CN115105142A

CN115105142A - Left auricle filling instrument

Info

Publication number: CN115105142A
Application number: CN202210778568.0A
Authority: CN
Inventors: 李彪; 邵烨; 胡炜飞; 吕世文
Original assignee: Ningbo Diochange Medical Technology Co Ltd
Current assignee: Ningbo Diochange Medical Technology Co Ltd
Priority date: 2022-06-30
Filing date: 2022-06-30
Publication date: 2022-09-27

Abstract

The application relates to a left auricle filling instrument, which comprises a bag, a support framework and a filler, wherein the support framework is arranged in the bag and used for anchoring and supporting, the filler is arranged in the bag, the bag is provided with a plurality of holes, the filler can absorb water and expand, the support framework is made of degradable polyurethane materials, and when the left auricle filling instrument is preassembled, the left auricle filling instrument is compressed and conveyed to a target position; when the bag is released, the supporting framework is restored to the preset shape and is anchored in the left auricle, and the filler gradually absorbs water and expands to enable the bag to be embedded into the folds on the inner wall of the left auricle; the supporting framework is utilized to perform early-stage anchoring, the supporting framework is degradable, the bag is provided with a plurality of holes, the filler expands after absorbing moisture, so that the bag fully contacts the inner wall of the left atrial appendage and is embedded into folds on the inner wall, and after the bag and the heart tissue complete endothelialization, the supporting framework starts to degrade so as to prevent the supporting framework from continuously supporting or abutting against the inner wall of the left atrial appendage.

Description

Left auricle filling instrument

Technical Field

The application belongs to the field of medical equipment, concretely relates to left atrial appendage filling instrument.

Background

The left atrial appendage is an elongated, curved, blind-end structure that extends down and forward along the anterior sidewall of the left atrium. The left auricle is a long tubular structure with a hook, the wall of the auricle forms a trabecula by the pectinate muscle, and gaps are arranged among the trabeculae. A neck with the diameter of 10-40 mm is arranged between the left auricle and the left atrial chamber and is positioned between the left superior pulmonary vein and the mitral valve annulus, and the coronaries of the coronary artery are close to the opening base part of the left auricle. The unique hook-shaped structure of the left atrial appendage and the rich trabecula musculi of the intima surface are easy to cause blood stasis.

Left atrial appendage occlusion and oral anticoagulation are currently the main methods to reduce the risk of atrial fibrillation stroke. Although effective at preventing atrial fibrillation stroke, compliance with long-term dosing is a problem and once anticoagulant is discontinued, the risk of stroke is as high as if the medication had not been taken. Left atrial appendage occlusion adopts the occluder to occlude the left atrial appendage in an interventional operation mode, so that thrombus of the left atrial appendage is prevented from being formed during atrial fibrillation, and the risk of long-term disability or death caused by thromboembolism of patients suffering from atrial fibrillation is reduced. It can effectively reduce the fatality rate and disability rate of patients and reduce the occurrence of bleeding. Atrial appendage occlusion avoids the various bleeding risks of patients with atrial fibrillation taking anticoagulants, such as common gastrointestinal bleeding; and the elderly are prone to falling caused by poor body quality, and left atrial appendage occlusion reduces the risk of the elderly falling and being prone to intracranial hemorrhage when taking anticoagulants. Left atrial appendage occlusion is a new treatment trend for preventing stroke of patients with atrial fibrillation globally at present.

The therapeutic approach of implanting a left atrial appendage occluder via minimally invasive intervention has many advantages over traditional surgery. However, the main stent material of the currently clinically used left heart occluder is a nickel-titanium alloy wire, and since such metal materials cannot be degraded and can react with human tissues to inflammation, blood coagulation and the like after being implanted for a long time, even a certain degree of damage is caused, certain defects exist, including the following use risks: (1) at present, a frame of the left atrial appendage occluder is made of metal as a raw material, the metal material is not degraded, and the problem of rejection is inevitably caused, so long-term and constant taking of anticoagulant drugs is required, and the risk of hemolytic hemorrhage is caused to some patients; (2) when the metal stent is used in vivo for a long time, the safety problem caused by triggering metal corrosion is caused. Once it happens, the risk of re-operation is high, (3) it is not good for the growth of heart cells on the surface of the stent. After the surface of the cardiac occluder is completely endothelialized and the cardiac defect is repaired by the body's own tissue, the cardiac occluder does not have to remain in the body at all. Therefore, the ideal heart plugging device should provide a temporary bridge infection for self-repair of the heart, and be degraded by the body after the completion of the historical mission, so that the defect is completely repaired by the self-tissue, thereby avoiding long-term complications and potential safety hazards caused by the retention of metal in the body. The degradable occluder in the prior art also has a plurality of problems.

Patent AU2020332564a1 discloses a medical implant (1) suitable for closing defects (D) or cavities, preferably defects in the atrium or the septal wall (W) or the left atrial appendix. The implant (1) comprises an occlusion device (6) and has two states. It is adapted to be deployed to a defect site (D) in a first state, where it can be brought into a second state by an activation mechanism. It is adapted to close said defect (D) in said second state. The patent scheme is that a support bracket is made of polylactic acid, and the polylactic acid is a bio-based material and has good biocompatibility and biodegradability, but the polylactic acid with high molecular weight is difficult to obtain. The synthesis of high molecular weight polylactic acid requires complex and expensive equipment and very strict requirements on the process, which finally leads to violent increase of the cost of the polylactic acid and seriously hinders the successful marketing of the polylactic acid. Meanwhile, polylactic acid itself has physical property defects such as poor impact resistance, low heat resistance, and the like. In addition, the polylactic acid product has simple structure and single product type. These directly limit the application field of polylactic acid and hinder the commercial success of polylactic acid.

Patent CN110313946A discloses an occlusion device and a method for making the same, comprising a frame and a flow-blocking membrane, wherein the frame comprises a waist portion and a barb connected with at least one end of the waist portion, the waist portion is coated with a solid xerogel, and the flow-blocking membrane is fixed at least one end of the waist portion and/or inside the barb. The patent technology utilizes a braided bracket to be supported at the position of a left auricle, the waist part of the bracket is coated with solid xerogel, and the characteristic that the bracket expands after being placed in a body and contacted with blood can fill irregular-shaped tissue defects and can be applied to the conditions that the edges of the defect parts are narrow and the shapes of the defect parts are complex. However, the fixing mode of the barbs at the two ends still damages tissues, the framework part is also undegradable, and the safety problem caused by triggering metal corrosion exists after long-term implantation. Once this occurs, the risk of re-surgery is high.

Patent EP3920810a1 discloses a system, device and method for closing the Left Atrial Appendage (LAA). The device excludes LAA from the blood. The implantable device is placed through a transcatheter in the LAA and secured inside the LAA. The implant includes an expandable and flexible framework and an expandable and conformable tubular foam. The tether deployment and retraction system includes a handle for controlling the pusher and tether. The pusher can be moved a certain distance away from the implant without changing the orientation of the implant while the clamp remains fixed to the implant. The tether is separated and the control on the handpiece is proximally retracted a distance such that the cutting end is distally advanced at least twice the distance. The loader comprises a conical section with guides and a container for immersing the foam prior to loading and laying. Utilize the tissue anchor to fix in the left atrial appendage in this patent scheme, during the operation, need find suitable fixed position through the influence, its operation degree of difficulty is higher to, the mode effect that this kind of anchoring mode does not have support inflation support far away is stable.

Patent US8603128B2 discloses an embolization device for occluding a body lumen, comprising one or more elongated, expandable, hydrophilic embolizing elements which are non-releasably carried along the length of an elongated filamentous carrier, preferably made of very thin, highly flexible nickel/titanium alloy filaments or microcoils. According to the technical scheme, the filamentous carrier is made of very thin and highly flexible nickel/titanium alloy filaments or microcoils, and after the device is implanted, if the highly flexible nickel/titanium alloy filaments can provide better supporting force, the nickel/titanium alloy filaments cannot be degraded, and the safety problem caused by triggering metal corrosion exists after the device is implanted for a long time. Once this occurs, the risk of re-surgery is high.

Therefore, those skilled in the art are dedicated to develop a left atrial appendage filling device with a degradable support framework, so that the occluder not only has good support force, but also can be adaptive to left atrial appendages with different anatomical shapes and sizes, so as to achieve effective occlusion, and meanwhile, the occluder is beneficial to endothelialization of heart tissues, and the material is degradable, so that the growth of the heart tissues is not influenced.

Content of application

The invention aims to solve the technical problem of providing a left atrial appendage filling instrument, so that the plugging device not only has good supporting force, but also can be self-adapted to left atrial appendages with different anatomical shapes and sizes to achieve effective plugging, and meanwhile, the plugging device is beneficial to endothelialization of heart tissues, and the material is degradable, so that the growth of the heart tissues is not influenced.

In order to solve the technical problem, the application is solved by the following technical scheme:

according to one aspect of the invention, a left atrial appendage filling device comprises a flow-blocking membrane, a support framework and a filler, wherein the flow-blocking membrane is used for anchoring and supporting the filler, the flow-blocking membrane can prevent the filler from entering a left atrium, the filler can be expanded, the support framework is made of degradable materials, the support framework is anchored in a left atrial appendage, and the filler is gradually expanded and embedded into folds on the inner wall of the left atrial appendage; the support skeleton is made of degradable materials.

According to another aspect of the present invention, a left atrial appendage filling device comprises a bladder, a support framework disposed within the bladder for anchoring and supporting, and a filler disposed within the bladder, wherein the bladder is provided with a plurality of holes, the filler is water-swellable, the support framework is made of a degradable polyurethane material, and when pre-filled, the left atrial appendage filling device is compressed into an elongated member and delivered to a target site; when the bag is released, the supporting framework is restored to the preset shape and is anchored in the left auricle, and the filler gradually absorbs water and expands to enable the bag to be partially embedded into the folds on the inner wall of the left auricle.

The purpose of the invention can be further realized by the following technical scheme:

according to one embodiment, the support scaffold has a first configuration in which the support scaffold is compressed and delivered to a target location and a second configuration in which the support scaffold is transformable from a self-expanding to the second configuration, and the support scaffold is supported and anchored within the left atrial appendage; the supporting framework has certain supporting force, so that after the left auricle filling instrument is implanted into the left auricle, the supporting framework can provide enough supporting and anchoring force, and the left auricle filling instrument can be firmly fixed in the left auricle.

According to one embodiment, the support skeleton comprises a plurality of support rods, and the wall thickness of the support rods is 0.1-0.6 mm; the support rod has high enough hardness and tensile strength and low elongation percentage, and can be formed into a medical-grade pipe through an extrusion molding process.

According to one embodiment, the support rods are formed with a patterned structure by a laser engraving technique and then formed into a support skeleton by a heat setting process.

According to an embodiment, the support armature is fixedly connected to the inner circumferential surface of the capsular bag.

According to one embodiment, the inner wall surface of the left atrial appendage on the side close to the left atrium is smooth, and the inner wall surface of the left atrial appendage on the side far from the left atrium is wrinkled, so that the support framework is arranged on one side in the bag, and one side of the bag is close to the left atrium; the advantages of such a design are: after the filler in the bag is expanded, the bag can be tightly attached to the folds on the inner wall surface of the left auricle, so that the anchoring effect of the left auricle filling instrument is enhanced.

According to one embodiment, the pouch is a membrane with a mesh structure, the mesh having a pore size of 0.15-1 mm.

According to one embodiment, the mesh is permeable to blood, allowing cardiac tissue to grow into the capsular bag, and the mesh prevents thrombus from exiting the left atrial appendage; the advantages of such a design are: after left auricle filling instrument was implanted left auricle, the heart tissue can climb and attach the bag and to the infiltration in the bag, makes its endothelialization for left auricle filling instrument and the further fixed of heart tissue implanted, simultaneously, the mesh can prevent the thrombus circulation, avoids taking place abominable circumstances such as apoplexy.

According to one embodiment, the support scaffold begins to degrade after the capsular bag is endothelialized by cardiac tissue, and the degraded support scaffold may flow out through the mesh openings; the support framework is made of degradable polyurethane materials, and can flow out through meshes to enter blood metabolism after being degraded, so that complete degradation and no residue are really realized, postoperative recovery of patients is facilitated, and complications of the patients are greatly reduced.

According to one embodiment, the pouch is woven from a polyurethane material through a spinning or drawing process to form filaments, and the filament or filament has a wire diameter of less than or equal to 0.3 mm; the combination of the filaments having a relatively high swelling ratio, e.g., 10 or more times water swellable property, and/or a relatively high elongation, allows the left atrial appendage filling device to significantly enhance adequate sealing with the interior of the left atrial appendage at the target placement area, ensuring effective occlusion of the left atrial appendage filling device.

According to an embodiment, the filler is an injectable gel material or the filler is a polyurethane material with foamed pores or water-swelling; the filler is soft or elastic, and after the filler expands, the left auricle filling instrument can be embedded into the folds on the inner wall surface of the left auricle, so that the anchoring force between the left auricle filling instrument and the inner wall of the left auricle is enhanced.

According to one embodiment, the supporting framework is made of a degradable polyurethane material, and the supporting framework starts to degrade after 6-12 months after the left atrial appendage filling device is implanted in the body, and the degraded supporting framework can flow out through the mesh openings.

According to another embodiment, the support frame may be positioned outside of the pocket and inside the left atrial appendage and away from the left atrium side when the left atrial appendage filling instrument is in place.

According to another embodiment, the support armature may be wrapped around the outside of the capsular bag.

Compared with the prior art, the application has the advantages that:

1. in the prior art, most stents for anchoring are made of memory metal alloy (such as nickel-titanium alloy wires), but the nickel/titanium alloy wires are not degradable, and the safety problem caused by triggering metal corrosion exists after long-term implantation, while the degradable stents adopted in the prior art also have the problems of insufficient supporting force, poor impact resistance and the like; in one embodiment of the invention, the supporting framework is used for early anchoring, is made of polyurethane material and has good physical and mechanical properties, good biocompatibility and blood compatibility, the bag is provided with a plurality of holes so that blood can flow through the bag and thrombus can be avoided flowing through the bag, and the filler expands after absorbing moisture so that the bag fully contacts the inner wall of the left atrial appendage and is embedded into folds on the inner wall so as to further anchor the bag; namely, the supporting anchoring through the supporting framework and the fold double anchoring of the sac embedded in the inner wall.

2. Compared with the prior art, the hole on the bag can promote tissue endothelialization, and the support framework starts to degrade after the bag and the heart tissue complete endothelialization, so that the risks of injury of the left auricle, pericardial stuffing, pericardial effusion and the like caused by the fact that the support framework can continuously support or abut against the inner wall of the left auricle due to the fact that the nickel-titanium alloy is permanently implanted and can not be degraded are overcome, and the influence of the existing heart occluder for permanently retaining the heart on the heart of a patient with immature development is influenced.

3. Unlike the prior art, the support frame is disposed on one side within the pocket, and one side of the pocket is adjacent to the left atrium; the advantages of such a design are: after the filler in the bag is expanded, the bag can be tightly attached to the folds on the inner wall surface of the left auricle, so that the anchoring effect of the left auricle filling instrument is enhanced.

4. Unlike the prior art, in one embodiment of the present invention, after the capsular bag is endothelialized by the heart tissue, the supporting scaffold begins to degrade, and the degraded supporting scaffold can flow out through the mesh openings; the support framework is made of degradable polyurethane materials, and can flow out through meshes to enter blood metabolism after being degraded, so that complete degradation and no residue are really realized, postoperative recovery of patients is facilitated, and complications of the patients are greatly reduced.

5. Different from the prior art, in one embodiment of the invention, the filler is soft or elastic, and after the filler expands, the left atrial appendage filling instrument can be embedded into the folds of the inner wall surface of the left atrial appendage, so that the anchoring force between the left atrial appendage filling instrument and the inner wall of the left atrial appendage is enhanced.

Embodiments of the present application are capable of achieving other advantageous technical effects not listed individually, which other technical effects may be described in part below and are anticipated and understood by those of ordinary skill in the art upon reading the present application.

Drawings

The above features and advantages and other features and advantages of these embodiments, and the manner of attaining them, will become more apparent and the embodiments of the application will be better understood by reference to the following description, taken in conjunction with the accompanying drawings, wherein:

fig. 1a to 1d are a schematic overall structure diagram and a schematic partial structure diagram of the left atrial appendage filling instrument of the present invention.

Fig. 2a to 2c are schematic structural diagrams of the supporting framework and schematic diagrams of the supporting framework in the first form.

Fig. 3a to 3e are schematic views illustrating the operation process of the left atrial appendage filling device for treating the left atrial appendage.

The names of the parts indicated by the numbers in the drawings are as follows: 1-capsular bag, 11-holes, 2-supporting framework, 21-supporting rod and 3-filler.

Detailed Description

The present application will be described in further detail with reference to the following drawings and examples.

The proximal end is the end close to the operator, and the distal end is the end far away from the operator.

The specific embodiment is as follows:

the details of one or more embodiments of the application are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the application will be apparent from the description and drawings, and from the claims.

It is to be understood that the embodiments illustrated and described are not limited in application to the details of construction and the arrangement of components set forth in the following description or illustrated in the following drawings. The illustrated embodiments are capable of other embodiments and of being practiced or of being carried out in various ways. Examples are provided by way of explanation of the disclosed embodiments, not limitation. Indeed, it will be apparent to those skilled in the art that various modifications and variations can be made in the embodiments of the present application without departing from the scope or spirit of the disclosure. For instance, features illustrated or described as part of one embodiment, can be used with another embodiment to yield a still further embodiment. Accordingly, the disclosure is intended to cover such modifications and variations as fall within the scope of the appended claims and their equivalents.

Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of "including," "comprising," or "having" and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items.

The present application will be described in more detail below with reference to various embodiments and examples of several aspects of the application.

Example one

According to one example, a left atrial appendage filling device with a degradable supporting framework comprises a sac 1, a supporting framework 2 arranged in the sac 1 and used for anchoring and supporting, and a filler 3 arranged in the sac 1, as shown in fig. 1a to 1c, wherein the sac 1 is provided with a plurality of holes 11, the filler 3 can be expanded by water, the supporting framework 2 is made of degradable polyurethane material, and when the supporting framework is pre-assembled, the left atrial appendage filling device is compressed into an elongated component and is delivered to a target position; when the release is carried out, the supporting framework 2 is restored to the preset shape and anchored in the left auricle, and the filler 3 gradually absorbs water and expands to enable the sac bag to be embedded into the folds on the inner wall of the left auricle.

In this embodiment, the support scaffold 2 has a first configuration in which the support scaffold 2 is compressed and delivered to the target site, as shown in fig. 2b and 2c, the support scaffold 2 is transformable by self-expansion to a second configuration in which the support scaffold 2 is supported and anchored within the left atrial appendage, as shown in fig. 1b and 3 c; the supporting framework 2 has a certain supporting force, so that after the left auricle filling instrument is implanted into the left auricle, the supporting framework 2 can provide enough supporting and anchoring force, and the left auricle filling instrument can be firmly fixed in the left auricle.

In this embodiment, the supporting framework 2 includes a plurality of supporting rods 21, as shown in fig. 2a, and the wall thickness of the supporting rods 21 is 0.1-0.6 mm; the support rod 21 has sufficiently high hardness and tensile strength, and relatively low elongation, and can be formed into a medical-grade tube by an extrusion molding process.

In this embodiment, the support rod 21 is formed with a pattern structure by a laser engraving technique, and then the support frame 2 is formed by a heat setting process.

In this embodiment, the supporting frame 2 is fixedly connected to the inner peripheral surface of the capsular bag 1, as shown in fig. 1 b.

In this embodiment, because the inner wall surface of the left atrial appendage on the side close to the left atrium is smooth, and the inner wall surface on the side far from the left atrium is wrinkled, the support frame 2 is arranged on one side in the bag 1, and one side of the bag 1 is close to the left atrium; the advantages of such a design are: after the filler 3 in the bag 1 is expanded, the bag 1 can be tightly attached to the folds of the inner wall surface of the left auricle, so that the anchoring effect of the left auricle filling instrument is enhanced.

In another embodiment, the two sides of the inside of the bag 1 are respectively provided with a supporting framework 2, so that the design has the advantages that: effectively improve the supporting force of the left auricle filling instrument.

In this embodiment, the bag 1 is a film with a mesh structure, and the mesh has a pore size of 0.15-1 mm.

In this embodiment, the mesh allows blood to flow, so that the heart tissue grows into the bag 1, and at the same time, the filler 3 in the bag 1 absorbs water and expands, so that the bag 1 can fully contact the inner wall surface of the left atrial appendage, as shown in fig. 1c and 1d, and the mesh prevents thrombus from flowing out of the left atrial appendage; the advantages of such a design are: after left auricle filling instrument was implanted left auricle, the heart tissue can climb and attach bag 1 and to bag 1 interior infiltration, makes its endothelialization for left auricle filling instrument and the further fixed of heart tissue implanted, simultaneously, the mesh can prevent the thrombus circulation, avoids taking place abominable circumstances such as apoplexy.

In this embodiment, after the capsular bag 1 is endothelialized by the heart tissue, the supporting framework 2 starts to degrade, and the degraded supporting framework 2 can flow out through the meshes; the support framework 2 is made of degradable polyurethane materials, and can flow out through meshes to enter blood metabolism after the support framework 2 is degraded, so that complete degradation and no residue are really realized, postoperative recovery of a patient is facilitated, and complications of the patient are greatly reduced.

In the embodiment, the pouch 1 is woven by spinning polyurethane material into fiber or drawing process into filament, and the diameter of the fiber or filament is less than or equal to 0.3 mm; the combination of the filaments having a relatively high swelling ratio, e.g., 10 or more times water swellable property, and/or a relatively high elongation, allows the left atrial appendage filling device to significantly enhance adequate sealing with the interior of the left atrial appendage at the target placement area, ensuring effective occlusion of the left atrial appendage filling device.

In this embodiment, the filler 3 is an injectable gel material, or the filler 3 is a polyurethane material with foamed pores or water-swelling; the filler 3 is soft or elastic, and when the filler 3 is expanded, the left atrial appendage filling device can be embedded into the folds of the inner wall surface of the left atrial appendage, so that the anchoring force between the left atrial appendage filling device and the inner wall of the left atrial appendage is enhanced, as shown in fig. 3c and 3 d.

An exemplary procedure for treating a left atrial appendage with a degradable support scaffold of the first embodiment is as follows:

1. the left atrial appendage filling instrument is loaded into the delivery system by compression, with the support scaffold 2 in the first configuration, and delivered to the left atrial appendage site using the delivery system, as shown in fig. 3a and 3 b;

2. operating the delivery system to release the left atrial appendage filling device within the left atrial appendage, the support frame 2 returning from the first configuration to the second configuration and supported within the left atrial appendage, the delivery system being withdrawn from the heart, as shown in figure 3 c;

3. the blood in the heart flows in through the hole 11 of the bag 1, so that the filler 3 in the bag 1 absorbs water and expands, and the bag 1 is fully contacted with the inner wall surface of the left atrial appendage, as shown in fig. 3 d;

4. after the endothelialization of the heart tissue and the capsular bag 1 is completed (about 6 months), the degradation of the supporting skeleton 2 is started, and the degraded supporting skeleton 2 flows out through the holes 11 of the capsular bag 1 and participates in the metabolism together with the autologous blood, as shown in fig. 3 e.

The foregoing is only a preferred embodiment of the present application, and those skilled in the art will appreciate that the present disclosure is not limited thereto.

Claims

1. A left atrial appendage filling device comprises a flow-resistant membrane, a supporting framework for anchoring and supporting, and a filler, and is characterized in that: the flow-blocking membrane may prevent filler from entering the left atrium, the filler may be expandable, the support frame may be anchored in the left atrial appendage, and the filler may be expandable and embedded into folds in the inner wall of the left atrial appendage.

2. A left atrial appendage filling instrument as in claim 1, wherein: the support scaffold having a first configuration in which the support scaffold is compressed and delivered to a target location and a second configuration into which the support scaffold is transformable by self-expansion and in which the support scaffold supports and anchors within the left atrial appendage; the support skeleton is made of degradable materials.

3. A left atrial appendage filling instrument as in claim 1, wherein: the supporting framework comprises a plurality of supporting rods, and the wall thickness of each supporting rod is 0.1-1 mm.

4. A left atrial appendage filling instrument as in claim 1, wherein: the left atrial appendage filling instrument further comprises a bag, the proximal end area of the bag is the flow blocking membrane, the bag is provided with a plurality of holes, the filler is arranged in the bag of the conveying system, and the bag is partially embedded into folds on the inner wall of the left atrial appendage after the filler is gradually expanded.

5. A left atrial appendage filling instrument as in claim 1, wherein: the support framework is fixedly connected with the inner peripheral surface of the bag.

6. A left atrial appendage filling instrument as in claim 1, wherein: the support frame is disposed on one side within the pocket, and one side of the pocket is adjacent to the left atrium.

7. A left atrial appendage filling instrument as in claim 1, wherein: the bag is a film with a mesh structure, and the aperture of the mesh is 0.15-1 mm.

8. A left atrial appendage filling instrument as in claim 7, wherein: the mesh can allow blood to circulate and can prevent thrombus from flowing out of the left atrial appendage; and the mesh holes enable the left atrial appendage filling instrument to enable the growth of heart tissue into the capsular bag.

9. A left atrial appendage filling instrument as in claim 8, wherein: after the capsular bag is endothelialized by the heart tissue, the supporting scaffold begins to degrade.

10. A left atrial appendage filling instrument as in claim 7, wherein: the bag is woven by spinning polyurethane material into fibers or forming filaments through a drawing process, and the wire diameter of the fibers or the filaments is less than or equal to 0.5 mm.

11. A left atrial appendage filling instrument as in claim 1, wherein: the filler is an injectable gel material, or the filler is a polyurethane material with foaming pores or water absorption expansion.

12. A left atrial appendage filling instrument as in claim 9, wherein: the prepared framework is made of degradable polyurethane material, the support framework begins to degrade after 6-12 months after the left atrial appendage filling device is implanted into a body, and the degraded support framework can flow out through the meshes.