A biodegradable cardiac occluder for bilateral rivetless ventricular septal defects

Abstract

This invention relates to a biodegradable cardiac occluder for bilateral ventricular septal defect closure, comprising a first disc-shaped mesh, a second disc-shaped mesh, a tubular portion, and a rivetless flat-face connector. The tubular portion connects the first and second disc-shaped meshes. The rivetless flat-face connector includes a delivery disc and threaded holes. The delivery disc has mesh fixing holes for connecting the first disc-shaped mesh and the delivery disc. A steel cable can be connected to the occluder via the threads and threaded holes. This invention uses a small disc to replace rivets, achieving both re-delivery and the goal of reducing thrombosis incidence through rivetless design. The rivetless flat-face connector can be biodegradable or non-biodegradable. During processing, it is woven into the mesh body, making it convenient, safe, and quick.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a bilateral rivetless biodegradable cardiac occluder for ventricular septal defects. Background Technology

[0002] Ventricular septal defect (VSD) is a common type of congenital heart disease. The human heart consists of four chambers (left atrium, left ventricle, right atrium, and right ventricle). There should normally be a complete interventricular septum between the left and right ventricles. If there is an opening in the interventricular septum, it is called a VSD. VSDs mainly form during fetal development, due to factors affecting heart development. In patients with VSDs, blood usually flows from the left ventricle into the right ventricle through the VSD, increasing the blood volume of the right ventricle. Long-term presence of a VSD can cause pulmonary hypertension, congestive heart failure, palpitations, shortness of breath, fatigue, and recurrent lung infections. The thickness of the interventricular septum increases from top to bottom at the apex. The thinner part of the interventricular septum is called the membranous portion, and the thicker part is called the muscular portion.

[0003] Ventricular septal defect is a common congenital heart disease, and the traditional treatment is surgery. Surgical treatment requires patients to undergo open-chest surgery, and its biggest disadvantages are: (1) cardiopulmonary bypass is required during the operation, and the operation may cause complications leading to death; (2) the surgery is highly invasive and leaves scars after the operation; (3) the operation is expensive.

[0004] Since the 1980s, with the development and improvement of catheter-based interventional diagnostic and therapeutic technologies, my country has gradually introduced minimally invasive interventional techniques for the treatment of congenital heart disease. The method of treating ventricular septal defects (VSDs) through minimally invasive intervention has developed rapidly and is now very mature. Compared with traditional surgery, minimally invasive intervention is a modern, high-tech, minimally invasive treatment. Through femoral vein puncture, an arteriovenous track is established using a guide wire under the guidance of medical imaging equipment. The delivery catheter is then placed along the guide wire at the VSD site. Finally, the VSD occluder is pushed into the delivery catheter to close the VSD. This minimally invasive intervention has advantages such as no incision, minimal trauma, fewer complications, rapid recovery, good efficacy, a wide range of indications, and relatively low surgical costs.

[0005] While minimally invasive interventional surgery for ventricular septal defect occluders has many advantages over traditional surgery, the main stent of the ventricular septal defect occluders currently used in clinical practice is made of nickel-titanium alloy wire. Since this type of metal material is non-degradable, long-term implantation can cause inflammation, coagulation, and even damage to human tissues, thus presenting certain defects. The following risks may still exist: (1) Nickel-titanium alloy is a non-degradable metal alloy material. Although its biocompatibility has been demonstrated, the long-term risks of long-term permanent implantation cannot be completely controlled; (2) Since nickel-titanium alloy is permanently implanted and non-degradable, there is a lack of long-term follow-up data on the safety of permanent implantation in the human body and the impact of a fixed-size cardiac occluder on the continuously growing and developing heart of children. It may affect the development and growth of the heart of patients who have not yet reached maturity; (3) Complications such as nickel precipitation and nickel allergy have not yet been clearly demonstrated by science.

[0006] Once the surface of the cardiac occluder is completely endothelialized and the heart defect is repaired by the body's own tissues, there is absolutely no need for the cardiac occluder to remain in the body. Therefore, an ideal cardiac occluder should provide a temporary bridge for the heart's self-repair, be degraded by the body after fulfilling its purpose, and allow the defect to be completely repaired by the body's own tissues, thereby avoiding the long-term complications and safety hazards caused by metal remaining in the body.

[0007] The present invention is to truly achieve a double-sided disc surface without rivets, thereby solving the problem of thrombus formation during endothelialization.

[0008] Chinese patent application CN201620007911.1 discloses a biodegradable ventricular septal defect occluder, comprising a first disc-shaped mesh, a tubular mesh, and a second disc-shaped mesh connected sequentially. Both the first and second disc-shaped meshes are double-layered mesh covers. The two ends of the tubular mesh are respectively connected to the inner mesh surface of the first disc-shaped mesh and the outer mesh surface of the second disc-shaped mesh. The first disc-shaped mesh, tubular mesh, and second disc-shaped mesh are integrally formed. A connector for closing the mesh surface is provided at the center of the inner mesh surface of the second disc-shaped mesh, and a connector for closing the mesh surface is provided at the center of the outer mesh surface of the first disc-shaped mesh. The materials of the first disc-shaped mesh, tubular mesh, second disc-shaped mesh, and connector are all biodegradable. The height of the tubular mesh is 3.5-9.5 mm. This design not only ensures that the biodegradable filaments constituting the disc-shaped mesh are firmly connected together, but also ensures that the connector is firmly connected to the biodegradable filaments constituting the disc-shaped mesh, preventing them from easily detaching. However, the occluder has an added connector 40, and the design of this structure has the defect of thrombosis during endothelialization, which poses a risk of causing secondary harm to the patient.

[0009] This invention relates to a biodegradable cardiac occluder for bilateral ventricular septal defects without rivets. No reports have been found to date. Summary of the Invention

[0010] In order to address the long-term risks associated with existing clinically used ventricular septal defect occluders and to overcome the shortcomings of poor compliance and resilience in existing biodegradable occluders, this invention provides a bilateral rivetless biodegradable cardiac occluder for ventricular septal defects.

[0011] To achieve the above objectives, the technical solution adopted by the present invention is as follows:

[0012] This invention provides a biodegradable cardiac occluder for bilateral ventricular septal defects without rivets. The occluder includes a main body, a flow-blocking component, a suture, and a rivetless flat-end connector 6. The main body includes a mesh structure and a tubular portion 11. The mesh structure consists of a first disc-shaped mesh 1 and a second disc-shaped mesh 2, with the diameter of the second disc-shaped mesh 2 being larger than that of the first disc-shaped mesh 1. The first disc-shaped mesh 1 includes a first outer mesh surface 101 and a first inner mesh surface 102, and the second disc-shaped mesh 2 includes a second outer mesh surface 201 and a second inner mesh surface 202. The tubular portion 11... The first disc-shaped mesh 1 and the second disc-shaped mesh 2 are connected together. The rivetless flat end face connector 6 includes a conveying disc 5 and a threaded hole 7. The threaded hole 7 is located at the center of the conveying disc 5. The conveying disc 5 is also provided with a mesh fixing hole 9. The first disc-shaped mesh 1 is connected to the conveying disc 5 through the mesh fixing hole 9. The suture connects the flow-blocking component to the main component. The flow-blocking component is a biodegradable membrane with at least two layers for blocking blood flow. The suture is a biodegradable suture used to sew the flow-blocking component onto the main component and as a closing line.

[0013] Furthermore, the occluder also includes a steel cable 10.

[0014] Furthermore, one end of the steel cable 10 is provided with a thread 8.

[0015] Furthermore, the steel cable 10 is connected to the threaded hole 7 via the thread 8.

[0016] Furthermore, the first outer mesh surface 101 constitutes the upper plate surface 3, and the second outer mesh surface 201 constitutes the lower plate surface 4.

[0017] Furthermore, the main body component is woven from biodegradable filaments.

[0018] Furthermore, the conveyor plate 5 is made of a biodegradable material.

[0019] Furthermore, the biodegradable filament is a biodegradable polymer material.

[0020] Furthermore, the degradable material is a biodegradable polymer material.

[0021] Furthermore, the biodegradable polymer material is selected from one or more of polylactide, polyglycolic acid, polycaprolactone, polydioxanone, polyhydroxybutyrate, polyhydroxy fatty acid ester, polyanhydride, polyphosphate, polyurethane or polycarbonate, and their derivatives.

[0022] The advantages of this invention are:

[0023] 1. Currently, ventricular septal defect occluders on the market are either double-riveted or single-riveted. To achieve a bilaterally rivetless effect, a biodegradable disc structure is used instead of the riveted side. The disc has threaded holes to facilitate the delivery connection. Bilaterally rivetless occluders offer the following advantages:

[0024] (1) From a physical perspective, the rivet head is not easy to break;

[0025] (2) In terms of chemistry, there is no thermal fusion riveting process, and the material structure is stable;

[0026] (3) In terms of materials, reduce the proportion of foreign bodies in the patient's body;

[0027] (4) During the release process, reduce the surgical risk caused by the unscrewing of the thread causing the already determined position of the occluder to change;

[0028] (5) The rivetless occluder shortens the time to complete endothelialization, reduces the period of use of anticoagulant drugs for patients, avoids other complications caused by coagulation, and can effectively shorten the recovery time of patients.

[0029] Meanwhile, rivetless occluders can effectively reduce the incidence of thrombosis with single / double rivet occluders.

[0030] 2. The occluder of the present invention is connected to a conveying device such as a steel cable through a delivery disc and threaded holes, which can directly deliver the occluder to the heart. This overcomes the shortcomings of the prior art, which requires additional manufacturing of devices or structures to deliver the occluder to the heart. Furthermore, the occluder of the present invention has a simple structure, low cost, can avoid complications, is convenient to use, and is highly practical. Attached Figure Description

[0031] Appendix Figure 1 This is a schematic diagram of the overall structure of the biodegradable cardiac occluder for bilateral ventricular septal defects of the present invention.

[0032] Appendix Figure 2 This is a side view of the biodegradable cardiac occluder for bilateral ventricular septal defects of the present invention.

[0033] Appendix Figure 3 This is a schematic diagram of the conveyor tray.

[0034] Appendix Figure 4 This is a structural diagram of the conveyor tray and steel cable.

[0035] Appendix Figure 5 This is a schematic diagram showing the connection between the plug and the steel cable.

[0036] Appendix Figure 6 This is a schematic diagram of the structure of an existing plugging device.

[0037] 1. First disc-shaped network;

[0038] 101. First outer network surface;

[0039] 102. First internal network surface;

[0040] 2. Second disc-shaped network;

[0041] 201. Second outer mesh surface;

[0042] 202. Second internal network surface;

[0043] 3. Top plate;

[0044] 4. Lower plate;

[0045] 5. Conveyor tray;

[0046] 6. Rivetless flat end face connector;

[0047] 7. Threaded hole;

[0048] 8. Thread;

[0049] 9. Mesh fixing holes;

[0050] 10. Steel cables;

[0051] 11. Tubular part. Detailed Implementation

[0052] The present invention will be further described below with reference to specific embodiments. It should be understood that these embodiments are for illustrative purposes only and are not intended to limit the scope of the invention. Furthermore, it should be understood that after reading the description of this invention, those skilled in the art can make various alterations or modifications to the invention, and these equivalent forms also fall within the scope defined by the appended claims.

[0053] Example 1

[0054] Please refer to Figure 6 , attached Figure 6 This is a schematic diagram of the structure of an existing plugging device.

[0055] Please refer to Figure 1 , attached Figure 1 This is a schematic diagram of the overall structure of the biodegradable cardiac occluder for bilateral ventricular septal defects of the present invention.

[0056] This embodiment provides a biodegradable cardiac occluder for bilateral rivetless ventricular septal defects. The occluder includes a main body, a flow-blocking component, a suture, and a rivetless flat-face connector 6. The main body includes a mesh structure and a tubular portion 11. The mesh structure consists of a first disc-shaped mesh 1 and a second disc-shaped mesh 2. The first disc-shaped mesh 1 includes a first outer mesh surface 101 and a first inner mesh surface 102. The second disc-shaped mesh 2 includes a second outer mesh surface 201 and a second inner mesh surface 202. The tubular portion 11 connects the first disc-shaped mesh 1 and the second disc-shaped mesh 2. The rivetless flat-face connector 6 includes a delivery disc 5 and a threaded hole 7 (see...). Figure 3 The threaded hole 7 is located at the center of the conveyor plate 5, and the conveyor plate 5 is also provided with a mesh fixing hole 9 (see...). Figure 3 The first disc-shaped mesh 1 is connected to the conveyor disc 5 through the mesh fixing holes 9 (see...). Figure 2 The suture connects the flow-blocking component to the main component. The occluder also includes a steel cable 10, one end of which is threaded 8 (see...). Figure 4 The steel cable 10 is connected to the threaded hole 7 via thread 8 (see...). Figure 5 The first outer mesh surface 101 constitutes the upper plate surface 3, and the second outer mesh surface 201 constitutes the lower plate surface 4. (See...) Figure 2 The main body component is woven from biodegradable filaments. The flow-blocking component is a biodegradable membrane of at least two layers used to block blood flow; wherein the suture is used to sew the flow-blocking component onto the main body component. The biodegradable material or biodegradable filament is a biodegradable polymer material. The biodegradable polymer material is selected from one or more of polylactide, polyglycolic acid, polycaprolactone, polydioxanone, polyhydroxybutyrate, polyhydroxyalkanoates, polyanhydrides, polyphosphates, polyurethanes, or polycarbonates, and their derivatives.

[0057] The usage method and working principle of this embodiment are as follows:

[0058] First, the wires of the first disc mesh 1 are connected to the conveyor plate 5 through the mesh fixing hole 9 of the conveyor plate 5. Then, the first disc mesh 1 and the second disc mesh 2 are connected through the tubular part 11. Finally, the steel cable 10 is threadedly connected to the occluder through the thread 8 and the threaded hole 7, thereby delivering the occluder to the heart and completing the subsequent operations.

[0059] It should be noted that, compared with existing blocking devices, the present invention (i.e., in contrast) Figure 1 and Figure 6The occluder of this invention reduces protruding connectors and adds a delivery disc, threaded holes, and braided mesh fixing holes. By using the delivery disc and threaded holes, the occluder can be directly connected to a delivery device such as a steel cable to deliver the occluder to the heart. This avoids the presence of connectors, which are detrimental to the endothelialization process of the disc surface, thus increasing healing time. Furthermore, connectors with protruding ends increase the length of the occluder release, potentially touching nearby heart tissue and causing cardiac damage. Existing rivetless occluders lack threads, making it impossible to connect and deliver with existing steel cables, requiring a redesigned delivery device. This invention creatively adds threaded holes to the occluder, allowing connection to conventional steel cables and delivery devices, achieving both rivetless design and delivery. Moreover, the structure of this invention uses biodegradable materials, avoiding secondary harm to the human body caused by long-term contact with the device.

[0060] The above description is only a preferred embodiment of the present invention. It should be noted that those skilled in the art can make several improvements and additions without departing from the principle of the present invention, and these improvements and additions should also be considered within the scope of protection of the present invention.

Claims

1. A biodegradable cardiac occluder for bilateral ventricular septal defects without rivets, characterized in that, The occluder includes a main body component, a flow-blocking component, a suture, and a rivetless flat end face connector (6). The main body component includes a mesh structure and a tubular part (11). The mesh structure consists of a first disc mesh (1) and a second disc mesh (2). The diameter of the second disc mesh (2) is larger than that of the first disc mesh (1). The first disc mesh (1) includes a first outer mesh surface (101) and a first inner mesh surface (102). The second disc mesh (2) includes a second outer mesh surface (201) and a second inner mesh surface (202). The tubular part (11) connects the first disc mesh (1) and the second disc mesh (202). The mesh (2) is connected together. The rivetless flat end face connector (6) includes a conveying disc (5) and a threaded hole (7). The threaded hole (7) is located in the center of the conveying disc (5). The conveying disc (5) is also provided with a mesh fixing hole (9). The first disc mesh (1) is connected to the conveying disc (5) through the mesh fixing hole (9). The suture connects the flow-blocking component to the main component. The flow-blocking component is a biodegradable membrane with at least two layers for blocking blood flow. The suture is a biodegradable suture used to sew the flow-blocking component onto the main component and as a closing line.

2. The occluder according to claim 1, characterized in that, The plugging device also includes a steel cable (10).

3. The occluder according to claim 2, characterized in that, One end of the steel cable (10) is provided with a thread (8).

4. The occluder according to claim 3, characterized in that, The steel cable (10) is connected to the threaded hole (7) via a thread (8).

5. The plugging device according to claim 1, characterized in that, The first outer mesh surface (101) forms the upper plate surface (3), and the second outer mesh surface (201) forms the lower plate surface (4).

6. The occluder according to claim 1, characterized in that, The main component is woven from biodegradable yarn.

7. The plugging device according to claim 1, characterized in that, The conveyor plate (5) is made of biodegradable material.

8. The occluder according to claim 6, characterized in that, The biodegradable filament is a biodegradable polymer material.

9. The plugging device according to claim 7, characterized in that, The biodegradable material is a biodegradable polymer material.

10. The occlusion device according to any one of claims 8-9, characterized in that, The biodegradable polymer material is selected from one or more of polylactide, polyglycolic acid, polycaprolactone, polydioxanone, polyhydroxybutyrate, polyhydroxy fatty acid ester, polyanhydride, polyphosphate, polyurethane or polycarbonate, and their derivatives.

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