WO2003013587A1 - Compositions pour l'occlusion vasculaire - Google Patents

Compositions pour l'occlusion vasculaire Download PDF

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Publication number
WO2003013587A1
WO2003013587A1 PCT/JP2002/007894 JP0207894W WO03013587A1 WO 2003013587 A1 WO2003013587 A1 WO 2003013587A1 JP 0207894 W JP0207894 W JP 0207894W WO 03013587 A1 WO03013587 A1 WO 03013587A1
Authority
WO
WIPO (PCT)
Prior art keywords
growth factor
cell growth
composition
aneurysm
composition according
Prior art date
Application number
PCT/JP2002/007894
Other languages
English (en)
Japanese (ja)
Inventor
Yasuhiko Tabata
Susumu Miyamoto
Keisuke Yamada
Original Assignee
Yasuhiko Tabata
Susumu Miyamoto
Keisuke Yamada
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Yasuhiko Tabata, Susumu Miyamoto, Keisuke Yamada filed Critical Yasuhiko Tabata
Publication of WO2003013587A1 publication Critical patent/WO2003013587A1/fr

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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
    • A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
    • A61L24/04—Surgical adhesives or cements; Adhesives for colostomy devices containing macromolecular materials
    • A61L24/10—Polypeptides; Proteins
    • A61L24/108—Specific proteins or polypeptides not covered by groups A61L24/102 - A61L24/106
    • 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
    • A61B17/1215—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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/18—Growth factors; Growth regulators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K49/00—Preparations for testing in vivo
    • A61K49/0004—Screening or testing of compounds for diagnosis of disorders, assessment of conditions, e.g. renal clearance, gastric emptying, testing for diabetes, allergy, rheuma, pancreas functions
    • 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
    • A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
    • A61L24/001—Use of materials characterised by their function or physical properties
    • A61L24/0015—Medicaments; Biocides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/14—Vasoprotectives; Antihaemorrhoidals; Drugs for varicose therapy; Capillary stabilisers
    • 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
    • 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/412—Tissue-regenerating or healing or proliferative agents
    • A61L2300/414—Growth factors
    • 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/60—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
    • A61L2300/602—Type of release, e.g. controlled, sustained, slow

Definitions

  • the present invention relates to a fibrous member, a member capable of sustained release of a cell growth factor (sustained release member), and a composition for vascular occlusion useful for treating an aneurysm, which comprises a cell growth factor.
  • vaso-occlusive substances include cellulose sponge (Japanese Patent Application Laid-Open No. 2-31762), gelatin particles (Japanese Patent Application Laid-Open No. 60-222045), helical coil (Japanese Patent Application Laid-Open No. 9-5107637), mainly made of metal.
  • a twisted coil (patent No. 3016418), a mouth made of hydrophilic resin (Japanese Patent Application Laid-Open No. 11-47138), and the like have been proposed.
  • the one generally used as a vaso-occlusive substance for treating an aneurysm is "mainly a platinum alloy microcoil", and various shapes and characteristics have been proposed.
  • This is connected to the distal end of the catheter (distal) and reaches a predetermined site in the blood vessel (for example, Japanese Patent Application Laid-Open No. 8-50101, Hei 7-502 674), and the artery is mechanically, electrically or hydraulically pressed. Dissect and place in the aneurysm.
  • a metal microcoil as a material for vascular occlusion for treating aneurysms is operated by operating a medical wire provided at the distal end of the guide wire until the distal end reaches the opening of the aneurysm.
  • An aneurysm treatment method has been put to practical use in which a metal microcoil, which is a substance for use, is cut off inside the aneurysm and placed there.
  • Metal microcoils are preferred for shaping and electrical separation, but are known to have the following problems that hinder widespread practical use in medicine. (1) By placing only the metal microcoils in the aneurysm, it is not possible to achieve the required average and high-density filling of the aneurysm lumen by any means. In some cases, it may not be possible to obtain a great embolic effect.
  • the thrombus generated by the metal microcoil may not be sufficiently organized, and may not be the expected non-ruptured tissue. As a result, metal microcoils may fall out of the aneurysm or protrude.
  • a first object of the present invention is to provide a vascular occlusion composition that can reliably and preferably occlude a blood vessel, preferably a blood vessel site such as an aneurysm.
  • a second object of the present invention is to provide a composition for vascular occlusion that can induce excellent organization as compared with the prior art using only a metal microphone coil, and a third object is
  • the fourth purpose is to provide a composition for vascular occlusion that does not hinder the resection of aneurysms or cerebral arteriovenous malformations by craniotomy surgery at a later date. The fourth purpose is to provide a metal coil, cellulose sponge, etc.
  • An object of the present invention is to provide a vascular occlusion composition that can stably close a blood vessel even when used in combination with a substance.
  • the present invention relates to a fibrous member, a member capable of sustained release of a cell growth factor, and a composition for vascular occlusion containing a cell growth factor.
  • FIG. 1 shows a tissue section of a model aneurysm after 6 weeks.
  • A 100 / Xg b FGF-impregnated gelatin hydrated gel microcoil treated group (95% water content)
  • B Microcapped coil treated group
  • C b FGF-free gelatin hydrated gel microcoil treated Science group (95% moisture content)
  • FIG. 2 is a diagram of factor VIII immunostaining 6 weeks after treatment with 100 zgb FGF-impregnated gelatin hydrogel (95% water content) with a microphone coil. The organized fibrous tissue surface is completely covered with vascular endothelial cells.
  • composition for vascular occlusion of the present invention is applied to a predetermined site of a blood vessel, particularly to an aneurysm, and is designed to surely cause organization at the site after embolization.
  • the term “organization” refers to not a thrombus generated around a material placed in a blood vessel but a thrombus which is replaced by fibrous tissue. If this tissue forms within the aneurysm, the area is non-ruptured and will not re-create the aneurysm.
  • the present invention relates to a composition for vascular occlusion, comprising a fibrous member, a cell growth factor, and a member capable of sustained release of a cell growth factor, preferably capable of inducing organization in vivo.
  • composition of the present invention When the composition of the present invention is applied to a rat internal carotid aneurysm, which is an aneurysm model, fibrous tissue is formed after 3 weeks and 6 weeks in the presence of a cell growth factor in a predetermined concentration range.
  • fibrous tissue In the case of the fibrous member alone, the case of the cell growth factor sustained release member alone, the case of the fibrous member and the cell growth factor sustained release member, and the case of the cell growth factor-containing substance having no sustained release. In all cases, a thrombus is formed but no organization is induced, and no therapeutically effective embolic tissue is produced.
  • a substance such as a metallic core or a cellulose sponge
  • composition of the present invention is as follows:
  • the fibrous member of the composition examples include polyesters, preferably, highly biocompatible polyesters such as polyethylene terephthalate, polybutylene terephthalate, etc., polyamides, preferably nylons, etc., polyacryls, polyolefins, and the like.
  • polypropylene or the like can be used.
  • polypropylene and nylon are particularly preferred.
  • Various materials such as multifilaments and monofilaments can be used as the fibrous member, and a wide range of unit filament diameters from 10 / m force to 300 ⁇ can be used. Also, these materials and diameters may be mixed.
  • a polyester monofilament with a diameter of 100 xm is processed into a microspiral with a diameter of about 0.7 mm, which is heat-fixed, and then used as a secondary coil with a diameter of 2 sq. You can also.
  • the cell growth factor sustained-release member examples include partially cross-linked gelatin and collagen.
  • a hydrogel may be prepared by adding a bifunctional aldehyde solution such as Daltar aldehyde to the aqueous solution. The fibrous member is immersed in this hydrogel, and the cell growth factor sustained-release member is adhered to and fixed to the fibrous member. By leaving this to stand, the gelatin crosslinking reaction proceeds, and the unreacted aldehyde is washed and removed, whereby a composition comprising a fibrous member and a cell growth factor sustained release member can be prepared.
  • a bifunctional aldehyde solution such as Daltar aldehyde
  • cell growth factors examples include basic fibroblast growth factor (b FGF), acidic fibroblast growth factor (a FGF), platelet-derived growth factor (PDGF), transforming growth factor i3 1 (TGF- ⁇ 1), vascular endothelial cell growth factor (VEGF) and connective tissue growth factor (CTGF).
  • b FGF basic fibroblast growth factor
  • a FGF acidic fibroblast growth factor
  • PDGF platelet-derived growth factor
  • TGF- ⁇ 1 transforming growth factor i3 1
  • VEGF vascular endothelial cell growth factor
  • CTGF connective tissue growth factor
  • the cell growth factor contained and fixed therein is gradually released over a long period of time in accordance with the degradation process of crosslinked gelatin and the like, and is released by fibroblasts and the like inside the aneurysm. It was clear that the organization was induced. Even if a non-sustained release substance such as non-crosslinked gelatin is made to absorb and contain bFGF and the like, and the same operation as above is performed, induction of organization is not observed. Thus, the release of a certain range of concentrations of cell growth factors over a prolonged period of time can only induce proper organization and form an effective embolus for the treatment of aneurysms. If fibrous tissue forms within the aneurysm, the site is non-ruptureable and the aneurysm is permanently packed. This is organization. The luminal side of the organizing site is covered with the same luminal cells as the natural substance.
  • Example 1 Example 1
  • the vein was excised from the inner cervix of rabbits, and the vein was excised and collected to a length of 8 mm. This was transplanted onto the internal carotid artery to prepare a pocket-type model aneurysm about 5 cm deep.
  • composition for vascular occlusion of 1-2 was placed in a model aneurysm of 1-3, and the non-vascular side of the aneurysm was closed with a suture.
  • Figure 1 shows the tissue section of the model aneurysm after 6 weeks.
  • Figure 1A shows a gelatin hydrogen gel (95% moisture content) one polyester coil impregnated with 100 bFGF
  • Figures 1B and 1C show microgels only and gelatin hydrogel (95% moisture content) coils, respectively.
  • the result The lumen of the aneurysm was occupied and closed by 80% of the lumen cross-section by organized fibrous tissue.
  • Fig. 1B the polyester microcoil and cross-linked gelatin hide gel alone
  • Fig. 1C formed a thrombus inside the model aneurysm.
  • the shape and diameter of the opening did not change, and no organized tissue was observed.
  • Polyester multifilament (unit filament diameter 12.5 / xm, number of filaments 48, false twist, length 20 sq.) Is converted to platinum alloy (platinum 91%) microcoil.
  • a fiber member was made by applying force to the four locations of the secondary coil with a primary coil diameter of 0.38 (primary coil diameter 2.7 mm, secondary coil diameter 2.7 mm). Using a method similar to that of Example 1, this fiber member was immersed in darthal aldehyde-crosslinked gelatin hydrogel having a water content of 95%, and then impregnated with bFGF in a gelatin hydrid gel and fixed. Three or five of the compositions were delivered to a rabbit model aneurysm using a catheter.
  • the rabbits were sacrificed and examined for the formation of fibrous tissue in the aneurysm.
  • the aneurysm opening was closed by fibrous tissue
  • the aneurysm opening was closed by fibrous tissue.
  • the findings of the fibrous tissue inside the aneurysm were the same as in Example 1.
  • An embolus-forming composition was prepared in the same manner as in Example 1, except that a small amount of cotton gauze was used instead of the polyester microphone opening coil. This embolizing composition was inserted into a rabbit model aneurysm, and the distal part of the aneurysm was sutured and closed. Comparison of gauze with partially cross-linked gelatin impregnated with 25 or 50 g of connective tissue growth factor as cell growth factor, and gauze with partially cross-linked gelatin not impregnated with growth factor did. Six weeks later, the rabbit was sacrificed and the inside of the model aneurysm was observed.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Surgery (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Biomedical Technology (AREA)
  • Vascular Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Epidemiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Chemical & Material Sciences (AREA)
  • Reproductive Health (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Materials Engineering (AREA)
  • Pathology (AREA)
  • Rheumatology (AREA)
  • Toxicology (AREA)
  • Urology & Nephrology (AREA)
  • Endocrinology (AREA)
  • Cardiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Diabetes (AREA)
  • Organic Chemistry (AREA)
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  • Zoology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Materials For Medical Uses (AREA)

Abstract

L'invention concerne l'obtention de compositions destinées à l'occlusion vasculaire utiles pour traiter l'anévrisme, lesquelles contiennent un élément fibreux, un élément capable de libérer graduellement un facteur de croissance cellulaire ainsi que le facteur de croissance cellulaire.
PCT/JP2002/007894 2001-08-03 2002-08-02 Compositions pour l'occlusion vasculaire WO2003013587A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2001-236422 2001-08-03
JP2001236422A JP2003048841A (ja) 2001-08-03 2001-08-03 血管閉塞用組成物

Publications (1)

Publication Number Publication Date
WO2003013587A1 true WO2003013587A1 (fr) 2003-02-20

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WO (1) WO2003013587A1 (fr)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2011526510A (ja) * 2008-07-04 2011-10-13 フジフィルム・マニュファクチュアリング・ヨーロッパ・ベスローテン・フエンノートシャップ 医療用デバイスのコーティング方法
WO2013112491A1 (fr) * 2012-01-23 2013-08-01 The Board Of Trustees Of The Leland Stanford Junior University Hydrogels ajustables et procédés de préparation associés
WO2024034610A1 (fr) * 2022-08-08 2024-02-15 三菱ケミカル株式会社 Hydrogel congelé et décongelé, son procédé de production, dispositif médical ophtalmique et lentille de contact

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1993006884A1 (fr) * 1991-10-02 1993-04-15 Target Therapeutics, Inc. Fil metallique helicoïdal de vasoocclusion auquel est rattache au moins un element fibreux
WO1994010936A1 (fr) * 1992-11-18 1994-05-26 Target Therapeutics, Inc. Dispositifs d'embolie ultrasouples et procede d'utilisation
WO1994015534A1 (fr) * 1993-01-15 1994-07-21 Target Therapeutics, Inc. Dispositif de vaso-occlusion contenant des fibres opaques aux rayons x
EP0739608A1 (fr) * 1995-04-28 1996-10-30 Target Therapeutics, Inc. Dispositifs vasoocclusives avec d'une fibre polymère fixée par chaud
WO2001030411A1 (fr) * 1999-10-26 2001-05-03 Kaken Pharmaceutical Co., Ltd. Materiau de traitement d'embolie vasculaire a base d'hydrogel et therapie correspondante

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1993006884A1 (fr) * 1991-10-02 1993-04-15 Target Therapeutics, Inc. Fil metallique helicoïdal de vasoocclusion auquel est rattache au moins un element fibreux
WO1994010936A1 (fr) * 1992-11-18 1994-05-26 Target Therapeutics, Inc. Dispositifs d'embolie ultrasouples et procede d'utilisation
WO1994015534A1 (fr) * 1993-01-15 1994-07-21 Target Therapeutics, Inc. Dispositif de vaso-occlusion contenant des fibres opaques aux rayons x
EP0739608A1 (fr) * 1995-04-28 1996-10-30 Target Therapeutics, Inc. Dispositifs vasoocclusives avec d'une fibre polymère fixée par chaud
WO2001030411A1 (fr) * 1999-10-26 2001-05-03 Kaken Pharmaceutical Co., Ltd. Materiau de traitement d'embolie vasculaire a base d'hydrogel et therapie correspondante

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