WO2022027231A1 - Dispositif de mise en place d'un fil de valvule cardiaque - Google Patents

Dispositif de mise en place d'un fil de valvule cardiaque Download PDF

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Publication number
WO2022027231A1
WO2022027231A1 PCT/CN2020/106812 CN2020106812W WO2022027231A1 WO 2022027231 A1 WO2022027231 A1 WO 2022027231A1 CN 2020106812 W CN2020106812 W CN 2020106812W WO 2022027231 A1 WO2022027231 A1 WO 2022027231A1
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WO
WIPO (PCT)
Prior art keywords
snap
heart valve
wire
power transmission
buckle
Prior art date
Application number
PCT/CN2020/106812
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English (en)
Chinese (zh)
Inventor
丁海雁
Original Assignee
丁海雁
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 丁海雁 filed Critical 丁海雁
Priority to PCT/CN2020/106812 priority Critical patent/WO2022027231A1/fr
Priority to CN202110756045.1A priority patent/CN114052989A/zh
Publication of WO2022027231A1 publication Critical patent/WO2022027231A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0467—Instruments for cutting sutures
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0469—Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0493—Protective devices for suturing, i.e. for protecting the patient's organs or the operator
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0464—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors for soft tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0469—Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
    • A61B2017/0474—Knot pushers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0075—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable

Definitions

  • the invention relates to the technical field of medical devices, in particular to a heart valve wire setter and a method for treating heart diseases by using the heart valve wire setter.
  • the heart valves control the flow of blood in the heart.
  • the mitral valve is located between the left atrium and the left ventricle
  • the tricuspid valve is located between the right atrium and the right ventricle. It opens and closes regularly, allowing blood to flow from the atrium to the ventricle in a single direction.
  • Heart valve disease leads to valve insufficiency and blood regurgitation occurs.
  • mitral regurgitation MR
  • Epidemiological data show that in my country, people over 60 years old in China
  • the prevalence of MR in the population is as high as 13.4%, and there are about 10 million moderate-to-severe MR patients requiring clinical intervention.
  • the incidence of MR will continue to rise. It has become one of the key directions of cardiovascular device research and development at home and abroad.
  • the inventor of the present application has invented a heart valve wire setter, a wire binding device and a wire trimmer used in conjunction with the wire setter. device, and a method for treating heart disease using the wire placement device.
  • Embodiment 1 A heart valve wire placement device, comprising: a catheter, a first snap member, and a second snap member, at least partially pierced through the catheter and fixedly connected to the first snap member. a wire, at least partially passing through the first power transmission part in the conduit, the first power transmission part and the first snap part can be disconnected;
  • the catheter sequentially includes: an extension section, an operating section, and an optional protective section; the proximal end of the operating section is provided with a first snap member direction guide, and the first snap member direction guide is provided with a supply for a guide channel through which the first power transmission component passes; a second snap-fit connector is provided on the operating section, and the second snap-fit connector is rotatably connected to the catheter at the distal end;
  • the buckle part can be disconnected;
  • the second snap part connector rotates and forms a fixed angle with the operating section, the direction of the guide channel Pointing to the second snap part, when the first power transmission part applies forward power to the first snap part, the first snap part and the second snap part form a latch Buckle connection.
  • Embodiment 2 The heart valve wire inserter according to Embodiment 1, wherein the first buckle component is a buckle component, and the second buckle component is a buckle component; or, the first buckle component is a A clip part, the second clip part is a clip part.
  • Embodiment 3 The heart valve wire inserter according to Embodiment 1, wherein the first snap member direction guide is one or more metal tubes fixedly arranged on the catheter, and the inside of the metal tube is That is, the guide channel.
  • Embodiment 4 The heart valve wire inserter of Embodiment 1, wherein the fixed angle is a right angle or an acute angle, eg, about 90 degrees, 20 degrees to 60 degrees, or 30 degrees to 50 degrees.
  • the fixed angle is a right angle or an acute angle, eg, about 90 degrees, 20 degrees to 60 degrees, or 30 degrees to 50 degrees.
  • Embodiment 5 The heart valve wire inserter according to Embodiment 1, wherein a distal end of the first power transmission member forms an external thread, a rear portion of the first snap member forms an internal thread, and the first power transmission member forms an internal thread.
  • the transmission member and the first snap member are detachably connected through the inner thread and the outer thread.
  • Embodiment 6 The heart valve wire placement device according to Embodiment 1 or 2, wherein the catheter is provided with a side opening at the operating section, the first snap part and the second snap part and the second snap-fit connector is provided at the side opening of the conduit.
  • Embodiment 7 The heart valve wire placement device according to Embodiment 1, wherein the catheter is provided with a rotating shaft at the distal end of the operating section, and the second snap member connector is provided with a shaft hole, so The second snap-fit connector is rotatably connected to the conduit through the shaft and the shaft hole.
  • Embodiment 8 The heart valve wire inserter of Embodiment 1, wherein the first power transmission member comprises a high memory wire.
  • Embodiment 9 The heart valve wire inserter according to Embodiment 1, wherein the length of the operation segment is 2 cm to 3 cm; and the length of the second snap member connector is 1.8 to 2.7 cm.
  • Embodiment 10 The heart valve wire inserter according to Embodiment 1, wherein the second snap member is snapped on an end of the second snap member connector.
  • Embodiment 11 The heart valve wire inserter according to Embodiment 2, wherein the clip member has an annular through hole through which the buckle member passes and a tab disposed in the annular through hole, the The tab is an elastic part with certain flexibility, the buckle part has a sharp head that can pass through the annular through hole, and an extension part connected with the sharp head and having at least one slot, when the When the sharp head passes through the annular through hole, the tab presses against the slot so as to form a snap connection.
  • Embodiment 12 The heart valve wire inserter of Embodiment 11, wherein the cross-sectional area of the clip member is greater than 0.1 square centimeters so as to provide better force dispersion.
  • Embodiment 13 The heart valve wire inserter of Embodiment 11 or 12, wherein the buckle member further has a tail portion connected to the extension.
  • the cross-sectional area of the tail excluding the extension is greater than 0.1 square centimeters.
  • Embodiment 14 The heart valve wire inserter according to Embodiment 13, wherein after the first snap member and the second snap member form a snap connection, the tail portion of the snap member is connected to the The distance between the card parts is 0.5mm to 2mm.
  • Embodiment 15 The heart valve wire inserter of Embodiment 11, wherein the clip member has a protective portion corresponding to the sharp head portion of the buckle member, the protective portion being rounded on the outside.
  • Embodiment 16 The heart valve wire inserter of Embodiment 1, wherein a visualization marker is provided on at least one component, eg, a visualization marker is provided on the distal end of the catheter.
  • Embodiment 17 The heart valve wire inserter of Embodiment 13, wherein the tail portion of the buckle member and the clip member each independently comprise at least two layers: a support layer that provides structural support, and a support layer that provides biological support. Compatible biocompatible layer.
  • the support layer has a plurality of sharp protrusions of 0.3 mm to 2.0 mm extending toward the biocompatible layer to enhance valve fixation.
  • Embodiment 18 The heart valve wire inserter of Embodiment 17, wherein the support layer providing structural support is made of metal or rigid plastic.
  • Embodiment 19 The heart valve wire inserter of Embodiment 1, wherein the protective segment has a rounded tip made of a soft material.
  • Embodiment 20 A wire binding device, comprising: a wire binding conduit; a wire binding clip arranged at the end of the wire binding conduit, with an opening that automatically closes; a wire tube at least partially penetrated through the wire binding conduit The middle and end parts are pre-clamped in the opening of the wire-tie card; the blocking part on the wire-tie guide tube is arranged next to the wire-tie card.
  • Embodiment 21 The tie-breaker of Embodiment 21, wherein the tie card is a self-closing loop formed from a high-memory steel sheet.
  • Embodiment 22 The wire knotter of Embodiment 21, further comprising a wire pre-threaded in the wire conduit.
  • Embodiment 23 A thread trimmer comprising a thread trimmer conduit; scissors provided at the end of the thread trimmer conduit; a power transmission member connected to the scissors, thereby enabling the scissors to perform cutting operate.
  • Embodiment 24 The thread cutter according to Embodiment 23, wherein the scissors comprise a blade connected to the power transmission member, and a shearing plate connected to the blade through an elastic connecting piece and arranged perpendicular to the blade,
  • the elastic connecting piece keeps a certain gap between the blade and the shearing plate
  • a wire groove is also provided on the side wall of the end of the wire-cutting conduit, and the wire groove can guide the wire to the blade and the shearing plate. in the gap between the plates.
  • Embodiment 25 The thread cutter of Embodiment 24, wherein the blade is disposed parallel to the axis of the thread trimmer conduit, and the shearing plate is disposed perpendicular to the axis of the thread trimmer conduit.
  • Embodiment 26 The wire cutter according to Embodiment 25, wherein the number of the blades and the shearing plates are both two, and two spirally extending wire grooves are correspondingly provided.
  • Embodiment 27 A method of treating heart disease, comprising, securing a first end of a first wire to a first heart valve, securing a first end of a second wire to a second heart valve, by The second end of the first wire and the second end of the second wire form a knot between the first wire and the second wire, thereby between the first heart valve and the second heart valve Traction is formed to reduce the distance between the first heart valve and the second heart valve, the first heart valve and the second heart valve being the same or different valves.
  • Embodiment 28 The method for treating a heart disease according to Embodiment 27, comprising forming a first snap member and a first snap member on the first heart valve, the first snap member passing through the first valve.
  • a heart valve forms a snap connection with the first clip, and the first end of the first wire is connected with at least one of the first clip and the first clip;
  • the second heart valve is formed with a second clip member and a second clip member, the second clip member passes through the second heart valve to form a clip connection with the second clip member, and the second clip is connected to the second clip member.
  • the first end of the wire is connected to at least one of the second card part and the second buckle part.
  • Embodiment 29 The method of treating heart disease according to Embodiment 27, wherein the step of "fixing the first end of the first wire to the first heart valve" is described in any of Embodiments 1-19
  • the device is completed, and the step of "fixing the first end of the second wire on the second heart valve” is completed by the device described in any one of Embodiments 1-19.
  • the unexpected technical effect brought about by the present invention is: using snap connection, the wire is anchored on the valve from the atrium side, the operation is simple and quick, and the valve work is not affected, and at the same time, through the knotting and cutting of the atrium side Line operation, pulling and knotting the line, can close the gap of the mitral valve or the tricuspid valve, and effectively solve the mitral valve or tricuspid valve regurgitation.
  • Fig. 1 is a schematic diagram of the structure of a heart valve wire setter
  • Fig. 2 is the schematic diagram that the heart valve wire setter forms the buckle structure
  • Figure 3 is a schematic structural diagram of a card part and a buckle part
  • Fig. 4 is the schematic diagram that the heart valve wire setter is anchored on the valve
  • Fig. 5 is a schematic diagram of the structure of the tie device
  • Figure 6 is a schematic diagram of the structure of the thread trimmer
  • Figure 7 is a schematic diagram of mitral valve placement
  • Figure 8 is a schematic diagram of mitral valve wire placement to reduce valve interval
  • Figure 9 is a schematic diagram of mitral valve wire placement to reduce valve interval
  • Figure 10 is a schematic diagram of tricuspid valve placement to reduce valve spacing.
  • 200-Second snap part 201-Card part, 202-Annular through hole, 203-Tag, 204-Protection part, 205-Support layer, 206-Biocompatible layer, 207-Sharp protrusion, 210-Section Two snap parts connectors, 211-shaft hole, 220-second power transmission part;
  • 600-wire knotting device 600-wire knotting device, 610-wire knotting guide, 620-wire knotting card, 630-wire tube, 640-stop part;
  • 700-Thread cutter 710-Thread cutter guide, 720-Scissors, 721-Blade, 722-Elastic connector, 723-Shear plate, 724-Wire groove, 730-Power transmission part.
  • a heart valve wire placement device which includes: a catheter, a first snap member, and a second snap member, at least partially penetrated through the catheter and fixed with the first snap member
  • the connecting wire is at least partially penetrated through the first power transmission part in the conduit, and the first power transmission part and the first buckle part can be disconnected
  • the conduit comprises: an extension section and an operation section in sequence and an optional protective segment; the proximal end of the operating segment is provided with a first snap-fit part direction guide, and the first snap-fit part direction guide is provided with a guide channel for the first power transmission part to pass through ;
  • a second snap-fit connector is provided on the operating section, and the second snap-fit connector is rotatably connected to the conduit at the distal end; a second power at least partially penetrated in the conduit a transmission part, the second power transmission part is connected with the second buckle part connector, and the second buckle part connector and the second buckle part can be disconnected; thus, when the first When the two power transmission components apply the opening rotational power
  • the heart valve wire setter described in the present application is used to anchor a wire on the heart valve, and the wire can be a medical puller wire or a medical suture, and the valve repair technology is inserted through a catheter to push the operation segment to the position of the heart valve , and then through the power provided by the first power transmission part and the second power transmission part, the first snap part and the second snap part move toward each other from both sides of the valve to form a snap connection , and positioned on the valve, the connectors of the first power transmission member and the second buckle member are disengaged, and the first buckle member, the second buckle member, and the first buckle member
  • the fixedly connected wire is anchored on the valve, and the wire connected with the first snap member is formed on the side of the atrium, and the wire can exert traction on the valve by means of the snap structure, so as to perform treatment.
  • the snap connection in this application has the meaning commonly understood by those skilled in the art, and specifically refers to the embedded locking connection between the first snap part and the second snap part, which includes sharp
  • the head is used to puncture the valve, and also includes an elastic part with certain flexibility, the elastic part deforms and rebounds during the snap connection, so as to realize the connection between the first snap part and the second snap part. atresia.
  • the valve can be quickly punctured at a single point of action to form a snap-fit connection, the operation time is short, and the valve works well. impact is minimal.
  • the wire is connected with the first snap member, so that the anchored wire is located on the atrium side of the valve, which does not affect the work of the valve and the chordae tendineae, and is also very beneficial to subsequent operations.
  • the "moving toward each other" mentioned in this application includes both the two parts approaching each other at the same time, and the two parts moving in succession to approach each other.
  • the present application controls the traveling direction of the first buckle member by setting a first buckle member direction guide, and the first buckle member direction guide is provided with a guide for the first power transmission member to pass through.
  • the guide channel of the guide channel points to the second snap part in the open state, when the first power transmission part applies longitudinal power to the first snap part (that is, along the axis of the catheter direction power) to ensure that the first snap member travels according to the prescribed route.
  • the setting form of the guide channel is not particularly limited, it only needs to play the required guiding role, for example, it can be a closed channel, an open channel, or a channel composed of a plurality of position fixing devices that can play a guiding role (such as a channel). multiple collars) etc.
  • a second snap member connector rotatably connected to the catheter is provided at the distal end of the operating section.
  • the adjustment of Drive the second snap member to travel from the catheter to a predetermined position on the ventricle side, combined with the first snap member direction guide, the first snap member and the second snap member can be formed. Snap connection.
  • the first power transmission component and the first snap component, the second snap component connector and the second snap component are all detachable, so that the After the first snap member and the second snap member form a snap connection and are positioned on the valve, the connectors of the first power transmission member and the second snap member are disengaged as soon as possible to avoid affecting the valve. Work.
  • the form of the detachable connection is not particularly limited, as long as the desired purpose can be achieved.
  • the present application is also provided with an optional protection segment, which is located at the end of the catheter and plays a role in protecting the heart during the operation, preventing the catheter from damaging the heart during the operation.
  • the protective segment may be formed by a flexible shape and/or material.
  • the first snap-fitting part is a snap-fitting part
  • the second snap-fitting part is a snap-fitting part
  • the first snap-fitting part is a snap-fitting part
  • the second snap-fitting part is a snap-fitting part part.
  • the snap connection is an embedded latching connection between two components, which includes a snap component and a buckle component.
  • the buckle component in the present application is a component that includes a sharp head piercing the valve, which passes through the valve. After inserting/passing through the card part, a snap connection is formed.
  • the first snap part can be a card part or a snap part; correspondingly, the second snap part can be a snap part or a card part.
  • the first snap part is a snap part
  • the second snap part is a snap part
  • this structure can protect the heart more effectively, and the snap part with a sharp head can The catheter exits immediately into the card member, reducing the potential for damage to the heart.
  • the terms embedded and penetrated have the same meaning when describing the kinematic relationship between the buckles, and both refer to the process in which at least a part of the finger buckle component enters the through hole of the buckle component to form a buckle connection.
  • the direction guide of the first snap member is one or more metal tubes fixedly arranged on the conduit, and the inside of the metal tubes is the guide channel.
  • the metal pipe is a relatively convenient setting. It can be either a closed pipe or an open pipe with an opening in the pipe wall, as long as it can guide the first snap part to form a snap connection with the second snap part. .
  • the fixed angle is a right angle or an acute angle, such as about 90 degrees, 20 to 60 degrees, or 30 to 50 degrees.
  • the second snap-fit connector opens and rotates under the action of the second power transmission member, and forms a fixed angle with the operating section.
  • the second snap member connector drives the second snap member to travel to the ventricular side of the valve.
  • the The second snap part travels to a suitable position on the ventricle side of the valve with the smallest moving distance, and fits with the shape of the valve. According to the size of the rotation angle and the length of the connector of the second snap part, the second snap part can be adjusted in the ventricle. The side is close to the position of the valve, so that the anchoring position of the snap-fitting part on the valve can be easily adjusted.
  • an end of the first power transmission member forms an external thread
  • a rear portion of the first buckle member forms an inner thread
  • the first power transmission member and the first buckle member pass through the The internal thread and the external thread form a detachable connection.
  • the conduit is provided with a side opening at the operating section, and the first snap part, the second snap part and the second snap part connector are provided on the conduit side opening.
  • the length of the side opening should be greater than the length of the second snap-fit connector, and the width should enable the first snap-fit and the second snap-fit to travel from the side opening to a predetermined position.
  • the catheter is provided with a rotating shaft at the distal end of the operating section
  • the second snap component connector is provided with a shaft hole
  • the second snap component connector passes through the rotating shaft and the A shaft hole is rotatably connected to the conduit.
  • the second power transmission member can be connected to the distal end of the second snap member connector relative to the position of the shaft hole. , and can also be connected to the proximal end relative to the position of the shaft hole, and the second latching member connector can be rotated by the pushing and pulling of the second power transmission member.
  • the first power transfer member includes a high memory wire.
  • the high-memory steel wire has high strength, good flexibility and light weight, and is the preferred material for the first power transmission component.
  • the first power transmission member made of high-memory steel wire recovers its shape after being protruded from the guide passage, thereby advancing the first latching member in a predetermined direction and forming with the second latching member Snap connection.
  • the operation section needs to penetrate the atrium and ventricle of the heart at the valve, and its length should be in line with the size of the human heart, and the second snap-fit connector drives the second snap-fit member to travel on the ventricular side valve in the ventricle , and a suitable length can locate the second snap-fit member at a suitable position of the valve, for example, near the root of the valve or at the valve annulus.
  • a suitable length can locate the second snap-fit member at a suitable position of the valve, for example, near the root of the valve or at the valve annulus.
  • the length of the operating segment is 2 cm to 3 cm
  • the length of the second snap-fit connector is 1.8 to 2.7 cm .
  • the length of the operating segment is 1 cm to 7 cm.
  • the second snap member is snapped onto an end of the second snap member connector.
  • the second snap part can be disengaged from the connector of the second snap part through the pulling of the first power transmission part, and those skilled in the art can appropriately set the snap connection
  • the device can be quickly disengaged from the connector of the first power transmission member and the second snap member through the operation on the atrial side, thereby reducing the adverse effect on the valve operation.
  • the card member has an annular through hole into which the buckle member is embedded, and a tab disposed in the annular through hole, the tab is an elastic member with certain flexibility, and the buckle
  • the component has a sharp head that can pass through the annular through hole, and an extension connected with the sharp head and has at least one slot, when the sharp head passes through the annular through hole, the The tabs press against the slots to form a snap connection.
  • Those skilled in the art can reasonably set different snap connection structures. For example, there can be multiple snap slots. When there are multiple snap slots, the snap can be adjusted according to the thickness of the valve and the number of snap slots to pass through. gaps between the buckle structures, so that the buckle structures can better adapt to the thickness of the valve.
  • the cross-sectional area of the clip part should not be too small, otherwise it may cause concentrated stress on a certain point of the valve.
  • the cross section of the card member refers to the surface of the card member in contact with the valve, and those skilled in the art can choose according to the actual situation. , to avoid damage to the valve.
  • the buckle member also has a tail portion connected to the extension portion, so as to be better secured to the valve.
  • the contact area of the tail with the valve should not be too small, otherwise it may cause concentrated force on a certain point of the valve.
  • Those skilled in the art can choose according to the actual situation, for example, setting the cross-sectional area of the tail excluding the extension is greater than 0.1 square centimeter, which can disperse the force and avoid damage to the valve.
  • the gap between the tail portion of the snap member and the snap member is 0.5 mm to 2 mm.
  • the distance of the above-mentioned gap depends on the thickness of the valve, so that the buckle structure can clamp the valve without sliding between the valve and the valve, so as to prevent the extension part in the buckle structure from damaging the valve.
  • the card member has a protective portion corresponding to the sharp head of the buckle member, and the protective portion is rounded on the outside.
  • the protective portion is rounded on the outside.
  • the sharp head In order to enable the buckle member to puncture the valve, it has a sharp head.
  • the sharp head after the sharp head of the buckle member is inserted into the card member to form a snap connection, the sharp head will extend to the card On the other side of the part, in order to prevent the sharp head from piercing other parts of the heart, the card part has a corresponding round protection part to cover the sharp head.
  • the heart valve wire setter is provided with a visualization marker on at least one component, for example, a visualization marker is provided on the distal end of the catheter.
  • the visualization marker can assist the doctor to see the position of the wire inserter in the patient's body in real time, and can precisely control the operation. There is no limitation on the development of the mark itself, and those skilled in the art can choose according to actual needs.
  • the tail portion of the buckle member and the card member each independently comprise at least two layers: a support layer that provides structural support, and a biocompatible layer that provides biocompatibility.
  • a support layer that provides structural support
  • a biocompatible layer that provides biocompatibility.
  • the biocompatible layer is set on the side that is in direct contact with the heart valve.
  • the support layer has a plurality of sharp protrusions of 0.3mm to 2.0mm (eg, 0.3mm to 0.8mm, such as 0.5mm) extending toward the biocompatible layer to strengthen the valve fixed effect.
  • the sharp protuberances make the snapping structure formed on the valve, the snapping part and the snapping part tightly bite the valve like teeth, so as to strengthen the fixing effect of the valve.
  • the support layer providing structural support is made of metal or rigid plastic
  • the biocompatible layer providing biocompatibility is made of thermoplastic polyurethane material.
  • Thermoplastic polyurethane material is a commonly used biocompatible material, which is very suitable for use in the technical solution of the present application.
  • the protective segment has a rounded tip made of a soft material, such as a thermoplastic polyurethane material, capable of protecting the heart from the hard parts of the catheter.
  • the protection segment is a pigtail segment made of a soft material, the outer diameter of the tube at the end is 1-3mm, a circle with a diameter of 7mm to 13mm is formed at the end, and there is a guide wire The arrangement of the through hole enables the pigtail segment to abut against the bottom of the atrium, which plays a stabilizing role during the operation.
  • the specific length of the protective segment can be specifically adjusted according to the condition of the heart and the specific shape of the protective segment.
  • a wire binding device comprising: a wire binding guide tube; a wire binding clip disposed at the end of the wire binding guide tube, with an opening that is automatically closed; and a wire tube at least partially passing through the In the conduit and the end portion is pre-clamped in the opening of the wire-tie card; the blocking portion on the wire-tie guide is arranged next to the wire-tie card.
  • the tie card may be a clip.
  • the tie card is a self-closing loop formed from high-memory steel sheets.
  • the wire binder further includes a wire pre-threaded in the wire conduit.
  • the present application also provides a thread trimmer, comprising: a thread trimmer conduit; scissors arranged at the end of the thread trimmer conduit; a power transmission part, the power transmission part is connected with the scissors, so that the scissors can be executed Cut operation.
  • a thread trimmer comprising: a thread trimmer conduit; scissors arranged at the end of the thread trimmer conduit; a power transmission part, the power transmission part is connected with the scissors, so that the scissors can be executed Cut operation.
  • the scissors include two blades, and under the action of the power transmission component, the two blades move toward each other to complete the cutting operation.
  • the scissors include a blade connected to the power transmission member, and a shearing plate connected to the blade through an elastic connection and arranged perpendicular to the blade, the elastic connection allows the A certain gap is maintained between the blade and the shearing plate, and a wire groove is also provided on the side wall of the end of the wire-cutting conduit, and the wire groove can guide the wire into the gap between the blade and the shearing plate.
  • the power transmission part drives the blade to move and completes the shearing operation on the shearing board. After the power transmission part is released, the elastic connecting piece automatically rebounds the blade to the initial position.
  • the blade is arranged parallel to the axis of the wire cutting conduit, and the shearing plate is arranged perpendicular to the axis of the wire cutting conduit.
  • the number of the blades and the shearing plates are both two, and the two helically extending wire grooves are correspondingly provided.
  • the two blades, shearing plates, and wire grooves are oppositely arranged in the wire-cutting conduit, and the spirally extended wire grooves can keep the wire stable and avoid detachment, so that the two wires can be simultaneously cut in the wire-cutting guide.
  • the contralateral side within the catheter completes the cut.
  • the present application also provides a method for treating heart disease, comprising: fixing the first end of the first wire on the first heart valve, and fixing the first end of the second wire on the second heart valve, A knot is formed between the first wire and the second wire by the second end of the first wire and the second end of the second wire, thereby forming a knot between the first heart valve and the second heart valve A traction is formed between the first heart valve and the second heart valve, so that the distance between the first heart valve and the second heart valve is reduced, and the first heart valve and the second heart valve are the same or different valves.
  • the method for treating heart disease includes forming a first snap member and a first snap member on the first heart valve, the first snap member passing through the first heart
  • the valve forms a snap connection with the first clip part, and the first end of the first wire is connected with at least one of the first clip part and the first clip part; on the second heart valve A second clip part and a second clip part are formed, the second clip part passes through the second heart valve to form a clip connection with the second clip part, and the first end of the second wire is connected to the second clip part.
  • At least one of the second snap member and the second buckle member is connected, and the first heart valve and the second heart valve are the same or different valves.
  • the method for treating heart disease wherein the step of "fixing the first end of the first wire on the first heart valve” is completed by the heart valve wire setter, "fixing the first end of the first wire on the first heart valve”.
  • the step of fixing the first ends of the two wires on the second heart valve is completed by the described heart valve wire setter.
  • the present application also provides a heart valve treatment system, which includes at least two wire inserters described in the present application, at least one wire binding device, and at least one wire cutter.
  • the connector is any of the connectors described herein.
  • the wire knotter is any of the wire cutters described herein.
  • the material selection and preparation method of the thread setter, thread knotter and thread trimmer in the present application can be selected by those skilled in the art according to the prior art, and may refer to prior art documents or existing related products.
  • a heart valve wire setter which includes:
  • a buckle force transmission part at least partially penetrated in the conduit, the buckle force transmission part and the buckle part being detachable;
  • the conduit comprises in turn: an extension section, an operating section and an optional protective section;
  • the proximal end of the operating segment is provided with a buckle member direction guide, and the buckle member direction guide is provided with a guide channel for the buckle force transmission member to pass through, (the direction of the guide channel points to the buckle member in the open state, When the buckle force transmission member applies longitudinal power to the buckle member, it is ensured that the buckle member travels according to the prescribed route);
  • a card part connector is provided on the operation section, and the card part connector is rotatably connected with the conduit;
  • a card power transmission member at least partially penetrated in the conduit, the card power transmission member is connected with the card member connector, and the card member connector is detachable from the card member;
  • the card part connector rotates and forms a fixed angle with the operating section, the direction of the guide channel is directed to the card part, and this
  • the buckle force transmission member applies forward power to the buckle member, the buckle member forms a snap connection with the card member.
  • This embodiment provides a device for treating mitral insufficiency, which includes a heart valve wire setter, a wire binding device 600 and a wire cutter 700 .
  • the heart valve wire placement device includes:
  • the catheter 300 includes an extension section 310, an operation section 320 and a protection section 330 in sequence, the protection section 330 has a rounded end made of thermoplastic polyurethane material, and a development mark is provided at the distal end of the operation section 320 , the operating section 320 is provided with a side opening 321;
  • a first snap part 100 and a second snap part 200 wherein the first snap part 100 is a snap part 101, and the second snap part 200 is a snap part 201;
  • the wire 400 which is passed through the conduit 300 and is fixedly connected with the first snap member 100 , the first power transmission member 110 and the second power transmission member 220 are passed through the conduit 300 .
  • the first power transmission member 110 is made of high-memory steel wire and has an outer thread formed at the end, and an inner thread is formed at the rear of the first snap member 100.
  • the first power transmission member 110 is connected to the first
  • the snap-fit component 100 is detachably connected through the internal thread and the external thread.
  • the proximal end of the operating section 320 is provided with a first buckling member direction guide 120, and the first buckling member direction guide 120 is a metal tube fixed on the catheter 300, A guide passage through which the first power transmission member 110 passes.
  • the operating section 320 is 3 centimeters long, and its distal end is provided with a rotating shaft 322, which is rotatably connected to the rotating shaft 322 with a second snap-fit connector 210 provided with a corresponding shaft hole.
  • the second power transmission member 220 Connect with the second snap part connector 210 at the distal end of the shaft hole, so that by pulling the second power transmission part 220 the second snap part connector 210 can be rotated to open and connect with the
  • the operating section 320 forms an included angle of 45 degrees, and at this time, the direction of the guide channel points to the second snap member 200 ; the length of the second snap member connector 210 is 2.5 cm, and the second snap member is 2.5 cm long. 200 is snapped on the end of the second snap-fit connector 210 .
  • the first snap part 100 , the second snap part 200 and the second snap part connector 210 are disposed at the side opening 321 of the operation section 320 .
  • the card member 201 has an annular through hole 202 into which the buckle member 101 is embedded and a tab 203 disposed in the annular through hole 202, the tab 203 is An elastic part with certain flexibility
  • the buckle part 101 has a sharp head 102 embedded in the annular through hole 202, and an extension part 104 connected with the sharp head 102 and having a plurality of card grooves 103
  • the For the tail portion 105 connected by the extension portion 104 when the sharp head 102 is inserted into the annular through hole 202, the tab 203 presses against the slot 103, thereby forming a snap connection.
  • the cross-sectional area of the clip part 201 and the tail part 105 of the buckle part 101 excluding the extension part 104 is about 0.11 square centimeters. The gap between them can be 1mm.
  • the operating segment 320 is pushed to the position of the heart valve, and then the power provided by the first power transmission part 110 and the second power transmission part 220 is used to make
  • the buckle member 101 and the clip member 201 move toward each other from both sides of the valve 500 to form a snap connection and are positioned on the valve 500 .
  • the first power transmission part 110 can be pulled to disengage the snap part 201 from the second snap part connector 210, and then the first power transmission part 110 is rotated to make After being disengaged from the buckle member 101 , the buckle member 101 , the clip member 201 , and the wire 400 fixedly connected to the buckle member 101 are anchored on the valve 500 .
  • the card member 201 may also be provided with a smooth protection portion 204 to cover the sharp head 102 .
  • the card part 201 includes a support layer 205 for providing structural support, and a biocompatibility layer 206 for providing biocompatibility.
  • the tail part 105 of the buckle part 101 also has the above two-layer structure, wherein the biological
  • the compatibility layer 206 is made of thermoplastic polyurethane material and is disposed on the contact surface of the valve 500 .
  • the present embodiment can also select the following structure: the card member 201 includes a support layer 205 that provides structural support, and a biocompatibility layer 206 that provides biocompatibility, wherein the support layer 205 There are a plurality of 0.5mm sharp protrusions 207 on the upper part, extending toward the biocompatible layer 206, and the tail portion 105 of the buckle member 101 also has the above-mentioned two-layer structure and sharp protrusions, so as to strengthen the fixation of the valve.
  • the support layer 205 is made of metal material.
  • the heart valve wire setter quickly punctures the valve on a single action point to form a snap connection, has a short operation time, and has minimal influence on the valve operation.
  • the wire 400 is connected with the first snap member 100, so that the anchored wire 400 is located on the atrium side of the valve, which does not affect the operation of the valve and the chordae tendineae, and is also very beneficial to subsequent operations.
  • the wire binding device 600 includes: a wire binding conduit 610; A ring formed by a high-memory steel sheet that automatically closes the opening; a wire tube 630, which is at least partially penetrated in the wire-tie guide 610 and its end is pre-clamped in the opening of the wire-tie card 620; The wire-tie card 620 is disposed on the blocking portion 640 on the wire-tie guide 610 . The wire tie device 600 automatically closes the wire tie card 620 to complete the wire tie by withdrawing the wire tube 630 pre-clamped in the opening of the wire tie card 620 .
  • the thread trimmer 700 includes a thread trimmer duct 710; scissors 720 disposed at the end of the thread trimmer duct 710; and a power transmission member 730.
  • the scissors 720 include two blades 721 connected with the power transmission member 730, and a shearing plate 723 connected with the blades 721 through elastic connecting pieces 722 and arranged perpendicular to the blades 721.
  • the elastic connecting pieces 722 is a spring, the blade 721 is arranged in parallel with the axis of the thread trimmer duct 710, the elastic connecting piece 722 keeps the blade 721 and the shearing plate 723 a certain gap, the side of the end of the thread trimmer duct 710
  • the wall is also provided with two helically extending wire grooves 724 correspondingly, the wire grooves 724 can guide the wire into the gap between the blade 721 and the shearing plate 723, so that the two wires can be guided in the space at the same time.
  • the power transmission member 730 drives the blade 721 to move and completes the cutting operation on the shearing plate 723. After the power transmission member 730 is released, the elastic connection member 722 The blade 721 automatically springs back to the initial position.
  • the device treats mitral regurgitation by:
  • a guide wire is set through the femoral vein and through the right atrium through the interatrial septum.
  • the heart valve wire setter is introduced through the femoral vein, and the operating segment 320 is pushed to the mitral valve by means of a developing marker.
  • the first end of the first wire is fixed on the first heart valve, and the first end of the second wire is fixed on the second heart valve opposite to the first heart valve .
  • the cutter 700 cuts the thread, withdrawing the thread cutter and the cut thread.
  • Fig. 8(a) is the mitral valve with incomplete regurgitation
  • Fig. 8(b), (c) is the mitral valve that has been completely closed after treatment, those skilled in the art can use the cross knot rope traction between multiple snap connectors , to achieve better treatment effect.
  • FIG(a) and (b) show another example.
  • the two The root wire provides traction on the valve insufficiency, thereby reducing the valve gap.
  • This embodiment provides a device for treating tricuspid regurgitation, which includes a heart valve wire setter, a wire binding device and a wire cutter.
  • the settings of the heart valve wire setter, the wire binding device and the wire cutter are the same as those of the embodiment 1, the difference is that the catheter in the embodiment 2 is shorter.
  • Figure 10(a) shows an insufficiency tricuspid valve, treated by:
  • the guide wire is set through the jugular vein puncture, and then the heart valve wire setter is introduced through the jugular vein, and the operating segment is pushed to the tricuspid valve with the help of the visualization indicator, and the first wire is inserted by the heart valve wire setter.
  • the first end of the wire is fixed on the first heart valve, and the first end of the second wire is fixed on the second heart valve opposite to the first heart valve.
  • the knotter is used to form a knot between the second end of the first wire and the second end of the second wire, thereby forming a knot between the first wire and the second wire.
  • a traction is formed between the first heart valve and the second heart valve, so that the gap between the first heart valve and the second heart valve is reduced, the thread is cut by the thread trimmer, and the thread trimmer is withdrawn and cut lines.
  • the first end of the third wire can also be selected to be fixed on the third heart valve opposite to the first heart valve and the second heart valve, and the wire binding device is used to make the A knot is formed between the second ends of the first thread, the second thread and the third thread, so as to form traction for the valve insufficiency and reduce the valve gap.

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Abstract

L'invention concerne un dispositif de mise en place de fil de valvule cardiaque, comprenant : un cathéter (300) ; un premier composant encliquetable (100) ; un second composant encliquetable (200) ; un fil (400) connecté de manière fixe au premier composant encliquetable (100) ; et un premier composant de transmission de puissance (110) et un second composant de transmission de puissance (220), qui sont au moins partiellement agencés dans le cathéter (300) d'une manière pénétrante, le cathéter (300) comprenant séquentiellement une section d'extension (310), une section de fonctionnement (320) et une section de protection facultative (330). Au moyen d'une technique de réparation de valvule interventionnelle par cathéter, la section de fonctionnement (320) est poussée jusqu'à la position d'une valvule cardiaque, puis le premier composant encliquetable (100) et le second composant encliquetable (200) se déplacent l'un vers l'autre depuis les deux côtés d'une valvule (500) au moyen d'une puissance fournie par le premier composant de transmission de puissance (110) et le second composant de transmission de puissance (220) de manière à former une connexion encliquetée, de telle sorte que le premier composant encliquetable (100), le second composant encliquetable (200) et le fil (400) connecté de manière fixe au premier composant encliquetable (100) sont ancrés sur la valvule (500).
PCT/CN2020/106812 2020-08-04 2020-08-04 Dispositif de mise en place d'un fil de valvule cardiaque WO2022027231A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
PCT/CN2020/106812 WO2022027231A1 (fr) 2020-08-04 2020-08-04 Dispositif de mise en place d'un fil de valvule cardiaque
CN202110756045.1A CN114052989A (zh) 2020-08-04 2021-07-05 一种心脏瓣膜置线器

Applications Claiming Priority (1)

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PCT/CN2020/106812 WO2022027231A1 (fr) 2020-08-04 2020-08-04 Dispositif de mise en place d'un fil de valvule cardiaque

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Citations (10)

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Publication number Priority date Publication date Assignee Title
US20070118151A1 (en) * 2005-11-21 2007-05-24 The Brigham And Women's Hospital, Inc. Percutaneous cardiac valve repair with adjustable artificial chordae
US20080288060A1 (en) * 2004-07-06 2008-11-20 Baker Medical Research Institute Treating Valvular Insufficiency
CN102164548A (zh) * 2008-11-06 2011-08-24 奥林巴斯医疗株式会社 缝合器及缝合***
US20130190863A1 (en) * 2008-03-10 2013-07-25 Mitralign, Inc. Method to reduce mitral regurgitation by cinching the commissure of the mitral valve
US20170189187A1 (en) * 2015-12-31 2017-07-06 Hangzhou DiNovA Medtech Co., Ltd. Method of repairing a heart valve
CN107427305A (zh) * 2015-01-05 2017-12-01 海峡接入控股（私人）有限公司 心脏瓣膜小叶捕获装置
CN107468378A (zh) * 2017-08-29 2017-12-15 王元 瓣环修复装置及其使用方法
US20190083264A1 (en) * 2017-09-19 2019-03-21 Boston Scientific Scimed, Inc. Percutaneous repair of mitral prolapse
US20190269513A9 (en) * 2009-05-07 2019-09-05 Valtech Cardio, Ltd. Multiple anchor delivery tool
CN111374800A (zh) * 2018-12-29 2020-07-07 杭州德晋医疗科技有限公司 一种瓣膜缩环***

Patent Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080288060A1 (en) * 2004-07-06 2008-11-20 Baker Medical Research Institute Treating Valvular Insufficiency
US20070118151A1 (en) * 2005-11-21 2007-05-24 The Brigham And Women's Hospital, Inc. Percutaneous cardiac valve repair with adjustable artificial chordae
US20130190863A1 (en) * 2008-03-10 2013-07-25 Mitralign, Inc. Method to reduce mitral regurgitation by cinching the commissure of the mitral valve
CN102164548A (zh) * 2008-11-06 2011-08-24 奥林巴斯医疗株式会社 缝合器及缝合***
US20190269513A9 (en) * 2009-05-07 2019-09-05 Valtech Cardio, Ltd. Multiple anchor delivery tool
CN107427305A (zh) * 2015-01-05 2017-12-01 海峡接入控股（私人）有限公司 心脏瓣膜小叶捕获装置
US20170189187A1 (en) * 2015-12-31 2017-07-06 Hangzhou DiNovA Medtech Co., Ltd. Method of repairing a heart valve
CN107468378A (zh) * 2017-08-29 2017-12-15 王元 瓣环修复装置及其使用方法
US20190083264A1 (en) * 2017-09-19 2019-03-21 Boston Scientific Scimed, Inc. Percutaneous repair of mitral prolapse
CN111374800A (zh) * 2018-12-29 2020-07-07 杭州德晋医疗科技有限公司 一种瓣膜缩环***

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