A repair system with precise positioning

Abstract

This application relates to the field of medical devices, and more particularly to a repair system with precise positioning capabilities, including a delivery catheter, a positioning bracket disposed within the delivery catheter, an anchoring mechanism, a flexible kit, and a guiding mechanism. The positioning bracket is disposed at the distal end of the delivery catheter, and the distal portion of the anchoring mechanism is disposed within the flexible kit. The positioning bracket has multiple circumferentially distributed positioning holes and connecting rings connected to the positioning holes. The guiding mechanism includes a single guide wire and a single disassembly wire. The guide wire has a guide hole, and the disassembly wire has a connecting rod. The distal end of the anchoring mechanism has a connecting hole. The guide wire first passes through the connecting hole, and after the connecting ring passes through the corresponding guide hole, the connecting rod passes through the corresponding connecting ring to form a detachable connection. This invention can achieve precise guidance and positioning of multiple anchoring positions using only a single guide wire and a single disassembly wire, which not only saves internal space of the sheath but also avoids the problem of interference between guide wires.

Description

Technical Field

[0001] This application belongs to the field of medical devices, specifically relating to a repair system with precise positioning capability. 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 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 located 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. While this solution allows for precise positioning of multiple anchoring locations through the positioning bracket and its guiding mechanism, the multiple guide lines are prone to interference within the limited cavity. Furthermore, when disassembling multiple anchoring locations sequentially, the resistance of the disassembly wires is significant, potentially causing problems such as bracket deformation.

[0004] Therefore, those skilled in the art are dedicated to developing a repair system that can be precisely positioned, mainly to solve the following problems: 1. Solving the problem of interference between multiple guide wires; 2. Solving the problem of excessive resistance during disassembly, which leads to deformation of the positioning bracket. Summary of the Invention

[0005] The purpose of this application is to provide a repair system with precise positioning. This novel anchoring mechanism has the following advantages: 1. The guidance and disassembly of multiple anchoring positions can be completed by only one guide wire and one disassembly wire, which effectively avoids the problem of interference between multiple guide wires in the sheath and greatly reduces the required sheath space; 2. Each anchoring position is equipped with its own connecting ring and connecting rod, and adopts a single anchoring and single disassembly method, which effectively avoids the impact on the positioning bracket and other anchoring positions during the guidance and disassembly process.

[0006] To solve the above-mentioned technical problems, this application provides the following technical solution: a repair system with precise positioning, comprising 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 the distal end of the anchoring mechanism is disposed within the flexible kit. The positioning bracket has multiple circumferentially distributed positioning holes and connecting rings connected to the positioning holes. The guiding mechanism includes a single guide wire and a single disassembly wire. The guide wire has a guide hole, and the disassembly wire has a connecting rod. The distal end of the anchoring mechanism has a connecting hole. During pre-assembly, the guide wire first passes through the connecting hole, and after the connecting ring passes through the corresponding guide hole, the connecting rod passes through the corresponding connecting ring to form a detachable connection.

[0007] As a further improvement of the present invention, the flexible kit is provided with a guide groove, and the connecting hole at the distal end of the anchoring mechanism is provided at the guide groove; the guide groove enables the connecting hole at the distal end of the anchoring mechanism to cooperate with the guide wire to reach the positioning holes distributed circumferentially on the positioning bracket, that is, the expected anchoring position, so as to achieve precise guidance and positioning.

[0008] As a further improvement of the present invention, the positioning hole is the expected anchoring position. When the positioning bracket is released, the guide wire is tightened, and the anchoring mechanism reaches the expected anchoring position along the guide wire.

[0009] As a further improvement of the present invention, after the anchoring mechanism completes the first anchoring by tightening the guide wire, the disassembly wire is tightened to separate the connecting rod from the connecting ring. The anchoring mechanism is then retracted, and the guide wire is tightened again, allowing the anchoring mechanism to reach the next anchoring position along the guide wire.

[0010] As a further improvement of the present invention, during pre-installation, the connection trajectory direction of the guide wire is opposite to the connection trajectory direction of the disassembly wire.

[0011] As a further improvement of the present invention, the anchoring mechanism includes an anchoring tube and an anchoring pin, the anchoring pin being pre-installed in the anchoring tube, and the distal portion of the anchoring tube having an adjustment capability.

[0012] As a further improvement of the present invention, the connecting hole is located at the far end of the anchoring tube, which makes there no movement error during guidance and positioning, that is, the guidance and positioning point is the expected anchoring point.

[0013] As a further improvement of the present invention, the delivery conduit is provided with a push tube, the distal end of the push tube is detachably connected to the proximal end of the flexible kit, and the anchoring tube is disposed inside the push tube.

[0014] As a further improvement of the present invention, after the anchoring mechanism completes anchoring and retracts, it pushes the push tube to push the flexible kit to the far end.

[0015] As a further improvement of the present invention, the flexible kit includes a fabric layer, a shrinking ring skeleton, and a control wire. The fabric layer wraps the shrinking ring skeleton, and after the shrinking ring skeleton is anchored to the autologous valve ring, pulling the control wire can cause the shrinking ring skeleton to cause the autologous valve ring to contract.

[0016] As a further improvement of the present invention, during pre-installation, the flexible kit is loaded in the delivery conduit in a linear or vertical state; and during anchoring, the anchoring mechanism is pushed to anchor the flexible kit in sequence.

[0017] As a further improvement of the present invention, after all anchoring positions are anchored, the flexible kit is anchored on the autologous valve annulus, and the control wire is further manipulated to cause the shrinking annulus skeleton to drive the autologous valve annulus to contract in order to treat annulus dilation.

[0018] Compared with the prior art, the advantages of this application are:

[0019] 1. In the prior art, during the guidance and positioning of the repair system, multiple guide wires interfere with each other inside the sheath, and excessive resistance during disassembly can cause deformation of the positioning bracket. In one embodiment of this application, the guidance mechanism has only one guide wire and one disassembly wire, which can complete the precise guidance and positioning of multiple anchoring positions, effectively avoiding the problem of interference between guide wires and greatly saving space inside the sheath. Furthermore, each anchoring position is provided with a corresponding connecting rod and connecting ring. After a certain anchoring position is completed, only the disassembly wire needs to be tightened to allow the connecting rod to disengage from the connecting ring. During separation, there is only friction between the connecting rod and the corresponding connecting ring, and the disassembly resistance is small. Moreover, it will not affect the other anchoring positions of the positioning bracket. The structural design is simple and easy to operate, and the operation requirements of the operator are not high, which has good clinical significance.

[0020] 2. Unlike the prior art, in one embodiment of this application, the flexible kit is provided with a guide groove, and the connecting hole at the far end of the anchoring mechanism is set at the guide groove, so that when the far end of the anchoring mechanism reaches the positioning hole along the guide wire, there will be no movement error, that is, the positioning hole is the expected anchoring position, thus achieving precise guidance and positioning. Attached Figure Description

[0021] Figure 1 This is a schematic diagram of the overall structure of the repair system of the present invention.

[0022] Figure 2 for Figure 1 Enlarged view of part A in the middle.

[0023] Figure 3 for Figure 1 Enlarged view of section B in the middle.

[0024] Figure 4 This is a schematic diagram of the guide wire structure of the present invention.

[0025] Figure 5 This is a schematic diagram of the disassembly wire structure of the present invention.

[0026] Figure 6 This is a schematic diagram of the anchoring mechanism of the present invention.

[0027] Figure 7 This is a pre-assembly diagram of the flexible kit of the present invention.

[0028] Figure 8 This is a schematic diagram of the structure of the flexible kit of the present invention.

[0029] Figures 9-16 This is a schematic diagram illustrating the working process of the repair system of the present invention.

[0030] The parts referred to by the numbers in the attached diagram are as follows: 1-Delivery conduit, 2-Positioning bracket, 21-Positioning hole, 22-Connecting ring, 3-Anchoring mechanism, 31-Anchoring tube, 32-Anchoring needle, 33-Connecting hole, 4-Flexible kit, 41-Guide groove, 42-Fabric layer, 43-Retracting ring skeleton, 44-Control wire, 5-Guide mechanism, 51-Guide wire, 511-Guide hole, 52-Disassembly wire, 521-Connecting rod, 6-Push tube. Implementation

[0031] The present application will now be described in further detail with reference to the accompanying drawings and embodiments.

[0032] The proximal end, as described in this application, refers to the end closer to the surgical operator, while the distal end refers to the end farther away from the surgical operator. Specific Implementation

[0033] like Figures 1 to 3 As shown, when this anchoring system is used for mitral valve annulus retraction repair, a precisely positioned repair system includes a delivery catheter 1, a positioning bracket 2 disposed within the delivery catheter 1, an anchoring mechanism 3, a flexible kit 4, and a guiding mechanism 5. The positioning bracket 2 is disposed at the distal end of the delivery catheter 1, and the distal portion of the anchoring mechanism 3 is disposed within the flexible kit 4. The positioning bracket 2 has multiple circumferentially distributed positioning holes 21 and multiple connecting rings 22 connected to the multiple positioning holes 21. The guiding mechanism 5 includes a single guide wire 51 and a single disassembly wire 52. The guide wire 51 has multiple guide holes 511 corresponding to the positioning holes 21, such as... Figure 4 As shown, the disassembly screw 52 is provided with a plurality of connecting rods 521 corresponding to the connecting ring 22, such as... Figure 5 As shown, the distal end of the anchoring mechanism 3 is provided with a connecting hole 33. During pre-installation, the guide wire 51 first passes through the connecting hole 33, and after the connecting ring 22 passes through the corresponding guide hole 511, the connecting rod 521 passes through the corresponding connecting ring 22 to form a detachable connection. When the delivery catheter 1 enters the heart, the positioning bracket 2 is released, so that the positioning hole 21 on the positioning bracket 2 is abutted against the expected anchoring position, such as... Figure 9 As shown, tightening the guide wire 51 and pushing the anchoring mechanism 3 causes the anchoring mechanism 3 to reach the positioning hole 21 along the path of the guide wire 51. Operating the anchoring mechanism 3 completes the anchoring of the first anchoring position. Then, tightening the disassembly wire 52 causes the connecting rod 521 at that point to disengage from the connecting ring 22, completing the disassembly. Figures 10 to 12 As shown, the anchoring mechanism 3 is then retracted, and the guide wire 51 is tightened again, pushing the anchoring mechanism 3 to the second anchoring position, as shown. Figure 13 and Figure 14As shown, continue in this manner to complete the anchoring at all anchoring positions, such as... Figure 15 and Figure 16 As shown.

[0034] In this embodiment, the flexible kit 4 is provided with a guide groove 41, and the connecting hole 33 at the distal end of the anchoring mechanism 3 is disposed at the guide groove 41, such as... Figure 3 As shown; the guide groove 41 enables the connecting hole 33 at the far end of the anchoring mechanism 3 to cooperate with the guide wire 51 to reach the positioning hole 21 distributed circumferentially on the positioning bracket 2, that is, the expected anchoring position, so as to achieve precise guidance and positioning.

[0035] In this embodiment, the positioning hole 21 is the expected anchoring position. When the positioning bracket 2 is released, the guide wire 51 is tightened, and the anchoring mechanism 3 reaches the expected anchoring position along the guide wire 51.

[0036] In this embodiment, after the anchoring mechanism 3 completes its initial anchoring by tightening the guide wire 51, the disassembly wire 52 is tightened, causing the connecting rod 521 to separate from the connecting ring 22. Figures 10 to 12 As shown, the anchoring mechanism 3 is retracted, and the guide wire 51 is tightened again. The anchoring mechanism 3 moves along the guide wire 51 to the next anchoring position, as shown. Figure 13 and Figure 14 As shown.

[0037] In this embodiment, during pre-installation, the connection trajectory direction of the guide wire 51 is opposite to the connection trajectory direction of the disassembly wire 52.

[0038] In this embodiment, the anchoring mechanism 3 includes an anchoring tube 31 and an anchoring needle 32. The anchoring needle 32 is pre-installed inside the anchoring tube 31, and the distal portion of the anchoring tube 31 has bending capability. Figure 6 As shown.

[0039] In this embodiment, the connecting hole 33 is located at the far end of the anchoring tube 31, which makes there no movement error during guidance and positioning, that is, the guidance and positioning point is the expected anchoring point.

[0040] In this embodiment, the delivery conduit 1 is provided with a push tube 6, the distal end of the push tube 6 is detachably connected to the proximal end of the flexible kit 4, and the anchoring tube 31 is disposed inside the push tube 6, such as... Figure 7 As shown.

[0041] In this embodiment, after the anchoring mechanism 3 completes anchoring and retracts, the push tube 6 is pushed to push the flexible kit 4 to the far end.

[0042] In this embodiment, the flexible kit 4 includes a fabric layer 42, a shrink ring skeleton 43, and control yarns 44. The fabric layer 42 wraps around the shrink ring skeleton 43, as shown below. Figure 8 As shown, after the shrinking ring skeleton 43 is anchored to the autologous valve annulus, pulling the control wire 44 can cause the shrinking ring skeleton 43 to drive the autologous valve annulus to contract.

[0043] In this embodiment, during pre-installation, the flexible kit 4 is loaded in the delivery conduit 1 in a linear or vertical state; and during anchoring, the anchoring mechanism 3 is pushed to anchor the flexible kit 4 in sequence.

[0044] In this embodiment, after all anchoring positions are anchored, the flexible kit 4 is anchored on the autologous valve annulus. The control wire 44 is then manipulated to cause the shrinking annulus skeleton 43 to cause the autologous valve annulus to contract in order to treat annulus dilation.

[0045] 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 precision-positioning repair system, comprising a delivery conduit, a positioning bracket disposed within the delivery conduit, an anchoring mechanism, a flexible assembly, and a guiding mechanism, wherein the positioning bracket is disposed at the distal end of the delivery conduit, the distal portion of the anchoring mechanism is disposed within the flexible assembly, and the positioning bracket has a plurality of circumferentially distributed positioning holes and connecting rings connected to the positioning holes, characterized in that: The guiding mechanism includes a single guide wire and a single disassembly wire. The guide wire has a guide hole, and the disassembly wire has a connecting rod. The distal end of the anchoring mechanism has a connecting hole. During pre-assembly, the guide wire first passes through the connecting hole, and after the connecting ring passes through the corresponding guide hole, the connecting rod passes through the corresponding connecting ring to form a detachable connection. After the guide wire is tightened and the anchoring mechanism completes the initial anchoring, the disassembly wire is tightened, causing the connecting rod to separate from the connecting ring. The anchoring mechanism is then retracted, and the guide wire is tightened again, allowing the anchoring mechanism to reach the next anchoring position along the guide wire.

2. The repair system with precise positioning according to claim 1, characterized in that: The flexible kit is provided with a guide groove, and the connecting hole at the distal end of the anchoring mechanism is located at the guide groove.

3. The repair system with precise positioning according to claim 1, characterized in that: The positioning hole is the intended anchoring position. When the positioning bracket is released, the guide wire is tightened, and the anchoring mechanism reaches the intended anchoring position along the guide wire.

4. The repair system with precise positioning according to claim 1, characterized in that: During pre-installation, the connection trajectory direction of the guide wire is opposite to that of the connection trajectory direction of the disassembly wire.

5. The repair system with precise positioning according to claim 1, characterized in that: The anchoring mechanism includes an anchoring tube and an anchoring pin. The anchoring pin is pre-installed in the anchoring tube, and the distal end of the anchoring tube has an adjustment capability.

6. The repair system with precise positioning according to claim 5, characterized in that: The delivery conduit is provided with a push tube, the distal end of which is detachably connected to the proximal end of the flexible kit, and the anchoring tube is disposed inside the push tube.

7. The repair system with precise positioning according to claim 6, characterized in that: After the anchoring mechanism completes anchoring and retracts, it pushes the push tube to push the flexible kit to the far end.

8. The repair system with precise positioning according to claim 1, characterized in that: The flexible kit includes a fabric layer, a shrinking ring skeleton, and control yarns. The fabric layer wraps around the shrinking ring skeleton, and after the shrinking ring skeleton is anchored to the autologous valve ring, pulling the control yarns can cause the shrinking ring skeleton to cause the autologous valve ring to contract.

9. The repair system with precise positioning according to claim 1, characterized in that: During pre-installation, the flexible kit is loaded into the delivery conduit in a linear or vertical state; and during anchoring, the anchoring mechanism is pushed to anchor the flexible kit in sequence.

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