A positioning device on a repair system

Abstract

The application relates to the field of medical devices, in particular to a positioning device on a repair system, which comprises a delivery catheter, a fixing member arranged at the distal end of the delivery catheter, a positioning device connected with the fixing member, an anchoring mechanism, a flexible sleeve and a guide mechanism, the positioning device comprises a plurality of circumferentially distributed positioning units, each of the positioning units comprises a connecting part and a supporting part, the connecting parts of adjacent positioning units are connected with each other in a winding mode to form a connecting section, and a connecting area is arranged on the connecting section, wherein the fixing member comprises an inner layer and an outer layer, a connecting channel is arranged between the inner layer and the outer layer, the outer layer is provided with an embedded claw structure, during pre-assembly, the connecting section is located in the connecting channel, the proximal end of the connecting section is fixed with the inner layer, and the embedded claw structure is fixed with the connecting section in a matched mode to limit the movement of the connecting section; the positioning device can meet the supporting rigidity required by clinical operation and will not be separated from the fixing member.

Description

Technical Field

[0001] This application belongs to the field of medical devices, specifically relating to a positioning device on a repair system. 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 CN202310567827.X discloses a precisely adjustable anchoring system, including a delivery catheter, a positioning device disposed within the delivery catheter, an anchoring device, and a guiding mechanism. The guiding mechanism connects the anchoring device and the positioning device. The positioning device includes a connecting part and a supporting part. The guiding mechanism is connected to the supporting part, and the position where the guiding mechanism connects to the supporting part is called the anchoring point. The supporting part can adhere to the heart tissue after release. The delivery catheter contains a control component, the distal end of which is connected to the supporting part. Operating the control component causes local deformation of the supporting part, displacing the anchoring point and allowing the anchoring device to reach the target anchoring position. The shortcomings of this patent solution are: firstly, the braided wires of the positioning device are only fixed to the delivery catheter by welding, which poses a risk of detachment at the connection point; secondly, because the braided wires on the positioning device are not mutually constrained or fixed, their supporting rigidity cannot meet the requirements of clinical surgery.

[0004] Therefore, those skilled in the art are dedicated to developing a positioning device for a repair system, mainly to solve the following problems: 1. How to fix the braided wire of the positioning device to the delivery catheter to prevent the positioning device from falling off; 2. How to improve the support rigidity of the positioning device to meet the needs of clinical surgery.

[0005] Application content

[0006] The purpose of this application is to provide a positioning device for a repair system. This novel positioning system has the following advantages: 1. The connecting parts are mutually constrained and the connecting segments can be firmly fixed to the fixing parts through the claw structure, effectively preventing the positioning device from falling off; 2. The positioning units are mutually constrained, so that the positioning device forms a whole, thereby effectively enhancing the support rigidity of the positioning device to meet the needs of clinical surgery.

[0007] To solve the above-mentioned technical problems, this application provides the following technical solution: a positioning device for a repair system, comprising a delivery conduit, a fixing member disposed at the distal end of the delivery conduit, a positioning device connected to the fixing member, an anchoring mechanism, a flexible kit, and a guiding mechanism. The positioning device includes multiple circumferentially distributed positioning units, each positioning unit including a connecting portion and a supporting portion. Adjacent connecting portions are intertwined to form a connecting segment, and the connecting segment has a connecting area. The fixing member includes an inner layer and an outer layer, with a connecting channel between the inner and outer layers. The outer layer has a claw structure. During pre-installation, the connecting segment is located within the connecting channel, the proximal end of the connecting segment is fixed to the inner layer, and the claw structure cooperates with the connecting segment to restrict movement of the connecting segment.

[0008] As a further improvement of the present invention, the positioning unit is composed of one or more strands of wire, and the diameter of the wire constituting the positioning unit is less than 0.5 mm.

[0009] As a further improvement of the present invention, a winding section is provided between the connecting part and the supporting part, and the winding section ensures that the length of the connecting part remains constant.

[0010] As a further improvement of the present invention, the connecting part includes two connecting wires, and the connecting wires of adjacent connecting parts are intertwined and interwoven to form a connecting area.

[0011] As a further improvement of the present invention, the connecting segment is arranged in a twisted structure.

[0012] As a further improvement of the present invention, the claw structure includes a fixing claw extending into the inner periphery of the outer layer, and the claw structure is arranged in a cross shape.

[0013] As a further improvement of the present invention, the connecting area is a closed-loop structure; the fixing claw of the claw structure overlaps and embeds itself into the connecting area at the center of the connecting area, so that the connecting segment is "nailed" in the connecting channel by the claw structure, which can effectively restrain the connecting segment and prevent the connecting segment from falling off during use.

[0014] As a further improvement of the present invention, the center of the claw structure coincides with the center of the connecting region.

[0015] As a further improvement of the present invention, the distal end of the support portion is provided with two lever arms, which intersect to form the anchoring point, and adjacent support portions are intertwined and connected to each other so that the length of the two lever arms at the distal end of the support portion remains constant.

[0016] As a further improvement of the present invention, the included angle formed by the two lever arms is greater than 90°.

[0017] As a further improvement of the present invention, the support portion is hexagonal, wherein adjacent support portions are intertwined to form two side edges of the support portion, and the number of turns between adjacent support portions is greater than or equal to 4.

[0018] As a further improvement of the present invention, the support portion is arranged in a symmetrical structure with respect to the line connecting the vertex of the near end of the support portion and the vertex of the far end of the support portion.

[0019] As a further improvement of the present invention, a connecting portion is formed between adjacent positioning units, and the connecting portion is arranged in a symmetrical structure with respect to the line connecting the vertex of the near end of the connecting portion and the vertex of the far end of the connecting portion.

[0020] As a further improvement of the present invention, the positioning device has a predetermined shape, wherein, during pre-installation, the positioning device is compressed inside the delivery conduit; when the distal end of the delivery conduit reaches the target position, the positioning device is released from the delivery conduit, and the distal end of the anchoring point is located at the expected anchoring position.

[0021] Compared with the prior art, the advantages of this application are:

[0022] 1. In the prior art, the braided wires of the positioning device are directly welded to the delivery conduit, and the weld points are prone to breakage during use, causing the positioning device to detach from the delivery conduit. In one embodiment of this application, adjacent connecting parts are intertwined to form a connecting segment, which is then inserted into the connecting channel of the fixing member. The head end of the connecting segment is welded to the inner layer, and the segment is embedded in the connecting area through a claw structure to achieve a fixed connection between the positioning device and the fixing member, restricting the movement of the connecting segment. This fixing method not only constrains the various positioning units to each other, enhancing the overall integrity and support rigidity of the positioning bracket, but also prevents the positioning bracket from dislodging from its fixing member, ensuring the safety of the device.

[0023] 2. In a different embodiment of the present application, the claw structure is cross-shaped, and the center of the claw structure is correspondingly set with the center of the connecting area. This allows the fixing claw of the claw structure to be fully embedded in the connecting area, restricting the movement of the connecting segment and "nailing" the connecting segment in the connecting channel. This can effectively restrain the connecting segment and thus effectively prevent the positioning device and the fixing member from falling off.

[0024] 3. In the prior art, to ensure the support rigidity of the positioning device, a support rod with high rigidity is used to manufacture the positioning device. Although this satisfies the support performance of the stent, excessive rigidity can lead to excessive self-expansion force of the stent at the moment of release, which can easily cause damage to the heart tissue. In one embodiment of this application, the positioning device is made of one or more strands of wire with a diameter of less than 0.5 mm, ensuring that the heart tissue will not be damaged due to excessive material rigidity. Furthermore, adjacent support parts and adjacent connecting parts are intertwined and connected to enhance the overall integrity of the positioning device. This unique structural design improves the support performance of the positioning device, which can meet the needs of clinical surgery and effectively avoid damage to the heart tissue.

[0025] 4. In a different embodiment of the present application, the two lever arms are of equal length. With the interval between the lever arm support points remaining unchanged, the angle between the two lever arms forming the anchor point is greater than 90°. This causes the bending line of the force deformation to move upward and become longer, resulting in a greater force required for the anchor point to move or deform. This ensures that the positioning device and its anchor point have sufficient support rigidity to meet the clinical surgical requirements. Attached Figure Description

[0026] Figure 1 This is a schematic diagram of the overall structure of the positioning device in Embodiment 1 of the present invention.

[0027] Figure 2 and Figure 3 This is a schematic diagram of the positioning device and fixing component in Embodiment 1 of the present invention.

[0028] Figure 4 This is a schematic diagram of the inner layer in Embodiment 1 of the present invention.

[0029] Figure 5 This is a schematic diagram of the connection between the connecting end and the inner layer in Embodiment 1 of the invention.

[0030] Figure 6 This is a schematic diagram of the outer layer in Embodiment 1 of the present invention.

[0031] Figure 7 This is a schematic diagram of the connection between the connecting end and the outer layer in Embodiment 1 of the invention.

[0032] The parts referred to by the numbers in the attached diagram are as follows: 1-Conveying conduit, 2-Positioning device, 21-Positioning unit, 211-Connecting part, 2111-Connecting area, 212-Supporting part, 2121-Lever arm, 22-Connecting section, 23-Winding section, 24-Connecting part, 3-Anchoring mechanism, 4-Flexible kit, 5-Guiding mechanism, 6-Anchoring point, 7-Fixing component, 71-Inner layer, 72-Outer layer, 721-Claw structure, 722-Fixing claw, 73-Connecting channel. Implementation

[0033] The present application will now be described in further detail with reference to the accompanying drawings and embodiments.

[0034] 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

[0035] like Figure 1 and Figure 2 As shown, when this anchoring system is used for mitral valve annulus retraction repair, a positioning device 2 on the repair system includes a delivery catheter 1, a fixation member 7 disposed at the distal end of the delivery catheter 1, a positioning device 2 connected to the fixation member 7, an anchoring mechanism 3, a flexible kit 4, and a guiding mechanism 5. The anchoring mechanism 3, the flexible kit 4, and the guiding mechanism 5 are consistent with the structural design disclosed in existing patent CN202310568240.0, and therefore will not be described further. The positioning device 2 includes multiple circumferentially distributed positioning units 21. Each positioning unit 21 is composed of one or more strands of wire, and the diameter of the wire constituting the positioning unit 21 is less than 0.5 mm. Each positioning unit 21 includes a connecting portion 211 and a supporting portion 212. Adjacent connecting portions 211 are intertwined to form a connecting segment 22. The connecting segment 22 has a connecting area 2111, and the connecting segment 22 has a twisted structure, such as... Figure 5As shown, this makes adjacent connecting parts 211 mutually constrained, making it difficult for the threads of the connecting parts 211 to detach individually, while also increasing the stability between each positioning unit 21. The fixing member 7 includes an inner layer 71 and an outer layer 72, with a connecting channel 73 between the inner layer 71 and the outer layer 72, such as... Figure 3 As shown, the outer layer 72 is provided with a claw structure 721, the claw structure 721 including a fixing claw 722 extending into the inner periphery of the outer layer 72, and the claw structure 721 is arranged in a cross shape, as shown. Figure 1 and Figure 6 As shown, during pre-assembly, the connecting segment 22 is located within the connecting channel 73, and the proximal end of the connecting segment 22 is fixed to the inner layer 71 (by welding). Figure 4 and Figure 5 As shown, the center of the claw structure 721 is correspondingly arranged with the connection area 2111, and the fixing claw 722 of the claw structure 721 is embedded into the connection segment 22 with the connection area 2111 as the center, so that the connection segment 22 is "nailed" into the connection channel 73 by the claw structure 721, as shown. Figure 7 As shown, it can effectively restrain the connecting segment 22 and prevent the connecting segment 22 from falling off during use.

[0036] In this embodiment, a winding section 23 is provided between the connecting part 211 and the supporting part 212, such as... Figure 2 As shown, the winding segment 23 ensures that the length of the connecting part 211 remains constant, and the winding segment 23 ensures that the length of the filament in the connecting part 211 remains constant. The constant length of the filament means that the connecting part 211 is a relatively fixed integral structure with better stability.

[0037] In this embodiment, the distal end of the support portion 212 is provided with two lever arms 2121, which intersect to form the anchoring point 6. Furthermore, adjacent support portions 212 are intertwined and connected to each other, so that the length of the two lever arms 2121 at the distal end of the support portion 212 remains constant. Adjacent support portions 212 and adjacent connecting portions 211 are intertwined and connected to each other, enhancing the overall integrity of the positioning device 2. The unique structural design improves the support performance of the positioning device 2, eliminating the need for a thicker rod to enhance the support rigidity of the positioning device 2. This not only meets the needs of clinical surgery but also effectively avoids damage to cardiac tissue.

[0038] In this embodiment, the included angle formed by the two lever arms 2121 is greater than 90°.

[0039] In this embodiment, the support portion 212 is hexagonal, wherein adjacent support portions 212 are intertwined to form two side edges of the support portion 212, and the number of turns between adjacent support portions 212 is greater than or equal to 4. Figure 2 As shown.

[0040] In this embodiment, the support portion 212 is arranged symmetrically with respect to the line connecting the vertex of the near end of the support portion 212 and the vertex of the far end of the support portion 212.

[0041] In this embodiment, a connecting portion 24 is formed between adjacent positioning units 21, and the connecting portion 24 is arranged symmetrically with respect to the line connecting the vertex of the proximal end of the connecting portion 24 and the vertex of the distal end of the connecting portion 24, such as... Figure 2 As shown.

[0042] In this embodiment, the connecting portion 24 is configured with a hexagonal structure.

[0043] In this embodiment, the positioning device 2 has a predetermined shape, wherein, during pre-installation, the positioning device 2 is compressed inside the delivery conduit 1; when the distal end of the delivery conduit 1 reaches the target position, the positioning device 2 is released from the delivery conduit 1, and the distal end of the anchoring point 6 is located at the expected anchoring position.

[0044] 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 positioning device on a repair system, comprising a delivery catheter, a fixation member disposed at a distal end of the delivery catheter, a positioning device connected to the fixation member, an anchoring mechanism, a flexible sleeve member, and a guiding mechanism, characterized in that: The positioning device comprises a plurality of circumferentially distributed positioning units, each of which comprises a connecting part and a supporting part, the connecting parts of adjacent positioning units are connected to each other in a winding manner to form a connecting section, and the connecting section is provided with a connecting area, wherein the fixing member comprises an inner layer and an outer layer, a connecting channel is arranged between the inner layer and the outer layer, the outer layer is provided with an embedded claw structure, during pre-assembly, the connecting section is located in the connecting channel, the proximal end of the connecting section is fixed to the inner layer, and the embedded claw structure is embedded in the connecting area and limits the movement of the connecting section.

2. A positioning device for a prosthetic system according to claim 1, characterized in that: The connecting part comprises two connecting wires, and the connecting wires of adjacent connecting parts are wound and interlaced to form a connecting area.

3. A positioning device for a prosthetic system according to claim 2, characterized in that: The embedded claw structure comprises a fixed claw extending towards the inner periphery of the outer layer, and the embedded claw structure is arranged in a cross-shaped structure.

4. A positioning device for a prosthetic system according to claim 3, characterized in that: The connecting area is in a closed loop structure.

5. A positioning device for a prosthetic system according to claim 1, characterized in that: The distal end of the supporting part is provided with two force arms, the two force arms intersect to form an anchor point, and adjacent supporting parts are connected to each other in a winding manner, so that the length of the two force arms at the distal end of the supporting part is always constant.

6. A positioning device for a prosthetic system according to claim 5, characterized in that: The included angle formed by the two force arms is greater than 90°.

7. A positioning device for a prosthetic system according to claim 1, characterized in that: The positioning unit is composed of one or more wires, and the diameter of the wire constituting the positioning unit is less than 0.5 mm.

8. A positioning device for a prosthetic system according to claim 1, characterized in that: The supporting part is a hexagon, wherein adjacent supporting parts are wound to form two sides of the supporting part, and the number of windings between adjacent supporting parts is greater than or equal to 4.

9. A positioning device for a prosthetic system according to claim 8, characterized in that: The supporting part is arranged in a symmetrical structure with respect to the line connecting the vertex of the proximal end of the supporting part and the vertex of the distal end of the supporting part.

10. A positioning device for a prosthetic system according to claim 1, characterized in that: Adjacent positioning units form a connecting part, and the connecting part is arranged in a symmetrical structure with respect to the line connecting the vertex of the proximal end of the connecting part and the vertex of the distal end of the connecting part.

11. A positioning device for a prosthetic system according to claim 1, characterized in that: A winding section is arranged between the connecting part and the supporting part, and the winding section ensures that the length of the connecting part is always constant.

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