Valve repair system

Abstract

The invention relates to medical instruments, in particular to a valve repair system which comprises a valve repair mechanism, a valve repair mechanism and a valve repair mechanism. The exchange-free outer tube is provided with an inner cavity capable of at least partially accommodating the valve repair mechanism; an expansion part is arranged at the far end of the exchange-free outer tube; the expansion part is arranged at the far end of the exchange-free outer pipe, the conveying device can drive the clamping device to break through the expansion part of the exchange-free outer pipe, and then the clamping device is driven to extend to the outside of the expansion part, the expansion part is arranged at the far end of the exchange-free outer pipe, and then the expansion part of the exchange-free outer pipe can penetrate through the atrial septum under driving of the conveying device; conveying the clamping device into the target atrium; and the conveying device drives the clamping device to break through the expansion part of the exchange-free outer tube, and the clamping device is clamped and released at the position of the valve to be repaired, so that the surgical operation process is simplified, the operation risk in the surgical process is reduced, the surgical operation time is saved, and the surgical operation efficiency is improved.

Description

Technical Field

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

[0002] Valvular heart disease is characterized by damage or defect in one of the four heart valves (mitral valve, aortic valve, tricuspid valve or pulmonary valve). The mitral valve and tricuspid valve control the flow of blood between the atria and ventricles (the upper and lower chambers of the heart). The pulmonary valve controls the blood flow from the heart to the lungs, while the aortic valve controls the blood flow between the heart and the aorta and thus to the blood vessels in the rest of the body. The mitral valve and aortic valve are most often affected by valvular heart disease.

[0003] The mitral valve or tricuspid valve is often treated by valve clamping. In the prior art, during the process of delivering the valve clamping device to the heart, it is necessary to cooperate with an outer tube and a dilator to pass the outer tube carrying the dilator through the inferior vena cava and then through the interatrial septum, thereby establishing a passage from the outside to the left atrium; after the passage is established, the dilator needs to be withdrawn along the outer tube, leaving only the outer tube as the delivery passage of the valve clamping device, and then the valve clamping device is delivered to the heart through the delivery passage; this process requires repeated instrument exchange, increasing the complexity of the operation, prolonging the operation time, and increasing the risk degree of the operation.

[0004] Therefore, there is an urgent need to provide an improved valve repair system to solve the above technical problems. Summary of the Invention

[0005] In order to solve the above technical problems, the present invention provides a valve repair system, including a control handle, and the control handle includes:

[0006] A valve repair mechanism, including a clamping device and a delivery device;

[0007] An exchange-free outer tube, having an inner cavity capable of at least partially accommodating the valve repair mechanism, and the clamping device is accommodated in the inner cavity;

[0008] The distal end of the exchange-free outer tube is provided with a dilation portion; the delivery device can drive the clamping device to break through the dilation portion of the exchange-free outer tube, and then drive the clamping device to extend to the outside of the dilation portion.

[0009] Further preferably, the dilation portion has a guide hole; the valve repair mechanism has a through cavity (13); the extending end of the through cavity can communicate with the guide hole.

[0010] Further preferably, the guide hole can allow a guide wire to pass through;

[0011] The valve repair mechanism has a through cavity, and the guide wire can extend into the through cavity and then extend into or out of the guide hole.

[0012] Further preferably, the expansion part includes a conical structure.

[0013] Further preferably, at least two breakable structures are provided on the expansion part, and the at least two breakable structures are arranged at intervals along the circumferential direction of the expansion part; the breakable structure includes at least two adjacent expansion grooves and connection bridges located between the adjacent two expansion grooves.

[0014] Further preferably, the connection bridge is a waist-shaped structure.

[0015] Further preferably, a guiding structure is provided on the side of the breakable structure facing the distal end, and the guiding structure includes a connected first guiding surface and a second guiding surface, and a connection tip is formed at the connection of the first guiding surface and the second guiding surface, and the connection tip is arranged on the side facing the distal end.

[0016] Further preferably, a buffer transition structure is provided on the side of the breakable structure facing the proximal end.

[0017] Further preferably, the buffer transition structure is an arc-shaped structure.

[0018] Further preferably, the non-exchangeable outer tube is a biocompatible polymer material.

[0019] Further preferably, the wall thickness of the expansion part is 0.2 mm - 0.3 mm.

[0020] Further preferably, the width of the breakable structure is 0.1 mm - 0.3 mm.

[0021] Further preferably, the length of the breakable structure is 8 mm - 15 mm.

[0022] Further preferably, the aperture of the guide hole is 0.9 mm - 1 mm.

[0023] Further preferably, the delivery device includes a transmission inner tube, and a control line is arranged on the transmission inner tube, and the control line is used to control the capture member of the clamping device to perform tissue capture.

[0024] Further preferably, the delivery device further includes an adjustable bending tube;

[0025] The adjustable bending tube can accommodate the transmission inner tube; the adjustable bending tube is provided with a first bending adjustment member and a second bending adjustment member at intervals; the first bending adjustment member is used to control at least part of the adjustable bending tube to bend along a first direction, and the second bending adjustment member is used to control at least part of the adjustable bending tube to bend along a second direction.

[0026] Further, the first direction and the second direction are non-coplanar.

[0027] Further preferably, the conveying device further includes a transmission shaft, and the transmission inner tube can accommodate the transmission shaft; the transmission shaft is in driving connection with the clamping device, and the transmission shaft can rotate relative to the transmission inner tube to control the opening and closing of the clamping members of the clamping device.

[0028] As described above, the present invention has the following beneficial effects:

[0029] During the valve repair process, in the present application, by providing the expansion part 21 at the distal end of the exchange-free outer tube 2, and then driven by the conveying device 12, the expansion part 21 of the exchange-free outer tube 2 can pass through the atrial septum to convey the clamping device 11 into the target atrium; then, the conveying device 12 drives the clamping device 11 to break through the expansion part 21 of the exchange-free outer tube 2, and the clamping device 11 is clamped and released at the valve to be repaired, thus simplifying the surgical operation process, reducing the operation risk during the surgery, saving the surgical operation time, improving the surgical operation efficiency. At the same time, in the present application, the first bending adjustment member and the second bending adjustment member provided on the adjustable bending tube 122 are used to realize the three-dimensional bending adjustment of the adjustable bending tube 122, so that the transmission inner tube 121 can smoothly reach the designated position of the heart, thereby improving the operation flexibility of the adjustable bending tube 122, reducing the operation difficulty of controlling the path during the cardiovascular surgery with complex bending, and further improving the success rate of the surgery. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] In order to more clearly illustrate the technical solutions of the present invention, the drawings required for the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings in the following description are only some embodiments of the present invention, and those of ordinary skill in the art can also obtain other drawings based on these drawings without creative efforts.

[0031] Attached Figure 1 is a schematic diagram of the overall structure of the valve repair system provided by the present application;

[0032] Attached Figure 2 is a schematic diagram of the overall structure of the valve repair mechanism provided by the present application;

[0033] Attached Figure 3 is a schematic diagram of the overall structure of the exchange-free outer tube provided by the present application;

[0034] Attached Figure 4 is Figure 3 a partial enlarged view of A in

[0035] Attached Figure 5Schematic diagram of a structure in which the expansion part is torn into four petals provided by this application;

[0036] Appendix Figure 6 Schematic diagram of the state where the valve repair system is transmitted to the atrial septum position during a heart valve operation provided by this application;

[0037] Appendix Figure 7 Schematic diagram of the state where the valve repair system penetrates through the atrial septum during a heart valve operation provided by this application;

[0038] Appendix Figure 8 Schematic diagram of the state where the clamping device breaks through the expansion part of the non-exchange outer tube during a heart valve operation provided by this application;

[0039] Appendix Figure 9 Schematic diagram of the state where the clamping device is opened during a heart valve operation provided by this application;

[0040] Appendix Figure 10 Schematic diagram of the overall structure of a valve repair mechanism provided by this application;

[0041] Appendix Figure 11 Schematic diagram of the three-dimensional bending adjustment state of the adjustable bent tube provided by this application.

[0042] Among them, the reference numerals are as follows:

[0043] 1 - Valve repair mechanism, 2 - Non-exchange outer tube, 10 - Guide wire, 11 - Clamping device, 12 - Delivery device, 13 - Through cavity, 21 - Expansion part, 100 - Heart tissue, 111 - Capture part, 112 - Clamping part, 1211 - Control line, 211 - Destructible structure, 212 - Guide hole, 2114 - Expansion groove, 2113 - Connection bridge, 2111 - Guide structure, 2112 - Buffer transition structure, 121 - Transmission inner tube, 122 - Adjustable bent tube, 123 - Transmission shaft. Detailed implementation manners

[0044] Next, the technical solutions in the embodiments of the present invention will be clearly and completely described in conjunction with 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 belong to the scope of protection of the present invention.

[0045] It should be noted that in this embodiment, the "proximal end" refers to the direction close to the operator; the "distal end" refers to the direction away from the operator.

[0046] See Figures 1 - 11The present embodiment provides a valve repair system, comprising: a valve repair mechanism 1 and an exchange-free outer tube 2; the valve repair mechanism 1 comprises a clamping device 11 and a conveying device 12 which can be connected in transmission; the exchange-free outer tube 2 has an inner cavity which can at least partially accommodate the valve repair mechanism 1, and the clamping device 11 is accommodated in the inner cavity; an expansion portion 21 is provided at the distal end of the exchange-free outer tube 2; the conveying device 12 can drive the clamping device 11 to break through the expansion portion 21 of the exchange-free outer tube 2, and then drive the clamping device 11 to extend to the outside of the expansion portion 21.

[0047] In this way, during the valve repair process, the present application sets an expansion portion 21 on the distal end of the non-exchange outer tube 2, and then under the drive of the conveying device 12, the expansion portion 21 of the non-exchange outer tube 2 can pass through the atrial septum and convey the clamping device 11 to the target atrium; and then the conveying device 12 drives the clamping device 11 to break through the expansion portion 21 of the non-exchange outer tube 2, clamps the clamping device 11 and releases it at the valve to be repaired, thereby simplifying the surgical operation process, reducing the operational risks during the operation, saving surgical operation time, and improving surgical operation efficiency.

[0048] In the embodiment of the present application, the expansion portion 21 has a guide hole 212 ; the valve repair mechanism 1 has a through cavity 13 ; and the extending end of the through cavity 13 can be in communication with the guide hole 212 .

[0049] Furthermore, the guide hole 212 can allow the guide wire 10 to pass through; the valve repair mechanism 1 has a through cavity 13, and the guide wire 10 can extend into or out of the through cavity 13 through the guide hole 212.

[0050] Specifically, the conveying device 12 in the valve repair mechanism 1 has a first through cavity, and the clamping device 11 has a second through cavity. When the conveying device 12 is connected to the clamping device 11 , the first through cavity is connected to the second through cavity to form a through cavity 13 .

[0051] Furthermore, the guide hole 212 is provided at the head end of the expansion portion 21 , and the guide wire 10 can extend into the through cavity 13 and extend along the through cavity 13 through the guide hole 212 to the target position.

[0052] It should be noted that the guide wire 10 can be made of stainless steel or nickel-titanium alloy, which has high strength and corrosion resistance to withstand stress and friction during surgery. In addition, the guide wire 10 usually has a smooth surface to move smoothly in the heart and reduce damage to the heart tissue 100.

[0053] Furthermore, the diameter of the guide wire 10 is selected according to specific surgical requirements, and the diameter of the guide hole 212 can be matched with the diameter of the guide wire 10 .

[0054] In some embodiments, the aperture diameter of the guide hole 212 is defined as 0.9 mm - 1 mm.

[0055] In the embodiments of the present application, the valve repair mechanism 1 has a through cavity 13. By providing a guide hole 212 at the head end of the expansion part 21, it is convenient for the guide wire 10 to extend into the through cavity 13 and smoothly extend to the target position along the through cavity 13 through the guide hole 212, so as to accurately guide the valve repair mechanism 1 to the target position during the operation.

[0056] In the embodiments of the present application, the expansion part 21 includes a conical structure.

[0057] In the embodiments of the present application, by designing the expansion part 21 as a conical structure, a better transition structure for contacting the tissue can be provided, enabling it to smoothly pass through the blood vessel and the atrial septum, improving the safety of the operation, and reducing the damage to the blood vessel and the atrial septum.

[0058] Avoid excessive stretching or compression of the tissue around the valve, thereby more effectively dilating the valve opening and reducing the damage to the heart tissue 100.

[0059] In the embodiments of the present application, at least two breakable structures 211 are provided on the expansion part 21, and the at least two breakable structures 211 are arranged at intervals along the circumferential direction of the expansion part 21.

[0060] In some embodiments, the width of the breakable structure 211 is set to 0.1 mm - 0.3 mm, and the length of the breakable structure 211 is set to 8 mm - 15 mm.

[0061] Specifically, two breakable structures 211 are provided on the expansion part 21, and the two breakable structures 211 are symmetrically arranged at an interval of 180° along the circumferential direction of the expansion part 21. Then, driven by the delivery device 12, the clamping device 11 can break through the breakable structure 211, causing the expansion part 21 to be torn into two petals, as Figure 1 shown.

[0062] In some embodiments, three breakable structures 211 are provided on the expansion part 21, and the three breakable structures 211 are arranged at intervals of 120° along the circumferential direction of the expansion part 21. Then, driven by the delivery device 12, the clamping device 11 can break through the breakable structure 211, causing the expansion part 21 to be torn into three petals along the breakable structure 211.

[0063] In other embodiments, four breakable structures 211 are provided on the expansion part 21, and the four breakable structures 211 are arranged at intervals of 90° along the circumferential direction of the expansion part 21. Then, driven by the delivery device 12, the clamping device 11 can break through the breakable structure 211, causing the expansion part 21 to be torn into four petals along the breakable structure 211, as Figure 5 shown.

[0064] Furthermore, the present application does not limit the number of breakable structures 211 provided on the expansion part 21.

[0065] In the embodiment of the present application, by providing at least two breakable structures 211 on the expansion part 21, the at least two breakable structures 211 are arranged at intervals along the circumferential direction of the expansion part 21. Then, driven by the conveying device 12, the clamping device 11 can break through the breakable structure 211, so that the expansion part 21 is torn along the breakable structure 211, thereby facilitating the clamping device 11 to break free from the expansion part 21 smoothly and extend to the outside of the expansion part 21.

[0066] As Figures 3 - 4 shown, in the embodiment of the present application, the breakable structure 211 includes at least two adjacent expansion grooves 2114 and a connecting bridge 2113 located between the two adjacent expansion grooves 2114.

[0067] Furthermore, the breakable structure 211 includes two adjacent expansion grooves 2114. The expansion grooves 2114 are arranged in sequence along the axial direction of the expansion part 21, and a connecting bridge 2113 is provided between the two adjacent expansion grooves 2114.

[0068] Specifically, by providing the connecting bridge 2113 between the two adjacent expansion grooves 2114, the integrity of the expansion part 21 during the process of being pushed in the blood vessel and passing through the atrial septum is ensured, avoiding part of the clamping device 11 scratching the tissue through the expansion groove 2114. At the same time, the connecting bridge 2113 provided also improves the support strength of the expansion part 21 to a certain extent, ensuring that it can smoothly pass through the atrial septum before being torn.

[0069] In other embodiments, the breakable structure 211 includes three expansion grooves 2114. The three expansion grooves 2114 are arranged in sequence along the axial direction of the expansion part 21, and a connecting bridge 2113 is provided between each two adjacent expansion grooves 2114.

[0070] Furthermore, the present application does not limit the number of expansion grooves 2114 provided on the expansion part 21.

[0071] In the embodiment of the present application, by providing at least two adjacent expansion grooves 2114 and a connecting bridge 2113 located between the two adjacent expansion grooves 2114, then, driven by the conveying device 12, it is convenient for the clamping device 11 to tear the connecting bridge 2113 through the expansion groove 2114, so as to break free from the expansion part 21 smoothly.

[0072] In the embodiment of the present application, the connecting bridge 2113 is in a kidney-shaped structure.

[0073] Specifically, the middle part of the kidney-shaped connecting bridge 2113 is thinner than the thickness of both ends.

[0074] Specifically, at least one of the two sides of the waist-shaped structure is provided with a tearing notch, and the tearing notch is recessed toward the connecting bridge 2113.

[0075] Furthermore, the tearing notch includes a first notch surface and a second notch surface connected to each other, and a guiding tip is formed at the connection between the first notch surface and the second notch surface. Thus, under the action of an external force, the tip is more likely to be affected by stress concentration and is more likely to tear.

[0076] In the embodiment of the present application, by setting the connecting bridge 2113 as a waist-shaped structure, the thickness of the middle part of the connecting bridge 2113 is thinner than that of other parts. Thus, under the expansion of an external force, the middle part of the connecting bridge 2113 is more likely to break, and then the expansion part 21 is torn, so that the clamping device 11 can break free from the expansion part 21 more smoothly.

[0077] In some other embodiments, the breakable structure 211 includes a separable fracture and a suture line sutured on the separable fracture. The connection strength of the suture line is less than the tensile strength of the expansion part 21 itself. Thus, driven by the conveying device 12, the clamping device 11 can break the suture line and then smoothly break free from the expansion part 21 through the separable fracture.

[0078] As Figure 4 shown, in the embodiment of the present application, a tearing guiding structure 2111 is provided on the side of the breakable structure 211 facing the distal end. The tearing guiding structure 2111 includes a first guiding surface and a second guiding surface connected to each other, and a connecting tip is formed at the connection between the first guiding surface and the second guiding surface. The connecting tip is arranged on the side facing the distal end.

[0079] Specifically, the connecting tip of the tearing guiding structure 2111 points to the guiding hole 212 at the head end of the expansion part 21.

[0080] In the embodiment of the present application, a tearing guiding structure 2111 is provided on the side of the breakable structure 211 facing the distal end, and the connecting tip of the tearing guiding structure 2111 points to the guiding hole 212. Thus, during the process of the clamping device 11 extending through the expansion part 21 to the outside of the expansion part 21, it is convenient for the breakable structure 211 to be torn along the tearing guiding structure 2111, and then the guiding hole 212 is torn, so that the clamping device 11 can smoothly break free from the expansion part 21.

[0081] In the embodiment of the present application, a buffer transition structure 2112 is provided on the side of the breakable structure 211 facing the proximal end.

[0082] Specifically, the buffer transition structure 2112 can be an arc surface structure.

[0083] Furthermore, the buffer transition structure 2112 can be an arc chamfer.

[0084] In the embodiment of the present application, a buffer transition structure 2112 with an arc surface structure is provided on the proximal side of the destructible structure 211. Since the arc surface structure can effectively disperse and reduce the concentration of stress, the ability of the destructible structure 211 to resist tearing is improved. Therefore, under the action of external force, the buffer transition structure 2112 is not easy to tear, thereby avoiding the risk of the destructible structure 211 tearing on one side of the buffer transition structure 2112, thereby controlling the tearing range and tearing direction of the destructible structure 211, and ensuring that the clamping device 11 can smoothly break free from the expansion portion 21.

[0085] In the embodiment of the present application, the exchange-free outer tube 2 is made of a biocompatible polymer material.

[0086] In the embodiment of the present application, by setting the exchange-free outer tube 2 to a biocompatible polymer material, since the biocompatible material has high durability and stability, postoperative complications and recovery time can be reduced.

[0087] In the embodiment of the present application, the wall thickness of the expansion portion 21 is 0.2 mm-0.3 mm.

[0088] In some embodiments, the exchange-free outer tube 2 includes a main body section and an expansion section connected to each other, the expansion portion 21 is arranged on the expansion section, the main body section and the expansion section are made of the same polymer material, and the wall thickness of the main body section and the expansion section is set to the same, so that the main body section and the expansion section have the same strength.

[0089] In other embodiments, the exchange-free outer tube 2 includes a main body section and an expansion section that are connected to each other, the expansion portion 21 is arranged on the expansion section, and the wall thickness of the main body section is greater than the wall thickness of the expansion section, so that under the drive of the conveying device 12, the clamping device 11 can easily break through the expansion portion 21 of the exchange-free outer tube 2, and then smoothly extend the clamping device 11 to the outside of the expansion portion 21.

[0090] In the embodiment of the present application, by setting the wall thickness of the expansion portion 21 to 0.2 mm-0.3 mm, the clamping device 11 can easily break through the expansion portion 21 of the non-exchangeable outer tube 2 under the drive of the conveying device 12 .

[0091] In the embodiment of the present application, the conveying device 12 includes a transmission inner tube 121 ; a control line 1211 is provided on the transmission inner tube 121 , and the control line 1211 is used to control the capture member 111 of the clamping device 11 to capture tissue.

[0092] Specifically, a control line channel is provided in the transmission inner tube 121 , and the control line 1211 is passed through the control line channel.

[0093] Specifically, a proximal end of the transmission inner tube 121 is further connected with an inner tube operation part. One end of the control line 1211 is disposed through the control line channel and connected with the capture part 111, and the other end of the control line 1211 is connected with the inner tube operation part.

[0094] Further, two control line channels and two control lines 1211 are disposed on the transmission inner tube 121. The two control lines 1211 can respectively be disposed through the corresponding control line channels and connected with the capture part 111 of the clamping device 11.

[0095] In an embodiment of the present application, the control line 1211 is disposed on the transmission inner tube 121, and by manipulating the control line 1211, the opening and closing of the capture part 111 of the clamping device 11 can be controlled, so as to facilitate the capture operation of the clamped tissue.

[0096] In an embodiment of the present application, the conveying device 12 further includes an adjustable bent tube 122; the adjustable bent tube 122 can accommodate the transmission inner tube 121; a first bending part and a second bending part are disposed on the adjustable bent tube 122 at intervals; the first bending part is used for controlling at least part of the adjustable bent tube 122 to be bent along a first direction, and the second bending part is used for controlling at least part of the adjustable bent tube 122 to be bent along a second direction.

[0097] Further, the adjustable bent tube 122 further includes a bending main body section, a first bending section and a second bending section are disposed on the bending main body section at intervals, and the hardness of the first bending section and the second bending section is less than that of the bending main body section.

[0098] Further, the first bending part is disposed on the first bending section and used for controlling at least part of the first bending section to be bent along the first direction, and the second bending part is disposed on the second bending section and used for controlling at least part of the second bending section to be bent along the second direction.

[0099] Specifically, the first direction and the second direction are non-coplanar, thereby realizing the three-dimensional bending of the adjustable bent tube 122. As Figure 11 shown, an operator can perform corresponding bending treatment according to different surgical requirements to make it meet the surgical requirements, and the operation is simple and easy to adjust.

[0100] In a preferred embodiment, the first direction and the second direction can be perpendicularly arranged in space.

[0101] Specifically, the first bending part and the second bending part can be bending guide wires, and the bending guide wires can be made of metal. By pulling the corresponding bending guide wires, the corresponding parts of the adjustable bent tube 122 can be bent and deformed.

[0102] In the embodiment of the present application, three-dimensional bending of the adjustable bend tube 122 is achieved through the first bending adjusting member and the second bending adjusting member, so that the transmission inner tube 121 can smoothly reach the specified position in the heart tissue 100, thereby improving the operational flexibility of the adjustable bend tube 122, reducing the operational difficulty of controlling the path during complex cardiovascular surgery, and thereby improving the success rate of the operation.

[0103] In the embodiment of the present application, the conveying device 12 also includes a transmission shaft 123, and the transmission inner tube 121 can accommodate the transmission shaft 123; the transmission shaft 123 is transmission-connected to the clamping device 11, and the transmission shaft 123 can rotate relative to the transmission inner tube 121 to control the opening and closing of the clamping member 112 of the clamping device 11.

[0104] Specifically, the distal end of the transmission shaft 123 is used for transmission connection with the clamping device 11 , and the proximal end of the transmission shaft 123 is provided with a transmission operating part for controlling the movement of the transmission shaft 123 .

[0105] Specifically, a connecting portion is provided at the distal end of the transmission shaft 123 , and the connecting portion is detachably connected to the clamping device 11 .

[0106] In the embodiment of the present application, the transmission shaft 123 cooperates with the transmission inner tube 121 to transport the clamping device 11 to the atrial septum, and then the opening and closing of the clamping member 112 of the clamping device 11 are controlled by controlling the rotation of the transmission shaft 123 relative to the transmission inner tube 121, and the capture operation of the clamping tissue by the capture member 111 of the clamping device 11 is controlled by manipulating the control line 1211. When the clamping device 11 completes the clamping repair of the heart valve, the control connection part is separated from the clamping device 11 to remain inside the human body.

[0107] Embodiment 1

[0108] See also Figures 1 - 11 The present embodiment provides a valve repair system, comprising: a valve repair mechanism 1 and an exchange-free outer tube 2; the valve repair mechanism 1 comprises a clamping device 11 and a conveying device 12 which are transmission-connected; the exchange-free outer tube 2 has an inner cavity which can at least partially accommodate the valve repair mechanism 1, and the clamping device 11 is accommodated in the inner cavity; an expansion portion 21 is provided at the distal end of the exchange-free outer tube 2; the conveying device 12 can drive the clamping device 11 to break through the expansion portion 21 of the exchange-free outer tube 2, and then drive the clamping device 11 to extend to the outside of the expansion portion 21.

[0109] The clamping device 11 in the valve repair mechanism 1 includes a capturing member 111 and a clamping member 112;

[0110] The conveying device 12 includes a driving inner tube 121, an adjustable elbow tube 122, and a transmission shaft 123. Two control line channels are provided inside the driving inner tube 121, and two control lines 1211 are respectively disposed in the control line channels. One end of the control line 1211 is connected to the capture member 111, and the other end of the control line 1211 is connected to the inner tube operation part. Thus, the control line 1211 is controlled through the inner tube operation part, and further, the opening and closing of the capture member 111 of the clamping device 11 are controlled, thereby facilitating the capture operation of the clamped tissue.

[0111] The distal end of the transmission shaft 123 is used to pass through the driving inner tube 121 and is in driving connection with the clamping device 11. The transmission operation part at the proximal end of the transmission shaft 123 can control the rotation of the transmission shaft 123 relative to the driving inner tube 121 to control the opening and closing of the clamping member 112 of the clamping device 11.

[0112] The distal end of the transmission shaft 123 is further provided with a connection part for detachably connecting with the clamping device 11. Thus, after the clamping device 11 completes the clamping repair of the heart valve, the connection part of the transmission shaft 123 is controlled by the transmission operation part to be separated from the clamping device 11 and left inside the human body.

[0113] The adjustable elbow tube 122 can accommodate the driving inner tube 121. A first bending guide wire is provided on the first bending section of the adjustable elbow tube, which can control at least part of the first bending section to bend along the first direction. A second bending guide wire is provided on the second bending section of the adjustable elbow tube, which can control at least part of the second bending section to bend along the second direction, realizing the three-dimensional bending of the adjustable elbow tube 122. Thus, through the adjustable elbow tube 122, the driving inner tube 121 can smoothly reach the designated position in the heart tissue 100.

[0114] In the valve repair mechanism 1, the conveying device 12 has a first guide wire through cavity, and the clamping device 11 has a second guide wire through cavity. In the connected state of the conveying device 12 and the clamping device 11, the first guide wire through cavity and the second guide wire through cavity are communicated to form the through cavity 13 of the valve repair mechanism 1, and the through cavity 13 is used to allow the guide wire 10 to pass through.

[0115] The conveying device 12 can drive the clamping device 11 to be accommodated in the inner cavity of the non-exchange outer tube 2, and the clamping device 11 is close to the distal end side of the non-exchange outer tube 2. An expansion part 21 with a wall thickness of 0.2 mm - 0.3 mm is provided at the distal end of the non-exchange outer tube 2. A guide hole 212 matching the aperture of the guide wire 10 is provided at the head end of the expansion part 21. The guide wire 10 can extend into the through cavity 13 and extend to the target position along the through cavity 13 through the guide hole 212.

[0116] The expansion part 21 includes a conical structure. Two breakable structures 211 are arranged circumferentially on the expansion part 21, and the two breakable structures 211 are symmetrically arranged at an interval of 180° along the circumference of the expansion part 21. The width of the breakable structure 211 is 0.1 mm - 0.3 mm, and the length of the breakable structure 211 is 8 mm - 15 mm.

[0117] Each breakable structure 211 includes two adjacent expansion slots 2114, and a connecting bridge 2113 with a waist-shaped structure is arranged between the two adjacent expansion slots 2114. Tear notches are arranged on both sides of the waist-shaped structure, and the tear notches are recessed towards the connecting bridge 2113. Thus, under the action of an external force, the tear notches are easily affected by stress concentration and are more likely to tear.

[0118] A tear guiding structure 2111 is arranged on the side of the breakable structure 211 facing the distal end, and the connecting tip of the tear guiding structure 2111 points to the guide hole 212. An arc chamfer is arranged on the side of the breakable structure 211 facing the proximal end.

[0119] Thus, during the process that the clamping device 11 extends to the outside of the expansion part 21 through the expansion part 21, it is convenient for the breakable structure 211 to be torn along the tear guiding structure 2111, and then the guide hole 212 is torn. Then, a buffer transition structure 2112 with an arc surface structure is arranged on the side of the breakable structure 211 facing the proximal end, which improves the tear resistance ability of the breakable structure 211, makes the buffer transition structure 2112 not easy to tear, avoids the risk of the breakable structure 211 tearing on one side of the buffer transition structure 2112, and then controls the tearing range and tearing direction of the breakable structure 211, ensuring that the clamping device 11 can break free from the expansion part 21 smoothly.

[0120] This embodiment also provides an operation process of a valve repair system, as Figures 6 - 9 shown, specifically as follows:

[0121] First, the guide wire 10 is passed through the blood vessel into the designated position at the terminal of the heart tissue 100, and then the non-exchange outer tube 2 containing the valve repair mechanism 1 is guided along the guide wire 10 to the heart tissue 100. Then, driven by the delivery device 12, the expansion part 21 of the non-exchange outer tube 2 can penetrate the atrial septum and deliver the clamping device 11 into the target atrium; then the guide wire 10 is withdrawn along the through cavity 13.

[0122] Then, the delivery device 12 drives the clamping device 11 to break through the expansion part 21 of the non-exchange outer tube 2 and deliver the clamping device 11 into the target atrium.

[0123] During the transmission process, the first bending section can be bent along the first direction by the first bending member on the adjustable bending pipe 122; after the clamping device 11 is transported into the target atrium, the second bending section can be bent along the second direction by the second bending member on the adjustable bending pipe 122, so as to accurately deliver the clamping device 11 to the position to be repaired.

[0124] The control line 1211 is controlled by the inner pipe operation part to open and close the capture part 111 of the clamping device 11, so as to facilitate the capture operation of the clamped tissue.

[0125] The transmission shaft 123 can be controlled to rotate relative to the transmission inner pipe 121 by the transmission operation part, and then the opening and closing of the clamping part 112 of the clamping device 11 can be controlled.

[0126] When the clamping device 11 completes the clamping repair of the valve, the connection part of the transmission shaft 123 is controlled by the transmission operation part to be separated from the clamping device 11 and left inside the human body.

[0127] Finally, the delivery device 12 and the non-exchange outer tube 2 are withdrawn.

[0128] In this article, the orientation words such as front, back, up, and down are defined based on the positions of the components in the drawings and the positions of the components relative to each other, only for the sake of clarity and convenience in expressing the technical solution. It should be understood that the use of the orientation words should not limit the scope of protection claimed in this application.

[0129] Without conflict, the above-mentioned embodiments and the features in the embodiments in this article can be combined with each other.

[0130] The above-disclosed is only a preferred embodiment of the present invention, and of course it cannot be used to limit the scope of the 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, It includes a valve repair mechanism (1) and a non-exchange outer tube (2); The valve repair mechanism (1) includes a clamping device (11) and a delivery device (12); The non-exchange outer tube (2) has an inner cavity capable of at least partially accommodating the valve repair mechanism (1); A dilation part (21) is provided at the distal end of the non-exchange outer tube (2); the delivery device (12) can drive the clamping device (11) to break through the dilation part (21) of the non-exchange outer tube (2), and then drive the clamping device (11) to extend to the outside of the dilation part (21).

2. The valve repair system according to claim 1, wherein the dilation part (21) has a guide hole (212); the valve repair mechanism (1) has a through cavity (13); the extension end of the through cavity (13) is communicated with the guide hole (212).

3. The valve repair system according to claim 1, wherein the dilation part (21) includes a conical structure.

4. The valve repair system according to any one of claims 1-3, characterized in that, At least two breakable structures (211) are provided on the dilation part (21), and at least two of the breakable structures (211) are arranged at intervals along the circumferential direction of the dilation part (21); The breakable structure (211) includes at least two adjacent dilation grooves (2114) and a connection bridge (2113) located between the two adjacent dilation grooves (2114).

5. The valve repair system according to claim 4, wherein A guiding structure (2111) is provided on one side of the breakable structure (211) facing the distal end, and the guiding structure (2111) includes a connected first guiding surface and a second guiding surface, and a connection tip is formed at the connection of the first guiding surface and the second guiding surface, and the connection tip is arranged on the side facing the distal end.

6. The valve repair system according to claim 5, wherein A buffer transition structure (2112) is provided on one side of the breakable structure (211) facing the proximal end; the buffer transition structure (2112) is an arc surface structure.

7. The valve repair system according to any one of claims 1-3, characterized in that The delivery device (12) includes a transmission inner tube (121); A control line (1211) is provided on the transmission inner tube (121), and the control line (1211) is used to control the capture member (111) of the clamping device (11) to capture tissue.

8. The valve repair system according to claim 7, wherein The delivery device (12) further includes an adjustable bending tube (122); The adjustable bending tube (122) can accommodate the transmission inner tube (121); a first bending adjustment member and a second bending adjustment member are arranged at intervals on the adjustable bending tube (122); the first bending adjustment member is used to control at least part of the adjustable bending tube (122) to bend along a first direction, and the second bending adjustment member is used to control at least part of the adjustable bending tube (122) to bend along a second direction.

9. The valve repair system according to claim 8, characterized in that, The first direction and the second direction are non-coplanar.

10. The valve repair system according to claim 9, wherein, The delivery device (12) further includes a transmission shaft (123), and the transmission inner tube (121) can accommodate the transmission shaft (123); The transmission shaft (123) is in transmission connection with the clamping device (11), and the transmission shaft (123) can rotate relative to the transmission inner tube (121) to control the opening and closing of the clamping member (112) of the clamping device (11).

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