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CN104739478B - Spring coil and production method thereof - Google Patents

Spring coil and production method thereof Download PDF

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Publication number
CN104739478B
CN104739478B CN201310751427.0A CN201310751427A CN104739478B CN 104739478 B CN104739478 B CN 104739478B CN 201310751427 A CN201310751427 A CN 201310751427A CN 104739478 B CN104739478 B CN 104739478B
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China
Prior art keywords
coil
turn
inch
chain
coiling
Prior art date
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Application number
CN201310751427.0A
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Chinese (zh)
Other versions
CN104739478A (en
Inventor
刘建民
谢志永
黄清海
郭远益
贾国庆
金巧蓉
陈冰
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Shendun medical technology (Shanghai) Co.,Ltd.
Original Assignee
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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Classifications

    • 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
    • A61B17/1214Coils 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
    • 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
    • A61B17/12109Occluding 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
    • 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
    • A61B17/1214Coils 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
    • A61B2017/00004(bio)absorbable, (bio)resorbable or 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.Progress and Ink vessel transfusing with image technology The development of biomaterial, intravascular Interventional Treatment is lower than the risk of surgical operation therapy because of it, replaces surgical aneurysm to press from both sides Closing operation becomes the prefered method for the treatment of intracranial aneurysm.
The method of PCI intracranial aneurysm is a lot, mainly there is the close net support of reconstructing blood vessel carried out on parent artery Embolization in art and aneurysm cavity.And embolism turn is to treat aneurysmal main method at present in aneurysm cavity.Mesh The turn of front aneurysm embolization is broadly divided into two kinds:One kind be bare metal turn, the such as GDC of Boston Scientific The MicroPlex turns of turn and Microvention;Another kind is bio-modification turn, such as Codman companies The Matrix of Cerecyte turns, the Hydrogel hydrogels turn of Microvention and Boston Scientific Turn.
Chinese patent application No.CN201120007508.6 discloses a kind of embolism spring that can quickly produce thrombus Circle product.This turn surface causes thrombus medicine with quick, and such as protamine sulfate, the control release of medicine is to pass through What carrier was realized, carrier is a kind of degradable medical macromolecular material.Can quickly produce after this turn implantation aneurysm Thrombus, by the complete embolism of aneurysm, and catabolite (oligomer) of the biodegradable carrier in human body can promote thrombus to turn Cellular tissue parenchyma is turned to, can accelerate aneurysmal to heal completely.
United States Patent (USP) No.US8,388,643B2 discloses biologically absorbable polymer implant and produces embolism using it Method.Specifically, the patent is that a kind of novel embolizing agent (biologically absorbable polymer material) is mixed into the de- bullet of electrolysis In spring coil (GDC), so as to improve intravascular Interventional Treatment intracranial aneurysm in long-term treatment effects.
Although current turn is greatly improved at aspects such as raising filling consistency, reduction aneurysm recurrence rates, But occupation time process of the turn in knurl chamber can not be solved always.
The content of the invention
Present invention seek to address that the problems such as long-term safety and occupation time process after existing turn implantation human body, and for this A kind of turn and preparation method thereof is provided.
The present invention relates to a kind of turn, it is characterised in that including first coil and the second coil, second coil around In the lateral surface of the first coil, one of which coil is degradation material, and another kind of coil is radiopaque material, It is 75%~95% that the volume of the degradation material accounts for the percentage of the turn volume.
The first coil is by diameter D1For 0.00001 inch~0.008 inch, preferably 0.0008 inch~0.004 The silk chain of inch is made.
Second coil is by diameter D2For 0.00001 inch~0.008 inch, preferably 0.0008 inch~0.002 The silk chain of inch is made.
The degradation material is selected from PLA (PLA), polyglycolic acid (PGA), PLLA (PLLA), poly- hydroxyl Acetic acid/copolymer of poly lactic acid (PLGA), polylcaprolactone (PCL) etc., preferably polyglycolic acid/copolymer of poly lactic acid (PLGA)。
Radiopaque material includes the alloy of one or more in platinum group metal, rhenium, tungsten, tantalum, gold or silver.Institute State radiopaque material and be preferably platinum/tungsten alloy.These metals have a significant radiopacity, and by adjust alloy into Divide to reach appropriate elasticity and rigidity.
The degradation time of the turn is 2~4 months, preferably 3 months.
The invention further relates to a kind of preparation method of turn, it is characterised in that comprise the following steps:
First chain and second chain are provided, one of which silk chain is degradation material, and another kind of silk chain is radiopaque Material, and the volume of the degradation material account for the turn volume percentage be 75%~95%;
First chain is wound on plug and makes first coil;
Second chain is wound on into first coil outside and makes the second coil;And
Heat treatment will be carried out on mould according to pre-set shape around the first coil for making and the second coil.
According to the present invention, the coiling direction of the radiopaque material is in opposite direction with the coiling of the degradation material. By the way of oppositely wound, the first coil in manufacturing process can be avoided mutually embedding with the second coil, make manufacture craft more suitable Freely.
According to the present invention, the spacing of the radiopaque material coiling is more than the spacing of the degradation material coiling.
" around the controlling angle " of the present invention is defined as the silk chain of the first or second coil and the axial direction of metal mandrel is formed Angle.
The turn of the present invention is made up of metal and degradable high polymer material, and thrombus in aneurysm can be accelerated after implantation Fibrillatable, and with the degraded of biomaterial, fibr tissue constantly shrinks in knurl makes aneurysm constantly reduce, so as to mitigate spring The occupation time process of circle, higher degradation material percent by volume, for solution occupation time process and long-term safety sex chromosome mosaicism bring More significant effect.
Description of the drawings
Fig. 1-4 is the longitudinal cross-section view of various embodiments of the invention turn;
Fig. 5 is the degraded schematic diagram after turn implantation aneurysm;And
Fig. 6 is that turn is implanted into aneurysmal therapeutic effect schematic diagram.
Specific embodiment
For a further understanding of the present invention, the preferred version of the present invention is described below in conjunction with embodiment.These Description is merely illustrative the feature and advantage of turn of the present invention and preparation method thereof, and the protection model of the unrestricted present invention Enclose.
Embodiment 1
Second coil is wound on the outside of first coil, as shown in Figure 1.Second coil by degradation material polyglycolic acid/ Copolymer of poly lactic acid (PLGA) is constituted, and the diameter of silk chain is 0.003 "(Inch);First coil adopts good biocompatibility, can show Shadow platinum/tungsten alloy filament 0.001 ".It is 83.3% that second winding volume accounts for the percentage of whole turn volume.
Preparation method is:(1) coiling first on metal mandrel in a diameter of 0.0001 "~0.1 ", preferably 0.005 " Coil, the tight coiling of coil, spacing is 0.001 ", it is 85 ° around controlling angle;(2) oppositely wound second line on the outside of first coil Circle, the tight coiling of coil, spacing is 0.003 ", it is 85 ° around controlling angle;(3) by around the first coil for making and the second coil by Heat treatment is carried out on mould according to pre-set shape;(4) biomaterial starts drop after the turn implantation aneurysm Solution, as shown in figure 5, the time of degraded is 3 months;(5) fibrillatable of thrombus in artery knurl is implanted into, and with biomaterial Degraded, the contraction of fibr tissue in knurl can also reduce aneurysm, and mitigate the occupation time process of turn, as shown in Figure 6.
Embodiment 2
Second coil is wound on the outside of first coil, as shown in Figure 2.First coil is by degradation material PLA (PLA) Composition, the diameter of silk chain is 0.004 ";Second coil using good biocompatibility, the spun gold that can develop, spun gold it is a diameter of 0.0008″.It is 75% that the first coil volume accounts for the percentage of whole turn volume.Preparation method is:(1) a diameter of 0.003 " coiling first coil on metal mandrel, the tight coiling of coil, spacing is 0.004 ", it is 75 ° around controlling angle;(2) exist Oppositely wound second coil on the outside of first coil, the tight coiling of coil, spacing is 0.0008 ", it is 75 ° around controlling angle;(3) will be around The first coil and the second coil for making carries out heat treatment according to pre-set shape on mould.
Embodiment 3
Second coil is wound on the outside of first coil.Second winding volume accounts for the percentage of whole turn volume 95%.Wherein (1) inner coil is first coil, using the platinum wire of good biocompatibility, from a diameter of of platinum wire 0.002 ", the sparse coiling of coil, spacing is 0.01 ", it is 90 ° around controlling angle;(2) outer coil is the second coil, and employing can drop Solution material polyglycolic acid/copolymer of poly lactic acid (PLGA) silk, the diameter of degradation material silk chain is 0.0008 ", coil is tight Coiling, spacing is 0.0008 ", it is 60 ° around controlling angle, as shown in Figure 3.
Embodiment 4
Second coil is wound on the outside of first coil.Wherein (1) inner coil is first coil, poly- using degradation material Hydroxyacetic acid/copolymer of poly lactic acid (PLGA) silk, the diameter of degradation material silk chain is 0.008 ", the tight coiling of coil, spacing For 0.008 ", it is 90 ° around controlling angle;(2) outer coil is the second coil, using the platinum/tungsten alloy filament of good biocompatibility, choosing With a diameter of the 0.0001 of platinum wire ", the sparse coiling of coil, spacing is 0.002 ", it is 60 ° around controlling angle, as shown in Figure 4.
The explanation of above example is only intended to the core concept for helping understand the present invention.It should be pointed out that for this area Those of ordinary skill for, under the premise without departing from the principles of the invention, can also to the present invention turn and its preparation Method carries out some improvement and modification, but these are improved and modification is also fallen in the range of the claims in the present invention are claimed.

Claims (11)

1. a kind of turn, including first coil and the second coil, it is characterised in that second coil is wound on the First Line The lateral surface of circle, one of which coil is degradation material, and another kind of coil is radiopaque material, the degradation material It is 75%~95% that volume accounts for the percentage of the turn volume.
2. turn as claimed in claim 1, it is characterised in that the first coil is by diameter D1For 0.00001 inch~ 0.008 inch of silk chain is made.
3. turn as claimed in claim 2, it is characterised in that the first coil by diameter D1 be 0.0008 inch~ 0.004 inch of silk chain is made.
4. turn as claimed in claim 1, it is characterised in that second coil is by diameter D2For 0.00001 inch~ 0.008 inch of silk chain is made.
5. turn as claimed in claim 4, it is characterised in that second coil by diameter D2 be 0.0008 inch~ 0.002 inch of silk chain is made.
6. the turn as described in any one of claim 1-5, it is characterised in that the degradation material is selected from PLA, poly- Hydroxyacetic acid, PLLA, polyglycolic acid/copolymer of poly lactic acid or polylcaprolactone.
7. the turn as described in any one of claim 1-5, it is characterised in that radiopaque material is selected from platinum family gold The alloy of one or more in category, rhenium, tungsten, tantalum, gold or silver.
8. turn as claimed in claim 7, it is characterised in that radiopaque material is platinum/tungsten alloy.
9. the preparation method of the turn as any one of claim 1-8, it is characterised in that comprise the following steps:
First chain and second chain are provided, one of which silk chain is degradation material, and another kind of silk chain is radiopaque material, And the volume of the degradation material account for the turn volume percentage be 75%~95%,
First chain is wound on plug and makes first coil,
Second chain is wound on into first coil outside and makes the second coil,
And
Heat treatment will be carried out on mould according to pre-set shape around the first coil for making and the second coil.
10. preparation method as claimed in claim 9, it is characterised in that the coiling direction of the radiopaque material with it is described The coiling of degradation material is in opposite direction.
11. preparation methods as claimed in claim 9, it is characterised in that the spacing of the radiopaque material coiling is more than institute State the spacing of degradation material coiling.
CN201310751427.0A 2013-12-31 2013-12-31 Spring coil and production method thereof Active CN104739478B (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
CN201310751427.0A CN104739478B (en) 2013-12-31 2013-12-31 Spring coil and production method thereof
PCT/CN2014/095745 WO2015101308A1 (en) 2013-12-31 2014-12-31 Spring coil and manufacturing method therefor

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN201310751427.0A CN104739478B (en) 2013-12-31 2013-12-31 Spring coil and production method thereof

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Publication Number Publication Date
CN104739478A CN104739478A (en) 2015-07-01
CN104739478B true CN104739478B (en) 2017-05-10

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WO (1) WO2015101308A1 (en)

Families Citing this family (12)

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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
CN110141294B (en) * 2019-06-28 2025-07-18 微创神通医疗科技(上海)有限公司 Medical spring ring
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
CN112274204B (en) * 2020-06-12 2022-07-19 微创神通医疗科技(上海)有限公司 Medical spring ring
CN112617949B (en) * 2020-12-31 2022-04-15 神遁医疗科技(上海)有限公司 Spring ring 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
CN113303859B (en) * 2020-12-31 2023-06-30 神遁医疗科技(上海)有限公司 Embolic material and preparation method thereof
CN112656476A (en) * 2020-12-31 2021-04-16 微创神通医疗科技(上海)有限公司 Embolism material and preparation method thereof
CN113288307B (en) * 2021-05-31 2025-09-12 微创神通医疗科技(上海)有限公司 Medical implant and method for preparing the same
CN116672017A (en) * 2022-02-23 2023-09-01 神遁医疗科技(上海)有限公司 Embolization device
CN114886496B (en) * 2022-04-19 2024-10-29 江苏畅医达医疗科技有限公司 Quick electrolytic stripping and conveying device and application method thereof
CN115054307B (en) * 2022-06-30 2024-08-23 上海微创医疗器械(集团)有限公司 Occlusion implant and method for the production thereof

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US6723112B2 (en) * 1998-11-10 2004-04-20 Scimed Life Systems, Inc. Bioactive three loop coil
US6585754B2 (en) * 2001-05-29 2003-07-01 Scimed Life Systems, Inc. Absorbable implantable vaso-occlusive member
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Publication number Publication date
WO2015101308A1 (en) 2015-07-09
CN104739478A (en) 2015-07-01

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Effective date of registration: 20210816

Address after: 201203 room 1509, building 1, No. 1601, Zhangdong Road, China (Shanghai) pilot Free Trade Zone, Pudong New Area, Shanghai

Patentee after: Shendun medical technology (Shanghai) Co.,Ltd.

Address before: 201318 building 16, Lane 222, Guangdan Road, Pudong New Area, Shanghai

Patentee before: Microport Neurotech (Shanghai) Co.,Ltd.

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