JP4681123B2 - 金属処理方法 - Google Patents
金属処理方法 Download PDFInfo
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- JP4681123B2 JP4681123B2 JP2000596185A JP2000596185A JP4681123B2 JP 4681123 B2 JP4681123 B2 JP 4681123B2 JP 2000596185 A JP2000596185 A JP 2000596185A JP 2000596185 A JP2000596185 A JP 2000596185A JP 4681123 B2 JP4681123 B2 JP 4681123B2
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- annealing
- implants
- annealed
- implant
- expandable
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- 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
- A61F2250/0039—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 diameter
-
- 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
- A61F2250/0043—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 electric properties, e.g. in electrical conductivity, in galvanic properties
-
- 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
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/006—Additional features; Implant or prostheses properties not otherwise provided for modular
- A61F2250/0063—Nested prosthetic parts
-
- 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
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
- A61F2250/0097—Visible markings, e.g. indicia
-
- 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
- A61F2310/00011—Metals or alloys
- A61F2310/00017—Iron- or Fe-based alloys, e.g. stainless steel
-
- 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
- A61F2310/00011—Metals or alloys
- A61F2310/00023—Titanium or titanium-based alloys, e.g. Ti-Ni alloys
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S606/00—Surgery
- Y10S606/907—Composed of particular material or coated
- Y10S606/91—Polymer
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Surgery (AREA)
- Heart & Thoracic Surgery (AREA)
- Veterinary Medicine (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Vascular Medicine (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Cardiology (AREA)
- Neurology (AREA)
- Medical Informatics (AREA)
- Molecular Biology (AREA)
- Dentistry (AREA)
- Physical Education & Sports Medicine (AREA)
- Biophysics (AREA)
- Prostheses (AREA)
- Electrical Discharge Machining, Electrochemical Machining, And Combined Machining (AREA)
- Signal Processing For Digital Recording And Reproducing (AREA)
- Screw Conveyors (AREA)
- Refuse Collection And Transfer (AREA)
- Materials For Medical Uses (AREA)
- Surgical Instruments (AREA)
- Compositions Of Macromolecular Compounds (AREA)
- Building Environments (AREA)
- Formation Of Insulating Films (AREA)
- Glass Compositions (AREA)
- Control Of Motors That Do Not Use Commutators (AREA)
Description
[関連する出願]
本出願は、米国を指定するPCT出願PCT/IB98/00523、及び1998年3月6日に提出されたシリアル番号09/036,719の米国出願の一部継続出願であり、これらの開示内容は、参照によりここに導入される。本出願は、その開示内容が参照によりここに導入される、1999年2月16日に提出された出願番号60/012,184の米国仮出願の119(e)による利益をも主張する。本出願は、出願人ディスコ−オ−テック・メディカル・テクノロジー社により、同日にイスラエル受理官庁へ提出され、米国を指定し、アトーニードケット110/01325及び110/01357を有し、その開示内容が参照によりここに導入される、2つのPCT出願にも関連する。
【0002】
[発明の分野]
本発明は、金属処理方法に関する。より具体的には、同一片の金属の異なる部分に異なる特性を与えるようにデザインされた金属処理方法に関する。
【0003】
[発明の背景]
金属を所定の機械加工プロセスにさらすと金属の機械的特性が変化することが知られている。例えば、スチールワイヤ又は管類が冷間加工されると、引っ張り強さ及び降伏強さが改善されるが、その伸び率は比較的低いままである。逆に、スチールワイヤ又は管類が焼きなまされると、その引っ張り及び降伏強さは低いままであるが、伸び率は比較的高くなる。与えられた金属片に所望の金属特性を与えるために適切な機械加工プロセスを選択することがときとして困難である。なぜならば、単一のプロセスは、通常、少なくとも一つの比較的劣悪な機械的特性を有する金属片に帰着するからである。
【0004】
機械加工プロセスを選択することが困難なデバイスの一例は、本発明と同じ譲受人に譲渡され、1998年3月6日に提出され、同時継続しており、その教えが参照することによりここに導入される、米国特許出願09/036,719号に記載されたような髄内骨固定釘である。図1A−Bに示されるように、髄内釘10は、長骨5の中央空洞の中へ挿入可能であり、回復が容易となるように、折れた長骨の片を比較的固定された位置に維持するのに使用される。図1Aに示されるように、釘10は、つぶされた形状で、骨髄(不図示)の中を通して挿入される。その後、釘10は、例えば食塩水を用いて図1Bに示す広がった形状に広げられる。骨髄は圧縮されるが傷つけられない。釘10は、好ましくはステンレススチールの単一片から作られており、縦の支持リブ14、及び柔軟な接続用の膜(web)18を含む。
【0005】
図1Aのつぶされた形状は、曲げられた、四つ葉のクローバー配置の膜(web)18を示している。釘が広げられた後、縦のリブ14は骨に接触、支持し、一方で、膜(web)18は比較的円筒状の形状を形成する。膜(web)18は、図1Aのつぶされた形状から図1Bの広がった形状へ曲げることができなければならないから、膜(web)18は、非常に薄くて柔軟でなければならない。しかしながら、縦のリブ14は、回復する折れた骨の支持するように設計されており、したがって、通常は、丈夫かつ比較的強固に作られる。さらに、ステンレス・スチール管の単一片から釘10を製造することが好ましい。単に釘全体に冷間加工を施すことは勧められる選択肢ではない。リブは十分に強固になるであろうが、薄い膜(web)18は、十分に柔軟にならないであろうし、釘を広げようとしたときや、釘をつぶされた形状に折り曲げたときに、ひび割れするであろう。釘全体の焼きなましも勧められる選択肢ではない。膜(web)18は、十分に柔軟になるであろうが、リブ14は、十分に強固とならないであろうし、折れた骨を支持するという釘の効果が弱くなるであろう。
【0006】
[発明の要約]
本発明のいくつかの好ましい実施形態の一側面は、金属の異なる部分が異なる機械特性、特に異なる降伏強さ及び/又は異なる伸び率を有するように、金属、特に医療用の埋込物を選択的に処理することに関する。本発明の好ましい実施形態において、埋込物の広げられるように設計された部分は、よりよい伸張特性を有するように焼きなまされる。本発明の好ましい実施形態において、選択的処理は、製造中に冷間加工により硬化させられた埋込物に利用される。
【0007】
本発明の好ましい実施形態において、選択的処理方法は、選択的焼きなましであり、好ましくは、焼きなまされるべき部分における、又はその近くにおける埋込物の電子ビーム加熱を使用することにより適用される。
【0008】
本発明のいくつかの好ましい実施形態の一側面は、医療用の埋込物、特に髄内釘のような整形外科用の埋込物を、埋込物が所望の特性を有するように製造する方法に関する。本発明の好ましい実施形態において、埋込物は金属の単一片から形成される。あるいは、埋込物は、互いに接合された2以上の片から形成され、接合処理、及び/又は片の異なる製造方法のために、接合後に好ましくない機械的特性を有する。
【0009】
本発明のいくつかの好ましい実施形態の一側面は、骨をつなぐための、膨張可能であり、少なくとも一つの突出部がその上にある頭部を有するスクリューに関する。本発明の好ましい実施形態において、頭部及び/又は突出部は、選択的に、少なくとも部分的に焼きなまされる、又は硬化させられる。典型的な実施形態では、突出部を含む頭部全体が焼きなまされ、次に、突出部のみが硬化させられる。上記に代えて又は上記に加えて、突出部を含む頭部全体が硬化させるために冷間加工を施され、次に、突出部の外側及び/又は頭部がそれらの膨張が可能となるように焼きなまされる。突出部は、頭部と共に一片から形成されてもよく、又は、突出部は、例えば溶接により、頭部に取り付けられてもよい。
【0010】
本発明の好ましい実施形態において、金属片は、はじめに、冷間圧延のような従来の処理により冷間加工を施すことにより処理される。冷間加工を施された片は、次に、予め定められた部分において焼きなまされる。必須ではないが好ましくは、焼きなます部分と焼きなまさない(しかし、その前に冷間加工されている)部分との間の境界領域が、それら部分が接する片の部分の弱化を防ぐために残される。
【0011】
好ましい実施形態において、髄内骨固定釘を製造するための方法が提供される。スチール管の一片が冷間加工される。次に管は、薄膜(membrane)又は膜(web)により互いに連結された1以上の縦のリブを備えるように機械加工される。次に膜(web)の部分が焼きなまされる。縦のリブは、したがって、冷間加工されたスチールの特性、つまり強さと耐久性を有し、一方で、膜(web)部分は、より大きな柔軟性を備える。好ましくは、焼きなましは、電子ビーム銃により行われる。
【0012】
したがって、本発明の好ましい実施形態によれば、少なくとも一つの広げることができる部分、及び少なくとも一つの広げることができない部分を有する成形外科用装置を提供すること;及びエネルギービームを使用して前記広げることができる部分の少なくとも一部を選択的に焼きなますことを含む成形外科用の埋込物の金属処理方法が提供される。
【0013】
好ましくは、その方法は、広げることができない部分を著しく焼きなまさないことを含む。好ましくは、その方法は、広げることができない部分は、広げることができる部分により伸ばされる。好ましくは、その方法は、広げることができない部分の少なくとも一部を著しく焼きなますことを含む。好ましくは、その方法は、広げることができる部分の一部分のみを選択的に焼きなますことを含む。好ましくは、選択的焼きなましは、広げることができる部分及び広げることができない部分の間に焼きなまされない境界領域を残す。
【0014】
好ましくは、その方法は、選択的焼きなましの前に埋込物に冷間加工を施すことを含む。好ましくは、広げることができる及び広げることができない部分は、埋込物の細長い部分を含む。好ましくは、埋込物は髄内釘、整形外科用の埋込物、歯科用のインプラント、股関節部スクリュー、又は股関節部埋込物、例えばメッシュ型の埋込物、を含む。
好ましくは、広げることができない部分は埋込物の厚い部分を含み、広げることができる部分は埋込物の薄い部分を含む。
好ましくは、ビームは電子ビーム、レーザビーム、及び/又は、プラズマビームを含む、。
【0015】
好ましくは、選択的焼きなましは、埋込物の一部を直接加熱することによるのと、直接加熱された埋込物の一部から移動する熱を用いて埋込物の第2の部分を間接的に加熱することによるのとの双方の焼きなましを含む。
好ましくは、選択的焼きなましは、埋込物の少なくとも一部を焼きなましの熱から保護することを含む。好ましくは、保護は、焼きなまさない部分の近傍にヒートシンクを備えること、及び/又は、焼きなまさない部分を能動的に冷却することを含む。
【0016】
好ましくは、その方法は、センサを用いて前記埋込物の少なくとも一部の温度を監視することを含む。好ましくは、監視される部分は、焼きなまされる部分を含む。上記に代えて又は上記に加えて、監視される部分は、焼きなまさない部分を含む。
好ましくは、温度を監視することは、焼きなまされる部分が溶けないように温度を監視することを含む。上記に代えて又は上記に加えて、温度を監視することは、温度が、焼きなましをするのに十分な水準以上であることを監視することを含む。好ましくは、選択的焼きなましは、センサの出力に応答して、加熱の強度を制御することを含む。
好ましくは、制御は、閉ループ制御、及び/又は、オープン・ループ制御を含む。上記に代えて又は上記に加えて、制御は、実時間でエネルギービームの特性を変更することを含む。好ましくは、制御は、前の焼きなまし処理時の測定値に応答して、エネルギービームの特性を後の処理時に変更することを含む。好ましくは、選択的焼きなましは、所望の焼きなまし効果が達成されるまで、同じ場所を数回繰り返して加熱することを含む。
【0017】
好ましくは、焼きなましは、広げることができる部分の厚み全体を焼きなますことを含む。好ましくは、焼きなましは、焼きなまされた部分の伸びを少なくとも30%、40%、50%、又は60%増大させる。好ましくは、焼きなましは、焼きなまされた部分の伸びを約12%から増大させる。
【0018】
本発明の好ましい実施形態によれば、複数の、細長く、冷間加工を施された部分;及び、複数の、細長く、焼きなまされた部分を備える髄内釘がさらに提供される。
好ましくは、冷間加工を施された部分は、少なくとも一つの境界部分により、焼きなまされた部分から隔てられている。好ましくは、境界部分は、釘の拡張可能な部分を含む。好ましくは、冷間加工を施された部分は、厚く、かつ、拡張不可能である。好ましくは、焼きなまされた部分は、薄く、かつ、拡張可能である。さらに好ましくは、焼きなまされた部分は、その厚み全体を焼きなまされている。好ましくは、釘はステンレス・スチール、及び/又は、チタンから形成されている。
【0019】
保護が求められている特徴及び特徴の組み合わせは、添付のクレームに詳細に指摘されている。発明は、一般原則並びにその目的及び利点と合わせた実施の両方に関し、続く、非制限的な、発明の好ましい実施形態の記載を添付の図面と共に参照することによりより完全に理解できるであろう。
【0020】
[好ましい実施形態の詳細]
空間的に選択的な焼きなましは、本発明のいくつかの実施形態において熟考される医療用の埋込物のための他の処置と同様に、いろいろな医療用の埋込物の類に適用できる。典型的な第1の埋込物として、髄内釘の製造について説明する。特に後述するように、髄内釘の製造に適用できる全ての細目は、医療用の埋込物の他の型にも適用できる。
【0021】
図2及び3は、本発明の好ましい実施形態による、髄内釘の製造方法を示す。最初に、図2に示すように、スチール管が用意される。管20の全体は、ある方法又は他の方法による冷間加工、例えば冷間圧延、を施されることが好ましい。次に、図3に示されるように、冷間圧延を施されたスチール管20の(アウトラインにおける)外側部分22が機械加工により除去される。このようして、管20から残るのは、より厚い縦のリブ14の間の薄い金属板から形成される実質上の釘10である。なお、図3に示されるような釘10は、薄い管にリブ14を溶接するような、機械加工に追加又は代わる方法を利用して製造することができる。
【0022】
一般的に、管20の加工処理、及び/又は、代替の製造方法の結果として、膜(web)18及び/又はリブ14の冶金特性は最適ではない。ここまでに記述した製造方法では、膜(web)18があまりのびず、(図1Aのように)釘10が折りたたまれたり、(図1Bのように)広げられたりした場合に、膜(web)18に亀裂が生じる可能性がある。
【0023】
図4は、本発明に係る選択的焼きなまし処置の好ましい実施形態を示す。焼きなましすべき膜(web)18を加熱するために電子銃30が備えられることが好ましい。銃30は、好ましくはビーム32を生成し、ビーム32は、膜(web)18の領域に選択的に向けられる。ビームは、好ましくは、膜(web)18の表面温度を焼きなまし温度まで上昇させる。例えば、チューブ20がASTM F138−92による316Lグレード2のスチールからなる場合には、膜(web)18は、約1000℃に加熱されることが好ましい。好ましくは、センサ60が、膜(web)18の温度を測定するために、焼きなましされている膜(web)18の表面近くに配置される。後述するように、センサ60の測定値は、好ましくは、膜(web)18が過度に加熱されていないこと(特に膜(web)18が溶かされていないこと)を保証するために、及び/又は、膜(web)が焼きなましのために十分に加熱されていることを確かめるために利用される。センサ60は、ビーム32が直接当たる部分の温度を監視することが好ましい。上記に代えて又は上記に加えて、センサ60は、ビーム32は直接は当たらないが、ビームが当たる部分に隣接するために加熱され、かつ、焼きなましされる部分の温度を監視する。さらに上記に代えて又は上記に加えて、センサ60は、膜(web)18及び/又はリブ14の焼きなましされるべきでない領域の温度を監視し、これらの領域が焼きなましされることを防止する。好ましくは、センサ60は、監視する領域の温度をそれらが加熱される前、及び/又は、後に測定する。上記に代えて又は上記に加えて、センサ60は、監視する領域の温度をそれらの加熱中に測定する。
【0024】
本発明の好ましい実施形態では、ビームスプリッター34が、ビーム32を2つ(以上)のサブビーム36に分割することを目的として、ビーム32の経路中に置かれる。好ましくは、サブビーム36は、膜(web)18の全体ではないがほとんどをカバーする。好ましくは、サブビーム36は、2つの領域54に当たる。領域54は、電子サブビーム36中の電子により引き起こされる励起により直接加熱される。好ましくは、領域54の間にあり、ビーム32が直接当たらない中央領域56は、領域54において発生した熱によって間接的に焼きなまされる。ビームスプリッター34を利用する代わりに、ビーム32が領域54に直接当たる。
【0025】
本発明のいくつかの好ましい実施形態では、膜(web)18及び/又はリブ14の焼きなましすべきでない所定領域が、ヒートシンク又は能動的な冷却をそれらの領域の近傍に提供することにより、冷たく維持される。本発明の好ましい実施形態において、リブ14(及び/又は膜(web)18の一部)は、リブ14の下側のチューブ20の内側にヒートシンクを取り付ける、又は冷却液を供給することにより冷却される。あるいは、釘10の一部が、好ましくは適当なマスクを利用して、アブレーション材料により被覆される。ビームがアブレーション材料に当たると、アブレーション材料がその下にある釘10の部分をビームから保護し、及び/又は、蒸発し、そのアブレーションによりその下にある面を冷却する。なお、ビームの分割、及び/又は、冷却方法は、膜(web)18に、及び広く医療用の埋込物に、実質的にあらゆる有用なパターンをやきなましするのに利用することができる。
【0026】
必須ではなく任意に、サブビーム36が、膜(web)18と隣接する縦のリブ14との間の境界領域52を残すように位置決めされる。境界領域52は、サブビーム36の一つの位置について示されており、好ましくは、リブ14と膜(web)18との間の境界に沿った全体に及ぶことが好ましい。境界領域52において、ビーム32は、膜(web)18を実質的に焼きなまさない。好ましくは、リブ14がヒートシンクとして働き、その結果、領域52が著しくは焼きなまされない。境界領域52の形成は、縦のリブ14と膜(web)18との間の境界におけるチューブ20の弱化を防ぐ。境界領域52が焼きなまされた場合、領域52が著しく弱化され、そして釘10が領域52に沿ってひび割れることがあり得る。領域52をやきなましをせずに維持することにより、領域52においてより大きな曲率半径も得られる。本発明の好ましい実施形態において、釘10を折りたたむのに使用する工具は、領域52に面するところに配置され、その領域におけるあまりに鋭い折れ曲がりを防止する、丸い要素を含む。領域52の大きさ及び形状は、埋込物の種類、埋込物の外形、加熱のフィードバック方法、熱源、埋込物の材料及び前処理、の1以上を恐らく含むいくつかのパラメータに依存するであろう。境界領域52の適当なパターンは、開示内容が参照によりここに導入される、ドイツ、ゲブラウフムスタ DE 199 04 852 U1に記載されている。
【0027】
サブビーム36又はビーム32は、好ましくは、一定のパルス強度および一定速度で選択された領域54を走査する。本発明の好ましい実施形態において、サブビーム36は、十分な加熱レベルが達成されるまで、膜(web)18上を繰り返し走査する。一定の走査速度を利用する代わりに、速度が変えられる。例えば、埋込物の不均一な部分又はヒートシンク近傍では、より大きな(又は低い)局所的な加熱を達成すべく、例えば、速度を落とす(又は加速される)。上記に代えて又は上記に加えて、要求される加熱水準を達成するために、パルス強度又はビームパターンが変えられる。パルスビームを利用する好ましい実施形態では、適切な加熱パターンを達成するために、パルス周波数、パルス形状、及び/又はオン、オフ周期の比が変えられる。
【0028】
典型的な実施形態において、例えば図5に示されるように、電子銃30(又は他の熱源)とセンサ60との間にフィードバック制御ループが備えられる。図5は、本発明の好ましい実施形態に従い採用されたフィードバック制御システムの概略ブロック図である。電子銃30は膜(web)18を加熱し、センサ60は、例えば接触式又は非接触式の高温計を利用して、膜(web)18の温度を測定する。焼きなましに関しては、通常、膜(web)18は加熱されるが溶かされないことが望まれる。したがって、センサ60は、好ましくは電子銃30に制御ライン70及びコントローラ72を介して接続される。センサ60によって検出された温度が、コントローラ72によって設定された、予め定められた所定のしきい値に達すると、コントローラ72から電子銃30へ、ビーム強度を低減する(又は切る)ための信号が送られる。同様に、センサ60によって検出された温度が低すぎる場合には、コントローラ72から電子銃30に、ビーム強度を増大するための信号が送られる。類似の制御メカニズムを速度およびパルス生成のパラメータとして利用することもできる。
【0029】
センサ及びフィードバックループを利用することに代えて又は加えて、加熱は、推定値および/または正確な温度が測定される較正運転に基づかせることもできる。上記に代えて又は上記に加えて、オープンループ制御システムが利用される。オープンループ制御システムでは、十分な温度が達成されなかった場合に走査が繰り返される。温度を測定することに代えて又は加えて、他のセンサ60、例えば、加熱された金属の冶金特性における変化を検出するのに使用できる輻射能センサ、を利用してもよい。本発明の好ましい実施形態では、センサ60の代わりに、温度および輻射能センサの組み合わせが利用される。
【0030】
本発明のいくつかの好ましい実施形態において、複数のセンサ60が焼きなましを監視するのに使用される。例えば、1以上のセンサが焼きなまされた領域を監視し、一方で、他のセンサが、焼きなまされない領域の温度を監視する。本発明の好ましい実施形態では、センサによって直接監視されない膜(web)18の1以上の表面又は深さ位置の温度が、1以上の他のセンサの記録に基づいて推定される。
【0031】
髄内骨固定釘10を製造する場合、焼きなましは、好ましくは、膜(web)19の伸び率を増大させるために行われる。例えば、典型的な応用例において、縦のリブ14は、通常、5%および20%の間、より典型的には10%および15%の間の比較的低い伸び率を有する。低い伸び率は、通常それらが冷間加工をされたことに起因する。他方、焼きなまされた膜(web)18は、好ましくは、少なくとも30%、そして好ましくは40%、50%、又は、60%のようにそれ以上の伸び率でさえ上述した焼きなましのために有する。結果としてあり得る膜(web)18の低い降伏強さは、リブ14が釘にかかるあらゆる体のひずみを支えることが意図されているから、釘10においてあまり重要でない。
【0032】
電子銃30を使用することに代えて又は加えて、焼きなましに使用する熱源は、プラズマ銃又はレーザのような、あらゆる他の適当なビーム源であってもよい。さらに上記に代えて又は上記に加えて、接触型熱源が使用される。なお、電子銃装置が通常レーザビーム装置より高価であり、かつ、電子銃装置には無菌環境が必要であるにもかかわらず、電子銃のエネルギー出力およびビームパターンを容易に制御できることから、電子銃が、医療用の埋込物の選択的アブレーションにとって好ましい。
【0033】
選択的焼きなましを行うのに代えて又は加えて、他の空間的に選択的な体積および表面処理を医療用の埋込物に適用できる。なお、医療用の埋込物は、通常、生物学的適合性のある材料の少数の種類から構成されており、たとえば自動車における応用例と異なり、要求される複数の特性の全てを備えた合金を選択することはできない。したがって、空間的な選択処理は重要である。空間的な選択的処理において、本発明の好ましい実施形態にしたがって利用できる典型的な冶金処理は、たとえば、その開示内容が参照によりここへ導入される、ウィリアム M.スティーン著「レーザ・マテリアル・プロセッシング」、第2版、1998年、スプリンガー出版社の「レーザ表面処理」というタイトルの第6章に記述されている。好ましくは、これらの冶金処理が表面又は体積処理として利用できる。医療用の埋込物の選択された部分に適用される典型的な処理には、焼き入れ、焼き戻し、応力緩和、および衝撃硬化が含まれる。いくつかの埋込物では体積処理が好まれているが、表面処理が望ましい。
【0034】
本発明の好ましい実施形態における選択的処理方法は、例えばステンレス・スチール、チタン、超合金、およびニチノールを含む広い範囲の金属に採用できる。
上の記述は髄内釘に焦点を合わせているが、他の種類の埋込物も選択的処理技術を利用して有利に処理できる。
【0035】
脊柱融合用のケージ、特に先に引用した同日提出に係るPCT出願に記載されているような拡張可能なケージは、圧力下でのケージの拡張を補助するために、骨に接触する位置において焼きなまされてもよい。上記に代えて又は上記に加えて、ケージは、曲がる位置において焼きなまされてもよい。
通常、焼きなましは、例えばバルーンのような膨張する装置において、又は、血液フィルターのようなメッシュ型の装置において、変形される及び/又は著しく曲げられる部分に有益である。
【0036】
局所的焼きなましは、特に、整形外科用の埋込物にも有益である。ここでは、埋込物全体が、変形せずに著しいひずみを支えることが要求されであろう一方で、埋込物のいくつかの小さい部分、例えば埋込物の固定要素にはいくらかの柔軟性が要求され、及び/又は圧力に対して最初に反応する場所として働くことが要求されるであろう。
【0037】
図6A及び6Bは、本発明の好ましい実施形態による歯科用のインプラント100を示す。インプラント100は、ワイヤ120を備えた膨らませることができるボディ110からなる。ワイヤ120は、ボディ110の回りに螺旋形を描いている、又は、他のいずれかパターンでボディ110に取り付けられている。本発明の好ましい実施形態では、ワイヤ120の領域122のような領域、又はワイヤ120の全体が、インプラントが膨らまされた場合にワイヤにおけるひび割れを防止するように焼きなまされる。上記に代えて又は上記に加えて、焼きなましは、インプラントが接触している骨又は歯の物質とワイヤ120との間で形が一致することを促進する。
【0038】
図7A及び7Bは、本発明の好ましい実施形態による股関節部用のスクリューを示す。図7Aは、圧縮式の股関節部スクリュー132を示す。股関節部スクリュー132は、第1股関節部分130に埋め込まれた頭部134を有し、かつ、第2股関節部分131内の基部140にねじ込まれた軸部138を有する。したがって、股関節部は、スクリュー132の2つの端部の間の圧縮により一つに保持される。本発明の好ましい実施形態において、頭部134は、膨張可能な頭部であり、股関節部分130の中に頭部134が十分に挿入された後に膨張させられる。好ましくは、1以上の耐久性のある棒状部136(又は他の突出部)が頭部134の周囲に、例えばスクリュー10の構造と類似の方法により、設けられる。棒状部136は、好ましくは、頭部134をその場に保持し、スクリュー134が股関節部内で動くことを防止する。いくつかのケースでは、棒状部136が、頭部134を強化するのに、及び/又は、頭部134が股関節部130の中に挿入されたときに海綿質の骨を圧縮するのに、利用される。他のケースでは、棒状部136及び/又は他の突出部が、骨の内部成長を促進するために備えられ、及び/又は機械加工される。
【0039】
頭部134に棒状部136を有することに代えて又は加えて、グリッドのような非リブ状の突出パターンが頭部134に配置される。このような非リブ突出部は、股関節部スクリュー132にとって都合がよい。なぜならば、頭部134は、髄内釘において要求されるほど、曲げ圧力に対向することが本質的に要求されないからである。
【0040】
図7Bは、頭部154及び軸部156からなる動的股関節部スクリュー150を示す。動的スクリュー150において、軸部156は基部152に不動に固定されない。その代わり、軸部156は、基部152の軸に沿って動くように拘束されている。好ましくは、頭部154は、螺旋状に成形された突出棒状部158を備えた膨張する頭部からなる。あるいは、棒状部136を備えた頭部134、及び/又は、あらゆる他の膨張する頭部をスクリュー150に利用することができる。
【0041】
いくつかの実施形態において、頭部は、シリコンゲルのような流体を利用して膨張させられる。流体は、軸部に蓄えられ、軸部の中のねじを回し、それにより軸部の中の自由な容積を減らすことにより頭部の中へ送られる。
【0042】
本発明のいくつかの好ましい実施形態において、頭部134及び/又は154は、頭部の膨張が壊れることなく可能となるように、部分的に又は全体的に焼きなまされる。本発明の好ましい実施形態において、棒状部136及び/又は158の部分も又は部分的に又は全体的に、例えばそれらが最大限伸張する場所において、焼きなまされる。スクリュー132及び150に類似している、又は少なくとも類似の頭部を利用しているスクリューは、普通の先行技術のスクリューのような他の埋込物に代えて、体の他の部分に使用することもできる。
【0043】
年老いた患者に良くあるような、弱い骨、特に骨粗鬆症の骨において、膨張できる頭部は、ねじを切られたスクリューよりもより良い保持力を示すことが一般的に期待されている。また、膨張を周期的に増大させることにより、緩いスクリューをきつくすることができる。なお、いくつかのケースにおいて、しばらくたってから、股関節部分130内において頭部134のグリップ部を弱化を許容することが都合がよいかもしれない。このようなケースでは、棒状部136及び/又は158が、結果的にスクリュー132又は150をタイミング良く回収できるように焼きなまされる。
【0044】
膨らますことができる埋込物の他の例は、大腿骨と係合する部分が、図1Aに記載の釘、又は図7A及び7Bに記載の頭部に類似のデザインの、膨らむ軸部であることができる股関節部埋込物である。
【0045】
本発明は、一例として提供され、本発明の範囲を制限する意図がない、好ましい実施形態の非制限的な詳細な説明を用いて説明された。記載された実施形態の変形を当業者は容易に思いつくであろう。特に、各実施形態の全ての特徴が必要なのではなく、また、記載された実施形態間で特徴を組み合わせてもよい。さらに、「からなる」、「含む」、「有する」の用語及びそれらの活用形は、クレームで使用された場合には、「含むが必ずしも限定されない」を意味する。本発明の範囲は、クレームによってのみ制限される。
【図面の簡単な説明】
【図1A】 図1Aは、本発明の好ましい実施形態により製造できる髄内骨固定釘の、つぶれた状態での、その場の断面である。
【図1B】 図1Aの髄内骨固定釘の、拡張した状態での、その場の断面である。
【図2】 金属管の断面である。
【図3】 本発明の好ましい実施形態にしたがい機械加工された図2の金属管の断面である。
【図4】 本発明の好ましい実施形態による選択的焼きなましステップの正面斜視図及び概略図である。
【図5】 本発明の好ましい実施形態により採用されるフィードバック制御システムの概略ブロック図である。
【図6A−6B】 図6A及び6Bは、本発明の好ましい実施形態による歯科用のインプラントを示す。
【図7A−7B】 図7A及び7Bは、本発明の好ましい実施形態による股関節部スクリューを示す。
【符号の説明】
14 リブ
18 膜(web)
20 管
30 電子銃
32 ビームスプリッター
52 境界領域
60 センサ
72 コントローラ
100 歯科用のインプラント
120 ワイヤ
132 股関節部スクリュー
134 頭部
138 軸部
150 股関節部スクリュー
154 頭部
156 軸部
Claims (33)
- 少なくとも一つの拡張可能部、及び少なくとも一つの非拡張部を有する整形外科用装置を提供すること;及び
前記拡張可能部の少なくとも一部について選択的に焼きなましを行い、その際、該選択的に焼きなましが行われる部分および焼きなましが行われない部分の温度を監視するフィードバックメカニズムの制御の下で、前記焼きなましが行われること、
を含む整形外科用の埋込物の金属処理方法。 - 前記非拡張部に対し焼きなましを行わないことを含む、請求項1の方法。
- 前記非拡張部は、前記拡張可能部により伸ばされる、請求項1の方法。
- 前記拡張可能部の一部分のみを選択的に焼きなますことを含む、請求項1−3のいずれかの方法。
- 前記選択的焼きなましは、前記拡張可能部及び前記非拡張部の間に焼きなまされない境界領域を残す、請求項4の方法。
- 前記選択的焼きなましの前に前記埋込物に冷間加工を施すことを含む、請求項1の方法。
- 前記拡張可能部及び非拡張部は、前記埋込物の細長い部分を含む、請求項1の方法。
- 前記埋込物は髄内釘を含む、請求項1−7のいずれかの方法。
- 前記埋込物は歯科用のインプラントである、請求項1−7のいずれかの方法。
- 前記埋込物は股関節部スクリューである、請求項1−7のいずれかの方法。
- 前記埋込物は股関節部埋込物である、請求項1−7のいずれかの方法。
- 前記埋込物はメッシュ型の埋込物である、請求項1−7のいずれかの方法。
- 前記非拡張部は前記埋込物の厚い部分を含み、前記拡張可能部は前記埋込物の薄い部分を含む、請求項1−12のいずれかの方法。
- 前記選択的焼きなましは、前記埋込物の一部を直接加熱することによるのと、直接加熱された前記埋込物の一部から移動する熱を用いて前記埋込物の第2の部分を間接的に加熱することによるのとの双方の焼きなましを含む、請求項1−13のいずれかの方法。
- 前記選択的焼きなましは、前記埋込物の少なくとも一部を焼きなましの熱から保護することを含む、請求項1−14のいずれかの方法。
- 前記保護は、焼きなまさない部分の近傍にヒートシンクを備えることを含む、請求項15の方法。
- 前記保護は、焼きなまさない部分を能動的に冷却することを含む、請求項15の方法。
- センサを用いて前記埋込物の少なくとも一部の温度を監視することを含む、請求項1−17のいずれかの方法。
- 前記監視される部分は、焼きなまされる部分を含む、請求項18の方法。
- 前記監視される部分は、焼きなまさない部分を含む、請求項18の方法。
- 温度を監視することは、前記焼きなまされる部分が溶けないように温度を監視することを含む、請求項18の方法。
- 温度を監視することは、温度が、焼きなましをするのに十分な水準以上であることを監視することを含む、請求項18の方法。
- 選択的焼きなましは、前記センサの出力に応答して、加熱の強度を制御することを含む、請求項18の方法。
- 前記制御は、閉ループ制御を含む、請求項23の方法。
- 前記制御は、オープン・ループ制御を含む、請求項23の方法。
- 前記選択的焼きなましは、所望の焼きなまし効果が達成されるまで、同じ場所を数回繰り返して加熱することを含む、請求項1−25のいずれかの方法。
- 前記焼きなましは、前記拡張可能部の厚み全体を焼きなますことを含む、請求項1−26のいずれかの方法。
- 前記焼きなましは、前記焼きなまされた部分の伸び率を少なくとも30%に増大させる、請求項1−27のいずれかの方法。
- 前記焼きなましは、前記焼きなまされた部分の伸び率を少なくとも40%に増大させる、請求項1−27のいずれかの方法。
- 前記焼きなましは、前記焼きなまされた部分の伸び率を少なくとも50%に増大させる、請求項1−27のいずれかの方法。
- 前記焼きなましは、前記焼きなまされた部分の伸び率を少なくとも60%に増大させる、請求項1−27のいずれかの方法。
- 前記焼きなましは、前記焼きなましが行われた部分の伸び率を約12%から、それより大きい値に増大させる、請求項1−31のいずれかの方法。
- 前記埋込物はチタンから形成されている、請求項1の方法。
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US128261 | 1980-03-07 | ||
IL12826199A IL128261A0 (en) | 1999-01-27 | 1999-01-27 | Expandable element |
US12018499P | 1999-02-16 | 1999-02-16 | |
US60/120,184 | 1999-02-16 | ||
PCT/IL2000/000055 WO2000044946A1 (en) | 1998-03-06 | 2000-01-27 | Metal processing method |
IL14114701A IL141147A0 (en) | 1999-01-27 | 2001-01-28 | Space filler |
Publications (3)
Publication Number | Publication Date |
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JP2002535109A JP2002535109A (ja) | 2002-10-22 |
JP2002535109A5 JP2002535109A5 (ja) | 2007-11-15 |
JP4681123B2 true JP4681123B2 (ja) | 2011-05-11 |
Family
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Family Applications (3)
Application Number | Title | Priority Date | Filing Date |
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JP2000595624A Expired - Fee Related JP4362235B2 (ja) | 1999-01-27 | 2000-01-27 | スペーサ |
JP2000596185A Expired - Fee Related JP4681123B2 (ja) | 1999-01-27 | 2000-01-27 | 金属処理方法 |
JP2000595626A Expired - Fee Related JP4257393B2 (ja) | 1999-01-27 | 2000-01-27 | 拡張可能な要素のデリバリーシステム |
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JP2000595624A Expired - Fee Related JP4362235B2 (ja) | 1999-01-27 | 2000-01-27 | スペーサ |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
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JP2000595626A Expired - Fee Related JP4257393B2 (ja) | 1999-01-27 | 2000-01-27 | 拡張可能な要素のデリバリーシステム |
Country Status (9)
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US (3) | US7097648B1 (ja) |
EP (4) | EP1148850B2 (ja) |
JP (3) | JP4362235B2 (ja) |
AT (2) | ATE326926T1 (ja) |
AU (3) | AU2316700A (ja) |
DE (2) | DE60028186T2 (ja) |
ES (2) | ES2242595T5 (ja) |
IL (2) | IL128261A0 (ja) |
WO (3) | WO2000044319A1 (ja) |
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