CN106419990A - Delivery sheath body and left atrial appendage occluder delivery system - Google Patents

Delivery sheath body and left atrial appendage occluder delivery system Download PDF

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Publication number
CN106419990A
CN106419990A CN201610955830.9A CN201610955830A CN106419990A CN 106419990 A CN106419990 A CN 106419990A CN 201610955830 A CN201610955830 A CN 201610955830A CN 106419990 A CN106419990 A CN 106419990A
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China
Prior art keywords
delivery sheath
sheath body
sheath
seat
occluder
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Pending
Application number
CN201610955830.9A
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Chinese (zh)
Inventor
王祖禄
韩雅玲
梁明
李锋
周而辰
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Shanghai Wei Wei Medical Technology Co Ltd
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Shanghai Wei Wei Medical Technology Co Ltd
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Priority to CN201610955830.9A priority Critical patent/CN106419990A/en
Publication of CN106419990A publication Critical patent/CN106419990A/en
Pending legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, 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, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B2017/1205Introduction devices

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

Abstract

The invention discloses a delivery sheath body and a left atrial appendage occluder delivery system employing the same. The delivery sheath body for the left atrial appendage occluder delivery system is divided into three sections in the length direction, namely, a sheath body proximal end, a sheath body distal end and a sheath body intermediate section, wherein a first bendable part is arranged at the joint of the sheath body distal end and the sheath body intermerdiate section, and a second bendable part is arranged on the sheath body intermediate section; 1 to 3 development rings are arranged at the position, close to the sheath body distal end, of the sheath body intermediate section; the sheath body distal end is provided with 2 to 10 imaging holes. According to the delivery sheath body and the left atrial appendage occluder delivery system, convenience is brought to operation of a doctor, and the probability of heart injury is reduced.

Description

Delivery sheath body and occluder for left auricle induction system
Technical field
The present invention relates to medical instruments field, more particularly, to a kind of delivery sheath for occluder for left auricle induction system Body and the occluder for left auricle induction system using this delivery sheath body.
Background technology
How using Nitinol as support, in the inside sewing polyester non-woven fabrics of support, left auricle seals occluder for left auricle Stifled device induction system is made up of delivery sheath, dilator, loader, hemostatic system and conveying wirerope, but traditional delivery system System is difficult to meet some complicated left auricle structures, in course of conveying, due to left auricle complex structure, traditional delivery sheath Harder (the Shao Shi hardness of distal structure:50-70D) and only one of which knee is it is impossible to be changed angle in complicated cardiovascular Degree and searching path, it is difficult to reach left auricle position, also may can be damaged to blood vessel, endocardial or its hetero-organization, and pass The delivery sheath universal only one of which developing ring of system, in doctor's actual mechanical process, a developing ring can only determine conveying sheath The remote location of pipe is it is impossible to assessment enters distance or the particular location of delivery sheath far-end left auricle.In operation, doctor is being carried out During left atrial appendage occlusion, the effect of contrast agent, it is clear that still traditional delivery sheath does not generally have radiography hole, does not therefore have There is the effect making full use of contrast agent so that operation process carries out difficulty it is difficult to accurately find placement left atrial appendage occlusion for a long time The optimum position of device.In sum, the invention provides a kind of induction system of occluder for left auricle, for improving above asking Topic.
Content of the invention
In view of the drawbacks described above of prior art, the invention provides a kind of delivery sheath body, for left atrial appendage occlusion Device induction system, described delivery sheath body has the first flexible place and the second flexible place, described first flexible place Bendable angle is 0 °~50 °, and the bendable angle at described second flexible place is 0 °~50 °.
Further, described delivery sheath body is divided into three sections in the longitudinal direction, respectively body near-end, body distal end With body interlude, positioned at the junction of body near-end and body interlude, described second is flexible at described first flexible place Place is located on body interlude.
Further, the pipe thickness of described delivery sheath body is:0.2~0.5mm, described tube wall is divided into three layers, point Not Wei internal layer, intermediate layer and outer layer, the material of described internal layer is PTFE film, and the material in described intermediate layer is 304 rustless steels, described The material of outer layer be Pebax material, described outer layer by three kinds of different hardness Pebax material adopt laser machine welding welding and Become, the outer layer of described body near-end uses Pebax7533 material, and the outer layer of body interlude uses Pebax5533 material, body The outer layer of far-end uses pebax2533 material, and described intermediate layer is entwined by 304 stainless steel silks, the diameter of 304 stainless steel silks For 0.01~0.2mm, canoe is wound around for 0~0.5mm mode using spacing for proximal end, far-end adopt spacing be 0.01~ 0.5mm mode is wound around, and the PTFE film thickness of described internal layer is 0.01~0.05mm.
Further, described delivery sheath body interlude has 1~3 developing ring at body distal end, and first shows Shadow ring is located most closely to far-end, and the first developing ring is apart from far-end 1.0~20.0mm, second developing ring distance the first developing ring 1.0~15.0mm, the 3rd developing ring distance the second developing ring 1.0~10.0mm.
Further, the body distal end of described delivery sheath has 2~10 radiography holes, described delivery sheath body remote End length is 1.0~10.0mm.
The present invention also provides a kind of occluder for left auricle induction system, and for loading and conveying occluder for left auricle, it is special Levy and be, described occluder for left auricle induction system includes delivery sheath, dilator, loader, hemostatic system and conveying wirerope, Described dilator may pass through the inside of delivery sheath and forms heart shedding motion, described heart shedding motion, loader and only Blood system is sequentially connected and forms passage, and described conveying wirerope can be inserted partially into described passage, described delivery sheath include as Delivery sheath body described in claim 1-5 and delivery sheath sheath seat.
Further, the described dilator in wherein said occluder for left auricle induction system includes dilator body and expansion Prop sheath seat, described dilator body and dilator sheath seat use quick-drying gemel connection or integrated injection molding to connect.
Further, the described hemostatic system in wherein said occluder for left auricle induction system includes haemostatic valve, connection Pipe and three-way valve, haemostatic valve and connecting tube connect through UV glue, and connecting tube and three-way valve pass through to connect through UV glue.
Further, in wherein said occluder for left auricle induction system, described loader includes protheca seat, rear sheath seat And sheath, for the delivery sheath seat cooperation with delivery sheath, described rear sheath seat is used for and haemostatic valve cooperation described protheca seat, after Sheath seat is connected by UV glue with haemostatic valve.
Further, described left auricle conveying wirerope includes wirerope, handle and bolt, and described wirerope can enter in handle Portion, and be bolted, so that wirerope can not be slided with respect to handle.
Further, the protheca seat of described left auricle induction system, rear sheath seat, three-way valve, dilator sheath seat and conveying sheath The joint of pipe sheath seat is standard luer fittings.
The occluder for left auricle induction system of the present invention adopts delivery sheath and dilator cooperation composition heart shedding motion, Attached together using the conveying group that delivery sheath is sequentially connected composition occluder for left auricle with loader, hemostatic system and conveying wirerope Put, the interventional therapy of achievable occluder for left auricle, complete the loading of occluder for left auricle, convey, strut, reclaim and discharge Function, can effectively and rapidly complete the interventional therapy of occluder for left auricle, provide safer efficiently new control for patient's treatment Treatment means.The occluder for left auricle induction system of the delivery sheath body being provided using the present invention is easy to the operation of doctor, reduces The probability of impair cardiac.
Brief description
Fig. 1 is the schematic diagram of delivery sheath part in the present invention;
Fig. 2A is the schematic diagram of delivery sheath body portion section in the present invention;
Fig. 2 B is the schematic diagram of delivery sheath body distal end part in the present invention;
Fig. 3 is the schematic diagram of dilator part in the present invention;
Fig. 4 is the schematic diagram of loader part in the present invention;
Fig. 5 is the schematic diagram conveying steel cable part in the present invention;
Fig. 6 is the schematic diagram of hemostasis valve portion in the present invention;
Fig. 7 is the heart shedding motion schematic diagram of induction system in the present invention;
Fig. 8 is the conveying combination unit schematic diagram of induction system in the present invention.
It is below the corresponding relation of in figure reference and part:
100:Delivery sheath;101:Delivery sheath body;
102:Delivery sheath sheath seat;103:Delivery sheath body near-end;
104:Delivery sheath body interlude;105:Delivery sheath body distal end;
106:Delivery sheath body intermediate layer;107:Developing ring;108:Radiography hole;
109:Delivery sheath body internal layer;121:First flexible place;122:Second flexible place;
132:Most advanced and sophisticated
200:Dilator;201:Dilator body;202:Dilator sheath seat;
300:Hemostatic system;301:Haemostatic valve;302:Connecting tube;303:Three-way valve;
400:Loader;401:Sheath seat afterwards;402:Protheca seat;403:Sheath
500:Conveying wirerope;501:Wirerope;502:Handle;503:Bolt.
Specific embodiment
Below in conjunction with the accompanying drawing of the present invention, technical scheme is clearly and completely described it is clear that institute The embodiment of description is only a part of embodiment of the present invention, rather than whole embodiments.Based on the embodiment in the present invention, The every other embodiment that those of ordinary skill in the art are obtained under the premise of not making creative work, broadly falls into this The scope of bright protection.
As shown in figure 8, the occluder for left auricle induction system of the embodiment in invention includes delivery sheath 100, dilator 200th, loader 300, hemostatic system 400 and conveying wirerope 500, wherein, delivery sheath 100 can coordinate composition with dilator 200 Heart shedding motion;Heart shedding motion, hemostatic system 400 are sequentially connected and are formed the passage of hollow, the steel of conveying wirerope 500 Cable 501 may pass through the passage of hollow.Described occluder for left auricle induction system is used for left auricle interventional therapy, can complete left auricle The loading of stopper, the function such as convey, strut, reclaim and discharge.
As shown in figure 1, in the present invention, delivery sheath 100 is via delivery sheath body 101 and delivery sheath sheath seat 102 are formed by connecting, and connection between the two is formed through ultraviolet light polymerization with UV glue.Delivery sheath body can be divided into three sections, I.e.:Delivery sheath body near-end 103, delivery sheath body interlude 104 and delivery sheath body distal end 105, wherein convey sheath Pipe body near-end 103 is used for one end that conduit connects, delivery sheath body distal end 105 one end inserted into the patient, conveys sheath Pipe body interlude 104 is one section of body in the middle of delivery sheath body near-end 103 and delivery sheath body distal end 105.
In the junction of body near-end and body interlude, there is the first flexible place 121, body interlude has Second flexible place 122, the bendable angle at the first flexible place is 0 °~50 °, and the bendable angle at the second flexible place is 0 °~50 °, and the first flexible place 122 and the second flexible place not only can bend in same plane, can also be in difference Plain bending, i.e. curvature of space.
The pipe thickness of delivery sheath body is:0.2~0.5mm, tube wall is divided into three layers, respectively internal layer 109, intermediate layer 106 and outer layer 112, the material of described internal layer 109 is PTFE film,
As shown in Figure 2 A, the tube wall of delivery pipe body 101 is divided into three layers, by delivery sheath outer layer 112, in the middle of delivery sheath Layer 106 and delivery sheath internal layer 109 pyrocondensation form, and thickness is:0.2~0.5mm.The material of internal layer 109 is PTFE film, intermediate layer Material be 304 rustless steels, the material of outer layer is Pebax material.
Outer layer is welded using laser machine by the Pebax material of three kinds of different hardness, the outer layer of body near-end 103 Using Pebax7533 material, the outer layer of body interlude 105 uses Pebax5533 material, and the outer layer of body distal end 105 uses Pebax2533 material.I.e. above-mentioned first flexible place 122 is located at the junction of material Pebax7533 and Pebax5533, and second Flexible place is located at material Pebax5533 middle.The material of such use different hardness can be turned or break-in in body During reduce resistance, be conducive to the steering of far-end, far-end uses the less material of hardness can be to protection blood vessel or other group Knit damage.
Delivery sheath intermediate layer 106 is to be entwined by 304 stainless steel silks, 304 stainless steel silks a diameter of 0.01~ 0.2mm, canoe proximal end is wound around for 0~0.5mm mode using spacing, and it is 0.01~0.5mm mode that far-end adopts spacing It is wound around.Intermediate layer 106 has support and protective effect to body, prevents from going out, in course of conveying middle tube body, the situation that body becomes flat.
Delivery sheath internal layer is made up of PTFE film, and PTFE film thickness is 0.01~0.05mm.Because PTFE film friction is little, The coefficient of friction of stopper less so that occluder for left auricle can slide freely in sheath, select suitable specification sheath Pipe and stopper cooperation, occluder for left auricle is discharged by behind the external left auricle position being pushed to heart through induction system, with Realize closure left auricle, reach therapeutic purposes.
As shown in Figure 2 B, delivery sheath body distal end 105 tapers off to a point 132, facilitates insertion in the patient, on most advanced and sophisticated 132 There is radiography hole 108, for strengthening the effect of contrast agent, be conducive in clinical course to the searching of tissue site and position really Fixed;If no radiography hole, during clinical operation, the time that contrast agent retains in diffusion is relatively short, to positioning and calmly Away from having any problem, harder most advanced and sophisticated cladding material difficult to manufacture radiography hole, and in the present invention, most advanced and sophisticated outer layer uses the less material of hardness Material, beneficial to manufacture radiography hole.The quantity in radiography hole 108 can be 2-10, is easy to fill the effect that part utilizes contrast agent.And it is defeated Sheath body distal end 105 is sent to have at least 2 developing rings 107, to avoid a developing ring cannot show or embody far-end Entering the distance of left auricle, thus being difficult to convey the situation of occluder for left auricle, being easy to clinical manipulation personnel observation assessment conveying sheath Pipe far-end enters distance or the particular location of left auricle.
As shown in figure 3, dilator 200 is to be formed by connecting via dilator body 201 and dilator sheath seat 203, loader 300 is to be formed by connecting through glue by protheca seat 401, rear sheath seat 402 and sheath 403.
As shown in figure 4, loader 400 is to be formed by connecting through glue by protheca seat 401, rear sheath seat 402 and sheath 403.
As shown in figure 5, conveying wirerope 500 is assembled by wirerope 501, handle 502 and bolt 503.
As shown in fig. 6, hemostatic system 300 is formed by connecting through glue by haemostatic valve 301, connecting tube 302 and threeway 303.
In the present invention, the heart shedding motion that delivery sheath 100 can be as shown in Figure 7 with dilator 200 cooperation composition, conveying Sheath 100 can be sequentially connected composition left auricle as shown in Figure 8 with loader 400, hemostatic system 300 and conveying wirerope 500 The induction system of stopper.
The preferred embodiment of the present invention described in detail above.It should be appreciated that the ordinary skill of this area need not be created The property made work just can make many modifications and variations according to the design of the present invention.Therefore, all technical staff in the art Pass through the available technology of logical analysis, reasoning, or a limited experiment under this invention's idea on the basis of existing technology Scheme, all should be in the protection domain being defined in the patent claims.

Claims (10)

1. a kind of delivery sheath body, for occluder for left auricle induction system it is characterised in that described delivery sheath body has There are the first flexible place and the second flexible place, the bendable angle at described first flexible place is 0 °~50 °, and described second can The bendable angle of knee is 0 °~50 °.
2. delivery sheath body according to claim 1, described delivery sheath body is divided into three sections in the longitudinal direction, point Not Wei body near-end, body distal end and body interlude, described first flexible place is located at body near-end and body interlude Junction, described second flexible place is located on body interlude.
3. delivery sheath body according to claim 2, the pipe thickness of described delivery sheath body is:0.2~ 0.5mm, described tube wall is divided into three layers, respectively internal layer, intermediate layer and outer layer, and the material of described internal layer is PTFE film, described in The material of interbed is 304 rustless steels, and the material of described outer layer is Pebax material, and described outer layer is by the Pebax of three kinds of different hardness Material is welded using laser machine, and the outer layer of described body near-end uses Pebax7533 material, outside body interlude Layer uses Pebax5533 material, and the outer layer of body distal end uses pebax2533 material, and described intermediate layer is twined by 304 stainless steel silks Around forming, a diameter of 0.01~0.2mm of 304 stainless steel silks, it is 0~0.5mm mode that canoe adopts spacing for proximal end It is wound around, far-end is wound around for 0.01~0.5mm mode using spacing, the PTFE film thickness of described internal layer is 0.01~0.05mm.
4. delivery sheath body according to claim 2, described delivery sheath body interlude has at body distal end Have 1~3 developing ring, the first developing ring is located most closely to far-end, the first developing ring apart from far-end 1.0~20.0mm, second Developing ring distance the first developing ring 1.0~15.0mm, the 3rd developing ring distance the second developing ring 1.0~10.0mm.
5. delivery sheath body according to claim 2, the body distal end of described delivery sheath has 2~10 radiographies Hole, the distal length of described delivery sheath body is 1.0~10.0mm.
6. a kind of occluder for left auricle induction system, for loading and conveying occluder for left auricle it is characterised in that the described left heart Ear stopper induction system includes delivery sheath, dilator, loader, hemostatic system and conveying wirerope, and described dilator can be worn Cross the inside of delivery sheath and form heart shedding motion, described heart shedding motion, loader and hemostatic system are sequentially connected And forming passage, described conveying wirerope can be inserted partially into described passage, and described delivery sheath is included as described in claim 1-5 Delivery sheath body and delivery sheath sheath seat.
7. occluder for left auricle induction system according to claim 6 is it is characterised in that described dilator includes dilator Body and dilator sheath seat, described dilator body and dilator sheath seat use quick-drying gemel connection or integrated injection molding to connect.
8. occluder for left auricle induction system according to claim 6 is it is characterised in that described hemostatic system includes stopping blooding Valve, connecting tube and three-way valve, haemostatic valve and connecting tube connect through UV glue, and connecting tube and three-way valve pass through through UV glue even Connect.
9. occluder for left auricle induction system according to claim 6 is it is characterised in that described loader includes protheca Seat, rear sheath seat and sheath, described protheca seat is used for the delivery sheath seat cooperation with delivery sheath, and described rear sheath seat is used for and hemostasis Valve coordinates, and described rear sheath seat is connected by UV glue with described haemostatic valve.
10. occluder for left auricle induction system according to claim 6 is it is characterised in that described conveying wirerope includes steel Cable, handle and bolt, described wirerope can enter handle inner, and is bolted, and so that wirerope can not be slided with respect to handle Dynamic.
CN201610955830.9A 2016-10-27 2016-10-27 Delivery sheath body and left atrial appendage occluder delivery system Pending CN106419990A (en)

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108926366A (en) * 2017-05-27 2018-12-04 无锡市第二人民医院 A kind of injecting glue closure left auricle of heart device of the front end with Nitinol mesh enclosure
CN108938036A (en) * 2017-05-27 2018-12-07 无锡市第二人民医院 A kind of injecting glue closure left auricle of heart device of the front end with closure sacculus
CN112971871A (en) * 2019-12-17 2021-06-18 先健科技(深圳)有限公司 Adjustable bent sheath tube
WO2024082902A1 (en) * 2022-10-17 2024-04-25 微创投资控股有限公司 Delivery system and delivery sheath tube for implant

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JPH10137341A (en) * 1996-11-12 1998-05-26 Junichi Tanaka Catheter
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JPH11206888A (en) * 1998-01-20 1999-08-03 Clinical Supply:Kk Implement for insertion into blood vessel
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CN103372260A (en) * 2012-04-19 2013-10-30 上海凯旦医疗科技有限公司 Multi-segment controllable-bending interventional catheter
CN203763641U (en) * 2014-01-26 2014-08-13 中国人民解放军第四军医大学 Double-outlet guide catheter for reverse angiography
CN203829424U (en) * 2014-05-13 2014-09-17 江苏省人民医院 Flexible injection needle apparatus used for hemostasis under endoscope
CN105903117A (en) * 2016-04-08 2016-08-31 上海庆之医疗科技有限公司 Conduit
CN105943210A (en) * 2015-12-23 2016-09-21 微创心脉医疗科技(上海)有限公司 Intervention apparatus sheath tube and manufacturing method thereof

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CN1204242A (en) * 1995-10-13 1999-01-06 血管转换公司 Method and apparatus for bypassing arterial obstructions and/or performing other transvascular procedures
JPH10137341A (en) * 1996-11-12 1998-05-26 Junichi Tanaka Catheter
JPH11206888A (en) * 1998-01-20 1999-08-03 Clinical Supply:Kk Implement for insertion into blood vessel
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Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108926366A (en) * 2017-05-27 2018-12-04 无锡市第二人民医院 A kind of injecting glue closure left auricle of heart device of the front end with Nitinol mesh enclosure
CN108938036A (en) * 2017-05-27 2018-12-07 无锡市第二人民医院 A kind of injecting glue closure left auricle of heart device of the front end with closure sacculus
CN108938036B (en) * 2017-05-27 2023-12-05 无锡市第二人民医院 Glue injection and left auricle blocking device with blocking saccule at front end
CN108926366B (en) * 2017-05-27 2023-12-22 无锡市第二人民医院 Rubber injection plugging left auricle device with nickel-titanium alloy mesh cover at front end
CN112971871A (en) * 2019-12-17 2021-06-18 先健科技(深圳)有限公司 Adjustable bent sheath tube
WO2024082902A1 (en) * 2022-10-17 2024-04-25 微创投资控股有限公司 Delivery system and delivery sheath tube for implant

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