A repair system

Abstract

The application relates to the field of medical devices, in particular to a repair system, which at least comprises a double-puncture structure, a catching device and a repair unit connected with the double-puncture structure, the double-puncture structure is used for guiding the repair unit, and the double-puncture structure can pass through the tissue to be repaired back and forth in the repair process; the catching device is arranged on the side of the starting point of the first puncture of the double-puncture structure in the repair process and is abutted against the tissue, so that the tissue for the second puncture of the double-puncture structure is provided with a supporting force, and thus the tissue for the second puncture is provided with the supporting force and the puncture force from the proximal end and the distal end directions respectively, the double-puncture structure can smoothly puncture at the target position, the accuracy of the puncture point is guaranteed, and the catching device is also responsible for catching the repair unit after the second puncture.

Description

Technical Field

[0001] This application relates to the field of medical devices, and in particular to a repair system. Background Technology

[0002] The foramen ovale is a physiological passage in the atrial septum of the heart during embryonic development. Since the fetus lacks pulmonary circulation, oxygenated blood from the umbilical cord flows from the right atrium into the left atrium through the foramen ovale. After birth, as pulmonary circulation develops, left atrial pressure increases, causing the secondary and primary septa to approach and fuse, gradually forming a permanent atrial septum. However, in some individuals, this fusion fails, resulting in patent foramen ovale (PFO). In patients with PFO, the remaining slit-like abnormal passage between the primary and secondary septa acts like a functional valve. Because the blood pressure in the left atrium is higher than in the right atrium, blood may flow from the left atrium into the right atrium through the foramen ovale. Prolonged blood flow from the left atrium to the right atrium leads to an increase in right atrial blood volume, causing right ventricular hypertrophy and increased pulmonary blood volume. When the pressure in the right atrium is higher than that in the left atrium, the weak primary septum on the left side is pushed open, resulting in blood shunting from right to left. In addition, the following emboli may enter the left heart system and cause corresponding clinical symptoms: thrombosis in the deep veins of the lower extremities or pelvic veins, air emboli caused by decompression sickness or diving, and fat emboli formed after surgery or trauma. For patients with patent foramen ovale who have had a thrombotic event, the risk of recurrence remains very high.

[0003] Currently, the mainstream product in clinical practice is the traditional double-disc foramen ovale occluder. This occluder has a double-disc structure with symmetrical left and right discs and a short waist connecting them. The left disc has a protruding collecting end in the middle of its left side, and the right disc has a protruding collecting end in the middle of its right side. However, all of these traditional double-disc foramen ovale occluders have some problems in clinical use. If the foramen ovale is close to the superior or inferior vena cava or the main pulmonary artery, the edge of the occluder may abrade the vessel, leading to occlusion failure. If a smaller-sized occluder with smaller disc sizes is chosen, the anchoring effect of the occluder is poor, resulting in poor occlusion stability. Furthermore, the foramen ovale is the puncture point for atrial septal puncture in interventional cardiac procedures. For patients with patent foramen ovale who have potential for interventional cardiac treatment, occluding the foramen ovale with the traditional occluder may lead to a situation where atrial septal puncture is difficult to perform, preventing interventional treatment and necessitating a switch to a riskier treatment method.

[0004] Patent CN202111079433.7 discloses a tissue defect repair device, comprising a repair unit and a release unit. The repair unit includes a connecting unit and a locking unit connected to the connecting unit. The locking unit is located in the proximal region of the connecting unit, and the release unit is also located in the proximal region of the locking unit. The connecting unit includes at least one or more connectors. The delivery system includes a puncture needle. When the repair device is located within the delivery system, the connecting unit includes a first free end located in the distal region of the connecting unit and a second free end located in the proximal region of the locking unit. The first free end is provided with a stop member, and the second free end is provided with a hook member. The puncture needle has a preset shape. After the puncture needle passes through the secundum and then through the proximal septum in the opposite direction, the puncture needle is retracted and pushed. The ejector pin releases the abutment, and the locking transmission rod is operated to hook the abutment with the hook. When the locking unit is locked, the connecting unit and the locking unit are in a repaired state and then connected to the release unit. Then, the release unit is operated to break and separate the release unit and the locking unit. The technical defects of this solution are: First, since the connecting unit and the locking unit are pre-installed in the puncture needle, the diameter of the puncture needle must be large enough to accommodate the connecting unit and the locking unit. However, this will leave a large-diameter hole in the punctured cardiac tissue, making it impossible to repair the foramen ovale. Second, the locking unit is made of metal. After the release unit breaks and separates, part of the locking unit or locking element remains in the atrium. The metal material is prone to thrombosis under long-term blood flow, which will affect the patient's health.

[0005] US Patent 20070032796A1 discloses a delivery system for deploying a medical device, comprising: a catheter shaft having a proximal end and a distal end; a deflectable tissue puncture structure slidably engaged within the catheter shaft, the deflectable tissue puncture structure having a tubular shape defining a longitudinal axis, having a lumen and a hollow surface and an open distal tip, at least a portion of the tissue puncture structure being deflectable relative to the longitudinal axis, the deflectable tissue puncture structure further comprising: a tubular needle foot along the proximal end of the tissue puncture structure; a tubular needle tip along the distal end of the tissue puncture structure, the needle tip terminating with a chamfer; a first longitudinal member forming a needle handle, which is attached to the distal end of the catheter shaft to form a tab, such that the catheter shaft and the needle handle cannot move relative to the other; a second longitudinal member forming a needle spine directly attached to the proximal end of the tubular needle tip and the distal end of the tubular needle body, rather than between the catheter shaft, such that the needle spine can move freely within the catheter shaft; and Furthermore, the needle support tube covers at least a portion of the tissue puncture structure to constrain at least a portion of the first and second longitudinal members during the deflection of the tissue puncture structure; and the actuator is slidably engaged within the catheter shaft and attached to the needle spine, such that the translational movement of the actuator relative to the catheter shaft causes the tissue puncture structure to deflect around the flap. The design flaws of this scheme are as follows: First, the deflectable tissue puncture structure needs to enter the right atrium from the left atrium during the second puncture, that is, the needle tip needs to pass through the primary septum from the left atrium to the right atrium. However, in reality, the primary septum is very flexible and is not supported at all, making it difficult for the deflectable tissue puncture structure to accurately puncture the primary septum, resulting in a high risk of surgical failure. Second, the locking device is pre-installed in the deflectable tissue puncture structure. After the puncture is completed, the transport device needs to be operated to send the locking device to the site to be repaired. This method requires simultaneous operation of the motion device and the deflectable tissue puncture structure for release, which is complicated and ineffective.

[0006] In summary, the existing technology has the following problems that urgently need to be solved: First, the large diameter of the puncture structure leaves a large hole in the foramen ovale; second, the metal residue left in the heart can induce thrombosis; third, the puncture structure is difficult to puncture accurately due to the lack of adequate support during puncture; and fourth, the operation steps for releasing the locking device are complicated. Summary of the Invention

[0007] This application is made in view of the above and other ideas.

[0008] One of the purposes of this application is to overcome the shortcomings of the prior art and to provide a repair system that addresses the unreasonable design of the puncture structure and the locking component.

[0009] The objective of this invention is achieved through the following solution:

[0010] A repair system includes at least a double-puncture structure, a gripping device, and a repair unit connected to the double-puncture structure. The double-puncture structure guides the repair unit and is capable of reciprocating through the tissue to be repaired during the repair process. The gripping device is positioned at the first puncture point of the double-puncture structure and abuts against the tissue during the repair process, providing support for the tissue punctured by the double-puncture structure in the second puncture and gripping the repair unit.

[0011] The objective of this invention can also be further achieved through the following technical solutions:

[0012] Furthermore, the capturing device includes a capturing rod and a capturing ring connected to the distal end of the capturing rod; and, in its natural state, the capturing rod and the capturing ring are not on the same plane.

[0013] Furthermore, in its natural state, the capture circle is a three-dimensional object, not a planar object.

[0014] Furthermore, the repair unit includes a connector and a limiting head disposed at the distal end of the connector, the limiting head being pre-installed with the double-puncture structure.

[0015] Furthermore, the limiting head is connected to the distal end of the double-puncture structure.

[0016] Furthermore, the connector has a repair ring formed or provided at its proximal end, and the repair ring is spatially fitted over the capture rod.

[0017] Furthermore, before the second puncture by the double-puncture structure, the entirety or distal portion of the capture circle abuts against the tissue; and, in the projection direction of the capture circle, the distal end of the double-puncture structure is within the capture circle.

[0018] Furthermore, when the double-puncture structure performs a second puncture, the tissue punctured in the second puncture receives the puncture force from the double-puncture structure and the supporting force from the capture ring. The puncture force of the double-puncture structure is concentrated at one point, and the supporting force of the capture ring is evenly distributed at the connection between the capture ring and the tissue. Moreover, the direction of the puncture force is towards the proximal end, and the direction of the supporting force is towards the distal end, so that the tissue punctured in the second puncture is confined between the two and stably clamped.

[0019] Furthermore, after the limiting head separates from the double-piercing structure, pulling the capture rod causes the limiting head to be constrained by the capture ring and move towards the proximal end.

[0020] Furthermore, the repair system also includes a delivery conduit, which includes a loading sheath and a support member connected to the double-puncture structure; and the capture rod is also fitted inside the loading sheath.

[0021] Furthermore, in its natural state, the tangent at the starting point of the double-puncture structure is parallel to or at an acute angle to the tangent at the ending point. The double-puncture structure is generally "J", "U", "C", "M", or "W" shaped. Moreover, when the double-puncture structure is pre-installed in the loading sheath, it is in a straight line or arc shape. After the double-puncture structure is pushed out of the loading sheath by the support member, it is in its natural state.

[0022] Furthermore, as the limiting head moves proximally along with the capture lever, the repair ring moves distally, and the limiting head passes through the repair ring; and the repair ring begins to shrink after approaching or touching the first puncture point, until the repair ring pulls or draws the two punctured intracardiac tissues together.

[0023] Furthermore, the repair unit or the connector is a polymer thread.

[0024] Furthermore, during the first puncture, the dual-puncture structure, carrying the restricting head, enters the left atrium from the right atrium; during the second puncture, the dual-puncture structure, carrying the restricting head, enters the right atrium from the left atrium.

[0025] Furthermore, the capture ring enters the loading sheath under the movement of the capture rod.

[0026] Furthermore, the capture ring includes two symmetrical shape memory metal strips, which move closer to each other as the capture ring enters the loading sheath along with the capture rod.

[0027] Furthermore, the direction of the first puncture of the double puncture structure is from the proximal end to the distal end, and the direction of the second puncture of the double puncture structure is from the distal end to the proximal end.

[0028] Furthermore, the first puncture of the double-puncture structure is from the right atrium through the secondary septum to the left atrium, and the second puncture of the double-puncture structure is from the left atrium through the primary septum to the right atrium.

[0029] Furthermore, the double-puncture structure penetrates both the tertiary and primary septa simultaneously during the first puncture.

[0030] Furthermore, the double-puncture structure simultaneously penetrates the primary septum / secondary septum during the second puncture.

[0031] Furthermore, the direction of the first puncture of the double puncture structure is opposite to the direction of the second puncture of the double puncture structure.

[0032] Furthermore, the direction of the first puncture of the double puncture structure forms an angle α with the direction of the second puncture of the double puncture structure, where α is between 90° and 180°.

[0033] Furthermore, the repair ring is fitted over the loading sheath.

[0034] Furthermore, the repair ring is spatially fitted over the capture rod and the support member.

[0035] Furthermore, the smaller the repair loop, the tighter the two punctured pieces of intracardiac tissue are pulled.

[0036] Compared with the prior art, the advantages of the technical solution of this application include at least the following:

[0037] 1. In existing technologies, the lack of support during puncture makes puncture difficult or inaccurate. Furthermore, after puncture, simultaneous operation of the motion device and the deflectable tissue puncture structure is required to release the repair unit, leading to complex surgical procedures and poor actual repair results. The technical solution of this application avoids these problems. This solution employs a repair system including a dual-puncture structure, a grasping device, and a repair unit connected to the dual-puncture structure. The dual-puncture structure guides the repair unit during puncture, eliminating the need for other components to release the repair unit. The repair unit moves along with the dual-puncture structure and passes through the tissue to be repaired. The grasping device ensures that the repair tissue remains within the tissue to be repaired. Proximal approach, meaning all repair actions are unilateral, is not only convenient but also causes less damage to body tissues, facilitating rapid postoperative recovery. Furthermore, the dual-puncture structure can traverse the tissue to be repaired during the repair process. The grasping device is positioned at the first puncture point of the dual-puncture structure and abuts against the tissue, providing support for the second puncture. Thus, the second puncture receives support and puncture force from both proximal and distal directions, allowing the dual-puncture structure to successfully puncture at the target location. The accuracy of the puncture point is ensured, facilitating the repair process and enabling a tighter repair of the two punctured tissues.

[0038] 2. In existing technologies, after the first puncture, the puncture structure struggles to support and penetrate the primary septum during the second puncture due to the lack of support, easily leading to puncture failure or tearing of the septum and causing secondary injury. The present application's solution avoids these problems. This solution employs a repair system, including a dual-puncture structure, a grasping device, and a repair unit connected to the dual-puncture structure. After the first puncture, the grasping device abuts against the primary septum or both the primary and secondary septum at the side of the first puncture starting point, providing distal support for the dual-puncture structure to penetrate the primary septum. Furthermore, since the second puncture is proximal, the system provides additional support. The primary septum thus receives forces from both the dual-puncture structure and the grasping device, firmly holding it in place during puncture. This prevents significant shaking or vibration during the second puncture, allowing the dual-puncture structure to easily complete the puncture at the target location without tearing intracardiac tissue, thus improving surgical safety. The procedure is simple, efficient, and clinically significant. Furthermore, after providing support, the grasping device can also grasp the repair unit. Under the action or pull of the grasping device, the repair unit pulls or tractions the two punctured intracardiac tissues together to complete the repair of the foramen ovale. In summary, the grasping device is ingeniously designed, multi-functional, and highly practical.

[0039] 3. According to a concept of this application, the repair unit includes a connector and a limiting head disposed at the distal end of the connector. During pre-installation, the limiting head is connected to the distal end of the double-puncture structure. The purpose of this design is that when the distal end of the puncture structure enters the left atrium through the secundum, the limiting head also enters the left atrium along with the puncture structure. When the distal end of the puncture structure enters the right atrium from the left atrium through the primum, the limiting head also enters the right atrium along with the puncture structure. The result of these two punctures is that holes are punctured in the secundum and primum, respectively. The connector passes through the holes in the secundum and primum. Pulling the connector can suture or connect the secundum and primum together, thereby solving the problem of unrepaired foramen ovale. The surgical principle is cleverly designed, leaving less implant in the body, which is beneficial to patient recovery and has a high level of humanization.

[0040] 4. According to a concept of this application, the capture device includes a capture rod and a capture ring disposed at the distal end of the capture rod. Since the capture ring is against the primary septum during puncture, the distal end of the double-puncture structure will inevitably be within the capture ring after puncture. That is, in the projection direction of the capture ring, the distal end of the double-puncture structure is within the capture ring. For this reason, after the restricting head enters from the left atrium into the right atrium and separates from the double-puncture structure, it will inevitably be fitted into the capture ring. In this case, pulling the capture rod can cause the restricting head to be captured into the capture hook, thereby pulling the repair unit to suture the foramen ovale. The operation is very smooth. In summary, all components are well coordinated, simplifying the surgical steps, increasing surgical efficiency, and improving the success rate of the surgery.

[0041] 5. According to a concept of this application, the tangent at the starting point of the double puncture structure is parallel to or at an acute angle to the tangent at the ending point, and is generally "J", "U", "C", "M" or "W" shaped. In order to puncture and guide the repair unit, the semi-closed double puncture structure is equivalent to a round-trip channel, which delivers the limiting head from the right atrium to the left atrium and back to the right atrium. During the delivery process, it passes through the secundum and the primary septum, thereby realizing the foramen ovale repair function. Unlike the prior art, the double puncture structure does not require pre-installed connecting units, locking units or other implants. Therefore, the diameter of the double puncture mechanism is designed to be small. This design is beneficial for better puncture of the secundum and the primary septum tissue, and the small diameter of the hole left by the puncture is beneficial for later recovery.

[0042] 6. According to a concept of this application, the connector has a repair ring formed or provided at its proximal end, and the repair ring is spatially fitted over the capture rod. The purpose of this design is that, in order to sew the secondary and primary septa together, the connector needs to pass through the inside of the repair ring after passing through the primary septa, and then pull the connector to make the repair ring continuously shrink to form a "knot". The capture rod being fitted over the repair ring ensures that the restraining head and the connector pass through the repair ring under the pull of the capture ring. On the other hand, the repair ring being fitted over the loading sheath, the loading sheath having a smooth surface and a large diameter, can prevent the repair ring from knotting prematurely as it moves along the loading sheath to the final knotting and sewing point.

[0043] 7. According to a concept of this application, the entire repair unit or the connector is made of polymer thread. Therefore, the repair loop formed by winding or knotting the connector is also made of polymer thread. Thus, after the foramen ovale repair is completed, the implant left in the atrial septum is only polymer thread. The implant will gradually integrate with the heart tissue. After this interventional procedure is completed, it will not put any burden on the heart, nor will it induce any disease or other sequelae. The effect is excellent and has high promotional value.

[0044] The embodiments of this application can achieve other advantageous technical effects not listed one by one, which may be partially described below; and these other technical effects can be expected and understood by those skilled in the art after reading this application. Attached Figure Description

[0045] The above-described features and advantages of these embodiments, as well as other features and advantages, and the ways in which they are implemented, will become more apparent from the following description in conjunction with the accompanying drawings; and embodiments of this application can be better understood, in which:

[0046] Figure 1a and 1b This is a schematic diagram of the overall structure of the repair system of the present invention.

[0047] Figure 2a and 2b This is a schematic diagram of the overall capture device of the present invention and a schematic diagram of the connection between the double puncture structure and the support member.

[0048] Figures 3a-3c This is a schematic diagram of the first puncture of the secondary septum using the double-puncture structure of the present invention.

[0049] Figures 4a-4d This is a schematic diagram of the process of the second puncture of the primary septum by the double-puncture structure of the present invention and a schematic diagram of the state after the double-puncture structure is recovered.

[0050] Figures 5a-5e This is a schematic diagram illustrating the process by which the connecting piece and the repair ring move when the capture rod is pulled, according to the present invention. Figures 5b-5e The loading sheath in the middle is not shown in the figure. Figures 5b-5e The loading sheath in the middle, such as Figure 5a As shown.

[0051] Figures 6a-6e This is a schematic diagram illustrating the process of gradually shrinking the repair ring of the present invention to pull or traction two punctured pieces of intracardiac tissue to one point.

[0052] The features represented by the numbers in the attached diagram are as follows:

[0053] 1-Double puncture structure, 2-Capture device, 21-Capture rod, 22-Capture ring, 3-Repair unit, 31-Connector, 32-Restriction head, 33-Repair ring, 4-Delivery conduit, 41-Loading sheath, 42-Support. Detailed Implementation

[0054] The details of one or more embodiments of this application will be set forth in the following description of the accompanying drawings and specific embodiments. Other features, objects, and advantages of this application will become clear from these descriptions, drawings, and claims.

[0055] It should be understood that the illustrated and described embodiments are not limited in application to the details of the construction and arrangement of the components set forth in the following description or illustrated in the drawings. The illustrated embodiments may be other embodiments; and can be implemented or performed in various ways. The examples are provided by way of explanation rather than limitation of the disclosed embodiments. In fact, it will be apparent to those skilled in the art that various modifications and variations can be made to the embodiments of this application without departing from the scope or spirit of this disclosure. For example, features illustrated or described as part of one embodiment may be used with another embodiment to still produce another embodiment. Therefore, this disclosure covers such modifications and variations that fall within the scope of the appended claims and their equivalents.

[0056] Similarly, it is understood that the phrases and terms used in this document are for descriptive purposes and should not be considered restrictive. The use of “including,” “contains,” or “has,” and their variations, in this document is intended to include, in an open-ended manner, the items listed thereafter, their equivalents, and any additional items.

[0057] The present application will now be described in more detail with reference to various embodiments and examples of several aspects thereof.

[0058] In this application, the terms "proximal" or "proximal" refer to the end or side closer to the surgeon, and "distal" or "distal" refer to the end or side farther from the surgeon.

[0059] In this application, the term "first puncture" refers to puncturing the distal end of the double puncture structure from the proximal end to the distal end, and the term "second puncture" refers to puncturing the distal end of the double puncture structure from the distal end to the proximal end.

[0060] In the existing technology, there are problems such as leaving large holes in the foramen ovale due to the large diameter of the puncture structure, leaving metal residues in the heart that may induce thrombosis, and the puncture structure being difficult to puncture accurately due to insufficient support during puncture.

[0061] One of the objectives of the embodiments described below is to address the aforementioned deficiencies, as well as other problems.

[0062] Example 1

[0063] like Figure 1a and 1b The illustration shows a repair system according to an embodiment of this application, comprising at least a double-puncture structure 1, a gripping device 2, and a repair unit 3 connected to the double-puncture structure 1. The double-puncture structure 1 guides the repair unit 3 and is capable of passing back and forth through the tissue to be repaired during the repair process. The gripping device 2 is positioned at the first puncture starting point of the double-puncture structure 1 and abuts against the tissue during the repair process, providing support for the tissue punctured by the double-puncture structure 1 for the second puncture, and gripping the repair unit 3.

[0064] In this first embodiment, the capturing device 2 includes a capturing rod 21 and a capturing ring 22 connected to the distal end of the capturing rod 21; and, in its natural state, the capturing rod 21 and the capturing ring 22 are not on the same plane, such as... Figure 2a As shown.

[0065] In this first embodiment, the repair unit 3 includes a connector 31 and a limiting head 32 disposed at the distal end of the connector 31. The limiting head 32 is connected to the double puncture structure 1 during pre-installation.

[0066] In this first embodiment, the limiting head 32 is connected to the distal end of the double puncture structure 1.

[0067] In this first embodiment, the connector 31 has a repair ring 33 formed or provided at its proximal end, and the repair ring 33 is spatially fitted over the capture rod 21.

[0068] In this first embodiment, before the second puncture of the double-puncture structure 1, the entirety or distal portion of the capture circle 22 abuts against the tissue; and, in the projection direction of the capture circle 22, the distal end of the double-puncture structure 1 is within the capture circle 22, such as... Figure 1b and 4b As shown.

[0069] In this first embodiment, when the double-puncture structure 1 performs a second puncture, the tissue punctured in the second puncture receives the puncture force from the double-puncture structure 1 and the supporting force from the capture ring 22. The puncture force of the double-puncture structure 1 is concentrated at one point, and the supporting force of the capture ring 22 is evenly distributed at the connection between the capture ring 22 and the tissue. Furthermore, the direction of the puncture force is towards the proximal end, and the direction of the supporting force is towards the distal end, so that the tissue punctured in the second puncture is confined between the two and stably clamped.

[0070] In this first embodiment, after the limiting head 32 separates from the double-piercing structure 1, pulling the capturing rod 21 causes the limiting head 32 to be constrained by the capturing ring 22 and move towards the proximal end, as shown. Figure 4d and 5a As shown.

[0071] In this first embodiment, the repair system also includes a delivery conduit 4, which includes a loading sheath 41 and a support member 42 connected to the double puncture structure 1; and the capture rod 21 is also sleeved inside the loading sheath 41.

[0072] In this first embodiment, under natural conditions, the tangent at the starting point of the double-puncture structure 1 is parallel to or at an acute angle to the tangent at the ending point. The double-puncture structure 1 is generally "J"-shaped, "U"-shaped, or "C"-shaped. Figure 2b As shown; and, when the double puncture structure 1 is pre-installed in the loading sheath 41, it is in a straight or arc shape, and after the double puncture structure 1 is pushed out of the loading sheath 41 by the support member 42, it is in a natural state.

[0073] In this first embodiment, as the limiting head 32 moves proximally along with the capturing rod 21, the repair ring 33 moves distally, and the limiting head 32 passes through the repair ring 33. Figures 5b-5eAs shown; and, the repair ring 33 begins to shrink after touching the first puncture site, until the repair ring 33 pulls or draws the two punctured intracardiac tissues together, as shown. Figures 6a-6d As shown.

[0074] In this first embodiment, the repair unit 3 or the connector 31 is a polymer thread.

[0075] In this first embodiment, during the first puncture, the double puncture structure 1, carrying the restricting head 32, enters the left atrium from the right atrium; during the second puncture, the double puncture structure 1, carrying the restricting head 32, enters the right atrium from the left atrium.

[0076] In this first embodiment, the capture ring 22 enters the loading sheath 41 under the movement of the capture rod 21.

[0077] In this first embodiment, the direction of the first puncture of the double puncture structure 1 is from the proximal end to the distal end, and the direction of the second puncture of the double puncture structure 1 is from the distal end to the proximal end.

[0078] In this embodiment, the first puncture of the double puncture structure 1 is from the right atrium through the secondary septum to the left atrium, and the second puncture of the double puncture structure 1 is from the left atrium through the primary septum to the right atrium.

[0079] The exemplary operation process of the repair system in this embodiment is as follows:

[0080] 1. The delivery system enters the right atrium via a femoral vein approach, with the loading sheath 41 pressing against the secondary septum, such as... Figure 3a As shown, the support member 42 is then operated to push out the double-puncture structure 1. The distal end of the double-puncture structure 1 punctures the secundum and, along with the restricting head 32, enters the left atrium, completing the first puncture of the double-puncture structure 1. Figure 3b and 3c As shown;

[0081] 2. Operate the capturing device 2 to cause the capturing ring 22 to exit from the loading sheath 41 and return to its original state, such as... Figure 4a As shown, the capture ring 22 abuts against the primary septum, pulling the support member 42 and causing the double-puncture structure 1 to move proximally. The distal end of the double-puncture structure 1 returns from the left atrium to the right atrium and punctures the primary septum, while the restricting head 32 returns to the right atrium. Figure 4b and 4c As shown, the second puncture of the double-puncture structure 1 is completed, and then the double-puncture structure 1 is retrieved, as follows. Figure 4d As shown;

[0082] 3. Operate the capturing device 2 to move it proximally. The limiting head 32 is caught within the capturing ring 22. Pull the capturing rod 21 to move it proximally. The limiting head 32 moves proximally along with the capturing ring 22. The repair ring 33 moves distally under the influence of the connecting member 31. During the pulling process, the limiting head 32 will pass through the repair ring 33. Figures 5a-5e As shown;

[0083] 4. Continuously pull the capture lever 21 towards the proximal end. When the repair ring 33 approaches the first puncture point, operate the loading sheath 41 to move towards the proximal end, as follows. Figure 6a As shown, the repair loop 33 then touches the starting point of the first puncture and begins to shrink until the repair loop 33 pulls or tractions the two punctured intracardiac tissues to one place, completing the knot of the repair loop 33, and no longer pulling the capture rod 21, as... Figures 6b-6d As shown;

[0084] 5. Retrieve the delivery catheter 4; implantation complete. Figure 6e As shown.

[0085] 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 repair system, comprising at least a double-puncture structure, a capture device, and a repair unit connected to the double-puncture structure, characterized in that: The double-puncture structure is used to guide the repair unit, and the double-puncture structure can pass back and forth through the tissue to be repaired during the repair process; The capture device is positioned at the first puncture point of the double-puncture structure during the repair process and abuts against the tissue, providing support for the tissue during the second puncture of the double-puncture structure, and capturing the repair unit after the second puncture. The capture device includes a capture rod and a capture ring connected to the distal end of the capture rod; and, in its natural state, the capture rod and the capture ring are not on the same plane; before the second puncture of the double-puncture structure, the entire or distal portion of the capture ring abuts against the tissue; and, in the projection direction of the capture ring, the distal end of the double-puncture structure is within the capture ring.

2. The repair system according to claim 1, characterized in that: The repair unit includes a connector and a limiting head disposed at the distal end of the connector, the limiting head being pre-installed with the double-puncture structure.

3. The repair system according to claim 2, characterized in that: The connector has a repair ring formed or provided at its proximal end, and the repair ring is spatially fitted over the capture rod.

4. The repair system according to claim 2, characterized in that: The limiting head separates from the double-puncture structure after the second puncture, and the limiting head is located within the capture circle in the projection direction of the capture circle.

5. A repair system according to claim 2, characterized in that: After the limiting head separates from the double-piercing structure, pulling the capture rod causes the limiting head to be constrained by the capture ring and move towards the proximal end.

6. A repair system according to claim 2, characterized in that: The repair system also includes a delivery conduit, which includes a loading sheath and a support connected to the double-puncture structure; and the capture rod is also fitted inside the loading sheath.

7. A repair system according to claim 6, characterized in that: In its natural state, the tangent at the starting point of the double-puncture structure is parallel to or at an acute angle to the tangent at the ending point. The double-puncture structure is generally "J", "U", "C", "M" or "W" shaped. Furthermore, when the double-puncture structure is pre-installed in the loading sheath, it is in a straight line or arc shape. After the double-puncture structure is pushed out of the loading sheath by the support member, it is in a preset state.

8. A repair system according to claim 3, characterized in that: As the restraining head moves proximally along with the capture lever, the repair coil moves distally, and the restraining head passes through the repair coil; furthermore, the repair coil begins to shrink after approaching or touching the first puncture site, until the repair coil pulls or draws the two punctured intracardiac tissues together.

9. A repair system according to claim 2, characterized in that: The repair unit or the connector is a polymer thread.

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