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WO1988001849A1 - Clavette pour l'osteosynthese - Google Patents

Clavette pour l'osteosynthese Download PDF

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Publication number
WO1988001849A1
WO1988001849A1 PCT/JP1987/000673 JP8700673W WO8801849A1 WO 1988001849 A1 WO1988001849 A1 WO 1988001849A1 JP 8700673 W JP8700673 W JP 8700673W WO 8801849 A1 WO8801849 A1 WO 8801849A1
Authority
WO
WIPO (PCT)
Prior art keywords
osteosynthesis
pin
poly
lactic acid
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.)
Ceased
Application number
PCT/JP1987/000673
Other languages
English (en)
French (fr)
Inventor
Yoshito Ikada
Hyu Hyon Suong
Yoshihiko Shimizu
Satoshi Watanabe
Tatsuo Nakamura
Masakazu Suzuki
Takeshi Shimamoto
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.)
Gunze Ltd
Original Assignee
Gunze Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Gunze Ltd filed Critical Gunze Ltd
Priority to DE3790560A priority Critical patent/DE3790560C2/de
Publication of WO1988001849A1 publication Critical patent/WO1988001849A1/ja
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • 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 or setting implements
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/04—Macromolecular materials
    • A61L31/06—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00004—(bio)absorbable, (bio)resorbable or 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
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30108—Shapes
    • A61F2002/30199—Three-dimensional shapes
    • A61F2002/30205—Three-dimensional shapes conical
    • A61F2002/30207—Double convex cones, i.e. element having two convex cones, one at each of its opposite ends
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0067—Three-dimensional shapes conical
    • 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
    • Y10S623/00—Prosthesis, i.e. artificial body members, parts thereof, or aids and accessories therefor
    • Y10S623/909—Method or apparatus for assembling prosthetic
    • Y10S623/911—Bone

Definitions

  • the present invention relates to an osteosynthesis pin used for fixation and reduction of a bone during a surgical operation, particularly at the time of rib cutting or fracture.
  • a metal or aluminum ceramic bone osteosynthesis pin that is inserted into the medullary cavity of the cut or broken bone to join the cut or broken bone is used clinically. ing.
  • osteosynthesis pins have poor elasticity, have no buffering effect on the movement of the bone anchoring part, and have the disadvantage of stimulating the bone to cause inflammation and delaying bone regeneration.
  • it has poor affinity for the living body and is non-absorbable to the living body.Therefore, it remains permanently in the living body even after healing of the fracture, causing bacterial contamination or causing inflammation. .
  • the present invention has moderate elasticity, has excellent affinity for living organisms, has bioabsorbability, can effectively perform bone regeneration and healing without inflammation at the joint, and is absorbed by the living body after surgery. There is an attempt to provide an osteosynthesis pin that can eliminate the adverse effects associated with permanent residue.
  • Another object of the present invention is to exhibit the effect of promoting bone regeneration during osteosynthesis. It is intended to provide an osteosynthesis pin which can be used.
  • the osteosynthesis pin of the present invention is distinguished by being substantially formed of poly-L-l-lactic acid having a molecular weight of about 70,000 or more.
  • the present inventors have studied the applicability of many polymeric substances having biocompatibility and bioabsorbability as osteosynthesis pins. Many of the macromolecules studied did not have the proper elasticity required of the joining pins, had poor initial strength, or could not maintain the required strength during the bone regeneration period (typically around 2 months). It was unsuitable as an osteosynthesis bottle. However, among the homopolymers of L-lactic acid, only poly-L-lactic acid, especially with a molecular weight of about 70,000 or more, has excellent initial strength and maintains the necessary strength during the period of bone regeneration to effectively perform bone regeneration. Therefore, it was found that it was suitable as an osteosynthesis pin.
  • the poly-L-lactic acid has a moderate elasticity, and therefore does not exert a shock absorbing action on the movement of the bone anchoring portion to stimulate the bone to cause inflammation or delay the regeneration of the bone.
  • the above poly-L-lactate has excellent affinity with the medulla tissue when inserted into the medullary cavity, and has the ability to be hydrolyzed in the living body and gradually absorbed into the living body. They do not remain permanently in the living body and do not cause any adverse effects as in the case of ceramics and alumina ceramics.
  • the poly-L-lactic acid used in the present invention is known per se, but there is no report that it was used as an osteosynthesis pin.
  • the poly-L-lactic acid suitable for the present invention has a molecular weight of about 70,000 or more, preferably has a molecular weight of about 100,000 or more, and most preferably has a molecular weight of about 150,000 or more. Things. Although the upper limit of the molecular weight is not particularly limited, one having a molecular weight of about 150,000 or less is usually used from the viewpoint of moldability and the like.
  • the molecular weight of poly-L-lactic acid is determined by dissolving poly-L-lactic acid in black-mouthed form to a concentration of 0.2 g Z d S, diluting it as a stock solution in black-mouthed form, and limiting viscosity.
  • [] Is the value obtained by calculating the viscosity average molecular weight by the following formula.
  • HAP hydroxyapatite
  • poly-L-lactic acid in order to further increase the in vivo affinity of the zygote and to exert an effect of promoting bone regeneration during osteosynthesis.
  • HA P is an expression C a ⁇ 0 (P 0 4) B ( OH) 2 in Table pictmap inorganic crystals known substance.
  • HAP is in powder form, preferably about 1 ⁇ ! In diameter. It is used in the form of a powder having a size of about 100 m, usually in a range of about 11 to 15% by weight, preferably about 5 to 10% by weight, based on poly (L-lactic acid).
  • the bottle of the present invention can be prepared by blending calcium phosphate fibers obtained from HAP as a raw material with poly (L-lactic acid).
  • the shape of the osteosynthesis pin may be arbitrarily determined, and may take the shape of a square, a polygonal column (for example, 4, 5, 6, octagonal column, etc.), a columnar shape, or the like. For example, it takes the form of a plate or polygon with a thickness of about 2-7fflin, a width of about 2-7 ⁇ , a length of about 20-5 Offlffl, a diameter of about 3-7 ⁇ , and a length of about 20-50 dragons.
  • the attached drawings show a preferred example of the osteosynthesis pin of the present invention.
  • FIG. 1 is a perspective view showing one example of a plate-shaped osteosynthesis pin
  • FIG. 2 is an example of a cylindrical osteosynthesis bin.
  • FIG. 1 is a perspective view showing one example of a plate-shaped osteosynthesis pin
  • FIG. 2 is an example of a cylindrical osteosynthesis bin.
  • (1) indicates the joining pin of the present invention, and the pin (1) It is preferable that both ends of the bead are tapered (2) so that the pin can be easily inserted into the medullary cavity.
  • (3) is a through-hole penetrated in the longitudinal direction of the pin, which is provided as desired. By providing the through-hole, the healing effect is improved without hindering the growth of bone marrow cells.
  • the osteosynthesis pin of the present invention can be produced by molding poly-L-lactic acid or a mixture thereof with HAP as a molding material. Poly-L-lactic acid has excellent moldability at a relatively low temperature, so that an osteosynthesis pin having a desired shape can be easily obtained.
  • a method in which the above molding material is heated at a temperature equal to or higher than the melting point of poly-L-lactic acid by a hot press to press-mold it, or a spinning machine is used to extrude a nozzle having an appropriate diameter at a temperature equal to or higher than the melting point. It is manufactured by stretching in the axial direction and taping if necessary. Stretching in the major axis direction further improves the elasticity and strength of the joining pin. Stretching is usually carried out at a temperature of about 70 to 120 ° C, and it is desirable that the stretching be performed about 2 to 10 times in the longitudinal direction.
  • the osteosynthesis pin of the present invention is used to join and repair bone by inserting it into the medullary cavity of a cut or fractured bone, and for treating bone fracture or cutting, as well as bone fracture or bone fracture of each part. It is suitably used for joining treatment for amputation.
  • Poly L-lactic acid powder having a molecular weight of about 1,300,000 was held at 200 ° C. for 5 minutes in a hot press machine without applying pressure to melt the poly L-lactic acid. After applying a pressure of 200 kg / em 2 at the temperature and maintaining the temperature for 5 minutes, the plate was rapidly cooled to prepare a poly-L-lactic acid plate having a thickness of 3. From this, a rib fixing pin with a width of 6 niffl and a length of 40 in in as shown in Fig. 1 was prepared by cutting.
  • the rib fixation pin was immersed in phosphate buffered saline (PBS) containing 0.9-wt% sodium chloride at 37 ° C to perform a hydrolytic test, and the immersion period, weight, The relationship between bending strength and bending Young's modulus was determined. Table 1 shows the results.
  • PBS phosphate buffered saline
  • the 9th, 10th and 11th left ribs are cut including the periosteum at about 2-4 em from the rib angle, and the above-mentioned columnar pin is stimulated into the costal bone marrow cavity to join the cut parts. did.
  • the ribs were ligated with a No. 7 silk thread at 1.5 cm proximal and distal to the incised end, respectively, and the threads were ligated to fix the joint.
  • osteosynthesis pins made of poly-L-l-lactic acid show excellent affinity with the living body, and after one month, osteosynthesis Had been completed.
  • stainless steel pins have poor affinity with intramedullary tissue, and a thick connective woven layer is formed around the pins. In some cases, the bones directly hit by the pins become thinner and the pins fall off.
  • Example 2 5 parts by weight of the same hydroxyapatite as in Example 2 was added to 1 part by weight of poly-L-lactic acid powder having a molecular weight of about 7200. After mixing well, the diameter was 3 using a single-screw screw spinning machine. 2 3 0 nozzle with a single hole of ⁇ .
  • a poly-L-lactic acid rod containing hydroxyaciapatite was extruded at a temperature of (:. The rod was stretched twice in the long axis direction under air at about 80 ° C, and then stretched to a length of 40 ⁇ . Then, both ends were tapered, and a rib fixing pin as shown in Fig. 2 was prepared.
  • the joining pin thus obtained had the strength shown in Table 2 below.
  • the table also shows the strength before stretching.

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  • Orthopedic Medicine & Surgery (AREA)
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Description

明 細 書 骨接合ピン
技術分野
本発明は、 外科手術特に肋骨切断や骨折等の際に、 骨 の固定、 整復のために用いる骨接合ピンに関する。
背景技術
従来切断又は骨折した骨の修復の為に、 切断又は骨折 した骨の髄腔部に差し込んで切断又は骨折した骨を接合 する金属製又はアルミ ナセラ ミ ック製骨接合ピンが臨床 的に用いられている。
しかし、 これら骨接合ピンはいずれも弾性に乏しく、 骨固定部の動きに対し緩衝作用がなく骨を剌榦して炎症 を生じたり骨の再生を遅らせたりする不利がある。 しか も生体に対する親和性に乏しく且つ生体に非吸収性であ り、 従って骨折治癒後も生体内に永久に残留して細菌汚 染の原因となつたり炎症を起したりする等の問題がある。
発明の開示
本発明は適度の弾性を有ししかも生体に対する親和性 に優れ且つ生体吸収性を有し、 接合部に炎症を伴うこと なく骨の再生治癒を有効に行うことができ術後は生体に 吸収され永久残留に伴う弊害を無く し得る骨接合ピンを 提供しょうとするもの 'ある。
また本発明の目的は骨接合時の骨再生促進効果を発現 し得る骨接合ピンを提供しようとするものである。
本発明の骨接合ピンは、 分子量約 7万以上のポリ 一 L 一乳酸で実質的に形成されていることにより特徵付けら れ 。
本発明者等は生体親和性及び生体吸収性を有する多く の高分子物質について、 骨接合ピンとしての適用可能性 を検討してきた。 検討した多くの高分子物質は接合ピン に要求ざれる適度の弾性を有しなかったり、 初期強度に 乏しかったり、 或いは骨再生期間 （通常 2ヶ月前後） 中 必要な強度を保ち得なかったり して骨接合ビンとして不 適であつた。 然るに L一乳酸のホモポリマーのうち特に 分子量約 7万以上のポリ一 L一乳酸のみが初期強度に優 れしかも骨再生期間中必要な強度を保持し骨の再生洽癒 を効果的に行わしめることができ、 従って骨接合ピンと して好適であることを見出した。 しかも上記ポリー L一 乳酸は、 適度の弾性を有し、 従って骨固定部の動きに緩 衝作用を発現し骨を刺戟して炎症を生じたり骨の再生を 遅らせたりすることがない。 加えて上記ポリ 一 L一乳酸 は髄腔内に差し込まれた時髄內組織との親和性に優れ、 しかも生体内に於て加水分解されて徐々に生体に吸収さ れる力、ら、 金属製やアルミナセラミ ツク製の場合のよう に生体内に永久残留して弊害を伴うことはない。 本発明に於て使用されるポリ - L -乳酸それ自身は公 知であるが、 骨接合ピンとして用いられた報告はない。 L一乳酸のホモボリマーであつても分子量が約 7万未満 のものは骨接合ピンとして要求される性質即ち初期強度 或は骨再生期間中の強度保持に乏しく骨接合ピンと して 使用できない。 本発明に好適なポリ — L—乳酸は約 7万 以上の分子量を有するものであり、 殊に分子量約 1 0万 以上のものが好ましく、 最も好ま しいのは約 1 5万以上 の分子量を有するものである。 分子量の上限は特に制限 されないが、 成形性等の見地から通常約 1 5 0万以下の ものが用いられる。
本明細書においてポリ — L一乳酸の分子量は、 ポリ 一 L—乳酸をクロ口ホルムに溶解させ濃度 0 . 2 g Z d S と し、 これを原液としてクロ口ホルムにて希釈し、 極限 粘度 〔 〕 を求め、 下の式によって粘度平均分子量を求 めた値である。
( n ] = K
Figure imgf000005_0001
本発明に於ては、 接合ピンの生体内親和性を更に高め 骨接合時の骨再生促進効果を発現させる為に、 ポリ 一 L —乳酸にハイ ドロキシアパタイ ト （以下 H A Pと記す） を混合して使用するのが好ましい。 HA Pは公知の物質 で式 C a〗 0 (P 04 ) B (OH) 2 で表ゎされる無機 結晶である。 本発明に於て H A Pは粉状好ましく は直径 約 1 η！〜 100 m程度の粉状の形態で、 通常ポリ一 L一乳酸に対し約 1一 1 5重量％好ましく は約 5— 10 重量％の範囲で均一に混合して用いられる。 ポリ 一 L一 乳酸に H A Pを混合するに当っては、 任意の方法たとえ ば両者の粉末を混合する方法、 前者重合体の溶液に後者 を均一に混合し溶剤を揮散させる方法等を採る-ことがで きる。 また骨再生を促進し且つピン強度を向上させる為 に、 ポリ 一 L一乳酸に H A Pを原料として得られるリ ン 酸カルシウム繊維を配合して本発明ビンとすることもで きる。
骨接合ピンの形状は任意でよく、 扳状、 多角柱状 （た とえば四、 五、 六、 八角柱状等） 、 円柱状等の形状をと り得る。 たとえば厚さ約 2— 7fflin、 巾約 2— 7πιπι、 長さ 約 20 - 5 Offlfflの板状乃至多角柱状、 直径約 3— 7ιπιπ、 長さ約 20 - 50龍程度の円柱状の形状をとる。 添附図 面は本発明骨接合ピンの好ましい例を示すもので、 第 1 図は板状の骨接合ピンの 1例を示す斜面図であり、 第 2 図は円柱 の骨接合ビンの 1例を示す斜面図である。 添 附図面に於て （1 ) は本発明接合ピンであり、 ピン （ 1) の両端はテーパ状 （2 ) に加工し、 髄腔部へのピンの差 し込みを容易にするのが好ま しい。 第 1図に於て （3 ) はピンの長軸方向に貫通された貫通孔であり、 所望によ り設けられるもので、 これを設けることにより骨髄細胞 の成長を妨げることなく治癒効果を高めることができる < 本発明骨接合ピンはポリ ー L一乳酸又はこれと H A P との混合物を成形材料として成形することにより製造さ れる。 ポリ — L -乳酸は比較的低温での成形性に優れる ため容易に所望の形状の骨接合ピンが得られる。 たとえ ば上記成形材料をホッ トプレス機にてポリ ー L一乳酸の 融点以上の温度で加熱してプレス成形する方法或は紡糸 機にて融点以上の温度で適当な直径を有するノズルょり 押出し長軸方向に延伸し、 必要に応じテー パー加工する ことにより製造される。 長軸方向への延伸により接合ピ ンの弾性及び強度が更に向上する。 延伸は通常約 7 0 〜 1 2 0 °Cの加温下に行われ、 長軸方向に約 2 〜 1 0倍延 伸するのが望ま しい。
本発明の骨接合ピンは切断又は骨折された骨の髄腔に 刺入して骨を接合し修復するのに用いられ、 肋骨の骨折 又は切断に対する治療用としてはもとより各部の骨の骨 折又は切断に対する接合治療用と して好適に使用される。
以下に本発明の実施例を挙げて本発明の特徴とする所 を明らかとする。
実 施 例
(実施例 1 )
分子量約 1 2 3 0 0 0のポリ一 L -乳酸粉末を、 ホッ トプレス機にて 2 0 0 Cで 5分閭圧力をかけずに保持し てポリ一 L—乳酸を融解させ、 次に同温度で 2 0 0 kg/ em2 の圧力をかけ 5分間保持した後急冷し、 厚さ 3 の ポリ— L一乳酸の板を作成した。 これより巾 6 niffl、 長さ 4 0 in inの第 1図に示す様な肋骨固定ピンを切削加工によ り作成した。
この肋骨固定ピンを 0 . 9-重量％の塩化ナ ト リ ウムを 含むリ ン酸緩衝溶液中 （P B S ) に 3 7 °Cで浸潰して加 水分解テス トを行い、 浸漬期間と重量、 曲げ強度及び曲 げヤング率との関係を求めた。 結果を表 1に示す。
88/01849
Figure imgf000009_0001
但し、 曲げ強度、 曲げャング率は J I S K 7 2 0 3 に準じて測定した。 重量保持率、 曲げ強度保持率、 曲げ ヤング率保持率は初期値に対する百分率 （％) で表わす, 実施例 2
分子量約 7 2 0 0 0のポリ — L—乳酸を塩化メチレ ン に溶解し、 これにハイ ドロキシァパタイ ト （主成分重量 組成 C a O : 5 5. 8 % P 2 05 : 4 2. 3 % o
M g 0 ： 0. 3%、 粒径 0. 08 Sfflffl以下） を 5重量％ 加え、 攪拌した後溶媒を除去し、 均質にハイ ドロキシァ パタイ トを含有させた材料を調製し、 ホッ トプレス機で プレー ト状に成形した後 80 °Cの温水中で 2倍に延伸し 直径 2πιιπ、 長さ 2 Onifflの円柱状の骨接合ピンを作成した。
上記骨接合ピンの初期曲げ強度は 16. 2 kgノ 2 で P B S中における in vitroテス トに於て 2ヶ月浸漬後に も初期値の 80 %の強度を保持していた。
雑種成犬 7頭 （体重 7〜 1 5Kg) に Ketaral 10 mg/ Kg, Rom pun 0. 1 fflgZKgで筋注麻酔を行い、 揷管下に陽 圧人工呼吸下で、 本例の骨接合ピン及び比較の為にスチ 一ル製骨接合ピンを用いて、 以下の手術を施行した。
即ち、 左第 9, 10, 1 1肋骨を肋骨角より約 2—4 emの部位で骨膜を含めて切断し、 肋骨髄腔内に前記の円 柱状のピンを剌入し、 切断部位を接合した。 その際、 切 断端より近位、 遠位各々 1. 5 cmの部位で肋骨を 7号絹 糸で結紮しさらにその糸どう しを結紮することにより接 合部を固定した。 術後経時的に骨治癒を X綠で観察、 2 週間、 3週間、 1力月、 2力月、 3力月後に接合部を en blockに摘し肋骨の組織反応、 材料の変化を見た。
経過においては、 ポリ一 L一乳酸よりなる骨接合ピン は、 生体と優れた親和性を示し、 1力月後には骨接合が 完了していた。 一方ステンレス製ピンは髄内組織との親 和性が乏しく厚い結合織層がピンを囲んで生じ、 また、 直接ピンが当る部分の骨が菲薄化しピンが脱落する例も 見られた。
実施例 3
分子量約 7 2 0 0 0のポリ 一 L一乳酸粉末 1 ◦ 0重量 部に例 2と同じハイ ドロキシァパタイ ト 5重量部を加え. よ く混合した後単軸スク リ ュー紡糸機を用い、 直径 3 ιππι の単孔を有するノズルょり 2 3 0。(：の温度でハイ ドロキ 'シアパタイ ト含有のポリ 一 L—乳酸棒を押出した。 この 棒を約 8 0 。Cの空気中下で長軸方向に 2倍延伸した後 4 0 ιπιπの長さに切断し両端にテーパー加工を施し、 第 2 図に示すような肋骨固定ピンを作成した。
この様にして得た接合ピンは下記第 2表の強度を有し ていた。 表には延伸前の強度を併記した。
1849
10
2
Figure imgf000012_0001
かかる肋骨固定ビンの 0. 9重量％の塩化ナ ト リ ウム を含むリ ン酸緩衝溶液中 （P B S) 37で下での加水分 解性テス ト （以下、 in vitroテス トという） —の結果は第 3表に示す通りであつた。
li
3 項目 \浸漬期間 初 期 2週間後 1ヶ月後 2ヶ月後 3ヶ月後 6ヶ月後 章暈勝率 100 100 100 100 100 98 (%)
曲げ搬 16. 2 13. 7 12. 9 12. 8 10. 0 3. 8
(KgZniffl2 )
曲げ 保 率 100 85 - 80 79 62 24 (%)
曲げヤング率 462 383 445 421 376 262
(Kg/DIDl2 )
曲げヤング率 100 S3 96 91 81 57 保持率 (%)
丄
つぎに成犬の切断した肋骨に固定ピンを接合して接合 状態を観察した。 2週間後には骨どう しの接合は未だ十 分ではないが肋骨固定ビンは骨内でしっかりと組織と結 合し、 十分固定ピンとしての役目を果たしていた。
比較例として直径 2 πππの Ki eschner 網線を長さ 2 einに 切断し、 上記と同様の i n vi vo テス トを行ったが、 2週 間後の知見では Ki r s ehn er 網線は、 全く骨内の組織と結 合せずガサガサの状態であり、 体外からの圧迫によって 骨髄内にて綱線が容易に移勤するので組織を剌戟し、 接 合ピンとしての役目を果たさないことがわかった。

Claims

丄 3
請求の範囲
分子量約 7万以上のポリ - L -乳酸で実質的に構成 されていることを特徵とする骨接合ピン。
ポリ - L—乳酸が約 1 0万以上の分子量を有するも のであることを特徵とする請求の範囲第 1項記載の骨 接合ピン。
ポリ 一 L一乳酸が約 1 5万以上の分子量を有するも のであることを特徴とする請求の範囲第 2項記載の骨 接合ピン。
ポリ — L一乳酸に約 1 一 1. 5重量％のハイ ドロキ シァパタイ トが配合されていることを特徴とする請求 の範囲第 1項記載の骨接合ピン。
ハイ ドロキシァパタイ トが約 5 - 1 0重量％配合さ れていることを特徵とする請求の範囲第 4項に記載の 骨接合ピン。
長軸方向に延伸されていることを特徵とする請求の 範囲第 1項及び第 4項に記載の骨接合ピン。
長軸方向に貫通孔を有することを特徵とする請求の 範囲第 1項及び第 4項に記載の骨接合ピン。
PCT/JP1987/000673 1986-09-11 1987-09-11 Clavette pour l'osteosynthese Ceased WO1988001849A1 (fr)

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DE3790560A DE3790560C2 (de) 1986-09-11 1987-09-11 Osteosynthetischer Nagel

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JP61/215077 1986-09-11
JP61215077A JPS6368155A (ja) 1986-09-11 1986-09-11 骨接合ピン

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DE3790560T1 (ja) 1988-09-15
DE3790560C2 (de) 1996-11-07

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