WO2023226779A1 - 一种导管介入心脏泵 - Google Patents
一种导管介入心脏泵 Download PDFInfo
- Publication number
- WO2023226779A1 WO2023226779A1 PCT/CN2023/093576 CN2023093576W WO2023226779A1 WO 2023226779 A1 WO2023226779 A1 WO 2023226779A1 CN 2023093576 W CN2023093576 W CN 2023093576W WO 2023226779 A1 WO2023226779 A1 WO 2023226779A1
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- WO
- WIPO (PCT)
- Prior art keywords
- catheter
- drainage tube
- heart pump
- pressure sensor
- tube
- Prior art date
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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
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/20—Type thereof
- A61M60/205—Non-positive displacement blood pumps
- A61M60/216—Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller
-
- 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
- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
- A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
-
- 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
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/10—Location thereof with respect to the patient's body
- A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
-
- 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
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/50—Details relating to control
- A61M60/508—Electronic control means, e.g. for feedback regulation
- A61M60/515—Regulation using real-time patient data
- A61M60/531—Regulation using real-time patient data using blood pressure data, e.g. from blood pressure sensors
Definitions
- This specification relates to the field of medical devices, and in particular to a catheter interventional heart pump.
- interventional devices such as coronary balloons, stents, etc.
- PCI percutaneous coronary intervention
- interventional devices may aggravate the degree of myocardial ischemia and affect the pumping function of the ventricle, causing the patient's Insufficient cardiac output, in turn, leads to insufficient oxygen-rich blood perfusion in the coronary arteries, further aggravating myocardial ischemia, making the operation more difficult, and even leading to cardiac shock and death of the patient during the operation.
- Catheter interventional heart pumps are usually used for hemodynamic maintenance, which can reduce the load on the ventricles, increase the blood input of the coronary arteries, thereby improving the myocardial ischemia state, allowing patients to obtain more complete revascularization during PCI surgery. and more thorough treatment.
- a catheter interventional heart pump which includes a drainage tube, an impeller, a driving motor and a catheter; the drainage tube is provided with a fluid inlet at its front end, and a fluid outlet is provided at its rear end.
- At least one section of the spring tube includes a spring tube, which is in a curved shape in a natural state; the impeller is arranged in the drainage tube, and the drive motor is used to drive the impeller to rotate, and the drive motor includes a stator side and an output Rotating shaft, the output rotating shaft is fixedly connected to the impeller, the front end on the stator side is fixedly connected to the rear end of the drainage tube, and the rear end on the stator side is fixedly connected to the front end of the conduit.
- the front end of the drainage tube is connected to a pigtail catheter
- the front end of the pigtail catheter is made of flexible material
- the front end of the pigtail catheter is curled in a natural state.
- the drainage tube is provided with a development ring, and the development ring is disposed at a curved portion of the drainage tube.
- the catheter interventional heart pump further includes a reducer tube, a suture pad and a sterile protective bag; the reducer tube, the suture pad and the sterile protective bag are connected in sequence and set on the Outside the conduit, the diameter of the reducing tube gradually increases from the front end of the reducing tube to the rear end of the reducing tube.
- the taper of the reducing tube is 5° to 30°.
- adjusting nuts are provided at both ends of the sterile protective bag, and the adjusting nuts can lock the two ends of the sterile protective bag with the catheter respectively.
- the catheter interventional heart pump further includes a controller configured to control the drive motor to drive the impeller to rotate.
- the catheter interventional heart pump further includes a first pressure sensor and/or a second pressure sensor; the first pressure sensor is disposed at the front end of the drainage tube; the second pressure sensor is disposed at the The rear end of the drainage tube.
- the first pressure sensor is positioned closer to the heart pump relative to the fluid inlet. Front end; the second pressure sensor is disposed closer to the front end of the heart pump relative to the fluid outlet.
- the controller is configured to determine the position of the drainage tube in the body according to the first pressure signal of the first pressure sensor and/or the second pressure signal of the second pressure sensor.
- the controller is configured to: determine a first position of the drainage tube according to the first pressure signal; determine a second position of the drainage tube according to the second pressure signal; The first position and the second position determine the position of the drainage tube within the body.
- the catheter interventional heart pump further includes a rectifying device, the rectifying device is sleeved on the output shaft of the driving motor through a bearing, and the rectifying device is in contact with the stator of the driving motor. Side fixed connection.
- the catheter-intervention heart pump further includes an extracorporeal positive pressure infusion device capable of applying positive pressure to the gap between the rectifying device and the drive motor through the catheter. Instill sealing fluid.
- the sealing liquid passes through the inside of the driving motor; the surface of the driving motor in contact with the sealing liquid is provided with a parylene coating.
- Figure 1 is a schematic structural diagram of a catheter-involved heart pump according to some embodiments of this specification
- Figure 2 is a partially exploded schematic diagram of a catheter-interposed heart pump according to some embodiments of this specification
- Figure 3 is a schematic structural diagram of a rectifier device according to some embodiments of this specification.
- Figure 4 is a schematic structural diagram of a rectifier device according to other embodiments of this specification.
- Figure 5 is a partial cross-sectional view of a catheter-interposed heart pump according to some embodiments of the present specification
- Figure 6 is a partial cross-sectional view of a catheter-interposed heart pump according to other embodiments of this specification.
- Figure 7 is a schematic structural diagram of a pigtail catheter according to some embodiments of this specification.
- Figure 8 is a schematic structural diagram of a pigtail catheter according to other embodiments of this specification.
- Figure 9 is a schematic structural diagram of a drainage tube according to some embodiments of this specification.
- Figure 10 is a partial structural schematic diagram of a catheter-interposed heart pump according to some embodiments of this specification.
- Figure 11 is a schematic diagram of the overall structure of a catheter-intervened heart pump according to some embodiments of this specification.
- Figure 12 is a partial structural schematic diagram of a catheter-interposed heart pump according to some embodiments of this specification.
- Figure 13 is an exemplary structural schematic diagram of a controller according to some embodiments of this specification.
- the reference numbers are: 10. Catheter interventional heart pump; 100. Drainage tube; 110. Fluid inlet; 120. Fluid outlet; 130. Spring tube; 140. Development ring; 150. Inlet halter; 160. Outlet halter; 200 , impeller; 300, drive motor; 310, rectifier; 311, core; 312, via hole; 313, small end; 314, big end; 315, blade; 316, mounting part; C, central symmetry axis; 320, Output shaft; 330, first seal; 340, second seal; 350, bearing; 360, sealing fluid; 400, conduit; 500, pigtail conduit; 510, first straight section; 520, curved section; 530, third Two straight sections; 600, reducer; 700, suture pad; 800, sterile protective bag; 810, adjusting nut; 900, controller; 910, first pressure sensor; 920, second pressure sensor; 930, storage Media; 940, processor.
- the catheter-intervention heart pump in the embodiment of this specification may be a pumping device introduced into a heart failure patient and maintaining blood power in the heart.
- Catheter-involved heart pumps can be used for revascularization in cardiogenic shock due to various causes. Cardiogenic shock refers to heart pumping dysfunction, which can lead to extremely critical situations such as organ failure due to low perfusion pressure in various organs.
- the catheter-involved heart pump can be punctured into the aorta through the femoral artery or axillary artery, and then retrograde along the aorta, through the aortic arch, through the aortic valve and into the left ventricle. After accurate positioning, the catheter can be started to intervene in the heart.
- the pump can pump the oxygen-rich blood from the left ventricle to the ascending aorta, thereby stabilizing the patient's hemodynamics in the short term, reducing the load on the ventricle to restore myocardial and ventricular functions, and increasing the arterial blood perfusion of various organs to avoid various organ factors. Insufficient blood supply may lead to functional abnormalities or even irreversible damage.
- the catheter-intervention heart pump in the embodiments of this specification can also be used in other organs or blood vessels, such as the right ventricle, renal artery, cerebral blood vessels, etc. This specification does not limit this.
- Figure 1 is a schematic structural diagram of a catheter-involved heart pump according to some embodiments of this specification.
- Figure 2 is a partially exploded schematic diagram of a catheter-interposed heart pump according to some embodiments of the present specification.
- the catheter-intervention heart pump 10 includes a drainage tube 100 , an impeller 200 , a driving motor 300 and a catheter 400 .
- the drainage tube 100 can be a tube that guides the blood flow path.
- the drainage tube 100 is provided with a fluid inlet 110 at the front end, and the fluid outlet 120 is provided at the rear end of the drainage tube 100. Blood flows into the drainage tube 100 from the fluid inlet 110, from Fluid outlet 120 exits drain tube 100 .
- the front end of the drainage tube 100 refers to the end that enters the human body first during the operation, and the rear end of the drainage tube 100 refers to the end that enters the human body later during the operation.
- the diameter of the drainage tube 100 may be in the range of 4 mm to 7 mm (such as 4 mm, 5 mm, 5.5 mm, 6 mm, 7 mm, etc.).
- an inlet trap 150 is provided at the fluid inlet 110.
- the inlet trap 150 is in the shape of a grid, which can prevent heart tissue (such as mitral valve chordae tendineae) from being sucked into the drainage tube 100, and prevent the ventricular wall from being blocked due to negative pressure. Blocking the blood flow inlet causes the drive motor 300 to be overloaded.
- the inlet trap 150 may be made of metal material or polymer material.
- an outlet trap 160 is provided at the fluid outlet 120 . At least part of the outlet trap 160 is in the shape of a grid, which can adjust the direction in which blood flows out of the fluid outlet 120 .
- the outlet trap 160 can be integrally formed with the drainage tube 100 , that is, multiple cutouts are made on the side wall of the rear end of the drainage tube 100 to form the outlet trap 160 .
- the outlet trap 160 can be a component independent of the drainage tube 100 and is fixed to the rear end of the drainage tube 100 by snapping, welding, bonding, or other means.
- the outlet trap 160 can be made of metal material or polymer material.
- At least one section of the drainage tube 100 includes a spring tube 130.
- the spring tube 130 is in a curved shape in a natural state.
- the spring tube 130 will elastically deform under the action of an external force. After the external force disappears, the elastic restoring force will return to its natural state.
- the drainage tube 100 may entirely include a spring tube 130, and the inner and/or outer walls of the spring tube 130 may be provided with a polymer material layer.
- portions of drainage tube 100 include spring tube 130 .
- a certain middle section of the drainage tube 100 includes a spring tube 130 , and the spring tube 130 constitutes a bent portion of the drainage tube 100 .
- the drainage tube 100 may also include but is not limited to polymer braided tubes, hypotubes, etc.; the scaffold material of the drainage tube 100 may be nickel-titanium alloy.
- the impeller 200 of the catheter-involved heart pump 10 is disposed in the drainage tube 100 for regulating the flow rate of the catheter-involved heart pump 10 .
- the impeller 200 includes spiral blades arranged around its rotation axis. When the impeller 200 rotates, the spiral blades can drive the fluid in the draft tube 100 to increase in speed and gyration pressure, thereby increasing the flow rate of the fluid in the draft tube 100 .
- the fluid outlet 120 outputs fluid with a higher flow rate and pressure to form a pressure difference between the fluid inlet 110 and the fluid outlet 120, thereby increasing the perfusion flow of the heart.
- the impeller 200 may be made of metal materials (such as stainless steel, titanium alloy, cobalt-chromium alloy, etc.) or polymer materials (such as polyetheretherketone PEEK). In some embodiments, the impeller 200 can be manufactured by metal machining or polymer material injection molding.
- the driving motor 300 is used to drive the impeller 200 to rotate.
- the drive motor 300 includes a stator side and an output shaft 320.
- the stator side may be a stationary component of the drive motor 300, such as a stator core, a stator winding, a frame, etc.
- the output shaft 320 may be a shaft that can rotate relative to the stator side.
- the output shaft 320 is fixedly connected to the impeller 200 , the front end on the stator side is fixedly connected to the rear end of the drainage tube 100 , and the rear end on the stator side is fixedly connected to the front end of the conduit 400 .
- the front end in the embodiment of this specification refers to the end that enters the human body first during the operation, and the rear end refers to the end that enters the human body later during the operation.
- the output shaft 320 drives the impeller 200 to rotate, causing the fluid in the drainage tube 100 to rotate with the impeller 200 to generate a gyrating pressure, so that the blood perfusion pressure at the fluid outlet 120 is relative to the pressure at the fluid inlet 110 Increased blood perfusion pressure.
- the catheter-involved heart pump 10 may further include a rectifying device 310 , which is disposed at the fluid outlet 120 for adjusting the fluid pattern at the fluid outlet 120 .
- the rectifier device 310 is sleeved outside the output shaft 320 of the drive motor 300 and is fixedly connected to the stator side of the drive motor 300 , that is, the rectifier device 310 remains relatively stationary relative to the stator side, and the output shaft 320 passes through the rectifier.
- Device 310 is connected to impeller 200 .
- the rectifying device 310 can buffer the impact force of the fluid and guide the direction of fluid flow.
- the rectifying device 310 can adjust the rotational flow pattern or the turbulent flow pattern of the fluid. It is a flow pattern along the axis of the blood vessel, thereby releasing the gyration pressure of the fluid and reducing the impact of the fluid on the blood vessel. See Figures 3 and 4 and their associated descriptions for more details about the rectification device 310.
- the catheter-interposed heart pump 10 in the above embodiment, it can be inserted into organs such as the heart or blood vessels, and the impeller 200 pressurizes the heart or blood vessels to increase the perfusion pressure of the organs such as the heart or blood vessels, thereby increasing the pumping function of the heart and reducing the burden on the heart.
- the drainage tube 100 has a certain bending angle to adapt to the angle between the left ventricle and the aorta, making it easier for the drainage tube 100 to guide the blood flow of the left ventricle into the aorta.
- Figure 3 is a schematic structural diagram of a rectifier device according to some embodiments of this specification.
- Figure 4 is a schematic structural diagram of a rectifier device according to other embodiments of this specification.
- the rectifying device 310 includes a core 311 , which is configured as a centrally symmetrical block.
- the centrally symmetrical block means that the core 311 can be rotated at any angle around the central symmetry axis C and can be aligned with itself. Overlapping block structures.
- the core 311 includes a small end 313 and a large end 314, and the cross-section from the small end 313 to the large end 314 gradually increases.
- the cross section from the small end 313 to the large end 314 can increase linearly. For example, as shown in FIG.
- the core 311 is configured in a truncated cone shape, with the small end 313 at the top of the truncated cone and the large end 314 at the bottom of the truncated cone.
- the cross section from the small end 313 to the large end 314 can increase non-linearly.
- the core 311 is configured as a hemisphere, the top of the hemisphere is set as the small end 313 , and the bottom of the hemisphere is set as is big endian 314.
- the small end 313 is disposed close to the impeller 200 and the large end 314 is disposed close to the drive motor 300 .
- the core 311 is also provided with a mounting portion 316 for fixing to the stator side of the drive motor 300 .
- the mounting portion 316 is configured as a cylinder, the mounting portion 316 is disposed at the large end 314 and the axis of the mounting portion 316 is co-linearly arranged with the central symmetry axis C of the core 311 .
- the cross-section of the mounting portion 316 is smaller than the cross-section of the large end 314 .
- the cross-section of the mounting portion 316 is equal to the cross-section of the large end 314 .
- the mounting portion 316 is fixed to the stator side of the drive motor 300, and various fixing methods such as laser welding, bonding, and threaded connection can be used, which are not limited in this specification.
- the core 311 is provided with a through hole 312 for avoiding the output rotating shaft 320 , and the through hole 312 extends from the small end 313 to the large end 314 along the central axis of symmetry C.
- the diameter of the through hole 312 of the core 311 is larger than the diameter of the output shaft 320 of the drive motor 300 .
- the rectification device 310 further includes a plurality of blades 315 , which are spacedly arranged on the outer surface of the core 311 around the central symmetry axis C of the core 311 , and are used for releasing The swirling pressure exerted by the impeller 200 on the blood.
- the blades 315 When the fluid in the rotating flow state or the turbulent flow state impacts the rectifying device 310, the blades 315 have a diversion effect on the fluid, thereby changing and adjusting the flow direction of the fluid to achieve the purpose of releasing its swirling pressure.
- the number of blades 315 can be set as needed.
- the number of blades 315 can be two, three, or four, etc., which is not limited in this specification.
- the angles formed by adjacent blades 315 and the central axis of symmetry C may be equal, that is, the blades 315 may be arranged around the core 311 at equally spaced angles relative to the central axis of symmetry C. In some embodiments, the angles formed by adjacent blades 315 with the central axis of symmetry C may be unequal.
- the blades 315 may be arranged in a swirling shape on the outer surface of the core 311 , and the rotation direction of the blades 315 may be opposite to the rotation direction of the blades of the impeller 200 , thereby better counteracting the swirling pressure of the fluid.
- the blades 315 can be arranged in an arc shape on the outer surface of the core 311 , and the blades 315 can have a larger radius of curvature to improve the rectification effect.
- the blades 315 can be arranged in a straight line on the outer surface of the core 311 , that is, the blades 315 extend straight from the small end 313 of the core 311 to the large end 314 of the core 311 , thereby adjusting the flow through the rectifying device 310
- the fluid can continue to flow in the direction of the central symmetry axis C of the rectifying device 310 .
- the rectifying device 310 may not be provided with blades 315 , but directly utilize the surface curvature of the core 311 to buffer the impact force of the fluid and perform a rectifying effect.
- the rectifying device 310 can be injection molded from plastic material to reduce the overall weight of the catheter-involved heart pump.
- the rectifying device 310 can be machined from metal materials.
- metal materials include but are not limited to cobalt-chromium alloys, stainless steel materials, etc.
- the rectifying device 310 made of metal has high strength and long service life.
- Figure 5 is a partial cross-sectional view of a catheter-involved heart pump according to some embodiments of the present specification.
- a seal is provided between the rectifying device 310 and the drive motor 300 .
- the seal is used to prevent blood from infiltrating into the drive motor 300 and causing the drive motor 300 to cause rust, leakage, short circuit and other failures.
- the number of seals may be determined according to the structure and sealing level of the drive motor 300 .
- the seal includes a first seal 330 and a second seal 340 that assist each other to increase the sealing performance of the drive motor 300 .
- the first seal 330 is disposed between the rectifying device 310 and the output rotating shaft 320 of the driving motor 300 to prevent blood from infiltrating into the driving motor 300 from the gap between the rectifying device 310 and the output rotating shaft 320 .
- the first seal 330 is configured as an annular structure, an accommodation cavity is formed inside the rectifying device 310 , the first seal 330 is disposed in the accommodation cavity and is in sliding contact with the output shaft 320 , so that the first seal The component 330 can block the gap between the output rotating shaft 320 and the rectifying device 310 .
- the first seal 330 may be made of polytetrafluoroethylene (Teflon or PTFE), so that the first seal 330 has the advantages of sealing performance, high lubrication and non-stickiness, and the high lubrication of the first seal 330
- Teflon or PTFE polytetrafluoroethylene
- the non-stickiness makes the friction force of the output rotating shaft 320 when it is in sliding contact with the output rotating shaft 320 very small, and the loss of the output rotating shaft 320 is very small.
- the second seal 340 is disposed between the rectifying device 310 and the stator side of the driving motor 300 to prevent blood from infiltrating into the driving motor 300 from the installation gap between the rectifying device 310 and the stator side.
- the second seal 340 is configured in a disc shape.
- the disc-shaped second seal 340 includes a flat bottom plate and a protrusion formed along the edge of the flat bottom plate.
- the flat bottom plate blocks the stator side of the drive motor 300
- the protrusions block the connection between the mounting part 316 of the rectification device 310 and the stator side, thereby improving the sealing performance of the connection.
- the second seal 340 may be made of materials such as medical rubber, medical silicone, or polytetrafluoroethylene, which is not limited in this specification.
- medical silicone grease can be coated between the seal and the rectifying device 310 and between the seal and the driving motor 300.
- the medical silicone grease plays a role in lubrication and sealing. For example, it can reduce the size of the first seal. The friction force between the component 330 and the output shaft 320.
- Figure 6 is a partial cross-sectional view of a catheter-interposed heart pump according to other embodiments of the present specification.
- the rectifying device 310 can be sleeved on the output shaft 320 of the drive motor 300 through the bearing 350.
- the arrangement of the bearing 350 can make the output shaft 320 rotate more smoothly inside the rectifying device 310, thereby improving the driving force of the output shaft 320. Stability of impeller 200 rotation.
- the bearing 350 may be disposed between the fairing device 310 and the output shaft 320 .
- the inner ring of the bearing 350 may be fixedly connected to the output shaft 320
- the outer ring of the bearing 350 may be fixedly connected to the inner wall of the rectifying device 310 .
- a second seal 340 may be disposed between the rectifying device 310 and the stator side of the driving motor 300 to improve the sealing between the rectifying device 310 and the stator side of the driving motor 300 . See Figure 5 and its associated description for more details on the second seal 340.
- the rectifying device 310 and the driving motor 300 can be sealed by a sealing liquid 360, where the sealing liquid 360 includes but is not limited to physiological saline, glucose solution, etc.
- the catheter-intervention heart pump further includes an extracorporeal positive pressure infusion device (not shown in the figure).
- the extracorporeal positive pressure infusion device can apply positive pressure to the gap between the rectifying device 310 and the drive motor 300 through the catheter 400 Instill sealing fluid.
- sealing fluid may pass through the interior of the drive motor 300 .
- the arrows in Figure 6 illustrate the flow path of the sealing liquid 360: the sealing liquid 360 is instilled through extracorporeal positive pressure and introduced from the catheter 400 into the driving motor 300.
- the housing it then flows from between the second seal 340 and the stator side of the drive motor 300 to the output shaft 320 , flows along the outer wall of the output shaft 320 and the rectifying device 310 to the outside of the bearing 350 , and flows from the bearing 350 to the rectifying device 310 continues to flow between the outer wall of the output shaft 320 and the rectifying device 310, and flows outward toward the organ at the position where the impeller 200 and the rectifying device 310 are butted.
- the gap between the rectifying device 310 and the driving motor 300 is filled with the sealing liquid 360, which can adapt to gaps of different sizes and has a good sealing effect.
- the surface of the driving motor 300 that is in contact with the sealing liquid is provided with parylene coating.
- a parylene coating may be provided on the surface of the drive motor 300 before assembling the catheter interventional heart pump.
- the disassembled drive motor can be soaked in a parylene solution, so that the stator side and the output shaft of the drive motor are both covered with parylene coating.
- the parylene coating can also be replaced by other biocompatible material coatings, which is not limited in this specification.
- the extracorporeal positive pressure infusion device can be implemented by a peristaltic pump or gravity.
- the infusion pressure can be in the range of 150 to 600mmHg, such as 200mmHg, 350mmHg, 400mmHg, 500mmHg, etc.
- Figure 7 is a schematic structural diagram of a pigtail catheter according to some embodiments of this specification.
- Figure 8 is a schematic structural diagram of a pigtail catheter according to other embodiments of this specification.
- a pigtail catheter 500 is connected to the front end of the drainage tube 100.
- the front end of the pigtail catheter 500 is made of flexible material to avoid damage to tissues and organs.
- the front end of the pigtail catheter 500 is curled in a natural state, and is used to assist the drainage tube 100, the driving motor 300 and other structures to enter the heart (such as entering the left ventricle), and its curled shape is not easy to fold in the left ventricle. , twisting and slipping.
- the pigtail catheter 500 may be a hollow tubular structure that is guided into the left ventricle through a guidewire or the like.
- the pigtail catheter 500 may be a solid soft structure, for example, made of materials such as thermoplastic urethane elastomer (Thermoplastic Urethane, TPU), polyether block polyamide, or the like.
- the pigtail catheter 500 includes a first straight section 510 and a curved section 520.
- the rear end of the first straight section 510 is connected to the front end of the drainage tube 100, and the front end of the first straight section 510 is connected to the front end of the drainage tube 100.
- the curved sections 520 are connected, and the curved section 520 is curved in an arc from the front end of the first straight section 510 toward the rear end.
- the pigtail catheter 500 includes a first straight section 510 , a second straight section 530 and a curved section 520 .
- the rear end of the first straight section 510 is connected to the front end of the drainage tube 100 .
- the front end of the straight section 510 is connected to the rear end of the second straight section 530
- the front end of the second straight section 530 is connected to the curved section 520
- the curved section 520 is curved in an arc from the front end of the second straight section 530 toward the rear end.
- the angle between the first straight line segment 510 and the second straight line segment 530 is greater than 90° and less than 180°.
- Figure 9 is a schematic structural diagram of a drainage tube according to some embodiments of this specification.
- the drainage tube 100 is provided with a developing ring 140.
- the developing ring 140 is disposed at a curved portion of the drainage tube 100.
- the developing ring 140 can be developed in an imaging device (such as an X-ray imaging device). , used to position and mark the position of the drainage tube 100 in the human body.
- the developing ring 140 may be made of metallic materials, such as tantalum, platinum-iridium alloy, etc.
- the developing ring 140 may be disposed in a non-bent portion of the drainage tube 100 .
- a plurality of developing rings 140 may be provided on the drainage tube 100 to more accurately display the position and posture of the drainage tube 100 in the human body.
- Figure 10 is a partial structural diagram of a catheter-interposed heart pump according to some embodiments of this specification.
- the catheter interventional heart pump 10 may further include a reducing tube 600 , a suture pad 700 and a sterile protective bag 800 .
- the reducing tube 600 , the suture pad 700 and the sterile protective bag 800 are connected in sequence and sheathed outside the catheter 400 .
- the diameter of the reducing tube 600 gradually increases from the front end of the reducing tube 600 to the rear end of the reducing tube 600 .
- the reducing tube 600 can be used to stop bleeding at the opening of the blood vessel.
- the taper of the reducing tube 600 is 5° ⁇ 30°, for example, the taper is 5°, 10°, 15°, 18°, 20°, 25°, 30°, etc.
- the taper of the reducing tube 600 is too large, it will easily cause damage to the opening of the blood vessel, while if the taper is too small, it will be difficult to achieve a hemostatic effect.
- By setting the taper of the reducing tube 600 in the range of 5° to 30° It can not only avoid damaging the opening of blood vessels, but also has a good hemostatic effect.
- the diameter of the entire reducing tube 600 gradually and continuously increases from the front end to the rear end, making the reducing tube 600 a tapered pipe.
- the diameter of the reducing tube 600 may increase in a stepwise manner from the front end to the rear end.
- the front end section, the middle section and the rear end section of the reducing pipe 600 are all equal diameter pipes.
- the diameter of the front end section is smaller than the diameter of the middle section, and the diameter of the middle section is smaller than the rear end section. The diameter of the section.
- the suture pad 700 may be used to suture tissue (eg, skin tissue at the opening of a blood vessel) to limit movement of the catheter-involved heart pump 10 within the body.
- suture tissue eg, skin tissue at the opening of a blood vessel
- the sterile protective bag 800 is placed on the catheter 400 to prevent the catheter 400 from being contaminated by bacteria during use or recovery, thereby reducing the risk of surgical infection.
- the sterile protective bag 800 can move axially along the catheter 400.
- adjusting nuts 810 are provided at both ends of the sterile protective bag 800. The adjusting nuts 810 can lock the two ends of the sterile protective bag 800 with the catheter 400, thereby limiting the relative contact between the sterile protective bag 800 and the catheter. 400 axial displacement.
- the adjusting nuts 810 at both ends of the sterile protective bag 800 can be locked to prevent wound infection caused by instrument withdrawal.
- an outer sheath is used to pass through the catheter 400 exposed outside the body and on the pump body during instrument retrieval, and the catheter 400 outside the body can be protected from infection by providing a sterile protective bag 800 .
- Figure 11 is a schematic diagram of the overall structure of a catheter-involved heart pump according to some embodiments of this specification.
- Figure 12 is a partial structural schematic diagram of a catheter-involved heart pump according to some embodiments of this specification.
- the catheter interventional heart pump 10 further includes a controller 900 , and the controller 900 can be used to control the drive motor 300 to drive the impeller 200 to rotate.
- the controller 900 may send control instructions to the drive motor 300 based on artificially set control parameters.
- the controller 900 can automatically determine the control parameters and send control instructions to the drive motor 300, thereby avoiding interference from human factors.
- the control parameters may include, but are not limited to, voltage, current, driving speed, power of the driving motor 300, pressure signals collected by sensors, etc.
- the controller 900 is arranged outside the body and is connected to the driving motor 300 via a signal signal.
- a part of the cable can pass through the catheter 400 into the body and be connected to the driving motor 300, and the other part is located outside the body and connected to the controller 900.
- the controller 900 can be powered by its own battery, or the controller 900 can be powered by a power source from the grid.
- the catheter interventional heart pump 10 further includes a first pressure sensor 910 and/or a second pressure sensor 920; the first pressure sensor 910 and the second pressure sensor 920 include but are not limited to piezoelectric sensors. Pressure sensor, piezoresistive pressure transmitter sensors, electromagnetic pressure sensors, capacitive pressure sensors, etc.
- the catheter-intervention heart pump 10 may include only one pressure sensor, that is, the first pressure sensor 910 or the second pressure sensor 920 .
- the catheter-intervention heart pump 10 may include two pressure sensors, ie, a first pressure sensor 910 and a second pressure sensor 920 .
- the working status of the catheter-involved heart pump 10 can be easily learned, so that the performance and clinical effect of the catheter-involved heart pump 10 can be monitored, and the catheter can be guided accordingly. Interventional heart pump 10 works better.
- the first pressure sensor 910 is disposed at the front end of the drainage tube 100, and the first pressure sensor 910 can be used to detect the blood perfusion pressure at the front end of the drainage tube 100. In some embodiments, if the drainage tube 100 is inserted into the left ventricle, the first pressure sensor 910 is used to detect the blood perfusion pressure in the left ventricle; if the drainage tube 100 is inserted into the aorta, the first pressure sensor 910 is used to detect blood perfusion pressure in the left ventricle. To detect the perfusion pressure in the aorta.
- the first pressure sensor 910 is disposed closer to the front end of the heart pump (the catheter is inserted into the heart pump 10) relative to the fluid inlet 110 (as shown in FIG. 12), so that the first pressure sensor 910 can detect the presence of blood in the heart pump 10.
- the blood perfusion pressure before entering the fluid inlet 110 may be 20 to 60 mm (such as 20 mm, 30 mm, 50 mm, 60 mm, etc.).
- the first pressure sensor 910 is disposed closer to the rear end of the heart pump relative to the fluid inlet 110 and is disposed close to the fluid inlet 110 . At this time, the first pressure sensor 910 can detect the blood perfusion pressure at the fluid inlet 110 .
- the second pressure sensor 920 is disposed at the rear end of the drainage tube 100, and the second pressure sensor 920 can be used to detect the blood perfusion pressure at the rear end of the drainage tube 100.
- the blood perfusion pressure at the rear end of the drainage tube 100 may be the blood pressure after the blood is pressurized through the drainage tube 100, the impeller 200 and other components.
- the second pressure sensor 920 is disposed closer to the front end of the heart pump relative to the fluid outlet 120 (as shown in FIG. 12 ). Since a turbulent flow area may appear at the fluid outlet 120 and affect the detection accuracy of the second pressure sensor 920, disposing the second pressure sensor 920 at the front end of the fluid outlet 120 can avoid the influence of turbulent flow at the fluid outlet 120 and improve the detection accuracy of the second pressure sensor 920. The second pressure sensor 920 detects the accuracy. In some embodiments, the distance between the second pressure sensor 920 and the fluid outlet 120 may be 30-70 mm (such as 30 mm, 40 mm, 50 mm, 70 mm, etc.). In some embodiments, as shown in FIG. 12 , the second pressure sensor 920 may be disposed on the outer surface of the outlet trap 160 .
- the second pressure sensor 920 may be positioned closer to the rear end of the heart pump relative to the fluid outlet 120 .
- the second pressure sensor 920 and the fluid outlet 120 can be separated by a preset distance range (such as 3cm, 5cm, etc.), so that the second pressure sensor 920 can avoid the turbulent flow area and improve the data collected by the second pressure sensor 920. Accuracy of data.
- the controller 900 is configured to determine the position of the drainage tube 100 in the body according to the first pressure signal of the first pressure sensor 910 and/or the second pressure signal of the second pressure sensor 920 . Since the blood perfusion pressures of different organs and parts of the human body are different, such as the left ventricle, aorta, veins, etc., the drainage can be determined through the pressure signals detected by the first pressure sensor 910 and the second pressure sensor 920 The position of tube 100 in the body. In some embodiments, the position of the drainage tube 100 in the body can be represented by the position of any point on the drainage tube 100 in the body. In some embodiments, the position of the drainage tube 100 within the body may be represented by the position of the imaging ring 140 on the drainage tube 100 within the body.
- the first pressure sensor 910 and the second pressure sensor 920 can determine the specific location of the drainage tube 100 in a certain organ or part of the body.
- the first pressure sensor 910 enters the left ventricle with the heart pump, and different positions in the left ventricle The device has different pressures, and the specific position of the first pressure sensor 910 in the left ventricle can be determined according to the pressure value detected by the first pressure sensor 910; thus, the drainage can be further deduced according to the position of the first pressure sensor 910 on the drainage tube 100.
- the specific location of tube 100 within the body is a certain organ or part of the body.
- the first pressure sensor 910 and the second pressure sensor 920 may also be used to determine changes in the position of the drainage tube 100 within the body. For example, if the pressure value of the first pressure sensor 910 changes significantly in a short period of time (for example, the change rate of the pressure value exceeds a set threshold), it indicates that the drainage tube 100 may suddenly move in the body, such as suddenly falling off from the left ventricle to the aorta. , at this time, the controller 900 can generate early warning information to alert the operator.
- the controller 900 may determine the position of the drainage tube 100 within the body based solely on the first pressure signal of the first pressure sensor 910 . In some embodiments, the controller 900 may determine the position of the drainage tube 100 within the body based solely on the second pressure signal of the second pressure sensor 920 . In some embodiments, the controller 900 may simultaneously determine the position of the drainage tube 100 in the body based on the first pressure signal of the first pressure sensor 910 and the second pressure signal of the second pressure sensor 920 to improve the accuracy of position determination.
- the controller 900 (such as the processor 940) can obtain the pre-stored correspondence between the position information and the pressure value from the storage medium (such as the storage medium 930). For example, the controller 900 may obtain pre-stored pressure values corresponding to different positions in the patient's left ventricle, pressure values corresponding to different positions in the aorta, and pressure values corresponding to different positions in the veins.
- the controller 900 may pre-collect position information and its corresponding pressure value through the developing ring 140 .
- the catheter-intervened heart pump 10 can be implanted into the human body and imaged by an imaging device to obtain position information of the imaging ring 140 .
- the position of the imaging ring 140 imaged under the imaging device can be collected in real time or periodically, and the first pressure sensor of the developing ring 140 at different positions can be simultaneously recorded. a pressure signal and/or a second pressure signal from a second pressure sensor.
- the corresponding relationship between the position information and the pressure value may be a one-to-one correspondence between the position and the pressure value, or it may be a functional relationship between the position and the pressure value obtained through a fitting algorithm.
- the position information of the left ventricle may be represented by spatial three-dimensional coordinates.
- the center point of the aortic valve is used as the coordinate origin, the left-right direction of the human body is the three-dimensional coordinates.
- the location information of the detection point in the aorta may be represented by the distance between the detection point and the aortic valve.
- the controller 900 may determine that the drainage tube 100 is in the body according to the first pressure signal of the first pressure sensor 910 and/or the second pressure signal of the second pressure sensor 920 s position. In some embodiments, the controller 900 can jointly determine the position of the drainage tube 100 in the body based on the first pressure signal of the first pressure sensor 910 and the second pressure signal of the second pressure sensor 920. Specific steps include:
- Step 1 Determine the first position of the drainage tube 100 according to the first pressure signal.
- the first pressure sensor 910 can acquire the first pressure signal and feed it back to the controller 900.
- the controller 900 can compare the first pressure signal with a pre-stored pressure value and obtain a comparison result. If the difference between the value of the first pressure signal and the pre-stored pressure value is within a preset range (for example, the difference is 0-5% of the pre-stored pressure value), then the first pressure sensor 910 can be roughly determined is at the position corresponding to the pre-stored pressure value. According to this position, the position of the drainage tube 100 can be determined. First position.
- the controller 900 may further calculate the precise position of the first pressure sensor 910 based on the difference between the value of the first pressure signal and the pre-stored pressure value. For example, the controller 900 can establish a functional relationship between position and pressure based on pressure values at different locations, and calculate the precise position of the first pressure sensor 910 through the functional relationship, and the first position of the drainage tube 100 can be determined based on the position.
- Step 2 Determine the second position of the drainage tube 100 according to the second pressure signal.
- the second pressure sensor 920 can acquire the second pressure signal and feed it back to the controller 900.
- the controller 900 compares the second pressure signal with a pre-stored pressure value and obtains a comparison result. If the difference between the value of the second pressure signal and the pre-stored pressure value is within a preset range (for example, the difference is 0-5% of the pre-stored pressure value), the second pressure sensor 920 can be roughly determined. is at a position corresponding to the pre-stored pressure value, and the second position of the drainage tube 100 can be determined based on this position.
- the controller 900 may further calculate the precise position of the second pressure sensor 920 based on the difference between the value of the second pressure signal and the pre-stored pressure value. For example, the controller 900 can establish a functional relationship between position and pressure based on pressure values at different locations, and calculate the precise position of the second pressure sensor 920 through the functional relationship, and the second position of the drainage tube 100 can be determined based on the position.
- Step 3 Determine the position of the drainage tube 100 in the body based on the first position and the second position.
- both the first position and the second position represent the position of the drainage tube 100 in the body, and the controller 900 can select the first position or the second position as the position of the drainage tube 100 in the body. For example, if the difference between the first position and the second position is within a preset range (for example, the difference is less than 5 mm), it means that the error between the first position and the second position is small, and the controller 900 can use the first position as the drainage tube. 100 in the body, or the second position is used as the position of the drainage tube 100 in the body.
- a preset range for example, the difference is less than 5 mm
- the controller 900 can take an intermediate position between the first position and the second position, and determine the intermediate position as the position of the drainage tube 100 in the body, thereby effectively improving the position determination accuracy of the drainage tube 100 .
- the position of the drainage tube 100 after the position of the drainage tube 100 is determined in the above manner, it can be determined based on the position whether the catheter-intervention heart pump 10 is installed at the position required for treatment. For example, it can be determined whether the front end of the drainage tube 100 is installed in the left ventricle or a specific position in the left ventricle (such as the apex position of the left ventricle). In some embodiments, by determining the position of the drainage tube 100 during the operation of the heart pump, it can be determined whether the position of the heart pump deviates during the operation. If the position of the heart pump deviates, there may be a possibility that the catheter may be inserted into the heart pump 10 from the left side unexpectedly. In case of ventricular detachment and other situations, the controller 900 can send out early warning information in time, thereby reducing the user's risk.
- the controller 900 may also adjust the current output value, voltage output value and/or power output value of the driving motor 300 based on the signals of the first pressure sensor 910 and the second pressure sensor 920 .
- the controller 900 can calculate and obtain control parameters based on the first pressure signal of the first pressure sensor 910 and the second pressure signal of the second pressure sensor 920 , and send a control instruction to the driving motor 300 based on the control parameters, thereby Adjust the current output value, voltage output value and/or power output value of the drive motor 300, etc.
- the controller 900 may determine whether the catheter-involved heart pump 10 is working abnormally based on the current signal of the driving motor 300 .
- the controller 900 can preset a safe current range value (or threshold), and after acquiring the current signal of the driving motor 300, compare the current signal with the safe current range value (or threshold): if the current If the signal is within the safe current range (eg, less than the threshold), the controller 900 generates a determination result that the catheter-involved heart pump 10 is working normally; if the current signal is outside the safe current range (eg, greater than the threshold), then The controller 900 generates a determination result that the catheter-involved heart pump 10 is operating abnormally.
- the controller 900 determines that the catheter-involved heart pump 10 is working abnormally, it can send an alarm message so that the operator can perform timely maintenance or correction.
- Figure 13 is an exemplary structural schematic diagram of a controller according to some embodiments of this specification.
- the controller 900 of the catheter-involved heart pump 10 may include a storage medium 930, a processor 940, and a communication bus.
- the processor 940 and the storage medium 930 can implement the communication process through the communication bus.
- the processor 940 may be used to execute the control method of the catheter-involved heart pump 10 provided by any of the above embodiments of the present application.
- the processor 940 may be implemented using a central processing unit, a server, a terminal device, or any other possible processing device.
- the above-mentioned central processor, server, terminal device or other processing device can be implemented on a cloud platform.
- the above-mentioned central processor, server or other processing device can be interconnected with various terminal devices, and the terminal device can complete information processing work or part of the information processing work.
- storage medium 930 may store data and/or instructions.
- the storage medium 930 may store computer instructions, and the processor 940 (or computer) may read the computer instructions to execute the control method of the catheter-involved heart pump 10 provided in any embodiment of this specification.
- the storage device may include mass memory, removable memory, volatile read-write memory, read-only memory (ROM), etc., or any combination thereof.
- the storage device may be implemented on a cloud platform.
- the catheter-interposed heart pump can be inserted into the heart (such as the left ventricle) to increase the perfusion pressure of the heart through impeller pressurization, increase the heart's pumping function, and provide the heart with Reduce the burden on.
- the drainage tube has a certain bending angle to adapt to the angle between the left ventricle and the aorta, making it easier for the drainage tube to guide the blood flow of the left ventricle into the aorta;
- the front end of the pigtail catheter It is curled in the natural state, and its curled shape is not easy to fold, twist and slip off in the heart;
- the sterile protective bag is placed on the catheter to prevent the catheter from being contaminated by bacteria during use or recycling and reduce infection Risk;
- the working status of the catheter-involved heart pump can be easily learned, so that the performance and clinical effect of the catheter-involved heart pump can be monitored, and guidance can be provided
- the catheter-intervention heart pump works better;
- By determining the position of the drainage tube it can be judged based on the position whether the catheter-intervention heart pump is installed at the location required for treatment.
- the controller can issue an early warning message in time. Reduce user risk. It should be noted that different embodiments may produce different beneficial effects. In different embodiments, the possible beneficial effects may be any one or a combination of the above, or any other possible beneficial effects.
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Abstract
一种导管介入心脏泵(10),包括引流管(100)、叶轮(200)、驱动电机(300)和导管(400);引流管(100)前端设有流体入口(110),引流管(100)后端设有流体出口(120),引流管(100)的至少一段包括弹簧管(130),弹簧管(130)在自然状态下成弯曲形状;叶轮(200)设置在引流管(100)内,驱动电机(300)用于驱动叶轮(200)转动,驱动电机(300)包括定子侧和输出转轴(320),输出转轴(320)与叶轮(200)固连,定子侧的前端与引流管(100)的后端固连,定子侧的后端与导管(400)的前端固连。
Description
交叉引用
本申请要求于2022年05月24日提交的中国专利申请202210569945.X的优先权,其全部内容通过引用结合于此。
本说明书涉及医疗器械领域,特别涉及一种导管介入心脏泵。
在诸如高危经皮冠状动脉介入手术(Percutaneous coronary intervention,PCI)等高危手术中,介入器械(例如冠脉球囊、支架等)可能加重心肌缺血程度进而影响心室的泵血功能,导致患者的心输出量不足,转而又导致冠脉的富氧血灌注不足进一步加剧心肌缺血,使手术难度增加,甚至导致术中患者心脏休克、死亡。导管介入心脏泵通常用于血液动力学维持,能够起到减轻心室的负荷的作用,增大冠脉的血液输入量从而改善心肌缺血状态,使得患者在PCI手术中得到更完整的血运重建和更为彻底的治疗。
发明内容
本说明书实施例之一提供一种导管介入心脏泵,包括引流管、叶轮、驱动电机和导管;所述引流管前端设有流体入口,所述引流管后端设有流体出口,所述引流管的至少一段包括弹簧管,所述弹簧管在自然状态下成弯曲形状;所述叶轮设置在所述引流管内,所述驱动电机用于驱动所述叶轮转动,所述驱动电机包括定子侧和输出转轴,所述输出转轴与所述叶轮固连,所述定子侧的前端与所述引流管的后端固连,所述定子侧的后端与所述导管的前端固连。
在一些实施例中,所述引流管前端连接有猪尾导管,所述猪尾导管的前端由柔性材料制成,且所述猪尾导管的前端在自然状态下成卷曲状。
在一些实施例中,所述引流管上设有显影环,所述显影环设置在所述引流管的弯曲部位。
在一些实施例中,所述导管介入心脏泵还包括变径管、缝合垫和无菌保护袋;所述变径管、所述缝合垫和所述无菌保护袋依次连接且套设在所述导管外部,所述变径管的直径从所述变径管的前端到所述变径管的后端逐渐增大。
在一些实施例中,所述变径管的锥度为5°~30°。
在一些实施例中,所述无菌保护袋的两端分别设有调节螺母,所述调节螺母能够将所述无菌保护袋的两端分别与所述导管锁定。
在一些实施例中,所述导管介入心脏泵还包括控制器,所述控制器用于控制所述驱动电机驱动所述叶轮转动。
在一些实施例中,所述导管介入心脏泵还包括第一压力传感器和/或第二压力传感器;所述第一压力传感器设置在所述引流管前端;所述第二压力传感器设置在所述引流管后端。
在一些实施例中,所述第一压力传感器的设置位置相对于所述流体入口更靠近所述心脏泵的
前端;所述第二压力传感器的设置位置相对于所述流体出口更靠近所述心脏泵的前端。
在一些实施例中,所述控制器用于:根据所述第一压力传感器的第一压力信号和/或所述第二压力传感器的第二压力信号,确定所述引流管在体内的位置。
在一些实施例中,所述控制器用于:根据所述第一压力信号确定所述引流管的第一位置;根据所述第二压力信号确定所述引流管的第二位置;根据所述第一位置和所述第二位置确定所述引流管在体内的位置。
在一些实施例中,所述导管介入心脏泵还包括整流装置,所述整流装置通过轴承套设在所述驱动电机的所述输出转轴上,所述整流装置与所述驱动电机的所述定子侧固定相连。
在一些实施例中,所述导管介入心脏泵还包括体外正压滴注装置,所述体外正压滴注装置能够通过所述导管向所述整流装置和所述驱动电机之间的间隙正压滴注密封液。
在一些实施例中,所述密封液从所述驱动电机内部通过;所述驱动电机与所述密封液接触的部位表面设有派瑞林涂层。
本说明书将以示例性实施例的方式进一步说明,这些示例性实施例将通过附图进行详细描述。这些实施例并非限制性的,在这些实施例中,相同的编号表示相同的结构,其中:
图1是根据本说明书一些实施例所示的导管介入心脏泵的结构示意图;
图2是根据本说明书一些实施例所示的导管介入心脏泵的局部分解示意图;
图3是根据本说明书一些实施例所示的整流装置的结构示意图;
图4是根据本说明书另一些实施例所示的整流装置的结构示意图;
图5是根据本说明书一些实施例所示的导管介入心脏泵的局部剖视图;
图6是根据本说明书另一些实施例所示的导管介入心脏泵的局部剖视图;
图7是根据本说明书一些实施例所示的猪尾导管的结构示意图;
图8是根据本说明书另一些实施例所示的猪尾导管的结构示意图;
图9是根据本说明书一些实施例所示的引流管的结构示意图;
图10是根据本说明书一些实施例所示的导管介入心脏泵的局部结构示意图;
图11是根据本说明书一些实施例所示的导管介入心脏泵的整体结构示意图;
图12是根据本说明书一些实施例所示的导管介入心脏泵的局部结构示意图;
图13是根据本说明书一些实施例所示的控制器的示例性结构示意图。
其中,附图标记为:10、导管介入心脏泵;100、引流管;110、流体入口;120、流体出口;130、弹簧管;140、显影环;150、入口笼头;160、出口笼头;200、叶轮;300、驱动电机;310、整流装置;311、芯部;312、过孔;313、小端;314、大端;315、叶片;316、安装部;C、中心对称轴线;320、输出转轴;330、第一密封件;340、第二密封件;350、轴承;360、密封液;400、导管;500、猪尾导管;510、第一直线段;520、弯曲段;530、第二直线段;600、变径管;700、缝合垫;800、无菌保护袋;810、调节螺母;900、控制器;910、第一压力传感器;920、第二压力传感器;930、存储
介质;940、处理器。
为了更清楚地说明本说明书实施例的技术方案,下面将对实施例描述中所需要使用的附图作简单的介绍。显而易见地,下面描述中的附图仅仅是本说明书的一些示例或实施例,对于本领域的普通技术人员来讲,在不付出创造性劳动的前提下,还可以根据这些附图将本说明书应用于其它类似情景。除非从语言环境中显而易见或另做说明,图中相同标号代表相同结构或操作。
如本说明书和权利要求书中所示,除非上下文明确提示例外情形,“一”、“一个”、“一种”和/或“该”等词并非特指单数,也可包括复数。一般说来,术语“包括”与“包含”仅提示包括已明确标识的步骤和元素,而这些步骤和元素不构成一个排它性的罗列,方法或者设备也可能包含其它的步骤或元素。
本说明书实施例中的导管介入心脏泵可以是导入心衰患者并为其心脏维持血液动力的泵送装置。导管介入心脏泵可以用于由于各种原因导致的心源性休克的血运重建。心源性休克是指心脏泵血功能障碍,心源性休克会导致各器官因较低的灌注压力而出现器官衰竭等极其危机情况。在一些实施例的应用场景中,导管介入心脏泵可以经皮股动脉或者腋动脉穿刺进入主动脉,接着沿主动脉逆行主动脉弓穿过主动脉瓣进入左心室,定位准确后,通过启动导管介入心脏泵能够将左心室的富氧血泵送至升主动脉,从而在短期内稳定患者的血液动力、减轻心室的负荷使得心肌、心室功能得到恢复,并增加各器官的动脉血灌注避免各器官因供血不足出现功能异常甚至导致不可逆的损伤。此外,本说明书实施例中的导管介入心脏泵也可以用于其他器官或血管中,例如右心室、肾动脉、脑血管等,本说明书对此不作限制。
图1是根据本说明书一些实施例所示的导管介入心脏泵的结构示意图。图2是根据本说明书一些实施例所示的导管介入心脏泵的局部分解示意图。
如图1和图2所示,本说明书实施例提供一种导管介入心脏泵10,该导管介入心脏泵10包括引流管100、叶轮200、驱动电机300和导管400。
在一些实施例中,引流管100可以是引导血液流动路径的管件,引流管100前端设有流体入口110,引流管100后端设有流体出口120,血液从流体入口110流入引流管100,从流体出口120流出引流管100。其中,引流管100前端是指在手术时先进入人体的一端,引流管100后端是指在手术时后进入人体的一端。在一些实施例中,引流管100的直径可以在4毫米~7毫米范围内(如4毫米、5毫米、5.5毫米、6毫米、7毫米等)。
在一些实施例中,流体入口110处设置有入口笼头150,入口笼头150呈格栅状,能够防止心脏组织(如二尖瓣腱索)被吸入引流管100,以及防止心室壁因负压堵住血流入口导致驱动电机300过载。在一些实施例中,入口笼头150可以由金属材料或高分子材料制成。
在一些实施例中,流体出口120处设置有出口笼头160,出口笼头160的至少部分呈格栅状,能够调整血液从流体出口120流出的方向。在一些实施例中,出口笼头160可以与引流管100一体成型,即在引流管100后端的侧壁开设多个切口以形成出口笼头160。在一些实施例中,出口笼头160可以是独立于引流管100的部件,通过卡合、焊接、粘接等方式固定到引流管100的后端。在一些实施例
中,出口笼头160可以由金属材料或高分子材料制成。
在一些实施例中,引流管100的至少一段包括弹簧管130,弹簧管130在自然状态下成弯曲形状,弹簧管130在受外力作用下会产生弹性变形,外力消失后在弹性恢复力的作用下恢复为自然状态。在一些实施例中,引流管100可以全部包括弹簧管130,弹簧管130的内壁和/或外壁可以设置有高分子材料层。在一些实施例中,引流管100的局部包括弹簧管130。例如,引流管100的中部某区段包括弹簧管130,弹簧管130构成引流管100的弯折部分。在一些实施例中,引流管100还可以包括但不限于高分子编织管、海波管等;引流管100的支架材料可以为镍钛合金。
在一些实施例中,导管介入心脏泵10的叶轮200设置在引流管100内,用于调节导管介入心脏泵10的流量。在一些实施例中,叶轮200包括绕其旋转轴线布置的螺旋形旋叶,叶轮200转动时在螺旋形旋叶的作用下能够带动引流管100内的流体的速度增加和回旋压力增加,从而在流体出口120处输出流速和压力更高的流体,以在流体入口110和流体出口120之间形成压力差,进而提高心脏的灌注流量。在一些实施例中,叶轮200的制造材料可以为金属材料(如不锈钢、钛合金、钴铬合金等),也可以是高分子材料(如聚醚醚酮PEEK)。在一些实施例中,叶轮200可以采用金属机加工的方式制造,也可以采用高分子材料注塑成型的方式制造。
在一些实施例中,驱动电机300用于驱动叶轮200转动。驱动电机300包括定子侧和输出转轴320,定子侧可以是驱动电机300静止不动的部件,例如定子铁芯、定子绕组和机座等,输出转轴320可以是能够相对于定子侧转动的轴。
在一些实施例中,输出转轴320与叶轮200固连,定子侧的前端与引流管100的后端固连,定子侧的后端与导管400的前端固连。其中,本说明书实施例中的前端是指在手术时先进入人体的一端,后端是指在手术时后进入人体的一端。驱动电机300驱动输出转轴320转动时,输出转轴320带动叶轮200旋转,使引流管100内的流体随叶轮200旋转而产生回旋压力,使流体出口120处的血液灌注压力相对于流体入口110处的血液灌注压力增加。
如图2所示,在一些实施例中,导管介入心脏泵10还可以包括整流装置310,整流装置310设置在流体出口120处,用于调整流体出口120处的流体形态。在一些实施例中,整流装置310套设在驱动电机300的输出转轴320外,并且与驱动电机300的定子侧固定相连,即整流装置310相对于定子侧保持相对静止,输出转轴320穿过整流装置310与叶轮200相连。在一些实施例中,整流装置310可以缓冲流体的冲击力,并引导流体流动的方向,引流管100的流体流经整流装置310后,整流装置310可以将流体的旋转流动形态或紊流形态调整为沿血管的轴线流动形态,从而释放流体的回旋压力,降低流体对血管的冲击力。有关整流装置310的更多细节请参见图3和图4及其相关描述。
根据上述实施例中的导管介入心脏泵10的结构,其可以介入心脏或血管等器官中,通过叶轮200增压提高心脏或血管等器官的灌注压力,增加心脏泵血功能,为心脏减轻负担。通过设置弹簧管130,使引流管100具有一定的弯折角度来适配左心室和主动脉之间的角度,更便于引流管100将左心室的血流引向主动脉内。
图3是根据本说明书一些实施例所示的整流装置的结构示意图。图4是根据本说明书另一些实施例所示的整流装置的结构示意图。
如图3和图4所示,整流装置310包括芯部311,芯部311构造为中心对称的块体,中心对称的块体是指芯部311绕中心对称轴线C旋转任意角度后能够与自身重合的块状结构。在一些实施例中,芯部311包括小端313和大端314,小端313至大端314的横截面逐渐增大。在一些实施例中,小端313至大端314的横截面可以呈线性增加,例如参见图3,芯部311构造为圆台状,圆台顶部为小端313,圆台底部为大端314。在一些实施例中,小端313至大端314的横截面可以呈非线性增加,例如参见图4,芯部311构造为半球体,半球体的顶部设置为小端313,半球体的底部设置为大端314。
在一些实施例中,小端313靠近叶轮200布置,大端314靠近驱动电机300布置。在一些实施例中,芯部311上还设置有用于与驱动电机300的定子侧固定的安装部316。在一些实施例中,安装部316构造为圆柱体,安装部316设置在大端314且安装部316的轴线与芯部311的中心对称轴线C共线布置。在一些实施例中,参见图3,安装部316的横截面小于大端314的横截面。在一些实施例中,参见图4,安装部316的横截面等于大端314的横截面。
在一些实施例中,安装部316与驱动电机300的定子侧固定,可以采用激光焊接、粘接、螺纹连接等多种固定方式,本说明书对此不作限制。
在一些实施例中,芯部311开设有用于避让输出转轴320的过孔312,该过孔312从小端313沿中心对称轴线C贯穿至大端314。在一些实施例中,芯部311的过孔312的孔径大于驱动电机300的输出转轴320的直径。
在一些实施例中,参见图3,整流装置310还包括多个叶片315,多个叶片315围绕芯部311的中心对称轴线C间隔布置在芯部311的外表面,多个叶片315用于释放叶轮200对血液施加的回旋压力。当旋转流态或紊流态的流体冲击到整流装置310上时,叶片315对流体具有引流作用,从而改变和调整流体的流向,达到释放其回旋压力的目的。
在一些实施例中,叶片315的数量可以根据需要设置,例如叶片315可以为两个、三个或四个等,本说明书对此不作限制。在一些实施例中,相邻叶片315与中心对称轴线C形成的夹角可以相等,即叶片315可以相对于中心对称轴线C呈等间隔角度围绕芯部311布置。在一些实施例中,相邻叶片315与中心对称轴线C形成的夹角可以不相等。
在一些实施例中,叶片315可以成旋流状布置在芯部311的外表面,叶片315的旋向可以与叶轮200的旋叶的旋向相反,从而更好的抵消流体的回旋压力。在一些实施例中,叶片315可以成弧状布置在芯部311的外表面,叶片315可以具有较大的曲率半径,以提高整流效果。在一些实施例中,叶片315可以成直线状布置在芯部311的外表面,即叶片315从芯部311的小端313直线延伸到芯部311的大端314,从而调整流经整流装置310的流体可以沿整流装置310的中心对称轴线C的方向继续流动。
在一些实施例中,参见图4,整流装置310可以不设置叶片315,而直接利用芯部311的表面弧度来缓冲流体的冲击力,起到整流作用。
在一些实施例中,整流装置310可以采用塑料材质注塑成型,以降低导管介入心脏泵整体重量。在一些实施例中,整流装置310可以由金属材料机加工而成,例如金属材料包括但不限于钴铬合金、不锈钢材料等,金属材质的整流装置310强度高,使用寿命长。
图5是根据本说明书一些实施例所示的导管介入心脏泵的局部剖视图。
在一些实施例中,如图5所示,整流装置310与驱动电机300之间设置有密封件,密封件用于防止血液浸入驱动电机300而造成驱动电机300生锈、漏电、短路等故障。在一些实施例中,密封件的数量可以根据驱动电机300的结构和密封等级确定。
在一些实施例中,密封件包括第一密封件330和第二密封件340,第一密封件330和第二密封件340相互辅助,以增加驱动电机300的密封性。
在一些实施例中,第一密封件330设置在整流装置310和驱动电机300的输出转轴320之间,避免血液从整流装置310和输出转轴320之间的间隙浸入驱动电机300。在一些实施例中,第一密封件330构造为环状结构,整流装置310的内部形成有容纳腔,第一密封件330设置在容纳腔中并且与输出转轴320滑动接触,这样,第一密封件330能够封挡输出转轴320和整流装置310之间的间隙。在一些实施例中,第一密封件330可以由聚四氟乙烯(Teflon或PTFE)制成,使得第一密封件330具有密封性、高润滑不粘性等优点,第一密封件330的高润滑不粘性使得输出转轴320与其滑动接触时摩擦力非常小,对输出转轴320的损耗非常小。
在一些实施例中,第二密封件340设置在整流装置310和驱动电机300的定子侧之间,避免血液从整流装置310和定子侧的安装间隙浸入驱动电机300。在一些实施例中,第二密封件340构造为圆盘状,圆盘状的第二密封件340包括平底盘和沿平底盘边缘形成的凸起,平底盘封挡在驱动电机300的定子侧的端面,凸起封挡在整流装置310的安装部316和定子侧连接处,从而提高连接处的密封性。在一些实施例中,第二密封件340可以由医用橡胶、医用硅胶或聚四氟乙烯等材料制成,本说明书对此不作限制。
在一些实施例中,密封件和整流装置310之间、以及密封件与驱动电机300之间可以涂设有医用硅脂,该医用硅脂起到润滑和密封作用,例如可以减小第一密封件330和输出转轴320之间的摩擦力。
图6是根据本说明书另一些实施例所示的导管介入心脏泵的局部剖视图。
在一些实施例中,整流装置310可以通过轴承350套设在驱动电机300的输出转轴320上,轴承350的设置能够使得输出转轴320在整流装置310的内部转动更加平稳,从而提高输出转轴320带动叶轮200转动的稳定性。在一些实施例中,轴承350可以设置在整流装置310和输出转轴320之间。在一些实施例中,轴承350的内圈可以与输出转轴320固定连接,和/或,轴承350的外圈可以与整流装置310的内壁固定连接。
在一些实施例中,整流装置310和驱动电机300的定子侧之间可以设置第二密封件340,以提高整流装置310和驱动电机300的定子侧之间的密封性。有关第二密封件340的更多细节请参见图5及其相关描述。
在一些实施例中,整流装置310和驱动电机300之间可以通过密封液360进行密封,其中,密封液360包括但不限于生理盐水、葡萄糖溶液等。在一些实施例中,导管介入心脏泵还包括体外正压滴注装置(图中未示出),体外正压滴注装置能够通过导管400向整流装置310和驱动电机300之间的间隙正压滴注密封液。在一些实施例中,密封液可以从驱动电机300内部通过。在一些实施例中,图6中的箭头示出了密封液360的流动路径:密封液360通过体外正压滴注,从导管400引入驱动电机300的
壳体内,然后从第二密封件340与驱动电机300的定子侧之间流向输出转轴320,沿输出转轴320的外壁和整流装置310之间流动至轴承350的外侧,并从轴承350与整流装置310的连接处继续流动至输出转轴320的外壁和整流装置310之间,在叶轮200与整流装置310对接的位置处向外流向器官。通过密封液360来填充整流装置310和驱动电机300之间的间隙,能够适应不同尺寸的间隙,密封效果好。在一些实施例中,驱动电机300与密封液接触的部位表面设有派瑞林涂层。通过设置派瑞林涂层,可以有效避免驱动电机300与密封液直接接触,能够对电机形成保护,同时可以避免电机污染密封液。在一些实施例中,在组装导管介入心脏泵前,可以先对驱动电机300表面设置派瑞林涂层。例如,可以将拆解状态的驱动电机在派瑞林溶液中浸泡,以使得驱动电机的定子侧和输出转轴上均覆上派瑞林涂层。在一些实施例中,派瑞林涂层也可以由其他生物相容性材料涂层替代,本说明书对此不作限制。
在一些实施例中,体外正压滴注装置可以通过蠕动泵或重力实现。滴注压力可以在150~600mmHg范围内,例如200mmHg、350mmHg、400mmHg、500mmHg等。
图7是根据本说明书一些实施例所示的猪尾导管的结构示意图。图8是根据本说明书另一些实施例所示的猪尾导管的结构示意图。
结合图1-2以及图7-8所示,在一些实施例中,引流管100前端连接有猪尾导管500,猪尾导管500的前端由柔性材料制成,避免对组织器官造成损伤。在一些实施例中,猪尾导管500的前端在自然状态下成卷曲状,用于辅助引流管100、驱动电机300等结构进入心脏(如进入左心室),其卷曲的形状在左心室内不易折叠、扭曲和滑脱。
在一些实施例中,猪尾导管500可以是中空管状结构,通过导丝等导引到左心室内。在一些实施例中,猪尾导管500可以是实心软质结构,例如由热塑性聚氨酯弹性体橡胶(Thermoplastic Urethane,TPU)、聚醚嵌段聚酰胺等材料制成。
如图7所示,在一些实施例中,猪尾导管500包括第一直线段510和弯曲段520,第一直线段510的后端与引流管100的前端连接,第一直线段510的前端与弯曲段520连接,弯曲段520从第一直线段510的前端朝向后端呈弧形弯曲。
如图8所示,在一些实施例中,猪尾导管500包括第一直线段510、第二直线段530和弯曲段520,第一直线段510的后端与引流管100的前端连接,第一直线段510的前端与第二直线段530的后端连接,第二直线段530的前端与弯曲段520连接,弯曲段520从第二直线段530的前端朝向后端呈弧形弯曲。在一些实施例中,第一直线段510和第二直线段530之间的夹角大于90°小于180°。
图9是根据本说明书一些实施例所示的引流管的结构示意图。
如图9所示,在一些实施例中,引流管100上设有显影环140,显影环140设置在引流管100的弯曲部位,显影环140能够在成像设备(如X射线成像设备)中显影,用于定位标记引流管100在人体中的位置。在一些实施例中,显影环140可以由金属材料制成,如钽、铂铱合金等。通过将显影环140设置在引流管100的弯曲部位,能够更准确的显示引流管100在人体中的位置;同时还能够便于观察引流管100在人体中的姿态。在一些替代性实施例中,显影环140可以设置在引流管100的非弯曲部位。在一些实施例中,引流管100上可以设有多个显影环140,以更准确是显示引流管100在人体中的位置及姿态。
图10是根据本说明书一些实施例所示的导管介入心脏泵的局部结构示意图。
如图10所示,在一些实施例中,导管介入心脏泵10还可以包括变径管600、缝合垫700和无菌保护袋800。在一些实施例中,变径管600、缝合垫700和无菌保护袋800依次连接且套设在导管400外部。
在一些实施例中,变径管600的直径从变径管600的前端到变径管600的后端逐渐增大。在一些实施例中,变径管600可以用于对血管的开口处进行止血。
在一些实施例中,变径管600的锥度为5°~30°,例如锥度为5°、10°、15°、18°、20°、25°、30°等。在一些实施例中,变径管600的锥度过大容易对血管的开口处造成损伤,而锥度过小难以起到止血效果,通过将变径管600的锥度设置在5°~30°范围内既能避免损伤血管的开口,又具有较好的止血效果。
在一些实施例中,整个变径管600的直径从前端到后端逐渐连续增加,使变径管600成为锥形管件。在一些实施例中,变径管600的直径从前端到后端可以呈阶梯状增加。例如变径管600的前端部分区段、中间部分区段和后端部分区段均为等径管,前端部分区段的直径小于中间部分区段的直径,中间部分区段的直径小于后端部分区段的直径。
在一些实施例中,缝合垫700可以用于与组织(例如血管开口处的皮肤组织)缝合,从而限制导管介入心脏泵10在体内的移动。
在一些实施例中,无菌保护袋800套设在导管400上,可以防止在使用或回收过程中导管400被细菌污染,以降低手术感染风险。在一些实施例中,无菌保护袋800可以沿着导管400轴向移动。在一些实施例中,无菌保护袋800的两端分别设有调节螺母810,调节螺母810能够将无菌保护袋800的两端分别与导管400锁定,从而限制无菌保护袋800相对与导管400的轴向位移。在一些实施例中,在手术结束后可以通过锁紧无菌保护袋800两端的调节螺母810以防止器械回撤导致的伤口感染。在一些实施例中,器械回收时要使用一根外鞘穿过暴露在体外的和泵体上的导管400,通过设置无菌保护袋800可以保护体外部分的导管400不被感染。
图11是根据本说明书一些实施例所示的导管介入心脏泵的整体结构示意图。图12是根据本说明书一些实施例所示的导管介入心脏泵的局部结构示意图。
如图11和图12所示,导管介入心脏泵10还包括控制器900,控制器900可以用于控制驱动电机300驱动叶轮200转动。在一些实施例中,控制器900可以基于人为设定的控制参数向驱动电机300发送控制指令。在一些实施例中,控制器900可以自动确定控制参数并向驱动电机300发送控制指令,从而能够避免人为因素的干扰。在一些实施例中,控制参数可以包括但不限于驱动电机300的电压、电流、驱动转速、功率以及传感器采集的压力信号等。
在一些实施例中,控制器900设置在体外,通过线缆与驱动电机300信号相连,线缆的一部分可以穿过导管400进入体内与驱动电机300相连,另一部分位于体外并与控制器900相连。在一些实施例中,控制器900可以通过自带的蓄电池供电,或者,控制器900可以通过电网的电源供电。
如图12所示,在一些实施例中,导管介入心脏泵10还包括第一压力传感器910和/或第二压力传感器920;第一压力传感器910和第二压力传感器920包括但不限于压电压力传感器、压阻压力传
感器、电磁压力传感器、电容压力传感器等。在一些实施例中,导管介入心脏泵10可以仅包括一个压力传感器,即包括第一压力传感器910或第二压力传感器920。在一些实施例中,导管介入心脏泵10可以包括两个压力传感器,即包括第一压力传感器910和第二压力传感器920。通过设置第一压力传感器910和/或第二压力传感器920,能够方便地获知导管介入心脏泵10的工作状态,从而能够监控导管介入心脏泵10的做功情况以及临床效果,并可以以此指导导管介入心脏泵10更好的工作。
在一些实施例中,第一压力传感器910设置在引流管100前端,第一压力传感器910可以用于检测引流管100前端的血液灌注压力。在一些实施例中,若引流管100介入到左心室内,则第一压力传感器910用于检测左心室内的血液灌注压力;若引流管100介入到主动脉内,则第一压力传感器910用于检测主动脉内的灌注压力。
在一些实施例中,第一压力传感器910的设置位置相对于流体入口110更靠近心脏泵(导管介入心脏泵10)的前端(如图12所示),从而第一压力传感器910可以检测血液在进入流体入口110之前的血液灌注压力。在一些实施例中,第一压力传感器910的设置位置相对于流体入口110的距离可以为20~60mm(如20mm、30mm、50mm、60mm等)。
在一些实施例中,第一压力传感器910的设置位置相对于流体入口110更靠近心脏泵的后端,并且靠近流体入口110设置。此时第一压力传感器910可以检测流体入口110处的血液灌注压力。
在一些实施例中,第二压力传感器920设置在引流管100后端,第二压力传感器920可以用于检测引流管100后端的血液灌注压力。引流管100后端的血液灌注压力可以是血液经过引流管100、叶轮200等组件加压后的血液压力。
在一些实施例中,第二压力传感器920的设置位置相对于流体出口120更靠近心脏泵的前端(如图12所示)。由于流体出口120处可能出现紊流区域而影响第二压力传感器920的检测精度,因此将第二压力传感器920设置在流体出口120的前端,可以避开流体出口120处的紊流影响,提高第二压力传感器920检测的准确性。在一些实施例中,第二压力传感器920的设置位置相对于流体出口120的距离可以为30-70mm(如30mm、40mm、50mm、70mm等)。在一些实施例中,如图12所示,第二压力传感器920可以设置在出口笼头160的外表面上。
在一些实施例中,第二压力传感器920的设置位置可以相对于流体出口120更靠近心脏泵的后端。在一些实施例中,第二压力传感器920与流体出口120可以相距预设距离范围(如3cm、5cm等),从而使第二压力传感器920避开紊流区域,提高第二压力传感器920采集的数据的准确性。
在一些实施例中,控制器900用于:根据第一压力传感器910的第一压力信号和/或第二压力传感器920的第二压力信号,确定引流管100在体内的位置。由于人体不同器官和部位的血液灌注压力不同,比如左心室、主动脉和静脉等部位的血液灌注压力各不相同,则可以通过第一压力传感器910和第二压力传感器920检测的压力信号确定引流管100在体内的位置。在一些实施例中,引流管100在体内的位置可以由引流管100上任意一点在体内的位置所表示。在一些实施例中,引流管100在体内的位置可以由引流管100上的显影环140在体内的位置所表示。
在一些实施例中,第一压力传感器910和第二压力传感器920可以确定引流管100在体内的某器官或部位中的具***置。例如,第一压力传感器910随心脏泵进入到左心室内,左心室内的不同位
置具有不同的压力,根据第一压力传感器910检测的压力值可以确定第一压力传感器910位于左心室中的具***置;从而根据第一压力传感器910在引流管100上的位置可以进一步推算出引流管100在体内的具***置。
在一些实施例中,第一压力传感器910和第二压力传感器920还可以用于确定引流管100在体内的位置变化。例如,第一压力传感器910短时间内的压力值产生较大变化(如压力值的变化率超过设定阈值),说明引流管100可能在体内产生突然移动,例如从左心室突然脱落至主动脉中,此时控制器900可以生成预警信息向操作人员报警。
在一些实施例中,控制器900可以单独基于第一压力传感器910的第一压力信号确定引流管100在体内的位置。在一些实施例中,控制器900可以单独基于第二压力传感器920的第二压力信号确定引流管100在体内的位置。在一些实施例中,控制器900可以同时基于第一压力传感器910的第一压力信号和第二压力传感器920的第二压力信号确定引流管100在体内的位置,以提高位置确定的准确率。
在一些实施例中,控制器900(如处理器940)可以从存储介质(如存储介质930)中获取预先存储的位置信息和压力值的对应关系。例如,控制器900可以获取预先存储的患者左心室中不同位置对应的压力值、主动脉的不同位置对应的压力值、以及静脉的不同位置对应的压力值。
在一些实施例中,控制器900可以通过显影环140来预先采集位置信息及其对应的压力值。在一些实施例中,可以将导管介入心脏泵10植入人体内,并通过成像设备进行成像,以获取显影环140的位置信息。在导管介入心脏泵10从主动脉植入左心室的过程中,可以实时或定期采集显影环140在成像设备下成像的位置,并同步记录显影环140在不同位置处的第一压力传感器的第一压力信号和/或第二压力传感器的第二压力信号。接着对采集的位置、第一压力信号和/或第二压力信号进行数据处理,以获得位置信息与压力值的对应关系。其中,该位置信息与压力值的对应关系可以是位置与压力值的一一对应关系,也可以是通过拟合算法获得的位置与压力值之间的函数关系。
在一些实施例中,左心室的位置信息可以通过空间三维坐标表示。例如以主动脉瓣膜的中心点为坐标原点,以人体的左右方向为X轴、人体的前后方向为Y轴、人体的高度方向为Z轴建立空间三维坐标系,从而确定左心室中各个位置的三维坐标。在一些实施例中,检测点在主动脉中的位置信息可以通过检测点与主动脉瓣膜之间的距离表示。
在一些实施例中,基于位置信息和压力值的对应关系,控制器900可以根据第一压力传感器910的第一压力信号和/或第二压力传感器920的第二压力信号确定引流管100在体内的位置。在一些实施例中,控制器900可以根据第一压力传感器910的第一压力信号和第二压力传感器920的第二压力信号共同确定引流管100在体内的位置,具体步骤包括:
步骤一,根据第一压力信号确定引流管100的第一位置。
在一些实施例中,第一压力传感器910可以获取第一压力信号并反馈至控制器900,控制器900可以根据第一压力信号与预先存储的压力值进行对比,并获得对比结果。若第一压力信号的值与预先存储的压力值之间的差值在预设范围内(例如差值为预先存储的压力值的0~5%),则可以粗略确定出第一压力传感器910的位置在预先存储的压力值对应的位置处,根据该位置可以确定引流管100的
第一位置。在一些实施例中,控制器900还可以基于第一压力信号的值与预先存储的压力值之间的差值进一步计算出第一压力传感器910的精确位置。例如,控制器900可以根据不同位置的压力值建立位置与压力的函数关系,通过该函数关系计算出第一压力传感器910的精确位置,根据该位置可以确定引流管100的第一位置。
步骤二,根据第二压力信号确定引流管100的第二位置。
在一些实施例中,第二压力传感器920可以获取第二压力信号并反馈至控制器900,控制器900根据第二压力信号与预先存储的压力值进行对比,并获得对比结果。若第二压力信号的值与预先存储的压力值之间的差值在预设范围内(例如差值为预先存储的压力值的0~5%),则可以粗略确定出第二压力传感器920的位置在预先存储的压力值对应的位置处,根据该位置可以确定引流管100的第二位置。在一些实施例中,控制器900还可以基于第二压力信号的值与预先存储的压力值之间的差值进一步计算出第二压力传感器920的精确位置。例如,控制器900可以根据不同位置的压力值建立位置与压力的函数关系,通过该函数关系计算出第二压力传感器920的精确位置,根据该位置可以确定引流管100的第二位置。
步骤三,根据第一位置和第二位置确定引流管100在体内的位置。
在一些实施例中,第一位置和第二位置均表征了引流管100在体内的位置,则控制器900可以择一选择第一位置或第二位置作为引流管100在体内的位置。例如,若第一位置和第二位置的差值在预设范围(例如差值小于5mm)内,说明第一位置和第二位置的误差较小,控制器900可以将第一位置作为引流管100在体内的位置,或者将第二位置作为引流管100在体内的位置。
在一些实施例中,控制器900可以在第一位置和第二位置之间取中间位置,并将该中间位置确定为引流管100在体内的位置,从而有效提升引流管100的位置确定精度。
在一些实施例中,通过上述方式确定出引流管100的位置后,可以根据该位置判断导管介入心脏泵10是否安装到治疗所需的位置。例如,可以判断引流管100前端是否安装到左心室内或左心室内的特定位置(如左心室的心尖位置)。在一些实施例中,通过在心脏泵工作过程中确定引流管100的位置,可以判断在工作过程中心脏泵位置是否发生偏移,若发生偏移,则可能存在导管介入心脏泵10意外从左心室脱离等情况,控制器900可以及时发出预警信息,从而降低使用者的风险。
在一些实施例中,控制器900还可以基于第一压力传感器910和第二压力传感器920的信号调整驱动电机300的电流输出值、电压输出值和/或功率输出值等。在一些实施例中,控制器900可以根据第一压力传感器910的第一压力信号和第二压力传感器920的第二压力信号计算获得控制参数,基于该控制参数向驱动电机300发送控制指令,从而调整驱动电机300的电流输出值、电压输出值和/或功率输出值等。
在一些实施例中,控制器900可以根据驱动电机300的电流信号判断导管介入心脏泵10是否工作异常。在一些实施例中,控制器900可以预先设置安全电流范围值(或阈值),在获取驱动电机300的电流信号后,将该电流信号与安全电流范围值(或阈值)进行比较:若该电流信号在安全电流范围值之内(如小于该阈值),则控制器900生成导管介入心脏泵10工作正常的判定结果;若该电流信号在安全电流范围值之外(如大于该阈值),则控制器900生成导管介入心脏泵10工作异常的判定结果。
在一些实施例中,控制器900判断导管介入心脏泵10工作异常时,可以发出报警信息,以便操作人员及时进行检修或修正。
图13是根据本说明书一些实施例所示的控制器的示例性结构示意图。
如图13所示,导管介入心脏泵10的控制器900可以包括存储介质930、处理器940和通信总线。处理器940和存储介质930可以通过通信总线实现通信过程。处理器940可以用于执行本申请上述任一实施例提供的导管介入心脏泵10的控制方法。
在一些实施例中,处理器940可以采用中央处理器、服务器、终端设备或其他任何可能的处理设备来实现。在一些实施例中,上述中央处理器、服务器、终端设备或其他处理设备可以在云平台上实施。在一些实施例中,上述中央处理器、服务器或其他处理设备可以与各种终端设备互联,终端设备可以完成信息处理工作或部分信息处理工作。
在一些实施例中,存储介质930(或计算机可读存储介质)可以储存数据和/或指令。在一些实施例中,存储介质930可以存储有计算机指令,处理器940(或计算机)可以通过读取该计算机指令以执行本说明书任一实施例提供的导管介入心脏泵10的控制方法。在一些实施例中,存储设备可包括大容量存储器、可移动存储器、易失性读写存储器、只读存储器(ROM)等或其任意组合。在一些实施例中,存储设备可在云平台上实现。
本申请实施例可能带来的有益效果包括但不限于:(1)导管介入心脏泵可以介入心脏(如左心室)中,通过叶轮增压提高心脏的灌注压力,增加心脏泵血功能,为心脏减轻负担。通过设置弹簧管,使引流管具有一定的弯折角度来适配左心室和主动脉之间的角度,更便于引流管将左心室的血流引向主动脉内;(2)猪尾导管的前端在自然状态下成卷曲状,其卷曲的形状在心脏内不易折叠、扭曲和滑脱;(3)无菌保护袋套设在导管上,可以防止在使用或回收过程中导管被细菌污染,降低感染风险;(4)通过设置第一压力传感器和/或第二压力传感器,能够方便地获知导管介入心脏泵的工作状态,从而能够监控导管介入心脏泵的做功情况以及临床效果,并可以以此指导导管介入心脏泵更好的工作;(5)通过确定引流管的位置,可以根据该位置判断导管介入心脏泵是否安装到治疗所需的位置。并且,通过确定引流管的位置后,可以判断在工作过程中位置是否发生偏移,若发生偏移,则可能存在导管介入心脏泵意外从左心室脱离的情况,控制器可以及时发出预警信息,降低使用者的风险。需要说明的是,不同实施例可能产生的有益效果不同,在不同的实施例里,可能产生的有益效果可以是以上任意一种或几种的组合,也可以是其他任何可能获得的有益效果。
上文已对基本概念做了描述,显然,对于本领域技术人员来说,上述详细披露仅仅作为示例,而并不构成对本说明书的限定。虽然此处并没有明确说明,本领域技术人员可能会对本说明书进行各种修改、改进和修正。该类修改、改进和修正在本说明书中被建议,所以该类修改、改进、修正仍属于本说明书示范实施例的精神和范围。
同时,本说明书使用了特定词语来描述本说明书的实施例。如“一个实施例”、“一实施例”、和/或“一些实施例”意指与本说明书至少一个实施例相关的某一特征、结构或特点。因此,应强调并注意的是,本说明书中在不同位置两次或多次提及的“一实施例”或“一个实施例”或“一个替代性实施例”并不一定是指同一实施例。此外,本说明书的一个或多个实施例中的某些特征、结构或特点可以进行适当的组
合。
同理,应当注意的是,为了简化本说明书披露的表述,从而帮助对一个或多个实施例的理解,前文对本说明书实施例的描述中,有时会将多种特征归并至一个实施例、附图或对其的描述中。但是,这种披露方法并不意味着本说明书对象所需要的特征比权利要求中提及的特征多。实际上,实施例的特征要少于上述披露的单个实施例的全部特征。
最后,应当理解的是,本说明书中所述实施例仅用以说明本说明书实施例的原则。其他的变形也可能属于本说明书的范围。因此,作为示例而非限制,本说明书实施例的替代配置可视为与本说明书的教导一致。相应地,本说明书的实施例不仅限于本说明书明确介绍和描述的实施例。
Claims (14)
- 一种导管介入心脏泵,其特征在于,包括引流管、叶轮、驱动电机和导管;所述引流管前端设有流体入口,所述引流管后端设有流体出口,所述引流管的至少一段包括弹簧管,所述弹簧管在自然状态下成弯曲形状;所述叶轮设置在所述引流管内,所述驱动电机用于驱动所述叶轮转动,所述驱动电机包括定子侧和输出转轴,所述输出转轴与所述叶轮固连,所述定子侧的前端与所述引流管的后端固连,所述定子侧的后端与所述导管的前端固连。
- 如权利要求1所述的导管介入心脏泵,其特征在于,所述引流管前端连接有猪尾导管,所述猪尾导管的前端由柔性材料制成,且所述猪尾导管的前端在自然状态下成卷曲状。
- 如权利要求1所述的导管介入心脏泵,其特征在于,所述引流管上设有显影环,所述显影环设置在所述引流管的弯曲部位。
- 如权利要求1所述的导管介入心脏泵,其特征在于,还包括变径管、缝合垫和无菌保护袋;所述变径管、所述缝合垫和所述无菌保护袋依次连接且套设在所述导管外部,所述变径管的直径从所述变径管的前端到所述变径管的后端逐渐增大。
- 如权利要求4所述的导管介入心脏泵,其特征在于,所述变径管的锥度为5°~30°。
- 如权利要求4所述的导管介入心脏泵,其特征在于,所述无菌保护袋的两端分别设有调节螺母,所述调节螺母能够将所述无菌保护袋的两端分别与所述导管锁定。
- 如权利要求1所述的导管介入心脏泵,其特征在于,还包括控制器,所述控制器用于控制所述驱动电机驱动所述叶轮转动。
- 如权利要求7所述的导管介入心脏泵,其特征在于,还包括第一压力传感器和/或第二压力传感器;所述第一压力传感器设置在所述引流管前端;所述第二压力传感器设置在所述引流管后端。
- 如权利要求8所述的导管介入心脏泵,其特征在于,所述第一压力传感器的设置位置相对于所述流体入口更靠近所述心脏泵的前端;所述第二压力传感器的设置位置相对于所述流体出口更靠近所述心脏泵的前端。
- 如权利要求7所述的导管介入心脏泵,其特征在于,所述控制器用于:根据所述第一压力传感器的第一压力信号和/或所述第二压力传感器的第二压力信号,确定所述引流管在体内的位置。
- 如权利要求10所述的导管介入心脏泵,其特征在于,所述控制器用于:根据所述第一压力信号确定所述引流管的第一位置;根据所述第二压力信号确定所述引流管的第二位置;根据所述第一位置和所述第二位置确定所述引流管在体内的位置。
- 如权利要求1所述的导管介入心脏泵,其特征在于,所述导管介入心脏泵还包括整流装置,所述整流装置通过轴承套设在所述驱动电机的所述输出转轴上,所述整流装置与所述驱动电机的所述定子侧固定相连。
- 如权利要求12所述的导管介入心脏泵,其特征在于,所述导管介入心脏泵还包括体外正压滴注装置,所述体外正压滴注装置能够通过所述导管向所述整流装置和所述驱动电机之间的间隙正压滴注密封液。
- 如权利要求13所述的导管介入心脏泵,其特征在于,所述密封液从所述驱动电机内部通过;所述驱动电机与所述密封液接触的部位表面设有派瑞林涂层。
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