JP4302515B2 - 単体型外科装置および方法 - Google Patents
単体型外科装置および方法 Download PDFInfo
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- JP4302515B2 JP4302515B2 JP2003513402A JP2003513402A JP4302515B2 JP 4302515 B2 JP4302515 B2 JP 4302515B2 JP 2003513402 A JP2003513402 A JP 2003513402A JP 2003513402 A JP2003513402 A JP 2003513402A JP 4302515 B2 JP4302515 B2 JP 4302515B2
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- Prior art keywords
- ecm
- meniscus
- surgical device
- base
- unitary surgical
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- FMSLJHZXDXHQPI-UHFFFAOYSA-N CCC(C)C1C2C(C)C(C)C(C)CC12 Chemical compound CCC(C)C1C2C(C)C(C)C(C)CC12 FMSLJHZXDXHQPI-UHFFFAOYSA-N 0.000 description 1
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- 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
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- A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
- A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61F2002/30428—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by inserting a protrusion into a slot
- A61F2002/30429—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by inserting a protrusion into a slot made by inserting a hook into a cooperating slot
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- A—HUMAN NECESSITIES
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- 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
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- A—HUMAN NECESSITIES
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- 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
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- 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
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- 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
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- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
- A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
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- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0004—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof bioabsorbable
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- A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
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- A—HUMAN NECESSITIES
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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
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- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
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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
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
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- A61F2230/0091—Three-dimensional shapes helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
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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
- 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
- A61F2230/0097—Harpoon-shaped
-
- 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
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Description
同時係属の「メニスカス・リジェネレーション・デバイス・アンド・メソッド(Meniscus Regeneration Device and Method)」を発明の名称とする米国特許出願第10/195,794号(代理人明細書番号第265280−71141号,DEP−745)、「デバイシーズ・フロム・ナチュラリー・オカーリング・バイオロジカリー・デライブド・マテリアルズ(Devices from Naturally Occurring Biologically Derived Materials)」を発明の名称とする米国特許出願第10/195,719号(代理人明細書番号第265280−71142号,DEP−748)、「カーテイレイジ・リペア・アパレイタス・アンド・メソッド(Cartilage Repair Apparatus and Method)」を発明の名称とする米国特許出願第10/195,347号(代理人明細書番号第265280−71143号,DEP−749)、「ハイブリッド・バイオロジック/シンセチック・ポーラス・エクストラセルラー・マトリクス・スキャホルズ(Hybrid Biologic/Synthetic Porous Extracellular Matrix Scaffolds)」を発明の名称とする米国特許出願第10/195,341号(代理人明細書番号第265280−71144号,DEP−751)、「カーテイレイジ・リペア・アンド・リジェネレーション・デバイス・アンド・メソッド(Cartilage Repair and Regeneration Device and Method)」を発明の名称とする米国特許出願第10/195,606号(代理人明細書番号第265280−71145号,DEP−752)、「ポーラス・エクストラセルラー・マトリクス・スキャフォルド・アンド・メソッド(Porous Extracellular Matrix Scaffold and Method)」を発明の名称とする米国特許出願第10/195,354号(代理人明細書番号第265280−71146号,DEP−747)、「カーテイレイジ・リペア・アンド・リジェネレーション・スキャフォルド・アンド・メソッド(Cartilage Repair and Regeneration Scaffolds and Method)」を発明の名称とする米国特許出願第10/195,334号(代理人明細書番号第265280−71180号,DEP−763)、および「ポーラス・デリバリー・スキャフォルド・アンド・メソッド(Porous Delivery Scaffold and Method)」を発明の名称とする米国特許出願第10/195,633号(代理人明細書番号第265280−71207号,DEP−762)に対してクロス・リファレンスが行なわれており、これらのそれぞれは本特許出願と同一の譲受人に譲渡されており、これらのそれぞれは本特許出願と同時に出願されていて、これらのそれぞれは本明細書に参考文献として含まれる。また、2002年6月14日に出願されている「ハイブリッド・バイオロジック・シンセチック・バイオアブソーバブル・スキャフォルズ(Hybrid Biologic-Synthetic Bioabsorbable Scaffolds)」を発明の名称とする米国特許出願第10/172,347号に対してもクロス・リファレンスが行なわれており、この特許出願は本特許出願と同一の譲受人に譲渡されていて、本明細書に参考文献として含まれる。
本発明は一般に損傷したまたは病気の線維軟骨を接合、修復または再生するための種々の外科装置に関連しており、さらに、これらの装置を使用する外科的な方法に関連している。
関節軟骨は一定の滑膜性の連結部分(例えば、膝関節、股関節、肩関節等)の中に対向している骨の表面部分に並んでいる一種の硝子軟骨である。この関節軟骨は骨の間に一定の無摩擦状態に近い接合状態を提供すると共に、関節内において生じる種々の圧縮力および剪断力を吸収および伝達するように機能する。さらに、関節軟骨に付随する組織に神経が無いために、このような負荷を吸収および伝達する機能は一定の健康な関節内において無痛の様式で生じている。
本発明は人間の膝関節内における半月板等のような病気のまたは損傷した関節内線維軟骨の修復および再生のための種々の装置および外科的方法に関連している。
本発明の原理を利用している種々の単体型外科装置10が添付の各図面においてそれぞれ示されている。これらの図示されている外科装置10は一定の患者の身体組織を修復するためにその患者の体内に移植するためのものである。これらの図示されている実施形態は膝関節の半月板等のような関節内線維軟骨の修復において最も一般的に使用されると考えられるが、本発明は特許請求の範囲において記載されていない限りにおいてこのような用法に限定されない。一定の半月板、または一定の半月板の一部分が各添付図面(図1乃至図2、図4、図6、図8、図10、図12、図15乃至図17、図19、図21、図24乃至図26、図29、図31、図33、図36、図38、図40、図46乃至図49、図51および図52)において符号12により概略的に示されている。また、一定の半月板の断裂部分の例が図1乃至図2、図4、図6、図8、図10、図46、図47および図51において符号14により示されている。本発明はまた別の身体の各部分における損傷したまたは病気の関節内線維軟骨の治療においても有用であると予想される。
なお、本発明の好ましい実施態様は以下の通りである。
(1) 一定の患者の線維軟骨組織を再生するためにその患者に外科的に移植するための単体型外科装置において、
1本の縫合線、一定の生体吸収性の突起付きダーツ、一定の生体吸収性の鋲、一定の生体吸収性の支持部分、および一定の生体吸収性のオス形係止部材の内の少なくとも1個を含む第1の固定機構、
1本の縫合線、一定の生体吸収性の突起付きダーツ、一定の生体吸収性の鋲、一定の生体吸収性の支持部分、および一定の生体吸収性のメス形係止部材の内の少なくとも1個を含む第2の固定機構、および
手術前に前記第1の固定機構および前記第2の固定機構に接続している組織修復材料を備えており、この組織修復材料が前記第1の固定機構および前記第2の固定機構に接続しているECM材料の一定のシート、前記第1の固定機構および前記第2の固定機構に接続している層状のECM材料、ECMの発泡体、粉砕したECM、ECMの線維、架橋したECM材料、成形したECM材料、および一定の生体吸収性の基部および当該基部における一定の異なる材料の内の少なくとも1種類を含み、前記基部および前記異なる材料の内の少なくとも一方がECMを含む単体型外科装置。
(2) 前記基部が
ECM材料の一定のシート、
層状のECM材料、
成形したECM材料、
架橋したECM、
織り状のECM、
不織状のECM、
編み組み状のECM、
ECMの発泡体、
生体相容性のポリマーの一定のシート、
層状の生体相容性のポリマー、
成形した生体相容性のポリマー、
架橋した生体相容性のポリマー、
織り状の生体相容性のポリマー、
不織状の生体相容性のポリマー、
編み状の生体相容性のポリマー、
たて編み状の生体相容性のポリマー、
編み組み状の生体相容性のポリマー、および
生体相容性の発泡体の内の少なくとも1種類を含む実施態様(1)に記載の単体型外科装置。
(3) 前記基部における異なる材料が
ECMの発泡体、
ECMの線維、
ECMの粉末、
粉砕したECM、
ECMの糸、
ECMの織地、
ECMの不織地、
編み組み状のECM、
ECMの溶液、
ECMのゲル、
ECMのペースト、および
架橋したECMの内の少なくとも1種類を含む実施態様(1)に記載の単体型外科装置。
(4) 前記組織修復材料が対向しているエッジ部分を有している一定の基部および当該基部のエッジ部分の内の1個に沿う複数の穴を有しており、前記単体外科装置がさらに前記基部の2個の対向しているエッジ部分の間に配置されているECM材料を備えている実施態様(1)乃至実施態様(3)のいずれかに記載の単体型外科装置。
(5) 前記組織修復材料が一定の患者の半月板における一定の部分の上に延在し、さらに、当該患者の半月板における一定の部分が除去されている一定の領域の上に延在するように寸法付けおよび形付けられている実施態様(1)乃至実施態様(3)のいずれかに記載の単体型外科装置。
(6) 前記生体吸収性の基部が一定の頂上部分において連接している2個の面部を有しており、前記異なる材料がこれら2個の面部の間に配置されているECM材料を含む実施態様(1)乃至実施態様(3)および実施態様(5)のいずれかに記載の単体型外科装置。
(7) 前記組織修復材料が断面において実質的にくさび形の形状である実施態様(1)乃至実施態様(3)および実施態様(5)乃至実施態様(6)のいずれかに記載の単体型外科装置。
(8) 前記組織修復材料が哺乳類動物の粘膜下組織から誘導されている材料を含む実施態様(1)乃至実施態様(7)のいずれかに記載の単体型外科装置。
(9) さらに、前記単体型外科装置を保持する一定の包装を含む実施態様(1)乃至実施態様(8)のいずれかに記載の単体型外科装置。
(10) 前記固定機構を前記組織修復材料に固定して前記単体型外科装置を形成する工程および当該単体型外科装置を滅菌処理する工程を含む実施態様(1)乃至実施態様(9)のいずれかに記載の装置を調製する方法。
12 半月板
15,17 固定要素
16 第1の固定装置
18 第2の固定装置
20 組織修復要素
21 基部
22 再生材料
Claims (10)
- 患者の線維軟骨組織を再生するためにその患者に外科的に移植するための単体型外科装置において、
生体吸収性の鋲および生体吸収性のオス形係止部材の内の少なくとも1個を含む第1の固定機構、
生体吸収性の突起付きダーツ、生体吸収性の鋲および生体吸収性のメス形係止部材の内の少なくとも1個を含む第2の固定機構、および
手術前に前記第1の固定機構および前記第2の固定機構に接続している組織修復材料と、
を備え、
前記組織修復材料が、前記第1の固定機構および前記第2の固定機構に接続しているECM材料のシート、前記第1の固定機構および前記第2の固定機構に接続している層状のECM材料、ECMの発泡体、粉砕したECM、ECMの線維、架橋したECM材料、成形したECM材料、および生体吸収性の基部および当該生体吸収性の基部における異なる材料の内の少なくとも1種類を含み、
前記生体吸収性の基部および前記異なる材料の内の少なくとも一方がECMを含み、
前記ECMが哺乳類動物の粘膜下組織に由来する細胞外基質である、
単体型外科装置。 - 請求項1に記載の単体型外科装置において、
前記生体吸収性の基部が
ECM材料のシート、
層状のECM材料、
成形したECM材料、
架橋したECM、
織り状のECM、
不織状のECM、
編み組み状のECM、
ECMの発泡体、
生体相容性のポリマーのシート、
層状の生体相容性のポリマー、
成形した生体相容性のポリマー、
架橋した生体相容性のポリマー、
織り状の生体相容性のポリマー、
不織状の生体相容性のポリマー、
編み状の生体相容性のポリマー、
たて編み状の生体相容性のポリマー、
編み組み状の生体相容性のポリマー、および
生体相容性の発泡体の内の少なくとも1種類を含み、
前記ECMが哺乳類動物の粘膜下組織に由来する細胞外基質である、単体型外科装置。 - 請求項1に記載の単体型外科装置において、
前記生体吸収性の基部における異なる材料が
ECMの発泡体、
ECMの線維、
ECMの粉末、
粉砕したECM、
ECMの糸、
ECMの織地、
ECMの不織地、
編み組み状のECM、
ECMの溶液、
ECMのゲル、
ECMのペースト、および
架橋したECMの内の少なくとも1種類を含み、
前記ECMが哺乳類動物の粘膜下組織に由来する細胞外基質である、単体型外科装置。 - 請求項1乃至請求項3のいずれかに記載の単体型外科装置において、
前記組織修復材料が対向しているエッジ部分を有している基部および当該エッジ部分を有している基部のエッジ部分の内の1個に沿う複数の穴を有しており、前記単体外科装置がさらに前記エッジ部分を有している基部の2個の対向しているエッジ部分の間に配置されているECM材料を備えており、前記ECMが哺乳類動物の粘膜下組織に由来する細胞外基質である、単体型外科装置。 - 請求項1乃至請求項3のいずれかに記載の単体型外科装置において、
前記組織修復材料が患者の半月板における部分の上に延在し、さらに、当該患者の半月板における部分が除去されている領域の上に延在するように寸法付けおよび形付けられている、単体型外科装置。 - 請求項1乃至請求項3および請求項5のいずれかに記載の単体型外科装置において、
前記生体吸収性の基部が頂上部分において連接している2個の面部を有しており、前記異なる材料がこれら2個の面部の間に配置されているECM材料を含み、前記ECMが哺乳類動物の粘膜下組織に由来する細胞外基質である、単体型外科装置。 - 請求項1乃至請求項3および請求項5乃至請求項6のいずれかに記載の単体型外科装置において、
前記組織修復材料が断面において実質的にくさび形の形状である、単体型外科装置。 - 請求項1乃至請求項7のいずれかに記載の単体型外科装置において、
前記組織修復材料が哺乳類動物の粘膜下組織に由来する材料を含む、単体型外科装置。 - 請求項1乃至請求項8のいずれかに記載の単体型外科装置において、
さらに、前記単体型外科装置を保持する包装を含む、単体型外科装置。 - 請求項1乃至請求項9のいずれかに記載の単体型外科装置を作製する方法において、
前記固定機構を前記組織修復材料に固定して前記単体型外科装置を形成することおよび当該単体型外科装置を滅菌処理することを含む、方法。
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PCT/US2002/022363 WO2003007788A2 (en) | 2001-07-16 | 2002-07-15 | Unitary surgical device and method |
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-
2002
- 2002-07-15 AU AU2002354913A patent/AU2002354913B2/en not_active Ceased
- 2002-07-15 EP EP02752331A patent/EP1416879A4/en not_active Withdrawn
- 2002-07-15 WO PCT/US2002/022363 patent/WO2003007788A2/en active Application Filing
- 2002-07-15 US US10/483,929 patent/US20050027307A1/en not_active Abandoned
- 2002-07-15 US US10/195,344 patent/US7163563B2/en not_active Expired - Lifetime
- 2002-07-15 JP JP2003513402A patent/JP4302515B2/ja not_active Expired - Fee Related
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2007
- 2007-10-30 US US11/928,710 patent/US20080294193A1/en not_active Abandoned
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WO2003007788A2 (en) | 2003-01-30 |
WO2003007788A3 (en) | 2003-05-22 |
US20050027307A1 (en) | 2005-02-03 |
EP1416879A2 (en) | 2004-05-12 |
AU2002354913B2 (en) | 2008-07-17 |
US20080294193A1 (en) | 2008-11-27 |
US7163563B2 (en) | 2007-01-16 |
US20030078617A1 (en) | 2003-04-24 |
JP2004535244A (ja) | 2004-11-25 |
EP1416879A4 (en) | 2007-04-25 |
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