Easy-to-hold transcatheter artificial chordae tendineae implantation device and system

Abstract

This application provides a transcatheter artificial chordae tendineae implantation device and system with easy clamping capability. The transcatheter artificial chordae tendineae implantation device includes a clamp assembly, a drive assembly, a puncture assembly, and a delivery assembly. The clamp assembly includes a first clamp and a second clamp, which are arranged side-by-side along the axial direction of the clamp assembly, with the proximal end of the first clamp movably connected to the proximal end of the second clamp. The drive assembly is connected to the first clamp and / or the second clamp and drives the distal end of the first clamp towards or away from the distal end of the second clamp to clamp the leaflet located between the first and second clamps. The puncture assembly extends from the clamp assembly to puncture the leaflet and implant the artificial chordae tendineae. The delivery assembly delivers the clamp assembly and the puncture assembly. In this application, the first and second clamps achieve relative opening and closing through axial rotation, and the clamping surface of the clamp assembly extends along the axial direction of the clamp assembly, giving the clamp assembly a large clamping area for easy clamping of the leaflet.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to an easy-to-hold transcatheter artificial chordae tendineae implantation device and system. Background Technology

[0002] The mitral and tricuspid valves, among others, are one-way valves in the heart. Normal, healthy atrioventricular valves control the flow of blood from the atria to the ventricles, while preventing blood from flowing from the ventricles to the atria. For example, the mitral valve, located between the left atrium and left ventricle, controls the flow of blood from the left atrium to the left ventricle, while preventing blood from flowing from the left ventricle to the left atrium; the tricuspid valve, located between the right atrium and right ventricle, controls the flow of blood from the right atrium to the right ventricle, while preventing blood from flowing from the right ventricle to the right atrium.

[0003] The mitral valve consists of anterior and posterior leaflets, while the tricuspid valve consists of anterior, posterior, and septal leaflets. Normally, when the left or right ventricle contracts, the edges of any two adjacent leaflets of the mitral or tricuspid valve completely close, preventing blood from flowing from the ventricle to the atrium. If organic or functional changes occur in the leaflets or other structures of the mitral or tricuspid valve, such as lesions or rupture of the chordae tendineae, causing poor closure of adjacent leaflets, the mitral or tricuspid valve cannot completely close when the left or right ventricle contracts. This leads to blood regurgitation from the ventricle to the atrium, causing a series of pathophysiological changes known as "mitral regurgitation" or "tricuspid regurgitation."

[0004] For mitral or tricuspid regurgitation caused by chordae tendineae lesions or ruptures, sutures can be implanted onto the valve leaflets as artificial chordae tendineae to provide tension and improve or treat the condition. Currently, most interventional devices for artificial chordae tendineae implantation first establish an extracorporeal-in vivo pathway via the transapical or transatrial septal approach, then clamp the prolapsed valve leaflets, and finally suture the sutures onto the leaflets to complete the implantation of the artificial chordae tendineae.

[0005] In existing technologies, most interventional devices used for artificial chordae tendineae implantation include a set of cylindrical clamps that open and close relative to each other through axial translation. The clamping surfaces of the clamps typically extend at an angle to the axial direction of the clamps. To meet the clamping area requirements for the leaflets, the axial length of the rigid end of the clamp must be at least 25-30 mm. However, when this interventional device is used via the transseptal or transaortic arch approach, the maximum bending radius of the left atrium and left ventricle is only about 20 mm, making it difficult for the rigid end of the clamp to turn within the chamber and grasp the leaflets, thus posing a risk of leaflet retrieval failure. Summary of the Invention

[0006] This application aims to provide an easy-to-grip transcatheter artificial chordae tendineae implantation device and system. The clamping assembly of the transcatheter artificial chordae tendineae implantation device achieves relative opening and closing by axial rotation. The clamping surface of the clamping assembly extends along the axial direction of the clamping assembly, so that the clamping assembly has a large clamping area and is easy to clamp the leaflet.

[0007] To achieve the above objectives, this application provides an easily clampable transcatheter artificial chordae tendineae implantation device, comprising a clamp assembly, a drive assembly, a puncture assembly, and a delivery assembly. The clamp assembly includes a first clamp and a second clamp, which are arranged side-by-side along the axial direction of the clamp assembly, with the proximal end of the first clamp movably connected to the proximal end of the second clamp. The drive assembly is connected to the first clamp and / or the second clamp and is used to drive the distal end of the first clamp towards or away from the distal end of the second clamp to clamp the leaflet located between the first clamp and the second clamp. The puncture assembly extends from the clamp assembly to puncture the leaflet and implant the artificial chordae tendineae. The delivery assembly is used to deliver the clamp assembly and the puncture assembly.

[0008] On the other hand, this application also provides a transcatheter artificial chord implantation system, including an artificial chord and an easily clampable transcatheter artificial chord implantation device as described above. The artificial chord is movably inserted into the puncture assembly, and the distal end of the artificial chord follows the puncture assembly through the leaflet and disengages from the puncture assembly when the puncture assembly is retracted.

[0009] The transcatheter artificial chordae tendineae implantation device and system provided in this application includes a clamp assembly comprising a first clamp and a second clamp arranged side by side along its axial direction. The proximal ends of the first clamp and the second clamp are movably connected, and the distal ends of the first clamp and the second clamp can move closer or further apart under the driving action of the drive assembly, so that the clamp assembly can achieve relative opening and closing by axial rotation. The clamping surface of the clamp assembly extends along the axial direction of the clamp assembly. In this way, the clamp assembly not only has a larger clamping area, making it easier to clamp the leaflets, but also reduces the overall size of the clamp assembly and the outer diameter of the delivery assembly. This is beneficial for delivering the clamp assembly into the human body through the delivery assembly, reducing damage to human tissues along the delivery path, and also facilitates the clamp assembly to turn within the cavity to clamp the leaflets. In addition, the clamping surface of the clamping assembly extends along the axial direction of the clamping assembly, which allows the distance between the distal edge of the clamping assembly and the edge of the leaflet to be adjusted within a large range when the clamping assembly clamps the leaflet. This allows the distance between the implantation point of the artificial tendon chord on the leaflet and the edge of the leaflet to be adjusted as needed, ensuring that the artificial tendon chord will not fall off after implantation into the leaflet and improving the implantation reliability of the artificial tendon chord. Attached Figure Description

[0010] To more clearly illustrate the technical solutions of the embodiments of this application, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are some embodiments of this application. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0011] Figure 1 This is an axial sectional view of the transcatheter artificial chordae tendineae implantation system provided in the first embodiment of this application.

[0012] Figure 2 yes Figure 1 The diagram shows a three-dimensional exploded view of the transcatheter artificial chordae tendineae implantation system.

[0013] Figure 3 yes Figure 2 The diagram shows an exploded three-dimensional structure of the chuck assembly.

[0014] Figure 4 yes Figure 3 The diagram shows the structure of the first chuck from another perspective.

[0015] Figure 5 yes Figure 1 The diagram shows the connection between the chuck assembly and the drive assembly.

[0016] Figure 6 yes Figure 1 The diagram shows a cross-sectional view of the puncture needle inserted into the first clamp, with the clamp assembly not holding the valve leaflet and closed.

[0017] Figure 7 yes Figure 6 The diagram shows a cross-sectional view of a clamp assembly holding a thin leaflet and a puncture needle piercing the leaflet.

[0018] Figure 8 yes Figure 6 The diagram shows a cross-sectional view of a clamp assembly holding a thick leaflet and a puncture needle piercing the leaflet.

[0019] Figure 9 yes Figure 1 The diagram shows the implantation of an artificial tendineae into the leaflet via a transcatheter artificial tendineae implantation device.

[0020] Figures 10 to 15 This is a schematic diagram illustrating the usage process of the transcatheter artificial chordae tendineae implantation system provided in this application.

[0021] Figure 16 This is a schematic diagram showing the connection between the clamp assembly and the drive assembly provided in the second embodiment of this application.

[0022] Figure 17This is a schematic diagram showing the connection between the clamp assembly and the drive assembly provided in the third embodiment of this application.

[0023] Figure 18 yes Figure 17 The diagram shows the second chuck rotating after being driven by the drive assembly.

[0024] Figure 19 This is a schematic diagram showing the connection between the clamp assembly and the drive assembly provided in the fourth embodiment of this application.

[0025] Figure 20 yes Figure 19 The diagram shows the drive component driving the chuck component after it is relatively opened.

[0026] Figure 21 This is a schematic diagram showing that the first clamp is fixed and the second clamp is connected to the drive assembly in one embodiment of the fourth embodiment.

[0027] Figure 22 yes Figure 21 The diagram shows the second chuck rotating after being driven by the drive assembly.

[0028] Figure 23 This is a schematic diagram showing the proximal end of the clamp assembly in the fifth embodiment being slidably connected via a guide rail.

[0029] Figure 24 yes Figure 23 The diagram shows the clamp assembly after it has been opened relative to each other.

[0030] Figure 25 This is a schematic diagram of the proximal end of the clamp assembly provided in the sixth embodiment of this application being engaged and connected by an engagement mechanism.

[0031] Figure 26 This is a schematic diagram of the proximal end of the chuck assembly provided in the seventh embodiment of this application being engaged and connected by an engagement mechanism.

[0032] The following detailed description, in conjunction with the accompanying drawings, will further illustrate this application. Detailed Implementation

[0033] The technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of this application, and not all of them. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0034] Furthermore, the following descriptions of various embodiments are based on the accompanying illustrations and are used to illustrate specific embodiments that can be implemented in this application. Directional terms used in this application, such as "up," "down," "front," "back," "left," "right," "inner," "outer," and "side," are merely for reference to the accompanying illustrations. Therefore, the directional terms used are for better and clearer explanation and understanding of this application, and are not intended to indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this application.

[0035] It should be noted that, in order to more clearly describe the structure of the easily clampable transcatheter artificial chordae tendineae implantation device and system provided in this application, the limiting terms "proximal" and "distal" used in the specification are conventional terms in the field of interventional medicine. Specifically, "distal" refers to the end away from the operator during the surgical procedure, and "proximal" refers to the end closer to the operator during the surgical procedure; the direction of the rotational axis of an object such as a cylinder or tube is defined as the axial direction; the circumferential direction is the direction around the axis of the object such as a cylinder or tube; and the radial direction is the direction along the diameter or radius.

[0036] It is worth noting that the term "end" appearing in terms such as "proximal end," "distal end," "one end," "the other end," "first end," "second end," "initial end," "end," "both ends," "head end," "upper end," and "lower end" is not limited to a head, end point, or end face, but also includes a portion extending axially and / or radially from the head, end point, or end face on the element to which the head, end point, or end face belongs. Unless otherwise defined, all technical and scientific terms used in this application have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The conventional terminology used in this application's specification is for the purpose of describing particular embodiments only and should not be construed as limiting this application.

[0037] Please combine Figures 1 to 3 This application provides an easy-to-clamp transcatheter artificial chordae tendineae implantation system 1, which includes an artificial chordae tendineae 2 and an easy-to-clamp transcatheter artificial chordae tendineae implantation device 3. The transcatheter artificial chordae tendineae implantation device 3 is used to implant the artificial chordae tendineae 2 into the patient's body to replace the diseased or ruptured chordae tendineae in the patient's heart, thereby pulling the valve leaflets during ventricular systole to treat or reduce blood regurgitation (including but not limited to mitral regurgitation and tricuspid regurgitation).

[0038] Specifically, such as Figures 1 to 3As shown, in this application, the transcatheter artificial chordae tendineae implantation device 3 may include a clamp assembly 20, a drive assembly 40, a delivery assembly 60, and a puncture assembly 80. The clamp assembly 20 includes a first clamp 21 and a second clamp 22 arranged side by side along its axial direction, with the proximal end of the first clamp 21 movably connected to the proximal end of the second clamp 22. The drive assembly 40 is connected to the first clamp 21 and / or the second clamp 22 and is used to drive the distal end of the first clamp 21 toward or away from the distal end of the second clamp 22, thereby realizing the relative opening and closing of the clamp assembly 20 to clamp the leaflet located between the first clamp 21 and the second clamp 22. The delivery assembly 60 includes an outer sheath 62 and an inner sheath 64 movably inserted into the outer sheath 62. The proximal ends of a first clamp 21 and / or a second clamp 22 are fixedly connected to the distal end of the inner sheath 64. When the first clamp 21 and the second clamp 22 are fully closed (i.e., the distal end of the first clamp 21 approaches and abuts the distal end of the second clamp 22), the maximum outer diameter of the clamp assembly 20 is smaller than the minimum inner diameter of the outer sheath 62, allowing the inner sheath 64 and the clamp assembly 20 connected to its distal end to be housed together within the outer sheath 62 (see [reference]). Figure 1 The delivery assembly 60 delivers the clamp assembly 20 to the vicinity of the leaflet, and the inner sheath 64 adjusts the position of the clamp assembly 20 so that the leaflet enters between the first clamp 21 and the second clamp 22. The puncture assembly 80 is movably inserted in the inner sheath 64. After the leaflet is clamped by the clamp assembly 20, the distal end of the puncture assembly 80 can extend from the distal end of the inner sheath 64 and pass through the clamp assembly 20 to puncture the leaflet. The artificial chordae tendineae 2 is movably inserted in the puncture assembly 80. The distal end of the artificial chordae tendineae 2 can follow the puncture assembly 80 through the leaflet and detach from the puncture assembly 80 when the puncture assembly 80 is withdrawn, so that the distal end of the artificial chordae tendineae 2 is implanted on the leaflet. The proximal end of the artificial chordae tendineae 2 can be fixed to the ventricular wall, papillary muscle, or apex of the heart to replace the natural chordae tendineae and maintain the tension between the leaflet and the ventricle or papillary muscle.

[0039] In this application, the proximal end of the first chuck 21 and the proximal end of the second chuck 22 are movably connected, and the distal ends of the first chuck 21 and the distal ends of the second chuck 22 can move closer or further apart under the driving action of the driving component 40, so that the chuck assembly 20 achieves relative opening and closing by axial rotation, and the clamping surface of the chuck assembly 20 extends along the axial direction of the chuck assembly 20. It is understood that, as described in the background art, existing chucks achieve relative opening and closing by axial translation, and their clamping surfaces usually extend obliquely in a direction at a certain angle to the axial direction of the chuck. However, the chuck assembly 20 in this application achieves relative opening and closing by axial rotation, and the clamping surface of the chuck assembly 20 extends along the axial direction of the chuck assembly 20. Compared with the clamping area of ​​existing chucks, the clamping area of ​​the chuck assembly 20 is larger, and therefore it is easier to clamp the leaflets. Furthermore, while satisfying the leaflet clamping area requirement, the clamping surface of the clamping assembly 20 extends along the axial direction of the clamping assembly 20, allowing the axial length of the clamping assembly 20 to be smaller than that of existing clamps. Moreover, the radial dimension of the clamping assembly 20 can also be smaller, thereby reducing the overall size of the clamping assembly 20. This, in turn, reduces the outer diameter of the outer sheath 62 that houses the clamping assembly 20. This facilitates the delivery of the clamping assembly 20 within the human body via the delivery assembly 60, reduces damage to human tissue along the delivery path caused by the outer sheath 62, and also allows the clamping assembly 20 to turn within the cavity to facilitate clamping the leaflets. Furthermore, the clamping surface of the clamping assembly 20 extends along the axial direction of the clamping assembly 20, which allows the clamping depth of the clamping assembly 20 to be adjusted within a large range. That is, when the clamping assembly 20 clamps the leaflet, the distance between the distal edge of the clamping assembly 20 and the edge of the leaflet can be adjusted within a large range. This allows the distance between the implantation point of the artificial tendon chord 2 on the leaflet and the edge of the leaflet to be adjusted as needed, ensuring that the artificial tendon chord 2 will not fall off after being implanted into the leaflet, and improving the implantation reliability of the artificial tendon chord 2.

[0040] like Figure 3 As shown, in this application, the first clamp 21 has a first clamping surface 212 facing the second clamp 22, and the second clamp 22 has a second clamping surface 222 that is opposite to and adapted to the first clamping surface 212. The first clamping surface 212 includes at least a first horizontal surface 2121, and the second clamping surface 222 includes at least a second horizontal surface 2221 that is adapted to the first horizontal surface 2121. It is easy to understand that when the clamp assembly 20 clamps the leaflet, the first horizontal surface 2121 and the second horizontal surface 2221 will respectively adhere to the opposite sides of the leaflet. The first clamp 21 can apply a first clamping force perpendicular to the first horizontal surface 2121 to the leaflet, and the second clamp 22 can apply a second clamping force perpendicular to the second horizontal surface 2221 to the leaflet. The first clamping force and the second clamping force can respectively act on the leaflet in a generally radial direction along the clamp assembly 20, thereby clamping the leaflet between the first clamp 21 and the second clamp 22.

[0041] It should be noted that, in order to ensure that the chuck assembly 20 has a sufficient clamping area, the axial length of the first horizontal plane 2121 and the second horizontal plane 2221 along the axial length of the chuck assembly 20 cannot be too small. However, in order not to affect the turning radius of the chuck assembly 20, the axial length cannot be too large either. For example, it can be 8mm, 10mm, 12mm or other reasonable axial length values. The specific value can be set according to actual needs and is not limited in this regard.

[0042] Preferably, such as Figure 3 As shown, in the first embodiment of this application, the first clamping surface 212 further includes a first arcuate surface 2123 smoothly connected to the proximal end of the first horizontal surface 2121, and the second clamping surface 222 further includes a second arcuate surface 2223 smoothly connected to the proximal end of the second horizontal surface 2221. The first arcuate surface 2123 and the second arcuate surface 2223 are adapted to each other. The first arcuate surface 2123 and the second arcuate surface 2223 can be a single arcuate surface structure or a multi-arc surface structure (not limited to an S-shaped curved surface), preferably a single arcuate surface structure that is easy to manufacture. In this embodiment, the first arcuate surface 2123 is a concave arcuate surface, and the second arcuate surface 2223 is a convex arcuate surface. In other embodiments, the first arcuate surface 2123 can be a convex arcuate surface, and the second arcuate surface 2223 can be a concave arcuate surface, as long as the first arcuate surface 2123 and the second arcuate surface 2223 are adapted to each other.

[0043] Understandably, when the clamp assembly 20 clamps the leaflet, the first arcuate surface 2123 and the second arcuate surface 2223 will respectively abut against the opposite sides of the leaflet. The first clamp 21 can also apply a third clamping force perpendicular to the first arcuate surface 2123 to the leaflet, and the second clamp 22 can also apply a fourth clamping force perpendicular to the second arcuate surface 2223 to the leaflet, so that the clamp assembly 20 can clamp the edge portion of the leaflet through the third clamping force and the fourth clamping force, and clamp the middle portion of the leaflet through the first clamping force and the second clamping force. It should be noted that the third clamping force includes multiple clamping forces acting on the leaflet perpendicular to the first arcuate surface 2123 and along different radial directions of the first arcuate surface 2123, and the fourth clamping force includes multiple clamping forces acting on the leaflet perpendicular to the second arcuate surface 2223 and along different radial directions of the second arcuate surface 2223.

[0044] In the first embodiment of this application, by adding a matching first arc-shaped surface 2123 and second arc-shaped surface 2223 to the proximal ends of the first horizontal surface 2121 and the second horizontal surface 2221, not only can the clamping area of ​​the first clamping surface 212 and the second clamping surface 222 be increased, making it easier to clamp the leaflet, but also the clamping head assembly 20 can apply multiple clamping forces (i.e., first clamping force, second clamping force, third clamping force and fourth clamping force) to the leaflet in different directions. Compared with simply relying on the first clamping force and the second clamping force acting on the leaflet in the approximate radial direction of the clamping head assembly 20 to clamp the leaflet, clamping the leaflet with multiple clamping forces in different directions can increase the clamping force of the clamping head assembly 20 on the leaflet, thereby effectively preventing the leaflet from slipping out of the clamping head assembly 20 when the puncture assembly 80 punctures the leaflet, and improving the reliability of the clamping head assembly 20 in clamping the leaflet. Optionally, in order to enable the chuck assembly 20 to stably clamp the edge portion of the leaflet, in this embodiment, the axial length of the first arcuate surface 2123 and the second arcuate surface 2223 along the chuck assembly 20 can both be 2mm to 4mm, and the curvature radius of the first arcuate surface 2123 and the second arcuate surface 2223 can both be 6mm to 7mm.

[0045] Further preferably, in the first embodiment of this application, the first clamping surface 212 and / or the second clamping surface 222 are provided with an anti-slip structure (not shown in the figure). The anti-slip structure can be formed by increasing the surface roughness on the first clamping surface 212 and / or the second clamping surface 222, and / or by forming a film on the first clamping surface 212 and / or the second clamping surface 222. In this way, the friction of at least one clamping surface of the chuck assembly 20 can be increased, thereby further increasing the clamping force of the chuck assembly 20, which is more conducive to preventing the leaflets held by the chuck assembly 20 from slipping out of the chuck assembly 20, and further improving the reliability of the chuck assembly 20 in holding the leaflets. It should be noted that the technical means of increasing the surface roughness on the first clamping surface 212 and / or the second clamping surface 222 include, but are not limited to, adding protrusions, barbs, forming grooves or patterns by cutting, etc. It is understandable that, since the areas of the first clamping surface 212 and the second clamping surface 222 are both larger than the area of ​​the clamping surface of the existing chuck, when the clamping surface of the existing chuck and the first clamping surface 212 and / or the second clamping surface 222 of the chuck assembly 20 are patterned by cutting, the clamping surface of the existing chuck with a smaller area will become too sharp after adding the pattern, resulting in abrasion or puncture of the petals, while the first clamping surface 212 and / or the second clamping surface 222 with a larger area will not become too sharp after adding the pattern, resulting in abrasion or puncture of the petals.

[0046] Specifically, please combine Figures 1 to 3In the first embodiment of this application, both the first clamp 21 and the second clamp 22 are generally semi-cylindrical clamps. The first clamp 21 includes a first clamping body and a connector 211 connected to the proximal end of the first clamping body. The second clamp 22 includes a second clamping body and a connecting portion 226 connected to the proximal end of the second clamping body. The surface of the first clamping body facing the second clamp 22 is the first clamping surface 212, and the surface of the second clamping body facing the first clamp 21 is the second clamping surface 222. Optionally, to prevent damage to the leaflet, the distal surface of the first clamping body and / or the distal surface of the second clamping body is a smooth curved surface, such as, but not limited to, a quarter-circle arc surface. Furthermore, optionally, the edges of the first clamping body on the first clamping surface 212 are chamfered or rounded, and / or the edges of the second clamping body on the second clamping surface 222 are chamfered or rounded, which can also prevent damage to the leaflet. Figure 3 As shown, in this embodiment, the distal surfaces of the first clamping body and the second clamping body are both quarter-circle arc surfaces, and the edges of the first clamping body at the first clamping surface 212 and the edges of the second clamping body at the second clamping surface 222 are both rounded.

[0047] like Figure 1 As shown, in this embodiment, the outer diameter of the insertion tube 211 is equal to the inner diameter of the inner sheath 64. The proximal portion of the insertion tube 211 is inserted into the distal end of the inner sheath 64, thereby connecting the first clamp 21 to the distal end of the inner sheath 64. In other embodiments, the outer diameter of the insertion tube 211 may be smaller than the inner diameter of the inner sheath 64. The proximal portion of the insertion tube 211 is inserted into the distal end of the inner sheath 64, and the insertion tube 211 is bonded and fixed to the inner sheath 64 by injecting glue (not limited to instant glue, medical glue, or UV glue) into the gap between the outer wall of the insertion tube 211 and the inner wall of the inner sheath 64, so that the first clamp 21 is connected to the distal end of the inner sheath 64. In other embodiments, the outer diameter of the insertion tube 211 may be less than or equal to the outer diameter of the inner sheath 64 and greater than the inner diameter of the inner sheath 64. The proximal end face of the insertion tube 211 at least partially overlaps with the distal end face of the inner sheath 64, and is fixed by adhesive bonding or welding, which also allows the first clamp 21 to be connected to the distal end of the inner sheath 64. It is understood that in other embodiments, the insertion tube 211 may also be connected to the distal end of the inner sheath 64 by other means such as threaded connection or snap-fit ​​connection, thereby connecting the first clamp 21 and its movably connected second clamp 22 to the inner sheath 64, which will not be elaborated further.

[0048] like Figure 2As shown, in this application, the connecting portion 226 is used to movably connect the proximal end of the first chuck 21, thereby allowing the proximal end of the second chuck 22 to be movably connected to the first chuck 21. Preferably, in this application, the proximal end of the first chuck 21 is provided with a receiving groove 216, and the connecting portion 226 at the proximal end of the second chuck 22 is at least partially received in the receiving groove 216. In this way, not only can the second chuck 22 be provided with a space for movement, but the overall volume of the chuck assembly 20 can also be reduced.

[0049] Specifically, please combine Figure 2 and Figure 3 In the first embodiment of this application, the connecting portion 226 includes two connecting seats disposed near the proximal end of the second clamping body. The two connecting seats are radially spaced along the clamping assembly 20 parallel to the second clamping surface 222 on opposite sides of the second clamping body. Each connecting seat extends toward the first clamping head 21 in a direction perpendicular to the second clamping surface 222, and each connecting seat has a first through hole (not shown in the figure) extending along the spacing direction between the two connecting seats. Figure 2 and Figure 3 As shown, the proximal end of the first clamping body is provided with a receiving groove 216, and the first clamping body has two second through holes on opposite sides of the receiving groove 216 corresponding to two connecting seats. Each second through hole penetrates the outer wall of the first clamping body and connects to the receiving groove 216. It can be understood that when the connecting part 226 (i.e., the two connecting seats) at the proximal end of the second clamp 22 is received in the receiving groove 216, each first through hole is connected to the corresponding second through hole. A rotating shaft is inserted from the outside of the first clamping body into the corresponding connected second through hole and first through hole in sequence, so that each connecting seat is rotatably connected to the first clamping body through a rotating shaft, that is, the proximal end of the second clamp 22 is rotatably connected to the proximal end of the first clamp 21. In this embodiment, the rotating shaft can be a pivot or a pin. That is, the proximal end of the first clamp 21 and the proximal end of the second clamp 22 can be rotatably connected by a pivot or a pin, so that the first clamp 21 can be driven to rotate relative to the second clamp 22 by the driving component 40, so that the distal end of the first clamp 21 is close to or away from the distal end of the second clamp 22 to achieve clamping of the leaflet.

[0050] Preferably, please combine Figure 3 and Figure 4In the first embodiment of this application, a positioning block 2161 protrudes from the first clamping body within the receiving groove 216. The positioning block 2161 is located in the middle of the receiving groove 216 and extends axially along the chuck assembly 20. The radial width of the positioning block 2161 along the chuck assembly 20 is less than the distance between the two connecting seats. The opposite side walls of the positioning block 2161 in its width direction form two receiving cavities with the opposite side walls of the receiving groove 216, respectively. It should be noted that when the two connecting seats near the second clamping head 22 are received within the receiving groove 216, the positioning block 2161 is located between the two connecting seats, and the end of each connecting seat away from the second clamping body is received within a corresponding receiving cavity. It is understood that by setting a positioning block 2161 in the receiving groove 216 to form two receiving cavities for partially receiving the two corresponding connecting seats, each receiving cavity can play a role in positioning and installation. Moreover, the positioning block 2161 located between the two connecting seats can also prevent the second chuck 22 from moving radially along the chuck assembly 20 during the rotation relative to the first chuck 21, which is beneficial to improving the stability of the rotation of the second chuck 22 relative to the first chuck 21.

[0051] Preferably, such as Figure 3 and Figure 4 As shown, in the first embodiment of this application, the first chuck 21 further includes a reinforcing platform 213 for strengthening the first chuck 21 to increase its rigidity. Specifically, the proximal end of the reinforcing platform 213 is connected to the distal end of the insertion tube 211, and the distal end of the reinforcing platform 213 is connected to the proximal end of the first clamping body. The reinforcing platform 213 closes the proximal side of the receiving groove 216, so that the receiving groove 216 has an opening facing the second chuck 22. The distal end of the reinforcing platform 213 may protrude from or be flush with the opening of the receiving groove 216 in the direction from the first chuck 21 to the second chuck 22. In this embodiment, the distal end of the reinforcing platform 213 protrudes from the opening of the receiving groove 216. Further preferably, as... Figure 3 and Figure 4 As shown, in this embodiment, the radial dimension of the reinforcing platform 213 gradually decreases from the distal end to the proximal end, so that the outer side of the reinforcing platform 213 forms a conical surface. Thus, when the closed clamp assembly 20 is gradually retracted into the outer sheath 62 (see...), Figure 1 During the process, the clamp assembly 20 can slide against the distal end of the outer sheath tube 62 through the outer conical surface of the reinforcing platform 213, thereby gradually being drawn into the outer sheath tube 62. In other words, the reinforcing platform 213 with the conical surface can play a guiding role.

[0052] Please combine Figure 1 , Figure 3 and Figure 4In this application, the first clamp 21 has a first puncture channel 214, which penetrates the proximal end of the first clamp 21 and the first clamping surface 212 (specifically, it penetrates the first horizontal surface 2121); correspondingly, the second clamp 22 has a second puncture channel 224, which penetrates the distal end of the second clamp 22 and the second clamping surface 222 (specifically, it penetrates the second horizontal surface 2221). Figure 1 As shown, the inner lumen of the inner sheath 64, the first puncture channel 214, and the second puncture channel 224 are connected to form a puncture channel for the puncture assembly 80 to pass through.

[0053] Specifically, such as Figure 1 As shown, in the first embodiment of this application, the first puncture channel 214 includes a horizontal puncture cavity 2141 and an arc-shaped puncture cavity 2143 connected to the distal end of the horizontal puncture cavity 2141. The horizontal puncture cavity 2141 extends axially along the inner sheath 64 and its proximal end extends to the proximal end of the first clamp 21. The arc-shaped puncture cavity 2143 gradually approaches and extends from the proximal end to the distal end, reaching the first horizontal surface 2121 of the first clamping surface 212. The arc-shaped puncture cavity 2143 allows the puncture needle 82 in the puncture assembly 80 to exit at a specific arc, thereby puncturing the leaflets held by the first clamp 21 and the second clamp 22. The distal section of the needle exit channel of the puncture needle 82 has a certain arc design, which can improve the efficiency, feasibility, and safety of puncturing the leaflets when the clamp assembly 20 uses axial rotation to clamp them.

[0054] Preferably, in this embodiment, the inner diameter of the horizontal puncture cavity 2141 ranges from 0.5mm to 1mm to ensure that the puncture needle tube 82 can pass smoothly without affecting the overall size of the clamp assembly 20; the axial length of the horizontal puncture cavity 2141 ranges from 8mm to 12mm, the radius of curvature of the arc-shaped puncture cavity 2143 ranges from 20mm to 25mm, and the arc length of the arc-shaped puncture cavity 2143 ranges from 6mm to 8mm. By reasonably designing the dimensions of the first puncture channel 214, it not only plays a certain positioning role for the puncture needle tube 82, but also allows the puncture point of the puncture needle tube 82 (i.e., the distal end of the arc-shaped puncture cavity 2143) to be located as close as possible to the edge of the leaflet, thereby ensuring puncture strength and avoiding leaflet tearing. At the same time, it can also adapt to leaflets of different thicknesses.

[0055] More preferably, such as Figure 1 As shown, in this embodiment, the diameter of the first puncture channel 214 gradually decreases from the proximal end to the distal end. Specifically, in this embodiment, the proximal port of the horizontal puncture cavity 2141 is designed as an flared opening with a diameter that gradually decreases from the proximal end to the distal end, so that the puncture needle tube 82 can be smoothly inserted into the first puncture channel 214.

[0056] like Figure 1 and Figure 3 As shown, in the first embodiment of this application, the second puncture channel 224 includes a puncture groove exposed on the second clamping surface 222, and the depth of the puncture groove gradually increases from the proximal end to the distal end. Figure 1 As shown, when the first clamp 21 and the second clamp 22 are fully closed, the proximal end of the puncture groove corresponds to the distal end of the arc-shaped puncture cavity 2143. Therefore, when the puncture needle 82 is withdrawn after the clamp assembly 20 clamps the leaflet, the puncture groove can position the puncture needle 82 to a certain extent, enabling the puncture needle 82 to effectively puncture and smoothly exit from the distal end of the clamp assembly 20. Furthermore, if the proximal end of the puncture groove does not correspond to the distal end of the arc-shaped puncture cavity 2143, it indicates that the clamp assembly 20 is not effectively clamping the leaflet or the clamping position is not ideal. In this case, the puncture needle 82 cannot be pushed out of the clamp assembly 20, prompting the operator to adjust the clamping position of the leaflet, thus improving the safety of the clamp assembly 20. Understandably, since the thickness of a normal human mitral valve ranges from 0.5mm to 2mm, the second puncture channel 222 adopts an open puncture groove, which can ensure that the clamp assembly 20 can communicate with the arc-shaped puncture cavity 2143 of the first puncture channel 214 when clamping leaflets of different thicknesses. This ensures that effective puncture can be achieved regardless of the position of the clamped leaflet or the thickness of the leaflet.

[0057] It should be noted that, for implantation safety, in this application, both the first clamp 21 and the second clamp 22 are made of biocompatible materials, including but not limited to stainless steel, nickel-chromium alloy, etc., with stainless steel having high hardness being preferred.

[0058] Please refer to the following: Figure 1 and Figure 5 In the first embodiment of this application, the drive assembly 40 includes an elastic element 43 and a control element 41. The elastic element 43 is disposed between the proximal end of the first clamp 21 and the proximal end of the second clamp 22. The distal end of the control element 41 is fixedly connected to the second clamp 22. The elastic element 43 and the control element 41 cooperate with each other to drive the distal end of the first clamp 21 to approach or move away from the distal end of the second clamp 22.

[0059] Specifically, such as Figure 1 and Figure 5 As shown, in this embodiment, the elastic element 43 is a spring, and one end of the spring ( Figure 5The first fixed end A1 is connected to the proximal end of the first clamp 21, and the other end of the elastic element 43 is connected to the proximal end of the second clamp 22; the control element 41 is a traction wire whose distal end is connected to the second clamp 22. When the first clamp 21 and the second clamp 22 are closed, the spring is in a relaxed state. By pulling the control element 41 to move it proximal, the second clamp 22 can rotate relative to the first clamp 21 around the first rotation axis A2 (i.e., the rotation axis on the connecting seat), so that the distal end of the second clamp 22 moves away from the distal end of the first clamp 21, and the elastic element 43 is stretched. When the control element 41 is released, under the action of the elastic restoring force of the elastic element 43, the second clamp 22 can rotate again relative to the first clamp 21 around the first rotation axis A2 so that the distal end of the second clamp 22 moves closer to the distal end of the first clamp 21. In this way, the opening and closing of the second clamp 22 relative to the first clamp 21 can be achieved by pulling or releasing the control element 41.

[0060] Among them, such as Figure 1 As shown, in this embodiment, a through hole is provided on the reinforcing platform 213 of the first clamp 21. The control member 41 passes through this through hole and extends out of the body through the inner cavity of the outer sheath tube 62. The control member 43 passes through the through hole of the reinforcing platform 213. When the control member 41 is pulled, the through hole corresponds to the second fixed end A3 (see...). Figure 5 It can serve as a guide, allowing the control component 41 to move axially along the extension direction of the through hole, thus preventing it from wobbling radially when pulling the second chuck 22.

[0061] Preferably, such as Figure 1 As shown, in this embodiment, the control member 41 has multiple branches 412 at its distal end, which extend to the distal end connected to the second chuck 22. This helps to improve the reliability and effectiveness of the control member 41 when it pulls the second chuck 22 to rotate.

[0062] It is understood that in this application, the elastic element 43 may also be replaced by other elastic elements besides springs, including but not limited to pawl springs, elastic nickel-titanium elastic sheets, nickel-titanium elastic rods, and compressible polymer materials.

[0063] Please combine Figure 1 and Figure 2 In this application, the outer sheath 62 and inner sheath 64 of the conveying assembly 60 are both hollow tubes of a certain length, and the two are fitted together. Figure 1 and Figure 2In the first embodiment shown, the distal end of the inner sheath 64 is used to insert the insertion tube 211 proximal to the first clamp 21, thereby connecting the clamp assembly 20 to the distal end of the inner sheath 64. As previously mentioned, in other embodiments, the proximal end of the second clamp 22 may be provided with an insertion tube and inserted into the distal end of the inner sheath 64, similarly connecting the clamp assembly 20 to the distal end of the inner sheath 64. The outer sheath 62 is used to establish an in vitro-in vivo pathway and to house the inner sheath 64 and the clamp assembly 20 connected to its distal end, which is not clamped and is fully closed, thereby allowing the clamp assembly 20 to be transported through the inner sheath 64 into the lumen of the outer sheath 62.

[0064] In the first embodiment, the first puncture channel 214 of the first clamp 21 is connected to the lumen of the inner sheath 64 to accommodate the puncture assembly 80. Obviously, in other embodiments, the puncture assembly 80 can be accommodated within the lumen of the inner sheath 64.

[0065] Since the outer sheath 62 and inner sheath 64 typically need to be used in conjunction with a guidewire to establish a channel from outside the body to inside, the outer sheath 62 and inner sheath 62 are at least adjustable in their distal portions and can also be pre-shaped to give them specific shapes to meet specific interventional pathways. It should be noted that the outer sheath 62 and inner sheath 64 are generally multi-layered tubes, consisting of, from the inside out, an inner membrane made of polymer materials such as PTFE (polytetrafluoroethylene), a middle braided mesh made of metal materials such as nickel-titanium or stainless steel, and an outer membrane made of elastomer materials such as Pebax (block polyetheramide). The outer sheath 62 and inner sheath 64 can use existing sheaths, which will not be elaborated further.

[0066] like Figure 1 and Figure 2 As shown, in the first embodiment of this application, the puncture assembly 80 specifically includes a puncture needle tube 82 and a push tube 84 movably inserted within the puncture needle tube 82. Please refer to... Figure 1 , Figures 6 to 7 In the first embodiment, the puncture needle 82 is movably accommodated in the lumen of the communicating first puncture channel 214 and the inner sheath 64, and the distal end of the puncture needle 82 can extend out of the distal end of the clamp assembly 20 sequentially through the lumen of the communicating inner sheath 64, the first puncture channel 214, and the second puncture channel 224, thereby being used to puncture the leaflet 5 held by the clamp assembly 20. Figures 6 to 7As shown, the puncture needle 82 is a hollow tube with a sharp needle tip at its distal end. Understandably, if the needle tip angle is too small, its strength will be lower, and it may break when facing a relatively tough or thick leaflet 5. Conversely, if the needle tip angle is too large, the sharpness will be insufficient, increasing the puncture force required to penetrate the leaflet 5, making it difficult to puncture. Therefore, the needle tip angle of the puncture needle 82 is in the range of 25 degrees to 45 degrees, preferably 30 degrees.

[0067] like Figure 1 As shown, in the first embodiment of this application, the artificial tendon chord 2 is movably inserted into the inner cavity of the push tube 84, and is also movably inserted into the inner cavity of the puncture needle tube 82 along with the push tube 84. Optionally, the distal end of the artificial tendon chord 2, after extending from the distal end of the push tube 84, can be movably connected to the distal end of the push tube 84 by means of interference fit, friction connection, knotting, or connecting washer 4. It should be noted that the minimum size of the knotted coil formed by the distal end of the artificial tendon chord 2 or the washer 4 connected to its distal end is larger than the inner diameter of the push tube 84. In this way, the artificial tendon chord 2 is movably inserted into the push tube 84, and the coil or washer 4 at its distal end is received in the distal inner cavity of the puncture needle tube 82. When the push tube 84 moves axially distally within the puncture needle tube 82, the distal end of the push tube 84 can push the suture or pad 4 to move the artificial tendon chord 2 distally. However, when the push tube 84 retracts proximally with the puncture needle tube 82, it will not retract the artificial tendon chord 2, so that the artificial tendon chord 2 is implanted on the leaflet.

[0068] Preferably, please refer to the following: Figure 1 and Figure 9 In the first embodiment of this application, a pad 4 is connected to the distal end of the artificial chord 2. The pad 4 is used to anchor onto the leaflet 5, thereby dispersing the tension of the artificial chord 2 on the leaflet 5 and preventing tearing of the leaflet 5. An axial distance (e.g., 3 mm) is maintained between the pad 4 and the tip of the puncture needle 82 to prevent the pad 4 from protruding from the tip of the puncture needle 82 and hindering the puncture needle 82 from puncturing the leaflet. The artificial chord 2 can be connected to the pad 4 by bonding or knotting, or a through hole can be provided in the pad 4 for the artificial chord 2 to pass through. The shape of the pad 4 can be any reasonable shape, such as square, round, or elliptical, and is not limited thereto.

[0069] Optionally, in some embodiments, the minimum size of the gasket 4 can be larger than the inner diameter of the puncture needle tube 82. The gasket 4 is squeezed and accommodated within the puncture needle tube 82, resulting in a squeezing contact and frictional connection between the gasket 4 and the inner wall of the puncture needle tube 82. This helps to prevent axial slippage of the gasket 4 within the puncture needle tube 82. However, after a certain pushing force is applied by the push tube 84, the gasket 4 can be pushed out of the puncture needle tube 82. Of course, in other embodiments, the maximum size of the gasket 4 can be smaller than the inner diameter of the puncture needle tube 82. The gasket 4 is movably disposed within the inner cavity of the puncture needle tube 82. In this embodiment, the gasket 4 can also be pushed out of the inner cavity of the puncture needle tube 82 by the push tube 84 and drive the artificial tendon chord 2 into the leaflet.

[0070] Among them, the puncture needle 82, the push tube 84 and the pad 4 are preferably made of medical metal materials such as nickel-titanium alloy.

[0071] The artificial tendon chord 2, as the implant, is flexible and can be bent arbitrarily without axial tension. To ensure implantation safety, the artificial tendon chord 2 can be made of a biocompatible polymer material, preferably PTFE (polytetrafluoroethylene), e-PTFE (expanded polytetrafluoroethylene), PET (polyethylene terephthalate), or UHMWPE (ultra-high molecular weight polyethylene), but there are no restrictions on the type.

[0072] The following will combine Figures 10 to 15 Taking transcatheter mitral valve chordae tendineae repair as an example, the usage process and working principle of the transcatheter artificial chordae tendineae implantation system 1 of the first embodiment of this application are explained. The surgical path is as follows: via femoral vein - aortic arch - aortic valve (AV) - left ventricle (LV) - mitral valve (MV) annulus - left atrium (LA).

[0073] First step, such as Figure 10 As shown, under ultrasound / CT guidance, the femoral artery is punctured and guided by a guidewire (not shown in the figure) to deliver the outer sheath 62 through the aortic arch to the position of the aortic valve near the left ventricle. Then, the inner sheath 64 and the clamp assembly 20 connected to it are extended from the outer sheath 62. Under ultrasound / CT guidance, the inner sheath 64 is extended and bent at the same time until the inner sheath 64 is bent to about 170 degrees and the clamp assembly 20 is located in the left atrium.

[0074] The second step, as Figure 11 As shown, by pulling the control member 41, the second chuck 22 is driven to rotate axially relative to the first chuck 21, so that the distal end of the second chuck 22 is moved away from the distal end of the first chuck 21, and the chuck assembly 20 is opened.

[0075] The third step, as Figure 12As shown, under ultrasound / CT guidance, while releasing the bending angle of the inner sheath 64, the inner sheath 64 is slowly retracted until the posterior leaflet of the mitral valve falls into the leaflet receiving space between the first clamp 21 and the second clamp 22.

[0076] Step four, as Figure 13 As shown, when the control member 41 is released, under the action of the elastic member 43, the distal end of the second clamp 22 approaches the distal end of the first clamp 21, and the clamp assembly 20 closes to clamp the leaflet. The inner sheath 64 is slightly and slowly retracted and released, and the inner sheath 64 is bent to about 90 degrees. The relative positions of the gasket 4, the push tube 84 and the puncture needle tube 82 remain unchanged. The puncture needle tube 82 is pushed out to puncture the leaflet.

[0077] Fifth step, as Figure 14 As shown, push tube 84 is pushed out until gasket 4 is completely pushed out of puncture needle tube 82. Gasket 4 is released on the lower surface of the leaflet. Then push tube 84 is pulled back into puncture needle tube 82 and puncture needle tube 82 is pulled back into the first clamp 21 to completely close the clamp assembly 20. Then pull back inner sheath tube 64 and completely release the bending angle of inner sheath tube 64. At this time, suture 2 is still inserted inside puncture needle tube 82.

[0078] Step 6, as follows Figure 15 As shown, the artificial tendon chord implantation device 2 is removed, and the end of the suture 2 is fixed to the posterior papillary muscle by means of an anchor or manual suturing to realize the implantation of the artificial tendon chord.

[0079] It is understood that the transcatheter artificial chordae tendineae implantation system 1 of this application can also be applied to the following scenarios, for example, transcatheter interventional implantation of artificial chordae tendineae for mitral valve via the route of jugular vein-superior vena cava-right atrium-atrial septum-left atrium-mitral valve, and transatrial interventional implantation of artificial chordae tendineae for mitral valve via the route of left atrium-mitral valve. Other examples include transcatheter interventional implantation of artificial chordae tendineae for tricuspid valve via the route of femoral vein-inferior vena cava-right atrium-tricuspid valve, transcatheter interventional implantation of artificial chordae tendineae for tricuspid valve via the route of jugular vein-superior vena cava-right atrium-tricuspid valve, and transatrial interventional implantation of artificial chordae tendineae for tricuspid valve via the route of right atrium-tricuspid valve. Further details are omitted here.

[0080] Please see Figure 16 The transcatheter artificial chordae tendineae implantation system 1 provided in the second embodiment of this application has a basically the same structure as the transcatheter artificial chordae tendineae implantation system 1 in the first embodiment, except that: in the second embodiment, the control element 41 is a push rod whose distal end is connected to the second clamp 22.

[0081] Specifically, such as Figure 16As shown, the distal end of the push rod (i.e., the second rotating end A4) is rotatably connected to the connecting seat of the second chuck 22 near the end of the first chuck 21. Thus, by axially moving the push rod towards the distal end, the second chuck 22 can be controlled to rotate relative to the first chuck 21 around the first rotating end A2, causing the distal end of the second chuck 22 to move away from the distal end of the first chuck 21. The elastic element 43 is stretched, releasing the push rod. Under the elastic restoring force of the elastic element 43, the second chuck 22 can rotate again relative to the first chuck 21 around the first rotating axis A2, causing the distal end of the second chuck 22 to move closer to the distal end of the first chuck 21. Therefore, by pulling or releasing the control element 41, the opening and closing of the second chuck 22 relative to the first chuck 21 can be achieved. It can be understood that pulling the push rod towards the proximal end increases the clamping force of the chuck assembly 20 on the leaflets.

[0082] Optionally, such as Figure 16 As shown, in the second embodiment, the elastic element 43 is connected to one end of the first clamp 21 (i.e., the first fixed end A1) and the distal end of the push rod (i.e., the second rotating end A4) at a specific distance of about 2mm-3mm, so as to limit the distance the push rod is pushed to the distal end and prevent the clamp assembly 20 from opening too large an angle and hooking the tendineae or damaging the tissue.

[0083] Please combine Figure 17 and Figure 18 The transcatheter artificial chordae tendineae implantation system 1 provided in the third embodiment of this application has a basically the same structure as the transcatheter artificial chordae tendineae implantation system 1 in the first embodiment. The difference is that in the third embodiment, the driving component 40 includes a slider 45 and a control component 41. The slider 45 is disposed between the proximal end of the first clamp 21 and the proximal end of the second clamp 22. The distal end of the control component 41 is fixedly connected to the slider 45. The slider 45 and the control component 41 cooperate with each other to drive the distal end of the first clamp 21 to approach or move away from the distal end of the second clamp 22.

[0084] Specifically, such as Figure 17 and Figure 18 As shown, in the third embodiment, the sliding member 45 is an eccentric wheel rotatably connected to the first chuck 21, and the control member 41 is a push rod with its distal end connected to the eccentric wheel. By pulling the push rod towards the proximal end, the eccentric wheel can be controlled to rotate clockwise, thereby causing the second chuck 22 to rotate relative to the first chuck 21, so that the distal end of the second chuck 22 moves away from the distal end of the first chuck 21. By pushing the push rod towards the distal end, the eccentric wheel can be controlled to rotate counterclockwise, thereby causing the second chuck 22 to rotate relative to the first chuck 21 again, so that the distal end of the second chuck 22 moves closer to the distal end of the first chuck 21.

[0085] It should be noted that when the chuck assembly 20 is closed, the connection between the sliding member 45 and the first chuck 21 is at the center point of the eccentric wheel, resulting in an eccentric distance in both the axial and radial directions of the first chuck 21. By rationally designing the outer contour shape of the eccentric wheel, the eccentric wheel can be made to rotate clockwise around the first fixed end A1 in the figure. At this time, the second chuck 22 rotates circumferentially around the first rotating end A2 as an axis, causing the chuck assembly 20 to open.

[0086] Of course, in other embodiments, the slider 45 can also be replaced by a cam mechanism.

[0087] Please combine Figures 19 to 22 The transcatheter artificial chordae tendineae implantation system 1 provided in the fourth embodiment of this application has a basically the same structure as the transcatheter artificial chordae tendineae implantation system 1 in the third embodiment, except that: in the fourth embodiment, the sliding member 45 is set as a roller, and a groove 24 is provided at the proximal end of the first clamp 21 and / or the second clamp 22. The depth of the groove 24 gradually decreases from the proximal end to the distal end, and the sliding member 45 slides axially in the groove 24. When the push rod (i.e., the control member 41) is pushed in the distal direction, it can push the roller (i.e., the sliding member 45) to roll in the groove 24 in the distal direction, thereby driving the second clamp 22 and / or the first clamp 21 to rotate, so that the distal end of the second clamp 22 moves away from the distal end of the first clamp 21; conversely, when the push rod is pulled back in the proximal direction, it can pull the sliding member 45 to roll in the groove 24 in the proximal direction, thereby driving the second clamp 22 and / or the first clamp 21 to rotate, so that the distal end of the second clamp 22 moves closer to the distal end of the first clamp 21.

[0088] Optionally, such as Figure 21 and Figure 22 As shown, in some embodiments, the first chuck 21 is fixedly connected to the inner sheath tube 64, while the second chuck 22 is rotatably connected to the first chuck 21. Therefore, when the push rod controls the roller to slide in the slide groove 24, the roller only drives the second chuck 22 to rotate, thereby realizing the single-sided opening and closing of the chuck assembly 20.

[0089] It is understood that in some other embodiments, the first chuck 21 can be rotatably connected to the inner sheath 21, so that when the roller slides in the groove 24, it can simultaneously drive the first chuck 21 and the second chuck 22 to rotate, thereby realizing the double-sided opening and closing of the chuck assembly 20.

[0090] In summary, in this embodiment, the rotation of at least one of the first chuck 21 and the second chuck 22 can be driven by the cooperation of the push rod and the roller, so as to realize the relative opening and closing of the chuck assembly 20.

[0091] Please combine Figure 23 and Figure 24The transcatheter artificial chordae tendineae implantation system 1 provided in the fifth embodiment of this application has a basically the same structure as the transcatheter artificial chordae tendineae implantation system 1 in the first embodiment, except that: in the fifth embodiment, a guide rail 2163 is provided on the first clamp 21, and the connecting part 226 of the second clamp 22 is a guide slider. The guide slider and the guide rail 2163 are adapted to each other, so that the proximal end of the first clamp 21 and the proximal end of the second clamp 22 are slidably connected through the guide rail. The guide rail 2163 can be a curved guide groove, and the guide slider is inserted into the guide rail 2163. Under the driving action of the driving component 40, the second clamp 22 can also be driven to rotate relative to the first clamp 21, realizing the unilateral opening and closing of the clamp component 20.

[0092] It is understood that in some embodiments, the second chuck 22 may also be provided with a guide rail, and the first chuck 21 may be provided with a corresponding connecting part. In this way, under the driving action of the driving component 40, the first chuck 21 and the second chuck 22 can be driven to rotate simultaneously, thereby realizing the double-sided opening and closing of the chuck component 20.

[0093] It should be noted that in the fifth embodiment, the driving component 40 can be a combination of the elastic element 43 and the control element 41, or a combination of the sliding element 45 and the control element 41, without limitation or further description.

[0094] Please combine Figure 25 and Figure 26 The transcatheter artificial chordae tendineae implantation system 1 provided in the sixth embodiment of this application has a basically the same structure as the transcatheter artificial chordae tendineae implantation system 1 in the first embodiment, except that in the sixth embodiment, the proximal end of the first clamp 21 and the proximal end of the second clamp 22 are engaged and connected by an engagement mechanism.

[0095] Specifically, such as Figure 25 As shown, in some embodiments, the first chuck 21 is provided with a rack and pinion track 2165, and the connecting part 226 of the second chuck 22 is a meshing gear. The connecting part 226 is meshed with the rack and pinion track 2165. Under the driving action of the driving assembly 40, the second chuck 22 can also be driven to rotate relative to the first chuck 21, so as to realize the single-sided opening and closing of the chuck assembly 20.

[0096] like Figure 26 As shown, in some other embodiments, the first chuck 21 is provided with a first gear 2167, and the second chuck 22 is provided with a second gear 2267 that meshes with the first gear 2167. In this way, under the driving action of the driving assembly 40, the first chuck 21 and the second chuck 22 can be driven to rotate simultaneously, thereby realizing the double-sided opening and closing of the chuck assembly 20.

[0097] It should be noted that in the sixth embodiment, the driving component 40 can be a combination of the elastic element 43 and the control element 41, or a combination of the sliding element 45 and the control element 41, and there are no further limitations or descriptions.

[0098] The above embodiments are not limited to the current description, but include similar extended forms. The above are implementation methods of the embodiments of this application. It should be noted that those skilled in the art can make several improvements and modifications without departing from the principles of the embodiments of this application, and these improvements and modifications are also considered to be within the scope of protection of this application.

Claims

1. A clampable transcatheter artificial chordae tendineae implantation device, characterized in that, include: A chuck assembly includes a first chuck and a second chuck, wherein the clamping surfaces of the first chuck and the second chuck extend along the axial direction of the chuck assembly, and the proximal end of the second chuck is movably connected to the proximal end of the first chuck. A drive assembly connected to the second chuck is used to drive the distal end of the second chuck closer to or further away from the distal end of the first chuck to clamp the leaflet located between the first chuck and the second chuck. A puncture assembly extends from the clamp assembly to puncture the leaflet and implant an artificial tendon chord; as well as A delivery assembly for delivering the clamp assembly and the puncture assembly, the delivery assembly including an inner sheath, the proximal end of the first clamp being fixedly connected to the distal end of the inner sheath, and the puncture assembly being movably inserted into the inner sheath; The first clamp has a first clamping surface facing the second clamp, and the second clamp has a second clamping surface opposite to and adapted to the first clamping surface. The first clamping surface includes a first horizontal surface and a first arcuate surface smoothly connected to the proximal end of the first horizontal surface. The second clamping surface includes a second horizontal surface and a second arcuate surface smoothly connected to the proximal end of the second horizontal surface. The first horizontal surface and the second horizontal surface are adapted to each other, and the first arcuate surface and the second arcuate surface are adapted to each other. The first clamp has a first puncture channel that is through-hole. The first clamp has a proximal end and a first clamping surface; the second clamp has a second puncture channel that extends through the distal end of the second clamp and the second clamping surface; the inner lumen of the inner sheath, the first puncture channel, and the second puncture channel are connected; the first puncture channel includes a horizontal puncture cavity and an arc-shaped puncture cavity connected to the distal end of the horizontal puncture cavity; the horizontal puncture cavity extends along the axial direction of the inner sheath and its proximal end extends through to the proximal end of the first clamp; the arc-shaped puncture cavity gradually approaches and extends through to the first clamping surface from the proximal end to the distal end.

2. The easily clampable transcatheter artificial chordae tendineae implantation device as described in claim 1, characterized in that, The first arc-shaped surface and the second arc-shaped surface have an axial length range of 2mm to 4mm along the chuck assembly, and the curvature radius of the first arc-shaped surface and the second arc-shaped surface has a range of 6mm to 7mm.

3. The easily clampable transcatheter artificial chordae tendineae implantation device as described in claim 1, characterized in that, The first clamping surface and / or the second clamping surface are provided with an anti-slip structure, which is formed by increasing the surface roughness.

4. The easily clampable transcatheter artificial chordae tendineae implantation device as described in claim 1, characterized in that, The proximal end of the first chuck is provided with a receiving groove, and the proximal end of the second chuck is at least partially received in the receiving groove.

5. The easily clampable transcatheter artificial chordae tendineae implantation device as described in claim 1, characterized in that, The proximal end of the first chuck and the proximal end of the second chuck are rotatably connected by a pivot or a pin; Alternatively, the proximal end of the first clamp and the proximal end of the second clamp are slidably connected by a guide rail; Alternatively, the proximal end of the first clamp and the proximal end of the second clamp are engaged and connected by an engagement mechanism.

6. The easily clampable transcatheter artificial chordae tendineae implantation device as described in claim 1, characterized in that, The drive assembly includes an elastic element and a control element. The elastic element is disposed between the proximal end of the first clamp and the proximal end of the second clamp. The distal end of the control element is fixedly connected to the second clamp. The elastic element and the control element cooperate with each other to drive the distal end of the second clamp to move closer to or away from the distal end of the first clamp.

7. The easily clampable transcatheter artificial chordae tendineae implantation device as described in claim 1, characterized in that, The driving assembly includes a slider and a control component. The slider is disposed between the proximal end of the first chuck and the proximal end of the second chuck. The distal end of the control component is fixedly connected to the slider. The slider and the control component cooperate to drive the distal end of the second chuck to move closer to or further away from the distal end of the first chuck.

8. The easy-to-clamp transcatheter artificial chordae tendineae implantation device as described in claim 7, wherein the proximal end of the first clamp and / or the second clamp is provided with a groove, the depth of the groove gradually decreasing from the proximal end to the distal end, and the sliding member slides axially in the groove.

9. The easily clampable transcatheter artificial chordae tendineae implantation device as described in claim 1, characterized in that, The conveying assembly further includes an outer sheath, with the inner sheath movably inserted within the outer sheath; wherein, when the first clamp and the second clamp are fully closed, the maximum outer diameter of the clamp assembly is smaller than the minimum inner diameter of the outer sheath.

10. The easily clampable transcatheter artificial chordae tendineae implantation device as described in claim 1, characterized in that, The inner diameter of the horizontal puncture cavity ranges from 0.5 mm to 1 mm, and the axial length of the horizontal puncture cavity ranges from 8 mm to 12 mm.

11. The easily clampable transcatheter artificial chordae tendineae implantation device as described in claim 1, characterized in that, The radius of curvature of the arc-shaped puncture cavity ranges from 20mm to 25mm, and the arc length of the arc-shaped puncture cavity ranges from 6mm to 8mm.

12. The easily clampable transcatheter artificial chordae tendineae implantation device as described in claim 1, characterized in that, The diameter of the first puncture channel gradually decreases from the proximal end to the distal end.

13. The easily clampable transcatheter artificial chordae tendineae implantation device as described in claim 1, characterized in that, The second puncture channel includes a puncture groove exposed on the second clamping surface, the depth of which gradually increases from the proximal end to the distal end.

14. The easily clampable transcatheter artificial chordae tendineae implantation device as described in claim 13, characterized in that, When the first clamp and the second clamp are fully closed, the proximal end of the puncture groove is connected to the distal end of the arc-shaped puncture cavity.

15. A transcatheter artificial chordae tendineae implantation system, characterized in that, The device includes an artificial tendon chord and an easily clampable transcatheter artificial tendon chord implantation device as described in any one of claims 1 to 14, wherein the artificial tendon chord is movably inserted in the puncture assembly, and the distal end of the artificial tendon chord follows the puncture assembly through the leaflet and disengages from the puncture assembly when the puncture assembly is withdrawn.

16. The transcatheter artificial chordae tendineae implantation system as described in claim 15, characterized in that, The puncture assembly includes a puncture needle and a push tube that is movably inserted inside the puncture needle, wherein the artificial tendon is movably inserted inside the push tube.

17. The transcatheter artificial chordae tendineae implantation system as described in claim 16, characterized in that, The distal end of the artificial tendon is connected to a pad, which is movably housed within the distal lumen of the puncture needle.

Images