A closure instrument including a pre-positioning mechanism

Abstract

The application relates to the field of medical devices, in particular to a closure device with a pre-positioning mechanism, which comprises a delivery catheter, an implant for closing a tissue defect, and a puncture mechanism and a positioning mechanism arranged in the delivery catheter, the positioning mechanism comprising a connecting mechanism, a support member arranged at the distal end of the connecting mechanism, and a pre-positioning mechanism arranged on the support member, the pre-positioning mechanism being located in the left atrium and hanging on the secondary septal tissue after the support member reaches a predetermined position, and the support member can provide a support force for the puncture mechanism when the puncture mechanism reciprocally punctures the tissue to be closed; in the application, the support member can provide bidirectional support for the puncture mechanism when the puncture mechanism reciprocally punctures the tissue, the puncture precision is improved, the tissue can be prevented from being damaged, the pre-positioning mechanism can prevent the positioning mechanism from deviating, and the application has good clinical significance.

Description

Technical Field

[0001] This application relates to the field of medical devices, and in particular to a closed device containing a prepositioning mechanism. 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, the pressure in the left atrium 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). The traditional treatment for PFO is surgery. This surgical approach requires open-chest surgery. The main disadvantages of surgery are: the need for cardiopulmonary bypass, the potential for complications leading to death, significant surgical trauma, postoperative scarring, and high cost. With the development and improvement of interventional techniques, minimally invasive interventional treatment for PFO is now very mature. Minimally invasive interventional treatment has advantages such as no incision, minimal trauma, fewer complications, faster recovery, better efficacy, wider range of indications, and relatively lower cost. However, each method has its own set of problems.

[0003] Patent CN202011562345.8 discloses a positioning and guiding mechanism for a tissue closure instrument, including a delivery catheter, an implant for closing tissue defects, and a puncture mechanism and a positioning component disposed within the delivery catheter. The puncture mechanism is capable of reciprocating punctures into the tissue to be closed. The positioning component includes a connecting mechanism and a positioning bracket disposed at the distal end of the connecting mechanism, and the positioning bracket provides support for the puncture mechanism during reciprocating punctures into the tissue to be closed. While this solution provides bidirectional support for the puncture mechanism, the continuous beating of the heart during surgery means that the positioning bracket's position may shift after reaching the intended location but before puncturing the secondary septum, resulting in a puncture site different from the intended one and affecting the surgical outcome.

[0004] In summary, the existing technology has the following problems that urgently need to be solved: First, after the clamping mechanism reaches the surgical position, its position may shift with the heartbeat, leading to puncture failure; Second, when performing a second puncture, the clamping mechanism needs to be rotated and adjusted through a rotating delivery system, but the rotation of the sheath may scratch the blood vessel wall, leading to postoperative complications. At the same time, the position of the second puncture needs to be re-determined, making the operation complicated and significantly prolonging the operation time. Summary of the Invention

[0005] This application is made in view of the above and other ideas.

[0006] One of the purposes of this application is to overcome the shortcomings of the prior art. In view of the problems that the predetermined position of the foramen ovale closure device is easily deviated with the heartbeat during puncture and that the lack of support during puncture leads to tissue tearing, this application provides a closure device with a prepositioning mechanism.

[0007] The objective of this invention is achieved through the following approach:

[0008] A closure device with a pre-positioning mechanism includes a delivery catheter, an implant for closing tissue defects, and a puncture mechanism and a positioning mechanism disposed within the delivery catheter. The positioning mechanism includes a connecting mechanism, a support member disposed at the distal end of the connecting mechanism, and a pre-positioning mechanism disposed on the support member. After the support member reaches a predetermined position, the pre-positioning mechanism engages with the tissue to be closed and achieves pre-positioning. Furthermore, the support member provides support force for the puncture mechanism to reciprocate through the tissue to be closed. The reciprocating puncture of the tissue to be closed by the puncture mechanism means that after puncturing the secondary septum, the puncture member then detours within the left atrium and punctures the primary septum.

[0009] The objective of this invention can also be further achieved through the following technical solutions:

[0010] As a further improvement of the present invention, the tissue to be closed is a secondary septum and a primary septum, and after the support member reaches the predetermined position, the prepositioning mechanism is located in the left atrium and attached to the secondary septum.

[0011] As a further improvement of the present invention, when the support member reaches the predetermined position and the puncture mechanism punctures the secondary septum, the upper region of the support member provides support for the puncture mechanism, and when the puncture mechanism punctures the primary septum in a roundabout manner, the lower region of the support member provides support for the puncture mechanism.

[0012] As a further improvement of the present invention, after the support member reaches the predetermined position, a portion of the support member is located between the secondary septum and the primary septum.

[0013] As a further improvement of the present invention, the support member is a sheet-like structure, and the support member is hinged to the distal end of the connecting mechanism. The support member is rotatable relative to the connecting mechanism. When the support member is transported to the foramen ovale, the support member can conform to the tunnel shape of the PFO, making it fit the tissue better, which is beneficial to adjust to the optimal puncture angle during puncture. Furthermore, the support member will not cause damage to the tissue during surgical operation.

[0014] As a further improvement of the present invention, the prepositioning mechanism includes a first hook and a second hook, the first hook and the second hook being fixed on both sides of the support member respectively. After the positioning mechanism completes the positioning in the heart, the hook structure is fixed on both sides of the secondary septum at the upper edge of the fossa ovalis.

[0015] As a further improvement of the present invention, after the support member reaches the predetermined position, the first hook and the second hook respectively attach to and abut against the secondary diaphragm.

[0016] As a further improvement of the present invention, the first and second hooks are symmetrically arranged about the central axis of the connecting mechanism; the symmetrical arrangement is beneficial to the stability of the position of the support member.

[0017] As a further improvement of the present invention, the first and second loops are arranged in an elliptical structure; the advantage of this design is that the first and second loops are easy to retract into the sheath during pre-installation, and the elliptical structure is less likely to cause damage to the tissue.

[0018] As a further improvement of the present invention, the first and second loops are made of shape memory metal material.

[0019] As a further improvement of the present invention, both the first and second loops are covered with a membrane material, which includes metal materials, polytetrafluoroethylene, polyethylene, polypropylene, polyester, or animal-derived materials.

[0020] As a further improvement of the present invention, after the positioning mechanism enters the heart and achieves positioning, the angle between the support member and the secondary septum is greater than or equal to the angle between the prepositioning mechanism and the support member.

[0021] As a further improvement of the present invention, after the first and second hooks are unfolded, the lateral length of the positioning mechanism is greater than the lateral length of the oval hole.

[0022] As a further improvement of the present invention, the supporting member has an H-shaped structure, and the distal end of the connecting mechanism is hinged to the middle region of the supporting member. Further, the distal end of the connecting mechanism is hinged to the middle rod of the supporting member. The upper end of the middle rod of the supporting member is referred to as the upper region, and the lower end of the middle rod is referred to as the lower region. The puncture mechanism punctures the secondary septum tissue. The upper region of the supporting member provides support for the puncture mechanism, and the distal end of the puncture mechanism exits from the upper region of the supporting member after passing through the first tissue. Alternatively, the distal end of the puncture mechanism may detour and puncture the primary septum tissue. The lower region of the supporting member provides support for the puncture mechanism, and the distal end of the puncture mechanism exits from the lower region of the supporting member after passing through the second tissue.

[0023] As a further improvement of the present invention, the positioning mechanism further includes a clamping mechanism, which includes a spring and a control line. The spring is disposed on the connecting mechanism, and after the supporting member reaches the predetermined position, it pulls the control line to open the spring and cooperate with the connecting mechanism to clamp the secondary septum.

[0024] As a further improvement of the present invention, the implant includes a T-shaped rod, a connecting wire, and a limiting structure, wherein the T-shaped rod and the limiting structure are respectively disposed at both ends of the connecting wire; the limiting structure is in the shape of a fishbone; after reciprocating punctures, the T-shaped rod is located on the side of the primary septum in the right atrium, and the limiting structure is located on the side of the secondary septum in the right atrium. By pulling the limiting structure, the closure of the foramen ovale is observed. When the limiting structure is pulled to the appropriate position, the foramen ovale closes, and then the delivery system is withdrawn from the body to complete the surgery.

[0025] Compared with the prior art, the advantages of the technical solution of this application include at least the following:

[0026] 1. Existing delivery systems, when entering the foramen ovale, suffer from positional deviation and poor puncture results due to the lack of pre-positioning and the continuous beating of the heart. Furthermore, insufficient support during puncture causes severe tearing and damage to the tissue. According to a concept of the present invention, the support member is equipped with a hook structure to hold the tissues on both sides of the secondary septum at the upper edge of the foramen ovale, allowing the support member to remain stably in the predetermined position without deviation due to the beating of the heart. This makes the puncture more accurate. At the same time, when the puncture mechanism detours to puncture the primary septum tissue, there is no need to observe the influence and reposition, saving surgical time and reducing the difficulty of the operation.

[0027] 2. According to a concept of this application, after the positioning component reaches the predetermined position, the supporting component is located partly on the side of the secundum in the left atrium and partly on the side of the primary septum in the right atrium. This allows the positioning component to provide bidirectional support to the puncture mechanism when it travels back and forth between the secundum and primary septum tissues, enabling the puncture mechanism to perform the surgery according to the predetermined puncture route. This avoids damage to cardiac tissue caused by direct puncture and improves puncture accuracy, which has significant clinical implications.

[0028] 3. According to a concept of this application, since the secondary septum is relatively thick, it is better to pre-fix and puncture the secondary septum. Therefore, this application enters from the right atrium, allowing the support mechanism to reach the tunnel of the PFO, and uses the first and second hooks to attach and abut against the secondary septum to achieve pre-positioning and avoid positional displacement of the support components.

[0029] 4. According to a concept of this application, the control line can both pull open the spring clip to clamp the secondary septum tissue, further stabilizing the support component, and guide the puncture mechanism to the target position for precise operation.

[0030] 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

[0031] 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:

[0032] Figures 1a-1c This is a schematic diagram of the overall structure and principle of the positioning mechanism of the present invention.

[0033] Figures 2a-2c This is a schematic diagram of the structure of each component of the positioning mechanism of the present invention.

[0034] Figures 3a-3d This is a schematic diagram of the process by which the positioning mechanism of the present invention enters the PFO tunnel.

[0035] Figures 4a-4f This is a schematic diagram of the process of puncturing the secondary septum and primary septum tissue using the puncture mechanism of the present invention.

[0036] Figures 5a-5b This is a schematic diagram illustrating the process by which the implant of the present invention achieves closure.

[0037] The features represented by the numbers in the attached diagram are as follows:

[0038] 1-Delivery catheter, 2-Implant, 21-T-shaped rod, 22-Connecting line, 23-Limiting structure, 3-Punch mechanism, 4-Positioning mechanism, 41-Connecting mechanism, 42-Supporting component, 43-Pre-positioning mechanism, 431-First loop, 432-Second loop, 44-Clamping mechanism, 441-Spring, 442-Control line. Detailed Implementation

[0039] 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.

[0040] It should be 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.

[0041] The present application will now be described in more detail with reference to various embodiments and examples of several aspects thereof.

[0042] 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.

[0043] In the prior art, the puncture instruments do not pre-position the secondary septum tissue and lack support during puncture, resulting in deviations from the intended position during the procedure.

[0044] One of the objectives of the embodiments described below is to address the aforementioned deficiencies, as well as other problems.

[0045] Example 1

[0046] like Figures 1a-1c As shown, the present invention, when used to close the foramen ovale tissue, illustrates a closure device 4 with a pre-positioning mechanism according to an embodiment of this application. The device includes a delivery catheter 1, an implant 2 for closing tissue defects, and a puncture mechanism 3 and a positioning mechanism 4 disposed within the delivery catheter 1. The positioning mechanism 4 includes a connecting mechanism 41, a support member 42 disposed at the distal end of the connecting mechanism 41, and a pre-positioning mechanism 43 disposed on the support member 42. After the support member 42 reaches the predetermined position, the pre-positioning mechanism 43 is located in the left atrium and abuts against the secondary septum. When the puncture mechanism 3 punctures the secondary septum, the upper region of the support member 42 provides support for the puncture mechanism 3. Furthermore, when the puncture mechanism 3 punctures the primary septum in a roundabout manner, the lower region of the support member 42 provides support for the puncture mechanism 3.

[0047] In this first embodiment, after the support member 42 reaches the predetermined position, a portion of the support member 42 is located between the secondary septum and the primary septum, such as... Figure 2a and 2b As shown.

[0048] In this first embodiment, the support member 42 is a sheet-like structure, and the support member 42 is hinged to the distal end of the connecting mechanism 41. The support member 42 is rotatable relative to the connecting mechanism 41. When the support member 42 is transported to the foramen ovale, the support member 42 can conform to the tunnel shape of the PFO, making it fit the tissue better, which is beneficial to adjust to the optimal puncture angle during puncture. Furthermore, the support member 42 will not cause damage to the tissue during the surgical procedure.

[0049] In this first embodiment, the pre-positioning mechanism 43 includes a first loop 431 and a second loop 432, as follows: Figure 2a As shown, the first loop 431 and the second loop 432 are respectively fixed on both sides of the support member 42. After the positioning mechanism 4 completes the positioning in the heart, the first loop 431 and the second loop 432 are fixed on both sides of the secondary septum at the upper edge of the fossa ovalis. This allows the positioning mechanism 4 to have a preliminary pre-position after entering the predetermined position, avoiding the support member 42 from being affected by the heartbeat and shifting its position during puncture.

[0050] In this first embodiment, both the first ear loop 431 and the second ear loop 432 are covered with a membrane material, which includes metal materials, polytetrafluoroethylene, polyethylene, polypropylene, polyester, or animal-derived materials; after the support member 42 reaches the predetermined position, the first ear loop 431 and the second ear loop 432 abut against the secondary septum of the left atrium.

[0051] In this first embodiment, after the first hook 431 and the second hook 432 are unfolded, the lateral length of the positioning mechanism 4 is greater than the lateral length of the oval hole, such as... Figure 2b As shown.

[0052] In this embodiment, the supporting member 42 has an H-shaped structure. The distal end of the connecting mechanism 41 is hinged to the middle region of the supporting member 42. Further, the distal end of the connecting mechanism 41 is hinged to the middle rod of the supporting member 42. The upper end of the middle rod of the supporting member 42 is called the upper region, and the lower end of the middle rod is called the lower region. The puncture mechanism 3 punctures the secondary septum tissue. The upper region of the supporting member 42 provides support for the puncture mechanism 3. The distal end of the puncture mechanism 3 exits from the upper region of the supporting member 42 after passing through the first tissue. Alternatively, the distal end of the puncture mechanism 3 can puncture the primary septum tissue after a detour. The lower region of the supporting member 42 provides support for the puncture mechanism 3. The distal end of the puncture mechanism 3 exits from the lower region of the supporting member 42 after passing through the second tissue.

[0053] In this first embodiment, the positioning mechanism 4 further includes a clamping mechanism 44, which includes a spring piece 441 and a control line 442, as shown below. Figure 1c and 2c As shown, the spring piece 441 is disposed on the connecting mechanism 41, and after the supporting member 42 reaches the predetermined position, it pulls the control line 442 to open the spring piece 441 and cooperate with the connecting mechanism 41 to clamp the secondary septum tissue.

[0054] In this first embodiment, the implant 2 includes a T-shaped rod 21, a connecting wire 22, and a limiting structure 23, as follows: Figure 5a and 5b As shown, the T-shaped rod 21 and the limiting structure 23 are respectively set at both ends of the connecting line 22. The limiting structure 23 is in the shape of a fishbone. After the puncture mechanism 3 performs reciprocating punctures, the T-shaped rod 21 is located on the side of the primary septum in the right atrium, and the limiting structure 23 is located on the side of the secondary septum in the right atrium. By pulling the limiting structure 23, the closure of the foramen ovale can be observed. When the limiting structure 23 is pulled to the appropriate position, the foramen ovale closes. Then, the delivery system is withdrawn from the body to complete the surgery.

[0055] The exemplary operation process of the closed system in this embodiment is as follows:

[0056] (1) The delivery catheter 1 is introduced into the right atrium via the femoral vein approach, and then pushed to the location of the patent foramen ovale between the secondary septum and the primary septum near the interatrial septum, such as... Figure 3a As shown;

[0057] (2) Retract the delivery conduit 1, as follows Figure 3b As shown, the support member 42 is restored to its preset shape. At this time, the support member 42 is located between the secondary septum and the primary septum, and the connecting mechanism 41 is operated so that the prepositioning mechanism 43 can hook onto both sides of the secondary septum at the upper edge of the fossa ovalis, as shown. Figure 3c As shown, subsequently, pulling the control line 442 causes the spring clip 441 to open and clamp the secondary septum tissue, as... Figure 3d As shown;

[0058] (3) Operate the puncture mechanism 3 to pass through the secondary septum tissue along the predetermined route, and continue the operation so that the puncture mechanism 3 can detour and puncture the primary septum tissue along the predetermined route, such as Figures 4a-4d As shown, after the puncture is completed, the shrapnel 441 is retracted and inserted into the delivery catheter 1, as follows. Figure 4e and 4f As shown;

[0059] (4) Observe the position of the foramen ovale in the right atrium to detect the release of a shunt. Pull the limiting structure 23 until no blood flow passes between the primary and secondary septa. Finally, cut the thread connected to the limiting structure 23 to complete the operation. Figure 5a and 5b As shown.

[0060] 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 closure device including a pre-positioning mechanism, comprising a delivery catheter, an implant for closing tissue defects, and a puncture mechanism and a positioning mechanism disposed within the delivery catheter, characterized in that: The positioning mechanism includes a support member and a pre-positioning mechanism disposed on the support member. After the support member reaches the predetermined position, the pre-positioning mechanism engages with the tissue to be closed and achieves pre-positioning. Furthermore, the support member provides support force for the puncture mechanism to reciprocate through the tissue to be closed. The positioning mechanism includes a connecting mechanism, and the support member is disposed at the distal end of the connecting mechanism. The tissue to be closed is a secondary septum and a primary septum. After the support member reaches the predetermined position, the pre-positioning mechanism is located in the left atrium and engages with the secondary septum. The pre-positioning mechanism includes a first lug and a second lug, which are respectively fixed on both sides of the support member.

2. A closing device including a pre-positioning mechanism according to claim 1, characterized in that: When the support member reaches the predetermined position and the puncture mechanism punctures the secondary septum, the upper region of the support member provides support for the puncture mechanism. Furthermore, when the puncture mechanism punctures the primary septum in a roundabout manner, the lower region of the support member provides support for the puncture mechanism.

3. A closing device including a pre-positioning mechanism according to claim 1, characterized in that: After the support member reaches the predetermined position, the first and second hooks respectively attach to and abut the secondary diaphragm.

4. A closing device including a pre-positioning mechanism according to claim 1, characterized in that: The first and second hooks are symmetrically arranged about the central axis of the connecting mechanism.

5. A closing device including a pre-positioning mechanism according to claim 1, characterized in that: The first and second loops are arranged in one or more of the following shapes: elliptical, straight, J-shaped, V-shaped, or spiral.

6. A closing device including a pre-positioning mechanism according to claim 1, characterized in that: The first and second loops are made of elastic material.

7. A closing device including a pre-positioning mechanism according to claim 1, characterized in that: After the positioning mechanism enters the heart and achieves positioning, the angle between the support member and the secondary septum is greater than or equal to the angle between the prepositioning mechanism and the support member.

8. A closing device including a pre-positioning mechanism according to claim 1, characterized in that: After the first and second loops are unfolded, the lateral length of the positioning mechanism is greater than the lateral length of the oval hole.

9. A closing device including a pre-positioning mechanism according to claim 1, characterized in that: The support member has an H-shaped structure, and the distal end of the connecting mechanism is connected to the central region of the support member.

10. A closing device including a pre-positioning mechanism according to claim 9, characterized in that: The connecting mechanism is hinged to the supporting member, and when the supporting member reaches the target position, the supporting member can conform to and fit the tissue to be closed.

Images