CN117958893A - Vascular occlusion device and molding process thereof - Google Patents
Vascular occlusion device and molding process thereof Download PDFInfo
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- CN117958893A CN117958893A CN202410272723.0A CN202410272723A CN117958893A CN 117958893 A CN117958893 A CN 117958893A CN 202410272723 A CN202410272723 A CN 202410272723A CN 117958893 A CN117958893 A CN 117958893A
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- filaments
- occlusion device
- vascular
- skeleton
- vascular occlusion
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- 206010053648 Vascular occlusion Diseases 0.000 title claims abstract description 45
- 208000021331 vascular occlusion disease Diseases 0.000 title claims abstract description 45
- 238000000034 method Methods 0.000 title claims abstract description 13
- 238000000465 moulding Methods 0.000 title abstract description 7
- 238000007789 sealing Methods 0.000 claims abstract description 26
- 239000000463 material Substances 0.000 claims abstract description 8
- 238000007731 hot pressing Methods 0.000 claims abstract description 4
- 239000012781 shape memory material Substances 0.000 claims description 6
- 239000002861 polymer material Substances 0.000 claims description 5
- 229920001343 polytetrafluoroethylene Polymers 0.000 claims description 5
- 239000004810 polytetrafluoroethylene Substances 0.000 claims description 5
- 239000012528 membrane Substances 0.000 claims description 4
- 229910001000 nickel titanium Inorganic materials 0.000 claims description 3
- 230000002792 vascular Effects 0.000 abstract description 28
- 230000000694 effects Effects 0.000 abstract description 5
- 239000007943 implant Substances 0.000 abstract 1
- 210000004204 blood vessel Anatomy 0.000 description 6
- 208000005189 Embolism Diseases 0.000 description 2
- 206010028980 Neoplasm Diseases 0.000 description 2
- 230000006978 adaptation Effects 0.000 description 2
- 230000000740 bleeding effect Effects 0.000 description 2
- 230000010102 embolization Effects 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 229910001285 shape-memory alloy Inorganic materials 0.000 description 2
- 210000000952 spleen Anatomy 0.000 description 2
- 210000001519 tissue Anatomy 0.000 description 2
- -1 Polytetrafluoroethylene Polymers 0.000 description 1
- 230000002159 abnormal effect Effects 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000036770 blood supply Effects 0.000 description 1
- 239000000919 ceramic Substances 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 230000002779 inactivation Effects 0.000 description 1
- 230000006386 memory function Effects 0.000 description 1
- 210000000056 organ Anatomy 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 230000004614 tumor growth Effects 0.000 description 1
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Abstract
The application provides a vascular occlusion device and a molding process thereof, and relates to the technical field of medical appliances. The vascular occlusion device comprises a framework and a sealing film, wherein the framework comprises a plurality of filaments, the first ends of the filaments are connected together, the second ends of the filaments are sequentially arranged in the circumferential direction, and the second ends of the filaments can be folded inwards or opened outwards; in the open state, cavities are formed in the inner sides of the filaments, and gaps are formed between adjacent filaments; a sealing film overlies the backbone and closes the interstices between adjacent filaments. The molding process comprises the following steps: carving the bar material to form skeleton of the vascular plugging device, and hot pressing the sealing film onto the skeleton. The vascular plugging device provided by the application can completely plug the section of the vascular cavity, achieves a good plugging effect, and can achieve the plugging purpose by implanting the vascular plugging device with a similar diameter no matter the diameter of the target vascular cavity, without multiple implants, thereby simplifying the operation.
Description
Technical Field
The application relates to the technical field of medical instruments, in particular to a vascular occlusion device and a molding process thereof.
Background
Transcatheter vascular embolization is a common therapeutic modality that treats disease by mechanically occluding the normal lumen or abnormal passage of a blood vessel. For example, palliative embolism treatment in which a tumor blood vessel is blocked to block blood supply to tumor tissue and thereby inhibit growth of tumor tissue, organ inactivation in which a part of spleen tissue is necrotized and absorbed to treat spleen hyperfunction and the like is blocked, blood vessels in which bleeding is ruptured to treat and control bleeding caused by various causes is blocked, and the like.
At present, a spring ring is used as a plugging device for transcatheter vascular embolism. The spring ring has the possibility of incomplete plugging, so that the flowing objects in the blood vessel cavity still circulate, a good plugging effect cannot be achieved, and when some blood vessel cavities with larger diameters are plugged, a plurality of spring rings are implanted for multiple times, so that the operation is very complicated.
In view of this, it is a technical problem that needs to be solved by those skilled in the art how to improve the occlusion device for vascular embolization.
Disclosure of Invention
In order to solve the technical problems, the application provides a vascular occlusion device, which comprises a framework and a sealing film, wherein the framework comprises a plurality of filaments, the first ends of the filaments are connected together, the second ends of the filaments are sequentially arranged in the circumferential direction, and the second ends of the filaments can be folded inwards or unfolded outwards; in the open state, a cavity is formed inside each filament, and a gap is formed between adjacent filaments; the sealing film overlies the backbone and closes the interstices between adjacent filaments.
In one embodiment of the vascular occlusion device, the scaffold is a shape memory material.
In one embodiment of the vascular occlusion device, the shape memory material comprises a nickel titanium alloy.
In one embodiment of the vascular occlusion device, the sealing film is coated on one side of the skeleton close to the cavity and one side of the skeleton far from the cavity.
In one embodiment of the vessel plugging device, the sealing film is made of a polymer material.
In one embodiment of the vessel occlusion device, the polymeric material comprises PTFE.
In one embodiment of the vessel occlusion device, the diameter of the scaffold in the expanded state increases gradually from the first end to the second end.
In one embodiment of the vascular occlusion device, said second end of each of said filaments is provided with a straight section, said straight sections of each of said filaments being parallel to each other.
In one embodiment of the vessel plugging device, the skeleton comprises connectors, the first ends of the filaments are connected around the connectors, and the connectors are in a circular ring structure, a cylindrical structure or a disc structure.
The application also provides a forming process of the vascular occlusion device, wherein the vascular occlusion device is any one of the vascular occlusion devices, and the forming process comprises the following steps:
carving the bar material to prepare the skeleton of the vascular occlusion device;
and hot-pressing a sealing film on the framework.
The application has the technical effects that:
After each filament of the vascular plugging device provided by the application is opened in the vascular cavity, the maximum diameter area of the vascular plugging device is abutted against the vascular wall, and the sealing film seals the gap between the adjacent filaments, so that the section of the vascular cavity is completely plugged, and the flow in the vascular cavity cannot pass through the vascular plugging device to continue flowing, thereby achieving good plugging effect.
Moreover, the vascular plugging device provided by the application can be designed into different specifications, and the maximum diameters of the vascular plugging devices with different specifications after being opened are different, so that the plugging purpose can be achieved by implanting one vascular plugging device with similar diameters no matter the diameters of target vascular cavities during use, and the vascular plugging device does not need to be implanted for multiple times, thereby simplifying operation.
Drawings
FIG. 1 is a front view of one embodiment of a vascular occlusion device provided by the present application;
FIG. 2 is a top view of FIG. 1;
fig. 3 is a front view of another embodiment of a vascular occlusion device according to the present application;
FIG. 4 is a top view of another embodiment of a vascular occlusion device according to the present application;
fig. 5 is a schematic illustration of a delivery system delivering a vascular occlusion device.
The reference numerals are explained as follows:
1 skeleton, 11 filaments, 11a straight section, 12 connectors, 2 sealing films, 3 guide wires, 4 guide pipes, 5Y valves and 6 chucks.
Detailed Description
In order to better understand the aspects of the present application, the present application will be described in further detail with reference to the accompanying drawings and detailed description.
As shown in fig. 1 to 4, the vascular occlusion device provided by the application comprises a framework 1 and a sealing membrane 2.
Wherein the skeleton 1 comprises a plurality of filaments 11, a first end (lower end in fig. 1) of each filament 11 is connected together, and a second end (upper end in fig. 1) of each filament 11 is arranged in sequence in a circumferential direction, and the second ends of each filament 11 can be folded inwards or unfolded outwards. In the expanded state, the inside of each filament 11 forms a cavity, and a gap is formed between adjacent filaments 11.
Wherein, a sealing film 2 is covered on the framework 1, and the sealing film 2 seals the gap between adjacent filars 11.
As shown in fig. 5, when in use, the above-mentioned vascular occlusion device can be delivered into a vascular lumen by means of a delivery system, when the position to be occluded is reached, the delivery system releases the vascular occlusion device, after the release, each filament 11 of the vascular occlusion device expands in the vascular lumen, after the expansion, the maximum diameter area of the vascular occlusion device abuts against the vascular wall, and as the sealing film 2 seals the gap between the adjacent filaments 11, the cross section of the vascular lumen is completely occluded, and the flow in the vascular lumen cannot continue to flow through the vascular occlusion device, thereby achieving a good occlusion effect.
Moreover, the vascular occlusion device can be designed into different specifications, and the maximum diameters of the vascular occlusion devices with different specifications after being opened are different, so that the vascular occlusion device with similar diameters can be implanted to achieve the occlusion purpose no matter the diameters of target vascular cavities, and the vascular occlusion device does not need to be implanted for multiple times, thereby simplifying operation.
It should be noted that the present application is not limited to the structure of the delivery system. For example, the delivery system shown in fig. 5 may be employed, the delivery system shown in fig. 5 comprising a guidewire 3, a catheter 4, a Y-valve 5 and a collet 6, the collet 6 being disposed at one end of the guidewire 3, the first end of the vascular occlusion device being gripped by the collet 6.
More specifically, the number of filaments 11 is preferably not less than three, and the number of filaments 11 may be configured according to the maximum diameter of the vessel occlusion device after opening, and the larger the maximum diameter of the vessel occlusion device after opening, the larger the number of filaments 11 to be configured. For example, the maximum diameter of the vascular occlusion device after opening in the embodiment shown in fig. 4 is larger than the maximum diameter of the vascular occlusion device after opening in the embodiment shown in fig. 2, eight filaments 11 are provided in the embodiment shown in fig. 4, and six filaments 11 are provided in the embodiment shown in fig. 2.
More specifically, the skeleton 1 is made of a shape memory material. Therefore, after the vascular occlusion device is released at the position to be occluded, the vascular occlusion device can be opened by self by virtue of the memory function of the material, and the vascular occlusion device does not need to be opened by external force, thereby being more beneficial to simplifying operation.
More specifically, the shape memory material includes a memory alloy, a memory ceramic, and the like. The memory alloy is preferably a nickel titanium alloy.
More specifically, the side of the skeleton 1 close to the cavity and the side far from the cavity are both covered with sealing films 2. In this way, on the one hand, reliable sealing can be ensured, and on the other hand, the filaments 11 can be clamped between the sealing films 2 on the two sides, so that the damage of the sharp filaments 11 to the blood vessel is avoided.
More specifically, the sealing film 2 is made of a polymer material. The polymer material not only has good sealing property, but also can be deformed adaptively along with the opening and closing of the filament 11, so that the opening and closing of the filament 11 is not affected.
More specifically, the polymer material includes PTFE (Polytetrafluoroethylene). PTFE materials are relatively low cost and are relatively easy to cover on the carcass 1.
More specifically, after the filament 11 is opened, the diameter of the skeleton 1 gradually increases from the first end (lower end in fig. 1) to the second end (upper end in fig. 1), so that the vascular occlusion device is tapered as a whole, and the maximum diameter region of the vascular occlusion device is located at the second end (upper end in fig. 1). Thus, the vascular occlusion device is easier to process and shape, and is more convenient to take out from the vascular cavity
More specifically, the second end (upper end in fig. 1) of each filament 11 is provided with a straight section 11a, and the straight sections 11a of each filament 11 are parallel to each other. Thus, after the filament 11 is opened, the straight section 11a abuts against the vessel wall, and the contact area with the vessel wall is large, so that the position is more stable.
More specifically, the skeleton 1 may further include a connecting body 12. The first end (lower end in fig. 1) of the filament 11 is attached around the connecting body 12. In this way, the first ends (lower ends in fig. 1) of the filaments 11 can be firmly connected together, not easily broken, and the connector 12 can also provide a gripping basis for the gripping head 6 of the delivery system.
More specifically, the connecting body 12 may have a disc structure (as shown in fig. 1 and 2), a cylindrical structure (as shown in fig. 3), or a ring structure (as shown in fig. 4). When the connecting body 12 has a circular ring structure, the inner space of the circular ring structure is also closed by the sealing film 2.
The application also provides a molding process of the vascular occlusion device, wherein the vascular occlusion device is the vascular occlusion device in any embodiment, and the molding process comprises the following steps: carving the bar material to prepare a framework 1 of the vascular plugging device; the sealing film 2 is hot-pressed on the frame 1. More specifically, a laser may be used to engrave the bar. The engraving process can ensure the precision, and the hot pressing fixation can ensure the fixation reliability.
The foregoing has outlined the principles and embodiments of the present application in order that the detailed description of the application may be better understood. It should be noted that it will be apparent to those skilled in the art that various modifications and adaptations of the application can be made without departing from the principles of the application and these modifications and adaptations are intended to be within the scope of the application as defined in the following claims.
Claims (10)
1. A vascular occlusion device, characterized by comprising a skeleton (1) and a sealing membrane (2), wherein the skeleton (1) comprises a plurality of filaments (11), first ends of the filaments (11) are connected together, second ends of the filaments (11) are sequentially arranged in the circumferential direction, and the second ends of the filaments (11) can be folded inwards or outwards; in the open state, a cavity is formed inside each filament (11), and a gap is formed between adjacent filaments (11); the sealing film (2) covers the skeleton (1) and closes the gap between adjacent filaments (11).
2. Vessel occlusion device according to claim 1, characterized in that the skeleton (1) is made of a shape memory material.
3. The vascular occlusion device of claim 2, wherein said shape memory material comprises a nickel titanium alloy.
4. Vessel occlusion device according to claim 1, characterized in that the side of the skeleton (1) close to the cavity and the side remote from the cavity are both covered with the sealing membrane (2).
5. Vessel occlusion device according to claim 1, characterized in that the sealing membrane (2) is made of a polymer material.
6. The vascular occlusion device of claim 5, wherein said polymeric material comprises PTFE.
7. Vessel occlusion device according to claim 1, characterized in that in the expanded state the diameter of the skeleton (1) increases gradually from the first end towards the second end.
8. Vessel occlusion device according to claim 7, characterized in that said second end of each filament (11) is provided with a straight section (11 a), said straight sections (11 a) of each filament (11) being parallel to each other.
9. Vascular occlusion device according to any of claims 1-8, characterised in that said skeleton (1) comprises connectors (12), said first end of each of said filaments (11) being connected around said connectors (12), said connectors (12) being of circular, cylindrical or disc configuration.
10. A process for forming a vascular occlusion device according to any one of claims 1 to 9, wherein the process comprises:
engraving the bar material to form the skeleton (1) of the vessel plugging device;
And (3) hot-pressing the sealing film (2) on the framework (1).
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202410272723.0A CN117958893A (en) | 2024-03-11 | 2024-03-11 | Vascular occlusion device and molding process thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202410272723.0A CN117958893A (en) | 2024-03-11 | 2024-03-11 | Vascular occlusion device and molding process thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN117958893A true CN117958893A (en) | 2024-05-03 |
Family
ID=90859560
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202410272723.0A Pending CN117958893A (en) | 2024-03-11 | 2024-03-11 | Vascular occlusion device and molding process thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN117958893A (en) |
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2024
- 2024-03-11 CN CN202410272723.0A patent/CN117958893A/en active Pending
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