CN116077125B - Left auricle plugging device - Google Patents
Left auricle plugging device Download PDFInfo
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- CN116077125B CN116077125B CN202310045944.XA CN202310045944A CN116077125B CN 116077125 B CN116077125 B CN 116077125B CN 202310045944 A CN202310045944 A CN 202310045944A CN 116077125 B CN116077125 B CN 116077125B
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- atrial appendage
- left atrial
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- 238000004873 anchoring Methods 0.000 claims abstract description 42
- 210000005248 left atrial appendage Anatomy 0.000 claims abstract description 31
- 239000013013 elastic material Substances 0.000 claims abstract description 4
- 229910001000 nickel titanium Inorganic materials 0.000 claims description 13
- 239000012528 membrane Substances 0.000 claims description 6
- 239000000463 material Substances 0.000 claims description 5
- 239000000956 alloy Substances 0.000 claims description 4
- 229920001296 polysiloxane Polymers 0.000 claims description 4
- HLXZNVUGXRDIFK-UHFFFAOYSA-N nickel titanium Chemical compound [Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni] HLXZNVUGXRDIFK-UHFFFAOYSA-N 0.000 claims description 3
- 238000004891 communication Methods 0.000 claims description 2
- 229920005597 polymer membrane Polymers 0.000 claims description 2
- ZZUFCTLCJUWOSV-UHFFFAOYSA-N furosemide Chemical compound C1=C(Cl)C(S(=O)(=O)N)=CC(C(O)=O)=C1NCC1=CC=CO1 ZZUFCTLCJUWOSV-UHFFFAOYSA-N 0.000 claims 1
- 239000007788 liquid Substances 0.000 abstract description 6
- 238000000465 moulding Methods 0.000 abstract description 2
- 239000010408 film Substances 0.000 description 7
- 230000000903 blocking effect Effects 0.000 description 4
- 206010003658 Atrial Fibrillation Diseases 0.000 description 3
- 239000013039 cover film Substances 0.000 description 3
- 210000004379 membrane Anatomy 0.000 description 3
- 230000001105 regulatory effect Effects 0.000 description 3
- 208000007536 Thrombosis Diseases 0.000 description 2
- 230000017531 blood circulation Effects 0.000 description 2
- 230000006870 function Effects 0.000 description 2
- 238000000034 method Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 229920006254 polymer film Polymers 0.000 description 2
- 208000028399 Critical Illness Diseases 0.000 description 1
- 208000005189 Embolism Diseases 0.000 description 1
- HZEWFHLRYVTOIW-UHFFFAOYSA-N [Ti].[Ni] Chemical compound [Ti].[Ni] HZEWFHLRYVTOIW-UHFFFAOYSA-N 0.000 description 1
- 206010003119 arrhythmia Diseases 0.000 description 1
- 230000006793 arrhythmia Effects 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 238000009954 braiding Methods 0.000 description 1
- 210000000038 chest Anatomy 0.000 description 1
- 230000004087 circulation Effects 0.000 description 1
- 230000006835 compression Effects 0.000 description 1
- 238000007906 compression Methods 0.000 description 1
- 238000004132 cross linking Methods 0.000 description 1
- 239000003292 glue Substances 0.000 description 1
- 230000004217 heart function Effects 0.000 description 1
- 238000009998 heat setting Methods 0.000 description 1
- 230000001771 impaired effect Effects 0.000 description 1
- 238000003698 laser cutting Methods 0.000 description 1
- 239000007769 metal material Substances 0.000 description 1
- 210000003516 pericardium Anatomy 0.000 description 1
- 229920000642 polymer Polymers 0.000 description 1
- 239000002861 polymer material Substances 0.000 description 1
- -1 polytetrafluoroethylene Polymers 0.000 description 1
- 229920001343 polytetrafluoroethylene Polymers 0.000 description 1
- 239000004810 polytetrafluoroethylene Substances 0.000 description 1
- 210000000115 thoracic cavity Anatomy 0.000 description 1
- 210000001519 tissue Anatomy 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
- A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/12136—Balloons
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00831—Material properties
- A61B2017/00867—Material properties shape memory effect
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B2017/1205—Introduction devices
- A61B2017/12054—Details concerning the detachment of the occluding device from the introduction device
Landscapes
- Health & Medical Sciences (AREA)
- Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Vascular Medicine (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Reproductive Health (AREA)
- Medical Informatics (AREA)
- Molecular Biology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
Abstract
The invention provides a left auricle occluder, which comprises a covering piece, an adjusting piece and an anchoring piece; the covering piece is used for covering the left auricle in a fitting way; one end of the adjusting piece is connected with the covering piece, and the other end of the adjusting piece is connected with the anchoring piece; the anchoring piece is made of elastic materials, can expand or contract, is provided with an anchoring structure on the outer surface and a cavity in the anchoring structure, and is used for anchoring and fixing the occluder on the inner wall of the left atrial appendage. The invention has simple structure and convenient use, and can adjust the molding state of the anchoring piece by adjusting the amount of injected liquid, and can completely seal the left auricle only by finishing the stable anchoring of the anchoring piece, thus being applicable to the inner cavity structure of the left auricle in various forms.
Description
Technical Field
The invention belongs to the technical field of medical instruments, and particularly relates to a left auricle occluder.
Background
Atrial fibrillation is the most common arrhythmia in clinic, the incidence rate of which is 1.0% -1.5%, and the incidence rate increases with age. Atrial fibrillation can cause the heart function of a patient to be impaired, and can also induce thrombosis, severely affecting quality of life. Because of the unique position relation of the left auricle and the characteristic of independent functions, researchers propose that the left auricle can be closed or removed by methods such as surgical operation, thoracic minimally invasive operation, interventional instrument blocking and the like, and embolism of patients suffering from atrial fibrillation is prevented. However, the surgical method of occlusion or excision of the left auricle is generally performed only simultaneously with the thoracotomy, and the patient is difficult to receive the simple left auricle excision or closure, especially for the elderly or critically ill patients. The interventional left auricle closure operation has small wound, does not need chest opening and extracorporeal circulation, and is considered to have more clinical application prospect.
The existing left auricle plugging device can be roughly divided into an inner plug type plugging disc type plugging device from the aspect of modeling. For example, chinese patent document CN104918559B discloses an inner plug type left atrial appendage occluder whose main body includes a stent (provided with barbs around) laser-cut thermo-formed from a nickel-titanium material and a polytetrafluoroethylene porous permeable membrane. When the inner plug type left auricle plugging device plugs into the left auricle, the left auricle can not be plugged through the deformation of the bracket because the shape, the inner cavity shape and the depth of the left auricle part of different individuals are different, and the plugging can not be stably fixed, so that the thrombus formation can not be avoided.
Patent document WO2018069523A1 discloses a plug-disc type left atrial appendage occlusion device, the main structure of which consists of two butterfly-shaped disc-shaped structures, and a waist-shaped structure is formed between the two plug discs. The butterfly-shaped blades are arranged in the left auricle to prevent the stopper from shifting, and the butterfly-shaped cap seals the mouth of the left auricle. However, because the inner structures of the left auricles of different individuals are different, the disc structures cannot adapt to the shapes of the inner cavities of the different left auricles, and the two butterfly-shaped disc structures cannot be independently formed and mutually influence the fixed positions. The left auricle part cannot be completely attached, and optimal fixation and blood flow blocking are difficult to achieve.
Disclosure of Invention
The invention provides a left auricle plugging device which can be compatible with left auricles with different shapes and different depths of different individuals, is tightly attached to a left auricle opening, and can effectively block blood flow so as to solve the problem that the existing left auricle plugging device is not strong in adaptability to left auricles with different shapes and different depths.
In order to solve the technical problems, the invention provides a left auricle occluder, which comprises a covering piece, an adjusting piece and an anchoring piece; the covering piece is used for covering the left auricle in a fitting way; one end of the adjusting piece is connected with the covering piece, and the other end of the adjusting piece is connected with the anchoring piece; the anchoring piece is made of elastic materials, can expand or contract, is provided with an anchoring structure on the outer surface and a cavity in the anchoring structure, and is used for anchoring and fixing the occluder on the inner wall of the left atrial appendage.
Further, the covering piece is in a shape and structure suitable for blocking the left auricle, and comprises a disc-shaped structure and a polygonal table-shaped structure.
Preferably, the cover comprises a cover support and a cover film, the cover film being attached to the cover support.
Preferably, the cover support is made of nickel-titanium alloy material.
Preferably, the covering membrane is animal pericardial tissue or a multi-layer dense polymer membrane.
Further, the adjusting member includes an elastic structure by which the length of the adjusting member can be adjusted.
Further, at least one passage is provided in the adjustment member, the passage being in communication with the interior cavity of the anchor member.
Preferably, the elastic structure comprises a single or a plurality of corrugated elastic units of nickel titanium alloy material.
Preferably, the elastic structure further comprises a single or multiple high polymer material sutures.
Preferably, the anchoring element is a spherical or ellipsoidal structure, the anchoring structure provided on the outer surface thereof is a barb or a convex structure, and the convex structure comprises hemispherical protrusions.
Preferably, the anchor is made of a silicone material.
Preferably, the anchoring piece is a nickel-titanium alloy cutting bracket, is an integrated structure formed by cutting nickel-titanium alloy pipes, and is covered with a choke film.
Preferably, the anchor is a nickel-titanium alloy braided stent, is a structure formed by braiding nickel-titanium alloy wires, and is covered with a choke film.
Preferably, the choke film is a multilayer compact high polymer film.
When the heart ear cavity anchoring device is used, filling liquid is filled into the cavity of the anchoring device through the channel of the adjusting device to enable the cavity of the anchoring device to expand into a spherical shape or an ellipsoidal shape, the section size of the anchoring device after expansion is larger than the size of the left heart ear opening, and the anchoring structure is anchored or closely attached to the inner wall of the left heart ear cavity.
The invention has the beneficial effects that:
according to the invention, the filling liquid is injected into the channel of the adjusting piece to enable the anchoring piece to be expanded and molded, so that the anchoring structure is fixedly connected with the inner wall of the left auricle, the distance between the covering piece and the anchoring piece is adjusted through the elastic unit of the adjusting piece, the anchoring piece and the covering piece are effectively connected, and the covering piece is stably fixed at the left auricle. The invention has simple structure and convenient use, and the molding state of the anchoring piece can be adjusted by adjusting the amount of injected liquid. The left auricle can be completely plugged only by finishing stable anchoring of the anchoring piece, so that the device can adapt to the inner cavity structures of the left auricle in various forms.
Drawings
FIG. 1 is a schematic view of the left atrial appendage closure of example 1 of the present invention;
FIG. 2 is a schematic representation of the position of the left atrial appendage occlusion device of example 1 of the present invention in the left atrial appendage anatomy;
FIG. 3a is a schematic representation of the delivery of the left atrial appendage occlusion device of example 1 of the present invention in a sheath;
FIG. 3b is a schematic view of the left atrial appendage closure of embodiment 1 positioned and secured within the left atrial appendage when the delivery system is not fully evacuated;
FIG. 3c is a schematic view of the left atrial appendage closure of example 1 of the present invention with the cover not fully withdrawn from the delivery system;
fig. 4 is a schematic structural view of a cover of the left atrial appendage occlusion device of embodiment 1 of the present invention;
FIG. 5a is a schematic view of an embodiment of an adjustment member of the present invention;
FIG. 5b is a schematic view of the structure of an embodiment of the inner liquid filling tube of the regulating member of the present invention;
FIG. 5c is a schematic view of an embodiment of an adjustment unit of an adjustment member in accordance with the present invention;
FIG. 6a is a schematic structural view of one embodiment of an anchor of the present invention;
fig. 6b is a schematic structural view of another embodiment of an anchor of the present invention.
Detailed Description
The invention will be further illustrated with reference to specific examples. It should be understood that the examples are only for illustrating the present invention and are not intended to limit the scope of the present invention. Further, it is understood that various changes and modifications of the present invention may be made by those skilled in the art after reading the disclosure of the present invention, and such equivalents are intended to fall within the scope of the present invention as defined by the appended claims.
For the sake of simplicity of the drawing, only the parts relevant to the technical solution of the invention are schematically represented in the figures, which do not represent the actual structure thereof as a product. Additionally, in order to simplify the drawing for ease of understanding, components having the same structure or function in some of the drawings are shown schematically with only one of them, or only one of them is labeled. Herein, "a" means not only "only this one" but also "more than one" case.
Example 1
Referring to fig. 1-5c, the present invention provides the following technical solutions: a left atrial appendage occlusion device includes a cover 300, an adjuster 200, and an anchor 100. As shown in fig. 4, the cover 300 includes a cover holder 320 and a cover film 330. In this embodiment, the cover support 320 is made of nickel-titanium alloy material, and is manufactured by laser cutting and heat setting. The covering film is animal pericardium after cross-linking and curing treatment. The cover support 320 includes a single or multiple hollowed-out structures, which can reduce the duty cycle of the metal material, thereby facilitating compression and release of the device, and the hollowed-out structures also facilitate suturing. In the present embodiment, the cover holder 320 has a disc shape, and a connection point 310 is provided at a central position thereof, and the adjusting member 200 is connected to the cover holder 320 through the connection point 310. As shown in fig. 1, the anchor 100 is a spherical structure made of a silicone material. The anchor 100 has a cavity formed therein, the surface of which includes a plurality of anchoring structures, in this embodiment barbs 101, which stably secure the anchor 100 to the inner wall of the left atrial appendage lumen, as shown in fig. 2. At least one passage is provided inside the regulating member 200, which passes through the regulating member 200. In this embodiment, as shown in fig. 5b, the adjusting member 200 is a multi-lumen polymeric tube. In this embodiment, two ends of the adjusting member 200 are fixedly connected to the anchor member 100 and the cover member 300, respectively, by means of screw connection. In other embodiments of the present invention, the connection may be achieved by glue or other means known to those skilled in the art.
In use, the left atrial appendage occlusion device is compressed and received into the sheath of the delivery system, as shown in figures 3 a-3 c. After the delivery system is in place, the anchor 100 is first released from the sheath. Liquid is then injected into the cavity of the anchor 100 via the channel (i.e., lumen in this embodiment) in the regulator 200, causing the anchor 100 to expand to a predetermined volume. The cross-sectional dimension of the expanded anchor 100 is greater than the dimension of the left atrial appendage, so that the anchor 100 does not fall out of the left atrial appendage. The outer surface of the anchor 100 is closely attached to the inner wall of the left atrial appendage, and barbs on the surface penetrate the inner wall surface of the left atrial appendage to combine with the pressure formed on the inner wall surface of the left atrial appendage after expansion of the anchor 100, thereby providing a fastening force to the anchor 100 to firmly anchor it. The cover 300 is then released and after its complete release, the stent graft 320 quickly returns to a disc shape due to the elasticity of the nitinol stent. The cover 300 is attached to the left auricle opening by adjusting the length of the piece 200, and if necessary, the cover 300 is connected with the left auricle opening by stitching, thereby realizing the blocking of the left auricle.
As shown in fig. 5a and 5b, the regulator 200 includes an inner tube 230 through the lumen of which the lumen of the anchor 100 is filled. As shown in fig. 5c, the adjusting member 200 is provided at the outside thereof with an adjusting unit 220, and the adjusting unit 220 includes a single or a plurality of bellows-shaped elastic units 221 made of nitinol to provide stable elastic force to the adjusting member 200. In this embodiment, one or more polymer sutures 222 are further provided outside the corrugated elastic unit 221 and connected between the two ends of the adjusting member 200, for fixing the overall length of the adjusting member 200.
Example 2:
the technical solution of embodiment 2 of the present invention is basically the same as that of embodiment 1, except that the structure of the anchor 100 adopts a combined structure of a stent and a membrane. As shown in fig. 6a, in this embodiment, the anchor 100 includes an anchor bracket 120 and a blocker film 130. The anchor bracket 120 is made of nickel titanium alloy, and a plurality of barb structures 101 are welded on the surface thereof. The anchoring bracket 120 is covered with a choke film 130, which is a multi-layer compact polymer film. Together, anchor stent 120 and blocker film 130 form a closed structure of anchor 100 in the shape of a balloon.
Example 3:
embodiment 3 of the present invention is substantially the same as embodiment 1, except that the external anchoring structure of the anchor 100 is a hemispherical protrusion 102. As shown in fig. 6b, the anchor 100 is a unitary structure made of an elastic material (e.g., silicone) with a cavity inside, and has hemispherical protrusions 102 on its outer surface. After the anchor 100 is expanded to a predetermined volume, the hemispherical protrusion 102 of the surface thereof applies pressure to the inner wall surface of the left atrial appendage, which causes the anchor 100 to be stably fixed in the left atrial appendage.
The embodiments of the present invention have been described above. However, the present invention is not limited to the above embodiment. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention should be included in the protection scope of the present invention.
Claims (8)
1. A left auricle occluder, which is characterized by comprising a covering piece, an adjusting piece and an anchoring piece; the covering piece is used for covering the left auricle in a fitting way; one end of the adjusting piece is connected with the covering piece, and the other end of the adjusting piece is connected with the anchoring piece; the anchoring piece is made of elastic materials, can expand or contract, is provided with an anchoring structure on the outer surface and a cavity in the anchoring structure, and is used for anchoring and fixing the occluder on the inner wall of the left atrial appendage; the anchoring piece is of a spherical or ellipsoidal structure, the anchoring structure arranged on the outer surface of the anchoring piece is of a barb or a bulge structure, and the bulge structure comprises a hemispherical bulge; the anchor is made of a silicone material.
2. The left atrial appendage occlusion device of claim 1, wherein said cover is shaped and configured to occlude a left atrial appendage orifice, including a discoid configuration and a polygonal mesa configuration.
3. The left atrial appendage occlusion device of claim 2, wherein said cover comprises a cover support and a cover membrane, said cover membrane being attached to said cover support.
4. The left atrial appendage occlusion device of claim 3, wherein said cover stent is a nickel titanium alloy material and said cover membrane is an animal pericardial tissue or a multi-layer dense polymer membrane.
5. The left atrial appendage occlusion device of any one of claims 1-4, wherein the adjustment member comprises a resilient structure by which the length of the adjustment member is adjustable.
6. The left atrial appendage occlusion device of claim 5, wherein said elastic structure comprises a single or multiple corrugated elastic elements of nitinol material.
7. The left atrial appendage occlusion device of claim 6, wherein said elastic structure further comprises a single or multiple polymeric sutures.
8. The left atrial appendage occlusion device of claim 7, wherein at least one channel is disposed within said adjustment member, said channel being in communication with an interior cavity of said anchor.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202310045944.XA CN116077125B (en) | 2023-01-30 | 2023-01-30 | Left auricle plugging device |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202310045944.XA CN116077125B (en) | 2023-01-30 | 2023-01-30 | Left auricle plugging device |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN116077125A CN116077125A (en) | 2023-05-09 |
| CN116077125B true CN116077125B (en) | 2024-04-12 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202310045944.XA Active CN116077125B (en) | 2023-01-30 | 2023-01-30 | Left auricle plugging device |
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107233114A (en) * | 2016-03-28 | 2017-10-10 | 上海微创医疗器械（集团）有限公司 | Occluder for left auricle |
| CN112206029A (en) * | 2020-10-28 | 2021-01-12 | 上海微创医疗器械（集团）有限公司 | Medical system and medical device |
| CN114641242A (en) * | 2019-09-26 | 2022-06-17 | 苏黎世大学 | Left atrial appendage occlusion device |
-
2023
- 2023-01-30 CN CN202310045944.XA patent/CN116077125B/en active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107233114A (en) * | 2016-03-28 | 2017-10-10 | 上海微创医疗器械（集团）有限公司 | Occluder for left auricle |
| CN114641242A (en) * | 2019-09-26 | 2022-06-17 | 苏黎世大学 | Left atrial appendage occlusion device |
| CN112206029A (en) * | 2020-10-28 | 2021-01-12 | 上海微创医疗器械（集团）有限公司 | Medical system and medical device |
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| CN116077125A (en) | 2023-05-09 |
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Denomination of invention: Left atrial appendage occluder Granted publication date: 20240412 Pledgee: Nanjing Branch of Jiangsu Bank Co.,Ltd. Pledgor: Nanjing Shengde Medical Technology Co.,Ltd. Registration number: Y2024980037316 |