JPH05146502A - Bonesetting member - Google Patents

Bonesetting member

Info

Publication number
JPH05146502A
JPH05146502A JP2414179A JP41417990A JPH05146502A JP H05146502 A JPH05146502 A JP H05146502A JP 2414179 A JP2414179 A JP 2414179A JP 41417990 A JP41417990 A JP 41417990A JP H05146502 A JPH05146502 A JP H05146502A
Authority
JP
Japan
Prior art keywords
bone
present
bonding
biocompatibility
bolt
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
JP2414179A
Other languages
Japanese (ja)
Other versions
JP3177848B2 (en
Inventor
Masahiro Kobayashi
雅博 小林
Yoshikatsu Kuroki
良克 黒木
Masutarou Morishita
益多郎 森下
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.)
Individual
Original Assignee
Individual
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Filing date
Publication date
Application filed by Individual filed Critical Individual
Priority to JP41417990A priority Critical patent/JP3177848B2/en
Publication of JPH05146502A publication Critical patent/JPH05146502A/en
Application granted granted Critical
Publication of JP3177848B2 publication Critical patent/JP3177848B2/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical 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
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/80Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical 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
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/683Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin comprising bone transfixation elements, e.g. bolt with a distal cooperating element such as a nut
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical 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
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86Pins or screws or threaded wires; nuts therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical 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
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86Pins or screws or threaded wires; nuts therefor
    • A61B17/8665Nuts

Abstract

PURPOSE:To create and provide a bonesetting member ensuring a remarkable advantage for living body treatment, and free from such defects as observed in the conventional or current treatment of a bone fracture where an internal fixing method is applied, using a metal bonesetting member, which has an excessive elastic modulus and causes bone absorption to be a cause for a future bone fracture, and a pin must be removed even after complete recovery due to a lack in biocompatibility. CONSTITUTION:An inorganic fiber containing calcium phosphate and an organic polymeric material not impairing biocompatibility are used to constitute an epoch-making medical treatment material, so that high dynamic and biological compatibility are ensured, the curing of a bone fracture is facilitated, and no operation is again required for the removal of pins.

Description

【発明の詳細な説明】 [産業上の利用分野]本発明は生体の長管骨の折損等傷
害骨を直接内固定して治療するためのいわゆる骨接合材
料で、かつ、生体に対して生物学的親和性,力学的親和
性を有する有形の材料に係る。即ち骨折損部等の治療に
金属製ボーンプレートを用いる従来技術における、折損
骨完治後において、これら金属製プレート、金属ねじ等
を除去する所謂抜釘手術を不要とし、患者の苦痛を画期
的に減少させる骨接合材に関するものである。尚、本発
明の骨接合材の用途は、長管骨,指骨,鎖骨等の骨折治
療に用いられる。 [従来の技術]従来、骨折損部等の治療には、患部を切
開して、骨折損部を突き合わせた金属製のボーンプレー
トを挟接し、そのボーンプレートを、同じく金属製のね
じ又はボルトナットで止め動かないように固定し、その
上に前記切開部を縫合して、先ず骨の折損部を完治させ
る。 次に患部を再切開し上記の金属製のボーンプレー
トとねじ等を除去した後、その患部を縫合し更に相当期
間治療することによって始めて完治をさせることができ
た。 即ちこの種治療に用いられた材料はすべて金属プ
レートとねじ及び,ボルト及びナットを用いていた。例
えばこの種従来技術の代表的例として、スイスのロバー
トマチス社のAOステンレスプレート,ステンレスねじ
及びステンレスボルトナット等があった(図示省略)。 [本発明の目的:解決すべき問題点]現在従来技術とし
て使用されている金属性骨接合材は弾性率が骨に比べて
過大なため長期間の使用で骨吸収を起し、抜釘後の再骨
折の原因となり、また、長期間の埋込で金属イオンの溶
出による周辺組織への悪影響など間題点がある。更にま
た、従来技術には、折角骨の折損部がほぼ治癒した後に
おいて、更にまた、患部の外側の肉等の部分を再切開
し、これらの金属材料を取り除かなければ、完治したこ
とにはならないという欠点がある。 これは費用も手間
も相当にかかる上、患者の苦痛も倍加し耐え難いとい
う、非常に大きな間題点があった。本発明は、上記従来
技術の間題点と諸欠点を大きく取り除くものであり、当
該治療に用いる材料として、生体との非親和性材料は一
切用いず、生物学的親和性及び力学的親和性ある材料の
使用により、早期の治癒をもたらし、一方、抜釘手術の
必要をなくし、患者の苦痛を画期的に減少させる骨接合
材を創始提供することを目的とする。 [本発明の構成:問題点解決の手段]本発明の骨接合材
は、先ずりん酸カルシウム質ガラスファイバーと生体親
和性を阻害しない有機高分子材料を含有し、かつこの複
合物の表面に該ファイバーの少なくも一部を露出させた
複合材料を用いることを特徴とする。 具象的には、こ
の複合材料を成形してボルト孔を適宜の位置に設けた板
状物ないしは円筒縦割り状湾曲材ないしはその近似形材
料を骨接合主材とし、そのボルト孔に適合しかつ上記の
複合材料と同じ材料を用いて成形され手術中に熱加工可
能なフック或いはボルト並にナットを骨接合副材として
構成されたことを特徴とする。而して、本発明で使用す
る材質の無定形の複合材料は発明の名称はインプラント
材として、本発明の主たる発明者と主たる発明者を同じ
くする特願59−255006号,特公告昭63−19
186号,特許第1471747号として、既に198
8(昭和63)年12月14日に特許登録された生体材
料と殆んど同様のものを用いるものであり、該特許権者
の了承が得られているものである。従って、本発明にい
うりん酸カルシウム質ガラスファイバーはヒドロキシア
パタイト、りん酸三カルシウム、酸化カルシウム、炭酸
カルシウム、りん酸アンモニウムなどのCaO及び/又
はPを含有する原料を混合・熔融・紡糸すること
により得られるものである。 而して、この製造方法に
ついても、本願発明と主たる発明者が同一である特許第
1419169号「りん酸カルシウム質ファイバーの製
造方法」が1988(昭和63)年1月14日に特許登
録されている。また本発明にいう「生体親和性を阻害し
ない有機高分子材料」とは、有機高分子材料のうち、生
体内に埋め込まれた場合にそれ自体が、毒性がなく、生
体からの拒絶反応もなく、かつまた複合共存する他の構
成材料の生体親和性、例えば骨生成性能などを阻害しな
い、換言すれば生体になじみのよい有機高分子材料をい
う。更に、請求項(2)にはより望ましいファイバーの
配合量を示したが、これは10[%]未満であると本発
明の骨接合材は十分な曲げ強度を得ることがやや困難と
なり、同時に、得られる複合材料の表面に露出するファ
イバーの量が過小となって、生体親和性が小さくなって
くるからである。 またファイバーの量を90重量
[%]以下とした理由は90重量[%]を超えると、樹
脂量が少くなり、複合化成形が若干困難となるからであ
る。而して、本発明においては前記有機高分子材料が、
望ましくは熱可塑性樹脂及び又は熱硬化性樹脂であるこ
とである。 熱可塑性樹脂は例えば、ポリメタクリル酸
メチル,ポリエチレン,ポリスチレン,ポリサルホン等
の樹脂で1種以上のものが、前記ファイバーに均一の混
合され、加熱されて、前記骨接合主材及び骨接合副材、
即ち、ボルト,ナット,ねじ又はフックの成形に用いら
れる。 [作 用]本発明に係る骨接合主材は、例えば生体の骨
折損部を挟持して、同質の骨接合副材、即ちボルト、ナ
ッ卜或いはフックにより緊結される。また本発明の骨接
合副材のうちフックは、熱可塑性樹脂により成形される
が、頭部は最初から曲げて作られており、棒部分は手術
中において、骨接合主材のボルト孔と骨を貫通させた
後、先端を加熱し軟化させ折り曲げることにより、骨接
合主材を折損骨に緊結する。このような作用により治療
するときは、該骨折損部を動かさず、安定した形状に保
ち治癒を従来以上に促進し得る。 この作用の理由は、
特に従来技術における金属製の骨接合材は、上記の弾性
率が生体自然骨に比し過大であって、骨吸収による再骨
折を起こし易い上に、生物学的親和性もなく、有害な金
属イオンの生体内溶出もあるのに比し、本発明の骨接合
材は、材質上生物化学的親和性がある上、弾性率も自然
骨に近いので、骨吸収もないからである。更に本発明の
骨接合材の大なる利点をもたらす作用としては、骨折損
部が接合治癒された後においても、有害な金属イオンの
溶出などはないので、従来技術の金属製骨接合材を使用
する場合のような抜釘のための再手術は、本発明の骨接
合材を使用すれば、全く必要なくなるということであ
る。 [実 施 例]りん酸カルシウム質ファイバーを60重
量[%]に、熱可塑性樹脂としてポリメタクリル酸メチ
ル(以下PMMAと略称する。)40重量[%]を均一
に混合して、第1図,第2図に示す本発明の骨接合主材
の平板1,及び第3図に示す縦断円筒形湾曲板6を各ボ
ルト孔7を設けて成形し加熱硬化させた。骨接合副材も
材質は同じものを用いるが、特にフックは、予じめ棒状
に成形し、頭部としての一端はL字形に成形し曲げて固
化しておく。第1図(a)は前記骨接合主材の平板1を
手術中に折損骨2の両側からフック3により貫通し挟接
した縦断面説明図であり、その上部3本のL字形フック
3はその棒状を単にボルト孔を右側より貫通させた状態
を示し、下の3本の左側先端3′は、250[℃]の加
熱ごてを20〜30秒間使用して軟化させ、曲げて圧着
冷却固化固定した状態を示すものである。 また第1図
(b)は、同様に、折損骨2の片側より平板1を当て緊
結した例である。第2図(a),(b)は夫々前記第1
図(a),(b)の場合のフックをボルト4及びナット
5の使用に置きかえた例であり、これらのフック,ボル
ト及びナットは本発明においては前記平板1と同材質の
ものを用いた。第3図は、前記の平板を縦断円筒形湾曲
板6にかえた本発明の骨接合主材を折損骨2の片側ない
し両側より挟接した例の斜視説明図であり、ボルト孔7
を設けてある。第4図(a),(b)は本発明の素材の
ねじの一例を示し、同図(c)は同じくボルト、ナッ卜
の一例を示す。 更に同図(d)は、本発明の素材中の
フックの一例を示し、一端は予じめL 型に曲げてあ
り、他端11は手術中に、前記説明の如く熱加工し、曲
げて圧着固定する構造になっている。具体的に、平板の
例について説明すると、上記の材質であって、幅が12
[mm]、厚さ2.2[mm]、ボルト孔3[mm]の
ものは破壊荷重が約300[kgf]、即ち引張強度は
約15[kg/mm]であった。 また、この平板を
2枚左右から折損骨の挟接しボルトで緊結した骨接合材
の形にしたものの破壊荷重の実測値は520[kgf]
であった。一般に、この種生体材料に必要な要件は、生
体親和性が必要であり、その内訳として生物学的親和性
と力学的親和性が必要である。 また、その力学的親和
性については、主として、強度と弾性率について吟味す
れば適切なものを得ることができる。 そこで上記の実
測値と本発明者等の他の実験例を含め、此等について説
明する。強度[MP]については、生体自然骨が12
3以下、従来技術のステンレスSVS316L板が、5
00〜1000である。 本発明の素材としてのファイ
バーは1850〜2200であるが、複数のファイバー
の形状は無定形であるからこのままでは強度保持体には
ならない。 前記PMMAは73であるが、骨の強度よ
り小さいので、このような目的には単独では使えない。
これらに対し、本発明の複合材即ち骨接合材はフックで
500〜1300、平板で200〜800で上記自然骨
よりやや強いものから作ることができるので、本発明の
目的に適合性がある。次に弾性率[GP]について
は、生体自然骨が19以下で、従来技術のステンレス板
が180〜200で自然骨に比し約10倍と過大である
から骨吸収が起り再骨折の原因となるなど、この面から
しても、従来一般に使われているステンレスは生体に不
適合であることがわかる。 次に本発明骨接合材の素材
としてのファイバーは70〜77であるが、前記の如く
無定形である。 またPMMAは3であり、弾性率が過
小であるから、これだけでは、本発明の目的には不適合
である。 次に本発明の平板状骨接合材は10〜40で
あって、フックは15〜45で、自然骨の弾性率である
から、本発明の目的に対し適合性を有している。従っ
て、本発明の骨接合板は強度と弾性率と両方において生
体に適合性を有するので、総合的に生体に対し、先ず力
学的親和性を有する。また生物学的親和性については、
本発明の骨接合材に用いる無定形の材料、即ち前記特許
登録済の「インプラント材」において証明されているの
で、同一素材を用いる本発明の骨接合材も当然に具備す
るといえる。 また寸法も種々大小様々に作ることがで
きる。依って本発明の骨接合材は生体親和性を充分に具
備する有形の材料であるといえるのである。従って上記
の説明の通り、強度においても、弾性率においても更に
また生体親和性も全然見られない従来技術の金属性骨接
合材に比較し、生体治療にとって重要な面での生体親和
性の点で、本発明の材料は、すべての適合性を具備した
点で大変な違いがあり、顕著に優れた画期的生体材料で
あるということができる。 [本発明の効果] (1) 本発明の骨接合材は、生体親和性がなく、金属
イオンも生体内に溶出して有毒的要素もある従来技術と
は、根本的に異なり、生物学的親和性と力学的親和性を
兼備し、生体親和性の卓越した、生体医療用材料となり
得るものである。 (2) 本発明の骨接合材は生体親和性が格段にすぐれ
ているので、第1次の骨接合手術完治後、従来技術の金
属性ボンプレートとねじと異なり、第2次の抜釘手術を
行なう必要がない。これはまさに従来技術の材料に比
し、莫大な、新しい効果である。 即ち患者をして、2
回目手術の非常に大きな苦痛から逃れしめるものであ
る。 特にこれは絶大な効果が、本発明により得られる
ということであって、この点を考えれば、本発明はまさ
に公益上も非常に有用な発明であるといえる程大きな効
果をもたらすものである。
Description: TECHNICAL FIELD The present invention is a so-called bone-bonding material for directly infixing and treating injured bone such as fracture of a long bone of a living body, and is a biological material for a living body. Related to tangible materials with mechanical and mechanical affinity. That is, in the prior art that uses a metal bone plate for treatment of a fractured part, etc., after the fractured bone is completely healed, so-called nailing surgery for removing these metal plate, metal screw, etc. is unnecessary, and the pain of the patient is epoch-making. The present invention relates to a bone cement material to be reduced. The bone cement of the present invention is used for treating fractures of long bones, phalanges, clavicle and the like. [Prior Art] Conventionally, for the treatment of a fractured part or the like, the affected part is incised, and a metal bone plate in which the fractured part is abutted is sandwiched, and the bone plate is also made of a metal screw or bolt nut. It is fixed so that it does not move, and the incision is sewn on it so that the fractured part of the bone is completely cured. Then, the affected area was re-incised, the metal bone plate and the screws and the like were removed, and then the affected area was sutured and treated for a considerable period of time, whereby the healing could be completed. That is, all the materials used for this kind of treatment used metal plates and screws, and bolts and nuts. For example, as typical examples of this type of conventional technology, there are AO stainless plates, stainless screws, stainless bolts and nuts (not shown) manufactured by Robert Mathis of Switzerland. [Purpose of the present invention: Problems to be solved] Since the metal bone-bonding material currently used as a conventional technique has an excessively large elastic modulus as compared with bone, bone resorption occurs after long-term use, and after bone removal It causes re-fracture, and there are problems such as adverse effects on surrounding tissues due to elution of metal ions during long-term implantation. Furthermore, in the prior art, after the fractured part of the fractured bone is almost healed, a part such as meat outside the affected part is re-incised, and if these metal materials are not removed, it is considered that the healing has been completed. It has the drawback of not becoming. This is very costly and labor-intensive, and the patient's pain is doubled and it is intolerable. The present invention largely eliminates the problems and drawbacks of the prior art described above. As a material used for the treatment, a non-biocompatible material is not used at all, and biological affinity and mechanical affinity are not used. The use of certain materials aims to provide a bone cement material that provides an early healing, while eliminating the need for nail extraction surgery and dramatically reducing patient distress. [Structure of the present invention: Means for solving problems] The bone cement of the present invention first contains calcium phosphate glass fiber and an organic polymer material which does not inhibit biocompatibility, and the surface of this composite is It is characterized by using a composite material in which at least a part of the fibers is exposed. Concretely, a plate-shaped material or a cylindrical longitudinal split curved material or its approximate shape material in which this composite material is formed and bolt holes are provided at appropriate positions is used as a bone-bonding main material, and it is suitable for the bolt holes and It is characterized in that it is formed by using the same material as the above-mentioned composite material and is constituted by a hook or a bolt which can be heat-processed during surgery and a nut as a bone-bonding auxiliary material. Thus, the amorphous composite material of the material used in the present invention is called an implant material, and the name of the invention is an implant material. Japanese Patent Application No. 59-255006 and Japanese Patent Publication No. 63- 19
No. 186, Japanese Patent No. 1471747, already 198
Almost the same biomaterial as the patent registered on December 14, 8 (Showa 63) is used, and the approval of the patentee has been obtained. Therefore, the calcium phosphate glass fiber according to the present invention is prepared by mixing, melting and spinning raw materials containing CaO and / or P 2 O 5 such as hydroxyapatite, tricalcium phosphate, calcium oxide, calcium carbonate and ammonium phosphate. It is obtained by doing. With respect to this manufacturing method as well, the patent No. 1419169 “Method for manufacturing calcium phosphate fiber”, whose principal inventor is the same as that of the present invention, was registered on January 14, 1988. There is. The term “organic polymer material that does not inhibit biocompatibility” as used in the present invention means, among organic polymer materials, that it is not toxic when implanted in a living body, and has no rejection reaction from a living body. Also, it means an organic polymer material that does not impair the biocompatibility of other constituent materials that coexist in a complex manner, for example, the bone formation performance, in other words, that is familiar to the body. Furthermore, although a more desirable amount of the fiber is shown in claim (2), if it is less than 10 [%], it becomes somewhat difficult for the bone cement of the present invention to obtain sufficient bending strength, and at the same time, This is because the amount of fibers exposed on the surface of the obtained composite material becomes too small and biocompatibility becomes small. The reason for setting the amount of fiber to 90% by weight or less is that if it exceeds 90% by weight, the amount of resin will be small and composite molding will be slightly difficult. Thus, in the present invention, the organic polymer material is
Desirably, it is a thermoplastic resin and / or a thermosetting resin. The thermoplastic resin is, for example, one or more kinds of resins such as polymethylmethacrylate, polyethylene, polystyrene, polysulfone, etc., which are uniformly mixed with the fibers and heated to form the bone-bonding main material and bone-bonding submaterial,
That is, it is used for forming bolts, nuts, screws or hooks. [Operation] The bone-bonding main material according to the present invention is, for example, sandwiching a fractured part of a living body, and tightly bound by a bone-bonding secondary material of the same quality, that is, a bolt, a nut or a hook. Further, the hook of the bone-bonding sub-material of the present invention is molded from a thermoplastic resin, but the head is made by bending from the beginning, and the rod portion is used during the operation so that the bolt hole and the bone of the bone-bonding main material are After being penetrated, the tip of the bone-bonding main material is tightly bonded to the fractured bone by heating and softening and bending the tip. When the treatment is performed by such an action, the fractured part can be kept in a stable shape and the healing can be promoted more than ever before. The reason for this action is
In particular, the metal bone-bonding material in the prior art has the above-mentioned elastic modulus larger than that of natural natural bone, is prone to re-bone fracture due to bone resorption, has no biological affinity, and is a harmful metal. This is because the bone-bonding material of the present invention has biochemical affinity in terms of material and has elastic modulus close to that of natural bone, so that there is no bone resorption, in contrast to the presence of ion elution in vivo. Further, as an action that brings about a great advantage of the bone cement of the present invention, since the harmful metal ions are not eluted even after the fracture fracture is bonded and healed, the conventional metal bone cement is used. The re-operation for nail extraction as in the case of using the bone-bonding material of the present invention is completely unnecessary. [Example] 60 wt% of calcium phosphate fiber was uniformly mixed with 40 wt% of polymethylmethacrylate (hereinafter abbreviated as PMMA) as a thermoplastic resin. The flat plate 1 of the bone-bonding main material of the present invention shown in FIG. 2 and the longitudinally-cylindrical curved plate 6 shown in FIG. 3 were formed by forming respective bolt holes 7 and heat-cured. The bone-bonding sub-material is made of the same material, but in particular, the hook is formed into a preliminarily rod shape, and one end as a head is formed into an L-shape and is bent and solidified. FIG. 1 (a) is a vertical cross-sectional explanatory view in which the flat plate 1 of the bone-bonding main material is penetrated and sandwiched by the hooks 3 from both sides of the fractured bone 2 during surgery, and the upper three L-shaped hooks 3 are The rod-like shape is shown in which the bolt holes are simply penetrated from the right side, and the lower three left tips 3'are softened by using a heating iron of 250 [° C] for 20 to 30 seconds, bent and crimped and cooled. It shows a state of being solidified and fixed. Similarly, FIG. 1 (b) is an example in which the flat plate 1 is pressed against one side of the fractured bone 2 and tightly connected thereto. 2 (a) and 2 (b) are respectively the above-mentioned first
This is an example in which the hooks in the cases of FIGS. 1A and 1B are replaced with the use of bolts 4 and nuts 5. These hooks, bolts and nuts are made of the same material as the flat plate 1 in the present invention. .. FIG. 3 is a perspective explanatory view of an example in which the bone-bonding main material of the present invention in which the above-mentioned flat plate is replaced with the longitudinally-cylindrical curved plate 6 is sandwiched from one side or both sides of the broken bone 2 and bolt holes 7 are provided.
Is provided. 4 (a) and 4 (b) show an example of the screw of the material of the present invention, and FIG. 4 (c) shows an example of a bolt and a nut. Further, FIG. 7D shows an example of the hook in the material of the present invention, one end of which is bent in advance to be L-shaped, and the other end 11 of which is heat-processed and bent as described above during surgery. It has a structure to be fixed by crimping. Specifically, an example of the flat plate will be described.
In the case of [mm], thickness 2.2 [mm], and bolt hole 3 [mm], the breaking load was about 300 [kgf], that is, the tensile strength was about 15 [kg / mm 2 ]. Also, the fracture load was actually measured at 520 [kgf] in the form of a bone joint material in which two fractured bones were sandwiched from the left and right sides and tightened with bolts
Met. In general, the biomaterial affinity is required as a requirement for this kind of biomaterial, and the bioaffinity and the mechanical affinity are required as the details thereof. Regarding the mechanical affinity, an appropriate one can be obtained mainly by examining strength and elastic modulus. Therefore, these will be described including the above measured values and other experimental examples of the present inventors. Regarding the strength [MP a ], the natural bone of the living body is 12
3 or less, the prior art stainless SVS316L plate is 5
It is 00 to 1000. The fibers used as the material of the present invention are 1850 to 2200, but since the shape of the plurality of fibers is amorphous, they cannot be used as strength holders as they are. The PMMA is 73, but it is smaller than the strength of bone and cannot be used alone for this purpose.
On the other hand, the composite material of the present invention, that is, the bone-bonding material, is 500 to 1300 for the hook and 200 to 800 for the flat plate, and can be made from a material slightly stronger than the natural bone, and thus is suitable for the purpose of the present invention. Next modulus for [GP a], the biological natural bone is 19 or less, the cause of the prior because art stainless steel plate is too large and approximately 10-fold compared to the natural bone in 180 to 200 occur bone resorption refracture From this aspect as well, it can be seen that stainless steel which has been generally used conventionally is incompatible with the living body. Next, the fibers as a raw material of the bone cement of the present invention are 70 to 77, but they are amorphous as described above. Further, PMMA is 3, and the elastic modulus is too small, so that this alone is not suitable for the purpose of the present invention. Next, the flat plate bone cement of the present invention has 10 to 40 and the hook has 15 to 45, which is the elastic modulus of natural bone, and thus is suitable for the purpose of the present invention. Therefore, the osteosynthesis plate of the present invention has biocompatibility in both strength and elastic modulus, so that it has a mechanical affinity to the organism as a whole. Regarding biological affinity,
Since the amorphous material used for the bone joint material of the present invention, that is, the above-mentioned patented “implant material”, has been proved, it can be said that the bone joint material of the present invention using the same material is naturally provided. Also, the size can be made in various sizes. Therefore, it can be said that the bone cement of the present invention is a tangible material having sufficient biocompatibility. Therefore, as described above, in comparison with the conventional metal bone cement, which has no strength, elastic modulus, and biocompatibility at all, the biocompatibility in terms of biocompatibility is important. Therefore, the material of the present invention has a great difference in that it has all the compatibility, and it can be said that it is a remarkably excellent breakthrough biomaterial. [Effects of the Present Invention] (1) The bone cement of the present invention is fundamentally different from the prior art in that it has no biocompatibility, metal ions are eluted in the living body, and is toxic. It has both affinity and mechanical affinity, and can be used as a biomedical material having excellent biocompatibility. (2) Since the osteosynthesis material of the present invention has remarkably excellent biocompatibility, after the first osteosynthesis operation is completely cured, unlike the conventional metal bomb plate and the screw, the second nail extraction operation is performed. There is no need to do it. This is a huge new effect compared to the materials of the prior art. That is, the patient, 2
It can escape the great pain of the second surgery. In particular, this means that a great effect can be obtained by the present invention, and in view of this point, the present invention brings about such a great effect that it can be said that it is a very useful invention in the public interest.

【図面の簡単な説明】 第1図(a)は本発明の骨接合主材を折損部の両側より
挟接しフックで緊結した縦断面説明図、第1図(b)
は、同じく、片側より当接しフックで緊結した例の図、
第2図(a),(b)は夫々第1図(a),(b)のフ
ックをボルト,ナットにかえた説明図、第3図は第1図
の本発明の骨接合主材平板を縦断円筒形湾曲板にかえた
説明図、第4図(a),(b)は本発明の素材のねじの
一例を示す図、同図(c)は、同じく、ボルト,ナット
の一例を示す図、同図(d)は本発明の骨接合副材の素
材中のフックの一例を示す図である。 1・・本発明の骨接合主材平板,2・・折損骨,3・・
フック,4・・ボルト,5・・ナット,6・・縦断円筒
形湾曲板,7・・ボルト孔,8・・ボルト,9・・ナッ
ト,10・・ワッシャ,11・・フックの先端。
BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 (a) is a longitudinal cross-sectional explanatory view in which the main bone-bonding material of the present invention is clamped from both sides of a broken portion and tightly connected by hooks, FIG. 1 (b).
Is a diagram of an example in which they are abutted from one side and tightened with a hook,
2 (a) and 2 (b) are explanatory views in which the hooks of FIGS. 1 (a) and 1 (b) are replaced with bolts and nuts, and FIG. 3 is a flat plate of the bone-bonding main material of the present invention of FIG. 4 is an explanatory view in which a vertical cylindrical curved plate is replaced, FIGS. 4 (a) and 4 (b) are views showing an example of a screw of the material of the present invention, and FIG. 4 (c) is an example of a bolt and a nut. FIG. 1D and FIG. 1D are views showing an example of the hook in the material of the bone joint submaterial of the present invention. 1 ... Plate of bone-bonding main material of the present invention, 2 ... Broken bone, 3 ...
Hooks, 4 ・ ・ Bolts, 5 ・ ・ Nuts, 6 ・ ・ longitudinal cylindrical curved plates, 7 ・ ・ Bolt holes, 8 ・ ・ Bolts, 9 ・ ・ Nuts, 10 ・ Washers, 11 ・ ・ Hook tips.

───────────────────────────────────────────────────── フロントページの続き (72)発明者 黒木 良克 神奈川県横浜市緑区あざみ野4−35−28 (72)発明者 森下 益多郎 東京都大田区池上6−1−23   ─────────────────────────────────────────────────── ─── Continued front page    (72) Inventor Yoshikatsu Kuroki             4-35-28 Azamino, Midori Ward, Yokohama City, Kanagawa Prefecture (72) Inventor Masudaro Morishita             6-1-23 Ikegami, Ota-ku, Tokyo

Claims (1)

【特許請求の範囲】 (1) りん酸カルシウム質ガラスファイバーと生体親
和性を阻害しない有機高分子材料とを含有する複合材料
であって、該複合材料の表面に前記ファイバーの少なく
も一部を露出させると共に、板状もしくは、中空円筒縦
割り状湾曲材もしくはその近似形状で、かつ、ボルト孔
を設けた骨接合主材と、更に複数の前記骨接合主材によ
り生体の長管骨の骨折部を内固定して治療すべく、前記
ボルト孔に適合しかつ同じく前記複合材料を用いたフッ
ク及び又はボルト並にナットとして形成した骨接合副材
と、により構成したことを特徴とする、骨接合材。 (2) 前記複合材料中のりん酸カルシウム質ガラスフ
ァイバーの配合量が10乃至90重量[%]である、請
求項(1)に記載の骨接合材。 (3) 前記有機高分子材料が熱可塑性樹脂及び又は熱
硬化性樹脂である請求項(1)又は(2)に記載の骨接
合材。
What is claimed is: (1) A composite material containing calcium phosphate glass fibers and an organic polymer material that does not impair biocompatibility, wherein at least a part of the fibers is provided on the surface of the composite material. Fracture of long bones of a living body by exposing and exposing a plate-shaped or hollow cylindrical vertical split curved material or its approximate shape and a bone joint main material provided with bolt holes and a plurality of the bone joint main materials A bone, which is adapted to the bolt hole and is treated with a hook and / or a bone-bonding auxiliary material formed as a nut in the same manner as a bolt so as to fix the part internally. Bonding material. (2) The bone cement according to claim 1, wherein the compounding amount of the calcium phosphate glass fiber in the composite material is 10 to 90% by weight. (3) The bone bonding material according to (1) or (2), wherein the organic polymer material is a thermoplastic resin and / or a thermosetting resin.
JP41417990A 1990-12-07 1990-12-07 Osteosynthesis material Expired - Fee Related JP3177848B2 (en)

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JP41417990A JP3177848B2 (en) 1990-12-07 1990-12-07 Osteosynthesis material

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