Valve repair system

Abstract

The invention provides a valve repairing system, a tissue fixing mechanism of the valve repairing system comprises a clamping assembly and a fixing assembly, and the clamping assembly comprises a valve leaflet closing assembly and a moving seat used for installing and driving the valve leaflet closing assembly; the fixing assembly comprises a fixing base and a center shaft arranged in the fixing base, the transmission end of the center shaft is in spiral transmission connection with the moving base, the shaft connecting end of the center shaft is used for being detachably connected with the conveying control mechanism, and a center cavity is formed in the center shaft; the conveying control mechanism comprises a conveying pipe assembly, a transmission shaft and a clutch mechanism, the clutch mechanism comprises a clutch piece and a connecting shaft arranged in the clutch piece in a penetrating mode, and the clutch piece is detachably connected with the fixing base; the connecting shaft is used for connecting the transmission shaft and the center shaft and internally provided with a channel communicating an inner cavity of the transmission shaft and the center cavity in a penetrating mode. By adopting the valve repair system, the connection stability, the transmission efficiency and the transmission stability can be improved, the tissue fixing mechanism can be loaded and withdrawn for multiple times, and the operation cost is reduced.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a valve repair system. Background Art

[0002] The mitral valve is an important valve in the human heart, located between the left atrium and the left ventricle, and plays a role in preventing blood backflow. However, with the increase of age and the influence of certain disease factors, the mitral valve may be damaged or diseased, resulting in mitral regurgitation, which seriously affects heart function and health.

[0003] Transcatheter valve repair has the advantages of no thoracotomy, small trauma, short operation time, no need for extracorporeal circulation support, and high surgical safety. In recent years, various minimally invasive treatments based on surgical mitral repair techniques have been applied clinically.

[0004] The existing valve repair systems have problems such as complex structure, low transmission efficiency, complex separation process of the valve clip, poor separation stability, and non-reusability of the valve repair system. Summary of the Invention

[0005] In order to solve the problems of complex structure, low transmission efficiency, complex separation process, poor separation stability, and non-reusability of the delivery control mechanism in the prior art, the present invention provides a valve repair system. By helically drivingly connecting a central shaft with a moving seat, the moving seat is directly driven to move along its axial direction to control the opening and closing of the closing member, improving the transmission efficiency and connection stability; by providing a separable connection between a clutch member and a fixed seat, and the clutch member can undergo reversible deformation, the delivery control mechanism can be loaded with the tissue fixation mechanism multiple times for delivery and retraction.

[0006] Specifically, the following solutions are included:

[0007] A valve repair system, comprising:

[0008] A tissue fixation mechanism, comprising a clamping assembly and a fixing assembly, the clamping assembly comprising a leaflet closing assembly and a moving seat for mounting and driving the leaflet closing assembly;

[0009] The fixing assembly comprises a fixed seat and a central shaft disposed in the fixed seat, the central shaft comprising a transmission end and a shaft connection end, the transmission end being helically drivingly connected with the moving seat, the shaft connection end being used for separable connection with a delivery control mechanism, and a central cavity being provided in the central shaft;

[0010] The conveying control mechanism includes a conveying pipe assembly, a transmission shaft, and a clutch mechanism. The clutch mechanism includes a clutch member and a connecting shaft passing through the clutch member. The clutch member is detachably connected to the fixed seat. The connecting shaft is used to connect the transmission shaft and the central shaft, and a channel is provided in the connecting shaft to penetrate and communicate the inner cavity of the transmission shaft and the central cavity.

[0011] Further, a first clamping structure is provided at one end of the connecting shaft connected to the central shaft, and a second clamping structure is provided on the central shaft. When the first clamping structure is clamped with the second clamping structure, the relative rotation between the connecting shaft and the central shaft can be restricted.

[0012] Further, the connecting shaft is arranged to be movable relative to the clutch member between a first position and a second position. When the connecting shaft moves proximally from the first position, the clutch member is separated from the fixed seat, and the first clamping structure is separated from the second clamping structure.

[0013] Further, a moving seat inner cavity is provided in the moving seat, and an internal thread is provided in the moving seat inner cavity. The internal thread is in transmission cooperation with the external thread provided at the transmission end.

[0014] Further, the lead angle of the internal thread in cooperation with the external thread at the transmission end is less than the friction angle.

[0015] Further, the flap closing assembly includes a pair of closing members and a pair of capturing members corresponding to the closing members. The closing members and the capturing members cooperate to clamp tissues.

[0016] Further, the capturing member connecting section includes a bent positioning end. The moving seat includes a positioning bottom surface, and a positioning groove is provided on the positioning bottom surface. The positioning end is in mating connection with the positioning groove.

[0017] Further, the fixing assembly includes a positioning sleeve. The positioning sleeve is sleeved outside the central shaft and contacts the inner wall of the fixed seat.

[0018] Further, the conveying pipe assembly includes a receiving pipe. The distal end of the receiving pipe is provided with a receiving end, and the receiving end is arranged to be frustum-shaped. The receiving pipe is arranged between the inner pipe assembly and the bending pipe of the conveying pipe assembly.

[0019] Further, the conveying pipe assembly includes a non-exchangeable outer pipe. The non-exchangeable outer pipe is wrapped around the outer wall of the bending pipe of the conveying pipe assembly.

[0020] The exchange-free outer tube includes an expansion section, and at least two breakable structures are provided along the circumferential direction of the expansion section. The breakable structures extend axially along the expansion section and are configured to be breakable when subjected to internal thrust.

[0021] Further, a guide hole is provided at the end of the expansion section, and the guide hole communicates with the extended end of the central cavity.

[0022] Further, a guiding member is included, and the guiding member is inserted into the inner cavity of the transmission shaft, the channel, and the central cavity of the central shaft.

[0023] Further, the clutch member includes a fixed end and a clutch end. The clutch end includes a first half clip and a second half clip connected to each other. Clamping portions are provided on both the first half clip and the second half clip, and clamping and cooperating portions corresponding to the clamping portions are provided on the fixed seat;

[0024] The clamping portion is connected to the clamping and cooperating portion in a cooperative manner to limit the axial displacement and circumferential rotation of the fixed seat.

[0025] As described above, the present invention has the following beneficial effects:

[0026] One end of the central shaft of the present application is connected to the transmission shaft through a connecting shaft, and the other end is in screw transmission connection with the moving seat. When the central shaft rotates, it can directly drive the moving seat to move axially along it. During the transmission process, the central shaft only rotates relative to the fixed seat and does not move axially, improving the transmission efficiency and connection stability, and making the transmission process smoother.

[0027] The clutch member of the present application is configured to be detachably connected to the fixed seat and can undergo reversible deformation. The inner cavity of the transmission shaft, the central cavity, and the channel are in communication, so that when the guiding member disposed therein is not withdrawn, the tissue fixation mechanism can be loaded and transported by the transport control mechanism multiple times, and the tissue fixation mechanism can also be retracted, improving the surgical safety and reducing the surgical cost.

[0028] The transport tube assembly of the present application includes a receiving tube with an inverted conical receiving end. When the tissue fixation mechanism is retracted from the heart, the receiving tube is used to accommodate the tissue fixation mechanism to avoid damage to the tissue by the capturing member and / or the closing member.

[0029] The present application is provided with an exchange-free outer tube. By integrally covering the transport tube assembly and the tissue fixation mechanism with the exchange-free outer tube, it is not necessary to establish a transport path in advance. The transport control mechanism directly cooperates with the guiding member to transport the tissue fixation mechanism to a designated position, avoiding exchange, simplifying the surgery, reducing the surgical time, and at the same time reducing the overall outer diameter of the system, which is beneficial to reducing tissue damage. Description of the Drawings

[0030] To more clearly illustrate the technical solutions of the present invention, the following will briefly introduce the drawings required for the description of the embodiments or the prior art. Obviously, the drawings in the following description are only some embodiments of the present invention. For those of ordinary skill in the art, without creative efforts, other drawings can be obtained based on these drawings.

[0031] Appendix Figure 1 It is a sectional view of the valve repair system according to the embodiment of the present application;

[0032] Appendix Figure 2 It is a schematic structural diagram of the valve repair system according to the embodiment of the present application;

[0033] Appendix Figure 3 It is a schematic structural diagram of the separation of the tissue fixation mechanism and the delivery control mechanism according to the embodiment of the present application;

[0034] Appendix Figure 4 It is a schematic structural diagram of the closure member and the capture member according to the embodiment of the present application;

[0035] Appendix Figure 5 It is a schematic structural diagram of the moving seat according to the embodiment of the present application;

[0036] Appendix Figure 6 It is a schematic structural diagram of the fixed seat according to the embodiment of the present application;

[0037] Appendix Figure 7 It is a schematic structural diagram of the central axis according to the embodiment of the present application;

[0038] Appendix Figure 8 It is a schematic structural diagram of the connecting seat according to the embodiment of the present application;

[0039] Appendix Figure 9 It is a schematic structural diagram of the clutch member according to the embodiment of the present application;

[0040] Appendix Figure 10 It is a schematic structural diagram of the clutch member in another embodiment of the present application;

[0041] Appendix Figure 11 It is a schematic structural diagram of the cooperation between the clutch member and the connecting shaft in the open and closed states in one embodiment of the present application;

[0042] Appendix Figure 12 It is a schematic structural diagram of the cooperation between the clutch member and the connecting shaft in the open and closed states in another embodiment of the present application;

[0043] Appendix Figure 13 It is a schematic diagram of the process of the connection end of the clutch member and the base from connection to separation according to the embodiment of the present application;

[0044] Appendix Figure 14Schematic diagram of the structure of the connecting shaft provided by the embodiment of the present application;

[0045] Appendix Figure 15 Cross-sectional view of the connecting shaft in another embodiment of the embodiment of the present application.

[0046] Appendix Figure 16 Schematic diagram of the structure of the outer tube without exchange and the detailed diagram of its expansion section provided by the embodiment of the present application;

[0047] Appendix Figure 17 Schematic diagram of the open state of the expansion section with different numbers of through slots in the embodiment of the present application;

[0048] Appendix Figure 18 Schematic diagram of the state of the repair system with an outer tube without exchange entering the designated position of the heart through transseptal puncture in the embodiment of the present application;

[0049] Appendix Figure 19 Schematic diagram of the state of the outer tube without exchange being opened by the internal thrust in the embodiment of the present application;

[0050] Appendix Figure 20 Schematic diagram of the structure of the delivery tube assembly with a storage tube and the tissue fixation mechanism in the present embodiment of the present application;

[0051] Appendix Figure 21 Schematic diagram of the process of retracting the tissue fixation mechanism through the storage tube after it is opened in the embodiment of the present application.

[0052] Among them, the corresponding reference numerals are as follows: tissue fixation mechanism 100, conveying control mechanism 200, clamping assembly 1, closing member 11, closing connection section 111, closing clamping section 112, sliding groove 113, capturing member 12, capturing member connection section 121, positioning end 1211, capturing clamping section 122, moving seat 13, inner cavity of moving seat 131, positioning bottom surface 132, positioning groove 133, first mounting side surface 134, closing member connection portion 1341, second mounting side surface 135, capturing member connection portion 1351, fixing assembly 2, fixing seat 21, base connection end 211, clamping cooperation portion 212, transmission cavity 213, support end 214, closing driving member 215, central shaft 22, transmission end 221, shaft connection end 222, central cavity 223, second clamping structure 224, positioning section 225, positioning sleeve 23, conveying pipe assembly 3, conveying outer pipe 30, inner pipe assembly 31, bending pipe 32, receiving pipe 33, non-exchangeable outer pipe 34, outer pipe body 341, expansion section 342, guide hole 3421, through groove 3422, connecting bridge 3423, connecting bridge 3424, transmission shaft 4, clutch assembly 5, connecting shaft 51, boss section 511, channel 512, shaft body 513, transition section 514, limiting shoulder 515, limiting sleeve 516, first clamping structure 5131, connecting seat 52, connecting sleeve 520, conveying connection end 521, clutch connection end 522, connecting portion 523, fixing hole 524, connecting cavity 5211, communicating cavity 5221, limiting ring 525, limiting groove 526, clutch member 53, fixed end 531, connecting hole 5311, open gap 5312, clutch end 532, first half clamp 5321, second half clamp 5322, clamping portion 5323, operating wire 6, guiding member 7. Detailed implementation manners

[0053] The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts shall fall within the protection scope of the present invention.

[0054] In the description of the present invention, it should be understood that the orientation or positional relationships indicated by the terms "upper", "lower", "inner", "outer", "top", "bottom", "side", etc. are based on the orientation or positional relationships shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus should not be construed as a limitation to the present invention. The terms "first" and "second" are only used for descriptive purposes and cannot be construed as indicating or implying relative importance or implicitly specifying the quantity of the indicated technical features. Thus, the features defined with "first" and "second" may explicitly or implicitly include one or more of such features.

[0055] In addition, in the present invention, unless otherwise clearly specified and defined, terms such as "mounted", "connected", etc. should be understood in a broad sense. For example, it may be a fixed connection, a detachable connection, or an integral connection; it may be a mechanical connection or an electrical connection; it may be directly connected or indirectly connected through an intermediate medium, and it may be the communication inside two elements. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0056] It should be noted that in this embodiment, the "proximal end" described refers to the direction close to the operator; the "distal end" refers to the direction away from the operator.

[0057] Embodiment

[0058] See Figure 1-21 , this embodiment provides a valve repair system, which specifically includes a tissue fixation mechanism 100 and a delivery control mechanism 200. The tissue fixation mechanism 100 is loaded at the distal end of the delivery control mechanism 200 and is delivered to a designated position through the delivery control mechanism 200. In this embodiment, cardiac valve clamping is used as the implementation scenario, and the tissue fixation mechanism 100 is a valve clip for clamping cardiac valve leaflets.

[0059] One end of the central axis in this application is connected to the transmission shaft through a connecting shaft, and the other end is in screw drive connection with the moving seat. The rotation of the central axis can directly drive the moving seat to move along its axial direction. During the transmission process, the central axis rotates relative to the fixed seat without moving along the axial direction, improving the transmission efficiency and connection stability, and making the transmission process smoother. The delivery control mechanism 200 is relatively separated from the tissue fixation mechanism 100 through the clutch assembly 5. The connection stability between the clutch assembly 5 and the tissue fixation mechanism 100 is high, and it can undergo reversible deformation, so as to facilitate the loading of the tissue fixation mechanism multiple times during the operation, realize the reuse of the delivery control mechanism, and reduce the surgical cost. After the tissue fixation mechanism closes and releases the tissue during the operation, and when the guiding member is not withdrawn, the tissue fixation mechanism can also be retracted through the delivery control mechanism.

[0060] Specifically, the tissue fixation mechanism 100 includes a clamping assembly 1 for closing the valve tissue and a fixing assembly 2 for mounting the clamping assembly 1. The delivery control mechanism 200 is used to deliver the tissue fixation mechanism 100 to a specified position, control the clamping assembly 1 to complete the clamping action, and is detachably connected to the fixing assembly 2.

[0061] Specifically, as Figure 4 shown, the clamping assembly 1 includes a leaflet closing assembly and a moving seat 13 for mounting and driving the leaflet closing assembly. The leaflet closing assembly includes a pair of closing members 11 and a pair of capturing members 12 arranged corresponding to the closing members 11, and the closing members 11 and the capturing members 12 cooperate to clamp the tissue. The closing member 11 includes a closing connection section 111 and a closing clamping section 112, and the capturing member 12 includes a capturing member connection section 121 and a capturing clamping section 122. The capturing clamping section 122 and the closing clamping section 112 cooperate to clamp the tissue. The moving seat 13 is used to mount the closing member 11 and the capturing member 12. The moving seat 13 is in threaded transmission connection with the central shaft 22, and the moving seat 13 moves up and down relative to the central shaft 22 to realize the opening and closing of the closing member 11, and the opening and closing of the capturing member 12 is realized by controlling the control wire 6 in the delivery control mechanism. As Figure 5 shown, in this embodiment, the moving seat 13 is provided with a moving seat inner cavity 131, and the moving seat inner cavity 131 is provided with an internal thread. The moving seat 13 includes a first mounting side surface 134 and a second mounting side surface 135 that are perpendicular to each other. The first mounting side surface 134 is provided with a closing member connection portion 1341, and the first mounting side surface 134 is connected to the closing connection section 111 through the closing member connection portion 1341; the second mounting side surface 135 is provided with a capturing member connection portion 1351, and the second mounting side surface 135 is connected to the capturing member connection section 121 through the capturing member connection portion 1351. In some embodiments, the capturing member connection section 121 includes a positioning end 1211 formed by bending, and the moving seat 13 includes a positioning bottom surface 132. The positioning bottom surface 132 is provided with a positioning groove 133, and the positioning end 1211 is in fit connection with the positioning groove 133. The fit connection between the positioning end and the positioning groove improves the space utilization rate and increases the reliability of the connection between the capturing member connection section and the moving seat.

[0062] Specifically, the fixing assembly 2 includes a fixing seat 21 and a central shaft 22 disposed in the fixing seat 21. As Figure 6As shown, the fixed seat 21 includes a base connection end 211 for detachably connecting with the clutch assembly 5 and a bracket end 214. The base connection end 211 is for detachably connecting with the clutch member 53, and the bracket end 214 is for connecting with the closing member 11. A clamping and fitting portion 212 for connecting with the clutch assembly 5 is provided on the base connection end 211. A transmission cavity 213 for accommodating the central shaft 22 is provided inside the fixed seat 21. In some embodiments, a closing driving member 215 is provided on the bracket end 214. The closing driving member 215 is at least partially located in the non-linear sliding groove 113 of the closing connection section. When the moving seat 13 moves relative to the central shaft 22, the closing driving member 215 can slide relative to the sliding groove 113 to drive the two closing clamping sections 112 to move closer to or away from each other.

[0063] Specifically, as Figure 7 shown, the central shaft 22 includes a transmission end 221 and a shaft connection end 222. The transmission end 221 is in screw drive connection with the moving seat 13, and the shaft connection end 222 is for detachably connecting with the conveying control mechanism. The shaft connection end 222 is detachably connected with the connecting shaft 51. An external thread is provided on the transmission end 221. The external thread on the transmission end 221 is in mating connection with the internal thread in the inner cavity 131 of the moving seat. The lead angle of the internal thread and the external thread in cooperation is less than the friction angle. After the external thread on the transmission end 221 of this example is in cooperation with the internal thread of the moving seat 13, because the lead angle of the spiral groove is less than the friction angle between the contact surfaces of the two spiral grooves, the screw drive has self-locking property and can only convert rotation into axial movement. When the central shaft 22 stops rotating, if only an axial force is applied to the central shaft 22 or the moving seat 13, it will not displace either. Therefore, the moving seat 13 can stay at any position through the thread fit. In this embodiment, the rotation of the central shaft can directly drive the moving seat to move along its axis. During the transmission process, the central shaft rotates relative to the fixed seat without moving axially, improving the transmission efficiency and connection stability, and making the transmission process smoother. A central cavity 223 for passing through the guiding member 7 is provided inside the central shaft 22.

[0064] In some embodiments, the fixing assembly 2 further includes a positioning sleeve 23. The positioning sleeve 23 is sleeved outside the central shaft 22 and contacts the inner wall of the fixed seat 21 to position the connection between the central shaft and the fixed seat, ensuring the centering of the connection between the central shaft and the fixed seat. Specifically, a positioning section 225 for installing the positioning sleeve 23 is provided on the central shaft 22. The cross-sectional diameter of the positioning section 225 is smaller than the cross-sectional diameters of the transmission end and the shaft connection end, so that when the positioning sleeve 23 is sleeved on the positioning section 225, the two ends of the positioning sleeve 23 can be limited.

[0065] Specifically, the conveying control mechanism 200 includes a conveying pipe assembly 3 and a transmission shaft 4. The transmission shaft 4 is disposed within the conveying pipe assembly 3. The transmission shaft 4 is used to rotate to provide driving force for the tissue fixation mechanism and control the separation of the clutch assembly 5 from the tissue fixation mechanism. In this embodiment, the transmission shaft 4 is a rod-shaped body with an inner cavity or a hollow tubular body. The transmission shaft 4 is connected to the connecting shaft 51 of the clutch assembly 5. The rotation of the transmission shaft 4 drives the rotation of the connecting shaft 51. Axially pulling the connecting shaft 51 can separate the connecting shaft 51 from the central shaft 22.

[0066] The conveying control mechanism 200 further includes a clutch assembly 5. The clutch assembly 5 is disposed between the conveying pipe assembly 3 and the tissue fixation mechanism. The clutch assembly 5 is detachably connected to the tissue fixation mechanism. The clutch assembly 5 includes a connecting shaft 51, a connecting seat 52, and a clutch member 53. The connecting shaft 51 passes through the connecting seat 52 and the clutch member 53. The clutch member 53 is detachably connected to the fixed seat 51. The clutch member 53 includes a fixed end 531 connected to the connecting seat 52 and a clutch end 532 detachably connected to the base connecting end 211. When the conveying control mechanism drives the transmission shaft 4 and the connecting shaft 51 to move proximally, the clutch end 532 opens and separates from the base connecting end 211, causing the connecting shaft 51 to separate from the central shaft 22. In this embodiment, when the clutch member 53 separates from the base connecting end 211, only by axially pulling the connecting shaft 51 proximally, the clutch end 532 of the clutch member 53 sleeved on the outside thereof opens and separates from the base connecting end 211, and the connecting shaft 51 separates from the central shaft 22. During the separation process, the base connecting end remains stationary, the separation process has high stability, the separation step is simple and fast, the clutch member can undergo reversible deformation, which is convenient for reloading the tissue fixation mechanism and realizing the reuse of the conveying control mechanism.

[0067] Specifically, the connecting seat 52 is used to connect the conveying pipe assembly 3 and the clutch member 53. As Figure 8 shown, the connecting seat 52 includes a conveying connection end 521 and a clutch connection end 522. The conveying connection end 521 is used to connect to the distal end of the conveying pipe assembly 3. The clutch connection end 522 includes a connecting portion 523 protruding axially distally. The clutch connection end 522 is connected to the fixed end 531 of the clutch member 53 through the connecting portion 523. The conveying connection end 521 is provided with a connection cavity 5211 that fits over the distal end of the conveying pipe assembly 3 so that the connecting seat 52 is connected to the distal end of the conveying pipe assembly 3. The clutch connection end 522 is provided with a communication cavity 5221 that has a clearance fit with the connecting shaft 51. The inner diameter of the connection cavity 5211 is larger than the inner diameter of the communication cavity 5221. In some embodiments, a connecting sleeve 520 is further provided within the connecting seat 52. The connecting sleeve 520 is sleeved between the connection cavity 5211 and the communication cavity 5221. The proximal end of the connecting sleeve 520 abuts against the distal end of the conveying pipe assembly 3, and the inner wall of the connecting sleeve 520 has a clearance fit with the connecting shaft 51.

[0068] In some embodiments, the connecting portion 523 may be two connecting lugs symmetrically arranged on the clutch connecting end 522. A fixing hole 524 is provided on the connecting portion 523, and the connecting portion 523 is connected to the fixed end 531 of the clutch member 53 through the fixing hole 524. In this embodiment, the connecting seat 52 is used to connect the conveying pipe assembly 3 and the clutch member 53, and a channel for the movement of the connecting shaft 51 is provided inside the connecting seat 52. Further, a limiting ring 525 is provided on the connecting seat 52, and a limiting groove 526 is provided on the limiting ring 525. The limiting groove 526 is used to accommodate the control wire 6 and limit the control wire 6.

[0069] Specifically, the clutch member 53 is connected to the connecting seat 52 and sleeved outside the connecting shaft 51. As Figure 9 shown, the clutch member 53 includes a fixed end 531 and a separable clutch end 532. In this embodiment, the fixed end 531 of the clutch member 53 is connected to the connecting portion 523, and the clutch end 532 is separably connected to the base connecting end 211. A connecting hole 5311 corresponding to the fixing hole 524 is provided on the fixed end 531 for connecting to the connecting seat 52. In some embodiments, one side of the connecting hole 5311 facing the clutch end 532 may be open to facilitate the opening of the clutch end 532 along the open gap. Specifically, when the clutch member 53 is completely closed, the inner wall of the clutch end 532 is in clearance fit with the outer wall of the base connecting end 211, the inner wall of the fixed end 531 is in clearance fit with the connecting shaft 51, the inner diameter of the clutch end 532 is larger than the inner diameter of the fixed end 531, and both ends of the clutch member 53 are connected to the connecting seat 52 and the fixed seat 21 respectively.

[0070] In some embodiments, the clutch end 532 includes a first half clip 5321 and a second half clip 5322 connected to each other. The first half clip 5321 and the second half clip 5322 are configured to be able to open or close relative to each other. An open gap 5312 is provided on one side of the connecting hole 5311 facing the clutch end 532 to enable the first half clip 5321 and the second half clip 5322 to open along the open gap 5312. Clamping portions 5323 are provided on both the first half clip 5321 and the second half clip 5322, and a clamping and mating portion 212 corresponding to the clamping portion 5323 is provided on the base connecting end 211; the clamping portion 5323 is in mating connection with the clamping and mating portion 212 to axially and circumferentially limit the fixed seat 21. When the conveying control mechanism moves proximally, the clamping portion 5323 is disengaged from the clamping and mating portion 212, so that the clutch member 53 is relatively separated from the base connecting end 211, Figure 13 which is a schematic diagram of the process of the clutch member 53 and the base connecting end 211 from connection to separation.

[0071] In some embodiments, the clutch member 53 can be made of an elastic material. The fixed end 531 and the clutch end 532 are integrally formed. The first half clip 5321 and the second half clip 5322 are elastically connected at the fixed end and can open or close relative to each other without irreversible deformation, so that the clutch member 53 can be reused, realizing the reuse of the conveying control mechanism. It should be noted that the natural state of the clutch end 532 of the clutch member 53 without external force is an open state. At this time, the inner hole of the fixed end 531 is approximately oval; when the fixed end 531 is squeezed into a circular shape by the boss section 511 of the connecting shaft 51, the clutch end 532 of the fixed end 531 closes and the opening is restricted. Specifically, in practical applications, after the previous set of tissue fixation mechanism is released, the conveying control mechanism is withdrawn. After aligning a new tissue fixation mechanism on the clutch member 53, the transmission shaft 4 is pushed distally, and the boss section 511 of the connecting shaft 51 squeezes the port of the fixed end 531, so that the clutch end 532 closes and connects to the fixed seat 21 to fix the new tissue fixation mechanism.

[0072] In other embodiments, as Figure 10 shown, a first hinge structure is provided on the first half clip 5321, and a second hinge structure is provided on the second half clip 5322. The first hinge structure and the second hinge structure are cooperatively connected so that the first half clip 5321 and the second half clip 5322 can open and close relative to each other. Exemplarily, the first hinge structure and the second hinge structure can be a mutually hinged ring structure and a circular structure, so that the first half clip 5321 and the second half clip 5322 do not deform during the process of opening and closing relative to each other, and the clutch member 53 can be reused, realizing the reuse of the conveying control mechanism. Figure 11-12 FIG. is a schematic structural diagram of the cooperation between the clutch member 53 and the connecting shaft 51 in the closed state and the open state.

[0073] The connecting shaft 51 is used to connect the transmission shaft 4 and the central shaft 22. As Figure 14 shown, a channel 512 is provided in the connecting shaft 51, which runs through and communicates with the inner cavity of the transmission shaft 4 and the central cavity 223. One end of the connecting shaft 51 connected to the central shaft 22 is provided with a first clamping structure 5131, and a second clamping structure 224 is provided on the central shaft 22. When the first clamping structure 5131 and the second clamping structure 224 are clamped, the relative rotation between the connecting shaft 51 and the central shaft 22 can be restricted. The connecting shaft 51 is arranged to be movable relative to the clutch member 53 between a first position and a second position. When the connecting shaft 51 moves proximally from the first position, the clutch member 53 is separated from the fixed seat 21, and the first clamping structure 5131 and the second clamping structure 224 are separated.

[0074] Specifically, the connecting shaft 51 includes a boss section 511 and a shaft body 513. The cross-sectional diameter of the boss section 511 is larger than that of the shaft body 513. The outer wall of the boss section 511 is in clearance fit with the inner wall of the fixed end 531 when the clutch clip 53 is in the closed state. The end of the shaft body 513 is axially separably connected to the central shaft 22. When the clutch member 53 is opened, the minimum inner diameter of the fixed end 531 is smaller than the cross-sectional diameter of the boss section 511; when the clutch member 53 is fully closed, the inner diameter of the fixed end 531 is equal to the cross-sectional diameter of the boss section 511, and the inner wall of the fixed end 531 is in clearance fit with the outer wall of the boss section 511. In this embodiment, a first clamping structure 5131 is provided at the end of the shaft body 513, and a second clamping structure 224 is provided at the shaft connection end 222 of the central shaft 22. When the connecting shaft 51 is in the first position, the first clamping structure is clamped with the second clamping structure, the clutch member 53 is connected to the fixed seat 21, and the connecting seat 52 and the clutch member 53 are sleeved outside the boss section 511; when the connecting shaft 51 is controlled to move proximally from the first position, the boss section 511 no longer presses the fixed end 531, and the clutch member 53 returns to its elastic initial free state. At this time, the inner hole of the fixed end 531 is approximately elliptical, the clutch end 532 opens, and the first clamping structure is separated from the second clamping structure. In this embodiment, the axial separable and circumferential anti-relative rotation transmission connection mode between the connecting shaft and the central shaft improves the connection reliability, transmission stability and transmission efficiency.

[0075] In some embodiments, a transition section 514 is provided between the boss section 511 and the shaft body 513. The transition section 514 is a tapered inclined surface connecting the boss section 511 and the shaft body 513. The setting of the transition section 514 plays a guiding role when the connecting shaft 51 moves distally and the boss section 511 presses the fixed end 531 of the clutch member 53, so that the clutch end 532 can be smoothly closed. Specifically, it enables the boss section 511 to smoothly enter the fixed end 531 with an approximately elliptical inner hole downward.

[0076] In some embodiments, such as Figure 14 and 15 shown, the boss section 511 can be provided as a split sleeve sleeved on the shaft body 513. When the boss section 511 is provided as a split sleeve sleeved on the shaft body 513, the shaft body 513 can rotate freely relative to the boss section 511, which is convenient for processing, disassembly and assembly. Limiting structures for axially limiting the boss section 511 are provided at both ends of the boss section 511. Exemplarily, a protruding limiting shoulder 515 is provided at one end of the boss section 511, and a limiting sleeve 516 is provided at the other end. In some other embodiments, the boss section 511 can also be integrally formed with the shaft body 513. The connecting shaft 51 in this embodiment is used for power transmission between the conveying control mechanism and the tissue fixing mechanism. The rotation of the connecting shaft 51 drives the rotation of the central shaft 22, and the connecting shaft 51 is axially separably connected to the central shaft 22, that is, it can provide a driving force for the tissue fixing mechanism and can also control the separation between the clutch assembly 5 and the tissue fixing mechanism 100.

[0077] Further, a channel 512 penetrating and communicating the transmission shaft 4 and the central shaft 22 is provided in the connecting shaft 51. Specifically, the channel 512 communicates with the inner cavity of the transmission shaft 4 and the central cavity 223 of the central shaft 22. In this embodiment, the inner cavity of the transmission shaft 4, the channel 512, and the central cavity 223 of the central shaft 22 are communicated to pass through the guiding member 7, and the conveying control mechanism can convey and retract the tissue fixation mechanism along the conveying path established by the guiding member.

[0078] Specifically, the valve repair system further includes a guiding member 7. In some embodiments, the guiding member 7 may be a guide wire. The valve repair system first establishes a conveying path through the guiding member 7 and the outer conveying tube. The conveying control mechanism 200 conveys the tissue fixation mechanism 100 along the established conveying path through the guiding member 7. Without withdrawing the guiding member, the tissue fixation mechanism 100 can be loaded and conveyed multiple times, and the tissue fixation mechanism 100 can also be retracted through the conveying control mechanism 200.

[0079] It should be noted that when the tissue fixation mechanism is in the heart and has completely and effectively fixed the valve leaflets, before releasing the tissue fixation mechanism, the guiding member can be first passed through the tissue fixation mechanism and the conveying control mechanism along the conveying path, and then the operator can perform a normal release operation. If, after the tissue fixation mechanism is released, it is evaluated that the state of the tissue fixation mechanism is stable and no dangerous situations such as unilateral detachment of the tissue fixation mechanism from the valve leaflet or large mobility occur, and the treatment effect reaches the predetermined goal, the guiding member can be successfully withdrawn to complete the operation; if the above-mentioned unexpected situations occur, or the treatment effect does not reach the predetermined goal, the conveying control mechanism can be controlled to find the tissue fixation mechanism along the guiding member, and the release action of the tissue fixation mechanism can be reversed, so that the tissue fixation mechanism can be retracted again, and the valve leaflets can be recaptured and fixed according to requirements until the repair is completed.

[0080] The retraction process of the tissue fixation mechanism in this embodiment: Control the conveying tube assembly 3 and the transmission shaft 4 to synchronously push distally along the guiding member 7. Under the observation of X-ray imaging or ultrasonic imaging, it is judged that the opened clutch member 53 has contacted the base connection end 211 of the fixed seat 21; keep the conveying tube assembly 3 stationary, and synchronously push the transmission shaft 4 distally, thereby pushing the connecting shaft 51. The boss section 511 of the connecting shaft 51 presses the fixed end 531 of the clutch member 53, so that the clutch end 532 closes, the clutch member 53 is connected to the fixed seat 21, and at the same time the connecting shaft 51 is also reconnected to the central shaft 22.

[0081] Specifically, the delivery tube assembly 3 includes an inner tube assembly 31, a bending adjustment tube 32, and a delivery outer tube 30 that are sleeved from the inside to the outside in sequence. The inner tube assembly 31 is used for threading a drive shaft 4 and a control wire 6. The drive shaft 4 and the control wire 6 can be controlled by an inner tube control handle provided at its proximal end to realize the opening, clamping, and separating actions of the tissue fixation mechanism 100. The distal end of the inner tube assembly is connected to the tissue fixation mechanism 100 through a connection seat 52. The cooperation of the delivery outer tube and the bending adjustment tube can achieve three-dimensional bending adjustment, which is convenient for controlling the delivery path in a complex curved cardiovascular channel, with simple operation, high flexibility, and reduced damage during the operation.

[0082] In some embodiments, the delivery outer tube 30 is provided as a non-exchangeable outer tube 34, and the non-exchangeable outer tube 34 covers the outer wall of the bending adjustment tube 32. The bending adjustment tube 32 is provided to include a first bending adjustment section and a second bending adjustment section, and the second bending adjustment section can be bent in three-dimensional space. The non-exchangeable outer tube 34 includes an expansion section 342. At least two breakable structures are provided along the circumferential direction of the expansion section 342. The breakable structures extend along the axial direction of the expansion section 342 and are configured to be breakable when subjected to an internal thrust force. As Figure 16 shown, in this embodiment, the non-exchangeable outer tube 34 includes an outer tube body 341 and an expansion section 342. At least two breakable structures are provided along the circumferential direction of the expansion section 342. The breakable structures can be through slots 3422 extending along the axial direction of the expansion section. At least two through slots 3422 are uniformly arranged along the axial direction of the expansion section 342. At least two through slots 3422 extend along the axial direction of the expansion section 342, and at least one connection bridge 3423 is provided in each through slot 3422. In some embodiments, by setting the connection bridge 3423 to a waist-shaped structure, the thickness of the middle part of the connection bridge 3423 is made thinner than other parts. Thus, under the expansion of external force, the middle part of the connection bridge 3423 is more likely to break, thereby tearing the expansion section 342 and enabling the tissue fixation mechanism 100 to break through the expansion section 342 more smoothly.

[0083] In other embodiments, the breakable structure includes a separable fracture and a tearable structure connecting the separable fracture. The tearable structure can be a suture, an adhesive structure, or a clamping structure. The connection strength of the tearable structure is less than the tensile strength of the expansion section 342 itself. Thus, under the drive of the delivery control mechanism, the tissue fixation mechanism can break the tearable structure and then smoothly break free from the expansion section through the separable fracture.

[0084] Furthermore, a guide hole 3421 is provided at the end of the expansion section 342.

[0085] A guide hole 3421 for the guide member 7 to pass through is connected to the extension end of the central cavity for the guide member 7 to be inserted. A connecting bridge 3424 is provided between the guide hole 3421 and the through groove 3422. When the expansion section 342 is subjected to internal thrust, the connecting bridge 3423 and the connecting bridge 3424 are broken. The connecting bridge 3424 can be an arc-shaped connecting section constituting the guide hole 3421. In some embodiments, the expansion section 342 is a tapered section whose cross-sectional diameter gradually decreases from the proximal end to the guide hole 3421, so that the expansion section has a guiding function and can be transported more smoothly along the blood vessel to reduce tissue damage. The connecting bridge 3423 and the connecting bridge 3424 are configured so that when the valve repair system is transported in the blood vessel channel, they will not open due to friction and resistance from the blood vessel, and can be broken when the internal thrust from the direction of the tissue fixing mechanism is greater than a preset thrust value. The preset thrust value is a thrust value that can cause the connecting bridge 3423 and the connecting bridge 3424 to tear.

[0086] Figure 17 Schematic diagram of the expansion section with different numbers of through slots, in some embodiments, the expansion section 342 is evenly provided with two through slots 3422 along its circumference, and when the expansion section is subjected to internal thrust, and the thrust is greater than the preset thrust value, the expansion section 342 can be separated into two parts along the through slots 3422. In other embodiments, the expansion section 342 can also be evenly provided with three through slots 3422 along its circumference, and when the expansion section 342 is subjected to internal thrust, and the internal thrust is greater than the preset thrust value, the expansion section 342 can be separated into three parts along the through slots 3422. By the exchange-free outer tube 34 integrally covering the inner tube assembly 31, the bending tube 32 and the tissue fixing mechanism, it is not necessary to establish a delivery path in advance through the dilator, and the delivery control mechanism 200 directly cooperates with the guide 7 to deliver the tissue fixing mechanism 100 to the designated position of the heart through the atrial septal puncture, avoiding the exchange of the dilator and the delivery control mechanism, simplifying the operation, reducing the operation time, and reducing the overall outer diameter of the system, which is conducive to reducing tissue damage. Figure 18 A rotation diagram of a repair system with a non-exchangeable outer tube entering a designated position of the heart through atrial septal puncture; Figure 19 To avoid exchange, the outer tube is opened by the internal thrust and the state diagram of the tissue fixing mechanism is exposed.

[0087] In some embodiments, the delivery tube assembly 3 of this embodiment further includes a receiving tube 33, the distal end of which is provided with a receiving end 331, the receiving end 331 being configured as an inverted cone, and the receiving tube 33 being disposed between the inner tube assembly 31 and the bending tube 32 of the delivery tube assembly 3. The receiving tube 33 is used to accommodate the tissue fixing mechanism 100 when the tissue fixing mechanism 100 is withdrawn from the heart, so as to prevent the capture member and / or the closing member from being hooked and entangled with the valve and the tendon cord, thereby damaging the tissue. The receiving end 331 being configured as an inverted cone in the shape of a trumpet can also provide a guide for the withdrawal of the tissue fixing mechanism 100 and reduce ultrasonic artifacts. Figure 20Schematic diagram of the delivery tube assembly with a storage tube and the tissue fixation mechanism for this embodiment; Figure 21 Schematic diagram of the process of retracting the tissue fixation mechanism through the storage tube after the tissue fixation mechanism is opened.

[0088] In some embodiments, preferably, the inner diameter of the opening of the receiving end 331 is larger than the inner diameter of the bending adjustment tube 32, so that the tissue fixation mechanism can enter the storage tube more smoothly. In some embodiments, a storage tube control handle is provided at the distal end of the storage tube 33 to independently control the movement of the storage tube. In other embodiments, a storage tube control member can also be provided on the inner tube control handle or the middle tube control handle to control the movement of the storage tube.

[0089] One end of the central axis of this application is connected to the transmission shaft through a connecting shaft, and the other end is in screw drive connection with the moving seat. The rotation of the central axis can directly drive the moving seat to move along its axial direction. During the transmission process, the central axis rotates relative to the fixed seat without moving along the axial direction, improving the transmission efficiency and connection stability, and making the transmission process smoother.

[0090] The clutch of this application is set to be separable from the fixed seat and can undergo reversible deformation. The inner cavity, central cavity, and channel of the transmission shaft are connected, so that when the guiding member disposed therein is not withdrawn, the delivery control mechanism can load the tissue fixation mechanism multiple times for delivery and can also retract the tissue fixation mechanism, reducing the surgical cost.

[0091] The delivery tube assembly of this application includes a storage tube with an inverted conical receiving end. When the storage tube is used to retract the tissue fixation mechanism from the heart, it can accommodate the tissue fixation mechanism to avoid damage to tissues by the capture member and / or the closing member.

[0092] This application is provided with a non-exchange outer tube. By integrally covering the delivery tube assembly and the tissue fixation mechanism with the non-exchange outer tube, it is not necessary to establish a delivery path in advance. The delivery control mechanism directly cooperates with the guiding member to deliver the tissue fixation mechanism to the designated position, avoiding exchange, simplifying the surgery, reducing the surgical time, and at the same time reducing the overall outer diameter of the system, which is beneficial to reducing tissue damage.

[0093] Without conflict, the above-mentioned embodiments and the features in the embodiments in this article can be combined with each other.

[0094] The above-disclosed is only a preferred exemplary embodiment of the present invention. Of course, it cannot be used to limit the scope of rights of the present invention. Therefore, equivalent changes made according to the claims of the present invention still fall within the scope covered by the present invention.

Claims

1. A valve repair system, characterized in that, Comprising: A tissue fixation mechanism, including a clamping assembly (1) and a fixation assembly (2), the clamping assembly (1) includes a leaflet closing assembly and a moving seat (13) for mounting and driving the leaflet closing assembly; The fixation assembly (2) includes a fixed seat (21) and a central shaft (22) disposed within the fixed seat (21), the central shaft (22) includes a transmission end (221) and a shaft connection end (222), the transmission end (221) is in screw drive connection with the moving seat (13), the shaft connection end (222) is detachably connected to the delivery control mechanism, and a central cavity is provided within the central shaft (22); The delivery control mechanism includes a delivery tube assembly (3), a transmission shaft (4) and a clutch mechanism (5), the clutch mechanism (5) includes a clutch member (53) and a connecting shaft (51) passing through the clutch member (53), the clutch member (53) is detachably connected to the fixed seat (51); the connecting shaft (51) is used to connect the transmission shaft (4) and the central shaft (22), and a channel (512) is provided within the connecting shaft (51) that penetrates and communicates the inner cavity of the transmission shaft (4) and the central cavity (223).

2. The valve repair system according to claim 1, wherein, One end of the connecting shaft (51) connected to the central shaft (22) is provided with a first clamping structure (5131), and a second clamping structure (224) is provided on the central shaft (22), and when the first clamping structure (5131) is clamped with the second clamping structure (224), the relative rotation between the connecting shaft (51) and the central shaft (22) can be restricted.

3. The valve repair system according to claim 2, wherein The connecting shaft (51) is arranged to be movable relative to the clutch member (53) between a first position and a second position. When the connecting shaft (51) moves proximally from the first position, the clutch member (53) is separated from the fixed seat (21), and the first clamping structure (5131) is separated from the second clamping structure (224).

4. The valve repair system according to claim 1, wherein The moving seat (13) has a moving seat inner cavity (131), and the wall of the moving seat inner cavity (131) is provided with internal threads, and the internal threads cooperate with the external threads provided on the transmission end (221) for transmission.

5. The valve repair system according to claim 4, wherein The thread lead angle of the cooperation between the internal threads and the external threads of the transmission end (221) is less than the friction angle.

6. The valve repair system according to claim 1, wherein The leaflet closing assembly includes a pair of closing members (11) and a pair of capturing members (12) correspondingly arranged with the closing members (11), and the closing members (11) and the capturing members (12) cooperate to clamp the tissue.

7. The valve repair system according to claim 6, wherein, The capturing member connecting section (121) includes a bent positioning end (1211), the moving seat (13) includes a positioning bottom surface (132), and a positioning groove (133) is provided on the positioning bottom surface (132), and the positioning end (1211) is in mating connection with the positioning groove (133).

8. The valve repair system according to claim 1, characterized in that The fixation assembly (2) includes a positioning sleeve (23), the positioning sleeve (23) is sleeved outside the central shaft (22) and contacts the inner wall of the fixed seat (21).

9. The valve repair system according to claim 1, wherein, The delivery tube assembly (3) includes a receiving tube (33). A receiving end (331) is provided at the distal end of the receiving tube (33), and the receiving end (331) is configured as an inverted cone. The receiving tube (33) is disposed between the inner tube assembly (31) and the bending adjustment tube (32) of the delivery tube assembly (3).

10. The valve repair system according to claim 1, characterized in that, The delivery tube assembly (3) includes a non-exchangeable outer tube (34), and the non-exchangeable outer tube (34) covers the outer wall of the bending adjustment tube (32) of the delivery tube assembly (3). The non-exchangeable outer tube (34) includes an expansion section (342). At least two breakable structures are provided along the circumferential direction of the expansion section (342). The breakable structures extend axially along the expansion section (342), and the breakable structures are configured to be breakable when subjected to an internal thrust force.

11. The valve repair system according to claim 10, wherein, A guide hole (3421) is provided at the end of the expansion section (342), and the guide hole (3421) communicates with the extension end of the central cavity (223).

12. The valve repair system according to claim 1, wherein It includes a guide member (7), and the guide member (7) is inserted into the inner cavity of the transmission shaft (4), the channel (512), and the central cavity (233).

13. The valve repair system according to claim 1, wherein The clutch member (53) includes a fixed end (531) and a clutch end (532). The clutch end (532) includes a first half clip (5321) and a second half clip (5322) connected to each other. Clamping portions (5323) are provided on both the first half clip (5321) and the second half clip (5322), and a clamping cooperation portion (212) corresponding to the clamping portion (5323) is provided on the fixed seat (21). The clamping portion (5323) is connected in cooperation with the clamping cooperation portion (212) to axially and circumferentially limit the fixed seat (21).

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