CN104739478A - Spring coil and production method thereof - Google Patents

Spring coil and production method thereof Download PDF

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Publication number
CN104739478A
CN104739478A CN201310751427.0A CN201310751427A CN104739478A CN 104739478 A CN104739478 A CN 104739478A CN 201310751427 A CN201310751427 A CN 201310751427A CN 104739478 A CN104739478 A CN 104739478A
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China
Prior art keywords
coil
turn
inch
chain
coiling
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Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
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CN201310751427.0A
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Chinese (zh)
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CN104739478B (en
Inventor
刘建民
谢志永
黄清海
郭远益
贾国庆
金巧蓉
陈冰
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Shendun medical technology (Shanghai) Co.,Ltd.
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Minimally Invasive Shentong Medical Technology (shanghai) Co Ltd
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Priority to CN201310751427.0A priority Critical patent/CN104739478B/en
Priority to PCT/CN2014/095745 priority patent/WO2015101308A1/en
Publication of CN104739478A publication Critical patent/CN104739478A/en
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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
    • A61B17/12131Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/1214Coils or wires
    • A61B17/1215Coils or wires comprising additional materials, e.g. thrombogenic, having filaments, having fibers, being coated
    • 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
    • A61B17/12109Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • A61B17/12113Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm
    • 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
    • A61B17/12131Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/1214Coils or wires
    • A61B17/12145Coils or wires having a pre-set deployed three-dimensional shape
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00004(bio)absorbable, (bio)resorbable, resorptive

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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)
  • Neurosurgery (AREA)
  • Surgical Instruments (AREA)
  • Materials For Medical Uses (AREA)

Abstract

The invention relates to the field of medical instruments, in particular to a spring coil and a production method thereof. The spring coil comprises a first coil body and a second coil body, the second coil body is wound on the outer side face of the first coil body, one of the coil bodies is made of degradable materials while the other coil body is made of radiopaque materials, and the volume of the coil body made of the degradable materials accounts for 75-95% of that of the spring coil. The spring coil made of metal and the degradable materials is capable of accelerating fibrosis of thrombi in arterial aneurysm after being implanted, and along with degradation of biological materials, in-aneurysm fibrous tissues shrink continuously to enable the arterial aneurysm to shrink continuously, so that mass effect of the spring coil is reduced.

Description

A kind of turn and preparation method thereof
Technical field
The present invention relates to medical instruments field.Specifically, the present invention relates to a kind of turn and preparation method thereof.
Background technology
Cerebral aneurysm or intracranial aneurysm, drastically influence the health of people.Along with the progress of image technology and the development of Ink vessel transfusing biomaterial, intravascular Interventional Treatment is lower than the risk of surgical operation therapy because of it, replaces the prefered method that surgical aneurysm Clipping becomes treatment intracranial aneurysm.
The method of interventional therapy intracranial aneurysm is a lot, mainly contains the Embolization in the close net stenting of the reconstructing blood vessel carried out on parent artery and aneurysm cavity.And thromboembolism turn treats aneurysmal main method at present in aneurysm cavity.The aneurysmal turn of current thromboembolism is mainly divided into two kinds: a kind of is bare metal turn, as the GDC turn of Boston Scientific and the MicroPlex turn of Microvention; Another kind is bio-modification turn, as the Matrix turn of the Cerecyte turn of Codman company, the Hydrogel hydrogel turn of Microvention and BostonScientific.
Chinese patent application No.CN201120007508.6 discloses a kind of thromboembolism turn product that can produce thrombosis fast.This turn surface is with quick hyperamization bolt medicine, and such as protamine sulfate, the Co ntrolled release of medicine is realized by carrier, and carrier is a kind of degradable medical macromolecular material.This turn can produce thrombosis after implanting aneurysm fast, and by complete for aneurysm thromboembolism, and the catabolite of biodegradable carrier in human body (oligomer) can promote that thrombosis is converted into cellular tissue parenchyma, can accelerate aneurysmally to heal completely.
U.S. Patent No. US8,388,643B2 disclose biologically absorbable polymer implant and use it to produce the method for thromboembolism.Specifically, this patent a kind of novel embolizing agent (biologically absorbable polymer material) is mixed in the de-turn (GDC) of electrolysis, thus improve the long-term treatment effects in intravascular Interventional Treatment intracranial aneurysm.
Although current turn has greatly improved in raising filling density, reduction aneurysm relapse rate etc., turn can not solve at the occupation time process of tumor intracavity always.
Summary of the invention
The present invention is intended to the problems such as the long-term safety after solving existing turn implant into body and occupation time process, and provides a kind of turn and preparation method thereof for this reason.
The present invention relates to a kind of turn, it is characterized in that, comprise the first coil and the second coil, described second coil is around the lateral surface of described first coil, wherein a kind of coil is degradation material, and another kind of coil is radiopaque material, the percentage ratio that the volume of described degradation material accounts for described turn volume is 75% ~ 95%.
Described first coil is by diameter D 1be 0.00001 inch ~ 0.008 inch, the silk chain being preferably 0.0008 inch ~ 0.004 inch is made.
Described second coil is by diameter D 2be 0.00001 inch ~ 0.008 inch, the silk chain being preferably 0.0008 inch ~ 0.002 inch is made.
Described degradation material is selected from polylactic acid (PLA), polyglycolic acid (PGA), Poly-L-lactic acid (PLLA), polyglycolic acid/copolymer of poly lactic acid (PLGA), polylcaprolactone (PCL) etc., preferably polyglycolic acid/copolymer of poly lactic acid (PLGA).
Described radiopaque material comprises the alloy of one or more in platinum group metal, rhenium, tungsten, tantalum, gold or silver.Described radiopaque material is preferably platinum/tungsten alloy.These metals have the radiopacity shown, and by adjustment alloying component to reach suitable elasticity and rigidity.
The degradation time of described turn is 2 ~ 4 months, is preferably 3 months.
The invention still further relates to a kind of preparation method of turn, it is characterized in that, comprise the following steps:
There is provided first chain and second chain, wherein a kind of silk chain is degradation material, and another kind of silk chain is radiopaque material, and the percentage ratio that the volume of described degradation material accounts for described turn volume is 75% ~ 95%;
First chain is made the first coil on plug;
Second chain is made the second coil outside the first coil; And
The first good for coiling coil and the second coil are carried out heat treatment according to pre-set shape on mould.
According to the present invention, the coiling direction of described radiopaque material is contrary with the coiling direction of described degradation material.Adopt the mode of reverse coiling, the first coil in manufacturing process can be avoided mutually embedding with the second coil, make processing technology more smooth and easy.
According to the present invention, the spacing of described radiopaque material coiling is greater than the spacing of described degradation material coiling.
The angle that the axial direction of silk chain and metal mandrel that " coiling angle " of the present invention is defined as the first or second coil is formed.
Turn of the present invention is made up of metal and degradable high polymer material, the fibrosis of thrombosis in aneurysm can be accelerated after implantation, and along with the degraded of biomaterial, in tumor, fibrous tissue is constantly shunk and aneurysm is constantly reduced, thus alleviate the occupation time process of turn, higher degradation material percent by volume, brings more significant effect for solution occupation time process and long-term safety sex chromosome mosaicism.
Accompanying drawing explanation
Fig. 1-4 is longitudinal cross-section views of various embodiments of the invention turn;
Fig. 5 is the degraded schematic diagram after aneurysm implanted by turn; And
Fig. 6 is that aneurysmal therapeutic effect schematic diagram implanted by turn.
Detailed description of the invention
In order to understand the present invention further, below in conjunction with embodiment, preferred version of the present invention is described.These describe the feature and advantage just illustrating turn of the present invention and preparation method thereof, but not limit the scope of the invention.
Embodiment 1
Second coil around the outside of the first coil, as shown in Figure 1.Second coil is made up of degradation material polyglycolic acid/copolymer of poly lactic acid (PLGA), and the diameter of silk chain is 0.003 " (inch); Platinum/tungsten alloy filament 0.001 that first coil adopts good biocompatibility, can develop ".The percentage ratio that described second winding volume accounts for whole turn volume is 83.3%.
Manufacture method is: (1) is 0.0001 " ~ 0.1 " at diameter, is preferably 0.005 " metal mandrel on coiling first coil, the tight coiling of coil, spacing is 0.001 ", coiling angle is 85 °; (2) reverse coiling second coil outside the first coil, the tight coiling of coil, spacing is 0.003 ", coiling angle is 85 °; (3) the first good for coiling coil and the second coil are carried out heat treatment according to pre-set shape on mould; (4) this turn implantation aneurysm artifact material starts degraded, and as shown in Figure 5, the time of degraded is 3 months; (5) implant the fibrosis of thrombosis in artery tumor, and along with the degraded of biomaterial, in tumor, the contraction of fibrous tissue also can reduce aneurysm, and alleviates the occupation time process of turn, as shown in Figure 6.
Embodiment 2
Second coil around the outside of the first coil, as shown in Figure 2.First coil is made up of degradation material polylactic acid (PLA), and the diameter of silk chain is 0.004 "; The spun gold that second coil adopts good biocompatibility, can develop, the diameter of spun gold is 0.0008 ".The percentage ratio that described first winding volume accounts for whole turn volume is 75%.Manufacture method is: (1) is 0.003 at diameter " metal mandrel on coiling first coil, the tight coiling of coil, spacing is 0.004 ", coiling angle is 75 °; (2) reverse coiling second coil outside the first coil, the tight coiling of coil, spacing is 0.0008 ", coiling angle is 75 °; (3) the first good for coiling coil and the second coil are carried out heat treatment according to pre-set shape on mould.
Embodiment 3
Second coil is around the outside of the first coil.The percentage ratio that described second winding volume accounts for whole turn volume is 95%.Wherein (1) inner coil is the first coil, adopts the platinum wire of good biocompatibility, selects the diameter of platinum wire to be 0.002 ", the sparse coiling of coil, spacing is 0.01 ", coiling angle is 90 °; (2) outer coil is the second coil, and adopt degradation material polyglycolic acid/copolymer of poly lactic acid (PLGA) silk, the diameter of degradation material silk chain is 0.0008 "; the tight coiling of coil; spacing is 0.0008 ", coiling angle is 60 °, as shown in Figure 3.
Embodiment 4
Second coil is around the outside of the first coil.Wherein (1) inner coil is the first coil, adopt degradation material polyglycolic acid/copolymer of poly lactic acid (PLGA) silk, the diameter of degradation material silk chain is 0.008 ", the tight coiling of coil; spacing is 0.008 ", coiling angle is 90 °; (2) outer coil is the second coil, adopts the platinum/tungsten alloy filament of good biocompatibility, selects the diameter of platinum wire to be 0.0001 ", the sparse coiling of coil, spacing is 0.002 ", coiling angle is 60 °, as shown in Figure 4.
The explanation of above embodiment just understands core concept of the present invention for helping.Should be understood that; for the ordinary skill in the art; under the premise without departing from the principles of the invention, some improvement and modification can also be carried out to turn of the present invention and preparation method thereof, but these improve and modification also falls in the scope of the claims in the present invention request protection.

Claims (11)

1. a turn, comprise the first coil and the second coil, it is characterized in that, described second coil is around the lateral surface of described first coil, wherein a kind of coil is degradation material, another kind of coil is radiopaque material, and the percentage ratio that the volume of described degradation material accounts for described turn volume is 75% ~ 95%.
2. turn as claimed in claim 1, it is characterized in that, described first coil is by diameter D 1be that the silk chain of 0.00001 inch ~ 0.008 inch is made.
3. turn as claimed in claim 2, it is characterized in that, the silk chain that described first coil is 0.0008 inch ~ 0.004 inch by diameter D1 is made.
4. turn as claimed in claim 1, it is characterized in that, described second coil is by diameter D 2be that the silk chain of 0.00001 inch ~ 0.008 inch is made.
5. turn as claimed in claim 4, it is characterized in that, the silk chain that described second coil is 0.0008 inch ~ 0.002 inch by diameter D2 is made.
6. the turn as described in any one of claim 1-5, is characterized in that, described degradation material is selected from polylactic acid, polyglycolic acid, Poly-L-lactic acid, polyglycolic acid/copolymer of poly lactic acid or polylcaprolactone.
7. the turn as described in any one of claim 1-5, is characterized in that, described radiopaque material is selected from the alloy of one or more in platinum group metal, rhenium, tungsten, tantalum, gold or silver.
8. turn as claimed in claim 7, it is characterized in that, described radiopaque material is platinum/tungsten alloy.
9. the preparation method of the turn according to any one of claim 1-8, is characterized in that, comprises the following steps:
There is provided first chain and second chain, wherein a kind of silk chain is degradation material, and another kind of silk chain is radiopaque material, and the percentage ratio that the volume of described degradation material accounts for described turn volume is 75% ~ 95%,
First chain is made the first coil on plug,
Second chain is made the second coil outside the first coil,
And
The first good for coiling coil and the second coil are carried out heat treatment according to pre-set shape on mould.
10. preparation method as claimed in claim 9, it is characterized in that, the coiling direction of described radiopaque material is contrary with the coiling direction of described degradation material.
11. preparation methoies as claimed in claim 9, is characterized in that, the spacing of described radiopaque material coiling is greater than the spacing of described degradation material coiling.
CN201310751427.0A 2013-12-31 2013-12-31 Spring coil and production method thereof Active CN104739478B (en)

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PCT/CN2014/095745 WO2015101308A1 (en) 2013-12-31 2014-12-31 Spring coil and manufacturing method therefor

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Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109009308A (en) * 2018-06-22 2018-12-18 威海维心医疗设备有限公司 Substance and preparation method thereof is shunk for aneurysmal degradable embolism
CN110141294A (en) * 2019-06-28 2019-08-20 微创神通医疗科技(上海)有限公司 Medical spring ring
CN110179516A (en) * 2019-06-28 2019-08-30 微创神通医疗科技(上海)有限公司 Medical spring ring and its manufacturing method, application method
CN112274204A (en) * 2020-06-12 2021-01-29 微创神通医疗科技(上海)有限公司 Medical spring ring
CN112617949A (en) * 2020-12-31 2021-04-09 微创神通医疗科技(上海)有限公司 Spring ring and preparation method thereof
CN112754583A (en) * 2020-12-31 2021-05-07 微创神通医疗科技(上海)有限公司 Spring ring and preparation method thereof
CN113303859A (en) * 2020-12-31 2021-08-27 微创神通医疗科技(上海)有限公司 Embolism material and preparation method thereof
CN113303860A (en) * 2020-12-31 2021-08-27 微创神通医疗科技(上海)有限公司 Embolism material and preparation method thereof
WO2024001718A1 (en) * 2022-06-30 2024-01-04 上海微创医疗器械(集团)有限公司 Closure implant and method for preparing same

Families Citing this family (1)

* Cited by examiner, † Cited by third party
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CN114886496A (en) * 2022-04-19 2022-08-12 江苏畅医达医疗科技有限公司 Rapid electrolytic stripping conveying device and using method thereof

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US20010034531A1 (en) * 1998-11-10 2001-10-25 Hanh Ho Bioactive three loop coil
US20080125807A1 (en) * 2001-05-29 2008-05-29 Wallace Michael P Absorbable implantable vaso-occlusive member
US20110184454A1 (en) * 2010-01-27 2011-07-28 Penumbra, Inc. Embolic implants
US20120089174A1 (en) * 2010-10-12 2012-04-12 Boston Scientific Scimed, Inc Vaso-occlusive device
US20130190801A1 (en) * 2012-01-20 2013-07-25 Tyco Healthcare Group Lp Aneurysm treatment coils

Cited By (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109009308A (en) * 2018-06-22 2018-12-18 威海维心医疗设备有限公司 Substance and preparation method thereof is shunk for aneurysmal degradable embolism
CN110141294A (en) * 2019-06-28 2019-08-20 微创神通医疗科技(上海)有限公司 Medical spring ring
CN110179516A (en) * 2019-06-28 2019-08-30 微创神通医疗科技(上海)有限公司 Medical spring ring and its manufacturing method, application method
CN110179516B (en) * 2019-06-28 2024-03-15 微创神通医疗科技(上海)有限公司 Medical spring ring and manufacturing method and using method thereof
CN112274204A (en) * 2020-06-12 2021-01-29 微创神通医疗科技(上海)有限公司 Medical spring ring
CN113303859A (en) * 2020-12-31 2021-08-27 微创神通医疗科技(上海)有限公司 Embolism material and preparation method thereof
CN112754583A (en) * 2020-12-31 2021-05-07 微创神通医疗科技(上海)有限公司 Spring ring and preparation method thereof
CN113303860A (en) * 2020-12-31 2021-08-27 微创神通医疗科技(上海)有限公司 Embolism material and preparation method thereof
CN112754583B (en) * 2020-12-31 2022-04-15 微创神通医疗科技(上海)有限公司 Spring ring and preparation method thereof
WO2022142788A1 (en) * 2020-12-31 2022-07-07 神遁医疗科技(上海)有限公司 Embolic material and manufacturing method therefor
WO2022142787A1 (en) * 2020-12-31 2022-07-07 神遁医疗科技(上海)有限公司 Embolic agent and preparation method therefor
CN113303860B (en) * 2020-12-31 2023-09-22 神遁医疗科技(上海)有限公司 Embolic material and preparation method thereof
CN112617949A (en) * 2020-12-31 2021-04-09 微创神通医疗科技(上海)有限公司 Spring ring and preparation method thereof
WO2024001718A1 (en) * 2022-06-30 2024-01-04 上海微创医疗器械(集团)有限公司 Closure implant and method for preparing same

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