Device for suturing patent foramen ovale under percutaneous intervention

Abstract

The device comprises a conveying sheathing canal, a suture needle, a conveying steel wire and a suture needle recycling device used for recycling the suture needle into the conveying sheathing canal are arranged in the conveying sheathing canal, the suture needle is of a spiral structure, the far end of the suture needle is detachably connected with the far end of the conveying steel wire, and the suture needle recycling device is used for recycling the suture needle into the conveying sheathing canal. The near end of the conveying steel wire, the near end of the suture needle recovery device and the other end of the suture line all extend out of the near end of the conveying sheath tube. The spiral suture needle with the suture line is adopted, and purse-string suture around the PFO tunnel can be completed by passing through the PFO tunnel once.

Description

Technical Field

[0001] The invention relates to a device for suturing a patent foramen ovale under percutaneous intervention, and belongs to the technical field of medical products. Background Art

[0002] For congenital heart disease such as patent foramen ovale (PFO) (incidence rate 20%-34%), the current mainstream treatment is percutaneous interventional occlusion. The occlusion devices used are mostly non-absorbable nickel-titanium-based memory alloy materials. The basic structure is the occlusion discs on the left and right atria connected to each other and the delivery and release devices. The main disadvantages of this method are as follows:

[0003] 1) Residual metal foreign bodies in the atrial septum may affect subsequent transseptal surgical procedures (such as interventional mitral valve clipping / replacement, atrial fibrillation ablation, left atrial appendage occlusion, etc.);

[0004] 2) Some patients experience cardiac discomfort due to the mechanical traction of the heart by the occluder;

[0005] 3) Due to the release of nickel ions, some patients will experience metal ion allergy symptoms;

[0006] 4) Antiplatelet / anticoagulant treatment is required for a period of time after occlusion, which is not friendly to patients with contraindications to anticoagulation;

[0007] 5) Residual shunt after closure, especially for long tunnel or complex PFO;

[0008] 6) Rare but fatal situation: erosion of the aortic root by the occluder, leading to fatal pericardial tamponade.

[0009] In order to circumvent the above problems, absorbable occlusion devices have emerged. Their structure is similar to that of nickel-titanium-based non-absorbable occluders. Both are double-sided occlusion disk structures, and the materials are mostly degradable materials such as polylactic acid / polypyrrolidone. However, they still have the following disadvantages:

[0010] 1) The plasticity and morphological recovery performance of the occluder are poor;

[0011] 2) The operation steps are complicated and the learning curve is increased;

[0012] 3) There is still a possibility of cardiac discomfort caused by foreign body traction in the early stage of implantation;

[0013] 4) Antiplatelet / anticoagulant treatment is still required for a period of time after occlusion, which is not friendly to patients with contraindications to anticoagulation;

[0014] 5) It takes about 1 year for the occluder to be absorbed, during which time septal access surgery cannot be performed;

[0015] 6) Residual leakage after occlusion surgery, especially for long tunnel or complex PFO.

[0016] In response to the shortcomings of implantable PFO closure devices, interventional PFO suturing devices have emerged. The typical design is the foreign Noble-stitch, which punctures and sutures the secondary atrial septum (SS) and primary atrial septum (SP) of the PFO, and then tightens the sutures with a buckle. This solution has no obvious residue and does not affect the second atrial septal puncture, but it still has the following disadvantages:

[0017] 1) The operation steps are complicated and the learning curve is long;

[0018] 2) Since the suture is performed on the upper and lower edges of the PFO, for larger PFOs, there is a risk of incomplete closure and residual leakage from both sides of the suture in a single operation;

[0019] 3) The device needs to pass through the PFO twice or even multiple times, which poses a risk of iatrogenic damage to the atrial septum. Summary of the invention

[0020] The technical problem to be solved by the present invention is: how to solve the problem that the existing treatment device cannot pass through and suture the patent oval foramen in one go, and the operation steps of suture the patent oval foramen are complicated.

[0021] In order to solve the above technical problems, the technical solution of the present invention is to provide a device for suturing a patent foramen ovale under percutaneous intervention, comprising a delivery sheath, characterized in that a suture needle, a delivery wire and a suture needle recovery device for retracting the suture needle into the delivery sheath are provided in the delivery sheath, the suture needle is a spiral structure, the distal end of the suture needle is detachably connected to the distal end of the delivery wire, the distal end of the suture needle is also connected to one end of the suture thread, and the proximal end of the delivery wire, the proximal end of the suture needle recovery device and the other end of the suture thread all extend out of the proximal end of the delivery sheath.

[0022] Preferably, a socket is provided on one side of the distal end of the delivery wire, and the socket is plugged with the distal end of the suture needle; one end of the suture thread is arranged in the socket together with the distal end of the suture needle.

[0023] Preferably, the suture needle, suture thread and conveying wire are all inserted into the suture needle recovery device.

[0024] Preferably, the suture needle recovery device includes a connecting tube and a capturing device for capturing the suture needle. The capturing device is an umbrella-shaped structure. After being released from the delivery sheath, the distal end of the capturing device is larger than the proximal end, and the proximal end of the capturing device is connected to the distal end of the connecting tube; the proximal end of the connecting tube extends from the proximal end of the delivery sheath.

[0025] Preferably, the outer diameter of the delivery wire is smaller than the inner diameter of the connecting tube; after being released from the delivery sheath, the inner diameter of the distal end of the capture device is larger than the maximum outer diameter of the suture needle.

[0026] Preferably, the delivery sheath is sleeved on the outside of the connecting tube, and the inner diameter of the delivery sheath is larger than the outer diameter of the connecting tube.

[0027] Preferably, the suture needle and the capture device are both made of medical elastic memory alloy.

[0028] Preferably, the capture device and the connecting pipe are an integrally formed structure.

[0029] Preferably, the distal end of the suture needle points to the center of the suture needle and is plugged into the socket of the delivery wire, and the delivery wire is located on the central axis of the suture needle.

[0030] The present invention adopts a spiral suture needle with a suture thread, so that the purse-string suture around the PFO tunnel can be completed by passing through the PFO tunnel once.

[0031] The present invention adopts the technical route of interventional suturing to avoid a series of disadvantages caused by implanted materials (such as: inability to puncture the atrial septum again, physical pulling of heart tissue, metal allergy, anticoagulation and antiplatelet, occluder erosion of the heart, etc.); compared with Noble-stitch and its imitations, the present invention simplifies the operation as much as possible and shortens the learning cost; it reduces the risk of atrial septal tear caused by repeated entry and exit of the instrument into the PFO as much as possible, and is suitable for long tunnel PFO.

[0032] Compared with the prior art, the present invention has the following advantages:

[0033] 1) The spiral suture needle (spring needle) converts the purse-string suture of repeated insertion and withdrawal of the needle in the left and right atria into an axial rotational motion, which reduces the dimensionality and simplifies the operation difficulty;

[0034] 2) Rotate and suture along the tunnel to ensure tight closure and avoid residual shunt;

[0035] 3) Automatic unfastening design of the suture needle tail and the delivery wire;

[0036] 4) By delivering the suture needle from the right atrium to the left atrium, suturing when the suture needle returns, and retrieving the suture needle on the right atrium side through the suture needle retrieval device, it only needs to pass through the PFO once, without repeated passage, thus reducing the chance of iatrogenic damage to the atrial septum. BRIEF DESCRIPTION OF THE DRAWINGS

[0037] Figure 1 This is an axonometric view of a device for suturing a patent foramen ovale under percutaneous intervention after release (I);

[0038] Figure 2 This is an axonometric view of a device for suturing a patent foramen ovale under percutaneous intervention after release (Part 2);

[0039] Figure 3This is a schematic diagram of a device for suturing a patent foramen ovale during percutaneous intervention after the delivery sheath is removed;

[0040] Figure 4 It is a schematic diagram of a device for suturing a patent foramen ovale under percutaneous intervention after removing the delivery sheath and the suturing needle recovery device;

[0041] Figure 5 A flowchart for the operation of a device for suturing a patent foramen ovale during percutaneous intervention. DETAILED DESCRIPTION

[0042] In order to make the present invention more clearly understood, preferred embodiments are described in detail below with reference to the accompanying drawings.

[0043] The present invention provides a device for suturing a patent foramen ovale under percutaneous intervention, which is used to treat a common congenital heart disease - patent foramen ovale (PFO). Figure 1-Figure 4 As shown, it includes a delivery sheath 1, a spiral suture needle 3 (i.e., a spring needle), a suture needle recovery device 2, a delivery wire 4, and a suture 5. The suture needle recovery device 2 includes a capture device 21 and a connecting tube 22. The capture device 21 is an umbrella-shaped structure, and the distal end is larger than the proximal end, similar to a funnel shape. The proximal end of the capture device 21 is connected to the distal end of the connecting tube 22; a plug hole 41 is provided on one side of the distal end of the delivery wire 4, and the plug hole 41 is plugged with the distal end of the suture needle 3. The distal end of the suture 5 is connected to the distal end of the suture needle 3 and is arranged together in the plug hole 41; the suture needle 3 and the delivery wire 4 are both arranged in the suture needle recovery device 2, and the suture needle recovery device 2 is arranged in the delivery sheath 1 with the spiral suture needle 3 and the delivery wire 4. The proximal end of the suture 5, the proximal end of the delivery wire 4, and the proximal end of the connecting tube 22 all extend from the proximal end of the delivery sheath 1.

[0044] The distal end of the suture needle 3 points to the center of the suture needle 3 , thereby being plugged into the insertion hole 41 of the delivery wire 4 , so that the delivery wire 4 is located on the central axis of the suture needle 3 .

[0045] The outer diameter of the delivery wire 4 is smaller than the inner diameter of the connecting tube 22. The inner diameter of the distal end of the capture device 21 is larger than the maximum outer diameter of the suture needle 3. The inner diameter of the proximal end of the capture device 21 and the inner diameter of the connecting tube 22 may be larger than the minimum outer diameter of the suture needle 3, or may be smaller than or equal to the minimum outer diameter of the suture needle 3. However, in order to facilitate the capture of the suture needle 3 by the capture device 21, the inner diameter of the proximal end of the capture device 21 and the inner diameter of the connecting tube 22 are generally selected to be smaller than the minimum outer diameter of the suture needle 3. The delivery sheath 1 is arranged on the outside of the connecting tube 22, and the inner diameter of the delivery sheath 1 is larger than the outer diameter of the connecting tube 22. The suture needle 3 and the capture device 21 are both made of medical elastic memory alloy. And the capture device 21 is a mesh structure woven from elastic memory alloy.

[0046] In this embodiment, the capture device 21 and the connecting pipe 22 are an integrally formed structure.

[0047] like Figure 5 As shown, the operating method of the present invention is as follows:

[0048] 1) inserting a guide wire through the femoral vein (i.e., the inferior vena cava 12) and passing through the PFO under the guidance of the delivery sheath 1, and guiding the delivery sheath 1 to pass through and establish a working path;

[0049] 2) withdraw the guide wire, push the core device "spiral suture needle with thread" (i.e. suture needle 3 connected with suture thread 5) through the delivery sheath 1 to the left atrium 9 and release it, and the released suture needle 3 quickly forms a spiral structure;

[0050] 3) withdrawing the delivery sheath 1 to the right atrium 6, and simultaneously releasing the umbrella-shaped capture device 21 on the right atrium surface (i.e., the second atrial septum 11), and the released capture device 21 quickly forms an umbrella-shaped structure with a large distal end and a small proximal end;

[0051] 4) Rotate the delivery wire 4 clockwise according to the direction of the thread attack angle of the suture needle 3, so that the suture needle 3 is sutured from the left atrial surface (i.e., the first atrial septum 10) to the right atrial 6 side (i.e., the second atrial septum 11) along the PFO tunnel diameter, and at the same time, the tail end (i.e., the distal end) of the suture needle 3 is separated from the delivery wire 4;

[0052] 5) The suture needle 3 is captured by the capture device 21 on the right atrium 6 side and received in the delivery sheath 1, so that the suture needle 3 is grasped by the capture device 21 (i.e., the suture needle 3 is confined in the capture device 21 through the delivery sheath 1) to prevent slipping, and then the capture device 21 is continuously rotated through the connecting tube 22, so that the capture device 21 drives the suture needle 3 to rotate, until the suture needle 3 is completely separated from the tissue, and then the capture device 21 takes the suture needle 3 back into the delivery sheath 1 and takes it out of the body, thereby completing the purse-string suture of the PFO tunnel;

[0053] 6) Two thread tails are obtained in vitro (one is the proximal end of the suture 5, and the other is the distal end of the suture 5 connected to the distal end of the suture needle 3), which are loaded into a locking device (including a suture tightening and locking buckle, used to tighten and lock the two ends of the suture 5), and pushed to the right atrium 6 side of the atrial septum by a pusher, the purse string suture is tightened and locked, and the excess thread is cut off by a thread cutting device;

[0054] 7) Remove all devices, compress the puncture site, and the operation is completed.

[0055] Figure 5 In the figure, the superior vena cava 7 is located on the same side and above the right atrium 6; the aorta 8 is located above the right atrium 6 and the left atrium 9.

[0056] The distal end is the end away from the surgeon (or operator), and the proximal end is the end close to the surgeon (or operator).

Claims

1. A device for suturing a patent foramen ovale under percutaneous intervention, comprising a delivery sheath (1), characterized in that: The delivery sheath (1) is provided with a suture needle (3), a delivery wire (4) and a suture needle recovery device (2) for recovering the suture needle (3) into the delivery sheath (1); the suture needle (3) is a spiral structure; the distal end of the suture needle (3) is detachably connected to the distal end of the delivery wire (4); the distal end of the suture needle (3) is also connected to one end of a suture thread (5); the proximal end of the delivery wire (4), the proximal end of the suture needle recovery device (2) and the other end of the suture thread (5) all extend out of the proximal end of the delivery sheath (1).

2. The device for suturing a patent foramen ovale under percutaneous intervention as claimed in claim 1, characterized in that: A plug hole (41) is provided at one side of the distal end of the delivery wire (4), and the plug hole (41) is plugged into the distal end of the suture needle (3); one end of the suture thread (5) is arranged in the plug hole (41) together with the distal end of the suture needle (3).

3. The device for suturing a patent foramen ovale under percutaneous intervention as claimed in claim 1, characterized in that: The suture needle (3), suture thread (5) and conveying wire (4) are all inserted into the suture needle recovery device (2).

4. The device for suturing a patent foramen ovale under percutaneous intervention as claimed in claim 1, characterized in that: The suture needle recovery device (2) comprises a connecting tube (22) and a catching device (21) for catching the suture needle (3); the catching device (21) is an umbrella-shaped structure; after being released from the delivery sheath tube (1), the distal end of the catching device (21) is larger than the proximal end; the proximal end of the catching device (21) is connected to the distal end of the connecting tube (22); the proximal end of the connecting tube (22) extends from the proximal end of the delivery sheath tube (1).

5. The device for suturing a patent foramen ovale under percutaneous intervention as claimed in claim 4, characterized in that: The outer diameter of the delivery wire (4) is smaller than the inner diameter of the connecting tube (22); after being released from the delivery sheath tube (1), the inner diameter of the distal end of the capture device (21) is larger than the maximum outer diameter of the suture needle (3).

6. The device for suturing a patent foramen ovale under percutaneous intervention as claimed in claim 4, characterized in that: The delivery sheath tube (1) is sleeved on the outside of the connecting tube (22), and the inner diameter of the delivery sheath tube (1) is greater than the outer diameter of the connecting tube (22).

7. The device for suturing a patent foramen ovale under percutaneous intervention as claimed in claim 4, characterized in that: The suturing needle (3) and the catching device (21) are both made of medical elastic memory alloy.

8. The device for suturing a patent foramen ovale under percutaneous intervention as claimed in claim 4, characterized in that: The catching device (21) and the connecting pipe (22) are an integrally formed structure.

9. The device for suturing a patent foramen ovale under percutaneous intervention as claimed in claim 1, characterized in that: The distal end of the suture needle (3) points to the center of the suture needle (3) and is plugged into the insertion hole (41) of the conveying wire (4), and the conveying wire (4) is located on the central axis of the suture needle (3).

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