JP3177848B2 - Osteosynthesis material - Google Patents

Osteosynthesis material

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Publication number
JP3177848B2
JP3177848B2 JP41417990A JP41417990A JP3177848B2 JP 3177848 B2 JP3177848 B2 JP 3177848B2 JP 41417990 A JP41417990 A JP 41417990A JP 41417990 A JP41417990 A JP 41417990A JP 3177848 B2 JP3177848 B2 JP 3177848B2
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Prior art keywords
osteosynthesis
bone
present
fiber
biocompatibility
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Expired - Fee Related
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JP41417990A
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Japanese (ja)
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JPH05146502A (en
Inventor
雅博 小林
良克 黒木
益多郎 森下
Original Assignee
雅博 小林
良克 黒木
益多郎 森下
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    • 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
    • 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
    • A61B17/683—Internal 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
    • 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
    • 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
    • A61B17/8665—Nuts

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  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Materials For Medical Uses (AREA)
  • Surgical Instruments (AREA)

Description

【発明の詳細な説明】DETAILED DESCRIPTION OF THE INVENTION

【０００１】[0001]

【発明の属する技術分野】 本発明は、生体骨の折損等傷
害骨を直接内固定して治療するための所謂骨接合材料
で、且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。なお、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。The present invention relates to the so-called osteosynthesis material for treating secure a breakage such injury bone BIOLOGICAL bone directly, and biological affinity for a living body, mechanical affinity A tangible material having: That is, after the complete healing of the broken bone in the prior art using a metal bone plate for treatment of a fractured part, the so-called nail removal operation for removing these metal plates, metal screws, etc. becomes unnecessary, and the pain of the patient is dramatically improved. It relates to an osteosynthesis material to be reduced. The use of the osteosynthesis material of the present invention is used for treatment of fractures of long bones, phalanges, clavicles and the like.

【０００２】[0002]

【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。骨
折部が完治した後に、患部を再切開し、前記の金属製の
ボーンプレートとねじ等を除去した後、その患部を再び
縫合し更に相当期間治療することによって始めて完治さ
せることができる。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、この種の従来技術の代表例として、
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）。また、他の従来技術は、金属は使用しな
いが、ポリーＬ−ラクチドの類を骨接合治療に使用する
ものがある。これは所謂ポリ乳酸系の材料であるから、
生体内吸収型のものである。更にまた、その他の従来技
術には、低級ヒドロキシカルボン酸のアクリル酸エステ
ル系材料を用いたものもあるが、これは生体組織内で、
分解可能、かつ、再吸収可能、生体吸収型の材料であ
る。2. Description of the Related Art Conventionally, for treatment of a fractured part, a metal bone plate in which the affected part is incised and the fractured part is abutted is sandwiched, and the bone plate is fixed with a metal screw or bolt nut. First, the incision is sutured thereon, and the broken part of the bone is first healed completely. Bone
After the folded part is completely cured , the affected part is re-incised, the above-mentioned metal bone plate, screws and the like are removed, and then the affected part is sutured again and further treated for a considerable period of time to be completely cured. That is, the materials used for this type of treatment all used metal plates and screws, and bolts and nuts. For example, as a typical example of this kind of conventional technology,
AO stainless steel plate of Robert Matisse of Switzerland,
There were a stainless screw and a stainless bolt nut (not shown). Also, other prior art uses no metal.
However, poly-L-lactide is used for osteosynthesis treatment
There is something. Since this is a so-called polylactic acid-based material,
It is of the in vivo absorption type. Furthermore, other conventional techniques
For surgery, lower hydroxy carboxylic acid acrylate
There are also those that use metal-based materials, but this is
Degradable, resorbable, bioabsorbable material
You .

【０００３】[0003]

【発明が解決しようとする課題】現在従来技術として使
用されている金属製骨接合材は、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問題点がある更にまた、従
来技術には、骨の折損部がほぼ治癒した後において、か
つまた、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
な問題点があった。次に、上記従来技術で、金属を用い
ないものは、すべて、生体内吸収型であるから、充分治
癒しない内に、生体内で一部が溶解するので、力学的に
は弱く、大きな荷重のかかる部分の骨折部の治療には使
えない、という大きな欠点がある。 The metal osteosynthesis currently used as the prior art has an excessively high modulus of elasticity as compared with bone, causing bone resorption over a long period of use and refracturing after nail removal. In addition, there are problems such as adverse effects on surrounding tissues due to elution of metal ions during long-term implantation.Furthermore, in the related art, after the fractured part of the bone is almost healed, and There is a drawback that the healing will not be complete unless the outer material such as meat is re-opened and these metallic materials are removed. This has been a very serious problem in that it is costly, time-consuming, doubling the patient's pain and unbearable. Next, in the above prior art, using metal
Anything that is not absorbed is in vivo absorption type
Before healing, it partially dissolves in the body,
Is weak and is used to treat fractures in areas with heavy loads.
There is a big drawback that you can not.

【０００４】本発明は、前記従来技術の問題点と諸欠点
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の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。この目的について更に説明する。既に公
知のこととして、手術患部の縫合に用いられた糸は、生
体非吸収材料であったが、抜糸の再手術を避けるため、
生体内分解吸収材料が開発されている。これは種類とし
ては、約３０種類ほどが知られている（整形外科、医用
材料マニュアル、金原出版、１６４頁）。この中には本
発明で使用するＰＭＭＡは含まれていない。これらの分
解吸収ポリマーを、骨接合材として使用したものがある
が、これを使用すると、骨折治療部が完治する約８ケ月
以前に、多量に生体内に吸収されるので、骨接合部の吸
収性プレートが強度不足となり、（バイオマテリアルの
最先端、株．シーエムシー、２５９頁）、患部が外力で
変形するから、全治に至る期間が長期化し不利である。
そこで本発明では、生体内非吸収材料であるＰＭＭＡと
生体親和性のあるガラスファイバーを用いた複合材料か
ら成る骨接合材は生体内で吸収されないので、強度が維
持されるから、この使用により、問題点を充足解決する
ことを目的とするものである。 [0004] The present invention largely eliminates the problems and disadvantages of the above-mentioned prior art, and does not use any material that is incompatible with a living body as a material used for the treatment, and has biological compatibility and mechanical properties. It is an object of the present invention to provide an osteosynthesis material that provides an early healing by using an affinity material, while eliminating the need for nail removal surgery and dramatically reducing the pain of the patient. This purpose will be further described. Already public
It is well known that the thread used to suture the affected area
It was a non-absorbable material, but to avoid re-operation of thread removal,
Biodegradable absorbent materials have been developed. This is a kind
About 30 types are known (orthopedics, medical
Material Manual, Kanehara Publishing, p. 164). In this book
The PMMA used in the invention is not included. These minutes
Some use depolymerized polymers as osteosynthesis materials
However, when this is used, the fracture treatment department will be completely cured for about 8 months
Previously, a large amount was absorbed into the living body, and
The yield plate becomes insufficiently strong,
State-of-the-art, shares. CMC, p. 259)
Since it is deformed, it is disadvantageous because the period until the complete cure is prolonged.
Therefore, in the present invention, PMMA which is a non-absorbable material in a living body is used.
Is it a composite material using biocompatible glass fiber?
Osteosynthesis material is not absorbed in vivo, so its strength is maintained.
This will solve the problem.
The purpose is to do so.

【０００５】[0005]

【課題を解決するための手段】本発明の骨接合材は、先
ず、骨接合材全体として、高度で、持続的な生体親和性
と、生体骨との力学的性質の近似性と、形状適合性とを
同時に兼備させるために、りん酸カルシウム質ガラスフ
ァイバーと生体親和性を有し、生体非吸収型である有機
高分子材料とから構成され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、板状又は湾曲材もしくはその近似形状で、且
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、且つ同じく前記複合材料を用い
たフック又はボルト・ナットとして形成した骨接合副材
とにより構成されたことを特徴とする。而して、前記生
体骨との力学的性質の近似性とは、弾性率，剛性，強
度，靭性などが、自然骨と近似していることであり、こ
れが、骨接合材の必須の要件とされており、上記の要件
を同時に満たし、かつ、生体非吸収型である骨接合材は
本発明のみであり、従来技術には全く無い、独創的手段
である。SUMMARY OF THE INVENTION The osteosynthesis material of the present invention is, as a whole, a high and sustained biocompatibility as a whole, a close approximation of mechanical properties with a living bone, and a shape matching. A composite material composed of a calcium phosphate glass fiber and a biocompatible organic polymer material that is non-bioabsorbable in order to simultaneously combine the properties with the surface of the composite material. At least a part of the fiber is exposed, and a plate-shaped or curved material or an approximate shape thereof, and an osteosynthesis main material provided with bolt holes, and a fracture portion of a living bone by a plurality of the osteosynthesis main materials. To fix internally and treat
It is characterized by being constituted by an osteosynthesis sub-material adapted to the bolt hole and also formed as a hook or a bolt and nut using the composite material. Thus, the approximation of the mechanical properties with the living bone is that the elastic modulus, stiffness, strength, toughness, etc. are close to those of the natural bone, which is an essential requirement of the osteosynthesis material. The osteosynthesis material which meets the above requirements and is non-bioabsorbable at the same time is only the present invention, and is an original means which is not at all in the prior art.

【０００６】 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Ｐ２Ｏ５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。しかして、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。 Accordingly, calcium phosphate vitreous fibers referred to in the present invention is hydroxyapatite, tricalcium phosphate, calcium oxide, calcium carbonate, and mixing the feedstock containing CaO and / or P 2 O 5, such as ammonium phosphate It is obtained by melting and spinning. As for this manufacturing method, Japanese Patent No. 1419169, entitled "Method for Manufacturing Calcium Phosphate Fiber", which is the same as the main inventor of the present invention, is 1988.
The patent was registered on January 14, (Showa 63).

【０００７】 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、且つまた複合共存する他の構成
材料の生体親和性、例えば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。 The term "organic polymer material which does not inhibit biocompatibility" as used in the present invention refers to an organic polymer material which, when implanted in a living body, has no toxicity and is not rejected from the living body. No reaction, and also does not hinder biocompatibility of other constituent materials that coexist, such as production performance,
In other words, it refers to an organic polymer material that is familiar to living organisms.

【０００８】 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
脂量が少なくなり、複合化成形が若干困難となるからで
ある。 [0008] Further, claim 2 shows a more desirable blending amount of the fiber. If the blending amount is less than 10 [%], it becomes somewhat difficult for the bone bonding material of the present invention to obtain a sufficient bending strength. At the same time, the amount of fibers exposed on the surface of the obtained composite material becomes too small, and the biocompatibility decreases. The reason for setting the amount of the fiber to 90% by weight or less is that if the amount of the fiber exceeds 90% by weight, the amount of the resin becomes small and the composite molding becomes slightly difficult.

【０００９】しかして、本発明においては前記有機高分
子材料が、熱可塑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に混合され、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。Thus, in the present invention, the organic polymer material is a thermoplastic resin . Thermoplastic resins include, for example, polymethyl methacrylate, polyethylene,
One or more resins such as polystyrene and polysulfone are uniformly mixed with the fiber and heated to be used for forming the osteosynthesis main material and the osteosynthesis auxiliary material, ie, bolts, nuts, screws or hooks. .

【００１０】 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，
ナット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。 [0010] The osteosynthesis main material according to the present invention, for example, sandwiches a fractured part of a living body, and is made of a homogenous osteosynthesis auxiliary material, ie, a bolt,
Tightened by nuts or hooks. Further, among the osteosynthesis sub-materials of the present invention, the hook is formed of a thermoplastic resin, but the head is bent from the beginning, and the rod portion is formed with a bolt hole of the osteosynthesis main material during surgery. After penetrating the bone, the tip is heated, softened, and bent, so that the osteosynthesis main material is tied to the broken bone.

【００１１】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技
術以上に促進し得る。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、前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、全く必要がなくなる。更に、特筆すべき本発明の
骨接合材の作用は、生体組織と親和性があり、かつ、生
体非吸収型であるから、完全治癒まで、患部の機械的強
度を保持し得るので、結局、治癒の期間が従来比最短と
なることである。 [0011] When the treatment is carried out by such an action, the fractured portion is not moved, and is maintained in a stable shape, so that the healing can be promoted more than the prior art. The reason for this effect is that, in particular, the metal osteosynthesis material of the prior art has an elastic modulus that is excessively large as compared with natural bone, which is liable to cause refracture due to bone resorption, and has a biological affinity. In contrast to the fact that there is no dissolution, harmful metal ions are also eluted in vivo, the osteosynthesis material of the present invention has biochemical affinity on the material and the elastic modulus is close to natural bone,
This is because there is no bone resorption. Furthermore, as an effect that brings a great advantage of the osteosynthesis material of the present invention, there is no harmful metal ion elution even after the fracture damaged part is healed, so that the conventional metal osteosynthesis material can be used. The use of the osteosynthesis material of the present invention eliminates the need for a reoperation for nail removal, such as when used. Furthermore, the present invention
The action of the osteosynthesis material is compatible with living tissues and
Since it is non-absorbable, the mechanical strength of the affected area is maintained until complete healing.
The healing period is shorter than before.
It is becoming.

【００１２】[0012]

【発明の実施の形態】 以下、本発明に係る骨接合材の実
施の形態を図面を参照して詳述する。 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
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。 BEST MODE FOR CARRYING OUT THE INVENTION Hereinafter, an example of an osteosynthesis material according to the present invention will be described.
Embodiments will be described in detail with reference to the drawings. 60 mass% of calcium phosphate fiber and polymethyl methacrylate (hereinafter abbreviated as PMMA) as a thermoplastic resin.
40 wt%] were uniformly mixed, FIG. 1, the shown to Gulf curved plate 6 to the flat plate 1 and Figure 3 osteosynthesis main material of the present invention shown in Figure 2 provided with a respective bolt hole 7 It was molded and cured by heating. The same material is used for the osteosynthesis auxiliary material, but in particular, the hook is formed in a rod shape in advance, and one end serving as a head is formed into an L-shape and bent to be solidified.

【００１３】 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。 FIG . 1 (a) is an explanatory longitudinal sectional view showing the flat plate 1 of the osteosynthesis main material penetrated by the hooks 3 from both sides of the fractured bone 2 during the operation, and has three L-shaped upper portions. The hook 3 shows a state in which the rod shape is simply penetrated through the bolt hole from the right side, and the lower three left ends 3 'are softened by using a heating iron of 250 ° C. for 20 to 30 seconds and bent. FIG. 3 shows a state of being fixed by compression bonding and solidification. FIG. 1 (b) is an example in which the flat plate 1 is similarly applied from one side of the fractured bone 2 and tightened.

【００１４】 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
の使用に置き換えた例であり、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の片側乃至両側より挟接
した例の斜視説明図であり、ボルト孔７を設けてある。 [0014] Figure 2 (a), (b) are each the 1 (a), the bolts 4 and nuts 5 to hook case of (b)
In the present invention, 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 osteosynthesis main material of the present invention in which the flat plate is replaced with a curved plate 6 is sandwiched from one side or both sides of the broken bone 2, and a bolt hole 7 is provided.

【００１５】 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，ナットの
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、一端は予めＬ型に曲げてあり、他端１
１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、前記の材質であって、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［ｋ
ｇ／ｍｍ２］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。そこで前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。 [0015] FIG. 4 (a), (b) shows an example of the material of the screw of the present invention, FIG. (C) shows also a bolt, an example of a nut. FIG. 4D shows an example of a hook in the material of the present invention.
Reference numeral 1 denotes a structure in which, during the operation, heat processing is performed as described above, and bending and pressure fixing are performed. Specifically, when explaining an example of a flat plate, a said material, width 12 [mm],
Those having a thickness of 2.2 [mm] and a bolt hole of 3 [mm] have a breaking load of about 300 [kgf], that is, a tensile strength of about 15 [k].
g / mm 2 ]. In addition, the actual measured value of the breaking load of the two flat plates formed into a bone-joining material in which the fractured bone was sandwiched and bolted from the left and right was 520 [kgf]. In general, the requirements for this type of biomaterial require biocompatibility, which requires biological affinity and mechanical affinity. Regarding its mechanical affinity,
An appropriate one can be obtained mainly by examining the strength and elastic modulus. Therefore, these will be described including the above-mentioned measured values and other experimental examples of the present inventors.

【００１６】 強度［ＭＰａ］については、生体自然骨が
１２３以下、従来技術のステンレスＳＶＳ３１６Ｌ板
が、５００〜１０００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５００〜１３００、平板で２００〜８００で前記自然
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。 The strength [MPa] is 123 or less for natural bone and 500 to 1000 for the conventional stainless SVS316L plate. The fibers used as the material of the present invention are 1850 to 2200. However, since the shape of the plurality of fibers is amorphous, it does not become a strength retainer as it is. The PMMA is 73, but cannot be used alone for such a purpose because it is less than the strength of bone. On the other hand, the composite material or osteosynthesis material of the present invention has hooks of 500 to 1300 and a flat plate of 200 to 800 and can be made from a material which is slightly stronger than the natural bone, and thus is suitable for the purpose of the present invention.

【００１７】 次に、弾性率［ＧＰａ］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。 [0017] Next, the elastic modulus [GPa], a biological natural bone 19 or less, prior art stainless steel plate 180
From about 200, it is about 10 times larger than natural bone, which is too large, causing bone resorption and causing re-fracture.
It can be seen that conventionally used stainless steel is incompatible with living organisms.

【００１８】 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
骨接合材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。 Next, the fiber as the material of the present invention osteosynthesis material is a 70 to 77, which is the amorphous as. Further, since PMMA is 3, and the elastic modulus is too small, this alone is not suitable for the purpose of the present invention. Next, since the plate-shaped osteosynthesis material of the present invention has a modulus of 10 to 40 and the hook has a modulus of 15 to 45, which is the elastic modulus of natural bone, it is suitable for the purpose of the present invention. Thus, bone junction material of the present invention because it has a compatible biological both strength and elastic modulus, relative to overall biological, first with mechanical affinity. In addition, the biocompatibility is proved in the amorphous material used for the osteosynthesis material of the present invention, that is, in the above-mentioned patented “implant material”. Of course. In addition, it can be made in various sizes and sizes. Therefore, it can be said that the osteosynthesis material of the present invention is a tangible material having sufficient biocompatibility.

【００１９】 従って、前記の説明のとおり、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製骨接合材に比較し、生体治癒に
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。 [0019] Therefore, as described above in the description, also in the strength, even compared Furthermore the metallic osteosynthesis material in the prior art that are not found at all even biocompatibility in modulus, in important aspects for biological healing In terms of biocompatibility, the material of the present invention is very different in that it has all compatibility,
It can be said to be a remarkably excellent breakthrough biomaterial.

【００２０】[0020]

【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
材料となりうる。 ２）本発明の骨接合材は、生体親和性が格段に優れてい
るので、第１次の骨接合手術完治後、従来技術の金属製
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。３）その上に、本発明材料は、吸収型の従来技術材料と
も異なり、非吸収型であるから、完全治癒まで、強度と
形状を保ち、かつ生体親和性もあるので、結論的には、
治癒期間は従来比最短となる、という顕著な効果をも有
するものである。 The osteosynthesis material of the present invention has no biocompatibility, and is fundamentally different from the prior art in which metal ions are also eluted in the living body and have toxic elements. And mechanical affinity, and can be a biomedical material with excellent biocompatibility. 2) Since the osteosynthesis material of the present invention is remarkably excellent in biocompatibility, after the first osteosynthesis operation is completely cured, unlike the conventional metal bonplate and screws, a second nail removal operation is performed. No need to do. This is an enormous, new effect compared to prior art materials. That is, it allows the patient to escape the enormous pain of the second surgery. In particular, this means that an enormous effect can be obtained by the present invention. In view of this point, the present invention has such a great effect that it can be said that it is a very useful invention in the public interest. 3) In addition, the material of the present invention is different from the absorption type prior art material.
Unlike the non-absorbable type, it has strength and
As it keeps its shape and has biocompatibility, in conclusion,
The healing period is also the shortest compared to the conventional method, which has a remarkable effect.
Is what you do.

【図面の簡単な説明】[Brief description of the drawings]

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。FIG. 1 (a) is a longitudinal cross-sectional view in which the osteosynthesis main material of the present invention is sandwiched from both sides of a broken portion and fastened by hooks, and FIG. 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, respectively, and FIG. 3 is the osteosynthesis main material of the present invention shown in FIG. plates explanatory diagram instead of curved plate, FIG. 4 (a), (b) is a diagram showing an example of the material of the screw of the present invention,
FIG. 2C is a diagram showing an example of a bolt and a nut, and FIG. 2D is a diagram showing an example of a hook in the material of the osteosynthesis auxiliary material of the present invention.

【符号の説明】 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 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 [Description of Signs] 1 Flat plate of osteosynthesis main material of the present invention 2 Broken bone 3 Hook 4 Bolt 5 Nut 6 Curved plate 7 Bolt hole 8 Bolt 9 Nut 10 Washer 11 Tip of hook

───────────────────────────────────────────────────── フロントページの続き (72)発明者 森下 益多郎 東京都大田区池上６−１−23 (56)参考文献 特開 昭54−154183（ＪＰ，Ａ) 特開 昭61−135671（ＪＰ，Ａ) 特開 昭62−268553（ＪＰ，Ａ) (58)調査した分野(Int.Cl.7，ＤＢ名) A61B 17/56 - 17/92 A61F 2/28 - 2/48 A61L 27/00 - 27/60 ──────────────────────────────────────────────────続 き Continuation of the front page (72) Inventor Mashiro Morishita 6-1-23 Ikegami, Ota-ku, Tokyo (56) References JP-A-54-154183 (JP, A) JP-A-61-135671 (JP, A) JP-A-62-268553 (JP, A) (58) Fields investigated (Int. Cl. 7 , DB name) A61B 17/56-17/92 A61F 2/28-2/48 A61L 27/00- 27/60

Claims (3)

(57)【特許請求の範囲】(57) [Claims] 【請求項１】 骨接合材全体として、高度で、持続的な
生体親和性と、生体骨との力学的性質の近似性と、形状
適合性とを同時に兼備させるために、りん酸カルシウム
質ガラスファイバーと生体親和性を有し、生体非吸収型
である有機高分子材料とから構成される複合材料であっ
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、板状又は湾曲材もしくはその近似
形状で、且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、且つ同じく前記複合
材料を用いたフック又はボルト・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。1. A calcium phosphate glass as the osteosynthesis material as a whole, in order to combine high and sustained biocompatibility, closeness of mechanical properties with living bone, and shape conformity at the same time. A composite material comprising a fiber and a biocompatible organic polymer material which is non-bioabsorbable, wherein at least a part of the fiber is exposed on the surface of the composite material, and Or a bone material having a curved material or an approximate shape thereof and provided with a bolt hole, and further adapted to the bolt hole so as to internally fix and treat a fractured portion of a living bone with a plurality of the bone material. And an osteosynthesis sub-material similarly formed as a hook or a bolt and a nut using the composite material. 【請求項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。2. The osteosynthesis material according to claim 1, wherein the content of the calcium phosphate glass fiber in the composite material is 10 to 90% by weight [%]. 【請求項３】 前記有機高分子材料が、熱可塑性樹脂で
ある請求項１又は２に記載の骨接合材。3. The bone bonding material according to claim 1, wherein the organic polymer material is a thermoplastic resin.
JP41417990A 1990-12-07 1990-12-07 Osteosynthesis material Expired - Fee Related JP3177848B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP41417990A JP3177848B2 (en) 1990-12-07 1990-12-07 Osteosynthesis material

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
JP41417990A JP3177848B2 (en) 1990-12-07 1990-12-07 Osteosynthesis material

Publications (2)

Publication Number Publication Date
JPH05146502A JPH05146502A (en) 1993-06-15
JP3177848B2 true JP3177848B2 (en) 2001-06-18

Family

ID=18522684

Family Applications (1)

Application Number Title Priority Date Filing Date
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Country Status (1)

Country Link
JP (1) JP3177848B2 (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6440628B1 (en) 1997-08-29 2002-08-27 Nippon Zeon Co., Ltd. Tones for development of electrostatic image and production process thereof

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7635365B2 (en) * 2003-08-28 2009-12-22 Ellis Thomas J Bone plates
JP2010005143A (en) * 2008-06-27 2010-01-14 St Marianna Univ School Of Medicine Internal fixing appliance for bone fracture
US9237910B2 (en) 2012-01-26 2016-01-19 Acute Innovations Llc Clip for rib stabilization
US8568417B2 (en) 2009-12-18 2013-10-29 Charles River Engineering Solutions And Technologies, Llc Articulating tool and methods of using
EP2760354B1 (en) 2011-09-30 2019-05-08 Acute Innovations, Llc Bone fixation system with opposed mounting portions
US10085781B2 (en) 2015-03-06 2018-10-02 Stryker European Holdings I, Llc Condylar fracture fixation system
CN107714169A (en) * 2017-11-10 2018-02-23 徐强 A kind of reversely screw and steel plate Bidirectional locking system

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6440628B1 (en) 1997-08-29 2002-08-27 Nippon Zeon Co., Ltd. Tones for development of electrostatic image and production process thereof

Also Published As

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