Repair system for valvuloplasty

Abstract

The invention relates to the field of medical instruments, in particular to a repair system for valvuloplasty, which comprises a delivery catheter, an anchoring device, a positioning support, a guide system and a contraction ring component, and the anchoring device comprises a needle hiding tube and an anchoring assembly; the guide system comprises at least two groups of pre-positioning pieces and guide pieces, and magnetic attraction force can be generated when the head ends of the pre-positioning pieces are close to the head ends of the guide pieces; the positioning support comprises a plurality of positioning rods, a limiting sleeve and a guiding channel, the shrinking ring component is detachably connected with the positioning rods in a matched mode, the far end of the needle hiding tube is preassembled in the limiting sleeve, and the guiding piece penetrates through the guiding channel; after the pre-positioning piece reaches the preset position in advance, the guiding piece is moved, the head end of the pre-positioning piece and the head end of the guiding piece attract each other and form connection, and the positioning support reaches the target position along the path of the guiding piece; by means of the repairing system, positioning can be achieved efficiently, rapidly and accurately, and damage to heart tissue can be avoided.

Description

Technical Field

[0001] This application belongs to the field of medical devices, and particularly relates to a repair system for valvuloplasty. Background Art

[0002] Minimally invasive interventional medical technology is an efficient diagnosis and treatment method that has gradually emerged in recent years. It has prominent advantages such as small trauma, simple operation, accurate intervention site, and few complications, and has now become one of the most important diagnosis and treatment means for cardiovascular and tumor diseases. In interventional medical surgery, usually professional doctors need to manually operate specific devices to enable one or more slender flexible catheters with different shapes or functions to pass through the complex and changeable internal cavity environment of the human body such as the cardiovascular system of the patient, and send instruments such as catheters, guide wires, and stents to the predetermined diagnosis and treatment lesion site for minimally invasive diagnosis and treatment. The incidence of mitral valve disease remains high among adult heart valve diseases. Mitral regurgitation (MR) in mitral valve disease has a very serious impact on patients. Normally, the mitral valve in the human heart acts as a hemostatic valve to prevent oxygen-rich blood from the lungs from flowing back into the left atrium. Once the mitral valve fails to close properly or is misaligned, MR will occur, which will significantly reduce the heart pumping efficiency and even cause heart failure. Mitral regurgitation is divided into functional and degenerative types. Functional mitral regurgitation (FMR) is characterized by mitral annulus dilation, insufficient leaflet coaptation, and mitral leaflet tethering, which is caused by left ventricular dysfunction and remodeling. Driven by the poor outcomes and high risks of surgical mitral valvuloplasty, people have started to look for alternative solutions using catheters and minimally invasive methods, such as percutaneous edge-to-edge repair, indirect annuloplasty, direct annuloplasty, etc. Mitral annuloplasty is one of the most common surgical procedures for treating FMR.

[0003] Patent CN202111466800.9 discloses a precisely positionable repair system, including a guiding and positioning mechanism, with an active guiding device provided at the distal end of the guiding and positioning mechanism; an anchoring and repairing mechanism, with a passive positioning device provided at the distal end of the anchoring and repairing mechanism, and a magnetic suction force is generated between the active guiding device and the passive positioning device; during positioning, the distal part of the guiding and positioning mechanism reaches a predetermined position in advance and remains stationary, the distal part of the anchoring and repairing mechanism enters the heart, and the active guiding device and the passive positioning device attract each other to make the distal part of the anchoring and repairing mechanism reach the target anchoring position; the defects of this patented technology are as follows: First, this repair system uses two sets of devices to complete the repair of the valve through different access paths, resulting in a long operation time and complex operation during the operation; Second, in this solution, only a single point can be guided and positioned. In the case of non-visualization during the operation and the general saddle-shaped morphology of the autologous valve annulus, it is very difficult to ensure that the guiding and positioning mechanism can be delivered to the ideal positioning position. Moreover, a single positioning point relies on imaging to find the position one by one and then anchor, which greatly increases the operation time during the operation and the operation difficulty rises linearly, which is neither conducive to the postoperative rehabilitation of patients nor conducive to the market promotion of products.

[0004] Patent CN 202310567779.4 discloses a guidable and positionable anchoring system, including a delivery catheter, a positioning stent arranged in the delivery catheter, an anchoring mechanism, a flexible kit, and a guiding mechanism. The positioning stent is arranged at the distal end of the delivery catheter, and the positioning stent is provided with a plurality of circumferentially distributed anchoring points. The flexible kit is provided with a plurality of connection points. The guiding mechanism includes a plurality of guide wires, and the guide wires respectively pass through the connection points and are cooperatively connected with the anchoring points. Among them, the distal part of the anchoring mechanism is sleeved in the flexible kit, and the flexible kit cooperates with the guide wires to enable the anchoring mechanism to be guided to each anchoring point along a predetermined route and complete the anchoring. In this solution, the anchoring mechanism is respectively guided and positioned by a plurality of guide wires. However, due to the limited diameter of the delivery catheter, the plurality of guide wires are prone to interfere with each other in the lumen. Secondly, using wires for guiding is prone to angular deviation, and the accuracy is still not high. Moreover, the head end of the anchoring mechanism can only be guided to the end of the rod of the positioning stent. When a certain part of the positioning stent cannot be attached to the heart tissue, the head end of the anchoring mechanism cannot abut against the heart tissue to perform anchoring. Therefore, when using wires for guiding, the position of the guiding points will be restricted.

[0005] Therefore, those skilled in the art are committed to developing a repair system for valvuloplasty, mainly solving the following problems: 1. Solving the problem of accurate intraoperative guidance while shortening the intraoperative time; 2. Solving the problem of mutual interference of guide wires in the lumen; 3. Solving the problem of angle deviation caused by using guide wires for guidance; 4. Solving the problem of limited guiding sites; 5. Solving the problem of excessive movement of the positioning stent. Summary of the Invention

[0006] The purpose of this application is to provide a repair system for valvuloplasty. This new type of anchoring mechanism has the following advantages: 1. Both the pre-positioning member and the guiding member are integrated in the same delivery catheter, eliminating the need to increase the access path. While simplifying the operation, it can reduce the intraoperative risk. And at least two groups of pre-positioning members can determine the height of the autologous valve annulus, enabling the positioning stent to move along the path of the guiding member to the autologous valve annulus, achieving rapid positioning and saving intraoperative operation time; 2. The limiting sleeve can accurately guide the anchoring device to the target anchoring position without mutual interference; 3. After the anchoring device abuts against the area to be anchored, it can continue to be pushed to ensure that the area to be anchored fits the heart tissue. Its guiding site is not restricted and the error tolerance rate is high; 4. The limiting sleeve can be compressed during loading, so that it does not occupy the loading space of the implantable device in the delivery catheter; 5. The rigid and flexible segmented design of the anchoring device makes it unaffected when bending in the blood vessel; 6. The hollow tube and the anchoring needle are separately designed and are detachably connected through a guide wire, enabling it to have the function of secondary anchoring and a higher error tolerance rate for the device.

[0007] To solve the above technical problems, this application is solved through the following technical solutions: A repair system for valvuloplasty, including a delivery catheter, an anchoring device arranged in the delivery catheter, a positioning stent, a guiding system, and a ring constricting member. The anchoring device includes a needle hiding tube and an anchoring assembly arranged in the needle hiding tube; The guiding system includes at least two groups of pre-positioning members and guiding members correspondingly arranged with the pre-positioning members. When the head ends of the pre-positioning members approach the head ends of the guiding members, a magnetic suction force will be generated; The positioning stent includes multiple positioning rods, limiting sleeves and guiding channels arranged on the positioning rods. Among them, the ring constricting member is detachably connected in cooperation with the positioning rods. The distal end of the needle hiding tube is pre-loaded in the limiting sleeve, and the guiding member passes through the guiding channel; And, after the pre-positioning member reaches the predetermined position in advance, move the guiding member. The head ends of the pre-positioning member and the guiding member attract each other and form a connection, and the positioning stent reaches the target position along the path of the guiding member.

[0008] As a further improvement of the present invention, the predetermined position is at the root of the valve leaf in the ventricle, and the target position is at the root of the valve leaf in the atrium.

[0009] As a further improvement of the present invention, an anchored area is provided on the constriction ring member. After the positioning bracket reaches the target position along the path of the guiding member, the needle hiding tube is pushed to move along the channel in the limiting sleeve until the head end of the needle hiding tube abuts against the anchored area.

[0010] As a further improvement of the present invention, the shape of the positioning bracket after deployment is similar to the shape of the autologous valve annulus to be treated. And after the positioning bracket is deployed, the anchored area fits the cardiac tissue. However, due to the physiological and anatomical differences among different patients, when the anchored area does not fit the cardiac tissue, the anchoring device is further pushed so that the head end of the anchoring device abuts against the anchored area until the anchored area fits the cardiac tissue.

[0011] As a further improvement of the present invention, a serrated structure is provided on the positioning rod, and the serrated structure is used to fix the limiting sleeve, and the serrated structure can prevent the limiting sleeve from sliding.

[0012] As a further improvement of the present invention, the positioning bracket further includes a detection element connected to the positioning rod, and the detection element has a imaging function.

[0013] As a further improvement of the present invention, multiple groups of the pre-positioning members form an anchor-shaped structure in the working state.

[0014] As a further improvement of the present invention, the pre-positioning member includes a positioning wire and a magnet or magnetic material provided at the head end of the positioning wire, and the guiding member includes a guiding wire and a magnet or magnetic material provided at the head end of the guiding wire. And during pre-installation, the head ends of the pre-positioning members and the head ends of the guiding members are axially offset.

[0015] As a further improvement of the present invention, the cross-section of the positioning wire / guiding wire is non-circular.

[0016] As a further improvement of the present invention, the head ends of the pre-positioning members and the head ends of the guiding members have N poles and S poles in the axial direction. And during pre-installation, the head ends of the pre-positioning members are at the same height axially, and the head ends of the guiding members are at the same height axially.

[0017] As a further improvement of the present invention, the limiting sleeve is made of a flexible material, and the channel of the limiting sleeve is located inside the positioning bracket.

[0018] As a further improvement of the present invention, the limiting sleeve has deformability.

[0019] As a further improvement of the present invention, the inner wall of the limiting sleeve is smooth, so that the limiting sleeve will not generate resistance to the anchoring device during the pushing process of the anchoring device.

[0020] As a further improvement of the present invention, the limiting sleeve is made of polymer material, such as PTFE material.

[0021] As a further improvement of the present invention, during pre-installation, the distal portion of the limiting sleeve is compressed and deformed, and when the positioning bracket is unfolded and pushes the needle tube to move along the channel in the limiting sleeve, the distal portion of the limiting sleeve is stretched open.

[0022] As a further improvement of the present invention, the anchoring assembly includes an anchoring needle, a hollow tube and a guide wire, wherein the guide wire is detachably connected to the anchoring needle, the guide wire is arranged in the hollow tube, and pushing the hollow tube can make the hollow tube move along the guide wire and form a detachable connection with the anchoring needle.

[0023] As a further improvement of the present invention, the anchoring needle includes a needle head and a connecting part, the connecting part is provided with a slot, and the distal end of the hollow tube is provided with a protrusion that cooperates with the slot, wherein the hollow tube moves along the guide wire so that the protrusion is inserted into the slot to form a connection.

[0024] As a further improvement of the present invention, the hollow tube is connected with the anchoring needle through the guide wire, so that the anchoring needle can be anchored multiple times and repeatedly.

[0025] As a further improvement of the present invention, the detection element is a flexible member, wherein the detection element is a spring made of metal wire, and the detection element is threadedly connected to the positioning rod.

[0026] As a further improvement of the present invention, the needle hiding tube comprises a rigid section and a flexible section, the rigid section is arranged at the distal end of the flexible section, and the rigid section is pre-installed in the limiting sleeve.

[0027] As a further improvement of the present invention, during preinstallation, the anchoring needle is arranged in the rigid section, the hollow tube is arranged in the flexible section, and the hollow tube is preinstalled in the proximal part of the needle-hiding tube. The advantage of such a design is that the needle-hiding tube is designed with rigid and flexible sections, the rigid section is used for preinstalling the anchoring needle, and the flexible section is used for bending in the blood vessel, and the hollow tube is preinstalled in the proximal part of the needle-hiding tube, which will not affect the bending of the flexible section, and at the same time can be connected with the anchoring needle through a guide wire to complete the anchoring operation.

[0028] As a further improvement of the present invention, the constriction ring member includes a first constriction portion, a second constriction portion disposed adjacent to the first constriction portion, a fabric layer covering the first constriction portion and the second constriction portion, and a control element. The control element is connected to the first constriction portion and the second constriction portion, and pulling the control element causes the first constriction portion and the second constriction portion to contract, and the adjacent ends of the first constriction portion and the second constriction portion all move closer to the center of the native valve.

[0029] As a further improvement of the present invention, the first constriction portion and the second constriction portion are adjacently anchored in the constriction ring area set by the native annulus or atrial tissue through the anchoring needles. Manipulating the control element causes the first constriction portion and the second constriction portion to contract, and the adjacent ends of the first constriction portion and the second constriction portion all move closer to the center of the native valve, and drive the middle part of the set constriction ring area to move closer to the center of the native valve.

[0030] As a further improvement of the present invention, the constriction ring member is of an integral structure, and the first constriction portion and the second constriction portion are connected by sutures or welding.

[0031] Compared with the prior art, the advantages of the present application are as follows: 1. In the existing repair system, it is difficult to determine the specific position of the native annulus only through imaging. Therefore, it is also difficult to confirm the release position and release timing of the positioning stent, resulting in a significant increase in the intraoperative time. And the existing system using magnetic suction for positioning requires two sets of systems to intervene in the treatment from different access paths, and can only perform positioning and anchoring at a single point. Not only is the operation difficult, but the intraoperative treatment time is also long. In an embodiment of the present application, at least two groups of pre-positioning members can reach the position of the root of the native leaflet in advance, and then use magnetic suction to make the guiding member attract the pre-positioning member and quickly determine the height of the native annulus. The positioning stent can reach the native annulus along the path of the guiding member. The positioning method is simple, fast, and accurate, and only one set of system can complete functions such as positioning, guiding, and repair. It has a high degree of integration and is convenient to operate, can save a large amount of surgical time, and reduce the possibility of postoperative complications.

[0032] 2. Different from the prior art, in an embodiment of the present application, the relative position between the positioning stent and the native annulus can be determined by the detection element with imaging function, so as to accurately attach the positioning stent to the native annulus. Its guiding and positioning method not only uses magnetic suction to pre-establish an accurate guiding path, but also further determines the relative position between the positioning stent and the native annulus through the detection element, avoiding excessive movement of the positioning stent by the surgeon and thus causing damage to the cardiac tissue.

[0033] 3. Different from the prior art, in an embodiment of the present application, the applicant uniquely sets a limit sleeve on the positioning rod. The limit sleeve forms a movable channel, and the needle-holding tube can slide along this channel and abut against the anchored area of the implanting device. By using the limit sleeve channel to guide the moving path of the anchoring device, it can not only avoid the mutual interference between the guiding components (the wires used for guiding in the prior art), save the loading space inside the sheath tube, and moreover, the needle-holding tube will not deflect in terms of path or angle when moving in the channel, improving the accuracy of guiding and positioning. And when the anchored area does not fit the heart tissue, continue to push the needle-holding tube so that the head end of the needle-holding tube presses against the anchored area until the anchored area fits the heart tissue. This enables the needle-holding tube to ensure that the anchoring needle penetrates into the heart tissue and guarantees its anchoring effect. And this also eliminates the influence of the irregularity of the valve annulus shape caused by the lesion on the anchoring device, further improving the fault tolerance rate of the instrument, which has great clinical significance.

[0034] 4. Different from the prior art, in an embodiment of the present application, the limit sleeve is made of a flexible material. And during loading, the distal part of the limit sleeve is compressed, and after pushing the anchoring device, the limit sleeve can restore the channel again, which makes the limit sleeve not occupy the loading space of the implanting device.

[0035] 5. Different from the prior art, in an embodiment of the present application, the needle-holding tube has a rigid-flexible segmented design. The rigid segment is used for preloading the anchoring needle, and the flexible segment is used for bending in the blood vessel. And the hollow tube is preloaded in the proximal part of the needle-holding tube, which will not affect the bending of the flexible segment, and at the same time can be connected with the anchoring needle through the guiding wire to complete the anchoring operation.

[0036] 6. Different from the prior art, in an embodiment of the present application, the anchoring needle and the hollow tube are separately designed and form a detachable connection through the guiding wire, so that the anchoring device has the function of secondary or multiple anchoring. BRIEF DESCRIPTION OF THE DRAWINGS

[0037] Figure 1 It is a schematic diagram of the overall structure of the repair system of the present invention.

[0038] Figure 2 and Figure 3 It is a schematic diagram of the structure of the positioning bracket of the present invention.

[0039] Figure 4 It is a schematic diagram of the movement of the anchoring device along the limit sleeve of the present invention.

[0040] Figure 5 It is a schematic diagram when the guiding system of the present invention is preloaded.

[0041] Figure 6 It is a schematic diagram of the structure of the anchoring device of the present invention.

[0042] Figure 7 This is a schematic structural diagram of the ring shrinking member of the present invention.

[0043] Figures 8 to 14 This is a schematic diagram of the operation process of the present invention, where Figure 12 is Figure 11 the view in the A direction in

[0044] The names of the parts referred to by the numbers in the drawings are as follows: 1 - delivery catheter, 2 - anchoring device, 21 - needle hiding tube, 211 - rigid section, 212 - flexible section, 22 - anchoring assembly, 221 - anchoring needle, 2211 - needle tip, 2212 - connecting part, 2213 - card slot, 222 - hollow tube, 2221 - protrusion, 223 - guiding wire, 3 - positioning bracket, 31 - positioning rod, 32 - limiting sleeve, 33 - guiding channel, 34 - detecting element, 4 - guiding system, 41 - pre - positioning member, 411 - positioning wire, 42 - guiding member, 421 - guiding wire, 5 - ring shrinking member, 51 - anchored area, 52 - first shrinking part, 53 - second shrinking part, 54 - fabric layer, 55 - control element. Specific embodiments

[0045] As Figure 1 and Figure 2 shown, a repair system for valvuloplasty includes a delivery catheter 1, an anchoring device 2 arranged in the delivery catheter 1, a positioning bracket 3, a guiding system 4, and a ring shrinking member 5. The anchoring device 2 includes a needle hiding tube 21 and an anchoring assembly 22 arranged in the needle hiding tube 21. The guiding system 4 includes at least two groups of pre - positioning members 41 and guiding members 42 corresponding to the pre - positioning members 41. When the head ends of the pre - positioning members 41 are close to the head ends of the guiding members 42, a magnetic suction force will be generated. The shape of the positioning bracket 3 after expansion is similar to the shape of the autologous valve annulus to be treated (this enables the anchored area 51 to fit the heart tissue after the positioning bracket 3 is expanded). The positioning bracket 3 includes multiple positioning rods 31, a limiting sleeve 32 and a guiding channel 33 arranged on the positioning rods 31. Among them, the ring shrinking member 5 is detachably connected with the positioning rods 31, and the ring shrinking member 5 is provided with an anchored area 51. The distal end of the needle hiding tube 21 is pre - installed in the limiting sleeve 32. As Figure 3 shown, the guiding member 42 passes through the guiding channel 33, as Figure 1 shown; and, as Figure 8 shown, after the pre - positioning member 41 reaches the predetermined position in advance (the predetermined position is at the root of the valve leaf in the ventricle), the guiding member 42 is moved, and the head end of the pre - positioning member 41 and the head end of the guiding member 42 attract each other and form a connection, as Figure 9 and Figure 10As shown, the positioning bracket 3 reaches the target position (the target position is at the root of the valve leaf in the atrium) along the path of the guide member 42, as Figure 11 shown, after the positioning bracket 3 reaches the target position along the path of the guide member 42, the needle housing 21 is pushed to move along the channel in the limit sleeve 32 until the head end of the needle housing 21 abuts against the anchored area 51, as Figure 4 shown. When the anchored area 51 does not fit the heart tissue, continue to push the anchoring device 2 so that the head end of the anchoring device 2 presses against the anchored area 51 until the anchored area 51 fits the heart tissue. Subsequently, operating the anchoring assembly 22 can anchor the constriction ring member 5 on the autologous valve annulus.

[0046] In this embodiment, a serrated structure is provided on the positioning rod 31, and the serrated structure is used to fix the limit sleeve 32, and the serrated structure can prevent the limit sleeve 32 from sliding, as Figure 2 shown.

[0047] In this embodiment, the positioning bracket 3 further includes a detection element 34 connected to the positioning rod 31, and the detection element 34 has a imaging function.

[0048] In this embodiment, multiple groups of the pre-positioning members 41 are in an anchor-shaped structure in the working state.

[0049] In this embodiment, the pre-positioning member 41 includes a positioning wire 411 and a magnet or magnetic material provided at the head end of the positioning wire 411, and the guide member 42 includes a guide wire 421 and a magnet or magnetic material provided at the head end of the guide wire 421. And during pre-installation, the head ends of the pre-positioning members 41 and the head ends of the guide members 42 are axially misaligned, as Figure 5 shown.

[0050] In this embodiment, the cross-section of the positioning wire 411 / the guide wire 421 is non-circular.

[0051] In this embodiment, the head ends of the pre-positioning members 41 and the head ends of the guide members 42 have N poles and S poles in the axial direction. And during pre-installation, the head ends of the pre-positioning members 41 are at the same axial height, and the head ends of the guide members 42 are at the same axial height.

[0052] In this embodiment, the limit sleeve 32 is made of a flexible material, and the channel of the limit sleeve 32 is located inside the positioning bracket 3.

[0053] In this embodiment, the limit sleeve 32 has deformability.

[0054] In this embodiment, the inner wall of the limiting sleeve 32 is smooth, so that the limiting sleeve 32 will not generate resistance to the anchoring device 2 during the pushing process of the anchoring device 2.

[0055] In this embodiment, the limiting sleeve 32 is made of polymer material PTFE.

[0056] In this embodiment, during pre-installation, the distal end portion of the limiting sleeve 32 is compressed and deformed. When the positioning bracket 3 is unfolded, the needle tube 21 is pushed to move along the channel in the limiting sleeve 32, and the distal end portion of the limiting sleeve 32 is stretched open.

[0057] In this embodiment, the anchoring assembly 22 includes an anchoring needle 221, a hollow tube 222, and a guide wire 223, wherein the guide wire 223 is detachably connected to the anchoring needle 221, the guide wire 223 is arranged in the hollow tube 222, and the hollow tube 222 is pushed so that the hollow tube 222 moves along the guide wire 223 and forms a detachable connection with the anchoring needle 221, as shown in FIG. Figure 6 shown.

[0058] In this embodiment, the anchoring needle 221 includes a needle head 2211 and a connecting part 2212, the connecting part 2212 is provided with a slot 2213, and the distal end of the hollow tube 222 is provided with a protrusion 2221 that cooperates with the slot 2213, wherein the hollow tube 222 moves along the guide wire 223 so that the protrusion 2221 is inserted into the slot 2213 to form a connection.

[0059] In this embodiment, the hollow tube 222 is connected with the anchoring needle 221 through the guide wire 223, so that the anchoring needle 221 can be anchored multiple times and repeatedly.

[0060] In this embodiment, the detection element 34 is a flexible member, wherein the detection element 34 is a spring made of metal wire, and the detection element 34 is threadedly connected to the positioning rod 31 .

[0061] In this embodiment, the needle hiding tube 21 includes a rigid section 211 and a flexible section 212 . The rigid section 211 is disposed at the distal end of the flexible section 212 , and the rigid section 211 is pre-installed in the limiting sleeve 32 .

[0062] In this embodiment, during pre-installation, the anchoring needle 221 is disposed in the rigid section 211, the hollow tube 222 is disposed in the flexible section 212, and the hollow tube 222 is pre-installed in the proximal portion of the needle-hiding tube 21. Figure 6As shown, the advantage of such a design is as follows: The needle-holding tube 21 has a rigid-flexible segmented design. The rigid segment 211 is used for pre-installing the anchoring needle 221, and the flexible segment 212 is used for bending in the blood vessel. Moreover, the hollow tube 222 is pre-installed in the proximal part of the needle-holding tube 21, which will not affect the bending of the flexible segment 212. At the same time, it can be connected with the anchoring needle 221 through the guiding wire 223 to complete the anchoring operation.

[0063] In this embodiment, the constriction ring member 5 includes a first constriction part 52, a second constriction part 53 adjacent to the first constriction part 52, a fabric layer 54 covering the first constriction part 52 and the second constriction part 53, and a control element 55. The control element 55 is connected to the first constriction part 52 and the second constriction part 53, as Figure 7 shown. Moreover, by pulling the control element 55, the first constriction part 52 and the second constriction part 53 are constricted, and the adjacent ends of the first constriction part 52 and the second constriction part 53 both move closer to the center of the native valve.

[0064] In this embodiment, the first constriction part 52 and the second constriction part 53 are adjacently anchored in the constriction ring area set on the native valve annulus or atrial tissue through the anchoring needle 221, as Figure 12 shown. By manipulating the control element 55, the first constriction part 52 and the second constriction part 53 are constricted, and the adjacent ends of the first constriction part 52 and the second constriction part 53 both move closer to the center of the native valve, and drive the middle part of the set constriction ring area (when used for mitral valve treatment, this set constriction ring area is the P2 area of the native valve annulus) to move closer to the center of the native valve, as Figure 13 shown.

[0065] In this embodiment, the constriction ring member 5 is of an integral structure, and the first constriction part 52 and the second constriction part 53 are connected by sutures or welding.

[0066] The operation process of this valve repair system includes the following steps.

[0067] 1) The delivery catheter 1 enters the heart along the path of the guide wire in the blood vessel, and the pre-positioning member 41 is pushed to extend out of the delivery catheter 1 and reach the root of the native valve leaflet, as Figure 8 shown; 2) After the head end of the pre-positioning member 41 abuts against the root of the native valve leaflet, the guiding member 42 is pushed so that the guiding member 42 and the corresponding pre-positioning member 41 attract each other and form a connection, as Figure 9 and Figure 10 shown; 3) Push the positioning bracket 3 so that the positioning bracket 3 moves towards the autologous valve annulus along the preset path of the guiding member 42, and observe the state of the detection element 34 through imaging. When the detection element 34 swings greatly following the autologous valve leaflet, it can be determined that the positioning bracket 3 has reached the autologous valve annulus, and the guiding and positioning is completed, as Figure 11 and Figure 12 shown; 4) Operate the anchoring mechanism so that the ring shrinking member 5 is anchored on the autologous valve annulus, and operate the control element 55 so that its first shrinking part 52 and second shrinking part 53 drive the autologous valve annulus to shrink, completing the valve repair. Finally, withdraw the repair system from the body, as Figure 13 and Figure 14 shown.

[0068] The foregoing description of several embodiments of the present application has been presented for purposes of illustration. The foregoing description is not intended to be exhaustive nor to limit the present application to the precise configuration, construction, and / or steps disclosed. Obviously, many modifications and variations are possible in light of the above teachings. The scope of the invention and all equivalents are intended to be defined by the appended claims.

Claims

1. A repair system for valvuloplasty, comprising a delivery catheter, an anchoring device arranged in the delivery catheter, a positioning stent, a guiding system, and a shrinking ring member, characterized in that: The anchoring device comprises a needle-hiding tube and an anchoring component arranged in the needle-hiding tube; The guiding system comprises at least two groups of pre-positioning members and guiding members arranged corresponding to the pre-positioning members, and a magnetic attraction force is generated when the head end of the pre-positioning member approaches the head end of the guiding member; The positioning bracket includes a plurality of positioning rods, a limiting sleeve arranged on the positioning rods and a guide channel, wherein the shrink ring component is detachably connected with the positioning rod, the distal end of the needle-hiding tube is pre-installed in the limiting sleeve, and the guide passes through the guide channel; Furthermore, after the pre-positioning member reaches the predetermined position in advance, the guiding member is moved, the head end of the pre-positioning member and the head end of the guiding member attract each other and form a connection, and the positioning bracket reaches the target position along the path of the guiding member.

2. The repair system for valvuloplasty according to claim 1, characterized in that: The predetermined position is located at the root of the valve leaflet in the ventricle, and the target position is located at the root of the valve leaflet in the atrium.

3. The repair system for valvuloplasty according to claim 1, characterized in that: An anchored area is provided on the shrinking ring component. When the positioning bracket reaches the target position along the path of the guide, the needle hiding tube is pushed to move along the channel in the limiting sleeve until the head end of the needle hiding tube abuts against the anchored area.

4. The repair system for valvuloplasty according to claim 1, characterized in that: The positioning bracket further includes a detection element connected to the positioning rod, and the detection element has a developing function.

5. The repair system for valvuloplasty according to claim 1, characterized in that: The plurality of groups of pre-positioning members are in an anchor-shaped structure in a working state.

6. The repair system for valvuloplasty according to claim 1, characterized in that: The pre-positioning member includes a positioning wire and a magnet or magnetic material arranged at the head end of the positioning wire, and the guide member includes a guide wire and a magnet or magnetic material arranged at the head end of the guide wire. In addition, during pre-installation, the head end of the pre-positioning member and the head end of the guide member are axially offset.

7. The repair system for valvuloplasty according to claim 6, characterized in that: The cross-section of the positioning wire / the guide wire is non-circular.

8. The repair system for valvuloplasty according to claim 6, characterized in that: The head end of the pre-positioning member and the head end of the guiding member have an N pole and an S pole in the axial direction, and when pre-installed, the head ends of the pre-positioning members are highly consistent in the axial direction, and the head ends of the guiding members are highly consistent in the axial direction.

9. The repair system for valvuloplasty according to claim 1, wherein: The limiting sleeve is made of a flexible material, and the channel of the limiting sleeve is located on the inner side of the positioning bracket.

10. The repair system for valvuloplasty according to claim 1, wherein: During pre-installation, the distal end portion of the limiting sleeve is compressed and deformed. When the positioning bracket is unfolded and the needle-hiding tube is pushed to move along the channel in the limiting sleeve, the distal end portion of the limiting sleeve is stretched open.

11. The repair system for valvuloplasty according to claim 1, wherein: The anchoring assembly includes an anchoring needle, a hollow tube and a guide wire, wherein the guide wire is detachably connected to the anchoring needle, the guide wire is arranged in the hollow tube, and pushing the hollow tube can make the hollow tube move along the guide wire and form a detachable connection with the anchoring needle.

12. The repair system for valvuloplasty according to claim 11, characterized in that: The anchoring needle includes a needle head and a connecting part, the connecting part is provided with a slot, and the distal end of the hollow tube is provided with a protrusion that cooperates with the slot, wherein the hollow tube moves along the guide wire so that the protrusion is inserted into the slot to form a connection.

13. The repair system for valvuloplasty according to claim 4, wherein: The detection element is a flexible member. Among them, the detection element is a spring made of a metal wire, and the detection element is threadedly connected to the positioning rod.

14. The repair system for valvuloplasty according to claim 1, characterized in that: The constriction ring member includes a first constriction portion, a second constriction portion disposed adjacent to the first constriction portion, a fabric layer covering the first constriction portion and the second constriction portion, and a control element. The control element is connected to the first constriction portion and the second constriction portion, and pulling the control element causes the first constriction portion and the second constriction portion to constrict, and the adjacent ends of the first constriction portion and the second constriction portion both move closer to the center of the autologous valve.

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