Positioning system for valve repair

Abstract

The invention relates to the field of medical instruments, in particular to a positioning system for valve repair, which comprises a delivery catheter, a positioning support arranged in the delivery catheter, an anchoring mechanism, a flexible sleeve and a guide mechanism, the positioning support is arranged at the far end of the delivery catheter, the positioning support is provided with a plurality of anchoring points distributed along the circumferential direction, and the flexible sleeve is arranged in the delivery catheter. The positioning support comprises a plurality of positioning units distributed in the circumferential direction, each positioning unit comprises a connecting part and a supporting part, the far end of each supporting part is provided with two force arms, the two force arms intersect to form the anchoring position, and the adjacent supporting parts are connected in a winding mode. The lengths of the two force arms at the far end of the supporting part are constant all the time; the positioning support can meet the requirement for supporting rigidity needed by a clinical operation, and damage to heart tissue can be avoided.

Description

Technical Field

[0001] The present application belongs to the field of medical devices, and specifically relates to a positioning system for valve repair. 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 bracket arranged in the delivery catheter, an anchoring device and a guiding mechanism, wherein 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 is connected to the supporting portion is called an anchoring point, and the supporting portion can be close to the heart tissue after release, 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 control member is operated to cause the supporting portion to be locally deformed, the anchoring point is displaced and the anchoring device can reach the target anchoring position. Although the positioning bracket in this scheme can guide the anchoring device to anchor, the positioning bracket formed by interweaving braided wires has insufficient supporting force, and in order to enhance the supporting force of the positioning bracket and increase the braiding density of the braided wire, the positioning bracket will be too long after contraction, and it will be difficult to operate when entering the atrium for release.

[0004] Patent CN202310568240.0 discloses a repair system that can be precisely positioned, including a delivery catheter, a positioning bracket arranged in the delivery catheter, an anchoring mechanism, a flexible kit and a guide wire, wherein the positioning bracket is arranged at the distal end of the delivery catheter, the positioning bracket is provided with a plurality of anchoring points distributed along the circumferential direction, and the flexible kit is provided with a plurality of connection sites corresponding to the anchoring points, wherein the guide wire passes through the connection sites and the anchoring points corresponding to the connection sites in sequence, and after the positioning bracket is released, the anchoring mechanism pushes the flexible kit so that the flexible kit cooperates with the guide wire and guides the anchoring mechanism to arrive at each anchoring point according to a predetermined route and complete the anchoring. In this scheme, the positioning bracket is formed by several straight rods. Although the thicker straight rod can improve the support strength of the positioning bracket, it will cause the positioning bracket to be too hard and not easy to be collected in the delivery sheath; and when the positioning bracket is opened, the instantaneous force is too large, which is easy to pierce the tissue.

[0005] Therefore, technicians in this field are committed to developing a positioning system for valve repair, mainly to solve the following problems: 1. How to ensure that the positioning stent has sufficient supporting strength while reducing its loading length to facilitate intracardiac operation; 2. How to ensure that the positioning stent has sufficient supporting strength while avoiding damage to tissues. Summary of the invention

[0006] The purpose of the present application is to provide a positioning system for valve repair, which has the following advantages: 1. It can provide support performance of sufficient strength and reduce its loading length to facilitate intracardiac operation; 2. On the premise of providing support performance of sufficient strength, it can avoid damage to tissues during release.

[0007] In order to solve the above technical problems, the present application is solved through the following technical solutions: a positioning system for valve repair, comprising a delivery catheter, a positioning stent arranged in the delivery catheter, an anchoring mechanism, a flexible kit and a guiding mechanism, wherein the positioning stent is arranged at the distal end of the delivery catheter, the positioning stent is provided with a plurality of anchoring points distributed along the circumferential direction, the positioning stent comprises a plurality of circumferentially distributed positioning units, wherein the positioning unit comprises a connecting portion and a supporting portion, the distal end of the supporting portion is provided with two force arms, the two force arms intersect to form the anchoring point, and the adjacent supporting portions are intertwined and connected with each other so that the lengths of the two force arms at the distal end of the supporting portion are always constant.

[0008] As a further improvement of the present invention, the support portion is a polygonal structure.

[0009] As a further improvement of the present invention, the support portion is arranged in a symmetrical structure with respect to a line connecting the vertex of the proximal end of the support portion and the anchor point.

[0010] As a further improvement of the present invention, the support portion is a quadrilateral, and the support portion is arranged in a symmetrical structure with respect to a line connecting a proximal vertex and a distal vertex of the support portion.

[0011] As a further improvement of the present invention, the support portion is hexagonal, and the support portion is arranged in a symmetrical structure with respect to a line connecting a proximal vertex and a distal vertex of the support portion.

[0012] As a further improvement of the present invention, 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 connecting rods of adjacent connecting portions.

[0013] As a further improvement of the present invention, the angle formed by the two connecting rods is an acute angle.

[0014] As a further improvement of the present invention, a connection area is formed between adjacent positioning units, and the connection area is arranged in a symmetrical structure with respect to a line connecting a vertex at a proximal end of the connection area and a vertex at a distal end of the connection area.

[0015] As a further improvement of the present invention, the structure of the connecting area is substantially similar to that of the supporting portion.

[0016] 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 rod always constant.

[0017] As a further improvement of the present invention, the angle formed by the two force arms at the distal end of the support portion is an obtuse angle.

[0018] As a further improvement of the present invention, the angle formed between the force arms at the distal ends of adjacent support portions is an obtuse angle.

[0019] 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.

[0020] As a further improvement of the present invention, the positioning stent has a predetermined shape, wherein, when pre-installed, the positioning stent is compressed in the delivery catheter; when the distal end of the delivery catheter reaches the target position, the positioning stent is released from the delivery catheter, and the distal end of the anchoring point is located at the expected anchoring position, wherein the expected anchoring position is located at the native valve ring. Compared with the prior art, the advantages of this application are: 1. In the prior art, in order to make the positioning stent have sufficient support rigidity, the braiding density of the positioning stent is usually increased, but this will cause the positioning stent to be too long when compressed and loaded, making intracardiac operation difficult. In addition, the conventional braided structure is too soft and the support rigidity cannot meet the surgical requirements. In one embodiment of the present application, adjacent support parts are intertwined and connected with each other, so that the support parts are connected to each other as a whole. When the anchor point is subjected to traction, the anchor point can transmit part of the traction force to the two force arms at the distal end of the support part and the support part adjacent to the force arm, thereby improving the anchor point. Stability, effectively enhancing the supporting rigidity of the positioning bracket, and the mutually intertwined connection between the supporting parts ensures that the lengths of the two force arms at the distal ends of the supporting parts will not change due to compression or release of the positioning bracket, which makes the force arms directly related to / connected to the anchoring points shorter than those in the prior art. The shorter the force arms, the greater the traction force that causes the force arms to deform or displace the anchoring points, thereby ensuring the stability of the anchoring points on the positioning bracket, thereby effectively improving the supporting rigidity of the positioning bracket without increasing the density of the braided wires, and meeting the needs of clinical surgery.

[0021] 2. In the prior art, in order to ensure the supporting rigidity of the positioning stent, a supporting rod with relatively large rigidity is used to make the positioning stent. 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 stent 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 stent. The unique structural design is used to improve the supporting performance of the positioning stent, which can not only meet the needs of clinical surgery, but also effectively avoid damage to the heart tissue.

[0022] 3. Different from the prior art, in one embodiment of the present application, the support portion is arranged in a symmetrical structure with respect to the line connecting the vertex at the proximal 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.

[0023] 4. Different from the prior art, in one embodiment of the present application, the positioning bracket has a predetermined shape, and the position of the positioning bracket after deployment is the position where the anchoring mechanism is expected to anchor. This allows the anchoring mechanism to guide the positioning bracket to each anchoring point through a guide wire and complete the anchoring after deployment. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Figure 1 It is a structural diagram of a positioning system in Embodiment 1 of the present invention.

[0025] Figure 2It is a schematic diagram of the structure of the positioning bracket in the first embodiment of the present invention.

[0026] The names of the parts indicated by the numbers in the accompanying drawings are as follows: 1-delivery catheter, 2-positioning bracket, 21-positioning unit, 211-connecting part, 2111-connecting rod, 212-supporting part, 2121-force arm, 22-connecting area, 23-winding section, 3-anchoring mechanism, 4-flexible kit, 5-guiding mechanism, 6-anchoring point. Implementation

[0027] The present application is further described in detail below in conjunction with the accompanying drawings and embodiments.

[0028] 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

[0029] like Figure 1 As shown, when the anchoring system is used for mitral valve ring plasty treatment, a positioning system for valve repair includes a delivery catheter 1, a positioning stent 2 arranged in the delivery catheter 1, 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 stent 2 is arranged at the distal end of the delivery catheter 1, and the positioning stent 2 is provided with a plurality of anchoring points 6 distributed along the circumferential direction, and the positioning stent 2 includes a plurality of circumferentially distributed positioning units 21, and the positioning unit 21 is composed of a strand of 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, has a certain flexibility, and can also prevent the positioning stent 2 from causing damage to the heart tissue due to excessive instantaneous force when it is released, wherein the positioning unit 21 includes a connecting portion 211 and a supporting portion 212, and the supporting portion 212 is hexagonal, as shown Figure 2As shown, 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 anchoring 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 end of the support portion 212 are always constant, wherein the connecting portion 211 is connected to the delivery catheter 1, wherein the connecting portion 211 includes two connecting rods 2111, and the two connecting rods 2111 are respectively connected to the connecting rods 2111 of adjacent connecting portions 211, so that each positioning unit 21 can be connected as a whole, when the anchoring point 6 is subjected to traction, the traction can be dispersed to the adjacent support units through the force arms 2121 at the distal end of the support portion 212, thereby effectively enhancing the support rigidity of the positioning bracket 2, so that the positioning bracket 2 does not need to use a thicker rod to meet the support strength, and can enhance and meet the support performance required for the operation from the perspective of structural design alone, thereby avoiding damage to the heart tissue during release.

[0030] In another embodiment, the support portion 212 is a quadrilateral structure.

[0031] In this embodiment, the support portion 212 is arranged in a symmetrical structure with respect to a line connecting the vertex of the proximal end of the support portion 212 and the anchor point 6 .

[0032] In this embodiment, the angle formed by the two connecting rods 2111 is an acute angle.

[0033] In this embodiment, a connection area 22 is formed between adjacent positioning units 21 , and the connection area 22 is arranged in a symmetrical structure with respect to a line connecting a vertex at a proximal end of the connection area 22 and a vertex at a distal end of the connection area 22 .

[0034] In this embodiment, the structures of the connecting area 22 and the supporting portion 212 are substantially similar.

[0035] In this embodiment, a winding section 23 is provided between the connecting portion 211 and the supporting portion 212. The winding section 23 ensures that the length of the connecting rod 2111 is always constant. The constant length of the connecting rod 2111 means that the connecting portion 211 is a relatively fixed overall structure with better stability.

[0036] In this embodiment, the angle formed by the two force arms 2121 at the far end of the support portion 212 is an obtuse angle. When the lengths of the force arms 2121 are the same and the angle between the two force arms 2121 is an obtuse angle, the traction force required to pull the anchor point 6 is greater and the positioning bracket 2 is more stable.

[0037] In this embodiment, the angle formed between the force arms 2121 at the distal ends of adjacent support portions 212 is an obtuse angle.

[0038] 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.

[0039] In this embodiment, the positioning stent 2 has a predetermined shape, wherein, when pre-installed, the positioning stent 2 is compressed in the delivery catheter 1; when the distal end of the delivery catheter 1 reaches the target position, the positioning stent 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 valve ring.

[0040] 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 system for valve repair, comprising a delivery catheter, a positioning stent arranged in the delivery catheter, an anchoring mechanism, a flexible kit and a guiding mechanism, wherein the positioning stent is arranged at the distal end of the delivery catheter, and the positioning stent is provided with a plurality of anchoring points distributed along the circumferential direction, characterized in that: The positioning bracket includes a plurality of circumferentially distributed positioning units, wherein the positioning unit includes a connecting portion and a supporting portion, and two force arms are provided at the distal end of the supporting portion, the two force arms intersect to form the anchoring point, and adjacent supporting portions are intertwined and connected with each other so that the lengths of the two force arms at the distal end of the supporting portion are always constant.

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

3. A positioning system for valve repair according to claim 2, characterized in that: The support portion is arranged in a symmetrical structure with respect to a line connecting the vertex of the proximal 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 portion is connected to the delivery conduit, wherein the connecting portion includes two connecting rods, and the two connecting rods are respectively connected to connecting rods of adjacent connecting portions.

5. A positioning system for valve repair according to claim 1, characterized in that: A connection area is formed between adjacent positioning units, and the connection area is arranged in a symmetrical structure with respect to a line connecting a vertex at a proximal end of the connection area and a vertex at a distal end of the connection area.

6. A positioning system for valve repair according to claim 4, 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 rod is always constant.

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

8. A positioning system for valve repair according to claim 1, characterized in that: The angle formed between the force arms at the distal ends of adjacent support parts 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 stent has a predetermined shape, wherein, when pre-installed, the positioning stent is compressed in the delivery catheter; when the distal end of the delivery catheter reaches the target position, the positioning stent is released from the delivery catheter, and the distal end of the anchoring point is located at the expected anchoring position.

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