Ventricular assist device

Abstract

The embodiment of the application provides a ventricular assist device, comprising: a cannula provided with a first blood port and a second blood port; the impeller is positioned in the sleeve; the driving unit is connected with one end of the sleeve, and the driving unit can further drive the impeller to rotate so that blood can flow between the first blood opening and the second blood opening; the catheter is provided with a near end and a far end, the far end is connected with one end, far away from the cannula, of the driving unit, the catheter is provided with a guide wire channel, and the guide wire channel is provided with an opening adjacent to the far end; and the guide wire can penetrate through the first blood port and the opening, and is partially accommodated in the sleeve and partially accommodated in the guide wire channel. According to the technical scheme provided by the embodiment of the invention, the ventricular assist device can be conveniently delivered into the body of a patient.

Description

Technical Field

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

[0002] Ventricular assist devices are mechanical circulatory support devices designed to assist and reduce the workload of the heart chambers in order to maintain or increase cardiac output.

[0003] However, since the VAD is long overall, especially the catheter part, and the catheter is easily bent, it is very difficult and obstructive to deploy the VAD into the ventricle. Summary of the invention

[0004] In view of the above problems, an embodiment of the present application is proposed to provide a ventricular assist device that can be easily delivered to a patient's body.

[0005] The present application provides a ventricular assist device, comprising:

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

[0007] an impeller, located in the casing;

[0008] a driving unit connected to one end of the sleeve, the driving unit being further capable of driving the impeller to rotate so that blood flows between the first blood port and the second blood port; and

[0009] A catheter having a proximal end and a distal end, wherein the distal end is connected to an end of the drive unit away from the sleeve, and the catheter is provided with a guide wire channel, wherein the guide wire channel has an opening adjacent to the distal end, so that the guide wire can be passed through the first blood port and the opening, and is partially accommodated in the sleeve and partially accommodated in the guide wire channel

[0010] Optionally, the conduit includes a first pipe segment, the first pipe segment has the distal end, the opening is arranged in the first pipe segment, the driving unit has a first cross-section, the first cross-section is perpendicular to the rotation axis of the impeller and is the maximum cross-section of the driving unit, and the orthographic projection of the first pipe segment on the plane where the first cross-section is located is located within the first cross-section.

[0011] Optionally, the conduit comprises a main body section and an extension section connected to the main body section, the main body section has a first end surface, and the opening is arranged on the first end surface;

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

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

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

[0015] Optionally, the sleeve has a gradual tube section, the outer diameter of which gradually decreases in a direction approaching the driving unit, and the first blood port is at least partially arranged in the gradual tube section; the maximum outer diameter of the driving unit is less than or equal to the minimum outer diameter of the gradual tube section;

[0016] Alternatively, the inner diameter of the sleeve at the distal end of the first blood port is greater than the outer diameter of the sleeve 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 sleeve at the proximal end of the first blood port.

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

[0018] Optionally, the conduit has a first end surface, the first end surface has an inclined surface portion inclined relative to the length direction of the conduit, and the opening is arranged on the inclined surface portion;

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

[0020] Optionally, the guidewire channel comprises a first hole segment and a second hole segment which are arranged along the length direction of the catheter and are connected in sequence;

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

[0022] In a direction from the proximal end to the distal end, a distance between a central axis of the second hole segment and a 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 pipeline to pass through, the side portion is provided with the guidewire channel, and 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 comprises a first arc segment, a second arc segment and a third arc segment connected in sequence, the first arc segment is connected to the proximal end, and the third arc segment is connected to 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 arranged in the same plane.

[0027] Optionally, the ventricular assist device further comprises a hemostatic valve for sealing the opening, wherein the hemostatic valve comprises 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 incision also has a through state for the guide wire to pass through, and in the through state, the hemostatic valve hugs and seals the guide wire.

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

[0031] Optionally, the first blood port is a blood inlet disposed in the right ventricle, and the second blood port is a blood outlet disposed in the pulmonary artery, and the driving unit can drive the impeller to rotate so as to pump blood from the blood inlet to the blood outlet.

[0032] Optionally, the driving unit is connected to the 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 hole edge disposed on a side closest to the second blood port, and the leading edge of the impeller blade is located between the first hole edge and the second blood port.

[0034] Optionally, the impeller includes a hub and blades spirally arranged on the hub, and 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, and the position of the maximum placement angle of the blades is adjacent to the leading edge of the blades.

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

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

[0037] Optionally, the impeller comprises a hub and blades spirally arranged on the hub, and 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 spirally arranged 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°.

[0040] The technical solution of the present application, when the guide wire is inserted into the guide wire channel in the catheter, the guide wire can play a shaping role, for example, the shape of the catheter can be straightened by the guide wire, so that the shape of the catheter is conducive to delivery into the patient's body, so the entire ventricular assist device can be more conveniently delivered to the designated position in the patient's body under the guidance of the guide wire. In addition, when the guide wire is inserted, the guide wire can pass through the cannula from the first blood port, then pass into the guide wire channel from the opening of the guide wire channel, and finally pass out from the proximal end of the catheter. The setting of the opening can facilitate the insertion of the guide wire, so that the guide wire can achieve the crossing from the cannula to the catheter. The guide wire can be inserted into the cannula and the catheter at the same time, and jointly guide the delivery of the cannula and the catheter. Furthermore, compared with the traditional method of only passing the guide wire through the cannula, the technical solution of the present application adds a guide wire channel in the catheter, increases the extension length of the guide wire in the entire ventricular assist device, can not only guide the cannula, but also guide the catheter, so it is conducive to the delivery of the ventricular assist device and reduces the difficulty of delivering the ventricular assist device into the body. BRIEF DESCRIPTION OF THE DRAWINGS

[0041] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0042] Figure 1 It is a schematic diagram of the structure of the ventricular assist device in the embodiment of the present application when cooperating with the right heart;

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

[0044] Figure 3 for Figure 2 A schematic diagram of the structure of the central ventricular assist device from another angle;

[0045] Figure 4 is a schematic structural diagram of another ventricular assist device in an embodiment of the present application;

[0046] Figure 5 for Figure 4 A partial cutaway diagram of a ventricular assist device;

[0047] Figure 6 for Figure 5 The enlarged schematic diagram of point A in the middle;

[0048] Figure 7a is a schematic diagram of an orthographic projection of the first pipe segment on the plane where the first cross section is located in the embodiment of the present application;

[0049] Figure 7b It is a schematic diagram of an orthographic projection of a first pipe segment on a plane where a first cross section is located in another embodiment of the present application;

[0050] Figure 7c It is a schematic diagram of an orthographic projection of a first pipe segment on a plane where a first cross section is located in another embodiment of the present application;

[0051] Figure 7d A schematic diagram of a partial structure of a ventricular assist device in an embodiment of the present application;

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

[0053] Figure 7f It is a schematic diagram of the partial structure of another ventricular assist device in an embodiment of the present application;

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

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

[0056] Figure 7i This is a schematic diagram of a partial structure of another ventricular assist device in an embodiment of the present application;

[0057] Figure 8a and Figure 8b It is a comparative schematic diagram when the opening is set at different positions;

[0058] Figure 9aA partial cutaway schematic diagram of another ventricular assist device in an embodiment of the present application;

[0059] Figure 9b for Figure 9a The enlarged schematic diagram of point B in the middle;

[0060] Fig.10 for Figure 9a The enlarged schematic diagram of the hidden hemostatic valve at B in the middle;

[0061] Fig.11 is a schematic structural diagram of another ventricular assist device in an embodiment of the present application;

[0062] Fig.12 for Fig.11 A schematic diagram of the structure of the central ventricular assist device from another angle;

[0063] Fig.13 for Fig.12 A schematic diagram of the structure of the central chamber assist device from another angle;

[0064] Fig.14a for Fig.11 Schematic diagram of the structure of the middle catheter;

[0065] Fig.14b for Fig.14a The enlarged schematic diagram of the center C;

[0066] Fig.15a is a schematic cross-sectional view of a catheter in an embodiment of the present application;

[0067] Fig.15b is a schematic cross-sectional view of another catheter in an embodiment of the present application;

[0068] Fig.16 It is a structural schematic diagram of the hemostasis valve in FIG8;

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

[0070] Fig.18 for Fig.17 A schematic cross-sectional view of a hemostasis valve;

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

[0072] Fig. 20 for Fig.19 Schematic diagram of the impeller in the middle;

[0073] Fig.21 for Fig. 20 Schematic diagram of the middle blade;

[0074] Fig. 22 for Fig.19 Another plan view of the middle impeller;

[0075] Fig.23 This is a schematic diagram of the structure of an impeller in another embodiment of the present application;

[0076] Fig.24 for Fig.23 Schematic diagram of the impeller in the middle;

[0077] Fig.25 for Fig.24 Schematic diagram of the middle blade.

[0078] Reference numerals:

[0079] Label name Label name Label name 100 Ventricular assist device 342 Second hole section 421 Leading edge 10 casing 343 The third hole section 422 Trailing Edge 11 The second proximal 344 Opening 50 Hemostatic valve 12 The second far end 351 Fourth Surface 51 Second surface 13 Second blood port 352 side 52 The third surface 14 First blood port 353 First end face 53 Cutting 15 First hole edge 3531 Bevel part 54 Grooves 16 Maximum outer diameter 361 The first arc segment 55 Groove side wall 17 Gradient pipe section 362 The second arc segment 56 Bottom of the tank 20 Drive unit 363 The third arc segment 57 Guide slope 21 stator 364 First straight line segment 60 Positioning components 22 Rotor 365 The second straight line segment 71 Superior vena cava 23 Rotation axis 371 First pipe section 72 Tricuspid valve 24 shell 372 Second pipe section 73 Right ventricle 25 First cross section 381 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 392 Side 80 Guidewire 32 First distal end 40 / 40a impeller 81 Paragraph 1 33 Supply channel 41 / 41a Wheels 82 Paragraph 2 34 Guidewire channel 42 / 42a blade 83 Paragraph 3 341 First hole section DETAILED DESCRIPTION

[0080] In order to make the purpose, technical solution and advantages of the embodiments of the present application clearer, the technical solution in the embodiments of the present application will be clearly and completely described below in conjunction with the drawings in the embodiments of the present application. Obviously, the described embodiments are part of the embodiments of the present application, not all of them. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the embodiments of the present application.

[0081] It should be noted that, in the description of this application, if the terms "first", "second", etc. appear, "first" and "second" are only used to facilitate the description of different components or names, and cannot be understood as indicating or implying a sequential relationship, relative importance, or implicitly indicating the number of technical features indicated. Therefore, the features defined as "first" and "second" may explicitly or implicitly include at least one of the features. In addition, if "and / or" appears in the full text, its meaning is that it includes three parallel solutions, taking "A and / or B as an example", including Solution A, or Solution B, or a solution that satisfies both A and B.

[0082] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by those skilled in the art to which this application belongs. The terms used herein in the specification of this application are only for the purpose of describing specific embodiments and are not intended to limit this application.

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

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

[0085] Please refer to Figures 2 to 6 The ventricular assist device 100 provided in the embodiment of the present application includes: a cannula 10, a driving unit 20, a catheter 30 and an impeller 40. The cannula 10 is provided with a first blood port 14 and a second blood port 13. The catheter 30 has a proximal end and a distal end. For the convenience of description, the proximal end of the catheter 30 is referred to as the first proximal end 31, and the distal end of the catheter 30 is referred to as the first distal end 32. One end of the driving unit 20 is connected to the cannula 10, and the other end of the driving unit 20 is connected to the first distal end 32 of the catheter 30. The impeller 40 is disposed in the cannula 10 and connected to the driving unit 20, so that the blood flows between the first blood port 14 and the second blood port 13 under the drive of the driving unit 20, for example, the blood is pumped from the first blood port 14 to the second blood port 13, or the 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 driving 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 the second blood port 13, and the second distal end 12 may be provided with the first blood port 14.

[0087] In some embodiments of the present application, Figure 1 As shown, taking the ventricular assist device 100 set in the right heart as an example, the cannula 10 is configured to be set across the pulmonary valve 74, the first blood port 14 serves as a blood inlet and is located in the right ventricle 73 or the conus artery, and the second blood port 13 serves as a blood outlet and is located in the pulmonary artery 75, so that 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 so that it can be better injected into the pulmonary artery 75.

[0088] It can be understood that in other embodiments of the present application, taking the ventricular assist device 100 being set in the left heart as an example, the cannula 10 is configured to be set across the aortic valve, the first blood port 14 can be used as a blood outlet and is located in the aorta, and the second blood port 13 can be used 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 and can be better injected into the aorta.

[0089] In order to facilitate the delivery of the ventricular assist device 100 into the body, further, a guide wire channel 34 for the guide wire 80 to pass through is provided in the catheter 30. Figure 6 Further, the guidewire channel 34 has an opening 344 adjacent to the first distal end 32, so that the guidewire 80 can be passed through the first blood port 14 and the opening 344, so that a portion of the guidewire 80 is accommodated in the sleeve 10 and a portion is accommodated in the guidewire channel 34. In one embodiment, the guidewire 80 can pass through the first blood port 14 and pass into the guidewire channel 34 from the opening 344.

[0090] After the guidewire 80 is inserted into the guidewire channel 34 in the catheter 30, the guidewire 80 can play a shaping role, for example, the shape of the catheter 30 can be straightened by the guidewire 80, so that the shape of the catheter 30 is conducive to delivery into the patient's body, so the entire ventricular assist device 100 can be more conveniently delivered to the designated position in the patient's body under the guidance of the guidewire 80. In addition, when the guidewire 80 is inserted, the guidewire 80 can pass through the cannula 10 from the first blood port 14, and then pass into the guidewire channel 34 from the opening 344 of the guidewire channel 34, and finally pass out from the proximal end of the catheter 30. The setting of the opening 344 can facilitate the insertion of the guidewire 80, so that the guidewire 80 can achieve the crossing from the cannula 10 to the catheter 30, and the guidewire 80 can be inserted into the cannula 10 and the catheter 30 at the same time to jointly guide the delivery of the cannula 10 and the catheter 30. Furthermore, compared with the conventional method of merely passing the guidewire 80 through the sheath 10, the technical solution of the present application adds a guidewire channel 34 in the catheter 30, thereby increasing the extension length of the guidewire 80 in the entire ventricular assist device 100, which can not only guide the sheath 10 but also guide the catheter 30, thereby 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, that is, the opening 344 is not blocked by the drive unit 20, nor is it set at a position of the catheter 30 that cooperates with the drive unit 20, but is directly exposed outside, and the opening 344 can be directly observed from outside the ventricular assist device 10. Since the opening 344 is exposed outside, when the guide wire 80 is inserted, the guide wire 80 can more conveniently pass through the cannula 10 through the first blood port 14, pass into the guide wire channel 34 from the opening 344, and finally pass out from the first proximal end 31 of the catheter 30. Therefore, the opening 344 exposed outside the drive unit 20 can facilitate the insertion of the guide wire 80.

[0092] The guidewire channel 34 extends along the length direction of the catheter 30 as a whole. 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 a shape memory material, and the catheter 30 is preformed, that is, pre-bent to form a corresponding shape. For example, when used as a right ventricular assist device, the catheter 30 is pre-bent to form 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, so that the catheter 30 is straightened; when the ventricular assist device 100 is delivered to a predetermined position, the guidewire 80 is withdrawn from the guidewire channel 34, and at this time, the catheter 30 will return to the pre-formed bent shape. The guidewire channel 34 for the guidewire 80 to pass through is provided in the catheter 30, which facilitates the delivery of the ventricular assist device 100.

[0093] Please refer to Figure 6 , a supply channel 33 for a supply line (not shown) is provided in the catheter 30, and the supply channel 33 runs 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 pipeline includes a wire, an infusion tube, etc. The drive unit 20 can be connected to the wire, and the wire transmits 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 catheter 30. The stator 21 and the rotor 22 are arranged in 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, and a driving magnetic field can be generated by energizing the stator 21 through the wire. 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 the additional provision of a guidewire channel 34 on the catheter 30 may cause the radial dimension of the catheter 30 to increase (in the present application, the length direction of the catheter 30 is the axial direction, and the direction perpendicular to the length direction of the catheter 30 is the radial direction), however, if the portion of the catheter 30 connected to the drive unit 20 is set with a larger outer diameter, the catheter 30 protrudes radially from the outer peripheral surface of the drive unit 20, which is equivalent to the catheter 30 forming a step surface protruding in the radial direction from the outer peripheral surface of the drive unit 20. When the ventricular assist device 100 is delivered into the patient's body and passes through the blood vessels, the drive unit 20 first enters the blood vessels, and the drive unit 20 stretches the blood vessels to make the blood vessels have a smaller diameter; then the catheter 30 enters the blood vessels, and the catheter 30 stretches the blood vessels to make the blood vessels have a larger diameter. In this process, the step surface is always located at the connection between the smaller diameter and the larger diameter of the blood vessel, so that the blood vessel wall is directly squeezed by the step surface along the length direction of the blood vessel, and the blood vessel wall is easily scratched and damaged. In order to avoid damage to the blood vessel wall due to the existence of the step surface, in the present application, the maximum radial dimension of the catheter 30 provided with the guidewire channel 34 is less than or equal to the diameter of the maximum cross section of the drive unit 20 (usually, the drive unit 20 is roughly cylindrical).

[0095] Please refer to it again Figure 2 In some embodiments of the present application, the catheter 30 includes a first tube segment 371, the distal end of the first tube segment 371 is the first distal end 32, and the opening 344 is provided in the first tube segment 371. The extension direction of the first tube segment 371 extends substantially along the rotation axis of the impeller 40. The orthographic projection of the first tube segment 371 on the drive unit 20 is entirely located within the drive unit 20, so the first tube segment 371 does not protrude from the outer peripheral surface of the drive unit 20 in the radial direction, that is, at least, a portion of the catheter 30 close to the drive unit 20 does not protrude from the outer peripheral surface of the drive unit 20 in the radial direction, so the position adjacent to the catheter 30 and the drive unit 20 does not form a step surface protruding from the outer peripheral surface of the drive unit 20 in the radial direction, so the portion of the catheter 30 close to the drive unit 20, i.e., the first tube segment 371, will not scratch the blood vessel wall.

[0096] Please refer to Figure 7a , 7b and Figure 7c Specifically, in the above description, the orthographic projection of the first pipe section 371 on the driving unit 20 is entirely located within the driving unit 20, which means that the driving unit 20 has a first cross section 25, the first cross section 25 is perpendicular to the rotation axis S5 of the impeller 40, and is the maximum cross section of the driving unit 20, and the orthographic projection of the first pipe section 371 on the plane where the first cross section 25 is located is located within the first cross section 25. In the illustrated embodiment, the first cross section 25 is substantially circular.

[0097] like Figure 7aAs shown, the maximum width J of the first pipe segment 371 in the radial direction is smaller than the diameter of the first cross section 25, and the central axis of the supply channel 33 in the first pipe segment 371 coincides with the central axis of the drive unit 20. In addition, the orthographic projection of the first pipe segment 371 on the plane where the first cross section 25 is located, one side of the orthographic projection along the maximum width direction is inscribed in the first cross section 25. In other embodiments, the central axis of the supply channel 33 in the first pipe segment 371 and the central axis of the drive unit 20 may be parallel and not coincident.

[0098] like Figure 7b As shown, the maximum width J of the first tube segment 371 in the radial direction is smaller than the diameter of the first cross section 25 , and the outer contour of the orthographic projection of the first tube segment 371 on the plane where the first cross section 25 is located is spaced from the outer contour of the first cross section 25 .

[0099] like Figure 7c As shown, the maximum radial width J of the first tube segment 371 is equal to the diameter of the first cross section 25, and the orthographic projection of the first tube segment 371 on the plane where the first cross section 25 is located, and the two opposite sides of the orthographic projection along the maximum width direction are respectively inscribed in the first cross section 25.

[0100] Of course, in other embodiments, the situation where the orthographic projection of the first pipe section 371 on the plane where the first cross section 25 is located is not limited to the above situation. Figure 7a , Figure 7b and Figure 7c There are three situations in .

[0101] The driving unit 20 as a whole may be in the shape of a column with a circular cross section, and the outer diameters of various parts may be the same or different. For example, the driving unit 20 has a larger and constant outer diameter at a section close to the impeller 40, and a section close to the conduit 30 of the driving unit 20 is tapered to form a truncated cone structure and has a smaller outer diameter, that is, the driving unit 20 has a constant outer diameter section 26 (such as Figure 7d The first pipe section 371 is connected to the truncated cone structure section of the drive unit 20. In this embodiment, the first cross section 25 refers to the cross section at the maximum position of the outer diameter of the drive unit 20, so the first cross section 25 is the cross section of the constant outer diameter section 26.

[0102] When the driving unit 20 is cylindrical, the central axis of the driving 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 driving unit 20 .

[0103] Please refer to Figure 4 Furthermore, the catheter 30 also includes a second pipe section 372 connected to the first pipe section 371. Figure 4The first tube section 371 is divided by a dotted line, and the second tube section 372 is divided by a dotted line. The proximal end of the second tube section 372 is the first proximal end 31; the outer diameter d2 of the second tube section 372 is equal to the outer diameter of the proximal end of the first tube section 371, and the outer circumference of the second tube section 372 is flush with the outer circumference of the first tube section 371. As a result, the entire catheter 30 will not form a step surface protruding outward in the radial direction relative to the drive unit 20, which can prevent the catheter 30 from causing damage to the blood vessel wall. Specifically, the outer diameter (in Figure 4 d2 in the figure is the outer diameter of the conduit 30) is less than or equal to the outer diameter d3 of the drive unit 20. The outer diameter d3 of the drive unit 20 here refers to the outer diameter of the outer shell of the drive unit 20.

[0104] In some embodiments, the catheter 30 adopts a prefabricated bending shape, and when the guide wire 80 passes through the catheter 30, the catheter 30 can be in a straight shape. In the straight shape, the central axis of the catheter 30 is parallel to the rotation axis S5 of the impeller 40, and the orthographic projection of the catheter 30 on the drive unit 20 falls within the drive unit 20, so the catheter 30 as a whole does not exceed the drive unit 20 in the radial direction.

[0105] Please refer to Figure 3 In some embodiments, the catheter 30 includes a main body section 381 and an extension section 382. One end of the main body section 381 is the first proximal end 31. The end of the main body section 381 away from the first proximal end 31 has a first end surface 353, and the opening 344 is arranged on the first end surface 353. The extension section 382 extends along the extension direction of the main body section 381. One end of the extension section 382 is connected to the end of the main body section 381 having the first end surface 353. The other end of the extension section 382 has a fourth surface 351. The fourth surface 351 faces the drive unit 20. In some embodiments, the supply channel 33 may pass through the fourth surface 351. Please refer to Figure 4 , wherein the maximum outer diameter d2 of the main body section 381 at the first end surface 353 is greater than the outer diameter d1 of the extension section 382. Overall, the catheter 30 is equivalent to forming a concave area T1 (such as Figure 3 and Figure 6 As shown in FIG. 3 , the concave area T1 can provide deformation space for the guide wire 80, so that the guide wire 80 can be inserted into the opening 344 after adjusting its shape there, and reduce the height of the guide wire 80 protruding outside the entire catheter 30. In this embodiment, the catheter 30 can have a smaller outer diameter at the position where the drive unit 20 is connected because the guide wire channel 34 does not need to be provided, and the catheter 30 can be provided with a larger outer diameter at other positions because the supply channel 33 and the guide wire channel 34 need to be provided at the same time.

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

[0107] like Figure 7d As shown, the outer diameter H2 at the distal end of the sleeve 10 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. In this way, the guide wire 80 can basically be close to the outer peripheral wall of the drive unit 20 and extend along the axial direction of the drive unit 20, thereby 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 section 26 (the portion between the dashed lines S6 and S8), and the drive unit 20 has a maximum outer diameter H3 in the constant outer diameter section 26, and the portion of the guide wire 80 located at the first blood port 14 and the constant outer diameter section 26 of the drive unit 20 is defined as the second section 82. The second section 82 is adjacent to the outer peripheral wall of the constant outer diameter section 26 and extends along the axial direction of the drive unit 20.

[0109] In some embodiments, the second section 82 is adjacent to the outer peripheral wall of the driving unit 20, that is, the second section 82 is in contact with the outer peripheral wall of the driving unit 20, or the second section 82 is approximately in contact with the outer peripheral wall of the driving unit 20, with a small gap between the two, or there is a small gap between the end of the second section 82 close to the first blood port 14 and the outer peripheral wall of the driving unit 20, and the end of the second section 82 close to 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 corresponding first blood port 14 of the cannula 10 is greater than the outer diameter H3 of the drive unit 20, which means that the outer diameter H2 is greater than the outer diameter at any position of the drive unit 20, so 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 is equivalent to forming a recessed area T2 in the area corresponding to the constant outer diameter section 26, and the recessed area T2 can provide a space for the guide wire 80, so that the guide wire 80 can be arranged close to the outer peripheral wall of the drive unit 20, and the height of the guide wire 80 protruding outside the entire drive unit 20 is reduced. Therefore, the second section 82 can make full use of the characteristic that the outer diameter of the constant outer diameter section 26 is smaller than the outer diameter of the cannula 10, so that the diameter after the second section 82 and the constant outer diameter section 26 are superimposed is small, and almost does not exceed the outer diameter H2 of the cannula 10, which can reduce the risk of squeezing and rupturing the blood vessel wall.

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

[0113] The guide wire 80 has two sides spaced apart along the radial direction of the driving unit 20 , and the side of the guide wire 80 facing away from the driving unit 20 refers to the side of the guide wire 80 that is away from the driving unit 20 .

[0114] Please refer to Figure 7d , Figure 7f and Figure 7g Further, the inner diameter H8 at the distal end of the cannula 10 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 through 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 cannula 10 at the distal end of the first blood port 14. In this way, when the guide wire 80 passes through the first blood port 14, the guide wire 80 can basically fit 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 cannula 10.

[0115] Combination Figure 7g It can be seen that when the inner diameter H8 at the distal end of the corresponding first blood port 14 of the cannula 10 is larger than the outer diameter H3 of the drive unit 20, the guide wire 80 can extend out of the first blood port 14 by adhering to the inner circumferential wall at the distal end of the corresponding first blood port 14 of the cannula 10, and the outer diameter H3 of the drive unit 20 is smaller than the inner diameter H8, which means that the outer circumferential wall of the drive unit 20 does not protrude laterally from the inner circumferential wall at the distal end of the corresponding first blood port 14 of the cannula 10, so it will not cause obstruction to the guide wire 80. Therefore, when the guide wire 80 reaches the drive unit 20, it does not need to bend in a direction perpendicular to the rotation axis S5 and away from the drive unit 20 to avoid it, so the guide wire 80 can basically be in a straight state and extend in close contact with the outer circumferential wall of the drive unit 20.

[0116] Please refer to 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 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 catheter 30, thereby ensuring that the maximum distance H6 from the side of the guide wire 80 that is 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 cannula 10 at the distal end of the first blood port 14.

[0117] Specifically, the maximum outer diameter of the driving unit 20 refers to the outer diameter H3 of the outer diameter constant section 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 proximal end of the guide wire 80 located at the constant outer diameter section 26 (the proximal end refers to Figure 7d The portion between the position corresponding to the dotted line S8 in the figure 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 proximal end of the constant outer diameter section 26.

[0119] The following description is made by defining the portion of the guide wire 80 between the proximal end of the constant outer diameter section 26 and the opening 344, i.e., the arc-shaped portion, as the third section 83. Specifically, the third section 83 is curved, and the entire deformation is relatively smooth. When it contacts the blood vessel wall, the pressure on the blood vessel wall is small. In addition, since the highest point K of the third section 83 corresponds to the proximal end of the constant outer diameter section 26, it indicates that the third section 83 gradually approaches the direction of the rotation axis S5 of the impeller, so that it can be better guided to be inserted into the opening 344.

[0120] When combined with the recessed area T1 in the above embodiment, the third section 83 is arranged corresponding to the recessed area T1, so that the third section 83 is inserted into the opening 344 after adjusting its shape there, and reduces the height of the guide wire 80 protruding outside the entire catheter 30.

[0121] In the above description, 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 farthest 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. At this time, when the guide wire 80 passes through the first blood port 14, it can extend toward the drive unit 20 in close contact with the outer peripheral wall of the cannula 10 at the proximal end of the first blood port 14, so as to reduce the height of the guide wire 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 can be gradually reduced in the direction close to the drive unit 20; or, the outer diameter of the portion of the cannula 10 at the first blood port 14 first increases and then decreases in the direction close to the drive unit 20.

[0123] Please refer to Figure 7hIn some embodiments, the sleeve 10 has a gradual tube section 17, and the outer diameter H7 of the gradual tube section 17 gradually decreases in the direction close to the driving unit 20, so the gradual tube section 17 is set in a tapered manner, and the first blood port 14 is at least partially set in the gradual tube section 17. The maximum outer diameter H3 of the driving unit 20 is less than or equal to the minimum outer diameter of the gradual tube section 17. In this way, the above-mentioned recessed area T2 can be formed, which is convenient for giving way to the guide wire 80. In addition, when the guide wire 80 passes through the first blood port 14, it is also beneficial for the guide wire 80 to fit the outer peripheral wall of the driving unit 20 with the maximum outer diameter. At this time, the inner diameter of the gradual tube section 17 at the distal end of the first blood port 14 can be greater than the outer diameter of the gradual tube section 17 at the proximal end of the first blood port 14; or, the inner diameter of the gradual tube section 17 at the distal end of the first blood port 14 is also less than or equal to the outer diameter of the gradual tube section 17 at the proximal end of the first blood port 14.

[0124] The first blood port 14 is at least partially disposed in the gradient tube section 17, but includes but is not limited to the following situations:

[0125] Scenario 1: If Figure 7h As shown, the distal end of the first blood port 14 exceeds the distal end of the gradient tube segment 17 and is arranged in the maximum outer diameter segment 16 (introduced in the following embodiment), and the proximal end of the first blood port 14 is located in the gradient tube segment 17.

[0126] Situation 2: the distal end of the first blood port 14 exceeds the distal end of the gradient tube segment 17 and is arranged in the maximum outer diameter segment 16 (described in the following embodiment), and the proximal end of the first blood port 14 exceeds the proximal end of the gradient tube segment 17.

[0127] Situation three: the first blood ports 14 are all located in the gradient tube section 17 .

[0128] Furthermore, the sleeve 10 may also have a maximum outer diameter section 16, the proximal end of the maximum outer diameter section 16 is connected to the distal end of the gradient tube section 17, the sleeve 10 has a constant outer diameter in the maximum outer diameter section 16, the outer diameter of the maximum outer diameter section 16 is equal to the maximum outer diameter of the gradient tube section 17, and the second blood port 13 is set in the maximum outer diameter section 16. Figure 7h In the embodiment, the maximum outer diameter section 16 and the gradual change section 17 are divided by the dotted line S9. Of course, in other embodiments, the entire sleeve 10 can be the gradual change section 17. Alternatively, in other embodiments, Figure 7d As shown, the entire sleeve 10 is a maximum outer diameter section 16 , that is, the outer diameter of the sleeve 10 is consistent at all locations.

[0129] In the embodiment of the present application, the opening 344 and the driving 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 direction of the rotation axis S5, so that the protruding height of the guide wire 80 between the opening 344 and the first blood port 14 relative to the outer peripheral wall of the driving unit 20 is lower.

[0130] Specifically, please refer to Figure 6 The catheter 30 has a fourth surface 351 at the first distal end 32 ; the catheter 30 also has a first end surface 353 , the opening 344 is arranged on the first end surface 353 , and the first end surface 353 is arranged away from the first distal end 32 relative to the fourth surface 351 . Therefore, the fourth surface 351 and the first end surface 353 are arranged at intervals in the length direction of the catheter 30, and the opening 344 has a certain distance from the drive unit 20 along the direction of the rotation axis S5. Compared with the scheme of setting the opening 344 on the fourth surface 351 adjacent to the drive unit 20, it is equivalent to making the distance between the opening 344 on the first end surface 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, and 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 almost extend along the outer peripheral surface of the drive unit 20 to form a shape close to a straight line, which can reduce the degree of the guide wire 80 tilting outside 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 pulled out, the straight-line guide wire 80 can also be more smoothly pulled out from the first blood port 14, the opening 344 and the guide wire channel 34.

[0131] Specifically, please refer to Figure 7i, the guide wire 80 has a first section 81 (the portion between the dotted lines S6 and S7) located between the opening 344 and the first blood port 14, and the maximum height H5 of the first section 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 section 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 section 81 protruding outside the drive unit 20 refers to the maximum distance between the first section 81 and the rotation axis S5 and the distance between the outer peripheral surface of the drive unit 20 in the vertical direction along the rotation axis S5. By limiting the maximum height H5 of the portion of the guide wire 80 located between the opening 344 and the first blood port 14, i.e., the first section 81 protruding outside the drive unit 20 to within 1.5 mm, the distance between the opening 344 and the first blood port 14 satisfies the setting of the maximum height H5, thereby preventing the first section 81 from being lifted too much outside the drive unit 20 and the catheter 30, thereby affecting the delivery of the entire ventricular assist device into the blood vessel. As a result, the height of the guide wire 80 protruding outside the drive unit 20 is relatively low, and at the same time, it is also convenient for the guide wire 80 to be smoothly inserted into the opening 344.

[0132] In addition, in order to ensure the normal operation of the ventricular assist device 100 and allow the blood to flow normally, it is necessary to ensure that the gap between the drive unit 20 and the inner wall of the blood vessel (referring to the unilateral gap) is greater than or equal to 0.4 mm, and the bilateral gap needs to be greater than or equal to 0.8 mm, so that the first section 81 can have a protrusion height of at least 0.8 mm relative to the outside of the drive unit 20. However, if the protrusion height is too large, it will cause excessive squeezing of the blood vessel wall, and when the limit force of the blood vessel wall is exceeded, it will cause the blood vessel wall to rupture. Therefore, limiting the maximum height H5 of the first section 81 protruding outside the drive unit 20 to less than or equal to 1.5 mm can avoid the above problems.

[0133] When the outer diameter of the sleeve 10 is set to be equal to or slightly smaller than the maximum outer diameter of the driving unit 20, the gap between the sleeve 10 and the inner wall of the blood vessel (referring to the single-side gap) will also be greater than or equal to 0.4 mm, thereby 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 sum of the maximum height of the guide wire 80 located outside the cannula 10 and close to the first blood port 14 (i.e., the first section 81) protruding from the drive unit 20 and the diameter of the drive unit 20 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 drive 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, in the direction along the rotation axis S5, the guide wire 80 can have a longer distance to adjust its angle. At the same time, in the vertical direction along the rotation axis S5, the recessed area T1 can guide the guide wire 80 to gradually fit the catheter 30 from the outside to the inside (referring to the direction along the radial direction of the drive 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 almost extend along the outer peripheral surface of the drive unit 20 to form a shape close to a straight line, which can reduce the degree of the guide wire 80 rising outside 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 pulled out, the straight-line guide wire 80 can also be pulled out more smoothly from the first blood port 14 , the opening 344 and the guide wire channel 34 .

[0135] By comparison Figure 8a and 8b It can be seen that Figure 8a As shown, when the opening 344 is set away from the first blood port 14, the portion of the guide wire 80 located at the opening 344 and the first blood port 14 is relatively flat, approximately a straight line or an arc with a small curvature, so it is easier to extend from the first blood port 14 into the opening 344. When the opening 344 is set close to the first blood port 14, the portion of the guide wire 80 located at the opening 344 and the first blood port 14 needs to bend more to adapt to extending from the first blood port 14 to the opening 344. However, when the portion of the guide wire 80 located at the opening 344 and the first blood port 14 has a large bending, it is difficult to align with the opening 344 and extend into the guide wire channel 34.

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

[0137] Figures 11 to 14bAnother structure of a ventricular assist device 100 is shown. In this embodiment, the opening 344 is disposed adjacent to the fourth surface 351 .

[0138] In some embodiments, the first pipe segment 371 refers to the second straight line segment 365 ( Fig.12 ). Since the catheter 30 is not completely straight, when the opening 344 is set at the bending position of the catheter 30, the distribution line of the opening 344 and the first blood port 14 is at a large angle to the rotation axis S5 of the impeller 40, which will cause the guide wire 80 to be greatly deformed. It is difficult for the guide wire 80 to align with the position of the opening 344 and the first blood port 14, so it is not conducive to the insertion and extraction of the guide wire 80. Therefore, in this embodiment, the opening 344 is set at the second straight line segment 365, and the second straight line segment 365 is parallel to the rotation axis S5 of the impeller 40. Therefore, the distribution line of the opening 344 and the first blood port 14 is basically parallel to the rotation axis S5 of the impeller 40, and the guide wire 80 can easily pass through the first blood port 14 and the opening 344 in the same direction, reducing the difficulty of inserting and extracting the guide wire 80 into and out of the catheter 30.

[0139] Please refer to Figure 4 , Figure 6 , Figure 9a , Figure 9b In some embodiments, the catheter 30 further comprises a first end face 353, the first end face 353 comprises an inclined surface 3531 inclined relative to the length direction of the catheter 30, the opening 344 is arranged on the inclined surface 3531, the inclined surface 3531 is arranged obliquely relative to the rotation axis S5 of the impeller 40, and the distance between the inclined surface 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 inclined surface 3531 is equivalent to playing a guiding role, and the inclined surface 3531 exerts a part of the force on the blood vessel wall along the radial direction of the blood vessel, while pushing inward, the blood vessel wall is slowly expanded, rather than directly squeezing the blood vessel wall along the length direction of the blood vessel, so that the risk of the blood vessel wall being scratched can be reduced. Optionally, the catheter 30 further comprises a side surface 352, the side surface 352 extends along the length direction of the catheter 30, the inclined surface 3531 is connected to the side surface 352, and the connection between the inclined surface 3531 and the side surface 352 is rounded to form a smooth transition connection to avoid 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 arranged at intervals. A portion of the first end face 353 (referring to the portion connected and overlapped with the extension section 382) is parallel to the fourth surface 351, and the supply channel 33 is arranged to pass through this portion. On this basis, the first end face 353 also has a sloped portion 3531, and the guide wire channel 34 passes through the sloped portion 3531.

[0141] like Fig.14b As shown, the first end surface 353 refers to the fourth surface 351 , on this basis, the first end surface 353 further has a slope portion 3531 , and the supply channel 33 passes through the area of ​​the first end surface 353 excluding the slope portion 3531 .

[0142] Of course, in other embodiments, such as Figure 3 As shown, the entire first end surface 353 is perpendicular to the rotation axis S5, and the entire first end surface 353 may 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 at the first distal end 32.

[0143] Please refer to Figure 9b and Fig.10 In some embodiments, the guide wire channel 34 includes a first hole segment 341, a second hole segment 342 and a third hole segment 343 arranged along the length direction and connected to each other, and the first hole segment 341 has an opening 344. Optionally, the first hole segment 341 and the second hole segment 342 are arranged at an angle. Specifically, the central axis S1 of the first hole segment 341 is substantially 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 hole segment 341 is also substantially parallel to the rotation axis S5 of the impeller 40. In the direction from the proximal end to the distal end, the distance between the central axis S2 of the second hole 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 central axis S2 and the rotation axis S5 of the impeller 40 also gradually increases. The third hole segment 343 is arranged in parallel with the supply channel 33.

[0144] When the guide wire 80 is inserted into the catheter 30, since the guide wire 80 is corrected to be substantially straight and substantially parallel to the rotation axis S5 of the impeller 40, the guide wire 80 does not need to be bent significantly and can be directly inserted into the first hole section 341 substantially parallel to the rotation axis S5 of the impeller 40. Then, the second hole section 342 with an inclined shape slowly guides the guide wire 80 toward the direction close to the supply channel 33, so that the guide wire 80 enters the third hole section 343.

[0145] The catheter 30 has a larger outer diameter at the position corresponding to the first hole section 341, so that the opening 344 of the first hole section 341 and the first blood port 14 can be close to overlap in the axial direction of the drive unit, and the deformation of the guide wire 80 between the opening 344 and the first blood port 14 is small. The outer diameter of the catheter 30 at the position corresponding to the second hole section 342 gradually decreases from the proximal end to the distal end, so that the second hole section 342 also forms a transition. The catheter 30 has a smaller outer diameter at the position corresponding to the third hole section 343, so that the outer diameter of most of the catheter 30 is small to avoid excessive squeezing of the blood vessel.

[0146] In the above, parallel means parallel or nearly parallel. In some embodiments, parallel also includes coincidence. For example, the central axis S1 of the first hole segment 341 coincides with the rotation axis S5 of the impeller 40. In addition, the direction from the proximal end to the distal end mentioned in this article refers to Fig.10 The first direction in .

[0147] In the embodiment of the present application, the shape of the cross section of the catheter 30 can be circular or non-circular. For the non-circular shape, it can be elliptical, teardrop-shaped or waist-shaped. Optionally, the outer contour of the cross section of the catheter 30 is a smoothly transitioned annular line, so that a sharp vertex angle can be avoided to avoid damaging 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 Fig.15a and Fig.15b In some embodiments, the cross section of the catheter 30 is teardrop-shaped and includes a main body 391 with a larger diameter and a side portion 392 with a smaller diameter. 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. Fig.15a The dotted line in the figure is a dividing line, one side of the dotted line is the main body 391, and the other side of the dotted line is the side 392. On the one hand, relative to the circular cross section, the diameter of the circular cross section must be equal to the maximum size of the water drop-shaped cross section in order to simultaneously meet the setting of the supply channel 33 and the guide wire channel 34, but the area of ​​the circular cross section is much larger than the area of ​​the water drop-shaped cross section, which results in the volume of the catheter 30 with a circular cross section being much larger than the volume of the catheter 30 with a water drop-shaped cross section, which will over-exert the blood vessel wall and easily cause the blood vessel wall to rupture. On the other hand, when the catheter 30 is delivered into the body, the catheter 30 needs to be bent more or less to adapt to the vascular structure, but since the shape of the catheter 30 with a circular cross section is regular and the thickness is large everywhere, it is difficult to deform. However, relative to the circular cross section, the diameter of the side 392 of the catheter 30 with a water drop-shaped cross section is smaller, which is equivalent to the thinning of a part of the cross section, so the deformation difficulty of the catheter 30 is reduced. Moreover, compared with the circular cross section, a concave portion is formed between the main body 391 and the side 392, which can provide a deformation space. Thus, the catheter 30 with a teardrop-shaped cross section can be deformed more easily, reducing the difficulty of being delivered into the body. Furthermore, the main body 391 with a larger diameter can be provided with a supply channel 33 with a larger inner diameter to allow wires such as guide wires and infusion tubes to pass through, meeting the needs of supply lines; while the side portion 392 with a smaller diameter only needs to be provided with a guide wire channel 34 with a smaller inner diameter, so the position of the setting can be reasonably arranged according to the inner diameter of different channels, and the shape of the catheter 30 can be reasonably utilized.

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

[0150] The cross-sectional shapes of the supply channel 33 and the guide wire channel 34 can be circular, semicircular, elliptical, etc., which are not limited in the present embodiment. Fig.15a As shown, the cross-sectional shapes of the supply channel 33 and the guide wire channel 34 are both circular; Fig.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 Figure 9b , Figures 16 to 18 After the guidewire channel 34 is set, in order to prevent blood from flowing out of the body from the guidewire channel 34, the ventricular assist device 100 further includes a hemostatic valve 50 that seals the opening 344. The hemostatic valve 50 can prevent blood from entering the guidewire channel 34 from the opening 344. The hemostatic valve 50 includes a second surface 51 and a third surface 52 that are arranged in opposite directions, and a slit 53 that passes through the second surface 51 and the third surface 52. The slit 53 can allow the guidewire 80 to pass through. Specifically, when no object such as the guidewire 80 is passed through the slit 53, the slit 53 is in an initial state, and the walls facing each other of the slit 53 are in contact with each other to form a seal, so that liquid such as blood cannot flow through the slit 53; at the same time, the hemostatic valve 50 is in sealing contact with the hole wall 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 slit 53 before passing out. The hemostatic valve 50 always tightly holds and fits the guide wire 80 at the slit 53 to form a seal, preventing blood from passing through the connection between the guide wire 80 and the hemostatic valve 50. At this time, the slit 53 is in a through state.

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

[0153] In the embodiment of the present application, the hemostatic valve 50 relies on its own deformation and squeezes into the guide wire channel 34 to seal and contact with the hole wall of the guide wire channel 34. In order to improve the connection stability between the hemostatic valve 50 and the catheter 30, the hemostatic valve 50 can be completely accommodated in the guide wire channel 34, so that the entire side surface 352 of the hemostatic valve 50 is in contact with the hole wall of the guide wire channel 34, with a larger contact area, and the hemostatic valve 50 can be held more tightly by the hole 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 longer, and the hemostatic valve 50 is in an elongated strip shape as a whole, which can also allow the hemostatic valve 50 to have a larger contact area with the hole wall of the guide wire channel 34.

[0155] When the hemostatic valve 50 is located in the guide wire channel 34, the second surface 51 of the hemostatic valve 50 faces the opening 344, and the third surface 52 faces away from the opening 344. Further, the second surface 51 is provided with a groove 54, and the slit 53 penetrates the groove bottom 56 of the groove 54. After such a setting, on the one hand, the hemostatic valve 50 can be set to have a larger length to increase the contact area with the hole wall of the guide wire channel 34, and the hemostatic valve 50 is more firmly clamped in the guide wire channel 34; on the other hand, it can also avoid that the penetration depth of the slit 53 is too large, resulting in the guide wire 80 needing to use too much force to penetrate the slit 53. Optionally, after the groove 54 is set, the thickness B2 of the groove side wall 55 of the groove 54 is substantially equal to the thickness B1 of the groove bottom 56.

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

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

[0158] In some embodiments, a portion of the hemostatic valve 50 is located in the first hole section 341, and another portion of the hemostatic valve 50 is located in the second hole section 342. Therefore, when the hemostatic valve 50 is assembled into the guide wire channel 34, a certain deformation will occur at the connection between the first hole section 341 and the second hole section 342 to adapt to the change in the angle between the first hole section 341 and the second hole section 342, so that the hemostatic valve 50 is further clamped at the connection between the first hole section 341 and the second hole section 342.

[0159] The following embodiments are described by taking the ventricular assist device 100 disposed in the right heart as an example.

[0160] Please refer to it again Figures 11 to 13Further, the catheter 30 includes a first arc segment 361, a second arc segment 362, and a third arc segment 363 which are sequentially arranged and connected from the proximal end to the distal end, and the curvature of the second arc segment 362 is greater than the curvature of the first arc segment 361, and greater than the curvature of the third arc segment 363. Therefore, the curvature of the second arc segment 362 in the middle is relatively large, and the bending and turning of the catheter 30 from the tricuspid valve 72 to the pulmonary valve 74 can be basically realized, while the curvature of the first arc segment 361 at the proximal end and the third arc segment 363 at the distal end are relatively small, and the first arc 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 segment 363 can further adjust the angle of the catheter 30 from the second arc segment 362 to the pulmonary valve 74 to avoid excessive bending of the second arc segment 362. By adopting three arc segments, the catheter 30 only needs to be bent three times to adapt to the shapes of the superior vena cava 71, the right ventricle 73 and the pulmonary artery 75. The catheter 30 as a whole has a small number of bends, which not only facilitates the shaping of the catheter 30, but also facilitates the delivery of the catheter 30 to a designated position 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 arc segment 361 , the proximal end of the second straight segment 365 is connected to the distal end of the third arc 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 axis of the first arc segment 361, the central axis of the second arc segment 362, and the central axis of the third arc segment 363 are not arranged in the same plane. Therefore, the central axis of the entire catheter 30 is not all located in the same plane, but is adjusted to be in multiple different planes according to the shapes of the superior vena cava 71, the right heart and the pulmonary artery 75, and 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 direction of the catheter 30.

[0163] Since the driving unit 20 is arranged 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, and the first blood port 14 is located in the right ventricle 73 or in the conus artery, it is equivalent to that the driving unit 20 is located in the right ventricle 73 or in the conus artery. Of course, the driving unit 20 can also be arranged in the right atrium without entering the pulmonary artery 75.

[0164] Further, in the embodiment of the present application, 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 smaller than the distance between the impeller 40 and the second blood port 13. Optionally, the impeller 40 is configured to be disposed in the right ventricle 73 or the conus artery.

[0165] In the embodiment of the present application, since the impeller 40 is arranged at the first blood port 14 adjacent to the second proximal end 11 of the sleeve 10, and the drive unit 20 is arranged at the second proximal end 11 of the sleeve 10, the axial distance between the impeller 40 and the drive unit 20 is shorter, and the rotational driving force transmitted to the impeller 40 by the drive unit 20 is less subject to external interference, so the loss will be smaller, and the driving force will be relatively more stable, so the impeller 40 will rotate 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 disposed in the pulmonary artery 75, it means that the portion of the entire ventricular assist device 100 in the pulmonary artery 75 is longer. 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 is prone to interference and collision with the blood vessel wall of the pulmonary artery 75. At the same time, the drive unit 20 is relatively hard and not easy to bend, which further aggravates the interference between the ventricular assist device 100 and the blood vessel wall of the pulmonary artery 75, and the blood vessel wall of the pulmonary artery 75 will be greatly squeezed and damaged. Furthermore, if the drive unit 20 is disposed in the pulmonary artery 75, it will occupy a larger volume in the pulmonary artery 75, which is likely to block the pulmonary artery 75, which is not conducive to the flow of blood in the pulmonary artery 75.

[0167] However, in the embodiment of the present application, since the drive unit 20 is located in the right ventricle 73 or the right atrium, the relatively large space of the right ventricle 73 or the right atrium is fully utilized, so that collision and interference with the blood vessel wall and the ventricular wall can be avoided, and obstruction to the flow of blood in the pulmonary artery 75 can also be avoided.

[0168] Further, the catheter 30 is configured to pass through the superior vena cava 71. Since the blood outflow outlet of the superior vena cava 71 directly faces the tricuspid valve 72, that is, the line connecting the superior vena cava 71, the tricuspid valve 72 and the right ventricle 73 is basically a straight line or a broken line with a small curvature or a curve with a small arc, when the catheter 30 passes through the superior vena cava 71 and the tricuspid valve 72 in sequence and reaches the right ventricle 73, the catheter 30 is basically not bent or only needs to be slightly bent, and the blood basically flows along the catheter 30, and the existence of the catheter 30 will hardly hinder the flow of blood. It should be noted that the catheter 30 mentioned in this embodiment that reaches the right ventricle 73 refers to when the catheter 30 extends into the right ventricle 73, and does not refer to a section of the catheter 30 that is bent in 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 there is a large angle between the direction of the blood outflow outlet of the inferior vena cava 76 and the tricuspid valve 72, the catheter 30 needs to make a large bend when passing through the tricuspid valve 72 from the inferior vena cava 76. The bending area is located in the right atrium, and the bending area will cause a large obstruction to the blood flowing out of the inferior vena cava 76, resulting in poor blood flow effect.

[0170] Please refer to Figures 19 to 21 The impeller 40 includes a hub 41 and blades 42. The blades 42 are spirally arranged on the hub 41. Along the liquid flow direction, the placement angle of the blades 42 increases first 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 position of the maximum placement angle α5 of the blades 42 is adjacent to the leading edge 421 of the blades 42. Such a configuration is conducive to increasing the radial liquid flow velocity at the outlet of the blades 42 and improving the hydraulic performance of the ventricular assist device 100. Among them, 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 the embodiment of the present application, the placement angle of the blade 42 shows an overall trend of first increasing and then decreasing, indicating that the blade 42 has a large degree of curvature. Therefore, when the length of the impeller 40 is short, the length of the flow channel formed between the blades 42 is longer, which not only ensures the hydraulic performance but also avoids the impeller 40 from being too long.

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

[0173] The following describes in detail two different shapes of impellers 40. Figures 19 to 22 A round-headed impeller 40 is shown in FIG. Figure 23 to Figure 25 4 shows a pointed impeller 40a, wherein some specific parameters of the round-headed impeller 40 and the pointed impeller 40a can be set to be different, for example, the inlet placement angle α1 of the round-headed blade 42 is 138°, and the outlet placement angle α2 of the blade 42 is 94°. The inlet placement angle α3 of the pointed blade 42a is 130°, and the outlet placement angle α4 of the blade 42a is 93°. Of course, in other embodiments, the impellers 40 with different hubs 41 can have substantially the same parameters.

[0174] The ventricular assist device 100 in the embodiment of the present application can adopt a round-headed impeller 40 or a pointed-headed impeller 40a. For the round-headed impeller 40, the distal surface 351 of the hub 41 is a spherical surface. Specifically, the distal end of the hub 41 is configured to be hemispherical, and in the direction from near to far (referring to the direction of blood flow), the outer diameter of the hub 41 gradually increases and reaches the maximum at the hemispherical position, and then gradually decreases.

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

[0176] When the pointed impeller 40a is selected, the outer diameter of the hub 41a gradually decreases along the blood flow direction, so the volume of the flow channel formed between the hub 41a and the impeller 40a gradually increases, which is conducive to the rapid flow of liquid and 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, two blades 42 are disposed on the hub 41 . Of course, in other embodiments, more blades 42 may also be disposed on the hub 41 .

[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 set in the right heart, the aperture of the superior vena cava 71 and the space at the right heart are relatively large, so the outer diameter of the impeller 40 can be set to be larger, and when ensuring performance and having a better pumping effect, the length of the impeller 40 can be set to be smaller. 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 (also referring 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 at the proximal 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 rounded 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-headed blade 42 ranges from about 173°, and the wrap angle of the pointed blade 42a ranges from about 160°. The wrap angle β of the blade 42 is defined as the angle between the line connecting the inlet edge (i.e., the leading edge 421) of the blade 42 and the center of the circle and the line connecting the outlet edge (i.e., the trailing edge 422) and the center of the circle. Such a design can ensure a higher hydraulic efficiency. According to empirical tests, when the wrap angle β of the blade 42 is too small, the impeller 40 will not do enough work and have low efficiency, that is, under the conditions of the set speed and size, the impeller 40 cannot output the required energy; and when the wrap angle β of the blade 42 is too large, the blade 42 will block the flow channel and the efficiency will decrease.

[0182] In the embodiment of the present application, 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 4.5 mm and 6 mm, indicating that the length of the blade 42 is relatively small, the degree of curvature of the blade 42 is relatively large, and the blade 42 is twisted more severely, so the structure is more compact. While meeting better hydraulic performance, the impeller 40 can have a smaller length, reducing excessive occupancy of the right ventricle 73 in the length direction.

[0183] Please refer to it again Figure 2 and Figure 9a The first blood port 14 has a first hole edge 15 which is arranged on the side closest to the second blood port 13. The leading edge 421 of the blade 42 is located between the first hole edge 15 and the second blood port 13. The leading edge 421 of the blade 42 can be flush with the first hole edge 15, or there is a certain distance between the leading edge 421 of the blade 42 and the first hole edge 15. Therefore, the blade 42 will not be exposed at the first blood port 14, and will not cause blood to be thrown out from the first blood port 14. It can be ensured that the blood enters the sleeve 10 from the first blood port 14 under the drive of the impeller 40.

[0184] Furthermore, the second distal end 12 of the cannula 10 is also provided with a positioning member 60, which can be a pigtail tube or other positioning structures, and the positioning member 60 can abut against the vessel wall of the pulmonary artery 75 to position and install the ventricular assist device 100 at a specified position. When the guide wire 80 is provided, the guide wire 80 passes through the positioning member 60.

[0185] The following describes a method for inserting the guide wire 80, but is not limited thereto:

[0186] First, the guide wire 80 is passed through the pigtail tube-shaped positioning component 60 into the sleeve 10, and then passed through the sleeve 10 from the first blood port 14. Next, the guide wire 80 is passed through the guide wire channel 34 from the opening 344, and finally passed out from the end of the guide wire 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 the present application, rather than to limit them. Although the embodiments of the present application have been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions recorded in the aforementioned embodiments, or make equivalent replacements for some of the technical features therein. However, these modifications or replacements do not deviate the essence of the corresponding technical solutions from the spirit and scope of the technical solutions of the embodiments of the embodiments of the present 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; an impeller, located in the casing; a driving unit connected to one end of the sleeve, the driving unit being further capable of driving the impeller to rotate so that blood flows between the first blood port and the second blood port; as well as, A catheter having a proximal end and a distal end, wherein the distal end is connected to an end of the drive unit away from the sleeve, and the catheter is provided with a guidewire channel, wherein the guidewire channel has an opening adjacent to the distal end so that a guidewire can be passed through the first blood port and the opening, and the guidewire is partially accommodated in the sleeve and partially accommodated in the guidewire channel.

2. The ventricular assist device according to claim 1, characterized in that: The conduit includes a first pipe segment, the first pipe segment has the distal end, the opening is arranged in the first pipe segment, the driving unit has a first cross-section, the first cross-section is perpendicular to the rotation axis of the impeller and is the maximum cross-section of the driving unit, and the orthographic projection of the first pipe segment on the plane where the first cross-section is located is located within the first cross-section.

3. The ventricular assist device according to claim 1, wherein: The conduit comprises a main body section and an extension section connected to the main body section, the main body section has a first end surface, and the opening is arranged on the first end surface; The extension section extends from the first end surface along the extension direction of the main body section, and the other end of the extension section is the distal end of the catheter; Wherein, the maximum outer diameter of the main body section at the first end surface is greater than the outer diameter of the extension section.

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

5. The ventricular assist device according to claim 4, characterized in that: The sleeve has a gradual tube section, the outer diameter of which gradually decreases in a direction close to the driving unit, and the first blood port is at least partially arranged in the gradual tube section; the maximum outer diameter of the driving unit is less than or equal to the minimum outer diameter of the gradual tube section; Alternatively, the inner diameter of the sleeve at the distal end of the first blood port is greater than the outer diameter of the sleeve 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 sleeve 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 rotation axis of the impeller is less than half of the maximum outer diameter of the drive unit.

7. The ventricular assist device according to claim 1, wherein: The conduit has a first end surface, the first end surface has an inclined surface portion inclined relative to the length direction of the conduit, and the opening is arranged on the inclined surface portion; Wherein, the distance between the inclined surface portion and the rotation axis of the impeller gradually decreases in the direction from the proximal end to the distal end; or, the entire first end surface is perpendicular to the rotation axis of the impeller.

8. The ventricular assist device according to claim 1, wherein: The guidewire channel comprises a first hole segment and a second hole segment which are arranged along the length direction of the catheter and are connected in sequence; The opening is located in the first hole segment, and the central axis of the first hole segment is parallel to or coincides with the rotation axis of the impeller; In a direction from the proximal end to the distal end, a distance between a central axis of the second hole segment and a rotation axis of the impeller gradually increases.

9. The ventricular assist device according to claim 1, wherein: 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 pipeline to pass through, and the side portion is provided with the guidewire channel. The cross section is perpendicular to the length direction of the catheter.

10. The ventricular assist device according to claim 1, wherein: The catheter can pass through the superior vena cava, and the catheter comprises a first arc segment, a second arc segment and a third arc segment connected in sequence, the first arc segment is connected to the proximal end, and the third arc segment is connected to 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 arranged in the same plane.

12. The ventricular assist device according to claim 1, wherein: The ventricular assist device further comprises a hemostatic valve for sealing the opening, wherein the hemostatic valve comprises 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 incision also has a through state for the guide wire to pass through, and in the through state, the hemostatic valve hugs and seals the guide wire.

13. The ventricular assist device according to claim 12, characterized in that: The hemostatic valve is located in the guide wire channel, and the second surface faces the opening; the second surface is provided with a groove, and the slit runs through 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 port is a blood inlet disposed in the right ventricle, and the second blood port is a blood outlet disposed in the pulmonary artery. The driving unit can drive the impeller to rotate so as to pump blood from the blood inlet to the blood outlet.

15. The ventricular assist device according to claim 14, characterized in that: The driving 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 hole edge disposed closest to the second blood port, and the leading edge of the impeller blade is located between the first hole edge and the second blood port.

17. The ventricular assist device according to claim 1, wherein: The impeller includes a hub and blades spirally arranged on the hub. Along the flow direction of the liquid, 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 position of the maximum placement angle of the blades is adjacent to the leading edge of the blades.

18. The ventricular assist device according to claim 17, characterized in that: The inlet placement angle of the blade is greater than or equal to 120° and less than or equal to 150°; and / or, The outlet placement 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, wherein: The impeller comprises 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, wherein: The impeller includes a hub and blades spirally arranged 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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