A closure device having a positioning and guiding puncture function

Abstract

The application relates to the field of medical devices, in particular to a closure device with positioning and guiding puncture functions, which comprises a delivery catheter, an implant for closing a tissue defect, and a puncture mechanism and a positioning member arranged in the delivery catheter, the puncture mechanism can puncture the tissue to be closed back and forth, the positioning member comprises a connecting member and a positioning support arranged at the distal end of the connecting member, and the positioning support can provide a supporting force for the puncture mechanism when puncturing the tissue to be closed back and forth; in the application, the positioning support can provide bidirectional support for the puncture mechanism when puncturing the tissue back and forth, the puncture precision is improved, the tissue can be prevented from being damaged, 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 with positioning and guiding puncture functions. 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 CN 202210790592.6 discloses a tissue puncture closure device with a control mechanism, comprising a double puncture structure, a grasping device, and a closure unit connected to the double puncture structure. The double puncture structure guides the closure unit and can pass back and forth through the tissue to be closed during the closure process. The grasping device is positioned on the first puncture starting point side of the double puncture structure and abuts against the tissue during the closure process, providing support for the tissue punctured by the double puncture structure in the second puncture, and grasping the closure unit after the second puncture. This patented solution's grasping device lacks a support structure at the secondary septum, causing the puncture structure to shift position when puncturing the secondary septum and potentially damaging it. Furthermore, the grasping device, being flexible to perform its grasping function, provides poor support when the puncture structure punctures the primary septum, leading to deviation in the puncture position and tearing of the primary septum tissue, causing damage.

[0004] Patent CN202011562345.8 discloses a clamping device and a suturing device. The clamping device of this invention includes a sheath assembly and a clamping assembly. The sheath assembly includes an inner tube and an outer tube, with the outer tube sleeved outside the inner tube and axially movable relative to the inner tube. The clamping assembly is connected to the distal end of the inner tube or positioned near the distal end of the inner tube. The clamping assembly includes a first clamping unit and a second clamping unit arranged opposite each other, with an adjustable angle between them. The drawbacks of this patented solution are: while the second clamping unit provides support and facilitates puncture, the beating heart during surgery can cause the predetermined position of the second clamping unit to shift, potentially leading to puncture failure. Furthermore, when puncturing the primary septum, the delivery sheath needs to be rotated to rotate and align the second clamping unit for puncture, which may cause the sheath to scratch the vessel wall during rotation. Additionally, the position of the second clamping unit needs to be re-observed and repositioned, making the operation complex and unstable.

[0005] In summary, the existing technology has the following problems that urgently need to be solved: First, the existing technology does not provide support when puncturing the secondary septum, resulting in poor puncture results; Second, after the clamping device reaches the surgical position, its position may shift with the heartbeat, leading to puncture failure; Third, when performing a second puncture, the clamping device 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 complex and significantly prolonging the operation time. Summary of the Invention

[0006] This application is made in view of the above and other ideas.

[0007] One of the purposes of this application is to overcome the shortcomings of the prior art and to provide a closed instrument with positioning and guiding puncture function, addressing the problems of the prior art's puncture instruments not providing support for secondary septal tissue and deviations in the predetermined position during surgery.

[0008] The objective of this invention is achieved through the following solution:

[0009] A closure device with positioning and guiding puncture functions includes 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 member and a positioning bracket disposed at the distal end of the connecting member. After the positioning bracket reaches a predetermined position, the distal end of the puncture mechanism abuts against the tissue to be closed. Furthermore, the positioning bracket and the distal end of the puncture mechanism are respectively located on both sides of the tissue to be closed, so that the positioning bracket provides support for the puncture mechanism during puncture.

[0010] The objective of this invention can also be further achieved through the following technical solutions:

[0011] As a further improvement of the present invention, the tissue to be closed includes a first tissue and a second tissue, wherein, when the positioning bracket reaches a predetermined position, the upper region of the positioning bracket provides support for the puncture mechanism when the puncture mechanism punctures the first tissue, and the lower region of the positioning bracket provides support for the puncture mechanism when the puncture mechanism punctures the second tissue in a roundabout manner; when this solution is used for foramen ovale closure surgery, the first tissue is a secondary septum tissue and the second tissue is a primary septum tissue.

[0012] As a further improvement of the present invention, when the puncture mechanism punctures the first tissue (i.e., the secondary septum), the lower region of the positioning bracket abuts against the connecting member and the upper region provides support for the puncture mechanism; and when the puncture mechanism punctures the second tissue (i.e., the primary septum) in a roundabout manner, the upper region of the positioning bracket abuts against the first tissue (i.e., the secondary septum) and the lower region provides support for the puncture mechanism.

[0013] As a further improvement of the present invention, after the positioning bracket reaches the predetermined position, a portion of the positioning bracket is located between the first tissue and the second tissue.

[0014] As a further improvement of the present invention, the positioning bracket is a sheet-like structure, and the positioning bracket is hinged to the distal end of the connecting member. The positioning bracket is rotatable relative to the connecting member. When the positioning bracket is delivered to the foramen ovale, the positioning bracket 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 positioning bracket will not cause damage to the tissue during the surgical procedure.

[0015] As a further improvement of the present invention, the positioning bracket has an H-shaped structure, and the distal end of the connecting member is hinged to the middle region of the positioning bracket. Further, the distal end of the connecting member is hinged to the middle rod of the positioning bracket. The upper end of the middle rod of the positioning bracket is called the upper region, and the lower end of the middle rod is called the lower region. When the puncture mechanism punctures the first tissue (i.e., punctures the secondary septum), the upper region of the positioning bracket provides support for the puncture mechanism, and the distal end of the puncture mechanism exits from the upper region of the positioning bracket after passing through the first tissue. When the distal end of the puncture mechanism detours to puncture the second tissue (i.e., punctures the primary septum), the lower region of the positioning bracket provides support for the puncture mechanism, and the distal end of the puncture mechanism exits from the lower region of the positioning bracket after passing through the second tissue.

[0016] As a further improvement of the present invention, a clamping device is also included, the clamping device comprising a spring and a control line, the spring being sleeved on the connecting member, and, after the positioning bracket reaches the predetermined position, pulling the control line causes the spring to open and cooperate with the connecting member to clamp the first tissue; since the secondary septum is relatively thick, when the positioning bracket reaches the predetermined position, the spring and the positioning bracket cooperate to clamp the secondary septum, so that the position of the positioning bracket can be anchored on the tissue to be closed.

[0017] As a further improvement of the present invention, the distal end of the spring is provided with a limiting port, and the distal end of the puncture mechanism can be guided along the control line to the limiting port and abut against the tissue to be closed.

[0018] 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.

[0019] As a further improvement of the present invention, the limiting structure is in the shape of a fishbone; after the puncture mechanism performs 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.

[0020] Compared with the prior art, the advantages of the technical solution of this application include at least the following:

[0021] 1. Existing delivery systems lack components to provide adequate support for the puncture tube during secundum puncture, leading to positional deviations and poor puncture results. Furthermore, direct puncture of the secundum tissue without support can cause severe tearing and damage to the tissue. According to a concept proposed in this application, after the positioning component reaches the predetermined position, part of the positioning support is located on the secundum side in the left atrium, and the other part is located on the primary secundum side in the right atrium. This allows the positioning component to provide bidirectional support to the puncture mechanism as it travels between the secundum and primary secundum tissues, enabling it to perform the procedure along the predetermined puncture route. This avoids damage to cardiac tissue caused by direct puncture and improves puncture accuracy, demonstrating significant clinical value.

[0022] 2. According to a concept of this application, the positioning bracket is hinged to the distal end of the connecting member. When the positioning bracket is delivered to the foramen ovale, the positioning bracket can conform to the tunnel shape of the PFO, making it fit the tissue better. This facilitates adjustment to the optimal puncture angle during puncture. Furthermore, the positioning bracket is designed with an H-shaped rod structure, so that during puncture, the rods on both sides can provide sufficient support and provide a puncture channel for the puncture mechanism, making the puncture more accurate.

[0023] 3. According to a concept of this application, the control line can both pull open the spring clip to clamp the secondary septum tissue and further stabilize the positioning support, and guide the puncture mechanism to the target position. Furthermore, the control line can directly guide the distal end of the puncture mechanism to the limiting port, which in turn can limit and stabilize the puncture mechanism, preventing it from deviating during needle insertion and improving the stability of instrument operation.

[0024] 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

[0025] 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:

[0026] Figures 1a-1c This is a schematic diagram of the overall structure and principle of the positioning and guidance device of the present invention.

[0027] Figures 2a-2c This is a schematic diagram of the positioning component and spring sheet of the present invention.

[0028] Figures 3a-3d This is a schematic diagram of steps (1) and (2) of the operation process of the present invention.

[0029] Figures 4a-4f This is a schematic diagram of step (3) of the operation process of the present invention.

[0030] Figure 5a and 5b This is a schematic diagram of step (4) of the operation process of the present invention.

[0031] The features represented by the numbers in the attached diagram are as follows:

[0032] 1-Delivery catheter, 2-Implant, 21-T-shaped rod, 22-Connecting line, 23-Limiting structure, 3-Punch mechanism, 4-Positioning component, 41-Connecting component, 42-Positioning bracket, 5-Secondary septum, 6-Primary septum, 7-Clamping device, 71-Spring, 711-Limiting port, 72-Control line. Implementation

[0033] 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.

[0034] 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.

[0035] The present application will now be described in more detail with reference to various embodiments and examples of several aspects thereof.

[0036] 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.

[0037] In the prior art, the puncture instrument does not provide support for the secondary septal tissue 5, and deviations occur in the predetermined position during the operation.

[0038] One of the objectives of the embodiments described below is to address the aforementioned deficiencies, as well as other problems. Example 1

[0039] like Figures 1a-1cAs shown, the present invention, when used to close the foramen ovale tissue, illustrates a closure device with positioning and guiding puncture functions according to an embodiment of this application. It includes a delivery catheter 1, an implant 2 for closing tissue defects, and a puncture mechanism 3 and a positioning component 4 disposed within the delivery catheter 1. The puncture mechanism 3 is capable of reciprocating punctures of the secondary septum 5 and the primary septum 6. The positioning component 4 includes a connecting member 41 and a positioning bracket 42 disposed at the distal end of the connecting member 41. After reaching a predetermined position, the upper portion of the positioning bracket 42 is located on the side of the secondary septum in the left atrium, and its lower portion is located on the side of the primary septum in the right atrium. When the distal end of the puncture mechanism 3 abuts against the tissue to be closed along the predetermined route (i.e., punctures...), the device... The distal end of the puncture mechanism 3 is located in the right atrium and abuts against the secondary septum 5. At this time, the distal end of the puncture mechanism 3 and the upper part of the positioning bracket 42 are located on both sides of the secondary septum 5, so that the positioning bracket 42 can provide support for the puncture mechanism 3 when puncturing the secondary septum 5. After the puncture mechanism 3 passes through the secondary septum and reaches the left atrium, the puncture mechanism 3 detours along the predetermined route and punctures the primary septum 6. At this time, the distal end of the puncture mechanism 3 and the lower part of the positioning bracket 42 are located on both sides of the primary septum 6. During puncture, the lower part of the positioning bracket 42 can provide good support for it. This allows the positioning bracket 42 to provide good support for the puncture mechanism 3 when puncturing the secondary septum 5 and the primary septum 6.

[0040] In this first embodiment, the positioning bracket 42 is a sheet-like structure, and the positioning bracket 42 is hinged to the distal end of the connecting member 41. The positioning bracket 42 is rotatable relative to the connecting member 41. When the positioning bracket 42 is delivered to the foramen ovale, the positioning bracket 42 can conform to the tunnel morphology of the PFO, making it fit the tissue more closely, which is beneficial for adjusting to the optimal puncture angle during puncture. Figure 2a and 2b As shown, the positioning bracket 42 will not cause damage to the tissue during the surgical procedure.

[0041] In this first embodiment, the positioning bracket 42 has an H-shaped structure, such as... Figure 2aAs shown, the distal end of the connecting member 41 is hinged to the middle region of the positioning bracket 42. Further, the distal end of the connecting member 41 is hinged to the middle rod of the positioning bracket 42. The upper end of the middle rod of the positioning bracket 42 is called the upper region, and the lower end of the middle rod is called the lower region. When the puncture mechanism 3 punctures the first tissue (i.e., punctures the secondary septum 5), the upper region of the positioning bracket 42 provides support for the puncture mechanism 3, and the distal end of the puncture mechanism 3 exits from the upper region of the positioning bracket 42 after passing through the first tissue. When the distal end of the puncture mechanism 3 detours to puncture the second tissue (i.e., punctures the primary septum 6), the lower region of the positioning bracket 42 provides support for the puncture mechanism 3, and the distal end of the puncture mechanism 3 exits from the lower region of the positioning bracket 42 after passing through the second tissue.

[0042] In this embodiment, a clamping device 7 is also included. The clamping device 7 includes a spring piece 71 and a control line 72. The spring piece 71 is disposed on the connecting member 41. After the positioning bracket 42 reaches the predetermined position, it pulls the control line 72 to open the spring piece 71 and cooperate with the connecting member 41 to clamp the first tissue.

[0043] In this first embodiment, the distal end of the spring piece 71 is provided with a limiting opening 711, such as... Figure 2c As shown, the distal end of the puncture mechanism 3 can be guided along the control line 72 to the limiting port 711 and abut against the tissue to be closed.

[0044] In this first embodiment, the implant 2 includes a T-shaped rod 21, a connecting line 22, and a limiting structure 23. The T-shaped rod 21 and the limiting structure 23 are respectively disposed at both ends of the connecting line 22.

[0045] In this first embodiment, 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 is 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.

[0046] The exemplary operation process of the closed system in this embodiment is as follows:

[0047] (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;

[0048] (2) Retract the delivery conduit 1, as follows Figure 3bAs shown, the positioning bracket 42 is restored to its preset shape. At this time, the positioning bracket 42 is located between the secondary septum and the primary septum, as shown. Figure 3c As shown, subsequently, pulling the control line 72 causes the spring clip 71 to open and clamp the secondary septum 5, as... Figure 3d As shown;

[0049] (3) Operate the puncture mechanism 3 to pass through the secondary septum 5 along the predetermined route, and continue the operation so that the puncture mechanism 3 can detour along the predetermined route and puncture the primary septum 6, such as Figures 4a-4d As shown, after the puncture is completed, the shrapnel 71 is retracted and inserted into the delivery catheter 1, as follows. Figure 4e and 4f As shown;

[0050] (4) Observe the release of shunt at the foramen ovale position in the right atrium, pull the limiting structure 23 until no blood flow passes between the primary and secondary septa, and finally cut the line connected to the limiting structure 23 to complete the operation. Figure 5a and 5b As shown.

[0051] 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 with positioning and guiding puncture functions, comprising a delivery catheter, an implant for closing tissue defects, and a puncture mechanism and a positioning component disposed within the delivery catheter, wherein the puncture mechanism is capable of reciprocating punctures into the tissue to be closed, characterized in that: The positioning component includes a connecting component and a positioning bracket disposed at the distal end of the connecting component. The positioning bracket provides support force for the puncture mechanism to reciprocate puncturing the tissue to be closed. The positioning bracket has an H-shaped structure. The distal end of the connecting component is hinged to the middle region of the positioning bracket. The component also includes a clamping device, which includes a spring and a control line. The spring is sleeved on the connecting component.

2. The closed instrument with positioning and guiding puncture function according to claim 1, characterized in that: The tissue to be closed includes a first tissue and a second tissue. When the positioning bracket reaches the predetermined position and the puncture mechanism punctures the first tissue, the upper region of the positioning bracket provides support for the puncture mechanism. When the puncture mechanism punctures the second tissue in a roundabout manner, the lower region of the positioning bracket provides support for the puncture mechanism.

3. A closed instrument with positioning and guiding puncture functions according to claim 2, characterized in that: After reaching the predetermined position, part of the positioning bracket is located between the first tissue and the second tissue.

4. A closed instrument with positioning and guiding puncture functions according to claim 3, characterized in that: When the puncture mechanism punctures the first tissue, the upper region of the positioning bracket provides support for the puncture mechanism, and the distal end of the puncture mechanism exits from the upper region of the positioning bracket after passing through the first tissue; wherein, when the distal end of the puncture mechanism detours and punctures the second tissue, the lower region of the positioning bracket provides support for the puncture mechanism, and the distal end of the puncture mechanism exits from the lower region of the positioning bracket after passing through the second tissue.

5. A closed instrument with positioning and guiding puncture functions according to claim 1, characterized in that: After the positioning bracket reaches the predetermined position, pulling the control line causes the spring to open and cooperate with the connecting member to clamp the first tissue to achieve positioning.

6. A closed instrument with positioning and guiding puncture functions according to claim 4, characterized in that: The distal end of the shrapnel is provided with a limiting port, and the distal end of the puncture mechanism can be guided along the control line to the limiting port and abut against the tissue to be closed.

7. A closed instrument with positioning and guiding puncture functions according to claim 1, characterized in that: The implant includes a T-shaped rod, a connecting wire, and a limiting structure, with the T-shaped rod and the limiting structure respectively disposed at both ends of the connecting wire.

8. A closed instrument with positioning and guiding puncture functions according to claim 7, characterized in that: The limiting structure is in the shape of a fishbone.

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