JP6336393B2 - 硬組織用インプラント - Google Patents
硬組織用インプラント Download PDFInfo
- Publication number
- JP6336393B2 JP6336393B2 JP2014538914A JP2014538914A JP6336393B2 JP 6336393 B2 JP6336393 B2 JP 6336393B2 JP 2014538914 A JP2014538914 A JP 2014538914A JP 2014538914 A JP2014538914 A JP 2014538914A JP 6336393 B2 JP6336393 B2 JP 6336393B2
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- JP
- Japan
- Prior art keywords
- hard tissue
- implant
- pillar
- slot
- pillar portion
- 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.)
- Active
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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
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
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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
- 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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- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
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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
- A61F2/30—Joints
- 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
- A61F2002/30838—Microstructures
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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
- 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
- A61F2/30767—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
- A61F2002/30878—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
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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
- A61F2/30—Joints
- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
- A61F2002/3093—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth for promoting ingrowth of bone tissue
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- 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
- 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
- A61F2210/0076—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof multilayered, e.g. laminated structures
-
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- 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
- A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2240/001—Designing or manufacturing processes
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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
- 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
- A61F2310/00359—Bone or bony tissue
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- 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
- A61L2400/18—Modification of implant surfaces in order to improve biocompatibility, cell growth, fixation of biomolecules, e.g. plasma treatment
-
- 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
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Description
この出願は、2011年10月26日に出願された米国非仮特許出願第13/317,719号の利益を主張し、その開示の全体は、参照により本明細書に組み込まれている。
例示的な硬組織用インプラントの特徴をより詳細に検討すると、図1は、1つの例示的な硬組織用インプラント100の斜視図の概略図を、図示目的のための斜視図で提供している。以下により詳細に説明されるように、硬組織用インプラント100は、21℃で測定したときに少なくとも10GPaの弾性のヤング率(すなわち、引張弾性係数)を有する材料から作製することができ、それは、例えば、(i)移植可能なグレードのポリエーテルエーテルケトン(例えば、炭素繊維強化型の移植可能なグレードのポリエーテルエーテルケトン)(少なくとも18GPaの弾性のヤング率を有する)、(ii)チタン(おおよそ110GPaの弾性のヤング率を有する)、(iii)ステンレス鋼(おおよそ200GPaの弾性のヤング率を有する)、(iv)コバルト−クロム合金(200GPaよりも大きい弾性のヤング率を有する)、または、(iv)チタン合金(おおよそ105〜120GPaの弾性のヤング率を有する)を含む(すべて21℃で測定した場合)。硬組織用インプラント100は、例えば、自己移植の硬組織、同種異形の硬組織、異種の硬組織、ヒトの軟骨、動物の軟骨、ヒトの骨、動物の骨、または、死体の骨などの、ヒトまたは動物から得られる硬組織から作製することもできる。ヒトまたは動物から得られるそのような硬組織は、例えば、10〜18GPaの弾性のヤング率を有することができる。また、ヒトまたは動物から得られるそのような硬組織は、移植の前に処理され、個体の中へ移植したときに個体の中に免疫反応を引き起こす硬組織の性質を減少させるか、または取り除くこともできる。また、硬組織用インプラントは、上述の材料および/または硬組織のうちの2つ以上から作製することもできる。したがって、硬組織用インプラント100は、少なくとも10GPa、例えば、18〜230GPa、18〜25GPa、100〜110GPa、190〜210GPa、200〜230GPa、105〜120GPa、または、10〜18GPaの弾性のヤング率を有している。
ここで、硬組織の中へ移植すると、即時の荷重伝達を提供し、かつ、応力遮蔽を防止する硬組織用インプラントを作製するための方法が説明されることとなる。図1〜図7を参照して上記に説明されているように、硬組織用インプラント100は、バルクインプラント110と、フェイス部120と、ピラー部140と、スロット150とを含む。フェイス部120は、バルクインプラント110の外部表面である。ピラー部140は、硬組織の中への移植のためのものである。ピラー部140は、硬組織用インプラント100のフェイス部120の上に、少なくとも80mm2の面積にわたって分配されている。ピラー部140は、硬組織用インプラント100のフェイス部120から遠位に延在している。それぞれのピラー部140は、バルクインプラント110と一体になっており、遠位端部430を有しており、(200μm×200μm)〜(10,000μm×10,000μm)、すなわち、4.0×104μm2〜1.0×108μm2の横断面積510を有しており、100〜10,000μmのピラー部高さ420を有している。スロット150は、硬組織によって占有されることとなる。スロット150は、ピラー部140によって画定されている。それぞれのスロット150は、隣接するピラー部140同士の間の最短距離に沿って測定したときに、100〜10,000μmの幅152を有している。硬組織用インプラント100は、少なくとも10GPaの弾性のヤング率を有しており、(i)スロット150の体積710の合計と、(ii)ピラー部140の体積520およびスロット150の体積710の合計との比率は、0.40:1〜0.90:1である。硬組織用インプラント100は、中空であるパーツを含まず、ピラー部140のいずれかの遠位端部430へ、または、ピラー部140のいずれかの遠位端部430を越えて延在する非ピラー部を含んでいない。
ここで、硬組織用インプラント100を必要としている個体の硬組織の中で、硬組織用インプラント100を使用するための方法が説明されることとなる。図1〜図7を参照して上記に説明されているように、硬組織用インプラント100は、バルクインプラント110と、フェイス部120と、ピラー部140と、スロット150とを含む。フェイス部120は、バルクインプラント110の外部表面である。ピラー部140は、硬組織の中への移植のためのものである。ピラー部140は、硬組織用インプラント100のフェイス部120の上に、少なくとも80mm2の面積にわたって分配されている。ピラー部140は、硬組織用インプラント100のフェイス部120から遠位に延在している。それぞれのピラー部140は、バルクインプラント110と一体になっており、遠位端部430を有しており、(200μm×200μm)〜(10,000μm×10,000μm)、すなわち、4.0×104μm2〜1.0×108μm2の横断面積510を有しており、100〜10,000μmのピラー部高さ420を有している。スロット150は、硬組織によって占有されることとなる。スロット150は、ピラー部140によって画定されている。それぞれのスロット150は、隣接するピラー部140同士の間の最短距離に沿って測定したときに、100〜10,000μmの幅152を有している。硬組織用インプラント100は、少なくとも10GPaの弾性のヤング率を有しており、(i)スロット150の体積710の合計と、(ii)ピラー部140の体積520およびスロット150の体積710の合計との比率は、0.40:1〜0.90:1である。硬組織用インプラント100は、中空であるパーツを含まず、ピラー部140のいずれかの遠位端部430へ、または、ピラー部140のいずれかの遠位端部430を越えて延在する非ピラー部を含んでいない。
Claims (10)
- (a)バルクインプラントと、
(b)前記バルクインプラントの外部表面であるフェイス部と、
(c)硬組織の中への移植のためのピラー部であって、前記ピラー部は、少なくとも80mm2の面積にわたって、前記フェイス部の上に分配されており、前記フェイス部から遠位に延在しており、それぞれのピラー部は、前記バルクインプラントと一体になっており、遠位端部を有しており、(200×200)〜(10,000×10,000)μm2の横断面積を有しており、100〜10,000μmの高さを有している、ピラー部と、
(d)前記硬組織によって占有されることとなるスロットであって、前記スロットは、前記ピラー部によって画定されており、それぞれのスロットは、隣接するピラー部同士の間の最短距離に沿って測定したときに、100〜10,000μmの幅を有している、スロットと
を含む、硬組織用インプラントであって、
前記硬組織用インプラントは、少なくとも10GPaの弾性のヤング率を有しており、0.40:1〜0.90:1の、(i)前記スロットの体積の合計と、(ii)前記ピラー部の体積および前記スロットの体積の合計との比率を有しており、中空である任意のパーツを含んでおらず、前記ピラー部のいずれかの遠位端部へ、または、前記ピラー部のいずれかの遠位端部を越えて延在する非ピラー部を含んでおらず、
前記ピラーは、上面の視点から見たときに、正方形形状を有し、かつ、
前記ピラーは遠位縁部と側方縁部を有し、該遠位縁部および該側方縁部は鋭利である、硬組織用インプラント。 - 前記硬組織用インプラントが、移植可能なグレードのポリエーテルエーテルケトン、チタン、ステンレス鋼、コバルト−クロム合金、およびチタン合金からなる群から選択される材料から作製されている、請求項1に記載の硬組織用インプラント。
- 前記硬組織用インプラントが、自己移植の硬組織、同種異形の硬組織、異種の硬組織、ヒトの軟骨、動物の軟骨、ヒトの骨、動物の骨、および、死体の骨からなる群から選択される別の硬組織から作製されている、請求項1に記載の硬組織用インプラント。
- それぞれのピラー部の横断面積が、(250×250)μm2〜(1,000×1,000)μm2である、請求項1に記載の硬組織用インプラント。
- それぞれのピラー部の高さが、200〜2,500μmである、請求項1に記載の硬組織用インプラント。
- 前記硬組織用インプラントのヤング率が、18〜25GPaであり、(i)前記スロットの体積の合計と、(ii)前記ピラー部の体積および前記スロットの体積の合計との比率が、0.51:1〜0.60:1である、請求項1に記載の硬組織用インプラント。
- 前記硬組織用インプラントのヤング率が、100〜110GPaであり、(i)前記スロットの体積の合計と、(ii)前記ピラー部の体積および前記スロットの体積の合計との比率が、0.72:1〜0.76:1である、請求項1に記載の硬組織用インプラント。
- 前記硬組織用インプラントが、移植すると即時の荷重伝達を提供し、経時的な応力遮蔽を防止する、請求項1に記載の硬組織用インプラント。
- 前記バルクインプラントが非多孔性であり、前記ピラー部が非多孔性である、請求項1に記載の硬組織用インプラント。
- 前記硬組織用インプラントが、移植すると即時の荷重伝達を提供し、経時的な応力遮蔽を防止し、前記バルクインプラントが非多孔性であり、前記ピラー部が非多孔性である、請求項1に記載の硬組織用インプラント。
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US13/317,719 | 2011-10-26 | ||
US13/317,719 US8771354B2 (en) | 2011-10-26 | 2011-10-26 | Hard-tissue implant |
PCT/US2012/061627 WO2013063069A1 (en) | 2011-10-26 | 2012-10-24 | Hard tissue implant |
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JP2014534860A JP2014534860A (ja) | 2014-12-25 |
JP2014534860A5 JP2014534860A5 (ja) | 2018-04-05 |
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JP (1) | JP6336393B6 (ja) |
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GB0918484D0 (en) * | 2009-10-22 | 2009-12-09 | Depuy Int Ltd | A medical implant device |
BR112014005660A2 (pt) * | 2011-09-15 | 2017-04-04 | Amedica Corp | implantes revestidos e métodos relacionados |
US8771354B2 (en) | 2011-10-26 | 2014-07-08 | George J. Picha | Hard-tissue implant |
US9526640B2 (en) | 2013-08-18 | 2016-12-27 | Boston Scientific Scimed, Inc. | Anti-migration micropatterned stent coating |
JP6446471B2 (ja) | 2014-04-02 | 2018-12-26 | ボストン サイエンティフィック サイムド,インコーポレイテッドBoston Scientific Scimed,Inc. | 体内人工器官およびその製造方法 |
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US9579206B2 (en) | 2017-02-28 |
WO2013063069A1 (en) | 2013-05-02 |
JP6336393B6 (ja) | 2018-08-15 |
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US20170119530A1 (en) | 2017-05-04 |
CA2853479A1 (en) | 2013-05-02 |
CA2853479C (en) | 2016-08-23 |
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