Valve repair system with artificial chordae tendineae implanted

Abstract

The invention discloses a valve repair system for implanting artificial tendon cords, comprising a handle operating device, a valve clamping device, a valve puncture device, a catheter, and a valve capture feedback device; the valve clamping device comprises a clamping control part, a proximal clamp and a distal clamp; the valve puncture device comprises a traction ring, a connector, a puncture needle, and a puncture hollow tube with a limit sleeve outside the puncture needle, and the puncture hollow tube is detachably connected to the connector; the traction ring and the connector are accommodated in the distal clamp, and the distal end of the puncture needle assembly is accommodated in the proximal clamp; the artificial tendon cord is inserted in the clamping control part; the handle operating device comprises a handle, a puncture operating mechanism, a clamping operating mechanism, and a feedback operating mechanism, the puncture operating mechanism is connected to the puncture needle assembly, the clamping operating mechanism is connected to the clamping control part, and the feedback operating mechanism is connected to the valve capture feedback device. The invention has small puncture damage, can implant and tie multiple groups of artificial tendon cords at one time, and can simply and reliably feedback the clamping situation.

Description

Technical Field

[0001] The invention belongs to the technical field of interventional medical devices and relates to a valve repair system implanted with artificial tendinous cords. Background Art

[0002] Mitral regurgitation is one of the most common heart valve diseases today. The main causes are rheumatic heart disease, myxoid degeneration of the mitral valve, ischemic heart disease, myocardial lesions, etc., which lead to lesions in the valve ring, valve leaflets, chordae tendineae and papillary muscles in the mitral valve structure, resulting in the inability of the mitral valve leaflets to close completely. Surgery is an effective method for treating mitral regurgitation, but due to the great trauma caused by surgery to the human body, there are more complications and higher mortality rates for elderly patients and patients with more comorbidities. Therefore, minimally invasive interventional surgery is now a better choice for most heart diseases. The main interventional treatment methods include artificial chord implantation, mitral valve annuloplasty and mitral valve edge-to-edge repair. Among them, implanting artificial chords on the valve leaflets can effectively treat mitral regurgitation caused by chord rupture, valve leaflet prolapse, etc., while maintaining the physiological integrity of the mitral valve structure.

[0003] There are some problems in the puncture and suturing process of the existing tendon chord implantation suturing device:

[0004] For example, an existing chordal implantation and suturing device uses a barbed needle to complete valve perforation suturing. The puncture point of this solution is relatively large, which causes greater damage to the valve and the risk of valve tearing. In addition, the success rate of the needle hooking the artificial chordal tendon is not high, which makes the success rate of the operation low and prolongs the operation time. In addition, only one set of artificial chordal tendons can be implanted at a time, which results in multiple suturings required for each operation, which is complicated and time-consuming.

[0005] For another example, another suturing device technology directly sutures a group of threads through the valve leaflet without winding or knotting the threads. This technology easily leads to loose and unstable sutures, and cannot achieve satisfactory clinical results. Moreover, only one group of artificial chords with a suture diameter of ≤0.5mm and ≥0.1mm can be implanted at a time, and multiple operations are required to implant multiple groups. The operation is complicated and the operation time is long, which cannot meet clinical needs.

[0006] At the same time, existing implantable devices also have some problems in the clamping process: for example, the valve leaflets are first clamped by a capture device, and then the clamping effect is judged by a capture verification system before the artificial chordae are implanted. The principle of the capture verification system is to use the different colors produced by the optical fiber when it encounters the valve leaflets and blood to determine whether the valve leaflets are clamped. However, the device structure of this solution is complex, and the optical fiber needs to enter the patient's body with the device body, increasing the risk of surgery. In addition, since the capture verification system also needs to be equipped with a capture verification monitor, it further leads to a cumbersome device structure, complex production process, and high production and surgical costs.

[0007] There is also an artificial chord implant device with a detection device. After entering the heart to capture the valve, the capture effect is judged by a mechanical detection mechanism. The mechanical mechanism is a probe extending from the proximal clamp and entering the distal clamp. If the valve is captured successfully, the probe will not enter the distal clamp. This is used for judgment. Since the success of valve capture is detected by extending the probe, the puncture force of the extended probe can easily cause damage to the valve. Summary of the invention

[0008] The technical problem to be solved by the present invention is to provide a valve repair system for implanting artificial chords, which has small puncture damage, can implant and tie multiple groups of artificial chords at one time, and can provide simple and reliable feedback on the clamping status.

[0009] The technical solution adopted by the present invention to solve the technical problem is:

[0010] A valve repair system for implanting artificial tendon chordae comprises a handle operating device at the proximal end, a valve clamping device at the distal end and at least one set of valve puncture devices, a catheter arranged therebetween, and a valve capture feedback device for determining whether the valve is correctly captured;

[0011] The valve clamping device comprises a distal clamping mechanism and a clamping control member connected to the clamping mechanism and controlling the opening and closing of the clamping mechanism; the clamping mechanism comprises a proximal clamp and a distal clamp;

[0012] The valve puncture device comprises a traction ring for pulling the artificial tendon, a connector for fixing the traction ring, and a puncture needle assembly;

[0013] The puncture needle assembly includes a puncture needle and a puncture hollow tube which is limitedly sleeved outside the puncture needle. The puncture hollow tube is detachably connected to the connecting piece, and the puncture hollow tube is limitedly linked to the puncture needle.

[0014] The traction ring and the connecting piece are accommodated in the distal clamp, and the distal end of the puncture needle assembly is accommodated in the proximal clamp; the artificial tendon cord is inserted into the clamping control piece;

[0015] The handle operating device includes a handle, a puncture operating mechanism arranged in the handle, a clamping operating mechanism, and a feedback operating mechanism. The puncture operating mechanism is connected to the puncture needle assembly, the clamping operating mechanism is connected to the clamping control component, and the feedback operating mechanism is connected to the valve capture feedback device.

[0016] Furthermore, in the valve repair system with implanted artificial chordae, the distal end of the puncture hollow tube is preferably provided with a limit head for limiting the protruding length of the puncture needle, and the needle tip taper of the distal end of the puncture needle is consistent with the taper of the outer wall of the limit head at the distal end of the puncture hollow tube.

[0017] Furthermore, in the valve repair system with implanted artificial chordae, the connector is preferably connected to the puncture hollow tube by threading, snap-fitting, limiting insertion or interference fit.

[0018] Furthermore, in the valve repair system with implanted artificial chordae, the limiting plug-in is preferably as follows: the outer wall of the connector is provided with at least one circle of grooves or teeth, and the inner wall of the corresponding puncture hollow tube is provided with at least one circle of teeth or grooves, and the teeth abut against the grooves to connect the connector and the puncture hollow tube together.

[0019] Furthermore, in the valve repair system with implanted artificial chordae, the distal clamp is preferably provided with a first accommodating chamber for accommodating a traction ring and a connecting piece, and one end of the first accommodating chamber is connected to the clamping control piece and the other end extends to the clamping surface of the distal clamp.

[0020] Furthermore, in the valve repair system with implanted artificial chordae, the clamping control element, the valve puncture device, and the valve capture feedback device are preferably arranged in pairs.

[0021] Furthermore, in the valve repair system implanted with artificial tendon chordae, the valve capture feedback device preferably includes a capture feedback mechanism and a feedback control mechanism connected to the capture feedback mechanism;

[0022] The capture feedback mechanism comprises a feedback main component inserted into the proximal clamp and a feedback auxiliary component arranged on the distal clamp, wherein the feedback main component and the feedback auxiliary component are arranged opposite to each other;

[0023] The feedback control mechanism includes a feedback control component inserted into the catheter, the proximal end of the feedback control component extends to the proximal end of the catheter and is connected to the feedback operating mechanism, and the distal end of the feedback control component is connected to the feedback main component to drive its rotation; the feedback main component and the feedback auxiliary component are plugged into each other to limit the rotation of the feedback main component and the feedback control component.

[0024] Furthermore, in the valve repair system with implanted artificial chordae, the feedback control component is preferably elastically connected to the feedback main component at the distal end to drive the feedback main component to rotate.

[0025] Furthermore, in the valve repair system with implanted artificial chordae, the proximal end of the feedback main component is preferably connected to a connecting component, the distal end of the feedback control component is provided with a radial limiter, and the connecting component is elastically connected to the radial limiter to drive the feedback main component to rotate radially.

[0026] Furthermore, in the valve repair system with implanted artificial chordae, the connecting component preferably includes a feedback connecting piece arranged at the proximal end of the feedback main piece and an elastic piece used for resetting the feedback main piece after being compressed; the elastic piece is sleeved on the outside of the feedback connecting piece or the radial limiting piece, and the feedback connecting piece and the radial limiting piece are limitedly plugged in, so that the two can move relative to each other in the axial direction and are radially linked.

[0027] Furthermore, in the valve repair system with implanted artificial chordae, the feedback connector and the radial limit member are preferably connected together by a key connection, a spline connection or a profile connection; or the feedback connector and the radial limit member are respectively provided with a limit groove and a limit member in the axial direction, and after the two are plugged in, the feedback connector and the radial limit member move relative to each other in the axial direction and are linked radially.

[0028] Furthermore, in the valve repair system with implanted artificial chordae, the feedback operating mechanism preferably includes a connecting block connected to the proximal end of the feedback control component, and a knob slidably connected to the axial upper limit of the handle, the knob is radially limitedly connected to the connecting block to drive the connecting block to rotate, and the connecting block is provided with a torsion spring for rotational reset of the connecting block.

[0029] The present invention adopts a connector and a puncture needle assembly, wherein the connector is connected to the puncture hollow tube, and the puncture needle drives the puncture hollow tube, and the two are linked. The puncture needle is manipulated to achieve the connection between the puncture hollow tube and the connector. Since the connector and the puncture hollow tube are connected into a long structure, the puncture damage can be reduced, and the withdrawal is smoother; a group of traction rings can pull a group of U-shaped closed ends of artificial tendons, and the puncture needle assembly passes through the valve and is connected with the connector. Then, the puncture needle assembly can be withdrawn to pull the U-shaped closed end and the open end out of the body at the same time, and then sent into the heart after completing the winding and knotting in vitro, and the annular structure of the traction ring can not only pull conventional sutures with a diameter of 0.1mm-0.5mm, but also sutures with a diameter of ≥0.5mm, so it can be adapted to sutures of various diameters. The present invention also adopts multiple groups of valve puncture devices, so multiple groups of artificial tendons that can be wound and knotted can be sutured at the same time.

[0030] The present invention also adopts a valve capture feedback device to determine whether the valve is captured correctly. Compared with the existing technology, it can reduce surgical risks and has lower production and research and development costs. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] The present invention will be further described below with reference to the accompanying drawings and embodiments, in which:

[0032] Figure 1 is a schematic structural diagram of an embodiment of the present invention;

[0033] Figure 2 is a cross-sectional view of a chuck mechanism according to an embodiment of the present invention;

[0034] Figure 3 is a schematic structural diagram of a distal clamp according to an embodiment of the present invention;

[0035] Figure 4 is a schematic structural diagram of a proximal clamp according to an embodiment of the present invention;

[0036] Figure 5 is a schematic structural diagram of a puncture needle assembly according to an embodiment of the present invention;

[0037] Figure 6 is a schematic structural diagram of a puncture hollow tube and a connecting piece according to an embodiment of the present invention;

[0038] Figure 7-9 It is a structural schematic diagram of the assembly of the puncture hollow tube and the connecting piece according to an embodiment of the present invention;

[0039] Figure 10-11 is a schematic diagram of the position of the valve capture feedback device on the clamping mechanism according to an embodiment of the present invention;

[0040] Figure 12-13 is a structural cross-sectional view of a valve capture feedback device in a clamping mechanism according to an embodiment of the present invention;

[0041] Fig.14 is a cross-sectional view of the feedback main component and the feedback auxiliary component of the embodiment of the present invention being plugged in and matched;

[0042] Fig.15 It is a structural schematic diagram of the positional relationship between the connection component and the feedback control component and the feedback main component of an embodiment of the present invention;

[0043] Fig.16 is a structural schematic diagram of the positional relationship between the feedback connector and the radial limiting member in an embodiment of the present invention;

[0044] Figure 17-18 is a schematic structural diagram of a plurality of valve capture feedback devices according to an embodiment of the present invention;

[0045] Figure 19-20 is a schematic structural diagram of an incompletely captured valve according to an embodiment of the present invention;

[0046] Figure 21-22 is a schematic structural diagram of a fully captured valve according to an embodiment of the present invention;

[0047] Figure 23-24 is a structural schematic diagram of the position of the knob on the handle according to an embodiment of the present invention;

[0048] Fig.25 is a schematic diagram of the connection block structure of an embodiment of the present invention;

[0049] Fig.26 is a schematic diagram of the knob structure of an embodiment of the present invention;

[0050] Fig. 27 is a schematic structural diagram of a chuck mechanism according to an embodiment of the present invention;

[0051] Fig.28 It is a structural schematic diagram of the positional relationship between the capture feedback mechanism and the chuck mechanism of the present invention;

[0052] Fig.29 is a schematic structural diagram of the feedback operation component of the present invention at the end position;

[0053] Fig.30 is a schematic structural diagram of the feedback operation component of the present invention in the initial position;

[0054] Fig.31 is a cross-sectional view of the feedback operation component of Embodiment 2 of the present invention at the end position;

[0055] Fig.32 It is a cross-sectional view of the feedback operation component of Example 2 of the present invention at the starting position. DETAILED DESCRIPTION

[0056] In order to have a clearer understanding of the technical features, purposes and effects of the present invention, specific embodiments of the present invention are now described in detail with reference to the accompanying drawings.

[0057] When a component is referred to as being “fixed to” or “disposed on” another component, it may be directly or indirectly located on the other component. When a component is referred to as being “connected to” another component, it may be directly or indirectly connected to the other component.

[0058] The directions or positions indicated by the terms “upper”, “lower”, “left”, “right”, “front”, “back”, “vertical”, “horizontal”, “top”, “bottom”, “inside”, “outside” etc. are based on the directions or positions shown in the drawings.

[0059] The terms "axial direction" and "radial direction" refer to the length direction of the entire device or component as the "axial direction" and the direction perpendicular to the axial direction as the "radial direction".

[0060] The term "circumferentially" refers to the circumferential direction.

[0061] The terms "first", "second", etc. are used only for descriptive purposes and should not be understood as indicating or implying relative importance or implicitly indicating the number of technical features. "Multiple" means two or more, unless otherwise clearly and specifically defined.

[0062] “Far” and “near” are based on the operator. The direction closer to the operator is near, and the direction farther from the operator is far.

[0063] The above terms are only for the convenience of description and should not be construed as limitations on the present technical solution.

[0064] like Figure 1-32 As shown, a valve repair system for implanting artificial chordae comprises a proximal handle operating device 3, a distal valve clamping device 1 and at least one group of valve puncture devices 2, a catheter 4 arranged therebetween, and also comprises a valve capture feedback device 5 for judging whether the valve is correctly captured; the valve clamping device 1 comprises a distal clamping mechanism 10, a clamping control member 13 connected to the clamping mechanism 10 and controlling the opening and closing of the clamping mechanism 10; the clamping mechanism 10 comprises a proximal clamp 12 and a distal clamp 11.

[0065] The valve puncture device 2 includes a traction ring 21 for pulling the artificial tendon M, a connector 22 for fixing the traction ring 21, and a puncture needle assembly 23. The puncture needle assembly 23 includes a puncture needle 231 and a puncture hollow tube 232 which is limitedly sleeved outside the puncture needle 231. The puncture hollow tube 232 is detachably connected to the connector 22, and the puncture hollow tube 232 is limitedly linked to the puncture needle 231; the traction ring 21 and the connector 22 are accommodated in the distal clamp 11, and the distal end of the puncture needle assembly 23 is accommodated in the proximal clamp 12; the artificial tendon M is inserted in the clamping control part 13.

[0066] The handle operating device 3 includes a handle 30, a puncture operating mechanism 31 arranged in the handle, a clamping operating mechanism 32, and a feedback operating mechanism 33. The puncture operating mechanism 31 is connected to the puncture needle assembly 23, the clamping operating mechanism 32 is connected to the clamping control component 13, and the feedback operating mechanism 33 is connected to the feedback control mechanism 52.

[0067] The valve repair system for implanting artificial chordae mainly includes four parts: a valve clamping device 1, a valve puncture device 2, a valve capture feedback device 5, and a handle operating device 3, which are connected by a catheter 4.

[0068] like Figure 2-4As shown, in the valve clamping device 1, the clamp mechanism 10 is used to clamp the valve. After clamping, the valve puncture device 2 is used to puncture and the artificial tendon M is pulled out of the body through the valve to tie a knot, and then sent back to the valve suture. The clamp mechanism 10 includes a distal clamp 11 set at the distal end and a proximal clamp 12 opposite thereto, both of which are provided with clamping surfaces, and the clamping surfaces are used to clamp the valve. The distal clamp 11 is a conical shape, and the proximal clamp 12 is fixedly connected to the catheter 4 or the two are an integral structure. The 111 and the clamping surface 121 of the distal clamp 11 and the proximal clamp 12 are both inclined surfaces, preferably 60° inclined surfaces. In order to clamp firmly, it is preferred that the clamping surface 111 and the clamping surface 121 are both toothed surfaces to increase the clamping force. The manufacturing material of the clamp mechanism 10 can be selected from polymer materials such as ABS, PC, PEEK, etc., and metal materials such as stainless steel, cobalt-chromium alloy, etc.

[0069] The distal clamp 11 is fixed with a clamping control member 13, and the clamping control member 13 is sequentially inserted into the proximal clamp 12 and the catheter 4. The distal end of the clamping control member 13 is fixedly connected to the distal clamp 11, and the proximal end passes through the catheter 4 and is connected to the clamping operating mechanism 32. Under the action of the clamping operating mechanism 32, the distal clamp 11 and the proximal clamp 12 are closed, clamped or separated. The clamping control member 13 is rod-shaped, and can be a solid rod or a hollow rod. In order to make full use of each component, the clamping control member 13 is preferably a hollow rod, in which the suture thread is used as an artificial tendon M. The number of clamping control members 13 is at least one, and multiple can be set according to the number of artificial tendons M. The connection methods of the clamping control member 13 and the distal clamp 11 mainly include welding, clamping, bonding, etc.

[0070] like Figure 2-4 As shown, the distal clamp 11 is provided with a first accommodating chamber 110 for accommodating the traction ring 21 and the connecting member 22, one end of the first accommodating chamber 110 is connected to the clamping control member 13, and the other end extends to the clamping surface 111 of the distal clamp 11. Since the traction ring 21 pulls the artificial tendon M to connect with the puncture needle assembly 23 through the connecting member 22, the opening 111a of the first accommodating chamber 110 on the clamping surface 111 of the distal clamp 11 corresponds to the position of the puncture needle assembly 23, that is, the first accommodating chamber 110 is a U-shaped structure, one end of which is connected to the inner cavity of the clamping control member 13, and the U-shaped closed end of the artificial tendon M is pulled from the clamping control member 13 to the first accommodating chamber 110, and the position of the connecting member 22 in the first accommodating chamber 110 corresponds to the opening 111a of the clamping surface 111 of the distal clamp 11. The proximal clamp 12 is provided with a puncture hole 121a for inserting the puncture needle assembly 23, a clamping hole 121b for inserting the clamping control component 13, and a through hole 121c for inserting the feedback main component.

[0071] Artificial tendon M usually adopts e-PTFE suture or PET suture, and the outer diameter is 0.2-0.5mm.

[0072] The distal clamp 11 is further provided with an inner cavity 131 for inserting and fixing the clamping control member 13 , and the inner cavity 131 is communicated with the first accommodating cavity 110 .

[0073] like Figure 6 As shown, the connector 22 is used to connect the puncture needle assembly 23 and the traction ring 21, and the connector 22 is a cylindrical structure, preferably a cylindrical structure without edges and corners: a cylinder, an elliptical cylinder, a prism with a smooth transition, etc., and a cylinder is preferred in this embodiment. One end of the connector 22 fixes the traction ring 21, and the other end is detachably connected to the puncture needle assembly 23. The material of the connector 22 can be a metal material such as stainless steel, cobalt-chromium alloy, or a polymer material, preferably stainless steel.

[0074] The traction ring 21 is an annular structure, and the U-shaped closed end of the artificial tendon M passes through the traction ring 21. The traction ring 21 is connected to the connector 22 by crimping, welding, bonding, etc. The material of the traction ring 21 can be metal or polymer monofilament or multi-strand wire.

[0075] like Figure 5 As shown, in the valve puncture device 2, there is a clearance fit or a sliding fit between the puncture needle 231 and the puncture hollow tube 232. The proximal end of the puncture needle 231 is connected to the puncture operating mechanism 32 in the handle operating device 3, and the puncture needle 231 is inserted into the clamping surface 121 of the proximal clamp 12 through the catheter 4. Specifically, the proximal clamp 12 is provided with a puncture hole 121a extending to the clamping surface 121, and the puncture needle assembly 23 is located in the puncture hole 121a, and the distal end of the puncture needle 231 is close to the clamping surface 121 of the proximal clamp 12.

[0076] The puncture hollow tube 232 is a component used to connect with the connector 22. It is a hollow tube with a limited inner diameter. The puncture hollow tube 232 is driven by the puncture needle 231 to puncture through the valve once, and then the puncture hollow tube 232 is operated to be detachably connected with the connector 22. The distal end of the puncture hollow tube 232 is provided with a limit head 2321 for limiting the extension length of the puncture needle 231. The needle taper at the distal end of the puncture needle 231 is consistent with the taper of the outer wall of the limit head 2321 at the distal end of the puncture hollow tube 232, which is conducive to the effectiveness of the puncture and reduces the puncture trauma.

[0077] The detachable connection between the connector 22 and the puncture hollow tube 232 can be a threaded connection, a snap connection, a limited insertion connection or an interference fit connection.

[0078] Among them, Figure 7 As shown, the screw connection method is: the distal end of the connector 22 or the puncture hollow tube 232 is respectively provided with an internal thread or an external thread, the two are screwed together, and the puncture needle 231 is inserted into the inner cavity of the proximal end of the connector 22 after the screw connection.

[0079] like Figure 6 ,8 As shown, the snap connection method is: a clamp head 221 is provided at the proximal end of the connector 22, and a bayonet 2322 is provided at the distal end of the puncture hollow tube 232, and the clamp head 221 is snapped into the bayonet 2322 to connect the two together. The clamp head 221 includes a matching portion 2211, a groove 2212, and a chamfer 2213. The matching portion 2211 is a structure for snap-fitting with the puncture hollow tube 232, the groove 2212 provides a deformation margin for snap-fitting, and the chamfer 2213 improves the smoothness of the puncture hollow tube 232 entering the bayonet 2322. A radial limiting portion 222 is provided at the distal end of the connector 22, and the radial limiting portion 222 cooperates with the puncture hole 121a on the distal clamp 11 to ensure that the radial position of the connector 22 accommodated in the distal clamp does not change.

[0080] like Fig. 9 As shown, the limit insertion is: the proximal outer wall of the connecting piece 22 is provided with at least one circle of oblique grooves or teeth 223, and the inner wall of the corresponding puncture hollow tube 232 is provided with at least one circle of teeth or oblique grooves 2323, and the teeth 223 are hooked in the oblique grooves 2323 to connect the connecting piece 22 and the puncture hollow tube 232 together.

[0081] Furthermore, in order to implant multiple sets of sutures at one time to form artificial tendon M, the clamping control member 13, the valve puncture device 2, and the valve capture feedback device 5 are all provided in multiple sets, preferably the clamping control member 13, the valve puncture device 2, and the valve capture feedback device 5 are all provided in pairs. That is, the clamping control member 13, the first accommodating chamber 110, the puncture needle assembly 23, and the valve capture feedback device 5 are provided in multiple sets, preferably in pairs and at intervals.

[0082] like Figure 10-13 As shown, the valve capture feedback device 5 includes a capture feedback mechanism 51 and a feedback control mechanism 52 connected to the capture feedback mechanism 51; the capture feedback mechanism 51 includes a feedback main component 512 inserted in the proximal clamp 12 and a feedback auxiliary component 511 arranged on the distal clamp 11, and the feedback main component 512 and the feedback auxiliary component 511 are arranged opposite to each other; the feedback control mechanism 52 includes a feedback control component 522 inserted in the catheter 4, the proximal end of the feedback control component 522 extends to the proximal end of the catheter 4 and is connected to the feedback operating mechanism 33, and the distal end of the feedback control component 522 is elastically connected to the feedback main component 512 to drive it to rotate; the feedback main component 512 and the feedback auxiliary component 511 are plugged into each other to limit the rotation of the feedback main component 512 and the feedback control component 522.

[0083] like Figure 10-13 As shown, the valve capture feedback device 5 includes two major parts: a capture feedback mechanism 51 and a feedback control mechanism 52 .

[0084] The valve capture feedback device 5 of the present invention is arranged in the valve repair system, and is used to determine whether the clamp mechanism 10 in the valve repair system has successfully clamped the valve. The capture feedback mechanism 51 includes a feedback main component 512 and a feedback auxiliary component 511. The feedback main component 512 and the feedback auxiliary component 511 are respectively arranged on the proximal clamp 12 and the distal clamp 11 of the clamp mechanism 10. When the proximal clamp 12 and the distal clamp 11 clamp the valve, the feedback main component 512 and the feedback auxiliary component 511 are arranged on both sides of the valve to realize different feedback on whether the valve is captured. It is necessary to determine whether the two are plugged in. Fig.13 As shown, when the valve is completely captured, the feedback main component 512 and the feedback auxiliary component 511 are blocked by the valve X and cannot be plugged into each other. The feedback operating mechanism set in the handle drives the feedback main component 512 to rotate through the feedback control component 522 in the catheter 4, and the valve is captured; Fig.12 As shown, when the valve is not clamped or the valve clamping is incomplete, the feedback main component 512 and the feedback auxiliary component 511 are plugged into each other, and the feedback main component 512 is radially limited by the feedback auxiliary component 511 and cannot rotate. The feedback main component 512 is connected to the feedback control component 522, which also makes the feedback control component 522 unable to rotate. When the operator cannot rotate the feedback control component 522, it is displayed that the capture is unsuccessful. Therefore, the capture result can be judged by whether the feedback control component 522 can be rotated.

[0085] Specifically, the feedback main component 512 and the feedback auxiliary component 511 are respectively a feedback plug and a feedback socket corresponding to each other; the feedback plug and the feedback socket are radially limited by a key connection, a spline connection or a profile connection; or a limit position is provided in the feedback socket to prevent the two from rotating relative to each other after the feedback plug is inserted, that is, when the feedback plug is plugged into the feedback socket, the feedback main component 512 is limited and does not rotate. There are two types of plug-in structures: the first is that the feedback main component 512 is provided with a feedback plug and the feedback auxiliary component 511 is provided with a feedback socket; the second is that the feedback auxiliary component 511 is provided with a feedback plug and the feedback main component 512 is provided with a feedback socket. Both methods can be implemented, and the first implementation method is preferred, that is, Figure 2-4 As shown in Figures 14, the feedback auxiliary component 511 is a feedback jack provided on the clamping surface 111 of the distal clamp 11, and the feedback main component 512 is a feedback plug that is passed from the inside of the proximal clamp 12 to the clamping surface 121. A through hole 121c is provided in the proximal clamp 12, and the feedback plug as the feedback main component 512 is inserted into the through hole 121c. A feedback jack as the feedback auxiliary component 511 is provided on the corresponding distal clamp 11. The feedback plug is to abut against the valve X, and the head of the feedback plug is smooth and has no edges or corners. Since the two are to form a limited plug-in connection, that is, the two can move relative to each other in the axial direction, plug in or unplug, but after plugging in, the feedback main component 512 and the feedback auxiliary component 511 cannot rotate relative to each other radially (or circumferentially).

[0086] like Figure 27-28 As shown, the proximal chuck 12 is provided with a through hole 121c for inserting the feedback main component 512, and the through hole 121c is provided with a chuck stopper for preventing the feedback main component 512 from being separated from the proximal chuck 12. Specifically, the chuck stopper is preferably a step 126 and a step 127 provided on the inner wall of the through hole 121c, that is, the through hole 121c is a stepped hole, the feedback connector 531 of the feedback main component 512 is limited below the step 126, and the radial stopper 521 is limited below the step 127. In addition to the steps 126 and 127, the chuck stopper can also be a protrusion, a protruding ring, etc. provided on the inner wall of the through hole 121c.

[0087] The limited insertion between the feedback main component 512 and the feedback auxiliary component 511 can be implemented in the following three categories:

[0088] The first implementation method is a loose key connection: the feedback plug and the feedback socket are connected by a key connection or a spline connection. The key connection is a flat key connection, a flat key is provided on the feedback plug, and a flat key slot is provided in the feedback socket as a limit stop. When the feedback plug is plugged into the feedback socket, the flat key is inserted into the flat key slot, so that the feedback plug cannot rotate in the feedback socket. The spline connection is the same, which will not be described in detail here.

[0089] The second type of implementation is the profile connection: the profile connection is a detachable connection method that uses a cylindrical body with a non-circular cross-section to cooperate with a hole with the same contour to transmit motion and torque. That is, the feedback plug is a cylindrical body with a non-circular cross-section, and the feedback socket is a hole with the same contour, and its wall surface is a limit stop. Since the cross-sections of the feedback plug and the feedback socket are both non-circular, and the gap between the two cannot enable the feedback plug to rotate in the feedback socket, the two form a radial limit. Preferably, the profile connection is a profile connection with a polygonal cross-section, and more preferably a triangular, quadrilateral, pentagonal or hexagonal profile connection, or the profile connection is a profile connection with a non-circular curved cross-section. All non-circular curved surface structures are applicable to the present invention. Fig.14 As shown, this embodiment adopts a profile connection method with a hexagonal cross section, that is, the cross sections of the feedback main component 512 and the feedback auxiliary component 511 are both hexagonal, and there is a gap fit between the two.

[0090] In both of the above two types, the feedback plug and the feedback socket have the same shape, and the gap between them cannot meet the rotation requirements of the feedback plug.

[0091] The third type is abutment fit: This type of fit is different from the above two types, and the feedback plug and the feedback socket have different shapes. The feedback socket is provided with a limit stopper to prevent the two from rotating relative to each other after the feedback plug is inserted. When the feedback plug is plugged into the feedback socket, the feedback plug abuts against the limit stopper, and the feedback main component 512 is limited and does not rotate. In this method, the limit stopper is set on the inner wall of the feedback socket. The limit stopper can be set at one or more. The limit stopper can be an axially arranged groove or an axially arranged boss. The feedback plug abuts against the groove or boss of the limit stopper to limit the rotation of the two relative to each other.

[0092] like Figure 12-13 As shown in 15-16, the proximal end of the feedback main component 512 is connected with a connecting component 53, and the connecting component 53 is used to connect the feedback main component 512 with the feedback control component 522, and the connecting component 53 and the feedback control component 522 are elastically connected. The distal end of the feedback control component 522 is provided with a radial limiter 521, and the connecting component 53 is elastically connected to the radial limiter 521 of the feedback control component 522, driving the feedback main component 512 to rotate radially. The connecting component 53 includes a feedback connection component 531 provided at the proximal end of the feedback main component 512, and an elastic component 532 used for resetting the feedback main component 512 after being compressed; the elastic component 532 is sleeved outside the feedback connection component 531 or the radial limiter 521. The elastic member 532 is used for the axial movement of the feedback main member 512, that is, after encountering the valve X, the feedback main member 512 elastically presses against the valve X, and is not likely to cause damage to the valve X. In this state, the elastic member 532 is pressurized, and the proximal end of the feedback main member 512 retreats toward the feedback control member 522. When there is no valve X, under the action of the elastic member 532, the feedback main member 512 is plugged into the feedback auxiliary member 511.

[0093] The elastic member 532 is a spring or an elastic material sleeve. The elastic member 532 is sleeved outside the feedback connector 531 or the radial stopper 521, and is not separated from the feedback connector 531 or the radial stopper 521 by the stopper 533 provided on the feedback connector 531 or the radial stopper 521, for example, the stopper 533 is a stopper ring or a stopper block. Fig.15 As shown, the elastic member 532 is sleeved outside the feedback connector 531, a stopper 533 is provided at the distal end of the feedback connector 531, two ends of the elastic member 532 respectively press against the stopper 533 and the distal end of the radial stopper 521, and the feedback connector 531 is inserted into the radial stopper 521. In other embodiments, the elastic member 532 may be sleeved outside the radial stopper 521, a stopper 533 is provided on the radial stopper 521, two ends of the elastic member 532 respectively press against the stopper 533 and the proximal end of the feedback connector 531, and the radial stopper 521 is inserted into the radial stopper 521 of the feedback connector 531.

[0094] The feedback connector 531 and the radial stopper 521 of the feedback control member 522 are inserted in a limited position so that the two can move relative to each other in the axial direction and are radially linked. The feedback connector 531 can be inserted into the radial stopper 521, and the radial stopper 521 can also be inserted into the feedback connector 531. The limited insertion of the feedback connector 531 and the radial stopper 521 has the following implementation methods, just like the feedback plug and the feedback jack:

[0095] The first implementation method is a loose key connection: connected together by a key connection or a spline; refer to the loose key connection of the feedback plug and the feedback jack for details, which will not be described here.

[0096] The second implementation method is the profile connection: please refer to the profile connection of the feedback plug and the feedback jack for details, which will not be described here. Fig.16 As shown, in this embodiment, the feedback connector 531 is a strip structure or a cylindrical structure, guide columns 534 are provided on both sides of the cylindrical structure, and the radial limit member 521 is axially provided with a strip structure or a circular structure with a guide groove inner cavity 521a, the shape of the inner cavity is consistent with the feedback connector 531, the two are slidingly fitted or clearance fit, but the clearance cannot cause the feedback connector 531 to rotate.

[0097] The third type is abutment fit: the feedback connector 531 and the radial limiter 521 are respectively provided with a limit groove and a limiter in the axial direction. After the two are plugged in, they move relative to each other in the axial direction and are radially linked. In this type of structure, one component is provided with a limit groove and the other component is provided with a limiter. When the two rotate, the limiter presses against the limit groove to prevent the two from rotating. The shapes of the limit groove and the limiter can be different, and the two only need to press against each other. For example, the limit groove is a circle of tooth grooves, the limiter is a limit tooth, and the limit tooth abuts against any tooth groove to limit the two to prevent radial rotation.

[0098] The length of the plug-in portion between the radial stopper 521 and the feedback connector 531 satisfies that when the elastic member 532 is in a free state, the two are still in a plug-in state, that is, the feedback connector 531 and the radial stopper 521 maintain a connection relationship.

[0099] like Figure 17-22 As shown, when the clamping device clamps the valve X, there are two situations: complete capture and incomplete capture. The complete capture means that the valve X is successfully and well clamped, and the incomplete capture means that only one side of the valve X is captured and clamped, and the other side is not captured and clamped, and the artificial tendon M cannot be implanted. Therefore, the capture feedback mechanism 51 needs to be set in two or more groups, and there is a gap between the two adjacent groups; each group of capture feedback mechanism 51 is connected to a feedback control mechanism 52. Figure 19-20The figure shows an incomplete capture and clamping, in which a set of feedback main components 512 of the capture feedback mechanism 51 is plugged into the feedback auxiliary component 511, and the corresponding feedback control component 522 cannot rotate. The other feedback control component 522 can rotate, indicating that the valve X at the corresponding position is captured and clamped. Figure 21-22 The figure shows complete capture and clamping, in which the feedback main components 512 of the two sets of capture feedback mechanisms 51 are blocked by the valve X and cannot be plugged into the feedback auxiliary components 511, and the corresponding feedback control components 522 can rotate.

[0100] The catheter 4 is provided with a plurality of lumens penetrating the proximal end and the distal end, including at least one group of first lumens for inserting the clamping control member 13 , at least one group of second lumens for inserting the puncture needle assembly 23 , and at least one group of third lumens for inserting the feedback control member 522 .

[0101] like Figure 1-9 As shown, the handle operating device 3 includes a handle 30 , a puncture operating mechanism 31 arranged in the handle 30 , a clamping operating mechanism 32 , and a feedback operating mechanism 33 .

[0102] The puncture operating mechanism 31 includes two puncture operating rods 312 connected to the proximal end of the puncture needle 231 and the proximal end of the puncture hollow tube 232 respectively. The proximal end of the puncture operating rod 312 passes through the proximal end of the handle 30 and is connected to the puncture handle 311 for easy operation.

[0103] The clamping operating mechanism 32 includes a clamping operating rod 322 connected to the proximal end of the clamping control member 13. The proximal end of the clamping operating rod 322 passes through the proximal end of the handle 30 and is connected to the clamping handle 321 for easy operation.

[0104] like Figure 23-26 As shown, the feedback operating mechanism 33 includes a connecting block 331 connected to the proximal end of the feedback control member 522, and a knob 332 slidably connected to the axial upper limit of the handle 30. The knob 332 is radially limitedly connected to the connecting block 331 to drive the connecting block 331 to rotate. The connecting block 331 is provided with a torsion spring 333 for rotating and resetting the connecting block 331.

[0105] Specifically, the connecting block 331 includes a shaft 3311, a blade 3312 extending on one side of the shaft 3311, a torsion spring 333 is sleeved on the shaft 3311, and protrusions or retaining rings 3313 are provided at both ends of the shaft 3311 to constrain the sleeved torsion spring 333. One end of the torsion spring 333 is fixed or abutted on the bone position 301 in the handle 30, and the other end abuts or is fixed on the blade 3312. The shaft 3311 is fixedly connected to the proximal end of the feedback control member 522, and the connection method includes welding, bonding, clamping, etc. The knob 332 includes a knob body 3321, and an arc plate 3322 and a matching sliding member 302 are sequentially provided at the rear of the knob body 3321. The matching sliding member 302 is provided with a sliding groove 303 with two ends through, and the sliding groove 303 is plugged into the blade 3312 on the connecting block 331 and the two can slide axially.

[0106] The knob 332 slides circumferentially around the handle 30, that is, rotates around the shaft 3311, driving the connection block 331 to rotate, and also driving the feedback control member 522 to rotate. At the same time, the torsion spring 333 stores torque or rotational force to drive the connection block 331 to reset.

[0107] like Figure 29-30 As shown, the handle 30 is provided with a sliding member 240, and a limiting groove 248 is provided on the sliding member 240 for limiting the movement direction of the knob 332; the limiting groove 248 is an L-shaped groove, including a stopper portion along the axial direction of the handle and a sliding portion perpendicular to the axial direction. The sliding member 240 also includes an arc sliding curved surface 245, the center of which is the axis 251 of the connecting block 331. The knob 332 is limitedly slidably connected to the sliding member 240 and is limitedly connected to the connecting block 331 through the limiting groove 248, and the connecting block 331 is driven to rotate by the circumferential movement of the knob 332 along the sliding member 240. That is, the arc plate 233 provided at the rear of the button body 3321 matches the shape of the arc sliding curved surface 245, and the two slide relative to each other, and at the same time, the arc sliding curved surface 245 forms a limit for the knob 332.

[0108] The handle 30 and the knob 332 are provided with marks 242 and 241 respectively. When the knob 332 is turned so that the two marks 241 and 242 overlap, the valve clamping device successfully captures the valve. When the knob 332 cannot be turned or the two marks 241 and 242 cannot overlap, the valve clamping device fails to capture the valve.

[0109] Implementation process: Figure 29-32The figure shows the starting position, the connecting block 331 rotates around the center of the torsion spring 260, and the torsion spring 260 has a torque or rotational force to pull 250 back to the starting position; the sliding groove 303 of the knob 332 is plugged into the blade 3312 on the connecting block 331, and the two can slide axially, wherein the arc plate 3322 on the knob 332 cooperates with the arc sliding surface 245 of the handle 30 to limit the radial position of the knob 332, and the knob 332 can rotate around the center of the shaft 3311, that is, follow the rotation of the connecting block 331; the knob 332 can also be rotated at The connecting block 331 slides axially along the shaft 3311. When the knob 332 or the connecting block 331 is rotated to the starting position, the knob 332 can move axially and slide into the stop portion of the limit groove 248 at the handle end to overcome the torque or rotational force of the torsion spring 260. When a capture feedback operation is required, the knob 332 is slid out of the stop portion of the limit groove 248 and enters the sliding portion of the limit groove 248. At this time, the torque or rotational force of the torsion spring 333 tends to pull the knob 332 back to the starting position. If the valve is captured successfully, the knob 332 is rotated to Fig.29 The end position shown is that the marks 241 and 242 coincide with each other, otherwise the knob 332 cannot be rotated to the end position and the marks 241 and 242 will not coincide with each other.

Claims

1. A valve repair system for implanting artificial tendon chordae, comprising a proximal handle operating device, a distal valve clamping device and at least one set of valve puncture devices, and a catheter arranged therebetween, characterized in that: Also included is a valve capture feedback device for determining whether the valve is correctly captured; The valve clamping device comprises a distal clamping mechanism and a clamping control member connected to the clamping mechanism and controlling the opening and closing of the clamping mechanism; the clamping mechanism comprises a proximal clamp and a distal clamp; The valve puncture device comprises a traction ring for pulling the artificial tendon, a connector for fixing the traction ring, and a puncture needle assembly; The puncture needle assembly includes a puncture needle and a puncture hollow tube which is limitedly sleeved outside the puncture needle. The puncture hollow tube is connected to the connecting piece by threading, snapping, limited insertion or interference fit, and the puncture hollow tube is limited in linkage with the puncture needle. The traction ring and the connecting piece are accommodated in the distal clamp, and the distal end of the puncture needle assembly is accommodated in the proximal clamp; the artificial tendon cord is inserted into the clamping control piece; The handle operating device comprises a handle, a puncture operating mechanism, a clamping operating mechanism and a feedback operating mechanism arranged in the handle, wherein the puncture operating mechanism is connected to the puncture needle assembly, the clamping operating mechanism is connected to the clamping control member, and the feedback operating mechanism is connected to the valve capture feedback device; The valve capture feedback device comprises a capture feedback mechanism and a feedback control mechanism connected to the capture feedback mechanism; The capture feedback mechanism comprises a feedback main component inserted into the proximal clamp and a feedback auxiliary component arranged on the distal clamp, wherein the feedback main component and the feedback auxiliary component are arranged opposite to each other; The feedback control mechanism comprises a feedback control member inserted in the catheter, the proximal end of the feedback control member extends to the proximal end of the catheter and is connected to the feedback operating mechanism, and the distal end of the feedback control member is connected to the feedback main member to drive the feedback main member to rotate; The feedback main component and the feedback auxiliary component are plugged into each other to limit the rotation of the feedback main component and the feedback control component.

2. The valve repair system with implanted artificial chordae according to claim 1, characterized in that: The distal end of the puncture hollow tube is provided with a limit head for limiting the extension length of the puncture needle, and the needle taper at the distal end of the puncture needle is consistent with the taper of the outer wall of the limit head at the distal end of the puncture hollow tube.

3. The valve repair system with implanted artificial chordae according to claim 1, characterized in that: The position-limiting plug-in is as follows: the outer wall of the connector is provided with at least one circle of oblique grooves or teeth, and the inner wall of the corresponding puncture hollow tube is provided with at least one circle of teeth or oblique grooves, and the teeth abut against the oblique grooves to connect the connector and the puncture hollow tube together.

4. The valve repair system with implanted artificial chordae according to claim 1, characterized in that: A first accommodating cavity for accommodating a traction ring and a connecting piece is provided in the distal clamp. One end of the first accommodating cavity is connected to the clamping control piece, and the other end of the first accommodating cavity extends to the clamping surface of the distal clamp.

5. The valve repair system with implanted artificial chordae according to claim 1, characterized in that: The clamping control member, the valve puncture device, and the valve capture feedback device are all arranged in pairs.

6. The valve repair system with implanted artificial chordae according to claim 1, characterized in that: The feedback control component is elastically connected to the feedback main component at the far end to drive the feedback main component to rotate.

7. The valve repair system with implanted artificial chordae according to claim 1, characterized in that: The proximal end of the feedback main component is connected with a connecting component, the distal end of the feedback control component is provided with a radial limiting component, and the connecting component is elastically connected to the radial limiting component to drive the feedback main component to rotate radially.

8. The valve repair system with implanted artificial chordae according to claim 7, characterized in that: The connection assembly includes a feedback connection piece arranged at the proximal end of the feedback main piece and an elastic piece used to reset the feedback main piece after being compressed; the elastic piece is sleeved outside the feedback connection piece or the radial limit piece, and the feedback connection piece and the radial limit piece are limitedly plugged in, so that the two can move relative to each other in the axial direction and are radially linked.

9. The valve repair system with implanted artificial chordae according to claim 8, characterized in that: The feedback connector and the radial limiter are connected together by a key connection, a spline connection or a profile; or the feedback connector and the radial limiter are respectively provided with a limit groove and a limiter in the axial direction, and after the two are plugged in, the feedback connector and the radial limiter move relative to each other in the axial direction and are radially linked.

10. The valve repair system with implanted artificial chordae according to claim 1, characterized in that: The feedback operating mechanism includes a connecting block connected to the proximal end of the feedback control member, and a knob slidably connected to the axial upper limit of the handle. The knob is radially limitedly connected to the connecting block to drive the connecting block to rotate. The connecting block is provided with a torsion spring for rotating and resetting the connecting block.

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