Interventional suturing apparatus

By designing an interventional suturing device, multiple needles can be sutured simultaneously using a rotary control knob, which solves the problems of poor suturing effect and high operation difficulty in the existing technology, and achieves complete closure of the foramen ovale and simple operation.

WO2026025481A1PCT designated stage Publication Date: 2026-02-05FUWAI HOSPITAL CHINESE ACAD OF MEDICAL SCI & PEKING UNION MEDICAL COLLEGE
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Patent Information

Application Number
PCT/CN2024/109450
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Filing Date
2024-08-02
Publication Date
2026-02-05

AI Technical Summary

Technical Problem

Existing devices have poor suturing results and are difficult to operate when suturing the foramen ovale. In particular, the "I" suture method is difficult to completely close the foramen ovale, and it requires high precision in needle exit angle and needle spacing.

Method used

An interventional suturing device was designed, including a front end, a main body, a fixed handle, a sliding handle, and an anti-reverse valve. The support structure is flexible, and the puncture needle is hollow and slidable. The needle insertion and retraction are controlled by rotating the puncture control knob, enabling simultaneous suturing of multiple needles and simplifying the operation process.

Benefits of technology

It achieves complete closure of the foramen ovale, improves surgical outcomes, reduces operational difficulty, and is simple and easy to control. The needle can be withdrawn and retracted by simply rotating the knob.

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Abstract

An interventional suturing apparatus. The present invention relates to the technical field of medical devices. The apparatus comprises: a front end part, provided with a plurality of support structures and a plurality of puncture needles, wherein the support structures can be bent by force, and the puncture needles are hollow, with sutures capable of penetrating mounted inside; a main tube body, wherein a front section portion is connected to the front end part, a plurality of threading cavities are formed inside the main tube body, the number of the threading cavities is the same as the number of the puncture needles, and the puncture needles are located in the threading cavities and are capable of sliding therein; a fixed handle, arranged at a middle section portion of the main tube body and provided with a puncture control knob; a sliding handle, connected to the main tube body and located behind the fixed handle, wherein the distance between the sliding handle and the fixed handle can be adjusted by rotating the puncture control knob, a suture shaft is arranged inside the sliding handle, and rear ends of the sutures are located on the suture shaft; and a check valve, arranged at the tail end of the main tube body.
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Description

An interventional suturing device Technical Field

[0001] This utility model relates to the field of medical device technology, and more specifically, to an interventional suturing device. Background Technology

[0002] The foramen ovale is a physiological passage in the atrial septum of the heart during embryonic development. After birth, as left atrial pressure increases and pulmonary artery resistance decreases, the primary and secondary septa of the atrial septum approach and fuse. In most people, the foramen ovale closes spontaneously within the first year after birth. In those cases, a potential passage forms in the middle of the atrial septum, known as patent foramen ovale (PFO).

[0003] Patent foramen ovale (PFO) was previously considered a benign and harmless condition. However, recent advances in clinical research have led to a consensus among experts that PFO is one of the causes of unexplained stroke, migraine, paradoxical embolism, and other conditions. Therefore, PFO closure or sealing is of great significance.

[0004] Currently, existing devices typically use a "one" suture method to close the foramen ovale, as mentioned in utility model patent CN209611222U, which describes a method of closure by suturing. However, this method has obvious drawbacks: "one" sutures are difficult to completely close the foramen ovale, and require extremely high precision in needle exit angle and needle spacing, which increases the difficulty of instrument operation.

[0005] Utility Model Content

[0006] The purpose of this invention is to provide an interventional suturing device to solve the problems of poor suturing effect and high operation difficulty of current devices.

[0007] To address the aforementioned problems, this utility model first provides an interventional suturing device, comprising: a front end portion having multiple support structures and multiple puncture needles, wherein the support structures are bendable under force, and the puncture needles are hollow and contain sutures that can pass through them; a main body, the front section of which is connected to the front end portion, having multiple threading cavities inside, the number of which is the same as the number of puncture needles, the puncture needles being located inside the threading cavities and capable of sliding within them; a fixed handle, located in the middle section of the main body, having a puncture control knob; a sliding handle, connected to the main body and located behind the fixed handle, the distance between the sliding handle and the fixed handle being adjustable by rotating the puncture control knob, having a suture shaft inside, the rear end of the suture located on the suture shaft; and an anti-reverse valve, located at the tail end of the main body.

[0008] With this configuration, the device can accommodate multiple puncture needles, which can be withdrawn and sutured simultaneously, completely closing the unclosed foramen ovale. Compared with the "I" suture method, this greatly improves the surgical outcome. The device is simple to operate and easy to control. The withdrawal and retraction of the puncture needles can be controlled by rotating the puncture control knob, reducing the difficulty of operating the device and solving the problems existing in the prior art.

[0009] Furthermore, the fixed handle includes a fixed handle cover and a fixed block. The fixed handle cover has a limiting groove inside, the fixed block is installed in the limiting groove, and the fixed block is sleeved on the outside of the main tube and fixedly connected to it.

[0010] Furthermore, the sliding handle is provided with a threaded rod inside, and the puncture control knob is mounted on the threaded rod, which can be rotated to control the sliding handle to move forward and backward.

[0011] Furthermore, the sliding handle is also provided with a guide, which has multiple thread holes and is located at the front end of the suture shaft. The suture thread led out from the suture shaft can pass through the thread holes and then be inserted into the puncture needle.

[0012] Furthermore, the threaded rod is provided with a mounting hole, a limiting slider is installed in the mounting hole, the fixed handle cover is provided with a limiting groove, and the limiting slider is configured to slide within the limiting groove.

[0013] Furthermore, the sliding handle is provided with a removable cover.

[0014] Furthermore, the front end of the main body is provided with a puncture hole, and the puncture needle is configured to be able to pass through the puncture hole.

[0015] Furthermore, the front end of the support structure is provided with a needle hole, and the size of the puncture needle is configured to pass through the needle hole.

[0016] Furthermore, the number of puncture needles is four. Attached Figure Description

[0017] To more clearly illustrate the technical solutions in the embodiments of this utility model or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only embodiments of this utility model. For those skilled in the art, other drawings can be obtained based on the provided drawings without creative effort.

[0018] Figure 1 is a schematic diagram of the interventional suturing device provided in an embodiment of the present invention;

[0019] Figure 2 is a cross-sectional view of the interventional suturing device provided in an embodiment of the present invention;

[0020] Figure 3 is a partial enlarged view of the main body provided in an embodiment of the present utility model;

[0021] Figure 4 is an exploded view (I) of the interventional suturing device provided in the embodiment of this utility model;

[0022] Figure 5 is an exploded view (II) of the interventional suturing device provided in the embodiment of this utility model;

[0023] Figure 6 is a schematic diagram of the internal structure of the sliding handle in the sewn state provided in the embodiment of this utility model;

[0024] Figure 7 is a schematic diagram of the guide wire passing through the oval hole provided in an embodiment of the present invention;

[0025] Figure 8 is a schematic diagram of the suture device near the interatrial space provided in an embodiment of the present invention;

[0026] Figure 9 is a schematic diagram of the support structure opening according to an embodiment of the present utility model;

[0027] Figure 10 is a schematic diagram of the puncture needle exiting the embodiment of this utility model;

[0028] Figure 11 is a schematic diagram showing the changes in the sliding handle for the puncture needle extension provided in an embodiment of the present invention;

[0029] Figure 12 is a schematic diagram of the suture push-up provided in an embodiment of the present utility model;

[0030] Figure 13 is a schematic diagram of the state after the suture is inserted into the main body according to an embodiment of the present invention;

[0031] Figure 14 is a schematic diagram of the needle retraction of the puncture needle provided in an embodiment of the present invention;

[0032] Figure 15 is a schematic diagram showing the changes in the sliding handle for retracting the puncture needle provided in an embodiment of this utility model.

[0033] Figure 16 is a schematic diagram of the suture state after the interventional suturing device provided in this embodiment of the present invention has been withdrawn;

[0034] Figure 17 is a schematic diagram of the closed oval foramen state after the suture is tightened according to an embodiment of the present invention.

[0035] Explanation of reference numerals in the attached drawings: 000-Guidewire; 010-Sheath; 100-Front end; 110-Support structure; 111-Needle hole; 120-Punch needle; 130-Suture; 200-Main body; 210-Threading chamber; 220-Punch exit hole; 300-Fixed handle; 310-Punch control knob; 320-Fixed handle cap; 321-Limiting groove; 322-Limiting slide groove; 330-Fixed block; 400-Sliding handle; 410-Suture shaft; 420-Threaded rod; 421-Mounting hole; 422-Limiting slider; 430-Guide; 431-Threading hole; 440-Cap; 500-Anti-reverse valve. Detailed Implementation

[0036] To make the above-mentioned objectives, features, and advantages of this utility model more apparent and understandable, specific embodiments of this utility model will be described in detail below with reference to the accompanying drawings. It should be understood that the specific embodiments described herein are merely illustrative of this utility model and are not intended to limit it.

[0037] To address the issues of poor suturing effect and high operational difficulty in current devices, this embodiment provides an interventional suturing device, as shown in Figures 1 and 2, comprising: a front end, a main body, a fixed handle, a sliding handle, and an anti-reverse valve. The front end is provided with multiple support structures and multiple puncture needles, in this embodiment there are four of each. The support structures can be bent under external force, as shown in Figure 3. When in use, the multiple support structures can be opened. The puncture needles are hollow inside and contain sutures that can pass through them.

[0038] The front section of the main body is connected to the front end, and a fixed handle, a sliding handle and an anti-reverse valve are installed sequentially from the rear direction on it; the inside of the main body has 4 threading cavities, and each threading cavity is equipped with a sliding puncture needle.

[0039] The fixed handle is fixedly connected to the main body and is equipped with a puncture control knob that can adjust the sliding handle. The distance between the sliding handle and the fixed handle can be adjusted by rotating the puncture control knob. A suture shaft is provided inside the sliding handle. The rear end of the suture is wound around the suture shaft. The suture can be released or retracted by controlling the rotation of the suture shaft. An anti-reverse valve is set at the tail end of the main body to prevent blood from flowing out of the main body.

[0040] Specifically, as shown in Figures 4 and 5, the fixed handle includes a fixed handle cover and a fixed block. The fixed handle cover has a limiting groove inside, and the fixed block is installed in the limiting groove. The center of the fixed block is sleeved on the outside of the main body.

[0041] A threaded rod is provided inside the sliding handle, and the puncture control knob is installed on the threaded rod. It can be rotated to control the sliding handle to move forward and backward, thereby realizing the insertion and retraction of the puncture needle.

[0042] Preferably, the threaded rod is provided with a mounting hole, a limiting slider is installed in the mounting hole, and a limiting groove is provided on the fixed handle cover, so that the limiting slider can slide in the limiting groove.

[0043] Optionally, in order to ensure smooth passage of the suture thread, a guide is provided at the front end of the suture spool. The guide has 4 threading holes, and the suture thread led out from the suture spool can pass through the threading holes and then into the puncture needle.

[0044] Optionally, in order to allow the suture to be manually pushed, the sliding handle is equipped with a removable cover, as shown in Figure 6. When it is necessary to push the suture manually, it is very convenient to remove the cover.

[0045] Preferably, as shown in Figure 9, the front end of the main tube is provided with a puncture hole, through which a puncture needle can pass. The front end of the support structure is provided with a needle hole, through which a puncture needle can pass.

[0046] The operating steps for using this device during foramen ovale closure surgery are as follows;

[0047] First, the guidewire is passed through the foramen ovale, as shown in Figure 7. The sheath is then moved along the guidewire to the right atrium. The interventional suturing device is then moved through the sheath to the right atrium, approaching the interatrial septum, as shown in Figure 8. Both the guidewire and the sheath are commonly used devices in this field and will not be described in detail here.

[0048] The supporting structure at the front end extends out of the sheath and is opened by force to fit the atrial septum, as shown in Figure 9.

[0049] By rotating the puncture control knob, the puncture needle is pushed out of the puncture hole, so that the puncture needle passes through the interatrial septum, as shown in Figure 10. The change of the sliding handle during the needle withdrawal process is shown in Figure 11.

[0050] The cover can be opened and the suture can be manually pushed out a certain distance, as shown in Figure 12, and the suture can be pushed out of the puncture needle for suturing;

[0051] Next, insert all four sutures into the main tube, as shown in Figure 13; retract the sutures by rotating the puncture control knob and withdraw the puncture needle from the interatrial septum, as shown in Figure 14; the change in the sliding handle during the needle withdrawal process is shown in Figure 15.

[0052] The interventional suturing device is withdrawn from the body through the sheath, as shown in Figure 16.

[0053] Tighten the suture and tie a knot to complete the suture of the oval foramen, as shown in Figure 17. When tightening and tying the knot, you can push the locking device only in the center of the cross suture to facilitate tying.

[0054] This device can be equipped with multiple puncture needles and can be deployed simultaneously. In this embodiment, the four suture needles can be used to suture at the same time, which can completely close the unclosed foramen ovale and greatly improve the surgical effect. It is also simple to operate and easy to control. The deployment and retraction of the puncture needles can be controlled by rotating the puncture control knob, which reduces the difficulty of operating the device. In addition, the cover of the sliding handle can be removed, which facilitates manual suture pushing and retraction.

[0055] While the present invention has been disclosed above, it is not limited thereto. Any person skilled in the art can make various modifications and alterations without departing from the spirit and scope of the present invention; therefore, the scope of protection of the present invention should be determined by the scope defined in the claims.

[0056] Finally, it should be noted that in this document, relational terms such as "first" and "second" are used only to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitations, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes said element.

[0057] The various embodiments in this specification are described in a progressive manner, with each embodiment focusing on the differences from other embodiments. The same or similar parts between the various embodiments can be referred to each other.

[0058] The above description of the disclosed embodiments enables those skilled in the art to make or use the present invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the present invention. Therefore, the present invention is not to be limited to the embodiments shown herein, but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. An interventional suturing device, characterized in that, The utility model relates to a kind of suture needle, including: Front end, it is equipped with multiple support structures and multiple puncture needles, the support structure can be bent under force, the puncture needle is hollow inside, and it is equipped with the suture line that can pass inside; Main pipe body, front section is connected with the front end, and it is equipped with multiple threading cavities inside, the number of the threading cavity is same with the number of the puncture needle, the puncture needle is located inside the threading cavity, and can slide in it; Fixed handle, it is arranged in the middle section of the main pipe body, and it is equipped with puncture control knob; Sliding handle, it is connected on the main pipe body and located behind the fixed handle, the distance between it and the fixed handle can be adjusted by rotating the puncture control knob, and it is equipped with suture shaft inside, the rear end of the suture line is located on the suture shaft; Anti-reverse valve, it is arranged in the tail end of the main pipe body.

2. The interventional suturing device according to claim 1, characterized in that The fixed handle includes fixed handle cover and fixed block, the fixed handle cover is equipped with limiting slot inside, the fixed block is installed in the limiting slot, and the fixed block is sleeved on the outside of the main pipe body and is fixedly connected with it.

3. The interventional suturing device according to claim 2, characterized in that The sliding handle is equipped with threaded rod inside, the puncture control knob is installed on the threaded rod, and the sliding handle can be moved forward and backward by rotating the threaded rod.

4. The interventional suturing device according to claim 3, characterized in that The sliding handle is also equipped with guide inside, the guide is equipped with multiple threading holes, and the guide is located in the front end of the suture shaft, the suture line led out from the suture shaft can be correspondingly threaded through the threading hole, and then correspondingly threaded into the puncture needle.

5. The interventional suturing device according to claim 4, characterized in that The threaded rod is equipped with mounting hole, the limiting sliding block is installed in the mounting hole, the fixed handle cover is equipped with limiting sliding slot, and the limiting sliding block is configured to slide in the limiting sliding slot.

6. The interventional suturing device according to claim 4, characterized in that The sliding handle is equipped with detachable cover.

7. The interventional suturing device according to any of claims 1-6, wherein, The front end of the main pipe body is equipped with puncture outlet hole, and the puncture needle is configured to be threaded out from the puncture outlet hole.

8. The interventional suturing device according to claim 7, characterized in that The front end of the support structure is equipped with needle hole, and the size of the puncture needle is configured to pass through the needle hole.

9. The interventional suturing device according to claim 7, characterized in that The number of the puncture needle is four.

Citation Information

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    CN116983026A

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