CN116889679A

CN116889679A - ventricular assist system

Info

Publication number: CN116889679A
Application number: CN202310676229.6A
Authority: CN
Inventors: 宗丰绪; 耿聪颖; 杨迁红; 蒋海洋; 黄霖
Original assignee: Shanghai Xinhengrui Medical Technology Co ltd
Current assignee: Shanghai Xinhengrui Medical Technology Co ltd
Priority date: 2023-06-08
Filing date: 2023-06-08
Publication date: 2023-10-17

Abstract

The application provides a ventricular assist system, which comprises a puncture device, a blood pump and a blocking piece, wherein the puncture device comprises a sheath tube and a sleeve assembly, the sheath tube is movably arranged in the sleeve assembly in a penetrating way and is used for synchronously puncturing with the sleeve assembly into a preset cavity, and the sheath tube is used for blocking the sleeve assembly in the process of synchronously puncturing with the sleeve assembly into the preset cavity; the plugging piece is used for being placed in the preset cavity and plugging the sleeve assembly after the synchronous puncture of the sheath tube and the sleeve assembly into the preset cavity is finished; the sheath is used for being separated from the sleeve assembly after the sleeve assembly is plugged by the plugging piece; the blood pump is adapted to be placed outside the predetermined chamber and to be connected to the cannula assembly after the sheath is separated from the cannula assembly. The system can ensure that the heart is always in a working state in the whole implantation process of the blood pump without an extra-corporeal cardiopulmonary circulatory system, thereby avoiding postoperative sequelae caused by the extra-corporeal cardiopulmonary circulatory system and reducing the cost of the operation.

Description

Ventricular assist system

Technical Field

The application relates to the technical field of medical equipment, in particular to a ventricular assist system.

Background

The heart chamber auxiliary device is characterized by an artificial blood pump connected with the heart in parallel, and the artificial blood pump can simulate the function of ventricular ejection to pump blood in the heart chamber into an arterial system to do work so as to play a role of partially or completely replacing the function of the heart. Ventricular assist devices are classified into Left Ventricular Assist Devices (LVAD), right Ventricular Assist Devices (RVAD), biventricular assist devices (BVAD), and Total Artificial Hearts (TAH). The present application relates to a fully magnetic suspension artificial heart (artificial heart for short), which can draw out blood in a ventricle and enable the blood to flow into an aorta or a pulmonary artery through an artificial blood vessel.

As shown in fig. 1, in the ventricular assist device of the prior art, the blood pump assembly 100 is attached to the apex 300 of the heart by the ventricular cuff 200, and the artificial line 400 has one end connected to the outlet 500 of the blood pump assembly 100 and the other end connected to the aorta. While the blood pump assembly 100 is implanted, the patient's heart is required to pause and open a hole in the patient's apex 300. Specifically, in an artificial heart implantation procedure, it is first necessary to establish an extracorporeal circulation path for blood of a patient through an extracorporeal cardiopulmonary circulatory system (e.g., extracorporeal pulmonary oxygenation, ECMO for short), and then it is necessary to suspend the operation of the patient's heart and to open the orifice at the apex 300, and insert the inflow end of the blood pump assembly 100 into the opening site. After the blood pump assembly 100 is in place, the extracorporeal cardiopulmonary circulatory system is withdrawn, the heart of the patient begins to work again with the aid of the blood pump assembly 100, blood enters the ventricle in the direction a in fig. 1, and after the work of the blood pump assembly 100 is pressurized, the blood flows into the aorta in the direction b through the artificial tube 400. However, after the introduction into the extracorporeal cardiopulmonary circulatory system, the surgical cost is increased, and the risk of post-operative hemolysis, coagulation and other sequelae is increased.

Therefore, it is a technical problem to be solved at present that a person skilled in the art is urgent to design a ventricular assist system that can be installed and implanted smoothly without using an extracorporeal cardiopulmonary circulation system.

Disclosure of Invention

The application aims to provide a ventricular assist system, which can ensure that the heart is always in a working state without an extracorporeal cardiopulmonary circulatory system in the process of implanting a blood pump, thereby avoiding postoperative sequelae caused by using the extracorporeal cardiopulmonary circulatory system and reducing the cost of operation.

In order to achieve the above object, the present application provides a ventricular assist system, comprising a puncture device, a blood pump and a blocking member, wherein the puncture device comprises a sheath tube and a sleeve assembly, the sheath tube is movably arranged in the sleeve assembly in a penetrating manner and is used for synchronously puncturing with the sleeve assembly into a preset chamber, and the sheath tube is used for blocking the sleeve assembly in the process of synchronously puncturing with the sleeve assembly into the preset chamber; the plugging piece is used for being placed in the preset cavity and plugging the sleeve assembly after the process of synchronously puncturing the sheath tube and the sleeve assembly into the preset cavity is finished; the sheath tube is used for being separated from the sleeve assembly after the sleeve assembly is blocked by the blocking piece; the blood pump is adapted to be placed outside the predetermined chamber and to be connected to the cannula assembly after the sheath is separated from the cannula assembly.

Optionally, the puncture device further comprises an opening member for forming a puncture hole in the predetermined chamber before the sheath tube and the sleeve assembly synchronously puncture into the predetermined chamber; when the sheath tube and the sleeve assembly synchronously puncture and enter the preset cavity, the distal end of the sheath tube extends out of the distal end of the sleeve assembly, the relative positions of the sheath tube and the sleeve assembly are fixed, and the sheath tube and the sleeve assembly synchronously enter the preset cavity through the puncture hole; after the sheath tube and the sleeve assembly synchronously penetrate into the preset cavity, the distal end of the sheath tube is retracted into the sleeve assembly, so that an accommodating space for placing the plugging piece is formed at the distal end of the sleeve assembly.

Optionally, the distal end of the sheath tube is a tapered structure, and an outer circumferential surface of the tapered structure gradually decreases toward the distal end, and the tapered structure is used for expanding an inner diameter of the puncture hole, so that the distal ends of the sheath tube and the sleeve assembly can both enter the predetermined cavity.

Optionally, the sleeve assembly comprises an inflow tube and a flow guide member, the flow guide member is connected with the distal end of the inflow tube, and the sheath tube is used for penetrating the inflow tube; the guide piece is positioned in a cavity at the distal end of the sheath tube before entering the preset cavity and is in a folded state; after the flow guide piece enters the preset cavity, the flow guide piece is separated from the cavity, and then is converted into an unfolding state from a folding state; after the flow guide piece is in the unfolding state, the distal end of the sheath tube is retracted into the sleeve assembly so as to form an accommodating space at the distal end of the sleeve assembly; the plugging piece is used for penetrating through the flow guiding piece to enter the containing space to plug the inflow pipe.

Optionally, the opening of the baffle is flared in the deployed state to direct blood flow into the inflow tube.

Optionally, the puncture device further comprises a handle and a clamping piece, wherein the handle is fixedly connected with the proximal end of the sheath tube, the clamping piece is arranged between the sheath tube assembly and the handle, so that the relative positions of the sheath tube and the sheath tube assembly are fixed, and the sheath tube assembly keep moving synchronously.

Optionally, at least one sealing ring is arranged on the sheath tube, and the sealing ring is used for being abutted against the inner wall of the inflow tube so as to seal the inflow tube and ensure that blood cannot overflow through the inflow tube.

Optionally, the quantity of sealing ring is a plurality of, and a plurality of the sealing ring is followed the axial interval setting of sheath, still be equipped with the viewpoint on the sheath, the viewpoint sets up in the distal end one the proximal end of sealing ring.

Optionally, the ventricular assist system further comprises a snare device, the sheath having a delivery channel disposed therethrough along its own axis; the snare device is for entering into the predetermined chamber along the delivery channel to capture the occluding member disposed within the predetermined chamber, and for urging the occluding member in a direction toward the cannula assembly until the cannula assembly is occluded.

Optionally, the blocking member is a balloon and/or the snare device is a wire.

Optionally, the ventricular assist system further comprises a fixation device for placement and fixation on an exterior of the predetermined chamber; the fixing device is provided with an inner cavity which is used for communicating with a puncture hole on the preset cavity; the sheath tube and the sleeve assembly are used for entering the puncture hole and then entering the preset cavity after passing through the inner cavity of the fixing device; the blood pump is used for being respectively connected with the fixing device and the sleeve assembly after the sheath tube is separated from the sleeve assembly.

Optionally, a first limiting member is arranged on the outer wall of the proximal end of the fixing device; a second limiting piece is arranged on the outer wall of the sleeve assembly; the sleeve assembly is used for moving along the axial direction of the sleeve assembly after the sheath tube is separated from the sleeve assembly, so that the first limiting piece and the second limiting piece are abutted; the blood pump comprises a pump body and a locking piece, wherein the locking piece is movably connected with the pump body and forms an accommodating groove with the pump body; the locking piece is used for moving along the radial direction of the locking piece, so that the first limiting piece and the second limiting piece which are abutted can enter and are limited in the containing groove.

Optionally, the ventricular assist system further comprises a sealing device for mounting on an outer wall of the cannula assembly to seal a gap between the fixation device and the cannula assembly.

The application provides a ventricular assist system, which comprises a puncture device, a blood pump and a blocking piece, wherein the puncture device comprises a sheath tube and a sleeve assembly, the sheath tube is movably arranged in the sleeve assembly in a penetrating way and is used for synchronously puncturing with the sleeve assembly into a preset cavity, and the sheath tube is used for blocking the sleeve assembly in the process of synchronously puncturing with the sleeve assembly into the preset cavity; the plugging piece is used for being placed in the preset cavity and plugging the sleeve assembly after the synchronous puncture of the sheath tube and the sleeve assembly into the preset cavity is finished; the sheath is used for being separated from the sleeve assembly after the sleeve assembly is plugged by the plugging piece; the blood pump is adapted to be placed outside the predetermined chamber and to be connected to the cannula assembly after the sheath is separated from the cannula assembly.

Therefore, in the whole process of implanting the blood pump, the sheath tube is used for blocking the sleeve assembly, and then the blocking piece is used for blocking the sleeve assembly, so that the preset chamber (particularly a heart chamber) is always in a sealing state, the heart is always kept in a working state without using an extracorporeal cardiopulmonary circulation system in the whole process, the cost of operation can be reduced, sequelae such as hemolysis, coagulation and the like generated by using the extracorporeal cardiopulmonary circulation system are avoided, the opening of the outer wall of the preset chamber can be prevented, the irreversible damage of myocardial tissues to the heart of a patient is removed, and the damage to the patient is further reduced.

Drawings

FIG. 1 is a schematic diagram of a prior art ventricular assist device;

FIG. 2 is an axial cross-sectional view of a preferred embodiment of the present application showing the puncturing device, the securing device, and the sealing device in use, wherein the flow guide is implanted in a predetermined chamber and is in a folded state;

FIG. 3 is an axial cross-sectional view of a preferred embodiment of the present application showing the application of the fixing device, sealing device, blocking member and blood pump;

FIG. 4 is an axial cross-sectional view of another preferred embodiment of the present application showing the application of the puncturing device, the securing device, and the sealing device, wherein the flow guide is implanted in a predetermined chamber and in a released state, and the sheath is moved to the distal end of the flow guide;

FIG. 5 is an axial cross-sectional view of a further preferred embodiment of the application showing the application of the puncturing device, the securing device and the sealing device, wherein the flow guide is implanted in a predetermined chamber and in a deployed state, and wherein the sheath is moved to the proximal end of the flow guide;

FIG. 6 is a schematic view showing the structure of the puncture device, the fixing device and the sealing device according to a preferred embodiment of the present application;

FIG. 7 is a simplified schematic diagram of an application scenario of the fixing device according to a preferred embodiment of the present application;

FIG. 8 is an axial cross-sectional view of an application scenario of a fixture in a preferred embodiment of the present application;

FIG. 9 is a schematic view showing the structure of a sealing device in a preferred embodiment of the present application;

FIG. 10 is a schematic view showing the structure of the fixing device and the sealing device in accordance with a preferred embodiment of the present application;

FIG. 11 is an axial cross-sectional view of a fixing device and a sealing device according to a preferred embodiment of the present application;

FIG. 12 is an axial cross-sectional view of a preferred embodiment of the present application showing the application of the fastening device, sealing device and closure member;

fig. 13 is an enlarged view of fig. 12;

FIG. 14 is an axial cross-sectional view of a first stent graft applied to a fixation device and a closure member according to another preferred embodiment of the present application;

FIG. 15 is a schematic view showing the structure of a blood pump according to a preferred embodiment of the present application;

fig. 16 is a schematic view of an application scenario of a second stent graft in a preferred embodiment of the present application;

FIG. 17a is a schematic perspective view of a hollow stent and inflow tube according to a preferred embodiment of the present application;

fig. 17b is a schematic front view of the hollow stent and the inflow tube according to a preferred embodiment of the present application.

In the figure:

a blood pump assembly 100; a ferrule 200; apex 300; an artificial line 400; an outlet 500;

a left ventricle 10; a target location 20; a puncture hole 30; a puncturing device 1; a sheath tube 11; a cavity 111; a seal ring 112; a viewpoint 113; a delivery channel 114; a sleeve assembly 12; an accommodating space 121; an inflow pipe 122; a flow guide 123; a first stent graft 1231; a second stent graft 1232; hollowed-out support 1233; a second stopper 124; a handle 13; a catch 14; a blood pump 2; a locking member 21; a pump body 22; a blocking member 3; a fixing device 4; an inner cavity 41; a sewing ring 42; a clamping portion 43; a sleeve 44; a first stopper 45; a sealing device 5; an annular collar 51; a clasp 52; an annular gasket 53.

Detailed Description

The application is described in further detail below with reference to the drawings and the specific examples. The advantages and features of the present application will become more apparent from the following description. It should be noted that the drawings are in a very simplified form and are all to a non-precise scale, merely for convenience and clarity in aiding in the description of embodiments of the application.

The terms "center," "longitudinal," "transverse," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," "counter-clockwise," "axial," "radial," "circumferential," etc. refer to an orientation or positional relationship based on that shown in the drawings, merely for convenience of description and to simplify the description, and do not indicate or imply that the devices or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore should not be construed as limiting the application.

In the present application, unless explicitly specified and limited otherwise, the terms "mounted," "connected," "secured," and the like are to be construed broadly and include, for example, either fixedly attached, detachably attached, or integrally formed; may be mechanically connected, may be electrically connected or may be in communication with each other; either directly, or through an intermediary, may be internal to the two elements or in an interactive relationship with the two elements, unless explicitly defined otherwise. The specific meaning of the above terms in the present application can be understood by those of ordinary skill in the art according to the specific circumstances. Herein, the term "axial" refers to the direction of the central axis of the sheath; the term "radial" refers to a direction perpendicular to the central axis of the sheath; the term "circumferential" refers to a direction about the central axis of the sheath.

The application will be described in detail below with reference to the drawings and the preferred embodiments. The following embodiments and features of the embodiments may be complemented or combined with each other without conflict.

A preferred embodiment of the present application provides a ventricular assist system that is implantable in a location of a predetermined chamber of a human body to replace or assist a heart in a pumping operation.

The following description will be given by taking the predetermined chamber as the left ventricle as an example, but those skilled in the art will recognize that the predetermined chamber may also be the right ventricle, i.e. the ventricular assist system may be implanted in the right ventricle as desired.

As shown in fig. 2 and 3, the ventricular assist system comprises a puncture device 1, a blood pump 2 and a closure member 3, wherein the puncture device 1 comprises a sheath tube 11 and a sleeve assembly 12, and the sheath tube 11 is used for being movably and axially penetrated in the sleeve assembly 12. The sheath 11 is used for simultaneous penetration into the left ventricle 10 with the cannula assembly 12, the sheath 11 being used for plugging the cannula assembly 12 during simultaneous penetration of the sheath 11 and the cannula assembly 12 into the predetermined chamber for plugging said cannula assembly 12 before the plugging member 3 plugs the cannula assembly 12. The occluding member 3 is intended to be placed within the left ventricle 10 and occludes the cannula assembly 12 after the end of the procedure of simultaneous penetration of the sheath 11 and cannula assembly 12 into the left ventricle 10 (see fig. 3). The sheath 11 is used to separate the cannula assembly 12 after the cannula assembly 12 is plugged by the plugging member 3. The blood pump 2 is adapted to be placed outside the left ventricle 10 and to be connected to the cannula assembly 12 after the sheath 11 is separated from the cannula assembly 12.

Preferably, the puncturing device 1 further comprises an opening member (not shown) for opening a puncture hole 30 (see fig. 8) in a target location 20 (apex) of the left ventricle 10 before the sheath 11 and the cannula assembly 12 simultaneously puncture into the left ventricle 10. When the sheath 11 and the sleeve assembly 12 are synchronously punctured into the left ventricle 10, the distal end of the sheath 11 extends out of the distal end of the sleeve assembly 12, and the sheath 11 and the sleeve assembly 12 synchronously enter the left ventricle 10 through the puncture hole 30. After the sheath 11 and the cannula assembly 12 are simultaneously pierced into the left ventricle 10, the distal end of the sheath 11 can also be retracted into the cannula assembly 12 to form a receiving space 121 at the distal end of the cannula assembly 12 for placement of the occluding component 3.

Before leaving the factory, inserting the sheath tube 11 into the sleeve assembly 12, wherein the distal end of the sheath tube 11 extends out of the distal end of the sleeve assembly 12, and keeping the relative positions of the sheath tube 11 and the sleeve assembly 12 fixed; in actual implantation, the sheath 11 and the cannula assembly 12 are moved distally in synchronism, and the sheath 11 and the cannula assembly 12 are delivered into the human body along a predetermined surgical path until the distal end of the sheath 11 is positioned at the intended location of the outer wall of the left ventricle 10; after positioning, the puncture 30 in the outer wall of the left ventricle 10 is first expanded by the distal end of the sheath 11 extending beyond the distal end of the cannula assembly 12, and then the distal end of the cannula assembly 12 enters the left ventricle 10 via the expanded puncture 30. After the distal end of the cannula assembly 12 has entered the left ventricle 10, the cannula assembly 12 remains stationary, moving the sheath 11 distally relative to the cannula assembly 12 to deploy the baffle 123 of the cannula assembly 12; after the flow guide member 123 is in the deployed state, the distal end of the sheath 11 is retracted back into the sleeve assembly 12, at this time, the sheath 11 is still disposed in the sleeve assembly 12, and the sheath 11 can function to block the sleeve assembly 12.

After the distal end of the sheath 11 has been retracted into the cannula assembly 12, the blocking member 3 in the left ventricle 10 is again moved towards the cannula assembly 12 until at least part of the blocking member 3 enters the receiving space 121 and blocks the distal end of the cannula assembly 12, after which the sheath 11 is completely withdrawn and the blood pump 2 is connected to the proximal end of the cannula assembly 12.

In summary, in the whole implantation process, the sheath tube 11 is used for blocking the sleeve assembly 12, and then the blocking piece 3 is used for blocking the sleeve assembly 12, so that the blood in the left ventricle 10 can not overflow through the sleeve assembly 12, and the left ventricle 10 always keeps normal working chamber pressure, so that the heart can always keep working state in the whole implantation process of the blood pump 2 without using an external cardiopulmonary circulatory system, thereby reducing the operation cost and avoiding postoperative sequelae such as hemolysis, coagulation and the like caused by using the external cardiopulmonary circulatory system. In addition, in the prior art, there is a need to open a hole in the apex 300 of the patient and remove myocardial tissue to enable the inflow end of the blood pump assembly 100 to be inserted into the open site, and during the implantation of the ventricular assist system of the present application, there is no need to remove myocardial tissue, avoiding irreversible damage to the patient's heart by removing myocardial tissue, and thus reducing damage to the patient.

It should be noted that, the opening member only opens a puncture hole 30 with a smaller inner diameter on the left ventricle 10, and only a small amount of blood in the left ventricle 10 overflows through the puncture hole 30, and the puncture hole 30 does not affect the normal operation of the heart. During the process of penetrating the sheath 11 through the puncture hole 30, the sheath 11 performs a reaming operation, the diameter of the puncture hole 30 gradually increases under the extrusion of the sheath 11, and myocardial tissue is accumulated around the puncture hole 30 under the extrusion of the sheath 11. The puncture 30 may facilitate easier penetration of the sheath 11 into the left ventricle 10, improving the maneuverability of the sheath 11 into the left ventricle 10.

Further, the distal end of the sheath 11 has a tapered structure, and the outer peripheral surface of the tapered structure gradually decreases toward the distal end. The tapered structure serves to enlarge the inner diameter of the puncture 30 to allow both the sheath 11 and the distal end of the cannula assembly 12 to enter the left ventricle 10. The tapered configuration of the distal end of the sheath 11 also facilitates the insertion of the sheath 11 into the puncture 30 and the reaming operation.

As shown in FIG. 4, in one embodiment, the cannula assembly 12 includes an inflow tube 122, and the sheath 11 is configured to movably extend through the inflow tube 122 and move in synchronism with the inflow tube 122.

As a preferred embodiment, the cannula assembly 12 further includes a baffle 123, the baffle 123 being connected to the distal end of the inflow tube 122. The sheath 11 is used to sequentially pass through the inflow tube 122 and the flow guide 123.

The flow guide 123 has a folded state and an unfolded state. Referring to fig. 2, the baffle 123 is shown in a collapsed condition in the cavity 111 distal to the sheath 11 prior to entry into the left ventricle 10. Referring to fig. 4, after the guide member 123 enters the left ventricle 10, the sheath 11 is moved distally relative to the guide member 123 to disengage the guide member 123 from the cavity 111 and thereby change from the folded state to the unfolded state.

Referring to fig. 5, after the deflector 123 is in the deployed state, the distal end of the sheath 11 is retracted into the sleeve assembly 12 such that the distal end of the sleeve assembly 12 forms the receiving space 121. The blocking member 3 is used to block the inflow pipe 122 through the flow guide 123 to enter the accommodating space 121.

Preferably, the opening of the flow guide is open in the deployed state. With this arrangement, the opening of the flow guide 123 in the expanded state is opened, and the inner diameter of the blood inflow port can be enlarged to guide the blood in the left ventricle 10 to flow into the blood pump 2.

Referring to fig. 14, in an embodiment, the flow guiding member 123 is a first stent graft 1231, and the overall outline of the first stent graft 1231 in the unfolded state is substantially horn-shaped, so that the horn-shaped opening of the first stent graft 1231 is opened to expand the inner diameter of the blood inflow port of the blood pump, so that the blood can smoothly flow into the pump body 22.

Referring to fig. 16, in yet another embodiment, the flow guiding member 123 is a second stent graft 1232, and the overall outline of the second stent graft 1232 in the deployed state is substantially umbrella-shaped; the edge of the outer circumferential surface of the second stent graft 1232 abuts against the puncture hole 30 of the left ventricle 10 in the expanded state to seal the cavity formed by the second stent graft 1232 and the inner wall of the left ventricle 10. A closed cavity is formed between the second stent graft 1232 and the inner wall of the left ventricle 10, and blood cannot flow into the closed cavity, so that the free flowing space of blood in the ventricle is reduced, and the arrangement is such that the volume of the ventricle can be reduced, i.e. the effective pumping volume of the ventricle is reduced, thereby enhancing the myocardial contractility and improving the cardiac function, so that the stroke volume of the heart can be matched with the pumping capacity of the heart of the patient.

Referring to fig. 17a and 17b, in another embodiment, the flow guiding member 123 is a mesh-shaped hollow support 1233, the overall outline of the hollow support 1233 is approximately umbrella-shaped in the unfolded state, and the peripheral edge of the outline of the hollow support 1233 abuts against the puncture hole 30 of the left ventricle 10 in the unfolded state. The reticular hollow support 1233 can enable blood to pass through the hollow support 1233 on one hand, and the blood always has a flowing state, so that the occurrence of coagulation is reduced; on the other hand, in the process of expanding the puncture hole 30 of the puncture device 1, myocardial tissue is accumulated on the inner wall around the puncture hole 30 of the left ventricle 10 under the extrusion of the puncture device 1, and the elongated bracket of the hollowed-out bracket 1233 is embedded into myocardial tissue on the inner wall around the puncture hole, so that the accumulated myocardial tissue can be fixed, and the displacement and growth of the myocardial tissue can be prevented from interfering with the blood pump.

With continued reference to fig. 2, the lancing device 1 further includes a handle 13 and a catch 14, the handle 13 being connected to the proximal end of the sheath 11 extending beyond the cannula assembly 12. The clamping member 14 is arranged between the sleeve assembly 12 and the handle 13, so that the relative positions of the sheath 11 and the sleeve assembly 12 are fixed, and the sheath 11 and the sleeve assembly 12 can synchronously move. Specifically, during simultaneous penetration of sheath 11 and cannula assembly 12 distally into left ventricle 10, catch 14 is positioned between cannula assembly 12 and handle 13 to define the relative positions of cannula assembly 12 and sheath 11 such that sheath 11 can be simultaneously penetrated into left ventricle 10 with cannula assembly 12. After the flow guide 123 has entered the left ventricle 10, the catch 14 is removed, whereupon the sheath 11 can be moved distally relative to the cannula assembly 12, thereby effecting release of the flow guide 123, whereupon the sheath 11 is moved proximally relative to the cannula assembly 12 and retracted into the cannula assembly 12.

In other embodiments, the operator may also operate the sheath 11 and the inflow tube 122, respectively, so that the sheath 11 and the inflow tube 122 can move in synchronization.

Referring to fig. 5, in a preferred embodiment, at least one sealing ring 112 is provided on the sheath 11, and the sealing ring 112 is used to abut against the inner wall of the inflow tube 122 to seal the inflow tube 122, so as to ensure that the blood in the left ventricle 10 does not overflow through the inflow tube 122. Therefore, the heart can always work normally in the process of moving the sheath tube 11 relative to the sleeve assembly 12, and further the damage to a patient caused by using an extracorporeal cardiopulmonary circulatory system is avoided.

Preferably, the number of the seal rings 112 is plural, and the plurality of seal rings 112 are arranged at intervals along the axial direction of the sheath tube 11. The sheath 11 also has a viewing point 113 (see fig. 6), the viewing point 113 being disposed proximal to a distal-most one of the sealing rings 112.

In operation, after penetration of the puncturing device 1 into the left ventricle 10 and the flow guide 123 in the deployed state, the sheath 11 is moved proximally relative to the cannula assembly 12. During this process, when the operator observes the observation point 113, the proximal continued movement of the sheath 11 is stopped, and at this time, since the one seal ring 112 at the most distal end is still located in the inflow tube 122, the seal ring 112 at the most distal end can seal the inflow tube 122 to prevent blood from flowing out of the inflow tube 122.

In one example, the distal end of the observation point 113 has only one sealing ring 112, and when the operator observes the observation point 113, the one sealing ring 112 at the most distal end is capable of sealing the inflow tube 122. In other embodiments, the distal end of the observation point 113 may also have a plurality of sealing rings 112, each sealing ring 112 at the distal end of the observation point 113 being capable of sealing the inflow tube 122 when the operator observes the observation point 113.

In the present embodiment, the observation point 113 is a bright yellow mark provided on the outer wall of the sheath 11 in the circumferential direction thereof. In other embodiments, the observation point 113 may be marks, graduations, symbols, or the like provided on the outer wall of the sheath 11.

The present application does not limit the location of the observation point 113, and the location of the observation point 113 only needs to be such that when the observation point 113 is moved out of the inflow tube 122, the sealing ring 112 at the most distal end of the sheath 11 is still in the inflow tube 122, and the sealing ring 112 at the most distal end of the sheath 11 can still seal the inflow tube 122. The function of the observation point 113 is to ensure that at least 1 sealing ring 112 remains in the inflow tube 122 during retraction of the sheath 11, to ensure that the inflow tube 122 remains sealed at all times, and to ensure that no outflow of blood from the left ventricle 10 occurs through the inflow tube 122.

Further, the ventricular assist system further comprises a snare device (not shown) having a delivery channel 114 disposed axially therethrough, the snare device being adapted to pass along the delivery channel 114 into the left ventricle 10. The snare device is used for capturing a closure member 3 placed in the left ventricle 10 and also for urging the closure member 3 in the direction of the cannula assembly 12 until the closure member 3 closes off the cannula assembly 12. The sealing piece 3 can ensure that the ventricle is still in a sealing state after the sheath tube 11 is withdrawn, thereby ensuring the heart to work normally all the time.

More specifically, after the operator has observed the observation point 113 and stopped moving the sheath 11 further, the occluding component 3 is percutaneously passed through the aorta into the left ventricle 10 and the snare device is advanced along the delivery channel 114 in the sheath 11 into the left ventricle 10. The snare device captures the occluding member 3 in the left ventricle 10 and pulls the occluding member 3 into the receiving space 121 distal of the inflow tube 122 to occlude the inflow tube 122. The sheath 11 may then be removed from the cannula assembly 12 and the blood pump 2 may be assembled with the cannula assembly 12.

Preferably, the occluding member 3 includes, but is not limited to, a balloon or an elastic member. More preferably, the snare device includes, but is not limited to, a wire-like body. It should be understood that the wire-like body includes, but is not limited to, a wire-drawn wire or a polymer-drawn wire.

In a specific embodiment, the distal end of the linear body can be wound into a ring-shaped structure, and when the linear body captures the balloon, the ring-shaped structure can be sleeved outside the balloon or on the connecting part of the balloon, so that the linear body can be connected with the balloon and drive the balloon to move.

As shown in fig. 7-11, the ventricular assist system preferably further comprises a fixation device 4, the fixation device 4 being adapted to be placed outside the left ventricle 10 and to be fixed in position at the apex of the left ventricle 10. The fixation device 4 has a lumen 41 extending axially through the sheath 11, the lumen 41 being adapted to communicate with the puncture 30 in the left ventricle 10, and the sheath 11 and cannula assembly 12 being adapted to pass through the lumen 41 of the fixation device 4 and into the puncture 30 and into the left ventricle 10. This allows the sheath 11 and cannula assembly 12 to be inserted into the puncture 30 under the restriction of the lumen 41 to ensure the accuracy of the insertion location of the sheath 11 and to avoid excessive penetration depth of the sheath 11 during surgery.

Preferably, the outer diameter of the cannula assembly 12 and the inner diameter of the lumen 41 are matched to allow the outer wall of the cannula assembly 12 to always abut the inner wall of the lumen 41 during movement of the cannula assembly 12, thereby reducing blood flow.

Referring to fig. 8, the fixation device 4 includes a sewing ring 42 (e.g., felt), a clamping portion 43, and a sleeve 44, the sewing ring 42 being adapted to be sewn in a cusp position, the shape of the sewing ring 42 matching that of the cusp so that the sewing ring 42 can better fit over the outer wall of the cusp. The distal end of the sleeve 44 is adapted to pass through the sewing ring 42, the distal end of the sleeve 44 being located on one side of the sewing ring 42; the clamping part 43 is arranged at one end of the sleeve 44 close to the apex of the heart, and the clamping part 43 is positioned at the other side of the sewing ring 42; the distal end of the sleeve 44 and the clamping portion 43 serve to clamp the edge of the sewing ring 42.

In actual implantation, the sewing ring 42, the clamping portion 43 and the sleeve 44 are assembled, and then the sewing ring 42 is sewn to the outer wall of the apex. A puncture hole 30 is formed at the apex of the left ventricle 10 by using the perforating member, and then the puncture device 1 is inserted through the inner cavity 41 formed by the sleeve 44 and the puncture hole 30, so as to drive the flow guiding member 123 to enter the left ventricle 10.

After the baffle 123 is implanted in the left ventricle 10, the implantation site of the cannula assembly 12 needs to be fixed. In addition, after the flow guide 123 enters the left ventricle 10, a seal is also required between the sleeve assembly 12 and the fixation device 4 to further prevent blood from flowing out of the gap between the sleeve assembly 12 and the fixation device 4.

To solve the above-mentioned problems, referring to fig. 9 to 11, the ventricular assist system further includes a sealing device 5, wherein the sealing device 5 is configured to be mounted on an outer wall of the sleeve assembly 12 and configured to abut against the fixing device 4 to seal a gap between the fixing device 4 and the sleeve assembly 12 to prevent outflow of blood.

Preferably, the blood pump 2 is adapted to be assembled with the fixation device 4 and the cannula assembly 12, respectively, after the sheath 11 is separated from the cannula assembly 12.

Referring to fig. 8 and 11, in one embodiment, a first stop 45 extending radially outwardly from itself is provided on the outer wall of the proximal end of the fixation device 4 (i.e., the end remote from the grip portion 43). In this embodiment, the first limiting member 45 is annular and is fixed on an outer wall of an end portion of the sleeve 44 away from the clamping portion 43.

In an alternative embodiment, as shown in fig. 9, the sealing device 5 includes an annular collar 51, a clip 52, and an annular gasket 53, the clip 52 being connected to the annular collar 51 and adapted to connect both ends of the annular collar 51. An annular seal 53 is secured to the inner wall of the annular collar 51, the annular seal 53 being adapted to secure the sleeve assembly 12 and to abut the first stop 45.

After the baffle 123 is implanted in the left ventricle 10, the sealing device 5 is mounted on the outer wall of the fixation device 4 and the cannula assembly 12. Specifically, the annular packing 53 is fastened to the outer wall of the sleeve assembly 12, and the first stopper 45 is abutted against the annular packing 53 in the axial direction of the sleeve assembly 12, thereby completing the installation of the sealing device 5.

More preferably, referring to fig. 12-14, the outer wall of the sleeve assembly 12 is provided with a second stop 124 extending radially outwardly therefrom, and the first stop 45 is preferably located distally of the second stop 124. The sealing device 5 is adapted to be fixed between the first stopper 45 and the second stopper 124, and to abut against the first stopper 45 and the second stopper 124, respectively, in the axial direction of the sleeve assembly 12. The sleeve assembly 12 can be axially limited by the sealing device 5, so that the sleeve assembly 12 can be prevented from moving far too far during the puncturing process, and the puncture depth of the sheath 11 can be prevented from being too deep.

Further, the sleeve assembly 12 is configured to move axially along itself after the sheath 11 is separated from the sleeve assembly 12, such that the first stopper 45 is configured to abut against the second stopper 124.

In more detail, after the sheath 11 is withdrawn from the cannula assembly 12, the sealing device 5 is removed and the cannula assembly 12 is moved distally until the second stop 124 abuts the first stop 45, and the blood pump 2 is then connected to the fixation device 4 and the cannula assembly 12 to effect fixation of the blood pump 2.

Specifically, referring to fig. 15, the blood pump 2 includes a locking member 21 and a pump body 22, and the locking member 21 is movably connected to a distal end of the pump body 22 and forms a receiving groove (not numbered) with the pump body 22. The locking member 21 is configured to move radially in itself to enable the abutting first and second stop members 45, 124 to enter and be retained in the receiving slot.

In more detail, the locking member 21 has an open state and a locked state. In the open state, the first stopper 45 and the second stopper 124 which are abutted can be moved into the receiving groove in the axial direction of the sheath 11. The locking member 21 is then switched to a locked state, and the first and second limiting members 45 and 124, which are in contact with each other, can be limited in the receiving groove along the axial direction of the sheath 11, so as to connect the blood pump 2 with the fixing device 4 and the cannula assembly 11.

In one example, the shape of the receiving groove matches the shape of the first and second stoppers 45 and 124 that abut each other. When the first and second stoppers 45 and 124 are stopped in the receiving groove, the first and second stoppers 45 and 124 can radially and axially abut against the inner wall of the receiving groove to prevent the blood pump 2 from moving radially and axially relative to the fixture 4 and the cannula assembly 12.

Further, the ventricular assist system further includes an artificial blood vessel (not shown), one end of which is connected to an outlet (not numbered) of the blood pump 2, and the other end of which is connected to a target line (an aorta or a pulmonary artery). After the ventricular assist system is implanted, blood can enter the blood pump 2 from the end part of the flow guiding piece 123, and after the blood pump 2 performs work and pressure boosting, the blood flows into a target pipeline through an artificial blood vessel so as to realize the pumping operation of the ventricular assist system.

The following describes the implantation procedure of the ventricular assist system by taking the example of the implantation of the ventricular assist system into the left ventricle:

1) Referring to fig. 7 and 8, the sewing ring 42, the clamping portion 43 and the sleeve 44 of the fixing device 4 are first assembled, and the sewing ring 42 is sewn at the apex position outside the left ventricle 10; a puncture 30 is then made in the apex of the left ventricle 10 using the fenestration product.

2) Referring to fig. 2 and 8, the sheath 11 is inserted through the inflow tube 122, and the guide 123 is placed in a folded state and in the cavity 111 at the distal end of the sheath 11;

a catch 14 is mounted between the cannula assembly 12 and the handle 13 to fix the relative positions of the sheath 11 and the cannula assembly 12, allowing the sheath 11 and the cannula assembly 12 to pass through the lumen 41 and the puncture 30 of the fixation device 4 in a synchronized sequence until the baffle 123 enters the left ventricle 10.

3) Referring to fig. 10 and 11, the annular packing 53 of the sealing device 5 is fastened to the outer wall of the sleeve assembly 12, and the first stopper 45 of the fixing device 4 and the second stopper 124 of the sleeve assembly 12 are abutted against both sides of the annular packing 53 in the axial direction to seal the gap between the sleeve assembly 12 and the fixing device 4.

4) Referring to fig. 4, the catch 14 is removed and the sheath 11 is moved distally until the baffle 123 transitions from the collapsed state to the expanded state;

referring to fig. 5 and 6, sheath 11 is moved proximally and continued movement of sheath 11 is stopped when viewpoint 113 is moved out of cannula assembly 12.

5) Referring to fig. 12 and 13, the occluding component 3 is delivered percutaneously into the aorta and into the left ventricle 10 via the aorta; inserting the snare device along the delivery channel 114 into the left ventricle 10; after the snare device captures the occluding component 3, the occluding component 3 is pulled proximally until at least a portion of the occluding component 3 enters the receiving space 121 and is capable of occluding the inflow tube 122.

6) Removing sheath 11 from inflow tube 122; referring to fig. 14, the sealing device 5 is removed and the cannula assembly 12 is moved distally until the second stop 124 of the cannula assembly 12 abuts the first stop 45 of the fixation device 4; the locking member 21 of the blood pump 2 is brought into an open state, and the blood pump 2 is moved distally until the first stopper 45 and the second stopper 124 are positioned in the accommodating groove.

7) Referring to fig. 3, the locking member 21 is placed in a locked state such that the second stopper 124 and the first stopper 45 are stopped in the receiving groove to complete the installation of the blood pump 2 with the fixing device 4 and the cannula assembly 12.

8) Withdrawing the occluding component 3 according to the implantation path; one end of the artificial blood vessel is connected with the outlet of the blood pump 2, and the other end is connected with the aorta, so that the whole implantation process of the ventricular assist system is completed.

In summary, the present application provides a ventricular assist system, in which, during the whole implantation process of a blood pump 2, a sheath tube 11 is used to seal a sleeve assembly 12, and then a sealing member 3 is used to seal the sleeve assembly 12, so that blood in a left ventricle 10 does not overflow through the sleeve assembly 12, and the left ventricle 10 always maintains a normal working chamber pressure, so that the heart always maintains a working state during the whole implantation process of the blood pump 2 without using an extracorporeal cardiopulmonary circulatory system, thereby reducing the operation cost and avoiding post-operative sequelae such as hemolysis and coagulation caused by using the extracorporeal cardiopulmonary circulatory system. In addition, the myocardial tissue is not required to be removed, so that irreversible damage of the removed myocardial tissue to the heart of the patient is avoided, and the damage to the patient is reduced.

The above description is only illustrative of the preferred embodiments of the present application and is not intended to limit the scope of the present application, and any alterations and modifications made by those skilled in the art based on the above disclosure shall fall within the scope of the present application.

Claims

1. A ventricular assist system comprising a puncture device, a blood pump and a blocking member, wherein the puncture device comprises a sheath tube and a sleeve assembly, the sheath tube is used for movably penetrating into the sleeve assembly and is used for synchronously puncturing with the sleeve assembly into a preset cavity, and the sheath tube is used for blocking the sleeve assembly in the process of synchronously puncturing with the sleeve assembly into the preset cavity;

the plugging piece is used for being placed in the preset cavity and plugging the sleeve assembly after the process of synchronously puncturing the sheath tube and the sleeve assembly into the preset cavity is finished;

the sheath tube is used for being separated from the sleeve assembly after the sleeve assembly is blocked by the blocking piece;

the blood pump is adapted to be placed outside the predetermined chamber and to be connected to the cannula assembly after the sheath is separated from the cannula assembly.

2. The ventricular assist system of claim 1 wherein the puncturing device further comprises an aperture member for providing a puncture in the predetermined chamber prior to simultaneous puncturing of the sheath and the cannula assembly into the predetermined chamber;

when the sheath tube and the sleeve assembly synchronously puncture and enter the preset cavity, the distal end of the sheath tube extends out of the distal end of the sleeve assembly, the relative positions of the sheath tube and the sleeve assembly are fixed, and the sheath tube and the sleeve assembly synchronously enter the preset cavity through the puncture hole;

after the sheath tube and the sleeve assembly synchronously penetrate into the preset cavity, the distal end of the sheath tube is retracted into the sleeve assembly, so that an accommodating space for placing the plugging piece is formed at the distal end of the sleeve assembly.

3. The ventricular assist system of claim 2, wherein the distal end of the sheath is a tapered structure, an outer peripheral surface of the tapered structure tapering distally, the tapered structure for expanding an inner diameter of the puncture to enable the distal ends of both the sheath and the cannula assembly to enter the predetermined chamber.

4. The ventricular assist system of claim 1, wherein the cannula assembly comprises an inflow tube and a flow guide coupled to a distal end of the inflow tube, the sheath for passing through the inflow tube;

the guide piece is positioned in a cavity at the distal end of the sheath tube before entering the preset cavity and is in a folded state;

after the flow guide piece enters the preset cavity, the flow guide piece is separated from the cavity, and then is converted into an unfolding state from a folding state;

after the flow guide piece is in the unfolding state, the distal end of the sheath tube is retracted into the sleeve assembly so as to form an accommodating space at the distal end of the sleeve assembly;

the plugging piece is used for penetrating through the flow guiding piece to enter the containing space to plug the inflow pipe.

5. The ventricular assist system of claim 4 wherein the opening of the deflector is flared in the deployed state to direct blood flow into the inflow tube.

6. The ventricular assist system of any one of claims 1-5, wherein the puncture device further comprises a handle fixedly coupled to the proximal end of the sheath and a catch for mounting between the sheath assembly and the handle to fix the relative positions of the sheath and the sheath assembly, the sheath and the sheath assembly remaining synchronously movable.

7. The ventricular assist system of claim 4 wherein at least one sealing ring is provided on the sheath for abutting an inner wall of the inflow tube to seal the inflow tube to ensure that blood does not spill over the inflow tube.

8. The ventricular assist system of claim 7 wherein the number of sealing rings is a plurality, the plurality of sealing rings being spaced axially along the sheath, the sheath further having a viewing point disposed thereon proximal to a distal-most one of the sealing rings.

9. A ventricular assist system as claimed in any one of claims 1 to 5, further comprising a snare device, the sheath having a delivery channel disposed therethrough along its own axis; the snare device is for entering into the predetermined chamber along the delivery channel to capture the occluding member disposed within the predetermined chamber, and for urging the occluding member in a direction toward the cannula assembly until the cannula assembly is occluded.

10. A ventricular assist system according to claim 9, wherein the occluding member is a balloon and/or the snare device is a wire.

11. The ventricular assist system of any one of claims 1-5, further comprising a securing device for placement and securing on an exterior of the predetermined chamber; the fixing device is provided with an inner cavity which is used for communicating with a puncture hole on the preset cavity; the sheath tube and the sleeve assembly are used for entering the puncture hole and then entering the preset cavity after passing through the inner cavity of the fixing device; the blood pump is used for being respectively connected with the fixing device and the sleeve assembly after the sheath tube is separated from the sleeve assembly.

12. The ventricular assist system of claim 11, wherein a first stop is provided on an outer wall of the proximal end of the fixation device; a second limiting piece is arranged on the outer wall of the sleeve assembly; the sleeve assembly is used for moving along the axial direction of the sleeve assembly after the sheath tube is separated from the sleeve assembly, so that the first limiting piece and the second limiting piece are abutted;

the blood pump comprises a pump body and a locking piece, wherein the locking piece is movably connected with the pump body and forms an accommodating groove with the pump body; the locking piece is used for moving along the radial direction of the locking piece, so that the first limiting piece and the second limiting piece which are abutted can enter and are limited in the containing groove.

13. The ventricular assist system of claim 11, further comprising a sealing device for mounting on an outer wall of the sleeve assembly to seal a gap between the securement device and the sleeve assembly.