CN113288312A - Membrane-free partially degradable left atrial appendage occluder - Google Patents
Membrane-free partially degradable left atrial appendage occluder Download PDFInfo
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- CN113288312A CN113288312A CN202110619531.9A CN202110619531A CN113288312A CN 113288312 A CN113288312 A CN 113288312A CN 202110619531 A CN202110619531 A CN 202110619531A CN 113288312 A CN113288312 A CN 113288312A
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- occluder
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- 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
- A61B17/12122—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder within the heart
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- 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
- A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
- A61B17/12172—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure having a pre-set deployed three-dimensional shape
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- 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
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- 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
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Abstract
The invention relates to a membrane-free partially degradable left atrial appendage occluder, and belongs to the technical field of medical instruments. Comprises an upper disc surface, a bracket body and a lower disc surface; a bracket body is arranged between the upper disc surface and the lower disc surface; the shape of the stopper is cylindrical or drum-shaped; the upper disc surface is set to be a closed structure. The closed plug design reduces the compression of the occluder on the peripheral structure tissue of the left atrial appendage; the complications caused by the puncture of the auricle are reduced; the requirement on the depth of the implanted left auricle is low, and the application range is wide. The occluder is woven with dense net, realizes the effect of stopping blood flow, has replaced traditional choked flow membrane, realizes the occluder and passes through littleer transport sheath, avoids the emergence of iatrogenic atrial septal defect. And the degradable high polymer material is adopted, so that the metal implantation amount of the left atrial appendage occluder and the heart load of a patient are reduced. Through the design of the forming ring in the occluder, the radial supporting force of the occluder is enhanced, and the stability of the occluder in the body is improved.
Description
Technical Field
The invention relates to a membrane-free partially degradable left atrial appendage occluder, and belongs to the technical field of medical instruments.
Background
According to research data, cerebral apoplexy has become the first disease causing death of Chinese people, and China is one of the countries with the highest proportion of global stroke risk factors. 1030 million new stroke patients exist in the world every year, and the latest statistics of China show that the annual prevalence rate of Chinese stroke is 1114.8/10 ten thousand, and the death rate is 114.8/10 ten thousand. In view of the characteristics of high disability rate, high fatality rate and easy relapse caused by stroke, the understanding and the prevention of stroke are significant to the whole world, especially China.
The 2013 global disease burden (GBD) study showed that over 90% of stroke is due to adjustable risk factors and that over 75% of stroke patients can reduce their occurrence by controlling metabolic and behavioral risk factors. Non-valvular atrial fibrillation is one of the risk factors for stroke modulation. Therefore, by effectively intervening atrial fibrillation, prevention of stroke is expected.
The transcatheter left atrial appendage occlusion is used as a new technology for preventing stroke and occurrence of systemic embolism events of patients with non-valvular atrial fibrillation, the development speed is high in recent years, and particularly with the research and development and application of different types of left atrial appendage occlusion devices and the publication of follow-up results of numerous clinical researches, the effectiveness and the safety of the left atrial appendage occlusion for preventing the stroke and the systemic embolism events are clinically accepted.
However, the left atrial appendage occluders which are on the market at home and abroad are all metal occluders, and have more problems. For example, a covering disc of a cover type occluder can cause abrasion phenomena to the ridge of the periphery of the left atrial appendage and the mitral valve ring, and cause edema; residual leakage is caused by incomplete capping; the left auricle is overloaded to press the left coronary artery branch, which leads to complications such as myocardial ischemia. The above complications are less likely to occur in a plug-type occluder, which is a risk of pericardial tamponade due to atrial appendage puncture because the distal end (near the tip of the left atrial appendage) is open, and is affected by the depth of the atrial appendage structure during use, and for a shallower left atrial appendage, an open-type plug-type occluder is relatively less preferred. On the other hand, the conveying sheath used by the currently marketed plug type occluder in China has the specification of 14F, the aperture caused by atrial septal puncture is large, and iatrogenic atrial septal defect is easy to occur. Therefore, the technical problem of abrasion of the metal stopper to the surrounding tissue structure of the auricle in the prior art needs to be solved; and the technical problems that the occluder can reduce the complication of pericardial tamponade caused by the puncture of auricle, reduce the metal implantation amount of the left auricle occluder, reduce the load to the heart and the like through a small-sized delivery sheath are realized.
Disclosure of Invention
The invention aims to overcome the defects in the prior art and solve the technical problem of abrasion of the metal stopper on the peripheral tissue structure of the auricle in the prior art; and the occluder can reduce the complication of pericardial tamponade caused by the puncture of auricle, reduce the metal implantation amount of the left auricle occluder and reduce the load to the heart through a small-sized delivery sheath.
In order to solve the problems, the invention adopts the technical scheme that a non-membrane partially degradable left atrial appendage occluder is provided; comprises an upper disc surface, a bracket body and a lower disc surface; a bracket body is arranged between the upper disc surface and the lower disc surface; the shape of the stopper is cylindrical or drum-shaped; the upper disc surface is set to be a closed structure.
Preferably, the lower disc surface is designed to be a concave structure or a plane structure.
Preferably, the occluder manufacturing material comprises a shape memory alloy material and a degradable high polymer material.
Preferably, the stent body comprises a metal stent, and the metal stent is formed by weaving a memory alloy wire or carving a nickel-titanium tube.
Preferably, the metal stent is provided with a dense mesh structure.
Preferably, one end of the left auricle occluder close to the bottom of the left auricle is set as an upper disc surface, and the other end close to the left atrium is set as a lower disc surface; the upper and lower disk surfaces are woven by wire material dense net made of degradable high molecular material.
Preferably, the upper disc surface is of a rivet-free weaving structure, and the center of the upper disc surface is provided with a forming ring; the lower disc surface is provided with a bundle of rivet heads, and through holes are formed in the rivet heads.
Preferably, the stent body comprises a stent woven by degradable wires and nickel titanium wires; the connection mode of the degradable wire and the nickel-titanium wire comprises winding connection or punching connection.
Preferably, the shape memory alloy material is a nickel-titanium alloy material, and the degradable high polymer material is one or two or a copolymer of polylactic acid and polydioxanone.
Preferably, the diameter of the left atrial appendage occluder support body is set to be 16-40 mm.
Compared with the prior art, the invention has the following beneficial effects:
1) the left auricle structure is a closed plug structure, and the closed plug structure is different from the existing open plug structure in that the closed plug structure can reduce the complication of pericardial plugging caused by auricle puncture; the compression and abrasion of the plugging device to the ridge of the left auricle, the mitral valve ring and other tissues are avoided; the left auricle occluder with the plug type structure has relatively lower requirements on the depth of the left auricle, and both shallow and deep left auricle structures can be suitable.
2) The stopper is provided with an inwards concave structure, so that the radial supporting force of the device can be enhanced, and the stability of the device in the left auricle can be improved. The occluder is arranged into a structure without concave inwards, so that the possibility of forming vortex again at the left auricle of the heart can be avoided.
3) The stent of the occluder is made of nickel-titanium alloy, so that the requirements of radial supporting force can be met, the occluder is complete, and residual leakage is avoided. The upper and lower disc surfaces of the plugging device are made of degradable materials, and can be degraded within a certain time after endothelialization, so that the metal implantation amount of a patient is reduced, and the load of the left auricle is reduced.
4) The bracket of the invention is formed by weaving or carving, so that the success rate and effectiveness of the manufacturing of the bracket can be enhanced. The two ends of the braided support are subjected to closing-up treatment, so that a working space can be reserved for the subsequent winding and braiding of the degradable wires and the nickel-titanium wires.
5) The left auricle occluder is different from the design that the existing left auricle occluder has 1-3 layers of flow-blocking films, the weaving mode of the whole left auricle occluder is dense-net weaving, and the dense-net weaving mode can play a role in blocking blood flow. The advantage of the occluder being membrane-free is that it is possible to pass the occluder through a smaller delivery sheath. Namely, on the premise of ensuring the flow-resisting effect of the occluder, the iatrogenic atrial septal defect is avoided by the smaller delivery sheath. On the other hand, the nickel-titanium stent is woven by adopting a dense net, so that the effect of enhancing the radial supporting force and the developing property of the occluder on the left auricle part can be achieved.
6) The left auricle occluder is designed to be closed at the far end, so that the deep scraping and puncturing of the left auricle by the occluder can be reduced, and the occurrence of complications such as pericardiocentesis and hydropericardium can be reduced.
7) According to the left auricle occluder, the forming ring and the through hole are arranged inside the left auricle occluder, the forming ring on the upper disk surface is pulled, the outer surface of the occluder through hole is pulled out through the through hole, and the upper disk surface and the lower disk surface are extruded, so that the effect of enhancing the radial supporting force of the left auricle occluder is achieved, complete occlusion is guaranteed, and no residual leakage exists. The lower disc surface of the left auricle plugging device is provided with a bunching rivet head, which can not only coagulate and bunch degradable high polymer wires, but also prevent the disc surface from scattering; but also can be used for connecting a delivery device to implant the occluder into the left atrial appendage.
8) The nickel-titanium alloy stent body and the degradable upper and lower disc surfaces are separately woven and shaped, and different materials can ensure the performance of the occluder through different treatments.
9) The connection mode of the nickel-titanium alloy stent body and the degradable upper and lower disk surfaces is winding connection or perforation sewing connection, so that the stable connection of metal materials and non-metal materials can be realized on the premise of not influencing the performance of the instrument.
10) The size range of the left atrial appendage occluder meets the size of a common left atrial appendage.
Drawings
Fig. 1 is a schematic view of the overall structure of the left atrial appendage occluder with a concave lower disk surface.
In the figure, A is the connection part of degradable wires and nickel-titanium wires on the upper and lower disc surfaces.
Fig. 2 is a schematic view of the overall structure of the stopper with the convex lower disk surface.
In the figure, A is the connection part of degradable wires and nickel-titanium wires on the upper and lower disc surfaces.
FIG. 3 is a schematic diagram of the connection of degradable filaments and braided nickel-titanium filaments at the upper and lower disc surfaces A of FIGS. 1 and 2 in a winding manner.
FIG. 4 is a schematic view of the perforated connection between the degradable filaments with the upper and lower disc surfaces and the carved nickel-titanium filaments at A position in FIGS. 1 and 2.
Figure 5 is a top view of the upper plate of the left atrial appendage occluder of the present invention.
Reference numerals: 1. a nickel-titanium wire framework; 2. the disc surface is arranged; 3. an auxiliary forming ring; 4. the lower disc is internally concave and is also used as a rivet head; 5. auxiliary forming lines; 6. the lower disc surface is provided with a convex through hole and a rivet head; 7. degradable filaments; 8. braided nickel-titanium wires; 9. a carved nickel titanium wire bracket; 10. and (5) arranging the lower disc surface.
Detailed Description
In order to make the invention more comprehensible, preferred embodiments are described in detail below with reference to the accompanying drawings:
as shown in fig. 1-5, a non-membrane partially degradable left atrial appendage occluder is provided for the present invention; comprises an upper disc surface 2, a bracket body and a lower disc surface 10; a bracket body is arranged between the upper disc surface 2 and the lower disc surface 10; the shape of the stopper is cylindrical or drum-shaped; the upper plate surface 2 is of a closed structure. The lower disc surface 10 is designed into an inward concave structure or a plane structure; the manufacturing material of the occluder comprises a shape memory alloy material and a degradable high polymer material. The stent body comprises a metal stent, and the forming mode of the metal stent comprises memory alloy wire weaving forming or nickel titanium tube carving forming. The metal support is of a dense net structure. One end of the left auricle occluder close to the bottom of the left auricle is arranged as an upper disc surface 2, and the other end close to the left atrium is arranged as a lower disc surface 10; the upper and lower disk surfaces are woven by wire material dense net made of degradable high molecular material. The upper disc surface 2 is of a rivetless weaving structure, and the center of the upper disc surface 2 is provided with an auxiliary forming ring 3; the lower disc surface 10 is provided with a bundle of rivet heads, and through holes are arranged on the rivet heads. The stent body comprises a stent woven by degradable wires and nickel-titanium wires; the connection mode of the degradable wire and the nickel-titanium wire comprises winding connection or punching connection. The shape memory alloy material is a nickel-titanium alloy material, and the degradable high polymer material is one or two or a copolymer of polylactic acid and polydioxanone. The diameter range of the left auricle occluder bracket body is set to be 16-40 mm.
The left auricle occluder is structurally designed as follows:
1) the left auricle occluder is of a closed plug type structure, namely the far end (upper disc surface) of the occluder is of a closed design, and the occluder can be integrally characterized by being cylindrical or drum-shaped and comprises an upper disc surface, a bracket body and a lower disc surface.
2) The proximal end (i.e., the lower disc surface) of the occluding device can be of a concave structure or a flat (non-concave) structure (as shown in fig. 1 and 2).
3) The left auricle occluder is made of shape memory alloy material and degradable high polymer material, the memory alloy material can be nickel-titanium alloy material, and the degradable high polymer material can be one or more of polylactic acid and polydioxanone or copolymer thereof.
4) The side surface of the left auricle occluder is a metal bracket, and the bracket can be formed by weaving a memory alloy wire or by carving a nickel-titanium tube. When weaving, the two ends of the bracket are in a closed-up rotary weaving mode.
5) The support is in a dense-mesh structure regardless of weaving or carving molding, namely dense-mesh weaving or dense-mesh carving, as shown in the attached figures 3 and 4.
6) The two ends of the bracket are respectively an upper disk surface and a lower disk surface, and the upper disk surface is one end close to the bottom of the tip of the left auricle, namely a far end. The lower disc surface is one end close to the left auricle part. The upper and lower disk surfaces are woven by dense net of superfine degradable high polymer material.
7) The upper disc surface and the lower disc surface of the left auricle occluder are both woven by degradable high polymer materials, the upper disc surface is woven without rivets, and the center of the upper disc surface is connected with a forming ring. The lower disc surface is provided with a wire binding rivet head which is a through hole formed by melting degradable high polymer material wires, such as the structure of a through hole and rivet head 4 with a concave inner surface of the lower disc and a through hole and rivet head 6 with a convex outer surface of the lower disc shown in the attached figures 1 and 2.
8) The nickel-titanium wire and the degradable polymer wire are two different materials, and the temperature parameters of the heat treatment are different, so that the stent body woven by the nickel-titanium wire and the upper and lower disk surfaces of the degradable fabric are separately woven and shaped by the heat treatment.
9) The connection mode of the degradable wire and the nickel-titanium wire braided bracket is winding connection or punching connection.
10) The winding connection is that the shaped upper and lower disk surfaces are connected together by a degradable wire or a nickel-titanium wire through the pores of the bracket and the upper and lower disks. The punching connection is that holes are punched at the two ends of the nickel-titanium wire bracket body, and the shaped upper and lower disk surfaces are fixed on the bracket body by degradable wires.
11) The size of the left atrial appendage occluder is based on the diameter of the support, and the diameter range is 16-40 mm.
Examples
As shown in figure 1, the left atrial appendage occluder is a schematic diagram of the whole structure and is characterized in that the lower disk is designed into a concave structure. Including nickel titanium silk skeleton 1 (contain weaving formula or carving formula all can), the last wall 2 that the degradable silk was woven, supplementary shaping ring 3, lower wall 10, the through-hole of indent formula is concurrently die 4 and supplementary shaping line 5, through supplementary shaping line 5, draws supplementary shaping ring 3 down, pulls out in through-hole concurrently die 4, increase radial holding power. In the figure, the position A is the connection part of the degradable filaments on the upper and lower disc surfaces and the nickel-titanium filaments (as shown in the partial enlarged views of figure 3 and figure 4).
Fig. 2 is a schematic diagram of the overall structure of another left atrial appendage occluder, which is characterized in that the lower disk surface is designed in an outward convex structure. Including nickel titanium silk skeleton 1 (contain weaving formula or carving formula all can), the last wall 2 that the degradable silk was woven, supplementary shaping ring 3, lower wall 10, the protruding through-hole of formula is concurrently die 6 and supplementary shaping line 5, through supplementary shaping line 5, pull down supplementary shaping ring 3, pull out in following through-hole concurrently die 6, increase radial holding power. In the figure, the position A is the connection part of the degradable filaments on the upper and lower disc surfaces and the nickel-titanium filaments (as shown in the partial enlarged views of figure 3 and figure 4).
Fig. 3 is a schematic diagram showing the connection of degradable filaments 7 and braided nickel-titanium filaments 8 on the upper and lower disc surfaces in a winding manner.
Fig. 4 is a schematic diagram showing the connection between the degradable filaments 7 on the upper and lower disc surfaces and the carved nickel-titanium filament stent 9. The carved nickel-titanium wire bracket 9 is provided with carved holes, so that the degradable wires 7 can pass through and be connected.
As shown in figure 5, the top view of the upper plate of the degradable left atrial appendage occluder is characterized in that the upper plate is woven by a membraneless structure and is flat. The top view of the upper plate surface is of a rivetless weaving structure, and the plate surface is flat.
The invention provides a membrane-free partially degradable left atrial appendage occluder.
The whole structure of the occluder is designed in a closed plug mode, so that the compression of the occluder on the peripheral structure tissue of the left atrial appendage is reduced; reducing complications caused by atrial appendage puncture; and the requirement on the depth of the implanted left auricle is lower, and the application range is relatively wider.
The left auricle occluder is woven by a dense net to achieve the effect of blocking blood flow, replaces a flow blocking film of the traditional left auricle occluder, can achieve a smaller delivery sheath, and avoids iatrogenic atrial septal defect.
The left atrial appendage occluder is made of memory alloy materials and degradable high polymer materials, so that partial degradability is realized, and the metal implantation amount of the left atrial appendage occluder and the heart load of a patient are reduced.
The left auricle occluder realizes the enhancement of the radial supporting force of the occluder and improves the stability of the occluder in the body by the design of the inner forming ring.
The size range of the left atrial appendage occluder meets the size of different left atrial appendages.
While the invention has been described with respect to a preferred embodiment, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the spirit and scope of the invention. Those skilled in the art can make various changes, modifications and equivalent arrangements, which are equivalent to the embodiments of the present invention, without departing from the spirit and scope of the present invention, and which may be made by utilizing the techniques disclosed above; meanwhile, any changes, modifications and variations of the above-described embodiments, which are equivalent to those of the technical spirit of the present invention, are within the scope of the technical solution of the present invention.
Claims (10)
1. A membraneless partially degradable left atrial appendage occluder; the method is characterized in that: comprises an upper disc surface, a bracket body and a lower disc surface; a bracket body is arranged between the upper disc surface and the lower disc surface; the shape of the stopper is cylindrical or drum-shaped; the upper disc surface is set to be a closed structure.
2. The membraneless, partially degradable left atrial appendage occluder of claim 1, wherein: the lower disc surface is designed to be of an inwards concave structure or a plane structure.
3. The membraneless, partially degradable left atrial appendage occluder of claim 1, wherein: the manufacturing material of the occluder comprises a shape memory alloy material and a degradable high polymer material.
4. The membraneless, partially degradable left atrial appendage occluder of claim 1, wherein: the stent body comprises a metal stent, and the forming mode of the metal stent comprises memory alloy wire weaving forming or nickel titanium tube carving forming.
5. The membraneless, partially degradable left atrial appendage occluder of claim 4, wherein: the metal support is of a dense net structure.
6. The membraneless, partially degradable left atrial appendage occluder of claim 1, wherein: one end of the left auricle occluder close to the bottom of the left auricle is set as an upper disc surface, and the other end close to the left atrium is set as a lower disc surface; the upper and lower disk surfaces are woven by wire material dense net made of degradable high molecular material.
7. The membraneless, partially degradable left atrial appendage occluder of claim 1, wherein: the upper disc surface is of a rivetless weaving structure, and the center of the upper disc surface is provided with a forming ring; the lower disc surface is provided with a bundle of rivet heads, and through holes are formed in the rivet heads.
8. The membraneless, partially degradable left atrial appendage occluder of claim 1, wherein: the stent body comprises a stent woven by degradable wires and nickel-titanium wires; the connection mode of the degradable wire and the nickel-titanium wire comprises winding connection or punching connection.
9. A membraneless, partially degradable left atrial appendage occluder as in claim 3, wherein: the shape memory alloy material is a nickel-titanium alloy material, and the degradable high polymer material is one or two or a copolymer of polylactic acid and polydioxanone.
10. The membraneless, partially degradable left atrial appendage occluder of claim 1, wherein: the diameter range of the left auricle occluder support body is set to be 16-40 mm.
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| Application Number | Priority Date | Filing Date | Title |
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| CN202110619531.9A CN113288312A (en) | 2021-06-03 | 2021-06-03 | Membrane-free partially degradable left atrial appendage occluder |
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| CN202110619531.9A CN113288312A (en) | 2021-06-03 | 2021-06-03 | Membrane-free partially degradable left atrial appendage occluder |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2023041058A1 (en) * | 2021-09-16 | 2023-03-23 | 杭州德诺电生理医疗科技有限公司 | Occluder and method for manufacturing occluder |
| CN117379129A (en) * | 2023-11-15 | 2024-01-12 | 上海形状记忆合金材料有限公司 | Left auricle plugging device capable of being unlocked |
-
2021
- 2021-06-03 CN CN202110619531.9A patent/CN113288312A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2023041058A1 (en) * | 2021-09-16 | 2023-03-23 | 杭州德诺电生理医疗科技有限公司 | Occluder and method for manufacturing occluder |
| CN117379129A (en) * | 2023-11-15 | 2024-01-12 | 上海形状记忆合金材料有限公司 | Left auricle plugging device capable of being unlocked |
| CN117379129B (en) * | 2023-11-15 | 2024-05-24 | 上海形状记忆合金材料有限公司 | Left auricle plugging device capable of being unlocked |
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