CN111920460A

CN111920460A - Mixed-braiding plugging device

Info

Publication number: CN111920460A
Application number: CN202010716106.7A
Authority: CN
Inventors: 姜小飞; 阮成民; 姜亚伦; 梁玉麟
Original assignee: Guangdong Pulse Medical Technology Co ltd
Current assignee: Guangdong Pulse Medical Technology Co ltd
Priority date: 2020-07-23
Filing date: 2020-07-23
Publication date: 2020-11-13

Abstract

The invention provides a mixed knitting occluder in the field of medical apparatus and instruments, which aims to reduce the damage to human body caused by corrosion of the occluder on the premise of increasing the strength of the occluder, and comprises a support net structure, wherein the support net structure comprises: a first disk-shaped body; the second disc-shaped body is connected with the first disc-shaped body and is used for matching with the first disc-shaped body and clamping the patent opening of the oval hole; the first disc-shaped body and the second disc-shaped body are both composed of a plurality of first supporting wires and a plurality of second supporting wires, the first supporting wires are made of non-degradable materials, and the second supporting wires are made of degradable materials; the mixed knitting occluder can reduce the damage to the human body caused by corrosion of the occluder on the premise of increasing the strength of the occluder.

Description

Mixed-braiding plugging device

Technical Field

The invention relates to the field of medical devices, in particular to a mixed knitting plugging device.

Background

According to the results of medical investigation, a considerable proportion of people in the general population have congenital heart-lung organ defects, such as atrial septal defect ASD, ventricular septal defect VSD, patent foramen ovale PFO and the like, and in the past, for such diseases, external shell surgery is usually required, and the defect part is sutured, so that the surgery risk is high; with the development of interventional therapy technology in recent years, a therapy method for treating a patent foramen ovale PFO by an occluder is increasingly adopted.

In the prior art, two types of occluders are usually provided, one type of occluder is made of degradable materials, and the occluder can be slowly degraded in a human body after being implanted into the human body and does not need to be taken out again through an operation, but the degradable materials have poor mechanical properties and are easy to deform after being implanted into the human body; the other occluder is made of non-degradable materials such as metal wires and the like, can be corroded after a certain time in a human body, and can cause a series of complications after a long time, thereby causing secondary damage to patients.

Disclosure of Invention

The present invention is directed to solving at least one of the problems of the prior art. Therefore, the invention provides a mixed knitting occluder which can reduce the damage to a human body caused by corrosion of the occluder on the premise of increasing the strength of the occluder.

The mixed knitting plugging device comprises a supporting net structure, wherein the supporting net structure comprises: a first disk-shaped body; the second disc-shaped body is connected with the first disc-shaped body and is used for matching with the first disc-shaped body and clamping the patent opening of the oval hole; the first disc-shaped body and the second disc-shaped body are both composed of a plurality of first supporting wires and a plurality of second supporting wires, the first supporting wires are composed of non-degradable materials, and the second supporting wires are composed of degradable materials.

Further, the number ratio of the first supporting wires to the second supporting wires is 1:4-1: 1.

Further, the first support wire and the second support wire are arranged in a crossing manner.

Further, the plurality of first supporting wires and the plurality of second supporting wires are coaxial and distributed in a staggered mode along the circumferential direction.

Further, a gap is formed between every two adjacent first supporting wires, and the gap can accommodate a cylinder with the diameter of 5mm to pass through.

Further, the supporting net structure comprises an integrally formed supporting net body, and the supporting net body is composed of a plurality of first supporting wires and a plurality of second supporting wires.

Further, the support net structure comprises a first support net body and a second support net body which are arranged in a stacked mode, the first support net body is composed of a plurality of first support wires, and the second support net body is composed of a plurality of second support wires.

Further, the first supporting net body is positioned on the outer layer of the second supporting net body.

Further, a first diaphragm is arranged inside the first disk-shaped body, and/or a second diaphragm is arranged inside the second disk-shaped body.

Furthermore, two ends of the first supporting wire are respectively connected with the first seal head and the second seal head, two ends of the second supporting wire are respectively connected with the first seal head and the second seal head, the first seal head is provided with a seal cover, the seal cover is provided with a threaded hole, and the threaded hole is used for being connected with a guide wire of the conveyor.

When the mixed-braided occluder is used, the mixed-braided occluder can be implanted into the heart of a human body, so that the first disk-shaped body and the second disk-shaped body clamp the patent foramen ovale opening, and the occluder can perform occlusion work on a defect part at the moment; compared with the plugging device made of the non-degradable material in the prior art, as one part of the plugging device is gradually degraded and metabolized in the human body, the part which is likely to be corroded subsequently is greatly reduced, and the secondary damage to the human body caused by the complications caused by corrosion is effectively reduced.

Additional aspects and advantages of the invention will be set forth in part in the description which follows and, in part, will be obvious from the description, or may be learned by practice of the invention.

Drawings

The above and/or additional aspects and advantages of the present invention will become apparent and readily appreciated from the following description of the embodiments, taken in conjunction with the accompanying drawings of which:

fig. 1 is an isometric view of a hybrid occluder in an embodiment of the present invention;

FIG. 2 is a cross-sectional view of the hybrid occluder shown in FIG. 1;

FIG. 3 is an enlarged view taken at I in FIG. 2;

FIG. 4 is a schematic view of a first support screen body according to an embodiment of the present invention;

FIG. 5 is a schematic view of a second support screen body according to an embodiment of the present invention;

the above figures contain the following reference numerals.

Reference numerals	Name (R)
		100	Supporting net structure
110	First disk-shaped body
		120	Second disk-shaped body
130	First end socket
		131	Sealing cover
132	Threaded hole
		140	Second end socket
150	First support wire
		160	Second supporting wire
210	First diaphragm
		220	Second diaphragm

Detailed Description

Reference will now be made in detail to embodiments of the present invention, examples of which are illustrated in the accompanying drawings, wherein like or similar reference numerals refer to the same or similar elements or elements having the same or similar function throughout. The embodiments described below with reference to the accompanying drawings are illustrative only for the purpose of explaining the present invention, and are not to be construed as limiting the present invention.

In the description of the present invention, it should be understood that the orientation or positional relationship referred to in the description of the orientation, such as the upper, lower, front, rear, left, right, etc., is based on the orientation or positional relationship shown in the drawings, and is only for convenience of description and simplification of description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus, should not be construed as limiting the present invention.

In the description of the present invention, the meaning of a plurality of means is one or more, the meaning of a plurality of means is two or more, and more than, less than, more than, etc. are understood as excluding the present number, and more than, less than, etc. are understood as including the present number. If the first and second are described for the purpose of distinguishing technical features, they are not to be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated or implicitly indicating the precedence of the technical features indicated.

In the description of the present invention, unless otherwise explicitly limited, terms such as arrangement, installation, connection and the like should be understood in a broad sense, and those skilled in the art can reasonably determine the specific meanings of the above terms in the present invention in combination with the specific contents of the technical solutions.

Referring to fig. 1 to 5, a mixed braiding occluder includes a support net structure 100, the support net structure 100 includes: a first disk-shaped body 110; a second disk member 120, connected to the first disk member 110, for engaging with the first disk member 110 and holding the patent opening of the foramen ovale; the first and second disk-

shaped bodies

110 and 120 are each comprised of a plurality of first support filaments 150 and a plurality of second support filaments 160, the first support filaments 150 being comprised of a non-degradable material and the second support filaments 160 being comprised of a degradable material.

When the mixed-braided occluder of the embodiment is applied, the mixed-braided occluder can be implanted into a heart of a human body, so that the first disk-shaped body 110 and the second disk-shaped body 120 clamp the patent foramen ovale opening, and the occluder can perform occlusion work on a defect part at the moment; compared with the plugging device made of the non-degradable material in the prior art, as one part of the plugging device is gradually degraded and metabolized in the human body, the part which is likely to be corroded subsequently is greatly reduced, and the secondary damage to the human body caused by the complications caused by corrosion is effectively reduced.

It is particularly noted that the co-weaving in this embodiment refers to the mixing of degradable materials and non-degradable materials.

Referring to CN110432934A and other prior arts, the first supporting wire 150 may be made of various known non-degradable materials, such as nitinol, stainless steel, etc. commonly used in medical devices, or may also be made of non-metallic materials such as polycarbonate, polyethylene, etc.

Similarly, referring to CN201591648U and other prior arts, the second support wire 160 can also be made of various known degradable materials, such as polylactic acid (PLA), Polyglycolide (PGA), polydioxanone (pdo), Polycaprolactone (PCL), polygluconate (polyglyconate), polyhydroxybutyrate (polyhydroxybutyrate), polyanhydride (polyanhydride), polyphosphate (polyphosphoester), or a copolymer or blend of at least two of them; after being implanted into the human body, the second support wire 160 can be gradually degraded in the human body and metabolized out of the human body along with the normal metabolic process of the human body without being taken out by a secondary operation.

It is understood that the first and

second support wires

150 and 160 can be formed into the first and second disk-

shaped bodies

110 and 120 in various ways, such as weaving the first and

second support wires

150 and 160 into a support net, and arranging the support net into the shape as in CN101120893B, where the support net has a disk-shaped structure at both ends, one end being the first disk-shaped body 110 and the other end being the second disk-shaped body 120; it is also possible to weave one support net using the first support wires 150 and another support net using the second support wires 160, and to stack the two support nets and set them in the shape of CN101120893B such that the first disk-shaped body 110 and the second disk-shaped body 120 each have a portion where the two support nets are stacked.

As shown in fig. 1, in order to reduce the undegradable part as much as possible and reduce the secondary damage to the patient due to complications while ensuring the mechanical strength of the hybrid occluder, the ratio of the number of the first support wires 150 to the number of the second support wires 160 in the occluder is 1:4 at the lowest and 1:1 at the highest.

As shown in fig. 1, the first support wire 150 and the second support wire 160 are arranged crosswise; at this time, the plurality of first supporting wires 150 and the plurality of second supporting wires 160 may cross each other, so as to increase the interval between the first supporting wires 150 and the second supporting wires 160, and facilitate other surgical instruments to conveniently pass through the occluder.

As shown in fig. 1, the plurality of first supporting wires 150 and the plurality of second supporting wires 160 are coaxial and distributed in a staggered manner in the circumferential direction; at this time, the plurality of first supporting wires 150 are distributed around an axis circumference, and the plurality of second supporting wires 160 are distributed around the same axis, so that the axial compression resistance of the occluder can be effectively improved compared with the occluder woven by a warp and weft crossing method in the prior art.

As shown in fig. 1, a gap is formed between two adjacent first supporting wires 150, and the gap can accommodate a cylinder with the diameter of 5mm to pass through; after the second supporting wires 160 are degraded in a human body, a certain gap can be left between two adjacent first supporting wires 150, and the diameter of a sheath used by a general doctor for the interatrial puncture is not more than 5 mm; after the second supporting wire 160 is degraded in the human body, the doctor can directly pass the sheath through the gap between two adjacent first supporting wires 150 for operation without detaching the occluder.

As shown in fig. 1 to 3, in order to reduce the thickness of the support net structure 100, the support net structure 100 includes an integrally formed support net body composed of a plurality of first support wires 150 and a plurality of second support wires 160.

As shown in fig. 4 and 5, the supporting net structure 100 may include a first supporting net body and a second supporting net body, which are stacked, wherein the first supporting net body is composed of a plurality of first supporting wires 150, and the second supporting net body is composed of a plurality of second supporting wires 160; at this time, the first supporting net body and the second supporting net body can be respectively woven by adopting degradable materials and non-degradable materials, and then the first supporting net body and the second supporting net body are stacked and formed into a first disk-shaped body 110 and a second disk-shaped body 120; the process difficulty is effectively reduced.

Wherein, in order to facilitate the degradation of the degradable material in the human body, the first supporting net body is positioned at the outer layer of the second supporting net body; the first support net made of the degradable material is closer to human tissue, and the first support net can be degraded faster than the case when the second support net is placed on the outer layer.

As shown in fig. 2 and 3, two ends of a first supporting wire 150 are respectively connected with a first sealing head 130 and a second sealing head 140, two ends of a second supporting wire 160 are respectively connected with the first sealing head 130 and the second sealing head 140, a sealing cover 131 is arranged on the first sealing head 130, a threaded hole 132 is arranged on the sealing cover 131, and the threaded hole 132 is used for connecting a guide wire of a conveyor; at this time, the convex parts of the first end socket 130, on which the first supporting wire 150 and the second supporting wire 160 are fixed, are covered by the cover 131, so that the risk of thrombus formation at the convex parts by blood in the heart and harm to human bodies is effectively prevented; and the threaded hole 132 arranged on the cover 131 can be conveniently connected with the guide wire of the conveyor, so that the plugging device can be conveniently implanted in the heart.

As shown in fig. 1, in order to better assist the growth of the endothelium of the defect portion, a first membrane 210 is disposed inside the first disk body 110, and/or a second membrane 220 is disposed inside the second disk body 120; wherein, the first membrane 210 and the second membrane 220 can be made of degradable materials.

The embodiments of the present invention have been described in detail with reference to the accompanying drawings, but the present invention is not limited to the above embodiments, and various changes can be made within the knowledge of those skilled in the art without departing from the gist of the present invention.

Claims

1. A co-woven occluder comprising a support mesh structure (100), the support mesh structure (100) comprising:

a first disc-shaped body (110);

a second disk-shaped body (120) connected to the first disk-shaped body (110) for cooperating with the first disk-shaped body (110) and gripping the patent opening of the foramen ovale;

the first disk-shaped body (110) and the second disk-shaped body (120) are each composed of a plurality of first support filaments (150) and a plurality of second support filaments (160), the first support filaments (150) being composed of a non-degradable material and the second support filaments (160) being composed of a degradable material.

2. The hybrid occluder of claim 1, wherein the number ratio of said first support wires (150) to said second support wires (160) is 1:4-1: 1.

3. The hybrid occluder of claim 2, wherein said first support wire (150) and said second support wire (160) are arranged crosswise.

4. The hybrid occluder of claim 3, wherein a plurality of said first support wires (150) and a plurality of said second support wires (160) are coaxial and circumferentially staggered.

5. The hybrid occluder of claim 4, wherein adjacent two of said first support wires (150) have a gap therebetween, said gap being capable of receiving a cylindrical body having a diameter of 5mm therethrough.

6. The hybrid occluder of claim 1, wherein said support screen structure (100) comprises an integrally formed support screen body comprised of a plurality of said first support wires (150) and a plurality of said second support wires (160).

7. The co-woven occluder of claim 1, wherein said support screen structure (100) comprises a first support screen body and a second support screen body arranged in a stack, said first support screen body being comprised of a plurality of said first support wires (150) and said second support screen body being comprised of a plurality of said second support wires (160).

8. The hybrid occluder of claim 7, wherein the first support screen body is located on the outer layer of the second support screen body.

9. The hybrid plugging device according to claim 1, wherein two ends of the first support wire (150) are respectively connected with a first sealing head (130) and a second sealing head (140), two ends of the second support wire (160) are respectively connected with the first sealing head (130) and the second sealing head (140), the first sealing head (130) is provided with a sealing cover (131), the sealing cover (131) is provided with a threaded hole (132), and the threaded hole (132) is used for connecting a guide wire of a conveyor.

10. Hybrid occluder according to claim 1, wherein a first membrane (210) is arranged inside the first disk-shaped body (110) and/or a second membrane (220) is arranged inside the second disk-shaped body (120).