WO2004069058A1 - 血管塞栓用デバイス - Google Patents
血管塞栓用デバイス Download PDFInfo
- Publication number
- WO2004069058A1 WO2004069058A1 PCT/JP2004/001283 JP2004001283W WO2004069058A1 WO 2004069058 A1 WO2004069058 A1 WO 2004069058A1 JP 2004001283 W JP2004001283 W JP 2004001283W WO 2004069058 A1 WO2004069058 A1 WO 2004069058A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- growth factor
- blood vessel
- cell growth
- aneurysm
- release member
- Prior art date
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS 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
- A61L31/00—Materials 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
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/145—Hydrogels or hydrocolloids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
- A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
- A61B17/12113—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/1214—Coils or wires
- A61B17/12145—Coils or wires having a pre-set deployed three-dimensional shape
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/1214—Coils or wires
- A61B17/1215—Coils or wires comprising additional materials, e.g. thrombogenic, having filaments, having fibers, being coated
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/12181—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices
- A61B17/1219—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices expandable in contact with liquids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS 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
- A61L31/00—Materials 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
- A61L31/02—Inorganic materials
- A61L31/022—Metals or alloys
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS 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
- A61L31/00—Materials 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
- A61L31/04—Macromolecular materials
- A61L31/043—Proteins; Polypeptides; Degradation products thereof
- A61L31/047—Other specific proteins or polypeptides not covered by A61L31/044 - A61L31/046
Definitions
- the present invention relates to a vascular occlusion device for use in vascular embolization effective for treating aneurysms and the like.
- vaso-occlusive substances include cellulose sponge (Japanese Patent Application Laid-Open No. 2-311762), gelatin particles (Japanese Patent Application Laid-Open No. 60-222045), helical coils (Japanese Patent Application Laid-Open No. 9-1510637), mainly metallic twisted coils. (Patent No. 30 16418), a rod made of hydrophilic resin (Japanese Patent Laid-Open No. 11-47138), a coil with a fibrous material attached (Japanese Patent Application Laid-Open No. 6-506622, Japanese Patent Application No. 6-5101093), etc. Have been.
- the one that is generally used as a vaso-occlusive substance for treating aneurysms is “mainly a micro coil made of a platinum-based alloy”, and various shapes and characteristics have been proposed.
- This is connected to the distal end of the catheter (distal), and after reaching a predetermined site in the blood vessel (for example, Japanese Patent Application Laid-Open No. 8-501015, Japanese Patent Application Laid-Open No. 7-0503674), mechanically, electrically or hydraulically Disconnect the microphone coil inside the aneurysm and place it.
- a predetermined site in the blood vessel for example, Japanese Patent Application Laid-Open No. 8-501015, Japanese Patent Application Laid-Open No. 7-0503674
- the placed microcoil promotes thrombus formation, thereby closing the aneurysm with the thrombus and completing the treatment.
- coil vascular occlusion is used to treat arterial ducts, arteriovenous fistulas, cerebral arteriovenous malformations, and other vascular lesions. Furthermore, as one of the methods for treating tumors, tumors are shrunk or eliminated by embolizing the tumor's nutritional vessels.
- a medical wire provided with a metal coil at the distal end of a guide wire is prepared, and this distal end is inserted into a target blood vessel site.
- a metal coil which is a vaso-occlusive substance, is cut off and placed.
- thromboembolism has problems such as contraction of the thrombus due to blood pressure, loss of the occlusive effect due to the movement of the thrombus in the blood vessel, and formation or rupture of an aneurysm at another site. Therefore, there is a need in the art for providing a vascular embolization device that can more effectively embolize blood vessels.
- An object of the present invention is to provide a vascular occlusion device that can occlude a vascular site such as an aneurysm, and can preferably induce organization in an in vivo. Disclosure of the invention
- the present invention provides a device for vascular occlusion comprising a metal coil, a sustained release member, and a cell growth factor.
- the present invention also provides a method of embolizing a blood vessel, comprising mounting a metal coil, a sustained-release member, and a device for vascular occlusion containing a cell growth factor to a site to be embolized in a blood vessel of a patient.
- the cell growth factor is basic fibroblast growth factor (bFGF), acidic fibroblast growth factor (aFGF), platelet-derived growth factor (PDGF), transforming growth factor j31 (TGF-181), vascular endothelium It is selected from the group consisting of cell growth factor (VEGF) and connective tissue growth factor (CTGF).
- the sustained release member is a hydrophilic hydrogel.
- FIG. 1 is a photographic drawing showing the appearance of the tissue at the connection between the aneurysm and the carotid artery of an aneurysm model animal treated using the metal microcoil of the present invention.
- FIG. 2 is a photographic drawing of the tissue at the connection between the aneurysm and the carotid artery of an aneurysm model animal treated using the metal microphone coil of the present invention, viewed from the lumen of the artery.
- the vascular occlusion device of the present invention is characterized by including a metal coil, a sustained-release member, and a cell growth factor.
- the device for vascular occlusion of the present invention can be applied to a predetermined site of a blood vessel, particularly, an aneurysm, to embolize the blood vessel at the site.
- the device for vascular occlusion of the present invention can induce organization in an in vivo.
- the term “organization” refers not to a thrombus generated around a material placed in a blood vessel but to a fibrous tissue that is replaced by fibrous tissue. If this tissue is formed and guided in the aneurysm and the inside of the aneurysm can be completely packed, the site becomes non-ruptureable and complete treatment of the aneurysm can be realized without re-occurring. .
- the aneurysm When the device of the present invention is filled into an aneurysm model, a heron's internal carotid aneurysm, the aneurysm can be healed by stromal matrix formation and vascular endothelial cell covering within 3 weeks.
- the material of the metal coil used in the device of the present invention platinum, gold, tungsten, stainless steel, alloys thereof, and the like can be used.
- the metal coil can be manufactured by forming a metal wire into a spiral shape.
- the coil may be single wrapped or double or triple wrapped.
- the coil may be further provided with a metallic or fibrous branch or loop, and may have a random three-dimensional structure when the secondary coil is extruded from the guide wire.
- Various types and shapes of metal coils for embolization are commercially available, and any of these can be suitably used in the present invention.
- a coil suitable for embolization of a cerebral aneurysm is a primary coil having a diameter of several millimeters using a wire having a diameter of 0.05 to 0.15 mm. And a secondary coil formed by further spiraling.
- sustained-release members examples include water-soluble polysaccharides such as alginic acid, hyaluronic acid, carboxymethyl cellulose; proteins such as gelatin and pectic acid; water-soluble polysaccharides such as polyvinyl alcohol, polyacrylic acid, and polymalic acid.
- a hydrogel can be formed by adding a bifunctional reagent such as daltaraldehyde to the aqueous solution to cause crosslinking, and then swelling with water or a buffer solution.
- the metal coil is immersed in an aqueous solution of a mixture of gelatin and dataraldehyde, the slow-release member is attached to the metal coil, and the gelatin is crosslinked by leaving the metal coil to fix the slow-release member to the metal coil. If necessary, wash and remove unreacted dartartaldehyde to remove metal coil and controlled release
- a device made of the material can be prepared.
- Gelatin can be crosslinked by ultraviolet light, gamma rays, electron beam irradiation, thermal dehydration, or the like. After immersing the metal coil in the aqueous gelatin solution, depressurize or freeze-dry. Next, a crosslinked gelatin is obtained by performing the above-mentioned operations.
- the degree of cross-linking of the gelatin hydrate gel can be adjusted by changing the cross-linking conditions, thereby enabling the degradable control of the hydrogel in the body.
- the sustained release pattern of the cell growth factor impregnated inside can be changed.
- the device comprising the metal coil and the sustained-release member thus obtained is impregnated with an aqueous solution of a cell growth factor.
- the cell growth factor means a substance having an activity of promoting organization of a tissue, and includes, for example, a protein, a peptide, a nucleic acid or a low molecular drug.
- preferred cell growth factors include basic fibroblast growth factor (bFGF), acidic fibroblast growth factor (aFGF), platelet-derived growth factor (PDGF), transforming growth factor] 31 (TGF -i81), vascular endothelial cell growth factor (VEGF) and connective tissue growth factor (CTGF).
- growth factors are commercially available or can be produced recombinantly using genes encoding these growth factor proteins.
- low molecular drugs that promote secretion of such cell growth factors eg, suputin, rapamycin, etc.
- genes encoding cell growth factors, and the like can also be used in the present invention.
- One or more of these substances may be used in combination.
- the sustained release member and the cell growth factor prepared in this way When the device composed of the metal coil, the sustained release member and the cell growth factor prepared in this way is applied to the vascular site to be embolized, the cell growth factor contained and fixed therein gradually elongates from the sustained release member. It is released over time, promotes proliferation of fibroblasts and the like inside blood vessels, and can induce organization by fibrous tissue. The release of a certain range of concentrations of cell growth factors over a long period of time induces appropriate organization and promotes vascular obstruction. In particular, in the case of treatment of aneurysms, it is thought that an ideal aneurysm filling treatment with own tissue can be performed.
- the site becomes non-destructive and the aneurysm stably closes for a long time. It is. In other words, organization occurs.
- the luminal surface of the organizing aneurysm at the site of the original blood vessel connection is covered with the same vascular endothelial cells as the surrounding natural blood vessels.
- a vein was excised and collected at a length of 8 mm in the internal cervix of rabbits.
- Implanted on the internal carotid artery a pocket model aneurysm about 5 mm deep was created.
- the device for embolization prepared in Example 1 or a metal microcoil to which a hydrogel not impregnated with bFGF was attached as a control was placed in the model aneurysm, and the non-vascular side of the aneurysm was closed with a suture. .
- the rabbits were sacrificed and the healing state of the aneurysm and the organization of the fibrous tissue in the aneurysm were examined.
- the aneurysm is completely filled with the organizing tissue containing the coil, and the arterial luminal surface at the connection between the arterial aneurysm and the internal carotid artery It was covered with the same vascular endothelial cells ( Figures 1 and 2).
- the group of metal coils attached to Hyde-mouth gel not impregnated with bFGF only the thrombus was filled in the aneurysm, and no organization and no endothelial cells were observed. Observation of the tissue section inside the aneurysm revealed that the inside of the aneurysm was completely filled with tissue.
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- Health & Medical Sciences (AREA)
- Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Vascular Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Heart & Thoracic Surgery (AREA)
- Molecular Biology (AREA)
- Medical Informatics (AREA)
- Biomedical Technology (AREA)
- Engineering & Computer Science (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Reproductive Health (AREA)
- Epidemiology (AREA)
- Chemical & Material Sciences (AREA)
- Neurosurgery (AREA)
- Dispersion Chemistry (AREA)
- Inorganic Chemistry (AREA)
- Materials For Medical Uses (AREA)
- Surgical Instruments (AREA)
Abstract
Description
Claims
Priority Applications (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP04708862A EP1600109A1 (en) | 2003-02-07 | 2004-02-06 | Device for blocing blood vessel |
US10/544,621 US20060259130A1 (en) | 2003-02-07 | 2004-02-06 | Device for blocing blood vessel |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2003-031490 | 2003-02-07 | ||
JP2003031490A JP2004261218A (ja) | 2003-02-07 | 2003-02-07 | 血管塞栓用組成物 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2004069058A1 true WO2004069058A1 (ja) | 2004-08-19 |
Family
ID=32844301
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/JP2004/001283 WO2004069058A1 (ja) | 2003-02-07 | 2004-02-06 | 血管塞栓用デバイス |
Country Status (4)
Country | Link |
---|---|
US (1) | US20060259130A1 (ja) |
EP (1) | EP1600109A1 (ja) |
JP (1) | JP2004261218A (ja) |
WO (1) | WO2004069058A1 (ja) |
Families Citing this family (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2006025177A1 (ja) * | 2004-08-30 | 2006-03-09 | Mie Tlo Co., Ltd. | 人工栓塞物 |
US8262693B2 (en) * | 2004-11-05 | 2012-09-11 | Accessclosure, Inc. | Apparatus and methods for sealing a vascular puncture |
US8871900B2 (en) | 2008-06-16 | 2014-10-28 | University Of Rochester | Fibroblast growth factor (FGF) analogs and uses thereof |
KR101249041B1 (ko) | 2010-04-28 | 2013-03-29 | 포항공과대학교 산학협력단 | 결합조직 성장인자를 이용한 약학적 조성물 |
US20130178892A1 (en) * | 2010-09-16 | 2013-07-11 | Kyoto University | Statin-loaded coils for acceleration of organization after endovascular coiling of aneurysms |
US8795319B2 (en) | 2011-03-02 | 2014-08-05 | Cook Medical Technologies Llc | Embolization coil |
Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO1994010936A1 (en) * | 1992-11-18 | 1994-05-26 | Target Therapeutics, Inc. | Ultrasoft embolism devices and process for using |
JP2002306518A (ja) * | 2000-12-21 | 2002-10-22 | Yuichi Mori | 体内留置用具 |
Family Cites Families (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6113629A (en) * | 1998-05-01 | 2000-09-05 | Micrus Corporation | Hydrogel for the therapeutic treatment of aneurysms |
US6280457B1 (en) * | 1999-06-04 | 2001-08-28 | Scimed Life Systems, Inc. | Polymer covered vaso-occlusive devices and methods of producing such devices |
US6398808B1 (en) * | 1999-06-15 | 2002-06-04 | Scimed Life Systems, Inc. | Localized delivery of genetic information from biostable materials |
CA2689598A1 (en) * | 2001-05-29 | 2002-12-05 | Microvention, Inc. | Method of manufacturing expansile filamentous embolization devices |
-
2003
- 2003-02-07 JP JP2003031490A patent/JP2004261218A/ja active Pending
-
2004
- 2004-02-06 US US10/544,621 patent/US20060259130A1/en not_active Abandoned
- 2004-02-06 EP EP04708862A patent/EP1600109A1/en not_active Withdrawn
- 2004-02-06 WO PCT/JP2004/001283 patent/WO2004069058A1/ja active Application Filing
Patent Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO1994010936A1 (en) * | 1992-11-18 | 1994-05-26 | Target Therapeutics, Inc. | Ultrasoft embolism devices and process for using |
JP2002306518A (ja) * | 2000-12-21 | 2002-10-22 | Yuichi Mori | 体内留置用具 |
Also Published As
Publication number | Publication date |
---|---|
JP2004261218A (ja) | 2004-09-24 |
US20060259130A1 (en) | 2006-11-16 |
EP1600109A1 (en) | 2005-11-30 |
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