A repair system for valvuloplasty

Abstract

The application relates to the field of medical devices, in particular to a repair system for valve reshaping, which comprises a delivery catheter, an anchoring device, a positioning support, a guide system and a ring shrinkage component, 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 a guide piece, and magnetic attraction force is generated when the head end of the pre-positioning piece is close to the head end of the guide piece; the positioning support comprises a plurality of positioning rods, a limiting sleeve and a guide channel, the ring shrinkage component is detachably connected with the positioning rods, the distal end of the needle hiding tube is preloaded in the limiting sleeve, and the guide piece passes through the guide channel; after the pre-positioning piece reaches the pre-positioning position, the guide piece is moved, the head end of the pre-positioning piece and the head end of the guide piece are attracted to each other and connected, and the positioning support reaches the target position along the path of the guide piece; the repair system can not only efficiently, quickly and accurately realize positioning, but also can avoid damage to the heart tissue.

Description

Technical Field

[0001] This application belongs to the field of medical devices, specifically relating to a repair system for valve repair. Background Technology

[0002] Minimally invasive interventional medical technology is a highly efficient diagnostic and treatment method that has gradually emerged in recent years. It boasts significant advantages such as minimal trauma, ease of operation, precise intervention site selection, and fewer complications, and has become one of the most important diagnostic and treatment methods for cardiovascular and oncological diseases. In interventional procedures, specialists typically use manual manipulation of specific devices to deliver one or more slender, flexible catheters of different shapes or functions through the complex and variable internal cavities of the patient's cardiovascular system. Catheters, guidewires, stents, and other instruments are then advanced to the intended lesion site for minimally invasive treatment. Mitral valve disease has a high incidence rate among adult heart valve diseases. Mitral regurgitation (MR) in mitral valve disease has a particularly serious impact on patients. Normally, the mitral valve in the human heart acts as a hemostatic valve, preventing oxygen-rich blood from the lungs from flowing back into the left atrium. If the mitral valve malfunctions or becomes misaligned, MR will occur, which significantly reduces the heart's pumping efficiency and can even lead to heart failure. Mitral regurgitation is classified into functional and degenerative types. Functional mitral regurgitation (FMR) is characterized by mitral annular dilation, inadequate leaflet junction, and mitral valve leaflet tethering, which is caused by left ventricular dysfunction and remodeling. Driven by the unfavorable outcomes and high risks of surgical mitral valve repair, alternatives using catheters and minimally invasive techniques have been sought, such as percutaneous rim-to-rim repair, indirect annulation, and direct annulation. Mitral annulation is one of the most common surgical procedures for treating FMR.

[0003] Patent CN202111466800.9 discloses a precise positioning repair system, including a guiding and positioning mechanism with an active guiding device at its distal end; and an anchoring repair mechanism with a passive positioning device at its distal end. The active guiding device and the passive positioning device generate a magnetic attraction. During positioning, the distal end of the guiding and positioning mechanism reaches a predetermined position and remains stationary, while the distal end of the anchoring repair mechanism enters the heart. Furthermore, the active guiding device and the passive positioning device attract each other, causing the distal end of the anchoring repair mechanism to... The end portion reaches the target anchoring position; the defects of this patented technology are as follows: First, the repair system requires two sets of devices to complete the valve repair through different access paths, which makes the operation time lengthy and the operation complex; Second, this solution can only guide and locate a single point. In cases where the valve is not visible during the operation and the autologous valve annulus is roughly saddle-shaped, it is difficult to ensure that the guiding and positioning mechanism can be delivered to the ideal positioning position. Furthermore, the single positioning point relies on images to find the position one by one and then anchor it, which greatly increases the operation time and the operation difficulty, which is not conducive to the postoperative recovery of patients, nor to the market promotion of the product.

[0004] Patent CN 202310567779.4 discloses a guideable anchoring system, including a delivery conduit, a positioning bracket disposed within the delivery conduit, an anchoring mechanism, a flexible kit, and a guiding mechanism. The positioning bracket is disposed at the distal end of the delivery conduit and has multiple circumferentially distributed anchoring points. The flexible kit has multiple connection points. The guiding mechanism includes multiple guide lines, which pass through the connection points and connect with the anchoring points. The distal portion of the anchoring mechanism is fitted within the flexible kit, and the flexible kit, in conjunction with the guide lines, allows the anchoring mechanism to be guided to each anchoring point along a predetermined route and complete anchoring. In this scheme, the anchoring mechanism uses multiple guide lines for guidance and positioning. However, due to the limited diameter of the delivery catheter, the multiple guide lines are prone to interference within the lumen. Secondly, using lines as guides can easily cause angular deviations, resulting in insufficient accuracy. Furthermore, the head of the anchoring mechanism can only guide to the end of the positioning stent's rod. When a part of the positioning stent cannot be against the heart tissue, the head of the anchoring mechanism cannot be against the heart tissue for anchoring. Therefore, using lines as guides limits the position of the guidance point.

[0005] Therefore, those skilled in the art are dedicated to developing a repair system for valve repair, primarily addressing the following issues: 1. Ensuring precise intraoperative guidance while shortening intraoperative time; 2. Resolving interference between guide wires within the lumen; 3. Addressing the issue of angular deviation caused by guide wires; 4. Resolving the issue of limited guidance sites; 5. Resolving the issue of excessive movement of the positioning stent. Summary of the Invention

[0006] The purpose of this application is to provide a repair system for valve repair, which has the following advantages: 1. The prepositioning element and guide are integrated into the same delivery catheter, eliminating the need for additional access paths, simplifying operation and reducing intraoperative risks. At least two prepositioning elements can determine the height of the autologous valve annulus, allowing the positioning stent to move along the guide path to the autologous valve annulus, enabling rapid positioning and saving intraoperative time; 2. The limiting sleeve can accurately guide the anchoring device to the target anchoring position without interference; 3. After the anchoring device is against the anchored area, it can continue to be pushed to ensure the anchored area conforms to the cardiac tissue, with unrestricted guidance points and high fault tolerance; 4. The limiting sleeve can be compressed during loading, preventing it from encroaching on the loading space of the implanted device within the delivery catheter; 5. The rigid and flexible segmented design of the anchoring device ensures it is not affected when bending within the blood vessel; 6. The hollow tube and anchoring needle are designed separately and can be detachably connected via a guide wire, providing secondary anchoring and further increasing the device's fault tolerance.

[0007] To solve the above-mentioned technical problems, this application provides the following technical solution: a repair system for valve repair, comprising a delivery catheter, an anchoring device disposed within the delivery catheter, a positioning bracket, a guiding system, and a constriction ring component, wherein the anchoring device comprises a needle tube and an anchoring assembly disposed within the needle tube; The guidance system includes at least two sets of prepositioning elements and guide elements corresponding to the prepositioning elements. When the head end of the prepositioning element approaches the head end of the guide element, a magnetic attraction force is generated. The positioning bracket includes multiple positioning rods, a limiting sleeve and a guide channel set on the positioning rods, wherein the shrink ring component is detachably connected to the positioning rod, the distal end of the needle tube is pre-installed in the limiting sleeve, and the guide passes through the guide channel; Furthermore, after the prepositioning component arrives at the predetermined position, the guide is moved, and the head end of the prepositioning component and the head end of the guide attract each other and form a connection. The positioning bracket arrives at the target position along the path of the guide.

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

[0009] As a further improvement of the present invention, the shrink ring member is provided with an anchoring area. When the positioning bracket reaches the target position along the path of the guide, it pushes the needle tube to move along the channel in the limiting sleeve until the head end of the needle tube abuts against the anchoring area.

[0010] As a further improvement of the present invention, the shape of the positioning stent after deployment is similar to that of the treated autologous valve annulus, and the anchored area of ​​the positioning stent conforms to the heart tissue after deployment; however, due to the differences in physiological and anatomical structures among different patients, when the anchored area does not conform to the heart tissue, the anchoring device is pushed further, so that the head end of the anchoring device presses against the anchored area until the anchored area conforms to the heart tissue.

[0011] As a further improvement of the present invention, the positioning rod is provided with a serrated structure, which is used to fix the limiting sleeve and 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 developing function.

[0013] As a further improvement of the present invention, the prepositioning components described herein have an anchor-shaped structure in the working state.

[0014] As a further improvement of the present invention, the prepositioning member includes a positioning wire and a magnet or magnetic material disposed at the head end of the positioning wire, the guide includes a guide wire and a magnet or magnetic material disposed at the head end of the guide wire, and during pre-assembly, the head end of the prepositioning member and the head end of the guide are offset in the axial direction.

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

[0016] As a further improvement of the present invention, the head end of the prepositioning member and the head end of the guide member have N poles and S poles in the axial direction, and during pre-assembly, the head ends of each prepositioning member are at the same height in the axial direction, and the head ends of each guide member are at the same height in the axial direction.

[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, which means that the limiting sleeve will not generate resistance to the anchoring device during the pushing process.

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

[0021] As a further improvement of the present invention, during pre-installation, the distal portion of the limiting sleeve is compressed and deformed. When the positioning bracket is unfolded, it pushes the needle tube to move along the channel inside the limiting sleeve, and 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 pin, a hollow tube, and a guide wire, wherein the guide wire is detachably connected to the anchoring pin, the guide wire is disposed inside the hollow tube, and pushing the hollow tube allows the hollow tube to move along the guide wire and form a detachable connection with the anchoring pin.

[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 groove, and the distal end of the hollow tube is provided with a protrusion that engages with the groove, wherein the hollow tube moves along the guide line so that the protrusion is inserted into the groove to form a connection.

[0024] As a further improvement of the present invention, the hollow tube is connected to the anchoring needle through the guide wire, which can achieve multiple and repeated anchoring of the anchoring needle.

[0025] As a further improvement of the present invention, the detection element is a flexible component, 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 tube includes a rigid section and a flexible section, the rigid section being disposed at the distal end of the flexible section, and the rigid section being pre-installed within the limiting sleeve.

[0027] As a further improvement of the present invention, during pre-installation, the anchoring needle is placed in the rigid section, the hollow tube is placed in the flexible section, and the hollow tube is pre-installed in the proximal part of the needle tube. The advantage of this design is that the needle tube is designed with rigid and flexible sections. The rigid section is used for pre-installing the anchoring needle, and the flexible section is used for bending within the blood vessel. Furthermore, the hollow tube is pre-installed in the proximal part of the needle tube, which will not affect the bending of the flexible section. At the same time, it can be connected to the anchoring needle through the guide wire to complete the anchoring operation.

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

[0029] As a further improvement of the present invention, the first contraction portion and the second contraction portion are anchored adjacently to the constriction ring region set by the anchoring pin on the autologous valve annulus or atrial tissue. The control element is manipulated to cause the first contraction portion and the second contraction portion to contract, and the adjacent ends of the first contraction portion and the second contraction portion move towards the center of the autologous valve, thereby driving the middle part of the set constriction ring region to move towards the center of the autologous valve.

[0030] As a further improvement of the present invention, the shrinking ring component is an integral structure, and the first shrinking part and the second shrinking part are connected by stitching or welding.

[0031] Compared with the prior art, the advantages of this application are: 1. Existing repair systems struggle to pinpoint the exact location of the autologous valve annulus using imaging alone. Consequently, determining the location and timing of stent placement is difficult, significantly increasing intraoperative time. Current magnetic positioning systems require two separate systems with different access routes, and can only perform single-point positioning and anchoring, resulting in high operational difficulty and extended treatment time. In one embodiment of this application, at least two pre-positioning elements can pre-arrive at the root of the autologous valve leaflet. Magnetic attraction then allows the guide element to be attracted to the pre-positioning elements, quickly determining the height of the autologous valve annulus. The stent can then reach the annulus along the guide element's path. This positioning method is simple, fast, and precise, requiring only one system to complete positioning, guidance, and repair functions. It boasts high integration and ease of operation, saving considerable surgical time and reducing the possibility of postoperative complications.

[0032] 2. Unlike existing technologies, in one embodiment of this application, a detection element with imaging function can determine the relative position of the positioning stent and the autologous valve annulus, so as to accurately attach the positioning stent to the autologous valve annulus. The positioning method not only uses magnetic attraction to pre-establish a precise guide path, but also uses the detection element to determine the relative position between the positioning stent and the autologous valve annulus, avoiding excessive movement of the positioning stent by the surgeon, thereby causing damage to the heart tissue.

[0033] 3. Unlike existing technologies, in one embodiment of this application, the applicant uniquely sets a limiting sleeve on the positioning rod. The limiting sleeve forms a movable channel, and the needle tube can slide along the channel and abut against the anchored area of ​​the implanted device. The movement path of the anchoring device is guided by the limiting sleeve channel, which not only avoids mutual interference between guiding components (the guiding line used in the prior art) and saves loading space inside the sheath, but also ensures that the needle tube does not deviate in path or angle when moving within the channel, thus improving the accuracy of guidance and positioning. Furthermore, when the anchored area is not in contact with the heart tissue, the needle tube is continued to be pushed so that the tip of the needle tube abuts against the anchored area until the anchored area is in contact with the heart tissue. This ensures that the needle tube can penetrate into the heart tissue, guaranteeing its anchoring effect. In addition, this also eliminates the influence of the irregularity of the valve annulus shape caused by lesions on the anchoring device, further improving the error tolerance of the device, which has great clinical significance.

[0034] 4. Unlike the prior art, in one embodiment of this application, the limiting sleeve is made of a flexible material, and during loading, the distal part of the limiting sleeve is compressed, while after the anchoring device is pushed, the limiting sleeve can restore the channel, which makes the limiting sleeve not encroach on the loading space of the implanted device.

[0035] 5. Unlike the prior art, in one embodiment of this application, the needle tube is designed with rigid and flexible sections. The rigid section is used to pre-install the anchoring needle, and the flexible section is used for bending within the blood vessel. Furthermore, the hollow tube is pre-installed in the proximal part of the needle tube, which will not affect the bending of the flexible section. At the same time, it can be connected to the anchoring needle through the guide wire to complete the anchoring operation.

[0036] 6. Unlike the prior art, in one embodiment of this application, the anchoring pin and the hollow tube are designed separately and guided by a guide line to form a detachable connection, so that the anchoring device has the function of secondary or multiple anchoring. Attached Figure Description

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

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

[0039] Figure 4 This is a schematic diagram of the anchoring device of the present invention moving along the limiting sleeve.

[0040] Figure 5 This is a schematic diagram of the guidance system of the present invention during pre-installation.

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

[0042] Figure 7 This is a schematic diagram of the shrink ring component of the present invention.

[0043] Figures 8 to 14 This is a schematic diagram of the operation process of the present invention, wherein... Figure 12 for Figure 11 View from direction A.

[0044] The parts referred to by the numbers in the attached diagram are as follows: 1-Delivery conduit, 2-Anchoring device, 21-Needle tube, 211-Rigid section, 212-Flexible section, 22-Anchoring assembly, 221-Anchoring needle, 2211-Needle tip, 2212-Connecting part, 2213-Slot, 222-Hollow tube, 2221-Protrusion, 223-Guide line, 3-Positioning bracket, 31-Positioning rod, 32-Limiting sleeve, 33-Guide channel, 34-Detection element, 4-Guide system, 41-Pre-positioning component, 411-Positioning wire, 42-Guide component, 421-Guide wire, 5-Contraction ring component, 51-Anchored area, 52-First contraction part, 53-Second contraction part, 54-Fabric layer, 55-Control element. Specific Implementation

[0045] like Figure 1 and Figure 2 As shown, a repair system for valve repair includes a delivery catheter 1, an anchoring device 2 disposed within the delivery catheter 1, a positioning bracket 3, a guiding system 4, and a retractable ring component 5. The anchoring device 2 includes a needle tube 21 and an anchoring assembly 22 disposed within the needle tube 21. The guiding system 4 includes at least two sets of pre-positioning elements 41 and guide elements 42 corresponding to the pre-positioning elements 41. When the tip of the pre-positioning element 41 approaches the tip of the guide element 42, a magnetic attraction is generated. The deployed shape of the positioning bracket 3 is similar to the shape of the treated autologous valve annulus (this ensures that the anchored area 51 of the positioning bracket 3 conforms to the heart tissue after deployment). The positioning bracket 3 includes multiple positioning rods 31, a limiting sleeve 32 disposed on the positioning rods 31, and a guiding channel 33. The retractable ring component 5 is detachably connected to the positioning rods 31, and the retractable ring component 5 has an anchored area 51. The distal end of the needle tube 21 is pre-installed within the limiting sleeve 32. Figure 3 As shown, the guide 42 passes through the guide channel 33, as... Figure 1 As shown; and, as Figure 8 As shown, after the prepositioning member 41 reaches the predetermined position (the predetermined position is located at the leaflet root in the ventricle), the guide member 42 is moved, and the head end of the prepositioning member 41 and the head end of the guide member 42 attract each other and form a connection, as shown. Figure 9 and Figure 10As shown, the positioning bracket 3 travels along the path of the guide 42 to the target position (the target position is located at the leaflet root in the atrium), as... Figure 11 As shown, when the positioning bracket 3 reaches the target position along the path of the guide 42, it pushes the needle tube 21 to move along the channel within the limiting sleeve 32 until the tip of the needle tube 21 abuts against the anchored area 51, as shown. Figure 4 As shown, when the anchored area 51 is not in contact with the heart tissue, the anchoring device 2 is pushed further so that the head end of the anchoring device 2 presses against the anchored area 51 until the anchored area 51 is in contact with the heart tissue. Then, the anchoring component 22 is operated so that the shrinking ring component 5 is anchored on the autologous valve annulus.

[0046] In this embodiment, the positioning rod 31 is provided with a serrated structure, which is used to fix the limiting sleeve 32. The serrated structure can prevent the limiting sleeve 32 from sliding. Figure 2 As 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 developing function.

[0048] In this embodiment, the multiple sets of prepositioning elements 41 have an anchor-shaped structure in the working state.

[0049] In this embodiment, the pre-positioning component 41 includes a positioning wire 411 and a magnet or magnetic material disposed at the head end of the positioning wire 411, and the guide component 42 includes a guide wire 421 and a magnet or magnetic material disposed at the head end of the guide wire 421. Furthermore, during pre-assembly, the head end of the pre-positioning component 41 and the head end of the guide component 42 are axially misaligned. Figure 5 As shown.

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

[0051] In this embodiment, the head end of the prepositioning member 41 and the head end of the guide member 42 have N poles and S poles in the axial direction. Furthermore, during pre-assembly, the head ends of each prepositioning member 41 are at the same axial height, and the head ends of each guide member 42 are at the same axial height.

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

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

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

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

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

[0057] In this embodiment, the anchoring assembly 22 includes an anchoring pin 221, a hollow tube 222, and a guide wire 223. The guide wire 223 is detachably connected to the anchoring pin 221. The guide wire 223 is disposed within the hollow tube 222. Pushing the hollow tube 222 allows it to move along the guide wire 223 and form a detachable connection with the anchoring pin 221. Figure 6 As shown.

[0058] In this embodiment, the anchoring needle 221 includes a needle tip 2211 and a connecting part 2212. The connecting part 2212 is provided with a slot 2213. The distal end of the hollow tube 222 is provided with a protrusion 2221 that cooperates with the slot 2213. The hollow tube 222 moves along the guide line 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 to the anchoring needle 221 through the guide line 223, which can achieve multiple and repeated anchoring of the anchoring needle 221.

[0060] In this embodiment, the detection element 34 is a flexible component, 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 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 within the rigid section 211, the hollow tube 222 is disposed within the flexible section 212, and the hollow tube 222 is pre-installed in the proximal portion of the needle tube 21, such as... Figure 6As shown, the advantages of this design are: the needle tube 21 is designed with rigid and flexible sections. The rigid section 211 is used to pre-install the anchoring needle 221, and the flexible section 212 is used for bending within the blood vessel. Furthermore, the hollow tube 222 is pre-installed in the proximal part of the needle tube 21, which will not affect the bending of the flexible section 212. At the same time, it can be connected to the anchoring needle 221 through the guide wire 223 to complete the anchoring operation.

[0063] In this embodiment, the shrink ring member 5 includes a first shrinking portion 52, a second shrinking portion 53 disposed adjacent to the first shrinking portion 52, a fabric layer 54 covering the first shrinking portion 52 and the second shrinking portion 53, and a control element 55. The control element 55 is connected to the first shrinking portion 52 and the second shrinking portion 53, such as... Figure 7 As shown, pulling the control element 55 causes the first contraction portion 52 and the second contraction portion 53 to contract, and the adjacent ends of the first contraction portion 52 and the second contraction portion 53 move closer to the center of the autologous valve.

[0064] In this embodiment, the first contraction portion 52 and the second contraction portion 53 are anchored adjacently to the contraction region of the autologous valve annulus or atrial tissue via the anchoring pin 221, such as... Figure 12 As shown, manipulating the control element 55 causes the first contraction portion 52 and the second contraction portion 53 to contract, and the adjacent ends of the first contraction portion 52 and the second contraction portion 53 move closer to the center of the autologous valve, thereby driving the middle of the set annulus contraction region (when used for mitral valve treatment, this set annulus contraction region is the P2 region of the autologous valve annulus) to move closer to the center of the autologous valve, as shown. Figure 13 As shown.

[0065] In this embodiment, the shrinking ring component 5 is an integral structure, and the first shrinking part 52 and the second shrinking part 53 are connected by stitching or welding.

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

[0067] 1) The delivery catheter 1 enters the heart along the path of the guidewire within the blood vessel, pushing the prepositioning element 41 to extend it from the delivery catheter 1 and reach the root of the autologous valve leaflet, as shown. Figure 8 As shown; 2) When the head end of the prepositioning member 41 abuts against the root of the autologous leaflet, the guide member 42 is pushed, causing the guide member 42 and the corresponding prepositioning member 41 to attract each other and form a connection, such as... Figure 9 and Figure 10 As shown; 3) Push the positioning bracket 3 so that it moves towards the autologous valve annulus along the preset path of the guide 42. Observe the state of the detection element 34 through imaging. When the detection element 34 swings significantly with the autologous valve leaflet, it can be determined that the positioning bracket 3 has reached the autologous valve annulus, completing the guidance and positioning. Figure 11 and Figure 12 As shown; 4) The anchoring mechanism is operated to anchor the shrinking ring component 5 onto the autologous valve annulus, and the control element 55 is operated so that its first contraction part 52 and second contraction part 53 drive the autologous valve annulus to contract, completing the valve repair. Finally, the repair system is removed from the body. Figure 13 and Figure 14 As shown.

[0068] The foregoing description of several embodiments of this application has been provided for illustrative purposes. This foregoing description is not intended to be exhaustive, nor is it intended to limit the application to the precise configurations, constructions, and / or steps disclosed; obviously, many modifications and variations can be made in light of the teachings above. The scope of the invention and all its equivalents are intended to be defined by the appended claims.

Claims

1. A repair system for valve repair, comprising a delivery catheter, an anchoring device, a positioning support, a guiding system, and a constricting ring member, wherein the anchoring device, the positioning support, the guiding system, and the constricting ring member are disposed within the delivery catheter, characterized in that: The anchoring device includes a needle tube and an anchoring component disposed within the needle tube; the guiding system includes at least two sets of pre-positioning elements and guide elements corresponding to the pre-positioning elements, wherein a magnetic attraction is generated when the head end of the pre-positioning element approaches the head end of the guide element; the positioning bracket includes multiple positioning rods, a limiting sleeve disposed on the positioning rods, and a guiding channel, wherein the shrinking ring component is detachably connected to the positioning rods, the distal end of the needle tube is pre-installed in the limiting sleeve, and the guide element passes through the guiding channel; furthermore, after the pre-positioning element reaches a predetermined position, the guide element is moved, and the head end of the pre-positioning element attracts and connects with the head end of the guide element, and the positioning bracket reaches the target position along the path of the guide element, wherein the predetermined position is located at the leaflet root in the ventricle, and the target position is located at the leaflet root in the atrium.

2. The repair system for valve repair according to claim 1, characterized in that: The shrink ring component has an anchoring area. When the positioning bracket reaches the target position along the path of the guide, it pushes the needle tube to move along the channel inside the limiting sleeve until the head end of the needle tube abuts against the anchoring area.

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

4. The repair system for valve repair according to claim 1, characterized in that: The prepositioning components described herein have an anchor-shaped structure when in operation.

5. The repair system for valve repair according to claim 1, characterized in that: The pre-positioning component includes a positioning wire and a magnetic material disposed at the head end of the positioning wire. The guide component includes a guide wire and a magnetic material disposed at the head end of the guide wire. Furthermore, during pre-assembly, the head end of the pre-positioning component and the head end of the guide component are axially misaligned.

6. The repair system for valve repair according to claim 5, characterized in that: The cross-section of the positioning wire / guide wire is non-circular.

7. The repair system for valve repair according to claim 5, characterized in that: The head end of the prepositioning member and the head end of the guide member have N and S poles in the axial direction. Furthermore, during pre-assembly, the head ends of each prepositioning member and the head ends of each guide member are at the same axial height.

8. The repair system for valve repair according to claim 1, characterized in that: The limiting sleeve is made of flexible material, and the channel of the limiting sleeve is located inside the positioning bracket.

9. The repair system for valve repair according to claim 1, characterized in that: During pre-installation, the distal portion of the limiting sleeve is compressed and deformed. When the positioning bracket is unfolded, it pushes the needle tube to move along the channel inside the limiting sleeve, and the distal portion of the limiting sleeve is stretched open.

10. The repair system for valve repair according to claim 1, characterized in that: The anchoring assembly includes an anchoring pin, a hollow tube, and a guide wire. The guide wire is detachably connected to the anchoring pin. The guide wire is disposed inside the hollow tube. Pushing the hollow tube allows it to move along the guide wire and form a detachable connection with the anchoring pin.

11. The repair system for valve repair according to claim 10, characterized in that: The anchoring needle includes a needle head and a connecting part. The connecting part is provided with a slot. The distal end of the hollow tube is provided with a protrusion that engages with the slot. The hollow tube moves along the guide line so that the protrusion is inserted into the slot to form a connection.

12. The repair system for valve repair according to claim 3, characterized in that: The detection element is a flexible component, wherein the detection element is a spring made of metal wire, and the detection element is threadedly connected to the positioning rod.

13. The repair system for valve repair according to claim 1, characterized in that: The shrinking ring component includes a first shrinking portion, a second shrinking portion disposed adjacent to the first shrinking portion, a fabric layer covering the first shrinking portion and the second shrinking portion, and a control element. The control element is connected to the first shrinking portion and the second shrinking portion, and pulling the control element causes the first shrinking portion and the second shrinking portion to shrink, and the adjacent ends of the first shrinking portion and the second shrinking portion move towards the center of the autologous valve.

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