Atrial septal defect suturing apparatus
Patent Information
- Application Number
- PCT/CN2025/084167
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Filing Date
- 2025-03-21
- Publication Date
- 2026-09-24
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Figure CN2025084167_24092026_PF_FP_ABST
Abstract
Description
Atrial septal defect suture device Technical Field
[0001] Embodiments of this application relate to the field of surgical devices, and more particularly to a device for suturing atrial septal defects. Background Technology
[0002] The statements herein are provided merely as background information in connection with this application and do not necessarily constitute prior art.
[0003] The atrial septum, located between the left and right atria, primarily separates the blood flow between them. Normally, the left atrium receives oxygen-rich blood from the lungs, while the right atrium receives oxygen-deficient blood from the rest of the body. An atrial septal defect (ASD) is a common heart condition characterized by a hole between the left and right atria. This defect causes blood from both atria to mix, preventing oxygen-rich and oxygen-deficient blood from entering their respective circulatory systems separately. This results in reduced oxygen levels in the left atrium, leading to symptoms such as hypoxia and impacting the patient's health and quality of life. Summary of the Invention
[0004] A brief overview of this application is provided below to offer a basic understanding of certain aspects thereof. It should be understood that this overview is not an exhaustive summary of the application. It is not intended to identify key or essential parts of the application, nor is it intended to limit its scope. Its purpose is merely to present certain concepts in a simplified form as a prelude to the more detailed description that follows.
[0005] An embodiment of this application provides an atrial septal defect suturing device suitable for suturing atrial septal defects of the heart. It includes: a suture, a sheath, a puncture needle, a suture thread, and a guide wire. The guide wire is configured to move the suture and the puncture needle within the sheath to deliver the suture along the sheath to a predetermined position in the atrium. At the predetermined position, the suture is configured to unfold and cover the atrial septal defect. The sheath is configured to have an opening at one end near the predetermined position, allowing the puncture needle to pass through. The puncture needle is configured to pass through the atrial septum, and the suture thread secures the suture to the atrial septal defect, thereby suturing the atrial septal defect.
[0006] The atrial septal defect suturing device provided in the embodiments of this application transports the suture to the atrial septal defect site through a guide wire and a sheath, so that the suture forms a covering at the atrial septal defect site, and the puncture needle can extend from the opening on the sheath, thereby passing through the atrial septum and the suture in sequence, so that the atrial septum and the suture are fixedly connected by sutures, thereby fixing the suture to the atrial septal defect site and preventing the suture from falling off. Attached Figure Description
[0007] To further illustrate the above and other advantages and features of this application, the specific embodiments of this application will be described in more detail below with reference to the accompanying drawings. The drawings, together with the following detailed description, are included in and form a part of this specification. Elements having the same function and structure are indicated by the same reference numerals. It should be understood that these drawings only depict typical examples of this application and should not be considered as limiting the scope of this application.
[0008] Figure 1 is a side view of the room partition defect suturing device provided in an embodiment of this application;
[0009] Figure 2 is a schematic diagram of the structure of the puncture needle and suture provided in the embodiment of this application;
[0010] Figure 3 is a schematic diagram of the atrial septal defect suturing device provided in an embodiment of this application placed at the atrial septal defect site of a patient.
[0011] Explanation of reference numerals in the attached drawings: 10, sheath; 101, opening; 20, puncture needle; 201, tip; 202, suture hole; 203, protrusion; 30, suture; 40, suture thread; 50, interatrial septum. Detailed Implementation
[0012] Exemplary embodiments of this application will be described below with reference to the accompanying drawings. For clarity and brevity, not all features of actual implementations are described in the specification. However, it should be understood that many implementation-specific decisions must be made in the development of any such actual embodiment to achieve the developer's specific goals, such as complying with constraints related to the system and business, and these constraints may vary depending on the implementation. Furthermore, it should be understood that while development work can be very complex and time-consuming, such development work is merely a routine task for those skilled in the art who benefit from the content of this application.
[0013] It should also be noted that, in order to avoid obscuring this application with unnecessary details, only the equipment structure and / or processing steps closely related to the solution according to this application are shown in the accompanying drawings, while other details that are not closely related to this application are omitted.
[0014] The following disclosure provides several different implementations or examples for carrying out this application. To simplify the disclosure of this application, specific examples of components and methods are described below. Of course, these are merely examples and are not intended to limit this application. In the description of the embodiments of this application, "multiple" means at least two, such as two, three, etc., unless otherwise explicitly specified.
[0015] For atrial septal defects that cannot close naturally or cause symptoms, surgical or minimally invasive interventional treatments are needed to fill the gap between the left and right atria, improve cardiac hemodynamics, reduce the shunting of oxygen-rich blood, and alleviate pulmonary hypertension, thereby reducing patient symptoms and improving quality of life. The inventors discovered that existing suturing devices cannot achieve the desired suturing effect: for example, because the suture may come into contact with the damaged area of the atrial septum, the suture may dislodge from the atrial septum during the suturing process, leading to suturing failure.
[0016] This application provides an atrial septal defect suturing device suitable for suturing atrial septal defects in the heart. Figure 1 shows a side view of the atrial septal defect suturing device provided in an embodiment of this application, and Figure 3 shows a schematic diagram of the atrial septal defect suturing device placed at the atrial septal defect of a patient. In some embodiments, as shown in Figures 1 and 3, the atrial septal defect suturing device includes: a suture 30, a sheath 10, a puncture needle 20, a suture 40, and a guidewire. The guidewire is configured to be able to drive... The suture 30 and the puncture needle 20 move within the sheath 10 to deliver the suture 30 along the sheath 10 to a predetermined position in the atrium. At the predetermined position, the suture 30 is configured to unfold and cover the atrial septal defect. The sheath 10 is configured to have an opening 101 at one end near the predetermined position, which is configured to allow the puncture needle 20 to pass through. The puncture needle 20 is configured to pass through the atrial septum 50 and the suture 40 fixes the suture 30 to the defect of the atrial septum 50 so that the atrial septal defect is sutured.
[0017] The atrial septal defect suturing device provided in this application delivers the suture 30 to the atrial septal defect site via a guide wire and sheath 10, allowing the suture 30 to cover the defect. A puncture needle 20 extends from an opening 101 in the sheath 10, passing sequentially through the atrial septum 50 and the suture 30. The atrial septum 50 and the suture 30 are then fixedly connected by sutures, ensuring the suture 30 is securely covered at the atrial septal defect site and preventing it from falling off. Compared to related techniques that directly suture the atrial septum with sutures, the contact area between the suture and the atrial septum in this application is significantly larger than the contact area between the suture and the atrial septum. This avoids the problem of sutures falling off at the suture site in related techniques, thus greatly improving the success rate of atrial septal defect suturing.
[0018] In some embodiments, as shown in FIG3, the puncture needle 20 is configured to drive the suture thread through the interatrial septum 50 and the suture 30 in sequence, so that the suture thread connects to the suture 30, and drives the suture thread through the interatrial septum again, so that the suture thread fixes the suture 30 to the defect of the interatrial septum, so that the defect of the interatrial septum is sutured.
[0019] In some embodiments, the suture 30 is configured to be detachably connected to a guidewire (not shown). The suture 30 and the guidewire are disposed within the sheath 10. The suture 30 is configured such that its size in the contracted state matches the inner diameter of the sheath 10, allowing the suture 30 to be smoothly disposed within the sheath 10. Transporting the suture 30 to a predetermined location on the heart via the sheath 10 facilitates accurate delivery of the suture 30 to the intended position.
[0020] In some embodiments, as shown in FIG3, the sheath 10 is configured to pass through the atrial septal defect, and the suture 30 is configured to be in a contracted state when moving within the sheath 10, and to unfold and cover the area around the atrial septal defect after the suture 30 extends out of the sheath 10.
[0021] In some embodiments, the delivery sheath 10 requires venipuncture of the patient to create a venous access for the movement of the sheath 10. The sheath 10 eventually moves to the atrial septal defect and passes through the hole formed in the defect, so that the suture 30, which is constricted and disposed inside the sheath 10, can cover the side opposite to the direction of movement of the sheath 10 out of the body after extending out of the sheath 10. This allows the atrial septum 50 to act as a stop when the sheath 10 leaves the atrial septal defect after the guidewire and suture 30 separate, preventing the suture 30 from being dragged and peeled off at the atrial septal defect.
[0022] Figure 2 shows a schematic diagram of the structure of the puncture needle and suture provided in an embodiment of the present application. In some embodiments, as shown in Figure 2, the puncture needle 20 is configured to have a thread hole 202 formed at a predetermined distance near its tip 201, and the suture 40 is configured to pass through the thread hole 202.
[0023] In some embodiments, as shown in Figures 2 and 3, one end of the puncture needle 20 is configured as a tip 201 for easy puncture, allowing the puncture needle 20 to penetrate the interatrial septum 50 and the suture 30, avoiding physical harm to the patient caused by repeated operations due to the inability to quickly penetrate and fix the suture 30. A suture hole 202 is formed at a predetermined position from the tip 201, radially penetrating the puncture needle 20. The suture hole 202 allows the suture 40 to pass through it, enabling the suture 40 to move with the puncture needle 20. Thus, when the puncture needle 20 passes through the interatrial septum 50 and the suture 30 in sequence, the suture 40 also passes through the interatrial septum 50 and the suture 30 in sequence, thereby connecting the interatrial septum 50 and the suture 30 together through the suture 40, fixing the suture 30 in the atrium, and preventing the suture 30 from separating from the interatrial septum 50 due to the force of heartbeat or blood flow during operation.
[0024] In some embodiments, as shown in FIG2, the puncture needle 20 forms a protrusion 203 at a predetermined distance from the thread hole 202 in a direction away from the tip 201. The protrusion 203 is configured to extend along the direction away from the tip 201 of the puncture needle 20 to form a barb structure.
[0025] In some embodiments, a protrusion 203 is formed at a predetermined position at the end of the suture hole 202 away from the tip 201. The protrusion 203 is configured as a barb structure extending away from the tip 201. The area between the tip 201 and the protrusion 203 is streamlined. The suture hole 202 is formed between the tip 201 and the protrusion 203, which allows the suture 40 passing through the suture hole 202 to smoothly pass through the interatrial septum 50 and the suture 30 along with the streamlined structure near the tip 201. At the same time, the protrusion 203 causes a predetermined portion of the suture 40 to bend, preventing the two ends of the suture 40 from being too close to the non-protruding part of the puncture needle 20, thereby preventing them from tangling or even knotting.
[0026] In some embodiments, the guidewire is configured to move the puncture needle 20 away from the suture 30 so that the barbed structure can move the suture 30 toward the interatrial septum 50 so that the suture 30 is fixedly connected to the interatrial septum 50.
[0027] In some embodiments, when the sheath 10 moves to the atrial septal defect, the suture 30 extends out from the sheath 10 and covers the atrial septal defect. At the same time, the puncture needle 20 inside the sheath 10 extends out from the opening 101 on the sheath 10, and drives the suture 40 provided in the suture hole 202 to extend out of the sheath 10 together, and penetrate the atrial septum 50 and the suture 30 in sequence at a predetermined angle.
[0028] In some embodiments, the sheath 10 is configured to be able to move away from the interatrial septum 50 and out of the body when the suture 30 is fixedly connected to the interatrial septum 50.
[0029] In some embodiments, the outer surface of the suture 30 can be configured as a dense coating structure that prevents blood from passing through, thereby blocking the mixing of blood between the left and right atria. After the puncture needle 20 penetrates the suture 30, the barbed structure formed by its protrusion 203 can drive the suture 30 to move closer to the interatrial septum 50 when the sheath 10 is withdrawn from the body, so that the suture 40 can more tightly fix the suture 30 and the interatrial septum, preventing the space between them that allows the suture 30 to move, and making the suture tighter.
[0030] In some embodiments, the suture 40 is configured to be knotted and detached from the thread hole 202 when the suture 30 is close to the interatrial septum 50.
[0031] In some embodiments, as shown in FIG2, the suture 40 is configured to pass through the suture hole 202, and both ends are set to a predetermined length, which is greater than the length of the puncture needle. The two ends of the suture 40 extend freely, and the two ends retain sufficient length to prevent the suture 40 from having enough room to move when subjected to external force during puncture, thus preventing the suture 40 from falling out of the suture hole 202.
[0032] In some embodiments, the puncture needle 20 is configured to move out of the body along with the sheath 10.
[0033] In some embodiments, the suture 40 is knotted to secure the interatrial septum 50 and the suture 30 to ensure the suture is secure. Then, the puncture needle 20 is configured to retract into the sheath 10 from the opening 101 and be withdrawn from the body along with the sheath 10. The sheath 10 can prevent the puncture needle 20 from scratching the blood vessel wall.
[0034] In some embodiments, as shown in FIG1, a plurality of openings 101 are provided, and the plurality of openings 101 are evenly distributed in the circumferential direction of the sheath 10.
[0035] In some embodiments, a plurality of openings 101 may be uniformly provided on the sheath 10 to allow a plurality of puncture needles 20 to extend from them, thereby driving the suture 40 to fix the interatrial septum 50 and the suture 30 together, thereby achieving multiple fixation of the suture 30 and further improving the firmness of the suture 30.
[0036] The following describes how to use the room partition defect suturing device provided in this application.
[0037] The precise location, size, and morphological characteristics of the atrial septal defect in the patient are determined using predetermined methods, and a suture 30 of appropriate size is selected based on the determined information; the location of the blood vessel connected to the heart is selected as the puncture site, generally the femoral vein is selected for puncture; after disinfection and local anesthesia are performed on the puncture site, the puncture site is punctured to form a puncture opening in the patient's epidermis; the puncture opening is kept dilated, and a guidewire is introduced into the vein at the puncture site through the puncture opening.
[0038] Guided by a guidewire, the sheath 10, the suture 30 constricted within the sheath 10, and the puncture needle 20 with suture 40 are placed into the vein at the puncture site. Under the monitoring of fluoroscopy and echocardiography, the sheath 10 and suture 30 are ensured to reach the atrial septal defect along the predetermined vascular path. After reaching the appropriate position, the suture 30 is released from the sheath 10 and expands. The suture 30 can be configured to expand and contract with the contraction and relaxation of the heart.
[0039] When the suture 30 expands to completely cover the atrial septal defect, the puncture needle 20 carried inside the sheath 10 extends out from the opening 101 formed on the sheath 10. The puncture needle 20 has a thread hole 202 for the suture 40 to pass through. The puncture needle 20 drives the suture 40 to pass through the atrial septum 50 and the suture 30 in sequence, so that the suture 40 also passes through the atrial septum 50 and the suture 30 in sequence, thereby connecting the atrial septum 50 and the suture 30 together through the suture 40. Furthermore, a barbed structure is formed near the thread hole 202 of the puncture needle, so that when the suture 30 leaves the atrial septal defect, it is driven by the barbed structure to adhere to the atrial septum 50, further reinforcing the coverage of the atrial septal defect by the suture 30.
[0040] After suturing, the puncture needle 20 retracts into the sheath 10 through the opening 101, and the suture 40 is released from the puncture needle through the thread hole 202 and tied in place. The sheath 10, puncture needle 20, and guide wire are then withdrawn from the body together, and pressure bandage is applied to the patient's puncture site.
[0041] Regarding the embodiments of this application, it should also be noted that, without conflict, the embodiments of this application and the features in the embodiments can be combined with each other to obtain new embodiments.
[0042] The above are merely specific embodiments of this application, but the scope of protection of this application is not limited thereto. The scope of protection of this application shall be determined by the scope of the claims.
Claims
1. An atrial septal defect suturing device, suitable for suturing atrial septal defects of the heart, characterized in that, It includes: sutures, sheath, puncture needle, suture thread, and guide wire. The guidewire is configured to move the suture and the puncture needle within the sheath, thereby guiding the suture along the sheath to a predetermined position in the atrium. At the predetermined position, the suture is configured to unfold and cover the atrial septal defect. The sheath is configured to have an opening at one end near the predetermined position, the opening being configured to allow the puncture needle to pass through. The puncture needle is configured to pass through the interatrial septum, and the suture secures the suture to the defect in the interatrial septum, thereby suturing the defect in the interatrial septum.
2. The apparatus according to claim 1, characterized in that, The puncture needle is configured to drive the suture through the interatrial septum and the suture piece in sequence, so that the suture connects to the suture piece and drives the suture through the interatrial septum again, so that the suture fixes the suture piece to the defect of the interatrial septum, so that the defect of the interatrial septum is sutured.
3. The apparatus according to claim 2, characterized in that, The puncture needle is configured to have a thread hole at a predetermined distance near its tip, and the suture is configured to pass through the thread hole.
4. The apparatus according to claim 3, characterized in that, The puncture needle has a protrusion at a predetermined distance from the threading hole in a direction away from the tip. The protrusion is configured to extend along the direction of the puncture needle away from the tip to form a barb structure.
5. The apparatus according to claim 4, characterized in that, The guidewire is configured to move the puncture needle away from the tip, so that the barbed structure can move the suture closer to the interatrial septum, thereby fixing the suture to the interatrial septum.
6. The apparatus according to claim 1, characterized in that, The sheath is configured to pass through the atrial septal defect, and the suture is configured to be in a contracted state when moving within the sheath, and to unfold and cover the atrial septal defect after the suture extends out of the sheath.
7. The apparatus according to claim 5 or 6, characterized in that, The sheath is configured to move away from the interatrial septum and out of the body when the suture is fixedly connected to the interatrial septum.
8. The apparatus according to claim 5, characterized in that, The suture is configured to be knotted and detached from the thread hole when the suture is close to the interatrial septum.
9. The apparatus according to claim 7, characterized in that, The puncture needle is configured to move out of the body along with the sheath.
10. The apparatus according to claim 1, characterized in that, The openings are configured as multiple, and the multiple openings are evenly distributed in the circumferential direction of the sheath.