A positioning system for valve repair

Abstract

This application relates to the field of medical devices, and more particularly to a positioning system for valve repair, comprising 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 has multiple circumferentially distributed anchoring points. The positioning bracket includes multiple circumferentially distributed positioning units, wherein each positioning unit includes a connecting portion and a supporting portion. The distal end of the supporting portion has two lever arms, which intersect to form the anchoring points. Furthermore, adjacent supporting portions are intertwined and connected to each other so that the lengths of the two lever arms at the distal end of the supporting portion remain constant. The positioning bracket of this invention can meet the support rigidity required for clinical surgery while avoiding damage to cardiac tissue.

Description

Technical Field

[0001] This application belongs to the field of medical devices, specifically relating to a positioning 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 CN202310567827.X discloses a precisely adjustable anchoring system, including a delivery catheter, a positioning bracket disposed within the delivery catheter, an anchoring device, and a guiding mechanism. The guiding mechanism connects the anchoring device and the positioning bracket. The positioning bracket includes a connecting portion and a supporting portion. The guiding mechanism is connected to the supporting portion, and the position where the guiding mechanism connects to the supporting portion is called the anchoring point. The supporting portion can adhere to the heart tissue after release. The delivery catheter contains a control element, the distal end of which is connected to the supporting portion. Operating the control element causes local deformation of the supporting portion, displacing the anchoring point and allowing the anchoring device to reach the target anchoring position. While the positioning bracket in this solution can guide the anchoring device for anchoring, the positioning bracket formed by interwoven braided fibers lacks sufficient support. Increasing the braiding density to enhance the support of the positioning bracket leads to an excessively long positioning bracket after contraction, making it difficult to operate during release into the atrium.

[0004] Patent CN202310568240.0 discloses a precise positioning repair system, including a delivery conduit, a positioning bracket disposed within the delivery conduit, an anchoring mechanism, a flexible kit, and a guide wire. 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 corresponding to the anchoring points. The guide wire sequentially passes through the connection points and the corresponding anchoring points. After the positioning bracket is released, the anchoring mechanism pushes the flexible kit, causing the flexible kit to cooperate with the guide wire and guide the anchoring mechanism to reach each anchoring point along a predetermined route and complete the anchoring. In this solution, the positioning bracket is formed by several straight rods. While thicker straight rods can increase the support strength of the positioning bracket, they also make the positioning bracket too rigid and difficult to retract into the delivery sheath. Furthermore, the instantaneous force when the positioning bracket is opened is too great, which can easily puncture tissue.

[0005] Therefore, those skilled in the art are dedicated to developing a positioning system for valve repair, mainly addressing the following issues: 1. How to ensure that the positioning stent has sufficient support strength while reducing its loading length for easy intracardiac operation; 2. How to ensure that the positioning stent has sufficient support strength while avoiding damage to tissues.

[0006] Application content

[0007] The purpose of this application is to provide a positioning system for valve repair. This novel positioning system has the following advantages: 1. It can provide sufficient support strength while reducing its loading length, making it convenient for intracardiac operation; 2. It can provide sufficient support strength while avoiding tissue damage during release.

[0008] To solve the above-mentioned technical problems, this application provides the following technical solution: a positioning system for valve repair, comprising 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 has multiple circumferentially distributed anchoring points. The positioning bracket includes multiple circumferentially distributed positioning units, wherein each positioning unit includes a connecting portion and a supporting portion. The distal end of the supporting portion has two lever arms, which intersect to form the anchoring points. Furthermore, adjacent supporting portions are intertwined and connected to each other so that the lengths of the two lever arms at the distal end of the supporting portion remain constant.

[0009] As a further improvement of the present invention, the support portion has a polygonal structure.

[0010] As a further improvement of the present invention, the support portion is arranged symmetrically with respect to the line connecting the vertex of the near end of the support portion and the anchoring point.

[0011] As a further improvement of the present invention, the support portion is quadrilateral, and the support portion is arranged symmetrically with respect to the line connecting the near vertex and the far vertex of the support portion.

[0012] As a further improvement of the present invention, the support portion is hexagonal, and the support portion is arranged symmetrically with respect to the line connecting the near vertex and the far vertex of the support portion.

[0013] As a further improvement of the present invention, the connecting part is connected to the delivery conduit, wherein the connecting part includes two connecting rods, and the two connecting rods are respectively connected to the connecting rods of the adjacent connecting parts.

[0014] As a further improvement of the present invention, the included angle formed by the two connecting rods is an acute angle.

[0015] As a further improvement of the present invention, a connecting region is formed between adjacent positioning units, and the connecting region is arranged in a symmetrical structure with respect to the line connecting the vertex of the near end of the connecting region and the vertex of the far end of the connecting region.

[0016] As a further improvement of the present invention, the connecting area is substantially similar in structure to the support portion.

[0017] 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 rod remains constant.

[0018] As a further improvement of the present invention, the included angle formed by the two lever arms at the distal end of the support portion is an obtuse angle.

[0019] As a further improvement of the present invention, the included angle formed between the lever arms at the distal ends of adjacent support portions is an obtuse angle.

[0020] 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.

[0021] As a further improvement of the present invention, the positioning bracket has a predetermined shape, wherein, during pre-installation, the positioning bracket is compressed within the delivery conduit; when the distal end of the delivery conduit reaches the target position, the positioning bracket is released from the delivery conduit, and the distal end of the anchoring point is located at the expected anchoring position, wherein the expected anchoring position is located at the autologous valve annulus.

[0022] Compared with the prior art, the advantages of this application are:

[0023] 1. In existing technologies, to ensure sufficient support rigidity of the positioning stent, the braiding density of the stent is typically increased. However, this results in an excessively long stent during compression loading, making intracardiac manipulation difficult. Furthermore, conventional braided structures are too soft, and their support rigidity cannot meet surgical requirements. In one embodiment of this application, adjacent support parts are intertwined and connected, forming a unified whole. When the anchoring point is subjected to traction, the anchoring point can transmit part of the traction force to the two lever arms at the distal end of the support part and the support part adjacent to the lever arms, thereby improving the anchoring point's stability. The stability is enhanced, effectively improving the support rigidity of the positioning bracket. Furthermore, the intertwined connection between the support parts ensures that the length of the two lever arms at the distal end of the support parts will not change due to compression or release of the positioning bracket. This results in a shorter lever arm directly related to / connected to the anchor point compared to the lever arm in the prior art. The shorter the lever arm, the greater the traction force required to deform the lever arm or cause displacement of the anchor point, thereby ensuring the stability of the anchor point on the positioning bracket. This effectively improves the support rigidity of the positioning bracket without increasing the braid density, meeting the needs of clinical surgery.

[0024] 2. In the prior art, to ensure the supporting rigidity of the positioning stent, a support rod with high rigidity is used to manufacture the positioning stent. Although this satisfies the support performance of the stent, excessive rigidity can lead to excessive self-expansion force at the moment of release, which can easily cause damage to cardiac tissue. In one embodiment of this application, the positioning stent is made of one or more strands of wire with a diameter of less than 0.5 mm, ensuring that it will not cause damage to cardiac tissue 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 stent. This unique structural design improves the support performance of the positioning stent, which can meet the needs of clinical surgery and effectively avoid damage to cardiac tissue.

[0025] 3. Unlike the prior art, in one embodiment of this application, 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 anchor point. The symmetrical structure makes the support portion more stable, thereby ensuring the support performance of the positioning support.

[0026] 4. In a different embodiment of the present application, the positioning bracket has a predetermined shape. The position of the positioning bracket after unfolding is the position that the anchoring mechanism intends to anchor at. This allows the anchoring mechanism to guide the positioning bracket to each anchoring point and complete the anchoring through the guide line after unfolding. Attached Figure Description

[0027] Figure 1 This is a schematic diagram of the positioning system in Embodiment 1 of the present invention.

[0028] Figure 2 This is a schematic diagram of the positioning bracket in Embodiment 1 of the present invention.

[0029] The parts referred to by the numbers in the attached diagram are as follows: 1-Conveying conduit, 2-Positioning bracket, 21-Positioning unit, 211-Connecting part, 2111-Connecting rod, 212-Supporting part, 2121-Lever arm, 22-Connecting area, 23-Wrapping section, 3-Anchoring mechanism, 4-Flexible kit, 5-Guiding mechanism, 6-Anchoring point. Implementation

[0030] The present application will now be described in further detail with reference to the accompanying drawings and embodiments.

[0031] 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

[0032] like Figure 1 As shown, when this anchoring system is used for mitral valve annulus retraction angioplasty, a positioning system for valve repair includes a delivery catheter 1, a positioning stent 2 disposed within the delivery catheter 1, 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 stent 2 is disposed at the distal end of the delivery catheter 1. The positioning stent 2 has multiple circumferentially distributed anchoring points 6. The positioning stent 2 includes multiple circumferentially distributed positioning units 21. Each positioning unit 21 is composed of a single wire, and the diameter of the wire constituting the positioning unit 21 is 0.4 mm. The wire is made of nickel-titanium alloy material, possessing a certain degree of flexibility, which can also prevent excessive instantaneous force from damaging the heart tissue when the positioning stent 2 is released. Each positioning unit 21 includes a connecting part 211 and a supporting part 212. The supporting part 212 is hexagonal, as shown... Figure 2As shown, the distal end of the support portion 212 is provided with two lever arms 2121, which intersect to form the anchoring point 6. Adjacent support portions 212 are intertwined and connected to each other, ensuring that the lengths of the two lever arms 2121 at the distal end of the support portion 212 remain constant. The connecting portion 211 is connected to the delivery conduit 1, and includes two connecting rods 2111. Each connecting rod 2111 is connected to the connecting rod 2111 of an adjacent connecting portion 211. This allows the positioning units 21 to be connected as a whole. When the anchoring point 6 is subjected to traction, the traction force can be distributed to adjacent support units through the lever arms 2121 at the distal end of the support portion 212, effectively enhancing the support rigidity of the positioning bracket 2. This eliminates the need for thicker rods to meet the support strength requirements; the structural design alone enhances and meets the required support performance for surgery, preventing damage to cardiac tissue during release.

[0033] In another embodiment, the support portion 212 has a quadrilateral structure.

[0034] 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 anchoring point 6.

[0035] In this embodiment, the included angle formed by the two connecting rods 2111 is an acute angle.

[0036] In this embodiment, a connection region 22 is formed between adjacent positioning units 21, and the connection region 22 is symmetrically arranged with respect to the line connecting the vertex of the near end of the connection region 22 and the vertex of the far end of the connection region 22.

[0037] In this embodiment, the structure of the connecting region 22 is generally similar to that of the support portion 212.

[0038] In this embodiment, a winding section 23 is provided between the connecting part 211 and the supporting part 212. The winding section 23 ensures that the length of the connecting rod 2111 remains constant. The constant length of the connecting rod 2111 means that the connecting part 211 is a relatively fixed integral structure with better stability.

[0039] In this embodiment, the included angle formed by the two lever arms 2121 at the far end of the support 212 is an obtuse angle. When the lengths of the lever arms 2121 are the same, the included angle between the two lever arms 2121 is an obtuse angle, which requires a greater traction force to pull the anchor point 6 and makes the positioning bracket 2 more stable.

[0040] In this embodiment, the included angle formed between the lever arms 2121 at the distal ends of adjacent support portions 212 is an obtuse angle.

[0041] In this embodiment, 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.

[0042] In this embodiment, the positioning bracket 2 has a predetermined shape, wherein, during pre-installation, the positioning bracket 2 is compressed inside the delivery conduit 1; when the distal end of the delivery conduit 1 reaches the target position, the positioning bracket 2 is released from the delivery conduit 1, and the distal end of the anchoring point 6 is located at the expected anchoring position, wherein the expected anchoring position is located at the autologous valve annulus.

[0043] 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 system for valve repair, comprising a delivery catheter, a positioning support disposed within the delivery catheter, an anchoring mechanism, a flexible assembly, and a guiding mechanism, wherein the positioning support is disposed at the distal end of the delivery catheter, and the positioning support has a plurality of circumferentially distributed anchoring points, characterized in that: The positioning bracket includes multiple circumferentially distributed positioning units, wherein each positioning unit includes a connecting part and a supporting part. The distal end of the supporting part is provided with two lever arms, which intersect to form the anchoring point. Furthermore, adjacent supporting parts are intertwined and connected to each other so that the length of the two lever arms at the distal end of the supporting part remains constant.

2. The positioning system for valve repair according to claim 1, characterized in that: The support portion has a polygonal structure.

3. A positioning system for valve repair according to claim 2, characterized in that: The support portion is arranged symmetrically with respect to the line connecting the vertex of the near end of the support portion and the anchor point.

4. A positioning system for valve repair according to claim 1, characterized in that: The connecting part is connected to the delivery conduit, wherein the connecting part includes two connecting rods, and the two connecting rods are respectively connected to the connecting rods of the adjacent connecting parts.

5. A positioning system for valve repair according to claim 1, characterized in that: A connection region is formed between adjacent positioning units, and the connection region is symmetrically arranged with respect to the line connecting the vertex of the near end of the connection region to the vertex of the far end of the connection region.

6. A positioning system for valve repair according to claim 4, characterized in that: A winding section is provided between the connecting part and the supporting part, which ensures that the length of the connecting rod remains constant.

7. A positioning system for valve repair according to claim 1, characterized in that: The angle formed by the two lever arms at the far end of the support is an obtuse angle.

8. A positioning system for valve repair according to claim 1, characterized in that: The included angle formed between the lever arms at the distal ends of adjacent support portions is an obtuse angle.

9. A positioning system for valve repair 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.

10. A positioning system for valve repair according to claim 1, characterized in that: The positioning bracket has a predetermined shape, wherein, during pre-installation, the positioning bracket is compressed within the delivery conduit; when the distal end of the delivery conduit reaches the target position, the positioning bracket is released from the delivery conduit, and the distal end of the anchoring point is located at the expected anchoring position.

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