CN117017372A - Ball-expanded fully-degradable oval hole plugging device - Google Patents
Ball-expanded fully-degradable oval hole plugging device Download PDFInfo
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- CN117017372A CN117017372A CN202310887974.5A CN202310887974A CN117017372A CN 117017372 A CN117017372 A CN 117017372A CN 202310887974 A CN202310887974 A CN 202310887974A CN 117017372 A CN117017372 A CN 117017372A
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00004—(bio)absorbable, (bio)resorbable, resorptive
Abstract
The application relates to a ball-expanded fully-degradable foramen ovale occluder, which comprises a supporting framework, a flow blocking film and flow blocking villi; the support framework is made of a fully degradable metal-based material and has full developability, and comprises a central tube part with a through middle part and two plugging parts which are respectively and correspondingly positioned at two ends of the central tube part, wherein the two plugging parts can be expanded and turned outwards to form a disc-shaped structure; the choke film and choke fluff are made of fully degradable high polymer materials, the choke film is respectively coated on the outer sides of the plugging parts correspondingly, the middle part of the choke film is fixed in the central pipe part, and when the plugging parts are expanded and turned outwards to form a disk-shaped structure, the choke film is positioned on the opposite side surfaces of the two plugging parts; the choked flow fluff is arranged at the openings at the two ends of the central tube part; the full-degradable oval hole plugging device has full-developability under the characteristic of full degradation, so that the success rate of the operation is greatly improved, and the full-degradable oval hole plugging device can be preloaded on a conveying device through a central tube part in the operation process, so that the operation time is shortened.
Description
Technical Field
The application relates to the technical field of cardiac disease interventional operation equipment, in particular to a ball-expanded fully-degradable oval hole plugging device.
Background
Patent foramen ovale (patent foramen ovale, PFO) is a clinically common congenital heart disease, with PFO being present in about one-fourth of adults. More and more studies have shown that PFO represents a potential possibility to trigger a shunt from right to left, closely related to cryptogenic strokes (cryptogenic stroke, CS), while PFO intervention occlusion is effective in preventing recurrence of stroke events.
Interventional cardiology was originally initiated in 1974 by the first application of transcatheter atrial septal defect (atrial septal defect, ASD) occlusion, after which transcatheter non-operative treatment of endocardial defects was selected as one of the treatments for congenital heart disease. Although the understanding of PFO and cerebral embolism can be traced to the end of the 19 th century, diagnosis of a prenatal PFO was possible until the last 80 th century due to the development of ultrasound technology and the use of right heart sonography. In 1877 and 1880 Cohnheim and Litten et al describe so-called "triplets", i.e. deep venous thrombosis, patent foramen ovale and systemic embolism, respectively. The mechanism is presumed to be abnormal embolism, i.e., embolism caused by thrombus from the venous system passing through the patent foramen ovale to the arterial system.
Cryptogenic stroke accounts for 30% of stroke patients, and most are young, epidemiologically shows that PFO is associated with cryptogenic stroke. Investigation has shown that 80 ten thousand stroke patients annually in the united states, 70 of which are ischemic, 10-40% of which are cryptogenic, are now also known as unexplained embolic strokes (embolic stroke of undetermined source, esas), and approximately half of which have PFOs. In 2004, the first domestic application of occluders successfully closed PFO; in 2008, domestic Cardi-O-Fix occluders are approved by domestic patents, and PFO occlusion treatment in China has been rapidly developed. The report 2020 of cardiovascular health and disease in China shows that 313 local hospitals for carrying out interventional operation of the prior heart disease in China in 2019, 483 doctors, 39027 interventional treatment total number of the interventional treatment data of the prior heart disease, 6.32% of the total interventional treatment data in 2018, and 73.77% of the PFO number in 2018.
The great clinical need has led to widespread deployment of transcatheter PFO interventional occlusion procedures worldwide. Interventional occlusion surgery has become the first treatment method for congenital heart diseases such as atrial septal defect (VSD), patent foramen ovale, etc. The anatomical complexity of the ventricular septum and the heart conduction system determines that interventional instruments present greater challenges in treating ventricular septal defects than cardiac structures such as the atrial septum, the foramen ovale, etc. Even if the occluder is successfully released, there is still a risk of valve damage or atrioventricular block after surgery. In addition, most of the prior occluders implanted in interventional occlusion are nickel-titanium alloy occluders, which are easy to induce various postoperative complications such as conduction block. Postoperative complete atrioventricular block is the most serious complication of VSD occlusion treatment, with an incidence of about 0.6% -20%.
Various clinical research results show that the traditional metal alloy occluder has good curative effect, but has some adverse reactions and complications, such as deformation, erosion, perforation, residual shunt, allergy, hemolysis, arrhythmia, thrombosis, valve injury and the like of the occluder, which are related to non-degradability of the occluder. Therefore, an ideal plugging device which can be degraded after the endothelialization of plugging is designed to become a hot spot in academic circles.
The biodegradable material is a substitute for traditional biocompatible materials and non-biodegradable high polymer materials. The degradable polymers such as polylactic acid, polyglycolic acid, polycaprolactone and the like and the copolymers thereof have good biocompatibility, and are hot spots for the current human tissue engineering research. The degradable polymer biological material is completely degraded in vivo without the participation of special enzymes, is hydrolyzed into an oligomer through an unstable ester bond on a main chain, is further degraded into water-soluble micromolecules to enter body fluid, is phagocytized by macrophages, neutrophils and the like, or is decomposed into CO2 and water to be discharged out of the body through kidneys and lungs. The fully degradable plugging device with good biocompatibility is developed, so that the fully degradable plugging device is used as a bridge for guiding the growth of autologous tissues to fill defects, the intervention is implant-free, and the fully degradable plugging device is an important way for solving the delayed arrhythmia after the intervention plugging VSD operation and the problem to be solved urgently.
The biodegradable products which are put into clinical application are very rare or none, because a plurality of technical problems are not solved, wherein the biodegradable materials have no excellent shape memory property, mechanical property and the like of nickel-titanium alloy and the like, and the poor adhesion property of the biodegradable materials after implantation leads to side leakage so as to lead to unsuccessful plugging or falling off of the oval foramen, thereby causing operation failure or leading to more serious safety accidents.
Disclosure of Invention
Based on the above description, the present application provides solutions to the technical problems in the prior art.
The technical scheme for solving the technical problems is as follows:
a ball-expanding type fully-degradable foramen ovale occluder comprises a supporting framework, a flow blocking film and flow blocking velvet;
the support framework is made of a fully degradable metal-based material and has full developability, and comprises a central tube part with a through middle part and two plugging parts respectively and correspondingly positioned at two ends of the central tube part, wherein the two plugging parts can be expanded and everted to form a disc-shaped structure;
the choke film and choke fluff are made of fully degradable high polymer materials, the choke film is respectively correspondingly coated on the outer sides of the plugging parts, the middle part of the choke film is fixed in the central pipe part, and when the plugging parts are expanded and everted to form a disc-shaped structure, the choke film is positioned on the opposite side surfaces of the two plugging parts; the choked flow fine hair is arranged at the openings at the two ends of the central tube part.
Compared with the prior art, the technical scheme of the application has the following beneficial technical effects:
the ball-expanded fully-degradable oval hole plugging device provided by the application has the advantages that the supporting framework is made of fully-degradable metal base materials and has full-developability, the choke film and choke villus are made of fully-degradable high polymer materials, so that the whole oval hole plugging device has the full-developability under the fully-degradable characteristic, the success rate of operation is greatly improved, the plugging device can be preloaded on the conveying device through the central tube part in the operation process, the operation time is shortened, the plugging part of the supporting framework is contracted before being conveyed and is convenient to convey, and the plugging part can be expanded and everted to form a disc-shaped structure through external force after being conveyed in place, so that the oval hole wall is clamped, and the stability of the position of the plugging device after the operation is ensured.
On the basis of the technical scheme, the application can be improved as follows.
Further, the central tube part and the two plugging parts are formed by laser cutting of degradable zinc-based alloy tubes.
Further, the choke membrane and the choke fluff are woven or knitted by PDO (PDO) wires or PLLA (PLLA) wires.
Further, the central tube portion is internally formed with internal threads for removable connection to the outside of the catheter delivering the occluder.
Further, the sealing device further comprises a braiding layer, wherein the braiding layer is arranged on the choke film and used for enabling the choke film to be tightly attached to the plugging part.
Further, wherein the outer diameter of the expanded everting of the occlusion forming a disc shape is smaller than the outer diameter of the expanded everting of the other occlusion forming a disc shape.
Drawings
Fig. 1 is a schematic structural view of a shrinkage state of a balloon-expanded fully-degradable foramen ovale occluder according to an embodiment of the present application;
fig. 2 is a schematic structural view of an expanded state of a balloon-expanded fully-degradable foramen ovale occluder according to an embodiment of the present application;
fig. 3 is an implantation schematic diagram of a balloon-expanded fully degradable foramen ovale occluder provided by an embodiment of the present application;
fig. 4 is a schematic top view of fig. 2.
Detailed Description
In order that the application may be readily understood, a more complete description of the application will be rendered by reference to the appended drawings. Embodiments of the application are illustrated in the accompanying drawings. This application may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used herein in the description of the application is for the purpose of describing particular embodiments only and is not intended to be limiting of the application.
It will be appreciated that spatially relative terms such as "under … …," "under … …," "below," "under … …," "over … …," "above," and the like may be used herein to describe one element or feature's relationship to another element or feature as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use and operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements or features described as "under" or "beneath" other elements would then be oriented "on" the other elements or features. Thus, the exemplary terms "under … …" and "under … …" may include both an upper and a lower orientation. Furthermore, the device may also include an additional orientation (e.g., rotated 90 ° or other orientations) and the spatial descriptors used herein interpreted accordingly.
It will be understood that when an element is referred to as being "connected" to another element, it can be directly connected to the other element or be connected to the other element through intervening elements. In the following embodiments, "connected" is understood to mean "electrically connected", "communicatively connected", and the like, if the connected circuits, modules, units, and the like have electrical or data transferred therebetween.
As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" and/or "comprising," and/or the like, specify the presence of stated features, integers, steps, operations, elements, components, or groups thereof, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, or groups thereof.
Referring to fig. 1-4, an embodiment of the present application provides a balloon-expandable fully degradable foramen ovale occluder, comprising a support scaffold 110, a flow blocking membrane 120, and flow blocking villi 130.
The supporting framework 110 is made of a fully degradable metal-based material and has full developability, and includes a central tube portion 112 with a through middle portion and two blocking portions respectively corresponding to two ends of the central tube portion, where the two blocking portions can be expanded and everted to form a disc structure, so as to describe the two blocking portions respectively called a first blocking portion 111 and a second blocking portion 112, it can be understood that, in order to facilitate the delivery of the occluder in operation, the two blocking portions are in a contracted state as shown in a state of fig. 1 when the delivery device is not delivered in place, and when the delivery device is not delivered in place, the two blocking portions need to be expanded and everted to form a disc structure so as to clamp the oval hole wall, so in some embodiments, as shown in a state of fig. 3 and 2, the expansion of the two blocking portions can be driven by the inflation expansion of the external connection member (such as balloon inflation expansion) in such a manner of everting to adapt to the oval hole structures with different lengths, and the clamping force is larger and the firmness is stronger.
In the preferred embodiment of the present application, the central tube 112 and the two plugging portions are integrally formed, specifically, the central tube is formed by laser cutting a degradable zinc-based alloy tube, and the overall thickness of the support skeleton 110 formed by laser cutting a zinc-based alloy tube is thinner, which is beneficial to the climbing attachment of endothelial cells.
Specifically, the central tube 112 is through in the middle, and is internally threaded for adapting to external threads of the connector on the catheter of the conveying device, and the upper and lower ends of the central tube are cut into an open-loop fence structure, so that the central tube can be inflated and expanded by the balloon to form a middle waisted structure and can be turned up and down to be a double-disc structure.
The choke film 120 and the choke fluff 130 are made of fully degradable polymer materials, and in a preferred embodiment of the present application, the choke film and the choke fluff are woven or knitted by PDO threads or PLLA threads, which have fully degradable characteristics, wherein the choke film 120 is respectively wrapped on the outer side of the plugging portion and the middle portion is fixed in the central tube portion 112, and when the plugging portion is expanded and turned outwards to form a disc-shaped structure, the choke film 120 is located on opposite sides of the two plugging portions.
The choke fluff 130 is fixed at the openings at the two ends of the central tube 112 by bonding or hot melting, so that the blood flow can be effectively blocked without affecting the passage of a relatively small catheter or guide wire in the delivery device.
In a more preferred embodiment of the present application, the oval hole occluder further comprises a braid 140, wherein the braid 140 is disposed on the flow blocking film 120, so that the flow blocking film 120 is tightly adhered to the occluding portion.
Wherein, during the operation, the first blocking part 111 is located at the distal end of the delivery device (i.e. the end farther away from the operator), and is delivered into the left atrium after implantation, the second blocking part 113 is located at the proximal end of the delivery device, and because arterial blood is in the left atrium and flows to each organ, if the volume of the first blocking part 111 is too large, thrombus is easily accumulated, and the risk is very high, therefore, it is preferable that the outer diameter of the first blocking part 111 formed by expanding and everting is smaller than the outer diameter of the second blocking part 113 formed by expanding and everting.
Referring to fig. 3, the balloon expandable fully degradable foramen ovale occluder provided by the present application is specifically implanted by first penetrating a puncture sheath 300 through the foramen ovale, and then passing the pre-assembled occluder 100 and delivery assembly 200 (balloon-type expansion assembly in the present application) along a guidewire 400 and through the puncture sheath to a target lesion site; observing the developability of the instrument to judge the optimal release position, respectively using a pressure pump to inject developer to punch saccules positioned in the left atrium and the right atrium, forcing the two plugging parts to plastically deform and clamp the oval hole wall; finally, the balloon catheter is integrally rotated and withdrawn from the body after the balloon pressure is completely removed.
The balloon-expanded fully-degradable foramen ovale occluder provided by the application has the advantages that the supporting framework 110 is made of fully-degradable metal-based materials and has full developability, the choke film 120 and the choke fluff 130 are made of fully-degradable polymer materials, so that the whole foramen ovale occluder has full developability under the fully-degradable characteristic, the success rate of operation is greatly improved, the foramen ovale occluder can be preloaded on a conveying device through the central tube part 112 in the operation process, the operation time is shortened, the occluding part of the supporting framework is contracted before the conveying, is convenient to convey, can be expanded and everted to form a disc-shaped structure through external force after the conveying, further clamps the foramen ovale wall, ensures the stability of the position of the occluder after the operation, and the ideal degradable occlusion after the endothelialization of the occlusion effectively avoids adverse reactions and complications after the operation caused by the traditional metal alloy occluder, such as deformation, erosion, perforation, residual shunt, allergy, hemolysis, arrhythmia, thrombus formation, injury and the like of the occluder, which are in non-degradable relation with the occluder itself, and the non-intervention valve can be truly realized.
The foregoing description of the preferred embodiments of the application is not intended to limit the application to the precise form disclosed, and any such modifications, equivalents, and alternatives falling within the spirit and scope of the application are intended to be included within the scope of the application.
Claims (6)
1. The ball-expanded fully-degradable foramen ovale occluder is characterized by comprising a supporting framework, a flow blocking film and flow blocking villi;
the support framework is made of a fully degradable metal-based material and has full developability, and comprises a central tube part with a through middle part and two plugging parts respectively and correspondingly positioned at two ends of the central tube part, wherein the two plugging parts can be expanded and everted to form a disc-shaped structure;
the choke film and choke fluff are made of fully degradable high polymer materials, the choke film is respectively correspondingly coated on the outer sides of the plugging parts, the middle part of the choke film is fixed in the central pipe part, and when the plugging parts are expanded and everted to form a disc-shaped structure, the choke film is positioned on the opposite side surfaces of the two plugging parts; the choked flow fine hair is arranged at the openings at the two ends of the central tube part.
2. The balloon expandable fully degradable foramen ovale occluder of claim 1 wherein the central tube portion and the two occluding portions are laser cut from a degradable zinc-based alloy tube.
3. The balloon expandable fully degradable foramen ovale occluder of claim 1 wherein the flow blocking membrane and the flow blocking villi are woven or braided from PDO or PLLA threads.
4. The balloon expandable fully degradable foramen ovale occluder of claim 1 wherein the central tube portion is internally threaded for removable attachment to the outside of the catheter delivering the occluder.
5. The balloon expandable fully degradable foramen ovale occluder of claim 1, further comprising a braid disposed on the flow blocking film for tightly adhering the flow blocking film to the occlusion.
6. The balloon expandable fully degradable foramen ovale occluder of claim 1 wherein the outer diameter of the expanded eversion of the occluding portion forming a disc is less than the outer diameter of the expanded eversion of the other occluding portion forming a disc.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202310887974.5A CN117017372A (en) | 2023-07-18 | 2023-07-18 | Ball-expanded fully-degradable oval hole plugging device |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202310887974.5A CN117017372A (en) | 2023-07-18 | 2023-07-18 | Ball-expanded fully-degradable oval hole plugging device |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN117017372A true CN117017372A (en) | 2023-11-10 |
Family
ID=88634498
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202310887974.5A Pending CN117017372A (en) | 2023-07-18 | 2023-07-18 | Ball-expanded fully-degradable oval hole plugging device |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN117017372A (en) |
-
2023
- 2023-07-18 CN CN202310887974.5A patent/CN117017372A/en active Pending
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