A positioning device for a valve repair system

Abstract

The application relates to the field of medical devices, in particular to a positioning device of a valve repair system, which comprises a delivery catheter, a positioning device arranged in the delivery catheter, an anchoring mechanism, a flexible sleeve and a guide mechanism, the positioning device is arranged at the distal end of the delivery catheter, the positioning device is provided with a plurality of anchoring points distributed in the circumferential direction, the positioning device comprises a plurality of positioning units which are circumferentially distributed and connected with each other, wherein the positioning unit comprises a connecting part and a supporting part, the distal end of the supporting part is provided with two force arms, the two force arms intersect to form the anchoring point, and the included angle formed by the two force arms is greater than 90 DEG; the positioning device can meet the supporting rigidity required by clinical operation and can avoid damage to the heart tissue.

Description

TECHNICAL FIELD

[0001] The present application belongs to the field of medical devices, and particularly relates to a positioning device of a valve repair system. BACKGROUND

[0002] Minimally invasive interventional medical technology is a high-efficiency diagnosis and treatment method that has gradually emerged in recent years, and has outstanding advantages such as small trauma, simple operation, accurate intervention site, and few complications, and has become one of the most important diagnosis and treatment methods for cardiovascular diseases and tumor diseases. In an interventional medical operation, a professional doctor usually needs to manually operate a specific device to realize that one or more elongated flexible catheters with different shapes or functions pass through a complex and changeable cardiovascular environment in a patient's body cavity, and to send the catheter, guide wire, stent and other instruments to a predetermined diagnosis and treatment lesion site to perform minimally invasive diagnosis and treatment on the lesion site. The incidence of mitral valve disease is high in 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 plays the role of a check valve to prevent oxygen-rich blood from the lungs from flowing back into the left atrium. Once the mitral valve does not close properly or is misaligned, MR will occur, which will significantly reduce the heart pumping efficiency and even cause heart failure. Mitral regurgitation is divided into functional and degenerative. The characteristic of functional mitral regurgitation (FMR) is mitral annulus dilation, insufficient leaflet coaptation, and mitral valve leaflet tethering, which is caused by left ventricular dysfunction and remodeling. Under the impetus of poor results and high risk of surgical mitral valvuloplasty, people began to look for alternative solutions 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 treating FMR.

[0003] Patent CN202310567827.X discloses a precisely controllable anchoring system, which comprises a delivery catheter, a positioning device arranged in the delivery catheter, an anchoring device, and a guide mechanism. The guide mechanism is connected to the anchoring device and the positioning device. The positioning device comprises a connecting part and a supporting part. The guide mechanism is connected to the supporting part, and the position where the guide mechanism is connected to the supporting part is called an anchoring point. The supporting part can adhere to the heart tissue after being released. The delivery catheter is provided with a control member. The distal end of the control member is connected to the supporting part. Operating the control member causes the supporting part to locally deform, the anchoring point to move, and the anchoring device to reach the target anchoring position. In this scheme, the positioning device can guide the anchoring device to anchor, but the positioning device formed by interweaving braided wires cannot meet the positioning and guiding requirements of clinical operations because the braided wires are not fixed or constrained relative to each other, which causes the anchoring point to easily move and deform.

[0004] The patent CN202310568240.0 discloses a repair system with precise positioning, which comprises a delivery catheter, a positioning device arranged in the delivery catheter, an anchoring mechanism, a flexible sleeve and a guide wire. The positioning device is arranged at the distal end of the delivery catheter and is provided with a plurality of anchoring points distributed in the circumferential direction. The flexible sleeve is provided with a plurality of connection points corresponding to the anchoring points. The guide wire passes through the connection points and the corresponding anchoring points in sequence. After the positioning device is released, the anchoring mechanism pushes the flexible sleeve so that the flexible sleeve cooperates with the guide wire to guide the anchoring mechanism to reach each anchoring point along a predetermined route and complete anchoring. In this scheme, the positioning device is formed by several straight rods. Although the thicker straight rods can improve the support strength of the positioning device, they make the positioning device too hard to be easily accommodated in the delivery sheath. Moreover, when the positioning device is opened, the instantaneous force is too large, which can easily injure the tissue.

[0005] Therefore, the skilled in the art is committed to developing a positioning device of a valve repair system to mainly solve the following problems: 1. how to make the anchoring points of the positioning device have sufficient support strength to meet the clinical operation requirements; and 2. how to make the positioning device have sufficient support strength while avoiding damage to the tissue. SUMMARY

[0006] The purpose of the present application is to provide a positioning device of a valve repair system. The new positioning system has the following advantages: 1. the anchoring points of the positioning device have sufficient support strength to ensure the accuracy of the positioning position during the guided positioning process; and 2. the positioning device has sufficient support strength while avoiding damage to the tissue when released.

[0007] To solve the above technical problems, the present application solves the problems by the following technical scheme: a positioning device of a valve repair system, which comprises a delivery catheter, a positioning device arranged in the delivery catheter, an anchoring mechanism, a flexible sleeve and a guide mechanism. The positioning device is arranged at the distal end of the delivery catheter and is provided with a plurality of anchoring points distributed in the circumferential direction. The positioning device comprises a plurality of positioning units distributed in the circumferential direction and connected to each other. The positioning unit comprises a connecting part and a support part. The distal end of the support part is provided with two force arms. The two force arms intersect to form the anchoring point. The included angle formed by the two force arms is greater than 90°.

[0008] As a further improvement of the present application, the lengths of the two force arms are equal.

[0009] As a further improvement of the present application, when the included angle formed by the two force arms is 180°, or the included angle formed by the two force arms is close to 180°, the support strength of the anchor point formed by the intersection of the two force arms is the largest.

[0010] As a further improvement of the present application, the adjacent support portions are connected by winding each other, so that the length of the two force arms at the distal end of the support portion is always constant.

[0011] As a further improvement of the present application, 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.

[0012] As a further improvement of the present application, the support portion is hexagonal, wherein the adjacent support portions are wound to form two sides of the support portion, and the number of windings between the adjacent support portions is greater than or equal to 4.

[0013] As a further improvement of the present application, the number of windings between the adjacent support portions is 6.

[0014] As a further improvement of the present application, the support portion is symmetrically arranged with respect to the line connecting the vertex at the proximal end of the support portion and the vertex at the distal end of the support portion.

[0015] As a further improvement of the present application, the connecting portion is connected to the delivery catheter, wherein the connecting portion includes two connecting rods, and the two connecting rods are respectively connected to the connecting rods of adjacent connecting portions.

[0016] As a further improvement of the present application, the adjacent connecting portions are connected by winding each other, and the adjacent support portions are also connected by winding each other, so that the positioning units are constrained with each other, the integrity of the positioning device is enhanced, and when the anchor point is subjected to the traction force applied by the guide mechanism, the positioning unit will not easily deform, and the support strength of the positioning device can meet the requirements of clinical surgery.

[0017] As a further improvement of the present application, the connecting region is formed between the adjacent positioning units, and the connecting region is symmetrically arranged with respect to the line connecting the vertex at the proximal end of the connecting region and the vertex at the distal end of the connecting region.

[0018] As a further improvement of the present application, the connecting region is hexagonal in structure.

[0019] As a further improvement of the present application, a winding section is provided between the connecting portion and the support portion, which makes the length of the connecting rod always constant.

[0020] As a further improvement of the present application, the included angle formed between the force arms of the distal ends of the adjacent support portions is obtuse.

[0021] As a further improvement of the present application, the positioning device has a predetermined form, wherein, when preloaded, 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 anchor point position is located at the expected anchor position, wherein the expected anchor position is located at the native valve annulus.

[0022] Compared with the prior art, the present application has the following advantages:

[0023] 1. In the prior art, since the braided wires of the positioning device are not mutually constrained, the positioning device will deform when subjected to a small traction force, further causing the position of the anchor point position on the positioning device to deviate; in an embodiment of the present application, the support portions are mutually constrained and fixedly connected, which enhances the integrity of the positioning device, and the lengths of the two force arms are equal, so that, under the condition that the interval between the force arm support points remains unchanged, the included angle between the two force arms forming the anchor point position is greater than 90°, which causes the bending line subjected to force deformation to move upward and lengthen, so that the force required for the anchor point position to move or deform is greater, thereby ensuring that the positioning device and the anchor point position thereof have sufficient support rigidity to meet the clinical operation requirements.

[0024] 2. In the prior art, in order to enable the positioning device to have sufficient support rigidity, the braided density of the positioning device is usually increased, but this will cause the length of the positioning device to be too long when compressed and loaded, making it difficult to operate in the heart, and the conventional braided structure is too soft, and the support rigidity cannot meet the operation requirements; in an embodiment of the present application, the adjacent support portions are connected by mutual winding, so that the support portions are connected as a whole, and when the anchor point position is subjected to a traction force, the anchor point position can transmit part of the traction force to the two force arms at the distal ends of the support portions and the support portions adjacent to the force arms, thereby improving the stability of the anchor point position and effectively enhancing the support rigidity of the positioning device, and the mutual winding connection between the support portions causes the lengths of the two force arms at the distal ends of the support portions to remain unchanged when the positioning device is compressed or released, which makes the force arm directly related / connected to the anchor point position shorter than the force arm in the prior art, and the shorter the force arm, the greater the traction force required for the force arm to deform or cause the anchor point position thereof to displace, thereby ensuring the stability of the anchor point position on the positioning device, so as to effectively improve the support rigidity of the positioning device without increasing the braided wire density, thereby meeting the requirements of clinical operations.

[0025] 3. In the prior art, in order to ensure the support rigidity of the positioning device, a support rod with high rigidity is used to manufacture the positioning device, which satisfies the support performance of the support, but the rigidity is too large to cause the self-expanding force of the support to be too large at the moment of release, which is easy to cause damage to the heart tissue. In an embodiment of the present application, the positioning device is made of one or more wires with a diameter less than 0.5 mm, which ensures that the heart tissue will not be damaged due to the excessive rigidity of the material, and the adjacent support parts and the adjacent connecting parts are connected by winding, which enhances the integrity of the positioning device, and the unique structure design improves the support performance of the positioning device, which can meet the clinical operation requirements and effectively avoid damage to the heart tissue.

[0026] 4. Different from the prior art, in an embodiment of the present application, the support part is arranged in a symmetrical structure about the line connecting the top point of the proximal end of the support part and the anchor point, and the symmetrical structure makes the stability of the support part stronger, thereby ensuring the support performance of the positioning support. BRIEF DESCRIPTION OF DRAWINGS

[0027] Figure 1 FIG. 1 is a schematic diagram of the overall structure of a positioning device of a valve repair system in an embodiment of the present application.

[0028] Figure 2 and Figure 3 FIG. 2 is a structural schematic diagram of the positioning device in an embodiment of the present application.

[0029] The part names referred to by the numbers in the drawings are as follows: 1-conveying catheter, 2-positioning device, 21-positioning unit, 211-connecting part, 2111-connecting rod, 212-support part, 2121-force arm, 22-connecting area, 23-winding section, 3-anchoring mechanism, 4-flexible sleeve, 5-guiding mechanism, 6-anchor point. DETAILED DESCRIPTION

[0030] As Figure 1As shown, when the anchoring system is used for mitral annuloplasty treatment, a positioning device 2 of a valve repair system includes a delivery catheter 1, a positioning device 2 arranged in the delivery catheter 1, an anchoring mechanism 3, a flexible sleeve 4, and a guide mechanism 5, wherein the anchoring mechanism 3, the flexible sleeve 4, and the guide mechanism 5 are consistent with the structure design disclosed in the existing patent CN202310568240.0, and therefore will not be described again; the positioning device 2 is arranged at the distal end of the delivery catheter 1, the positioning device 2 is provided with a plurality of anchoring points 6 distributed in the circumferential direction, the positioning device 2 includes a plurality of positioning units 21 distributed in the circumferential direction, the positioning unit 21 is composed of a wire, and the diameter of the wire constituting the positioning unit 21 is 0.4 mm, wherein the wire is made of nickel-titanium alloy material and has a certain flexibility, which can also avoid damage to the heart tissue caused by excessive force of the positioning device 2 at the moment of release, wherein the positioning unit 21 includes a connecting part 211 and a support part 212, the support part 212 is hexagonal, the distal end of the support part 212 is provided with two force arms 2121, the two force arms 2121 intersect to form the anchoring point 6, and the adjacent support parts 212 are connected to each other by winding to form two equal-length sides, the mutual winding of the sides fixes the length of the two force arms 2121 at the distal end of the support part 212 to be constant, and the two force arms 2121 intersect to form the anchoring point 6, and the included angle formed by the two force arms 2121 is greater than 90°, as shown in Figure 3 The connecting part 211 is connected with the delivery catheter 1, wherein the connecting part 211 includes two connecting rods 2111, and the two connecting rods 2111 are respectively connected with the connecting rods 2111 of the adjacent connecting parts 211, which enables the individual positioning units 21 to be connected into a whole, as shown in Figure 2 and Figure 3 When the anchoring point 6 is subjected to a traction force, the traction force can be dispersed to the adjacent support units through the force arms 2121 at the distal end of the support part 212, thereby effectively enhancing the support rigidity of the positioning device 2, so that the positioning device 2 does not need to use thicker rods to meet the support strength, and only the structural design can enhance and meet the support performance required for the operation, thereby avoiding damage to the heart tissue during release.

[0031] In this embodiment, the support part 212 is hexagonal, wherein the adjacent support parts 212 are wound with each other to form two sides of the support part 212, and the number of windings between the adjacent support parts 212 is 6.

[0032] In this embodiment, the support part 212 is symmetrically arranged with respect to the line connecting the vertex at the proximal end of the support part 212 and the vertex at the distal end of the support part 212.

[0033] In the embodiment, the adjacent connecting portions 211 are connected by winding each other, and the adjacent supporting portions 212 are also connected by winding each other, so that the positioning units 21 are constrained to each other, the integrity of the positioning device 2 is enhanced, and the supporting strength of the positioning device 2 can meet the requirements of clinical surgery, and the positioning unit 21 will not be easily deformed when the anchoring point 6 is subjected to the traction force applied by the guide mechanism 5.

[0034] In the embodiment, the connecting regions 22 are formed between the adjacent positioning units 21, and the connecting regions 22 are symmetrically arranged with respect to the line connecting the vertex near the proximal end of the connecting region 22 and the vertex near the distal end of the connecting region 22.

[0035] In the embodiment, the connecting regions 22 are hexagonal structures.

[0036] In the embodiment, the winding sections 23 are arranged between the connecting portions 211 and the supporting portions 212, so that the length of the connecting rod 2111 is always constant.

[0037] In the embodiment, the included angle between the force arms 2121 of the distal ends of the adjacent supporting portions 212 is obtuse.

[0038] In the embodiment, the positioning device 2 has a predetermined form, wherein, when preassembled, the positioning device 2 is compressed in 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 anchoring point 6 is located at the expected anchoring position, wherein the expected anchoring position is located at the native annulus.

[0039] The foregoing description of several embodiments of the application has been presented for the purposes of illustration and description. It is not intended to be exhaustive or to limit the application to the precise configuration, constructions, and / or steps disclosed, as obviously many modifications and variations are possible in light of the above teachings. The scope of the application is to be defined by the following claims.

Claims

1. A positioning device for a valve repair system, comprising a delivery catheter, a positioning device disposed within the delivery catheter, an anchoring mechanism, a flexible assembly, and a guiding mechanism, wherein the positioning device is disposed at the distal end of the delivery catheter, and the positioning device has a plurality of circumferentially distributed anchoring points, characterized in that: The positioning device includes multiple circumferentially distributed and interconnected positioning units. Each positioning unit includes a connecting part and a supporting part. The far end of the supporting part is provided with two lever arms. The two lever arms intersect to form the anchoring point. The included angle between the two lever arms is greater than 90°. The connecting part includes a connecting rod. A winding section is provided between the connecting part and the supporting part. The winding section ensures that the length of the connecting rod remains constant.

2. The positioning device for a valve repair system according to claim 1, characterized in that: The adjacent support portions are intertwined and connected so that the lengths of the two lever arms at the distal ends of the support portions remain constant.

3. The positioning device for a valve repair system according to claim 2, 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.

4. The positioning device for a valve repair system according to claim 3, characterized in that: The support portion is hexagonal, wherein adjacent support portions are intertwined to form two sides of the support portion, and the number of turns between adjacent support portions is greater than or equal to 4.

5. The positioning device for a valve repair system according to claim 4, 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 vertex of the far end of the support portion.

6. The positioning device for a valve repair system 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.

7. The positioning device for a valve repair system 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.

8. The positioning device for a valve repair system according to claim 7, characterized in that: The connecting area is configured with a hexagonal structure.

9. The positioning device for a valve repair system 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.

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