Positioning device on repairing system

Abstract

The invention relates to the field of medical instruments, in particular to a positioning device on a repair system, which comprises a conveying catheter, a fixing piece arranged at the far end of the conveying catheter, a positioning device connected with the fixing piece, an anchoring mechanism, a flexible sleeve piece and a guiding mechanism, each positioning unit comprises a connecting part and a supporting part, the adjacent connecting parts are mutually wound and connected to form a connecting section, a connecting area is arranged on the connecting section, each fixing part 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, and during preassembling, the embedded claw structures are arranged on the inner layer and the outer layer. The connecting section is located in the connecting channel, the near end of the connecting section is fixed to the inner layer, and the embedded claw structure is fixed to the connecting section in a matched mode so as to limit movement of the connecting section; the positioning device can meet the supporting rigidity required by a clinical operation, and does not fall off from a fixing piece.

Description

Technical Field

[0001] The present application belongs to the field of medical devices, and specifically relates to a positioning device on a repair system. Background Art

[0002] Minimally invasive interventional medical technology is an efficient diagnosis and treatment method that has gradually emerged in recent years. It has outstanding advantages such as less trauma, simple operation, accurate intervention site, and fewer complications. It has now become one of the most important diagnosis and treatment methods for cardiovascular diseases and tumor diseases. In interventional medical surgery, professional doctors usually need to manually operate specific devices to enable one or more slender flexible catheters with different shapes or functions to pass through the patient's complex and changeable cardiovascular and other human body cavity environments, and send catheters, guide wires, stents and other instruments to the predetermined diagnosis and treatment lesion site for minimally invasive diagnosis and treatment of the lesion site. The incidence of mitral valve disease is high among adult heart valve diseases. Mitral regurgitation (MR) in mitral valve disease has a very serious impact on patients. Under normal circumstances, 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 is improperly closed or misplaced, MR will occur, which will significantly reduce the heart's pumping efficiency and even cause heart failure. Mitral regurgitation is classified into two types: functional and degenerative. Functional mitral regurgitation (FMR) is characterized by mitral annular dilatation, inadequate leaflet coaptation, and tethered mitral valve leaflets, which are caused by left ventricular dysfunction and remodeling. Driven by the poor results and higher risks of surgical mitral valvuloplasty, people have begun to look for alternatives using catheters and minimally invasive methods, such as percutaneous edge-to-edge repair, indirect annuloplasty, and direct annuloplasty. Mitral annuloplasty is one of the most common surgical procedures for the treatment of FMR.

[0003] Patent CN202310567827.X discloses a precisely controllable anchoring system, including a delivery catheter, a positioning device arranged in the delivery catheter, an anchoring device and a guiding mechanism, wherein the guiding mechanism connects the anchoring device and the positioning device, the positioning device includes a connecting portion and a supporting portion, the guiding mechanism is connected to the supporting portion, and the position where the guiding mechanism is connected to the supporting portion is called an anchoring point, and the supporting portion can be close to the heart tissue after being released, wherein a control member is provided in the delivery catheter, the distal end of the control member is connected to the supporting portion, and the operation of the control member causes the supporting portion to be locally deformed, the anchoring point is displaced and the anchoring device can reach the target anchoring position. The defects of this patent solution are: First, the braided wire of the positioning device is fixed to the delivery catheter only by welding, and there is a risk of falling off at the connection; second, because the braided wires on the positioning device are not mutually constrained or fixed, the support rigidity thereof cannot meet the requirements of clinical surgery.

[0004] Therefore, technicians in this field are committed to developing a positioning device on the repair system, mainly to solve the following problems: 1. How to strengthen the fixed connection between the braided wire of the positioning device and the delivery catheter to prevent the positioning device from falling off the delivery catheter; 2. How to improve the supporting rigidity of the positioning device to meet clinical surgical needs. Application Contents

[0005] The purpose of the present application is to provide a positioning device on a repair system, and the new positioning system has the following advantages: 1. The connecting parts are mutually constrained and the connecting section can be firmly fixed to the fixing part through the claw structure, effectively preventing the positioning device from falling off; 2. The various positioning units are mutually constrained, so that the positioning device forms a whole, thereby effectively enhancing the supporting rigidity of the positioning device to meet clinical surgical needs.

[0006] In order to solve the above technical problems, the present application is solved by the following technical solutions: a positioning device on a repair system, comprising a delivery catheter, a fixing piece arranged at the distal end of the delivery catheter, a positioning device connected to the fixing piece, an anchoring mechanism, a flexible sleeve and a guiding mechanism, the positioning device comprising a plurality of circumferentially distributed positioning units, the positioning unit comprising a connecting portion and a supporting portion, adjacent connecting portions are intertwined and connected to form a connecting segment, a connecting area is provided on the connecting segment, wherein the fixing piece comprises an inner layer and an outer layer, a connecting channel is provided between the inner layer and the outer layer, the outer layer is provided with a claw structure, when pre-installed, the connecting segment is located in the connecting channel, the proximal end of the connecting segment is fixed to the inner layer, and the claw structure is cooperated and fixed with the connecting segment to limit the movement of the connecting segment.

[0007] 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.

[0008] As a further improvement of the present invention, a winding section is provided between the connecting portion and the supporting portion, and the winding section makes the length of the connecting portion always constant.

[0009] As a further improvement of the present invention, the connecting portion includes two connecting wires, and the connecting wires of adjacent connecting portions are intertwined and interwoven to form a connecting area.

[0010] As a further improvement of the present invention, the connecting section is arranged in a twisted structure.

[0011] As a further improvement of the present invention, the claw structure includes fixed claws extending toward the inner periphery of the outer layer, and the claw structure is arranged in a cross-shaped structure.

[0012] As a further improvement of the present invention, the connecting area is a closed-loop structure; the fixing claw of the claw structure coincides with the center of the connecting area and is embedded in 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.

[0013] As a further improvement of the present invention, the center of the claw structure coincides with the center of the connecting area.

[0014] As a further improvement of the present invention, two force arms are provided at the distal end of the support portion, the two force arms intersect to form the anchoring point, and the adjacent support portions are intertwined and connected with each other so that the lengths of the two force arms at the distal end of the support portion are always constant.

[0015] As a further improvement of the present invention, the angle formed by the two force arms is greater than 90°.

[0016] 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 of the adjacent support portions is greater than or equal to 4.

[0017] As a further improvement of the present invention, the support portion is arranged in a symmetrical structure with respect to a line connecting a vertex at a proximal end of the support portion and a vertex at a distal end of the support portion.

[0018] 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 a line connecting a vertex at a proximal end of the connecting portion and a vertex at a distal end of the connecting portion.

[0019] As a further improvement of the present invention, the positioning device has a predetermined shape, wherein, when pre-installed, the positioning device is compressed in the delivery catheter; when the distal end of the delivery catheter reaches the target position, the positioning device is released from the delivery catheter, and the distal end of the anchoring point is located at the expected anchoring position.

[0020] Compared with the prior art, the advantages of this application are: 1. In the prior art, the braided wire of the positioning device is directly welded to the delivery catheter, and the welding point is easily disconnected during use, causing the positioning device and the delivery catheter to fall off; in one embodiment of the present application, adjacent connecting parts are intertwined to form a connecting section, and then the connecting section is inserted into the connecting channel of the fixing piece, the head end of the connecting section is welded to the inner layer, and embedded in the connecting area through a claw structure to achieve a fixed connection between the positioning device and the fixing piece, thereby limiting the movement of the connecting section. This fixing method not only constrains each positioning unit to each other, enhances the integrity of the positioning bracket and its support stiffness, but also avoids the positioning bracket from being dislocated from its fixing piece, thereby ensuring the safety of the device.

[0021] 2. Different from the prior art, in one embodiment of the present application, the claw structure is a cross-shaped structure, and the center of the claw structure is arranged corresponding to the center of the connection area, so that the fixing claw of the claw structure can be completely embedded in the connection area, restricting the movement of the connection section, and "pinning" the connection section in the connection channel, which can effectively restrain the connection section and effectively prevent the positioning device and the fixing member from falling off.

[0022] 3. In the prior art, in order to ensure the supporting rigidity of the positioning device, a supporting rod with relatively large rigidity is used to make the positioning device. Although the supporting performance of the stent is met, excessive rigidity will cause excessive self-expansion force of the stent at the moment of release, which is easy to cause damage to the heart tissue. In one embodiment of the present application, the positioning device is made of one or more strands of wire, and the diameter of the wire is less than 0.5 mm, ensuring that the heart tissue will not be damaged due to excessive rigidity of the material. In addition, adjacent supporting parts and adjacent connecting parts are intertwined and connected with each other to enhance the integrity of the positioning device. The unique structural design is used to improve the supporting performance of the positioning device, which can not only meet the needs of clinical surgery, but also effectively avoid damage to the heart tissue.

[0023] 4. Different from the prior art, in one embodiment of the present application, the two force arms are of equal length. When the interval between the force arm support points remains unchanged, the angle between the two force arms forming the anchor point is greater than 90°, so that the bending line deformed by force moves up and becomes longer, so that the force required for the anchor point to move or deform is greater, thereby ensuring that the positioning device and its anchor point have sufficient support rigidity to meet its clinical surgical needs. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Figure 1 It is a schematic diagram of the overall structure of the positioning device in the first embodiment of the present invention.

[0025] Figure 2 and Figure 3 It is a schematic diagram of the structure of the positioning device and the fixing member in the first embodiment of the present invention.

[0026] Figure 4 This is a schematic diagram of the inner layer in Embodiment 1 of the present invention.

[0027] Figure 5 It is a schematic diagram of the connection between the connection end and the inner layer in the first embodiment of the invention.

[0028] Figure 6 This is a schematic diagram of the outer layer in Embodiment 1 of the present invention.

[0029] Figure 7 It is a schematic diagram of the connection between the connection end and the outer layer in the first embodiment of the invention.

[0030] The names of the parts indicated by the numbers in the accompanying drawings are as follows: 1-delivery catheter, 2-positioning device, 21-positioning unit, 211-connecting part, 2111-connecting area, 212-supporting part, 2121-force arm, 22-connecting section, 23-winding section, 24-connecting part, 3-anchoring mechanism, 4-flexible kit, 5-guiding mechanism, 6-anchoring point, 7-fixing part, 71-inner layer, 72-outer layer, 721-claw structure, 722-fixing claw, 73-connecting channel. Implementation

[0031] The present application is further described in detail below in conjunction with the accompanying drawings and embodiments.

[0032] The proximal end mentioned in the present application refers to the end close to the surgical operator, and the distal end refers to the end far away from the surgical operator. Specific embodiments

[0033] like Figure 1 and Figure 2 As shown, when the anchoring system is used for mitral valve contraction ring plasty treatment, a positioning device 2 on a repair system includes a delivery catheter 1, a fixing member 7 arranged at the distal end of the delivery catheter 1, a positioning device 2 connected to the fixing member 7, an anchoring mechanism 3, a flexible sleeve 4 and a guiding mechanism 5, wherein the anchoring mechanism 3, the flexible sleeve 4 and the guiding mechanism 5 are consistent with the structural design disclosed in the existing patent CN202310568240.0, so they are not repeated here; the positioning device 2 includes a plurality of circumferentially distributed positioning units 21, the 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, the positioning unit 21 includes a connecting portion 211 and a supporting portion 212, adjacent connecting portions 211 are intertwined and connected to form a connecting segment 22, the connecting segment 22 is provided with a connecting area 2111, and the connecting segment 22 has a twisted structure, such as Figure 5As shown, this makes the adjacent connecting parts 211 constrained to each other, and the wires of the connecting parts 211 are difficult to be detached separately, while increasing the stability between the positioning units 21. The fixing member 7 includes an inner layer 71 and an outer layer 72, and a connecting channel 73 is provided between the inner layer 71 and the outer layer 72. Figure 3 As shown, the outer layer 72 is provided with a claw structure 721, and the claw structure 721 includes a fixing claw 722 extending toward the inner periphery of the outer layer 72, and the claw structure 721 is arranged in a cross-shaped structure, as shown in FIG. Figure 1 and Figure 6 As shown, during pre-assembly, the connecting section 22 is located in the connecting channel 73, and the proximal end of the connecting section 22 is fixed to the inner layer 71 (fixed by welding). Figure 4 and Figure 5 As shown, the center of the claw structure 721 is arranged corresponding to the connection area 2111, and the fixing claw 722 of the claw structure 721 is embedded in the connection section 22 with the connection area 2111 as the center, so that the connection section 22 is "pinned" in the connection channel 73 by the claw structure 721, as shown in FIG. Figure 7 As shown, the connecting section 22 can be effectively restrained to prevent the connecting section 22 from falling off during use.

[0034] In this embodiment, a winding section 23 is provided between the connecting portion 211 and the supporting portion 212. Figure 2 As shown, the winding section 23 makes the length of the connecting portion 211 always constant. The winding section 23 makes the length of the wire of the connecting portion 211 always constant. The constant length of the wire means that the connecting portion 211 is a relatively fixed overall structure with better stability.

[0035] In this embodiment, two force arms 2121 are provided at the distal end of the support portion 212, and the two force arms 2121 intersect to form the anchor point 6, and the adjacent support portions 212 are intertwined and connected to each other, so that the lengths of the two force arms 2121 at the distal ends of the support portions 212 are always constant, and the adjacent support portions 212 and the adjacent connecting portions 211 are intertwined and connected to each other, thereby enhancing the integrity of the positioning device 2. The unique structural design is used to improve the supporting performance of the positioning device 2, and there is no need to use a thicker rod to improve the supporting rigidity of the positioning device 2, which can not only meet the clinical surgical needs, but also effectively avoid damage to the heart tissue.

[0036] In this embodiment, the angle formed by the two force arms 2121 is greater than 90°.

[0037] In this embodiment, the support portion 212 is a hexagon, wherein adjacent support portions 212 are intertwined to form two sides of the support portion 212, and the number of turns of the adjacent support portions 212 is greater than or equal to 4. Figure 2 shown.

[0038] In this embodiment, the support portion 212 is arranged in a symmetrical structure with respect to a line connecting a vertex at a proximal end of the support portion 212 and a vertex at a distal end of the support portion 212 .

[0039] In this embodiment, a connecting portion 24 is formed between adjacent positioning units 21, and the connecting portion 24 is symmetrically arranged with respect to a line connecting a vertex at a proximal end of the connecting portion 24 and a vertex at a distal end of the connecting portion 24. Figure 2 shown.

[0040] In this embodiment, the connecting portion 24 is arranged in a hexagonal structure.

[0041] In this embodiment, the positioning device 2 has a predetermined shape, wherein, when pre-installed, the positioning device 2 is compressed inside the delivery catheter 1; when the distal end of the delivery catheter 1 reaches the target position, the positioning device 2 is released from the delivery catheter 1, and the distal end of the anchor point 6 is located at the expected anchor position.

[0042] The foregoing description of several embodiments of the present application is presented for illustrative purposes. The foregoing description is not intended to be exhaustive, nor is it intended to limit the present application to the precise configurations, constructions and / or steps disclosed, and it is apparent that many modifications and variations may be made in light of the teachings above. The scope of the present invention and all equivalents are intended to be defined by the appended claims.

Claims

1. A positioning device on a repair system, comprising a delivery catheter, a fixing member arranged at the distal end of the delivery catheter, a positioning device connected to the fixing member, an anchoring mechanism, a flexible kit and a guiding mechanism, characterized in that: The positioning device includes a plurality of circumferentially distributed positioning units, the positioning unit includes a connecting portion and a supporting portion, adjacent connecting portions are intertwined and connected to form a connecting segment, a connecting area is provided on the connecting segment, wherein the fixing member includes an inner layer and an outer layer, a connecting channel is provided between the inner layer and the outer layer, and the outer layer is provided with a claw structure, when pre-installed, the connecting segment is located in the connecting channel, the proximal end of the connecting segment is fixed to the inner layer, and the claw structure is embedded in the connecting area and limits the movement of the connecting segment.

2. A positioning device on a repair system according to claim 1, characterized in that: The connecting portion includes two connecting wires, and the connecting wires of adjacent connecting portions are intertwined and interwoven to form a connecting area.

3. The positioning device on the repair system according to claim 2, characterized in that: The claw structure includes a fixing claw extending toward the inner periphery of the outer layer, and the claw structure is arranged in a cross-shaped structure.

4. The positioning device on the repair system according to claim 3, characterized in that: The connection area is a closed loop structure.

5. The positioning device on the repair system according to claim 1, characterized in that: The distal end of the support portion is provided with two force arms, the two force arms intersect to form the anchoring point, and the adjacent support portions are intertwined and connected with each other so that the lengths of the two force arms at the distal end of the support portion are always constant.

6. The positioning device on the repair system according to claim 5, characterized in that: The angle formed by the two force arms is greater than 90°.

7. The positioning device on the repair system according to claim 1, characterized in that: 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.

8. The positioning device on the repair system according to claim 1, characterized in that: The support portion is hexagonal, wherein adjacent support portions are wound around each other 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.

9. A positioning device on a repair system according to claim 8, characterized in that :: The support portion is arranged in a symmetrical structure with respect to a line connecting a vertex at a proximal end of the support portion and a vertex at a distal end of the support portion.

10. The positioning device on the repair system according to claim 1, characterized in that: A connecting portion is formed between adjacent positioning units, and the connecting portion is arranged in a symmetrical structure with respect to a line connecting a vertex at a proximal end of the connecting portion and a vertex at a distal end of the connecting portion.

11. The positioning device on the repair system according to claim 1, characterized in that: A winding section is provided between the connecting portion and the supporting portion, and the winding section ensures that the length of the connecting portion is always constant.

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