Ventricular assist device and assembly

Abstract

Embodiments of the present application relate to the field of mechanical devices for driving circulation within the ventricles, and in particular, to a ventricular assist device and assembly. The ventricular assist device provided in the present application comprises: a tube body, a pump, an isolation member, and a guide wire. The guide wire is configured to be capable of transporting the isolation member to a predetermined position of a ventricle. The tube body provides a flow channel for blood, and a blood inlet and a blood outlet are formed at two ends of the tube body, respectively. The pump is disposed at the blood outlet of the tube body and is configured to pump the blood. The isolation member is disposed at the blood inlet of the tube body and covers the blood inlet of the tube body, and the isolation member is configured to allow the blood to enter the blood inlet through the isolation member, ensuring that the tube body does not come into contact with the ventricular wall during the blood suction process. The present application further provides a ventricular assist assembly, which comprises the ventricular assist device and a sheath assembly. The sheath assembly is configured to block the blood outlet before the ventricular assist device enters a blood vessel of a user during the delivery of the ventricular assist device into the ventricle, so as to prevent blood from flowing out of the blood outlet.

Description

Ventricular assist devices and components Technical Field

[0001] Embodiments of this application relate to the field of mechanical devices for driving circulation within the ventricles, and particularly to a ventricular assist device and component. Background Technology

[0002] The statements herein are provided merely as background information in connection with this application and do not necessarily constitute prior art.

[0003] Heart weakness or heart failure can affect a patient's cardiac function and endanger their life. In clinical practice, ventricular assist devices are often used to help enhance cardiac function and alleviate heart failure. A ventricular assist device is an implantable mechanical pump that pumps blood from the lower chamber of the heart to other parts of the body, ensuring that the heart's blood supply function is maintained at a normal level. At the same time, it can reduce ventricular load, reduce myocardial cell oxygen consumption, increase cardiac output, stabilize hemodynamics and blood circulation, and provide a guarantee for the patient's cardiac function recovery and further treatment.

[0004] Summary of the Invention

[0005] A brief overview of this application is provided below to offer a basic understanding of certain aspects thereof. It should be understood that this overview is not an exhaustive summary of the application. It is not intended to identify key or essential parts of the application, nor is it intended to limit its scope. Its purpose is merely to present certain concepts in a simplified form as a prelude to the more detailed description that follows.

[0006] An embodiment of this application provides a ventricular assist device for assisting ventricular function, comprising: a tube, a pump, an isolator, and a guidewire, the guidewire being configured to deliver the isolator to a predetermined position in the ventricle; the tube provides a flow channel for blood, forming a blood inlet at one end and a blood outlet at the other end; the pump is disposed at the blood outlet of the tube, for drawing blood from the ventricle through the blood inlet and pumping it out through the blood outlet; the isolator is disposed at the blood inlet of the tube and covers the blood inlet, the isolator being configured to allow blood to enter the blood inlet through the isolator and to prevent the tube from touching the ventricular wall during blood aspiration.

[0007] Embodiments of this application also provide a ventricular assist device, which includes the aforementioned ventricular assist device and a sheath assembly. The sheath assembly is configured to block the blood outlet before the ventricular assist device enters the user's blood vessel when it is delivered into the ventricle, so as to prevent blood from flowing out of the blood outlet.

[0008] The ventricular assist device provided in the embodiments of this application uses a guide wire to transport an isolation member to the blood inlet of the tube, so that the isolation member forms a covering at the blood inlet, and blood can pass through the isolation member into the tube, so that the blood inlet is flexibly wrapped to prevent the blood inlet end of the tube from touching and damaging the ventricular wall when the ventricular assist device pumps blood.

[0009] The ventricular assist device provided in the embodiments of this application prevents blood from flowing out of the puncture site by using a sheath assembly to block the blood outlet of the ventricular assist device when it is inserted into a blood vessel, thus ensuring that the patient does not lose too much blood during the process of placing the ventricular assist device into the patient's body. Attached Figure Description

[0010] To further illustrate the above and other advantages and features of this application, the specific embodiments of this application will be described in more detail below with reference to the accompanying drawings. The drawings, together with the following detailed description, are included in and form a part of this specification. Elements having the same function and structure are indicated by the same reference numerals. It should be understood that these drawings only depict typical examples of this application and should not be considered as limiting the scope of this application.

[0011] Figure 1 is a schematic diagram of the assembled components of the ventricular assist device provided in an embodiment of this application;

[0012] Figure 2 is a schematic diagram of the ventricular assist device provided in the embodiment of this application when placed in the patient's ventricle;

[0013] Figure 3 is a partial structural diagram of the guidewire and the isolation element provided in an embodiment of this application;

[0014] Figure 4 is a partial structural diagram of the connection between the isolation member and the blood inlet of the tube provided in an embodiment of this application;

[0015] Figure 5 is another partial structural schematic diagram of the isolation member and the blood inlet of the tube provided in the embodiment of this application;

[0016] Figure 6 is a schematic diagram of the assembly of the various components of the ventricular assist device provided in an embodiment of this application.

[0017] Figure 7 is a schematic diagram of the sheath assembly structure provided in an embodiment of this application;

[0018] Figure 8 is a schematic diagram of the top structure of the sheath provided in an embodiment of this application;

[0019] Figure 9 is a partial structural diagram of the isolation section in a contracted state when the guide wire conveys the isolation element into the tube body according to an embodiment of this application;

[0020] Figure 10 is a partial structural diagram of the isolation member provided in the embodiment of this application, which is in a slightly expanded state when it extends from the blood inlet;

[0021] Figure 11 is a partial structural diagram of the isolation member provided in the embodiment of this application when it is in a fully deployed state.

[0022] Explanation of reference numerals in the attached drawings: 100, Ventricular assist device; 200, Ventricular assist assembly; 10, Tube body; 11, Blood inlet; 111, Fitting wall portion; 112, Protrusion of fitting wall portion; 12, Blood outlet; 20, Pump; 30, Isolator; 31, Isolation portion; 32, First fitting portion; 321, Isolator wall portion; 322, Protrusion of Isolator wall portion; 40, Guide wire; 41, Second fitting portion; 50, Sheath assembly; 51, Sheath; 511, Half sheath; 52, Tube. Detailed Implementation

[0023] Exemplary embodiments of this application will be described below with reference to the accompanying drawings. For clarity and brevity, not all features of actual implementations are described in the specification. However, it should be understood that many implementation-specific decisions must be made in the development of any such actual embodiment to achieve the developer's specific goals, such as complying with constraints related to the system and business, and these constraints may vary depending on the implementation. Furthermore, it should be understood that while development work can be very complex and time-consuming, such development work is merely a routine task for those skilled in the art who benefit from the content of this application.

[0024] It should also be noted that, in order to avoid obscuring this application with unnecessary details, only the equipment structure and / or processing steps closely related to the solution according to this application are shown in the accompanying drawings, while other details that are not closely related to this application are omitted.

[0025] The following disclosure provides several different implementations or examples for carrying out this application. To simplify the disclosure of this application, specific examples of components and methods are described below. Of course, these are merely examples and are not intended to limit this application. In the description of the embodiments of this application, "multiple" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0026] When treating patients with ventricular assist devices (VADs), the aortic blood vessel is inserted via puncture. The VAD then travels through the aortic valve via the arterial blood vessel and is finally placed inside the ventricle, thereby drawing blood from the ventricle and pumping it to the artery. The inventors of this application have discovered that, during the use of current VADs, the blood inlet end of the VAD may come into contact with the ventricular wall during the blood aspiration process, potentially causing damage to the ventricular wall and, in severe cases, endangering the user's life.

[0027] Based on this, in order to solve the above problems, the embodiments of this application provide a ventricular assist device for assisting ventricular function. Figure 1 shows a schematic diagram of the structure of the ventricular assist device provided by the embodiments of this application assembled together. As shown in Figure 1, the ventricular assist device 100 includes: a tube 10, a pump 20, an isolator 30, and a guide wire 40. The guide wire 40 is configured to transport the isolator 30 to a predetermined position in the ventricle. The tube 10 provides a flow channel for blood, forming a blood inlet 11 at one end of the tube 10 and a blood outlet 12 at the other end of the tube 10. The pump 20 is disposed at the blood outlet 12 of the tube 10 and is used to draw blood from the ventricle from the blood inlet 11 and pump it out from the blood outlet 12. The isolator 30 is disposed at the blood inlet 11 of the tube 10 and forms a cover over the blood inlet 11 of the tube 10. The isolator 30 is configured to allow blood to enter the blood inlet 11 through the isolator 30 and prevent the tube 10 from touching the wall of the ventricle during the blood draw process.

[0028] According to the embodiments of this application, the ventricular assist device forms a covering at the blood inlet of the tube by means of the isolation member 30, so that when blood is drawn from the blood inlet, the tube will not touch the ventricular wall, thereby avoiding the harm to the patient caused by the tube touching the ventricular wall, and thus reducing the potential risks during the use of the ventricular assist device.

[0029] Here, those skilled in the art can select different forms of isolation components as needed; for example, a flexible mesh structure can be used.

[0030] Figure 3 shows a partial structural diagram of the guide wire and the isolation element provided in the embodiment of this application. In some embodiments, as shown in Figures 1 and 3, the ventricular assist device 100 provided in the embodiment of this application uses the guide wire 40 to transport the isolation element 30 to the blood inlet 11 of the tube body 10, so that the isolation element 30 forms a cover at the blood inlet 11, and blood can pass through the isolation element 30 into the tube body 10, so that the blood inlet 11 is flexibly wrapped, preventing the blood inlet 11 end of the tube body 10 from touching and damaging the ventricular wall when the ventricular assist device 100 pumps blood, thereby reducing damage to the patient's body.

[0031] In some embodiments, as shown in FIG3, the isolation member 30 includes an isolation portion 31 and a first mating portion 32. The isolation portion 31 is fixedly connected to the first mating portion 32. The isolation portion 31 is configured to cover the blood inlet 11 of the tube body 10. The first mating portion 32 is configured to be detachably connected to the guide wire 40.

[0032] The isolation element 30 is fixedly connected to the inlet of the tube body 10 through the first mating part 32, so that the isolation part 31 can be fixedly covered on the blood inlet 11 of the tube body 10. This can cover the exposed blood inlet 11, preventing the open perforated structure at the blood inlet 11 from scraping against the ventricular assist device 100 when pumping blood, thus avoiding damage to the patient's heart. At the same time, it can also prevent scraped human tissue from blocking the blood inlet 11, thus avoiding affecting the function of the ventricular assist device 100 in pumping blood.

[0033] In some embodiments, as shown in FIG3, one end of the guidewire 40 forms a second mating portion 41, and the first mating portion 32 and the second mating portion 41 can be detachably connected, so that the isolation member 30 and the guidewire 40 can be detachably connected.

[0034] In some embodiments, the second mating part 41 formed by the first mating part 32 and the guide wire 40 can be configured to be threadedly connected. The connection or disconnection of the first mating part 32 and the second mating part 41 can be achieved by rotating the guide wire 40, which facilitates installation and disassembly. Thus, after the isolation member 30 is placed in a predetermined position using the guide wire 40, the guide wire 40 can be disconnected from the isolation member 30 and the guide wire 40 can be removed from the patient's body.

[0035] In some embodiments, the guide wire 40 is configured to guide the isolator 30 from the blood outlet 12 into the tube body 10 and extend from the blood inlet 11. With this configuration, when the isolator 30 moves from the blood outlet of the tube body to the outside of the tube body 10, the guide wire 40 is still inside the tube body 10. At this time, the isolator 30 begins to change from a contracted state to an extended state. Since the guide wire 40 is inside the tube body 10 and the isolator 30 is outside the tube body, this configuration facilitates the fixation of the isolator 30 to the blood inlet end of the tube body 10 via the guide wire 40.

[0036] Figure 2 shows a schematic diagram of the ventricular assist device provided in the embodiments of this application when placed in the ventricle of a patient. In some embodiments, as shown in Figures 1 and 2, the ventricular assist device 100 is placed between the ventricle and the artery through the ventricular valve. The tube 10 at the blood inlet 11 end is in the ventricle, and the pump 20 is in the artery. The ventricular assist device 100 draws blood from the ventricle through the pump 20 and pushes the blood to the blood outlet 12, thereby assisting the heart in supplying blood to the artery.

[0037] Figure 9 shows a partial structural schematic diagram of the isolator in a contracted state when the guidewire of the embodiment of this application delivers the isolator into the tube. During the process of preventing the ventricular assist device from being activated, the tube 10 of the ventricular assist device 100, equipped with the pump 20, is first delivered to the junction of the ventricle and artery. Then, the guidewire 40 drives the isolator 30 into the blood vessel and to the position of the tube 10 and pump 20, entering the tube from the blood outlet 12. Since the isolator 30 is constantly pulled by the guidewire 40 at this time, and the movement path is between the blood vessel and the tube 10, the path... The diameter is relatively narrow, so the isolation portion 31 of the isolation member 30 is in a contracted state when it is in the blood vessel and the tube body 10. Figure 10 shows a partial structural schematic diagram of the isolation member provided in the embodiment of this application in a slightly expanded state when it extends from the blood inlet. As shown in Figures 2 and 10, the guide wire 40 finally extends the isolation member 30 out of the blood inlet 11 of the tube body 10. Since the blood inlet 11 is located in the ventricle, the space is larger than that of the tube body 10 and the blood vessel wall. The isolation portion 31 of the isolation member 30 extending out of the tube body 10 is freed from the action of external force and begins to be in a slightly expanded state.

[0038] In some embodiments, the isolation portion 31 of the isolation member 30 is configured to cover the end of the blood inlet 11 of the tube body 10 after the isolation member 30 extends out of the blood inlet 11, and the guide wire 40 is configured to be disconnected from the isolation member 30 after the isolation portion 31 covers the end of the blood inlet 11 of the tube body 10.

[0039] Figure 11 shows a partial structural schematic diagram of the isolation member provided in the embodiment of this application when it is in a fully deployed state. In some embodiments, as shown in Figures 2 and 11, the isolation portion 31 of the isolation member 30 fully deploys after extending out of the tube body 10 because it is no longer constrained by external forces. The fully deployed isolation portion 31 has a shape that is centrally symmetrical about the first mating portion 32 (e.g., umbrella-shaped), so that the fully deployed isolation portion 31 completely covers the blood inlet 11 of the tube body 10. After the isolation portion 31 has completed covering the blood inlet 11, the guidewire 40 needs to be withdrawn from the patient's body. Therefore, the guidewire 40 needs to be disconnected from the isolation member 30.

[0040] In some embodiments, as shown in FIG3, the first mating portion 32 of the isolation member 30 includes an isolation member wall portion 321, which is configured to extend along the direction toward the blood inlet 11 of the tube body 10. The second mating portion 41 mates with the inner side of the isolation member wall portion 321 so that the isolation member wall portion 321 is connected to or disconnected from the second mating portion 41. The outer side of the isolation member wall portion 321 mates with the tube body 10 at the blood inlet 11 end so that the isolation member wall portion 321 is fixedly connected to the tube body 10.

[0041] In some embodiments, the isolation portion 31 is symmetrical about the first mating portion 32 as the center point, and the first mating portion 32 is disposed on the side of the isolation portion in the covered state. The length of the first mating portion 32 extending toward the blood inlet 11 does not exceed the length covered by the isolation portion 31, as shown in Figures 3 and 9. This allows the isolation portion 31 to completely cover the first mating portion 32 when it is in the contracted state.

[0042] In some embodiments, the spacer wall portion 321 and the second mating portion 41 are configured in a mating shape (e.g., threaded pattern) such that the first mating portion 32 and the second mating portion 41 of the spacer 30 form a detachable connection (e.g., threaded connection).

[0043] In some embodiments, the outer side of the isolation member wall 321 is provided with a plurality of protrusions, which are configured to snap-fit ​​with the wall of the tube forming the blood inlet 11.

[0044] As shown in Figure 3, the wall portion 321 of the isolation member has a protrusion. As shown in Figure 9, when the isolation portion 31 is in the contracted state, it completely covers the first mating portion 32. That is, the isolation portion 31 completely covers the part where the first mating portion 32 is connected to the second mating portion 41. This can prevent the protrusion on the wall portion 321 of the isolation member from being exposed outside the isolation portion 31, and prevent the protrusion from damaging the inner wall of the blood vessel during transport in the blood vessel.

[0045] Figure 5 shows a partial structural diagram of the isolation member and the blood inlet of the tube body according to an embodiment of the present application. Figure 4 shows another partial structural diagram of the connection between the isolation member and the blood inlet of the tube body according to an embodiment of the present application. The two figures show different structures. In some embodiments, as shown in Figures 4 and 5, the tube body 10 forms a mating wall portion 111 at the blood inlet 11. The mating wall portion 111 extends in a direction away from the isolation member 30. The mating wall portion 111 has a plurality of protrusions, which are arranged opposite to each other. The outer side of the isolation member wall portion 321 has a plurality of protrusions. The protrusions 112 of the mating wall portion and the protrusions 322 of the isolation member wall portion mate with each other to fix the isolation member wall portion 321 to the tube body 10.

[0046] The protrusions 112 of the mating wall are symmetrically arranged with the tube body axis as the symmetrical point and extend towards the tube body axis. In some embodiments, as shown in FIG5, both the protrusions 112 of the mating wall and the protrusions 322 of the spacer wall are configured as right-angled triangular toothed structures. Both the protrusions 112 of the mating wall and the protrusions 322 of the spacer wall are configured to be elastic, and the inclined surfaces of the two right-angled triangles are configured to contact each other and complement each other. In this way, when the protrusions 112 of the mating wall and the protrusions 322 of the spacer wall mate... During the movement, the right-angled triangular inclined surfaces of the protrusion 322 of the isolating member wall and the protrusion 112 of the mating member wall can fit together. As the isolating member 30 continues to be pushed into the tube body 10, the elastic protrusion 322 of the isolating member wall causes the equally elastic protrusion 112 of the mating member wall to expand, thereby causing the right-angled step surface of the protrusion 322 of the isolating member wall to engage with the right-angled step surface of the protrusion 112 of the mating member wall, and the isolating member 30 and the tube body 10 are completely engaged and fixed.

[0047] In some embodiments, as shown in FIG4, the blood inlet end of the tube body 10 may not form a mating wall 111. Instead, an elastic suspension portion extending toward the axis of the tube body 10 is formed directly at the blood inlet 11 of the tube body 10. This suspension portion is configured as an eave-like structure extending toward the axis of the tube body 10. The protrusion 322 of the isolator wall is configured as an elastic right-angled triangular toothed structure. The inclined surface of the right-angled triangle deforms during the process of the isolator 30 continuing to engage and advance with the tube body 10. Ultimately, the right-angled side of the protrusion 322 of the isolator wall is suspended and engaged on the eave-like structure, and the isolator 30 and the tube body 10 are completely engaged and fixed.

[0048] In some embodiments, the protrusion 112 of the mating wall and the protrusion 322 of the partition wall are configured such that during the process of fixing the partition wall 321 to the tube 10, the movement direction between the partition 30 and the tube 10 is unidirectional.

[0049] In some embodiments, as shown in FIG5, since the right-angled edge of the protrusion 322 of the isolation member wall engages with the right-angled edge of the protrusion 112 of the mating wall, after the isolation member 30 and the tube body 10 are completely engaged and fixed, although both the protrusion 112 of the mating wall and the protrusion 322 of the isolation member wall are elastic, after the right-angled edge step surface engages, due to the limited elasticity, the protrusion 112 of the mating wall and the protrusion 322 of the isolation member wall cannot be released from the engagement state by reverse movement. Therefore, the isolation member 30 can be continuously fixed at the blood inlet 11 of the tube body 10, so as to achieve continuous coverage of the blood inlet 11 by the isolation member 30.

[0050] In some embodiments, as shown in FIG4, the right-angled edge of the protrusion 322 of the partition wall is suspended and engaged on the eaves-like structure. After the partition 30 and the tube 10 are fully engaged and fixed, although both the protrusion 322 of the partition wall and the eaves-like structure are elastic, the protrusion 322 of the partition wall and the eaves-like structure cannot be released from the engagement state by reverse movement due to the limited elasticity after the right-angled edge is engaged.

[0051] An embodiment of this application also provides a ventricular assist device 200. FIG6 shows a schematic diagram of the structure of the ventricular assist device 200 provided in the embodiment of this application assembled together. As shown in FIG6, the ventricular assist device 200 includes the aforementioned ventricular assist device 100 and a sheath assembly 50. The sheath assembly 50 is configured to block the blood outlet 12 before the ventricular assist device 100 enters the user's blood vessels when it is inserted into the ventricle, so as to prevent blood from flowing out of the blood outlet.

[0052] The ventricular assist device 200 provided in the embodiments of this application prevents blood from flowing out of the puncture site through the blood outlet 12 by using a sheath assembly 50 to block the blood outlet 12 of the ventricular assist device 100 when it is punctured into a blood vessel, thereby preventing excessive blood loss in the patient.

[0053] Figure 7 shows a schematic diagram of the sheath assembly structure provided in an embodiment of this application. In some embodiments, as shown in Figure 7, the sheath assembly 50 includes a sheath 51 and a tube 52. The sheath 51 is fixedly connected to the tube 52, and the sheath 51 is configured as two separable half-sheaths 511. As shown in Figure 6, when the ventricular assist device 100 is delivered into the ventricle, one end of the two half-sheaths 511 is located at the blood outlet 12 and blocks the blood outlet 12. The other end of the two half-sheaths 511 is fixedly connected to the tube 52. The tube 52 extends along the tube body 10. When the ventricular assist device 100 is delivered into the ventricle, the two half-sheaths 511 are configured to move together with the tube body 10 of the ventricular assist device 100 so that the blood outlet 12 remains blocked. When the blood outlet 12 enters the user's body, the two half-sheaths 511 are detached.

[0054] Figure 8 shows a schematic diagram of the top structure of the sheath provided in an embodiment of this application. The tube body 10 passes through the middle of the two half-sheaths 511. As shown in Figure 6, the part of the tube body near the blood outlet 12 is nested in the tube 52, so that the tube 52 can wrap around the blood outlet 12, thereby reducing blood leakage during the puncture and intervention of blood vessels.

[0055] When the blood is about to enter the blood vessel at the outlet of the ventricular assist device 100, the two half-sheaths can be separated by applying force, and then the tube 10 can be completely inserted into the blood vessel to continue to deliver blood to the ventricle.

[0056] Regarding the embodiments of this application, it should also be noted that, without conflict, the embodiments of this application and the features in the embodiments can be combined with each other to obtain new embodiments.

[0057] The above are merely specific embodiments of this application, but the scope of protection of this application is not limited thereto. The scope of protection of this application shall be determined by the scope of protection of the claims.

Claims

1. A ventricular assist device for assisting ventricular function, characterized in that, It includes: Pipe body, pump, isolation components, and guide wire, The guidewire is configured to deliver the isolation element to a predetermined location in the ventricle; The tube provides a flow channel for blood, with a blood inlet at one end and a blood outlet at the other end. The pump is located at the blood outlet of the tube body and is used to draw blood from the ventricle from the blood inlet and pump it out from the blood outlet. The isolation element is disposed at the blood inlet of the tube and covers the blood inlet of the tube. The isolation element is configured to allow blood to enter the blood inlet through the isolation element and to prevent the tube from touching the ventricular wall during blood aspiration.

2. The apparatus according to claim 1, characterized in that, The isolation component includes an isolation part and a first mating part, wherein the isolation part is fixedly connected to the first mating part. The isolation section is configured to cover the blood inlet of the tube; The first mating part is configured to be detachably connected to the guide wire.

3. The apparatus according to claim 2, characterized in that, One end of the guidewire forms a second mating portion, and the first mating portion and the second mating portion can be detachably connected, so that the isolation member and the guidewire can be detachably connected.

4. The apparatus according to claim 1, characterized in that, The guidewire is configured to guide the isolation element from the blood outlet into the tube body and extend from the blood inlet.

5. The apparatus according to claim 2, characterized in that, The isolation portion of the isolation member is configured to cover the blood inlet end of the tube body after the isolation member extends out of the blood inlet, and the guide wire is configured to be disconnected from the isolation member after the isolation portion covers the blood inlet end of the tube body.

6. The apparatus according to claim 3, characterized in that, The first mating portion of the isolation member includes an isolation member wall portion, which is configured to extend along the direction toward the blood inlet of the tube body. The second mating part mates with the inner side of the wall of the isolation member, so that the wall of the isolation member can be connected to or disconnected from the second mating part; The outer side of the isolation element wall mates with the tube body at the blood inlet end, so that the isolation element wall is fixedly connected to the tube body.

7. The apparatus according to claim 6, characterized in that, The outer side of the wall of the isolation component is provided with a plurality of protrusions, which are configured to snap together with the wall of the tube forming the blood inlet.

8. The apparatus according to claim 6, characterized in that, The tube body forms a mating wall portion at the blood inlet, and the mating wall portion extends in a direction away from the spacer. The mating wall portion has multiple protrusions, which are arranged opposite to each other. The outer side of the wall of the isolation component is provided with a plurality of protrusions, and the protrusions of the mating wall cooperate with the protrusions of the wall of the isolation component to fix the wall of the isolation component to the tube body.

9. The apparatus according to claim 8, characterized in that, The protrusions of the mating wall and the protrusions of the isolation member wall are configured to fix the isolation member wall to the tube body during the process, and the movement direction between the isolation member and the tube body is unidirectional.

10. A ventricular assist device, characterized in that, It includes, The ventricular assist device according to any one of claims 1-9, A sheath assembly configured to block the blood outlet before the ventricular assist device enters the user's blood vessels during delivery to the ventricle, thereby preventing blood from flowing out of the blood outlet.

11. The component according to claim 10, characterized in that, The sheath assembly includes a sheath member and a tube member, the sheath member being fixedly connected to the tube member, and the sheath member being configured as two separable half-sheaths. When the ventricular assist device is inserted into the ventricle, one end of each of the two semi-sheaths is positioned at the blood outlet and blocks the blood outlet; the other ends of the two semi-sheaths are fixedly connected to the tubing. The component extends along the tube body. When the ventricular assist device is delivered to the ventricle, the two half-sheaths are configured to move together with the tube of the ventricular assist device to keep the blood outlet blocked, and the two half-sheaths are detached when the blood outlet enters the user's body.

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