JPH02246970A - 内義肢の製造法 - Google Patents

内義肢の製造法

Info

Publication number
JPH02246970A
JPH02246970A JP1328543A JP32854389A JPH02246970A JP H02246970 A JPH02246970 A JP H02246970A JP 1328543 A JP1328543 A JP 1328543A JP 32854389 A JP32854389 A JP 32854389A JP H02246970 A JPH02246970 A JP H02246970A
Authority
JP
Japan
Prior art keywords
shaft
shells
welding
hollow shaft
hollow
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.)
Granted
Application number
JP1328543A
Other languages
English (en)
Other versions
JP2768516B2 (ja
Inventor
Curt Kranz
クルト・クランツ
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Johnson and Johnson
Johnson and Johnson Hospital Services Inc
Original Assignee
Johnson and Johnson Products Inc
Johnson and Johnson
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Johnson and Johnson Products Inc, Johnson and Johnson filed Critical Johnson and Johnson Products Inc
Publication of JPH02246970A publication Critical patent/JPH02246970A/ja
Application granted granted Critical
Publication of JP2768516B2 publication Critical patent/JP2768516B2/ja
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
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    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
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    • A61F2/36Femoral heads ; Femoral endoprostheses
    • A61F2/3662Femoral shafts
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    • A61F2002/30476Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements locked by an additional locking mechanism
    • A61F2002/30495Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements locked by an additional locking mechanism using a locking ring
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0071Additional features; Implant or prostheses properties not otherwise provided for breakable or frangible
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2310/00Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005The prosthesis being constructed from a particular material
    • A61F2310/00011Metals or alloys
    • A61F2310/00023Titanium or titanium-based alloys, e.g. Ti-Ni alloys
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2310/00Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00389The prosthesis being coated or covered with a particular material
    • A61F2310/00592Coating or prosthesis-covering structure made of ceramics or of ceramic-like compounds
    • A61F2310/00796Coating or prosthesis-covering structure made of a phosphorus-containing compound, e.g. hydroxy(l)apatite
    • YGENERAL 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
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S623/00Prosthesis, i.e. artificial body members, parts thereof, or aids and accessories therefor
    • Y10S623/901Method of manufacturing prosthetic device
    • YGENERAL 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
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S623/00Prosthesis, i.e. artificial body members, parts thereof, or aids and accessories therefor
    • Y10S623/909Method or apparatus for assembling prosthetic
    • Y10S623/911Bone

Landscapes

  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)
  • Forging (AREA)

Abstract

(57)【要約】本公報は電子出願前の出願データであるた
め要約のデータは記録されません。

Description

【発明の詳細な説明】 〔産業上の利用分野〕 本発明は中空シャフト内義肢、特に股関節内義肢を製造
する方法に関する。
〔従来の技術〕
金属合金から成る中空シャフト内義肢はこれまで専ら鋳
造法によって製造されてきた。しかしながら、この鋳造
技術は特定の材料に制限されている。義肢シャフトに対
して専ら使用されてきた鋳造可能な材料とは、これまで
コバル)−クロム−モリブデン鋳造合金ならびに316
鋳鋼であった。。この場合に欠点となるのは、これらの
材料が僅かな疲れ強さしか有しないので、高められた交
番曲げ応力に基づき疲れ破壊が生じ得ることである。他
の材料、たとえばクロム−ニッケルーモリブデン−チタ
ン鍛造合金、コバルト−クロム−ニッケルーモリブデン
−チタン鍛造合金およびチタンーアルミニウムーバナジ
な ラム鍛造合金はこれまで専ら中空シャフト義肢において
使用されてきた。1つの工作物から切削加工法によって
中空シャフトを製造することは経済的でない。
〔発明が解決しようとする課題〕
本発明の課題は、中空シャフト義肢に形状全厚える際に
、中空シャフト義肢の外壁範囲に関しても内壁範囲に関
しても大きな自由性を許すような、中空シャフト内義肢
の製造法を提供することである。
〔課題を解決するための手段〕
この課題を解決するために本発明の方法では、接合され
てシャフトの形状、つまり義肢を形成することができて
、この接合時に11ぼ長手方向に延びる2つの継ぎ目線
の範囲で互いに隣接するような2つのハーフシェルをプ
レス加工または鍛造加工によって形成し、前記両ハーフ
シェルを前記継ぎ目線の範囲で溶接するようにした。
〔発明の効果〕
本発明は次のような認識に基づくものである。
すなわち、有利に使用可能なチタン−アルミニウム−バ
ナジウム合金は公知のプレス加工法または鍛造加工法に
よって任意の管部分に成形可能であり、これらの管部分
は溶接法によって結合可能である。この場合に静接創の
管部分を、鋳造された中空シャフトの後処理または複雑
な鋳造コアの使用よりも著しく閤単に、複雑でなく処理
することができることは特に有利である。
チタン−アルミニウム−バナジウム鍛造合金(TIAJ
6V4)は艮好な生体適合性、高い疲れ強さおよび良好
な耐食性を有していて、したがって義肢シャフトを製造
するための材料として特に適していることが判明した。
この材料を鍛造加工法またはプレス加工法および溶接法
によって処理することは経済的である。その理由は、単
純な型しか必要とせず、1工作物あたりの製造時間消費
が小さいからである。
管部分は2つのハーフシェルの形状を有している。これ
らのハーフシェルはできる限り、プレス加工時または鍛
造加工時において、関節に近い方の端部か゛ら関節から
遠い方の端部の方向に厚さが連続的に陳少するように成
形さnる。
処理すべき材料の最小厚さの形状における鍛造加工法の
技術的な限界を補償するために、特にエツチングによる
後処理が好都合でるることが判明した。
曲げ剛性および/または長手方向剛性の局部的な変化を
生ぜしめるために、シャフト周壁を意図的に弱くするこ
とができる。
また、既にプレス加工時または鍛造加工時にハーフシェ
ルの周壁に貫通孔を設けることもできる。場合によって
生じるパリは、本発明による方法が2工程であることに
基づき両個別部分の接合前に迅速にかつ問題なく除去さ
れ得る。
同様に、規則的形状からずれた別の成形部、たとえばノ
・−フシエルの凹状または凸状の表面における凹部をも
、プレス加工法または鍛造加工法によって少なくとも予
備成形することができる。。
本発明による方法の有利な実施態様では、両ハーフシェ
ルの接合が電子ビーム溶接によって行なわれる。この電
子ビーム溶接法とは、とシわけ極めて小鴨で均一な溶接
継ぎ目が得られることによりすぐれておシ、シたがって
糀肢シャフトに課せられるべき高い品質要求を満たすも
のである。その上、電子ビーム溶接の場合には溶接継ぎ
目の両側に生じる熱影響帯域が、たとえばT工G溶接(
タングステン不活性ガス溶接)の場合ニジも著しく伏く
なる。溶接継ぎ目を滑らかにするための後処理の手間も
、電子ビーム溶接の場合には少ない。
接合された中空シャフトが貫通孔を備えている場合、中
空室をポリエチレンで満たすことができる。この手段は
必要である。その理由はこれらの貫通孔により、骨が成
長してシャフトの中空室にはいシ込み、この糧の絶対的
な形状接続が、場合によっては必要になる義肢の取出し
を困難にしてしまうからである。
ポリエチレンの僅かな剛性は中空義肢の最適化された形
状特性および材料特性に対して極めて僅かな影響しか及
ぼさない。貫通孔に設けられたポリエチレンが直接に骨
と接触することを阻止するために、これらの貫通孔にア
パタイト被覆体が設けられていると有利である。
義肢シャフトが凸状の外面に凹部を有している場合、こ
れらの凹部をポロコー) (Porocoat)材料で
満たすことが好都合である。
義肢の頚範囲は差込み円錐体を備えていると有利であシ
、これにxi)異なる直径と、異なる円錐体差込み長さ
とを有する球体を使用することが可能となる。
本発明の有利な方法は請求項2以下に記載されている。
〔実施例〕
以下に、本発明による方法の有利な実施例を、股関節内
義肢の製造例につき詳しく説明する。
第1の方法工程では、接合されて中空シャフトを形成す
る、互いに形状の合わされた2つの異なるハーフシェル
1および2(第1図参照)がプレス加工時母るか、また
は鍛造力l工される。
材料としては、チタンーアルミニウムーバナジクム鍛造
合金が使用されると有利でるる。この材料は鋳造不可能
である。しかし、この材料は関節形成術において望ます
る多くの性質を有している。
両ハーフシェル1および2の形状は互いに調和されてお
)、この場合これらのハーフシェルは接合時に、徐々に
増大する直径と同一方向で徐々に増大する壁厚とを有す
る湾曲させられた管を形成することができる。中空シャ
フトの軸方向に壁厚を連続的に変化させることならびに
規定の壁貫通孔3と、両ハーフシェル1および2の内面
における規定の凹部とを設けることはプレス加工過程も
しくは鍛造加工過程において既に元号に行なわtている
。この種の構造上の細かさは、応力特性を周辺の骨範囲
の生理学的強度および曲げ特性に近付けることに役立つ
ハーフシェル1および2は中空シャフトの外方に曲げら
れた内側部分(ハーフシェル1)と、内方に曲げられた
外側部分(ハーフシェル2)とを形成する。このような
分割は技術的に好都合である。その理由は、外方に曲げ
られた内側部分の関節から遠い方の端部が内方に曲げら
れた外側部分に比べて短縮されていると有利であるから
である(本出願人によシ同時に出願された西ドイツ国特
許出願第P 6844157.8号明細書参照)。
両ハーフシェル1および2をプレス加工するか、または
鍛造加工して、場合によっては壁貫通孔および/または
凹部を形成した後に、これらのハーフシェル1および2
はパリ取りされて、清らかにされる。場合によって続い
て行なわれる、連続的な厚さ増大を良好にするためのエ
ツチングまたは別の切削方法は中空シャフトのまだ「切
シ開かれた」状態において内方からも外方からも好都合
に実施可能である。
甲をシャフト5の外周壁に設けられた凹部はポロコート
材料を詰められている。その理由は、この場所に成長し
てはいり込んで来る骨は、義肢切欠き内に中実に成長し
てはいゃ込む骨ビーる変化形が示されている。球体7と
差込み円錐体8とから成る関節部分6は中空シャフトに
溶接されず、解離可能に7ランジ締結される。このこと
は、目標破断個所を有する緊定リング11を用いて行な
われると有利である。関節部分6の解離後に中空シャフ
ト5の内部は接近可能になシ、外科医は場合によって中
を室に成長してはいシ込んだ骨をフライス工具または穿
孔工具を用いて、皮質を損うことなく収り除くことがで
きる。
【図面の簡単な説明】
第1図は本発明による方法によシ製造さnたハーフシェ
ルの分解斜視図、第2図は本発明による方法によシ溶接
された中空シャフトの側面図、第3図は第2図のA−A
線に沿った断面図、第4図は第2図のB−B線に宿った
断面図、第5図は解離可能な関節部分を備えた中空シャ
フト義肢を部分的に断面して示す図である。 1.2・・・ハーフシェル、3・・・壁貫通孔、4・・
・凹部、5・・・中をシャフト、6・・・関節部分、7
・・・球体、8・・・差込み円錐体、9.10・・・溶
接継ぎ目、11・・・緊定リング、 第5図 第4図

Claims (11)

    【特許請求の範囲】
  1. 1. 中空シヤフト内義肢を製造する方法において、 接合されてシヤフトの形状、つまり義肢を 形成することができて、この接合時にほぼ長手方向に延
    びる2つの継ぎ目線の範囲で互いに隣接するような2つ
    のハーフシエル(1,2)をプレス加工または鍛造加工
    によつて形成し、前記両ハーフシエル(1,2)を前記
    継ぎ 目線の範囲で溶接することを特徴とする、中空シヤフト
    内義肢の製造法。
  2. 2. ハーフシエル(1,2)をチタン−アルミニウム
    −バナジウム鍛造合金(TiAl6V4)から製造する
    、請求項1記載の方法。
  3. 3. ハーフシエル(1,2)の関節に近い方の端部か
    ら、関節から遠い方の端部の方向に、前記ハーフシエル
    のほぼ連続的な厚さ減少を化学的エッチングによつて生
    ぜしめるか、もしくはプレス加工または鍛造加工時にあ
    らかじめ厚さ減少を生ぜしめ、化学的エッチングにより
    後処理する、請求項1または2記載の方法。
  4. 4. ハーフシエル(1,2)に貫通孔(3)を設ける
    か、もしくはあらかじめ設けられた貫通孔(3)を清ら
    かにして、バリ取りする、請求項1から6までのいずれ
    か1項記載の方法。
  5. 5. 貫通孔をシヤフトの外面でカバーによつて覆い、
    シヤフトの関節から遠い方の開口に栓を詰め、シヤフト
    (5)の中空室をポリエチレンで満たし、前記カバーと
    前記栓とを除去し、次いで前記貫通孔(3)内のポリエ
    チレン表面にアパタイトを被覆する、請求項4記載の方
    法。
  6. 6. ハーフシエル(1,2)の凸状の外面に凹部を設
    け、該凹部をポロコート材料で満たす、請求項1から5
    までのいずれか1項記載の方法。
  7. 7. ハーフシエル(1,2)の凹状の内面に凹部(4
    )を設ける、請求項1から6までのいずれか1項記載の
    方法。
  8. 8. 中空シヤフト(5)の関節に近い方の端部に差込
    み円錐体(8)を溶接する、請求項1から7までのいず
    れか1項記載の方法。
  9. 9. 目標破断個所を有する緊定リング(11)によつ
    て、差込み円錐体(8)を中空シヤフト(5)の関節に
    近い方の端部と解離可能に結合する、請求項1から7ま
    でのいずれか1項記載の方法。
  10. 10. ハーフシエル(1,2)を電子ビーム溶接法に
    よつて互いに結合する、請求項1から9までのいずれか
    1項記載の方法。
  11. 11. ハーフシエル(1,2)の間の溶接継ぎ目(9
    )および/または差込み円錐体(8)と、中空シヤフト
    (5)の関節に近い方の端部との間の溶接継ぎ目(10
    )を手によるか、または研削装置を用いて滑らかにする
    、請求項10記載の方法。
JP1328543A 1988-12-23 1989-12-20 内義肢の製造法 Expired - Lifetime JP2768516B2 (ja)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE3844155.1 1988-12-23
DE3844155A DE3844155C2 (de) 1988-12-23 1988-12-23 Endoprothese und Verfahren zu ihrer Herstellung

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JPH02246970A true JPH02246970A (ja) 1990-10-02
JP2768516B2 JP2768516B2 (ja) 1998-06-25

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EP (1) EP0375600B1 (ja)
JP (1) JP2768516B2 (ja)
AT (1) ATE112952T1 (ja)
CA (1) CA2006595C (ja)
DE (2) DE3844155C2 (ja)
ES (1) ES2064479T3 (ja)

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ATE112952T1 (de) 1994-11-15
ES2064479T3 (es) 1995-02-01
DE58908535D1 (de) 1994-11-24
CA2006595C (en) 2001-05-08
JP2768516B2 (ja) 1998-06-25
DE3844155A1 (de) 1990-06-28
EP0375600B1 (de) 1994-10-19
EP0375600A2 (de) 1990-06-27
US5015817A (en) 1991-05-14
DE3844155C2 (de) 1994-01-27
EP0375600A3 (de) 1991-04-17
CA2006595A1 (en) 1990-06-23

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