WO2023053710A1 - 組織修復材キット及び組織修復方法 - Google Patents

組織修復材キット及び組織修復方法 Download PDF

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Publication number
WO2023053710A1
WO2023053710A1 PCT/JP2022/029561 JP2022029561W WO2023053710A1 WO 2023053710 A1 WO2023053710 A1 WO 2023053710A1 JP 2022029561 W JP2022029561 W JP 2022029561W WO 2023053710 A1 WO2023053710 A1 WO 2023053710A1
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WO
WIPO (PCT)
Prior art keywords
tissue repair
repair material
tissue
opening
kit according
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/JP2022/029561
Other languages
English (en)
French (fr)
Japanese (ja)
Inventor
和人 福永
伸彦 加藤
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.)
Fujifilm Corp
Original Assignee
Fujifilm Corp
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 Fujifilm Corp filed Critical Fujifilm Corp
Priority to JP2023550419A priority Critical patent/JPWO2023053710A1/ja
Priority to EP22875587.2A priority patent/EP4393453A4/en
Publication of WO2023053710A1 publication Critical patent/WO2023053710A1/ja
Priority to US18/612,129 priority patent/US20240374789A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/28—Bones
    • 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14—Macromolecular materials
    • A61L27/22—Polypeptides or derivatives thereof, e.g. degradation products
    • A61L27/222—Gelatin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/46—Special tools for implanting artificial joints
    • A61F2/4601—Special tools for implanting artificial joints for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity
    • 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
    • A61K38/39—Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin, cold insoluble globulin [CIG]
    • 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14—Macromolecular materials
    • A61L27/22—Polypeptides or derivatives thereof, e.g. degradation products
    • A61L27/227—Other specific proteins or polypeptides not covered by A61L27/222, A61L27/225 or A61L27/24
    • 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/78—Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin or cold insoluble globulin [CIG]
    • 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
    • A61L2400/00—Materials characterised by their function or physical properties
    • A61L2400/06—Flowable or injectable implant compositions
    • 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
    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/02—Materials or treatment for tissue regeneration for reconstruction of bones; weight-bearing implants

Definitions

  • FIG. 1 is a schematic diagram showing an example of a tissue repair material kit.
  • FIG. 2 is a schematic diagram showing a syringe assembled using the tissue repair material kit of FIG.
  • FIG. 3 is a schematic diagram showing an example of a tissue repair material kit.
  • FIG. 4 is a schematic diagram showing an example of a tissue repair material kit.
  • the tissue repair material kit includes a cylindrical container having an opening with an opening diameter smaller than the inner diameter of the container, and a tissue repair material. Since the storage elastic modulus at 25° C. is as small as 0.1 kPa to 100 kPa, that is, the tissue repair material is easily deformed, the tissue repair material accommodated in the cylindrical container through the opening can be easily applied to a narrow tissue defect site. can supply.
  • the opening diameter of the opening may be, for example, 15 mm or less. As described above, the opening can function as a part that supplies the tissue repair material to the tissue defect.
  • the opening diameter of is preferably 0.8 mm to 10 mm, more preferably 0.8 mm to 6.6 mm. More preferably, the upper limit of the opening diameter of the opening is 5 mm or less. More preferably, the opening diameter of the opening is 0.8 mm to 2.5 mm.
  • the inner diameter of the discharge part means the diameter of a circle having an area equal to the area of the hollow part in a cross section perpendicular to the longitudinal direction of the discharge part.
  • the inner diameter of the discharge part is not uniform in the longitudinal direction, it means the diameter of a circle having an area equal to the area of the hole through which the tissue repair material flows out from the outside of the discharge part in plan view.
  • the discharge part (and cavity) is a rod tapering from one end to the other end (the hole through which the tissue repair material flows out) in the longitudinal direction
  • the inner diameter of the discharge part is the hole at the tapered tip. It means the diameter of the part and becomes the minimum value.
  • the opening diameter of the ejection part is a value measured by, for example, a projection image measuring instrument, a laser displacement meter, or a vernier caliper.
  • the inner diameter of the discharge part is preferably 10% to 70% of the inner diameter of the cylindrical container, and 20% to 70% or less. is more preferable. Further, by making the cylindrical container thicker than the discharge part, the container can be made compact and short. Therefore, the inner diameter of the discharge part is more preferably 20% to 60% of the inner diameter of the cylindrical container.
  • the tissue repair material kit may include pressurizing means provided at the other end of the cylindrical container.
  • the pressurizing means is not particularly limited, and examples thereof include plungers, pistons, compressed air, and the like. Among these, from the viewpoint of convenience, the pressurizing means is preferably a plunger.
  • a plunger is a member that slides on the inner wall of the cylindrical container and pushes out the tissue repair material contained in the cylindrical container.
  • the plunger may include a gasket (e.g., gasket 42 shown in FIG. 1) to improve airtightness with the inner wall of the tubular container, and a pusher (e.g., , the pusher 44 shown in FIG.
  • the plunger may be driven by pressure, such as a medium.
  • the material of the gasket is not particularly limited, and synthetic rubber, for example, may be used and may contain a lubricant.
  • tissue repair material is a material that, when implanted in a living body, contributes to the formation of tissue at the implantation site, and may or may not contain cells. In addition, the tissue repair material may or may not contain components such as growth factors, drugs, etc. that promote biological reactions. Also, a tissue repair material mixed with an inorganic material such as hydroxyapatite or forming a composite may be applied. Furthermore, the tissue repair material does not necessarily contribute to the formation of normal tissue that normally exists in a tissue defect site (e.g., implantation site), and includes materials that promote the formation of non-normal tissue including scar tissue and the like. can be anything.
  • the shape of the tissue repair material is not particularly limited, and may be, for example, granular or block-shaped.
  • Granular means granules, powders, slurries and the like.
  • the shape of the granules is not particularly limited, and may be amorphous, spherical, powdery, porous, fibrous, spindle-shaped, flattened, sheet-shaped, or the like.
  • the shape of the granules is preferably amorphous, spherical, powdery, or porous.
  • amorphous means a shape with a non-uniform surface shape, such as a rock-like uneven shape.
  • tissue repair material kit contains the tissue repair material is not particularly limited. At that time, the tissue repair material may be contained in a tubular container.
  • the tissue repair material kit may include an aqueous liquid to mix with the tissue repair material.
  • the water-containing liquid may be, for example, a solution or dispersion in which water is used as a solvent.
  • the water-containing liquid is not particularly limited, and examples include water for injection, physiological saline, hyaluronic acid aqueous solution, carboxymethylcellulose aqueous solution, polyethylene glycol aqueous solution, growth factor aqueous solution, antibiotic aqueous solution, blood, bone marrow fluid, platelet-rich plasma, and mixtures thereof. can be
  • tissue repair material kit contains the water-containing liquid
  • the hydrous liquid may be mixed with the tissue repair material.
  • the water-containing liquid may be pre-mixed with the tissue repair material.
  • the content of the water-containing liquid is preferably 50% to 2000% by mass, more preferably 100% to 2000% by mass, relative to the dry mass of the tissue repair material.
  • a state in which the tissue repair material is mixed with a water-containing liquid to increase its mass is sometimes referred to as a water-containing state.
  • the tissue repair material may contain a biocompatible polymer.
  • Biocompatibility means that when in contact with a living body, it does not cause significant adverse reactions such as long-term and chronic inflammatory reactions.
  • biocompatible substances include proteins, polysaccharides, and the like.
  • Examples of natural gelatin and its recombinant gelatin include those derived from animals such as fish and mammals, but those derived from mammals are preferred. Examples of mammalian animals include humans, horses, pigs, mice, rats, and the like. When the tissue repair material according to this embodiment contains recombinant gelatin, the recombinant gelatin is more preferably derived from humans.
  • the molecular weight of the recombinant gelatin is preferably 2 kDa to 100 kDa, more preferably 5 kDa to 90 kDa or less, even more preferably 10 kDa to 90 kDa.
  • the recombinant gelatin preferably satisfies at least one of the following aspects (2-1) to (2-4).
  • the recombinant gelatin may have the following aspects (2-1) to (2-4) alone, or may have two or more aspects in combination.
  • (2-1) the carbamoyl group is not hydrolyzed;
  • (2-2) Does not have procollagen. (2-3) does not have a telopeptide;
  • (2-4) A substantially pure collagen-like material prepared with a nucleic acid encoding native collagen.
  • the step of supplying the tissue repair material may be performed as appropriate, taking into consideration the configuration of the tissue repair material kit.
  • the syringe 100 shown in FIG. 4 is assembled using the tissue repair material kit 1000 shown in FIG. 1, the syringe 100 shown in FIG. 4 is assembled.
  • the hole portion 34 of the discharge portion 30 is inserted near the tissue defect.
  • the plunger 40 is pressed into the cylindrical container 10 to supply the tissue repair material 50 to the tissue defect site through the hole 34 .
  • the storage modulus was measured as follows. A test substance is placed in a SUS ring with an inner diameter of 15 mm and a height of 7.5 mm, and a disposable parallel plate ( ⁇ 12 mm) of a rheometer (Anton Paar, MCR302) is used to apply an oscillating flow in the shear direction while pressing with a constant load of 1 N. was given and linear viscoelastic measurements were performed. The test substance was used in such an amount that the height when pressed was 3.5 mm or more and 4.5 mm or less. The angular frequency was swept from 1 rad/sec to 50 rad/sec and then from 50 rad/sec to 1 rad/sec, and the storage modulus at 1 rad/sec in the latter sweep was measured. The above measurements were repeated three times, and the average value was taken as the storage elastic modulus of the test substance.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Transplantation (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biomedical Technology (AREA)
  • Dermatology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Immunology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Toxicology (AREA)
  • Genetics & Genomics (AREA)
  • Cardiology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Materials For Medical Uses (AREA)
PCT/JP2022/029561 2021-09-30 2022-08-01 組織修復材キット及び組織修復方法 Ceased WO2023053710A1 (ja)

Priority Applications (3)

Application Number Priority Date Filing Date Title
JP2023550419A JPWO2023053710A1 (https=) 2021-09-30 2022-08-01
EP22875587.2A EP4393453A4 (en) 2021-09-30 2022-08-01 TISSUE RESTORATION MATERIAL KIT AND TISSUE RESTORATION METHOD
US18/612,129 US20240374789A1 (en) 2021-09-30 2024-03-21 Tissue repair material kit and tissue repair method

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JP2021-162131 2021-09-30
JP2021162131 2021-09-30

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US18/612,129 Continuation US20240374789A1 (en) 2021-09-30 2024-03-21 Tissue repair material kit and tissue repair method

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WO2023053710A1 true WO2023053710A1 (ja) 2023-04-06

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EP (1) EP4393453A4 (https=)
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Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1014176A2 (en) 1998-12-23 2000-06-28 Fuji Photo Film B.V. Silver halide emulsions containing recombinant gelatin-like proteins
WO2004085473A2 (en) 2003-03-28 2004-10-07 Fuji Photo Film B.V. Rgd-enriched gelatine-like proteins with enhanced cell binding
US6992172B1 (en) 1999-11-12 2006-01-31 Fibrogen, Inc. Recombinant gelatins
WO2008103041A1 (en) 2007-02-21 2008-08-28 Fujifilm Manufacturing Europe B.V. Recombinant gelatins
WO2010128672A1 (ja) 2009-05-07 2010-11-11 富士フイルム株式会社 遺伝子組み換えゼラチンを含む血管新生誘導剤
WO2010147109A1 (ja) 2009-06-15 2010-12-23 富士フイルム株式会社 遺伝子組み換えゼラチン及び塩基性線維芽細胞増殖因子を含む血管新生誘導剤
JP2012130672A (ja) * 2010-11-30 2012-07-12 Kanagawa Acad Of Sci & Technol 注入可能なペースト状組成物及びそれから成る骨又は歯充填材
JP2017042477A (ja) * 2015-08-28 2017-03-02 富士フイルム株式会社 生体親和性高分子を含む成型物の製造方法及び生体親和性高分子を含む成型物
JP2018094401A (ja) 2016-12-12 2018-06-21 オリンパステルモバイオマテリアル株式会社 骨補填材および骨補填材の製造方法
JP2021162131A (ja) 2020-04-02 2021-10-11 パナソニックＩｐマネジメント株式会社 アクチュエータ診断システムおよび部品装着装置

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB201516179D0 (en) * 2015-09-14 2015-10-28 Fujifilm Mfg Europe Bv Bone void filling composite

Patent Citations (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1014176A2 (en) 1998-12-23 2000-06-28 Fuji Photo Film B.V. Silver halide emulsions containing recombinant gelatin-like proteins
US6992172B1 (en) 1999-11-12 2006-01-31 Fibrogen, Inc. Recombinant gelatins
WO2004085473A2 (en) 2003-03-28 2004-10-07 Fuji Photo Film B.V. Rgd-enriched gelatine-like proteins with enhanced cell binding
JP2010519252A (ja) 2007-02-21 2010-06-03 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 Ｒｇｄを含有する組換えゼラチン
JP2010519293A (ja) 2007-02-21 2010-06-03 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 機能性が増大した非天然の組換えゼラチン
JP2010519251A (ja) 2007-02-21 2010-06-03 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 組換えゼラチン
WO2008103041A1 (en) 2007-02-21 2008-08-28 Fujifilm Manufacturing Europe B.V. Recombinant gelatins
JP2010518833A (ja) 2007-02-21 2010-06-03 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 高い安定性を有する組換えｘｒｇｄ富化ゼラチン
WO2010128672A1 (ja) 2009-05-07 2010-11-11 富士フイルム株式会社 遺伝子組み換えゼラチンを含む血管新生誘導剤
WO2010147109A1 (ja) 2009-06-15 2010-12-23 富士フイルム株式会社 遺伝子組み換えゼラチン及び塩基性線維芽細胞増殖因子を含む血管新生誘導剤
JP2012130672A (ja) * 2010-11-30 2012-07-12 Kanagawa Acad Of Sci & Technol 注入可能なペースト状組成物及びそれから成る骨又は歯充填材
JP2017042477A (ja) * 2015-08-28 2017-03-02 富士フイルム株式会社 生体親和性高分子を含む成型物の製造方法及び生体親和性高分子を含む成型物
JP2018094401A (ja) 2016-12-12 2018-06-21 オリンパステルモバイオマテリアル株式会社 骨補填材および骨補填材の製造方法
JP2021162131A (ja) 2020-04-02 2021-10-11 パナソニックＩｐマネジメント株式会社 アクチュエータ診断システムおよび部品装着装置

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JPWO2023053710A1 (https=) 2023-04-06
EP4393453A4 (en) 2024-12-18
US20240374789A1 (en) 2024-11-14

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