Heart valve delivery device

Abstract

The present invention provides a heart valve delivery device, wherein a handle is connected to the distal end of a catheter delivery assembly through a first drawing wire, and the handle only needs to be used to pull the first drawing wire toward the proximal end of the handle, so that the curved shape of the distal end of the catheter delivery assembly roughly conforms to the shape of the aortic arch, thereby enabling the artificial valve on the balloon to pass through the aortic arch smoothly. In addition, a sheath tube with a freely adjustable curvature and / or curvature direction is provided at the distal end of the balloon, and the handle is connected to the distal end of the sheath tube through a second drawing wire, and the second drawing wire can be slidably arranged inside the catheter delivery assembly along the axial direction of the catheter delivery assembly. After the balloon passes through the aortic arch, the handle only needs to be used to pull the second drawing wire toward the proximal end of the handle, so as to achieve adaptive adjustment of the curvature and / or curvature direction of the distal end of the sheath tube, so that the sheath tube can avoid the heart valve and quickly align with the aortic valve orifice, thereby ensuring that the artificial valve on the balloon can be directly delivered to the aortic valve orifice.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular, relates to a heart valve delivery device. Background Art

[0002] Heart valve diseases are mostly treated with transvascular technology that uses a catheter delivery assembly to deliver and implant an artificial heart valve. The artificial valve is installed in a curled state at the distal end of the catheter delivery assembly. The catheter delivery assembly advances through the patient's blood vessels to the implantation site, and the artificial valve at the distal end of the catheter delivery assembly is propped open by balloon inflation. This treatment method can effectively improve treatment efficiency and relieve patients' pain.

[0003] Currently, existing heart valve delivery devices generally use a handle to adjust the curvature of the catheter delivery assembly to adapt to the course of the blood vessels. However, after the distal end of the catheter delivery assembly passes through the aortic arch, the tip tube at the distal end of the catheter delivery assembly usually cannot be aligned with the aortic valve orifice and is easily held against the heart valve, making it difficult to quickly deliver the artificial valve at the distal end of the catheter delivery assembly to the implantation position. During the operation, a long time is required to repeatedly adjust the handle to move the distal end of the catheter delivery assembly in order to deliver the artificial valve at the distal end of the catheter delivery assembly to the implantation position, which makes the operation more difficult, affects the success rate of the operation, and increases the risk of the operation. Summary of the invention

[0004] Based on the above-mentioned problems existing in the prior art, an object of an embodiment of the present invention is to provide a heart valve delivery device to solve the technical problem existing in the prior art that the tip tube at the distal end of the catheter delivery assembly of the heart valve delivery device is easily stuck on the heart valve after passing through the aortic arch, resulting in difficulty in quickly delivering the artificial valve at the distal end of the catheter delivery assembly to the implantation position in the patient's heart.

[0005] To achieve the above object, the technical solution adopted by the present invention is: to provide a heart valve delivery device, comprising:

[0006] A balloon for loading the curled prosthetic valve in a contracted state and for expanding the prosthetic valve in an expanded state;

[0007] A catheter delivery assembly, used for delivering a balloon loaded with an artificial valve to an implantation position in a patient's heart, wherein the proximal end of the balloon is connected to the distal end of the catheter delivery assembly;

[0008] a handle connected to the proximal end of the catheter delivery assembly;

[0009] A sheath tube, used for pre-aligning and piercing the aortic valve orifice after the balloon passes through the aortic arch, the sheath tube being connected to the distal end of the balloon;

[0010] at least one first drawing wire, connecting the distal end of the catheter delivery assembly to the handle, the first drawing wire being slidably disposed inside the catheter delivery assembly along the axial direction of the catheter delivery assembly, and the first drawing wire being actuated by the handle to adjust the curvature of the distal end of the catheter delivery assembly so that the artificial valve on the balloon can pass through the aortic arch; and

[0011] at least one second drawing wire, connecting the distal end of the sheath tube to the handle, the second drawing wire being slidably disposed inside the catheter delivery assembly along the axial direction of the catheter delivery assembly;

[0012] Among them, the sheath is a soft rubber tube whose bending curvature and / or bending direction can be freely adjusted. The second drawing wire can be actuated by the handle to adjust the bending curvature and / or bending direction of the distal end of the sheath, so that the sheath can avoid the heart valve and align with the aortic valve orifice after passing through the aortic arch.

[0013] Furthermore, the handle includes a handle body connected to the proximal end of the catheter delivery assembly, a first adjustment assembly for pulling or releasing the first drawing wire, and a second adjustment assembly for pulling or releasing the second drawing wire, the first adjustment assembly includes a first positioning tube fixedly arranged inside the handle body and sleeved on the catheter delivery assembly, a first sliding member slidably arranged on the first positioning tube along the axial direction of the first positioning tube, a first adjusting knob rotatably mounted on the handle body, and a first sleeve connected to the first adjusting knob, a first internal thread is provided on the inner wall of the first sleeve, a first external thread adapted to the first internal thread is provided on the outer peripheral surface of the first sliding member, the first internal thread is screwed together with the first external thread, and the first pulling The proximal end of the wire is connected to the first sliding member, and the distal end of the first wire drawing is connected to the distal end of the catheter delivery assembly; the second adjustment assembly includes a second positioning tube fixedly arranged inside the handle body and sleeved on the catheter delivery assembly, a second sliding member slidably arranged on the second positioning tube along the axial direction of the second positioning tube, a second adjustment knob rotatably installed on the handle body and a second sleeve connected to the second adjustment knob, a second internal thread is provided on the inner wall of the second sleeve, a second external thread adapted to the second internal thread is provided on the outer peripheral surface of the second sliding member, the second internal thread is screwed together with the second external thread, the proximal end of the second wire drawing is connected to the second sliding member, and the distal end of the second wire drawing is connected to the distal end of the sheath tube.

[0014] Further, the first adjustment component is located at the distal end of the handle body, and the second adjustment component is located at the proximal end of the handle body.

[0015] Further, the catheter delivery assembly includes a first catheter for guiding the guide wire to the aortic valve orifice and passing through the balloon, a second catheter sleeved on the outside of the first catheter and passing through the balloon, a third catheter sleeved on the outside of the second catheter, a fourth catheter sleeved on the outside of the third catheter and a fifth catheter sleeved on the outside of the fourth catheter, the proximal ends of the first catheter, the second catheter, the third catheter, the fourth catheter and the fifth catheter are respectively connected to the handle body, the distal end of the sheath is connected to the distal end of the second wire, the distal end of the fourth catheter is connected to the distal end of the first wire, the distal end of the second catheter is connected to the distal end of the balloon, the distal end of the third catheter is connected to the proximal end of the balloon, and the distal ends of the fourth catheter and the fifth catheter extend to the proximal end of the balloon, respectively.

[0016] Furthermore, the second wire drawing can be axially slidably arranged in a first defined space between the first conduit and the second conduit, the first wire drawing can be axially slidably arranged in a second defined space between the fourth conduit and the fifth conduit, and the third conduit can be axially slidable along the fourth conduit and / or can be circumferentially rotatably arranged in the fourth conduit.

[0017] Furthermore, a first serpentine structure for adaptively adjusting the curvature and / or bending direction of the sheath is provided inside the sheath, the proximal end of the first serpentine structure is connected to the distal end of the first catheter and / or the second catheter, and the distal end of the second wire drawing is connected to the distal end of the first serpentine structure; or, the distal end of the first catheter and / or the second catheter is provided with a first serpentine structure for adaptively adjusting the curvature and / or bending direction of the sheath, the first serpentine structure extends into the sheath, the proximal end of the first serpentine structure is integrally formed with the distal end of the first catheter, and the distal end of the second wire drawing is connected to the distal end of the first serpentine structure.

[0018] Furthermore, the distal end of the fourth catheter is provided with a second serpentine structure for adaptively adjusting the bending curvature and / or bending direction of the distal end of the catheter delivery assembly, the proximal end of the second serpentine structure is fixedly connected to or integrally formed with the distal end of the fourth catheter, and the distal end of the first drawing wire is connected to the distal end of the second serpentine structure; or, the distal end of the fourth catheter is sleeved with a second serpentine structure for adaptively adjusting the bending curvature and / or bending direction of the distal end of the catheter delivery assembly, and the distal end of the first drawing wire is connected to the distal end of the second serpentine structure.

[0019] Further, the handle includes a handle body connected to the proximal end of the catheter delivery assembly, a first adjustment assembly for pulling or releasing the first drawwire, a second adjustment assembly for pulling or releasing the second drawwire and a third adjustment assembly for adjusting the position of the balloon, the third adjustment assembly includes a third positioning tube fixedly arranged inside the handle body and sleeved on the catheter delivery assembly, a third sliding member slidably arranged on the third positioning tube along the axial direction of the third positioning tube, an active tube connected to the third sliding member, a third adjustment knob rotatably installed on the handle body and a third sleeve connected to the third adjustment knob, a third internal thread is provided on the inner wall of the third sleeve, a third external thread matching the third internal thread is provided on the outer peripheral surface of the third sliding member, the third internal thread is screwed together with the third external thread, the active tube can be slidably installed on the third positioning tube along the axial direction, and the proximal end of the third catheter is connected to the third sliding member and / or the active tube.

[0020] Furthermore, the sheath includes an insertion tube section for matching and inserting into the interface at the distal end of the balloon, a conical tube section for aligning and inserting into the aortic valve orifice, and a bendable tube section connecting the insertion tube section and the conical tube section. The bending curvature and / or bending direction of the bendable tube section can be adaptively adjusted according to the position of the aortic valve orifice.

[0021] Furthermore, the catheter delivery assembly also includes a first stopping member for stopping the balloon, the first stopping member includes a sleeve that is sleeved and fixed on the distal end of the catheter delivery assembly and a cat's claw-shaped claw spring that is arranged at one end of the sleeve close to the balloon, and the cat's claw-shaped claw spring can clamp the proximal end of the balloon and confine it to the distal end of the catheter delivery assembly.

[0022] Compared with the prior art, the one or more technical solutions in the embodiments of the present invention have at least one of the following beneficial effects:

[0023] In the heart valve delivery device in the embodiment of the present invention, the handle is connected to the distal end of the catheter delivery assembly through a first drawwire, and the first drawwire can be slidably disposed inside the catheter delivery assembly along the axial direction of the catheter delivery assembly. The handle only needs to be used to pull the first drawwire toward the proximal end of the handle so that the curved shape of the distal end of the catheter delivery assembly roughly conforms to the shape of the aortic arch, so that the artificial valve on the balloon can smoothly pass through the aortic arch. In addition, a sheath tube with a freely adjustable curvature and / or bending direction is provided at the distal end of the balloon, and the handle is connected to the distal end of the sheath tube through a second drawwire, and the second drawwire can be slidably disposed inside the catheter delivery assembly along the axial direction of the catheter delivery assembly. After the balloon passes through the aortic arch, it is only necessary to use the handle to pull the second draw wire toward the proximal end of the handle to adaptively adjust the bending curvature and / or bending direction of the distal end of the sheath, so that the sheath can avoid the heart valve and quickly align with the aortic valve orifice, ensuring that the artificial valve on the balloon can be directly delivered to the aortic valve orifice after passing through the aortic arch, thereby shortening the operation time, reducing patient pain, improving the success rate of the operation, and reducing the risk of surgery. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] In order to more clearly illustrate the technical solutions in the embodiments of the present invention, 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 only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative labor.

[0025] Figure 1 A schematic diagram of the three-dimensional structure of a heart valve delivery device provided by an embodiment of the present invention;

[0026] Figure 2 for Figure 1 A schematic cross-sectional view of the heart valve delivery device shown in ;

[0027] Figure 3 for Figure 2 A schematic diagram of the structure of the partial enlargement of the middle A part;

[0028] Figure 4 for Figure 2 A schematic diagram of the structure of a partial enlargement of part B in the middle;

[0029] Figure 5 for Figure 2 A schematic diagram of the structure of a partial enlargement of the middle C part;

[0030] Figure 6 A schematic diagram of the three-dimensional structure of a balloon provided in an embodiment of the present invention;

[0031] Figure 7 for Figure 6 A schematic diagram of the cross-sectional structure of the balloon shown in ;

[0032] Figure 8 A schematic cross-sectional view of a catheter delivery assembly provided in an embodiment of the present invention;

[0033] Fig. 9 for Figure 8 The structural schematic diagram of the local enlargement of the D part in the middle;

[0034] Fig.10 Another schematic diagram of the three-dimensional structure of the heart valve delivery device provided by the embodiment of the present invention;

[0035] Fig.11 A schematic cross-sectional view of a handle provided in an embodiment of the present invention;

[0036] Fig.12 for Fig.11 The schematic diagram of the structure of the partial enlargement of the E part in the middle;

[0037] Fig.13 Another schematic diagram of the three-dimensional structure of the heart valve delivery device provided by the embodiment of the present invention;

[0038] Fig.14 Another schematic diagram of the three-dimensional structure of the heart valve delivery device provided by the embodiment of the present invention;

[0039] Fig.15 A schematic diagram of the three-dimensional structure of a handle provided in an embodiment of the present invention;

[0040] Fig.16 A schematic diagram of the three-dimensional structure of a first locking member provided in an embodiment of the present invention;

[0041] Fig.17 An exploded view of a handle provided by an embodiment of the present invention;

[0042] Fig.18 A schematic diagram of the three-dimensional structure of a second locking member provided in an embodiment of the present invention;

[0043] Fig.19 An exploded view of a first adjustment assembly provided by an embodiment of the present invention;

[0044] Fig. 20 An exploded view of a catheter delivery assembly provided in accordance with an embodiment of the present invention.

[0045] Among them, the reference numerals in the figure are:

[0046] 1-balloon; 11-first conical capsule; 12-second conical capsule; 13-columnar capsule; 14-anti-slip step;

[0047] 2-catheter delivery assembly; 21-first catheter; 22-second catheter; 23-third catheter; 24-fourth catheter; 25-fifth catheter; 26-delivery channel; 27-injection tube; 28-exhaust channel; 29-blood discharge valve;

[0048] 3-handle; 31-handle body; 311-first hand-held part; 312-second hand-held part; 313-tightening member; 32-first adjustment assembly; 321-first positioning tube; 322-first sliding member; 323-first adjustment knob; 324-first sleeve; 325-first internal thread; 326-first external thread; 327-first guide column; 328-first guide groove; 329-first strip avoidance hole; 33-second adjustment assembly; 331-second positioning tube; 332-second sliding member Component; 333-second adjusting knob; 334-second sleeve; 335-second internal thread; 336-second external thread; 337-second guide column; 338-second guide groove; 339-second strip-shaped avoidance hole; 34-third adjusting component; 341-third positioning tube; 342-third sliding component; 343-third adjusting knob; 344-third sleeve; 345-third internal thread; 346-third external thread; 347-third guide column; 348-third guide groove; 349-movable tube;

[0049] 4-sheath; 41-cannula section; 42-conical tube section; 43-bendable tube section;

[0050] 5-first wire drawing; 6-second wire drawing;

[0051] 7-first stopper; 71-sleeve; 72-cat's claw spring;

[0052] 8-second retaining member; 9-first snake-bone structure; 10-second snake-bone structure; 20-artificial valve. DETAILED DESCRIPTION

[0053] In order to make the technical problems, technical solutions and beneficial effects to be solved by the present invention more clearly understood, the present invention is further described in detail below in conjunction with the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not intended to limit the present invention.

[0054] It should be noted that when an element is referred to as being "connected to" or "set on" another element, it can be directly on the other element or indirectly on the other element. When an element is referred to as being "connected to" another element, it can be directly connected to the other element or indirectly connected to the other element. In addition, the terms "first", "second" and "third" are used for descriptive purposes only and cannot be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Therefore, the features defined as "first", "second" and "third" can explicitly or implicitly include one or more of the features. In the description of the present invention, the meaning of "multiple" is two or more, unless otherwise clearly and specifically defined. The meaning of "multiple" is one or more, unless otherwise clearly and specifically defined. In the description of the present invention, it should be noted that, unless otherwise clearly specified and defined, the terms "installed", "connected" and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements. For those skilled in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0055] Reference throughout the specification to "one embodiment" or "an embodiment" means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present application. Thus, when the phrases "in one embodiment," "in some embodiments," or "in some of these embodiments" appear in various places throughout the specification, not all references are to the same embodiment. Furthermore, in one or more embodiments, the particular features, structures, or characteristics may be combined in any suitable manner.

[0056] Please also read Figures 1 to 20 The heart valve delivery device provided by the embodiment of the present invention is now described. The heart valve delivery device provided by the embodiment of the present invention is used to deliver an artificial valve 20 or a valve stent to the heart of a patient. Figure 1 , Figure 2 and Fig. 20 The heart valve delivery device provided in the embodiment of the present invention includes a balloon 1, a catheter delivery assembly 2, a handle 3, a sheath 4, at least one first drawwire 5 and at least one second drawwire 6. The artificial valve 20 is sleeved on the contracted balloon 1. The balloon 1 is used to load the curled artificial valve 20 in the contracted state and to expand the artificial valve 20 in the expanded state.

[0057] Please refer to further Figure 6 and Figure 7The balloon 1 comprises a first conical capsule body 11 constituting the distal end of the balloon 1, a second conical capsule body 12 constituting the proximal end of the balloon 1, and a columnar capsule body 13 disposed between the first conical capsule body 11 and the second conical capsule body 12 to constitute the middle part of the balloon 1, and the artificial valve 20 is sleeved on the columnar capsule body 13. The sheath tube 4 is disposed at the distal end of the balloon 1, and the sheath tube 4 is a soft rubber tube with a freely adjustable bending curvature and / or bending direction, and the soft rubber tube is a conical tube made of medical polymer materials. After the balloon 1 loaded with the artificial valve 20 passes through the aortic arch, the sheath tube 4 can be pre-aligned and pierced into the aortic valve orifice, so that the balloon 1 and the artificial valve 20 at the distal end of the catheter delivery component 2 can be smoothly delivered to the aortic valve orifice, thereby using the catheter delivery component 2 to deliver the balloon 1 to achieve delivery of the artificial valve 20 or valve stent to the patient's heart transplantation position.

[0058] Please refer to further Figure 2 , Fig.13 , Fig.14 and Fig. 20 The catheter delivery component 2 is used to deliver the balloon 1 loaded with an artificial valve 20 to the implantation position of the patient's heart. The proximal end of the balloon 1 is connected to the distal end of the catheter delivery component 2, and the handle 3 is connected to the proximal end of the catheter delivery component 2. The handle 3 is connected to the distal end of the catheter delivery component 2 by at least one first drawwire 5, and the first drawwire 5 can be slidably penetrated into the interior of the catheter delivery component 2 along the axial direction of the catheter delivery component 2. The first drawwire 5 can be pulled toward the proximal end of the handle 3 by the handle 3, and the first drawwire 5 can pull the distal end of the catheter delivery component 2 back toward the proximal end of the handle 3, so that the part of the catheter delivery component 2 close to its distal end is bent, and the curvature of the distal part of the catheter delivery component 2 can be adjusted by adjusting the moving distance of the first drawwire 5, until the curved shape of the distal part of the catheter delivery component 2 roughly conforms to the shape of the aortic arch, so that the artificial valve 20 on the balloon 1 can pass through the aortic arch smoothly.

[0059] Please refer to further Figure 2 , Fig.13 , Fig.14 and Fig. 20 The handle 3 is connected to the distal end of the sheath 4 through at least one second drawwire 6, and the second drawwire 6 can be slidably disposed inside the catheter delivery assembly 2 along the axial direction of the catheter delivery assembly 2. After the balloon 1 loaded with the artificial valve 20 passes through the aortic arch, the second drawwire 6 can be pulled by the handle 3 to achieve adaptive adjustment of the curvature and / or bending direction of the distal end of the sheath 4, so that the sheath 4 after passing through the aortic arch can avoid the heart valve and quickly align with the aortic valve orifice, thereby preventing the sheath 4 from abutting against the heart valve and causing the artificial valve 20 on the balloon 1 to be unable to be delivered to the implantation position.

[0060] It should be noted that the distal end of the catheter delivery assembly 2 refers to the end of the catheter delivery assembly 2 that is close to or facing the operator, and the proximal end of the catheter delivery assembly 2 refers to the end of the catheter delivery assembly 2 that is close to or facing the patient's heart. Similarly, the proximal end of the handle 3, the proximal end of the sheath 4, the proximal end of the first wire drawing 5, the proximal end of the second wire drawing 6, etc. all refer to the end of the corresponding component that is close to or facing the operator, and the distal end of the handle 3, the distal end of the sheath 4, the distal end of the first wire drawing 5, the distal end of the second wire drawing 6, etc. all refer to the end of the corresponding component that is close to or facing the patient's heart. In addition, it can be understood that the number of the first wire drawing 5 can be set to one, two or more, and the number of the first wire drawing 5 can be reasonably set according to the actual use requirements of the catheter delivery assembly 2. When the number of the first wire drawing 5 is two, the handle 3 can be used to control the catheter delivery assembly 2 to bend and deform in two different dimensions, so as to avoid frequent rotation of the catheter delivery assembly 2 in the patient's blood vessel and realize that the shape of the distal end of the catheter delivery assembly 2 is roughly consistent with the shape of the aortic arch. When the number of the first drawing wires 5 is multiple, the handle 3 can be used to control the catheter delivery assembly 2 to bend and deform in multiple different dimensions. It is not necessary to rotate the catheter delivery assembly 2 in the patient's blood vessel to quickly realize that the shape of the distal end of the catheter delivery assembly 2 roughly conforms to the shape of the aortic arch, shortening the operation time, reducing the patient's pain, and reducing the risk of surgery. Similarly, the number of the second drawing wires 6 can be set to one, two, or more, and the number of the second drawing wires 6 can be reasonably set according to the actual use requirements of the sheath 4 to adjust the curvature or dimension. When the number of the second drawing wires 6 is multiple, the handle 3 can be used to control the sheath 4 to bend in multiple different dimensions. It is not necessary to rotate the catheter delivery assembly 2 in the patient's blood vessel to quickly realize that the distal end of the sheath 4 is bent in a direction away from the heart valve, shortening the operation time, reducing the patient's pain, and reducing the risk of surgery.

[0061] Compared with the prior art, the heart valve delivery device provided by the embodiment of the present invention has a handle 3 connected to the distal end of the catheter delivery component 2 through a first wire 5, and the first wire 5 can be slidably disposed inside the catheter delivery component 2 along the axial direction of the catheter delivery component 2. The handle 3 only needs to be used to pull the first wire 5 toward the proximal end of the handle 3, so that the curved shape of the distal end of the catheter delivery component 2 roughly conforms to the shape of the aortic arch, so that the artificial valve 20 on the balloon 1 can smoothly pass through the aortic arch. In addition, a sheath 4 with a freely adjustable curvature and / or bending direction is provided at the distal end of the balloon 1, and the handle 3 is connected to the distal end of the sheath 4 through a second wire 6, and the second wire 6 can be slidably disposed inside the catheter delivery component 2 along the axial direction of the catheter delivery component 2. After the balloon 1 passes through the aortic arch, it is only necessary to use the handle 3 to pull the second drawwire 6 toward the proximal end of the handle 3 to adaptively adjust the bending curvature and / or bending direction of the distal end of the sheath 4, so that the sheath 4 can avoid the heart valve and quickly align with the aortic valve orifice, ensuring that the artificial valve 20 on the balloon 1 can be directly delivered to the aortic valve orifice after passing through the aortic arch, thereby shortening the operation time, reducing the patient's pain, improving the success rate of the operation, and reducing the risk of the operation.

[0062] Please refer to Figure 2 , Fig.10 and Fig.11 In some embodiments, the handle 3 includes a handle body 31, a first adjustment component 32 and a second adjustment component 33. The handle body 31 is connected to the proximal end of the catheter delivery component 2, and the first adjustment component 32 and the second adjustment component 33 are arranged on the handle body 31. In this way, the first draw wire 5 can be pulled or released by the first adjustment component 32, so that the curved shape of the distal end of the catheter delivery component 2 roughly conforms to the shape of the aortic arch, so that the artificial valve 20 on the balloon 1 can pass through the aortic arch smoothly. At the same time, the second draw wire 6 can be pulled or released by the second adjustment component 33 to achieve adaptive adjustment of the curvature and / or bending direction of the distal end of the sheath tube 4, so that the sheath tube 4 can avoid the heart valve and quickly align with the aortic valve orifice.

[0063] Please refer to Figure 3 , Fig.17 and Fig.19In some embodiments, the first adjustment component 32 includes a first positioning tube 321, a first sliding member 322, a first adjustment knob 323 and a first sleeve 324. The first positioning tube 321 is fixedly arranged inside the handle body 31 and sleeved on the catheter delivery component 2. The first sliding member 322 can be slidably arranged on the first positioning tube 321 along the axial direction of the first positioning tube 321. The first adjustment knob 323 is movably installed on the handle body 31. The first sleeve 324 is connected to or integrally formed with the first adjustment knob 323. A first internal thread 325 is provided on the inner wall of the first sleeve 324. A first external thread 326 adapted to the first internal thread 325 is provided on the outer peripheral surface of the first sliding member 322. The first sliding member 322 is located in the first sleeve 324 so that the first internal thread 325 is screwed with the first external thread 326. The proximal end of the first wire drawing 5 is connected to the first sliding member 322, and the distal end of the first wire drawing 5 is connected to the distal end of the catheter delivery component 2. Please refer to further Fig.13 and Fig.14 When the first adjustment knob 323 is rotated clockwise, the first sliding member 322 moves toward the proximal end of the handle 3, and at the same time, the first sliding member 322 pulls the first draw wire 5 toward the proximal end of the handle 3, so that the shape of the distal end of the catheter delivery component 2 is roughly consistent with the shape of the aortic arch, so that the artificial valve 20 on the balloon 1 can pass through the aortic arch smoothly. When the first adjustment knob 323 is rotated counterclockwise, the first sliding member 322 moves toward the distal end of the handle 3, and at the same time, the first draw wire 5 is released toward the distal end of the handle 3, so that the curved catheter delivery component 2 returns to a straight shape.

[0064] Please refer to Fig.15 , Fig.17 and Fig.19 In some embodiments, a first guide post 327 is provided on the first sleeve 324, and a first guide groove 328 is provided on the first sliding member 322 for sliding and inserting the first guide post 327. Under the guidance of the first guide post 327 and the first guide groove 328, the first sliding member 322 is prevented from shaking or jamming with the first positioning tube 321 during the sliding process, so that the first adjustment component 32 of the handle 3 can smoothly and quickly adjust the curvature of the distal end of the catheter delivery component 2, and effectively improve the adjustment accuracy of the first adjustment component 32 of the handle 3 on the curvature of the catheter delivery component 2, which is conducive to shortening the operation time and improving the operation efficiency. It should be noted that a first strip-shaped avoidance hole 329 is provided on the first positioning tube 321 to avoid the first wire drawing 5, so as to avoid the first positioning tube 321 from interfering with the movement of the first wire drawing 5.

[0065] Please refer to Fig.17In some embodiments, at least two first guide posts 327 are protruding from the first sleeve 324, and corresponding first guide grooves 328 are respectively provided on the inner side wall of the first sliding sleeve at positions corresponding to the first guide posts 327. Each first guide post 327 can be slidably installed in the corresponding first guide groove 328, so as to guide the first sliding sleeve to slide stably and smoothly along the first positioning tube 321, and effectively prevent the first sliding sleeve from shaking or getting stuck with the first positioning tube 321 during the sliding process.

[0066] Please refer to Fig.17 In some embodiments, two first guide posts 327 are convexly provided on the first sleeve 324, and the central axis of the first positioning tube 321 is used as the symmetry axis, and the two first guide posts 327 are symmetrically arranged on the first positioning tube 321. It can be understood that in other embodiments, a plurality of first guide posts 327 are convexly provided on the first sleeve 324, and the plurality of first guide posts 327 are distributed at intervals along the circumference of the first sleeve 324, and the distance between two adjacent first guide posts 327 is equal, which can enhance the balanced stability of the force on the first sliding sleeve.

[0067] Please refer to Figure 5 , Fig.12 and Fig.17 In some embodiments, the second adjustment component 33 includes a second positioning tube 331, a second sliding member 332, a second adjustment knob 333 and a second sleeve 334. The second positioning tube 331 is fixedly arranged inside the handle body 31 and sleeved on the catheter delivery assembly 2. The second sliding member 332 can be slidably arranged on the second positioning tube 331 along the axial direction of the second positioning tube 331. The second adjustment knob 333 is movably installed on the handle body 31. The second sleeve 334 is connected to or integrally formed with the second adjustment knob 333. A second internal thread 335 is provided on the inner wall of the second sleeve 334. A second external thread 336 adapted to the second internal thread 335 is provided on the outer peripheral surface of the second sliding member 332. The second sliding member 332 is located in the second sleeve 334. The second internal thread 335 is screwed with the second external thread 336. The proximal end of the second wire drawing 6 is connected to the second sliding member 332, and the distal end of the second wire drawing 6 is connected to the distal end of the sheath tube 4. Please refer to further Fig.13 and Fig.14When the second adjustment knob 333 is rotated clockwise, the second sliding member 332 moves toward the proximal direction of the handle 3, and at the same time, the second sliding member 332 pulls the second drawing wire 6 toward the proximal direction of the handle 3, so that the sheath tube 4 is bent in the direction away from the active valve and aligned with the aortic valve orifice, so that the bending curvature and / or bending direction of the distal end of the sheath tube 4 are adaptively adjusted according to the position of the active valve, so that the sheath tube 4 can avoid the heart valve and quickly align with the aortic valve orifice, ensuring that the artificial valve 20 on the balloon 1 can be directly delivered to the aortic valve orifice after passing through the aortic arch. When the second adjustment knob 333 is rotated counterclockwise, the second sliding member 332 moves toward the distal direction of the handle 3, and at the same time, the second drawing wire 6 is released toward the distal direction of the handle 3, so that the bent sheath tube 4 returns to a straight shape.

[0068] Please refer to Fig.17 In some embodiments, the second sleeve 334 is provided with a second guide column 337 whose axis is parallel to the axis of the second sleeve 334, and the second sliding member 332 is provided with a second guide groove 338 for sliding and inserting the second guide column 337. Under the guidance of the second guide column 337 and the second guide groove 338, the second sliding member 332 is prevented from shaking or jamming with the second positioning tube 331 during the sliding process, so that the second adjustment component 33 of the handle 3 can smoothly and quickly adjust the curvature of the sheath tube 4, and effectively improve the adjustment accuracy of the curvature of the sheath tube 4 by the second adjustment component 33 of the handle 3, which is conducive to shortening the operation time and improving the operation efficiency. It should be noted that the second positioning tube 331 is provided with a second strip-shaped avoidance hole 339 for avoiding the second wire drawing 6, so as to avoid the second positioning tube 331 interfering with the movement of the second wire drawing 6 when the second sliding member 332 pulls the second wire drawing 6 to move.

[0069] Please refer to Figure 1 , Figure 2 and Fig.10 In some embodiments, the first adjustment component 32 is located at the distal end of the handle body 31, and the second adjustment component 33 is located at the proximal end of the handle body 31, so that the first adjustment component 32 can be operated to pull or release the first drawing wire 5, and the second adjustment component 33 can be operated to pull or release the second drawing wire 6. It should be noted that the first drawing wire 5 and / or the second drawing wire 6 can be, but are limited to, braided stainless steel wires.

[0070] Please refer to Fig.10 , Fig.15 and Fig.17In some embodiments, the handle body 31 includes a first hand-held portion 311, a second hand-held portion 312 connected to the first hand-held portion 311, and a tightening member 313 for tightening the catheter delivery assembly 2 to the distal end of the first hand-held portion 311. The tightening member 313 is arranged at the distal end of the first hand-held portion 311, and the second hand-held portion 312 is located at the proximal end of the first hand-held portion 311. The second hand-held portion 312 is fixedly connected to an end of the movable tube 349 away from the first hand-held portion 311, so that the second hand-held portion 312 is connected to the first hand-held portion 311 through the movable tube 349. At this time, the third sliding member 342 can drive the second hand-held portion 312 and / or the movable tube 349 to move axially along the third positioning tube 341.

[0071] Please refer to Figure 8 , Fig. 9 and Fig. 20 In some embodiments, the catheter delivery assembly 2 includes a first catheter 21, a second catheter 22, a third catheter 23, a fourth catheter 24 and a fifth catheter 25. The first catheter 21 is used to guide the guide wire to the aortic valve orifice and pass through the balloon 1. The second catheter 22 is sleeved on the outside of the first catheter 21. The second catheter 22 passes through the balloon 1 and extends to the distal end of the balloon 1 and / or the distal end of the sheath 4. The third catheter 23 is sleeved on the outside of the second catheter 22. The fourth catheter 24 is sleeved on the outside of the third catheter 23. The fifth catheter 25 is sleeved on the outside of the fourth catheter 24. The proximal ends of the first catheter 21, the second catheter 22, the third catheter 23, the fourth catheter 24 and the fifth catheter 25 are respectively connected to the handle body 31. Specifically, the proximal end of the first catheter 21 and the proximal end of the second catheter 22 are fixedly connected to the second hand-held portion 312 of the handle body 31 through a fixed tube, the proximal end of the third catheter 23 is fixedly connected to the second hand-held portion 312 of the handle body 31 through the movable tube 349 of the third adjustment component 34 and / or the injection tube 27, the proximal end of the fourth catheter 24 and the proximal end of the fifth catheter 25 are fixedly connected to the first hand-held portion 311 of the handle body 31 through the first positioning tube 321 of the first adjustment component 32, the distal end of the sheath 4 is connected to the distal end of the second wire 6, the distal end of the first catheter 21 extends to the inside of the sheath 4, the distal end of the fourth catheter 24 is connected to the distal end of the first wire 5, the distal end of the second catheter 22 is connected to the distal end of the balloon 1 and / or the distal end of the sheath 4, the distal end of the third catheter 23 is connected to the proximal end of the balloon 1, and the distal ends of the fourth catheter 24 and the fifth catheter 25 extend to the proximal end of the balloon 1 respectively.

[0072] In some embodiments, the second wire 6 can be axially slidably disposed in the first limited space between the first catheter 21 and the second catheter 22, and the first limited space can limit the second wire 6, which can effectively prevent the second wire 6 from bending. The first wire 5 can be axially slidably disposed in the second limited space between the fourth catheter 24 and the fifth catheter 25, and the second limited space can limit the first wire 5, which can effectively prevent the first wire 5 from bending. The third catheter 23 can be axially slidably disposed in the fourth catheter 24, and the proximal end of the third catheter 23 is fixedly connected to the movable tube 349 and / or the second hand-held part 312. The third catheter 23 can be driven to slide axially along the fourth catheter 24 by the third adjustment component 34 of the handle 3, so as to achieve axial movement of the balloon 1 and accurately adjust the position of the balloon 1 or "fine-tune" the position of the artificial valve 20. And / or, the third catheter 23 can be rotatably arranged in the fourth catheter 24 along the circumferential direction of the fourth catheter 24, and the proximal end of the third catheter 23 is fixedly connected to the movable tube 349 and / or the second hand-held part 312. The third catheter 23 can be driven by the second hand-held part 312 of the handle 3 to produce circumferential rotation relative to the fourth catheter 24, thereby realizing the rotation of the sheath tube 4 on the balloon 1.

[0073] Please refer to Figure 2 and Figure 8 In some embodiments, a first snake-bone structure 9 for adaptively adjusting the curvature and / or bending direction of the sheath 4 is provided inside the sheath 4, the proximal end of the first snake-bone structure 9 is connected to the distal end of the first catheter 21 and / or the second catheter 22, and the distal end of the second drawwire 6 is connected to the distal end of the first snake-bone structure 9. In this embodiment, by providing the first snake-bone structure 9 inside the sheath 4, the bending direction and / or bending angle of the sheath 4 can be adjusted by the second drawwire 6 only by pulling or releasing the second drawwire 6, which is convenient to adjust and has strong stability.

[0074] Please refer to Figure 2 and Figure 8 In some other embodiments, the distal end of the first catheter 21 and / or the second catheter 22 is provided with a first snake bone structure 9 for adaptively adjusting the curvature and / or bending direction of the sheath 4, the first snake bone structure 9 extends into the sheath 4, the proximal end of the first snake bone structure 9 is integrally formed with the distal end of the first catheter 21, and the distal end of the second wire drawing 6 is connected to the distal end of the first snake bone structure 9. Please refer to Figure 8 and Fig. 20In some embodiments, the distal end of the fourth catheter 24 is provided with a second snake-bone structure 10 for adaptively adjusting the curvature and / or bending direction of the distal end of the catheter delivery assembly 2, the proximal end of the second snake-bone structure 10 is fixedly connected or integrally formed with the distal end of the fourth catheter 24, and the distal end of the first wire drawing 5 is connected with the distal end of the second snake-bone structure 10. In this embodiment, by arranging the second snake-bone structure 10 at the distal end of the fourth catheter 24, the bending direction and / or bending angle of the distal end of the fourth catheter 24 can be adjusted by the first wire drawing 5 only by pulling or releasing the first wire drawing 5, which is convenient to adjust and has strong stability. In addition, due to the arrangement of the second snake-bone structure 10, the bending adjustment of the distal end of the fourth catheter 24 has a wide range of applications, adapts to the impact of blood, and avoids the distal end of the fourth catheter 24 from touching and interfering with peripheral blood vessels when the bending is adjusted, which can effectively prevent the balloon 1 from being flushed out by high-pressure blood, reduce the burden on patients, and improve the success rate of surgery.

[0075] Please refer to Figure 8 and Fig. 20 In some other embodiments, the distal end of the fourth catheter 24 is provided with a second serpentine structure 10 for adaptively adjusting the bending curvature and / or bending direction of the distal end of the catheter delivery assembly 2, and the distal end of the first drawing wire 5 is connected to the distal end of the second serpentine structure 10, so that the bending adjustment of the distal end of the fourth catheter 24 has a wide range of applications and can adapt to the impact of blood, and avoid the fourth catheter 24 The distal end of the catheter 24 is touched and interfered with peripheral blood vessels when the distal end is greatly bent, and can effectively prevent the balloon 1 from being flushed out by high-pressure blood, thereby reducing the burden on patients and improving the success rate of the operation.

[0076] Please refer to Figure 1 , Figure 2 and Fig.10 In some embodiments, the handle 3 includes a handle body 31, a first adjustment component 32, a second adjustment component 33 and a third adjustment component 34. The handle body 31 is connected to the proximal end of the catheter delivery component 2. The first adjustment component 32 is used to pull or release the first draw wire 5, the second adjustment component 33 is used to pull or release the second draw wire 6, and the third adjustment component 34 is used to adjust the position of the balloon 1 to accurately adjust the position of the balloon 1 or "fine-tune" the position of the artificial valve 20. For details, please refer to Fig.13 and Fig.14When the first adjustment knob 323 is rotated clockwise, the first sliding member 322 moves toward the proximal end of the handle 3, and at the same time, the first sliding member 322 pulls the first draw wire 5 toward the proximal end of the handle 3, so that the fourth catheter 24 near the distal end is bent in a shape that roughly conforms to the shape of the aortic arch, so that the artificial valve 20 on the balloon 1 can pass through the aortic arch smoothly. When the first adjustment knob 323 is rotated counterclockwise, the first sliding member 322 moves toward the distal end of the handle 3, and at the same time, the second draw wire 6 is released toward the distal end of the handle 3, so that the bent fourth catheter 24 returns to a straight shape. Please refer to further Fig.13 and Fig.14 When the second adjustment knob 333 is rotated clockwise, the second sliding member 332 moves toward the proximal direction of the handle 3, and at the same time, the second sliding member 332 pulls the second drawing wire 6 toward the proximal direction of the handle 3, so that the sheath 4 bends in a direction away from the active valve and aligned with the aortic valve orifice, thereby adaptively adjusting the bending curvature and / or bending direction of the distal end of the sheath 4 according to the position of the active valve, so that the sheath 4 can avoid the heart valve and quickly align with the aortic valve orifice, ensuring that the artificial valve 20 on the balloon 1 can be directly delivered to the aortic valve orifice after passing through the aortic arch. When the second adjustment knob 333 is rotated counterclockwise, the second sliding member 332 moves toward the distal direction of the handle 3, and at the same time, the second drawing wire 6 is released toward the distal direction of the handle 3, so that the bent sheath 4 returns to a straight shape. Please refer to further. Figure 1 and Fig.10 When the third adjustment knob 343 is rotated clockwise, the third sliding member 342 moves toward the proximal direction of the handle 3, and at the same time, the third sliding member 342 pulls the third catheter 23 toward the proximal direction of the handle 3, so that the balloon 1 at the distal end of the third catheter 23 moves toward the proximal direction of the handle 3. When the third adjustment knob 343 is rotated counterclockwise, the third sliding member 342 moves toward the distal direction of the handle 3, and at the same time, the third sliding member 342 pushes the third catheter 23 toward the distal direction of the handle 3, so that the balloon 1 at the distal end of the third catheter 23 moves toward the proximal direction of the handle 3.

[0077] Please refer to Figure 2 , Figure 4 and Fig.15In some embodiments, the third adjustment component 34 includes a third positioning tube 341, a third sliding member 342, a movable tube 349, a third adjustment knob 343 and a third sleeve 344. The third positioning tube 341 is fixedly arranged inside the handle body 31 and sleeved on the catheter delivery component 2. The third sliding member 342 can be slidably arranged on the third positioning tube 341 along the axial direction of the third positioning tube 341. The movable tube 349 is connected to the third sliding member 342. The third adjustment knob 343 is movably installed on the handle body 31. The sleeve 344 is connected to or integrally formed with the third adjustment knob 343, a third internal thread 345 is provided on the inner wall of the third sleeve 344, a third external thread 346 matching the third internal thread 345 is provided on the outer circumferential surface of the third sliding member 342, the third sliding member 342 is located in the third sleeve 344, the third internal thread 345 is screwed with the third external thread 346, the movable tube 349 can be axially slidably installed on the third positioning tube 341, and the proximal end of the third catheter 23 is connected to the third sliding member 342 and / or the movable tube 349. When the third adjustment knob 343 is rotated clockwise, the third sliding member 342 moves toward the proximal end of the handle 3, and at the same time, the third sliding member 342 pulls the third catheter 23 to move toward the proximal end of the handle 3, so that the balloon 1 at the distal end of the third catheter 23 moves toward the proximal end of the handle 3. When the third adjusting knob 343 is rotated counterclockwise, the third sliding member 342 moves toward the distal end of the handle 3 , and at the same time, the third sliding member 342 pushes the third catheter 23 to move toward the distal end of the handle 3 , so that the balloon 1 at the distal end of the third catheter 23 moves toward the proximal end of the handle 3 .

[0078] Please refer to Fig.17 In some embodiments, the third sleeve 344 is provided with a third guide post 347 whose axial direction is parallel to the axial direction of the third sleeve 344, and the third sliding member 342 is provided with a third guide groove 348 for sliding insertion of the third guide post 347. Since the third sleeve 344 is provided with a third guide post 347 whose axial direction is parallel to the axial direction of the third sleeve 344, and the third sliding member 342 is provided with a third guide groove 348 for sliding insertion of the third guide post 347, the third sliding member 342 is guided by the third guide post 347 and the third guide groove 348 to avoid shaking or jamming between the third sliding member 342 and the third positioning tube 341 during the sliding process, so that the third adjustment component of the handle 3 can smoothly and quickly adjust the curvature of the sheath tube 4, and effectively improve the adjustment accuracy of the third adjustment component 34 of the handle 3 on the position of the balloon 1, which is conducive to shortening the operation time and improving the operation efficiency.

[0079] Please refer to Figure 6 and Figure 8In some embodiments, the sheath tube 4 includes an insertion tube section 41 for matching and inserting into the interface at the distal end of the balloon 1, a tapered tube section 42 for aligning and piercing the aortic valve orifice, and a bendable tube section 43 connecting the insertion tube section 41 and the tapered tube section 42, and the first snake bone structure is placed inside the bendable tube section 43. The second drawing wire 6 is pulled by the second adjustment component 33, so that the bending curvature and / or bending direction of the bendable tube section 43 can be adaptively adjusted according to the position of the aortic valve orifice, so that the sheath tube 4 can avoid the heart valve and quickly align with the aortic valve orifice, ensuring that the artificial valve 20 on the balloon 1 can be directly delivered to the aortic valve orifice after passing through the aortic arch.

[0080] Please refer to Figure 6 , Figure 7 and Fig.16 In some embodiments, the catheter delivery assembly 2 further includes a first stopper 7 for stopping the balloon 1 and / or the artificial valve 20. The first stopper 7 includes a sleeve 71 sleeved and fixed to the distal end of the catheter delivery assembly 2 and a cat's claw-shaped claw spring 72 provided at one end of the sleeve 71 close to the balloon 1. The cat's claw-shaped claw spring 72 can clamp the proximal end of the balloon 1 and limit it to the distal end of the catheter delivery assembly 2. Specifically, the distal end of the fourth catheter 24 is fixedly provided with the first stopper 7 for stopping the balloon 1 and / or the artificial valve 20. The artificial valve 20 is sandwiched between the first stopper 7 and the distal end of the balloon 1. The balloon 1 loaded with the artificial valve 20 can be delivered to the patient's heart through the catheter delivery assembly 2 via the blood vessels. In this embodiment, before the balloon 1 is delivered to the implantation position or during the operation, the third catheter 23 is pulled by the third adjustment component 34, and the balloon 1 is pulled toward the first locking member 7 by the third catheter 23 until the proximal end of the balloon 1 is engaged and confined in the cat-claw-shaped claw spring 72 of the first locking member 7, which can overcome the impact of high-pressure blood on the balloon 1 and prevent the artificial valve 20 on the balloon 1 from being unloaded.

[0081] Please refer to Figure 6 , Figure 7 and Fig.10 In some embodiments, the first retaining member 7 is located outside the balloon 1, and the first retaining member 7 is arranged near the proximal end of the artificial valve 20. During the operation, even if the artificial valve 20 is displaced or slipped from the balloon 1 due to the impact of high-pressure blood flow or the obstruction of calcified heart valves, since the first retaining member 7 is located outside the balloon 1, the third catheter 23 is driven by the handle 3 to axially contract in the fourth catheter 24, so that the first retaining member 7 at the distal end of the fourth catheter 24 approaches and abuts against the artificial valve 20, and the artificial valve 20 can be reloaded on the balloon 1, effectively preventing the artificial valve 20 from being unloaded from the balloon 1 and making it impossible for the artificial valve 20 to be retracted.

[0082] Please refer to Figure 7 and Figure 8 In some embodiments, the catheter delivery assembly 2 also includes a second locking member 8 for locking the artificial valve 20 to prevent the artificial valve 20 from being unloaded from the balloon 1. The second locking member 8 is arranged on the second catheter 22 and is adjacent to the distal end of the artificial valve 20. When the third catheter 23 pulls the balloon 1 back, the artificial valve 20 loaded on the balloon 1 can be clamped between the first locking member 7 and the second locking member 8, which can effectively prevent the artificial valve 20 from being unloaded from the balloon 1 during delivery, thereby improving the stability of the artificial valve 20 loaded on the balloon 1.

[0083] Please refer to Figure 8 , Fig.10 and Fig.18 In some embodiments, the second stopper 8 is disposed inside the balloon 1. After the balloon 1 contracts, the second stopper 8 props up the distal end of the balloon 1 to form an anti-slip step 14 on the balloon 1 to stop the artificial valve 20. When the third catheter 23 pulls the balloon 1 back, the artificial valve 20 loaded on the balloon 1 can be sandwiched between the first stopper 7 and the anti-slip step 14, which can effectively prevent the artificial valve 20 from being unloaded from the balloon 1 during transportation, thereby improving the stability of the artificial valve 20 loaded on the balloon 1.

[0084] Please refer to Fig. 9 , Fig.11 and Fig.12 In some embodiments, a delivery channel 26 for delivering fluid medium to the balloon 1 is formed between the third catheter 23 and the second catheter 22, one end of the delivery channel 26 is connected to the balloon 1, and the other end of the delivery channel 26 is connected to the injection tube 27. After the balloon 1 with the artificial valve 20 enters the heart valve, a syringe is used to inject gas and / or saline into the injection tube 27, and the gas and / or saline is delivered to the balloon 1 through the delivery channel 26, so that the balloon 1 expands, and the expanded balloon 1 can open the artificial valve 20. After the operation is completed, the gas and / or saline in the balloon 1 can be slowly extracted by the syringe, so that the balloon 1 shrinks and separates from the artificial valve 20, and then the handle 3 is slowly adjusted to separate the catheter delivery assembly 2 from the patient.

[0085] Please refer to Fig. 9 , Fig.10 and Fig.11 In some embodiments, an exhaust channel 28 is formed between the fourth conduit 24 and the fifth conduit 25, and the exhaust channel 28 is connected to the blood discharge valve 29 through a connecting pipe, so that the gas and / or blood during the operation can be discharged through the blood discharge valve 29. The second wire drawing 6 can be axially slidably arranged in the second limited space between the fourth conduit 24 and the fifth conduit 25, effectively preventing the second wire drawing 6 from bending.

[0086] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions and improvements made within the spirit and principles of the present invention should be included in the protection scope of the present invention.

Claims

1. A heart valve delivery device, characterized in that: include: A balloon for loading the curled prosthetic valve in a contracted state and for expanding the prosthetic valve in an expanded state; A catheter delivery assembly, used for delivering a balloon loaded with an artificial valve to an implantation position in a patient's heart, wherein the proximal end of the balloon is connected to the distal end of the catheter delivery assembly; a handle connected to the proximal end of the catheter delivery assembly; A sheath tube, used for pre-aligning and piercing the aortic valve orifice after the balloon passes through the aortic arch, the sheath tube being connected to the distal end of the balloon; At least one first drawing wire connects the distal end of the catheter delivery assembly to the handle, the first drawing wire can be slidably disposed inside the catheter delivery assembly along the axial direction of the catheter delivery assembly, and the first drawing wire is actuated by the handle to adjust the curvature of the distal end of the catheter delivery assembly so that the artificial valve on the balloon can pass through the aortic arch; as well as at least one second drawing wire, connecting the distal end of the sheath tube to the handle, the second drawing wire being slidably disposed inside the catheter delivery assembly along the axial direction of the catheter delivery assembly; Wherein, the sheath is a soft rubber tube whose bending curvature and / or bending direction can be freely adjusted, and the second drawing wire is actuated by the handle to adjust the bending curvature and / or bending direction of the distal end of the sheath, so that the sheath can avoid the heart valve and align with the aortic valve orifice after passing through the aortic arch; the handle includes a handle body connected to the proximal end of the catheter delivery assembly, a first adjustment assembly for pulling or releasing the first drawing wire and a second adjustment assembly for pulling or releasing the second drawing wire, the first adjustment assembly includes a first positioning tube fixedly arranged inside the handle body and sleeved on the catheter delivery assembly, a first sliding member slidably arranged on the first positioning tube along the axial direction of the first positioning tube, a first adjusting knob rotatably installed on the handle body and a first sleeve connected to the first adjusting knob, the inner wall of the first sleeve is provided with a first internal thread, the outer periphery of the first sliding member A first external thread matched with the first internal thread is provided on the surface, the first internal thread is screwed together with the first external thread, the proximal end of the first wire is connected to the first sliding member, and the distal end of the first wire is connected to the distal end of the catheter delivery assembly; the second adjustment assembly includes a second positioning tube fixedly arranged inside the handle body and sleeved on the catheter delivery assembly, a second sliding member slidably arranged on the second positioning tube along the axial direction of the second positioning tube, a second adjustment knob rotatably installed on the handle body and a second sleeve connected to the second adjustment knob, a second internal thread is provided on the inner wall of the second sleeve, a second external thread matched with the second internal thread is provided on the outer peripheral surface of the second sliding member, the second internal thread is screwed together with the second external thread, the proximal end of the second wire is connected to the second sliding member, and the distal end of the second wire is connected to the distal end of the sheath tube.

2. The heart valve delivery device according to claim 1, characterized in that: The first adjustment component is located at the distal end of the handle body, and the second adjustment component is located at the proximal end of the handle body.

3. The heart valve delivery device according to claim 1, characterized in that: The catheter delivery assembly includes a first catheter for guiding the guide wire to the aortic valve orifice and passing through the balloon, a second catheter sleeved on the outside of the first catheter and passing through the balloon, a third catheter sleeved on the outside of the second catheter, a fourth catheter sleeved on the outside of the third catheter and a fifth catheter sleeved on the outside of the fourth catheter. The proximal ends of the first catheter, the second catheter, the third catheter, the fourth catheter and the fifth catheter are respectively connected to the handle body, the distal end of the sheath is connected to the distal end of the second wire, the distal end of the fourth catheter is connected to the distal end of the first wire, the distal end of the second catheter is connected to the distal end of the balloon, the distal end of the third catheter is connected to the proximal end of the balloon, and the distal ends of the fourth catheter and the fifth catheter extend to the proximal end of the balloon, respectively.

4. The heart valve delivery device according to claim 3, characterized in that: The second wire drawing can be axially slidably arranged in a first defined space between the first conduit and the second conduit, the first wire drawing can be axially slidably arranged in a second defined space between the fourth conduit and the fifth conduit, and the third conduit can be axially slidable along the fourth conduit and / or can be circumferentially rotatably arranged in the fourth conduit.

5. The heart valve delivery device according to claim 3, characterized in that: A first serpentine structure for adaptively adjusting the curvature and / or bending direction of the sheath is provided inside the sheath, the proximal end of the first serpentine structure is connected to the distal end of the first catheter and / or the second catheter, and the distal end of the second wire drawing is connected to the distal end of the first serpentine structure; or, the distal end of the first catheter and / or the second catheter is provided with a first serpentine structure for adaptively adjusting the curvature and / or bending direction of the sheath, the first serpentine structure extends into the sheath, the proximal end of the first serpentine structure is integrally formed with the distal end of the first catheter, and the distal end of the second wire drawing is connected to the distal end of the first serpentine structure.

6. The heart valve delivery device according to claim 3, characterized in that: The distal end of the fourth catheter is provided with a second serpentine structure for adaptively adjusting the bending curvature and / or bending direction of the distal end of the catheter delivery assembly, the proximal end of the second serpentine structure is fixedly connected to or integrally formed with the distal end of the fourth catheter, and the distal end of the first drawing wire is connected to the distal end of the second serpentine structure; or, the distal end of the fourth catheter is sleeved with a second serpentine structure for adaptively adjusting the bending curvature and / or bending direction of the distal end of the catheter delivery assembly, and the distal end of the first drawing wire is connected to the distal end of the second serpentine structure.

7. The heart valve delivery device according to claim 3, characterized in that: The handle includes a handle body connected to the proximal end of the catheter delivery assembly, a first adjustment assembly for pulling or releasing the first drawwire, a second adjustment assembly for pulling or releasing the second drawwire and a third adjustment assembly for adjusting the position of the balloon, the third adjustment assembly includes a third positioning tube fixedly arranged inside the handle body and sleeved on the catheter delivery assembly, a third sliding member slidably arranged on the third positioning tube along the axial direction of the third positioning tube, an active tube connected to the third sliding member, a third adjustment knob rotatably installed on the handle body and a third sleeve connected to the third adjustment knob, a third internal thread is provided on the inner wall of the third sleeve, a third external thread adapted to the third internal thread is provided on the outer peripheral surface of the third sliding member, the third internal thread is screwed together with the third external thread, the active tube can be slidably installed on the third positioning tube along the axial direction, and the proximal end of the third catheter is connected to the third sliding member and / or the active tube.

8. The heart valve delivery device according to any one of claims 1 to 6, characterized in that: The sheath tube includes an insertion tube section for matching and inserting into the interface at the distal end of the balloon, a tapered tube section for aligning and piercing the aortic valve orifice, and a bendable tube section connecting the insertion tube section and the tapered tube section. The bending curvature and / or bending direction of the bendable tube section can be adaptively adjusted according to the position of the aortic valve orifice.

9. The heart valve delivery device according to any one of claims 1 to 6, characterized in that: The catheter delivery assembly also includes a first stopping member for stopping the balloon, the first stopping member includes a sleeve that is sleeved and fixed on the distal end of the catheter delivery assembly and a cat's claw-shaped claw spring that is arranged at one end of the sleeve close to the balloon, and the cat's claw-shaped claw spring can clamp the proximal end of the balloon and confine it to the distal end of the catheter delivery assembly.

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