JP4793985B2 - Tendon or ligament tissue regeneration device - Google Patents
Tendon or ligament tissue regeneration device Download PDFInfo
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- JP4793985B2 JP4793985B2 JP2005517268A JP2005517268A JP4793985B2 JP 4793985 B2 JP4793985 B2 JP 4793985B2 JP 2005517268 A JP2005517268 A JP 2005517268A JP 2005517268 A JP2005517268 A JP 2005517268A JP 4793985 B2 JP4793985 B2 JP 4793985B2
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- 102000008186 Collagen Human genes 0.000 claims description 41
- 108010035532 Collagen Proteins 0.000 claims description 41
- 229920001436 collagen Polymers 0.000 claims description 41
- 239000002131 composite material Substances 0.000 claims description 40
- 229920000747 poly(lactic acid) Polymers 0.000 claims description 30
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- JVTAAEKCZFNVCJ-UHFFFAOYSA-N lactic acid Chemical compound CC(O)C(O)=O JVTAAEKCZFNVCJ-UHFFFAOYSA-N 0.000 claims description 12
- 230000001172 regenerating effect Effects 0.000 claims description 12
- 238000009958 sewing Methods 0.000 claims description 10
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- AEMRFAOFKBGASW-UHFFFAOYSA-N Glycolic acid Chemical compound OCC(O)=O AEMRFAOFKBGASW-UHFFFAOYSA-N 0.000 claims description 6
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- SLXKOJJOQWFEFD-UHFFFAOYSA-N 6-aminohexanoic acid Chemical compound NCCCCCC(O)=O SLXKOJJOQWFEFD-UHFFFAOYSA-N 0.000 claims description 3
- 229920000954 Polyglycolide Polymers 0.000 claims description 3
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- 239000002253 acid Substances 0.000 claims description 3
- 229960002684 aminocaproic acid Drugs 0.000 claims description 3
- 229920000933 poly (ε-caprolactam) Polymers 0.000 claims description 3
- 239000004633 polyglycolic acid Substances 0.000 claims description 3
- 238000000465 moulding Methods 0.000 claims description 2
- 210000001519 tissue Anatomy 0.000 description 14
- 230000008929 regeneration Effects 0.000 description 7
- 238000011069 regeneration method Methods 0.000 description 7
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- ONIBWKKTOPOVIA-BYPYZUCNSA-N L-Proline Chemical compound OC(=O)[C@@H]1CCCN1 ONIBWKKTOPOVIA-BYPYZUCNSA-N 0.000 description 1
- 206010061223 Ligament injury Diseases 0.000 description 1
- 208000016285 Movement disease Diseases 0.000 description 1
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- 241000288906 Primates Species 0.000 description 1
- ONIBWKKTOPOVIA-UHFFFAOYSA-N Proline Natural products OC(=O)C1CCCN1 ONIBWKKTOPOVIA-UHFFFAOYSA-N 0.000 description 1
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/08—Muscles; Tendons; Ligaments
-
- 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
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0004—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof bioabsorbable
Landscapes
- Health & Medical Sciences (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Rehabilitation Therapy (AREA)
- Rheumatology (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
- Materials For Medical Uses (AREA)
Description
本発明は、腱もしくは靱帯組織再生器具に関し、さらに詳細には、病変、損傷のために切断したヒト腱もしくは靱帯組織を再生するための器具に関する。 The present invention relates to a tendon or ligament tissue regeneration device, and more particularly to a device for regenerating human tendon or ligament tissue that has been cut due to a lesion or injury.
本出願は、参照によりここに援用されるところの、日本特許出願特願２００４‐０１５０２５号からの優先権を請求する。 This application claims the priority from Japanese Patent Application No. 2004-015025, which is incorporated herein by reference.
靭帯の損傷は、スポーツ関連の外傷としては最も頻度の高い疾患の一つである。靭帯の損傷を放置すれば、痛みや運動障害のみでなく、軟骨や間接半月の損傷などにより大きな障害に発展する可能性がある。腱の損傷としては、アキレス腱の断裂がよく知られている。腱もしくは靱帯の再建が必要な症例に対して現在最も広く行われている治療方法は、自家組織の移植である。自家組織の移植例については、臨床成功例は比較的良好であるが、採取部位の弊害や不足、さらに長さと強度が不十分なことから新たな人工の移植材料が求められている。 Ligament injury is one of the most common diseases for sports-related trauma. If the ligament damage is neglected, it may develop into a major disorder not only due to pain and movement disorders but also due to cartilage and indirect meniscus damage. As for tendon damage, tearing of the Achilles tendon is well known. The most widely used treatment for cases requiring tendon or ligament reconstruction is autologous tissue transplantation. As for autologous tissue transplantation cases, clinical success cases are relatively good, but new artificial transplantation materials are required because of the adverse effects and lack of collection sites and insufficient length and strength.
人工の移植材料の提案は多数存在する。例えば、組紐状に仕上げた吸収性人工腱（特許文献１）、束状の繊維糸の外周を生分解性吸収性繊維糸で螺旋状に巻回してある人工靭帯（特許文献２）、多層渦巻ロール形態の完全吸収性人工器官（特許文献３）、第１の構成要素は織物で第２の構成要素は細胞の接種および細胞の生長支持が可能な材料からなる移植可能な製品（特許文献４）がある。それらはいずれも生分解性材料で形成された円筒状のものを再生器具として使うものであるが、強度および可撓性において大きな問題が存在した。さらに、これらの再生器具では完全に組織が再生するまでには至っていない。また、人工腱および靭帯の展望を記述する文献も存在する（非特許文献１）。 There are many proposals for artificial implant materials. For example, an absorbent artificial tendon finished in a braid shape (Patent Document 1), an artificial ligament (Patent Document 2) in which the outer periphery of a bundle of fiber yarns is spirally wound with a biodegradable absorbent fiber yarn, and a multi-layer spiral Fully absorbable prosthesis in roll form (Patent Document 3), the first component is a woven fabric and the second component is an implantable product made of a material that can inoculate cells and support cell growth (Patent Document 4) ) All of them use a cylindrical shape made of a biodegradable material as a regenerating device, but there are significant problems in strength and flexibility. Furthermore, these regeneration devices have not completely regenerated the tissue. There is also a document describing the prospects of artificial tendons and ligaments (Non-Patent Document 1).
本発明は、従来の腱もしくは靱帯組織再生器具に代えて、強度および可撓性において優れており、臨床的に完全なる組織再生を可能とする腱もしくは靱帯組織再生器具を提供することにある。 An object of the present invention is to provide a tendon or ligament tissue regenerating instrument that is excellent in strength and flexibility and enables clinically complete tissue regeneration in place of a conventional tendon or ligament tissue regenerating instrument.
本発明者らは、上記事情を考慮して、種々鋭意検討したところ、腱もしくは靱帯組織再生器具として、生分解性材料で成型された糸状物で形成された長手方向の中空部を有するメッシュ構造の筒状体への改良、さらに筒状体が扁平形状に調製されることへの改良、加えて器具の全体が生分解性材料によって成型された糸状物によって縫製されていることへの改良によって、速やかに腱もしくは靱帯組織の再生が行われ、かつ生体吸収性が良く、生体内に残留異物を残さない腱もしくは靱帯組織再生器具を完成した。 The present inventors have conducted various studies in view of the above circumstances, and as a tendon or ligament tissue regeneration device, a mesh structure having a longitudinal hollow portion formed of a filamentous material molded from a biodegradable material. By improving to a cylindrical body, further improving the cylindrical body to be flattened, in addition to improving that the entire device is sewn with a thread formed from a biodegradable material As a result, a tendon or ligament tissue regeneration device was completed that rapidly regenerates the tendon or ligament tissue, has good bioabsorbability, and does not leave residual foreign matter in the living body.
すなわち本発明は、以下よりなる。
１．コラーゲンで成型された単糸とポリ乳酸で成型された単糸の組み合わせによる複合糸で形成された長手方向の中空部を有するメッシュ構造の筒状体の中空部長手方向に、生分解性材料で成型された糸状物の束が充填され、器具の全体が生分解性材料によって成型された糸状物によって長手方向に対して一定間隔で縫製されている扁平形状の腱もしくは靱帯組織再生器具。
２．コラーゲンで成型された単糸とポリ乳酸で成型された単糸の組み合わせによる複合糸が、合計2〜200本の単糸の組み合わせによる複合糸である前項１に記載の腱もしくは靱帯組織再生器具。
３．前記筒状体において、充填される糸状物の束の占める体積充填率が約50〜90％である前項１または２に記載の腱もしくは靱帯組織再生器具。
４．前記糸状物を成型する生分解性材料が、コラーゲン、ポリ乳酸、ポリグリコール酸、グリコール酸と乳酸の共重合体、乳酸とε−アミノカプロン酸の共重合体、ポリヒドロキシ酸、ポリ（ε−カプロラクタム）、及びポリアミノ酸から選ばれることを特徴とする前項１〜３のいずれか一に記載の腱もしくは靱帯組織再生器具。
５．前記糸状物が、単糸もしくは単糸の組み合わせによる複合糸である前項１〜４のいずれか一に記載の腱もしくは靱帯組織再生器具。
６．糸状物が、同一の生分解性材料で成型された単糸の組み合わせによる複合糸である前項１〜５のいずれか一に記載の靱帯組織再生器具
７．糸状物が、異なる生分解性材料で成型された単糸の組み合わせによる複合糸である前項１〜５のいずれか一に記載の靱帯組織再生器具。
８．異なる生分解性材料で成型された単糸の組み合わせが、コラーゲンで成型された単糸とコラーゲン以外の生分解性材料で成型された単糸の組み合わせである前項７に記載の腱もしくは靱帯組織再生器具。
９．コラーゲン以外の生分解性材料がポリ乳酸である前項８に記載の腱もしくは靱帯組織再生器具。
１０．複合糸が、合計2〜200本の単糸の組み合わせによる複合糸である前項５〜９に記載の腱もしくは靱帯組織再生器具。
１１．コラーゲンで成型された単糸とポリ乳酸で成型された単糸を合計2〜200本を組み合わせることによって調製された複合糸で形成され、長手方向に中空部を有するメッシュ構造の筒状体の中空部に、コラーゲンで成型された単糸とポリ乳酸で成型された単糸を合計2〜200本を組み合わせることによって調製された複合糸の束が充填され、器具の全体がコラーゲンで成型された単糸および／またはポリ乳酸で成型された単糸2〜200本を組み合わせて調製された複合糸によって長手方向に対して一定間隔で縫製されていることを特徴とする扁平形状の腱もしくは靱帯組織再生器具。
１２．コラーゲンで成型された単糸とポリ乳酸で成型された単糸の組み合わせによる複合糸を編み込むことにより、長手方向の中空部を有するメッシュ構造の筒状体を得、その中空部長手方向に、生分解性材料で成型された糸状物の束を充填し、さらにこの筒状体全体を生分解性材料で成型された糸状物によって長手方向に対して一定間隔で縫製することにより、筒状体を扁平状に調製する工程を含む、前項１〜１１に記載の腱もしくは靱帯組織再生器具の製造方法。
That is, this invention consists of the following.
1 . A biodegradable material is used in the longitudinal direction of the hollow portion of the mesh-structured cylindrical body having a hollow portion in the longitudinal direction formed by a composite yarn formed by a combination of a single yarn molded from collagen and a single yarn molded from polylactic acid. bundle of molded filamentous materials is filled, tendon or ligament tissue regenerating instrument of flat shape which is sewn at regular intervals to the longitudinal direction of the entire filamentous material that is molded by the biodegradable material of the device.
2. 2. The tendon or ligament tissue regeneration device according to item 1 above, wherein the composite yarn comprising a combination of a single yarn molded from collagen and a single yarn molded from polylactic acid is a composite yarn comprising a combination of 2 to 200 single yarns in total.
3. 3. The tendon or ligament tissue regenerating instrument according to item 1 or 2, wherein a volume filling factor occupied by a bundle of filaments to be filled is about 50 to 90% in the cylindrical body.
4 . The biodegradable material for molding the filamentous material is collagen, polylactic acid, polyglycolic acid, a copolymer of glycolic acid and lactic acid, a copolymer of lactic acid and ε-aminocaproic acid, polyhydroxy acid, poly (ε-caprolactam ), And a polyamino acid, The tendon or ligament tissue regeneration device according to any one of items 1 to 3 above.
5 . 5. The tendon or ligament tissue regeneration device according to any one of the preceding items 1 to 4, wherein the filamentous material is a single yarn or a composite yarn composed of a single yarn.
6 . Filamentous materials is the same as defined in any one of claim 1 to 5 before a composite yarn with a combination of single yarns which are molded of a biodegradable material ligament tissue regenerating instrument 7. Filamentous materials is different ligament tissue regenerating instrument according to any one of claim 1 to 5 before a composite yarn with a combination of single yarns which are molded of a biodegradable material.
8). Different combinations of single yarns which are molded of a biodegradable material, tendon or ligament tissue regeneration according to the above 7, which is a combination of single yarns which are molded of a biodegradable material other than single yarn and collagen molded collagen Instruments.
9. 9. The tendon or ligament tissue regeneration device according to item 8 above, wherein the biodegradable material other than collagen is polylactic acid.
10. 10. The tendon or ligament tissue regeneration device as described in 5 to 9 above, wherein the composite yarn is a composite yarn comprising a combination of a total of 2 to 200 single yarns.
11 . Is formed of a composite yarn prepared by combining the single yarn total 2-200 present which is molded with a single yarn and polylactic acid molded with collagen, the mesh structure having a hollow portion in the longitudinal direction of the tubular body The hollow part was filled with a bundle of composite yarns prepared by combining a total of 2 to 200 single yarns molded with collagen and polylactic acid, and the entire device was molded with collagen A flat tendon or ligament tissue characterized by being sewn at a constant interval in the longitudinal direction with a composite yarn prepared by combining 2 to 200 single yarns molded with single yarn and / or polylactic acid Reproduction equipment.
12 By knitting a composite yarn composed of a combination of a single yarn molded with collagen and a single yarn molded with polylactic acid, a tubular body having a mesh structure having a hollow portion in the longitudinal direction is obtained. By filling a bundle of thread-like materials molded with a degradable material and further sewing the entire tubular body with a thread-like material molded with a biodegradable material at regular intervals in the longitudinal direction , 12. A method for producing a tendon or ligament tissue regeneration device as described in 1 to 11 above , which comprises a step of preparing a flat shape.
本発明の腱もしくは靱帯組織再生器具は、強度および可撓性において優れており、臨床的に完全なる組織再生を可能とする腱もしくは靱帯組織再生器具である。 The tendon or ligament tissue regeneration device of the present invention is a tendon or ligament tissue regeneration device that is excellent in strength and flexibility and enables clinically complete tissue regeneration.
１１・・・中空筒状体
１２・・・糸状物の束
２１・・・腱もしくは靱帯組織再生器具
２２・・・手術糸
２３・・・骨
２４・・・ドリルなどであけた穴DESCRIPTION OF SYMBOLS 11 ... Hollow cylindrical body 12 ... Bundle of filamentous material 21 ... Tendon or ligament tissue regeneration device 22 ... Surgical thread 23 ... Bone 24 ... Hole drilled
本発明における腱もしくは靱帯組織とは、ヒト霊長類、非ヒト霊長類または齧歯類動物の腱もしくは靱帯が例示される。 Examples of the tendon or ligament tissue in the present invention include human primate, non-human primate or rodent tendon or ligament.
本発明において、腱もしくは靱帯組織再生器具は、全て生分解性材料で成型された糸状物を使用する。基本構成は、長手方向の中空部を有するメッシュ構造の筒状体であって、その中空部長手方向に、糸状物の束が充填されている構成を含む。このメッシュ構造は、本発明の本質的特徴の一つであり、再生器具の可撓性における優位性を達成する。このメッシュ構造の密度は、後記する形成される糸状物の口径に依存するが、一般的には編み密度が、長手方向に5〜20本/cm、好ましくは8〜15本/cm、円周方向に15〜35本/cm、好ましくは20〜30本/cmである。メッシュ体は市販の編み機で容易に作製することができる。 In the present invention, the tendon or ligament tissue regeneration device uses a thread-like material that is molded from a biodegradable material. The basic configuration includes a cylindrical body having a mesh structure having a hollow portion in the longitudinal direction, and a bundle of filaments is filled in the longitudinal direction of the hollow portion. This mesh structure is one of the essential features of the present invention and achieves an advantage in the flexibility of the regenerative device. The density of this mesh structure depends on the diameter of the thread-like material to be described later, but generally the knitting density is 5 to 20 yarns / cm in the longitudinal direction, preferably 8 to 15 yarns / cm, and the circumference. The direction is 15 to 35 / cm, preferably 20 to 30 / cm. The mesh body can be easily produced with a commercially available knitting machine.
本発明の別の本質的な特徴は、長手方向の中空部に糸状物の束が充填されたメッシュ構造の筒状体が扁平形状であることである。扁平形状とは、例えば筒状体に糸状物の束が充填された後に、筒状体の横側、つまり長手方向に対して直角に適当な圧力を加え、円形の筒状体を扁平形の筒状体にすることで達成される。この筒状体の扁平化によって、再生器具の強度の優位性を達成する。扁平形の筒状体の形状は、再生する組織つまり腱もしくは靱帯によって適時選択可能であり、例えば腱再生器具の場合、短径は約0.2mm〜約5mm、好ましくは約0.5mm〜約3mm、長径は約0.5mm〜約50mm、好ましくは約1mm〜約30mmが例示され、靱帯再生器具の場合、短径は約0.2mm〜約2mm、好ましくは約0.5mm〜約1.5mm、長径は約2mm〜約15mm、好ましくは約3mm〜約10mmが例示される。 Another essential feature of the present invention is that the cylindrical body having a mesh structure in which a hollow portion in the longitudinal direction is filled with a bundle of filamentous materials has a flat shape. The flat shape means that, for example, after a cylindrical body is filled with a bundle of yarns, an appropriate pressure is applied to the side of the cylindrical body, that is, at a right angle to the longitudinal direction, so that the circular cylindrical body is flattened. This is achieved by forming a cylindrical body. By this flattening of the cylindrical body, the strength advantage of the regenerative device is achieved. The shape of the flat cylindrical body can be selected as appropriate depending on the tissue to be regenerated, i.e., the tendon or ligament. For example, in the case of a tendon regeneration device, the minor axis is about 0.2 mm to about 5 mm, preferably about 0.5 mm to about 3 mm, The major axis is about 0.5 mm to about 50 mm, preferably about 1 mm to about 30 mm. In the case of a ligament regeneration device, the minor axis is about 0.2 mm to about 2 mm, preferably about 0.5 mm to about 1.5 mm, and the major axis is about 2 mm. To about 15 mm, preferably about 3 mm to about 10 mm.
さらに、本発明の別の本質的な特徴は、長手方向の中空部に糸状物の束が充填されたメッシュ構造の筒状体である器具全体が、生分解性材料によって成型された糸状物によって縫製されていることである。特に、扁平形の筒状体について縫製されていることが好ましい。縫製は例えば、長手方向に対して交差させて一定間隔でミシン等の機具で縫うことで達成できる。この縫製によって、再生器具の強度における優位性を達成する。ここで一定間隔とは、例えば、1mm〜10mm、特に好ましくは1.5mm〜8mmが例示され、縫製におけるミシンピッチとしては0.5mm〜2mm、特に好ましくは0.7mm〜1.5mmが例示される。本発明の腱もしくは靱帯組織再生器具は、適当な長さに切断後、端部を生分解性材料によって成型された糸状物によって縫い、最終的な仕上げを行うことができる。製品は、たとえば、中和処理、洗浄、風乾することで完成する。さらに所望によりガンマ線滅菌等を処すことも可能である。 Further, another essential feature of the present invention is that the entire device, which is a mesh-shaped tubular body in which a bundle of filamentous materials is filled in a hollow portion in the longitudinal direction, is formed by a filamentous material molded from a biodegradable material. That is to be sewn. In particular, it is preferable that the flat cylindrical body is sewn. Sewing can be accomplished, for example, by crossing with the longitudinal direction and sewing with a machine such as a sewing machine at regular intervals. This sewing achieves an advantage in the strength of the regenerative device. Here, the fixed interval is, for example, 1 mm to 10 mm, particularly preferably 1.5 mm to 8 mm, and the sewing pitch in sewing is 0.5 mm to 2 mm, particularly preferably 0.7 mm to 1.5 mm. After the tendon or ligament tissue regeneration device of the present invention is cut to an appropriate length, the end can be sewn with a thread-like material molded from a biodegradable material, and the final finish can be performed. The product is completed by, for example, neutralization, washing, and air drying. Further, gamma sterilization or the like can be performed as desired.
前記筒状体に充填される糸状物の束は、筒状体における体積充填率が約50〜90％、より好ましくは50〜80％である。糸状物の束の数は、糸状物の後記定義する口径に依存するものであるが、一般的には300〜900本、より好ましくは400〜750本程度である。例えば中抜きの四角の枠に糸状物を巻きつけ所望回数回転させたのち、枠から取り出し、端部を切断すれば、巻き回数の2倍の数の糸状物からなる束が調製される。束の充填方法は特に限定されるものではないが、例えば、糸状物の束を調製後、これに予め生分解性材料で成型された糸状物から調製されたメッシュ構造のシーツを巻きつけることによってもよい。あるいは、予め生分解性材料で成型された糸状物から調製された長手方向の中空部を有するメッシュ構造の円形の筒状体を作っておき、この中空部に挿入可能な口径に調整された糸状物の束を挿入していくことでもよい。 The bundle of filaments filled in the cylindrical body has a volume filling rate in the cylindrical body of about 50 to 90%, more preferably 50 to 80%. The number of bundles of the filamentous material depends on the diameter defined later, but is generally about 300 to 900, more preferably about 400 to 750. For example, if a filament is wound around a hollow rectangular frame and rotated a desired number of times, then taken out from the frame and cut at the end, a bundle of filaments twice as many as the number of windings is prepared. The method for filling the bundle is not particularly limited. For example, after preparing a bundle of filamentous material, a sheet of mesh structure prepared from a filamentous material previously molded from a biodegradable material is wrapped around the bundle. Also good. Alternatively, a circular cylindrical body having a mesh structure having a hollow portion in the longitudinal direction prepared from a filamentous material previously molded from a biodegradable material is prepared, and the thread shape is adjusted to have a diameter that can be inserted into the hollow portion. It is also possible to insert a bundle of things.
前記筒状体の長さは、折りたたんで使用するのであれば長いものでも良いが、各使用目的の例えば人の靭帯もしくは腱の長さから適当な長さに切断されていればよい。例えば、以下から選ばれる外形である腱もしくは靱帯組織再生器具は好適な実施態様である。
１）腱組織再生器具の場合において、長手方向の長さが約10mm〜約1000mm、より好ましくは約20mm〜約800mm、幅が約0.5mm〜約50mm、より好ましくは約1mm〜約32mmである。
２）靱帯組織再生器具の場合において、長手方向の長さが約10mm〜約500mm、より好ましくは約50mm〜約400mm、幅が約2mm〜約15mm、より好ましくは約3mm〜約10mmである。The length of the cylindrical body may be long as long as it is folded and used, but it may be cut to an appropriate length from the length of a human ligament or tendon for each purpose of use. For example, a tendon or ligament tissue regeneration device having an outer shape selected from the following is a preferred embodiment.
1) In the case of a tendon tissue regeneration device, the length in the longitudinal direction is about 10 mm to about 1000 mm, more preferably about 20 mm to about 800 mm, and the width is about 0.5 mm to about 50 mm, more preferably about 1 mm to about 32 mm. .
2) In the case of a ligament tissue regeneration device, the longitudinal length is about 10 mm to about 500 mm, more preferably about 50 mm to about 400 mm, and the width is about 2 mm to about 15 mm, more preferably about 3 mm to about 10 mm.
本発明で使用する糸状物は生分解性材料によって成型されたものである。生分解性材料とは、生体内の分解酵素、酸またはアルカリにより分解する材料であって、体液の浸透を許容することが特徴である。例えば生分解性材料としては公知の材料を広く利用でき、市販の糸状物あるいは公知の方法で調製される糸状物が利用できる。好適な生分解性材料としては、コラーゲン、ポリ乳酸、ポリグリコール酸、グリコール酸と乳酸の共重合体、乳酸とε−アミノカプロン酸の共重合体、ポリヒドロキシ酸、ポリ（ε−カプロラクタム）、およびポリアミノ酸から選ばれる。
本発明に使用されるコラーゲンとしては、その由来は特に限定されないが、一般的には、牛、豚、鳥類、魚類、霊長類、兎、羊、鼠、人などが挙げられる。また、コラーゲンはこれらの皮膚、腱、骨、軟骨、臓器などから公知の各種抽出方法により得られるものであるが、これらの特定の部位に限定されるものではない。さらに、本発明に利用されるコラーゲンのタイプについては、特定の分類可能な型に限定されるものではないが、取扱い上の観点から、I、III、IV型が好適である。The filamentous material used in the present invention is formed from a biodegradable material. The biodegradable material is a material that is decomposed by a degrading enzyme, acid, or alkali in a living body, and is characterized by allowing permeation of body fluids. For example, as the biodegradable material, known materials can be widely used, and commercially available filamentous materials or filamentous materials prepared by a known method can be utilized. Suitable biodegradable materials include collagen, polylactic acid, polyglycolic acid, copolymers of glycolic acid and lactic acid, copolymers of lactic acid and ε-aminocaproic acid, polyhydroxy acids, poly (ε-caprolactam), and Selected from polyamino acids.
The origin of the collagen used in the present invention is not particularly limited, but generally includes cows, pigs, birds, fishes, primates, rabbits, sheep, rabbits, humans, and the like. Collagen can be obtained from these skin, tendon, bone, cartilage, organ and the like by various known extraction methods, but is not limited to these specific sites. Furthermore, the type of collagen used in the present invention is not limited to a specific type that can be classified, but types I, III, and IV are preferred from the viewpoint of handling.
糸状物は、単糸、単糸を組み合わせた複合糸である。
単糸は、十分な強度が得られるのであれば、好適に利用できる。単糸の径は、約5μm〜約100μm、より好ましくは約10μm〜80μmである。
単糸は、市販のものを広く利用可能である。好適な材料の１例として、コラーゲン単糸を用いることができ、該コラーゲン単糸は例えばコラーゲン溶液を押出成形することにより調製できる。コラーゲンを溶解する溶媒は、既知のいかなる物質を用いても良いが、常法に準じて水を使用することが好ましい。コラーゲン溶液濃度は、0.1〜30ｗｔ％であり、好ましくは0.5〜10ｗｔ％である。コラーゲン繊維を製造するための押出成形法としては、特に制限されないが、通常、凝固浴はエチルアルコールであり、押出速度は約100mm〜500mm／秒である。凝固浴から取り出した繊維の冷却は、コラーゲンの変性が起きる約40℃付近以下であれば良いが、好ましくは4℃〜20℃に保つ。該繊維径は約5μm〜100μm、好ましくは約10μm〜80μmである。The filamentous material is a single yarn or a composite yarn obtained by combining single yarns.
A single yarn can be suitably used as long as sufficient strength is obtained. The diameter of the single yarn is about 5 μm to about 100 μm, more preferably about 10 μm to 80 μm.
As the single yarn, commercially available ones can be widely used. As an example of a suitable material, a collagen single yarn can be used, and the collagen single yarn can be prepared, for example, by extruding a collagen solution. As the solvent for dissolving collagen, any known substance may be used, but it is preferable to use water according to a conventional method. The collagen solution concentration is 0.1-30 wt%, preferably 0.5-10 wt%. Although it does not restrict | limit especially as an extrusion method for manufacturing a collagen fiber, Usually, a coagulation bath is ethyl alcohol and an extrusion rate is about 100 mm-500 mm / sec. The fiber taken out from the coagulation bath may be cooled to about 40 ° C. or less at which collagen denaturation occurs, but preferably kept at 4 ° C. to 20 ° C. The fiber diameter is about 5 μm to 100 μm, preferably about 10 μm to 80 μm.
また、生体内での分解性の調整あるいは強度の強化を行うためには単糸を組み合わせた複合糸が、より好適である。複合糸は、合計2〜200本より好ましくは2〜30本の単糸からなり、単糸を単に平行に引き揃えた集合体、単糸を縒り合わせた縒糸、または一部の単糸のみを縒り合わせた縒糸を作成し、残りの単糸を引き揃えた集合体として使用するなど、特に限定されるものではない。
したがって、複合糸は、以下のいずれかである。
１）同種の生分解性材料からなる単糸の、合計2〜200本、より好ましくは2〜30本の組み合わせである。
２）異種の生分解性材料からなる単糸の、合計2〜200本、より好ましくは2〜30本の組み合わせである。
同種の場合、複合糸は、上記のコラーゲン単糸、ポリ乳酸単糸等を単品で合計2〜200本より好ましくは2〜30本を単に引き揃えた集合体、または市販の糸撚り機で縒り合わせた縒糸等として調製される。縒糸は、再生器具の強度あるいは溶解時間の調整の優位性を達成する。異種の場合、複合糸は、異なる単糸を組み合わせて合計2〜200本より好ましくは2〜30本を引き揃えたり、あるいは縒り合わせたりすることで調製され、組み合わせの比率によって、生体内での詳細な分解時間の制御を可能とする。例えば、コラーゲン単糸とポリ乳酸単糸の組み合わせでは、コラーゲン単糸の比率が多いと分解しやすく、一方、ポリ乳酸単糸の比率が多いと分解しにくく、長く体内に残るという性質をもつ。本発明の好適な実施態様は、異種の生分解性材料からなる単糸の組み合わせであって、コラーゲンで成型される単糸とポリ乳酸で成型される単糸の組み合わせである。Further, in order to adjust the degradability in the living body or strengthen the strength, a composite yarn combining single yarns is more preferable. The composite yarn consists of 2 to 200 single yarns in total, more preferably 2 to 30 single yarns. It is not particularly limited, for example, to create a kite string obtained by twisting together yarns and using the remaining single yarn as an aggregate.
Therefore, the composite yarn is one of the following.
1) A total of 2 to 200, more preferably 2 to 30, single yarns made of the same kind of biodegradable material.
2) A total of 2 to 200, more preferably 2 to 30, single yarns made of different types of biodegradable materials.
In the case of the same type, the composite yarn is twisted with the above-mentioned collagen single yarn, polylactic acid single yarn, etc. in a single piece, a total of 2 to 200, more preferably 2 to 30, or a commercially available yarn twister. It is prepared as a combined silk thread. The kite string achieves the advantage of adjusting the strength or dissolution time of the regenerator. In the case of different types, the composite yarn is prepared by combining or twisting a total of 2 to 200, more preferably 2 to 30 by combining different single yarns, and depending on the combination ratio, Enables detailed control of disassembly time. For example, a combination of a collagen single yarn and a polylactic acid single yarn has a property of being easily decomposed when the ratio of the collagen single yarn is large, whereas it is difficult to be decomposed when the ratio of the polylactic acid single yarn is large and remains in the body for a long time. A preferred embodiment of the present invention is a combination of single yarns made of different types of biodegradable materials, which is a combination of a single yarn molded from collagen and a single yarn molded from polylactic acid.
また、その他、市販の単糸または縒糸を広く利用できる。例えば、ポリ乳酸の単糸（商品名：ラクトロン、モノフィラメント カネボウ合繊社製）、ポリ乳酸の単糸6本からなる縒糸（商品名：ラクトロン、マルチフィラメント カネボウ合繊社製）等が例示される。 In addition, commercially available single yarn or kite yarn can be widely used. Examples include polylactic acid single yarn (trade name: Lactron, manufactured by Monofilament Kanebo Synthetic Co., Ltd.), warp yarn consisting of six polylactic acid single yarns (trade name: Lactron, manufactured by Multifilament Kanebo Synthetic Co., Ltd.)
本発明の腱もしくは靱帯組織再生器具の好適な実施態様は、長手方向を有し、扁平状である腱もしくは靱帯組織再生器具において、コラーゲンで成型された単糸とポリ乳酸で成型された単糸を合計2〜200本、より好ましくは2〜30本を組み合わせることによって調製された複合糸で形成され、長手方向に中空部を有するメッシュ構造の扁平筒状体であって、その中空部に、コラーゲンで成型された単糸とポリ乳酸で成型された単糸を合計2〜200本、より好ましくは2〜30本を組み合わせることによって調製された複合糸の束が充填されていることを特徴とする腱もしくは靱帯組織再生器具である。さらに、本発明の好適な実施態様は、腱もしくは靱帯組織再生器からなる器具の全体がコラーゲンで成型された単糸および／またはポリ乳酸で成型された単糸を合計2〜200本、より好ましくは2〜30本を組み合わせることによって調製された複合糸によって縫製されている腱もしくは靱帯組織再生器具である。 A preferred embodiment of the tendon or ligament tissue regeneration device of the present invention is a tendon or ligament tissue regeneration device having a longitudinal direction and having a flat shape, and a single yarn molded with collagen and a single yarn molded with polylactic acid. Is a flat cylindrical body having a mesh structure formed of a composite yarn prepared by combining 2 to 200 in total, more preferably 2 to 30 and having a hollow portion in the longitudinal direction, and in the hollow portion, It is characterized by being filled with a bundle of composite yarns prepared by combining a total of 2 to 200, more preferably 2 to 30, single yarns molded with collagen and polylactic acid. Tendon or ligament tissue regeneration device. Furthermore, a preferred embodiment of the present invention is preferably a total of 2 to 200 single yarns made of collagen and / or polylactic acid. Is a tendon or ligament tissue regeneration device that is sewn with a composite thread prepared by combining 2-30 strands.
本発明は、以上のように定義された腱もしくは靱帯組織再生器具の製造方法も対象とし、より好適な実施態様としては、生分解性材料で成型された糸状物を編み込むことにより、長手方向の中空部を有するメッシュ構造の筒状体を得、その中空部長手方向に、生分解性材料で成型された糸状物の束を充填し、さらにこの筒状体全体を生分解性材料で成型された糸状物によって縫製することにより、筒状体を扁平状に調製する工程を含む腱もしくは靱帯組織再生器具の製造方法である。なお、この各文言の意味は、全て上記説明が援用される。 The present invention is also directed to a method for producing a tendon or ligament tissue regeneration device as defined above, and in a more preferred embodiment, by braiding a filamentous material molded from a biodegradable material, A mesh-shaped cylindrical body having a hollow portion is obtained, and in the longitudinal direction of the hollow portion, a bundle of filaments molded with a biodegradable material is filled, and the entire cylindrical body is molded with a biodegradable material. This is a method for manufacturing a tendon or ligament tissue regeneration device, which includes a step of preparing a cylindrical body in a flat shape by sewing with a thread. The above explanation is used for the meaning of each word.
以下に本発明を、実施例を用いて詳細に説明するが、本発明はこれらの実施例に限定されるものではない。 Hereinafter, the present invention will be described in detail using examples, but the present invention is not limited to these examples.
実施例
I型およびIII型コラーゲンの混合物7重量％水溶液150mLを99.5容量％エタノール（和光純薬製、特級）3L凝固浴中に押し出し脱水凝固することで、繊維径50μmのコラーゲン単糸を得た。
コラーゲン単糸3本と、ポリ乳酸単糸6本からなる縒糸（ラクトロン、マルチフィラメント カネボウ合繊社製）3本を引き揃え、編み機（圓井繊維機械株式会社製）を用いて、編み密度が長手方向に約10本/cm、円周方向に約27本/cm、長さ30mm、幅4mmの中空メッシュ体を作成した。
一方で、コラーゲン単糸1本と、上記ポリ乳酸縒糸1本を組み合わせた複合糸を作成した。この複合糸を、１辺が40mmの中抜きの正方形の枠に巻き付けた後、端部をカットすることにより、複合糸の束を得た。
この複合糸の束を、中空メッシュ体の中空部長手方向に挿入した後、扁平状になるように押しつぶし、ポリ乳酸縒糸2本を組み合わせた複合糸で、ミシンを用いて縫製した。端部のメッシュ体からはみ出している複合糸の束をカット後、メッシュ体の端部をポリ乳酸縒糸2本を組み合わせた複合糸で縫製した。
図１に具体例を示した。Example
A collagen single yarn having a fiber diameter of 50 μm was obtained by extruding 150 mL of a 7 wt% aqueous solution of a mixture of type I and type III into a 9 L ethanol (manufactured by Wako Pure Chemicals, special grade) 3 L coagulation bath and dehydrating and solidifying.
The three knitting yarns (Lactron, manufactured by Multifilament Kanebo Gosei Co., Ltd.) consisting of 3 collagen single yarns and 6 polylactic acid single yarns are aligned and the knitting density is adjusted using a knitting machine (Sakurai Textile Machinery Co., Ltd.) A hollow mesh body having a length of about 10 / cm, a circumference of about 27 / cm, a length of 30 mm, and a width of 4 mm was prepared.
On the other hand, a composite yarn was produced by combining one collagen single yarn and one polylactic acid cocoon yarn. The composite yarn was wound around a square frame with a side of 40 mm, and then the end portion was cut to obtain a bundle of composite yarn.
This bundle of composite yarns was inserted in the longitudinal direction of the hollow portion of the hollow mesh body, then crushed so as to be flat, and sewn using a sewing machine with a composite yarn combining two polylactic acid cocoon yarns. After cutting the bundle of composite yarn protruding from the mesh body at the end, the end of the mesh body was sewn with a composite yarn combining two polylactic acid silk threads.
A specific example is shown in FIG.
実験例１
実施例で得られた靱帯組織再生器具の一点支持引張強度をオートグラフにより測定した。具体的には、靱帯組織再生器具を生理食塩水に約１５分浸漬後、端から5mmの位置に4-0プロリン縫合糸を通して輪を作った方を試験片の上部として、4-0プロリンの輪をオートグラフに取り付けたフック状物に掛けた。試験片下端より10mmまでの部分をチャックにより固定して測定した。その結果、靱帯組織再生器具の一点支持引張強度は、約85Nであった。Experimental example 1
The one-point support tensile strength of the ligament tissue regeneration device obtained in the examples was measured by an autograph. Specifically, after immersing the ligament tissue regeneration device in physiological saline for about 15 minutes and using a 4-0 proline suture thread at a position 5 mm from the end as the top of the test piece, The ring was hung on a hook attached to the autograph. Measurement was performed by fixing a portion up to 10 mm from the lower end of the test piece with a chuck. As a result, the single point support tensile strength of the ligament tissue regeneration device was about 85N.
実験例２
実施例で得られた靱帯組織再生器具を用いて、家兎の内側側副靱帯の再生を行った。具体的には、家兎の内側側副靱帯を切除後、大腿骨および脛骨にドリルを用いて4.5mmの穴をあけた。ナイロン手術糸を実施例で得られた靱帯組織再生器具の端部にかけ、ドリル穴に挿入後、図２に示すように縫合した（写真：図３）。5ヶ月後、靱帯の再生が確認され、さらに、再生した靱帯は骨に接合していた（図４）。ここで、大腿骨および脛骨ごと取り出し、引っ張り試験器を用いて再生後の靱帯の引っ張り強度を測定した。引っ張り速度は、2mm/minとした。その結果、降伏点113M、最大付加加重119Nであった。健常な家兎は、降伏点209M、最大付加加重約200Nであるが、臨床における靱帯再生の程度としては十分な強度であるといえる。Experimental example 2
Using the ligament tissue regeneration device obtained in the examples, the inner collateral ligament of the rabbit was regenerated. Specifically, after excising the medial collateral ligament of the rabbit, a 4.5mm hole was drilled in the femur and tibia using a drill. A nylon surgical thread was applied to the end of the ligament tissue regeneration device obtained in the example, inserted into a drill hole, and then sutured as shown in FIG. 2 (photo: FIG. 3). After 5 months, regeneration of the ligament was confirmed, and the regenerated ligament was joined to the bone (FIG. 4). Here, the femur and tibia were taken out together, and the tensile strength of the ligament after regeneration was measured using a tensile tester. The pulling speed was 2 mm / min. As a result, the yield point was 113M and the maximum additional load was 119N. A healthy rabbit has a yield point of 209M and a maximum additional weight of about 200N, but it can be said to have sufficient strength as a level of ligament regeneration in clinical practice.
本発明の腱もしくは靱帯組織再生器具は、強度および可撓性において優れており、医療分野において極めて有用な腱もしくは靱帯組織の再生器具を提供するものである。 The tendon or ligament tissue regeneration device of the present invention is excellent in strength and flexibility, and provides a tendon or ligament tissue regeneration device that is extremely useful in the medical field.
Claims (12)
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| JP2005517268A JP4793985B2 (en) | 2004-01-23 | 2005-01-21 | Tendon or ligament tissue regeneration device |
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| JP2004015025 | 2004-01-23 | ||
| JP2004015025 | 2004-01-23 | ||
| PCT/JP2005/000740 WO2005070340A1 (en) | 2004-01-23 | 2005-01-21 | Tendon or ligament tissue regenerator |
| JP2005517268A JP4793985B2 (en) | 2004-01-23 | 2005-01-21 | Tendon or ligament tissue regeneration device |
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| JP4793985B2 true JP4793985B2 (en) | 2011-10-12 |
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| CA2598268C (en) | 2005-02-18 | 2011-01-04 | Synthasome Inc. | Synthetic structure for soft tissue repair |
| JP2010522042A (en) | 2007-03-20 | 2010-07-01 | セリカ テクノロジーズ インコーポレイティッド | Tendon prosthesis and method of manufacturing the same |
| JP5320726B2 (en) * | 2007-11-07 | 2013-10-23 | ニプロ株式会社 | Method for producing collagen fiber bundle |
| KR101275163B1 (en) * | 2011-05-26 | 2013-06-17 | 한국생산기술연구원 | 3-dimensional porous scaffold and manufacturing method thereof |
| CN110693629A (en) * | 2019-11-19 | 2020-01-17 | 上海市第六人民医院 | Sectional and gradient functional tendon sleeve implantation instrument and preparation method thereof |
Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS51148289A (en) * | 1975-06-12 | 1976-12-20 | Nippi Inc | Method of producing artificial tendon |
| US4584772A (en) * | 1983-05-24 | 1986-04-29 | Black & Decker Overseas Ag | Hand-held planing tool with a rotary cutter |
| JPH0252648A (en) * | 1988-07-01 | 1990-02-22 | Minnesota Mining & Mfg Co <3M> | Method and apparatus for substituting wounded biological organization |
| US5116373A (en) * | 1989-08-28 | 1992-05-26 | Sulzer Brothers Limited | Pull-through appliance |
| JP2003500162A (en) * | 1999-05-27 | 2003-01-07 | スミス アンド ネフュー ピーエルシー | Connective tissue reconstruction implant |
-
2005
- 2005-01-21 JP JP2005517268A patent/JP4793985B2/en not_active Expired - Fee Related
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Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS51148289A (en) * | 1975-06-12 | 1976-12-20 | Nippi Inc | Method of producing artificial tendon |
| US4584772A (en) * | 1983-05-24 | 1986-04-29 | Black & Decker Overseas Ag | Hand-held planing tool with a rotary cutter |
| JPH0252648A (en) * | 1988-07-01 | 1990-02-22 | Minnesota Mining & Mfg Co <3M> | Method and apparatus for substituting wounded biological organization |
| US5116373A (en) * | 1989-08-28 | 1992-05-26 | Sulzer Brothers Limited | Pull-through appliance |
| JP2003500162A (en) * | 1999-05-27 | 2003-01-07 | スミス アンド ネフュー ピーエルシー | Connective tissue reconstruction implant |
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| WO2005070340A1 (en) | 2005-08-04 |
| JPWO2005070340A1 (en) | 2007-09-06 |
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