JP2005193049A - 植込み可能な組織修復器具及びその製造方法 - Google Patents
植込み可能な組織修復器具及びその製造方法 Download PDFInfo
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- JP2005193049A JP2005193049A JP2004380779A JP2004380779A JP2005193049A JP 2005193049 A JP2005193049 A JP 2005193049A JP 2004380779 A JP2004380779 A JP 2004380779A JP 2004380779 A JP2004380779 A JP 2004380779A JP 2005193049 A JP2005193049 A JP 2005193049A
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- 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
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0063—Three-dimensional shapes
- A61F2230/0082—Three-dimensional shapes parallelepipedal
-
- 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
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0063—Three-dimensional shapes
- A61F2230/0086—Pyramidal, tetrahedral, or wedge-shaped
-
- 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
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
- A61F2250/0036—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in thickness
-
- 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
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00005—The prosthesis being constructed from a particular material
- A61F2310/00179—Ceramics or ceramic-like structures
- A61F2310/00293—Ceramics or ceramic-like structures containing a phosphorus-containing compound, e.g. apatite
-
- 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
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00005—The prosthesis being constructed from a particular material
- A61F2310/00365—Proteins; Polypeptides; Degradation products thereof
-
- 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
- A61L2430/06—Materials or treatment for tissue regeneration for cartilage reconstruction, e.g. meniscus
Abstract
【解決手段】 植込み可能な組織修復器具(10)はカバー(12)及び組織再生材料(14)を有する。カバーは頂部パネル(16)と底部パネル(18)を有し、組織再生材料はこれらの間に配置される。カバーは、先導縁部を横切って頂部及び底部パネル中へ延びる生体適合性材料の連続シートを有する。カバーは、頂部パネルの少なくとも一部よりも先導縁部に沿って厚く且つその少なくとも一部より厚い。組織再生材料を被覆するパネルのうちの一方の少なくとも一部は、他方のパネルの一部よりも厚い。外科用器具の製造方法も提供される。
【選択図】 図9
Description
別のSIS製品、RESTORE(登録商標)、オーソバイオロジック・インプラント(Orthobiologic Implant)は、インディアナ州ワーソー所在のデピュイ・オーソピーディックス・インコーポレイテッドから入手できる。デピュイ製品は、回旋筋手術中に使用可能であると説明されており、回旋筋腱が再生できるようにする再吸収可能なフレーム構造として提供される。RESTOREインプラントは、ブタの小腸粘膜下組織、清拭され、消毒滅菌されたコラーゲン質たんぱくで構成された天然に産出するECMから取り出される。他の生物学的分子、例えば成長因子、グリコサミノグリカン等も又、SIS中に認められる。これについては、非特許文献12、非特許文献13、非特許文献14、非特許文献15、非特許文献16、非特許文献17、非特許文献18及び非特許文献19を参照されたい。動物における9年間の前臨床試験中、インプラント、例えばRESTORE(登録商標)から宿主への感染の転位の発生数はゼロであった。オーソバイオロジック・インプラント(Orthobiologic Implant)は、免疫系の全身活動に悪影響を及ぼさなかった。これについては、非特許文献20、非特許文献21を参照されたい。
(1)先導縁部に沿って互いに接合された頂部パネルと底部パネルを有するカバーと、頂部パネルと底部パネルとの間に設けられた組織再生材料とを有する植え込み可能な組織修復器具であって、カバーは、先導縁部を横切って頂部パネル及び底部パネル内へ延びる生体適合性材料の連続シートを有し、カバーは先導縁部に沿って頂部パネルの少なくとも一部よりも厚く且つ底部パネルの少なくとも一部よりも厚く、組織再生材料を被覆する前記パネルのうちの一方の少なくとも一部は、他方のパネルの一部よりも厚いことを特徴とする植え込み可能な組織修復器具。
(2)頂部パネルの少なくとも一部は、先導縁部の少なくとも一部に沿って底部パネルの少なくとも一部に平行であることを特徴とする実施態様(1)記載の植え込み可能な組織修復器具。
(3)頂部パネルと底部パネルは、後続縁部に沿って互いに接合されていることを特徴とする実施態様(1)記載の植え込み可能な組織修復器具。
(4)カバー及び組織再生材料のうちの少なくとも一方は、天然に産出する細胞外マトリックス材料を有することを特徴とする実施態様(1)記載の植え込み可能な組織修復器具。
(5)カバーは、小腸粘膜化組織のシートから成ることを特徴とする実施態様(4)記載の植え込み可能な組織修復器具。
(7)先導縁部は、折り返し線から成ることを特徴とする実施態様(1)記載の植え込み可能な組織修復器具。
(8)前記装置は、半月板インプラントとして用いられるような寸法形状であることを特徴とする実施態様(1)記載の植え込み可能な組織修復器具。
(9)先導縁部に沿って互いに接合された頂部パネルと底部パネルを有するカバーと、頂部パネルと底部パネルとの間に設けられた組織再生材料とを有する植え込み可能な組織修復器具であって、カバーは、複数の生体適合性材料薄層を有し、カバーの薄層のうちの幾つかは、先導縁部を横切って頂部パネル及び底部パネル内へ延びており、カバーは、頂部パネルの少なくとも一部よりも先導縁部に沿って多くの薄層を有し、底部パネルの少なくとも一部よりも先導縁部に沿って多くの薄層を有し、組織再生材料を被覆する前記パネルのうちの一方の少なくとも一部は、他方のパネルの一部よりも多くの薄層を有することを特徴とする植え込み可能な組織修復器具。
(10)頂部パネルの少なくとも一部は、先導縁部の少なくとも一部に沿って底部パネルの少なくとも一部に平行であることを特徴とする実施態様(9)記載の植え込み可能な組織修復器具。
(12)カバー及び組織再生材料のうちの少なくとも一方は、天然に産出する細胞外マトリックス材料を有することを特徴とする実施態様(9)記載の植え込み可能な組織修復器具。
(13)薄層は、小腸粘膜化組織のシートから成ることを特徴とする実施態様(12)記載の植え込み可能な組織修復器具。
(14)組織再生材料は、小腸粘膜化組織を含むことを特徴とする実施態様(13)記載の植え込み可能な組織修復器具。
(15)先導縁部は、折り返し線から成ることを特徴とする実施態様(9)記載の植え込み可能な組織修復器具。
(17)先導縁部に沿って互いに接合された頂部パネルと底部パネルを有するカバーと、頂部パネルと底部パネルとの間に設けられていて、第1の側部及び第2の側部を備えた組織再生材料とを有する植え込み可能な組織修復器具であって、カバーは、生体適合性材料の外側薄層群及び生体適合性材料の内側薄層群を有し、内側群の薄層は、組織再生材料の第1の側部上に延び、外側群の薄層は、先導縁部を横切り、内側群の薄層上及び組織再生材料の第2の側部上に延びていることを特徴とする植え込み可能な組織修復器具。
(18)頂部パネルの少なくとも一部は、先導縁部の少なくとも一部に沿って底部パネルの少なくとも一部に平行であることを特徴とする実施態様(17)記載の植え込み可能な組織修復器具。
(19)頂部パネルと底部パネルは、後続縁部に沿って互いに接合されていることを特徴とする実施態様(17)記載の植え込み可能な組織修復器具。
(20)カバー及び組織再生材料のうちの少なくとも一方は、天然に産出する細胞外マトリックス材料を有することを特徴とする実施態様(17)記載の植え込み可能な組織修復器具。
(22)内側群の薄層は、小腸粘膜化組織のシートから成ることを特徴とする実施態様(20)記載の植え込み可能な組織修復器具。
(23)組織再生材料は、小腸粘膜化組織を含むことを特徴とする実施態様(17)記載の植え込み可能な組織修復器具。
(24)先導縁部は、折り返し線から成ることを特徴とする実施態様(17)記載の植え込み可能な組織修復器具。
(25)前記装置は、半月板インプラントとして用いられるような寸法形状であることを特徴とする実施態様(17)記載の植え込み可能な組織修復器具。
(27)第1のシートを折り畳む前に生体適合性材料の第2のシートを組織再生材料の頂部上に配置する工程を更に有していることを特徴とする実施態様(26)記載の方法。
(28)生体適合性材料の第2のシートを配置すると共に生体適合性材料の第1のシート上を延びて溝内に延びるようにする工程を更に有し、折り畳み工程は、第1のシートと第2のシートの両方を溝内の一部に沿って折り畳んで組織再生材料を第1のシートと第2のシートの両方で被覆して第2のシートの2つの薄層が組織再生材料を被覆するようにする工程を含むことを特徴とする実施態様(26)記載の方法。
(29)生体適合性材料の第1のシートは、薄層から成ることを特徴とする実施態様(26)記載の方法。
(30)生体適合性材料の第2のシートは、薄層から成ることを特徴とする実施態様(28)記載の方法。
(32)生体適合性材料の第2のシートを組織再生材料上に配置する工程は、生体適合性材料の1対の第2のシートを生体適合性材料の第1のシート上に配置する工程を含み、第1のシートを第2のシート上に折り重ねる工程は、第1のシートの一部をそれ自体の上に折り重ねる工程を含むことを特徴とする実施態様(31)記載の方法。
(33)第1のシートは、薄層から成り、第2のシートは、薄層から成ることを特徴とする実施態様(31)記載の方法。
12 カバー
14 組織再生材料
16 頂部パネル
18 底部パネル
23,25 タブ又はウイング
26 先導縁部又は折り返し線
28 半月板
30 縫合糸
32,34 薄層
38 後続縁部
50 製造装置
52 金型
62 金型キャビティ
64 溝
66 エアベント
68 プレナム
Claims (16)
- 先導縁部に沿って互いに接合された頂部パネルと底部パネルを有するカバーと、頂部パネルと底部パネルとの間に設けられた組織再生材料とを有する植え込み可能な組織修復器具であって、カバーは、先導縁部を横切って頂部パネル及び底部パネル内へ延びる生体適合性材料の連続シートを有し、カバーは先導縁部に沿って頂部パネルの少なくとも一部よりも厚く且つ底部パネルの少なくとも一部よりも厚く、組織再生材料を被覆する前記パネルのうちの一方の少なくとも一部は、他方のパネルの一部よりも厚いことを特徴とする植え込み可能な組織修復器具。
- 頂部パネルの少なくとも一部は、先導縁部の少なくとも一部に沿って底部パネルの少なくとも一部に平行であることを特徴とする請求項1記載の植え込み可能な組織修復器具。
- 頂部パネルと底部パネルは、後続縁部に沿って互いに接合されていることを特徴とする請求項1記載の植え込み可能な組織修復器具。
- カバー及び組織再生材料のうちの少なくとも一方は、天然に産出する細胞外マトリックス材料を有することを特徴とする請求項1記載の植え込み可能な組織修復器具。
- カバーは、小腸粘膜化組織のシートから成ることを特徴とする請求項4記載の植え込み可能な組織修復器具。
- 組織再生材料は、粉砕された小腸粘膜化組織を含むことを特徴とする請求項5記載の植え込み可能な組織修復器具。
- 先導縁部は、折り返し線から成ることを特徴とする請求項1記載の植え込み可能な組織修復器具。
- 前記装置は、半月板インプラントとして用いられるような寸法形状であることを特徴とする請求項1記載の植え込み可能な組織修復器具。
- 先導縁部に沿って互いに接合された頂部パネルと底部パネルを有するカバーと、頂部パネルと底部パネルとの間に設けられた組織再生材料とを有する植え込み可能な組織修復器具であって、カバーは、生体適合性材料の複数の薄層を有し、カバーの薄層のうちの幾つかは、先導縁部を横切って頂部パネル及び底部パネル内へ延びており、カバーは、頂部パネルの少なくとも一部よりも先導縁部に沿って多くの薄層を有し、底部パネルの少なくとも一部よりも先導縁部に沿って多くの薄層を有し、組織再生材料を被覆する前記パネルのうちの一方の少なくとも一部は、他方のパネルの一部よりも多くの薄層を有することを特徴とする植え込み可能な組織修復器具。
- 先導縁部に沿って互いに接合された頂部パネルと底部パネルを有するカバーと、頂部パネルと底部パネルとの間に設けられていて、第1の側部及び第2の側部を備えた組織再生材料とを有する植え込み可能な組織修復器具であって、カバーは、生体適合性材料の外側薄層群及び生体適合性材料の内側薄層群を有し、内側群の薄層は、組織再生材料の第1の側部上に延び、外側群の薄層は、先導縁部を横切り、内側群の薄層上及び組織再生材料の第2の側部上に延びていることを特徴とする植え込み可能な組織修復器具。
- 植え込み可能な修復器具を製造する方法であって、キャビティ、キャビティを包囲する表面及びキャビティから間隔を置いて位置する溝を有する金型を用意する工程と、生体適合性材料の第1のシートを、前記シートの一部がキャビティ内に受け入れられ、前記シートの一部が溝内に受け入れられた状態で金型の表面上に配置する工程と、組織再生材料をキャビティ内の第1のシートの一部上に配置する工程と、第1のシートを溝内の一部に沿って折り畳んで組織再生材料をシートで被覆する工程とを有することを特徴とする方法。
- 第1のシートを折り畳む前に生体適合性材料の第2のシートを組織再生材料の頂部上に配置する工程を更に有していることを特徴とする請求項11記載の方法。
- 生体適合性材料の第2のシートを配置すると共に生体適合性材料の第1のシート上を延びて溝内に延びるようにする工程を更に有し、折り畳み工程は、第1のシートと第2のシートの両方を溝内の一部に沿って折り畳んで組織再生材料を第1のシートと第2のシートの両方で被覆して第2のシートの2つの薄層が組織再生材料を被覆するようにする工程を含むことを特徴とする請求項12記載の方法。
- 生体適合性材料の第1のシートは、薄層から成ることを特徴とする請求項11記載の方法。
- 生体適合性材料の第2のシートは、薄層から成ることを特徴とする請求項13記載の方法。
- 植え込み可能な組織修復器具を製造する方法であって、キャビティ及びキャビティを包囲した表面を有する金型を用意する工程と、生体適合性材料の第1のシートをシートの一部がキャビティ内に受け入れられた状態で金型の表面上に配置する工程と、組織再生材料をキャビティ内の第1のシートの一部上に配置する工程と、生体適合性材料の第2のシートを組織再生材料上に配置する工程と、第1のシートを第2のシート上に折り重ねる工程とを有することを特徴とする方法。
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2003
- 2003-12-29 US US10/747,349 patent/US7819918B2/en active Active
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2004
- 2004-12-21 AU AU2004240254A patent/AU2004240254A1/en not_active Abandoned
- 2004-12-23 EP EP04258075A patent/EP1554989A1/en not_active Withdrawn
- 2004-12-28 JP JP2004380779A patent/JP4570951B2/ja not_active Expired - Fee Related
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WO2003007788A2 (en) * | 2001-07-16 | 2003-01-30 | Depuy Products, Inc. | Unitary surgical device and method |
WO2003007784A2 (en) * | 2001-07-16 | 2003-01-30 | Depuy Products, Inc. | Meniscus regeneration device and method |
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CN104491927A (zh) * | 2014-11-19 | 2015-04-08 | 中山大学 | 一种脱细胞舌基质材料及其制备方法 |
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AU2004240254A1 (en) | 2005-07-14 |
JP4570951B2 (ja) | 2010-10-27 |
US20040143344A1 (en) | 2004-07-22 |
US7819918B2 (en) | 2010-10-26 |
EP1554989A1 (en) | 2005-07-20 |
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