CN112472197A - Left auricle plugging device - Google Patents

Left auricle plugging device Download PDF

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Publication number
CN112472197A
CN112472197A CN202011611705.9A CN202011611705A CN112472197A CN 112472197 A CN112472197 A CN 112472197A CN 202011611705 A CN202011611705 A CN 202011611705A CN 112472197 A CN112472197 A CN 112472197A
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CN
China
Prior art keywords
fixing part
connecting cap
disc
cap
atrial appendage
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Pending
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CN202011611705.9A
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Chinese (zh)
Inventor
顾兴中
李书翔
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Taizhou Institute Of Biomedicine And Medical Devices Southeast University
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Taizhou Institute Of Biomedicine And Medical Devices Southeast University
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Priority to CN202011611705.9A priority Critical patent/CN112472197A/en
Publication of CN112472197A publication Critical patent/CN112472197A/en
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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
    • 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
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B23—MACHINE TOOLS; METAL-WORKING NOT OTHERWISE PROVIDED FOR
    • B23P—METAL-WORKING NOT OTHERWISE PROVIDED FOR; COMBINED OPERATIONS; UNIVERSAL MACHINE TOOLS
    • B23P15/00—Making specific metal objects by operations not covered by a single other subclass or a group in this subclass
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00526—Methods of manufacturing

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Public Health (AREA)
  • Vascular Medicine (AREA)
  • Reproductive Health (AREA)
  • Veterinary Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Cardiology (AREA)
  • Mechanical Engineering (AREA)
  • Surgical Instruments (AREA)

Abstract

The invention relates to a left auricle occluder, which comprises a near-end occluding disc, a connecting piece and a far-end fixing piece, wherein the near-end occluding disc consists of an upper-end connecting cap of the occluding disc, a woven reticular structure and a lower-end connecting cap of the occluding disc; the far end fixing part consists of a connecting cap at the upper end of the fixing part, a framework structure and a connecting cap at the lower end of the fixing part; the upper end connecting cap of the plugging disc is provided with a threaded hole for connecting with a conveying system; spherical space is arranged in the connecting cap at the lower end of the plugging disc and the connecting cap at the upper end of the fixing part, connecting pieces with spherical two ends are embedded into the spherical space so as to realize the relative rotation between the near-end plugging disc and the far-end fixing part, and a flow-stopping film is arranged on the near-end plugging disc and the far-end fixing part. The invention has high adaptability to different individual left atrial appendage structures and excellent performance.

Description

Left auricle plugging device
Technical Field
The invention belongs to the technical field of medical instrument design, and particularly relates to a novel left atrial appendage occluder.
Background
Atrial fibrillation (atrial fibrillation) is the most common clinical arrhythmia, the prevalence rate of the atrial fibrillation in the total population is 0.4% -1.0%, the main harm of the atrial fibrillation is to promote thrombosis, and the atrial fibrillation is the main reason of causing complications such as ischemic stroke, peripheral vascular embolism and the like. The stroke is the most common complication with the greatest harm in atrial fibrillation, the incidence rate is 1.9% -18.2%, and the related disability rate is as high as 30%. Studies have shown that atrial thrombi occur in the left atrial appendage in more than 90% of patients with non-valvular atrial fibrillation and 60% of patients with valvular atrial fibrillation. The left atrial appendage, which is the remnant of the original left atrium at the embryonic stage, is in the shape of a curved, elongated tubular structure with a narrow apex. Meanwhile, the heart muscle has abundant pectinate muscles and small musculature beams, has the functions of active contraction and secretion, and has very important significance for relieving the pressure rise in the left atrium and ensuring the blood fullness of the left ventricle. When sinus rhythms are encountered, the left atrial appendage exhibits normal contractions to reduce thrombus formation. And left atrial pressure increases when the atrial fibrillation, and left atrium and left atrial appendage all can alleviate left atrial pressure through increase internal diameter and enhancement initiative shrink in order to guarantee that the left ventricle can be full of sufficient blood. However, this also causes the entrance of the left atrial appendage to widen significantly, and the effective regular contraction is lost, and the inward movement of the wall of the left atrial appendage makes it difficult to achieve sufficient evacuation of the left atrial appendage, and in addition, the blind end structure of the left atrial appendage and the structures of the comb-shaped muscles and the musculoskeletal beams which are concave and convex in the blind end structure of the left atrial appendage cause the blood flow to swirl and slow down, resulting in blood stasis and thrombus formation. Therefore, the intervention research of the left atrial appendage has important theoretical basis and clinical significance for preventing the thromboembolism of patients with atrial fibrillation.
At present, there are two main types of methods for preventing stroke of patients with atrial fibrillation, namely drug therapy and non-drug therapy. The drug therapy is therapy with an anticoagulant drug, but the anticoagulant therapy must be performed under the guidance of a professional doctor, if the anticoagulation is excessive, obvious bleeding complications occur, and if the anticoagulation strength is insufficient, the corresponding prevention effect cannot be achieved. In addition, when warfarin is used for anticoagulation treatment, the anticoagulation treatment needs to be monitored and controlled periodically, the process is very long, and the side effects of the warfarin are more. The non-drug treatment mainly comprises catheter radio frequency ablation and surgical treatment, but the radio frequency ablation is easy to cause atrioventricular conduction block, vague reflex and other problems, and the surgical treatment is not accepted by most patients due to large open wound.
The left atrial appendage occluder is a new technology for treating and preventing thromboembolism of patients with atrial fibrillation emerging in recent years, has the advantages of no need of thoracotomy, small wound, better curative effect than anticoagulation treatment, lower postoperative adverse reactions such as bleeding rate, disability rate, lethality rate and the like than anticoagulation treatment, and is considered to have good clinical application prospect. At present, the left atrial appendage occluder in the market is mainly divided into two types, one type is an inner plug type occluder represented by Wctchman, and the other type is a plug disc type occluder represented by ACP. However, the two types of left atrial appendage occluders have corresponding defects and deficiencies. The inner plug type plugging device has the following defects: the structural shape of different people's left auricle is different and the oral area shape is very irregular, and interior stopper type left auricle plugging device can not match all left auricle structures completely, and because of its deformability is limited, probably can't carry out the shutoff to left auricle oral area completely, and to the shutoff of big auricle, the performance of interior stopper type plugging device still lacks to some extent simultaneously. The traditional plug disc type plugging device has the following defects: the plugging disc and the fixed disc of the traditional plugging disc type left atrial appendage plugging device are designed in an integrated mode, and cannot be completely and independently deformed, so that when the plugging disc type plugging device is used for plugging, the plugging disc is covered and buckled at the mouth of a left atrial appendage, and can be pulled by the fixed disc penetrating into the left atrial appendage, so that the plugging disc cannot be fully attached to the mouth, residual shunt can occur, and the plugging effect of the plugging disc is affected. The invention aims to provide a novel left atrial appendage occluder to solve some problems of the existing left atrial appendage occluder.
Disclosure of Invention
The invention aims to overcome the defects in the prior art and provides a novel left atrial appendage occluder which is reasonable in design, ingenious in structure and convenient to use.
The invention relates to a left auricle occluder, which comprises a near-end occluding disc, a connecting piece and a far-end fixing piece, wherein the near-end occluding disc consists of an upper-end connecting cap of the occluding disc, a woven net structure and a lower-end connecting cap of the occluding disc; the far-end fixing part consists of a connecting cap at the upper end of the fixing part, a framework structure and a connecting cap at the lower end of the fixing part; the upper end connecting cap of the plugging disc is provided with a threaded hole for connecting with a conveying system; spherical space is arranged in the connecting cap at the lower end of the plugging disc and the connecting cap at the upper end of the fixing part, spherical connecting pieces are embedded into the spherical space, the two ends of the spherical connecting pieces are spherical, so that relative rotation between the near-end plugging disc and the far-end fixing part is realized, and a flow-blocking film is arranged on the near-end plugging disc and the far-end fixing part.
Further, the net structure is formed by weaving nickel-titanium alloy wires into a net structure by a mechanical weaving machine, then carrying out corresponding heat treatment to obtain a shaped cylindrical net structure, fixing two ends of the nickel-titanium alloy cylindrical net, placing the nickel-titanium alloy cylindrical net into a mold, and carrying out heat treatment shaping.
Furthermore, the upper end connecting cap of the plugging disc, the lower end connecting cap of the plugging disc, the upper end connecting cap of the fixing part and the lower end connecting cap of the fixing part are respectively connected with the net structure and the framework structure in a laser welding or microbeam welding mode.
Further, a waist structure is arranged on the proximal plugging disc.
Furthermore, the upper end of the near-end plugging disc is concave.
Furthermore, a J-shaped barb is arranged on the framework structure.
Further, the framework structure is integrally cut and formed.
The left auricle occluder has the advantages that the plugging disc and the fixing piece can rotate relatively to adjust the relative positions of the plugging disc and the fixing piece in the special-shaped bag-shaped space of the left auricle, and the waist feature is arranged on the plugging disc, so that the plugging disc can be aligned with the left auricle from the center. Above-mentioned characteristics can significantly reduce and go deep into left auricle internal fixation spare because the influence of tractive action to the shutoff dish makes the shutoff dish fully laminate with left auricle oral area, realizes best shutoff effect, can see in particular figure 4. Preferably, a flexible connection member with excellent elastic properties is provided, so that the axial position between the plugging disc and the fixing member can be adjusted to adapt to the left atrial appendage with different depths. On the contrary, as can be seen from fig. 5, when the traditional left atrial appendage occluder is implanted, the occluder disc and the fixing piece can not be completely and independently deformed along with the special-shaped bag-shaped space of the left atrial appendage, the compliance is poor, the fixing piece is dragged inside the left atrial appendage, the position of the occluder disc at the mouth of the left atrial appendage is affected, the state that the graphical representation can not be fully attached to the mouth is generated, and the residual shunt phenomenon is caused. Therefore, the invention has high adaptability to the structures of the left auricle of different individuals, has small influence on the original shape of the left auricle of the organism, reduces the occurrence of complications to a certain extent and has very excellent performance.
Drawings
Fig. 1 is a schematic structural diagram of an embodiment of the present invention.
Fig. 2 is a partial cross-sectional view of an embodiment of the present invention.
Fig. 3 is a schematic perspective view of an embodiment of the present invention.
Fig. 4 is a schematic view of the left atrial appendage after implantation of an embodiment of the present invention.
Fig. 5 is a schematic view of a state in which a conventional left atrial appendage occluder is implanted in a left atrial appendage.
Detailed Description
The invention is further explained below with reference to the drawings.
According to the technical scheme provided by the invention, the left atrial appendage occluder comprises a near end occluding disk 1, a connecting piece 6 and a far end fixing part 2, wherein corresponding flow resisting membranes are arranged on the near end occluding disk 1 and the far end fixing part 2. The near-end plugging disc 1 consists of a connecting cap 3 at the upper end of the plugging disc, a net structure 4 woven by nickel-titanium alloy wires and a connecting cap 5 at the lower end of the plugging disc; the far-end fixing part 2 consists of a fixing part upper end connecting cap 7, a framework structure 8 and a fixing part lower end connecting cap 9; wherein, the connecting cap 3 is provided with a threaded hole for connecting with a conveying system; spherical spaces are arranged on the connecting cap 5 at the lower end of the plugging disc and the connecting cap 7 at the upper end of the fixing part and are used for being matched with the connecting piece 6 to realize the relative rotation between the proximal plugging disc 1 and the distal fixing part 2; the four connecting caps 3, 5, 7 and 9 are respectively connected with the nickel-titanium alloy mesh 4 and the skeleton structure 8 in a laser welding or microbeam welding mode; the waist structure 10 on the proximal plugging disc 1 is beneficial to the self-centering alignment of the proximal plugging disc 1 at the mouths of the left auricles 12 of different individuals, so that the plugging head is better attached to the mouths of the left auricles 12 of the left ventricle 14, and the residual shunt 13 is reduced; the concave design of the upper end of the proximal plugging disc 1 is beneficial to reducing the length of the left atrial appendage plugging device after being unfolded and reducing the influence of the left atrial appendage plugging device on the inside of the left atrium; the framework structure 8 is integrally formed by cutting, and is provided with a J-shaped barb 11 which is flexible and tough, can bear repeated stretching for many times and is not broken, so that the operability and the operation reliability of doctors are improved.
The invention relates to a preparation method of a main body structure of a left atrial appendage occluder, which comprises the following steps:
proximal plugging disc 1: weaving nickel-titanium alloy wires with specified specifications into a net structure by adopting a mechanical weaving machine, and then carrying out corresponding heat treatment to obtain a shaped cylindrical net structure; fixing the two ends of the nickel-titanium alloy cylindrical net, placing the fixed net into a specified mould, and carrying out heat treatment setting at a corresponding temperature to obtain the near-end plugging disc 1.
Distal end fixing member 2: and cutting the nickel-titanium alloy tube by a laser cutting machine according to an input drawing, and then placing the cut nickel-titanium alloy tube into a specified die for heat treatment and shaping, so that the distal end fixing component 2 can be manufactured.

Claims (7)

1. A left auricle occluder comprises a proximal end occluding disk, a connecting piece and a distal end fixing part, and is characterized in that the proximal end occluding disk consists of an upper end connecting cap of the occluding disk, a woven net structure and a lower end connecting cap of the occluding disk; the far-end fixing part consists of a connecting cap at the upper end of the fixing part, a framework structure and a connecting cap at the lower end of the fixing part; the upper end connecting cap of the plugging disc is provided with a threaded hole for connecting with a conveying system; spherical space is arranged in the connecting cap at the lower end of the plugging disc and the connecting cap at the upper end of the fixing part, spherical connecting pieces are embedded into the spherical space, the two ends of the spherical connecting pieces are spherical, so that relative rotation between the near-end plugging disc and the far-end fixing part is realized, and a flow-blocking film is arranged on the near-end plugging disc and the far-end fixing part.
2. The left atrial appendage occluder of claim 1, wherein the mesh structure is formed by braiding nitinol wires into a mesh structure by a mechanical braiding machine, performing a corresponding heat treatment to obtain a shaped cylindrical mesh structure, fixing the two ends of the nitinol cylindrical mesh structure, placing the fixed nitinol cylindrical mesh structure in a mold, and performing a heat treatment to shape the mesh structure.
3. The left atrial appendage occluder of claim 1 or 2, wherein the upper connection cap of the occlusion disk, the lower connection cap of the occlusion disk, the upper connection cap of the fixing member and the lower connection cap of the fixing member are respectively connected with the net structure and the skeleton structure by laser welding or microbeam welding.
4. The left atrial appendage occluder of claim 1, wherein the proximal occluding disk has a waist feature thereon.
5. The left atrial appendage occluder of claim 4, wherein the proximal occluding disk is concave inwardly at its upper end.
6. The left atrial appendage occluder of claim 1 or 5, wherein said framework is provided with "J" shaped barbs.
7. The left auricle occluder of claim 6, wherein the skeleton structure is formed by cutting a nitinol tube by a laser cutting machine, and then placing the cut nitinol tube into a designated mold for heat treatment and shaping.
CN202011611705.9A 2020-12-30 2020-12-30 Left auricle plugging device Pending CN112472197A (en)

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Application Number Priority Date Filing Date Title
CN202011611705.9A CN112472197A (en) 2020-12-30 2020-12-30 Left auricle plugging device

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CN112472197A true CN112472197A (en) 2021-03-12

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113520486A (en) * 2021-06-24 2021-10-22 珠海市人民医院 Adjustable plugging device
CN114027912A (en) * 2021-12-03 2022-02-11 上海心玮医疗科技股份有限公司 Left auricle occluder capable of adjusting angle in multiple directions
CN114145802A (en) * 2021-12-06 2022-03-08 东南大学泰州生物医药与医疗器械研究院 Left atrial appendage occluder forming tool and manufacturing process

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113520486A (en) * 2021-06-24 2021-10-22 珠海市人民医院 Adjustable plugging device
CN114027912A (en) * 2021-12-03 2022-02-11 上海心玮医疗科技股份有限公司 Left auricle occluder capable of adjusting angle in multiple directions
CN114145802A (en) * 2021-12-06 2022-03-08 东南大学泰州生物医药与医疗器械研究院 Left atrial appendage occluder forming tool and manufacturing process
CN114145802B (en) * 2021-12-06 2023-07-14 东南大学泰州生物医药与医疗器械研究院 Left auricle plugging device forming tool and manufacturing process

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