CN109009308A - Substance and preparation method thereof is shunk for aneurysmal degradable embolism - Google Patents

Substance and preparation method thereof is shunk for aneurysmal degradable embolism Download PDF

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Publication number
CN109009308A
CN109009308A CN201811029106.9A CN201811029106A CN109009308A CN 109009308 A CN109009308 A CN 109009308A CN 201811029106 A CN201811029106 A CN 201811029106A CN 109009308 A CN109009308 A CN 109009308A
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China
Prior art keywords
embolism
degradable
substance
spiral winding
aneurysm
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CN201811029106.9A
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Chinese (zh)
Inventor
张鹏
田立剑
俞华沣
王英平
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WEIHAI VISEE MEDICAL DEVICES CO Ltd
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WEIHAI VISEE MEDICAL DEVICES CO Ltd
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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
    • A61B17/12099Occluding 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
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/04Macromolecular materials
    • A61L31/06Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00526Methods of manufacturing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831Material properties

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Biomedical Technology (AREA)
  • Reproductive Health (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Neurosurgery (AREA)
  • Materials For Medical Uses (AREA)
  • Surgical Instruments (AREA)

Abstract

The invention discloses one kind to shrink substance for aneurysmal degradable embolism, it is characterized in that it is that the embolism made of degradable material shrinks substance that degradable embolism, which shrinks substance, degradable material is by poly-p-dioxanone, either polyglycolic acid, either poly (glycolide-lactide), either polylactic acid is silk material made of material, it is the spherical surface body that the unit spiral winding formed by single silk material continuous winding is constituted that the embolism, which shrinks substance, the axis of the unit spiral winding is extended outwardly with the spherical surface body centre of sphere, the present invention is due to using the above structure, with structure novel, therapeutic effect is significant, without complication, the advantages that thoroughly solving postoperative aneurysm occupation time process.

Description

Substance and preparation method thereof is shunk for aneurysmal degradable embolism
Technical field
The present invention relates to the field of medical instrument technology, specifically a kind of to be used for aneurysmal degradable embolism constrictor Matter and preparation method thereof.
Background technique
Currently, intracranial aneurysm prevalence is about 6%, clinically for aneurysm patient, primary treatments at present First is that endovascular intervention treat, generally use spring ring to aneurysm carry out physics filling treatment.The material of spring ring Generally platinum alloy.The purpose of embolotherapy is to make to be clogged by spring ring machinery in a short time in aneurysm body, and in chronic phase Promote thrombosis in tumor, promotes endothelialization at tumor neck, aneurysm is made to entirely shut and achieve the effect that non-permanent treatment.But Spring ring can be permanently present in knurl, and aneurysm volume will not change over time small, and big or giant aneurysm is then formed Permanent occupation time process.For these big or huge complicated intracranial aneurysms, clinical essential therapeutic arsenals include opening cranium artery Tumor is directly pressed from both sides and is closed, and aneurysm is isolated plus put up a bridge, and intervention Coil embolization treatment etc., but treatment difficulty is high, operation risk is big, art Infectious-related complication incidence is higher.For the treatment prognosis for improving this kind of patient, the blood flow guiding device for belonging to interventional therapy scope is answered It transports and gives birth to, and be worldwide used widely.It has operation relatively easy, and wound is small, and cure rate is high, and recurrence rate is low Even without recurrence, complication rate is compared with other therapeutic modalities without advantages such as increases.The metal covering of blood flow guiding device Rate is significantly improved compared with ordinary stent.It is entirely different with conventional springs circle aneurysm embolization to treat principle.It mainly passes through increasing Add the metal coverage rate of tumor neck position, so that the blood flow entered in aneurysm cavity be made to significantly reduce, or even disappear, to induce dynamic The intracavitary thrombosis of arteries and veins tumor, and promote endothelialization at tumor neck.But it is found in practical clinical, big or giant aneurysm uses After this method treatment, if aneurysm is easy to appear rupture haemorrhage in a short time after the treatment without any embolism materials in tumor, And the death rate after occurring is very high.The thrombus for being considered newly being formed of tracing it to its cause is highly unstable, can generate thrombus self-dissolving, To discharge lyase, makes the aneurysm rupture of some patientss and lead to postoperative hemorrhage.So to reduce or preventing such case Occur, clinically big or giant aneurysm is suggested putting in aneurysm at present when being treated using blood flow guiding device Set enough spring rings.The spring ring placed in aneurysm belongs to foreign matter, and the thrombus Partial Conversion formed in aneurysm at this time To be denaturalized thrombus, and autolysis does not occur for this thrombus, to reduce the generation of autolytic enzyme, and reduces aneurysm rupture Probability.It is thirdly the presence due to blood flow guiding device at tumor neck, the blood still entered in tumor flows out difficulty from tumor neck, It is excessively formed so as to cause thrombus in aneurysm, so as to cause aneurysm rupture.And with spring ring carry out filling can be further It reduces blood at tumor neck to enter in aneurysm, to reduce the slip gradient for the treatment of artery tumor.Due to taking blood flow guiding Device places appropriate spring ring after placing in aneurysm, clinically considerably reduces the probability of postoperative hemorrhage really.But this Kind method equally brings new problem: since there is still a need for the metal elastic spring coils of filling nonabsorable in aneurysm, so that artery The volume of tumor is retained, and occupation time process persistently exists, even if aneurysm heals completely, completely interior membranization at tumor neck.Institute Aneurysm cavity, which is temporarily filled, with the material that can be absorbed for a long time in use in this case reduces short-term bleeding probability, and middle length Phase can be absorbed again and reduce occupation time process, become more satisfactory treatment method.
Through retrieving, CN104739478B discloses a kind of patent of invention of spring ring and preparation method thereof comprising first Coil and the second coil, the first coil are wound on the second coil lateral surface, and one of coil is degradation material, another Coil is nontransmissive material, and the percentage that the volume of degradation material accounts for spring ring volume is 75%-95%.The essence of this structure Property deficiency is: can accelerate the fibrosis of thrombus in aneurysm after the implantation, although biomaterial is being degraded, since its structure is The first coil is wound on the second coil lateral surface, and one of coil is not transmission metal material, still suffers from spring ring It is permanently present in knurl, shape does not have substantial reduction, and therefore, the occupation time process of aneurysm inner body is not from basic Upper solution.
Summary of the invention
Present invention aim to address above-mentioned the deficiencies in the prior art, provide that a kind of structure novel, therapeutic effect be significant, nothing Complication, the aneurysmal degradable embolism that is used for for thoroughly solving postoperative aneurysm occupation time process shrink substance and its preparation side Method.
The present invention solve above-mentioned technical problem the technical solution adopted is that:
One kind shrinking substance for aneurysmal degradable embolism, it is characterised in that it is by degradable that degradable embolism, which shrinks substance, Material made of embolism shrink substance, degradable material be by poly-p-dioxanone or be polyglycolic acid or Person is poly (glycolide-lactide) or is polylactic acid for silk material made of material, and the silk material diameter is 0.05-0.4mm, the embolism Shrinking substance is the spherical surface body that the unit spiral winding formed by single silk material continuous winding is constituted, the unit spiral winding Axis is extended outwardly with the spherical surface body centre of sphere, so that degradable embolism is shunk at substance fitting aneurysm tumor wall and knurl footpath, in turn So that the present invention reduces or block during surgery the blood flow still entered in aneurysm, keep the present invention quick in the aneurysm Cause to be denaturalized thrombosis, and further promotes endothelialization at aneurysm neck in chronic phase;In addition, the contraction substance that embolism uses Within 2-6 months time gradually degradation releases carbon dioxide and water, not no embolism materials in aneurysm after some months In the presence of the occupy-place effect for significantly solving big or giant aneurysm so that disappearing is gradually reduced in aneurysm gradually atrophy, volume It answers, improves the postoperative recovery effects of intracranial aneurysm patients.
The angle of adjacent cells spiral winding axis in spherical surface body of the present invention is different, the unit spiral winding Different angle is less than 180 degree being more than or equal to 10 degree, fits closely so as to be implanted to each face in aneurysm with aneurysm wall, Stablize thrombus, prevents aneurysm rupture bleeding.
Of the present invention different according to spherical surface body quantity, adjacent cells spiral winding angle is different, unit spiral coil it is straight Diameter is different, and the different-diameter of the unit spiral winding further stops thrombus impact aneurysm between 1-30mm, to reach, and prevents Only aneurysm rupture haemorrhage.
The diameter of the silk material of unit spiral winding of the present invention is preferably 0.1-0.35mm, further to promote aneurysm Endothelialization improves the postoperative therapeutic effect of intracranial aneurysm patients.
A kind of preparation method for shrinking substance for aneurysmal degradable embolism, characteristic method and step are as follows:
One, the silk material of degradable material and the shaper of spherical surface body are made;
Two, degradable embolism is made by shaper and shrinks substance.
First method step of the present invention specifically:
Using poly-p-dioxanone or be polyglycolic acid or be poly (glycolide-lactide) or be polylactic acid be material It is spare after the silk material of 0.05-0.4mm that diameter, which is made,;
Prepare polyhedron shaper, cylindrical body is stretched out in each face, then the cylindrical body in each face is numbered, by silk material along volume Number successively it is wound up as multiple and different diameters, the unit spiral winding of different angle constitutes the spherical surface body of embolism;
It is 50-200 degree that high-temperature shaping temperature is carried out after the completion of coiling, removed from shaper after sizing cylindrical body to get to Molding degradable embolism shrinks substance.
The present invention due to using the above structure and preparation method, have structure novel, therapeutic effect it is significant, without complication, The advantages that thoroughly solving postoperative aneurysm occupation time process.
Detailed description of the invention
Fig. 1 is structural schematic diagram of the invention.
Fig. 2 is the structural schematic diagram of the shaper of 6 face spherical surface bodies of the invention.
Fig. 3 is the structural schematic diagram that embolism shrinks that substance is wrapped in the shaper of Fig. 2.
Fig. 4 is the structural schematic diagram of the shaper of 12 face spherical surface bodies of the invention.
Fig. 5 is the structural schematic diagram that embolism shrinks that substance is wrapped in the shaper of Fig. 4.
Appended drawing reference: embolism shrinks substance 13.
Specific embodiment
The following further describes the present invention with reference to the drawings:
As shown in Fig. 1, a kind of to shrink substance for aneurysmal degradable embolism, it is characterised in that degradable embolism constrictor Matter is that the embolism made of degradable material shrinks substance 13, degradable material be by poly-p-dioxanone or It is polyglycolic acid or is poly (glycolide-lactide) or be polylactic acid is silk material made of material, the silk material diameter is 0.05-0.4mm, it is the spherical surface that the unit spiral winding formed by single silk material continuous winding is constituted that the embolism, which shrinks substance, Body, the axis of the unit spiral winding are extended outwardly with the spherical surface body centre of sphere, are moved so that degradable embolism shrinks substance fitting At vein tumour paries and knurl footpath, so that the present invention reduces or block during surgery the blood flow still entered in aneurysm, make this Invention quickly results in denaturation thrombosis described in aneurysm, and further promotes endothelium at aneurysm neck in chronic phase Change;In addition, the contraction substance that embolism uses gradually degraded within 2-6 months time and releases carbon dioxide and water, some months The not presence of embolism materials in aneurysm later, aneurysm gradually atrophy, volume-diminished or disappearance have well solved big Or the occupation time process of giant aneurysm, improve the postoperative recovery effects of intracranial aneurysm patients
The angle of adjacent cells spiral winding axis in spherical surface body of the present invention is different, the difference of the unit spiral winding Angle is less than 180 degree being more than or equal to 10 degree, fits closely so as to be implanted to each face in aneurysm with aneurysm wall, stablizes Thrombus prevents aneurysm rupture bleeding.
Of the present invention different according to spherical surface body quantity, adjacent cells spiral winding angle is different, and specification is different, unit spiral shell The diameter of volution is different, and the different-diameter of the unit spiral winding further stablizes thrombus between 1-30mm, to reach, and prevents Aneurysm rupture bleeding.
The diameter of the silk material of unit spiral winding of the present invention is preferably 0.1-0.35mm, further to promote aneurysm Endothelialization improves the postoperative therapeutic effect of intracranial aneurysm patients.
A kind of preparation method for shrinking substance for aneurysmal degradable embolism, characteristic method and step are as follows:
One, the silk material of degradable material and the shaper of spherical surface body are made;
Two, degradable embolism is made by shaper and shrinks substance.
First method step of the present invention specifically:
Using poly-p-dioxanone or be polyglycolic acid or be poly (glycolide-lactide) or be polylactic acid be material It is spare after the silk material of 0.05-0.4mm that diameter, which is made,;Either using poly-p-dioxanone or be polyglycolic acid, Either poly (glycolide-lactide) or to be that polylactic acid is that material is made spare after the silk material that diameter is 0.1-0.35mm;
Prepare the shaper of multiple spherical surface bodies, multiple spherical surface body shapers of the present invention are preferably distinguished with 6 faces and 12 faces It is illustrated:
Prepare 6 face shapers, cylindrical body is stretched out in each face, then the cylindrical body in each face is numbered, by silk material along number It is wound in circle for 1 cylindrical body, is then successively wound up as 6 unit spiral windings by number for the cylindrical body of 2-3-4-5-6, 6 different-diameters, different angle unit spiral winding constitute the spherical surface body of embolism;
Prepare 12 face shapers, cylindrical body is stretched out in each face, then the cylindrical body in each face is numbered, by silk material along number It is wound in circle for 1 cylindrical body, is then successively wound up as by number for the cylindrical body of 2-3-4-5-6-7-8-9-10-11-12 12 unit spiral windings, 12 different-diameters, different angle unit spiral winding constitute the spherical surface body of embolism;
It is 50-200 degree that high-temperature shaping temperature is carried out after the completion of coiling, removed from shaper after sizing cylindrical body to get to Molding degradable embolism shrinks substance, as shown in Fig. 1.
In clinical use, doctor is first discharged blood flow guiding device by transportation system the present invention along microtubular In parent artery where cerebral aneurysm, and stablize covered tumor neck, is then again put into the present invention in aneurysm cavity along in advance Microtubular be implanted in aneurysm, freed by machinery, electric heating is freed, electric ways of relief stays degradable embolism contraction substance In aneurysm, degradable embolism shrink substance due to use poly-p-dioxanone completely or be polyglycolic acid or Person is made of poly (glycolide-lactide) or is polylactic acid material, and it is spherical surface body that degradable embolism, which shrinks substance, adjacent in spherical surface body The angle of unit spiral winding axis is different with the diameter of adjacent cells spiral winding, further stablizes thrombus in tumor, anti-stop Arteries and veins tumor rupture haemorrhage, meanwhile, degradable embolism, which shrinks substance, can further promote to form thrombus, degradable embolism in aneurysm Filling aneurysm can be stablized in 2 months by shrinking substance, and gradually promote aneurysm neck endothelialization, degradable after 2 months Embolism shrinks substance and is gradually degraded into water and carbon dioxide, and degradation material is degraded completion substantially after 6 months, does not have in aneurysm Any foreign matter residual, without the presence of any occupation time process, aneurysm gradually atrophy, and then in blood flow guiding device at tumor neck Endothelialization under skeleton cures aneurysmal purpose to reach, and the aneurysm for protruding arterial wall thoroughly disappears.
The present invention due to using the above structure and preparation method, have structure novel, therapeutic effect it is significant, without complication, The advantages that thoroughly solving postoperative aneurysm occupation time process.

Claims (6)

1. one kind shrinks substance for aneurysmal degradable embolism, it is characterised in that it is by that can drop that degradable embolism, which shrinks substance, Embolism made of the material of solution shrink substance, degradable material be by poly-p-dioxanone or be polyglycolic acid, Either poly (glycolide-lactide) or be polylactic acid be material made of silk material, the silk material diameter be 0.05-0.4mm, the bolt It is the spherical surface body that the unit spiral winding formed by single silk material continuous winding is constituted that plug, which shrinks substance, and spherical surface body is the face 6-12, The axis of the unit spiral winding is extended outwardly with the spherical surface body centre of sphere.
2. according to claim 1 a kind of for aneurysmal degradable embolism contraction substance, it is characterised in that the ball The angle of adjacent cells spiral winding axis on the body of face is different, and the different angle of the unit spiral winding is more than or equal to 10 degree And it is less than 180 degree.
3. according to claim 2 a kind of for aneurysmal degradable embolism contraction substance, it is characterised in that the ball The diameter of adjacent cells spiral winding on the body of face is different, and the different-diameter of the unit spiral winding is between 1-30mm.
4. according to claim 2 a kind of for aneurysmal degradable embolism contraction substance, it is characterised in that the list The diameter of the silk material of first spiral winding is 0.1-0.35mm.
5. a kind of preparation method for shrinking substance for aneurysmal degradable embolism according to claim 3 or 4, special Sign is method and step are as follows:
Make the silk material of degradable material and the shaper of spherical surface body;
Degradable embolism, which is made, by shaper shrinks substance.
6. a kind of preparation method for shrinking substance for aneurysmal degradable embolism according to claim 5, feature It is first method step of the present invention specifically:
Using poly-p-dioxanone or be polyglycolic acid or be poly (glycolide-lactide) or be polylactic acid be material It is spare after the silk material of 0.05-0.4mm that diameter, which is made,;
Prepare polyhedron shaper, cylindrical body is stretched out in each face, then the cylindrical body in each face is numbered, by silk material along volume Number successively it is wound up as multiple and different diameters, the unit spiral winding of different angle constitutes the spherical surface body of embolism;
It is 50-200 degree that high-temperature shaping temperature is carried out after the completion of coiling, removed from shaper after sizing cylindrical body to get to Molding degradable embolism shrinks substance.
CN201811029106.9A 2018-06-22 2018-09-05 Substance and preparation method thereof is shunk for aneurysmal degradable embolism Pending CN109009308A (en)

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CN201810651971 2018-06-22
CN2018106519710 2018-06-22

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113288315A (en) * 2021-06-21 2021-08-24 上海鸿脉医疗科技有限公司 Medical implant and manufacturing method thereof

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6322576B1 (en) * 1997-08-29 2001-11-27 Target Therapeutics, Inc. Stable coil designs
WO2001093937A2 (en) * 2000-06-08 2001-12-13 Micrus Corporation Three dimensional, low friction coil, and method of manufacture
CN104739479A (en) * 2013-12-31 2015-07-01 微创神通医疗科技(上海)有限公司 Spring coil and production method thereof
CN104739478A (en) * 2013-12-31 2015-07-01 微创神通医疗科技(上海)有限公司 Spring coil and production method thereof
US20150182227A1 (en) * 2013-12-27 2015-07-02 Blockade Medical, LLC Coil system
CN107773283A (en) * 2016-08-31 2018-03-09 微创神通医疗科技(上海)有限公司 Implant, implant preparation method and implant system

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6322576B1 (en) * 1997-08-29 2001-11-27 Target Therapeutics, Inc. Stable coil designs
WO2001093937A2 (en) * 2000-06-08 2001-12-13 Micrus Corporation Three dimensional, low friction coil, and method of manufacture
US20150182227A1 (en) * 2013-12-27 2015-07-02 Blockade Medical, LLC Coil system
CN104739479A (en) * 2013-12-31 2015-07-01 微创神通医疗科技(上海)有限公司 Spring coil and production method thereof
CN104739478A (en) * 2013-12-31 2015-07-01 微创神通医疗科技(上海)有限公司 Spring coil and production method thereof
CN107773283A (en) * 2016-08-31 2018-03-09 微创神通医疗科技(上海)有限公司 Implant, implant preparation method and implant system

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113288315A (en) * 2021-06-21 2021-08-24 上海鸿脉医疗科技有限公司 Medical implant and manufacturing method thereof
WO2022267904A1 (en) * 2021-06-21 2022-12-29 上海鸿脉医疗科技有限公司 Medical implant and manufacturing method therefor

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