CN212346814U

CN212346814U - Transcatheter suture implantation device and transcatheter chordae tendineae implantation system

Info

Publication number: CN212346814U
Application number: CN201922424288.6U
Authority: CN
Inventors: 郭荣辉; 谢琦宗; 张庭超
Original assignee: Hangzhou Valgen Medtech Co Ltd
Current assignee: Hangzhou Valgen Medtech Co Ltd
Priority date: 2019-12-25
Filing date: 2019-12-25
Publication date: 2021-01-15
Anticipated expiration: 2029-12-25

Abstract

The utility model provides a transcatheter suture implanting device, which comprises a chuck component capable of being opened and closed relatively, a sheath tube connected with the near end of the chuck component, a puncture component arranged in the chuck component, a group of implanting lines and a group of pulling lines, the puncture assembly comprises a puncture piece which is slidably arranged on the chuck assembly and a puncture connecting piece which corresponds to the puncture piece, a group of implant lines are arranged in the inner cavity of the sheath tube after being folded, two ends of the implantation line are respectively connected with the two puncture connecting pieces, the pulling line comprises a bending part which is pre-arranged in the chuck component and bypasses the two puncture connecting pieces, the puncture piece is connected with the puncture connecting piece and then drives the puncture connecting piece and the implantation line to enter the bending part of the pulling line, the pull wire is withdrawn to drive the implantation wire to enter the sheath tube until the implantation wire is pulled out of the sheath tube. The utility model discloses still relate to a system is implanted to transcatheter chordae tendineae.

Description

Transcatheter suture implantation device and transcatheter chordae tendineae implantation system

Technical Field

The utility model relates to the technical field of medical equipment, especially, relate to a system is implanted to device and through pipe chordae tendineae through pipe suture implantation.

Background

The mitral valve is a one-way valve between the left atrium and the ventricle, which ensures blood flow from the left atrium to the left ventricle. As shown in fig. 1, a normal, healthy mitral valve 1 can control blood flow from the left atrium 2 to the left ventricle 3 while avoiding blood flow from the left ventricle 3 to the left atrium 2. The mitral valve 1 includes a pair of leaflets, referred to as an anterior leaflet 1a and a posterior leaflet 1 b. The anterior leaflet 1a and the posterior leaflet 1b are fixed to papillary muscles of the left ventricle 3 by chordae tendineae 4. Normally, when the left ventricle 3 of the heart contracts, the edges of the anterior leaflet 1a and the posterior leaflet 1b are completely apposed, preventing blood from flowing from the left ventricle 3 to the left atrium 2. As shown in fig. 2, when the leaflets of the mitral valve 1 or their related structures are organically or functionally changed, such as the rupture of the chordae tendineae 4, the anterior leaflet 1a and the posterior leaflet 1b of the mitral valve 1 are poorly coaptated, so that when the left ventricle 3 of the heart contracts, the mitral valve 1 cannot be completely closed, causing blood to flow back from the left ventricle 3 to the left atrium 2, thereby causing a series of pathophysiological changes, called "mitral regurgitation".

At present, the surgical implantation suture line can be used as an artificial chordae tendineae mode to treat chordae tendineae lesion, but an invasive chest opening technology is needed, general anesthesia and moderate low-temperature extracorporeal circulation are carried out as auxiliary support, the operation process is complex, the operation cost is high, the wound degree of a patient is high, the risk of complications is high, the hospitalization time is long, and the recovery process is painful.

Another treatment is the implantation of artificial chordae tendineae in a minimally invasive manner. For example, using a short, relatively thick, straight tube as the delivery device for the implant and puncture assembly, a suture with anti-slip elements is implanted on the leaflet surface of the mitral valve after insertion directly into the patient's heart through the transapical path, with both ends of the suture secured to the apex of the heart as artificial chordae tendinae to maintain tension of the ventricular wall against the leaflets. However, the drawback of this treatment is that transapical is required, the injury to the human body is large, the risk of surgery is high, and the implant delivery device cannot be used for remote intervention, as follows: the transapical path is shorter, in order to guarantee the reliability of the puncture valve leaflet, its puncture assembly is mostly rigid material and structure, when adopting the mode of long-range intervention, in order to guarantee that the antiskid is implanted in the left atrium side, its operation route needs to pass through aortic arch-aortic valve-left ventricle-left atrium, the operation route is comparatively crooked, require the conveyor of implant to possess better compliance, and rigid puncture assembly is difficult to pass through complicated vascular route, if change its rigid puncture assembly into flexible material and structure, under the operation route of such crooked, when puncturing through the thrust of puncturing the assembly on the handle, the flexibility of material can cause the loss to the puncture force, increase the puncture degree of difficulty, reduce the validity of puncture, the operation risk is higher, the apparatus validity is relatively poor.

SUMMERY OF THE UTILITY MODEL

The to-be-solved technical problem of the utility model lies in, to prior art's defect, provide a through pipe suture implantation device and through pipe chordae tendineae implantation system, through the mode of wicresoft, implant at least a set of suture as artificial chordae tendineae to the leaflet of mitral valve, then fix the end of suture at ventricular wall, papillary muscle or apex of the heart to the suture replaces natural chordae tendineae.

In order to solve the technical problem, the utility model provides a device is implanted to suture through pipe, including the cartridge subassembly that can open and shut relatively, connect in the sheath pipe of cartridge subassembly near-end, set up puncture subassembly in the cartridge subassembly, a group implants line and a set of pulling line, puncture subassembly includes the puncture piece that sets up in the cartridge subassembly slidably and corresponds the puncture connecting piece of puncture piece, set up in the inner chamber of sheath pipe after a set of implantation line pair is broken, two are connected respectively at the both ends of implantation line, the pulling line is including preinstallation in the cartridge subassembly and by-pass two flexion of puncture connecting piece, puncture piece with puncture connecting piece drive the puncture connecting piece and the implantation line gets into the flexion of pulling line after connecting, pulling line back is in order to drive the implantation line gets into in the sheath pipe, until the implant wire is pulled out of the sheath.

Preferably, the chuck assembly comprises a proximal chuck, a distal chuck, and a clamping driving rod disposed between the proximal chuck and the distal chuck, the clamping driving rod moves axially to drive the distal chuck to open and close relative to the proximal chuck, the puncturing member is disposed on the distal chuck, and the puncturing connecting member is disposed on the proximal chuck.

Preferably, the puncture connecting piece is a sleeve arranged in the near-end chuck at intervals, the puncture piece is a puncture needle arranged in the far-end chuck corresponding to the sleeve, and the two puncture needles penetrate through the valve leaflets and then are fixedly connected with the corresponding sleeves in a detachable or non-detachable mode.

Preferably, the puncture needle comprises a conical needle head, and one side of the sleeve facing the puncture needle is provided with an accommodating cavity for accommodating the needle head.

Preferably, the chuck assembly further comprises a guide rod disposed between the proximal chuck and the distal chuck, the guide rod is parallel to the clamping driving rod at intervals, and the distal chuck can slide along with the guide rod in the axial direction.

Preferably, the collet assembly further comprises a probe slidably disposed in the sheath, a distal end of the probe extending from the proximal collet to probe a leaflet between the proximal collet and the distal collet.

Preferably, a thread guide cavity is axially formed in the middle of the proximal end chuck, and at least one probe cavity is axially formed in one side of the proximal end chuck, which is located in the thread guide cavity; the near-end chuck is provided with at least one clamping traction cavity at one side of the thread guide cavity along the axial direction, and the clamping driving rod is accommodated in the clamping traction cavity; the near-end chuck is provided with a connecting cavity along the axial direction at one side of the clamping traction cavity, and the near end of the guide rod is arranged in the connecting cavity.

Preferably, the implantation wire and the pulling wire are both flexible wires made of a biocompatible polymer material or a softer metal material, and the length of the implantation wire and the length of the pulling wire are both greater than twice the length of the sheath.

Preferably, the implantation wire is slidably sleeved with a slip-proof piece, the distal end of the implantation wire is bent to form a bent portion, the slip-proof piece is located at the bent portion, and the implantation wire drives the slip-proof piece to move in the process that the pulling wire drives the implantation wire to move until the slip-proof piece is attached to the surface of the valve leaflet.

Preferably, the anti-slip piece is provided with two through holes at intervals along the thickness direction of the anti-slip piece, a connecting line between the two through holes and the axial direction of the anti-slip piece form a certain included angle, and two ends of the implantation line penetrate through the two through holes respectively and then are connected to the two puncture connecting pieces.

Preferably, the chuck assembly is provided with an implant accommodating cavity along the axial direction, the anti-slip member is detachably accommodated in the implant accommodating cavity, the implant wire and the puncture connecting member are accommodated in the implant accommodating cavity, the implant wire is driven by the pulling wire to move out of the implant accommodating cavity, and the anti-slip member can be pulled out of the implant accommodating cavity by pulling the implant wire towards the proximal end.

Preferably, the distal end chuck is provided with two puncture channels along the axial direction, the two puncture pieces are respectively accommodated in the two puncture channels, and the two puncture channels correspond to the puncture connecting pieces on two sides of the implant accommodating cavity, so that the puncture pieces correspond to the puncture connecting pieces.

Preferably, the chuck component is provided with a pulling wire accommodating tube, the proximal end of the pulling wire accommodating tube passes through the proximal end chuck and is communicated with the sheath tube, the bending part of the pulling wire is accommodated in the distal end of the pulling wire accommodating cavity, and the proximal end of the pulling wire enters the sheath tube from the pulling wire accommodating cavity and passes through the proximal end of the sheath tube.

Preferably, an end cover is arranged at the far end of the far-end chuck, a guide rod is axially arranged at the near end of the end cover, a limiting part stopping on the near-end chuck is arranged at the near end of the guide rod, and the far-end chuck is slidably sleeved on the guide rod.

Preferably, the end cap is a smooth structure made of metal.

Preferably, a contact surface in the distal end cartridge, which is attached to the curved portion of the pull wire, is obliquely arranged, and an opening end of the curved portion is biased to the proximal end of the distal end cartridge, so that the curved portion and the moving direction of the puncture piece form an acute angle.

Preferably, a contact surface, attached to the bent portion of the pull wire, in the distal end cartridge is provided with a limiting groove, the limiting groove surrounds the two piercing connectors, and the bent portion of the pull wire is accommodated in the limiting groove.

Preferably, the end of the implantation wire is detachably connected to the puncture connecting member, and the implantation wire is disconnected from the puncture connecting member in the process of driving the implantation wire by the pulling wire.

Preferably, the transcatheter suture implantation device further comprises a control handle for actuating the jaw assembly to open and close relative to each other to grip the leaflets, controlling the probe to probe the leaflets, actuating the piercing member to pierce the leaflets, and actuating the pullback of the pull wire.

The utility model also provides a system is implanted to tendinous cable through pipe, include through pipe suture implantation device and guiding device, implant the device through pipe suture and wear the dress movably in the guiding device, guiding device includes adjustable return bend and locates the accent curved mechanism of adjustable return bend near-end, the cartridge assembly certainly the distal end of adjustable return bend stretches out, the distal end of adjustable return bend is equipped with at least one adjustable curved section, the accent curved mechanism including set up in the accent curved member of adjustable return bend near-end and with the regulation silk that the accent curved member links to each other, the distal end of regulation silk with adjustable curved section links to each other, the accent curved member pulling the regulation silk makes adjustable curved section is crooked, with the adjustment implant the distal end position of device through pipe suture.

Preferably, at least one adjusting wire channel is axially formed in the pipe wall of the adjustable bent pipe, the adjusting wire penetrates through the adjusting wire channel, an adjusting ring is embedded in the adjustable bent section, and the far end of the adjusting wire is connected with the adjusting ring.

The sheath canal bending adjusting mechanism of the transcatheter chordae tendineae implantation system provided by the utility model can be used for adjusting the bending adjustable section of the sheath canal to be in a bending state, so that the sheath canal can meet the requirement of the bent lumen structure of the human body and is suitable for remote intervention; a group of implantation lines and a group of pulling lines are arranged in a chuck component and a sheath pipe of the catheter suture implantation device, the puncture connecting piece is connected with the puncture connecting piece after the puncture valve leaflet is punctured by the puncture piece, and the puncture piece can be retracted to drive the puncture connecting piece and the implantation lines to penetrate through the valve leaflet; the implantation line can be pulled out of the sheath tube through the movement of the pulling line, an operator can cut the implantation line according to the requirement and fix the implantation line on the ventricular wall or papillary muscle, the use is convenient, the operation is simple, the injury to the human body is small, and the operation risk is reduced.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings used in the embodiments will be briefly described below.

Fig. 1 is a schematic view of a mitral valve in a normal state.

Fig. 2 is a schematic view of a diseased mitral valve.

Figure 3 is a schematic structural view of a transcatheter chordae implantation system according to a first embodiment of the invention.

Figure 4 is a schematic perspective view of a transcatheter suture implantation device of a transcatheter chordae implantation system according to a first embodiment of the present invention.

FIG. 5 is a perspective view of a cartridge assembly of the transcatheter suture implantation device of FIG. 4.

Figure 6 is a perspective view of another perspective of the cartridge assembly of figure 4.

Fig. 7 is a schematic structural view of an implantation wire, a slip prevention member and a piercing connection member of the transcatheter suture implantation device according to the first embodiment of the present invention.

FIG. 8 is a schematic view of the implant line, anti-slip member and piercing connector of FIG. 7 from another perspective.

Fig. 9 is a schematic view of the engagement of the piercing member and piercing connector of the transcatheter suture implantation device according to the first embodiment of the present invention.

FIG. 10 is a cross-sectional view of the connector of the transcatheter suture implantation device of FIG. 4.

Fig. 11 is a cross-sectional view of a stylet of a first embodiment of the present invention of a transcatheter suture implantation device.

FIG. 12 is a perspective view of the proximal cartridge of the transcatheter suture implantation device of FIG. 4.

Fig. 13 is a side view of the proximal cartridge of fig. 12.

Fig. 14 is a cross-sectional view of the proximal collet of fig. 12 taken along line XIV-XIV.

FIG. 15 is a perspective, block diagram of the distal cartridge of the transcatheter suture implantation device of FIG. 4.

Fig. 16 is a side view of the distal collet of fig. 15.

Figure 17 is a cross-sectional view of the distal clip of figure 16 taken along line XVII-XVII.

Fig. 18 is a cross-sectional view of the distal collet of fig. 15 taken along line XVIII-XVIII.

Fig. 19 is a cross-sectional view of the proximal and distal jaws of the transcatheter suture implantation device of the first embodiment of the present invention after attachment.

Fig. 20 is a schematic structural view of one embodiment of a connecting rod of the transcatheter suture implantation device according to the first embodiment of the present invention.

Fig. 21 is a schematic structural view of one embodiment of a connecting rod of a transcatheter suture implantation device according to a first embodiment of the present invention.

Fig. 22 is a schematic structural view of one embodiment of a connecting rod of the transcatheter suture implantation device according to the first embodiment of the present invention.

Fig. 23 is a schematic structural view of another embodiment of a connecting rod of the transcatheter suture implantation device according to the first embodiment of the present invention.

Fig. 24 is a schematic structural view of a control handle of a transcatheter suture implantation device according to a first embodiment of the present invention.

Fig. 25 is a schematic view of the control handle of fig. 24 from another perspective.

Figure 26 is a schematic structural view of the guiding device of the transcatheter chordal implantation system of the first embodiment of the invention.

Fig. 27 is a partial cross-sectional view of the guide of fig. 26.

Figure 28 is a schematic view of the initial configuration of the transcatheter chordal implantation system of figure 1.

Figure 29 is a cross-sectional view of the cartridge assembly of the transcatheter suture implantation device of the transcatheter chordae implantation system of figure 28.

Figure 30 is a schematic structural view of the open state of the jaw assembly of the transcatheter suture implantation device of the transcatheter chordae implantation system of figure 28.

Figure 31 is a cross-sectional view of the cartridge assembly of figure 30 in an open state.

Figure 32 is a schematic view of the cartridge assembly of figure 30 after opening and insertion of the leaflets.

Fig. 33 is a schematic view of the collet assembly of fig. 32 gripping a leaflet.

Figure 34 is a schematic view of the cartridge assembly of figure 33 gripping leaflets and the piercing assembly piercing the leaflets.

Fig. 35 is an enlarged view of the XXXV portion in fig. 34.

Fig. 36 is a schematic view of the puncturing assembly of fig. 34 in combination with a sleeve and retracted.

FIG. 37 is a schematic view of the pull wire of FIG. 36 pulling back the implanted wire.

Figures 38-50 are schematic illustrations of the use of the transcatheter chordae tendineae implantation system provided by the present invention; wherein FIG. 39 is an enlarged view of the XXXIX portion of FIG. 38; FIG. 41 is an enlarged view of the XLI portion of FIG. 40; fig. 50 is an enlarged view of portion L of fig. 49.

Figure 51 is a schematic structural view of a collet assembly of a transcatheter chordae implantation system according to a second embodiment of the invention.

Figure 52 is a partial cross-sectional view of the cartridge assembly of figure 51.

Figure 53 is a schematic cross-sectional view of a collet assembly of a transcatheter chordae implantation system according to a third embodiment of the invention.

Figure 54 is a schematic structural view of a collet assembly of a fourth embodiment of the transcatheter chordae implantation system of the present invention.

Figure 55 is a side view of a collet assembly of a fifth embodiment transcatheter chordae implantation system of the present invention.

FIG. 56 is an end view of the cartridge assembly of FIG. 55.

Figure 57 is a schematic view of the implant wire and sleeve of a sixth embodiment of the transcatheter chordal implantation system of the present invention.

FIG. 58 is a structural schematic view of another view of the implant wire and sleeve of FIG. 57.

Figure 59 is a schematic view of the implant and puller wires of a seventh embodiment of the transcatheter chordae implantation system of the present invention.

Detailed Description

The technical solutions in the embodiments of the present invention will be described clearly and completely with reference to the accompanying drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by a person of ordinary skill in the art without any creative effort belong to the protection scope of the present invention.

Furthermore, the following description of the various embodiments refers to the accompanying drawings, which are included to illustrate specific embodiments in which the invention may be practiced. Directional phrases used in this disclosure, such as "upper," "lower," "front," "rear," "left," "right," "inner," "outer," "side," and the like, refer only to the direction of the appended figures and, therefore, are used in order to better and more clearly illustrate and understand the present invention without indicating or implying that the device or element so referred to must have a particular orientation, be constructed and operated in a particular orientation and, therefore, should not be construed as limiting the invention.

To more clearly describe the structure of the transcatheter suture implant device and the transcatheter chordae tendineae implant system, the terms "proximal" and "distal" as used herein are used conventionally in the interventional medical field. Specifically, "distal" refers to the end of the surgical procedure that is distal from the operator, and "proximal" refers to the end of the surgical procedure that is proximal to the operator. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used in the description of the invention herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention.

Referring to fig. 2-6, the present invention provides a transcatheter chordae tendineae implantation system 100 comprising a transcatheter suture implantation device 20 for implanting sutures into a leaflet and a guide device 60; the guiding device 60 comprises an adjustable elbow 61 and an adjustable elbow mechanism 62 disposed at a proximal end of the adjustable elbow. The transcatheter suture implantation device 20 is threaded into the guide device 60 and the transcatheter suture implantation device 20 is advanced to a predetermined location by adjusting the orientation of the adjustable elbow 61.

The transcatheter suture implanting device 20 comprises a control handle 21, a clamping head component 22 capable of being opened and closed relatively, a bendable sheath 24 connected to the proximal end of the clamping head component 22, a puncture component 25 arranged in the clamping head component 22, a group of implanting wires 271 and a group of pulling wires 275; the puncturing assembly 25 comprises a puncturing part 251 slidably arranged on the chuck assembly 22 and a puncturing connector 254 corresponding to the puncturing part 251; a group of implantation lines 271 is folded in half and then arranged in the inner cavity of the sheath 24, two ends of the implantation lines 271 are respectively connected with the two puncture connectors 254, and the pulling line 275 comprises a bending part 2750 which is pre-arranged in the chuck component 22 and passes through the two puncture connectors 254; the puncture element 251 and the puncture connecting element 254 are connected to drive the puncture connecting element 254 and the implantation wire 271 to enter the bending portion 2750 of the pulling wire 275, and the pulling wire 275 is retracted to drive the implantation wire 271 to enter the sheath 24 until the implantation wire 271 is pulled out of the sheath 24. In this embodiment, after the operator has delivered the distal ends of the guide device 60 and the transcatheter suture implantation device 20 into the patient by way of intervention, the cartridge assembly 22 of the transcatheter suture implantation device 20 is adjusted by the guide device 60 outside the patient to a predetermined treatment position; then the control handle 21 of the catheter suture implanting device 20 controls the chuck component 22 to clamp the valve leaflets, controls the puncture piece 251 to puncture the valve leaflets to be connected with the corresponding puncture connecting piece 254, and retracts the puncture piece 25 to drive the puncture connecting piece 254 and the implanting line 271 to penetrate through the valve leaflets; pulling the pulling line 27 towards the proximal end, so that the bending part 2750 of the pulling line 275 drives the implant line 271 passing through the valve leaflet into the sheath 24 until the folded part of the implant line 271 is attached to the surface of the valve leaflet, thereby implanting the implant line 271 on the valve leaflet of the valve; pulling the pull wire 275 is continued until the free end of the implant wire 271 is pulled out of the sheath 24, and the operator can then fixate the end of the implant wire 271 in the ventricular wall, papillary muscle or apex, replacing the natural chordae tendineae with the implant wire 271, maintaining tension between the leaflets and the ventricular wall.

The utility model provides a set of implantation line 271 and a set of pulling line 275 are arranged in the chuck component 22 and the sheath 24 of the transcatheter suture implantation device 20, and are connected with the puncture connecting piece 254 after the puncture piece 251 punctures the valve leaflet, and the withdrawal of the puncture piece 251 can drive the puncture connecting piece 254 and the implantation line 271 to pass through the valve leaflet; the implantation line 271 can be pulled to the surface of the valve leaflet and pulled out of the sheath 24 through the movement of the pulling line 275, the use is convenient, the operation is simple, the implantation of the implantation line 271 is driven through the flexible pulling line 275, the remote intervention is more suitable, and the operation risk is reduced. In addition, each body that uses in the device is flexible structure, and is less to the human body damage, suitable long-range intervention. The guide device 60 of the transcatheter chordal implantation system 100 enables adjustment of the distal position of the transcatheter suture implantation device 20 for ease of operation.

As shown in fig. 4 to 8, the implantation wire 271 is folded in half and then disposed in the lumen of the sheath 24. The fold 273 of the implantation line 271 is located at the proximal end of the sheath 24, and two free ends of the implantation line 271 are respectively connected with the two puncture connectors 254 in a knotting, winding, welding, bonding, clamping and other fixing manners. The implantation line 271 is a flexible line, i.e., the implantation line 271 can be bent arbitrarily without being stretched in the axial direction; the implant line 271 may be made of a biocompatible polymer material or a relatively soft metal material, preferably a polymer material such as PTFE, e-PTFE, PET, etc. In this example, an e-PTFE thread was used.

The pull wire 275 is also a flexible wire and may be made of a polymeric material, such as, for example, a single or multiple strand of one or more of PP, PE, PET, PTFE, e-PTFE, PEBAX; or made of flexible metal material, such as single-strand or multi-strand wires made of one or more of stainless steel, copper, iron and nickel titanium. The material of the pull wire 275 and the implant wire 271 may be the same or different, and preferably the pull wire 275 is stronger than the implant wire 271 to facilitate pulling of the implant wire 271.

As shown in fig. 7-9, a piercing connector 254 is disposed in proximal cartridge 221. In this embodiment, the piercing connector 254 is two spaced sleeves, and the end of the implant thread 271 is tied off and then fixedly connected to the piercing connector 254. Specifically, as shown in fig. 9, one end of the puncture connector 254 along the axial direction is provided with a receiving cavity 2541, the other end is provided with a through hole 2543 communicating with the receiving cavity 2541, and the inner diameter of the through hole 2543 is smaller than the inner diameter of the receiving cavity 2541. After the end of the implantation wire 271 sequentially passes through the through hole 2543 and the accommodating cavity 2541, a coil with a diameter larger than the inner diameter of the through hole 2543 and smaller than the inner diameter of the accommodating cavity 2541 is formed by knotting at the end of the implantation wire 271, or a round ball with a diameter larger than the inner diameter of the through hole 2543 and smaller than the inner diameter of the accommodating cavity 2541 is welded at the end of the implantation wire 271, or a positioning rod is arranged at the end of the implantation wire 271, the axial direction of the positioning rod under the natural state is not coaxial with the axial direction of the implantation wire 271 and the puncture connecting piece 254, after the positioning rod and one end of the implantation wire 271 pass through the puncture connecting piece 254, the positioning rod recovers the natural state, namely, the positioning rod is clamped on the step surface between the accommodating cavity 2541 and the through hole 2543 of the puncture connecting piece 254, so that one end of the implantation.

Piercing member 251 is disposed in distal cartridge 225. Each piercing member 251 is adapted to pierce a leaflet at one end and is coupled at the other end to distal collet 225 by a piercing pull rod. The proximal end of the piercing pull rod extends into sheath 24. When the puncture traction rod is controlled, the puncture piece 251 can move back and forth along with the puncture traction rod, so that the puncture piece 251 is connected with the puncture connecting piece 254 and carries the implantation line 271 to move towards the far end, and the function that the implantation line 271 penetrates through valve leaflets is realized. In this embodiment, the piercing elements 251 are two piercing needles disposed in the distal cartridge 225 with a corresponding sleeve therebetween, and the piercing needles are detachably or non-detachably fixed to the corresponding piercing connectors 254 after passing through the leaflets. In order to facilitate puncturing and to reduce the diameter of the puncture point formed on the valve leaflet, it is preferable that the needle of the puncturing member 251 has a straight tip with a tapered shape such that the diameter of the puncture point formed on the valve leaflet ranges from 0.3mm to 2mm, and further, is controlled to about 0.7 mm. The puncture needle 251 and the puncture drawbar are preferably made of metal materials, such as stainless steel, and can be connected by adopting a welding process, or can be connected by adopting high polymer materials with higher strength, such as PEEK (polyether-ether-ketone) tubes, PA (polyamide) tubes and the like for mechanical connection such as cementation, threaded connection and the like.

Specifically, the distal end of the puncturing element 251 is provided with a tapered sharp portion 2510, and the side of the puncturing connector 254 facing the puncturing element 251 is provided with a receiving cavity 2541 for receiving the sharp portion 2510. The shape of the receiving cavity 2541 needs to match the shape of the sharp 2510 of the piercing member 251, which is typically a conical or cylindrical cavity. The entire outer shape of the puncture connector 254 may be cylindrical, and the cross-sectional shape of the puncture connector 254 may be various ring shapes such as a circular ring shape, an elliptical ring shape, a polygonal ring shape, and the like, and preferably a circular ring shape and an elliptical ring shape.

The inner sidewall of the connecting piercing element 254 defines at least one recess or aperture that forms an interference fit, snap fit, or keyed connection with the needle 2510 of the piercing element 251. In this embodiment, three grooves are radially formed in the inner sidewall of the piercing connector 254, so as to ensure the connection stability between the piercing connector 254 and the piercing member 251 and reduce the shaking amplitude of the piercing member 251 after connection.

As shown in fig. 7 and 8, in order to increase the point contact between the implantation line 271 and the valve leaflet to surface contact, thereby reducing the risk of the artificial chordae tendineae tearing the valve leaflet, the implantation line 271 is sleeved with a slip-preventing member 272, the implantation line 271 is pulled out of the sheath 24 in the process of pulling the line 275 to drive the implantation line 271 to move, then the implantation line 271 is pulled proximally, the implantation line 271 drives the slip-preventing member 272 to move until the slip-preventing member 272 is driven to the puncture point by the implantation line 271 and is attached to the surface of the valve leaflet, and the slip-preventing member 272 and the implantation line 271 are fixed together on the valve leaflet, thereby preventing the valve leaflet from tearing.

Preferably, the anti-slip member 272 has two through holes 2721 spaced apart from each other along the thickness direction thereof, and the two ends of the implantation wire 271 are connected to the two penetration connection members 254 after passing through the two through holes 2721, respectively. In order to reduce the size of the sheath 24, the implant wire 271 and the anti-slip member 272 should be longitudinally disposed in the collet assembly 22, and therefore, the two through holes 2721 should be longitudinally offset, i.e., one through hole 2721 is located at the distal end, the other through hole 2721 is located at the proximal end, and a connecting line between the two through holes forms an angle with the axial direction of the anti-slip member 272, so that the anti-slip member 272 can be disposed in the collet assembly 22 in parallel with the implant wire 271.

The anti-slip member 272 has an engaging surface 2723 engaging with the valve leaflet, and the engaging surface 2723 faces away from the folded part 273 of the implantation line 271. The anti-slip members 272 may be in the form of a sheet, a disc or a sphere having a certain area, or even an irregular shape, preferably a sheet. The material can be a non-porous structure, a net structure, a bar grid structure and the like, and is made of biocompatible materials, elastic materials or non-elastic materials. Specifically, the anti-slip members 272 are selected from at least one of an elastic pad, a heart patch, a felt patch, a mesh structure, a disc structure, or a double disc structure. The structure of the anti-slip member 272 having a disc structure or a double disc structure is similar to the stopper in the prior art, and will not be described in detail herein.

Preferably, in order to reduce the overall size of the instrument, cleats 272 having a disc-like structure or a double disc-like structure should be made of a shape memory material. That is, when the anti-slip member 272 is received in the collet assembly 22, the anti-slip member 272 can be contracted to a smaller volume, and after the anti-slip member 272 is separated from the collet assembly 22, the anti-slip member 272 can be automatically expanded to increase the contact area between the anti-slip member 272 and the valve leaf.

As shown in fig. 4 to 6, a plurality of separated inner cavities are axially formed in the sheath 24, and the central inner cavity is a guide wire cavity. The sheath 24 may be a multi-lumen tube formed integrally, or the outer tube and the inner tube may be fixed together in a sleeved manner to form the sheath 24 of an integral structure. In this embodiment, the sheath 24 includes a hollow flexible outer tube, in which a plurality of flexible inner tubes are inserted, the central tube is used as a guide wire cavity, and the rest tubes are respectively inserted with the pull wire 275, the implantation wire 271, the puncture assembly 25, and the like. The proximal end of the sheath 24 is provided with a control handle 21 for operating the sheath 24 to be pushed distally or retracted proximally. The sheath 24 may be made of a biocompatible polymer material (e.g., polyoxymethylene POM, polyethylene PE, nylon PA, polyvinyl chloride PVC, acrylonitrile-butadiene-styrene copolymer ABS, nylon elastomer Pebax, or polyurethane PU) or a metal material (e.g., stainless steel or nitinol). The flexible inner tube material inserted into the sheath tube 24 may be polymer material such as PI, PEBAX, PET, PA, PEEK, etc., or may be flexible metal tube such as nickel-titanium tube, stainless steel tube, etc., so as to facilitate remote intervention.

As shown in fig. 4 and 10, the distal end of the sheath 24 is provided with a connector 23 for connecting with the chuck assembly 22, and the connection can be a mechanical connection such as gluing. The connecting head 23 has a distal end surface 231 and a proximal end surface 232, and an inner cavity 233 extending through the proximal end surface 232 and the distal end surface 231, the distal end surface 231 being matingly connected to the cartridge assembly 22 in a tight or snap-fit connection. The proximal end face 232 is connected with the distal end of the sheath 24 in a matching manner in a tight connection. The internal cavity 233 is used to accommodate the proximal collet 221, etc., of the collet assembly 22. Specifically, the distal end of the peripheral wall of the connector 23 is provided with a connecting hole 234 communicating with the inner cavity 233, and the connecting hole 234 is used for connecting the proximal end chuck 221; the proximal end of the peripheral wall of the connector 23 is provided with a fixing hole 235 communicated with the inner cavity 233, and the fixing hole 235 is used for fixedly connecting the distal end of the sheath 24. The connector 23 may be made of polymer, such as one or more of PP, PE, PET, PTFE, PEBAX, ABS. Or made of metal material, such as one or more of stainless steel, iron, copper, nickel titanium, platinum and gold.

In this embodiment, as shown in fig. 11, two probes 223 are slidably and symmetrically disposed in the sheath 24, and the distal ends of the probes 223 can extend from the proximal collet 221, so that the forward and backward movement of the probes 223 can be controlled by the control handle 21. When the collet assembly 22 is stable holding the leaflets, the probe 223 is pushed distally, indicating that the leaflets are effectively held and that the operator can proceed with subsequent operations when the probe 223 is prevented from entering the distal collet 225 by the leaflets. The probe 223 may be a metal rod or a metal tube, or may be another polymer flexible rod or tube, and the probe 223 may also be made of a thin stainless steel wire and a stainless steel sleeve by welding, gluing, or other mechanical connection methods.

Referring to fig. 4 to 6 and 12, the collet assembly 22 further includes a clamping driving rod 2251 disposed between the proximal collet 221 and the distal collet 225, and the clamping driving rod 2251 moves axially to drive the distal collet 225 to move axially to open and close relative to the proximal collet 221, so as to clamp the valve leaflet. I.e., proximal collet 221 and distal collet 225, are connected by a collet drive stem 2251 disposed on distal collet 225. The distal cartridge 225 is fixedly attached to the grip drive stem 2251 by welding, adhesive, threading, or the like. The grip drive lever 2251 is preferably made of a metallic material, such as 304 stainless steel, 316 stainless steel, or nickel titanium; high molecular materials with higher strength, such as PEEK, POM and PA, can also be selected; but also composite flexible tube assemblies such as metal cut tubes and the like. In this embodiment, a PEEK tube is used as the holding drive rod.

In order to avoid the shaking of the chuck assembly 25 and the falling-off separation caused by the excessive opening of the chuck, a guide rod 2253 is further provided between the proximal chuck 221 and the distal chuck 225, and the guide rod 2253 is symmetrically provided with the chuck driving rod 2251. Specifically, guide bar 2253 is disposed between proximal cartridge 221 and distal cartridge 225, with guide bar 2253 spaced parallel to grip drive bar 2251, and distal cartridge 225 being axially slidable with guide bar 2253.

As shown in fig. 4-6 and 12-14, a guide wire cavity 2211 is axially formed through the proximal end of the proximal clamp 221, and the guide wire cavity 2211 is used for guiding a guide wire. The proximal end of the proximal collet 221 is connected to the distal end of the sheath 24 by a snap and adhesive fit connection to the connector 23. In this embodiment, the proximal portion of the proximal collet 221 is provided with a buckle 2212 corresponding to the connection hole 234 of the connector 23, and the buckle 2212 of the proximal collet 221 is clamped into the connection hole 234 corresponding to the connector 23, so that the proximal collet 221 and the connector 23 are fixedly connected. The proximal end of the proximal collet 221 has a gripping surface 2213, and the gripping surface 2213 has a slip-resistant structure for more effectively gripping the valve leaflets. The anti-slip structure can be one or more of concave-convex, corrugation and screw thread, and corrugation is preferred. Preferably, the gripping surface 2213 is arranged obliquely to the axial direction to facilitate sliding of the leaflets onto the gripping surface 2213 and to increase the area of the gripping surface 2213. The proximal collet 221 has a plurality of lumens, each of which can be individually inserted with a flexible inner tube, each of which extends behind the sheath 24 and out of the proximal end of the sheath 24 or is connected to the control handle 21 for manipulation by the operator. The proximal collet 221 may be made of a polymer material, such as one or more of PP, PE, PET, PTFE, PEBAX, ABS, PC. Or a metal material, such as one or more of stainless steel, iron, copper, nickel titanium, platinum and gold.

As shown in fig. 14, at least one stylet lumen 2214 is axially disposed inside the proximal collet 221 on one side of the guidewire lumen 2211, and the distal end of the stylet 223 slidably extends out of the stylet lumen 2214 to detect whether a leaflet is clamped between the proximal collet 221 and the distal collet 225; in this embodiment, two probe cavities 2214 are symmetrically disposed on either side of the guidewire cavity 2211 inside the proximal clamp 221. An implant accommodating cavity 2215 is formed in one side of the guidewire cavity 2211 of the proximal chuck 221, the implant accommodating cavity 2215 is used for accommodating the implant line 271 and the anti-slip piece 272, a puncture connecting piece accommodating cavity 2216 communicated with the implant accommodating cavity 2215 is formed in each of two ends of the proximal chuck 221 in the radial direction of the implant accommodating cavity 2215, and the puncture connecting piece accommodating cavity 2216 is used for accommodating the puncture connecting piece 254; pulling the wire 275 moves the implant wire 271 out of the implant receiving cavity 2215 and continuing to pull the implant wire 271 proximally pulls the anti-slip member 272 out of the implant receiving cavity 2215. The other side of the guide wire cavity 2211 is symmetrically provided with a clamping traction cavity 2217 and a guide rod cavity 2218, in which a clamping driving rod 2251 and a guide rod 2253 are respectively penetrated. The pull wire receiving tube 228 is positioned intermediate the grip distraction lumen 2217 and the guide rod lumen 2218, the proximal end of the pull wire receiving tube 228 extends into the sheath 24, the side walls of the pull wire receiving tube 228 are slotted to facilitate extension of the distal end of the pull wire 275 and entry of the implant wire 271, i.e., the proximal end of the pull wire 275 passes into the sheath 24 via the pull wire receiving tube 228. Thus, in use, an operator can advance an instrument along the guidewire to a predetermined treatment site through the guidewire lumen 2211; actuation of distal collet 225 to expand relative to proximal collet 221 by grip actuation bar 2251 to grip a leaflet while guide bar 2253 prevents distal collet 225 from falling out; the clamping state of the valve leaflets is detected through the probes 223; the distal chuck 225 is driven to approach the proximal chuck 221 by the grip driving rod 2251, and the puncturing element 251 disposed on the distal chuck 225 is driven to puncture the valve leaflet and engage with the puncturing connection 254 of the implantation line 271; the pull wire 275 is then pulled, and the pull wire 275 pulls the implant wire 271 through the pull wire receiving tube 228 into the sheath 24.

Referring to fig. 4-6 and 15-18, distal cartridge 225 includes a cartridge body 2250, a housing 2252 disposed at a distal end of cartridge body 2250, and a piercing base 2254 disposed at a proximal end of cartridge body 2250, the piercing base 2254 being located on a side thereof opposite implant receiving cavity 2215. A centered position of the cartridge body 2250 is axially provided with a guidewire lumen 2255. The distal cartridge 225 is axially provided with two piercing passages 2256, the two piercing passages 2256 extend through the piercing base 2254, and the two piercing elements 251 are slidably received in the two piercing passages 2256, respectively. Two piercing passages 2256 correspond to piercing connector receiving cavities 2216 of proximal cartridge 221 such that piercing elements 251 correspond to piercing connectors 254. . To more effectively grip the leaflets, the gripping surface of distal collet 225 has a non-slip configuration. The anti-slip structure can be one or more of concave-convex, corrugation and screw thread, and corrugation is preferred. Preferably, the gripping surface of the distal collet 225 is disposed obliquely to the axial direction to facilitate sliding of the leaflets between the gripping surface 2213 of the proximal collet 221 and the gripping surface of the distal collet 225 and increase the gripping area. The proximal end of the cartridge body 2250 provides two probe cavities 2257 alongside the guidewire cavity 2255, the two probe cavities 2257 being adapted to receive the distal ends of the two probes 223. The chuck body 2250 is provided with a symmetrical clamping and pulling cavity 2258 and a guide rod cavity 2268 at the other side of the guide wire cavity 2255, wherein the distal ends of the clamping driving rod 2251 and the guide rod 2253 are respectively penetrated; the collet body 2250 has a pull wire connection cavity 2259 axially intermediate the grip pull cavity 2258 and the guide bar cavity 2268, and the distal end of the pull wire receiving tube 228 is disposed in the pull wire connection cavity 2259.

As shown in fig. 18 and 19, an arc-shaped pull wire receiving chamber 2755 is formed between the inner wall of the cartridge body 2250 of the distal cartridge 225 and the inner wall of the puncture base 2254, and the distal end of the pull wire 275 extends from the sidewall of the pull wire receiving tube 228 and is inserted into the arc-shaped pull wire receiving chamber 2755, so that the bent portion 2750 at the distal end of the pull wire 275 is U-shaped and passes around the proximal ends of the two puncture elements 251 to be received in the distal cartridge 225. After the puncture element 251 is combined with the puncture connecting member 254, the puncture element 251 can drive the implantation line 271 to pass through the valve leaflet, at this time, the end of the puncture element 251 is far away from the pull line 275, the implantation line 271 enters the bending portion 2750 of the pull line 275, at this time, the pull line 275 can drive the implantation line 271 to move by pulling the pull line 275 until the implantation line 271 is pulled out from the implantation element accommodating cavity 2215 of the proximal end clamping head 221 and attached to the lower surface of the valve leaflet, the anti-slip element 272 is attached to the lower surface of the valve leaflet, the implantation line 271 enters the sheath tube 24 from the side wall of the pull line accommodating tube 228 and extends out from the proximal end of the sheath tube 24, then the catheter suture implanting device 20 is withdrawn, the implantation line 271 is cut as required, and the end of the implantation line 271 is fixed to the ventricular wall and other parts.

Since the collet assembly 22 and the sheath 24 are required to reach the predetermined site by remote intervention, each connecting rod (e.g., the clamping driving rod, the guiding rod, the puncture traction rod, the pull wire accommodating tube, and the probe) penetrating through the collet assembly 22 and the sheath 24 is required to have flexibility and rigidity, preferably, the two ends of the connecting rod have good rigidity, and the middle part of the connecting rod has good flexibility on the basis of keeping rigidity, so as to reduce the resistance of collet bending, collet opening and closing, probe detection, and puncture.

Referring to fig. 20-23, various embodiments of the connecting rod are shown, as shown in fig. 20, where the distal portion of the stainless steel tube is cut alternately in a circumferential direction to provide both rigidity and flexibility to the distal portion. As shown in fig. 21, the distal end of the stainless steel tube is a section of stainless steel rod or steel tube, the proximal end of the steel tube is connected to a section of steel cable core (formed by winding multiple strands of thin steel wires) with good flexibility, the steel cable core is an adjustable bending section, the proximal end of the steel cable core is connected to a section of stainless steel tube or stainless steel rod, the connection between the steel cable core and the stainless steel rod or steel tube is preferably laser welded, and mechanical connection such as threads can be adopted. As shown in fig. 22 and 23, in another embodiment, two ends are steel pipes, nickel-titanium wires are inserted into the middle of the steel pipes, and the nickel-titanium wires are welded or mechanically pressed with the steel pipes at the two ends; be equipped with the spring between the both ends steel pipe, and the spring is extruded between the steel pipe, from this, both ends can keep certain rigidity, and the middle section has better compliance and rigidity.

Referring to fig. 3-5 and 24-25, to facilitate remote operation outside the body, the transcatheter suture implantation device 20 is further provided with a control handle 21. Specifically, a control handle 21 is provided at the proximal end of the sheath 24 for actuating the opening and closing of the cartridge assembly 22, the movement of the puncture assembly 25, the movement of the probe 223 and the pull wire 275. The handle 21 includes a housing 211, a driving assembly penetrated in the housing 211, and a probe display plate 212 provided on the housing 211 to indicate the position of the probe 223 to an operator. The housing 211 is connected to the proximal end of the sheath 24 via a rotating wheel 213, and the connection may be made by gluing, injection molding, or screwing. The rotating wheel 213 can drive the sheath tube 24 and the internal components of the sheath tube 24 to rotate. The sheath 24 can be advanced distally or retracted proximally by the overall movement of the handle 21, which in turn drives the movement of the transcatheter suture implantation device 20, such that the cartridge assembly 22 can smoothly reach the desired location.

The drive assembly includes a clamp drive 214 for controlling opening and closing of the chuck assembly 22, a probe drive 215 for controlling movement of the probe 223, a lancing drive 216 for controlling movement of the lancing element 251, and a pull wire drive 217 for controlling the pull wire 275. A linkage mechanism for connecting the clamping driving member 214 and the puncturing driving member 216 is arranged between the clamping driving member 214 and the puncturing driving member 216, and the clamping driving member 214 and the puncturing driving member 216 can be independently controlled through the linkage mechanism. The clamp drive 214 is coupled to the distal collet 225 by a clamp drive stem 2251. The stylet drive 215 is coupled to the proximal end of the stylets 223 and its movement causes the stylets 223 to move forward or backward a distance. The puncture driving member 216 is connected to the puncture drawbar, and can drive the puncture member 251 to move back and forth, thereby achieving the function of puncturing the valve leaflet. The pulling wire driving member 217 is connected to the pulling wire 275, and when the retraction of the puncturing member 251 and the puncturing connection 254 is completed, the pulling wire driving member 217 can drive the pulling wire 275 to move, so as to drive the implantation wire 271 to be pulled from the chuck assembly 22 to the tail end of the handle 21.

All components of the control handle 21 may be made of polymer material, such as ABS, PC, POM, PA, etc., or metal material, such as stainless steel, aluminum alloy, etc., or a combination of multiple materials. In this embodiment, ABS and PC are used.

Referring to fig. 3 and 26-27, the guiding device 60 includes an adjustable bending tube 61 having a certain axial length and a bending adjusting mechanism 62, and the distal end of the adjustable bending tube 61 is provided with at least one adjustable bending section 611. The bending adjusting mechanism 62 includes a bending adjusting member 621 disposed at the proximal end of the adjustable bending tube 61 and an adjusting wire 601 inserted into the adjustable bending tube 61, the distal end of the adjusting wire 601 is connected to the adjustable bending section 611, and the bending adjusting member 621 pulls the adjusting wire 601 to bend the adjustable bending section 611, so as to adjust the distal end position of the transcatheter suture implantation device 20. For convenience of operation, the proximal end of the adjustable elbow 61 is further provided with a bending adjustment handle 605, and a bending adjustment member 621 is disposed on the bending adjustment handle 605.

As shown in fig. 27, at least one pull wire channel 613 is formed in the tube wall of the adjustable bent tube 61 along the axial direction thereof, the distal end of the pull wire channel 613 extends to the distal end of the adjustable bent section 611, the proximal end of the pull wire channel 613 extends to the bending adjustment handle 605, an adjustment wire 601 is inserted into the pull wire channel 613, the distal end of the adjustment wire 601 is connected to the distal end of the adjustable bent section 611, the proximal end of the adjustment wire 601 is connected to the bending adjustment member 621, and the adjustable bent section 611 can be bent toward one side of the pulled adjustment wire 601 by pulling the adjustment wire 601 proximally through the bending adjustment member 621; the tension on the adjusting wire 601 is released, and the adjustable bending section 611 automatically resets. Preferably, a plurality of traction wire channels 613 are formed in the wall of the adjustable elbow 61 along the axial direction thereof, the traction wire channels 613 are arranged along the circumferential direction of the adjustable elbow 61, an adjusting wire 601 is inserted into each traction wire channel 613, and each adjusting wire 601 is pulled towards the proximal end by the bending adjusting handle 605 to bend the adjustable bending section 611 towards one side of the pulled adjusting wire 601, so that the adjustable bending section 611 can be bent towards different directions, so that the adjustable elbow 61 can meet the requirements of the lumen structure of a bent human body.

One end of the adjusting wire 601 connected with the adjustable bent section 611 is provided with an anchoring ring 603, the anchoring ring 603 is fixedly sleeved on the adjustable bent section 611, that is, the distal end of the adjusting wire 601 is connected with the adjustable bent section 611 through the anchoring ring 603. Anchoring ring 603 may be made of a metallic material or a polymeric material. In this embodiment, anchor ring 603 is made of 304 stainless steel. The means for connecting adjustment wire 601 to anchoring ring 603 includes, but is not limited to, bonding, welding, heat fusing, knotting, etc., and is not limited thereto.

The adjusting wire 601 is sleeved with a wire wrapping tube 606, the part of the adjusting wire 601, which is positioned in the tube body, is movably arranged in the wire wrapping tube 606, and the wire wrapping tube 606 limits the traction direction of the adjusting wire 601 and protects the adjusting wire 601. The hardness of the wire-wrapping tube 606 corresponding to the adjustable bending section 611 should be less than that of the other parts, i.e., the part of the wire-wrapping tube 606 corresponding to the adjustable bending section 611 is flexible, so as not to affect the bending of the adjustable bending section 611. For example, the portion of the filament-covered tube 606 embedded in the adjustable bent section 611 may be a soft PTFE thin tube, while the other portion may be a PI thin tube or a stainless steel thin tube.

Referring to fig. 28-37, the process of opening and grasping the leaflets by the collet assembly 22, withdrawing the leaflets after the piercing assembly 25 has pierced the leaflets, and pulling the implant wire 271 back by the pulling wire 275 is shown.

Figures 28-29 illustrate the initial state of the jaw assembly, wherein proximal jaw 221 and distal jaw 225 are closed and jaw assembly 22 is rotated or moved back and forth as a unit by control handle 21. The implant wire 271 and the anti-slip member 272 are preloaded in the proximal cartridge 221 and the sheath 24, the puncturing member 251 is preloaded in the distal cartridge 225, and the distal end of the puncturing member 251 is disposed corresponding to the puncturing connectors 254 at both ends of the implant wire 271. The distal bend 2750 of the pull wire 275 is preloaded into the distal collet 225, the loop bend 2750 is wrapped around the outside of the two piercing members 251, and the proximal end of the pull wire 275 extends sequentially from the proximal collet 221 and the sheath 24 to the outside of the patient.

Fig. 30-31 illustrate the jaw assembly 22 in an open state, with the distal jaw 225 moved distally by the jaw drive stem 2251, with the leaflet receiving space 224 formed between the proximal jaw 221 and the distal jaw 225.

Fig. 32 shows the position of the collet assembly 22 adjusted by viewing the leaflet position and status with ultrasound or other medical imaging equipment after the collet assembly 22 is opened until the leaflet enters the leaflet receiving space 224 between the proximal collet 221 and the distal collet 225.

Fig. 33 shows the collet assembly 22 closed until the leaflets are stably clamped between the proximal collet 221 and the distal collet 225.

Fig. 34-35 show the piercing element 251 passing through the leaflets and in mating engagement with the piercing connector 254 in the proximal cartridge 221.

Figure 36 shows the puncture element 251 retracted, bringing the puncture connector 254 and the implant wire 271 attached to the puncture connector 254 through the leaflet, at which point the implant wire 271 enters the bend 2750 at the distal end of the pull wire 275.

Fig. 37 shows pulling the pull wire 275 proximally, thereby moving the implant wire 271 proximally therewith until the implant wire 271 is pulled from the side wall of the pull wire receiving tube 228 into the pull wire receiving tube 228 and into the sheath 24, after which the implant wire 271 may be pulled proximally out of the sheath 24 and the control handle 21.

Referring to fig. 38-50, the following description of the use of the transcatheter chordae implantation system of the present invention is provided by way of example for transcatheter mitral valve prosthesis chordae tendineae repair. The operation path is as follows: transfemoral-inferior vena cava-left ventricle-interatrial septum-left atrium-mitral valve.

The first step is as follows: transfixing through femoral vein, sending a guide wire (not shown in the figure) to the left ventricle, then puncturing the fossa ovalis position of the interatrial septum through instruments (not shown in the figure) such as an interatrial septum puncture needle and the like, sending the guide wire to the left atrium from the left ventricle, and reaching the vicinity of the mitral valve, thereby establishing a track from the outside to the inside of the body;

the second step is that: as shown in fig. 38-39, the sheath 24 of the transcatheter suture implantation device 20 is threaded into the guide device 60, the cartridge assembly 22 extends from the distal end of the adjustable elbow 61 of the guide device 60, and both are advanced over the guide wire to the left atrium, and the distal end of the transcatheter suture implantation device 20 is advanced further and positionally adjusted through the guide device 60 until the cartridge assembly 22 reaches the vicinity of the mitral valve, intermediate the anterior leaflet and the posterior leaflet;

the third step: as shown in fig. 40-41, operating the clamp actuator 214 on the control handle 21 opens the distal collet 225 and the proximal collet 221 and adjusting the leaflet into the leaflet receiving space 224 between the distal collet 225 and the proximal collet 221 by operating the bend adjustment handle 605 and the control handle 21 and adjusting the opening and closing distance of the collet assembly 22;

the fourth step: as shown in fig. 42, the grasping drive 214 on the control handle 21 is operated to retract the distal collet 221 until the leaflet is stably grasped between the proximal collet 225 and the distal collet 221;

the fifth step: the probe 223 is controlled to move towards the far end through the probe driving piece 215 on the control handle 21, if the valve leaflet is clamped, the probe 223 can be blocked by the valve leaflet and can not move towards the far end, an operator can visually observe whether the moving distance of the probe 223 is in a position for stably clamping the valve leaflet through the probe display board 212 on the control handle 21, if the valve leaflet is not successfully clamped, the third step and the fourth step are repeated until the moving distance of the probe 223 is visually observed to be proper from the probe display board 212, and the valve leaflet is stably clamped. The relative positions of the piercing member 251, piercing connector 254, implant wire 271, and pull wire 275 are now as shown in FIG. 43.

And a sixth step: referring to fig. 44, the puncture driving member 216 of the control handle 21 is operated to drive the puncture element 251 to penetrate through the valve leaflet and to be inserted into the puncture connecting member 254, so as to realize the matching connection with the puncture connecting member 254. At this time, the relative positions of the puncture piece 251, the puncture connecting member 254, the implantation wire 271, and the pulling wire 275 are as shown in fig. 45.

The seventh step: as shown in fig. 46, the puncturing drive element 216 of the control handle 21 is operated to retract the puncturing element 251, and since the puncturing element 251 and the puncturing connection element 254 are connected, the puncturing connection element 254 moves along with the retraction of the puncturing element 251, so as to drive the implant wire 271 through the valve leaflet and into the bending portion 2750 bent by the pulling wire 275.

Eighth step: as shown in fig. 47-48, the pulling wire 275 is pulled back in the direction shown by the arrow by the pulling wire driving member 217 on the control handle 21, so as to pull the implantation wire 271 in the bending portion 2750 back, until the anti-slip member 272 is driven to the lower surface of the valve leaflet, and the implantation wire 271 moves to the outer end of the control handle 21.

The ninth step: the length of the artificial chordae tendineae is determined as appropriate based on the medical image, and the implantation line 271 drawn outside the body is cut off as needed, and the cut end is fixed to the ventricular wall, papillary muscle, apex, or the like.

The tenth step: as shown in fig. 49 and 50, after the transcatheter suture implantation device 20 and the guiding device 60 are withdrawn from the patient, the operation is completed, the anti-slip member 272 and the implantation wire 271 are retained in the patient, and one end of the implantation wire 271 is fixed to the valve leaflet in a U-shape by the anti-slip member 272 to replace the diseased chordae tendineae and maintain the tension between the valve leaflet and the ventricular wall.

Fig. 51 and 52 illustrate a second embodiment of the present invention, in which, in contrast to the first embodiment, the housing 2252 of the distal collet 225 is eliminated, the distal end of the collet body 2250 is provided with an end cap 2501, the end cap 2501 being made of metal and being of a smooth construction to facilitate access to the instrument. Therefore, the overall size of the chuck component 22 can be effectively reduced, the smoothness of the operation is improved, and the friction damage of the chuck component 22 to the heart in the operation process is reduced; and the end cap 2501 made of metal can improve the connection strength and increase the reliability of the instrument.

Fig. 53 shows a third embodiment of the present invention, compared to the second embodiment, a separate guiding rod 250 is added between the proximal chuck 221 and the distal chuck 225, one end of the guiding rod 250 has a position-limiting portion 2503 with a cylindrical or triangular or other geometric structure, the position-limiting portion 2503 is disposed in the proximal chuck 221, and the maximum opening and closing amount of the chuck assembly 22 can be controlled because the position-limiting portion 2503 has an axial position-limiting effect on the proximal chuck 221. The other end of guide rod 250 extends through distal collet 225 and is fixedly attached to collet body 2250 by laser welding, gluing, threading, or the like. Therefore, the stability of the whole chuck component 22 can be improved, particularly when the chuck component 22 is opened and closed and the internal components move relatively, the stability of the movement can be improved, and the chuck is prevented from shaking and falling off.

Fig. 54 shows the fourth embodiment of the present invention, compared with the third embodiment, the plane 2505 to be attached with the bending portion 2750 is inclined, so as to adjust the angle of the embedded bending portion 2750 at the embedded position, so that the opening end of the bending portion 2750 is deviated to the near end of the distal chuck 225, so that the plane 2505 and the piercing part are at an acute angle, and the pulling force when the pulling wire 275 is effectively lowered, thereby lowering the overall pulling force of the chuck assembly 22, and effectively improving the stability of the instrument and the stability of the operation in the process of the operation.

Fig. 55 and 56 show a fifth embodiment of the present invention, which is to add a limiting groove 2506 inside the distal end cartridge 225, and to pre-embed the bending portion 2750 of the pulling wire 275 in the limiting groove 2506 when the bending portion 2750 is assembled to the distal end cartridge 225, compared to the first embodiment, the limiting groove 2506 can prevent the pre-embedded bending portion 2750 from affecting the movement of the puncturing member 251. In addition, the stopper groove 2506 can prevent the bending portion 2750 from being detached in advance, and even if the puncture piece 251 is accidentally withdrawn when not punctured, the bending portion 2750 can be prevented from being detached from the restriction of the puncture piece 251 and passing over the puncture piece 251, and the bending portion 2750 can be held on the outer ring of the puncture piece 251, thereby ensuring the effectiveness of pulling the wire 275.

Fig. 57 and fig. 58 show a sixth embodiment of the present invention, which changes the connection mode of the implantation line 271 and the puncture connecting piece 254 from non-detachable connection to detachable connection by adjusting the connection mode, so that the implantation line 271 and the puncture connecting piece 254 can be separated during pulling the pulling line 275, thereby reducing the pulling force applied to the collet assembly 22 during pulling, minimizing the pulling force applied to the valve leaflet during pulling, and reducing the damage to the valve leaflet; and because the puncture connector 254 and the implant line 271 separate when tension is applied to the pull wire 275, the required length of the implant line 271 is greatly reduced, thereby reducing the cost and difficulty of use of the device.

As shown in fig. 57, the implant wire 271 is pre-tensioned into the piercing connector 254 by a crimping pliers or other pressure mechanism with a pre-tension sufficient to pull the wire 275 through the leaflets, and when the pull wire 275 is pulled, the force exerted by the pull wire 275 is sufficient to pull the pull wire 275 away from the piercing connector 254.

As shown in fig. 58, a wire 2507 is additionally arranged between the puncture connecting piece 254 and the implant line 271 for connection, two ends of the wire 2507 are fixedly connected with the puncture connecting piece 254, and the middle part of the wire 2507 hoops the free end of the implant line 271 between the wire 2507 and the puncture connecting piece 254, the hooping force is adjusted to be reasonable, and when the pull line 275 is pulled, the free end of the implant line 271 is separated from the puncture connecting piece 254 and is pulled out.

Alternatively, a groove may be formed in the puncture connector 254, and the implantation wire 271 may be hung in the groove, so that the implantation wire 271 may be detached from the puncture connector 254 when pulling the wire.

In this embodiment, since the free end of the implantation wire 271 can be disengaged from the piercing connector 254, a pulling wire with a knot 508 at its distal end can be used to pull the wire, as shown in FIG. 59, and the knot 508 automatically locks the implantation wire 271 when a force is applied, so that the implantation wire 271 can be pulled out of the body by pulling the wire 275.

The above is an implementation manner of the embodiments of the present invention, and it should be noted that, for those skilled in the art, a plurality of improvements and decorations can be made without departing from the principles of the embodiments of the present invention, and these improvements and decorations are also considered as the protection scope of the present invention.

Claims

1. A transcatheter suture implanting device is characterized by comprising a jaw component capable of being opened and closed relatively, a sheath tube connected to the proximal end of the jaw component, a puncture component arranged in the jaw component, a group of implanting wires and a group of pulling wires, the puncture assembly comprises a puncture piece which is slidably arranged on the chuck assembly and a puncture connecting piece which corresponds to the puncture piece, a group of implant lines are arranged in the inner cavity of the sheath tube after being folded, two ends of the implantation line are respectively connected with the two puncture connecting pieces, the pulling line comprises a bending part which is pre-arranged in the chuck component and bypasses the two puncture connecting pieces, the puncture piece is connected with the puncture connecting piece and then drives the puncture connecting piece and the implantation line to enter the bending part of the pulling line, the pull wire is withdrawn to drive the implantation wire to enter the sheath tube until the implantation wire is pulled out of the sheath tube.

2. The transcatheter suture implantation device of claim 1, wherein the cartridge assembly comprises a proximal cartridge, a distal cartridge, and a clamp drive rod disposed between the proximal cartridge and the distal cartridge, the clamp drive rod moving axially to move the distal cartridge relative to the proximal cartridge, the puncture member disposed on the distal cartridge, and the puncture connector disposed on the proximal cartridge.

3. The transcatheter suture implantation device of claim 2, wherein the puncture connecting member is a plurality of spaced sleeves disposed within the proximal collet, and the puncture member is a puncture needle disposed within the distal collet corresponding to the plurality of sleeves, the two puncture needles being removably or non-removably fixedly coupled to the corresponding sleeves after passing through the leaflets.

4. The transcatheter suture implantation device of claim 3, wherein the puncture needle includes a tapered needle tip, and a side of the sleeve facing the puncture needle is provided with a receiving cavity for receiving the needle tip.

5. The transcatheter suture implantation device of claim 2, wherein the cartridge assembly further includes a guide rod disposed between the proximal cartridge and the distal cartridge, the guide rod spaced parallel to the clamp drive rod, the distal cartridge axially slidable with the guide rod.

6. The transcatheter suture implantation device of claim 5, wherein the collet assembly further includes a stylet slidably disposed in the sheath, a distal end of the stylet extending from the proximal collet to detect a leaflet between the proximal collet and the distal collet.

7. The transcatheter suture implantation device according to claim 6, wherein a guidewire lumen is axially formed in a middle portion of the proximal collet, and the proximal collet is axially formed with at least one probe lumen at one side of the guidewire lumen; the near-end chuck is provided with at least one clamping traction cavity at one side of the thread guide cavity along the axial direction, and the clamping driving rod is accommodated in the clamping traction cavity; the near-end chuck is provided with a connecting cavity along the axial direction at one side of the clamping traction cavity, and the near end of the guide rod is arranged in the connecting cavity.

8. The transcatheter suture implantation device of claim 2, wherein the implantation wire and the pull wire are each flexible wires made of a biocompatible polymeric material or a softer metallic material, the implantation wire and the pull wire each having a length greater than twice a length of the sheath.

9. The transcatheter suture implantation device according to claim 8, wherein a slip prevention member is slidably sleeved on the implantation wire, a bent portion is formed at a distal end of the implantation wire, the slip prevention member is located at the bent portion, and the implantation wire drives the slip prevention member to move until the slip prevention member is attached to a surface of the valve leaflet during the process of driving the implantation wire to move by the pulling wire.

10. The transcatheter suture implantation device according to claim 9, wherein the anti-slip member is provided with two through holes spaced apart from each other in a thickness direction thereof, a connecting line between the two through holes forms an included angle with an axial direction of the anti-slip member, and both ends of the implantation line are connected to the two puncture connection members after passing through the two through holes, respectively.

11. The transcatheter suture implantation device of claim 9, wherein the collet assembly defines an implant receiving cavity in an axial direction, the anti-slip member is removably received within the implant receiving cavity, the implant wire and the puncture connecting member are received within the implant receiving cavity, and the pull wire drives the implant wire out of the implant receiving cavity and pulls the implant wire proximally to pull the anti-slip member out of the implant receiving cavity.

12. The transcatheter suture implantation device of claim 11, wherein the distal collet defines two axial piercing passages, and the two piercing elements are respectively received in the two piercing passages, and the two piercing passages correspond to the piercing connectors on both sides of the implant receiving cavity, such that the piercing elements correspond to the piercing connectors.

13. The transcatheter suture implantation device of claim 11, wherein the collet assembly is configured with a pull wire receiving lumen, a proximal end of the pull wire receiving lumen extending through the proximal collet and into the sheath, a curved portion of the pull wire received in a distal end of the pull wire receiving lumen, and a proximal end of the pull wire passing from the pull wire receiving lumen into the sheath and out through a proximal end of the sheath.

14. The transcatheter suture implantation device of claim 2, wherein an end cap is disposed at a distal end of the distal collet, a guide rod is axially disposed at a proximal end of the end cap, a stopper portion stopping at the proximal collet is disposed at a proximal end of the guide rod, and the distal collet is slidably sleeved on the guide rod.

15. The transcatheter suture implantation device of claim 14, wherein the end cap is a smooth structure made of metal.

16. The transcatheter suture implantation device of claim 2, wherein a contact surface in the distal collet that engages the curved portion of the pull wire is angled, and an open end of the curved portion is biased toward a proximal end of the distal collet such that the curved portion is at an acute angle to a direction of movement of the puncture member.

17. The transcatheter suture implantation device of claim 2, wherein a contact surface of the distal collet that is engaged with the curved portion of the pull wire defines a limit groove, the limit groove surrounding the two piercing connectors, the curved portion of the pull wire being received within the limit groove.

18. The transcatheter suture implantation device of claim 1, wherein an end of the implantation wire is removably connectively coupled to the puncture connector, the implantation wire being disconnected from the puncture connector during the pulling of the wire to drive the implantation wire.

19. The transcatheter suture implantation device of any one of claims 1-18, further comprising a control handle for actuating the jaw assembly relative to one another to clamp the leaflet, controlling a probe to probe the leaflet, actuating the puncture member to puncture the leaflet, and actuating the withdrawal of the pull wire.

20. A transcatheter chordal implantation system comprising the transcatheter suture implantation device and a guiding device according to any one of claims 1-19, the transcatheter suture implantation device being movably disposed in the guiding device, the guiding device comprising an adjustable elbow and a bend adjustment mechanism disposed at a proximal end of the adjustable elbow, the cartridge assembly extending from a distal end of the adjustable elbow, the distal end of the adjustable elbow being provided with at least one adjustable bend segment, the bend adjustment mechanism comprising a bend adjustment member disposed at the proximal end of the adjustable elbow and an adjustment wire connected to the bend adjustment member, a distal end of the adjustment wire being connected to the adjustable bend segment, the bend adjustment member pulling the adjustment wire to bend the adjustable bend segment to adjust a position of the distal end of the transcatheter suture implantation device.

21. The transcatheter chordal implantation system according to claim 20, wherein at least one adjusting wire channel is axially opened in a wall of the adjustable elbow, the adjusting wire is threaded into the adjusting wire channel, an adjusting ring is embedded in the adjustable elbow section, and a distal end of the adjusting wire is connected to the adjusting ring.