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CN110025350B - Adjustable left atrial appendage occluder with sliding damping - Google Patents

Adjustable left atrial appendage occluder with sliding damping Download PDF

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Publication number
CN110025350B
CN110025350B CN201910381800.5A CN201910381800A CN110025350B CN 110025350 B CN110025350 B CN 110025350B CN 201910381800 A CN201910381800 A CN 201910381800A CN 110025350 B CN110025350 B CN 110025350B
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CN
China
Prior art keywords
connecting sleeve
movable rod
atrial appendage
left atrial
sliding damping
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CN201910381800.5A
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Chinese (zh)
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CN110025350A (en
Inventor
徐亚伟
阮成民
陈维
麦志伟
吴庆桓
姜亚伦
林伟林
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Guangdong Pulse Medical Technology Co ltd
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Guangdong Pulse Medical Technology Co ltd
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Priority to CN201910381800.5A priority Critical patent/CN110025350B/en
Publication of CN110025350A publication Critical patent/CN110025350A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/12Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12122Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder within the heart
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/12Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12168Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
    • A61B17/12172Occluding 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/12Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12168Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
    • A61B17/12177Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure comprising additional materials, e.g. thrombogenic, having filaments, having fibers or being coated
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B2017/00831Material properties
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B2017/00982General structural features
    • A61B2017/00995General structural features having a thin film

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

Abstract

The invention relates to the field of implantable medical equipment, in particular to an adjustable left auricle plugging device with sliding damping, which comprises a plugging piece and a fixing piece, wherein the plugging piece comprises a flat cage-shaped plug body formed by woven wires and a movable rod vertically arranged at the top of the plug body, the fixing piece comprises a connecting sleeve and a plurality of inverted U-shaped fixing strips arranged at the upper end of the connecting sleeve, the upper end of the movable rod penetrates through the connecting sleeve and is provided with a limiting end, the width of the limiting end is larger than the inner diameter of the connecting sleeve, the movable rod comprises two elastic wire bundles, the elastic wire bundles comprise a plurality of elastic wires, a separation pin is fixedly arranged in the connecting sleeve, and the two elastic wire bundles penetrate through the connecting sleeve through two sides of the separation pin. The relative distance between the blocking piece and the fixing piece is adjustable, damping exists in the adjusting process, and the conduction of force between the blocking piece and the fixing piece and the distribution of external force can be improved.

Description

Adjustable left atrial appendage occluder with sliding damping
Technical Field
The invention relates to the field of implantable medical devices, in particular to an adjustable left auricle plugging device with sliding damping.
Background
Atrial fibrillation (i.e., atrial fibrillation) is a common sustained arrhythmia disease, and related research data shows that the prevalence of atrial fibrillation for adults over 30 years old in China is 0.65%, about 420 thousands of people, the incidence of atrial fibrillation with the increase of the age is continuously increased, and the prevalence of atrial fibrillation for people over 75 years old is as high as 10%. When the atria are in atrial fibrillation, the atria lose the contractile function, blood is easy to stagnate in the atria, especially in the left auricle to form thrombus, and after the thrombus is shed, the thrombus can flow to the whole body everywhere along with the blood and can cause cerebral apoplexy. Atrial fibrillation is a main risk factor of cerebral apoplexy, and 21.95% of patients suffering from atrial fibrillation have cerebral apoplexy, which is more than 5 times higher than the risk of normal people.
Studies have demonstrated that about 91% of the thrombi in atrial fibrillation patients originate from the left atrial appendage. Aiming at cerebral apoplexy caused by atrial fibrillation, the traditional treatment method has two ways of anticoagulation treatment and operation treatment. Anticoagulation requires patients to take anticoagulants for a long period of time, and is therefore inconvenient to apply. Surgical treatment approaches require the left atrial appendage to be surgically closed or resected, and the surgical procedure can be extremely traumatic to the patient and present a risk. Minimally invasive interventional occlusion left atrial appendage surgery developed in the last decade is increasingly being applied to clinical treatment and achieves relatively ideal curative effects.
The minimally invasive interventional left auricle plugging operation is to implant a left auricle plugging device into the left auricle and plug the left auricle through a catheter interventional method, so that blood flow entering the left auricle is blocked, and thrombus of the left auricle during atrial fibrillation can be prevented from the source. The plug disc type left atrial appendage occlusion device widely applied in the occlusion device is generally of a connected structure and mainly comprises a fixing piece clamped into the left atrial appendage and an occlusion piece positioned at the mouth of the left atrial appendage. Because the left auricle and the whole heart are always in the systolic and diastolic circulation motion, the sealing piece and the fixing piece are required to be deformed independently and the relative distance can be changed, the prior products can change the relative distance of the two parts along with the movement of the heart within a certain range by improving the connecting structure of the two parts, but the damping is hardly generated in the changing process, so that the conduction of force between the two parts and the uniform distribution of external force in the two parts are not facilitated, and the inconsistent loss degree of the two parts is easy to cause.
Disclosure of Invention
The invention mainly aims to provide an adjustable left atrial appendage plugging device with sliding damping, wherein the relative distance between a plugging piece and a fixing piece is adjustable, and the sliding damping exists in the adjusting process.
In order to achieve the above purpose, the invention provides an adjustable left auricle plugging device with sliding damping, which comprises a plugging piece and a fixing piece, wherein the plugging piece comprises a flat cage-shaped plug body formed by braiding wires and a movable rod vertically arranged at the top of the plug body, the fixing piece comprises a connecting sleeve and a plurality of inverted U-shaped fixing strips arranged at the upper end of the connecting sleeve, the upper end of the movable rod penetrates through the connecting sleeve and is provided with a limiting end, and the width of the limiting end is larger than the inner diameter of the connecting sleeve.
According to the scheme, the movable rod in the connecting sleeve is forcibly separated into two elastic tows by the separating pin, the two elastic tows which are originally clung to each other are separated and then the internal elastic yarns are changed in shape and distribution, so that the two elastic tows are elastically deformed and clung to and press the separating pin, a certain friction force is generated when the movable rod moves relative to the connecting sleeve, and a damping mechanism is introduced into the movement process. In addition, the silk bundle rod formed by the elastic silk is convenient to bend and twist, can well connect the plug body and the fixing piece in the dynamic movement process of the heart, and provides a sufficient relative movement range for the plug body and the fixing piece.
The plugging piece comprises a plurality of memory alloy wires, wherein the memory alloy wires comprise a braiding section and a free section positioned above the braiding section, the braiding section of the memory alloy wires is braided to form a flat cage-shaped plug body, the free sections of the memory alloy wires are folded to form a movable rod in a tow shape, and the movable rod in the connecting sleeve is divided into two strands of memory alloy tows by a separation pin.
The integral plug body and the movable rod are beneficial to simplifying the manufacturing process and improving the overall structural strength of the plugging piece, and the memory alloy wire has good elasticity and shape memory performance, and can simultaneously meet the performance requirements of the plug body and the movable rod after being manufactured by different processes.
The further scheme is that the limiting end head comprises a ball head formed by hot melt polymerization of the top ends of free sections of all memory alloy wires and an end sealing cover fixedly sleeved on the ball head, and the outer diameter of the end sealing cover is larger than the inner diameter of the connecting sleeve.
The free section top of all memory alloy wires is convenient for fix the end cover on the free section top through the ball head of hot melt polymerization as an organic whole through the welding mode after, can guarantee the structural strength of spacing end and the joint strength of ball head and end cover.
The further scheme is that the separation pin is arranged on the connecting sleeve in a penetrating way and comprises a bolt pin body and a nut pin cap which are connected through threads.
The size of the connecting sleeve in the length direction of the separation pin can be finely adjusted through the bolt pin body and the nut pin cap, so that the tightening degree of the connecting sleeve on the movable rod is adjusted to change the damping between the movable rod and the connecting sleeve.
The further proposal is that the lower end of the movable rod is fixedly sleeved with a tightening sleeve.
The tightening sleeve is arranged at the lower end of the movable rod, and can be used for gathering the free section of the memory alloy wire and maintaining the shape of the lower end of the movable rod.
The further scheme is that the end part of the fixing strip is provided with a lifting hook which is bent inwards, and the end part of the lifting hook is provided with a hook end ball head.
The further scheme is that the end part of the fixing strip is also provided with an anchor which is bent outwards.
The hook with the hook end ball head at the end part can hook the comb muscle in the left auricle, the anchor can hook the wall of the left auricle, and the two structures are matched with each other to stably fix the fixing piece in the left auricle.
Further, the fixing piece is coated with an upper choke film, and the plug body is coated with a lower choke film.
The further proposal is that the upper flow blocking film is a polyester film which is arranged on the inner side of the fixing strip and is connected with the fixing strip in a sewing way, or a double-layer expanded polytetrafluoroethylene film which is adhered and fixed on the inner side and the outer side of the fixing strip.
Further, the lower flow blocking film is a polyester film sewn and fixed on the inner side of the plug body or an expanded polytetrafluoroethylene film adhered and fixed on the inner side and the outer side of the plug body.
The polyester film and the polytetrafluoroethylene film belong to polymer films which are commonly used in the field of implantable medical devices and have excellent biocompatibility, tensile strength, impact strength and other mechanical properties, and are ideal choke film materials of the left atrial appendage occluder.
Drawings
FIG. 1 is a block diagram of an embodiment of an adjustable left atrial appendage closure of the present invention having sliding damping.
Fig. 2 is a cross-sectional view at a in fig. 1.
FIG. 3 is a block diagram of the connection of the anchor to the movable rod in an embodiment of the adjustable left atrial appendage closure of the present invention having sliding damping.
Fig. 4 is a block diagram of the connection sleeve to the movable rod in an embodiment of the adjustable left atrial appendage closure of the present invention having sliding damping.
Fig. 5 is a block diagram of an embodiment of the adjustable left atrial appendage occlusion device of the present invention having sliding damping in a first state of use.
Fig. 6 is a block diagram of an embodiment of the adjustable left atrial appendage occlusion device of the present invention having sliding damping in a second in-use condition.
The invention is further described below with reference to the drawings and examples.
Detailed Description
Referring to fig. 1 to 4, the adjustable left atrial appendage plugging device with sliding damping provided by the invention comprises a plugging piece 1 and a fixing piece 2, wherein the plugging piece 1 comprises a flat cage-shaped plug body 11 formed by braiding wires and a movable rod 12 vertically arranged at the top of the plug body 11, the fixing piece 2 comprises a connecting sleeve 21 and a plurality of inverted U-shaped fixing strips 22 arranged at the upper end of the connecting sleeve 21, the upper end of the movable rod 12 penetrates through the connecting sleeve 21 and is provided with a limiting end head 13, and the width of the limiting end head 13 is larger than the inner diameter of the connecting sleeve 21. The movable bar 12 comprises two strands of elastic strands containing a plurality of elastic filaments. A separating pin 23 is fixedly arranged in the connecting sleeve 21, and two elastic tows pass through the connecting sleeve 21 through two sides of the separating pin 23.
The movable rod 12 in the connecting sleeve 21 is forcedly divided into two elastic tows by the dividing pin 23, and the two elastic tows which are originally clung to each other are divided into two elastic tows, and the internal elastic tows are changed in form and distribution, so that the two elastic tows are elastically deformed and clung to and press the dividing pin 23, thereby generating a certain friction force when the movable rod 12 moves relative to the connecting sleeve 21, and introducing a damping mechanism for the movement process. In addition, the tow rod formed by the elastic wires is convenient to bend and twist, can well connect the plug body 11 and the fixing piece 2 in the dynamic movement process of the heart, and provides a sufficient relative movement range for the plug body 11 and the fixing piece 2.
Alternatively, the spacer pin 23 may be a headless pin or a headed pin, and accordingly, both ends of the headless pin need to be welded to the connecting sleeve 21, and the headed pin needs to be welded to the connecting sleeve 21 at the end of the shank. The separation pin 23 may be integrally formed in the connecting sleeve 21, and at least one end thereof is fixedly connected to the inner wall of the connecting sleeve 21. It is further easily conceivable that a plurality of separating pins 23 may be provided, the plurality of separating pins 23 extending in the radial direction of the connecting sleeve and not being parallel, which contributes to an increased damping between the connecting sleeve 21 and the movable rod 12.
The plugging member 1 comprises a plurality of memory alloy wires 14, the memory alloy wires 14 comprise a knitting section 141 and a free section 142 positioned above the knitting section 141, the knitting section 141 of the plurality of memory alloy wires 14 is knitted to form a flat cage-shaped plug body 11, the free sections 142 of the plurality of memory alloy wires 14 are folded to form a movable rod 12 in a tow shape, and the movable rod 12 in the connecting sleeve 21 is divided into two memory alloy tows by a division pin 23.
The plug body 11 and the movable rod 12 which are integrally formed are beneficial to simplifying the manufacturing process and improving the overall structural strength of the plugging piece 1. The memory alloy wires, such as nickel titanium alloy, generally have good elasticity and shape memory performance, and after the plug 11 and the movable rod 12 are manufactured by different processes, the performance requirements of the two can be met simultaneously.
The partition pin 23 is penetratingly provided on the connection sleeve 21, and the partition pin 23 includes a bolt pin body 231 and a nut pin cap 232 which are screw-coupled. The size of the connecting sleeve 21 in the length direction of the separation pin 23 can be finely adjusted through the bolt pin body 231 and the nut pin cap 232, so that the tightening degree of the connecting sleeve 21 on the movable rod 12 is adjusted, and the damping between the movable rod 12 and the connecting sleeve 21 is changed.
The lower end of the movable rod 12 is fixedly sleeved with a tightening sleeve 15. The tightening sleeve 15 is arranged at the lower end of the movable rod 12, and can be used for gathering the free section 142 of the memory alloy wire 14 so as to maintain the shape of the lower end of the movable rod 12, and the tightening sleeve 15 can be fixedly connected with the memory alloy wire 14 at the periphery of the movable rod 12 in a tow rod shape through laser welding.
The limiting end head 13 comprises a ball head 131 formed by hot melt polymerization of the top ends of free sections 142 of all the memory alloy wires 14 and a sealing cover 132 fixedly sleeved on the ball head 131, and the outer diameter of the sealing cover 132 is larger than the inner diameter of the connecting sleeve 21. The end of the fixing strip 22 is provided with a lifting hook 24 which is bent inwards, the end of the lifting hook 24 is provided with a hook end ball head 25, and the end of the fixing strip 22 is also provided with an anchor 26 which is bent outwards.
The top ends of the free sections 142 of all the memory alloy wires 14 are fixedly sleeved on the free sections through the end-sealing cover 132 in a laser welding mode after being polymerized into the ball head 131 integrally through hot melting, so that the structural strength of the limiting end 13 and the connection strength of the ball head 131 and the end-sealing cover 132 can be ensured. As shown in fig. 5 and 6, the hook 24 with the hook end ball 25 at the end can hook the comb muscle 51 in the left auricle 5, the anchor 26 can hook the inner wall of the left auricle 5, and the two structures are matched with each other to stably fix the fixing piece 2 in the left auricle 5.
When the plug 11 and the movable rod 12 are integrally manufactured, a plurality of memory alloy wires 14 are firstly taken and woven into a weaving cylinder at the lower section, and the upper section is kept in a free state. The braiding pot is then trimmed to form a flat cage-like plug 11, the lower end of which may be secured by a threaded connection assembly including an inner and outer nut and a serrated washer. And bending the upper section of the memory alloy wire 14 to be perpendicular to the plug 11 and gathering the memory alloy wire into a bundle. And then a tightening sleeve 15 is welded and fixed at the lower end of a silk bundle formed by the upper section of the memory alloy silk 14, and the upper end of the silk bundle passes through a connecting sleeve 21 and then is manufactured into a ball head with the width larger than the connecting sleeve 21 through a hot melting process, so that the movable rod 12 is manufactured.
Referring to fig. 1, the fixing member 2 is coated with an upper choke film 3, and the plug body 11 is coated with a lower choke film 4. The upper choke film 3 is a polyester film which is arranged on the inner side of the fixing strip 22 and is connected with the fixing strip 22 in a sewing way or a double-layer expanded polytetrafluoroethylene film which is adhered and fixed on the inner side and the outer side of the fixing strip 22. The lower choke film 4 is a polyester film sewn and fixed on the inner side of the plug body 11 or an expanded polytetrafluoroethylene film adhered and fixed on the inner side and the outer side of the plug body 11.
The polyester film and the polytetrafluoroethylene film belong to polymer films which are commonly used in the field of implantable medical devices and have excellent biocompatibility, tensile strength, impact strength and other mechanical properties, and can have ideal plugging effect on the left auricle after being applied to the fixing piece 2 and the plug 11. Because the plug body 11 is of a three-dimensional cage-shaped structure, the lower choke film 4 can be split into two pieces, and is respectively coated on the upper part and the lower part of the plug body 11 and then is sewn or bonded into a whole.

Claims (9)

1. The utility model provides an possess sliding damping's adjustable left auricle stopper, includes shutoff piece and mounting, the shutoff piece including weave the flat cage form cock body that the silk formed and set up perpendicularly in the movable rod at cock body top, the mounting include the adapter sleeve and locate many back U type fixed strips of adapter sleeve upper end, the upper end of movable rod passes the adapter sleeve is equipped with spacing end, the width of spacing end is greater than the internal diameter of adapter sleeve, its characterized in that:
The movable rod comprises two strands of elastic tows, the elastic tows comprise a plurality of elastic filaments, a separation pin is fixedly arranged in the connecting sleeve, and the two strands of elastic tows penetrate through the connecting sleeve through two sides of the separation pin;
The plugging piece comprises a plurality of memory alloy wires, wherein the memory alloy wires comprise a braiding section and a free section positioned above the braiding section, the braiding sections of the memory alloy wires are braided to form the flat cage-shaped plug body, the free sections of the memory alloy wires are folded to form the movable rod in a tow shape, and the movable rod in the connecting sleeve is divided into two strands of memory alloy tows by the separation pin;
the separation pin is arranged on the connecting sleeve in a penetrating way.
2. The adjustable left atrial appendage closure with sliding damping of claim 1, wherein:
The limiting end head comprises a ball head formed by hot melt polymerization of the top ends of free sections of all the memory alloy wires and an end sealing cover fixedly sleeved on the ball head, and the outer diameter of the end sealing cover is larger than the inner diameter of the connecting sleeve.
3. The adjustable left atrial appendage closure with sliding damping of claim 1 or 2, wherein:
The separation pin comprises a bolt pin body and a nut pin cap which are in threaded connection.
4. The adjustable left atrial appendage closure with sliding damping of claim 3, wherein:
The lower end of the movable rod is fixedly sleeved with a tightening sleeve.
5. The adjustable left atrial appendage closure with sliding damping of claim 3, wherein:
The end part of the fixing strip is provided with a lifting hook which is bent inwards, and the end part of the lifting hook is provided with a hook end ball head.
6. The adjustable left atrial appendage closure with sliding damping of claim 3, wherein:
the end part of the fixing strip is provided with an anchor which is bent outwards.
7. The adjustable left atrial appendage closure with sliding damping of claim 3, wherein:
the upper choke film is coated on the fixing piece, and the lower choke film is coated on the plug body.
8. The adjustable left atrial appendage closure with sliding damping of claim 7, wherein:
The upper choke film is a polyester film which is arranged on the inner side of the fixing strip and is connected with the fixing strip in a sewing way or a double-layer expanded polytetrafluoroethylene film which is fixed on the inner side and the outer side of the fixing strip in an adhesion way.
9. The adjustable left atrial appendage closure with sliding damping of claim 7, wherein:
The lower choke film is a polyester film sewn and fixed on the inner side of the plug body or a bulked polytetrafluoroethylene film adhered and fixed on the inner side and the outer side of the plug body.
CN201910381800.5A 2019-05-08 2019-05-08 Adjustable left atrial appendage occluder with sliding damping Active CN110025350B (en)

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CN110025350B true CN110025350B (en) 2024-06-18

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CN111419302B (en) * 2020-06-10 2020-09-01 上海介入医疗器械有限公司 Left atrial appendage plugging device with adjustable distance and left atrial appendage plugging system
EP4384085A1 (en) * 2021-08-13 2024-06-19 Boston Scientific Scimed, Inc. Left atrial appendage implant with distal engagement element
CN114305818B (en) * 2021-12-01 2025-08-05 宁波迪创医疗科技有限公司 Implantable device and its assembly and removal tool assembly
CN116763384A (en) * 2023-05-23 2023-09-19 上海玮启医疗器械有限公司 An anticoagulant-coated left atrial appendage occlusion device and its preparation method

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