JP5535446B2 - 皮膚の治療または検査用外科用デバイス - Google Patents
皮膚の治療または検査用外科用デバイス Download PDFInfo
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- JP5535446B2 JP5535446B2 JP2008101712A JP2008101712A JP5535446B2 JP 5535446 B2 JP5535446 B2 JP 5535446B2 JP 2008101712 A JP2008101712 A JP 2008101712A JP 2008101712 A JP2008101712 A JP 2008101712A JP 5535446 B2 JP5535446 B2 JP 5535446B2
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- 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
- A61F2/10—Hair or skin implants
- A61F2/105—Skin implants, e.g. artificial skin
-
- 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
- A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
- A61L27/38—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix containing added animal cells
- A61L27/3804—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix containing added animal cells characterised by specific cells or progenitors thereof, e.g. fibroblasts, connective tissue cells, kidney cells
-
- 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
- A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
- A61L27/38—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix containing added animal cells
- A61L27/3886—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix containing added animal cells comprising two or more cell types
-
- 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
- A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
- A61L27/38—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix containing added animal cells
- A61L27/3895—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix containing added animal cells using specific culture conditions, e.g. stimulating differentiation of stem cells, pulsatile flow conditions
-
- 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
- A61L27/60—Materials for use in artificial skin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
- A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- C12N5/00—Undifferentiated human, animal or plant cells, e.g. cell lines; Tissues; Cultivation or maintenance thereof; Culture media therefor
- C12N5/06—Animal cells or tissues; Human cells or tissues
- C12N5/0697—Artificial constructs associating cells of different lineages, e.g. tissue equivalents
- C12N5/0698—Skin equivalents
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- C12N2502/00—Coculture with; Conditioned medium produced by
- C12N2502/09—Coculture with; Conditioned medium produced by epidermal cells, skin cells, oral mucosa cells
- C12N2502/094—Coculture with; Conditioned medium produced by epidermal cells, skin cells, oral mucosa cells keratinocytes
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- C12N2502/00—Coculture with; Conditioned medium produced by
- C12N2502/13—Coculture with; Conditioned medium produced by connective tissue cells; generic mesenchyme cells, e.g. so-called "embryonic fibroblasts"
- C12N2502/1323—Adult fibroblasts
Description
コラーゲン(6.42mg/ml)を酢酸(0.01M〜1.0M)に、通常は16時間まで予め可溶化させることによりコラーゲン分散液を調製し、その後この分散液を4℃で保存する。炭水化物を加える場合には、次いでコンドロイチン-6-硫酸などのグリコサミノグリカン(GAG)との共沈物を調製することができる。コンドロイチン-6-硫酸(3.45mg/ml)を酢酸(0.01M〜3.0M)に加える。
炭水化物を含むまたは含まないタンパク質含有流体を調製してマトリックスを形成する。予備的ステップとして、凍結乾燥機を予め約-35℃から約-50℃に冷却する。一実施形態では、約-45℃に少なくとも4時間予め冷却してある95%エタノールを含む高密度ポリエチレン(HDPE)容器中で、凍結浴を準備する。しかし、制御された速度で熱を除去してマトリックスを凍結させるのに十分な温度の低下が約4時間までの時間枠内で起こる任意の型の装置または構成を使用することができる。例えば、約2時間以内に約4℃から約-40℃までの温度の低下、または約4時間以内に約4℃から約-75℃までの温度低下をもたらすように時間および温度を制御することができる。
すべての溶液は0.22μmフィルターで滅菌濾過し、すべての手順は当業者に公知の無菌手技を用いて実施する。
デバイスの外科的移植に先立って、微生物汚染を最少にし、血管供給を最高にすることによって創傷の準備を行う。これらの条件は通常、早期(すなわち熱傷後1週間未満)に接線方向に生存している基底まで焼痂を切開し、切開した創傷を死体同種皮膚移植片または皮膚代替物(すなわち、Integra Artificial Skin(商標))で一時的に保護することで達成される。
Claims (17)
- 生体適合性コラーゲン含有網目状マトリックスに培養真皮細胞および培養表皮細胞を接種して、接種したマトリックスを形成する工程、および前記接種したマトリックスを、培養皮膚デバイスを形成するために十分な条件下で、インキュベートする工程を含み、前記真皮細胞が前記マトリックス上に直接接種されてラミネーション層を構成し、前記表皮細胞が前記ラミネーション層上に接種され、前記真皮細胞ラミネーション層にのみ直接接触して、前記マトリックスには接触しない、培養皮膚デバイス製造方法。
- 条件が、インスリン、少なくとも1種の必須脂肪酸、ビタミンCおよびそれらの組合せからなる群から選択される成分を含む培地でインキュベートすることを含む請求項1に記載の方法。
- インスリンが0.05μg/mlから500μg/mlの範囲の濃度である請求項1に記載の方法。
- 前記表皮細胞を接種する前に真皮細胞を接種する請求項1に記載の方法。
- 前記マトリックスがコラーゲンからなる請求項1に記載の方法。
- 前記表皮細胞がメラノサイトを含み、前記培養皮膚組成物が皮膚の色素沈着を回復させる請求項1に記載の方法。
- 前記真皮細胞が内皮細胞を含み、培養皮膚組成物が血管成長を刺激する請求項1に記載の方法。
- 生体適合性コラーゲン含有網目状無細胞マトリックスに皮膚から単離して培養した培養真皮細胞および培養表皮細胞を接種して、接種したマトリックスを形成する工程、および前記接種したマトリックスを、少なくとも1つの細胞集団を形成する条件下で、インキュベートする工程を含み、前記真皮細胞が前記マトリックス上に直接接種されてラミネーション層を構成し、前記表皮細胞が前記ラミネーション層上に接種され、前記真皮細胞ラミネーション層にのみ接触して、前記マトリックスには接触しない、培養皮膚デバイス製造方法。
- 細胞が皮膚デバイスのレシピアント由来である請求項8に記載の方法。
- 細胞が、自己細胞、同種細胞および異種細胞からなる群から選択される請求項8に記載の方法。
- 培養皮膚デバイスがキメラの遺伝子型である請求項8に記載の方法。
- 熱傷患者用の永久培養皮膚デバイス製造方法であって、
生体適合性コラーゲン含有網目状無細胞マトリックス上に熱傷患者の皮膚の無傷部分から単離して別々に培養した培養真皮細胞および培養表皮細胞を接種して、接種したマトリックスを形成する工程、接種した前記マトリックスを、細胞接種後1カ月以内に培養皮膚デバイスを形成する条件下でインキュベートする工程、および
デバイスを患者に提供する工程
を含み、前記真皮細胞が前記マトリックス上に直接接種されてラミネーション層を構成し、前記表皮細胞が前記ラミネーション層上に接種され、前記真皮細胞ラミネーション層にのみ接触して、前記マトリックスには接触しない、方法。 - 真皮細胞が、線維芽細胞、内皮細胞、免疫担当細胞、神経細胞、筋細胞、幹細胞およびそれらの組合せからなる群から選択され、表皮細胞が、角化細胞、メラノサイト、免疫担当細胞、幹細胞およびそれらの組合せからなる群から選択される請求項12に記載の方法。
- 培養皮膚デバイスが表皮のバリア機能を回復させる請求項12に記載の方法。
- 培養皮膚デバイスが外科的適用の2から7日以内に血管新生する請求項12に記載の方法。
- 細胞培養培地で飽和されている吸収剤材料を重ねた、生体適合性コラーゲン含有網目状マトリックスを提供する工程、
次いで、前記吸収剤材料を介して培地を導き、細胞をマトリックス上に沈着させる十分な条件下で、ある体積の培地に懸濁させた培養真皮細胞および培養表皮細胞を前記マトリックス上面上に提供する工程
を含み、前記真皮細胞が前記マトリックス上にラミネーション層を構成し、前記表皮細胞が前記ラミネーション層上に接種され、前記真皮細胞ラミネーション層にのみ接触して、前記マトリックスには接触しない、マトリックスに細胞懸濁液を接種する方法。 - 前記の網目状マトリックスの底面を、実質的に接着性のない非細胞傷害性表面と接触させる請求項16に記載の方法。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US10/092,237 | 2002-03-06 | ||
US10/092,237 US7741116B2 (en) | 2002-03-06 | 2002-03-06 | Surgical device for skin therapy or testing |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
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JP2003574811A Division JP4555576B2 (ja) | 2002-03-06 | 2003-03-03 | 皮膚の治療または検査用外科用デバイス |
Related Child Applications (1)
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JP2011113424A Division JP5689023B2 (ja) | 2002-03-06 | 2011-05-20 | 皮膚の治療または検査用外科用デバイス |
Publications (2)
Publication Number | Publication Date |
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JP2008200520A JP2008200520A (ja) | 2008-09-04 |
JP5535446B2 true JP5535446B2 (ja) | 2014-07-02 |
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Family Applications (3)
Application Number | Title | Priority Date | Filing Date |
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JP2003574811A Expired - Lifetime JP4555576B2 (ja) | 2002-03-06 | 2003-03-03 | 皮膚の治療または検査用外科用デバイス |
JP2008101712A Expired - Lifetime JP5535446B2 (ja) | 2002-03-06 | 2008-04-09 | 皮膚の治療または検査用外科用デバイス |
JP2011113424A Expired - Fee Related JP5689023B2 (ja) | 2002-03-06 | 2011-05-20 | 皮膚の治療または検査用外科用デバイス |
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JP2003574811A Expired - Lifetime JP4555576B2 (ja) | 2002-03-06 | 2003-03-03 | 皮膚の治療または検査用外科用デバイス |
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JP2011113424A Expired - Fee Related JP5689023B2 (ja) | 2002-03-06 | 2011-05-20 | 皮膚の治療または検査用外科用デバイス |
Country Status (11)
Country | Link |
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US (4) | US7741116B2 (ja) |
EP (3) | EP2302035B1 (ja) |
JP (3) | JP4555576B2 (ja) |
AT (1) | ATE431400T1 (ja) |
AU (1) | AU2003217907A1 (ja) |
CA (1) | CA2478107C (ja) |
DE (1) | DE60327603D1 (ja) |
DK (1) | DK1483373T3 (ja) |
ES (1) | ES2326873T3 (ja) |
HK (1) | HK1156073A1 (ja) |
WO (1) | WO2003076604A2 (ja) |
Families Citing this family (42)
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JP2005270477A (ja) * | 2004-03-26 | 2005-10-06 | Kazutaka Soejima | 細胞含有人工真皮及びその調製方法 |
DE102004039537A1 (de) * | 2004-08-13 | 2006-02-23 | Phenion Gmbh & Co. Kg | Vernetzte Kollagenmatrix zur Herstellung eines Hautäquivalentes |
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JP2008200520A (ja) | 2008-09-04 |
US8765468B2 (en) | 2014-07-01 |
EP2302035B1 (en) | 2016-05-11 |
US20130259919A1 (en) | 2013-10-03 |
JP4555576B2 (ja) | 2010-10-06 |
HK1156073A1 (zh) | 2012-06-01 |
US20100254955A1 (en) | 2010-10-07 |
JP5689023B2 (ja) | 2015-03-25 |
EP2302035A2 (en) | 2011-03-30 |
US9089417B2 (en) | 2015-07-28 |
US8450108B2 (en) | 2013-05-28 |
WO2003076604A3 (en) | 2004-03-04 |
DE60327603D1 (de) | 2009-06-25 |
AU2003217907A1 (en) | 2003-09-22 |
EP2302035A3 (en) | 2011-06-01 |
US20140287020A1 (en) | 2014-09-25 |
US20030170892A1 (en) | 2003-09-11 |
EP1483373A2 (en) | 2004-12-08 |
CA2478107A1 (en) | 2003-09-18 |
WO2003076604A2 (en) | 2003-09-18 |
EP1483373B1 (en) | 2009-05-13 |
DK1483373T3 (da) | 2009-09-07 |
ATE431400T1 (de) | 2009-05-15 |
EP2075330A1 (en) | 2009-07-01 |
CA2478107C (en) | 2014-05-13 |
JP2005518910A (ja) | 2005-06-30 |
ES2326873T3 (es) | 2009-10-21 |
JP2011172592A (ja) | 2011-09-08 |
EP2075330B1 (en) | 2016-05-11 |
US7741116B2 (en) | 2010-06-22 |
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