Tricuspid chordae tendineae cutter and artificial heart valve regurgitation device

Abstract

This invention relates to a tricuspid chordae tendineae cutter and an artificial heart valve regurgitation device. The tricuspid chordae tendineae cutter comprises: a capturing tube with a hook-shaped structure at its distal end for capturing the chordae tendineae; and a cutting tube with a cutting portion at its distal end, which cooperates with the hook-shaped structure to cut the chordae tendineae. One of the capturing tube and the cutting tube is movably fitted over the other. The tricuspid chordae tendineae cutter proposed in this invention can artificially create conditions for tricuspid regurgitation, providing a cardiac experimental structure similar to that of a patient with tricuspid regurgitation for evaluating the safety and effectiveness of artificial heart valves.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a tricuspid valve chordae tendineae cutter and an artificial heart valve regurgitation device. Background Technology

[0002] This section provides only background information relevant to this disclosure and is not necessarily prior art.

[0003] Due to congenital developmental abnormalities or acquired diseases, the tricuspid valve is prone to problems such as tricuspid stenosis and tricuspid regurgitation. The former reduces blood flow from the atria to the ventricles, while the latter causes tricuspid regurgitation; both can lead to serious heart diseases such as heart failure and other complications. Tricuspid valve disease commonly occurs in elderly patients, and the prevalence rate is very high. Clinically, the common solution is to replace the diseased valve with an artificial heart valve.

[0004] Transcatheter tricuspid valves must undergo animal testing to assess their safety and efficacy before clinical trials can begin. Clinical trials involve patients with tricuspid regurgitation whose heart structure has significantly altered, exhibiting symptoms such as decreased cardiac function and heart failure. Animal subjects, on the other hand, are animals with normal cardiac function, such as pigs and sheep. These differences in cardiac function and structure result in significant variations in the effectiveness of the artificial valve implanted in the tricuspid valve of the experimental subjects. For example, in patients, implantation of an artificial valve can lead to a significant improvement in cardiac function, while in animals, cardiac function may only recover to its pre-implantation state at best.

[0005] Therefore, in order to better evaluate the safety and effectiveness of artificial tricuspid valves in animals, it is necessary to artificially create a tricuspid regurgitation environment in animals and simulate the heart structure of patients with tricuspid regurgitation in animals, so as to more accurately evaluate the safety and effectiveness after implantation of artificial heart valves in animals.

[0006] In summary, there is a need for a device that can artificially induce tricuspid regurgitation in animals. Summary of the Invention

[0007] The purpose of this invention is to provide a device for artificially inducing tricuspid regurgitation. This purpose is achieved through the following technical solution:

[0008] According to a first aspect of the present invention, a tricuspid valve chordae tendineae cutter is provided, the tricuspid valve chordae tendineae cutter comprising: a capturing tube having a hook-shaped structure at its distal end for capturing the chordae tendineae; and a cutting tube having a cutting portion at its distal end for cooperating with the hook-shaped structure for cutting the chordae tendineae; wherein one of the capturing tube and the cutting tube is movably fitted over the other.

[0009] In some embodiments of the present invention, the hook-shaped structure includes a receiving groove for accommodating the tendineae, the receiving groove forming a first opening on the proximal side; the capturing tube is provided with a clearance groove located on the proximal side of the hook-shaped structure and communicating with the receiving groove, the clearance groove forming a second opening on the circumferential wall of the capturing tube.

[0010] In some embodiments of the present invention, the tricuspid chordae tendineae cutter further includes a push-pull member that is axially movable relative to the capture tube; the distal end of the capture tube is provided with a blocking portion located on one side of the proximal end of the hook-shaped structure, and when the distal end of the push-pull member passing through the blocking portion in the axial direction abuts against the blocking portion, the blocking portion prevents the push-pull member from continuing to move proximally relative to the blocking portion.

[0011] In some embodiments of the present invention, the capturing tube is provided with a limiting groove extending along the axial direction, and the blocking part is a groove-shaped structure provided at the distal end of the limiting groove, the distal end of the groove-shaped structure being open; the push-pull member includes a body part and a push-pull head provided at the distal end of the body part, the body part being movably inserted through the limiting groove, and when the push-pull head enters the groove-shaped structure through the opening, the groove-shaped structure prevents the push-pull head from moving towards the proximal end relative to the groove-shaped structure.

[0012] In some embodiments of the present invention, the blocking part is a plate-shaped structure arranged in the radial direction, and the blocking part is provided with a through hole; the push-pull member includes a body part and a push-pull head disposed at the distal end of the body part, the body part is movably disposed through the through hole, the push-pull head is located on one side of the distal end of the plate-shaped structure, and when the proximal end of the push-pull head abuts against the plate-shaped structure, the plate-shaped structure prevents the push-pull head from moving towards the proximal end relative to the blocking part.

[0013] In some embodiments of the present invention, the hook-shaped structure includes a hook shank, a hook bottom, and a hook end connected in sequence, the hook end being the free end of the hook-shaped structure, the hook shank, the hook bottom, and the hook end jointly defining the receiving groove, the depth and / or width of the receiving groove being less than the diameter of the primary tendon cord and greater than or equal to the diameter of the secondary tendon cord; the distal end face of the push-pull head can abut against the proximal end of the hook end.

[0014] In some embodiments of the present invention, a first sensor is provided on the distal end face of the push-pull head, and a second sensor is provided on the proximal end of the hook end. The first sensor and the second sensor have an abutting state and a separated state. When the first sensor and the second sensor are in the abutting state, the first sensor and the second sensor output tendon capture information.

[0015] In some embodiments of the present invention, the push-pull head is provided with a first developing mark, and the hook handle is provided with a plurality of second developing marks corresponding to the first developing mark.

[0016] In some embodiments of the present invention, the tricuspid valve chordae tendineae cutter further includes: a propulsion member, the distal end of which is connected to the proximal end of the capture tube, the propulsion member being helical in shape and sleeved inside the cut tube.

[0017] In some embodiments of the present invention, when the distal end of the push-pull member abuts against the blocking part, and when the push-pull member continues to be subjected to a force toward the proximal end, the push-pull member can cause the capturing tube to bend to one side.

[0018] In some embodiments of the present invention, the outer surface of the capturing tube is provided with a plurality of grooves, each groove being spaced apart along the axial direction of the capturing tube and located between the proximal end face and the distal end face of the capturing tube; and / or the outer surface of the cutting tube is provided with a plurality of grooves, each groove being spaced apart along the axial direction of the cutting tube and located between the proximal end face and the distal end face of the cutting tube.

[0019] According to a second aspect of the present invention, an artificial heart valve regurgitation device is also proposed, wherein the artificial heart valve regurgitation device includes the tricuspid valve chordae tendineae cutter as described in any one of the first aspects of the present invention.

[0020] The tricuspid chordae tendineae cutter proposed in this invention is placed in the right ventricle of the heart via interventional means. The hook-shaped structure captures the chordae tendineae, and the cutting part is used in conjunction with the hook-shaped structure to cut part of the chordae tendineae, thereby artificially creating an environment for tricuspid regurgitation. This provides a cardiac experimental structure similar to that of patients with tricuspid regurgitation for evaluating the safety and effectiveness of artificial heart valves. Attached Figure Description

[0021] Various other advantages and benefits will become apparent to those skilled in the art upon reading the following detailed description of preferred embodiments. The accompanying drawings are for illustrative purposes only and are not intended to limit the invention. Furthermore, the same reference numerals denote the same parts throughout the drawings. In the drawings:

[0022] Figure 1 A schematic diagram illustrating the process of chordae tendineae cutter intervention in the heart according to an embodiment of the present invention is shown.

[0023] Figure 2 A schematic diagram of the internal structure of the heart is shown.

[0024] Figure 3A schematic diagram of the structure of a chordae tendon cutter according to one embodiment of the present invention is shown.

[0025] Figure 4 A schematic diagram of the structure of a chordae tendon cutter according to one embodiment of the present invention is shown.

[0026] Figure 5 A schematic diagram of the structure of a chordae tendon cutter according to one embodiment of the present invention is shown.

[0027] Figure 6 schematically shown Figure 5 An enlarged schematic diagram of part A in the middle;

[0028] Figure 7 A partial structural schematic diagram of a chordae tendon cutter according to one embodiment of the present invention is shown schematically;

[0029] Figure 8 A schematic diagram of a capture tube and hook-like structure according to an embodiment of the present invention is shown.

[0030] Figure 9 A schematic diagram of a capture tube and hook-like structure according to an embodiment of the present invention is shown.

[0031] Figure 10 A schematic diagram illustrating the state of a chordae tendineae captured by a chordae tendineae cutter according to an embodiment of the present invention is shown.

[0032] Figure 11 A partial structural schematic diagram of a chordae tendon cutter according to one embodiment of the present invention is shown schematically;

[0033] Figure 12 A schematic diagram of the structure of a tendon cutter according to another embodiment of the present invention is shown;

[0034] Figure 13 A partial structural schematic diagram of a chordae tendon cutter according to one embodiment of the present invention is shown schematically;

[0035] Figure 14 A schematic diagram of the structure of a cutting tube according to one embodiment of the present invention is shown.

[0036] Figure 15 A schematic diagram of the structure of a chordae tendon cutter according to one embodiment of the present invention is shown.

[0037] Figure 16 A partial cross-sectional structural schematic diagram of a chordae tendon cutter according to an embodiment of the present invention is shown schematically;

[0038] Figure 17 A schematic diagram of a chordae tendon cutter from an axial perspective is shown according to one embodiment of the present invention;

[0039] Figure 18 A schematic diagram of a tendon cutter from an axial perspective is shown according to another embodiment of the present invention;

[0040] Figure 19 A schematic diagram of the structure of a capture element according to one embodiment of the present invention is shown;

[0041] Figure 20 A schematic diagram of a chordae tendon cutter from a three-dimensional perspective is shown according to one embodiment of the present invention;

[0042] Figure 21 A partial structural schematic diagram of a chordae tendon cutter according to one embodiment of the present invention is shown schematically;

[0043] Figure 22 A schematic diagram of a hook-shaped structure according to an embodiment of the present invention is shown.

[0044] Figure 23 A partial structural schematic diagram of a chordae tendon cutter according to one embodiment of the present invention is shown schematically;

[0045] Figure 24 A schematic diagram of the capture tube and capture element from a first perspective according to an embodiment of the present invention is shown.

[0046] Figure 25 A schematic diagram of the capture tube and capture element from a second perspective is shown according to an embodiment of the present invention.

[0047] The attached figures are labeled as follows:

[0048] 1' Chordus tendinus, 11' Primary chordae tendinus, 12' Secondary chordae tendinus, 2' Anterior leaflet, 3' Posterior leaflet, 4' Papillary muscle;

[0049] 100-chordae tendon cutter;

[0050] 10-Hook-shaped structure; 11-Catching element; 111-Connecting part; 1111 First segment; 1112 Second segment; 112-Catching part; 1121-Connecting end; 1122-Free end; 1123-Head segment; 1124-Filtering segment; 1125-Tail segment; 1126-First support rod; 1127-Second support rod; 12-Hook handle; 121-Second developing mark; 13-Hook bottom; 14-Hook end; 141-Guide surface; 15-Accommodation groove; 151-First opening;

[0051] 20 - Cutting section;

[0052] 30-Capturing tube, 31-First straight handle, 311-Through groove, 3111-First sidewall, 3112-Second sidewall, 32-First curved part, 33-First carrier part, 34-Avoiding groove, 341-Second opening, 35-Blocking part, 36-Limiting groove;

[0053] 40-Cutting tube, 41-Second straight handle, 42-Second curved section, 43-Second carrier section;

[0054] 50-Push-pull component, 51-Main body, 52-Push-pull head, 521-First developing mark;

[0055] 60 - Propulsion component;

[0056] 101-First gap, 102-Second gap, 1021-First segment, 1022-Second segment, 1023-Third segment, 1024-Groove;

[0057] 201 Outer sheath. Detailed Implementation

[0058] Exemplary embodiments of the present disclosure will now be described in more detail with reference to the accompanying drawings. While exemplary embodiments of the present disclosure are shown in the drawings, it should be understood that the present disclosure may be implemented in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the disclosure to those skilled in the art.

[0059] It should be understood that the terminology used herein is for the purpose of describing particular exemplary embodiments only and is not intended to be limiting. Unless the context clearly indicates otherwise, the singular forms “a,” “an,” and “described” as used herein may also include the plural forms. The terms “comprising,” “including,” “containing,” and “having” are inclusive and therefore indicate the presence of the stated features, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, steps, operations, elements, components, and / or combinations thereof. The method steps, processes, and operations described herein are not construed as requiring them to be performed in a particular order described or illustrated unless the order of performance is explicitly indicated. It should also be understood that additional or alternative steps may be used.

[0060] Although terms such as first, second, third, etc., may be used in this document to describe multiple elements, components, regions, layers, and / or segments, these elements, components, regions, layers, and / or segments should not be limited by these terms. These terms may be used only to distinguish one element, component, region, layer, or segment from another. Unless the context clearly indicates otherwise, terms such as "first," "second," and other numerical terms used herein do not imply order or sequence. Therefore, the first element, component, region, layer, or segment discussed below may be referred to as the second element, component, region, layer, or segment without departing from the teachings of the exemplary embodiments.

[0061] For ease of description, spatial relative terms may be used in the text to describe the relationship of one element or feature relative to another element or feature, as shown in the figure. These relative terms include, for example, "inside," "outside," "middle," "outer," "below," "below," "above," "over," etc. Such spatial relative terms are intended to include different orientations of the device in use or operation, other than those depicted in the figure. For example, if the device in the figure is flipped, an element described as "below other elements or features" or "below other elements or features" would subsequently be oriented as "above other elements or features" or "above other elements or features." Therefore, the example term "below" can include both upper and lower orientations. The device may be otherwise oriented (rotated 90 degrees or in other directions), and the spatial relative descriptors used in the text will be interpreted accordingly.

[0062] It should be noted that the terms "distal" and "proximal" are used as directional terms, which are commonly used in the field of interventional medical devices. "Distal" refers to the end furthest from the operator during the procedure, while "proximal" refers to the end closest to the operator. Axial direction refers to the direction parallel to the line connecting the center of the distal and proximal ends of the medical device; radial direction refers to the direction perpendicular to the aforementioned axial direction.

[0063] Please combine Figure 1 , Figure 3 and Figure 10 As shown, according to an embodiment of the present invention, a chordae tendineae cutter is proposed.

[0064] The chordae tendineae cutter includes a capture tube 30 and a cutting tube 40. A hook-shaped structure 10 is provided at the distal end of the capture tube 30, and a cutting section 20 is provided at the distal end of the cutting tube 40. Specifically, the hook-shaped structure 10 is used to hook and capture the chordae tendineae. During the procedure, the hook-shaped structure 10 and the cutting section 20 can be pushed into the left ventricle of the experimental subject's (experimental animal's) heart via the capture tube 30 and the cutting tube 40, respectively, either through interventional or open-chest surgery. For example, during interventional procedures, a puncture can be made at a location on the carotid artery, a guidewire can be inserted, and the guidewire can be pushed into the aorta, crossing the aortic valve and entering the left ventricle. The chordae tendineae cutter is moved to the left ventricle via a guidewire-established path. After X-ray angiography confirms its location, the hook structure 10 is released from the outer sheath. The hook structure 10 is moved proximally by manipulating the capture tube 30 externally to hook and capture the chordae tendineae. During manual manipulation, the tension exerted by the chordae tendineae on the capture tube 30 after hooking the hook structure 10 is clearly felt, allowing the operator to accurately determine whether capture has been completed using X-ray angiography. The cutting tube 40 is then moved axially relative to the capture tube 30, causing the cutting section 20 to engage with the hook structure 10 to sever the captured chordae tendineae. After severing, the cutter is retracted into the outer sheath and withdrawn from the body along its original path. This interventional method of chordae tendineae cutting eliminates the need for open-chest surgery and cardiac puncture, reducing damage during regurgitation of the animal's heart valves. Furthermore, by severing at least part of the chordae tendineae, an environment for mitral regurgitation is artificially created, providing a cardiac experimental structure similar to that of patients with mitral regurgitation for evaluating the safety and effectiveness of artificial heart valves.

[0065] In some implementations, such as Figure 4 and Figure 10 As shown, the outer diameter of the capturing tube 30 is smaller than the inner diameter of the cutting tube 40. The cutting tube 40 is movably sleeved outside the capturing tube 30. When the cutting tube 40 is pushed to move relative to the capturing tube 30 in the axial direction, the cutting part 20 engages with the hook-shaped structure 10, cutting the chordae tendineae that are captured and bound on the hook-shaped structure 10, thereby artificially creating an environment for mitral regurgitation. In this embodiment, the middle section of the chordae tendineae is hooked onto the hook-shaped structure 10, and both ends of the chordae tendineae are located outside the capturing tube 30. Since the cutting tube 40 is sleeved outside the capturing tube 30, the inner surface of the cutting tube 40 engages with the outer peripheral surface of the hook-shaped structure 10. When the cutting tube 40 is pushed to the position of the chordae tendineae, the cutting part 20 and the outer peripheral surface of the hook-shaped structure 10 compress and cut the chordae tendineae.

[0066] In other embodiments, the inner diameter of the capturing tube 30 is larger than the outer diameter of the cutting tube 40. The capturing tube 30 is movably sleeved outside the cutting tube 40. When the cutting tube 40 is pushed to move relative to the capturing tube 30 in the axial direction, the cutting part 20 engages with the hook-shaped structure 10, cutting the chordae tendineae captured and bound on the hook-shaped structure 10, thereby artificially creating an environment for mitral regurgitation. In this embodiment, the cutting part 20 needs to be configured to match the shape of the inner wall of the hook-shaped structure 10 so that the cutting part 20 can extend into the hook-shaped structure 10. When the hook-shaped structure 10 hooks the chordae tendineae, the middle section of the chordae tendineae is placed transversely inside the hook-shaped structure 10. Pushing the cutting tube 40 distally allows the cutting part 20 to extend into the hook-shaped structure 10 and cut the chordae tendineae.

[0067] In some embodiments, when the cutting part 20 and the hook-shaped structure 10 are engaged, the cutting part 20 and the hook-shaped structure 10 abut against each other to sever the chordae tendineae. In other embodiments, when the cutting tube 40 and the hook-shaped structure 10 are engaged, the gap between the cutting part 20 and the hook-shaped structure 10 is smaller than the diameter of the secondary chordae tendineae, to ensure that the cutting part 20 and the hook-shaped structure 10 can sever the secondary chordae tendineae. The specific size of the gap between the cutting part 20 and the hook-shaped structure 10 needs to be determined based on the size of the secondary chordae tendineae of the experimental subject. If the experimental subject is a larger animal such as a cow or sheep, the engagement gap between the cutting part 20 and the hook-shaped structure 10 can be set to a larger size; if the experimental subject is a smaller animal such as a rabbit, the engagement gap between the cutting part 20 and the hook-shaped structure 10 can be set to a smaller size. No specific limitation is made here.

[0068] It should be noted that, as Figure 3 and Figure 4 As shown, the hook-shaped structure 10 can be a structure with an approximate hook shape formed at the distal end of the capture tube 30 by cutting off part of the tube wall of the capture tube 30 through a cutting process. Alternatively, the hook-shaped structure 10 can also be independently processed and fixed to the distal end of the capture tube 30 by means of bonding, welding, fusion bonding, or indirect fixing through connectors.

[0069] In some embodiments of the present invention, such as Figure 8 and Figure 9As shown, the hook-shaped structure 10 has a receiving groove 15, the depth direction of which extends along the axial direction. A first opening 151 is formed on the proximal side of the receiving groove 15. During the capture of the tendineae, by pulling the capturing tube 30 to move proximally, the tendineae enter the receiving groove 15 from the first opening 151 and are confined to the bottom wall of the receiving groove 15 (the bottom wall of the receiving groove 15 refers to the wall that is axially opposite to the first opening 151), thereby completing the capture of the tendineae. Furthermore, to increase the success rate of a single capture, a clearance groove 34 is provided on the capture tube 30. The clearance groove 34 is located on one side of the proximal end of the hook-shaped structure 10 and communicates with the receiving groove 15. The clearance groove 34 forms a second opening 341 on the circumferential wall of the capture tube 30. Since the second opening 341 is located on the circumferential wall of the capture tube 30, based on actual needs, the opening length of the second opening 341 is greater than the opening length of the first opening 151, so that the tendineae can more easily enter the clearance groove 34 through the second opening 341 and enter the receiving groove 15 under the guidance of the bottom wall of the clearance groove 34, thereby improving the success rate of a single capture.

[0070] The opening length of the second opening 341 refers to the distance between the proximal edge and the distal edge of the second opening 341 along the axial direction. The opening length of the first opening 151 refers to the distance between the opposite edges of the first opening 151 along the circumferential direction.

[0071] In this embodiment, the bottom wall of the clearance groove 34 is flush with or smoothly transitions to one side wall of the receiving groove 15, so that the bottom wall of the clearance groove 34 has a guiding function, so that after the tendon enters the clearance groove 34, it smoothly slides into the receiving groove 15 under the guidance of the bottom wall of the clearance groove 34, thereby completing the capture of the tendon.

[0072] Furthermore, such as Figure 5 and Figure 6 As shown, the capturing tube 30 is provided with a blocking part 35, which is located in the clearance groove 34 (please refer to...). Figure 8The chordae tendon cutter is positioned proximal to the second opening 341. The chordae tendon cutter also includes a push-pull member 50, which comprises a body portion 51 and a push-pull head 52 located distal to the body portion 51. The body portion 51 is a bendable rod-shaped structure, axially positioned and movable relative to the capture tube 30. The proximal end of the body portion 51 extends from the proximal end of the capture tube 30 to facilitate operator control of the axial movement of the body portion 51, and the distal end of the body portion 51 extends through the blocking portion 35. The axial movement of the body portion 51 drives the push-pull head 52 to reciprocate between the blocking portion 35 and the hook-shaped structure 10. The proximal end face of the push-pull head 52 abuts against the blocking portion 35. When the body portion 51 is pushed to move distally relative to the capture tube 30, the push-pull head 52 moves away from and separates from the blocking portion 35. When the main body 51 is pulled to move proximally relative to the capture tube 30, the push-pull head 52 approaches and abuts against the blocking part 35. It should be noted that when the push-pull head 52 abuts against the blocking part 35, and the main body 51 is continuously pulled proximally, because the blocking part 35 is located near the second opening 341, the distal end of the capture tube 30 bends towards the side of the second opening 341, causing the side of the second opening 341 facing proximally to tilt. This makes it easier for the tendon chord to enter the clearance groove 34 from the second opening 341 when the capture tube 30 is pulled proximally, thereby increasing the probability of tendon chord capture.

[0073] The blocking part 35 and the push-pull head 52 can be configured in various structural forms. For example, the push-pull head 52 and the blocking part 35 can be a groove structure and a protrusion structure that cooperate with each other, respectively. The push-pull head 52 and the blocking part 35 can also be baffle structures that abut against each other. No specific limitation is given here.

[0074] It should be noted that mild to moderate mitral regurgitation does not have a significant immediate impact on the heart and will not cause immediate death. However, as the regurgitation progresses, it may gradually develop into a severe mitral regurgitation environment, leading to severe pulmonary congestion, heart failure, and other symptoms. Figure 1 and Figure 2 As shown, chordae tendineae are cord-like collagen fibers connecting the anterior leaflet 2', posterior leaflet 3', and papillary muscle 4'. Chordae tendineae 1' are generally classified into three grades according to their origin. Chordae tendineae originating directly from papillary muscle 4' are called primary chordae tendineae 11', which are relatively thick. Branches of primary chordae tendineae 11' are called secondary chordae tendineae 12'. Branches of secondary chordae tendineae 12' are called tertiary chordae tendineae (not shown in the figure). Rupture or elongation of primary chordae tendineae 11' will cause significant mitral valve prolapse and severe valvular regurgitation, potentially leading to death in a short period. Rupture of secondary chordae tendineae 12' can cause mild prolapse and mild valvular insufficiency. Rupture of tertiary chordae tendineae generally does not cause significant impact. To achieve moderate regurgitation while ensuring no harm to the animal's life, rupture of secondary chordae tendineae 12' is a better option.

[0075] To enable the chordae tendon cutter provided by the present invention to produce mild to moderate reflux, the chordae tendon cutter provided by the present invention is further provided with a structure or fitting for screening primary and secondary chordae tendons.

[0076] Understandably, the screening of primary and secondary chordae tendineae can take other forms. The technical solution of the present invention will be further described in detail below with reference to specific embodiments.

[0077] Implementation Method 1

[0078] In this embodiment, please refer to Figure 5 , Figure 7 and Figure 8 As shown, the chordae tendon cutter includes a capturing tube 30, a cutting tube 40, and a push-pull component 50. The capturing tube 30 is sleeved over the cutting tube 40. The distal end of the capturing tube 30 has a hook-shaped structure 10, which is formed at the distal end of the capturing tube 30 by removing part of the tube wall through a cutting process. The distal end of the cutting tube 40 has a cutting section 20 (please refer to...). Figure 10 A sharp edge is formed at the distal end of the cutting section 20 to increase the sharpness of the cutting section 20, so as to facilitate smoother cutting of the tendineae.

[0079] The hook-shaped structure 10 includes a hook shank portion 12, a hook bottom portion 13, and a hook end portion 14 connected in sequence. The hook end portion 14 is the free end of the hook-shaped structure 10. The hook shank portion 12, the hook bottom portion 13, and the hook end portion 14 together define a receiving groove 15. The receiving groove 15 opens on the proximal side to form a first opening 151. Through a cutting process, the hook-shaped structure 10 and a clearance groove 34 located on the proximal side of the hook-shaped structure 10 are integrally formed on the capturing tube 30. The clearance groove 34 forms a second opening 341 on the circumferential wall of the capturing tube 30, allowing the tendineae to enter the receiving groove 15 through the second opening 341 and the first opening 151.

[0080] It should be noted that there can be one or more hook ends 14. For example, in this embodiment, the chordae tendineae capture head 10 has two hook ends 14, and from the distal to the proximal direction, the two hook ends 14 are inclined in a direction away from each other in the circumferential (or transverse) direction, which helps to improve the efficiency of capturing chordae tendineae. The proximal end of the hook end 14 is relatively smooth to prevent it from piercing the heart wall.

[0081] like Figure 6As shown, the wall of the capturing tube 30 is provided with a limiting groove 36 extending in the axial direction. The limiting groove 36 extends from the proximal end of the capturing tube 30 to the side wall of the clearance groove 34, and a blocking part 35 is formed at the distal end of the limiting groove 36. The blocking part 35 is specifically a groove-shaped structure formed on the side wall of the clearance groove 34, and the opening of the blocking part 35 faces the distal end. The push-pull member 50 includes a body part 51 and a push-pull head 52. The body part 51 is movably disposed in the limiting groove 36, and the moving direction of the body part 51 is limited by the limiting groove 36. The body part 51 is rod-shaped, and the push-pull head 52 is a protrusion-shaped structure that cooperates with the groove-shaped structure.

[0082] In other implementations, such as Figure 11 As shown, the blocking part 35 is a plate-shaped structure located at the far end of the capturing tube 30. A through hole 351 is provided on the blocking part 35, through which the main body part 51 passes. The push-pull head 52 is also a plate-shaped structure, and the diameter of the push-pull head 52 is larger than the diameter of the through hole 352. The plate surface on the proximal side of the push-pull head 52 abuts against the plate surface on the far side of the blocking part 35.

[0083] In this embodiment, such as Figure 7 , Figure 8 As shown, along the axial direction, the depth D of the receiving groove 15 is less than the diameter of the primary tendon cord and greater than or equal to the diameter of the secondary tendon cord. The depth D of the receiving groove 15 is the distance from the first opening 151 to the bottom wall of the receiving groove 15. When the tendon cord is in the receiving groove 15, due to the larger diameter of the primary tendon cord, part of the tendon cord will protrude from the first opening 151. The distal end face of the push-pull head 52 abuts against the proximal end of the hook end 14. After hooking the tendon cord, by pushing the push-pull head 52 toward the distal end, if the secondary tendon cord is hooked into the receiving groove 15, the distal end of the push-pull head 52 can abut against the proximal end of the hook end 14. If the primary tendon cord is hooked into the receiving groove 15, the distal end of the push-pull head 52 directly presses against the primary tendon cord, so that the distal end of the push-pull head 52 cannot abut against the proximal end of the hook end 14. Therefore, the operator can determine the type of tendineae captured based on the above two situations.

[0084] Furthermore, the minimum width L of the receiving groove 15 is less than the diameter of the primary tendon cord and greater than or equal to the diameter of the secondary tendon cord. The width L of the receiving groove 15 is used to screen the primary and secondary tendon cords, ensuring that the secondary tendon cords can enter the receiving groove 15 while preventing the primary tendon cords from entering. Only the secondary tendon cords are cut, preventing the primary tendon cords from being cut, thereby achieving the purpose of creating light to moderate backflow. In some embodiments, the width L of the receiving groove 15 ranges from 0.1 to 0.2 mm.

[0085] It should be noted that the width L and depth D of the receiving groove 15 can also be set to other dimensions. The specific gap dimensions of the width L and depth D of the receiving groove 15 need to be determined based on the dimensions of the secondary tendineae of the experimental subject. If the experimental subject is a larger animal such as a cow or sheep, the width L and depth D of the receiving groove 15 can be set to larger dimensions. If the experimental subject is a smaller animal such as a rabbit, the width L and depth D of the receiving groove 15 can be set to smaller dimensions. No specific limitation is made here.

[0086] In one exemplary implementation, such as Figure 6 and Figure 8 As shown, the push-pull head 52 is provided with a first developing mark 521, and the hook handle 12 is provided with multiple second developing marks 121 corresponding to the first developing mark 521. Both the first developing mark 521 and the second developing mark 121 are formed by coating with developing material. Understandably, the diameters of the chordae tendineae captured in the receiving groove 15 are different, and the push-pull head 52 has different positions along the axial direction. Therefore, the first developing mark 521 and the second developing mark 121 have different correspondences. Thus, the operator can determine the type of captured chordae tendineae based on the alignment of the first developing mark 521 and the second developing mark 121, accurately distinguishing between primary and secondary chordae tendineae, thereby achieving the purpose of treating moderate or mild mitral regurgitation.

[0087] In another exemplary implementation, such as Figure 7 As shown, the distal end face of the push-pull head 52 is provided with a first sensor (not shown in the figure), and the proximal end of the hook end 14 is provided with a second sensor (not shown in the figure). The first sensor and the second sensor abut against each other. If a secondary tendon is hooked into the receiving groove 15, the first sensor and the second sensor abut against each other. In this state, the tendon capture information output by the first sensor and the second sensor indicates that the secondary tendon has been successfully captured. If a primary tendon is hooked into the receiving groove 15, the first sensor presses against the primary tendon, preventing the first sensor from abutting against the second sensor. In this state, the first sensor and the second sensor do not output any information. Therefore, it can be determined that the captured tendon is a primary tendon.

[0088] In this embodiment, the second sensing element is a metal conductive element, and the first sensing element is a conductive contact. The first sensing element is externally connected to a conductive line. If a secondary tendon is hooked into the receiving groove 15, the conductive line is open when the first sensing element and the second sensing element are in contact. If a primary tendon is hooked into the receiving groove 15, the conductive line is open when the first sensing element and the second sensing element are separated. Therefore, the type of tendon captured by the hook structure 10 can be determined based on the continuity of the conductive line. In other embodiments, the resistivity of the conductive line can also be used to determine whether the first sensing element and the second sensing element are in contact.

[0089] In this embodiment, such as Figure 3 and Figure 4 As shown, the chordae tendineae cutter also includes a propeller 60, the distal end of which is connected to the proximal end of the capture tube 30. The propeller 60 is used to push the capture tube 30 into the left atrium of the heart under the guidance of a guidewire, or to pull the capture tube 30 out of the left atrium. The propeller 60 is helical in shape, allowing it to bend at a certain angle to adapt to the anatomical features of blood vessels, such as the bifurcation of the carotid artery and aorta.

[0090] Implementation Method 2

[0091] The structures of the capture tube 30 and the cutting tube 40 in this embodiment are basically the same as those in the first embodiment. The difference lies in the structure of the hook structure 10 and the cutting part 20. The differences between the second embodiment and the first embodiment will be described below. The similarities or similarities between the second embodiment and the first embodiment will not be repeated here.

[0092] In this embodiment, such as Figure 9 and Figure 10 As shown, the hook-shaped structure 10 is an independent device, connected to the distal end of the capture tube 30. The hook-shaped structure 10 includes a hook shank 12, a hook bottom 13, and a hook end 14 connected in sequence. The hook end 14 is the free end of the hook-shaped structure 10. The hook shank 12, hook bottom 13, and hook end 14 together define a receiving groove 15. The receiving groove 15 opens on the proximal side to form a first opening 151. Through a cutting process, a clearance groove 34 located on the proximal side of the hook-shaped structure 10 is integrally formed on the capture tube 30. The clearance groove 34 forms a second opening 341 on the circumferential wall of the capture tube 30, allowing the tendineae to enter the receiving groove 15 through the second opening 341 and the first opening 151.

[0093] In this embodiment, the cutting tube 40 is sleeved outside the capturing tube 30, and the inner surface of the cutting tube 40 abuts against the outer peripheral surface of the hook-shaped structure 10. The distal end face of the cutting tube 40 is set into a sharp chamfer shape to form the cutting part 20. After the tendon chord capture is completed, the middle section of the tendon chord is hooked onto the hook-shaped structure 10, and both ends of the tendon chord are located outside the capturing tube 30. Since the cutting tube 40 is sleeved outside the capturing tube 30, the inner surface of the cutting tube 40 abuts against the outer peripheral surface of the hook-shaped structure 10. When the cutting tube 40 is pushed to the tendon chord position, the cutting part 20 and the outer peripheral surface of the hook-shaped structure 10 squeeze the tendon chord and cut it.

[0094] In this embodiment, along the circumferential direction, the width H of the receiving groove 15 is less than the diameter of the primary tendon cord and greater than or equal to the diameter of the secondary tendon cord. The width H of the receiving groove 15 is used to screen the primary and secondary tendon cords, ensuring that the secondary tendon cords can enter the receiving groove 15 while preventing the primary tendon cords from entering. Only the secondary tendon cords are cut, preventing the primary tendon cords from being cut, thereby achieving the purpose of creating a light to moderate backflow. In some embodiments, the width H of the receiving groove 15 ranges from 0.1 to 0.2 mm.

[0095] It should be noted that the width H of the receiving groove 15 can also be set to other dimensions. The specific gap dimension of the width H of the receiving groove 15 needs to be determined based on the size of the secondary tendon of the experimental subject. If the experimental subject is a larger animal such as a cow or sheep, the width H of the receiving groove 15 can be set to a larger size. If the experimental subject is a smaller animal such as a rabbit, the width H of the receiving groove 15 can be set to a smaller size. No specific limitation is made here.

[0096] And, as Figure 9 As shown, a guide surface 141 is also provided at the hook end 14. The proximal side of the guide surface 141 is located close to the axis of the capture tube 30, and the distal side of the guide surface 141 is located away from the axis of the capture tube 30. The guide surface 141 can be a flat surface or an arc surface. The function of the guide surface 141 is to allow the primary tendon cord to slide out of the relief groove 34 under the action of the guide surface 141 when the capture tube 30 is pulled towards the proximal end, so as to avoid accidental damage to the primary tendon cord when cutting the secondary tendon cord.

[0097] Implementation Method 3

[0098] Reference Figure 11 , Figure 12 In this embodiment, the hook-shaped structure is composed of at least one capturing element connected to the capturing tube. Specifically, the capturing element has a compressed state and an extended state, and the capturing element is made of shape memory alloy material. In the extended state, the free end 1122 is oriented towards the proximal end and away from the axis of the capturing tube 30, so that the capturing element 11 and the capturing tube 30 together form an inverted hook-shaped structure.

[0099] The capturing element 11 can be a bendable and deformable rod-shaped structure, plate-shaped structure, hook-shaped structure, etc. The capturing element 11 is supported by a shape memory alloy material, so that the capturing element 11 has a compressed state and an extended state. In the compressed state, the capturing element 11 retracts into the outer sheath 201 (see reference). Figure 1 The hook-shaped structure 10 is inserted into the left ventricle of the heart under the guidance of a guidewire. In its deployed state, due to the mechanical properties of the shape memory alloy material, the capture element 11 can maintain its deployed state and provide some support, so that it can maintain its deployed shape under the tension of the chordae tendineae after capture. Specifically, the capture element 11 includes a connecting portion 111 and a capturing portion 112. The connecting portion 111 is connected to the capturing tube 30. The capture element 11 includes a connecting end 1121 and a free end 1122. The connecting end 1121 of the capture element 11 is connected to the connecting portion 111. The connecting part 111 is located distally relative to the capturing part 112. During the cutting of the tendineae, the hook-shaped structure 10 is first released and unfolded at the distal end of the tendineae. Then, the capturing tube 30 is pulled to move its proximal end. When the tendineae is located in the area between the free end 1122 and the capturing tube 30, as the capturing tube 30 and the hook-shaped structure 10 continue to move proximally, the tendineae gradually move to the connection position between the connecting part 111 and the capturing tube 30, hooking the tendineae. Then, the cutting tube 40 is pushed distally relative to the capturing tube 30, so that the abutment between the cutting part 20 and the connecting part 111 cuts the tendineae bound at the position of the connecting part 111, completing the cutting of the tendineae. It can be understood that the connecting part 111 can be omitted. The advantage of setting the connecting part 111 is that it can buffer the radial force on the capturing part 112, which helps to reduce the probability of stress concentration at the distal end of the capturing part 112.

[0100] It is important to emphasize that by positioning the free end 1122 of the capturing unit 112 proximally and pulling the capturing tube 30 proximally to hook the chordae tendineae, the distal end of the capturing unit 112 can be prevented from contacting the ventricular wall, atrial septum, papillary muscles, or other tissues, thus avoiding tissue damage. Furthermore, during manual operation, the pulling force exerted by the chordae tendineae on the capturing tube 30 after hooking it can be clearly felt, allowing the operator to accurately determine whether the chordae tendineae capture has been completed using X-ray angiography.

[0101] In some embodiments of the present invention, please refer to Figure 13 and Figure 16As shown, the capture tube 30 is provided with at least one through groove 311, and the capture member 11 corresponds one-to-one with the through groove 311. The through groove 311 is generally elongated, and the length direction of the through groove 311 extends approximately along the axis of the capture tube 30. In this embodiment, the through groove 311 is rectangular in shape and includes two first sidewalls 3111 arranged opposite each other in the axial direction and two second sidewalls 3112 arranged opposite each other in the circumferential direction. The connecting portion 111 is located in the through groove 311, and the distal end of the connecting portion 111 is connected to the distal first sidewall 3111 of the two first sidewalls 3111. The connecting portion 111 extends from the distal end of the through groove 311 toward the proximal end. A first gap 101 is formed between the connecting portion 111 and the two second sidewalls 3112. The proximal end of the first gap 101 is open, so that after the tendon is hooked by the capturing member 11, it is inserted into the first gap 101 from the opening of the first gap 101 to bind the tendon between the connecting portion 111 and the second sidewalls 3112 of the through groove 311. The width of the first gap 101 is the distance between the connecting portion 111 and its opposite second sidewall in the circumferential direction.

[0102] In this embodiment, at least one of the two first gaps 101 has a width smaller than the diameter of the primary chordae tendineae 11' and greater than or equal to the diameter of the secondary chordae tendineae 12'. This allows the first gap 101 to filter the primary chordae tendineae 11' and the secondary chordae tendineae 12', excluding the primary chordae tendineae 11' from the first gap 101 and allowing only the secondary chordae tendineae 12' to be inserted into the first gap 101. The secondary chordae tendineae 12' is then bound at the position of the connecting part 111. The secondary chordae tendineae 12' is cut off only by the cooperation of the cutting part 20 and the connecting part 111, thereby artificially creating an environment of moderate or mild mitral regurgitation.

[0103] The width of the first gap 101 needs to be adapted to the diameter of the secondary chordae tendineae 12' of the experimental subject. In some exemplary embodiments, the width H of the first gap 101 is in the range of 0.1-0.2 mm.

[0104] In some embodiments of the present invention, the hook-like structure 10 includes at least two capturing elements 11, for example, two, three, four, five, six, etc. Specifically, as... Figure 17 and Figure 18As shown, in the deployed state, all the capturing elements 11 are arranged at intervals along the circumference of the capturing tube 30, forming a ring shape around the axis of the capturing tube 30. A second gap 102 is formed between any two adjacent capturing parts 112. The proximal end of the second gap 102 is open, and the distal end of the second gap 102 communicates with the first gap 101. The tendon chord can enter the second gap 102 through the proximal opening and, as the capturing tube 30 and the hook-shaped structure 10 continue to move towards the proximal end, the tendon chord moves through the second gap 102 to the first gap 101 under the guidance of the capturing elements 11, thus completing the capture of the tendon chord. In this embodiment, by arranging at least two capturing elements 11 along the circumference of the capturing tube 30, the capture range of the hook-shaped structure 10 is increased, thereby improving the success rate of tendon chord capture.

[0105] The specific structure of the capturing element 11 can take many forms. The technical solution of the present invention will be further described in detail below with reference to specific embodiments.

[0106] In this embodiment, such as Figure 12 As shown, the chordae tendineae cutter 100 includes a capture tube 30, a cutting tube 40, a hook-shaped structure 10, and a cutting section 20.

[0107] like Figure 14 and Figure 15 As shown, the inner diameter of the capturing tube 30 is larger than the outer diameter of the cutting tube 40, and the capturing tube 30 is movably fitted over the cutting tube 40. The capturing tube 30 includes a first straight handle portion 31 located at the proximal end, a first curved portion 32 located in the middle region, and a first carrier portion 33, with a hook-shaped structure 10 disposed on the first carrier portion 33. The cutting tube 40 includes a second straight handle portion 41 located at the proximal end, a second curved portion 42 located in the middle region, and a second carrier portion 43, with the cutting portion 20 disposed on the second carrier portion 43. The first straight handle portion 31 and the second straight handle portion 41 facilitate operation and gripping, thereby facilitating the cutting procedure.

[0108] Please combine Figure 1 and Figure 14As shown, since the path from the puncture point to the left ventricle is not straight, especially with a very large bend at the bifurcation of the carotid artery and aorta, multiple grooves 1024 are provided on the first bend 32 of the capturing tube 30 and the second bend 42 of the cutting tube 40 to facilitate instrument delivery. The grooves 1024 are located on the outer surfaces of the capturing tube 30 and the cutting tube 40. The grooves 1024 can be through slots penetrating the capturing tube 30 and the cutting tube, or they can be recessed structures formed on the outer surfaces of the capturing tube 30 and the cutting tube 40. The grooves 1024 are spaced apart axially and are located between the proximal and distal end faces of the capturing tube 30 (i.e., the first bend 32) and between the proximal and distal end faces of the cutting tube 40 (i.e., the second bend 42). By providing a groove 1024 structure on the capturing tube 30 and the cutting tube 40, the first curved portion 32 of the capturing tube 30 and the second curved portion 42 of the cutting tube 40 can be bent at a certain angle to adapt to the anatomical features of blood vessels such as the bifurcation of the carotid artery and the aorta, thus changing the straight state of the capturing tube 30 and the cutting tube 40 into a curved state. The bending angle A is 90-120°, and the total length of the tendineae cutter 100 is 400-500 mm.

[0109] In this embodiment, the capturing tube 30 and the cutting tube 40 are made of stainless steel, with the capturing tube 30 having an outer diameter of 3.2 mm and a wall thickness of 0.25 mm. The cutting tube 40 has an outer diameter of 2.4 mm and a wall thickness of 0.15 mm. In other embodiments, the capturing tube 30 and the cutting tube 40 can be made of any other suitable material, such as other biocompatible metals or polymers, and the dimensions of the capturing tube 30 and the cutting tube 40 can be selected according to the actual application scenario.

[0110] In this embodiment, such as Figure 12 As shown, the capturing tube 30 is provided with two rows of grooves 1024 symmetrically arranged with the axis of the capturing tube 30 as the center, and the cutting tube 40 is also provided with two rows of grooves 1024 symmetrically arranged with the axis of the cutting tube 40 as the center, so as to improve the bending performance of the capturing tube 30 and the cutting tube 40, so as to smoothly pass through the tortuous carotid artery and aorta.

[0111] It should also be noted that the tendon cutter 100 has a certain degree of rigidity and is not easily deformed or broken.

[0112] like Figure 15 and Figure 16 As shown, the hook-shaped structure 10 includes eight capturing elements 11. In the unfolded state, the eight capturing elements 11 are arranged sequentially at intervals along the circumference of the capturing tube 30, and are centrally symmetrical about the axis of the capturing tube 30. The first carrier portion 33 of the capturing tube 30 is provided with eight through slots 311 (see reference). Figure 21 Each through slot 311 is provided with a corresponding catcher 11.

[0113] In this embodiment, please refer to Figure 19 and Figure 22 As shown, in its unfolded state, the hook-shaped structure 10, from proximal to distal, includes a head segment 1123, a filtering segment 1124, and a tail segment 1125 connected in sequence. The proximal end of the head segment 1123 is the free end 1122 of the capture section 112, and the distal end of the tail segment 1125 is the connecting end 1121 of the capture section 112. The distal end of the tail segment 1125 is connected to the proximal end of the connecting section 111. In this embodiment, a second gap 102 is formed between any two circumferentially adjacent capture sections 112. The second gap 102 is divided into a first segment 1021, a second segment 1022, and a third segment 1023, corresponding to the head segment 1123, the filtering segment 1124, and the tail segment 1125, respectively. Understandably, in two adjacent capturing sections 112, the gap between the two head segments 1123 is the first segment 1021 of the second gap 102, the gap between the two filtering segments 1124 is the second segment 1022 of the second gap 102, and the gap between the two tail segments 1125 is the third segment 1023 of the second gap 102. Here, the circumferential dimension of the second gap 102 is defined as the width of the second gap 102, and the minimum widths of both the first segment 1021 and the third segment 1023 are greater than the minimum width of the second segment 1022. For example... Figure 9 As shown, from the distal end to the proximal end, the width of the second segment 1022 of the second gap 102 first decreases to a minimum width and then gradually increases, forming a shape that is wide at both ends and narrow in the middle. The minimum width H of the second segment 1022 is less than the diameter of the primary chordae tendineae 11', so that the primary chordae tendineae 11' cannot pass through the second segment 1022, thereby preventing the primary chordae tendineae 11' from sliding to the connecting part 111. Furthermore, the minimum width of the second segment 1022 has a diameter greater than or equal to the diameter of the secondary chordae tendineae 12', so that the secondary chordae tendineae 12' can smoothly slide through the second segment 1022 into the first gap 101 to complete the capture of the secondary chordae tendineae 12'.

[0114] In other embodiments, along the circumferential direction, the minimum width of the second gap 102 may be less than the diameter of the primary chordae tendineae and greater than or equal to the diameter of the secondary chordae tendineae, and the minimum width of the first gap 101 may be greater than the minimum width of the second gap 102, thereby making it easier for the chordae tendineae that have passed through the second gap 102 to enter the first gap 101.

[0115] The minimum width of the second segment 1022 needs to be adapted to the diameters of the primary chordae tendineae 11' and the secondary chordae tendineae 12' of the experimental subject. In some exemplary embodiments, the width H of the first gap 101 is in the range of 0.1-0.2 mm. Since the diameter of the secondary chordae tendineae 12' is smaller than H, the secondary chordae tendineae 12' can fall smoothly into the connecting part 111.

[0116] The shape of the second segment 1022, which is wide at both ends and narrow in the middle, not only facilitates the entry of the chordae tendineae 1' into the second segment 1022, but also serves to filter out the secondary chordae tendineae 12'. Furthermore, after the secondary chordae tendineae 12' passes through its minimum width, the widened second segment 1022 allows the secondary chordae tendineae 12' to enter the third segment 1023 more smoothly, thus improving the efficiency of chordae tendineae 1' capture.

[0117] Furthermore, from the distal to the proximal direction, the width of the first segment 1021 of the second gap 102 gradually increases, resulting in a larger opening at the proximal end of the second gap 102. This facilitates the easier entry of the chordae tendineae 1' into the second gap 102 from the opening during capture, reducing the difficulty of capturing the chordae tendineae 1'. Furthermore, from the proximal to the distal direction, the width of the third segment 1023 of the second gap 102 gradually decreases, which helps guide the chordae tendineae 1' falling into the third segment 1023 to smoothly slide down to the vicinity of the connecting portion 111, facilitating cutting.

[0118] It should be noted that in some embodiments, the capturing part 112 is a plate-like structure that is wide in the middle and pointed at both ends (not shown in the figure), so that the second gap 102 between any two adjacent capturing parts 112 has a structure that is narrow in the middle and wide at both ends.

[0119] In one exemplary implementation, such as Figure 19As shown, the capturing part 112 includes a first support rod 1126 and a second support rod 1127. Both the first support rod 1126 and the second support rod 1127 are rod-shaped structures. The distal ends of the first support rod 1126 and the second support rod 1127 are connected to form a tail segment 1125. The proximal ends of the first support rod 1126 and the second support rod 1127 are connected to form a head segment 1123. Both the head segment 1123 and the tail segment 1125 are long and thin. The head segment 1123 is used to capture the tendineae. The middle regions of the first support rod 1126 and the middle regions of the second support rod 1127 are bent in a direction away from each other to form a filtering segment 1124, so that the width (dimension along the circumferential direction) of the filtering segment 1124 has a structural feature of being narrow at both ends and wide in the middle. In the unfolded state, the tail segment 1125 and the filtering segment 1124 are bent relative to the connecting portion 111 in a direction away from the axis of the capture tube 30, causing the entire capture portion 112 to open away from the axis of the capture tube 30, thereby increasing the capture range of the hook structure 10. Furthermore, the head segment 1123 is bent towards the axis of the capture tube 30, causing the free end 1122 of the capture portion 112 to form a retractable hook structure. This prevents the captured chordae tendineae from detaching from the hook structure 10, and by positioning the head end of the capture portion 112 towards the axis of the capture tube 30, it prevents the free end 1122 from contacting the ventricular wall, atrial septum, papillary muscles 4', or other tissues, thus avoiding tissue damage.

[0120] It should also be noted that, in this embodiment, as Figure 15 and Figure 16 As shown, in the unfolded state, the capturing part 112 is bent towards the proximal side along the axial direction, making the capturing part 112 as a whole arc shape, so that the hook structure 10 composed of multiple capturing parts 11 is as umbrella-shaped as a whole. This allows the outline of the hook structure 10 to be as close as possible to the inner wall of the heart ventricle during the unfolding process, so that the hook structure 10 has a larger contact surface with the heart wall during the unfolding process, thereby reducing the average pressure of the hook structure 10 in contact with the heart wall and thus avoiding damage to the heart.

[0121] In this embodiment, such as Figure 12 , Figure 16 and Figure 17 As shown, when at least one capturing member 11 captures the secondary tendon chord 12', the secondary tendon chord 12' is folded in half under the pull of the capturing member 11 to form a semi-circular structure. The semi-circular structure slides into the first gap 101, and part of the semi-circular structure enters the interior of the capturing tube 30 through the through groove 311. The cutting part 20 is provided at the distal end of the cutting tube 40, and the cutting part 20 is a tubular structure. After capturing the secondary tendon chord 12', the cutting tube 40 is pushed towards the distal end relative to the capturing tube 30, so that the cutting part 20 cooperates with the connecting part 111 to cut the secondary tendon chord 12'.

[0122] Implementation Method 4

[0123] The hook structure 10 and the capturing tube 30 in this embodiment are basically the same as those in embodiment three. The difference lies in the structure of the cutting part 20 and the cutting tube 40. The differences between embodiment four and embodiment three will be described below. The similarities or similarities between embodiment four and embodiment three will not be repeated here.

[0124] In this embodiment, such as Figure 20 and Figure 21 As shown, the outer diameter of the capturing tube 30 is smaller than the inner diameter of the cutting tube 40. The cutting tube 40 is movably fitted over the capturing tube 30. The cutting section 20 is a plurality of elongated structures located at the distal end of the cutting tube 40. The plurality of cutting sections 20 are arranged sequentially at intervals along the circumference of the cutting tube 40. Each cutting section 20 corresponds to a second gap 102. The cutting section 20 can move between two adjacent connecting sections 111. The secondary tendon chord 12' bound to the connecting section 111 is cut by the abutting engagement between the side of the cutting section 20 and the side of the connecting section 111.

[0125] Implementation Method 5

[0126] The structure of the cutting tube 40, the capturing tube 30, and the cutting part 20 in this embodiment is basically the same as that in Embodiments 3 and 4. The difference lies in the structure of the hook structure 10. The differences between Embodiment 5 and Embodiment 4 will be described below. The similarities or similarities between Embodiment 5 and Embodiment 4 will not be repeated here.

[0127] In this embodiment, both the connecting part 111 and the capturing part 112 are rod-shaped. The connecting part 111 is located in the through groove 311 and extends from the far end of the through groove 311 toward the near end. The capturing part 112 is connected to the near end of the connecting part 111 and the capturing part 112 is bent relative to the connecting part 111 in a direction away from the axis of the capturing tube 30.

[0128] In this embodiment, in the unfolded state, the connecting part 111 is inclined relative to the axis of the capturing tube 30, and the proximal end of the connecting part 111 is closer to the axis of the capturing tube 30 than the distal end of the connecting part 111, so that when the hook structure 10 is squeezed by the outer sheath, the free end 1122 of the capturing part bends to the distal end and is retracted into the outer sheath, so as to facilitate the retraction of the capturing head.

[0129] In some embodiments, the cutting tube 40 is sleeved outside the capturing tube 30, and the cutting tube 40 serves as an outer sheath. When the cutting tube 40 pushes the constricting hook structure 10 distally relative to the capturing tube 30, it cooperates with the hook structure 10 to cut the tendon cord.

[0130] Implementation Method Six

[0131] The structures of the cutting tube 40, the capturing tube 30, and the cutting part 20 in this embodiment are basically the same as those in embodiment three. The difference lies in the structure of the capturing member 11. The differences between embodiment six and embodiment three will be described below. The similarities or similarities between embodiment six and embodiment three will not be repeated here.

[0132] In this embodiment, such as Figure 23 and Figure 24 As shown, the connecting part 111 is generally rod-shaped and includes a first segment 1111 and a second segment 1112 connected together. The first segment 1111 is connected to the capturing tube 30, and the second segment 1112 is connected to the capturing part 112. Along the axial direction, the first segment 1111 and the second segment 1112 are staggered. This ensures that in the compressed state, the first segment 1111 and the second segment 1112 are circumferentially staggered, and when the second segment 1112 is at least partially flipped and folded towards its distal end, the first segment 1111 located at the distal end of the second segment 1112 will not interfere with the second segment 1112.

[0133] In this embodiment, a clearance section corresponding to the second segment 1112 is provided at the far end of the through groove 311. The clearance section extends from the far end of the second segment 1112 toward the far end of the capture tube 30 and passes through the far end of the capture tube 30 in the axial direction. In the compressed state, the second segment 1112 bends toward the far end of the capture tube 30 at the connection with the first segment 1111, and the second segment 1112 can be at least partially embedded in the clearance section to avoid the second segment 1112 from interfering with the tube wall at the tube opening of the capture tube 30 and causing deformation.

[0134] like Figure 25As shown, in some embodiments, the connecting portion 111 is inclined overall relative to the axis of the capturing tube 30, and the proximal end of the connecting portion 111 is closer to the axis of the capturing tube 30 than the distal end of the connecting portion 111. The second segment 1112 is closer to the axis of the capturing tube 30 than the first segment 1111, so that the capturing member 11 can be more smoothly retracted into the outer sheath during compression. In this embodiment, in the compressed state, the capturing portion 112 is bent towards the distal end of the capturing tube 30 at the connection with the second segment 1112 (i.e., the distal end of the capturing portion 112). Since the second segment 1112 is closer to the axis of the capturing tube 30 than the first segment 1111, the proximal end of the second segment 1112 moves into the interior of the capturing tube 30 during bending, providing more bending space for the distal end of the capturing portion 112 during bending, which facilitates smoother compression of the capturing portion 112 and makes it easier to retract the tendon chord capturing head 10.

[0135] According to a second aspect of the invention, an artificial heart valve regurgitation device is also provided, such as Figure 1 As shown, the artificial heart valve regurgitation device includes an outer sheath 201, a chordae tendineae cutter 100, and an operating handle (not shown in the figure). The proximal end of the outer sheath 201 is connected to the handle, and the chordae tendineae cutter 100 is movably disposed within the outer sheath 201. This allows the chordae tendineae cutter 100 to be inserted into the left ventricle of the heart via the operating handle and the outer sheath 201 to perform a chordae tendineae cutter procedure. This artificially creates an environment of moderate or mild mitral regurgitation, providing a cardiac experimental structure similar to that of patients with mitral regurgitation for evaluating the safety and effectiveness of the artificial heart valve.

[0136] It should be emphasized that in Embodiment 1, a movable push-pull component is provided on the capture tube, and a first sensor and a second sensor are respectively provided on the capture tube and the push-pull component. The method of using the first sensor and the second sensor to screen and confirm the captured chordae tendineae can also be applied to any of Embodiments 3 to 6. Furthermore, any of the above embodiments are applicable to tricuspid chordae tendineae cutting. The chordae tendineae cutter is placed in the right ventricle of the heart via interventional means, the hook-shaped structure is used to capture the chordae tendineae, and a portion of the chordae tendineae is cut through the cooperation of the cutting part and the hook-shaped structure, thereby artificially creating an environment for tricuspid regurgitation. This provides a cardiac experimental structure similar to that of patients with tricuspid regurgitation for evaluating the safety and effectiveness of artificial heart valves.

[0137] The above description is merely a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the technical scope disclosed in the present invention should be included within the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be determined by the scope of the claims.

Claims

1. A tricuspid valve chordae tendineae cutter, characterized in that, The tricuspid valve chordae tendineae cutter includes: A capture tube, the distal end of which is provided with a hook-shaped structure for capturing chordae tendineae; A cutting tube, wherein the distal end of the cutting tube is provided with a cutting portion, the cutting portion cooperating with the hook-shaped structure to cut the tendineae; In this embodiment, one of the capturing tube and the cutting tube is movably sleeved on the outside of the other; The hook-like structure includes a receiving groove for receiving the chordae tendineae, the receiving groove forming a first opening on the proximal side; The capture tube is provided with a clearance groove, which is located on one side of the proximal end of the hook-shaped structure and communicates with the receiving groove. The clearance groove forms a second opening on the circumferential wall of the capture tube. The far end of the capture tube is provided with a blocking part, which is located at the near end of the avoidance groove and close to the second opening; The tricuspid valve chordae tendineae cutter further includes a push-pull member, which includes a body and a push-pull head located at the distal end of the body. The body is arranged in an axial direction and can move axially relative to the capture tube. The distal end of the body can extend through the blocking part. The axial movement of the body can drive the push-pull head to reciprocate between the blocking part and the hook-shaped structure. The hook-like structure includes a hook shank, a hook bottom, and a hook end connected in sequence. The hook end is the free end of the hook-like structure. The hook shank, the hook bottom, and the hook end together define a receiving groove. The depth and / or width of the receiving groove is less than the diameter of the primary tendinous cord and greater than or equal to the diameter of the secondary tendinous cord. The distal end face of the push-pull head can abut against the proximal end of the hook end.

2. The tricuspid valve chordae tendineae cutter according to claim 1, characterized in that, The blocking part is located on one side of the proximal end of the hook-shaped structure. When the distal end of the push-pull member, which passes through the blocking part in the axial direction, abuts against the blocking part, the blocking part prevents the push-pull member from continuing to move towards the proximal end relative to the blocking part.

3. The tricuspid valve chordae tendineae cutter according to claim 2, characterized in that, The capturing tube is provided with a limiting groove extending along the axial direction, and the blocking part is a groove-shaped structure provided at the distal end of the limiting groove, with the distal end of the groove-shaped structure being open. The main body is movably inserted into the limiting groove. When the push-pull head enters the grooved structure through the opening, the grooved structure prevents the push-pull head from moving towards the proximal end relative to the grooved structure.

4. The tricuspid valve chordae tendineae cutter according to claim 2, characterized in that, The blocking part is a plate-shaped structure arranged in the radial direction, and the blocking part is provided with through holes; The push-pull member includes a body portion and a push-pull head disposed at the distal end of the body portion. The body portion is movably disposed through the through hole. The push-pull head is located on one side of the distal end of the plate-like structure. When the proximal end of the push-pull head abuts against the plate-like structure, the plate-like structure prevents the push-pull head from moving toward the proximal end relative to the blocking portion.

5. The tricuspid valve chordae tendineae cutter according to claim 1, characterized in that, The distal end of the push-pull head is provided with a first sensor, and the proximal end of the hook end is provided with a second sensor. The first sensor and the second sensor have a contact state and a separation state. When the first sensor and the second sensor are in the contact state, the first sensor and the second sensor output tendon capture information.

6. The tricuspid valve chordae tendineae cutter according to claim 1, characterized in that, The distal end of the push-pull head is provided with a first developing mark, and the hook handle is provided with a plurality of second developing marks at intervals along its axial direction for corresponding to the first developing mark.

7. The tricuspid valve chordae tendineae cutter according to claim 1, characterized in that, The tricuspid valve chordae tendineae cutter also includes: The propulsion component has its distal end connected to the proximal end of the capture tube, and the propulsion component is spiral-shaped and sleeved inside the cutting tube.

8. The tricuspid valve chordae tendineae cutter according to any one of claims 1 to 7, characterized in that, When the distal end of the push-pull member abuts against the blocking part, and the push-pull member continues to be subjected to a force toward the proximal end, the push-pull member can cause the capturing tube to bend to one side.

9. An artificial heart valve regurgitation device, characterized in that, The artificial heart valve regurgitation device includes The tricuspid valve chordae tendineae cutter as described in any one of claims 1-8.

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