JP6668406B2 - 融合型大腿骨ステムシステム - Google Patents
融合型大腿骨ステムシステム Download PDFInfo
- Publication number
- JP6668406B2 JP6668406B2 JP2018089921A JP2018089921A JP6668406B2 JP 6668406 B2 JP6668406 B2 JP 6668406B2 JP 2018089921 A JP2018089921 A JP 2018089921A JP 2018089921 A JP2018089921 A JP 2018089921A JP 6668406 B2 JP6668406 B2 JP 6668406B2
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- Prior art keywords
- stem
- femoral
- fused
- curved
- short stem
- 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.)
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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
- 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
- A61F2/3094—Designing or manufacturing processes
- A61F2/30942—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
- A61F2002/30957—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques using a positive or a negative model, e.g. moulds
-
- 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
- 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
- A61F2/3094—Designing or manufacturing processes
- A61F2002/30968—Sintering
-
- 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
- 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
- A61F2/3094—Designing or manufacturing processes
- A61F2002/30985—Designing or manufacturing processes using three dimensional printing [3DP]
-
- 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
- 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
- A61F2/32—Joints for the hip
- A61F2/36—Femoral heads ; Femoral endoprostheses
- A61F2/3609—Femoral heads or necks; Connections of endoprosthetic heads or necks to endoprosthetic femoral shafts
- A61F2002/3654—Connections of heads directly to shafts
-
- 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
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- Health & Medical Sciences (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Engineering & Computer Science (AREA)
- Vascular Medicine (AREA)
- Transplantation (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Cardiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Manufacturing & Machinery (AREA)
- Prostheses (AREA)
Description
本発明は、湾曲ショートステムと、固定機構と、大腿骨頭補綴とを備え、前記固定機構は、大転子に挿入される融合型ネジスリーブと、術後に大腿骨頭が体重荷重を受けるときに生じる下向きの曲げモーメントを解消するように前記融合型ネジスリーブを貫通して接続機構に接続されてロックされるラグネジと、を含み、前記湾曲ショートステムの一端には、前記大腿骨頭補綴のテーパ状接続孔に接続されるテーパ状接続体が設けられ、前記湾曲ショートステムの他端は大腿骨頚の骨切り面から小転子以下の髄腔位置まで挿入され、前記湾曲ショートステムは前記固定機構によって前記大転子に固定される融合型大腿骨ステムシステムである。
ラグネジ7は、大転子11の外部から融合型ネジスリーブ8を貫通して接続機構6に接続されてロックされる。ラグネジ7は、このロックの過程において、術後、環状構造9における多孔質構造10が大転子の表面の骨皮質と成長性オッセオインテグレーションを行うように、ネジキャップが融合型ネジスリーブ8の環状構造9を大転子の骨皮質の外面に押し締める。
1.鍛造又は鋳造プロセスで湾曲ショートステムの半加工品を製造し、骨融合層のスプレーコーティングの厚みを予め残すように通常の機械加工である切削プロセスによって半加工品を完成品の寸法に加工し、コーティングが必要な部分について高温プラズマスプレーを行って粗いコーティングを得る。
2.鍛造又は鋳造プロセスで湾曲ショートステムの半加工品を製造し、骨融合層のスプレーコーティングの厚みを予め残すように通常の機械加工である切削プロセスによって半加工品を完成品の寸法に加工し、コーティングが必要な部分について金属粉末又は金属粒子を焼結して金属粒子焼結による多孔質層を得る。
3.コンピュータで湾曲ショートステムの表面における所望部位を多孔質金属構造の三次元モデルに設計するように湾曲ショートステムの三次元モデルを設計するとともに、残された生理学的大腿骨頭の下半部分に対してCT又はMIR断層走査を行って、走査データを逆モデリングして残された生理学的大腿骨頭の下半部分の皮質骨20の内壁の曲面形状特徴を取得し、生理学的大腿骨頭の下半部分の皮質骨20の内壁の曲面形状特徴に基づいて、将来において、湾曲ショートステムにおけるテーパ状接続体に近い側のステム本体下部の外面が残された生理学的大腿骨頭の下半部分の皮質骨20の内壁の曲面と良好に合わせるように、テーパ状接続体に近い側のステム本体下部の表面の形態を設計する。そして、完成した設計ファイルを金属3Dプリント装置に入力してプリント成形を行いて、ステム本体及びその表面の多孔質金属構造を一括してプリントした後、通常の機械加工である切削プロセスで、テーパ状接続体及びラグネジに接合された接続機構の加工を行う。
4.適当な直径を有する金属棒を用いて、通常の機械加工である切削プロセスでラグネジの加工を行う。
5.コンピュータで融合型ネジスリーブの表面における所望部位を多孔質金属構造の三次元モデルを設計するように融合型ネジスリーブの三次元モデルを設計する。そして、完成した設計ファイルを金属3Dプリント装置に入力して直接プリント成形を行う。
6.金属又はセラミック製大腿骨頭補綴は、本分野で一般的に使用されている金属機械加工又はセラミック焼結研磨加工等の方法によって製造できる。
2 大腿骨頭補綴
3 テーパ状接続体
4 テーパ状接続孔
5 骨融合層
6 接続機構
7 ラグネジ
8 融合型ネジスリーブ
9 環状構造
10 多孔質構造
11 大転子
12 髄腔
13 切除された生理学的大腿骨頭の破損部分の輪郭
14 実体金属スリーブ
15 大腿骨頚
16 大腿骨頭
17 張力ライン
18 圧力ライン
19 海綿骨
20 皮質骨
21 小転子
22 円状プラットフォーム
23 プラットフォーム
24 寛骨臼カップ補綴
Claims (8)
- 湾曲ショートステムと、固定機構と、大腿骨頭補綴とを備え、
前記固定機構は、大転子に挿入される融合型ネジスリーブと、術後に大腿骨頭が体重荷重を受けた時に生じる下向きの曲げモーメントを解消するように前記融合型ネジスリーブを貫通して接続機構に接続されてロックされるラグネジと、を含み、
前記湾曲ショートステムの一端には前記大腿骨頭補綴のテーパ状接続孔と嵌め合い接続するテーパ状接続体が設けられ、前記湾曲ショートステムの他端は大腿骨頚の骨切り面から小転子以下の髄腔位置まで挿入され、前記湾曲ショートステムは前記固定機構によって前記大転子に接続して固定され、
前記融合型ネジスリーブは、前記大転子の外部から貫き通す、外表面が金属多孔質構造であり、内表面が中実金属スリーブ構造である中空チューブであり、
前記融合型ネジスリーブには、前記大転子の骨皮質の外部に膨出する環状構造が設計されている、
ことを特徴とする融合型大腿骨ステムシステム。 - 前記湾曲ショートステムは、テーパ状接続体に近い側のステム本体下部の表面の形状が、残存する生理学的大腿骨頭の下半部分の皮質骨内壁の曲面形状特徴に符合する金属ショートステムであることを特徴とする請求項1に記載の融合型大腿骨ステムシステム。
- 前記湾曲ショートステムの横断面形状は、長方形、円形、楕円形、液滴形状、多角形のいずれかであることを特徴とする請求項2に記載の融合型大腿骨ステムシステム。
- 前記湾曲ショートステムにおける、前記髄腔、前記大転子と接触する部位には、骨融合層が設けられていることを特徴とする請求項3に記載の融合型大腿骨ステムシステム。
- 前記骨融合層は、高温プラズマスプレーにより得られた粗いコーティング、又は金属粉末又は金属粒子を焼結して得た多孔質層、又は3Dプリントにより直接生成した多孔質金属層であることを特徴とする請求項4に記載の融合型大腿骨ステムシステム。
- 前記湾曲ショートステムの前記大転子に対向する一側には、接続機構が設けられていることを特徴とする請求項4に記載の融合型大腿骨ステムシステム。
- 前記環状構造の前記大転子の皮質骨の表面に近い側には、多孔質構造が設けられていることを特徴とする請求項1に記載の融合型大腿骨ステムシステム。
- 前記湾曲ショートステムは、テーパ状接続体に近い側のステム本体下部の表面が金属多孔質構造であることを特徴とする請求項2に記載の融合型大腿骨ステムシステム。
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