内设有储能元件,所述储能元件在所述密封膜形变时、通过与所述活塞的相互作用储能或释能。
本申请还公开了一种止血阀,包括壳体以及安装于壳体内且呈管状结构的密封膜,所述管状结构的内腔作为器械通道且贯通所述壳体,所述壳体内设有处在所述密封膜***可填充流体的驱动室,所述壳体内还设有平衡室和储能室,其中所述平衡室与所述驱动室连通;所述平衡室和/或所述储能室内设有作为储能元件的弹性囊,所述弹性囊在所述密封膜形变时受流体作用储能或释能。
本申请还公开了一种止血阀,包括壳体以及安装于壳体内且呈管状结构的密封膜,所述管状结构的内腔作为器械通道且贯通所述壳体,所述壳体内设有处在所述密封膜***用于填充流体的驱动室,所述止血阀还包括增压机构,所述增压机构具有采集血压的输入端口,以及经增压后的输出端口,并通过所述输出端口将血压变化反馈于所述流体。
本申请还公开了一种止血阀,包括壳体以及安装于壳体内且呈管状结构的密封膜,所述管状结构的内腔作为器械通道且贯通所述壳体,所述壳体内设有处在所述密封膜***可填充流体的驱动室,所述壳体内还设有平衡室和储能室,其中所述平衡室与所述驱动室连通,所述平衡室与所述储能室之间滑动安装有活塞,在储能室内设有储能元件,所述储能元件在所述密封膜形变时、通过与所述活塞的相互作用储能或释能;所述止血阀还包括增压机构,所述增压机构具有采集血压的输入端口,以及经增压后的输出端口,所述输出端口至少连通所述驱动室、所述平衡室和所述储能室中的一者,用以将血压变化反馈于所述流体。
本申请还公开了一种止血阀,包括壳体以及安装于壳体内且呈管状结构的密封膜,所述管状结构的内腔作为器械通道且贯通所述壳体,所述壳体内设有处在所述密封膜***可填充流体的驱动室,所述壳体内还设有平衡室和储能室,其中所述平衡室与所述驱动室连通;所述平衡室和/或所述储能室内设有作为储能元件的弹性囊,所述弹性囊在所述密封膜形变时受流体作用储能或释能;所述止血阀还包括增压机构,所述增压机构具有采集血压的输入端口,以及经增压后的输出端口,所述输出端口至少连通所述驱动室、所述平衡室和所述储能室中的一者,用以将血压变化反馈于所述流体。
本申请还公开了一种多腔体的止血阀,包括壳体以及安装于壳体内且呈管状结构的密封膜,所述管状结构的内腔作为器械通道,沿所述器械通道的径向,所述壳体内设有处在所述密封膜***用于填充流体的驱动室和位于所述驱动室外侧的平衡室,所述驱动室与所述平衡室之间相互连通且所述平衡室环绕在所述驱动室的外周;
所述止血阀还包括可与所述流体相联动的储能机构,所述驱动室内的流体经由所述平衡室与所述储能机构联动;所述储能机构在所述密封膜状态变化时相应的储能或释能,且在释能时驱使所述密封膜密封闭所述器械通道。
可选的,所述平衡室有多个且在所述驱动室的外周间隔布置,针对每个平衡室分别配置所述储能机构。
可选的,所述平衡室的数量为2至8个。
可选的,各平衡室均匀间隔设置在所述驱动室的外周。
可选的,各平衡室通过独立的平衡孔与所述驱动室连通。
可选的,至少两个平衡室共用同一个平衡孔与所述驱动室连通。
可选的,各平衡室通过同一个平衡孔与所述驱动室连通。
可选的,所述储能机构包括:
储能室;所述壳体内还设置有平衡室,所述驱动室与所述平衡室之间相互连通;
活塞,密封滑动在所述平衡室与所述储能室之间;
储能元件,所述储能元件为处在所述储能室内且与所述活塞相作用的可压缩气体和/或弹性件;
所述壳体上设有至少两个供所述活塞滑动的筒状空间,所述筒状空间被所述活塞分割为所述平衡室和所述储能室。
可选的,各活塞通过自身外缘的密封边缘和对应的所述筒状空间的内壁密封配合,在活 塞的滑动方向上,所述密封边缘与所述筒状空间的内壁至少设有两道密封。
可选的,所述壳体上设有至少两个供所述活塞滑动的筒状空间,各筒状空间内设有独立的所述储能元件,且各储能元件的储能性能一致或不一致。
可选的,所述止血阀还包括压力调节结构,所述压力调节结构设有用于提供所述流体的流体管路,所述流体管路直接或间接的与所述平衡室或所述驱动室或所述平衡孔连通。
可选的,所述平衡室设有多个且周向分布在所述驱动室外侧,各平衡室通过独立的平衡孔与驱动室连通;各平衡孔一侧与驱动室联动,另一侧在径向上延伸至所述壳体的外周壁上,各平衡孔在所述外周壁上封闭或与所述流体管路对接。
可选的,所述壳体至少在驱动室的外周为刚性结构。
可选的,所述驱动室还连通有流体管路,并通过该流体管路连接外部流体源。
可选的,所述流体管路上配置有控制阀。
可选的,所述驱动室还连通有平衡室,所述驱动室内的流体经由所述平衡室与所述储能机构联动;所述流体管路与所述驱动室的连通方式为一下方式的至少一种:
直接连通至所述驱动室;或
直接连通至所述平衡室;或
直接连通至所述驱动室与所述平衡室之间。
可选的,所述外部流体源由一压力调节结构提供。
可选的,所述压力调节结构的驱动方式为手动、电动或气动。
可选的,所述压力调节结构至少具有一储存室,所述流体管路与该储存室连通。
可选的,所述壳体内形成有筒状空间,所述储能机构包括:
活塞,滑动设置在所述筒状空间内,且将所述筒状空间分隔为所述平衡室和所述储能室;
储能元件,处在所述储能室内,且所述储能元件为与所述活塞相作用的气体和/或弹性件。
可选的,所述壳体为环形,且具有环形壁,所述筒状空间处在所述环形壁内。
可选的,所述筒状空间为直筒结构,且所述直筒结构的轴线与所述壳体的轴线相互平行。
可选的,所述器械通道沿所述壳体的轴线贯通所述壳体。
可选的,所述筒状空间为一个或多个。
可选的,所述筒状空间为2~8个。
可选的,所述筒状空间沿所述壳体的周向依次分布。
本申请公开的技术方案通过储能机构的设计,将密封膜形变能量储存起来,在器械与止血阀产生相对位移的过程中能够自适应的调整密封膜的姿态和形态,从而实现不同器械通过时的兼容性好,密封效果好;通过密封膜自身参数的设置、储能结构的参数设置以及两者之间的匹配,实现器械拉拔操作感好,操作力变化小的优点,并且为调节拉拔器械的手感调节提供结构基础。
本申请还提供了一种导管鞘,包括轴向延伸的鞘管,所述鞘管具有轴向贯通的腔体,所述鞘管具有近端和远端,所述鞘管近端连接有上述止血阀。
可选的,所述鞘管的远端带有显影环。
可选的,所述止血阀上设有与所述鞘管连接的管接头,所述管接头通过密封件与所述鞘管配合,且所述管接头有设有防止所述鞘管与所述管接头分离的卡合结构。
可选的,所述鞘管的管壁为卷壁结构,横截面为盘绕形,所述管壁具有展开相应部位卷壁结构的受胀状态以及自行恢复卷壁结构的预定型状态。
可选的,所述管壁为能够在受胀状态和预定型状态之间自主切换的弹性材料。
可选的,预定型状态的管壁外径为4-9mm。
可选的,预定型状态的管壁卷绕大于一个圆周,超出360度圆周部分与360度内的部分相互叠搭。
可选的,相互叠搭部位具有光滑的接触面。
可选的,预定型状态的管壁卷绕小于720度。
可选的,所述卷壁结构在周向上卷绕的起始侧和末尾侧通过柔性包络膜连接。
可选的,所述柔性包络膜的转折处设有折痕线。
可选的,柔性包络膜壁厚为0.1-1mm。
可选的,所述柔性包络膜为周向封闭的管状结构,所述柔性包络膜管状结构截面周长大于所述管壁截面的壁长,管壁固定贴覆在柔性包络膜的外壁。
可选的,管壁的远端外周包裹有弹性套。
可选的,管壁的远端与鞘柄连接,连接部由所述弹性套包裹。
可选的,所述弹性套的轴向长度为5~50cm。
可选的,所述管壁的外部包有用于将管壁限定在预定型状态的束套,且该束套在管壁受胀状态下涨裂。
可选的,所述束套沿管壁轴向延伸出管壁近端,延伸出的部位为收口结构。
可选的,所述卷壁结构在周向上卷绕的末尾侧上,在临近管壁近端处为切角结构。
本申请还提供了一种介入器械密封方法,包括利用可形变的密封膜构建器械通道,在密封膜的外周通过流体驱动密封膜形变以密封器械通道,在介入器械进、出器械通道的过程中,利用与流体相联动的储能机构在密封膜形变时相应的储能或释能,以保持介入器械与器械通道间的密封。
本申请还提供了一种基于止血阀的介入器械密封方法,所述止血阀包括壳体以及安装于壳体内且呈管状结构的密封膜,所述管状结构的内腔作为器械通道且贯通所述壳体,所述壳体内设有处在所述密封膜***可填充流体的驱动室以及可与流体联动的储能机构,所述介入器械密封方法包括:
向所述驱动室内注入流体,所述流体驱动所述密封膜关闭所述器械通道,所述流体还作用于所述储能机构,使所述储能机构预储能以保持密封膜状态;
向所述器械通道内***介入器械时,所述密封膜受介入器械挤压形变且通过流体驱使所述储能机构储能;
介入器械撤出所述器械通道时,所述储能机构释能,通过流体驱动密封膜形变关闭所述器械通道。
本申请各介入器械密封方法均可基于根据上述技术方案中的止血阀实施。
本申请公开的技术方案通过储能机构的设计,将密封膜形变能量储存起来,在器械与止血阀产生相对位移的过程中能够自适应的调整密封膜的姿态和形态,从而实现不同器械通过时的兼容性好,密封效果好;通过密封膜自身参数的设置、储能结构的参数设置以及两者之间的匹配,实现器械拉拔操作感好,操作力变化小的优点,并且为调节拉拔器械的手感调节提供结构基础。
具体的有益技术效果将在具体实施方式中结合具体结构或步骤进一步阐释。
图1a为一实施例中止血阀的初始状态示意图;
图1b为图1a中止血阀的壳体示意图;
图1c为图1a中止血阀的工作状态示意图;
图1d为器械进入图1c中止血阀的示意图;
图2a为另一实施例中止血阀的初始状态示意图;
图2b为图2a中止血阀的工作状态示意图;
图2c为器械进入图2b中止血阀的示意图;
图2d为图2a中止血阀的另一实施方式的初始状态示意图;
图2e为图2d中止血阀的工作状态示意图;
图2f为器械进入图2e中止血阀的示意图;
图3为调节件机构示意图;
图4a为又一实施例中止血阀的初始状态示意图;
图4b为图4a中止血阀的工作状态示意图;
图4c为器械进入图4b中止血阀的示意图;
图5a为图4a中止血阀的另一实施方式的工作状态示意图;
图5b为器械进入图5a中止血阀的示意图;
图5c为图4a中止血阀的又一实施方式的工作状态示意图;
图6a和图6b为一实施例中导管鞘的鞘管和止血阀配合关系示意图;
图7a为一实施例中止血阀的初始状态示意图;
图7b为图7a中止血阀填充状态示意图;
图7c为图7a中止血阀工作状态示意图;
图8为一实施例中增压机构另一实施方式示意图;
图9为一实施例中增压机构另一连通方式示意图;
图10a为一实施例中增压机构设置在止血阀内示意图;
图10b为图10a中止血阀另一实施方式示意图;
图11a为一实施例中止血阀采用另一储能机构示意图;
图11b为图11a中止血阀中增压机构另一连通方式示意图;
图12a和6b为导管鞘的鞘管和止血阀配合关系示意图;
图13为一实施例中外平衡式的止血阀在未注满平衡介质时的结构示意图;
图14为一实施例中外平衡式的止血阀在注入平衡介质状态下的结构示意图;
图15为图14中的外平衡式的止血阀在有介入器械通过时的结构示意图;
图16为图15的内部结构示意图;
图17为一实施例中导管鞘的结构示意图;
图18为一实施例中内平衡式的止血阀在未注满填充物状态下的结构示意图;
图19为一实施例中内平衡式的止血阀在注入填充物状态下的结构示意图;
图20为图19中的内平衡式的止血阀在无介入器械通过时的结构示意图;
图21为图19中的内平衡式的止血阀在有介入器械通过时的结构示意图;
图22为一实施例中导管鞘的结构示意图;
图23a至图23b为一实施例中多腔体的止血阀的结构示意图;
图24a至图27d为其他实施例中多腔体的止血阀的结构示意图;
图28a至图29f为一实施例中鞘管示意图。
图中附图标记说明如下:
1、壳体;11、器械通道;12、驱动室;13、贯通区;14、第一端盖;15、第二端盖;16、排气孔;161、血压反馈孔;
2、密封膜;21、内腔;
3、储能机构;31、平衡室;311、平衡孔;32、第一压力调节孔;33、储能室;331、第二压力调节孔;332、第三端盖;34、活塞;341、弹性件;342、调节件;343、调节操作部;35、弹性囊;351、第三压力调节孔;
4、增压机构;40、支撑体;401、第一缸室;402、第二缸室;41、输入端口;42、输出端口;43、第一滑动件;431、输入室;432、连接件;44、第二滑动件;441、输出室;442、共用联动室;443、第一联动室;444、第二联动室;451、第四压力调节孔;452、第五压力调节孔;453、第六压力调节孔;454、第七压力调节孔;
9、介入器械;91、鞘管;
100、壳体;110、支撑部;120、端盖;121、避让孔;122、管接头;130、密封膜;131、器械通道;140、弹性囊;141、囊体;142、第一接头;143、第二接头;150、驱动室;151、平衡孔;160、介入器械;170、鞘管;111、中段;112、缩径段;144、囊体;145、形变部;152、注射通道;153、注射口;154、连接管;
204、管壁;205、接头;206、弹性套;207、末尾侧边界;208、受压部位;209、起始侧;210、末尾侧;211、超出部分;212、未超出部分;213、重叠搭置区域;214、柔性包络膜;215、迂回部分;216、转折处;217、转折处。
下面将结合本申请实施例中的附图,对本申请实施例中的技术方案进行清楚、完整地描述,显然,所描述的实施例仅是本申请一部分实施例,而不是全部的实施例。基于本申请中的实施例,本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例,都属于本申请保护的范围。
需要说明的是,当组件被称为与另一个组件“连接”时,它可以直接与另一个组件连接或者也可以存在居中的组件。当一个组件被认为是“设置于”另一个组件,它可以是直接设置在另一个组件上或者可能同时存在居中组件。
除非另有定义,本文所使用的所有的技术和科学术语与属于本申请的技术领域的技术人员通常理解的含义相同。本文中在本申请的说明书中所使用的术语只是为了描述具体的实施例的目的,不是在于限制本申请。本文所使用的术语“和/或”包括一个或多个相关的所列项目的任意的和所有的组合。
参考图1a至图5c,本申请一实施例中公开了一种止血阀,包括壳体1以及安装于壳体1内且呈管状结构的密封膜2,管状结构的内腔21作为器械通道11且贯通壳体1,壳体1内设有处在密封膜2***用于填充流体的驱动室12,止血阀还包括可与流体相联动的储能机构3,储能机构3在密封膜2状态变化时相应的储能或释能,且在释能时驱使密封膜2密封闭器械通道11。
密封膜2的功能实际上在壳体1内分隔了两个相互独立的空间,即器械通道11和驱动室12,两者通过密封膜2实现隔离。其中器械通道11两端开放以供介入器械9穿行。
密封膜2本身为管状结构,内腔21作为器械通道11。器械通道11为了保证介入器械9 穿行壳体1,器械通道11需要贯通壳体1,因此密封膜2的内腔21作为器械通道11应理解为密封膜2的内腔21构成至少一部分器械通道11。
在相互作用关系上,驱动室12内的流体能够驱动密封膜2改变自身状态,从而实现器械通道11的封闭或开放。器械通道11是在介入治疗过程中介入器械9(例如导管、导丝等)进出人体的通道,因此可以理解为,管状结构所包围的区域至少为器械通道11的一部分。为配合介入器械9的进入,壳体1上相应的开设与器械通道11连通的进、出口,也可视为器械通道11贯通壳体1。驱动室12的作用在于约束流体并将流体做功引导至密封膜2上。密封膜2在封闭器械通道11时,密封膜2自身的管状结构至少一部分会产生径向收拢趋势,从而缩小器械通道11的腔径直至封闭器械通道11。介入器械9处于或不处于器械通道11内,密封膜2均可实现封闭器械通道11或者开放器械通道11。介入器械9处于器械通道11内时,密封膜2的内腔21径向收拢密封包裹介入器械9的外周以实现封闭器械通道11;介入器械9不处于器械通道11内时,密封膜2的内腔21径向收拢直至自身相互贴靠闭合以实现封闭器械通道11。
从原理上分析,流体驱动密封膜2主要通过压强实现,当驱动室12内流体压力足以克服器械通道11内的阻力时,驱动室12就能够驱动密封膜2自身形变以改变密封膜2的内腔21。器械通道11的封闭效果取决于驱动室12内流体压力大小。
改变驱动室12内的流体压力大小可以通过多种形式,例如外接压力源、改变流体温度、改变流体的物理特性等等。本实施例中的储能机构3能够自适应的调整流体的压力状态。当密封膜2状态变化时,储能机构3能够相应的储能或释能,并将储存的能量用于驱动密封膜2密封闭器械通道11。相较于外置能量源的设计形式而言,本实施例的技术方案能够有效提高止血阀的集成度,提高密封膜2转换形态的程度和效果,从而为更大腔径的器械通道11以及不同外观尺寸的介入器械9提供设计的结构基础。
其中本申请中提到的密封膜2的管状结构不局限于严格意义的圆管,在实际产品中,密封膜2的内腔的内径可能在轴向上变化,在截面上,密封膜2的内腔可能为长方形等规整的形状,也可能为沙漏形、梨形、球形等边缘变化的形状,也可能为不规则的变化形状。
在一实施例中,密封膜2的内腔上设有亲水润滑涂层(图未示)。密封膜2的内腔是实际与介入器械9接触的部分,亲水润滑涂层能够降低密封膜2的内腔的摩擦力,即使密封膜2在流体作用下束紧介入器械9的外周,介入器械9仍可以较顺滑的在器械通道11内穿行。同时,亲水润滑涂层还能通过调节涂层材料来实现其他功能。例如,通过在涂层材料添加耐磨材料来增加密封膜2寿命;再例如,调节涂层表面的理化性能来实现密封膜2的自清洁等。
密封膜2的直接能量来自驱动室12。在一实施例中,止血阀具有驱动室12填充流体的工作状态(例如图1c),以及未填充流体的初始状态(例如图1a),流体为不可压缩的液体。
初始状态下,驱动室12内应该为常压的空气;在一些使用在特殊场景中的产品中,初始状态下的驱动室12内可以设置为真空。在本实施例中,液体的不可压缩是指相对气体而言的,并非绝对意义上的不可压缩。液体不可压缩的特性能够方便医护人员等操作人员精准的控制密封膜2的形变程度。具体的,在一实施例中,流体为生理盐水或水。生理盐水或水作为上文中提到的流体的优点在于在医疗领域中方便取得,更重要的是即使在意外情况下,密封膜2的密封作用失效,则流体也不会对介入部位产生影响,确保安全。
在密封膜2的工作过程中,储能机构3能够改善密封膜2的工作表现。具体的,在一实施例中,密封膜2具有受介入器械9挤压以开放器械通道11的第一状态(例如图1d),储能 机构3受流体驱动储能;容易理解的,储能机构3在储能状态下,流体具有较高的压力能够保证器械通道11的封闭状态;即处于储能状态下的储能机构3仍驱使密封膜2密封闭器械通道11。
密封膜2具有受流体驱动以关闭器械通道11的第二状态(例如图1c),储能机构3释能以维持将密封膜2保持在第二状态的流体压力。
在实际使用过程中,对于器械通道11内是否存在介入器械9的不同工况下,驱动室12内的流体预设的压力的选择存在矛盾,例如在没有设置储能机构3的技术方案中:
在介入器械9进入止血阀时,密封膜2需要开放器械通道11以避免干涉介入器械9。因此密封膜2会对驱动室12内的流体做功。若驱动室12内的流体预设的压力太高,则会造成密封膜2变形的驱动力要求太高,介入器械9需要较大的驱动力才能实现挤压密封膜2以开放器械通道11,操作不便;若驱动室12内的流体预设的压力太低,则会造成密封膜2在封闭器械通道11的状态下密闭压力不足,容易造成密闭失效的情况。
本实施例中的储能机构3可以很好的克服上述问题。在介入器械9进入止血阀时,密封膜2需要开放器械通道11以避免干涉介入器械9。此时密封膜2会对驱动室12内的流体做功,同时储能机构3储能以吸收流体的能量以降低介入器械9的进入难度,为介入器械9的进入过程提供良好的手感;在介入器械9退出止血阀时,密封膜2需要封闭器械通道11以起到止血阀的功能。此时驱动室12内的流体会对密封膜2做功,同时储能机构3释能以实现对流体的做功,保证密封膜2对器械通道11的封闭效果。
密封膜2在变化的过程中,实际上是流体和密封膜2相互做功的过程。为了确保做功的有效性,在一实施例中,壳体1至少在驱动室12的外周为刚性结构。
壳体1能够限制驱动室12在其他方向上的做功,从而保证流体的能量都作用于密封膜2上,在能量一定的情况下,提高密封膜2形变的行程和封闭的效果。本实施例中提到的刚性是相对于可以形变的柔性的密封膜2而言的,并非物理概念上的刚体的刚性。在实际产品中,壳体1可能为塑料等材料,在流体的作用下可能会发生轻微的变形,但是该轻微的变形不会影响密封膜2的工作效果。下文中刚性的描述同理。在不同的产品中,壳体1可能为金属、塑料等常见材料,也有可能是有机材料或无机材料;也有可能是合成材料或自然材料等等。
在壳体1的整体设计上,在一实施例中,壳体1整体上为刚性结构。
流体对周围的部件都会产生作用力,因此在流体压力较高的情况下,可能会造成壳体1的形变。在壳体1不是整体刚性的技术方案中,壳体1可能产生形变以消耗流体的能量,影响密封膜2的工作效果。本实施例中的技术方案能克服该问题。
为了方便观察密封膜2的状态,在一实施例中,壳体1采用透明材料。
从原理来看,透明材料是相对于无法观察内部的材料而言的,因此只要能够观察内部结构的设计且能够满足本实施例中的使用需求也应认为是本实施例的中透明的表述类型,例如半透明的材料等。相应的,在一些特殊的实施例中,透明可能是局部的。例如在需要观察内部结构的部位设置观察窗等形式来实现。在壳体1与密封膜2的配合关系上,在一实施例中,壳体1内开设有贯通区13,密封膜2布置于该贯通区13,密封膜2的外周与所在贯通区13内壁之间围成驱动室12。
贯通区13收容了密封膜2,避免了外部环境从除了器械通道11以外的方向对贯通区13内产生影响,能够提高密封膜2工作的稳定性。同时贯通区13还参与形成了驱动室12,提高了止血阀的部件集成度,有利于控制止血阀的整体体积,方便治疗过程中的使用。
在一实施例中,贯通区13的两开放端分别密封安装有第一端盖14和第二端盖15,各端盖上开设有与器械通道11相应的避让孔,密封膜2的轴向两端夹持固定在壳体1与相应侧的端盖之间。
第一端盖14和第二端盖15能够固定密封膜2,从而引导密封膜2的工作方向。避让孔在工作过程中还能起到引导的作用,保证介入器械9在进入器械通道11时与密封膜2的接触位置,降低了介入器械9对密封膜2造成损伤的可能。
在一实施例中,器械通道11一端为介入器械9入口,另一端为介入器械9出口,位于介入器械9出口一侧的端盖上开设有径向贯通的排气孔16。
进入体内的导管等医疗器械在使用时,通常需要排除器械内的气体,排气孔16能够克服器械使用前携带气体的问题。同时,操作人员可以在使用前通过向排气孔16注射生理盐水去除止血阀内的气体。进一步的,排气孔16本身也是一个接口,在特殊的使用场景中能够为特殊操作提供结构基础。
在排气孔16的设置上,在一实施例中,排气孔16连通有排气阀(图未示);
排气阀直接安装于排气孔16或通过外部管路连通于排气孔16。
排气阀的灵活设置可以根据不同病例的使用需要调整。例如排气阀直接安装于排气孔16的设计,能够提高止血阀的集成度,方便操作;再例如排气阀通过外部管路连通于排气孔16的设计可以进一步降低止血阀的外部尺寸,提供适应性能。
在部件的组装关系上,在一实施例中,各端盖通过螺钉(图未示)固定于壳体1。
端盖需要形成壳体1内相对封闭的空间,在一些实施方式中还需要固定密封膜2,因此端盖的安装稳定性关系到止血阀的工作稳定。端盖本身也可以通过自身结构实现安装,为了提高安装的方便程度,螺钉是合理的优选。
在储能机构3的设计上,在一实施例中,壳体1内还设置有平衡室31,驱动室12与平衡室31之间相互连通,驱动室12内的流体经由平衡室31与储能机构3联动。
平衡室31的作用在于约束储能机构3的运动,在特殊的实施例中,平衡室31也可能和驱动室12大面积连通。因此平衡室31的概念需要从储能机构3的原理上来理解,而非结构上与驱动室12相对隔离的空间。例如,在一实施例中,平衡室31与驱动室12之间开放式连通(图未示)。
平衡室31的设计细节上,在一实施例中,沿器械通道11的径向,平衡室31处在驱动室12的外侧。
驱动室12是直接驱动密封膜2工作的部件,和密封膜2相互靠近是合理的设计。平衡室31设计在驱动室12沿器械通道11的径向的外侧能够减少止血阀在器械通道11轴向上的长度,方便治疗过程中的操作。
在一实施例中,平衡室31环绕在驱动室12的外周。
介入器械9在进入器械通道11时,流体会受密封膜2挤压而径向扩散,平衡室31设计在外周能够承接流体的扩散趋势,动态响应好。
平衡室31具有约束储能机构3的功能。在一实施例中,驱动室12与平衡室31之间相互隔离,仅通过平衡孔311连通。
平衡孔311用于供流体通过,以实现储能机构3对驱动室12内的流体储能或释能。驱动室12与平衡室31相互隔离的设计能够避免驱动室12内的流体对储能机构3的工作造成影响,从而提高储能机构3工作的稳定性。
在平衡孔311的设置上,在一实施例中,器械通道11一端为介入器械9入口,另一端为介入器械9出口,平衡孔311邻近介入器械9出口。
器械通道11是介入器械9进入止血阀的通道,在介入器械9进入止血阀的过程中,可能会存在介入器械9先接触密封膜2的一部分的过程。相应的,驱动室12内的流体也会逐渐的被介入器械9影响。平衡孔311设置在邻近介入器械9出口的位置能够适应介入器械9进入止血阀的过程,更好的将流体的动态变化通过平衡孔311反应至平衡室31内。
在对于流体的压力调节的进一步优化上,在一实施例中,平衡室31或驱动室12的室壁开设有第一压力调节孔32。
第一压力调节孔32能够实现外部对驱动室12内的压力调节。在一些使用场景中,可以设置外界的压力源来调节驱动室12内的流体的压力。同时第一压力调节孔32本身也是一个接口,在特殊的使用场景中能够为特殊操作提供结构基础。
在一实施例中,第一压力调节孔32连通有第一调节阀(图未示);
第一调节阀直接安装于第一压力调节孔32或通过外部管路连通于第一压力调节孔32。
第一调节阀的灵活设置可以根据不同病例的使用需要调整。例如第一调节阀直接安装于第一压力调节孔32的设计,能够提高止血阀的集成度,方便医护人员等操作人员进行操作;再例如第一调节阀通过外部管路连通于第一压力调节孔32的设计可以进一步降低止血阀的外部尺寸,提供适应性能。
在储能机构3的进一步优化上,储能机构3包括储能室33和安装在储能室33内的储能元件,储能元件在密封膜2状态变化时相应的储能或释能,且在释能时驱使密封膜2密封闭器械通道11。
具体的,在一实施例中,储能机构3包括:
储能室33;壳体1内还设置有平衡室31,驱动室12与平衡室31之间相互连通;
活塞34,密封滑动在平衡室31与储能室33之间;
储能元件,储能元件为处在储能室33内且与活塞34相作用的可压缩气体和/或弹性件。
本实施例中,活塞34的位置变化实现了储能机构3的储能或释能。在储能过程中,能量被可压缩气体和/或弹性件341吸收,在释能过程中,可压缩气体和/或弹性件341做功以实现释能。储能室33是储能机构3在储能过程中的功能表述,在释能过程中,储能元件在储能室33中,实际功能为释能。
活塞34在平衡室31与储能室33之间密封滑动,实际上活塞34本体就是平衡室31与储能室33的分割界限,因此平衡室31与储能室33的相对空间是发生变化的。当储能机构3释能时,活塞34向平衡室31运动,部分平衡室31变成了储能室33;当储能机构3储能时,活塞34向储能室33运动,部分储能变成了平衡室31室。活塞34的密封配合实际上时为了避免平衡室31内的流体(即驱动室12内的流体)进入储能室33,该设计在止血阀没有连接外部压力源时十分重要。在一些治疗过程中,储能机构3可能要进行相应的调整。在一实施例中,储能室33的室壁开设有第二压力调节孔331。
第二压力调节孔331能够调整储能机构3储能量的变化,从而根据不同的治疗过程进行微调,提高止血阀的适应性。同时第二压力调节孔331本身也是一个接口,在特殊的使用场景中能够为特殊操作提供结构基础。
在一实施例中,器械通道11一端为介入器械9入口,另一端为介入器械9出口,沿器械通道11的轴向,平衡室31邻近介入器械9出口,储能室33邻近介入器械9入口。
器械通道11是介入器械9进入止血阀的通道,在介入器械9进入止血阀的过程中,可能会存在介入器械9先接触密封膜2的一部分的过程。相应的,驱动室12内的流体也会逐渐的被介入器械9影响。平衡室31是直接与驱动室12连通的结构,因此平衡室31设置在邻近介入器械9出口的位置能够适应介入器械9进入止血阀的过程,更好的将流体的动态变化通过平衡室31反应至储能机构3上。
在一实施例中,储能室33在背向平衡室31的一侧为开放结构且密封安装有第三端盖332,第二压力调节孔331设置在该第三端盖332上。
第三端盖332实际构成了储能室33的侧壁,因此密封安装时保持储能室33内压力的关键。同时第二压力调节孔331设置在第三端盖332上可以避免在储能室33上开孔,降低工艺难度的同时避免了泄漏的可能。
第二压力调节孔331的设置细节上,在一实施例中,第二压力调节孔331连通有第二调节阀(图未示);
第二调节阀直接安装于第二压力调节孔331或通过外部管路连通于第二压力调节孔331。
第二调节阀的灵活设置可以根据不同病例的使用需要调整。例如第二调节阀直接安装于第二压力调节孔331的设计,能够提高止血阀的集成度,方便医护人员等操作人员进行操作;再例如第二调节阀通过外部管路连通于第二压力调节孔331的设计可以进一步降低止血阀的外部尺寸,提供适应性能。
在储能室33的细节结构上,在一实施例中,储能室33内设有与弹性件341相抵的调节件342,调节件342的至少一部分暴露于储能室33作为调节操作部343。
调节件342的作用在于调节弹性件341的预载、回弹速度等参数,方便医护人员的操作人员对止血阀的参数进行微调以适应不同的治疗过程。调节操作部343暴露于储能室33方便操作,避免了对止血阀的拆卸,能够实现在治疗过程中的微调。在没有弹性件341的设计方案中,与储能室33连通的第二压力调节孔331也可以认为是调节件342的一种变形。
在调节件342的装配上,在一实施例中,储能室33在背向平衡室31的一侧为开放结构且密封安装有第三端盖332,调节件342设置在该第三端盖332上。
第三端盖332固定于壳体1,强度好,能够承受弹性件341载荷的同时方便调节与装配。
在调节件342的具体部件结构上,在一实施例中,调节件342为与储能室33的室壁螺纹配合的调节螺杆,调节螺杆的头部作为调节操作部343,调节螺杆与头部相对的一端与弹性件341相抵配合。
调节螺杆的形式简单可靠,最重要的是调节精度较高,方便医护人员等操作人员精细的调节止血阀的工作参数。同时螺纹配合能够在实现的调节的前提下方便的实现密封配合。
在活塞34的细节设置上,在一实施例中,活塞34的运动方向与器械通道11的延伸方向相互平行或夹角设置。
活塞34的作用在于将流体的压力输送至储能机构3中,运动方向的设置并不影响活塞34功能的实现,更多的是止血阀整体布局结构的考虑。在实际产品中,可能按需设置。例如,活塞34的运动方向与器械通道11的延伸方向相互平行的设计能够得到更为规整的整体造型;再例如活塞34的运动方向与器械通道11的延伸方向夹角设置的设计能够在一些特殊需要的产品中实现更为紧凑实用的整体造型。
储能机构3还能通过其他结构实现工作效果。在一实施例中,储能元件为置于储能室内或储能室外的弹性囊。在附图中,储能室的功能实际由平衡室31来替代。弹性囊35能够协 同实现储能或释能,从而进一步调高储能技能的储能量或者释能量。
具体的,在一实施例中,弹性囊35悬浮于平衡室31内或固定于平衡室31的室壁。
弹性囊35的储能和释能通过自身形变实现。因此固定方式具有多种。
例如参考图5c,弹性囊35悬浮于平衡室31内,且可以设计多个。该设计能够充分释放弹性囊35的形变,并且弹性囊35的位置变化还能在一些特殊的场景中提供格外功能的结构基础。例如可以指示平衡室31内的流体的密度变化等。其中悬浮是相对于固定而言的,具体弹性囊35在储能室33内的位置需要更具弹性囊35内存储的介质密度和储能室33内的介质密度决定。
再例如参考图4a至图5b,弹性囊35固定于平衡室31的室壁。该设计能够确定弹性囊35的位置,避免在储运或者使用过程中弹性囊35和平衡室31相互摩擦造成弹性囊35受损。
参考图4a至图4c,在一实施例中,弹性囊35固定于平衡室31的室壁,在平衡室31的室壁上开设有与弹性囊35连通的第三压力调节孔351。
第三压力调节孔351能够实现外部对弹性囊35内的压力调节。在一些使用场景中,可以设置外界的压力源来调节弹性囊35内的流体的压力。同时第三压力调节孔351本身也是一个接口,在特殊的使用场景中能够为特殊操作提供结构基础。
在一实施例中,第三压力调节孔351连通有第三调节阀(图未示);
第三调节阀直接安装于第三压力调节孔351或通过外部管路连通于第三压力调节孔351。
第三调节阀的灵活设置可以根据不同病例的使用需要调整。例如第三调节阀直接安装于第三压力调节孔351的设计,能够提高止血阀的集成度,方便医护人员等操作人员进行操作;再例如第三调节阀通过外部管路连通于第三压力调节孔351的设计可以进一步降低止血阀的外部尺寸,提供适应性能。
在弹性囊35的具体结构上,在一实施例中,弹性囊35为空心结构,且填充有气体,通过气体储能或释能。
气体相较于其他弹性的设计形式的优点在于形变量较大,方便更好的储能或释能,弹性囊35能够约束气体,降低对介入操作产生影响的风险。
相应的,在一实施例中,弹性囊35为弹性材料,通过弹性材料的形变储能或释能。
弹性囊35自身为弹性材料,能避免气体可能对介入操作产生的影响,带来更安全的介入操作保证。更重要的是,通过弹性囊自身的弹性,能够实现与其他方案不同的技术效果。例如,在壳体上开释放孔,释放孔上罩设弹性囊,流体在密封膜的挤压下进入弹性囊并驱使弹性囊形变储能;在释能阶段,弹性囊自身形变将内部的流体挤压回壳体,从而实现释能。
如上文所实例的一样,在一些情况中,储能元件设置在储能室33内可能有变形。因此下文的几种示例性的实施例应理解为本申请方案的等同方案。
在壳体上开释放孔,释放孔上罩设弹性件,流体在密封膜的挤压下进入弹性囊并驱使弹性囊形变储能,类似于生活中吹气球的状态此时弹性件扩大了储能室的容积;在释能阶段,弹性囊自身形变将内部的流体挤压回壳体,从而实现释能。该方案中的储能元件处于储能室33的边界上,可以理解为储能元件在储能的过程中,储能元件自身扩张并扩大储能室。
储能元件为拉簧,设置在附图中标号为平衡室内的位置,流体在密封膜的挤压下进入储能室并驱使拉簧拉伸储能,此时的平衡室实际上构成了储能室的概念,在储能室的概念上的判断,应该以实际功能来看。在一些方案中,储能室可能和平衡室共用。
参考图6a和图6b,本申请还公开了导管鞘,包括相互对接连通的鞘管91和止血阀,止 血阀根据上述技术方案。
鞘管91介入与人体内部,止血阀封闭鞘管,介入器械9从经由止血阀进入鞘管91内,从而进入人体内部,实施治疗过程。
在一实施例中,止血阀上设有与鞘管91连接的管接头,管接头通过密封件与鞘管91配合,且管接头有设有防止鞘管91与管接头分离的卡合结构。在本实施例中,管接头由第二端盖15延伸形成。通过卡合结构的配合,能够实现鞘管91和止血阀的快速组装,也能实现在紧急情况下的分离。
在具体细节操作上,鞘管91的头部设有显影点,方便医护人员在医疗设备的帮助下更好的完成手术过程。
止血阀在使用过程中,对接连通的鞘管和止血阀协同形成器械通道11,其中鞘管可以与两侧的端盖一体化或分体设置。各端盖背向止血阀延伸,从而在器械通道11的轴向上延伸,进一步包裹保护器械通道11以供介入器械9穿行。
本申请还公开了介入器械密封方法,包括利用可形变的密封膜构建器械通道,在密封膜的外周通过流体驱动密封膜形变以密封器械通道,其特征在于,在介入器械进、出器械通道的过程中,利用与流体相联动的储能机构在密封膜形变时相应的储能或释能,以保持介入器械与器械通道间的密封。
在一实施例中,根据上述技术方案中的止血阀实施所述介入器械密封方法。具体的止血阀结构细节详情可参考上文中关于止血阀的描述,在此不再赘述。
参考图7a至图7c,本申请公开了止血阀,包括壳体1以及安装于壳体1内且呈管状结构的密封膜2,管状结构的内腔21作为器械通道11且贯通壳体1,壳体1内设有处在密封膜2***用于填充流体的驱动室12,止血阀还包括增压机构4,用于将血压变化反馈于流体。
密封膜2的功能实际上在壳体1内分隔了两个相互独立的空间,即器械通道11和驱动室12,两者通过密封膜2实现隔离。其中器械通道11两端开放以供器械穿行。
其中本申请中提到的密封膜2的管状结构不局限于严格意义的圆管,在实际产品中,密封膜2的内腔的内径可能在轴向上变化,在截面上,密封膜2的内腔可能为长方形等规整的形状,也可能为沙漏形、梨形、球形等边缘变化的形状,也可能为不规则的变化形状。
在一实施例中,密封膜2的内腔上设有亲水润滑涂层(图未示)。密封膜2的内腔是实际与介入器械9接触的部分,亲水润滑涂层能够降低密封膜2的内腔的摩擦力,方便介入器械9在密封膜2内外存在压差的情况下在器械通道11内穿行。同时,亲水润滑涂层还能通过调节涂层材料来实现其他功能。
在相互作用关系上,驱动室12能够驱动密封膜2改变自身状态,从而实现器械通道11的封闭或开放。器械通道11是在介入治疗过程中介入器械9(例如导管、导丝等)进出人体的通道,因此可以理解为,管状结构所包围的区域至少为器械通道11的一部分。为配合介入器械9的进入,壳体1上相应的开设与器械通道11连通的进、出口,也可视为器械通道11贯通壳体1。驱动室12的作用在于约束流体并将流体做功引导至密封膜2上。密封膜2在封闭器械通道11时,密封膜2自身的管状结构至少一部分会产生径向收拢趋势,从而缩小器械通道11的腔径直至封闭器械通道11。器械处于或不处于器械通道11内,密封膜2均可实现封闭器械通道11或者开放器械通道11。
介入器械处于器械通道11内时,密封膜2的内腔21径向收拢与器械相互配合实现封闭器械通道11。
介入器械不处于器械通道11内时,密封膜2的内腔21径向收拢直至自身相互贴靠闭合以实现封闭器械通道11。
从原理上分析,流体驱动密封膜2主要通过压强实现,当驱动室12内流体压力足以克服器械通道11内的阻力时,驱动室12就能够驱动密封膜2自身形变以改变密封膜2的内腔21。具体器械通道11的封闭效果取决于驱动室12内流体压力大小。改变驱动室12内的流体压力大小可以通过多种形式,例如外接压力源、改变流体温度、改变流体的物理特性等等。本实施例中的增压机构4通过将止血阀一端的血压反馈至流体上,从而改变驱动室12内的流体压力,进一步调整密封膜2的工作状态,从而调整器械通道11的封闭效果。该设计能够改善在介入器械9相对密封膜2运动过程时密封膜2封闭器械通道11的效果,改善医护人员等操作人员的操作体验,提供稳定的治疗过程,提高治疗效果。
壳体1能够限制驱动室12在其他方向上的做功,从而保证流体的能量都作用于密封膜2上,在能量一定的情况下,提高密封膜2形变的行程和封闭的效果。本实施例中提到的刚性是相对于可以形变的柔性的密封膜2而言的,并非物理概念上的刚体的刚性。在实际产品中,壳体1可能为塑料等材料,在流体的作用下可能会发生轻微的变形,但是该轻微的变形不会影响密封膜2的工作效果。下文中刚性的描述同理。在不同的产品中,壳体1可能为金属、塑料等常见材料,也有可能是有机材料或无机材料;也有可能是合成材料或自然材料等等。
在增压机构4的具体设置上,在一实施例中,增压机构4具有采集血压的输入端口41,以及经增压后的输出端口42,增压机构4的输出直接或间接的作用于驱动室12内的流体。
增加机构的能量输入来自血压,因此需要和人体内部建立连接。在止血阀的使用场景中,人体内部的血液环境是很容易连通的。因此增压机构4能够通过简洁的连通关系将血压变化反馈至流体上。在反馈的过程中,增压机构4可以直接与流体作用,也可以通过部件之间的传动间接联动。
从增加机构的结构上来看,在一实施例中,增压机构4包括支撑体40,支撑体40的内部设置有缸径不同的两缸室,各缸室内均密封滑动安装有滑动件,且两缸室内的滑动件相互联动;
输入端口41连通缸径较大的第一缸室401;输出端口42连通缸径较小的第二缸室402。
支撑体40提供了稳定的工作环境,两缸室能够约束各自滑动件的工作行程。滑动件通过与对应缸室内的流体作用从而实现能量的传递。需要解释的是,缸径较大的第一缸室401、缸径较小的第二缸室402中的较大、较小的表述是指第一缸室401和第二缸室402两者想对比的结果。下文同理。
两缸室的缸径不同,能够实现压力调节的效果。根据实际产品的需要,调节血压和流体之间的反馈关系。
在两缸室内的滑动件之间的联动可以通过多种形式实现,例如在一实施例中,两缸室内的滑动件之间通过实体部件实现连接;再例如通过填充流体来实现联动,在一实施例中,两缸室相互连通,在连通部位处为位于两滑动件之间的联动室,两滑动件之间通过共用联动室442内的介质压力相互联动;又例如通过能量场或者力场实现联动,在一实施例中,两缸室内的滑动件之间通过磁场相互联动。
在两缸室的具体分配关系上,参考图10a,在一实施例中,第一缸室401内的滑动件为第一滑动件43,第一滑动件43的一侧为与输入端口41连通的输入室431,另一侧为共用联动室442;
第二缸室402内的滑动件为第二滑动件44,第二滑动件44的一侧为与输出端口42连通的输出室441,另一侧为共用联动室442。
共用联动室442的作用在于为两缸室内的滑动件之间的联动关系提供运动空间。在两缸室内的滑动件运动过程中,输入室431、共用联动室442以及输出室441之间可能发生变化。例如第一滑动件43受血压驱动朝向第二滑动件44的方向运动时,原本属于共用联动室442的部分会被压缩并变为输入室431的空间。
共用联动室442也可以改变设计,变为独立的联动室。参考图8,在一实施例中,两缸室相互隔离,两滑动件通过连接件432直接相连,连接件432的两端密封穿入各缸室与对应的滑动件相连。
在一实施例中,第一缸室401内的滑动件为第一滑动件43,第一滑动件43的一侧为与输入端口41连通的输入室431,另一侧为第一联动室443;
第二缸室402内的滑动件为第二滑动件44,第二滑动件44的一侧为与输出端口42连通的输出室441,另一侧为第二联动室444;
连接件432的两端密封穿入各联动室并与对应的滑动件相连。
分体的联动室设计方式能够方便增压机构4的布置,从而为止血阀针对不同治疗案例调整整体造型提供结构基础。
增压机构4的能量源来自血压,在输入方式的设置上,在一实施例中,止血阀开设有使用状态下可与血管连通的血压反馈孔161,血压反馈孔161通过反馈管路与输入端口41连通。
血压反馈孔161能够实现将血压的压力输送至增压机构4,从而实现血压对增压机构4的能量输送。
从原理上,血压反馈孔161应该设计在止血阀靠近人体的一侧,以实现在止血的同时满足增压机构4的使用要求。具体的,在一实施例中,器械通道11一端为器械入口,另一端为器械出口,血压反馈孔161邻近位于器械出口一侧。
器械出口一侧更靠近人体,血压反馈孔161临近器械出口能方便与人体的血液建立连接。并且可以通过更短的管路实现血压和增压机构4的能量输送,改善增压机构4在动态工况下的工作效果。
在一实施例中,止血阀开设有排气孔(图未示),该排气孔与血压反馈孔161分别配置。
进入体内的导管等医疗器械在使用时,通常需要排除器械内的气体,排气孔能够克服器械使用前携带气体的问题。同时,操作人员可以在使用前通过向排气孔16注射生理盐水去除止血阀内的气体。进一步的,排气孔本身也是一个接口,在特殊的使用场景中能够为特殊操作提供结构基础。排气孔和血压反馈孔161是否分别配置具有不同的优点和局限,可以按需设置。例如排气孔和血压反馈孔161分别配置具有避免排气孔中的气体对血液的影响,提高安全性。在一些产品中,排气孔和血压反馈孔161也可以一同配置。在一实施例中,止血阀开设有排气孔,该排气孔兼做血压反馈孔161,反馈管路上连通有排气旁路,该排气旁路上设置有排气阀。
排气孔兼做血压反馈孔161能够提高止血阀的部件集成度,在增加功能的同时保证止血阀的整体体积。排气阀排出的气体也可以用于增压机构4来实现更好的器械通道11封闭效果。但是相应的,需要单向阀等结构避免排气阀排出的气体对人体内血液的影响。
排气阀的灵活设置可以根据不同病例的使用需要调整。例如排气阀直接安装于排气孔的设计,能够提高止血阀的集成度,方便操作;再例如排气阀通过外部管路连通于排气孔的设 计可以进一步降低止血阀的外部尺寸,提供适应性能。
在增压机构4的安装方式上,在一实施例中,支撑体40与壳体1为一体或分体结构。
参考图8,分体结构的支撑体40与壳体1能够实现增压机构4相对于壳体1灵活布置,从而给介入部位提供更灵活的止血阀积表现,提高适应性;参考图7a和图10a,一体结构的支撑体40与壳体1能够实现增压机构4和壳体1的一体化,减少连通的管路等设置,方便医护人员等操作人员的使用感受,同时减少可能产生故障的环节,尤其是带有压力的管路部分。
在增加机构的内部设置细节上,在一实施例中,两缸室同轴布置、并排布置或内外嵌套布置。
两缸室的不同布置能够带来不同的技术效果。例如同轴布置的两缸室能够方便两滑动件之间的联动设置,从而降低生产装配难度;例如并排布置的两缸室能够有效控制增压机构4在滑动件滑动方向上的长度,改善止血阀的整体空间表现;例如内外嵌套布置的两缸室能够有效控制增压机构4在滑动件滑动方向上和滑动件滑动方向的径向上的尺寸,进一步改善止血阀的整体空间表现;具体的设置方式可以根据止血阀的不同应用场景按需设置。
两缸室的布置形式从另一个维度来说,在一实施例中,两缸室的轴线平行或斜交或垂直。
两缸室的作用在于将血液的压力输送至流体中,轴线方向的设置并不影响两缸室功能的实现,更多的是止血阀整体布局结构的考虑。在实际产品中,可能按需设置。例如,两缸室的轴线方向相互平行的设计能够得到更为规整的整体造型;再例如两缸室的轴线方向斜角或垂直设置的设计能够在一些特殊需要的产品中实现更为紧凑实用的整体造型。
不论两缸室的布置形式如何,增压机构4最终的目的在于将血液的压力输送至流体上,在一实施例中,增压机构4的输出端口42与驱动室12连通。
驱动室12是直接驱动密封膜2形变的腔体,因此增压机构4的输出端口42与驱动室12连通能够直接的将血压变化反应至驱动室12内的流体上,从而带来更为灵敏的工作效果。
参考图10a和图10b,增压机构4可以整合到止血阀中,增压机构4的两滑动件之间除了可以通过连接件432实现两者的相互联动外,通过两者之间的介质压力实现连通。具体的,在一实施例中,增压机构4包括支撑体40,支撑体40的内部设置有缸径不同的两缸室,各缸室内均密封滑动安装有滑动件,且两缸室内的滑动件相互联动;
输入端口41连通缸径较大的第一缸室401;输出端口42连通缸径较小的第二缸室402;
两缸室相互连通,在连通部位处为位于两滑动件之间的联动室,两滑动件之间通过联动室内的介质压力相互联动。
通过介质压力联动的两滑动件能够解放连接件432的物理尺寸的束缚,从而更灵活的布置。更重要的是,介质压力可以在治疗过程中灵活调整,从而带来更丰富的使用方法。
在一实施例中,联动室的室壁上开设有与联动室连通的第四压力调节孔451;缸径较小的缸室室壁上,开设有与输出端口42连通的第五压力调节孔452。
第四压力调节孔451能够调节联动室内的介质压力,从而改变两滑动件之间的联动关系。例如联动室内介质压力较高时,两滑动件之间的联动关系更接近与刚性的传动,在血压变化速度较快或者范围较大等场景中,增压机构4有更好的动态响应表现;再例如联动室内介质压力较低时,两滑动件之间的联动关系更接近与柔性的传动,两滑动件等部分运动能量被联动室内的介质所吸收,从而为增压机构4提供更为柔顺的工作效果。
第五压力调节孔452相较于第四压力调节孔451更为直接,能够直接调节输出端口42压力,从而通过外部压力源直接调节增压机构4的工作结果,为止血阀提供了更为丰富的调节 选择。
相应的,压力调节孔也可以设置在连接件432联动的增压机构4上。在一实施例中,增压机构4包括支撑体40,支撑体40的内部设置有缸径不同的两缸室,各缸室内均密封滑动安装有滑动件,且两缸室内的滑动件相互联动;
输入端口41连通缸径较大的第一缸室401;输出端口42连通缸径较小的第二缸室402;
两缸室相互隔离,两滑动件通过连接件432直接相连,连接件432的两端密封穿入各缸室与对应的滑动件相连。
具体的,在一实施例中,第二缸室402的室壁上分别开设有:
第六压力调节孔453,连通至第二缸室402内滑动件的一侧;第七压力调节孔454,连通至第二缸室402内滑动件的另一侧,且输出端口42也连通于该侧。
第六压力调节孔453调节的是输入端口41的压力,第七压力调节孔454调节的是输出端口42的压力,能够带来更为丰富的调节选项。
其中,第四压力调节孔451、第五压力调节孔452、第六压力调节孔453以及第七压力调节孔454本身也是接口,在特殊的使用场景中能够为特殊操作提供结构基础。
在一实施例中,各压力调节孔连通有调节阀;各调节阀直接安装于相应的压力调节孔或通过外部管路连通于相应的压力调节孔。
调节阀的灵活设置可以根据不同病例的使用需要调整。例如调节阀直接安装于压力调节孔的设计,能够提高止血阀的集成度,方便医护人员等操作人员进行操作;再例如调节阀通过外部管路连通于压力调节孔的设计可以进一步降低止血阀的外部尺寸,提供适应性能。
在一实施例中,壳体1内还设置有平衡室31,驱动室12与平衡室31之间相互连通;
增压机构4的输出端口42与驱动室12和/或平衡室31连通。
平衡室31是一个功能区域的划分,平衡室31可以和驱动室12相互独立的腔体只通过管路连通,也可以共用一个实体腔体只是功能不同。
在平衡室31的作用上,在一实施例中,止血阀还包括可与流体相联动的储能机构3,储能机构3在密封膜2状态变化时相应的储能或释能,用以驱使密封膜2关闭器械通道11;
驱动室12内的流体经由平衡室31与储能机构3联动;
增压机构4的输出直接作用于储能机构3,或增压机构4的输出端口42与驱动室12和/或平衡室31连通。
在介入器械9进入止血阀时,密封膜2需要开放器械通道11以避免干涉介入器械9。因此密封膜2会对驱动室12内的流体做功。若驱动室12内的流体预设的压力太高,则会造成密封膜2变形的驱动力要求太高,介入器械9需要较大的驱动力才能实现挤压密封膜2以开放器械通道11,对医护人员等操作人员的使用造成影响;若驱动室12内的流体预设的压力太低,则会造成密封膜2在封闭器械通道11的状态下密闭压力不足,容易造成密闭失效的情况。
本实施例中的储能机构3可以很好的克服上述问题。在介入器械9进入止血阀时,密封膜2需要开放器械通道11以避免干涉介入器械9。此时密封膜2会对驱动室12内的流体做功,同时储能机构3储能以吸收流体的能量以降低介入器械9的进入难度,为器械的进入过程提供良好的手感;在介入器械9退出止血阀时,密封膜2需要封闭器械通道11以起到止血阀的功能。此时驱动室12内的流体会对密封膜2做功,同时储能机构3释能以实现对流体的做功,保证密封膜2对器械通道11的封闭效果。增压机构4与储能机构3配合,能够进一步 兼顾器械通道11密封效果和介入器械9进入止血阀时的使用手感。
参考图11a和图11b,在一实施例中,储能机构3包括置于平衡室31内的弹性囊35;
增压机构4的输出端口42与平衡室31连通。
弹性囊35能够实现储能或释能,提高储能技能的储能量或者释能量。增压机构4的输出端口42与平衡室31连通,在释能的过程中,除了密封膜2自身的弹性外,弹性囊35和增压机构4能够协同做功以补充流体的能量。增压机构4的输出端口42也有其他设置方式,在一实施例中,储能机构3包括置于平衡室31内的弹性囊35;增压机构4的输出端口42与弹性囊35连通。
当增压机构4的输出端口42与弹性囊35连通时,增压机构4输出的能量通过弹性囊35释放。弹性囊35作为储能机构3的储能部件,能够缓冲增压机构4释放的能量,从而为流体的压力变化提供更为平顺的表现,改善止血阀的整体工作效果。
相应的,储能机构3还能设置为其他方式。参考图7a至图7c,在一实施例中,储能机构3包括:
与平衡室31相连通的储能室33;
在平衡室31与储能室33之间密封滑动的活塞34;
处在储能室33内且与活塞34相作用的可压缩气体和/或弹性件;
增压机构4的输出端口42与储能室33连通。
在该技术方案中,增压机构4实际和储能机构3部件结构共用,联动室起到了储能室33的作用,第二缸室402起到了平衡室31的作用。活塞34的位置变化实现了储能机构3的储能或释能。在储能过程中,能量被可压缩气体和/或弹性件吸收,在释能过程中,可压缩气体和/或弹性件做功以实现释能。储能室33是储能机构3在储能过程中的功能表述,在释能过程中,储能室33在功能上实际为释能。
增压机构4的输出端口42与储能室33连通,在释能的过程中,增压机构4输出的能量通过活塞34释放。活塞34能够缓冲增压机构4释放的能量,从而为流体的压力变化提供更为平顺的表现,改善止血阀的整体工作效果。增压机构4的输出端口42也有其他设置方式,
参考图9,在一实施例中,储能机构3包括:
与平衡室31相连通的储能室33;
在平衡室31与储能室33之间密封滑动的活塞34;
处在储能室33内且与活塞34相作用的可压缩气体和/或弹性件;
增压机构4的输出端口42与平衡室31连通。
增压机构4的输出端口42与平衡室31连通,在释能的过程中,除了密封膜2自身的弹性外,弹性囊35和增压机构4能够协同做功以补充流体的能量。增压机构4的输出效果更为直接,在一些需要较好的动态表现的产品中,更为合适。
增压机构4与人体的血液连通的结构还能为其他功能提供基础。在一实施例中,止血阀还包括与输入端口41相连的血压指示装置(图未示)。
血压在治疗过程中是一个重要的指标,相较于单独配置传感器和输出装置的监视设备而言,通过增压机构4实现的血压指示装置结构简单,稳定易读,方便实现。
在血压指示装置的读数方式上,在一实施例中,血压指示装置为单独配置的血压计或集成至增压机构4。
在一实施例中,增压机构4中至少带有与血压相关的运动部件,增压机构4中设有血压 标识,该血压标识与运动部件的位置相关。
在一实施例中,增压机构4包括支撑体40,支撑体40的内部设置有缸径不同的两缸室,各缸室内均密封滑动安装有滑动件,且两缸室内的滑动件相互联动;
输入端口41连通缸径较大的第一缸室401;输出端口42连通缸径较小的第二缸室402;
运动部件为第一缸室401内的滑动件和/或第二缸室402内的滑动件。
参考图12a至图12b,本申请还公开了导管鞘,包括相互对接连通的鞘管91和止血阀,止血阀为上述技术方案中的一种。
鞘管91介入与人体内部,止血阀封闭鞘管,介入器械9从经由止血阀进入鞘管91内,从而进入人体内部,实施治疗过程。
在一实施例中,止血阀上设有与鞘管91连接的管接头,管接头通过密封件与鞘管91配合,且管接头有设有防止鞘管91与管接头分离的卡合结构。在本实施例中,管接头由第二端盖15延伸形成。通过卡合结构的配合,能够实现鞘管91和止血阀的快速组装,也能实现在紧急情况下的分离。
在具体细节操作上,鞘管91的头部设有显影点,方便医护人员在医疗设备的帮助下更好的完成手术过程。
止血阀在使用过程中,对接连通的鞘管91和止血阀协同形成器械通道11,其中鞘管91可以与两侧的端盖一体化或分体设置。各端盖背向止血阀延伸,从而在器械通道11的轴向上延伸,进一步包裹保护器械通道11以供介入器械9穿行。
本申请还公开了介入器械密封方法,包括利用可形变的密封膜构建器械通道,在密封膜的外周通过流体驱动密封膜形变以密封器械通道,其特征在于,在介入器械进、出器械通道的过程中,利用与流体相联动的储能机构在密封膜形变时相应的储能或释能,以保持介入器械与器械通道间的密封。
在一实施例中,根据上述技术方案中的止血阀实施所述介入器械密封方法。具体的止血阀结构细节详情可参考上文中关于止血阀的描述,在此不再赘述。
如图13~16所示,外平衡式的止血阀,包括壳体100以及安装于壳体100内且呈管状结构的密封膜130,管状结构的内腔作为器械通道131,壳体内设有处在密封膜***的驱动室150,在壳体上开设有与驱动室连通的平衡孔151,在壳体100的外部设有与平衡孔151连通的弹性囊140,弹性囊140通过形变适应驱动室150内的压力变化使得密封膜130关闭或开放器械通道131。
器械通道131是在介入治疗过程中介入器械160(例如导管、导丝等)进出人体的通道,因此可以理解为,管状结构所包围的区域至少为器械通道131的一部分。为配合介入器械7的进入,壳体1上相应的开设与器械通道3连通的进、出口,也可视为器械通道3贯通壳体1。
为了减少介入器械进出止血阀时与密封膜130的摩擦阻力,密封膜130采用非弹性体材质,例如膨体聚四氟乙烯(EPTFE)。
在使用止血阀之前,通过弹性囊140和平衡孔151朝驱动室150内注入流体或水凝胶等平衡介质。为了提高安全性,流体可采用生理盐水。驱动室150内注入平衡介质后的止血阀如图14所示,平衡介质充满弹性囊140,并将弹性囊140收缩产生的压力传递至驱动室150内,使密封膜130贴紧介入器械,阻止血液通过止血阀。
止血阀内***介入器械160时的结构如图15所示,介入器械160沿密封膜130的径向朝 外挤压密封膜130,使驱动室150的体积缩小,驱动室150内多余的平衡介质经由平衡孔151流入弹性囊140内,弹性囊140的体积膨胀并存储弹性势能。
在壳体内,平衡介质驱动密封膜130对介入器械160外周的压力。在壳体外,弹性囊140通过弹性收缩对平衡介质产生压力。壳体内外的两处压力通过流过平衡孔151的平衡介质保持平衡。
随着介入器械160穿出止血阀,密封膜130内被介入器械160占据的空间逐渐缩小。为了维持壳体内外的两处压力保持平衡,弹性囊140通过弹性收缩挤压弹性囊140内的平衡介质,使平衡介质流回驱动室150内,弹性囊140的体积随之缩小,驱动室150的体积随之增大。在此过程中,弹性囊140并未完全回复到如图13所示的自然状态,而是保持一定的弹性形变和收缩压力,从而使密封膜130始终保持对介入器械160外周的压紧力,维持器械通道131的密封。
介入器械160完全穿出止血阀后,止血阀依靠弹性囊140存储的弹性势能恢复到如图14所示的初始状态,密封膜130的内表面相互贴紧,阻止血液通过止血阀。
本实施例通过在壳体外设置囊体,并通过平衡介质和平衡孔保持壳体内外的压力平衡,不需要在止血阀外连接专门的调压装置,体积较小,携带和操作更加方便。
在一实施例中,如图14所示,壳体为刚性的筒状结构且套于密封膜的外周,密封膜的轴向两端与壳体采用密封连接,密封膜的轴向中部与壳体的内壁之间围成驱动室。刚性材质的壳体对密封膜130具有更好的保护作用,还能防止壳体因人体或外物的挤压变形而使驱动室150内的平衡介质压力产生波动。
在一实施例中,如图14所示,壳体包括支撑部110和两个端盖120。平衡孔151贯穿支撑部110的侧壁;两个端盖分别对接于支撑部的轴向两端,各端盖上开设有与器械通道位置相应的避让孔121。端盖120和支撑部110之间采用一体结构或可拆卸连接,一体结构的密封性更好,安全性高。可拆卸连接的结构便于对壳体内的密封膜130和囊体的组装,成本更低。
为了便于操作止血阀,在一实施例中,如图14所示,平衡孔151的位置邻近器械通道131的进口。通过将平衡孔151设置在靠近器械通道131的进口处,既可以使平衡孔151尽量沿径向延伸,降低产品加工难度,又能在壳体外留出较大的持握空间,避免操作时手指误碰弹性囊140。
具体的,在一实施例中,密封膜的轴向两端与壳体的连接方式分别为以下方式的至少一种:与支撑部110粘结固定;与对应侧的端盖120粘结固定;夹持固定在支撑部110与对应侧的端盖120之间;嵌装于支撑部并通过填塞件封堵固定;嵌装于对应侧的端盖并通过填塞件封堵固定;嵌装于支撑部与对应侧的端盖之间并通过填塞件封堵固定。
采用与支撑部110粘结的固定方式,安装端盖120时可以不接触密封膜130,密封膜130不易损坏。采用密封膜130与端盖120粘结固定的方式,更容易保证器械通道131外周的密封性。采用夹持固定在支撑部与对应侧的端盖之间的方式,既容易安装密封膜130和囊体,又能够在密封膜130和端盖120之间获得较好的密封性。另外,为了兼顾密封性和安装方便,也可以在支撑部110或端盖120上设置嵌槽,通过嵌入嵌槽中的填塞件封堵密封膜130两端的周缘。
在一实施例中,弹性囊140包括囊体141、第一接头142和第二接头143。囊体141采用弹性材料且为中空结构;第一接头142与囊体141相对接连通且与平衡孔151对接连通。第 二接头143与囊体141相对接连通并用于灌注可在弹性囊140和驱动室150之间流动的平衡介质。组装时,先将第一接头142插接于平衡孔151内,再通过第二接头143将平衡介质灌满囊体141并封闭第二接头143上端的开口。第一接头142和第二接头143位于囊体141的两相对侧,更容易将囊体141内灌满平衡介质,减少空气的混入。
具体的,在一实施例中,第一接头142和第二接头143与囊体之间为一体结构,密封性更好,平衡介质不易渗漏。在另一实施例中,第一接头142和第二接头143与囊体之间为分体结构,例如囊体141的两端形成管状缩颈部,第一接头142和第二接头143采用比囊体141刚度更高的材质并插接于相应的缩颈部,以保证第一接头142和平衡孔151之间的密封性。
为了封闭第二接头143,使止血阀内维持恒定的介质容量,在一实施例中,第二接头143的开口处安装有密封塞。将囊体141内灌满平衡介质后,使用密封塞封堵第二接头143处的注入口。
为方便注入和封堵平衡介质,在一实施例中,第二接头连接有控制阀(图中未示)。控制阀既可以是完整的阀体结构,也可以是相应的适配结构,例如采用鲁尔接头等方式。
使用时,首先根据介入器械的外周尺寸朝囊体141内注入适应量的平衡介质,再关闭第二接头143上的控制阀,将平衡介质保持在囊体141和驱动室150内,从而获得相对稳定的接触压力。通过控制阀还可以即时的调节囊体的压力。
本申请还提供一种导管鞘,如图17所示,导管鞘包括相互对接连通的鞘管170和止血阀,止血阀为以上实施例中的外平衡式的止血阀。使用时可将鞘管在预穿刺部位伸入体内,采用本申请的止血阀,在介入器械进出的过程中避免血液经由器械通道流出。为了与鞘管对接,其中一端盖上可设置一体或分体结构的管接头122,鞘管170套接固定在管接头122上。
如图18~图21所示,在一实施例中,内平衡式的止血阀包括壳体100以及安装于壳体100内且呈管状结构的密封膜130,管状结构的内腔作为器械通道131且贯通壳体,壳体100内设有处在密封膜***的驱动室,在驱动室内设有与密封膜130相作用的囊体144,囊体144与密封膜130相抵配合用以关闭或开放器械通道。
器械通道131是在介入治疗过程中介入器械160进出人体的通道,因此可以理解为,管状结构所包围的区域至少为器械通道131的一部分。为配合介入器械7的进入,壳体1上相应的开设与器械通道3连通的进、出口,也可视为器械通道3贯通壳体1。
在初始状态下,沿器械通道131的长度方向,密封膜130至少在局部被囊体144挤压而关闭器械通道131。
在有介入器械通过止血阀内时,囊体144被介入器械160的外周挤压而形变或移动,密封膜130的内孔随之变大,从而开放器械通道131。
囊体144既可以采用实心结构也可以采用空心结构。当囊体144采用实心结构时,可以采用硅胶等弹性件材料,在介入器械160进入密封膜130的内腔时,囊体144形变存储弹性势能,介入器械160撤出时囊体144释能并恢复初始状态。
当囊体144采用空心结构时,囊体144可选用弹性材质,囊体144填充流体或水凝胶或其他吸水膨胀材料等,为了提高安全性,流体可采用生理盐水。
在介入器械160进入密封膜130的内腔时,囊体144形变存储弹性势能。在介入器械160通过止血阀后,囊体144存储的弹性势能释放,密封膜130整体或局部通过形变而收缩内孔,关闭器械通道。
在器械通道打开和关闭的过程中,囊体144始终保持对密封膜130的压力,从而保证在 器械通道长度方向上,密封膜130的至少其中一段与介入器械160的外周贴紧,阻止血液流出。
本实施例由于囊体144设置在壳体100的内部,不需要在止血阀外连接专门的调压装置,体积较小,携带和操作更加方便。
在一实施例中,囊体具有通过自身弹性和/或通过填充物保持的涨鼓状态,涨鼓状态下的囊体挤压密封膜以关闭器械通道;介入器械160穿过器械通道时,囊体具有通过自身形变和/或通过位移达到的让位状态,让位状态下的囊体容许密封膜形变以开放器械通道。
为了尽量简化止血阀的结构,便于加工,在一实施例中,囊体144的数量为1个,且至少绕器械通道一周。为了提高止血阀对不同尺寸介入器械160的兼容性,在一实施例中,囊体的数量为多个,各囊体绕器械通道分布在密封膜***,分布方式为周向均匀分布或非均匀分布,各囊体的形状相同或不同。
采用多个囊体相互配合密封介入器械160外周的方式,每个囊体配合密封膜的相应部位将介入器械160外周的一部分密封,可有效减少褶皱的形成,提高密封效果。
综合考虑止血阀的加工成本和密封性,在一实施例中,如图19、图20所示,囊体的数量为2、3或4个。具体的,在器械通道131的长度方向上,囊体144至少在自身中部为形变部145,且各囊体的形变部位置共同作用于密封膜130。
器械通道131的关闭和开放是通过密封膜130的形变实现的。因此,密封膜130需要采用可形变材质,例如柔软可折叠。
在介入器械160通过密封膜130进出人体时,为了防止密封膜130与介入器械160之间发生粘连或摩擦力过大而被介入器械160带出壳体,密封膜130采用非弹性体的材质,尽量减少弹性形变。
在一实施例中,密封膜130采用膨体聚四氟乙烯(EPTFE)。进一步的,在一实施例中,密封膜130的厚度为0.1~0.3mm。
囊体144采用弹性体材质,如橡胶等。
为了限制囊体144径向的形变幅度并有效的储能,壳体100为刚性的筒状结构且套在密封膜130的外周,密封膜130的轴向两端与壳体100采用密封连接,密封膜130的轴向中部与壳体100的内壁之间围成所述驱动室。
筒状结构并不严格限制截面形状,例如可采用圆形或椭圆形等,在沿器械通道的长度方向上,壳体各部位的截面积可适当变化,可与囊体144的形状变化相匹配,为了避让器械通道,壳体100至少具有两处开口,且将密封膜130的外周包围。
在一实施例中,如图19所示,壳体100包括支撑部110和两个端盖120。器械通道131贯通支撑部110。两个端盖120分别对接于支撑部110的轴向两端,各端盖120上开设有与器械通道位置相应的避让孔121。
端盖120和支撑部110之间采用一体结构或可拆卸连接,一体结构的密封性更好,安全性高。可拆卸连接的结构便于对壳体内的密封膜130和囊体144的组装,成本更低。在一实施例中,密封膜130的轴向两端与壳体100的连接方式分别为以下方式的至少一种:与支撑部110粘结固定;与对应侧的端盖粘结固定;夹持固定在支撑部与对应侧的端盖之间;嵌装于支撑部;嵌装于对应侧的端盖;嵌装于支撑部与对应侧的端盖之间。
采用与支撑部110粘结固定的方式,安装端盖120时可以不接触密封膜130,密封膜130不易损坏。采用密封膜130与端盖120粘结固定的方式,更容易保证器械通道131外周的密 封性。采用夹持固定在支撑部与对应侧的端盖之间的方式,既容易安装密封膜130和囊体144,又能够在密封膜130和端盖120之间获得较好的密封性。另外,为了兼顾密封性和安装方便,也可以在支撑部110或端盖120上设置嵌槽,采用与嵌槽相配合的嵌条或嵌圈等部件将密封膜130的两端嵌入支撑部110或端盖120。
在一实施例中,支撑部110包括球壳状的中段111以及对接于中段两侧的缩径段112,两个端盖120分别插接固定于对应侧的缩径段112,驱动室处在中段的内部。
沿器械通道131的方向,止血阀中部相对两端胀大并形成驱动室,为囊体144提供了容纳空间。通过插接的方式安装端盖120更方便产品的组装,具体的,可以先将密封膜130的一端套接在其中一端盖120的外圈,在囊体144的让位状态下,将密封膜130的另一端伸入缩径段112的内孔中,再将另一端盖插接入密封膜130内,使密封膜130夹在缩径段112和端盖120之间。为了进一步保证连接强度,端盖120与缩径段112之间还可以进一步设置螺栓或螺钉。
在另一实施例中,缩径段112和端盖120之间也可以采用螺纹配合,例如密封膜130的两端固定于支撑部110,而端盖120采用螺纹方式与缩径段112相连。
具体的,壳体100和/或各端盖上设有定位槽,囊体沿器械通道的长度方向延伸,且囊体的两端分别插接固定在相应侧定位槽内。在一实施例中,如图19所示,定位槽开设在壳体100内壁。
在一实施例中,支撑部或至少一端盖开设有注射通道152,囊体的至少一端为开放结构且连通至注射通道152,支撑部或至少一端盖上开设有与注射通道152连通的注射口153。
通过注射通道152和注射口153将囊体144的内腔连通至壳体100的外部。在应对不同外周尺寸的介入器械160或需要调节囊体压力时,可直接通过注射通道152和注射口153向囊体144内注入或吸出气体或液体。
具体的,在一实施例中,如图21所示,注射口153安装有密封塞,或注射口密封插接有连接管154,该连接管154上安装有控制阀(图中未示)。控制阀既可以是完整的阀体结构,也可以是相应的适配结构,例如采用鲁尔接头等方式。
使用时,首先根据介入器械160的外周尺寸朝囊体144内注入适应量的填充物,再关闭连接管154上的控制阀,将填充物保持在囊体144内,从而获得相对稳定的接触压力。通过控制阀还可以即时的调节囊体144的压力。
参考图23a和图23b,本申请还公开了一种多腔体的止血阀,包括壳体1以及安装于壳体1内且呈管状结构的密封膜2,管状结构的内腔21作为器械通道11,沿器械通道11的径向,壳体1内设有处在密封膜2***用于填充流体的驱动室12和位于驱动室12外侧的平衡室31,驱动室12与平衡室31之间相互连通且平衡室31环绕在驱动室12的外周;
止血阀还包括可与流体相联动的储能机构3,驱动室12内的流体经由平衡室31与储能机构3联动;储能机构3在密封膜2状态变化时相应的储能或释能,且在释能时驱使密封膜2密封闭器械通道11。
平衡室31环绕在驱动室12的外周能够从多个方向向驱动室12提供用于驱动密封膜2运动的流体,从而实现封闭器械通道11。平衡室31内的流体的动力通过储能机构3来提供,因此在装配过程中,可以向储能机构3预先输入能量,来提高止血阀对不同外径的介入器械9的适应能力。
参考图24a至图27b,本申请还公开了一种多腔体的止血阀,包括壳体1以及安装于壳 体1内且呈管状结构的密封膜2,管状结构的内腔21作为器械通道11,沿器械通道11的径向,壳体1内设有处在密封膜2***用于填充流体的驱动室12和位于驱动室12外侧的平衡室31,驱动室12与平衡室31之间相互连通且平衡室31环绕在驱动室12的外周;
止血阀还包括可与流体相联动的储能机构3,驱动室12内的流体经由平衡室31与储能机构3联动;储能机构3在密封膜2状态变化时相应的储能或释能,且在释能时驱使密封膜2密封闭器械通道11。
平衡室31环绕在驱动室12的外周能够从多个方向向驱动室12提供用于驱动密封膜2运动的流体,从而实现封闭器械通道11。在实际的环绕形式上,具有多种实现方式。例如,在一实施例中,平衡室31有多个且在驱动室12的外周间隔布置,针对每个平衡室31分别配置储能机构3;进一步的,各平衡室31均匀或不均匀间隔设置在驱动室12的外周。再例如,在一实施例中,各平衡室31通过独立的平衡孔311与驱动室12连通或者至少两个平衡室31共用同一个平衡孔311与驱动室12连通,进一步的,各平衡室31通过同一个平衡孔311与驱动室12连通。再例如,在一实施例中,平衡室31的数量为2至8个。
储能机构3的不同设置和以及各种设置方式之间的搭配也会产生影响。例如,在一实施例中,储能机构3包括:储能室33;壳体1内还设置有平衡室31,驱动室12与平衡室31之间相互连通;活塞34,密封滑动在平衡室31与储能室33之间;储能元件,储能元件为处在储能室33内且与活塞34相作用的可压缩气体和/或弹性件341;壳体1上设有至少两个供活塞34滑动的筒状空间,筒状空间被活塞34分割为平衡室31和储能室33。再例如,在一实施例中,各活塞34通过自身外缘的密封边缘和对应的筒状空间的内壁密封配合,在活塞34的滑动方向上,密封边缘与筒状空间的内壁至少设有两道密封。再例如,
在一实施例中,壳体1上设有至少两个供活塞34滑动的筒状空间,各筒状空间内设有独立的储能元件,且各储能元件的储能性能一致或不一致。
具体的组合形式以及带来的技术效果可以参考下文中示例性给出的几种实施方式。
参考图24a至图24d的实施例中,平衡室31的数量为优选为三个,各平衡室31均匀间隔设置在驱动室12的外周,且分别用独立的平衡孔311与驱动室12连通,每个平衡室31分别配置储能机构3,储能机构3包括:储能室33;壳体1内还设置有平衡室31,驱动室12与平衡室31之间相互连通;活塞34,密封滑动在平衡室31与储能室33之间;储能元件,储能元件为处在储能室33内且与活塞34相作用的可压缩气体和/或弹性件341;各活塞34通过自身外缘的密封边缘和对应的筒状空间的内壁密封配合,在活塞34的滑动方向上,密封边缘与筒状空间的内壁至少设有两道密封,密封边缘的两道密封之间设有密封间隙。
从各部件的设计原理上来看,平衡室31数量上的增加能够提供更为均匀,细致的密封膜2驱动效果,但是数量如果太多,会增加壳体1的加工难度;而且在相同体积的壳体1下,相邻平衡室31之间的侧壁会变薄,从而带来相应的隐患,因此平衡室31的数量优选为2至8个。平衡室31均匀间隔设置在驱动室12的外周能够带来良好的观感的同时,还能够为器械通道11的各个方向提供较为稳定的作用力,相应的,在一些特殊情况中,平衡室31也可以不均匀间隔设置在驱动室12的外周,从而提供不均匀的驱动力以实现特殊的效果。在本实施例中,各平衡室31分别用独立的平衡孔311与驱动室12连通,该设计带来的好处是可以避免平衡室31之间相互干扰工作过程,能够提供更为细致的调节效果。相应的,在一些特殊情况下,各平衡室31也可以共用平衡孔311与驱动室12连通,该设计的优点在于能够同步不同平衡室31的工作过程,具体的设计可以根据不同的工况和设计需要来调整。在储能机构 3的设置上,活塞34为主要的做功部件,储能元件在本实施例中为弹性件341,两端分别抵压活塞34和第三端盖332来实现储能和释能。因此,活塞34需要能够保证与筒状空间的良好密封来避免流体的压力泄漏,在本实施例中,通过活塞34自身的两道密封边缘来实现。同时为了避免过大的密封接触面积带来的阻力,在密封边缘之间还设有密封间隙,该密封间隙还能够释放密封边缘的形变,从而提升密封效果。
在具体产品中,除了平衡室31是否均匀设置在驱动室12外周外,还能够通过不同平衡室31之间的区别设置来实现不同的效果。例如本实施例中,各筒状空间的直径长度相同,弹性件341的弹性系数相同,以获得更为均衡的流体驱动效果。在其他实施例中,各筒状空间的直径长度可以不同,弹性件341的弹性系数也可以不同,从而能根据不同的工况和设计需求灵活调整。相应的,当储能元件为可压缩气体是,可压缩气体的理化指标也可以调整,例如可压缩气体的预设工作压力、预设工作温度等参数可以相应变化。
本实施例的产品在装配过程中,可以按照以下方式操作:从第一压力调节孔32注入一定量的液体,使活塞34略微向左移动,保持稳定,这时平衡室31与储能室33压力平衡,密封膜2被驱动室12内的液体挤压并紧贴,将器械通道11密封;
通过排气孔16将器械通道11进入体内一侧的气体排尽,然后***血管,此时血管与导管鞘连通,形成一个器械进入的窗口,而血液被密封膜2密封在体内。
本实施例的产品在进行介入手术时,器械从密封膜2中间处进入体内,并被密封膜2紧紧包裹,血液始终被密封膜2阻挡在体内。而器械穿过通道,驱动室12因体积变小而压力上升,从而通过液体推动活塞34向左运动,弹性件341被压缩储能,内部压力达到一个新的平衡,仍可密封。当器械退出时,弹性件341释能,推动活塞34向右运动。回到初始状态。在器械出入过程中,密封膜2始终被挤压,持续密封。
参考图25a至图25d,本申请还公开了一种多腔体的止血阀,包括壳体1以及安装于壳体1内且呈管状结构的密封膜2,管状结构的内腔21作为器械通道11,沿器械通道11的径向,壳体1内设有处在密封膜2***用于填充流体的驱动室12和位于驱动室12外侧的平衡室31,驱动室12与平衡室31之间相互连通且平衡室31环绕在驱动室12的外周;
止血阀还包括可与流体相联动的储能机构3,驱动室12内的流体经由平衡室31与储能机构3联动;储能机构3在密封膜2状态变化时相应的储能或释能,且在释能时驱使密封膜2密封闭器械通道11。平衡室31的数量为优选为六个。在不考虑产品体积和生产工艺等其他情况下,理论上平衡室31设置数量是越多越好。根据目前产品的驱动室12与平衡室31的体积,以及从结构设计、弹簧选型到量产化,考虑功能及成本,目前最佳的腔体数量为5~6个。
本实施例的主要差别在于平衡室31的数量,6个平衡室31能够实现更好的器械兼容性,器械在通过时阻力表现比较少平衡室31的实施例更好。
除了平衡室31的不同设置外,储能元件也能相应变化和调整。参考图26a至图26d,本申请还公开了一种多腔体的止血阀,包括壳体1以及安装于壳体1内且呈管状结构的密封膜2,管状结构的内腔21作为器械通道11,沿器械通道11的径向,壳体1内设有处在密封膜2***用于填充流体的驱动室12和位于驱动室12外侧的平衡室31,驱动室12与平衡室31之间相互连通且平衡室31环绕在驱动室12的外周;
止血阀还包括可与流体相联动的储能机构3,驱动室12内的流体经由平衡室31与储能机构3联动;储能机构3在密封膜2状态变化时相应的储能或释能,且在释能时驱使密封膜2密封闭器械通道11。储能元件包括弹性件341和可压缩气体。
壳体1是一个带有多个筒状空间的实体,中间一个器械通道11,在器械通道11四周的筒状空间用于安装多个活塞34以形成储能室33和平衡室31,其中平衡室31与驱动室12相连,每个储能室33内内置一个弹簧,且储能室33有一个第二压力调节孔331,第二压力调节孔331在本实施例中用于实现注入气体的功能。壳体1与第二端盖15相连,内置一个密封件用于密封,其中第二端盖15上设置有第一压力调节孔32;第二端盖15与第一端盖14将密封膜2固定密封在壳体1上。排气孔16与血液连通,用于排除器械通道11内的气体。
相较于储能元件为单独弹性件341的设置方式而言,本实施例增加气体这一压缩介质,便于不同直径器械通过的阻力的调节,更灵活,但是相应的,对储能室33、平衡室31以及涉及部件的密封性要求较高,工艺相对复杂。
根据附图不难看出,在本实施例中,每个平衡室31实际上能够通过驱动室12实现相互联通,即密封膜2为一个整体,驱动室12围绕密封膜2布置并与各个平衡室31联通。在其他实施例中,密封膜2可以不是一个整体,多个密封膜2组合一同实现器械通道11的封闭;在该实现方式中,不同密封膜2之间的驱动室12可以不连通,相应的,不同驱动室12之间平衡室31也不联通。
同理的,储能元件还能进一步变化。参考图27a至图27d,本申请还公开了一种多腔体的止血阀,包括壳体1以及安装于壳体1内且呈管状结构的密封膜2,管状结构的内腔21作为器械通道11,沿器械通道11的径向,壳体1内设有处在密封膜2***用于填充流体的驱动室12和位于驱动室12外侧的平衡室31,驱动室12与平衡室31之间相互连通且平衡室31环绕在驱动室12的外周;
止血阀还包括可与流体相联动的储能机构3,驱动室12内的流体经由平衡室31与储能机构3联动;储能机构3在密封膜2状态变化时相应的储能或释能,且在释能时驱使密封膜2密封闭器械通道11。储能元件包为可压缩气体。
本实施例的产品在装配过程中可以按照如下方式操作:
先从第二压力调节孔331注入一定体积的气体。再从第一压力调节孔32注入一定量的液体,使活塞34略微向左移动,保持稳定,这时储能室33与驱动室12压力平衡,密封膜2被驱动室12内的液体挤压并紧贴,将器械通道11密封。
本实施例的产品在使用过程中可以按照如下方式操作:通过第一压力调节孔32将器械通道11进入体内一侧的气体排尽,然后***血管,此时血管与导管鞘连通,形成一个器械进入的器械通道11,而血液被密封膜2密封在体内。当进行介入手术时,器械从密封膜2中间处进入体内,并被密封膜2紧紧包裹,血液始终被密封膜2阻挡在体内。而器械穿过通道,驱动室12因体积变小而压力上升,从而推动活塞34向左运动,可压缩气体被压缩储能,内部压力达到一个新的平衡,仍可密封。当器械退出时,可压缩气体释能,推动活塞34向右运动。回到初始状态。在器械出入过程中,密封膜2始终被挤压,持续密封。
相较于储能元件为弹性件341和可压缩气体结合的设置方式而言,本实施例在纯可压缩气体作为弹性介质的情况下,不同直径器械通过的阻力进一步趋于平缓;便于不同直径器械通过的阻力的调节,更灵活。相应的,对储能室33、平衡室31以及涉及部件的密封性要求较高,工艺相对复杂。
结合上述几个实施例综合来看,多个平衡室31构成的多腔体结构相对于其他实施方式的单腔体而言,具有以下优点和设计出发点:
1、结构简单可靠,对弹簧的弹性性能要求较低,且便于量产;
2、多腔结构对不同器械的兼容性较强,通过阻力可以稳定在一个较小的范围,可以概括为通过直径的器械通过阻力基本相同;
3、最佳腔体数量需根据驱动室12的体积与平衡室31的体积进行计算,最大器械进入器械通道11使得驱动室12排出液体的体积使多个平衡室31内的活塞34同时移动小于5mm,移动的行程越小越好。
上文中的第三端盖332用于封闭储能室33,在本实施例中,多个平衡室31的设置会让第三端盖332的数量增多,安装流程复杂,造成不必要的稳定性隐患,因此在本实施例中第三端盖332的功能由第一端盖14实现。
在本实施例中,第二端盖15也具有细节上的变化,为了方便组装和实现各部件之间的紧凑配合,第二端盖15实际上具有两个部分,分别用于实现与壳体1的配合以及鞘管的安装,两部分上分别设有上文中提到的第一压力调节孔32和排气孔16。
从整体产品上来看,止血阀还包括用于输送流体的压力调节结构(图未示)。参考一实施例中,止血阀还包括压力调节结构,压力调节结构设有用于提供流体的流体管路,流体管路直接或间接的与平衡室或驱动室或平衡孔连通。
流体管路可以直接与平衡室或驱动室或平衡孔中的任一者连通,也可以和多者直接连通,也可以通过平衡室、驱动室、平衡孔三者中的相互连通来实现间接连通。在实际产品中,具有多种变形方式,但是从实现原理上,流体管路的流体需要能够实现填充驱动室的功能。流体管路中的流体是由压力调节结构提供的,压力调节机构可以选择临床上常用的柱塞泵或者蠕动泵等形式,也可以简化设计,降低生产成本,例如可以是临床上常用的针筒式的输送筒,也可以是单独的输送设备。具体可以根据实际需要灵活调整。
具体连接关系上,参考一实施例中,平衡室设有多个且周向分布在驱动室外侧,各平衡室通过独立的平衡孔与驱动室连通;各平衡孔一侧与驱动室联动,另一侧在径向上延伸至壳体的外周壁上,各平衡孔在外周壁上封闭或与流体管路对接。平衡孔自身延伸形成通道,能够连通驱动室、平衡室。平衡孔延伸至壳体的外周壁上一端可以通过封堵材料实现封闭或者开放与流体管路对接,用于接受流体。具体封闭的数量和开放的数量可以按需调整。
本发明还公开了一种导管鞘组件,包括轴向延伸的鞘管,鞘管具有轴向贯通的腔体,鞘管具有近端和远端,鞘管近端连接有上述止血阀。
在一实施例中,鞘管的远端设有显影环。
本发明还公开了一种基于止血阀的介入器械密封方法,止血阀包括壳体以及安装于壳体内且呈管状结构的密封膜,管状结构的内腔作为器械通道且贯通壳体,壳体内设有处在密封膜***可填充流体的驱动室以及可与流体联动的储能机构,介入器械密封方法包括:
向驱动室内注入流体,流体驱动密封膜关闭器械通道,流体还作用于储能机构,使储能机构预储能以保持密封膜状态;
向器械通道内***介入器械时,密封膜受介入器械挤压形变且通过流体驱使储能机构储能;
介入器械撤出器械通道时,储能机构释能,通过流体驱动密封膜形变关闭器械通道。
从止血阀来看,止血阀包括:
壳体以及安装于壳体内且呈管状结构的密封膜;
密封膜具有内表面和外表面,密封膜内表面形成一用于***器械的器械通道;
壳体具有内壁,壳体内壁与密封膜外表面形成一驱动室,驱动室用于填充流体;
止血阀还包括可与流体相联动的储能机构;
驱动室和/或连接有流体管路。
从止血阀的的密封方法来看:
经流体管路往驱动室内注入预定流体,驱动室内的流体与储能机构联动,储能机构储能,密封膜关闭,器械通道密封;
往器械通道内***器械,驱动室内的流体与储能机构联动,储能机构进一步储能。
本实施例中,通过储能机构的设计提高了止血阀的变化范围,能够允许不同外径的器械穿过器械通道同时保证密封效果,克服了相关技术中介入器械穿行手感和允许介入器械穿行的尺寸范围之间的矛盾。从而自动调节驱动室内压力,提高器械的穿过性。
在一实施例中,驱动室还连通有流体管路,并通过该流体管路连接外部流体源。在流体管路的具体设置上,参考一实施例中,流体管路上配置有控制阀。控制阀能够实现流体管路的流量调节等功能。在流体管体的连通设置上,参考一实施例中,驱动室还连通有平衡室,驱动室内的流体经由平衡室与储能机构联动;流体管路与驱动室的连通方式为一下方式的至少一种:
直接连通至驱动室;或
直接连通至平衡室;或
直接连通至驱动室与平衡室之间。
流体管路在提供流体时,需要流体源提供动力支撑。参考一实施例中,外部流体源由一压力调节结构提供。压力调节机构具有多种设置方式,参考一实施例中,压力调节结构的驱动方式为手动、电动或气动。在具体的选择上,压力调节机构可以选择临床上常用的柱塞泵或者蠕动泵等形式,具体可以根据实际需要灵活调整。从压力调节机构的实现原理上,参考一实施例中,压力调节结构至少具有一储存室,流体管路与该储存室连通。
在平衡室和驱动室的具体设置上,参考一实施例中,壳体内形成有筒状空间,储能机构包括:
活塞,滑动设置在筒状空间内,且将筒状空间分隔为平衡室和储能室;
储能元件,处在储能室内,且储能元件为与活塞相作用的气体和/或弹性件。
在筒状空间和壳体的配合方式上,参考一实施例中,壳体为环形,且具有环形壁,筒状空间处在环形壁内。
筒状空间具有多种设计形式,例如轴线为曲线形式,筒状空间的截面发生变化的异形筒,为了保证储能机构的平稳运行和加工难度,参考一实施例中,筒状空间为直筒结构,且直筒结构的轴线与壳体的轴线相互平行。在筒状结构的具体选择上,参考一实施例中,筒状空间为一个或多个。相应的,筒状空间为2~8个。相应的,筒状空间沿壳体的周向依次分布。
筒状结构为平衡室和驱动室提供的实际空间,在整体配合关系上,参考一实施例中,器械通道沿壳体的轴线贯通壳体。
本申请还提供一种导管鞘,如图22所示,导管鞘包括相互对接连通的鞘管170和止血阀,止血阀为以上实施例中的内平衡式的止血阀。使用时可将鞘管170在预穿刺部位伸入体内,采用本申请的止血阀,在介入器械160进出的过程中避免血液经由器械通道流出。为了与鞘管对接,其中一端盖上可设置一体或分体结构的管接头122,鞘管170套接固定在管接头122上。
上文中各实施例中的止血阀均能够实现与鞘管的配合。本申请也公开了一种鞘管,包括 管壁204,管壁204为卷壁结构,横截面为盘绕形,管壁204具有展开相应部位卷壁结构的受胀状态以及自行恢复卷壁结构的预定型状态。
在一实施例中,管壁204为能够在受胀状态和预定型状态之间自主切换的弹性材料。
在一实施例中,预定型状态的管壁204外径为4-9mm。
在一实施例中,预定型状态的管壁204卷绕大于一个圆周,超出360度圆周部分与360度内的部分相互叠搭。
在一实施例中,相互叠搭部位具有光滑的接触面。
在一实施例中,预定型状态的管壁204卷绕小于720度。
在一实施例中,卷壁结构在周向上卷绕的起始侧209和末尾侧210通过柔性包络膜连接。
在一实施例中,柔性包络膜的转折处设有折痕线。
在一实施例中,柔性包络膜壁厚为0.1-1mm。
在一实施例中,柔性包络膜为周向封闭的管状结构,柔性包络膜管状结构截面周长大于管壁204截面的壁长,管壁204固定贴覆在柔性包络膜的外壁。
在一实施例中,管壁204的远端外周包裹有弹性套206。
在一实施例中,管壁204的远端与鞘柄连接,连接部由弹性套206包裹。
在一实施例中,弹性套206的轴向长度为5~50cm。
在一实施例中,管壁204的外部包有用于将管壁204限定在预定型状态的束套,且该束套在管壁204受胀状态下涨裂。
在一实施例中,束套沿管壁204轴向延伸出管壁204近端,延伸出的部位为收口结构。
在一实施例中,卷壁结构在周向上卷绕的末尾侧210上,在临近管壁204近端处为切角结构。
具体的参见附图28a至图29f所示,本实施例中,鞘管的管壁204为卷壁结构,横截面为盘绕形,管壁204具有展开相应部位卷壁结构的受胀状态以及恢复卷壁结构的预定型状态。
预定型状态下,鞘管外径为5mm(15Fr),内径4mm。在受胀状态下内径可达8mm(24Fr),能够通过相应的直径输送鞘管。
参见图28b,鞘管的远端安装有与输送装置配合的接头205,鞘管与接头205的连接处被弹性套206包裹。可以防止血液(或体液)从管壁搭接部分的缝隙处外逸。弹性套选用弹性尼龙,厚度为0.1-0.2mm。
在周向上,卷壁结构由起始侧开始螺旋延伸,直至末尾侧,起始侧的末尾侧边界可沿鞘管轴向延伸或绕鞘管轴线螺旋延伸,图28b可见末尾侧边界207为直线且沿鞘管轴向延伸。采用螺旋线时,可使鞘管弯曲时的受力分布更均匀些。
结合图28c~图28f,介入器械由右向左穿行,经过之处会挤压管壁内侧,使得管壁的卷壁结构相应展开,受压部位208即转入受胀状态。
介入器械9穿过后,由于管壁204自身的弹性会自行复原,回到初始的预定型状态。
本实施例中管壁材质选自HDPE或Pebax等,为了保证管壁能够自主复原,且保持一定的强度和顺应性,管壁的厚度为0.5mm。
参见图29a,为未植入器械时,处于预定型状态(初始状态时)下鞘管的截面示意图,为了包覆并形成输送鞘管的通道,预定型状态的管壁卷绕大于360度,即从卷绕的起始侧209至末尾侧210在周向上延伸大于360度,超出360度部分与未超出360度的部分相叠。
图29a中可见,超出部分211与未超出部分212相互搭接,超出部分211包裹在未超出 部分212的外周,管壁内部形成完整的通道。
图29c为植入介入器械9时,鞘管受胀时的截面示意图。为了避免受胀状态下输送鞘管以及植入器械不外露,图29c可见,受胀状态下的管壁卷绕大于等于360度,即仍有重叠搭接区域213。
图29e中即重叠搭接区域213加大,管壁卷绕的度数即所对应的圆心角越大进一步加大为540度,其展开后会获得更大的内径,容许通过更粗的介入器械9。
如图29a所示,尽管超出部211与未超出部分212相互搭接,但并非相对固定,它们之间可相对滑动,形成间隙,使得血液或体液有可能进出管壁,为了在不同状态下,均可以形成介入器械的封闭通道,本发明提供了另一种实施方式,通过在管壁的起始侧和末尾侧设置柔性包络膜的形式,封闭管壁。
图29b中,管壁卷绕的起始侧209和末尾侧210通过柔性包络膜214连接。柔性包络膜主要起到一个径向的支撑力,束缚植入器械,防止其外露,同时还可阻止血液或体液溢出管壁。
柔性包络膜214由于在管壁切换状态时要打折或扭动,因此壁厚以及刚度比管壁本身要低。本实施例柔性包络膜214采用PTFE材料,壁厚为0.25-0.5mm。
管壁无论出于何种状态,柔性包络膜214均可以保持鞘管的封闭,柔性包络膜214可以通过焊接等方式与管壁相固定。
为了收纳柔性包络膜214,柔性包络膜214处在管壁搭接部分的中间层。柔性包络膜214在周向上可以延伸一段,即并没有360的包络整个管壁的的内腔,在预定型状态下,柔性包络膜214绷紧在管壁卷绕的起始侧209和末尾侧210之间,柔性包络膜214的作用是封闭起始侧209和末尾侧210之间形成的间隙,防止血液或体液有进出管壁。因此柔性包络膜214与管壁的固定点并不严格要求在起始侧209和末尾侧210,也可以适当调整。
图29d中,作为另一实施方式,柔性包络膜214为周向封闭的管状结构,管壁固定贴覆在柔性包络膜214的外壁,柔性包络膜214的其中一部分为迂回部分215,迂回部分215处在管壁的起始侧209和末尾侧210之间。
迂回部位215的转折处216以及转折处217设有折痕线,折痕线可以通过热定型处理加工,在预定型状态下,折痕线可使得迂回部位的转折处更加平整。
参见图29f,迂回部位215在管壁受胀状态下展开,可以容许管壁具有更大的形变范围。
以上所述实施例的各技术特征可以进行任意的组合,为使描述简洁,未对上述实施例中的各技术特征所有可能的组合都进行描述,然而,只要这些技术特征的组合不存在矛盾,都应当认为是本说明书记载的范围。不同实施例中的技术特征体现在同一附图中时,可视为该附图也同时披露了所涉及的各个实施例的组合例。
以上所述实施例仅表达了本申请的几种实施方式,其描述较为具体和详细,但并不能因此而理解为对申请专利范围的限制。应当指出的是,对于本领域的普通技术人员来说,在不脱离本申请构思的前提下,还可以做出若干变形和改进,这些都属于本申请的保护范围。
Claims (87)
- 止血阀,包括壳体以及安装于壳体内且呈管状结构的密封膜,所述管状结构的内腔作为器械通道,所述壳体内设有处在所述密封膜***用于填充流体的驱动室,其特征在于,所述止血阀还包括可与所述流体相联动的储能机构,所述储能机构在所述密封膜状态变化时相应的储能或释能,且在释能时驱使所述密封膜密封闭所述器械通道。
- 根据权利要求1所述的止血阀,其特征在于,所述止血阀具有驱动室填充流体的工作状态,以及未填充流体的初始状态,所述流体为不可压缩的液体。
- 根据权利要求2所述的止血阀,其特征在于,所述流体为生理盐水或水。
- 根据权利要求1所述的止血阀,其特征在于,所述密封膜具有受介入器械挤压以开放器械通道的第一状态,所述储能机构受流体驱动储能;所述密封膜具有受流体驱动以关闭器械通道的第二状态,所述储能机构释能以维持将所述密封膜保持在第二状态的流体压力。
- 根据权利要求4所述的止血阀,其特征在于,所述壳体至少在所述驱动室的外周为刚性结构。
- 根据权利要求5所述的止血阀,其特征在于,所述壳体整体上为刚性结构。
- 根据权利要求6所述的止血阀,其特征在于,所述壳体采用透明材料。
- 根据权利要求1所述的止血阀,其特征在于,所述壳体内开设有贯通区,所述密封膜布置于该贯通区,所述密封膜的外周与所在贯通区内壁之间围成所述驱动室。
- 根据权利要求8所述的止血阀,其特征在于,所述贯通区的两开放端分别密封安装有第一端盖和第二端盖,各端盖上开设有与所述器械通道相应的避让孔,所述密封膜的轴向两端夹持固定在所述壳体与相应侧的端盖之间。
- 根据权利要求9所述的止血阀,其特征在于,所述器械通道一端为器械入口,另一端为器械出口,位于器械出口一侧的端盖上开设有径向贯通的排气孔。
- 根据权利要求10所述的止血阀,其特征在于,所述排气孔连通有排气阀;所述排气阀直接安装于所述排气孔或通过外部管路连通于所述排气孔。
- 根据权利要求11所述的止血阀,其特征在于,各端盖通过螺钉固定于所述壳体。
- 根据权利要求1所述的止血阀,其特征在于,所述壳体内还设置有平衡室,所述驱动室与所述平衡室之间相互连通,所述驱动室内的流体经由所述平衡室与所述储能机构联动。
- 根据权利要求13所述的止血阀,其特征在于,沿所述器械通道的径向,所述平衡室处在所述驱动室的外侧。
- 根据权利要求14所述的止血阀,其特征在于,所述平衡室环绕在所述驱动室的外周。
- 根据权利要求13所述的止血阀,其特征在于,所述平衡室与所述驱动室之间开放式连通。
- 根据权利要求13所述的止血阀,其特征在于,所述驱动室与所述平衡室之间相互隔离,仅通过平衡孔连通。
- 根据权利要求17所述的止血阀,其特征在于,所述器械通道一端为器械入口,另一端为器械出口,所述平衡孔邻近所述器械出口。
- 根据权利要求13所述的止血阀,其特征在于,所述平衡室或所述驱动室的室壁开设有第一压力调节孔。
- 根据权利要求19所述的止血阀,其特征在于,所述第一压力调节孔连通有第一调节阀;所述第一调节阀直接安装于所述第一压力调节孔或通过外部管路连通于所述第一压力调节孔。
- 根据权利要求1所述的止血阀,其特征在于,所述储能机构包括储能室和安装在所述储能室内的储能元件,所述储能元件在所述密封膜状态变化时相应的储能或释能。
- 根据权利要求21所述的止血阀,其特征在于,所述储能机构包括:所述储能室;所述壳体内还设置有平衡室,所述驱动室与所述平衡室之间相互连通;活塞,密封滑动在所述平衡室与所述储能室之间;所述储能元件,所述储能元件为处在所述储能室内且与所述活塞相作用的可压缩气体和/或弹性件。
- 根据权利要求22所述的止血阀,其特征在于,所述储能室的室壁开设有第二压力调节孔。
- 根据权利要求23所述的止血阀,其特征在于,所述器械通道一端为器械入口,另一端为器械出口,沿所述器械通道的轴向,所述平衡室邻近器械出口,所述储能室邻近器械入口。
- 根据权利要求24所述的止血阀,其特征在于,所述储能室在背向所述平衡室的一侧为开放结构且密封安装有第三端盖,所述第二压力调节孔设置在该第三端盖上。
- 根据权利要求23所述的止血阀,其特征在于,所述第二压力调节孔连通有第二调节阀;所述第二调节阀直接安装于所述第二压力调节孔或通过外部管路连通于所述第二压力调节孔。
- 根据权利要求22所述的止血阀,其特征在于,所述储能室内设有与所述弹性件相抵的调节件,所述调节件的至少一部分暴露于所述储能室作为调节操作部。
- 根据权利要求27所述的止血阀,其特征在于,所述储能室在背向所述平衡室的一侧为开放结构且密封安装有第三端盖,所述调节件设置在该第三端盖上。
- 根据权利要求27所述的止血阀,其特征在于,所述调节件为与所述储能室的室壁螺纹配合的调节螺杆,所述调节螺杆的头部作为所述调节操作部,所述调节螺杆与头部相对的一端与所述弹性件相抵配合。
- 根据权利要求22所述的止血阀,其特征在于,所述活塞的运动方向与所述器械通道的延伸方向相互平行或夹角设置。
- 根据权利要求21所述的止血阀,其特征在于,所述储能元件为置于所述储能室内或所述储能室外的弹性囊。
- 根据权利要求31所述的止血阀,其特征在于,所述弹性囊悬浮于所述储能室内或固定于所述储能室的室壁。
- 根据权利要求31所述的止血阀,其特征在于,所述弹性囊固定于所述储能室的室壁,在所述储能室的室壁上开设有与所述弹性囊连通的第三压力调节孔。
- 根据权利要求33所述的止血阀,其特征在于,所述第三压力调节孔连通有第三调节阀;所述第三调节阀直接安装于所述第三压力调节孔或通过外部管路连通于所述第三压力调节孔。
- 根据权利要求31所述的止血阀,其特征在于,所述弹性囊为空心结构,且填充有气 体,通过所述气体储能或释能。
- 根据权利要求31所述的止血阀,其特征在于,所述弹性囊为弹性材料,通过所述弹性材料的形变储能或释能。
- 根据权利要求1所述的止血阀,其特征在于,所述止血阀还包括增压机构,用于将血压变化反馈于所述流体。
- 根据权利要求37所述的止血阀,其特征在于,所述增压机构具有采集血压的输入端口,以及经增压后的输出端口,所述增压机构的输出直接或间接的作用于所述驱动室内的流体。
- 根据权利要求38所述的止血阀,其特征在于,所述增压机构包括支撑体,所述支撑体的内部设置有缸径不同的两缸室,各缸室内均密封滑动安装有滑动件,且两缸室内的滑动件相互联动;所述输入端口连通缸径较大的第一缸室;所述输出端口连通缸径较小的第二缸室。
- 根据权利要求39所述的止血阀,其特征在于,所述两缸室相互连通,在连通部位处为位于两滑动件之间的联动室,两滑动件之间通过共用联动室内的介质压力相互联动。
- 根据权利要求40所述的止血阀,其特征在于,第一缸室内的滑动件为第一滑动件,第一滑动件的一侧为与所述输入端口连通的输入室,另一侧为所述共用联动室;第二缸室内的滑动件为第二滑动件,第二滑动件的一侧为与所述输出端口连通的输出室,另一侧为所述共用联动室。
- 根据权利要求39所述的止血阀,其特征在于,所述两缸室相互隔离,两滑动件通过连接件直接相连,所述连接件的两端密封穿入各缸室与对应的滑动件相连。
- 根据权利要求42所述的止血阀,其特征在于,第一缸室内的滑动件为第一滑动件,第一滑动件的一侧为与所述输入端口连通的输入室,另一侧为第一联动室;第二缸室内的滑动件为第二滑动件,第二滑动件的一侧为与所述输出端口连通的输出室,另一侧为第二联动室;所述连接件的两端密封穿入各联动室并与对应的滑动件相连。
- 根据权利要求39所述的止血阀,其特征在于,所述止血阀开设有使用状态下可与血管连通的血压反馈孔,所述血压反馈孔通过反馈管路与所述输入端口连通。
- 根据权利要求44所述的止血阀,其特征在于,所述器械通道一端为器械入口,另一端为器械出口,所述血压反馈孔邻近位于器械出口一侧。
- 根据权利要求45所述的止血阀,其特征在于,所述止血阀开设有排气孔,该排气孔与所述血压反馈孔分别配置。
- 根据权利要求45所述的止血阀,其特征在于,所述止血阀开设有排气孔,该排气孔兼做所述血压反馈孔,所述反馈管路上连通有排气旁路,该排气旁路上设置有排气阀。
- 根据权利要求44所述的止血阀,其特征在于,所述支撑体与所述壳体为一体或分体结构。
- 根据权利要求44所述的止血阀,其特征在于,所述两缸室同轴布置、并排布置或内外嵌套布置。
- 根据权利要求44所述的止血阀,其特征在于,所述两缸室的轴线平行或斜交或垂直。
- 根据权利要求38所述的止血阀,其特征在于,所述增压机构的输出端口与所述驱动室连通。
- 根据权利要求51所述的止血阀,其特征在于,所述增压机构包括支撑体,所述支撑体的内部设置有缸径不同的两缸室,各缸室内均密封滑动安装有滑动件,且两缸室内的滑动件相互联动;所述输入端口连通缸径较大的第一缸室;所述输出端口连通缸径较小的第二缸室;所述两缸室相互连通,在连通部位处为位于两滑动件之间的联动室,两滑动件之间通过联动室内的介质压力相互联动。
- 根据权利要求52所述的止血阀,其特征在于,所述联动室的室壁上开设有与所述联动室连通的第四压力调节孔;缸径较小的缸室室壁上,开设有与所述输出端口连通的第五压力调节孔。
- 根据权利要求51所述的止血阀,其特征在于,所述增压机构包括支撑体,所述支撑体的内部设置有缸径不同的两缸室,各缸室内均密封滑动安装有滑动件,且两缸室内的滑动件相互联动;所述输入端口连通缸径较大的第一缸室;所述输出端口连通缸径较小的第二缸室;所述两缸室相互隔离,两滑动件通过连接件直接相连,所述连接件的两端密封穿入各缸室与对应的滑动件相连。
- 根据权利要求54所述的止血阀,其特征在于,第二缸室的室壁上分别开设有:第六压力调节孔,连通至第二缸室内滑动件的一侧;第七压力调节孔,连通至第二缸室内滑动件的另一侧,且所述输出端口也连通于该侧。
- 根据权利要求55所述的止血阀,其特征在于,各压力调节孔连通有调节阀;各调节阀直接安装于相应的压力调节孔或通过外部管路连通于相应的压力调节孔。
- 根据权利要求38所述的止血阀,其特征在于,所述壳体内还设置有平衡室,所述驱动室与所述平衡室之间相互连通;所述增压机构的输出端口与驱动室和/或平衡室连通。
- 根据权利要求57所述的止血阀,其特征在于,所述止血阀还包括可与所述流体相联动的储能机构,所述储能机构在所述密封膜状态变化时相应的储能或释能,用以驱使所述密封膜关闭所述器械通道;所述驱动室内的流体经由所述平衡室与所述储能机构联动;所述增压机构的输出直接作用于所述储能机构,或所述增压机构的输出端口与所述驱动室和/或所述平衡室连通。
- 根据权利要求58所述的止血阀,其特征在于,所述储能机构包括置于所述平衡室内的弹性囊;所述增压机构的输出端口与所述平衡室连通。
- 根据权利要求58所述的止血阀,其特征在于,所述储能机构包括置于所述平衡室内的弹性囊;所述增压机构的输出端口与所述弹性囊连通。
- 根据权利要求58所述的止血阀,其特征在于,所述储能机构包括:与所述平衡室相连通的储能室;在所述平衡室与所述储能室之间密封滑动的活塞;处在所述储能室内且与所述活塞相作用的可压缩气体和/或弹性件;所述增压机构的输出端口与所述储能室连通。
- 根据权利要求58所述的止血阀,其特征在于,所述储能机构包括:与所述平衡室相连通的储能室;在所述平衡室与所述储能室之间密封滑动的活塞;处在所述储能室内且与所述活塞相作用的可压缩气体和/或弹性件;所述增压机构的输出端口与所述平衡室连通。
- 根据权利要求38所述的止血阀,其特征在于,还包括与所述输入端口相连的血压指示装置。
- 根据权利要求63所述的止血阀,其特征在于,所述血压指示装置为单独配置的血压计或集成至所述增压机构。
- 根据权利要求64所述的止血阀,其特征在于,所述增压机构中至少带有与血压相关的运动部件,所述增压机构中设有血压标识,该血压标识与所述运动部件的位置相关。
- 根据权利要求65所述的止血阀,其特征在于,所述增压机构包括支撑体,所述支撑体的内部设置有缸径不同的两缸室,各缸室内均密封滑动安装有滑动件,且两缸室内的滑动件相互联动;所述输入端口连通缸径较大的第一缸室;所述输出端口连通缸径较小的第二缸室;所述运动部件为第一缸室内的滑动件和/或第二缸室内的滑动件。
- 根据权利要求1所述的止血阀,其特征在于,所述密封膜的内腔上设有亲水润滑涂层。
- 止血阀,包括壳体以及安装于壳体内且呈管状结构的密封膜,所述管状结构的内腔作为器械通道,其特征在于,沿所述器械通道的径向,所述壳体内设有处在所述密封膜***用于填充流体的驱动室和位于所述驱动室外侧的平衡室,所述驱动室与所述平衡室之间相互连通且所述平衡室环绕在所述驱动室的外周;所述止血阀还包括可与所述流体相联动的储能机构,所述驱动室内的流体经由所述平衡室与所述储能机构联动;所述储能机构在所述密封膜状态变化时相应的储能或释能,且在释能时驱使所述密封膜密封闭所述器械通道。
- 根据权利要求68所述的止血阀,其特征在于,所述平衡室有多个且在所述驱动室的外周间隔布置,针对每个平衡室分别配置所述储能机构。
- 根据权利要求69所述的止血阀,其特征在于,所述平衡室的数量为2至8个;各平衡室均匀或不均匀的间隔设置在所述驱动室的外周。
- 根据权利要求69所述的止血阀,其特征在于,各平衡室通过独立的平衡孔与所述驱动室连通;至少两个平衡室共用同一个平衡孔与所述驱动室连通;各平衡室通过同一个平衡孔与所述驱动室连通。
- 根据权利要求68所述的止血阀,其特征在于,所述储能机构包括:储能室;活塞,密封滑动在所述平衡室与所述储能室之间;储能元件,所述储能元件为处在所述储能室内且与所述活塞相作用的可压缩气体和/或弹性件;所述壳体上设有至少两个供所述活塞滑动的筒状空间,所述筒状空间被所述活塞分割为所述平衡室和所述储能室。
- 根据权利要求72所述的止血阀,其特征在于,各活塞通过自身外缘的密封边缘和对 应的所述筒状空间的内壁密封配合,在活塞的滑动方向上,所述密封边缘与所述筒状空间的内壁至少设有两道密封。
- 根据权利要求72所述的止血阀,其特征在于,所述壳体上设有至少两个供所述活塞滑动的筒状空间,各筒状空间内设有独立的所述储能元件,且各储能元件的储能性能一致或不一致。
- 根据权利要求71所述的止血阀,其特征在于,所述止血阀还包括压力调节结构,所述压力调节结构设有用于提供所述流体的流体管路,所述流体管路直接或间接的与所述平衡室或所述驱动室或所述平衡孔连通。
- 根据权利要求75所述的止血阀,其特征在于,所述平衡室设有多个且周向分布在所述驱动室外侧,各平衡室通过独立的平衡孔与驱动室连通;各平衡孔一侧与驱动室联动,另一侧在径向上延伸至所述壳体的外周壁上,各平衡孔在所述外周壁上封闭或与所述流体管路对接。
- 根据权利要求68所述的止血阀,其特征在于,所述壳体至少在驱动室的外周为刚性结构。
- 导管鞘,包括轴向延伸的鞘管,所述鞘管具有轴向贯通的腔体,所述鞘管具有近端和远端,其特征在于,所述鞘管近端连接有根据权利要求1至77任一项所述的止血阀。
- 根据权利要求78所述的导管鞘,其特征在于,所述止血阀上设有与所述鞘管连接的管接头,所述管接头通过密封件与所述鞘管配合,且所述管接头有设有防止所述鞘管与所述管接头分离的卡合结构。
- 根据权利要求78所述的导管鞘,其特征在于,所述鞘管的远端设有显影环。
- 介入器械密封方法,包括利用可形变的密封膜构建器械通道,在密封膜的外周通过流体驱动密封膜形变以密封器械通道,其特征在于,在介入器械进、出器械通道的过程中,利用与流体相联动的储能机构在密封膜形变时相应的储能或释能,以保持介入器械与器械通道间的密封。
- 根据权利要求81所述的介入器械密封方法,其特征在于,利用根据权利要求1至77任一项所述的止血阀实施所述介入器械密封方法。
- 基于止血阀的介入器械密封方法,其特征在于,所述止血阀包括壳体以及安装于壳体内且呈管状结构的密封膜,所述管状结构的内腔作为器械通道且贯通所述壳体,所述壳体内设有处在所述密封膜***可填充流体的驱动室以及可与流体联动的储能机构,所述介入器械密封方法包括:向所述驱动室内注入流体,所述流体驱动所述密封膜关闭所述器械通道,所述流体还作用于所述储能机构,使所述储能机构预储能以保持密封膜状态;向所述器械通道内***介入器械时,所述密封膜受介入器械挤压形变且通过流体驱使所述储能机构储能;介入器械撤出所述器械通道时,所述储能机构释能,通过流体驱动密封膜形变关闭所述器械通道。
- 根据权利要求83所述的基于止血阀的介入器械密封方法,其特征在于,所述驱动室还连通有流体管路,并通过该流体管路连接外部流体源。
- 根据权利要求84所述的基于止血阀的介入器械密封方法,其特征在于,所述壳体内形成有筒状空间,所述储能机构包括:活塞,滑动设置在所述筒状空间内,且将所述筒状空间分隔为平衡室和储能室;储能元件,处在所述储能室内,且所述储能元件为与所述活塞相作用的气体和/或弹性件。
- 根据权利要求85所述的基于止血阀的介入器械密封方法,其特征在于,所述壳体为环形,且具有环形壁,所述筒状空间处在所述环形壁内。
- 根据权利要求86所述的基于止血阀的介入器械密封方法,其特征在于,所述筒状空间为直筒结构,且所述直筒结构的轴线与所述壳体的轴线相互平行。
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EP4085964A4 (en) | 2024-01-31 |
CN114867519A (zh) | 2022-08-05 |
US20220339419A1 (en) | 2022-10-27 |
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