Single-disc type barb plugging device

Abstract

The invention relates to the technical field of atrial septal defect plugging, and particularly discloses a single-disc type barb plugging device which is provided with a nickel-titanium mesh disc, a mesh disc connecting piece and at least one re-puncture channel, at least one barb is arranged in the circumferential direction of one end of the nickel-titanium mesh disc, the barb punctures first tissue and / or second tissue near the position needing plugging, and the re-puncture channel is communicated with the first tissue and / or the second tissue. The first tissue and the second tissue are close to a position needing to be plugged; the net disc connecting piece is arranged in the center of the nickel-titanium net disc and used for being connected with a conveying system; and the re-puncture channel is used for reserving a puncture channel or a conveying channel for a subsequent required atrial septum puncture interventional operation. The plugging device is not prone to falling off, a puncture channel or a conveying channel is reserved, the treatment pain and economic burden of a patient are relieved, the treatment success probability of the patient is greatly improved, and the structure has the advantages of being simple in design, high in practicability, easy and convenient to operate by a doctor, short in learning curve and low in safety risk.

Description

Technical Field

[0001] The present invention relates to the technical field of atrial septal defect occlusion, and particularly to a single-disk barbed occlusion device. Background Art

[0002] The statements in this section merely provide background art related to the disclosure of the present invention and do not necessarily constitute prior art.

[0003] Atrial septal defect (ASD) refers to a residual unclosed defect in the septum between the two atria during embryonic development, that is, there is a hole in the septum between the two atria. In the human body, the foramen ovale is one of the essential life channels for fetal development. Under normal circumstances, it will fuse and form a permanent atrial septum. However, if the foramen ovale remains unclosed after the age of 3, or there is a shunt at the atrial level, it is called Patent Foramen Ovale (PFO). Interventional occlusion surgery has become the preferred treatment method for congenital heart diseases such as ASD and PFO. It has the advantages of less trauma, no thoracotomy, extracorporeal circulation and other discomforts, fewer complications and high success rate, and has now been widely recognized and accepted.

[0004] Currently, the mainstream product in clinical practice is the traditional double-disk foramen ovale occluder, which has a double-disk structure (a left disk and a right disk that are symmetric left and right), and both are made of densely woven nickel-titanium alloy wires. With the wide development of ASD and PFO occlusion surgeries, the complications after ASD / PFO occlusion have attracted more and more attention. Occluder detachment or displacement, occluder abrasion of the heart, and thrombus formation are rare but serious complications after atrial septal occlusion. If a smaller-sized occluder with a smaller left and right disk surface is selected, the anchoring effect of the occluder is poor, resulting in occlusion detachment or displacement. If the foramen ovale is close to the superior or inferior vena cava or the main pulmonary artery, the edge of the occluder may abrade the blood vessel, leading to occlusion failure.

[0005] ASD and PFO are common congenital heart diseases, and most of the patients with ASD / PFO occlusion are young patients. As these patients age, the prevalence of diseases such as atrial fibrillation and mitral regurgitation is much higher than that of ordinary people. These concurrent diseases can be treated by minimally invasive interventional surgeries that puncture the atrial septum into the left atrium, such as radiofrequency ablation, mitral clip, left atrial appendage occlusion, etc. Existing conventional occluders are all of a densely woven structure. After occlusion, the left and right atria will be separated by 2-4 layers of densely woven metal meshes, and thickened hyperplastic tissues will be generated between the double disks. It is difficult to puncture the fossa ovalis, and it is extremely difficult to puncture the atrial septum again to send the sheath from the right atrium into the left atrium. The patient is very likely to lose this important interventional treatment channel of the atrial septum, and thus lose the opportunity for subsequent minimally invasive interventional treatment of diseases such as atrial fibrillation and mitral regurgitation.

[0006] To address these issues, degradable occluders and puncturable occluders have emerged. Degradable occluders such as BioSTAR, BioDisk, and MemoSorb have successively come out and been successfully applied in transcatheter interventional occlusion of ASD and PFO surgeries. The degradable occluder has achieved an upgrade from metal materials to degradable materials. It can not only fully play the role of a "temporary bridge" after implantation, but also its main structure can gradually degrade with the endothelialization process, ultimately completing autologous tissue repair, achieving "no residue after implantation", avoiding the potential complication risks brought by the lifelong presence of metal occluders in the body, and also leaving a safe passage for future interventional treatments such as transseptal puncture, bringing long-term health benefits and an improvement in the quality of life for patients. However, biodegradable occluders also have certain defects, such as not being visible under fluoroscopy, the risk of fragment embolism, thrombosis, and the elasticity of the material being far inferior to that of metal materials. After the sample is stretched and sent into the lesion in the body through the delivery sheath, it has a poor ability to resume into a double umbrella disc structure, and its shape is bulky and unable to effectively clamp the defect edge. The ReAces puncturable occluder maintains the basic structure and working principle of traditional atrial septal occluders. There is no metal object in the central area, and the metal content is greatly reduced compared with similar products, which can reduce metal-related side effects. At the same time, it can be easily punctured, reserving a passage for possible subsequent transseptal puncture interventional surgeries for patients. However, there are also risks similar to those of the double disc structure, such as insecure anchoring, displacement, or detachment, as well as the risk of inhomogeneous disintegration of the "channel covering film".

[0007] The following problems that urgently need to be solved exist in the prior art: First, the problem of direct detachment due to unreasonable anchoring design, structural design, and position of the occluder. Second, the problem that the atrial septal channel is blocked, resulting in the inability to carry out secondary interventional treatment. Summary of the Invention

[0008] To overcome the above deficiencies of the prior art, the present invention provides an occluder anchoring structure design different from the traditional I-shaped double disc. The single disc of the present invention is provided with 3 - 24 barbed structures for anchoring in the circumferential direction, and 1 - 4 re-puncture through holes are provided in the center of the single disc. The entire single disc is wrapped by a sealing film, and the occlusion device is connected to the delivery system through an intermediate mesh disc connector. After the delivery system sheath enters the right atrium, under the guidance of imaging, the occlusion device of the present invention is pushed to the anatomical position of ASD or PFO. Multiple barbs of the occlusion device can directly penetrate into the basal tissue inside ASD or PFO, so as to achieve the treatment effect of occlusion, which is a single disc barbed occlusion device.

[0009] The technical solution adopted by the present invention is: A single disc barbed occlusion device, the occlusion device having: A nitinol mesh disc, at least one barb is arranged on the circumference at one end of the nitinol mesh disc, and the barb penetrates the first tissue and / or the second tissue near the position to be occluded, for fitting and occluding the first tissue and the second tissue near the position to be occluded; and The nickel-titanium mesh disk connector is arranged at the central part of the nickel-titanium mesh disk and is used to connect with the delivery system to compress the occlusion device into the sheath and push it to the atrial septal defect site; and At least one re-puncture channel, which reserves a puncture channel or a delivery channel for subsequent atrial septal puncture interventional surgery as needed.

[0010] In this technical solution, the number of barbs is 3 - 24.

[0011] In this technical solution, the structure of the barb is one or a combination of arc-shaped barbs, straight barbs, and spiral barbs.

[0012] In this technical solution, a mesh disk film is wrapped outside the nickel-titanium mesh disk, and the mesh disk film and the nickel-titanium mesh disk form an integral structure through suture or one-piece molding.

[0013] In this technical solution, the nickel-titanium mesh disk is circular, oval, or square.

[0014] In this technical solution, the nickel-titanium mesh disk is a dense mesh single-disk structure processed from nickel-titanium alloy or nickel-titanium wire.

[0015] In this technical solution, the re-puncture channel is any one or a combination of circular, oval, semi-circular, semi-oval, two-leaf clover, three-leaf clover, four-leaf clover, and irregular or regular deformations of these shapes are also acceptable.

[0016] In this technical solution, the re-puncture channel can at least provide a sheath with an outer diameter of 2 - 12 mm to pass through.

[0017] In this technical solution, the number of re-puncture channels is 1 - 4.

[0018] In this technical solution, the material of the mesh disk film is one of poly-β-hydroxybutyric acid, polycaprolactone, polylactic acid, polyglycolide, poly-p-dioxanone, polybutylene succinate, lactide-caprolactone copolymer, polytetrafluoroethylene, expanded polytetrafluoroethylene, polyurethane, polyethylene terephthalate, polyvinyl alcohol, high-density polyethylene, hydrogel, thermoplastic polyurethane elastomer rubber.

[0019] Compared with the prior art, the beneficial effects of the present invention are: 1. At least one barb is arranged circumferentially at one end of the nickel-titanium mesh disk. The barb punctures the first tissue and / or the second tissue near the required occlusion position to fit and occlude the first tissue and the second tissue near the required occlusion position. The barb can quickly penetrate into the interior of the first tissue and the second tissue, thereby firmly anchoring the nickel-titanium mesh disk on the first tissue and the second tissue and being not easily detached.

[0020] 2. At least one of the re-puncture channels is provided at the middle position of the nickel-titanium mesh disk. The re-puncture channels reserve a puncture channel or a delivery channel for subsequent transseptal puncture interventional surgery as needed, thereby reserving a puncture and delivery channel for re-intervention for the patient, reducing the patient's treatment pain and economic burden, and greatly increasing the success probability of the treatment.

[0021] 3. The single-disk type of the present invention is provided with 3-24 barbed structures in the circumferential direction for anchoring, which greatly improves the sealing and anchoring effects and the endothelialization speed; at the same time, the entire single disk is wrapped by a sealing film, and 1-4 re-puncture through holes are provided in the center of the single disk to reserve a puncture and delivery channel for re-intervention for the patient.

[0022] A single-disk type barbed occlusion device of the present invention has a nickel-titanium mesh disk firmly anchored to the first tissue and the second tissue, and is not easily detached; a puncture channel or a delivery channel is reserved, reducing the patient's treatment pain and economic burden, and greatly increasing the success probability of the treatment. Moreover, the structure has a simple design, high practicability, simple and convenient operation for doctors, a short learning curve, and low safety risks. Brief Description of the Drawings

[0023] Figure 1 It is a projection schematic diagram of the occlusion device according to Embodiment 1 of the present invention; Figure 2 It is a schematic diagram of different barbs of the occlusion device of the present invention; Figure 3 It is a side view of the occlusion device of the present invention; Figure 4 It is a schematic diagram of the connection of the straight barbs of the occlusion device of the present invention; Figure 5 It is a schematic diagram of the connection of the arc barbs of the occlusion device of the present invention; Figure 6 It is a schematic diagram of the connection of the spiral barbs of the occlusion device of the present invention; Figure 7 It is a schematic diagram of a re-puncture channel of the occlusion device of the present invention; Figure 8 It is a projection schematic diagram of the occlusion device provided by the present invention anchored to an atrial septal defect; Figure 9 It is a projection schematic diagram of the occlusion device provided by the present invention anchored to a patent foramen ovale; Wherein: 1-nickel-titanium mesh disk, 2-barbs, 21-arc barbs, 22-straight barbs, 23-spiral barbs, 3-mesh disk connector, 4-re-puncture channel, 41-four-leaf re-puncture channel; 5-mesh disk film, 6-first tissue, 7-second tissue. Detailed Embodiments

[0024] Embodiments of the present invention will be described in detail below. Examples of the embodiments are shown in the accompanying drawings, where the same or similar reference numerals denote the same or similar elements or elements having the same or similar functions throughout. The embodiments described below with reference to the accompanying drawings are exemplary and are only used to explain the present invention and should not be construed as a limitation of the present invention.

[0025] In the description of the present invention, it should be understood that the orientation or positional relationships indicated by the terms "center", "upper", "lower", "front", "rear", "left", "right", etc. are based on the orientation or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the referred combination or element must have a specific orientation, be constructed and operated in a specific orientation, and thus should not be construed as a limitation of the present invention. In addition, during the description of the embodiments of the present invention, the positional relationships of "upper", "lower", "front", "rear", "left", "right", etc. of all the devices in the drawings are all Figure 1 the standard.

[0026] As Figure 8 and Figure 9 shown, a single-disk barbed occlusion device, characterized in that the occlusion device has a nitinol disk 1, barbs 2, a disk connector 3 and at least one re-puncture channel 4; specifically: at least one barb 2 is arranged circumferentially at one end of the nitinol disk 1, and the barb 2 punctures the first tissue 6 and / or the second tissue 7 near the position to be occluded, for fitting and occluding the first tissue 6 and the second tissue 7 near the position to be occluded; the disk connector 3 is arranged at the central part of the nitinol disk 1 and is used to connect with the delivery system to compress the occlusion device into the sheath and push it to the atrial septal defect site; the re-puncture channel 4 reserves a puncture channel or a delivery channel for subsequent atrial septal puncture intervention surgery as needed. The advantages of the single-disk barbed occlusion device of the present invention are as follows: the structure of the nitinol disk 1 is simple and has a large mesh design, reducing the metal content in the occlusion device, and the barbs are firmly anchored and endothelialize relatively quickly. After the occlusion device is implanted into the tissue gap, it can ensure that the puncture sheath and the delivery sheath can pass through the re-puncture channel 4 for puncture and establish a delivery channel, providing a safe channel for the subsequent treatment of the patient, and the barbs 2 can quickly penetrate into the interior of the first tissue 6 and the second tissue 7, thereby firmly anchoring the nitinol disk 1 on the first tissue 6 and the second tissue 7 and being not easily detached. Therefore, the occlusion device provided by the embodiment of the present application has the advantages of simple operation by doctors, short learning curve, high practicability and low safety risk.

[0027] As Figure 1As shown, the occlusion device includes a nitinol mesh disk 1, which is a single-disk form of a dense mesh structure made of nitinol alloy. There are 6 barbs 2 arranged in the circumferential direction of the single disk. In the central area of the single disk, there is a mesh disk connector 3 and 3 circular re-puncture channels 4. The mesh disk connector 3 is used to connect to the delivery system, compress the occlusion device into the sheath tube and push it to the atrial septal defect site. The re-puncture channel 4 reserves a channel for subsequent possible atrial septal puncture interventional procedures. The whole device is wrapped by a mesh disk film 5 to form an occlusion device. As Figure 8 shown, the 6 straight barbs 22 can quickly penetrate into the first tissue 6 and the second tissue 7, and then fasten and anchor the single disk on the first tissue 6 and the second tissue 7, making it not easy to fall off.

[0028] In some embodiments, the number of the barbs 2 is 3 - 24. As Figure 3 shown, the barbs protrude from the nitinol mesh disk 1 for puncturing and anchoring. In some other embodiments, the structure of the barb 2 is one or a combination of an arc-shaped barb 21, a straight barb 22, and a spiral barb 23. As Figure 2 shown, the structure of the barb 2 is a combination of an arc-shaped barb 21, a straight barb 22, and a spiral barb 23. Figure 3 This is an embodiment of a straight barb. Figure 4 This is an embodiment of an arc-shaped barb. Figure 5 This is an embodiment of a spiral barb. As Figure 2 shown, the number of barbs of the arc-shaped barb 21, the straight barb 22, and the spiral barb 23 can be 0 - 10. The barb 2 can be cut out from the connection point of the cross-connections of the nitinol mesh disk 1 and then processed to form an integral connection ( Figure 4 shown), or it can be welded at the cross-connection points of the nitinol mesh disk ( Figure 5 and Figure 6 shown).

[0029] In addition, in one implementation, a spiral barb 23 is adopted. This is because after the spiral structure penetrates into the first tissue 6 and the second tissue 7, the gap between the spirals will tightly hold the tissue, and the occlusion device will not fall off. In one implementation, a straight barb 22 with 2 rows of 4 barbs 2 is adopted. This type of straight barb 22 hooks the nearby tissues where the first tissue 6 and the second tissue 7 are penetrated retrogradely, so as to achieve the effect of stable anchoring. In another implementation, an arc-shaped barb 21 with 2 barbs 2 is adopted. After penetrating into the first tissue 6 and the second tissue 7, the occlusion device can only fall off when the arc-shaped structure becomes a straight shape. However, during the process of the arc-shaped structure becoming a straight shape, the tissue will be pulled, and conversely, the tissue will resist this deforming force, thereby preventing the deformation of the arc-shaped barb and achieving the anchoring effect.

[0030] In at least some embodiments, a mesh film 5 is wrapped around the outside of the nitinol mesh disk 1, with the barbs 2 exposed. The mesh film 5 and the nitinol mesh disk 1 are formed into an integral structure by suture or integrally molding. The mesh film 5 provides a blocking function, which is beneficial for the attachment of the blocking device to the tissue and has a relatively fast endothelialization rate. The material of the mesh film 5 can be a degradable material or a non-degradable material.

[0031] In some embodiments, the nitinol mesh disk 1 is circular, oval or square. In some embodiments, the nitinol mesh disk 1 is a dense mesh single disk structure processed from nitinol alloy or nitinol wire.

[0032] In some embodiments, the re-puncture channel 4 is any one or a combination of several of circular, oval, semi-circular, semi-oval, two-leaf clover, three-leaf clover, four-leaf clover, etc., as well as irregular or regular deformations of these shapes. In some embodiments, the re-puncture channel 4 can at least provide a sheath tube with an outer diameter of 2 - 12 mm to pass through. In some embodiments, the number of the re-puncture channels 4 is 1 - 4. In one implementation, a design with 3 circular re-puncture channels 4 is adopted. After the blocking device is completely endothelialized, the 3 re-puncture channels can provide three atrial septum puncture surgeries, such as pulsed ablation, left atrial appendage occlusion, etc. In another implementation, a design with 4 four-leaf clover-shaped re-puncture channels 41 is adopted ( Figure 7 as shown). After the blocking device is completely endothelialized, the 4 re-puncture channels can provide 4 atrial septum puncture surgeries, constructing puncture channels and delivery channels for subsequent re-treatment.

[0033] In some embodiments, the material of the mesh film 5 is a degradable material. The mesh film 5 is degraded and absorbed in the human body while providing a support structure and assisting endothelialization. The re-puncture channel 4 is covered by an endothelialized film to ensure the smoothness of the re-puncture channel 4. Degradable materials include, but are not limited to, at least one of a series of copolymers such as poly-4-hydroxybutyric acid, polycaprolactone, polylactic acid, polyglycolide, poly-p-dioxanone, polybutylene succinate, and lactide-caprolactone copolymer. In some implementations, the material of the mesh film 5 is a non-degradable material. Non-degradable materials include, but are not limited to, at least one of polytetrafluoroethylene, expanded polytetrafluoroethylene, polyurethane, polyethylene terephthalate, polyvinyl alcohol, high-density polyethylene, hydrogel, and thermoplastic polyurethane elastomer rubber. The mesh film 5 made of these non-degradable materials can be easily punctured by a puncture sheath tube, and then a puncture and delivery channel can be successfully established. The blocking device is used to block atrial septal defects, as Figure 8 shown. In some implementations, the defect can also be other defects, such as patent foramen ovale ( Figure 9 shown), ventricular septal defect, patent ductus arteriosus, etc.

[0034] Another embodiment different from the above-described embodiments is as follows: The occlusion device includes a nitinol mesh disk 1, which is a single-disk form of a dense mesh structure woven from nitinol wires. Twelve spiral barbs 23 are welded in the circumferential direction around the single disk. A disk connector 3 and two oval re-puncture channels 4 are provided in the central area of the single disk. The two oval re-puncture channels 4 can provide passage for an 18F sheath for mitral valve repair surgery. The disk connector 3 is used to connect to the delivery system, for compressing the occlusion device into the sheath and pushing it to the atrial septal defect site. The entire device is wrapped with a disk coating film 5 made of polyvinyl alcohol on the occlusion device. As Figure 9 shown, the twelve spiral barbs 23 can quickly penetrate into the interior of the first tissue 6 and the second tissue 7, thereby firmly anchoring the entire single disk to the first tissue 6 and the second tissue 7, and thus achieving the purpose of treating patent foramen ovale.

[0035] Another embodiment different from the above-described embodiments is as follows: The occlusion device includes a nitinol mesh disk 1, which is a dense mesh single-disk structure processed from nitinol alloy. Ten arc barbs 21 are welded in the circumferential direction of the single disk. A disk connector 3 and two re-puncture channels 4 are provided in the central area of the single disk. For the two re-puncture channels 4, one can provide passage for an 8F sheath, and the other can provide passage for an 18F sheath, enabling different re-interventional surgical methods to be carried out through different re-puncture channels 4. The disk connector 3 is used to connect to the delivery system, for compressing the occlusion device into the sheath and pushing it to the atrial septal defect site. The entire device is wrapped with a disk coating film 5 made of polylactic acid on the occlusion device. After the endothelialization of the occlusion device, the disk coating film 5 is gradually degraded and absorbed. As Figure 9 shown, the ten arc barbs 21 can quickly penetrate into the interior of the first tissue 6 and the second tissue 7, thereby firmly anchoring the entire single disk to the first tissue 6 and the second tissue 7, and thus achieving the purpose of treating patent foramen ovale.

[0036] The disclosed embodiments of the present invention are preferred embodiments, but are not limited thereto. Those of ordinary skill in the art can easily understand the spirit of the present invention based on the above embodiments and make different extensions and changes. However, as long as they do not depart from the spirit of the present invention, they are within the protection scope of the present invention.

Claims

1. A single-disk barbed plugging device, characterized in that The plugging device has: a nitinol mesh disk (1), at least one barb (2) is arranged on the circumference at one end of the nitinol mesh disk (1), and the barb (2) punctures the first tissue (6) and / or the second tissue (7) near the required plugging position for fitting and plugging the first tissue (6) and the second tissue (7) near the required plugging position; and a mesh disk connecting piece (3), the mesh disk connecting piece (3) is arranged at the central part of the nitinol mesh disk (1) and is used for connecting with a delivery system to compress the plugging device into the sheath and push it to the atrial septal defect site; and at least one re-puncture channel (4), the re-puncture channel (4) reserves a puncture channel or a delivery channel for subsequent atrial septal puncture interventional surgery if needed.

2. The single-disk barbed plugging device according to claim 1, wherein: The number of the barbs (2) is 3 - 24.

3. The single-disk barbed plugging device according to claim 2, characterized in that: The structure of the barb (2) is one or a combination of an arc-shaped barb (21), a straight barb (22), and a spiral shape (23).

4. A single-disk barbed plugging device according to claim 1, characterized in that: A mesh disk film (5) is wrapped outside the nitinol mesh disk (1), and the mesh disk film (5) and the nitinol mesh disk (1) form an integral structure by sewing or integrally molding.

5. The single-disk barbed plugging device according to claim 4, characterized in that: The nitinol mesh disk (1) is circular, oval, or square.

6. The single-disk barbed plugging device according to claim 5, wherein: The nitinol mesh disk (1) is a dense mesh single-disk structure made of nitinol alloy or nitinol wire.

7. A single-disk barbed plugging device according to claim 1, characterized in that: The re-puncture channel (4) is any one or a combination of circular, oval, semi-circular, semi-oval, two-leaf clover shape, three-leaf clover shape, and four-leaf clover shape.

8. A single-disk barbed plugging device according to claim 7, characterized in that: The re-puncture channel (4) can at least provide a sheath with an outer diameter of 2 - 12 mm to pass through.

9. The single-disk barbed plugging device according to claim 8, wherein: The number of the re-puncture channels (4) is 1 - 4.

10. A single-disk barbed plugging device according to any one of claims 4-9, characterized in that: The material of the mesh disk film (5) is one of poly-4-hydroxybutyric acid, polycaprolactone, polylactic acid, polyglycolide, poly-p-dioxanone, polybutylene succinate, lactide-caprolactone copolymer, polytetrafluoroethylene, expanded polytetrafluoroethylene, polyurethane, polyethylene terephthalate, polyvinyl alcohol, high-density polyethylene, hydrogel, and thermoplastic polyurethane elastomer rubber.

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