JP3323244B2 - 骨折の内固定および腱と骨との取付用の自己固定式分解吸収性ねじおよび板 - Google Patents
骨折の内固定および腱と骨との取付用の自己固定式分解吸収性ねじおよび板Info
- Publication number
- JP3323244B2 JP3323244B2 JP24404792A JP24404792A JP3323244B2 JP 3323244 B2 JP3323244 B2 JP 3323244B2 JP 24404792 A JP24404792 A JP 24404792A JP 24404792 A JP24404792 A JP 24404792A JP 3323244 B2 JP3323244 B2 JP 3323244B2
- Authority
- JP
- Japan
- Prior art keywords
- screw
- osteosynthesis
- resorbable
- plate
- bone
- 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.)
- Expired - Lifetime
Links
- 210000000988 bone and bone Anatomy 0.000 title claims abstract description 32
- 210000002435 tendon Anatomy 0.000 title claims description 5
- 229920000642 polymer Polymers 0.000 claims description 18
- 230000001097 osteosynthetic effect Effects 0.000 claims description 2
- 239000002344 surface layer Substances 0.000 claims 1
- 238000003780 insertion Methods 0.000 abstract description 2
- 230000037431 insertion Effects 0.000 abstract description 2
- 239000007943 implant Substances 0.000 description 14
- 230000003014 reinforcing effect Effects 0.000 description 10
- 229910052751 metal Inorganic materials 0.000 description 9
- 239000002184 metal Substances 0.000 description 9
- 230000036961 partial effect Effects 0.000 description 7
- 229920001577 copolymer Polymers 0.000 description 6
- 239000000463 material Substances 0.000 description 6
- 238000000034 method Methods 0.000 description 5
- 230000002028 premature Effects 0.000 description 4
- RKDVKSZUMVYZHH-UHFFFAOYSA-N 1,4-dioxane-2,5-dione Chemical compound O=C1COC(=O)CO1 RKDVKSZUMVYZHH-UHFFFAOYSA-N 0.000 description 3
- MUBZPKHOEPUJKR-UHFFFAOYSA-N Oxalic acid Chemical compound OC(=O)C(O)=O MUBZPKHOEPUJKR-UHFFFAOYSA-N 0.000 description 3
- 239000000919 ceramic Substances 0.000 description 3
- 229920006237 degradable polymer Polymers 0.000 description 3
- 239000011521 glass Substances 0.000 description 3
- JJTUDXZGHPGLLC-UHFFFAOYSA-N lactide Chemical compound CC1OC(=O)C(C)OC1=O JJTUDXZGHPGLLC-UHFFFAOYSA-N 0.000 description 3
- 229920000728 polyester Polymers 0.000 description 3
- 229920000954 Polyglycolide Polymers 0.000 description 2
- 239000012620 biological material Substances 0.000 description 2
- 210000001124 body fluid Anatomy 0.000 description 2
- 239000010839 body fluid Substances 0.000 description 2
- 239000002131 composite material Substances 0.000 description 2
- JVTAAEKCZFNVCJ-UHFFFAOYSA-N lactic acid Chemical compound CC(O)C(O)=O JVTAAEKCZFNVCJ-UHFFFAOYSA-N 0.000 description 2
- 239000000203 mixture Substances 0.000 description 2
- 229920000747 poly(lactic acid) Polymers 0.000 description 2
- 229920002463 poly(p-dioxanone) polymer Polymers 0.000 description 2
- 239000000622 polydioxanone Substances 0.000 description 2
- 238000001356 surgical procedure Methods 0.000 description 2
- 238000003466 welding Methods 0.000 description 2
- SJZRECIVHVDYJC-UHFFFAOYSA-M 4-hydroxybutyrate Chemical compound OCCCC([O-])=O SJZRECIVHVDYJC-UHFFFAOYSA-M 0.000 description 1
- WHUUTDBJXJRKMK-UHFFFAOYSA-N Glutamic acid Natural products OC(=O)C(N)CCC(O)=O WHUUTDBJXJRKMK-UHFFFAOYSA-N 0.000 description 1
- AEMRFAOFKBGASW-UHFFFAOYSA-N Glycolic acid Polymers OCC(O)=O AEMRFAOFKBGASW-UHFFFAOYSA-N 0.000 description 1
- WHUUTDBJXJRKMK-VKHMYHEASA-N L-glutamic acid Chemical compound OC(=O)[C@@H](N)CCC(O)=O WHUUTDBJXJRKMK-VKHMYHEASA-N 0.000 description 1
- 241000283973 Oryctolagus cuniculus Species 0.000 description 1
- 239000004952 Polyamide Substances 0.000 description 1
- 229920002732 Polyanhydride Polymers 0.000 description 1
- 229920001273 Polyhydroxy acid Polymers 0.000 description 1
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- 229920001710 Polyorthoester Polymers 0.000 description 1
- 208000024288 Rotator Cuff injury Diseases 0.000 description 1
- KDYFGRWQOYBRFD-UHFFFAOYSA-N Succinic acid Natural products OC(=O)CCC(O)=O KDYFGRWQOYBRFD-UHFFFAOYSA-N 0.000 description 1
- 229910001069 Ti alloy Inorganic materials 0.000 description 1
- RTAQQCXQSZGOHL-UHFFFAOYSA-N Titanium Chemical compound [Ti] RTAQQCXQSZGOHL-UHFFFAOYSA-N 0.000 description 1
- 230000002745 absorbent Effects 0.000 description 1
- 239000002250 absorbent Substances 0.000 description 1
- 239000011358 absorbing material Substances 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 230000002411 adverse Effects 0.000 description 1
- 150000001408 amides Chemical class 0.000 description 1
- 235000001014 amino acid Nutrition 0.000 description 1
- 150000001413 amino acids Chemical class 0.000 description 1
- 230000036770 blood supply Effects 0.000 description 1
- KDYFGRWQOYBRFD-NUQCWPJISA-N butanedioic acid Chemical compound O[14C](=O)CC[14C](O)=O KDYFGRWQOYBRFD-NUQCWPJISA-N 0.000 description 1
- 239000001506 calcium phosphate Substances 0.000 description 1
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- 238000005260 corrosion Methods 0.000 description 1
- 230000007797 corrosion Effects 0.000 description 1
- 230000001054 cortical effect Effects 0.000 description 1
- 230000007423 decrease Effects 0.000 description 1
- 230000003247 decreasing effect Effects 0.000 description 1
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- 150000002009 diols Chemical class 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 230000003628 erosive effect Effects 0.000 description 1
- 238000001125 extrusion Methods 0.000 description 1
- -1 for example Polymers 0.000 description 1
- 239000012634 fragment Substances 0.000 description 1
- 235000013922 glutamic acid Nutrition 0.000 description 1
- 239000004220 glutamic acid Substances 0.000 description 1
- 229920001519 homopolymer Polymers 0.000 description 1
- 229910052588 hydroxylapatite Inorganic materials 0.000 description 1
- 238000001727 in vivo Methods 0.000 description 1
- 238000001746 injection moulding Methods 0.000 description 1
- 239000004310 lactic acid Substances 0.000 description 1
- 235000014655 lactic acid Nutrition 0.000 description 1
- 238000010128 melt processing Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000001338 necrotic effect Effects 0.000 description 1
- 235000006408 oxalic acid Nutrition 0.000 description 1
- XYJRXVWERLGGKC-UHFFFAOYSA-D pentacalcium;hydroxide;triphosphate Chemical compound [OH-].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O XYJRXVWERLGGKC-UHFFFAOYSA-D 0.000 description 1
- UQGPCEVQKLOLLM-UHFFFAOYSA-N pentaneperoxoic acid Chemical compound CCCCC(=O)OO UQGPCEVQKLOLLM-UHFFFAOYSA-N 0.000 description 1
- 229920003023 plastic Polymers 0.000 description 1
- 239000004033 plastic Substances 0.000 description 1
- 229920001434 poly(D-lactide) Polymers 0.000 description 1
- 229920001432 poly(L-lactide) Polymers 0.000 description 1
- 229920001308 poly(aminoacid) Polymers 0.000 description 1
- 239000005015 poly(hydroxybutyrate) Substances 0.000 description 1
- 229920000218 poly(hydroxyvalerate) Polymers 0.000 description 1
- 229920001606 poly(lactic acid-co-glycolic acid) Polymers 0.000 description 1
- 229920002647 polyamide Polymers 0.000 description 1
- 229920001610 polycaprolactone Polymers 0.000 description 1
- 239000004632 polycaprolactone Substances 0.000 description 1
- 229920000515 polycarbonate Polymers 0.000 description 1
- 239000004417 polycarbonate Substances 0.000 description 1
- 229920006149 polyester-amide block copolymer Polymers 0.000 description 1
- 239000004626 polylactic acid Substances 0.000 description 1
- 239000002861 polymer material Substances 0.000 description 1
- 238000010094 polymer processing Methods 0.000 description 1
- 238000003672 processing method Methods 0.000 description 1
- 230000002829 reductive effect Effects 0.000 description 1
- 239000010935 stainless steel Substances 0.000 description 1
- 229910001220 stainless steel Inorganic materials 0.000 description 1
- 210000002303 tibia Anatomy 0.000 description 1
- 210000001519 tissue Anatomy 0.000 description 1
- 239000010936 titanium Substances 0.000 description 1
- 229910052719 titanium Inorganic materials 0.000 description 1
- QORWJWZARLRLPR-UHFFFAOYSA-H tricalcium bis(phosphate) Chemical compound [Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O QORWJWZARLRLPR-UHFFFAOYSA-H 0.000 description 1
- 229940078499 tricalcium phosphate Drugs 0.000 description 1
- 229910000391 tricalcium phosphate Inorganic materials 0.000 description 1
- 235000019731 tricalcium phosphate Nutrition 0.000 description 1
- YFHICDDUDORKJB-UHFFFAOYSA-N trimethylene carbonate Chemical compound O=C1OCCCO1 YFHICDDUDORKJB-UHFFFAOYSA-N 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/84—Fasteners therefor or fasteners being internal fixation devices
- A61B17/86—Pins or screws or threaded wires; nuts therefor
- A61B17/8605—Heads, i.e. proximal ends projecting from bone
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/80—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
- A61B17/8052—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates immobilised relative to screws by interlocking form of the heads and plate holes, e.g. conical or threaded
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F16—ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
- F16B—DEVICES FOR FASTENING OR SECURING CONSTRUCTIONAL ELEMENTS OR MACHINE PARTS TOGETHER, e.g. NAILS, BOLTS, CIRCLIPS, CLAMPS, CLIPS OR WEDGES; JOINTS OR JOINTING
- F16B39/00—Locking of screws, bolts or nuts
- F16B39/22—Locking of screws, bolts or nuts in which the locking takes place during screwing down or tightening
- F16B39/28—Locking of screws, bolts or nuts in which the locking takes place during screwing down or tightening by special members on, or shape of, the nut or bolt
- F16B39/282—Locking by means of special shape of work-engaging surfaces, e.g. notched or toothed nuts
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/84—Fasteners therefor or fasteners being internal fixation devices
- A61B17/86—Pins or screws or threaded wires; nuts therefor
- A61B17/866—Material or manufacture
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00004—(bio)absorbable, (bio)resorbable, resorptive
-
- 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
- A61F2/08—Muscles; Tendons; Ligaments
- A61F2/0811—Fixation devices for tendons or ligaments
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Engineering & Computer Science (AREA)
- Life Sciences & Earth Sciences (AREA)
- Surgery (AREA)
- Heart & Thoracic Surgery (AREA)
- Molecular Biology (AREA)
- Neurology (AREA)
- Veterinary Medicine (AREA)
- Biomedical Technology (AREA)
- General Engineering & Computer Science (AREA)
- Medical Informatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Mechanical Engineering (AREA)
- Surgical Instruments (AREA)
- Materials For Medical Uses (AREA)
- Prostheses (AREA)
- Dowels (AREA)
Description
および/または組織内に取り込まれる分解吸収可能のポ
リマーおよび/または分解吸収可能のポリマーと分解吸
収可能のガラス/セラミックとの複合材料で製造され
た、骨折の内固定に用いられる骨接合用ねじおよび骨接
合板に関するものである。
定部材のような一時的内固定および/または外固定装置
を用いて通常整復される。
主として医療用ステンレス鋼、純チタニウムまたはチタ
ニウム合金から製造されている。
埋植片(インプラント)もまたいくつかの欠点を有す
る。これらの埋植片は骨のヤング率と比較してヤング率
が大きく相違し、しばしば生体内腐食を受け、また、骨
折が直った後に除去しなければならない。
から除去する必要がなく、腐食しない、骨のヤング率に
近いヤング率を有し、骨に増大する負荷を伝え、しかも
骨片を確実に適切に固定し得る内固定装置を開発するた
めに多くの努力が行なわれてきた。
材料は分解吸収可能のガラスおよび/またはセラミック
スで補強された生分解吸収可能のポリマーおよび最終的
に分解吸収可能のポリマーである。
のポリマーを使用することは多数の刊行物の主題となっ
ており、これらの刊行物としては例えば、次のようなも
のがある。
C,他(1969年)、「外科用埋植片用のポリ乳
酸」、Arch Surg 93,839;Cutri
ght DE,Hunsuck EE,他(1971
年)、「生分解性材料、乳酸を用いる骨折整復」、J
Oral Surg 29,393;Vert M,C
habot F,他(1981年)、「高分子生物材料
における、骨外科用の生分解吸収可能プラスチック材
料」、CRC Press,Boca Raton,1
19;Leenslag JW,Pennings A
J,他(1987年)、「骨折内固定用の板およびね
じ」、生物材料8(Biomaterials 8),
70;Tunc R(1990年)、「吸収可能の骨接
合板」、米国特許第4,905,680号、1990年
3月6日;Matsusue Y,Yamamuro
T,他(1991年)、「ウサギ脛骨近位骨切り術の生
分解吸収性ねじ固定」、J Appl Biomat
2,1。
解吸収性ポリマー材のねじおよび板の主な欠点は、機械
的特性が相対的に低く、そして骨折固定の安定性が早期
に失われることがしばしばあるということである。後者
はポリマーの少なくとも部分的な配向をもたらす方法を
用いて製造された埋植片に主として観察される。これ
は、体液内での固定素子の不均一な膨みの結果として生
じるねじ頭部と板のねじ孔との間の接触の緩みと、多く
は金属製ねじのねじ山のコピーである前記ポリマーねじ
のねじ山の早期の腐食によるものと考えられる。
よってねじの頭部と板のねじ孔との間の接触の緩みをな
くす企てが行なわれた。しかし、この方法は最適な方法
ではなく、加熱した帯域におけるポリマーの構造が変化
して加熱された区域におけるポリマーの品質が熱によっ
て劣化し、その結果として溶接区域の早期の生体内品質
低下が生じる。また、溶接中に発生した熱の作用によっ
て組織を壊死させるという問題が発生する。
定性が早期に失われることを防止し得る、分解吸収性の
骨接合用ねじ(ボーンスクリュー)および骨接合板(ボ
ーンプレート)システムを提供する。
るねじ付軸部と、骨接合板の円錐形のねじ孔に剛固に連
結される頭部とを具え、前記頭部が前記軸部方向に少な
くとも部分的に円錐形に傾斜している吸収性の骨接合用
ねじであって、前記頭部の円錐形部分の外側表面の少な
くとも一部には前記ねじ孔の内側表面に設けられている
3次元構造と相互に接触して自己固定を生じさせるため
の3次元構造が設けられていることを特徴とする。
骨に接触する下側表面と、長さ方向軸と、該軸に沿って
設けられた複数個のねじ孔とを有する、上記骨接合用ね
じとともに用いるための吸収性の骨接合板であって、前
記骨接合用ねじの前記頭部の外側表面上の前記3次元構
造に対応する3次元構造が前記ねじ孔の内側表面に設け
られていて、該2個の3次元構造の自己固定が生じるよ
う構成されている、吸収性の骨接合板である。
片を体液にさらした後にねじ頭部の板ねじ孔中への自己
固定(セルフロッキング)がさらに強まるように構成し
ている。
ば、波形または鋸歯形付外側表面を設け、これに板ねじ
孔の同様の3次元構造を設けた表面を接触させる構成に
よって達成される。
る少なくとも2個の波形または鋸歯からなる3次元構造
を構成する。波形および/または鋸歯付表面は、波形/
鋸歯の対称的および/または非対称的配置を有してもよ
い。2個の連続する波形/鋸歯の間の角度は5°〜17
5°、好ましくは、30°〜130°の範囲内とすべき
である。本発明による骨接合用ねじの頭部は、円錐形ま
たは凹面形状の骨接合板の適当なねじ孔に整合する円錐
形または凸形状とするのが好ましく、このようにするこ
とによって、ねじ孔の直径は前記板の骨接触面に向けて
減少している。
もよく、波形を対称的、非対称的または螺旋形状あるい
はこれらの組合せとすることができる。
形を形成することができ、あるいは、波形を部分的に
(例えばねじ頭部の上部の大径部分だけに)設けること
もできる。
全体としての寸法に依存するが、一般的にはねじ頭部の
1〜50%切り込み、好ましくはねじ頭部の5〜10%
切り込む。波形/鋸歯形の頂(crest)はねじ頭部
の頂と等しくおよび/または1〜20%薄く(好ましく
は5〜10%薄く)する。
のに好適な骨接合板は、該ねじと同じまたは同様の分解
吸収性ポリマーおよび/または分解吸収性ポリマーと分
解吸収性ガラス/セラミックとの複合材で造ることがで
きる。ねじ孔の内側表面には骨接合用ねじの頭部の外側
表面上の3次元構造に対応する3次元構造を設けて、そ
れら2つの3次元構造(ねじ頭部/板ねじ孔)の自己固
定が生じるように構成される。
接合板の軸線に沿って延長する連続補強棒部分を設け、
この棒部分にねじ孔を設ける。補強棒部分は骨接合板の
上部に位置し、ねじ孔が位置する中心部分から板側縁に
向けて高さが減少している。このように構成することに
よって、骨接合板の全体としての強度が増大されると同
時に相当量の材料(骨接合板の側縁部分において)が節
減される。補強棒部分を有する骨接合板を1個の材料片
から、または内側板部材(矩形断面形状)と上側補強棒
部材(台形断面形状)との2個の材料片から製造するこ
とができる。
さは骨接合板の側縁で測った板厚より少なくとも1.1
〜2.0倍厚くするのが好ましく、該板の側縁より1.
2〜1.5倍厚くするのが最も好ましい。
は、骨に接触する下側表面の少なくとも一部に、例え
ば、円錐(円錐クレーター)形または角錐形の表面凹凸
よりなる3次元構造を設ける。かかる表面凹凸が、骨と
接触する際、板の下側に位置する骨の区域への血液の供
給に対する該板の悪影響を少なくできる。あるいは上記
の板の骨接触表面における3次元構造を、好ましくは板
の長さ方向軸線と平行に延在するアンダーカットで構成
することもできる。
成形、圧縮成形、押し出し、またはポリマー処理に用い
られる他の方法を用いて埋植片に加工し得る分解吸収性
ポリマー(resorbable polymer)で
製造される。確実に適用するためには、ゲル加工法が溶
融加工法に比べてポリマーの品質を劣化させることがな
いので好ましい。
(顎顔面/小 破片/長 骨/腱手術)に依存し、一般
に既存の金属製装置のものと同様である。
いる場合には、本発明の埋植片は従来のものより大きい
寸法にして金属とポリマーとの間の機械的性質の差を補
償することができる。
は金属製埋植片のねじ孔の数と同様であるが、埋植片を
増大した負荷の区域に用いる場合にはねじ孔の数を増加
させることが必要である。
分的に配向した分解吸収性ポリマーで製造するのが好ま
しく、これは処理に際して形成される少なくとも表面
(表皮)層に小繊維(フィブリル化)構造を有すること
を意味する。
合用ねじのねじ山の頂の厚さが0.11〜1.00m
m、好ましくは0.12〜0.50mmであり、これは
金属製の網状組織/皮質骨接合用ねじあるいはメートル
法(ISO)または英国式(ANSI)ねじ山を有する
標準金属ねじのねじ山の頂より少なくとも0.01〜
5.00倍分厚く、好ましくは、この種のねじのねじ山
の頂より0.5〜1.0倍分厚い。
対する典型的なねじ山の厚さを用いるとその結果として
その頂の早期腐食が生じ、骨折固定の安定性が失われ
る。
が用いられる典型的な場所に用いることができるが、腱
裂断(例えば、回旋腱板の裂断腱)の場合における骨に
腱を取り付けるために用いることもできる。
解吸収性ポリマーを表1に示す。しかしながら、この表
には市販のポリマーを示したにすぎず、この表に記載し
たもの以外のポリマーを用い得ることは勿論である。
例:ポリヒドロキシ酸類、例えば、ポリ(L−ラクチ
ド)、ポリ(D−ラクチド)、ポリ(L/D−ラクチ
ド)、ポリ(L/DL−ラクチド)、ポリグリコリド、
種々の組成のラクチドおよびグリコリドの共重合体、他
のポリエステル類と前記ラクチドおよび/またはグリコ
リドの共重合体、グリコリドおよびトリメチレンカーボ
ネートの共重合体、ポリヒドロキシブチレート、ポリヒ
ドロキシバレレート、種々の組成のヒドロキシブチレー
トおよびヒドロキシバレレートの共重合体、ポリオルト
エステル類、ポリアンヒドライド類、ポリジオキサノ
ン、ポリジオキサンジオン類、ポリエステルアミド類、
ポリリンゴ酸、ジオール類および蓚酸および/または琥
珀酸のポリエステル類、ポリアミノ酸類、アミノ酸およ
びグルタミン酸の共重合体、ポリアミド類、ポリカプロ
ラクトン、ポリカーボネート類。
/共重合体)は、ポリラクチド類、ポリグリコリド、ポ
リジオキサノン、ポリ/グリコリド−コ−トリメチレン
カーボネート)、ポリ(ラクチド−コ−グリコリ
ド)、およびポリエステルアミド類である。
能のポリマーの分子量は、下記の式:
囲内、好ましくは120,000〜600,000の範
囲内(粘度平均分子量)にあるべきである。
カルシウムホスフェートおよび/またはヒドロキシアパ
タイトを混入して用いてもよい。
範囲およびこの明細書の開示によって明らかにされてい
るところである。本発明、その操作上の利点および本発
明を用いることによって達成される特定の目的をよりよ
く理解するため、本発明の好適な実施態様を示しかつ説
明した添付図面、実施例および説明について言及する。
合用ねじの1実施態様を示す側面図であり、図1(b)
は図1(a)に示すねじの頭部の部分側面図であり、図
1(c)は本発明の骨接合用ねじの頭部の変形態様を示
す側面図であり、図2は波形/鋸歯付ねじ孔および補強
棒が設けられた骨接合板の斜視図であり、図3は図2に
示す骨接合板の波形/鋸歯付ねじ孔の拡大部分斜視図で
あり、図4(a)は図2に示す骨接合板に嵌合している
図1に示す骨接合用ねじの断面図であり、図4(b)は
図4(a)に示す骨接合用ねじ/骨接合板システムの部
分平面図であり、図5(a)は3次元構造下面を設けた
図4にかかるねじ/骨接合板システムの変形態様の縦断
面図であり、図5(b)は図5(a)による骨接合板の
下面に設けられた3次元凹凸の拡大詳細斜視図であり、
図6は本発明の骨接合用ねじの他の実施態様を示す側面
図である。
接合板を図面を参照してさらに説明する。
収可能の骨接合用ねじ10は、骨内に挿入される尖端2
を有するねじ付軸部1と骨接合板のねじ孔に剛固に連結
するための頭部3とを基本的に具えている。頭部3の直
径は軸部1とは反対方向に頭部3の全長にわたって増大
して円錐台を形成している。頭部3の外側表面にはその
全周にわたって3次元構造4を設け、対称的波形付表面
を形成している。波形の凹凸は頭部3の上端(約5mm
の大径を有する)から頭部3の下部(約3mmの小径を
有する)まで延長している。
面の3次元構造4の変形を示している(図1(b)は対
称の波形付表面、図1(c)は螺旋形の波形付表面)。
軸部3のねじ山5には厚さ0.2mmの頂6が設けられ
ている。
した骨接合板20を図2に示す。この骨接合板は長さが
約50mmで、幅が7mmである。骨接合板の断面11
の形状はその内側部分(骨に接触する側)はほぼ矩形
で、上側部分はほぼ台形である。その長さ方向軸線12
に沿って、複数個のねじ孔13が吸収可能の骨接合用ね
じ10を受けるよう設けられている。ねじ孔13は円錐
台形状を有しており、このねじ孔内に挿入されるべき骨
接合用ねじ10の対応した形状の頭部3に整合するよう
構成されている。約5mmのねじ孔13の大きい側の直
径が骨接合板20の上側に位置し、約3mmのねじ孔1
3の小さい側の直径が骨接合板20の下側(骨接触側)
に位置している。分解吸収可能の板20は補強棒部分1
5を有し、この部分は板20に沿って長さ方向に延在
し、ねじ孔13を有している。補強棒部分15を横切っ
て測った板20の厚さは5mmであり、板20の側縁で
測った板20の厚さは3mmである。
には骨接合用ねじ10の頭部3の外側表面上の3次元構
造4に対応する3次元構造14が設けられていて、骨接
合用ねじ10をねじ孔13内に挿入する際に、2個の3
次元構造4および14の自己固定が生じるようになって
いる。
が骨接合板20のねじ孔13内に嵌合し、咬合帯域16
においてねじ孔と相互にかみ合っている状態を詳細に示
している。骨接合用ねじ10の挿入を容易にするため
に、六角孔17が頭部3に設けられている。
適な実施態様においては、骨接合板20の下側表面22
に、骨接合板20と骨との間の接触面積を減少させるよ
う構成された円錐形素子23または四角錐形素子24よ
りなる規則正しい3次元構造21が設けられている。骨
接合板20の下側表面22には、好ましくはその長さ方
向軸線と平行に延在するアンダーカット(図示せず)を
さらに設けても良い。
おいては、骨接合用ねじ10の円錐形頭部3の外側表面
の上部だけに頭部3の全周にわたる波形の3次元構造4
を設けている。
を示す側面図であり、(b)は図1(a)に示すねじの
頭部の部分側面図であり、(c)は本発明の骨接合用ね
じの頭部の変形態様を示す側面図である。
れた骨接合板の斜視図である。
拡大部分斜視図である。
図1に示す骨接合用ねじの断面図であり、(b)は図4
(a)に示す骨接合用ねじ/骨接合板システムの部分平
面図である。
るねじ/骨接合板システムの変形態様の縦断面図であ
り、(b)は図5(a)による骨接合板の下面に設けら
れた3次元凹凸の拡大詳細斜視図である。
側面図である。
ねじ山、6:ねじ山の頂、10:骨接合用ねじ、11:
骨接合板の断面、12:骨接合板の長さ方向軸線、1
3:ねじ孔、14:3次元構造、15:補強棒部分、1
6:咬合帯域、17:六角孔、20:骨接合板、21:
3次元構造、22:下側表面、23:円錐形素子、2
4:四角錐形素子。
Claims (16)
- 【請求項1】 骨内に挿入されるねじ付軸部(1)と、
骨接合板の円錐形のねじ孔(13)に剛固に連結される頭
部(3)とを具え、前記頭部(3)が前記軸部(1)方
向に少なくとも部分的に円錐形に傾斜している吸収性の
骨接合用ねじであって、前記頭部(3)の円錐形部分の
外側表面の少なくとも一部には前記ねじ孔の内側表面に
設けられている3次元構造(14)と相互に接触して自己
固定を生じさせるための3次元構造(4)が設けられて
いることを特徴とする前記ねじ。 - 【請求項2】 前記軸部(1)のねじ山に厚さ0.11
〜1.00mmの頂が設けられている請求項1に記載の
吸収性の骨接合用ねじ。 - 【請求項3】 前記軸部(1)のねじ山に厚さ0.12
〜0.50mmの頂が設けられている請求項2に記載の
吸収性の骨接合用ねじ。 - 【請求項4】 前記頭部(3)が凸形状である請求項1
に記載の吸収性の骨接合用ねじ。 - 【請求項5】 前記3次元構造(4)が前記頭部(3)
の外側表面の周りに延在する波形または鋸歯形凹凸より
なる請求項1に記載の吸収性の骨接合用ねじ。 - 【請求項6】 前記3次元構造(4)が前記頭部(3)
の外側表面の上部に限られている請求項1に記載の吸収
性の骨接合用ねじ。 - 【請求項7】 少なくとも2個の波形または鋸歯形凹凸
を有する請求項5に記載の吸収性の骨接合用ねじ。 - 【請求項8】 配向または少なくとも部分的に配向した
分解吸収性のポリマーから製造された請求項1に記載の
吸収性の骨接合用ねじ。 - 【請求項9】 前記骨接合用ねじの少なくとも表面層が
フィブリル化構造を有する請求項8に記載の吸収性の骨
接合用ねじ。 - 【請求項10】 上側表面と、骨に接触する下側表面
と、長さ方向軸と、該軸に沿って設けられた複数個のね
じ孔(13)とを有する、請求項1に記載の吸収性の骨接
合用ねじとともに用いるための吸収性の骨接合板であっ
て、前記骨接合用ねじの前記頭部(3)の外側表面上の
前記3次元構造(4)に対応する3次元構造(14)が前
記ねじ孔の内側表面に設けられていて、該2個の3次元
構造の自己固定が生じるよう構成されている、吸収性の
骨接合板。 - 【請求項11】 前記板の軸に沿って延在しておりかつ
前記ねじ孔が設けられている少なくとも1つの補強棒を
具えている請求項10に記載の吸収性の骨接合板。 - 【請求項12】 前記下側表面の少なくとも一部に3次
元構造が設けられている請求項10に記載の吸収性の骨
接合板。 - 【請求項13】 前記3次元構造が骨接合板と骨との間
の接触面積を減少させるよう構成された円錐形または角
錐形素子を具える請求項10に記載の吸収性の骨接合
板。 - 【請求項14】 前記下側表面に、好ましくは前記長さ
方向軸と平行に延びるアンダーカットが設けられている
請求項10に記載の吸収性の骨接合板。 - 【請求項15】 請求項1記載の吸収性の骨接合用ねじ
と請求項10に記載の吸収性の骨接合板とを具えた、骨
折の内固定用の骨接合用ねじ/骨接合板システム。 - 【請求項16】 請求項1記載の吸収性の骨接合用ねじ
と請求項10に記載の吸収性の骨接合板とを具えた、腱
と骨とを取付けるための骨接合用ねじ/骨接合板システ
ム。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US07/753,837 US5275601A (en) | 1991-09-03 | 1991-09-03 | Self-locking resorbable screws and plates for internal fixation of bone fractures and tendon-to-bone attachment |
US753,837 | 1991-09-03 |
Publications (2)
Publication Number | Publication Date |
---|---|
JPH07178115A JPH07178115A (ja) | 1995-07-18 |
JP3323244B2 true JP3323244B2 (ja) | 2002-09-09 |
Family
ID=25032368
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP24404792A Expired - Lifetime JP3323244B2 (ja) | 1991-09-03 | 1992-08-21 | 骨折の内固定および腱と骨との取付用の自己固定式分解吸収性ねじおよび板 |
Country Status (6)
Country | Link |
---|---|
US (1) | US5275601A (ja) |
EP (1) | EP0530585B1 (ja) |
JP (1) | JP3323244B2 (ja) |
AT (1) | ATE146351T1 (ja) |
CA (1) | CA2076501C (ja) |
DE (1) | DE69216009T2 (ja) |
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EP0530585B1 (en) | 1996-12-18 |
DE69216009T2 (de) | 1997-04-03 |
EP0530585A2 (en) | 1993-03-10 |
CA2076501C (en) | 1996-06-18 |
JPH07178115A (ja) | 1995-07-18 |
DE69216009D1 (de) | 1997-01-30 |
CA2076501A1 (en) | 1993-03-04 |
EP0530585A3 (ja) | 1994-01-19 |
ATE146351T1 (de) | 1997-01-15 |
US5275601A (en) | 1994-01-04 |
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