Ventricular assist device

Abstract

The embodiment of the present application provides a kind of ventricular assist device, ventricular assist device includes: sleeve, is provided with first blood port and second blood port;Impeller, in the sleeve;Drive unit, with the one end of the sleeve is connected, the drive unit can also drive the rotation of the impeller, to make blood flow between the first blood port and the second blood port;And catheter, with proximal end and distal end, the distal end is connected the one end of the drive unit away from the sleeve, the catheter is provided with guide wire channel, the guide wire channel has opening adjacent the distal end, so that guide wire can be arranged in the first blood port and the opening, and part is housed in the sleeve and part is housed in the guide wire channel.The technical scheme provided by the embodiment of the present application can conveniently deliver ventricular assist device to patient's body.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a ventricular assist device. Background Technology

[0002] A ventricular assist device is a mechanical circulatory support device designed to assist the heart chambers and reduce their workload in order to maintain or increase cardiac output.

[0003] However, because the ventricular assist device is relatively long, especially the catheter, and the catheter is easy to bend, it is very difficult and obstructive to deploy the ventricular assist device into the ventricle. Summary of the Invention

[0004] In view of the above problems, embodiments of this application are proposed to provide a ventricular assist device that can be conveniently delivered into a patient.

[0005] This application provides a ventricular assist device, including:

[0006] The cannula is equipped with a first blood port and a second blood port;

[0007] The impeller is located inside the sleeve;

[0008] A drive unit, connected to one end of the sleeve, is also capable of driving the impeller to rotate, causing blood to flow between the first blood port and the second blood port; and...

[0009] The catheter has a proximal end and a distal end, the distal end being connected to the end of the drive unit remote from the cannula. The catheter is provided with a guidewire channel having an opening adjacent to the distal end, such that the guidewire can pass through the first blood port and the opening, and be partially received within the cannula and partially received within the guidewire channel.

[0010] Optionally, the conduit includes a first pipe segment having the distal end, the opening being disposed in the first pipe segment, the drive unit having a first cross-section perpendicular to the rotation axis of the impeller and being the maximum cross-section of the drive unit, and the orthographic projection of the first pipe segment onto the plane of the first cross-section being located within the first cross-section.

[0011] Optionally, the catheter includes a main body segment and an extension segment connected to the main body segment, the main body segment having a first end face, and the opening being disposed on the first end face;

[0012] The extension segment extends from the first end face along the extension direction of the main body segment, and the other end of the extension segment is the distal end of the catheter;

[0013] Wherein, the maximum outer diameter of the main body segment at the first end face is greater than the outer diameter of the extension segment.

[0014] Optionally, the inner diameter of the sleeve at the distal end corresponding to the first blood port is greater than the outer diameter of the drive unit, so that when the guide wire is inserted through the first blood port and the opening, the maximum distance from the side of the guide wire away from the drive unit to the rotation axis of the impeller is less than or equal to half the outer diameter of the sleeve at the distal end of the first blood port.

[0015] Optionally, the cannula has a tapered section whose outer diameter gradually decreases in the direction close to the drive unit, and the first blood port is at least partially disposed in the tapered section; the maximum outer diameter of the drive unit is less than or equal to the minimum outer diameter of the tapered section.

[0016] Alternatively, the inner diameter of the cannula at the distal end of the first blood port is greater than the outer diameter of the cannula at the proximal end of the first blood port, and the maximum outer diameter of the drive unit is less than or equal to the minimum outer diameter of the cannula at the proximal end of the first blood port.

[0017] Optionally, the maximum distance between the edge of the opening and the axis of rotation of the impeller is less than half of the maximum outer diameter of the drive unit.

[0018] Optionally, the catheter has a first end face, the first end face having a beveled portion inclined relative to the length direction of the catheter, and the opening is disposed on the beveled portion;

[0019] Wherein, the distance between the inclined surface and the axis of rotation of the impeller gradually decreases from the proximal end to the distal end; or, the entire first end face is perpendicular to the axis of rotation of the impeller.

[0020] Optionally, the guidewire channel includes a first section and a second section that are arranged along the length of the catheter and connected in sequence;

[0021] The opening is located in the first hole section, and the central axis of the first hole section is parallel to or coincides with the rotation axis of the impeller;

[0022] In the direction from the proximal end to the distal end, the distance between the central axis of the second bore segment and the rotation axis of the impeller gradually increases.

[0023] Optionally, the cross-section of the catheter is teardrop-shaped and includes a main body with a larger diameter and a side portion with a smaller diameter. The main body is provided with a supply channel for the supply line to pass through, and the side portion is provided with the guide wire channel. The cross-section is perpendicular to the length direction of the catheter.

[0024] Optionally, the catheter can pass through the superior vena cava, and the catheter includes a first arc-shaped segment, a second arc-shaped segment, and a third arc-shaped segment connected in sequence, the first arc-shaped segment connecting the proximal end and the third arc-shaped segment connecting the distal end;

[0025] The curvature of the second arc segment is greater than the curvature of the first arc segment and greater than the curvature of the third arc segment.

[0026] Optionally, the central axis of the first arc segment, the central axis of the second arc segment, and the central axis of the third arc segment are not coplanar.

[0027] Optionally, the ventricular assist device further includes a hemostatic valve for sealing the opening, the hemostatic valve including a second surface and a third surface disposed opposite to each other, and a slit penetrating the second surface and the third surface;

[0028] The incision has an initial state in which the hemostatic valve forms a seal at the incision.

[0029] The slit also has a through-hole state through which the guide wire passes, and in the through-hole state, the hemostatic valve grips and seals the guide wire.

[0030] Optionally, the hemostatic valve is located within the guide wire channel, and the second surface faces the opening; the second surface is provided with a groove, and the slit penetrates the bottom of the groove.

[0031] Optionally, the first blood port is a blood inlet located in the right ventricle, and the second blood port is a blood outlet located in the pulmonary artery. The drive unit can drive the impeller to rotate so that blood is pumped from the blood inlet to the blood outlet.

[0032] Optionally, the drive unit is connected to one end of the sleeve having the first blood port, and the impeller is disposed between the first blood port and the second blood port, and adjacent to the first blood port.

[0033] Optionally, the first blood port has a first aperture edge disposed closest to the side of the second blood port, and the leading edge of the impeller blade is located between the first aperture edge and the second blood port.

[0034] Optionally, the impeller includes a hub and blades arranged in a spiral on the hub. Along the liquid flow direction, the placement angle of the blades first increases and then decreases, and the inlet placement angle of the blades is greater than the outlet placement angle of the blades. The maximum placement angle of the blades is located near the leading edge of the blades.

[0035] Optionally, the inlet angle of the blade is greater than or equal to 120° and less than or equal to 150°; and / or,

[0036] The exit angle of the blade is greater than or equal to 80° and less than or equal to 110°.

[0037] Optionally, the impeller includes a hub and blades spirally arranged on the hub, wherein the length of the hub is greater than or equal to 6 mm and less than or equal to 8 mm; and / or,

[0038] The maximum outer diameter of the impeller is greater than or equal to 5 mm and less than or equal to 7 mm.

[0039] Optionally, the impeller includes a hub and blades arranged in a spiral shape on the hub, wherein the height of the blades is greater than or equal to 4.5 mm and less than or equal to 6 mm; and the wrap angle of the blades is greater than or equal to 150° and less than or equal to 180°.

[0040] The technical solution of this application, when the guidewire is inserted into the guidewire channel within the catheter, allows the guidewire to play a shaping role, for example, straightening the shape of the catheter and facilitating its delivery into the patient's body. Therefore, the entire ventricular assist device can be more easily delivered to the designated location within the patient's body under the guidance of the guidewire. Furthermore, during guidewire insertion, the guidewire exits the cannula through the first blood port, then enters the guidewire channel through the opening, and finally exits from the proximal end of the catheter. The opening facilitates guidewire insertion, allowing the guidewire to cross from the cannula to the catheter. The guidewire can be inserted into both the cannula and the catheter simultaneously, jointly guiding their delivery. Moreover, compared to the traditional method of simply inserting the guidewire through the cannula, the technical solution of this application adds a guidewire channel within the catheter, increasing the guidewire's extension length within the entire ventricular assist device. This not only guides the cannula but also the catheter, thus facilitating the delivery of the ventricular assist device and reducing the difficulty of delivering it into the body. Attached Figure Description

[0041] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0042] Figure 1 This is a schematic diagram of the ventricular assist device in conjunction with the right heart in an embodiment of this application;

[0043] Figure 2This is a schematic diagram of the structure of a ventricular assist device according to an embodiment of this application;

[0044] Figure 3 for Figure 2 A structural schematic diagram of the central chamber auxiliary device from another angle;

[0045] Figure 4 This is a schematic diagram of another ventricular assist device in the embodiments of this application;

[0046] Figure 5 for Figure 4 A partial cross-sectional view of the central chamber auxiliary device;

[0047] Figure 6 for Figure 5 Enlarged view of point A in the middle;

[0048] Figure 7a This is a schematic diagram of the orthographic projection of the first pipe segment on the plane containing the first cross-section in an embodiment of this application;

[0049] Figure 7b This is a schematic diagram of the orthographic projection of the first pipe segment on the plane containing the first cross-section in another embodiment of this application;

[0050] Figure 7c This is a schematic diagram of the orthographic projection of the first pipe segment on the plane containing the first cross-section in another embodiment of this application;

[0051] Figure 7d This is a partial structural schematic diagram of a ventricular assist device according to an embodiment of this application;

[0052] Figure 7e for Figure 7d Schematic diagram of the cross section at the middle EE;

[0053] Figure 7f This is a partial structural schematic diagram of another ventricular assist device in the embodiments of this application;

[0054] Figure 7g This is a partial structural schematic diagram of another ventricular assist device in the embodiments of this application;

[0055] Figure 7h This is a partial structural diagram of the sleeve in an embodiment of this application;

[0056] Figure 7i This is a partial structural schematic diagram of another ventricular assist device in the embodiments of this application;

[0057] Figure 8a and Figure 8b A comparative diagram showing the opening in different positions;

[0058] Figure 9aThis is a partial cross-sectional schematic diagram of another ventricular assist device in an embodiment of this application;

[0059] Figure 9b for Figure 9a Enlarged view of point B in the middle;

[0060] Figure 10 for Figure 9a Enlarged schematic diagram of the hidden hemostatic valve at point B;

[0061] Figure 11 This is a schematic diagram of another ventricular assist device in the embodiments of this application;

[0062] Figure 12 for Figure 11 A structural schematic diagram of the central chamber auxiliary device from another angle;

[0063] Figure 13 for Figure 12 A structural schematic diagram of the central chamber auxiliary device from another angle;

[0064] Figure 14a for Figure 11 Schematic diagram of the middle conduit;

[0065] Figure 14b for Figure 14a Enlarged view of point C in the middle;

[0066] Figure 15a This is a schematic cross-sectional view of a catheter according to an embodiment of this application;

[0067] Figure 15b This is a schematic cross-sectional view of another type of conduit in an embodiment of this application;

[0068] Figure 16 Figure 8 shows a schematic diagram of the hemostatic valve.

[0069] Figure 17 for Figure 16 A schematic diagram of the hemostasis valve from another angle;

[0070] Figure 18 for Figure 17 Cross-sectional view of the hemostasis valve;

[0071] Figure 19 for Figure 5 Schematic diagram of the middle impeller;

[0072] Figure 20 for Figure 19 A plan view of the intermediate impeller;

[0073] Figure 21 for Figure 20 A plan view of the middle blade;

[0074] Figure 22 for Figure 19 Another schematic diagram of the intermediate impeller;

[0075] Figure 23 This is a schematic diagram of the impeller structure in another embodiment of this application;

[0076] Figure 24 for Figure 23 A plan view of the intermediate impeller;

[0077] Figure 25 for Figure 24 A plan view of the middle blade.

[0078] Figure label:

[0079] label name label name label name 100 Ventricular assist device 342 Second section 421 Past Life 10 casing 343 Third section 422 trailing edge 11 Second proximal end 344 Opening 50 hemostatic valve 12 Second distal end 351 Fourth surface 51 Second surface 13 Second blood port 352 side 52 Third Surface 14 First Blood Port 353 First end face 53 Cutting seam 15 First hole edge 3531 Bevel part 54 groove 16 Maximum outer diameter section 361 First arc segment 55 tank sidewall 17 Gradual pipe section 362 Second arc segment 56 trough bottom 20 drive unit 363 Third arc segment 57 Guide slope 21 stator 364 First straight segment 60 Positioning components 22 Rotor 365 Second straight segment 71 superior vena cava 23 Rotating shaft 371 First Pipe Section 72 Tricuspid valve 24 shell 372 Second section 73 Right ventricle 25 First cross section 381 Main body 74 pulmonary valve 26 constant outer diameter section 382 extension 75 Pulmonary artery 30 catheter 391 Main body 76 Inferior vena cava 31 First proximal end 392 Side 80 guide wire 32 First remote end 40 / 40a impeller 81 First paragraph 33 Supply channels 41 / 41a wheel hub 82 Second paragraph 34 Guide wire channel 42 / 42a blade 83 Third paragraph 341 First section Detailed Implementation

[0080] To make the objectives, technical solutions, and advantages of the embodiments of this application clearer, the technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the embodiments of this application, and not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the protection scope of the embodiments of this application.

[0081] It should be noted that in the description of this application, if the terms "first" or "second" appear, they are only used for the convenience of describing different components or names, and should not be construed as indicating or implying a sequential relationship, relative importance, or implicitly specifying the number of technical features indicated. Therefore, a feature specified with "first" or "second" may explicitly or implicitly include at least one of those features. Furthermore, if the word "and / or" appears throughout the text, it means that it includes three parallel solutions; taking "A and / or B" as an example, it includes solution A, solution B, or a solution that simultaneously satisfies A and B.

[0082] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application.

[0083] In this paper, "proximal end" is defined as the end closer to the operator, and "distal end" is defined as the end farther from the operator.

[0084] like Figure 1As shown, this application embodiment provides a ventricular assist device 100, which can be used as a right ventricular assist device to pump blood from the right ventricle 73 into the pulmonary artery 75, thereby achieving an assist function for the right ventricle 73; of course, the ventricular assist device 100 can also be used as a left ventricular assist device to better pump blood from the left ventricle into the aorta, thereby achieving an assist function for the left ventricle.

[0085] Please refer to the reference. Figures 2 to 6 The ventricular assist device 100 provided in this application embodiment includes: a cannula 10, a drive unit 20, a catheter 30, and an impeller 40. The cannula 10 has a first blood port 14 and a second blood port 13. The catheter 30 has a proximal end and a distal end; for ease of explanation, the proximal end of the catheter 30 is referred to as the first proximal end 31, and the distal end of the catheter 30 as the first distal end 32. One end of the drive unit 20 is connected to the cannula 10, and the other end of the drive unit 20 is connected to the first distal end 32 of the catheter 30. The impeller 40 is disposed within the cannula 10 and connected to the drive unit 20 to allow blood to flow between the first blood port 14 and the second blood port 13 under the drive of the drive unit 20; for example, blood is pumped from the first blood port 14 to the second blood port 13, or blood is pumped from the second blood port 13 to the first blood port 14.

[0086] Specifically, the cannula 10 has a second proximal end 11 and a second distal end 12. The second proximal end 11 is provided with a first blood port 14, and the second distal end 12 is provided with a second blood port 13. The drive unit 20 is connected to the second proximal end 11 of the cannula 10. Of course, in other embodiments, the second proximal end 11 may be provided with a second blood port 13, and the second distal end 12 may be provided with a first blood port 14.

[0087] In some embodiments of this application, such as Figure 1 As shown, taking the ventricular assist device 100 installed in the right heart as an example, the cannula 10 is configured to cross the pulmonary valve 74. The first blood port 14 serves as the blood inlet and is located in the right ventricle 73 or the conus artery. The second blood port 13 serves as the blood outlet and is located in the pulmonary artery 75. Therefore, the impeller 40 can pump blood from the right ventricle 73 to the pulmonary artery 75. Under the action of the impeller 40, the blood is pressurized, thereby better injecting it into the pulmonary artery 75.

[0088] It is understood that in some other embodiments of this application, taking the ventricular assist device 100 located in the left ventricle as an example, the cannula 10 is configured to cross the aortic valve, the first blood port 14 can serve as a blood outlet and is located in the aorta, and the second blood port 13 can serve as a blood inlet and is located in the left ventricle. Therefore, the impeller 40 can pump blood from the left ventricle to the aorta. Under the action of the impeller 40, the blood is pressurized, thereby better injecting it into the aorta.

[0089] To facilitate the delivery of the ventricular assist device 100 into the body, the catheter 30 is further provided with a guidewire channel 34 for the guidewire 80 to pass through. Please refer to the reference. Figure 6 Furthermore, the guidewire channel 34 has an opening 344 adjacent to the first distal end 32, allowing the guidewire 80 to pass through the first blood port 14 and the opening 344, thereby allowing a portion of the guidewire 80 to be received in the cannula 10 and a portion to be received in the guidewire channel 34. In one embodiment, the guidewire 80 can pass through the first blood port 14 and enter the guidewire channel 34 through the opening 344.

[0090] After the guidewire 80 is inserted into the guidewire channel 34 within the catheter 30, the guidewire 80 can play a shaping role, for example, straightening the shape of the catheter 30, making its delivery into the patient's body easier. Therefore, the entire ventricular assist device 100 can be more conveniently delivered to the designated location within the patient's body under the guidance of the guidewire 80. Furthermore, when inserting the guidewire 80, it can exit the cannula 10 from the first blood port 14, then enter the guidewire channel 34 through the opening 344, and finally exit from the proximal end of the catheter 30. The opening 344 facilitates the insertion of the guidewire 80, allowing it to cross from the cannula 10 to the catheter 30. The guidewire 80 can be inserted into both the cannula 10 and the catheter 30 simultaneously, jointly guiding their delivery. Furthermore, compared to the traditional method of simply passing the guidewire 80 through the cannula 10, the technical solution of this application adds a guidewire channel 34 inside the catheter 30, increasing the extension length of the guidewire 80 within the entire ventricular assist device 100. This not only guides the cannula 10 but also the catheter 30, thus facilitating the delivery of the ventricular assist device 100 and reducing the difficulty of delivering the ventricular assist device 100 into the body.

[0091] In some embodiments, the opening 344 is exposed outside the drive unit 20, meaning that the opening 344 is not obstructed by the drive unit 20, nor is it located at the position on the catheter 30 that mates with the drive unit 20; rather, it is directly exposed and can be directly observed from outside the ventricular assist device 10. Because the opening 344 is exposed, when inserting the guidewire 80, the guidewire 80 can more easily pass through the first blood port 14 to exit the cannula 10, then enter the guidewire channel 34 through the opening 344, and finally exit from the first proximal end 31 of the catheter 30. Therefore, the exposure of the opening 344 outside the drive unit 20 facilitates the insertion of the guidewire 80.

[0092] The guidewire channel 34 extends generally along the length of the catheter 30. In some embodiments, the guidewire channel 34 may pass through the first proximal end 31 and the first distal end 32. Alternatively, in some embodiments, the guidewire channel 34 may pass through the first proximal end 31 and a position adjacent to the first distal end 32. Specifically, the catheter 30 is made of shape memory material and is pre-formed, i.e., pre-bent into a corresponding shape. For example, when used as a right ventricular assist device, the catheter 30 is pre-bent into a shape that matches the superior vena cava 71, the right ventricle 73, and the pulmonary artery 75. The guidewire 80 is inserted into the guidewire channel 34, causing the catheter 30 to be straightened. When the ventricular assist device 100 is delivered to a predetermined position, the guidewire 80 is withdrawn from the guidewire channel 34, at which point the catheter 30 returns to its pre-formed bent shape. The guidewire channel 34 provided in the catheter 30 for the guidewire 80 to pass through facilitates the delivery of the ventricular assist device 100.

[0093] Please refer to the reference. Figure 6 The conduit 30 is also provided with a supply channel 33 for a supply line (not shown) to pass through, the supply channel 33 passing through the first proximal end 31 and the first distal end 32. The guidewire channel 34 and the supply channel 33 are arranged in parallel. The supply line includes wires, infusion tubing, etc. The drive unit 20 can be connected to the wires, and the wires supply power to the drive unit 20. Specifically, the drive unit 20 includes a housing 24, a stator 21, a rotor 22 and a rotating shaft 23. The distal end of the housing 24 is connected to the second proximal end 11 of the sleeve 10, and the proximal end of the housing 24 is connected to the first distal end 32 of the conduit 30. The stator 21 and the rotor 22 are disposed inside the housing 24, the rotor 22 is fixed on the rotating shaft 23, and the distal end of the rotating shaft 23 is fixed to the impeller 40. The stator 21 is connected to a wire. When the stator 21 is energized through the wire, a driving magnetic field is generated. The rotor 22 rotates under the drive of the driving magnetic field, and drives the rotating shaft 23 and the impeller 40 to rotate together, thereby pumping blood from the first blood port 14 to the second blood port 13, or pumping blood from the second blood port 13 to the first blood port 14.

[0094] Since providing a guidewire channel 34 on the catheter 30 may increase the radial dimension of the catheter 30 (in this application, the length direction of the catheter 30 is axial, and the length direction perpendicular to the catheter 30 is radial), if the part of the catheter 30 that connects to the drive unit 20 is provided with a larger outer diameter, the catheter 30 protrudes radially on the outer peripheral surface of the drive unit 20, which is equivalent to the catheter 30 forming a stepped surface that protrudes radially on the outer peripheral surface of the drive unit 20. When the ventricular assist device 100 is delivered to the patient and passes through a blood vessel, the drive unit 20 first enters the blood vessel, expanding it to have a smaller diameter. Then, the catheter 30 enters the blood vessel, expanding it to have a larger diameter. During this process, the step surface is always located at the junction of the smaller and larger diameters of the blood vessel, causing the blood vessel wall to be directly compressed along the length of the blood vessel by the step surface. The blood vessel wall is easily scratched and damaged. To avoid damage to the blood vessel wall caused by the step surface, in this application, the maximum radial dimension of the catheter 30 with the guidewire channel 34 is less than or equal to the diameter of the maximum cross-section of the drive unit 20 (typically, the drive unit 20 is approximately cylindrical).

[0095] Please refer to the reference again. Figure 2 In some embodiments of this application, the catheter 30 includes a first tube segment 371, the distal end of which is a first distal end 32, and an opening 344 is disposed in the first tube segment 371. The first tube segment 371 extends approximately along the rotation axis of the impeller 40. The orthographic projection of the first tube segment 371 onto the drive unit 20 is entirely within the drive unit 20. Therefore, the first tube segment 371 does not protrude radially from the outer peripheral surface of the drive unit 20. That is, at least, a portion of the catheter 30 near the drive unit 20 does not protrude radially from the outer peripheral surface of the drive unit 20. Therefore, the adjacent positions of the catheter 30 and the drive unit 20 do not form a stepped surface protruding radially from the outer peripheral surface of the drive unit 20. Thus, the portion of the catheter 30 near the drive unit 20, i.e., the first tube segment 371, will not rub against the blood vessel wall.

[0096] Please refer to the reference. Figure 7a , 7b and Figure 7c Specifically, as mentioned above, the orthographic projection of the first pipe segment 371 onto the drive unit 20 being entirely within the drive unit 20 means that the drive unit 20 has a first cross-section 25, which is perpendicular to the rotation axis S5 of the impeller 40 and is the largest cross-section of the drive unit 20. The orthographic projection of the first pipe segment 371 onto the plane of the first cross-section 25 is located within the first cross-section 25. In the illustrated embodiment, the first cross-section 25 is approximately circular.

[0097] like Figure 7aAs shown, the maximum radial width J of the first pipe segment 371 is less than the diameter of the first cross-section 25, and the central axis of the supply channel 33 located within the first pipe segment 371 coincides with the central axis of the drive unit 20. Furthermore, one side of the orthographic projection of the first pipe segment 371 onto the plane containing the first cross-section 25 is internally tangent to the first cross-section 25 along its maximum width direction. In other embodiments, the central axis of the supply channel 33 located within the first pipe segment 371 may be parallel to and not coincident with the central axis of the drive unit 20.

[0098] like Figure 7b As shown, the maximum radial width J of the first pipe segment 371 is less than the diameter of the first cross-section 25. The orthographic projection of the first pipe segment 371 on the plane of the first cross-section 25 is spaced apart from the outer contour of the first cross-section 25.

[0099] like Figure 7c As shown, the maximum radial width J of the first pipe segment 371 is equal to the diameter of the first cross-section 25. The orthographic projection of the first pipe segment 371 onto the plane of the first cross-section 25 has two opposite sides along the maximum width direction that are internally tangent to the first cross-section 25.

[0100] Of course, in other embodiments, the case where the orthographic projection of the first pipe segment 371 on the plane containing the first cross-section 25 is located within the first cross-section 25 is not limited to the above-described case. Figure 7a , Figure 7b and Figure 7c The three scenarios.

[0101] The drive unit 20 can be cylindrical with a circular cross-section, and its outer diameter can be the same or different at various points. For example, the drive unit 20 has a larger and constant outer diameter in the section near the impeller 40, while the section near the duct 30 is tapered, forming a frustum structure with a smaller outer diameter. That is, the drive unit 20 has a section 26 with a constant outer diameter (e.g., Figure 7d As shown in the diagram, the first pipe segment 371 connects to the frustum-shaped segment of the drive unit 20. In this embodiment, the first cross-section 25 refers to the cross-section at the position of the maximum outer diameter of the drive unit 20. Therefore, the first cross-section 25 is the cross-section of the segment 26 with a constant outer diameter.

[0102] When the drive unit 20 is cylindrical, the central axis of the drive unit 20 coincides with the rotation axis S5 of the impeller 40, and the length direction of the first pipe section 371 is parallel to the central axis of the drive unit 20.

[0103] Please refer to the reference. Figure 4 Furthermore, the conduit 30 also includes a second conduit 372 connected to the first conduit segment 371. Figure 4The catheter is divided by a dashed line, with one side of the dashed line representing the first segment 371 and the other side representing the second segment 372. The proximal end of the second segment 372 is the first proximal end 31; the outer diameter d2 of the second segment 372 is equal to the outer diameter of the proximal end of the first segment 371, and the outer circumferential surface of the second segment 372 is flush with the outer circumferential surface of the first segment 371. Therefore, the entire catheter 30 will not form a radially protruding step surface relative to the drive unit 20, thus avoiding damage to the blood vessel wall caused by the catheter 30. Specifically, the outer diameter of the catheter 30 (as shown in the figure) is... Figure 4 In this context, d2 (as the outer diameter of the conduit 30) is less than or equal to the outer diameter d3 of the drive unit 20. Here, the outer diameter d3 of the drive unit 20 refers to the outer diameter of the housing of the drive unit 20.

[0104] In some embodiments, the conduit 30 adopts a pre-formed bent shape, and the conduit 30 can be straight when the guide wire 80 passes through it. In the straight shape, the central axis of the conduit 30 is parallel to the rotation axis S5 of the impeller 40, and the orthographic projection of the conduit 30 onto the drive unit 20 falls within the drive unit 20. Therefore, the conduit 30 as a whole does not extend radially beyond the drive unit 20.

[0105] Please refer to the reference. Figure 3 In some embodiments, the conduit 30 includes a main body segment 381 and an extension segment 382. One end of the main body segment 381 is a first proximal end 31, and the end of the main body segment 381 away from the first proximal end 31 has a first end face 353, with an opening 344 disposed on the first end face 353. The extension segment 382 extends along the extension direction of the main body segment 381. One end of the extension segment 382 is connected to the end of the main body segment 381 having the first end face 353, and the other end of the extension segment 382 has a fourth surface 351 facing the drive unit 20. In some embodiments, the supply channel 33 may penetrate the fourth surface 351. Please refer to the reference. Figure 4 In this case, the maximum outer diameter d2 of the main body segment 381 at the first end face 353 is greater than the outer diameter d1 of the extension segment 382. Overall, the conduit 30 effectively forms a recessed region T1 in the area corresponding to the smaller outer diameter of the extension segment 382 (e.g., ...). Figure 3 and Figure 6 As shown, this recessed area T1 provides deformation space for the guidewire 80, allowing it to adjust its shape before entering the opening 344, and reducing the height of the guidewire 80 protruding outside the entire catheter 30. In this embodiment, the catheter 30 can have a smaller outer diameter at the location connecting to the drive unit 20 because a guidewire channel 34 is not required; at other locations, the catheter 30 can have a larger outer diameter because both the supply channel 33 and the guidewire channel 34 need to be provided simultaneously.

[0106] Of course, in other embodiments, the opening 344 may also be located on the fourth surface 351. Alternatively, the supply channel 33 may not penetrate the fourth surface 351.

[0107] like Figure 7d As shown, the outer diameter H2 of the sleeve 10 at the distal end of the first blood port 14 is greater than the outer diameter H3 of the drive unit 20, so that when the guide wire 80 is inserted into the first blood port 14 and the opening 344, the maximum distance H6 from the side of the guide wire 80 away from the drive unit 20 to the rotation axis S5 of the impeller 40 is less than or equal to half of the outer diameter H2 of the sleeve 10 at the distal end of the first blood port 14. In this way, the guide wire 80 can be basically close to the outer peripheral wall of the drive unit 20 and extend along the axial direction of the drive unit 20, reducing the height of the guide wire 80 protruding radially outward relative to the sleeve 10.

[0108] In some embodiments, the drive unit 20 includes a constant outer diameter segment 26 (the portion between dashed lines S6 and S8), where the drive unit 20 has its maximum outer diameter H3. The portion of the guidewire 80 located between the first blood port 14 and the constant outer diameter segment 26 of the drive unit 20 is defined as a second segment 82. The second segment 82 is adjacent to the outer peripheral wall of the constant outer diameter segment 26 and extends axially along the drive unit 20.

[0109] In some embodiments, the second segment 82 is adjacent to the outer peripheral wall of the driving unit 20, that is, the second segment 82 is in contact with the outer peripheral wall of the driving unit 20, or the second segment 82 is approximately in contact with the outer peripheral wall of the driving unit 20, with a small gap between them; or, there is a small gap between the end of the second segment 82 near the first blood port 14 and the outer peripheral wall of the driving unit 20, and the end of the second segment 82 near the catheter 30 is in contact with the outer peripheral wall of the driving unit 20.

[0110] It should be noted that the outer diameter H2 at the distal end of the first blood port 14 of the cannula 10 is greater than the outer diameter H3 of the drive unit 20. This means that the outer diameter H2 is greater than the outer diameter of any position of the drive unit 20. Therefore, the outer diameter H3 refers to the maximum outer diameter of the drive unit 20.

[0111] Overall, when compared with the outer diameter H2 of the cannula 10, the drive unit 20 effectively forms a recessed region T2 in the area corresponding to the constant outer diameter segment 26. This recessed region T2 provides clearance for the guidewire 80, allowing it to be positioned close to the outer peripheral wall of the drive unit 20 and reducing the height of the guidewire 80 protruding outside the entire drive unit 20. Therefore, the second segment 82 can fully utilize the characteristic that the outer diameter of the constant outer diameter segment 26 is smaller than the outer diameter of the cannula 10, resulting in a smaller combined diameter of the second segment 82 and the constant outer diameter segment 26, which almost does not exceed the outer diameter H2 of the cannula 10, thus reducing the risk of compression and rupture of the blood vessel wall.

[0112] In this embodiment, the axial direction of the drive unit 20 refers to the direction in which the rotation axis S5 of the impeller 40 extends. Optionally, the central axis of the drive unit 20 coincides with the rotation axis S5 of the impeller 40.

[0113] The guidewire 80 has two sides that are radially spaced along the drive unit 20. The side of the guidewire 80 that is away from the drive unit 20 refers to the side of the guidewire 80 that is furthest from the drive unit 20.

[0114] Please refer to the reference. Figure 7d , Figure 7f and Figure 7g Furthermore, the inner diameter H8 of the sleeve 10 at the distal end corresponding to the first blood port 14 is greater than the outer diameter H3 of the drive unit 20, so that when the guide wire 80 is inserted into the first blood port 14 and the opening 344, the maximum distance H6 from the side of the guide wire 80 away from the drive unit 20 to the rotation axis S5 of the impeller 40 is less than or equal to half of the outer diameter H2 of the sleeve 10 at the distal end of the first blood port 14. Thus, when the guide wire 80 exits from the first blood port 14, the guide wire 80 can essentially conform to the outer peripheral wall of the drive unit 20 and extend along the axial direction of the drive unit 20, reducing the radial outward protrusion of the guide wire 80 relative to the sleeve 10.

[0115] Combination Figure 7g It can be seen that when the inner diameter H8 at the distal end of the first blood port 14 of the cannula 10 is greater than the outer diameter H3 of the drive unit 20, the guide wire 80 can extend out of the first blood port 14 along the inner peripheral wall at the distal end of the first blood port 14 of the cannula 10. The outer diameter H3 of the drive unit 20 is smaller than the inner diameter H8, which means that the outer peripheral wall of the drive unit 20 does not bulge laterally on the inner peripheral wall at the distal end of the first blood port 14 of the cannula 10, so it will not obstruct the guide wire 80. Therefore, when the guide wire 80 reaches the drive unit 20, it does not need to bend along the direction perpendicular to the rotation axis S5 and away from the drive unit 20 to avoid it. Thus, the guide wire 80 can basically be in a straight line and extend along the outer peripheral wall of the drive unit 20.

[0116] Please refer to the reference. Figure 7d and Figure 7e In some embodiments, the maximum distance H4 between the edge of the opening 344 and the rotation axis S5 of the impeller 40 is less than half of the maximum outer diameter H3 of the drive unit 20. Therefore, when the guide wire 80 is inserted into the position of the opening 344, it will not cause the entire guide wire 80 to bulge excessively radially outward between the first blood port 14 and the opening 344 relative to the drive unit 20 and the conduit 30. This ensures that the maximum distance H6 from the side of the guide wire 80 away from the drive unit 20 to the rotation axis S5 of the impeller 40 is less than or equal to half of the outer diameter H2 of the sleeve 10 at the distal end of the first blood port 14.

[0117] Specifically, the maximum outer diameter of the drive unit 20 refers to the outer diameter H3 of the constant outer diameter segment 26.

[0118] In some embodiments, the maximum distance H4 between the edge of the opening 344 and the rotation axis S5 of the impeller 40 is less than half of the maximum outer diameter H3 of the drive unit 20, so that the guide wire 80 is located at the proximal end of the constant outer diameter segment 26 (the proximal end refers to...). Figure 7d The portion between the dashed line S8 (the position corresponding to the position in the diagram) and the opening 344 is arc-shaped, and the highest point K of the arc-shaped portion relative to the rotation axis S5 of the impeller corresponds to the near end of the constant outer diameter section 26.

[0119] The third segment 83, defined below, is the arc-shaped portion of guidewire 80 located between the proximal end of the constant outer diameter segment 26 and the opening 344. Specifically, the third segment 83 is arc-shaped, with a smooth overall deformation, resulting in less compression of the vessel wall upon contact. Furthermore, since the highest point K of the third segment 83 corresponds to the proximal end of the constant outer diameter segment 26, it indicates that the third segment 83 gradually approaches the impeller's rotation axis S5, thus allowing for better guidance and insertion into the opening 344.

[0120] When combined with the recessed area T1 in the above embodiment, the third segment 83 is set to correspond to the recessed area T1, so that the third segment 83 is adjusted in shape at this location and inserted into the opening 344, and the height of the guide wire 80 protruding outside the entire catheter 30 is reduced.

[0121] In the above, the maximum distance H4 between the edge of the opening 344 and the rotation axis S5 of the impeller 40 refers to the vertical distance between the edge of the opening 344 furthest from the rotation axis S5 of the impeller 40 and the rotation axis S5.

[0122] In some embodiments, the inner diameter of the cannula 10 at the distal end of the first blood port 14 is greater than the outer diameter of the cannula 10 at the proximal end of the first blood port 14, and the maximum outer diameter of the drive unit 20 is less than or equal to the minimum outer diameter of the cannula 10 at the proximal end of the first blood port 14. In this case, when the guidewire 80 exits from the first blood port 14, it can extend towards the drive unit 20 in contact with the outer peripheral wall of the cannula 10 at the proximal end of the first blood port 14, thereby reducing the height of the guidewire 80 protruding from the outer peripheral wall of the drive unit 20. Specifically, the outer diameter of the portion of the cannula 10 at the first blood port 14 may gradually decrease along the direction closer to the drive unit 20; or, the outer diameter of the portion of the cannula 10 at the first blood port 14 may first increase and then decrease along the direction closer to the drive unit 20.

[0123] Please refer to the reference. Figure 7hIn some embodiments, the cannula 10 has a tapered section 17, the outer diameter H7 of which gradually decreases towards the drive unit 20. Therefore, the tapered section 17 is tapered, and the first blood port 14 is at least partially located within the tapered section 17. The maximum outer diameter H3 of the drive unit 20 is less than or equal to the minimum outer diameter of the tapered section 17. This creates the aforementioned recessed region T2, facilitating the repositioning of the guidewire 80. Furthermore, when the guidewire 80 exits from the first blood port 14, it also facilitates the guidewire 80's contact with the outer peripheral wall of the drive unit 20 at its maximum outer diameter. In this case, the inner diameter of the tapered section 17 at the distal end of the first blood port 14 can be greater than the outer diameter of the tapered section 17 at the proximal end of the first blood port 14; or, the inner diameter of the tapered section 17 at the distal end of the first blood port 14 can also be less than or equal to the outer diameter of the tapered section 17 at the proximal end of the first blood port 14.

[0124] The first blood inlet 14 is at least partially located in the tapering section 17, including but not limited to the following situations:

[0125] Scenario 1: For example Figure 7h As shown, the distal end of the first blood port 14 extends beyond the distal end of the tapered tube section 17 and is located in the maximum outer diameter section 16 (described in the following embodiments), while the proximal end of the first blood port 14 is located in the tapered tube section 17.

[0126] Scenario 2: The distal end of the first blood port 14 extends beyond the distal end of the gradient tube section 17 and is located in the maximum outer diameter section 16 (described in the following embodiments), and the proximal end of the first blood port 14 extends beyond the proximal end of the gradient tube section 17.

[0127] Scenario 3: The first blood inlet 14 is entirely located in the gradient tube segment 17.

[0128] Furthermore, the cannula 10 may also have a maximum outer diameter section 16, the proximal end of which is connected to the distal end of the tapered section 17. The cannula 10 has a constant outer diameter in the maximum outer diameter section 16, and the outer diameter of the maximum outer diameter section 16 is equal to the maximum outer diameter of the tapered section 17. The second blood port 13 is provided in the maximum outer diameter section 16. Figure 7h In the diagram, the maximum outer diameter section 16 and the tapered section 17 are separated by the dashed line S9. Of course, in other embodiments, the entire sleeve 10 can be the tapered section 17. Alternatively, in other embodiments, such as... Figure 7d As shown, the entire sleeve 10 is the maximum outer diameter section 16, meaning that the outer diameter of the sleeve 10 is consistent everywhere.

[0129] In this embodiment, the opening 344 and the drive unit 20 are spaced apart along the rotation axis S5 of the impeller 40. Therefore, the opening 344 and the first blood port 14 are also spaced apart along the rotation axis S5, so that the portion of the guide wire 80 between the opening 344 and the first blood port 14 has a lower protrusion height relative to the outer peripheral wall of the drive unit 20.

[0130] Specifically, please refer to the reference. Figure 6 The catheter 30 has a fourth surface 351 at the first distal end 32; the catheter 30 also has a first end face 353, and an opening 344 is disposed on the first end face 353, which is disposed away from the first distal end 32 relative to the fourth surface 351. Therefore, the fourth surface 351 and the first end face 353 are spaced apart along the length of the catheter 30. The opening 344 is a certain distance away from the drive unit 20 along the rotation axis S5. Compared to the scheme where the opening 344 is placed on the fourth surface 351 adjacent to the drive unit 20, this is equivalent to making the distance between the opening 344 on the first end face 353 and the first blood port 14 larger. When the guide wire 80 is inserted from the first blood port 14 into the opening 344, the guide wire 80 can have a longer distance to adjust its angle. The deformation of the guide wire 80 between the opening 344 and the first blood port 14 is relatively gentle. The guide wire 80 can extend almost along the outer peripheral surface of the drive unit 20 to form a near-straight shape, which can reduce the degree of the guide wire 80 lifting on the outside of the drive unit 20 and the catheter 30, and reduce the risk of the guide wire 80 squeezing the blood vessel wall. At the same time, when the guide wire 80 is withdrawn, the straight-shaped guide wire 80 can also be withdrawn more smoothly from the first blood port 14, the opening 344 and the guide wire channel 34.

[0131] Specifically, please refer to the reference. Figure 7iThe guidewire 80 has a first segment 81 (the portion between dashed lines S6 and S7) located between the opening 344 and the first blood port 14. The maximum height H5 of the first segment 81 protruding outside the drive unit 20 is less than or equal to 1.5 mm. For example, the maximum height H5 of the first segment 81 protruding outside the drive unit 20 can be 1.5 mm, 1.3 mm, 1.2 mm, 1 mm, etc. It should be noted that the maximum height H5 of the first segment 81 protruding outside the drive unit 20 refers to the distance between the maximum distance between the first segment 81 and the rotation axis S5 in the vertical direction along the rotation axis S5, and the distance between the first segment 81 and the outer peripheral surface of the drive unit 20. By limiting the maximum height H5 of the portion of guidewire 80 located between opening 344 and first blood port 14—that is, the first segment 81—protruding outside the drive unit 20 to within 1.5mm, the distance between opening 344 and first blood port 14 meets this maximum height H5 setting. This prevents the first segment 81 from protruding too much outside the drive unit 20 and catheter 30, which could affect the intravascular delivery of the entire ventricular assist device. Therefore, the guidewire 80 protrudes less outside the drive unit 20, which also facilitates smooth insertion of the guidewire 80 into opening 344.

[0132] Furthermore, to ensure the normal operation of the ventricular assist device 100 and allow for normal blood flow, the gap between the drive unit 20 and the inner wall of the blood vessel (referring to the single-sided gap) must be greater than or equal to 0.4 mm, and the double-sided gap must be greater than or equal to 0.8 mm. This allows the first segment 81 to protrude at least 0.8 mm from the outer side of the drive unit 20. However, if the protrusion is too large, it will cause excessive compression of the blood vessel wall, which may lead to rupture if the pressure exceeds the limit of the blood vessel wall. Therefore, limiting the maximum height H5 of the first segment 81 protruding outside the drive unit 20 to less than or equal to 1.5 mm can avoid the above-mentioned problems.

[0133] When the outer diameter of the cannula 10 is set to be equal to or slightly smaller than the maximum outer diameter of the drive unit 20, the gap between the cannula 10 and the inner wall of the blood vessel (referring to the single-sided gap) will also be greater than or equal to 0.4 mm, thus ensuring the normal flow of blood between the first blood port 14 and the second blood port 13.

[0134] Optionally, the distance L5 between the opening 344 and the drive unit 20 along the rotation axis S5 of the impeller 40 is greater than or equal to 5 mm, so that when the guide wire 80 is inserted through the first blood port 14 and the opening 344, the portion of the guide wire 80 located outside the sleeve 10 and close to the first blood port 14 (i.e., the first segment 81) protruding from the drive unit 20 has a maximum height equal to the sum of its maximum height and the diameter of the drive unit 20, which is less than or equal to the inner diameter of the blood vessel. Specifically, the distance L5 between the opening 344 and the drive unit 20 along the rotation axis S5 of the impeller 40 can be 5 mm, 6 mm, 8 mm, or 10 mm, etc. In this embodiment, the distance L5 between the opening 344 and the driving unit 20 is relatively large, which is equivalent to limiting the recessed area T1 to have a longer distance along the rotation axis S5. When the guide wire 80 is inserted from the first blood port 14 into the opening 344, the guide wire 80 can have a longer distance along the rotation axis S5 to adjust its angle. At the same time, in the direction perpendicular to the rotation axis S5, the recessed area T1 can guide the guide wire 80 to gradually conform to the catheter 30 from the outside to the inside (referring to the direction along the radial direction of the driving unit 20 and close to the rotation axis S5). In this way, the deformation of the guide wire 80 between the opening 344 and the first blood port 14 is relatively gentle, and the guide wire 80 can extend almost along the outer peripheral surface of the driving unit 20 to form a near-straight shape, which can reduce the degree of the guide wire 80 lifting on the outside of the driving unit 20 and the catheter 30, and reduce the risk of the guide wire 80 compressing the blood vessel wall. At the same time, when the guidewire 80 is withdrawn, the straight guidewire 80 can be withdrawn more smoothly from the first blood port 14, the opening 344 and the guidewire channel 34.

[0135] By comparison Figure 8a and 8b It can be seen that, as Figure 8a As shown, when the opening 344 is positioned away from the first blood port 14, the portion of the guide wire 80 located between the opening 344 and the first blood port 14 is relatively flat, approximating a straight line or a small-curvature arc, making it easier to extend from the first blood port 14 into the opening 344. When the opening 344 is positioned close to the first blood port 14, the portion of the guide wire 80 located between the opening 344 and the first blood port 14 requires a larger bend to accommodate the extension from the first blood port 14 into the opening 344. However, when the bend of the guide wire 80 located between the opening 344 and the first blood port 14 is large, it is difficult to align it with the opening 344 and extend it into the guide wire channel 34.

[0136] It should be noted that the distance L5 between the opening 344 and the drive unit 20 refers to the distance between the side of the opening 344 closest to the drive unit 20 and the side of the drive unit 20 closest to the opening 344.

[0137] Figures 11 to 14bAnother ventricular assist device 100 is shown, in which the opening 344 is located near the fourth surface 351.

[0138] In some embodiments, the first pipe segment 371 refers to the second straight segment 365. Figure 12 Since the conduit 30 is not perfectly straight, when the opening 344 is positioned at the bend of the conduit 30, the distribution line of the opening 344 and the first blood port 14 forms a large angle with the rotation axis S5 of the impeller 40. This causes significant deformation of the guide wire 80, making it difficult to align the guide wire 80 with the opening 344 and the first blood port 14, thus hindering its insertion and withdrawal. Therefore, in this embodiment, the opening 344 is positioned on the second straight segment 365, which is parallel to the rotation axis S5 of the impeller 40. Consequently, the distribution line of the opening 344 and the first blood port 14 is essentially parallel to the rotation axis S5 of the impeller 40. This allows the guide wire 80 to pass more easily through the first blood port 14 and the opening 344 in the same direction, reducing the difficulty of inserting and withdrawing the guide wire 80 from the conduit 30.

[0139] Please refer to the reference. Figure 4 , Figure 6 , Figure 9a , Figure 9b In some embodiments, the catheter 30 further has a first end face 353, which has a beveled portion 3531 inclined relative to the length direction of the catheter 30. An opening 344 is disposed on the beveled portion 3531, which is inclined relative to the rotation axis S5 of the impeller 40. The distance between the beveled portion 3531 and the rotation axis S5 gradually decreases from the proximal end to the distal end. When the catheter 30 is pushed into the blood vessel, the inclined portion 3531 acts as a guide. A portion of the force exerted by the beveled portion 3531 on the blood vessel wall is along the radial direction of the blood vessel, pushing inward while gradually expanding the blood vessel wall, rather than directly squeezing the blood vessel wall along the length direction of the blood vessel. Therefore, the risk of the blood vessel wall being ruptured can be reduced. Optionally, the catheter 30 also has a side 352 extending along the length direction of the catheter 30. The beveled portion 3531 is connected to the side 352, and the connection between the beveled portion 3531 and the side 352 is rounded to form a smooth transition connection, avoiding scratching the blood vessel wall.

[0140] like Figure 4 and Figure 6 As shown, the first end face 353 and the fourth surface 351 are two different surfaces and are spaced apart. A portion of the first end face 353 (referring to the portion that overlaps with the extension section 382) is parallel to the fourth surface 351, and the supply channel 33 is provided through this portion. In addition, the first end face 353 also has a beveled portion 3531, and the guide wire channel 34 passes through the beveled portion 3531.

[0141] like Figure 14b As shown, the first end face 353 refers to the fourth surface 351. Based on this, the first end face 353 also has a beveled portion 3531. The supply channel 33 passes through the area of ​​the first end face 353 excluding the beveled portion 3531.

[0142] Of course, in other embodiments, such as Figure 3 As shown, the entire first end face 353 is perpendicular to the rotation axis S5, and the entire first end face 353 can also be a surface parallel to the fourth surface 351. In some embodiments, the rotation axis S5 coincides with the central axis S4 of the supply channel 33 located at the first distal end 32.

[0143] Please refer to the reference. Figure 9b and Figure 10 In some embodiments, the guide wire channel 34 includes a first segment 341, a second segment 342, and a third segment 343 arranged along its length and interconnected, the first segment 341 having an opening 344. Optionally, the first segment 341 and the second segment 342 are arranged at an angle. Specifically, the central axis S1 of the first segment 341 is generally parallel to the central axis S4 of the supply channel 33 located at the first distal end 32, and the central axis S1 of the first segment 341 is also generally parallel to the rotation axis S5 of the impeller 40. From the proximal end to the distal end, the distance between the central axis S2 of the second segment 342 and the central axis S4 of the supply channel 33 located at the first distal end 32 gradually increases, and the distance between the second segment 342 and the rotation axis S5 of the impeller 40 also gradually increases. The third segment 343 is arranged parallel to the supply channel 33.

[0144] When the guide wire 80 is inserted into the guide tube 30, since the guide wire 80 is corrected to be basically straight and is generally parallel to the rotation axis S5 of the impeller 40, the guide wire 80 can be directly inserted into the first hole section 341, which is basically parallel to the rotation axis S5 of the impeller 40, without needing to undergo significant bending. Then, the inclined second hole section 342 slowly guides the guide wire 80 towards the supply channel 33, allowing the guide wire 80 to enter the third hole section 343.

[0145] The catheter 30 has a larger outer diameter at the position corresponding to the first port segment 341, thus allowing the opening 344 of the first port segment 341 to nearly coincide with the first blood port 14 in the axial direction of the drive unit, resulting in minimal deformation of the guidewire 80 between the opening 344 and the first blood port 14. The outer diameter of the catheter 30 at the position corresponding to the second port segment 342 gradually decreases from proximal to distal, creating a smooth transition in the second port segment 342. The catheter 30 has a smaller outer diameter at the position corresponding to the third port segment 343, ensuring that most of the outer diameter of the catheter 30 is small, preventing excessive compression of the blood vessel.

[0146] In the above, "parallel" refers to being parallel or nearly parallel. In some embodiments, "parallel" also includes the case of overlap, for example, the central axis S1 of the first bore section 341 coincides with the rotation axis S5 of the impeller 40. Furthermore, the direction from proximal to distal mentioned herein refers to... Figure 10 The first direction in the middle.

[0147] In this embodiment, the cross-sectional shape of the catheter 30 can be circular or non-circular. For non-circular shapes, it can be elliptical, teardrop-shaped, or waist-shaped. Optionally, the outer contour of the catheter 30's cross-section is a smoothly transitioning annular line, thus avoiding sharp apex angles and preventing damage to the blood vessel wall. It should be noted that the cross-section is perpendicular to the length direction of the catheter 30.

[0148] Please refer to the reference. Figure 15a and Figure 15b In some embodiments, the conduit 30 has a teardrop-shaped cross-section and includes a larger diameter main body 391 and a smaller diameter side portion 392. The main body 391 is provided with a supply channel 33 for the supply line to pass through, and the side portion 392 is provided with a guide wire channel 34. Figure 15a The dashed line in the diagram serves as a dividing line, with the main body 391 on one side and the side portion 392 on the other. On one hand, compared to a circular cross-section, the diameter of the circular cross-section must be equal to the maximum size of the teardrop-shaped cross-section to simultaneously accommodate the supply channel 33 and the guidewire channel 34. However, the area of ​​the circular cross-section is much larger than that of the teardrop-shaped cross-section, resulting in a much larger volume of the catheter 30 with the circular cross-section compared to the teardrop-shaped cross-section. This excessive compression of the blood vessel wall could easily lead to rupture. On the other hand, when the catheter 30 is delivered into the body, it needs to bend to some extent to adapt to the vascular structure. However, due to the regular shape and greater thickness of the circular cross-section catheter 30, deformation is more difficult. In contrast, the teardrop-shaped cross-section catheter 30 has a smaller diameter at the side portion 392 compared to the circular cross-section, effectively thinning a portion of the cross-section and reducing the difficulty of deformation. Furthermore, compared to the circular cross-section, a concave portion is formed between the main body 391 and the side portion 392, providing space for deformation. Therefore, the teardrop-shaped cross-section of the catheter 30 allows for easier deformation, reducing the difficulty of delivery into the body. Furthermore, the larger diameter main body 391 can be provided with a supply channel 33 with a larger inner diameter to allow wires, infusion tubes, and other filaments to pass through, meeting the needs of the supply line; while the smaller diameter side part 392 only needs to be provided with a guidewire channel 34 with a smaller inner diameter. Therefore, the placement of the different channels can be arranged reasonably according to their inner diameters, making better use of the shape of the catheter 30.

[0149] Specifically, in the teardrop-shaped cross-section, the main body 391 and the side 392 are smoothly connected. For example, the outer contour of the cross-section of the conduit 30 can be approximated as including a semicircle with a larger diameter, a semicircle with a smaller diameter, and a cone connecting the two semicircles. The cone is tangent to the two semicircles respectively, thus forming a smooth contour.

[0150] The cross-sectional shapes of the supply channel 33 and the guide wire channel 34 can be circular, semi-circular, elliptical, etc., and this application embodiment does not impose any limitations on this. Figure 15a As shown, the cross-sectional shape of both the supply channel 33 and the guide wire channel 34 is circular; Figure 15b As shown, the cross-sectional shape of the supply channel 33 is approximately larger than a semicircle and smaller than a circle.

[0151] Please refer to the reference. Figure 9b , Figures 16 to 18 To prevent blood from flowing out of the ventricular assist device 100 after the guidewire channel 34 is provided, the ventricular assist device 100 further includes a hemostatic valve 50 that seals the opening 344. The hemostatic valve 50 prevents blood from entering the guidewire channel 34 through the opening 344. The hemostatic valve 50 includes a second surface 51 and a third surface 52 disposed opposite to each other, and a slit 53 penetrating the second surface 51 and the third surface 52, through which the guidewire 80 can pass. Specifically, when no object such as the guidewire 80 is inserted at the slit 53, the slit 53 is in its initial state, and the opposing walls of the slit 53 are in contact with each other, forming a seal, preventing liquids such as blood from flowing through the slit 53; at the same time, the hemostatic valve 50 is in sealed contact with the walls of the guidewire channel 34 on all sides, thereby sealing the opening 344. When it is necessary to insert the guide wire 80, the guide wire 80 squeezes the hemostatic valve 50 and expands the incision 53 before being inserted. The hemostatic valve 50 always tightly holds and adheres to the guide wire 80 at the incision 53, forming a seal to prevent blood from passing through the connection between the guide wire 80 and the hemostatic valve 50. At this time, the incision 53 is in a penetrating state.

[0152] The hemostatic valve 50 is an elastic sealing element, such as a silicone pad. Specifically, the hemostatic valve 50 can be a liquid silicone pad.

[0153] In this embodiment, the hemostatic valve 50, through its own deformation, is squeezed into the guide wire channel 34 to seal against the orifice wall of the guide wire channel 34. To improve the connection stability between the hemostatic valve 50 and the catheter 30, the hemostatic valve 50 can be completely housed within the guide wire channel 34. Thus, the entire side 352 of the hemostatic valve 50 contacts the orifice wall of the guide wire channel 34, providing a larger contact area. The hemostatic valve 50 can then be more tightly held in place by the orifice wall of the second through hole.

[0154] Furthermore, the length of the hemostatic valve 50 along the direction of the opening 344 can be set to be relatively long, and the hemostatic valve 50 is generally elongated, which can also make the hemostatic valve 50 have a large contact area with the wall of the guide wire channel 34.

[0155] When the hemostatic valve 50 is located within the guide wire channel 34, the second surface 51 of the hemostatic valve 50 faces the opening 344, while the third surface 52 faces away from the opening 344. Further, the second surface 51 is provided with a groove 54, and a slit 53 penetrates the bottom 56 of the groove 54. This configuration allows the hemostatic valve 50 to have a larger length, increasing the contact area with the wall of the guide wire channel 34, thus securing the hemostatic valve 50 more firmly within the guide wire channel 34. It also prevents the slit 53 from having an excessively deep penetration, which would require excessive force for the guide wire 80 to penetrate the slit 53. Optionally, when the groove 54 is provided, the thickness B2 of the groove sidewall 55 is approximately equal to the thickness B1 of the groove bottom 56.

[0156] The shape of the slit 53 can be cross-shaped, straight, spiral, etc.

[0157] To facilitate the assembly of the hemostatic valve 50 with the guide wire channel 34, in some embodiments, the end of the hemostatic valve 50 near the third surface 52 is tapered, thereby forming a guide slope 57 at the end of the hemostatic valve 50 near the third surface 52 to guide it when inserted into the guide wire channel 34.

[0158] In some embodiments, a portion of the hemostatic valve 50 is located within the first orifice 341, and another portion of the hemostatic valve 50 is located within the second orifice 342. Therefore, when the hemostatic valve 50 is assembled into the guide wire channel 34, it will undergo a certain deformation at the connection between the first orifice 341 and the second orifice 342 to accommodate the change in angle between the first orifice 341 and the second orifice 342, thereby further securing the hemostatic valve 50 at the connection between the first orifice 341 and the second orifice 342.

[0159] The following embodiments are specifically illustrated using the example of the ventricular assist device 100 being installed in the right ventricle.

[0160] Please refer to the reference again. Figures 11 to 13Furthermore, the catheter 30 includes a first arc-shaped segment 361, a second arc-shaped segment 362, and a third arc-shaped segment 363, which are sequentially arranged and connected from proximal to distal. The curvature of the second arc-shaped segment 362 is greater than that of the first arc-shaped segment 361 and also greater than that of the third arc-shaped segment 363. Therefore, the curvature of the middle second arc-shaped segment 362 is relatively large, which can basically realize the bending and turning of the catheter 30 from the tricuspid valve 72 to the pulmonary valve 74. The curvature of the proximal first arc-shaped segment 361 and the distal third arc-shaped segment 363 is relatively small. The first arc-shaped segment 361 can realize a small angle change of the catheter 30 from the superior vena cava 71 to the tricuspid valve 72, and the third arc-shaped segment 363 can further adjust the angle of the catheter 30 from the second arc-shaped segment 362 to the pulmonary valve 74, avoiding excessive bending of the second arc-shaped segment 362. By employing three arc-shaped segments, the catheter 30 only needs to be bent three times to adapt to the shape of the superior vena cava 71, right ventricle 73, and pulmonary artery 75. The overall number of bends of the catheter 30 is small, which facilitates the shaping of the catheter 30 and also makes it easier to deliver the catheter 30 to the designated location in the body.

[0161] Furthermore, the catheter 30 includes a first straight segment 364 and a second straight segment 365. The distal end of the first straight segment 364 is connected to the proximal end of the first arcuate segment 361, the proximal end of the second straight segment 365 is connected to the distal end of the third arcuate segment 363, and the distal end of the second straight segment 365 is connected to the drive unit 20.

[0162] In some embodiments, the central axes of the first arc segment 361, the second arc segment 362, and the third arc segment 363 are not coplanar. Therefore, the central axis of the entire catheter 30 is not entirely located in the same plane, but is adjusted to lie in multiple different planes according to the shape of the superior vena cava 71, the right heart, and the pulmonary artery 75, and also according to the delivery situation. It should be noted that the central axis mentioned in this embodiment refers to the axis extending along the length of the catheter 30.

[0163] Since the drive unit 20 is located between the second proximal end 11 of the cannula 10 and the first distal end 32 of the catheter 30, and the second proximal end 11 of the cannula 10 is provided with a first blood port 14, which is located in the right ventricle 73 or the conus artery, it is equivalent to the drive unit 20 being located in the right ventricle 73 or the conus artery. Of course, the drive unit 20 can also be located in the right atrium without entering the pulmonary artery 75.

[0164] Furthermore, in this embodiment, the impeller 40 is disposed adjacent to the first blood port 14, that is, the distance between the impeller 40 and the first blood port 14 is less than the distance between the impeller 40 and the second blood port 13. Optionally, the impeller 40 is configured to be disposed within the right ventricle 73 or the conus artery.

[0165] In this embodiment, since the impeller 40 is located near the first blood port 14 of the second proximal end 11 of the sleeve 10, and the drive unit 20 is located at the second proximal end 11 of the sleeve 10, the axial distance between the impeller 40 and the drive unit 20 is relatively short. The rotational driving force transmitted from the drive unit 20 to the impeller 40 is less affected by external interference, so the loss is smaller, and the driving force is relatively more stable. Therefore, the impeller 40 rotates more smoothly, which can greatly reduce the risk of collision between the impeller 40 and the inner wall of the sleeve 10.

[0166] If the drive unit 20 is placed inside the pulmonary artery 75, it means that the portion of the entire ventricular assist device 100 within the pulmonary artery 75 will be relatively long. When the ventricular assist device 100 is delivered from the right ventricle 73 to the pulmonary artery 75, the ventricular assist device 100 needs to extend a longer portion into the pulmonary artery 75, which can easily cause interference and collision with the vessel wall of the pulmonary artery 75. At the same time, the drive unit 20 is relatively rigid and not easily bent, which further exacerbates the interference between the ventricular assist device 100 and the vessel wall of the pulmonary artery 75, potentially causing significant compression and damage to the vessel wall. Furthermore, if the drive unit 20 is placed inside the pulmonary artery 75, it occupies a large volume within the pulmonary artery 75, potentially obstructing the pulmonary artery 75 and hindering blood flow.

[0167] However, in this embodiment, since the driving unit 20 is located in the right ventricle 73 or right atrium, it makes full use of the relatively large space of the right ventricle 73 or right atrium, thus avoiding collision and interference with the blood vessel wall and ventricular wall, and also avoiding obstruction of blood flow in the pulmonary artery 75.

[0168] Furthermore, the catheter 30 is configured to pass through the superior vena cava 71. Since the blood outlet of the superior vena cava 71 directly faces the tricuspid valve 72, meaning the line connecting the superior vena cava 71, tricuspid valve 72, and right ventricle 73 is essentially a straight line, a slightly bent line, or a slightly curved line, the catheter 30 passes through the superior vena cava 71, tricuspid valve 72, and reaches the right ventricle 73 with minimal or no bending. Blood flows almost directly along the catheter 30, and its presence hardly obstructs blood flow. It should be noted that in this embodiment, the phrase "the catheter 30 reaches the right ventricle 73" refers to the point where the catheter 30 extends into the right ventricle 73, and does not refer to a section of the catheter 30 bending within the right ventricle 73 to connect to the drive unit 20.

[0169] If the catheter 30 is passed through the inferior vena cava 76, since the direction of the blood outflow outlet of the inferior vena cava 76 and the tricuspid valve 72 form a large angle, the catheter 30 needs to make a large bend when passing through the tricuspid valve 72 from the inferior vena cava 76. The bend area is located in the right atrium, and the bend area will greatly obstruct the blood flowing out of the inferior vena cava 76, resulting in poor blood flow.

[0170] Please refer to the reference. Figures 19 to 21 The impeller 40 includes a hub 41 and blades 42. The blades 42 are spirally arranged around the hub 41. Along the liquid flow direction, the placement angle of the blades 42 first increases and then decreases, and the inlet placement angle α11 of the blades 42 is greater than the outlet placement angle α22 of the blades 42. The maximum placement angle α5 of the blades 42 is located near the leading edge 421 of the blades 42. This arrangement helps to increase the radial liquid flow velocity at the outlet of the blades 42 and improve the hydraulic performance of the ventricular assist device 100. The placement angle of the blades 42 refers to the angle between the outer edge of the blades 42 and the plane perpendicular to the axis of the impeller 40.

[0171] In this embodiment, the placement angle of the blade 42 generally shows a trend of first increasing and then decreasing, indicating that the blade 42 has a large degree of curvature. Therefore, when the impeller 40 is short, the length of the flow channel formed between the blades 42 is long, which not only ensures the hydraulic performance, but also avoids the impeller 40 from being too long.

[0172] In some embodiments, the inlet angle α1 of the blade 42 is greater than or equal to 120° and less than or equal to 150°, and the outlet angle α2 of the blade 42 is greater than or equal to 80° and less than or equal to 110°. Specifically, the inlet angle α1 of the blade 42 can be 120°, 130°, 135°, 142°, 150°, etc., and the outlet angle α2 of the blade 42 can be 80°, 90°, 95°, 102°, 110°, etc., as long as the inlet angle α1 of the blade 42 is greater than the outlet angle α2 of the blade 42, it is beneficial to increase the radial flow velocity at the outlet of the blade 42 and improve the hydraulic performance of the ventricular assist device 100.

[0173] The following details two different impeller shapes, 40. Figures 19 to 22 The impeller 40 with a round head is shown in the figure. Figures 23 to 25 The diagram shows a pointed impeller 40a. Some specific parameters of the round-headed impeller 40 and the pointed impeller 40a can be set differently. For example, the inlet angle α1 of the round-headed blade 42 is 138°, and the outlet angle α2 of the blade 42 is 94°. The inlet angle α3 of the pointed blade 42a is 130°, and the outlet angle α4 of the blade 42a is 93°. Of course, in other embodiments, impellers 40 with different hubs 41 can have essentially the same relevant parameters.

[0174] The ventricular assist device 100 in this embodiment can be a round-headed impeller 40 or a pointed impeller 40a. For the round-headed impeller 40, the distal end surface 351 of its hub 41 is spherical. Specifically, the distal end of the hub 41 is set as a hemisphere, and the outer diameter of the hub 41 gradually increases from near to far (referring to the direction of blood flow), reaching its maximum at the hemisphere position, and then gradually decreasing.

[0175] For the pointed impeller 40a, the outer diameter of its hub 41a gradually decreases from near to far until a tip is formed at the far end of the hub 41a, where the outer diameter is close to 0.

[0176] When a pointed impeller 40a is selected, the outer diameter of the hub 41a gradually decreases along the blood flow direction. Therefore, the volume of the flow channel formed between the hub 41a and the impeller 40a gradually increases, which is conducive to rapid liquid flow and results in better hydraulic performance. Of course, in other embodiments, the hub of the pointed impeller can also gradually increase along the liquid flow direction.

[0177] Optionally, the hub 41 is provided with two blades 42. Of course, in other embodiments, the hub 41 may also be provided with more blades 42.

[0178] In some embodiments, the length L2 of the hub 41 is greater than or equal to 6 mm and less than or equal to 8 mm; the maximum outer diameter D3 of the impeller 40 is greater than or equal to 5 mm and less than or equal to 7 mm. When a ventricular assist device is installed in the right ventricle, the orifice of the superior vena cava 71 and the space in the right ventricle are relatively large, so the outer diameter of the impeller 40 can be set to be larger, while the length of the impeller 40 can be set to be smaller to ensure performance and good pumping effect. Specifically, the length L2 of the hub 41 can be set to 6 mm, 6.5 mm, 7.2 mm, 8 mm, etc.; the maximum outer diameter D3 of the impeller 40 can be set to 5 mm, 5.5 mm, 6 mm, 7 mm, etc.

[0179] In some specific embodiments, the length L2 of the round-headed impeller 40 (which also refers to the length of the hub 41) can be set to 7.25 mm, the maximum diameter D3 of the impeller 40 is 5.8 mm, the minimum diameter D1 near the end of the hub 41 is 1.8 mm, and the maximum diameter D2 of the hub 41 is 3.2 mm; the length L4 of the pointed impeller 40a is 6.5 mm, the maximum diameter D5 of the impeller 40a is 6.0 mm, and the maximum diameter D4 of the hub 41a is 2.2 mm.

[0180] In some embodiments, the length L1 of the blade 42 is greater than or equal to 4.5 mm and less than or equal to 6 mm. Specifically, the length L1 of the blade 42 can be set to 4.5 mm, 5 mm, 5.3 mm, 6 mm, etc. Optionally, the length L1 of the round-tipped blade 42 is set to 5.1 mm, and the length L3 of the pointed blade 42a is set to 4.8 mm. The length L1 of the blade 42 refers to the straight-line distance between the leading edge 421 and the trailing edge 422 of the blade 42 along the axis of the impeller 40.

[0181] In some embodiments, the wrap angle β of the blade 42 is greater than or equal to 150° and less than or equal to 180°. Specifically, the wrap angle β of the blade 42 can be set to 150°, 160°, 170°, 180°, etc. Optionally, the wrap angle β of the round-tipped blade 42 is around 173°, and the wrap angle of the pointed blade 42a is around 160°. The wrap angle β of the blade 42 is defined as the angle between the line connecting the inlet edge (i.e., leading edge 421) of the blade 42 and the center of the circle and the line connecting the outlet edge (i.e., trailing edge 422) of the blade 42 and the center of the circle. This design ensures high hydraulic efficiency. Empirical tests show that when the wrap angle β of the blade 42 is too small, the impeller 40 does insufficient work and has low efficiency; that is, under the conditions of set speed and size, the impeller 40 cannot output the required energy. Conversely, when the wrap angle β of the blade 42 is too large, the blade 42 obstructs the flow channel, resulting in decreased efficiency.

[0182] In this embodiment, the wrap angle β of the blade 42 is set between 150° and 180°, and the length of the blade 42 is also set between 4.5mm and 6mm. This indicates that the blade 42 is relatively short, has a large degree of curvature, and is severely twisted. Therefore, the structure is more compact. While satisfying good hydraulic performance, it can make the impeller 40 have a smaller length, reducing excessive occupation of the right ventricle 73 in the length direction.

[0183] Please refer to the reference again. Figure 2 and Figure 9a The first blood port 14 has a first aperture 15 located closest to the second blood port 13. The leading edge 421 of the blade 42 is located between the first aperture 15 and the second blood port 13. The leading edge 421 of the blade 42 can be flush with the first aperture 15, or there can be a certain distance between the leading edge 421 of the blade 42 and the first aperture 15. Therefore, the blade 42 will not be exposed at the first blood port 14, and will not cause blood to be thrown out of the first blood port 14. This ensures that the blood, driven by the impeller 40, enters the sleeve 10 entirely from the first blood port 14.

[0184] Furthermore, the second distal end 12 of the cannula 10 is also provided with a positioning component 60. This positioning component 60 can be a pigtail cannula or other positioning structures. The positioning component 60 can abut against the wall of the pulmonary artery 75 to position the ventricular assist device 100 in a designated location. When the guidewire 80 is installed, the guidewire 80 passes through the positioning component 60.

[0185] The following describes one method of threading the guidewire 80, but it is not limited to this:

[0186] First, the guidewire 80 is inserted into the cannula 10 through the positioning component 60 in the form of a pigtail tube, and then it is inserted out of the cannula 10 through the first blood port 14. Next, the guidewire 80 is inserted into the guidewire channel 34 through the opening 344, and finally it is inserted out from the end of the guidewire channel 34 away from the opening 344.

[0187] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the embodiments of this application, and are not intended to limit them; although the embodiments of this application have been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the foregoing embodiments, or make equivalent substitutions for some of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of this application.

Claims

1. A ventricular assist device, characterized in that, include: The cannula is provided with a first blood port and a second blood port; The impeller is located inside the sleeve; A drive unit is connected to one end of the sleeve. The drive unit can also drive the impeller to rotate so that blood flows between the first blood port and the second blood port. as well as, The catheter has a proximal end and a distal end, the distal end being connected to the end of the drive unit that is away from the cannula. The catheter is provided with a guidewire channel, the guidewire channel having an opening adjacent to the distal end, so that the guidewire can be inserted through the first blood port and the opening, and the guidewire is partially received in the cannula and partially received in the guidewire channel. The guidewire channel includes a first hole segment and a second hole segment that are arranged along the length direction of the catheter and connected in sequence. The opening is located in the first hole section, and the central axis of the first hole section is parallel to or coincides with the rotation axis of the impeller; In the direction from the proximal end to the distal end, the distance between the central axis of the second bore segment and the rotation axis of the impeller gradually increases.

2. The ventricular assist device according to claim 1, characterized in that, The conduit includes a first pipe segment having the distal end, the opening being disposed in the first pipe segment, the drive unit having a first cross-section, the first cross-section being perpendicular to the rotation axis of the impeller and being the maximum cross-section of the drive unit, and the orthographic projection of the first pipe segment onto the plane of the first cross-section being located within the first cross-section.

3. The ventricular assist device according to claim 1, characterized in that, The catheter includes a main segment and an extension segment connected to the main segment, the main segment having a first end face, and the opening being disposed on the first end face; The extension segment extends from the first end face along the extension direction of the main body segment, and the other end of the extension segment is the distal end of the catheter; Wherein, the maximum outer diameter of the main body segment at the first end face is greater than the outer diameter of the extension segment.

4. The ventricular assist device according to claim 1, characterized in that, The inner diameter of the sleeve at the distal end corresponding to the first blood port is greater than the outer diameter of the drive unit, so that when the guide wire is inserted through the first blood port and the opening, the maximum distance from the side of the guide wire away from the drive unit to the rotation axis of the impeller is less than or equal to half the outer diameter of the sleeve at the distal end of the first blood port.

5. The ventricular assist device according to claim 4, characterized in that, The cannula has a tapered section, the outer diameter of which gradually decreases in the direction close to the drive unit, and the first blood port is at least partially disposed in the tapered section; the maximum outer diameter of the drive unit is less than or equal to the minimum outer diameter of the tapered section. Alternatively, the inner diameter of the cannula at the distal end of the first blood port is greater than the outer diameter of the cannula at the proximal end of the first blood port, and the maximum outer diameter of the drive unit is less than or equal to the minimum outer diameter of the cannula at the proximal end of the first blood port.

6. The ventricular assist device according to claim 4, characterized in that, The maximum distance between the edge of the opening and the axis of rotation of the impeller is less than half the maximum outer diameter of the drive unit.

7. The ventricular assist device according to claim 1, characterized in that, The catheter has a first end face, the first end face has a beveled portion that is inclined relative to the length direction of the catheter, and the opening is disposed on the beveled portion; Wherein, the distance between the inclined surface and the axis of rotation of the impeller gradually decreases from the proximal end to the distal end; or, the entire first end face is perpendicular to the axis of rotation of the impeller.

8. The ventricular assist device according to claim 1, characterized in that, The outer diameter of the catheter at the location corresponding to the second orifice gradually decreases from the proximal end to the distal end.

9. The ventricular assist device according to claim 1, characterized in that, The catheter has a teardrop-shaped cross-section and includes a main body with a larger diameter and a side part with a smaller diameter. The main body is provided with a supply channel for the supply line to pass through, and the side part is provided with a guide wire channel. The cross-section is perpendicular to the length direction of the catheter.

10. The ventricular assist device according to claim 1, characterized in that, The catheter is capable of passing through the superior vena cava, and the catheter includes a first arc-shaped segment, a second arc-shaped segment, and a third arc-shaped segment connected in sequence, the first arc-shaped segment connecting the proximal end and the third arc-shaped segment connecting the distal end; The curvature of the second arc segment is greater than the curvature of the first arc segment and greater than the curvature of the third arc segment.

11. The ventricular assist device according to claim 10, characterized in that, The central axis of the first arc segment, the central axis of the second arc segment, and the central axis of the third arc segment are not coplanar.

12. The ventricular assist device according to claim 1, characterized in that, The ventricular assist device also includes a hemostatic valve that seals the opening, the hemostatic valve including a second surface and a third surface disposed opposite to each other, and a slit penetrating the second surface and the third surface; The incision has an initial state in which the hemostatic valve forms a seal at the incision. The slit also has a through-hole state through which the guide wire passes, and in the through-hole state, the hemostatic valve grips and seals the guide wire.

13. The ventricular assist device according to claim 12, characterized in that, The hemostatic valve is located inside the guide wire channel, and the second surface faces the opening; the second surface is provided with a groove, and the slit penetrates the bottom of the groove.

14. The ventricular assist device according to any one of claims 1 to 13, characterized in that, The first blood inlet is a blood inlet located in the right ventricle, and the second blood inlet is a blood outlet located in the pulmonary artery. The drive unit can drive the impeller to rotate so that blood is pumped from the blood inlet to the blood outlet.

15. The ventricular assist device according to claim 14, characterized in that, The drive unit is connected to one end of the sleeve having the first blood port, and the impeller is disposed between the first blood port and the second blood port, and adjacent to the first blood port.

16. The ventricular assist device according to claim 15, characterized in that, The first blood port has a first aperture edge disposed on the side closest to the second blood port, and the impeller includes a hub and blades, the blades having a leading edge located between the first aperture edge and the second blood port.

17. The ventricular assist device according to claim 1, characterized in that, The impeller includes a hub and blades arranged in a spiral on the hub. Along the direction of liquid flow, the placement angle of the blades first increases and then decreases, and the inlet placement angle of the blades is greater than the outlet placement angle of the blades. The maximum placement angle of the blades is located near the leading edge of the blades.

18. The ventricular assist device according to claim 17, characterized in that, The inlet angle of the blade is greater than or equal to 120° and less than or equal to 150°; and / or, The exit angle of the blade is greater than or equal to 80° and less than or equal to 110°.

19. The ventricular assist device according to claim 1, characterized in that, The impeller includes a hub and blades spirally arranged on the hub, wherein the length of the hub is greater than or equal to 6 mm and less than or equal to 8 mm; and / or, The maximum outer diameter of the impeller is greater than or equal to 5 mm and less than or equal to 7 mm.

20. The ventricular assist device according to claim 1, characterized in that, The impeller includes a hub and blades arranged in a spiral on the hub. The height of the blades is greater than or equal to 4.5 mm and less than or equal to 6 mm. The wrap angle of the blades is greater than or equal to 150° and less than or equal to 180°.

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