WO2024131805A1 - Ventricular assist device - Google Patents

Ventricular assist device Download PDF

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Publication number
WO2024131805A1
WO2024131805A1 PCT/CN2023/140001 CN2023140001W WO2024131805A1 WO 2024131805 A1 WO2024131805 A1 WO 2024131805A1 CN 2023140001 W CN2023140001 W CN 2023140001W WO 2024131805 A1 WO2024131805 A1 WO 2024131805A1
Authority
WO
WIPO (PCT)
Prior art keywords
tube
perfusion
accommodating cavity
assist device
tube wall
Prior art date
Application number
PCT/CN2023/140001
Other languages
French (fr)
Chinese (zh)
Inventor
李寒松
唐智荣
Original Assignee
丰凯利医疗器械(上海)有限公司
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 丰凯利医疗器械(上海)有限公司 filed Critical 丰凯利医疗器械(上海)有限公司
Publication of WO2024131805A1 publication Critical patent/WO2024131805A1/en

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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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • 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
    • A61M60/126—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel
    • A61M60/13—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel by means of a catheter allowing explantation, e.g. catheter pumps temporarily introduced via the vascular system
    • 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
    • A61M60/126—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel
    • A61M60/135—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel inside a blood vessel, e.g. using grafting
    • A61M60/139—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel inside a blood vessel, e.g. using grafting inside the aorta, e.g. intra-aortic balloon pumps
    • 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
    • A61M60/165—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart
    • A61M60/178—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart drawing blood from a ventricle and returning the blood to the arterial system via a cannula external to the ventricle, e.g. left or right ventricular assist devices
    • 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
    • A61M60/30—Medical purposes thereof other than the enhancement of the cardiac output
    • A61M60/31—Medical purposes thereof other than the enhancement of the cardiac output for enhancement of in vivo organ perfusion, e.g. retroperfusion
    • 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
    • A61M60/80—Constructional details other than related to driving
    • A61M60/855—Constructional details other than related to driving of implantable pumps or pumping devices
    • A61M60/857—Implantable blood tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/855—Constructional details other than related to driving of implantable pumps or pumping devices
    • A61M60/865—Devices for guiding or inserting pumps or pumping devices into the patient's body

Definitions

  • the present application belongs to the field of medical device technology, and in particular to ventricular assist devices.
  • a ventricular assist device needs to be inserted into the heart to assist the heart in pumping blood.
  • the existing ventricular assist device uses the principle of heart pumping blood to pump the blood out of the heart through the pumping mechanism and guide the blood to the aorta outside the heart to flow to the whole body.
  • the existing ventricular assist device includes a catheter and a blood pumping mechanism.
  • the blood pumping mechanism is arranged at the distal end of the catheter (the end away from the operator or physician).
  • the catheter is inserted into the left ventricle of the patient's heart through the femoral artery, axillary artery or carotid artery, and the blood pumping mechanism then enters the left ventricle of the patient.
  • the blood pumping mechanism can also be inserted into the right ventricle of the patient's heart through veins such as the femoral vein with the aid of the catheter.
  • the interventional blood vessel path is curved, and the catheter is prone to bends and kinks during insertion into the blood vessel, which in turn causes the perfusion line in the catheter to bend and kink, causing the blood pumping mechanism to lose the flushing of the perfusion fluid and cause blood coagulation, thereby affecting the blood pumping function of the ventricular assist device.
  • the embodiments of the present application provide a ventricular assist device that can reduce the probability of kinking of the perfusion tube.
  • An embodiment of the first aspect of the present application provides a ventricular assist device, including an interventional catheter and a blood pumping mechanism arranged in the interventional catheter, the interventional catheter including a first tube wall and a first accommodating cavity formed by the first tube wall, a perfusion tube connected to the blood pumping mechanism is arranged in the first accommodating cavity, the perfusion tube includes a second tube wall and a second accommodating cavity formed by the second tube wall, a supporting guide wire is arranged in the second accommodating cavity, and the second tube wall and the supporting guide wire are both extended from the distal end to the proximal end of the interventional catheter.
  • the support guide wire is fixedly connected to the second accommodating cavity at at least one of the proximal end and the distal end.
  • the stiffness of the supporting guidewire is greater than that of the second tube wall, and/or the stiffness of the supporting guidewire is greater than that of the first tube wall.
  • the length of the supporting guide wire is greater than or equal to the first tube wall, and/or the length of the supporting guide wire is less than or equal to the second tube wall.
  • a wiring harness tube is further provided in the first accommodating cavity, and the wiring harness tube extends from the distal end to the proximal end of the interventional catheter.
  • the blood pumping mechanism includes a first through tube, a connecting tube, and a second through tube connected in sequence from the proximal end to the distal end, and the second through tube is connected to the interventional catheter.
  • a pump body is disposed in the second through pipe, and the perfusion tube is connected to the pump body, and the perfusion tube is used to transport perfusion liquid to the pump body.
  • both the first through-tube and the second through-tube are provided with windows communicating with the outside of the tube.
  • the perfusion fluid includes an anticoagulant.
  • a pump body is provided in the second through tube
  • the perfusion tube includes a first perfusion tube and a second perfusion tube
  • the first perfusion tube and the second perfusion tube both include a second tube wall and a second accommodating cavity formed by the second tube wall
  • the first perfusion tube and the second perfusion tube are both connected to the pump body
  • the first perfusion tube is used to transport perfusion liquid to the pump body
  • the perfusion liquid in the pump body flows out through the second perfusion tube
  • support guide wires are provided in the second accommodating cavities of the first perfusion tube and the second perfusion tube.
  • the ventricular assist device of an embodiment of the present application includes an interventional catheter and a blood pumping mechanism connected to the proximal end of the interventional catheter, the interventional catheter includes a first tube wall and a first accommodating cavity formed by the first tube wall, a perfusion tube connected to the blood pumping mechanism is provided in the first accommodating cavity, the perfusion tube is used to transport perfusion fluid to the blood pumping mechanism, the perfusion tube includes a second tube wall and a second accommodating cavity formed by the second tube wall; the present application improves the kink resistance of the perfusion tube and reduces the probability of kinking of the perfusion tube by providing a support guide wire extending from the distal end to the proximal end of the interventional catheter in the second accommodating cavity, thereby reducing the probability of blood pumping function failure caused by coagulation in the blood pumping mechanism.
  • FIG1 is a schematic diagram of the structure of a ventricular assist device according to some embodiments of the present application.
  • FIG2 shows a cross-sectional view of an example of the interventional catheter in FIG1 at section A-A.
  • the interventional vascular pathway is curved, and the catheter is prone to bends and kinks during insertion into the blood vessel, which in turn causes the perfusion line in the catheter to bend and kink, making it impossible for the blood pumping mechanism to receive adequate perfusion and flushing, resulting in coagulation, which in turn affects the blood pumping function of the ventricular assist device.
  • the ventricular assist device includes an interventional catheter and a blood pumping mechanism connected to the proximal end of the interventional catheter, the interventional catheter includes a first tube wall and a first accommodating cavity formed by the first tube wall, a perfusion tube connected to the blood pumping mechanism is arranged in the first accommodating cavity, the perfusion tube is used to transport perfusion fluid to the blood pumping mechanism, the perfusion tube includes a second tube wall and a second accommodating cavity formed by the second tube wall; the present application improves the kink resistance of the perfusion tube and reduces the probability of kinking of the perfusion tube by extending from the distal end to the proximal end of the interventional catheter in the second accommodating cavity, thereby reducing the probability of blood pumping function failure caused by coagulation in the blood pumping mechanism.
  • Figure 1 is a schematic diagram of the structure of a ventricular assist device according to some embodiments of the present application;
  • Figure 2 shows a cross-sectional view of an example interventional catheter in Figure 1 at section A-A.
  • the present application provides a ventricular assist device, including an interventional catheter 10 and a blood pumping mechanism 20 connected to the proximal end of the interventional catheter 10, wherein the interventional catheter 10 includes a first tube wall 11 and a first accommodating cavity 12 formed by the first tube wall 11, wherein a perfusion tube 13 connected to the blood pumping mechanism 20 is provided in the first accommodating cavity 12, and the perfusion tube 13 is used to deliver perfusion fluid (not shown) to the blood pumping mechanism 20.
  • the perfusion tube 13 includes a second tube wall 131 and a second accommodating cavity 132 formed by the second tube wall 131, wherein a support guide wire 14 is provided in the second accommodating cavity 132, and both the second tube wall 131 and the support guide wire 14 are extended from the distal end to the proximal end of the interventional catheter 10.
  • the interventional catheter 10 is a hollow tubular structure, including a proximal end and a distal end, and the proximal end is connected to the blood pumping mechanism 20.
  • the blood pumping mechanism 20 When in use, the blood pumping mechanism 20 is inserted into the patient's heart through the femoral artery, aorta, carotid artery, femoral vein and other blood vessels with the help of the interventional catheter 10 to achieve the blood pumping function.
  • the distal end of the interventional catheter 10 extends out of the patient's body and is connected to other extracorporeal devices.
  • the interventional catheter 10 is a soft catheter that is used to adapt to the shape of the aorta, especially the aortic arch, when inserted into the blood vessel.
  • the ventricular assist device provided in this embodiment includes an interventional catheter 10 and a blood pumping mechanism 20 connected to the proximal end of the interventional catheter 10.
  • the interventional catheter 10 includes a first tube wall 11 and a first accommodating cavity 12 formed by the first tube wall 11.
  • the first accommodating cavity 12 is provided with a perfusion tube 13 connected to the blood pumping mechanism 20.
  • the perfusion tube 13 is used to supply blood to the blood pumping mechanism 20.
  • the perfusion tube 13 For delivering perfusion liquid, the perfusion tube 13 includes a second tube wall 131 and a second accommodating cavity 132 enclosed by the second tube wall 131; the present application improves the anti-kinking property of the perfusion tube 13 and reduces the probability of kinking of the perfusion tube 13 by arranging a supporting guide wire 14 extending from the distal end to the proximal end of the interventional catheter 10 in the second accommodating cavity 132, thereby reducing the probability of coagulation of the blood pumping mechanism 20 and causing failure of the blood pumping function.
  • the diameter of the support guide wire 14 is smaller than the inner diameter of the perfusion tube 13 .
  • the anti-kink performance of the support guide wire 14 is greater than the anti-kink performance of the perfusion tube 13.
  • the support guide wire 14 is not connected to the perfusion tube 13, and the support guide wire 14 has a certain amount of movement in the perfusion tube 13.
  • the interventional catheter 10 is extended into a blood vessel, the bending angles of the perfusion tube 13 and the support guide wire 14 corresponding to the same blood vessel position may be different.
  • the ventricular assist device reduces the influence of the support guide wire 14 on the delivery of the perfusion fluid in the perfusion tube 13 by making the diameter of the support guide wire 14 smaller than the inner diameter of the perfusion tube 13, and allows the support guide wire 14 to have a certain amount of movement in the perfusion tube 13.
  • the support guide wire 14 improves the anti-kink performance of the perfusion tube 13, and at the same time allows the perfusion tube 13 to have a certain degree of bendability to adapt to the shape of the blood vessel.
  • the rigidity of the support guide wire 14 is greater than the rigidity of the second tube wall 131, and/or the rigidity of the support guide wire 14 is greater than the rigidity of the first tube wall 11.
  • the length of the support guide wire 14 is greater than or equal to the length of the first tube wall 11, and/or the length of the support guide wire 14 is less than or equal to the length of the second tube wall 131.
  • the support guide wire 14 is fixedly connected to the second accommodating cavity 132 at least one side of the distal end and the proximal end, that is, the support guide wire 14 is not connected to the second accommodating cavity 132 between the distal end and the proximal end, and the support guide wire 14 has a certain amount of movement in the middle position of the perfusion tube 13.
  • the bending angles of the perfusion tube 13 and the support guide wire 14 corresponding to the same blood vessel position can be different, and the support guide wire 14 can also be prevented from blocking the perfusion channel, that is, preventing the connection position of the perfusion tube 13 and the pump body in the perfusion channel from being blocked.
  • the ventricular assist device provided in this embodiment can make the bending angles of the support guidewire 14 and the perfusion tube 13 corresponding to the same blood vessel position different by setting the stiffness of the support guidewire 14 to be different from the stiffness of the second tube wall 131, thereby enhancing the support of the support guidewire 14 for the perfusion channel of the perfusion tube 13 to avoid bending and kinking of the perfusion tube 13, thereby ensuring the normal delivery of the perfusion fluid; further, by making the stiffness of the support guidewire 14 greater than the stiffness of the second tube wall 131 and the first tube wall 11, the anti-kinking performance of the perfusion tube 13 is improved, and the anti-kinking performance of the interventional catheter 10 is also improved.
  • the support guide wire 14 is made of a shape memory material that meets biological safety requirements.
  • the shape memory material includes a metal memory material and a polymer memory material, such as a nickel-titanium alloy.
  • the number of the support guide wires 14 in the perfusion tube 13 can be multiple, and the multiple support guide wires 14 can be woven and twisted to form a torsion-resistant
  • the support guide wire 14 can be a solid structure or a hollow tubular structure.
  • the ventricular assist device provided in this embodiment adopts a support guide wire 14 made of shape memory material, so that the support guide wire 14 has the property of returning to the initial shape, further improving the bending and kinking resistance of the perfusion tube 13.
  • a wiring harness tube 15 is further provided in the first accommodating cavity 12 , and the wiring harness tube 15 extends from the distal end to the proximal end of the interventional catheter 10 .
  • the blood pumping mechanism 20 includes a first through tube 21 , a second through tube 22 and a connecting tube 23 , the connecting tube 23 connects the first through tube 21 and the second through tube 22 , and the second through tube 22 is connected to the interventional catheter 10 .
  • the first through-tube 21, the second through-tube 22 and the connecting tube 23 are all hollow tubular structures, and blood flows in from the first through-tube 21, passes through the connecting tube 23 and then flows out of the blood pumping mechanism 20.
  • the first through-tube 21 is placed in the left ventricle, and the second through-tube 22 is placed in the aorta.
  • the blood pumping mechanism 20 pumps the blood in the left ventricle to the aorta, thereby replacing part of the blood pumping function of the heart.
  • the first through-tube 21 and the second through-tube 22 can also be placed in other chambers of the heart.
  • a pump body (not shown) is disposed in the second through pipe 22, and the perfusion tube 13 is connected to the pump body, and the perfusion tube 13 is used to transport perfusion liquid to the pump body.
  • the delivery fluid includes physiological saline and an anticoagulant
  • the anticoagulant may be heparin.
  • the perfusion tube 13 continuously delivers perfusion fluid to the pump body, so that a certain pressure is maintained in the pump body to prevent the blood pressure in the second through tube 22 from flowing into the pump body.
  • the anticoagulant in the perfusion fluid reduces the probability of blood coagulation, thereby reducing the probability of failure of the pumping function of the pump body due to blood coagulation.
  • a pump body is disposed in the second through tube 22, and the perfusion tube 13 includes a first perfusion tube and a second perfusion tube, and the first perfusion tube and the second perfusion tube both include a second tube wall 131 and a second accommodating cavity 132 formed by the second tube wall 131.
  • the first perfusion tube and the second perfusion tube are both connected to the pump body, and the first perfusion tube is used to transport perfusion liquid to the pump body, and the perfusion liquid in the pump body flows out through the second perfusion tube.
  • Support guide wires 14 are disposed in the second accommodating cavities of the first perfusion tube and the second perfusion tube, and the second tube walls 131 of the first perfusion tube and the second perfusion tube and the support guide wire 14 are both arranged along the second perfusion tube wall 131.
  • the interventional catheter 10 is extended from the distal end to the proximal end.
  • the first through-tube 21 includes a first window 211 connecting the inside and outside of the first through-tube 21, and the second through-tube 22 includes a second window 221 connecting the inside and outside of the second through-tube 22.
  • blood enters the second through-tube 22 through the second window 221 flows through the connecting tube 23 and the first through-tube 21, and then flows out of the blood pumping mechanism 20 from the first window 211.
  • the blood pumping mechanism 20 further includes a flexible tip member 24 , and the flexible tip member 24 is connected to an end of the first through tube 21 that is away from the connecting tube 23 .
  • the physician first connects the distal ends of the perfusion tube 13 and the harness tube 15 to the device, locates the femoral artery implantation point, performs a subcutaneous incision on the patient, and implants a guide wire (not shown) from the femoral artery through the incision.
  • the guide wire passes through the abdominal aorta, thoracic aorta, and renal aorta, crosses the aortic valve, and finally enters the left ventricle.
  • the ventricular assist device is removed, and the surface of the ventricular assist device is smoothed, soaked in heparin or treated by other special synthetic methods.
  • an X-ray marker is set on the first through tube 21, and the flexible tip 24 on the blood pumping mechanism 20 is implanted into the femoral artery along the guide wire through the subcutaneous incision.
  • the physician observes the position of the blood pumping mechanism 20 in real time based on X-ray related equipment.
  • the second through tube 22 is located in the patient's aorta.
  • the ventricular assist device provided in this embodiment includes an interventional catheter 10 and a blood pumping mechanism 20 connected to the proximal end of the interventional catheter 10.
  • the interventional catheter 10 includes a first tube wall 11 and a first accommodating chamber 12 formed by the first tube wall 11.
  • a perfusion tube 13 connected to the blood pumping mechanism 20 is provided in the first accommodating chamber 12.
  • the perfusion tube 13 is used to transport perfusion fluid to the blood pumping mechanism 20.
  • the perfusion tube 13 includes a second tube wall 131 and a second accommodating chamber 132 formed by the second tube wall 131.
  • the present application improves the bending and kinking resistance of the perfusion tube 13 by extending from the distal end to the proximal end of the interventional catheter 10 in the second accommodating chamber 132, reduces the probability of bending and kinking of the perfusion tube 13, and thereby reduces the probability of blood pumping function failure caused by coagulation in the blood pumping mechanism 20.

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Abstract

A ventricular assist device, comprising an interventional catheter and a blood pumping mechanism connected to a proximal end of the interventional catheter. The interventional catheter comprises a first tube wall and a first accommodating cavity defined by the first tube wall. A perfusion tube in communication with the blood pumping mechanism is arranged in the first accommodating cavity. The perfusion tube comprises a second tube wall and a second accommodating cavity defined by the second tube wall. A supporting guide wire is arranged in the second accommodating cavity. Both the second tube wall and the supporting guide wire extend from a distal end to the proximal end of the interventional catheter.

Description

心室辅助装置Ventricular assist device
相关申请的交叉引用CROSS-REFERENCE TO RELATED APPLICATIONS
本申请要求享有于2022年12月20日提交的名称为“心室辅助装置”的中国专利申请202223416928.7的优先权，该申请的全部内容通过引用并入本文中。This application claims priority to Chinese patent application 202223416928.7, filed on December 20, 2022, entitled “Ventricular Assist Device,” the entire contents of which are incorporated herein by reference.
技术领域Technical Field
本申请属于医疗器械技术领域，尤其涉及心室辅助装置。The present application belongs to the field of medical device technology, and in particular to ventricular assist devices.
背景技术Background technique
心脏外科手术中，由于患者自身疾病或手术的需要，患者心脏功能变弱，泵血能力不足。此时需要对心脏***心室辅助装置辅助心脏泵血。现有的心室辅助装置是利用心脏泵血原理，将心脏内血液通过泵血机构泵出，并将血液导流至心脏外的主动脉以流向全身。During cardiac surgery, due to the patient's own illness or the need for surgery, the patient's heart function becomes weak and the blood pumping capacity is insufficient. At this time, a ventricular assist device needs to be inserted into the heart to assist the heart in pumping blood. The existing ventricular assist device uses the principle of heart pumping blood to pump the blood out of the heart through the pumping mechanism and guide the blood to the aorta outside the heart to flow to the whole body.
现有的心室辅助装置包括导管和泵血机构，泵血机构设置在导管的远端(远离操作者或者医师的一端)，导管经过股动脉或腋动脉或颈动脉***患者的心脏的左心室中，泵血机构随之进入患者的左心室中，泵血机构还可以借助于导管经过股静脉等静脉***患者的心脏的右心室中。然而，介入血管路径有弯曲，导管在***血管的期间容易出现弯折扭结，进而造成导管内的灌注管路弯折扭结，使得泵血机构失去灌注液的冲洗而发生凝血，进而影响心室辅助装置的泵血功能。The existing ventricular assist device includes a catheter and a blood pumping mechanism. The blood pumping mechanism is arranged at the distal end of the catheter (the end away from the operator or physician). The catheter is inserted into the left ventricle of the patient's heart through the femoral artery, axillary artery or carotid artery, and the blood pumping mechanism then enters the left ventricle of the patient. The blood pumping mechanism can also be inserted into the right ventricle of the patient's heart through veins such as the femoral vein with the aid of the catheter. However, the interventional blood vessel path is curved, and the catheter is prone to bends and kinks during insertion into the blood vessel, which in turn causes the perfusion line in the catheter to bend and kink, causing the blood pumping mechanism to lose the flushing of the perfusion fluid and cause blood coagulation, thereby affecting the blood pumping function of the ventricular assist device.
发明内容Summary of the invention
本申请实施例提供心室辅助装置，能够降低灌注管扭结的概率。The embodiments of the present application provide a ventricular assist device that can reduce the probability of kinking of the perfusion tube.
本申请第一方面的实施例提供一种心室辅助装置，包括介入导管和与设置在介入导管的泵血机构，介入导管包括第一管壁和由第一管壁围合形成的第一容纳腔，第一容纳腔内设有与泵血机构连通的灌注管，灌注管包括第二管壁和由第二管壁围合形成的第二容纳腔，第二容纳腔内设有支撑导丝，第二管壁与支撑导丝均沿介入导管的远心端至近心端延伸设置。 An embodiment of the first aspect of the present application provides a ventricular assist device, including an interventional catheter and a blood pumping mechanism arranged in the interventional catheter, the interventional catheter including a first tube wall and a first accommodating cavity formed by the first tube wall, a perfusion tube connected to the blood pumping mechanism is arranged in the first accommodating cavity, the perfusion tube includes a second tube wall and a second accommodating cavity formed by the second tube wall, a supporting guide wire is arranged in the second accommodating cavity, and the second tube wall and the supporting guide wire are both extended from the distal end to the proximal end of the interventional catheter.
根据本申请前述任一第一方面的实施方式，支撑导丝在近心端与远心端的至少一端与第二容纳腔固定连接。According to any one of the aforementioned embodiments of the first aspect of the present application, the support guide wire is fixedly connected to the second accommodating cavity at at least one of the proximal end and the distal end.
根据本申请前述任一第一方面的实施方式，支撑导丝的刚度大于第二管壁，和/或支撑导丝的刚度大于第一管壁。According to any one of the aforementioned embodiments of the first aspect of the present application, the stiffness of the supporting guidewire is greater than that of the second tube wall, and/or the stiffness of the supporting guidewire is greater than that of the first tube wall.
根据本申请前述任一第一方面的实施方式，支撑导丝的长度大于等于第一管壁，和/或支撑导丝的长度小于等于第二管壁。According to any one of the aforementioned embodiments of the first aspect of the present application, the length of the supporting guide wire is greater than or equal to the first tube wall, and/or the length of the supporting guide wire is less than or equal to the second tube wall.
根据本申请前述任一第一方面的实施方式，第一容纳腔内还设有线束管，线束管沿介入导管的远心端至近心端延伸设置。According to any one of the aforementioned embodiments of the first aspect of the present application, a wiring harness tube is further provided in the first accommodating cavity, and the wiring harness tube extends from the distal end to the proximal end of the interventional catheter.
根据本申请前述任一第一方面的实施方式，泵血机构包括沿近心端至远心端的方向顺次连接的第一通管、连通管和第二通管，第二通管与介入导管连接。According to any one of the aforementioned first aspects of the present application, the blood pumping mechanism includes a first through tube, a connecting tube, and a second through tube connected in sequence from the proximal end to the distal end, and the second through tube is connected to the interventional catheter.
根据本申请前述任一第一方面的实施方式，第二通管内设有泵体，灌注管与泵体连通，灌注管用于向泵体输送灌注液。According to any one of the aforementioned embodiments of the first aspect of the present application, a pump body is disposed in the second through pipe, and the perfusion tube is connected to the pump body, and the perfusion tube is used to transport perfusion liquid to the pump body.
根据本申请前述任一第一方面的实施方式，第一通管和第二通管上均设有与管外连通的窗口。According to any one of the aforementioned implementations of the first aspect of the present application, both the first through-tube and the second through-tube are provided with windows communicating with the outside of the tube.
根据本申请前述任一第一方面的实施方式，灌注液包括抗凝血剂。According to any one of the aforementioned embodiments of the first aspect of the present application, the perfusion fluid includes an anticoagulant.
根据本申请前述任一第一方面的实施方式，第二通管内设有泵体，灌注管包括第一灌注管和第二灌注管，第一灌注管和第二灌注管均包括第二管壁和由第二管壁围合形成的第二容纳腔，第一灌注管和第二灌注管均与泵体连通，第一灌注管用于向泵体输送灌注液，泵体内的灌注液通过第二灌注管流出，第一灌注管和第二灌注管的第二容纳腔内均设有支撑导丝。According to an implementation scheme of any of the aforementioned first aspects of the present application, a pump body is provided in the second through tube, the perfusion tube includes a first perfusion tube and a second perfusion tube, the first perfusion tube and the second perfusion tube both include a second tube wall and a second accommodating cavity formed by the second tube wall, the first perfusion tube and the second perfusion tube are both connected to the pump body, the first perfusion tube is used to transport perfusion liquid to the pump body, the perfusion liquid in the pump body flows out through the second perfusion tube, and support guide wires are provided in the second accommodating cavities of the first perfusion tube and the second perfusion tube.
本申请实施例的心室辅助装置包括介入导管和与介入导管的近心端连接的泵血机构，介入导管包括第一管壁和由第一管壁围合形成的第一容纳腔，第一容纳腔内设有与泵血机构连通的灌注管，灌注管用于向泵血机构输送灌注液，灌注管包括第二管壁和由第二管壁围合形成的第二容纳腔；本申请通过在第二容纳腔内沿介入导管的远心端至近心端延伸设置的支撑导丝，提高灌注管的抗扭结性，降低灌注管扭结的概率，进而降低泵血机构发生凝血造成泵血功能失效的概率。The ventricular assist device of an embodiment of the present application includes an interventional catheter and a blood pumping mechanism connected to the proximal end of the interventional catheter, the interventional catheter includes a first tube wall and a first accommodating cavity formed by the first tube wall, a perfusion tube connected to the blood pumping mechanism is provided in the first accommodating cavity, the perfusion tube is used to transport perfusion fluid to the blood pumping mechanism, the perfusion tube includes a second tube wall and a second accommodating cavity formed by the second tube wall; the present application improves the kink resistance of the perfusion tube and reduces the probability of kinking of the perfusion tube by providing a support guide wire extending from the distal end to the proximal end of the interventional catheter in the second accommodating cavity, thereby reducing the probability of blood pumping function failure caused by coagulation in the blood pumping mechanism.
附图说明BRIEF DESCRIPTION OF THE DRAWINGS
为了更清楚地说明本申请实施例的技术方案，下面将对本申请实施例中所需要使 用的附图作简单的介绍，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其他的附图。In order to more clearly illustrate the technical solution of the embodiment of the present application, the following will describe the technical solution required in the embodiment of the present application. The accompanying drawings used are briefly introduced. For ordinary technicians in this field, other accompanying drawings can be obtained based on these accompanying drawings without any creative work.
图1为本申请一些实施例的心室辅助装置的结构示意图；FIG1 is a schematic diagram of the structure of a ventricular assist device according to some embodiments of the present application;
图2示出一种示例的图1中介入导管在A-A截面的剖视图。FIG2 shows a cross-sectional view of an example of the interventional catheter in FIG1 at section A-A.
附图标记：
10、介入导管；11、第一管壁；12、第一容纳腔；13、灌注管；131、第二管壁；
132、第二容纳腔；14、支撑导丝；15、线束管；
20、泵血机构；21、第一通管；211、第一窗口；22、第二通管；221、第二窗口；
23、连通管；24、柔性尖端件。Reference numerals:
10. interventional catheter; 11. first tube wall; 12. first accommodating cavity; 13. perfusion tube; 131. second tube wall;
132, second accommodating cavity; 14, supporting guide wire; 15, wiring harness tube;
20. blood pumping mechanism; 21. first through-tube; 211. first window; 22. second through-tube; 221. second window;
23. Connecting tube; 24. Flexible tip part.
具体实施方式Detailed ways
下面将详细描述本申请的各个方面的特征和示例性实施例，为了使本申请的目的、技术方案及优点更加清楚明白，以下结合附图及具体实施例，对本申请进行进一步详细描述。应理解，此处所描述的具体实施例仅意在解释本申请，而不是限定本申请。对于本领域技术人员来说，本申请可以在不需要这些具体细节中的一些细节的情况下实施。下面对实施例的描述仅仅是为了通过示出本申请的示例来提供对本申请更好的理解。The features and exemplary embodiments of various aspects of the present application will be described in detail below. In order to make the purpose, technical solutions and advantages of the present application clearer, the present application will be further described in detail below in conjunction with the accompanying drawings and specific embodiments. It should be understood that the specific embodiments described herein are only intended to explain the present application, rather than to limit the present application. For those skilled in the art, the present application can be implemented without the need for some of these specific details. The following description of the embodiments is only to provide a better understanding of the present application by illustrating the examples of the present application.
需要说明的是，在本文中，诸如第一和第二等之类的关系术语仅仅用来将一个实体或者操作与另一个实体或操作区分开来，而不一定要求或者暗示这些实体或操作之间存在任何这种实际的关系或者顺序。而且，术语“包括”、“包含”或者其任何其他变体意在涵盖非排他性的包含，从而使得包括一系列要素的过程、方法、物品或者设备不仅包括那些要素，而且还包括没有明确列出的其他要素，或者是还包括为这种过程、方法、物品或者设备所固有的要素。在没有更多限制的情况下，由语句“包括……”限定的要素，并不排除在包括所述要素的过程、方法、物品或者设备中还存在另外的相同要素。It should be noted that, in this article, relational terms such as first and second, etc. are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Moreover, the terms "include", "comprise" or any other variants thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device including a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, article or device. In the absence of further restrictions, the elements defined by the statement "include..." do not exclude the existence of other identical elements in the process, method, article or device including the elements.
申请人发现在相关技术中，介入血管路径有弯曲，导管在***血管的期间容易出现弯折扭结，进而造成导管内的灌注管路弯折扭结，使得泵血机构不能得到足够的灌注冲洗而发生凝血，进而影响心室辅助装置的泵血功能。 The applicant found that in the related technology, the interventional vascular pathway is curved, and the catheter is prone to bends and kinks during insertion into the blood vessel, which in turn causes the perfusion line in the catheter to bend and kink, making it impossible for the blood pumping mechanism to receive adequate perfusion and flushing, resulting in coagulation, which in turn affects the blood pumping function of the ventricular assist device.
鉴于上述问题，申请人提出一种心室辅助装置，包括介入导管和与介入导管的近心端连接的泵血机构，介入导管包括第一管壁和由第一管壁围合形成的第一容纳腔，第一容纳腔内设有与泵血机构连通的灌注管，灌注管用于向泵血机构输送灌注液，灌注管包括第二管壁和由第二管壁围合形成的第二容纳腔，第二容纳腔内设有支撑导丝，第二管壁与支撑导丝均沿介入导管的远心端至近心端延伸设置。In view of the above problems, the applicant proposes a ventricular assist device, including an interventional catheter and a blood pumping mechanism connected to the proximal end of the interventional catheter, the interventional catheter including a first tube wall and a first accommodating cavity formed by the first tube wall, a perfusion tube connected to the blood pumping mechanism is provided in the first accommodating cavity, the perfusion tube is used to transport perfusion fluid to the blood pumping mechanism, the perfusion tube includes a second tube wall and a second accommodating cavity formed by the second tube wall, a supporting guide wire is provided in the second accommodating cavity, and the second tube wall and the supporting guide wire are both extended from the distal end to the proximal end of the interventional catheter.
本申请提供的心室辅助装置包括介入导管和与介入导管的近心端连接的泵血机构，介入导管包括第一管壁和由第一管壁围合形成的第一容纳腔，第一容纳腔内设有与泵血机构连通的灌注管，灌注管用于向泵血机构输送灌注液，灌注管包括第二管壁和由第二管壁围合形成的第二容纳腔；本申请通过在第二容纳腔内沿介入导管的远心端至近心端延伸设置的支撑导丝，提高灌注管的抗扭结性，降低灌注管扭结的概率，进而降低泵血机构发生凝血造成泵血功能失效的概率。The ventricular assist device provided by the present application includes an interventional catheter and a blood pumping mechanism connected to the proximal end of the interventional catheter, the interventional catheter includes a first tube wall and a first accommodating cavity formed by the first tube wall, a perfusion tube connected to the blood pumping mechanism is arranged in the first accommodating cavity, the perfusion tube is used to transport perfusion fluid to the blood pumping mechanism, the perfusion tube includes a second tube wall and a second accommodating cavity formed by the second tube wall; the present application improves the kink resistance of the perfusion tube and reduces the probability of kinking of the perfusion tube by extending from the distal end to the proximal end of the interventional catheter in the second accommodating cavity, thereby reducing the probability of blood pumping function failure caused by coagulation in the blood pumping mechanism.
下面结合附图对本申请实施例所提供的显示模组进行介绍。在附图中，为了方便绘图，图中的尺寸与现实尺寸并不一定成比例。The display module provided by the embodiment of the present application is introduced below in conjunction with the accompanying drawings. In the accompanying drawings, for the convenience of drawing, the dimensions in the drawings are not necessarily proportional to the actual dimensions.
请参考图1和图2，图1为本申请一些实施例的心室辅助装置的结构示意图；图2示出一种示例的图1中介入导管在A-A截面的剖视图。Please refer to Figures 1 and 2. Figure 1 is a schematic diagram of the structure of a ventricular assist device according to some embodiments of the present application; Figure 2 shows a cross-sectional view of an example interventional catheter in Figure 1 at section A-A.
如图1和图2所示，本申请提供一种心室辅助装置，包括介入导管10和与介入导管10的近心端连接的泵血机构20，介入导管10包括第一管壁11和由第一管壁11围合形成的第一容纳腔12，第一容纳腔12内设有与泵血机构20连通的灌注管13，灌注管13用于向泵血机构20输送灌注液(未画出)。灌注管13包括第二管壁131和由第二管壁131围合形成的第二容纳腔132，第二容纳腔132内设有支撑导丝14，第二管壁131与支撑导丝14均沿介入导管10的远心端至近心端延伸设置。As shown in Fig. 1 and Fig. 2, the present application provides a ventricular assist device, including an interventional catheter 10 and a blood pumping mechanism 20 connected to the proximal end of the interventional catheter 10, wherein the interventional catheter 10 includes a first tube wall 11 and a first accommodating cavity 12 formed by the first tube wall 11, wherein a perfusion tube 13 connected to the blood pumping mechanism 20 is provided in the first accommodating cavity 12, and the perfusion tube 13 is used to deliver perfusion fluid (not shown) to the blood pumping mechanism 20. The perfusion tube 13 includes a second tube wall 131 and a second accommodating cavity 132 formed by the second tube wall 131, wherein a support guide wire 14 is provided in the second accommodating cavity 132, and both the second tube wall 131 and the support guide wire 14 are extended from the distal end to the proximal end of the interventional catheter 10.
可选的，介入导管10为空心管状结构，包含近心端与远心端，近心端与泵血机构20连接。在使用时，泵血机构20借助介入导管10经过股动脉、主动脉、颈动脉、股静脉等血管***患者的心脏并实现泵血功能。介入导管10的远心端伸出患者体外，并与其他体外设备连接。介入导管10为软质导管，用以在伸入血管时适应主动脉特别是主动脉弓的形状。Optionally, the interventional catheter 10 is a hollow tubular structure, including a proximal end and a distal end, and the proximal end is connected to the blood pumping mechanism 20. When in use, the blood pumping mechanism 20 is inserted into the patient's heart through the femoral artery, aorta, carotid artery, femoral vein and other blood vessels with the help of the interventional catheter 10 to achieve the blood pumping function. The distal end of the interventional catheter 10 extends out of the patient's body and is connected to other extracorporeal devices. The interventional catheter 10 is a soft catheter that is used to adapt to the shape of the aorta, especially the aortic arch, when inserted into the blood vessel.
本实施例提供的心室辅助装置，包括介入导管10和与介入导管10的近心端连接的泵血机构20，介入导管10包括第一管壁11和由第一管壁11围合形成的第一容纳腔12，第一容纳腔12内设有与泵血机构20连通的灌注管13，灌注管13用于向泵血机构20输 送灌注液，灌注管13包括第二管壁131和由第二管壁131围合形成的第二容纳腔132；本申请通过在第二容纳腔132内设置沿介入导管10的远心端至近心端延伸的支撑导丝14，提高灌注管13的抗扭结性，降低灌注管13扭结的概率，进而降低泵血机构20发生凝血造成泵血功能失效的概率。The ventricular assist device provided in this embodiment includes an interventional catheter 10 and a blood pumping mechanism 20 connected to the proximal end of the interventional catheter 10. The interventional catheter 10 includes a first tube wall 11 and a first accommodating cavity 12 formed by the first tube wall 11. The first accommodating cavity 12 is provided with a perfusion tube 13 connected to the blood pumping mechanism 20. The perfusion tube 13 is used to supply blood to the blood pumping mechanism 20. For delivering perfusion liquid, the perfusion tube 13 includes a second tube wall 131 and a second accommodating cavity 132 enclosed by the second tube wall 131; the present application improves the anti-kinking property of the perfusion tube 13 and reduces the probability of kinking of the perfusion tube 13 by arranging a supporting guide wire 14 extending from the distal end to the proximal end of the interventional catheter 10 in the second accommodating cavity 132, thereby reducing the probability of coagulation of the blood pumping mechanism 20 and causing failure of the blood pumping function.
在一些可选的实施例中，支撑导丝14的直径小于灌注管13的内径。In some optional embodiments, the diameter of the support guide wire 14 is smaller than the inner diameter of the perfusion tube 13 .
可选的，支撑导丝14的抗扭结性能大于灌注管13的抗扭结性能。支撑导丝14与灌注管13不连接，支撑导丝14在灌注管13内有一定活动量。介入导管10伸入血管时，对应同一血管位置的灌注管13与支撑导丝14的弯曲角度可以不同。Optionally, the anti-kink performance of the support guide wire 14 is greater than the anti-kink performance of the perfusion tube 13. The support guide wire 14 is not connected to the perfusion tube 13, and the support guide wire 14 has a certain amount of movement in the perfusion tube 13. When the interventional catheter 10 is extended into a blood vessel, the bending angles of the perfusion tube 13 and the support guide wire 14 corresponding to the same blood vessel position may be different.
本实施例提供的心室辅助装置，通过使支撑导丝14的直径小于灌注管13的内径，减小支撑导丝14对灌注管13内灌注液输送的影响，且使得支撑导丝14在灌注管13内有一定活动量，在介入导管10位于血管内时，支撑导丝14提高灌注管13的抗扭结性能，同时允许灌注管13有一定弯折性用以适应血管的形状。The ventricular assist device provided in this embodiment reduces the influence of the support guide wire 14 on the delivery of the perfusion fluid in the perfusion tube 13 by making the diameter of the support guide wire 14 smaller than the inner diameter of the perfusion tube 13, and allows the support guide wire 14 to have a certain amount of movement in the perfusion tube 13. When the interventional catheter 10 is located in the blood vessel, the support guide wire 14 improves the anti-kink performance of the perfusion tube 13, and at the same time allows the perfusion tube 13 to have a certain degree of bendability to adapt to the shape of the blood vessel.
在一些可选的实施例中，支撑导丝14的刚度大于第二管壁131的刚度，和/或支撑导丝14的刚度大于第一管壁11的刚度。支撑导丝14的长度大于等于第一管壁11的长度，和/或支撑导丝14的长度小于等于第二管壁131的长度。In some optional embodiments, the rigidity of the support guide wire 14 is greater than the rigidity of the second tube wall 131, and/or the rigidity of the support guide wire 14 is greater than the rigidity of the first tube wall 11. The length of the support guide wire 14 is greater than or equal to the length of the first tube wall 11, and/or the length of the support guide wire 14 is less than or equal to the length of the second tube wall 131.
可选的，支撑导丝14与第二容纳腔132在远心端、近心端的至少一侧固定连接，即支撑导丝14与第二容纳腔132在远心端、近心端之间不连接，支撑导丝14在灌注管13的中部位置内有一定活动量。使得介入导管10伸入血管时，对应同一血管位置的灌注管13与支撑导丝14的弯曲角度可以不同，也可以防止支撑导丝14堵住灌注通道，即防止堵住灌注通道中灌注管13与泵体的连通位置。Optionally, the support guide wire 14 is fixedly connected to the second accommodating cavity 132 at least one side of the distal end and the proximal end, that is, the support guide wire 14 is not connected to the second accommodating cavity 132 between the distal end and the proximal end, and the support guide wire 14 has a certain amount of movement in the middle position of the perfusion tube 13. When the interventional catheter 10 is extended into the blood vessel, the bending angles of the perfusion tube 13 and the support guide wire 14 corresponding to the same blood vessel position can be different, and the support guide wire 14 can also be prevented from blocking the perfusion channel, that is, preventing the connection position of the perfusion tube 13 and the pump body in the perfusion channel from being blocked.
本实施例提供的心室辅助装置，通过设置支撑导丝14的刚度与第二管壁131的刚度不同，可以使对应同一血管位置的支撑导丝14和灌注管13的弯曲角度不同，可以增强支撑导丝14对灌注管13的灌注通道的支撑，以避免灌注管13出现弯折扭结，从而保证灌注液的正常输送；进一步的，通过使支撑导丝14的刚度大于第二管壁131、第一管壁11的刚度，既提高灌注管13的抗扭结性能，同样提高介入导管10的抗扭结性能。The ventricular assist device provided in this embodiment can make the bending angles of the support guidewire 14 and the perfusion tube 13 corresponding to the same blood vessel position different by setting the stiffness of the support guidewire 14 to be different from the stiffness of the second tube wall 131, thereby enhancing the support of the support guidewire 14 for the perfusion channel of the perfusion tube 13 to avoid bending and kinking of the perfusion tube 13, thereby ensuring the normal delivery of the perfusion fluid; further, by making the stiffness of the support guidewire 14 greater than the stiffness of the second tube wall 131 and the first tube wall 11, the anti-kinking performance of the perfusion tube 13 is improved, and the anti-kinking performance of the interventional catheter 10 is also improved.
在一些可选的实施例中，支撑导丝14由满足生物安全性的形状记忆材料构成。In some optional embodiments, the support guide wire 14 is made of a shape memory material that meets biological safety requirements.
可选的，形状记忆材料包括金属记忆材料和聚合物记忆材料，例如镍钛合金。灌注管13内支撑导丝14的数量可以为多根，多根支撑导丝14可以编制、捻制形成抗扭 结性能更强的组件，进而进一步提高灌注管13的抗弯折扭结性能。支撑导丝14可以为实心结构，也可以为空心管状结构。Optionally, the shape memory material includes a metal memory material and a polymer memory material, such as a nickel-titanium alloy. The number of the support guide wires 14 in the perfusion tube 13 can be multiple, and the multiple support guide wires 14 can be woven and twisted to form a torsion-resistant The support guide wire 14 can be a solid structure or a hollow tubular structure.
本实施例提供的心室辅助装置，通过采用形状记忆材料构成的支撑导丝14，使得支撑导丝14拥有回到初始形态的特性，进一步提高灌注管13的抗弯折扭结性。The ventricular assist device provided in this embodiment adopts a support guide wire 14 made of shape memory material, so that the support guide wire 14 has the property of returning to the initial shape, further improving the bending and kinking resistance of the perfusion tube 13.
在一些可选的实施例中，第一容纳腔12内还设有线束管15，线束管15沿介入导管10的远心端至近心端延伸设置。In some optional embodiments, a wiring harness tube 15 is further provided in the first accommodating cavity 12 , and the wiring harness tube 15 extends from the distal end to the proximal end of the interventional catheter 10 .
可选的，线束管15与泵血机构20连通，线束管15内容纳有供电线路、通讯线路中的至少一种。Optionally, the wiring harness tube 15 is connected to the blood pumping mechanism 20 , and the wiring harness tube 15 contains at least one of a power supply line and a communication line.
在一些可选的实施例中，泵血机构20包括第一通管21、第二通管22和连通管23，连通管23连接第一通管21和第二通管22，第二通管22与介入导管10连接。In some optional embodiments, the blood pumping mechanism 20 includes a first through tube 21 , a second through tube 22 and a connecting tube 23 , the connecting tube 23 connects the first through tube 21 and the second through tube 22 , and the second through tube 22 is connected to the interventional catheter 10 .
可选的，第一通管21、第二通管22和连通管23均为空心管状结构，血液由第一通管21流入，经过连通管23后流出泵血机构20。在使用时，第一通管21置于左心室，第二通管22置于主动脉，泵血机构20将左心室内的血液泵送至主动脉，进而代替心脏的部分泵血功能。根据实际需要，第一通管21和第二通管22也可以置于心脏的其他腔室。Optionally, the first through-tube 21, the second through-tube 22 and the connecting tube 23 are all hollow tubular structures, and blood flows in from the first through-tube 21, passes through the connecting tube 23 and then flows out of the blood pumping mechanism 20. When in use, the first through-tube 21 is placed in the left ventricle, and the second through-tube 22 is placed in the aorta. The blood pumping mechanism 20 pumps the blood in the left ventricle to the aorta, thereby replacing part of the blood pumping function of the heart. According to actual needs, the first through-tube 21 and the second through-tube 22 can also be placed in other chambers of the heart.
可选的，让泵血机构20反向泵血，图中第二通管22置于右心室，同时图中第一通管21作为排出管置于右心房或肺动脉处，泵血机构20将右心室内的血液泵送至主动脉，进而代替心脏的部分泵血功能。Optionally, the blood pumping mechanism 20 pumps blood in reverse, with the second through tube 22 in the figure placed in the right ventricle, and the first through tube 21 in the figure placed as a discharge tube in the right atrium or pulmonary artery. The blood pumping mechanism 20 pumps the blood in the right ventricle to the aorta, thereby replacing part of the heart's blood pumping function.
在一些可选的实施例中，第二通管22内设有泵体(未画出)，灌注管13与泵体连通，灌注管13用于向泵体输送灌注液。In some optional embodiments, a pump body (not shown) is disposed in the second through pipe 22, and the perfusion tube 13 is connected to the pump body, and the perfusion tube 13 is used to transport perfusion liquid to the pump body.
可选的，输送液包括生理盐水和抗凝血剂，抗凝血剂可以为肝素。在泵血机构20处于泵血状态时，灌注管13持续向泵体输送灌注液，使泵体内保持一定压力，避免第二通管22内的血压流入泵体。同时，灌注液中的坑凝血剂降低血液凝固的概率，进而降低泵体因凝血造成的泵血功能失效的概率。Optionally, the delivery fluid includes physiological saline and an anticoagulant, and the anticoagulant may be heparin. When the blood pumping mechanism 20 is in the blood pumping state, the perfusion tube 13 continuously delivers perfusion fluid to the pump body, so that a certain pressure is maintained in the pump body to prevent the blood pressure in the second through tube 22 from flowing into the pump body. At the same time, the anticoagulant in the perfusion fluid reduces the probability of blood coagulation, thereby reducing the probability of failure of the pumping function of the pump body due to blood coagulation.
在一些可选的实施例中，第二通管22内设有泵体，灌注管13包括第一灌注管和第二灌注管，第一灌注管和第二灌注管均包括第二管壁131和由第二管壁131围合形成的第二容纳腔132。第一灌注管和第二灌注管均与泵体连通，第一灌注管用于向泵体输送灌注液，泵体内的灌注液通过第二灌注管流出。第一灌注管和第二灌注管的第二容纳腔内均设有支撑导丝14，第一灌注管和第二灌注管的第二管壁131与支撑导丝14均沿 介入导管10的远心端至近心端延伸设置。In some optional embodiments, a pump body is disposed in the second through tube 22, and the perfusion tube 13 includes a first perfusion tube and a second perfusion tube, and the first perfusion tube and the second perfusion tube both include a second tube wall 131 and a second accommodating cavity 132 formed by the second tube wall 131. The first perfusion tube and the second perfusion tube are both connected to the pump body, and the first perfusion tube is used to transport perfusion liquid to the pump body, and the perfusion liquid in the pump body flows out through the second perfusion tube. Support guide wires 14 are disposed in the second accommodating cavities of the first perfusion tube and the second perfusion tube, and the second tube walls 131 of the first perfusion tube and the second perfusion tube and the support guide wire 14 are both arranged along the second perfusion tube wall 131. The interventional catheter 10 is extended from the distal end to the proximal end.
在一些可选的实施例中，第一通管21包括连通第一通管21内外的第一窗口211，第二通管22包括连通第二通管22内外的第二窗口221。血液通过第一窗口211进入第一通管21，流经连通管23和第二通管22后从第二窗口221流出泵血机构20。或者，血液通过第二窗口221进入第二通管22，流经连通管23和第一通管21后从第一窗口211流出泵血机构20。In some optional embodiments, the first through-tube 21 includes a first window 211 connecting the inside and outside of the first through-tube 21, and the second through-tube 22 includes a second window 221 connecting the inside and outside of the second through-tube 22. Blood enters the first through-tube 21 through the first window 211, flows through the connecting tube 23 and the second through-tube 22, and then flows out of the blood pumping mechanism 20 from the second window 221. Alternatively, blood enters the second through-tube 22 through the second window 221, flows through the connecting tube 23 and the first through-tube 21, and then flows out of the blood pumping mechanism 20 from the first window 211.
在一些可选的实施例中，泵血机构20还包括柔性尖端件24，柔性尖端件24与第一通管21背离连通管23的一端连接。In some optional embodiments, the blood pumping mechanism 20 further includes a flexible tip member 24 , and the flexible tip member 24 is connected to an end of the first through tube 21 that is away from the connecting tube 23 .
可选的，在手术过程中，实施医师首先将灌注管13、线束管15的远心端与设备连接，定位股动脉植入点，对患者进行皮下切口手术，通过切口将导引导丝(未画出)从股动脉植入，导引导丝穿过腹主动脉、胸主动脉、肾主动脉，跨过主动脉瓣，最终进入左心室。之后，取出心室辅助装置，对心室辅助装置进行表面光滑处理、浸泡肝素或其他特殊合成方法处理。之后，在第一通管21上设置X射线标记物，泵血机构20上的柔性尖端件24沿着导引导丝经皮下切口植入股动脉。实施医师在对心室辅助装置的植入过程中，根据X射线相关设备实时观察泵血机构20的位置。直至第一通管21伸入患者左心室，此时第二通管22位于患者主动脉内。Optionally, during the operation, the physician first connects the distal ends of the perfusion tube 13 and the harness tube 15 to the device, locates the femoral artery implantation point, performs a subcutaneous incision on the patient, and implants a guide wire (not shown) from the femoral artery through the incision. The guide wire passes through the abdominal aorta, thoracic aorta, and renal aorta, crosses the aortic valve, and finally enters the left ventricle. Afterwards, the ventricular assist device is removed, and the surface of the ventricular assist device is smoothed, soaked in heparin or treated by other special synthetic methods. Afterwards, an X-ray marker is set on the first through tube 21, and the flexible tip 24 on the blood pumping mechanism 20 is implanted into the femoral artery along the guide wire through the subcutaneous incision. During the implantation of the ventricular assist device, the physician observes the position of the blood pumping mechanism 20 in real time based on X-ray related equipment. Until the first through tube 21 extends into the patient's left ventricle, the second through tube 22 is located in the patient's aorta.
本实施例提供的心室辅助装置，包括介入导管10和与介入导管10的近心端连接的泵血机构20，介入导管10包括第一管壁11和由第一管壁11围合形成的第一容纳腔12，第一容纳腔12内设有与泵血机构20连通的灌注管13，灌注管13用于向泵血机构20输送灌注液，灌注管13包括第二管壁131和由第二管壁131围合形成的第二容纳腔132；本申请通过在第二容纳腔132内沿介入导管10的远心端至近心端延伸设置的支撑导丝14，提高灌注管13的抗弯折扭结性，降低灌注管13弯折扭结的概率，进而降低泵血机构20发生凝血造成泵血功能失效的概率。The ventricular assist device provided in this embodiment includes an interventional catheter 10 and a blood pumping mechanism 20 connected to the proximal end of the interventional catheter 10. The interventional catheter 10 includes a first tube wall 11 and a first accommodating chamber 12 formed by the first tube wall 11. A perfusion tube 13 connected to the blood pumping mechanism 20 is provided in the first accommodating chamber 12. The perfusion tube 13 is used to transport perfusion fluid to the blood pumping mechanism 20. The perfusion tube 13 includes a second tube wall 131 and a second accommodating chamber 132 formed by the second tube wall 131. The present application improves the bending and kinking resistance of the perfusion tube 13 by extending from the distal end to the proximal end of the interventional catheter 10 in the second accommodating chamber 132, reduces the probability of bending and kinking of the perfusion tube 13, and thereby reduces the probability of blood pumping function failure caused by coagulation in the blood pumping mechanism 20.
以上所述，仅为本申请的具体实施方式，所属领域的技术人员可以清楚地了解到，为了描述的方便和简洁，上述描述的***、模块和单元的具体工作过程，可以参考前述方法实施例中的对应过程，在此不再赘述。应理解，本申请的保护范围并不局限于此，任何熟悉本技术领域的技术人员在本申请揭露的技术范围内，可轻易想到各种等效的修改或替换，这些修改或替换都应涵盖在本申请的保护范围之内。 The above is only a specific implementation of the present application. Those skilled in the art can clearly understand that for the convenience and simplicity of description, the specific working processes of the systems, modules and units described above can refer to the corresponding processes in the aforementioned method embodiments, and will not be repeated here. It should be understood that the protection scope of the present application is not limited to this. Any technician familiar with the technical field can easily think of various equivalent modifications or replacements within the technical scope disclosed in this application, and these modifications or replacements should be included in the protection scope of this application.

Claims (10)

  1. 一种心室辅助装置，其中，包括介入导管和与设置所述介入导管的泵血机构，所述介入导管包括第一管壁和由所述第一管壁围合形成的第一容纳腔，所述第一容纳腔内设有与所述泵血机构连通的灌注管，所述灌注管包括第二管壁和由所述第二管壁围合形成的第二容纳腔，所述第二容纳腔内设有支撑导丝，所述第二管壁与所述支撑导丝均沿所述介入导管的远心端至近心端延伸设置。A ventricular assist device, comprising an interventional catheter and a blood pumping mechanism arranged with the interventional catheter, the interventional catheter comprising a first tube wall and a first accommodating cavity formed by the first tube wall, a perfusion tube connected to the blood pumping mechanism being arranged in the first accommodating cavity, the perfusion tube comprising a second tube wall and a second accommodating cavity formed by the second tube wall, a supporting guide wire being arranged in the second accommodating cavity, the second tube wall and the supporting guide wire both extending from the distal end to the proximal end of the interventional catheter.
  2. 根据权利要求1所述的心室辅助装置，其中，所述支撑导丝在近心端与远心端的至少一端与所述第二容纳腔固定连接。The ventricular assist device according to claim 1, wherein the support guide wire is fixedly connected to the second accommodating cavity at at least one of the proximal end and the distal end.
  3. 根据权利要求1所述的心室辅助装置，其中，所述支撑导丝的刚度大于所述第二管壁，和/或所述支撑导丝的刚度大于所述第一管壁。The ventricular assist device according to claim 1, wherein the stiffness of the support guidewire is greater than that of the second tube wall, and/or the stiffness of the support guidewire is greater than that of the first tube wall.
  4. 根据权利要求1所述的心室辅助装置，其中，所述支撑导丝的长度大于等于第一管壁，和/或所述支撑导丝的长度小于等于所述第二管壁。The ventricular assist device according to claim 1, wherein the length of the support guide wire is greater than or equal to the first tube wall, and/or the length of the support guide wire is less than or equal to the second tube wall.
  5. 根据权利要求1所述的心室辅助装置，其中，所述第一容纳腔内还设有线束管，所述线束管沿所述介入导管的远心端至近心端延伸设置。The ventricular assist device according to claim 1, wherein a wire harness tube is further provided in the first accommodating cavity, and the wire harness tube extends from the distal end to the proximal end of the interventional catheter.
  6. 根据权利要求1所述的心室辅助装置，其中，所述泵血机构包括沿近心端至远心端的方向顺次连接的第一通管、连通管和第二通管，所述第二通管与所述介入导管连接。The ventricular assist device according to claim 1, wherein the blood pumping mechanism comprises a first through tube, a connecting tube and a second through tube connected in sequence from the proximal end to the distal end, and the second through tube is connected to the interventional catheter.
  7. 根据权利要求6所述的心室辅助装置，其中，所述第二通管内设有泵体，所述灌注管与所述泵体连通，所述灌注管用于向所述泵体输送灌注液。The ventricular assist device according to claim 6, wherein a pump body is provided in the second through tube, the perfusion tube is connected to the pump body, and the perfusion tube is used to transport perfusion fluid to the pump body.
  8. 根据权利要求6所述的心室辅助装置，其中，所述第二通管内设有泵体，所述灌注管包括第一灌注管和第二灌注管，所述第一灌注管和所述第二灌注管均包括所述第二管壁和由所述第二管壁围合形成的第二容纳腔，所述第一灌注管和所述第二灌注管均与所述泵体连通，所述第一灌注管用于向所述泵体输送灌注液，所述泵体内的灌注液通过所述第二灌注管流出，所述第一灌注管和所述第二灌注管的所述第二容纳腔内均设有所述支撑导丝。The ventricular assist device according to claim 6, wherein a pump body is disposed in the second through tube, the perfusion tube comprises a first perfusion tube and a second perfusion tube, the first perfusion tube and the second perfusion tube both comprise the second tube wall and a second accommodating cavity formed by the second tube wall, the first perfusion tube and the second perfusion tube are both connected to the pump body, the first perfusion tube is used for conveying perfusion fluid to the pump body, the perfusion fluid in the pump body flows out through the second perfusion tube, and the support guide wire is disposed in the second accommodating cavity of the first perfusion tube and the second perfusion tube.
  9. 根据权利要求7或8任一项所述的心室辅助装置，其中，所述灌注液包括抗凝血剂。A ventricular assist device according to any one of claims 7 or 8, wherein the perfusate comprises an anticoagulant.
  10. 根据权利要求6所述的心室辅助装置，其中，所述第一通管和所述第二通管上 均设有与管外连通的窗口。 The ventricular assist device according to claim 6, wherein the first through tube and the second through tube are All of them are equipped with windows communicating with the outside of the pipe.
PCT/CN2023/140001 2022-12-20 2023-12-19 Ventricular assist device WO2024131805A1 (en)

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Publication number Priority date Publication date Assignee Title
CN219231205U (en) * 2022-12-20 2023-06-23 丰凯利医疗器械(上海)有限公司 Ventricular assist device

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020077600A1 (en) * 2000-12-19 2002-06-20 Laksen Sirimanne Percutaneous catheter assembly
CN112891732A (en) * 2021-05-07 2021-06-04 丰凯医疗器械（上海）有限公司 Perfusate conveying device and control method thereof
WO2021152019A1 (en) * 2020-01-31 2021-08-05 Abiomed Europe Gmbh Intravascular blood pump
WO2021156257A1 (en) * 2020-02-06 2021-08-12 Abiomed Europe Gmbh Blood pump placement and intravascular blood pump
CN113856036A (en) * 2021-01-22 2021-12-31 苏州心擎医疗技术有限公司 Power transmission assembly and blood pump
CN115192895A (en) * 2022-07-01 2022-10-18 微创投资控股有限公司 Medical instrument
CN219231205U (en) * 2022-12-20 2023-06-23 丰凯利医疗器械(上海)有限公司 Ventricular assist device

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020077600A1 (en) * 2000-12-19 2002-06-20 Laksen Sirimanne Percutaneous catheter assembly
WO2021152019A1 (en) * 2020-01-31 2021-08-05 Abiomed Europe Gmbh Intravascular blood pump
WO2021156257A1 (en) * 2020-02-06 2021-08-12 Abiomed Europe Gmbh Blood pump placement and intravascular blood pump
CN113856036A (en) * 2021-01-22 2021-12-31 苏州心擎医疗技术有限公司 Power transmission assembly and blood pump
CN112891732A (en) * 2021-05-07 2021-06-04 丰凯医疗器械（上海）有限公司 Perfusate conveying device and control method thereof
CN115192895A (en) * 2022-07-01 2022-10-18 微创投资控股有限公司 Medical instrument
CN219231205U (en) * 2022-12-20 2023-06-23 丰凯利医疗器械(上海)有限公司 Ventricular assist device

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