A bilateral rivet-free patent foramen ovale occluder with degradability

Abstract

The present application relates to a kind of bilateral rivetless patent foramen ovale occlusion device, the occlusion device includes main component, resistance flow component, suture and rivetless flat end connector, the main component includes first disc, second disc and waist, the rivetless flat end connector includes delivery disc and screw hole, the suture connects resistance flow component and main component.The present application replaces rivet point with a small disc, through screw hole and delivery disc, can directly connect occlusion device with steel cable and other conveying devices, and transport occlusion device into heart, the present application can realize the effect of retransportation, also can realize the purpose of reducing thrombosis incidence, and rivetless flat end connector is degradable.In the process of processing, it is convenient, safe and fast to be knitted on net body.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a double-sided rivet-free patent foramen ovale occluder. BACKGROUND

[0002] Patent foramen ovale is one of the common congenital heart diseases. Patent foramen ovale is mainly formed during the growth and development of the fetus. During embryonic development, a sickle-shaped septum, called the secondary septum or secondary septum, grows on the right side of the first septum. The septum also grows towards the endocardial cushion, covering the second atrial hole, but does not fuse with the endocardial cushion, forming an oval hole, called the oval hole. After the birth of the fetus, the oval hole is generally closed within the first year after birth, and if the oval hole of a child older than three years old is still not closed, it is called patent foramen ovale. 20-25% of adults have incomplete closure of the oval hole, leaving a small gap or a small hole through which a probe can pass. If the oval hole does not close normally after birth, due to the failure of the primary septum and the secondary septum to naturally adhere and fuse, the gap-like abnormal channel between the two, similar to a functional valve, when the right atrial pressure is higher than the left atrial pressure, the left thin primary septum is pushed away, that is, right-to-left shunt occurs. The long-term existence of patent foramen ovale can cause migraine, cerebral ischemia, stroke, decompression disease, supine respiratory orthostatic hypoxia syndrome, and high altitude disease.

[0003] Heart patent foramen ovale is a common congenital heart disease, and the traditional treatment method is surgery. The surgical treatment method requires the patient to undergo surgical thoracotomy, and the biggest disadvantage is that: (1) extracorporeal circulation is required during the operation, and the operation may cause complications and death; (2) surgical trauma is large, and postoperative scars are left; (3) the cost of surgery is expensive.

[0004] Since the 1980s, with the development and improvement of catheter-based interventional diagnosis and treatment technology, China has gradually introduced minimally invasive interventional technology to treat congenital heart disease. The method of treating patent foramen ovale by 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. After confirming right-to-left shunt by right atrial angiography, the end-hole catheter is placed in the left atrium or left upper pulmonary vein through the patent foramen ovale. The exchange guide wire is sent into the left atrium or left upper pulmonary vein through the end-hole catheter, and the corresponding size delivery sheath is sent into the left atrium. The occluder is loaded and sent into the left atrium through the sheath tube. After the left atrial disc of the occluder is fully opened and the thin waist part is out of the sheath, the delivery rod and long sheath are withdrawn together, so that the left atrial disc is tightly attached to the left atrial wall, and the thin waist part is completely clamped at the patent foramen ovale. Then the sheath tube is withdrawn to open the right atrial disc. The position and shape of the occluder are monitored by fluoroscopy and echocardiography to meet the requirements. Right atrial angiography shows no right-to-left shunt. The occluder is released, and the delivery device is removed to complete the operation. Such minimally invasive intervention has the advantages of no incision, small trauma, fewer complications, rapid recovery, good effect, wide range of indications, and relatively low cost.

[0005] Although the treatment method of implanting patent foramen ovale occluder through minimally invasive interventional surgery has many advantages over traditional surgery. However, the main body of the occluder used in clinical practice is mainly made of nickel-titanium alloy wire. Since this type of metal material cannot be degraded, long-term implantation may cause inflammation, coagulation, and even some degree of damage to the human body tissue, thus there are certain defects, and there may be the following risks: (1) nickel-titanium alloy is a non-degradable metal alloy material. Although its biocompatibility has been demonstrated, the long-term risk of permanent implantation cannot be completely controlled; (2) since the nickel-titanium alloy is permanently implanted and non-degradable, the permanent retention of the heart may affect the development of the heart of the growing child, and there is still a lack of long-term follow-up data on the safety of the heart to the human body and the impact of the fixed size heart occluder on the growing heart of the child; (3) nickel precipitation and nickel allergy still have no clear scientific evidence.

[0006] After the surface of the heart occluder is completely endothelialized and the heart defect is repaired by the body's own tissue, the heart occluder is completely unnecessary to remain in the body. Therefore, the ideal heart occluder should provide a temporary bridge for the heart to repair itself, be degraded after completing its historical mission, and allow the defect to be completely repaired by the body's own tissue, thereby avoiding the long-term complications and safety hazards caused by the retention of metal in the body.

[0007] The current market is all double rivet or single rivet heart occluder, whether it is single rivet or double rivet, the center of the disc surface is convex, which can increase the risk of thrombosis on the surface of the occluder, which is not conducive to the endothelialization process of the surface of the occluder, at the same time, the release length of the occluder is longer during the implantation operation, which can easily damage the heart tissue, and the occluder made by this method has poor compliance and recovery, which needs to be assisted by the locking device to recover the initial shape.

[0008] Chinese patent application CN202011619405.5 discloses a degradable heart patent foramen ovale occluder and a manufacturing method thereof. The degradable heart patent foramen ovale occluder is made of degradable wire, and comprises a main body component, a flow blocking component and a suture. The main body component comprises a net body and a connecting piece, the net body comprises a first disc-shaped part, a tubular part and a second disc-shaped part connected in sequence, and the two ends of the tubular part are connected to the centers of the first disc-shaped part and the second disc-shaped part respectively. The flow blocking component is at least two layers of degradable or non-degradable membranes for blocking blood flow. The heart patent foramen ovale occluder is made of a special mold. The special mold comprises a core mold. The core mold comprises a first cover body, a center component, a second cover body and a center column. The special mold is used to shape the heart patent foramen ovale occluder, which is simple, fast and low in cost. However, the occluder adds a convex connecting piece, which can cause thrombosis and other complications during endothelialization.

[0009] The present application is to truly realize the structure of the degradable occluder without rivet points on both sides to solve the problem of thrombosis during endothelialization. There is no report on the present application of a bilateral rivet point-free patent foramen ovale degradable heart occluder. SUMMARY

[0010] The present application aims to solve the problem of long-term risk of the existing clinical use of patent foramen ovale occluder, overcome the defects of high cost and poor self-expanding recovery of the existing technology, and provide a bilateral rivet point-free patent foramen ovale degradable heart occluder.

[0011] To achieve the above-mentioned purpose, the technical solution adopted by the present application is:

[0012] The application provides a double-sided rivet-free patent foramen ovale occlusion device, which comprises a main body component, a flow blocking component, a suture and a rivet-free flat end connector 3, the main body component comprises a first disc-shaped part 1, a second disc-shaped part 2 and a waist part 4, the waist part 4 connects the first disc-shaped part 1 and the second disc-shaped part 2, the suture connects the flow blocking component and the main body component, the rivet-free flat end connector 3 comprises a delivery disc 10 and a threaded hole 9, the delivery disc 10 is further provided with a mesh fixing hole 11, the mesh wire of the second disc-shaped part 2 is connected with the delivery disc 10 through the mesh fixing hole 11, and the threaded hole 9 is located at the center of the delivery disc 10.

[0013] Further, the outer mesh surface of the second disc-shaped part 2 constitutes an upper disc surface 5, and the outer mesh surface of the first disc-shaped part 1 constitutes a lower disc surface 6.

[0014] Further, the device further comprises a steel cable 7.

[0015] Further, the steel cable 7 is further provided with a thread 8.

[0016] Further, the steel cable 7 is connected with the threaded hole 9 through the thread 8.

[0017] Further, the main body component is woven by degradable silk.

[0018] Further, the flow blocking component is at least two layers of degradable membranes for blocking blood flow, and the suture is a degradable suture for suturing the flow blocking component on the main body component and as a closing line.

[0019] Further, the delivery disc 10 is made of degradable material.

[0020] Further, the degradable material or degradable silk is a biodegradable high molecular material.

[0021] Further, the biodegradable high molecular material is one or more than two selected from polylactide, polyglycolide, polycaprolactone, poly-p-dioxanone, polyhydroxybutyrate, polyhydroxyalkanoate, polyanhydride, polyphosphate, polyurethane or polycarbonate, and derivatives thereof.

[0022] The application has the following advantages:

[0023] 1. The occlusion devices on the market are all double-rivet or single-rivet, in order to realize the effect of double-sided rivet-free, the application replaces the side that should have rivets with a degradable disc surface structure, the disc surface has a threaded hole, the connection problem of delivery can be realized, and the double-sided rivet-free has the following advantages:

[0024] (1) In terms of physics, the rivet head is not easy to break;

[0025] (2) Chemically, the hot-melt rivet process is non-thermal, and the material structure is stable;

[0026] (3) Materially, the proportion of foreign matter in the patient's body is reduced;

[0027] (4) During the release process, the risk of surgery caused by the change in the position of the occluder due to the back-rotating threads is reduced;

[0028] (5) The endothelialization time of the rivet-free occluder is shortened, the use period of anticoagulant drugs for patients is reduced, other complications caused by blood coagulation are avoided, and the recovery time of patients can be effectively shortened.

[0029] At the same time, the rivet-free occluder can effectively reduce the thrombosis rate of single / double rivet occluders.

[0030] 2. The present application is further improved on the basis of the existing occluder. The improved occluder can not only achieve the purpose of reducing the thrombosis rate without rivets, but also can directly deliver the occluder into the heart without the need for additional devices, and has strong practicability and good application prospect. BRIEF DESCRIPTION OF DRAWINGS

[0031] Figure 1 is a schematic diagram of the overall structure of the bilateral rivet-free patent foramen ovale occluder according to the present application. Figure 1 Figure 2 is a schematic diagram of the longitudinal section of the bilateral rivet-free patent foramen ovale occluder according to the present application.

[0032] Figure 2 Figure 3 is an enlarged schematic diagram of the rivet-free flat end connector in Figure 1.

[0033] Figure 4 is a schematic diagram of the steel cable and the occluder structure. Figure 3 Figure 1 Figure 5 is a schematic diagram of the connection between the steel cable and the occluder.

[0034] Figure 6 is a schematic diagram of the structure of the delivery disc. Figure 4 Figure 7 is a schematic diagram of the connection between the steel cable and the occluder.

[0035] Figure 5 Figure 8 is a schematic diagram of the structure of the delivery disc.

[0036] Figure 9 is a schematic diagram of the structure of the existing patent foramen ovale occluder. Figure 6 1. First disc portion;

[0037] Figure 7 2. Second disc portion;

[0038] 3. Rivet-free flat end connector;

[0039] 4. Waist portion;

[0040] 3. Rivet-free flat end connector;

[0041] 4. Waist portion;

[0042] ​​​​5, upper disc surface;

[0043] 6, lower disc surface;

[0044] 7, steel cable;

[0045] 8, thread;

[0046] 9, threaded hole;

[0047] 10, conveying disc;

[0048] 11, net fixing hole. DETAILED DESCRIPTION

[0049] The application will be further described below in connection with specific embodiments. It should be understood that these embodiments are only used to illustrate the application and not used to limit the scope of the application. Furthermore, it should be understood that after reading the content described in the application, those skilled in the art can make various modifications or changes to the application, and these equivalent forms also fall within the scope of the appended claims.

[0050] Example 1

[0051] Please refer to Figure 7 , attached Figure 7 is a prior art structure diagram of a patent foramen ovale heart occluder.

[0052] Please refer to Figures 1-2 , attached Figure 1 is a whole structure diagram of a bilateral rivet-free patent foramen ovale degradable heart occluder of the application. Attached Figure 2 is a longitudinal section diagram of a bilateral rivet-free patent foramen ovale degradable heart occluder of the application.

[0053] The embodiment provides a double-sided rivet-free patent foramen ovale occlusion degradable heart occluder, the occluder comprises a main body component, a flow blocking component, a suture and a rivet-free flat end connector 3, the main body component comprises a first disc-shaped part 1, a second disc-shaped part 2 and a waist part 4, the waist part 4 connects the first disc-shaped part 1 and the second disc-shaped part 2, the suture connects the flow blocking component and the main body component, the rivet-free flat end connector 3 comprises a delivery disc 10 and a threaded hole 9, the delivery disc 10 is further provided with a mesh fixing hole 11, mesh wires of the second disc-shaped part 2 are connected with the delivery disc 10 through the mesh fixing hole 11, and the threaded hole 9 is located at the center of the delivery disc 10. An outer mesh surface of the second disc-shaped part 2 constitutes an upper disc surface 5, and an outer mesh surface of the first disc-shaped part 1 constitutes a lower disc surface 6, further comprising a steel cable 7, the steel cable 7 further comprises a thread 8, and the steel cable 7 is connected with the threaded hole 9 through the thread 8. The main body component is woven by degradable filaments. The flow blocking component is at least two layers of degradable membranes for blocking blood flow. The suture is a degradable suture for suturing the flow blocking component on the main body component and as a closing line. The delivery disc 10 is made of degradable material. The degradable material or degradable filament is a biodegradable high molecular material. The biodegradable high molecular material is one or more than two selected from polylactide, polyglycolide, polycaprolactone, poly-p-dioxanone, polyhydroxybutyrate, polyhydroxyaliphatic ester, polyanhydride, polyphosphate, polyurethane or polycarbonate, and derivatives thereof.

[0054] The use method and working principle of the embodiment are as follows:

[0055] First, the mesh wires of the second disc-shaped part 2 are connected with the delivery disc 10 through the mesh fixing hole 11 of the delivery disc 10, then the first disc-shaped part 1 and the second disc-shaped part 2 are connected through the waist part 4, then the steel cable 7 is threadedly connected with the occluder through the thread 8 and the threaded hole 9, and finally the occluder is delivered into the heart by using a delivery device such as a steel cable.

[0056] It should be noted that some occluders in the prior art increase the protruding connectors (such as Figure 7), the occluder is connected with the conveying device such as steel cable through the protruding connecting piece, and then the subsequent operation is completed according to the steps after the occluder is conveyed into the heart by the conveying device such as steel cable. The present application is further improved on the basis of the prior art. The improved occluder eliminates the original protruding connecting piece, and increases the conveying disc and the threaded hole. The threaded hole and the conveying disc can be directly connected with the steel cable and convey the occluder directly into the heart, avoiding the previous structure of the protruding connecting piece which is not conducive to the endothelialization process of the disc surface. The endothelialization process at the protruding connecting piece is relatively slow, which affects the healing process after the occluder is implanted, thereby increasing the healing time. At the same time, the protruding connecting piece at both ends will increase the release length of the occluder, which may touch the nearby heart tissue and cause heart damage. Moreover, the existing rivetless occluder has no thread, and the existing steel cable cannot be connected and cannot be conveyed, so the conveying device needs to be redesigned. The present application creatively increases the threaded hole on the occluder, which can connect the conventional steel cable and conveying device on the market, and at the same time achieves the purpose of rivetless and conveying. Moreover, the structure of the present application uses degradable material, which avoids the secondary damage to the human body caused by the long-term existence of the device in the human body.

[0057] The above only describes the preferred embodiments of the present application. It should be noted that those skilled in the art can make several improvements and supplements without departing from the principles of the present application, and these improvements and supplements should also be considered within the protection scope of the present application.

Claims

1. A bi-leaflet, rivetless patent foramen ovale (PFO) occluder device, comprising: The occluder comprises a main body part, a flow blocking part, a suture and a rivetless flat end connector (3), the main body part comprises a first disc part (1), a second disc part (2) and a waist part (4), the waist part (4) connects the first disc part (1) and the second disc part (2), the diameter of the first disc part (1) is larger than that of the second disc part (2), the suture connects the flow blocking part and the main body part, the rivetless flat end connector (3) comprises a delivery disc (10) and a threaded hole (9), the delivery disc (10) is further provided with a mesh fixing hole (11), the mesh wire of the second disc part (2) is connected with the delivery disc (10) through the mesh fixing hole (11), and the threaded hole (9) is located at the center of the delivery disc (10).

2. The occluder of claim 1, wherein, The outer mesh surface of the second disc part (2) of the occluder constitutes an upper disc surface (5), and the outer mesh surface of the first disc part (1) constitutes a lower disc surface (6).

3. The occluder of claim 1, wherein, The steel cable (7) is further provided.

4. The occluder of claim 3, wherein, The steel cable (7) is further provided with a thread (8).

5. The occluder of claim 4, wherein, The steel cable (7) is connected with the threaded hole (9) through the thread (8).

6. The occluder of claim 1, wherein, The main body part is woven by degradable silk.

7. The occluder of claim 1, wherein, The flow blocking part is at least two layers of degradable film for blocking blood flow; and the suture is a degradable suture for suturing the flow blocking part on the main body part and as a closing line.

8. The occluder of claim 1, wherein, The delivery disc (10) is made of degradable material.

9. The occluder of claim 6 or 8, wherein, The degradable material or degradable silk is biodegradable high molecular material.

10. The occluder of claim 9, wherein, The biodegradable high molecular material is one or more than two selected from polylactide, polyglycolide, polycaprolactone, poly-p-dioxanone, polyhydroxybutyrate, polyhydroxyalkanoate, polyanhydride, polyphosphate, polyurethane or polycarbonate, and derivatives thereof.

Images