Positioning device of valve repair system

Abstract

The invention relates to the field of medical instruments, 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 far end of the delivery catheter, the positioning device 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 device comprises a plurality of positioning units which are distributed in the circumferential direction and connected with one another, 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 point, and the included angle formed by the two force arms is larger than 90 degrees. The positioning device provided by the invention not only can meet the supporting rigidity required by a clinical operation, but also can avoid damage to heart tissues.

Description

Technical Field

[0001] The present application belongs to the field of medical devices, and specifically relates to a positioning device for a valve 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. Although the positioning device in this scheme can guide the anchoring device to anchor, the positioning device formed by interweaving braided wires is prone to movement and deformation due to the lack of mutual fixation and constraint between the braided wires, resulting in the positioning device being unable to meet the positioning and guiding requirements of clinical surgery.

[0004] Patent CN202310568240.0 discloses a repair system that can be precisely positioned, including a delivery catheter, a positioning device arranged in the delivery catheter, an anchoring mechanism, a flexible kit and a guide wire, wherein 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 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 device 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 device is formed by several straight rods. Although the thicker straight rods can improve the supporting strength of the positioning device, it will cause the positioning device to be too hard and not easy to be collected in the delivery sheath; and when the positioning device 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 device for a valve repair system, mainly to solve the following problems: 1. How to ensure that the anchoring points of the positioning device have sufficient support strength to meet clinical surgical needs; 2. How to ensure that the positioning device has sufficient support strength while avoiding damage to the tissue. Application Contents

[0006] The purpose of the present application is to provide a positioning device for a valve repair system. The new positioning system has the following advantages: 1. The anchoring points of the positioning device have sufficient supporting strength to ensure the accuracy of the positioning position during the guided positioning process; 2. While providing supporting performance of sufficient strength, it can also avoid damage to the tissue during release.

[0007] In order to solve the above technical problems, the present application is solved through the following technical solutions: a positioning device of a valve repair system, comprising a delivery catheter, a positioning device arranged in the delivery catheter, an anchoring mechanism, a flexible kit and a guiding mechanism, wherein the positioning device is arranged at the distal end of the delivery catheter, the positioning device is provided with a plurality of circumferentially distributed anchoring points, the positioning device comprises a plurality of circumferentially distributed and interconnected 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 angle formed by the two force arms is greater than 90°.

[0008] As a further improvement of the present invention, the two force arms are equal in length.

[0009] As a further improvement of the present invention, when the angle formed by the two force arms is 180°, or the angle formed by the two force arms is close to 180°, the anchor point formed by the intersection of the two force arms has the greatest supporting strength.

[0010] As a further improvement of the present invention, the adjacent support parts are intertwined and connected with each other so that the lengths of the two force arms at the far ends of the support parts are always constant.

[0011] 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.

[0012] 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.

[0013] As a further improvement of the present invention, the number of turns wound between adjacent support parts is 6 turns.

[0014] 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.

[0015] 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.

[0016] As a further improvement of the present invention, adjacent connecting parts are intertwined and connected with each other, and adjacent supporting parts are also intertwined and connected with each other, so that each positioning unit is constrained to each other, thereby enhancing the integrity of the positioning device. When the anchor point is subjected to the traction force applied by the guide mechanism, the positioning unit will not be easily deformed, and the supporting strength of the positioning device can also meet the needs of clinical surgery.

[0017] 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.

[0018] As a further improvement of the present invention, the connection area is arranged in a hexagonal structure.

[0019] 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.

[0020] 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.

[0021] 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, wherein the expected anchoring position is located at the autologous valve ring. Compared with the prior art, the advantages of this application are: 1. In the prior art, since there is no mutual constraint between the braided wires of the positioning device, the positioning device will be deformed when subjected to a small traction force, further causing the position of the anchor point on the positioning device to deviate; in one embodiment of the present application, the support parts are mutually constrained and fixedly connected to enhance the integrity of the positioning device, and the two force arms are equal in 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 the 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.

[0022] 2. In the prior art, in order to make the positioning device have sufficient support rigidity, it is usually chosen to increase the braiding density of the positioning device, 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 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, and 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 stability of the anchor point and effectively enhancing the support rigidity of the positioning device, and the support parts are intertwined and connected with each other so that the length of the two force arms at the distal end of the support part will not change due to compression or release of the positioning device, which makes the force arm directly related to / connected to the anchor point shorter than the force arm in the prior art, and the shorter the force arm, the greater the traction force that causes the force arm to deform or cause the anchor point to displace, thereby ensuring the stability of the anchor point on the positioning device, thereby achieving the effective improvement of the support rigidity of the positioning device without increasing the braiding wire density, and meeting the needs of clinical surgery.

[0023] 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.

[0024] 4. 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. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1 The figure is a schematic diagram of the overall structure of a positioning device of a valve repair system in the first embodiment of the present invention.

[0026] Figure 2 and Figure 3 It is a schematic diagram of the structure of the positioning device in the first embodiment of the present invention.

[0027] 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 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. Specific embodiments

[0028] like Figure 1As shown, when the anchoring system is used for mitral valve contraction ring plasty 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 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 is arranged at the distal end of the delivery catheter 1, and the positioning device 2 is provided with a plurality of circumferentially distributed anchoring points 6, and the positioning device 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 The alloy material has a certain flexibility and can also prevent the positioning device 2 from causing damage to the heart tissue due to excessive instantaneous force when it is released. The positioning unit 21 includes a connecting portion 211 and a supporting portion 212. The supporting portion 212 is hexagonal. Two force arms 2121 are provided at the distal end of the supporting portion 212. The two force arms 2121 intersect to form the anchoring point 6. In addition, the adjacent supporting portions 212 are intertwined and connected to form two equal-length side edges. The side edges are intertwined and fixed to each other so that the lengths of the two force arms 2121 at the distal end of the supporting portion 212 are always constant. In addition, the two force arms 2121 intersect to form the anchoring point 6. In addition, the angle formed by the two force arms 2121 is greater than 90°. Figure 3 As shown, 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 the adjacent connecting portions 211, so that each positioning unit 21 can be connected into a whole, as shown in FIG. Figure 2 and Figure 3 As shown, when the anchor point 6 is subjected to traction, the traction can be dispersed to the adjacent support units through the force arm 2121 at the distal end of the support portion 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 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.

[0029] In this embodiment, the support portion 212 is hexagonal, wherein adjacent support portions 212 are wound around each other to form two sides of the support portion 212 , and the number of turns of the winding between adjacent support portions 212 is 6.

[0030] 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 .

[0031] In this embodiment, adjacent connecting parts 211 are intertwined and connected with each other, and adjacent supporting parts 212 are also intertwined and connected with each other, so that each positioning unit 21 is mutually constrained, thereby enhancing the integrity of the positioning device 2. When the anchor point 6 is subjected to the traction force applied by the guide mechanism 5, the positioning unit 21 will not be easily deformed, and the supporting strength of the positioning device 2 can also meet the needs of clinical surgery.

[0032] 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 .

[0033] In this embodiment, the connection area 22 is arranged in a hexagonal structure.

[0034] In this embodiment, a winding section 23 is provided between the connecting portion 211 and the supporting portion 212 , and the winding section 23 makes the length of the connecting rod 2111 always constant.

[0035] In this embodiment, the angle formed between the force arms 2121 at the distal ends of adjacent support portions 212 is an obtuse angle.

[0036] In this embodiment, the positioning device 2 has a predetermined shape, wherein, when pre-installed, 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 autologous valve ring.

[0037] 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 for a valve repair system, comprising a delivery catheter, a positioning device arranged in the delivery catheter, an anchoring mechanism, a flexible kit and a guiding mechanism, wherein the positioning device is arranged at the distal end of the delivery catheter, and the positioning device is provided with a plurality of anchoring points distributed along the circumferential direction, characterized in that: The positioning device includes a plurality of positioning units distributed circumferentially and interconnected with each other, 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 the angle formed by the two force arms is greater than 90°.

2. The positioning device of a valve repair system according to claim 1, characterized in that: The adjacent support parts are connected to each other in a winding manner so that the lengths of the two force arms at the distal ends of the support parts are always constant.

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

5. The positioning device of a valve repair system according to claim 4, 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.

6. The positioning device of a valve repair system 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.

7. The positioning device of a valve repair system 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.

8. The positioning device of the valve repair system according to claim 7, characterized in that: The connection area is arranged in a hexagonal structure.

9. The positioning device of a valve repair system according to claim 2, 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.

10. The positioning device of a valve repair system 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.

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