JP2008237896A - Connective tissue forming base material, and manufacturing method for connective tissue using it - Google Patents
Connective tissue forming base material, and manufacturing method for connective tissue using it Download PDFInfo
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本発明は、体内に埋入することで欠損組織の代替材としての結合組織体を形成することのできる結合組織体形成基材ならびに該結合組織体の製造方法に関する。 The present invention relates to a connective tissue-forming substrate capable of forming a connective tissue body as a substitute for a defective tissue by being implanted in the body, and a method for producing the connective tissue body.
生体に対して化学的に安定な人工物の構造体を生体の皮下や腹腔などへ埋入移植し、一ヶ月程度放置することで、構造体の表面に組織体をカプセル形成して結合組織体とし、これを欠損組織の代替材として適用する試みが実施されている。しかし、結合組織体形成用基材としての構造体の表面に形成された組織体は、極めて薄いために自立性が無く、結合組織体を欠損組織の代替材として移植するには、生体組織との吻合操作が極めて困難であると同時に、大きな臓器の代替材料、例えば中大口径の血管として使用するには機械的強度が不足する欠点を持っている。 An artificial structure that is chemically stable to the living body is implanted and transplanted into the subcutaneous body or abdominal cavity of the living body, and left for about a month to form a tissue body on the surface of the structure to form a connective tissue body. Attempts have been made to apply this as a substitute for a defective tissue. However, the tissue formed on the surface of the structure as a base material for forming a connective tissue is extremely thin and has no self-supporting property. To transplant a connective tissue as a substitute for a defective tissue, The anastomosis operation is extremely difficult, and at the same time, the mechanical strength is insufficient for use as a substitute material for a large organ, for example, a blood vessel having a medium or large diameter.
この欠点を克服するために構造体の表面を親水性、イオン性などに改質し、組織体の付着を促進することにより組織体の厚みを厚くする技術が開発されている（例えば、特許文献１参照）。 In order to overcome this drawback, a technique has been developed to increase the thickness of the tissue by modifying the surface of the structure to be hydrophilic or ionic, and promoting adhesion of the tissue (for example, Patent Documents). 1).
結合組織体の厚みを厚くする目的で、生体内に埋入させる基材を工夫することで、複数の代替用結合組織体を得、これらを積層させて、体内において一体化させることによって、厚みを増す技術が開発されている（例えば、特許文献２参照）。 For the purpose of increasing the thickness of the connective tissue body, by devising a base material to be embedded in the living body, a plurality of alternative connective tissue bodies are obtained, and these are laminated and integrated in the body to obtain a thickness. Has been developed (see, for example, Patent Document 2).
同様に、生体内に埋入させる基材を工夫することで、結合組織体の一部分の厚みを厚くして、生体組織の機械的な自立性を増す技術が開発されている（例えば、特許文献３参照）。 Similarly, by devising a base material to be embedded in a living body, a technique for increasing the mechanical independence of a living tissue by increasing the thickness of a part of a connective tissue body has been developed (for example, Patent Documents). 3).
他の方法では、カプセル状に形成された結合組織体の生体組織との吻合部分のみに自立性を持たせるために、例えばシリコン樹脂のリングにより補強を加えて、吻合操作を容易にするようにしている（例えば、特許文献４参照）。
上記特許文献１に代表されるような埋入構造体を表面処理する方法では、構造体を生体の皮下に１ヶ月間埋入すると最大で０．３ｍｍ程度の厚みの組織体が構造体表面に形成される。しかし、この組織体からなる結合組織体を人工血管として使用するために、組織体に覆われた構造体を取り除くと、厚さ０．３ｍｍでは、結合組織体だけで自立することは難しく、生体組織との吻合操作が困難である。また、厚さが薄いために大きな人工臓器、例えば、中大口径の人工血管として利用するには、機械的な強度が不足している。 In the method of surface-treating an embedded structure as represented by Patent Document 1 above, when the structure is implanted subcutaneously in a living body for one month, a tissue having a thickness of about 0.3 mm at the maximum is formed on the surface of the structure. It is formed. However, in order to use a connective tissue body composed of this tissue body as an artificial blood vessel, if the structure covered with the tissue body is removed, it is difficult to stand alone with a connective tissue body at a thickness of 0.3 mm. Anastomosis with tissue is difficult. Further, since the thickness is small, the mechanical strength is insufficient for use as a large artificial organ, for example, a medium-large-diameter artificial blood vessel.
特許文献２による別途、組織体を重ねる方法では、結合組織体の厚みを厚くすることができるが、積層させた組織体を一体化する必要がある。そのためには、生体に埋入することによって作製した複数の組織体を、生体外で重ねた後に再度生体内に埋入して、組織体間を結合する必要がある。このため、結合組織体の形成に２倍以上の時間がかかることと、埋入、摘出術を２回行う必要があり、生体への負荷が大きい欠点がある。 In the method of stacking tissue bodies separately according to Patent Document 2, the thickness of the connective tissue body can be increased, but the stacked tissue bodies need to be integrated. For this purpose, it is necessary to combine a plurality of tissue bodies produced by embedding in a living body and then burying them in the living body again after being stacked outside the living body, thereby connecting the tissue bodies. For this reason, it takes two or more times for the formation of the connective tissue body, and it is necessary to perform implantation and extraction twice, resulting in a large burden on the living body.
特許文献３による埋入構造物表面に凹凸を形成する方法では、凹部分に結合組織体が厚く形成されるので機械的強度は人工臓器として満足できるが、結合組織体の内面に構造物の凹凸が転写されるために、内面の平滑性を要求される人工臓器、例えば、人口血管として利用するには平滑性が不足している。 In the method of forming irregularities on the surface of the embedded structure according to Patent Document 3, the connective tissue is formed thick in the concave portion, so that the mechanical strength is satisfactory as an artificial organ, but the irregularities of the structure are formed on the inner surface of the connective tissue. Therefore, smoothness is insufficient for use as an artificial organ that requires smooth inner surface, for example, artificial blood vessel.
また、特許文献４に代表されるような方法では、吻合部に使用される樹脂などの人工物が移植後に生体内に留置されることから、炎症の可能性など生体組織との適合性が問題となる。また、人工血管として使用した場合には、人工物の劣化に伴って、生体組織の吻合部が瘤化あるいは乖離する原因となる可能性がある。また、樹脂は大きさが変化しないので、移植された生体の成長には追随できないない欠点がある。 In addition, in the method represented by Patent Document 4, since an artificial material such as a resin used for an anastomosis is placed in a living body after transplantation, compatibility with a living tissue such as inflammation may be a problem. It becomes. Further, when used as an artificial blood vessel, there is a possibility that the anastomosis portion of the living tissue becomes aneurysm or dissociates with the deterioration of the artifact. In addition, since the size of the resin does not change, there is a drawback that it cannot follow the growth of the transplanted living body.
このように生体に埋入した人工物の構造体の表面に形成される組織体からなる結合組織体を人工臓器として使用するには、結合組織体の厚みが薄く、自立性が無いことが欠点となり、実用化されていなかった。 In order to use a connective tissue body composed of a tissue body formed on the surface of an artificial structure embedded in a living body as an artificial organ, it is disadvantageous that the connective tissue body is thin and not self-supporting. It was not put into practical use.
特に、人工血管に上記結合組織体を適用する場合には、人工血管が自由に曲がるためには、結合組織体の厚みが薄い必要があるが、薄いと血流の内圧に耐えることができずに破裂してしまう。また、曲げる時に簡単に潰れてしまい血流が維持できない。逆に結合組織体を厚くすると血流には強くなるが、自由に曲がらなくなってしまう不具合があった。 In particular, when the connective tissue is applied to an artificial blood vessel, the connective tissue must be thin in order for the artificial blood vessel to bend freely, but if it is thin, it cannot withstand the internal pressure of blood flow. Will burst. In addition, it is easily crushed when bent, and blood flow cannot be maintained. On the contrary, when the connective tissue body is thickened, the blood flow becomes stronger, but there is a problem that it cannot bend freely.
また、人工血管として適用した結合組織体の内面の平滑性が悪いと血流が滞留し、血栓などの形成のおそれがあることから、実用化されていなかった。 In addition, if the smoothness of the inner surface of the connective tissue applied as an artificial blood vessel is poor, the blood flow is retained and there is a risk of formation of thrombus and the like.
上記目的を達成するため、本発明は、結合組織体の厚みを部分的に厚くすると同時に結合組織体形成用基材の一部分を結合組織体内部に包埋させることにより、結合組織体の機械的強度を増強し、自立性を向上させ、吻合操作を容易にすると同時に結合組織体の内面を平滑に形成する方法を提供するものである。即ち、結合組織体形成用基材として生体内に埋入する構造部材の外縁表面に開口部を持たせた外郭部材を連続的に形成し、組織体を開口部に形成される凹部分に誘導侵入させることにより、外郭部材周囲の組織体の厚さを厚くすると同時に構造部材と外郭部材の間隙に組織体を誘導して外郭部材を結合組織体で包埋したことを特徴とする。 In order to achieve the above object, the present invention provides a mechanical structure of a connective tissue body by partially increasing the thickness of the connective tissue body and simultaneously embedding a part of the connective tissue-forming substrate in the connective tissue body. The present invention provides a method for enhancing the strength, improving the independence, facilitating the anastomosis operation, and at the same time forming the inner surface of the connective tissue body smoothly. That is, an outer member having an opening on the outer edge surface of a structural member to be embedded in a living body as a base material for forming a connective tissue is continuously formed, and the tissue is guided to a concave portion formed in the opening. By intruding, the thickness of the tissue body around the outer member is increased, and at the same time, the tissue body is guided in the gap between the structural member and the outer member, and the outer member is embedded with the connective tissue body.
生体内に埋入する結合組織体形成用基材の表面構造を検討した結果、基材の表面に凹部（溝、穴など）があると凹部に生体組織が侵入し、生体組織の表面を平滑にしようとする性質があることが判明した。この性質を利用し、基材表面に組織体を厚くしたい部分に凹部を作れば、その部分の生体組織の厚みを厚くすることができる。 As a result of examining the surface structure of the base material for connective tissue formation that is embedded in the living body, if there is a recess (groove, hole, etc.) on the surface of the base material, the living tissue enters the recess and the surface of the living tissue becomes smooth. It turns out that there is a nature to try. Utilizing this property, if a concave portion is formed in a portion where the tissue body is desired to be thickened on the surface of the base material, the thickness of the biological tissue in that portion can be increased.
一方、基材表面近傍に生体適合材料の小片を留置させて生体内に埋入すると、基材を覆う組織体と小片を被う組織体が結合し、基材と小片を一体化して包埋することが判明した。また、基材表面に生体適合材料の小片を密着させて生体内に埋入すると、生体組織が小片の弾性による密着力に対抗して密着面に侵入し、小片全体を生体組織で包埋することが判明した。 On the other hand, when a small piece of biocompatible material is placed in the vicinity of the surface of the base material and embedded in the living body, the tissue body covering the base material and the tissue body covering the small piece are combined, and the base material and the small piece are integrated and embedded. Turned out to be. Moreover, when a small piece of biocompatible material is brought into close contact with the surface of the base material and embedded in the living body, the living tissue enters the close contact surface against the adhesive force due to the elasticity of the small piece, and the entire small piece is embedded with the living tissue. It has been found.
これらの性質を利用し、結合組織体の内面形状を決定する構造部材の表面は必要とされる平滑度とし、構造部材の外縁に開口部を有する外郭部材を連続的に形成すれば、外郭部材の開口部が相対的に凹部となり、凹部の組織体の厚みを厚くできる。また、開口部を通じて生体組織が構造部材と外郭部材の間隙に侵入し、外郭部材は組織体に完全に包埋されるので、構造部材から結合組織体を剥離したときに結合組織体内に外郭部材が残置することにより、結合組織体の生体適合性に何ら影響を与えることなく、結合組織体の機械的強度を向上させることができる。 By utilizing these properties, the surface of the structural member that determines the inner surface shape of the connective tissue body has the required smoothness, and the outer member having an opening at the outer edge of the structural member is continuously formed. Thus, the opening portion becomes a concave portion, and the thickness of the structure of the concave portion can be increased. In addition, since the living tissue enters the gap between the structural member and the outer member through the opening, and the outer member is completely embedded in the tissue body, when the connective tissue body is peeled from the structural member, the outer member in the connective tissue body As a result, the mechanical strength of the connective tissue body can be improved without affecting the biocompatibility of the connective tissue body.
構造部材と外郭部材の組合せを生体に埋入することで形成した結合組織体を生体の欠損組織、臓器の代替材とするときに、生体の変化に合わせて、結合組織体の形状が適合する必要がある。この目的で、外郭部材の結合組織体からの剥離を容易にする目的で、外郭部材の形状を螺旋形状に形成したことを特徴とする。 When a connective tissue formed by embedding a combination of a structural member and an outer member into a living body is used as a substitute for a defective tissue or organ in the living body, the shape of the connective tissue conforms to changes in the living body. There is a need. For this purpose, the outer member is formed in a spiral shape for the purpose of facilitating peeling of the outer member from the connective tissue body.
さらに、前記の目的で、外郭部材が生体に埋入され結合組織体を形成する期間に生体に分解吸収されて消滅するか、あるいは、摘出した結合組織体を生体の欠損組織、臓器の代替材として、新たに生体に埋入した後に生体に分解吸収されて消滅するように外郭部材の材料を生体吸収材料で構成したことを特徴とする。 Furthermore, for the above purpose, the outer member is decomposed and absorbed by the living body during the period in which the outer member is embedded in the living body and forms a connective tissue body, or the removed connective tissue body is replaced with a defective tissue or organ of the living body. As described above, the material of the outer member is made of a bioabsorbable material so that it is decomposed and absorbed by the living body and disappears after being newly implanted in the living body.
結合組織体に外郭部材を残して機械的強度などを増強する場合、その外郭部材が結合組織体の拡張性を阻害するおそれがあるが、外郭部材を伸縮性を有する糸から形成することにより、結合組織体の拡張性を阻害することなく、機械的強度や自立性、吻合操作性を高めることができる。これにより、機械的強度などを高めつつ、血管などの自由な拡径を許容すると共に、その形状を生体の変化に適合させることができる。 When enhancing the mechanical strength and the like by leaving the outer member in the connective tissue body, the outer member may impair the expandability of the connective tissue body, but by forming the outer member from a stretchable thread, Mechanical strength, independence, and anastomosis operability can be improved without inhibiting the expandability of the connective tissue body. Thereby, while increasing mechanical strength etc., while allowing free diameter expansion of the blood vessel etc., the shape can be adapted to the change of the living body.
また、結合組織体の拡張性を阻害することなく、機械的強度や自立性、吻合操作性を高めるための別の手段として、生体吸収材料からなる掛け留め部材と、この掛け留め部材に掛け留めして配置する生体非吸収材料からなる糸とを組み合わせて外郭部材を形成し、そのうちの生体吸収材料からなる掛け留め部材を消滅させることにより、結合組織体を拡張自在とすることもできる。 In addition, as another means for improving mechanical strength, self-sustainability, and anastomosis operability without hindering the expandability of the connective tissue body, a hanging member made of a bioabsorbable material and the hanging member The connective tissue body can also be made expandable by combining the yarn made of the non-bioabsorbable material to be arranged to form the outer member and eliminating the hanging member made of the bioabsorbable material.
つまり、生体非吸収材料からなる糸を拡張自在な状態に配置して残すことによって、結合組織体をその機械的強度などを高めつつ拡張自在にすることができるが、糸の拡張自在な状態は、ばらばらになりやすい状態でもあり、その配置を難しくする。そこで、一旦、生体吸収材料からなる掛け留め部材と生体非吸収材料からなる糸とを組み合わせて、ばらばらにすることなく配置した後、生体吸収材料からなる掛け留め部材を生体に吸収させて消滅させることにより、残りの生体非吸収材料からなる糸を拡張自在な状態に配置することができる。 In other words, it is possible to make the connective tissue body expandable while increasing its mechanical strength, etc. by leaving the thread made of a non-bioabsorbable material in an expandable state, but the expandable state of the thread is It is also in a state of being easily broken up, making it difficult to arrange. Therefore, once a hanging member made of a bioabsorbable material and a thread made of a bioabsorbable material are combined and arranged without being separated, the hanging member made of the bioabsorbable material is absorbed by the living body and disappears. Thus, the remaining yarn made of a non-bioabsorbable material can be arranged in an expandable state.
具体的には、構造部材を棒状とし、外郭部材のうち、生体吸収材料からなる掛け留め部材を、構造部材の表面かつ長さ方向に沿って配置した縦糸とすると共に、生体非吸収材料からなる糸を、縦糸に掛けて周方向に蛇行させつつ構造部材の表面に沿って配置した横糸とした構造を例示することができる。 Specifically, the structural member has a rod shape, and the hanging member made of a bioabsorbable material among the outer members is a warp arranged along the surface and the length direction of the structural member, and made of a non-bioabsorbable material. An example of the structure is a weft thread that is arranged along the surface of the structural member while the thread is hung around the warp thread and meandering in the circumferential direction.
この構造では、縦糸が残っている間は横糸をばらばらにならないよう留めることができ、縦糸が生体に吸収されて消滅することにより、横糸を自由に拡張させることができる。なお、横糸を周方向に蛇行させるには、構造部材の周方向に１周させるごとに縦糸に掛けて折り返してもよいが、縦糸が消滅した後の横糸の拡張を阻害しない程度に、２周あるいは３周するごとに縦糸に掛けて折り返すこともできる。 In this structure, while the warp yarn remains, the weft yarn can be kept from falling apart, and the warp yarn can be freely expanded by being absorbed by the living body and disappearing. In order to meander the weft yarn in the circumferential direction, it may be folded around the warp yarn every time it is turned in the circumferential direction of the structural member. However, it is necessary not to impede the expansion of the weft yarn after the warp yarn disappears. Alternatively, it can be folded over the warp every three turns.
また、構造部材を棒状とし、外郭部材のうち、生体吸収材料からなる掛け留め部材を、構造部材の表面に沿って巻き付けた横糸とすると共に、生体非吸収材料からなる糸を、横糸に編み込みつつ構造部材の表面かつ長さ方向周方向に沿って配置した縦糸とした構造も採用可能である。さらに、掛け留め部材は、縦糸や横糸だけでなく、網目状のものや、糸を構造部材の表面に編み込んだものであってもよい。 Further, the structural member has a rod shape, and the hanging member made of a bioabsorbable material among the outer members is a weft wound around the surface of the structural member, and a yarn made of a bioabsorbable material is knitted into the weft. A structure in which warps are arranged on the surface of the structural member and along the circumferential direction in the length direction can also be employed. Furthermore, the hooking member may be not only warp and weft, but also a mesh-like one, or one obtained by knitting yarn on the surface of the structural member.
外郭部材を構造部材の長さ方向に連続して形成すれば、結合組織体の全長に渡って、その機械的強度や自立性、吻合操作性を高めることができるので、結合組織体を所望の長さに切断することができる。また、外郭部材を構造部材の長さ方向に間隔をあけて断続的に形成すれば、外郭部材を形成する範囲を少なくしつつ、その外郭部材を形成した部位で切断することにより、結合組織体の長さを選択することができる。 If the outer member is continuously formed in the length direction of the structural member, the mechanical strength, self-supporting property and anastomosis operability can be improved over the entire length of the connective tissue body. Can be cut to length. Further, if the outer member is formed intermittently at intervals in the length direction of the structural member, the connective tissue body can be cut by cutting the portion where the outer member is formed while reducing the range in which the outer member is formed. The length of can be selected.
以上に述べたように本発明に係わる構造部材と外郭部材より構成した基材を生体内に埋入して、表面に組織体を形成させることにより、生体組織は、外郭部材の開口部分に誘導侵入し、外郭部材を組織体に包埋すると同時に構造部材と外郭部材を一体化して包埋するので、開口部分の組織体の厚さが厚くなる。従って、組織体からなる結合組織体の自立性が向上し、生体との吻合操作性が向上する。また、結合組織体の厚みが厚く外郭部材を結合組織体の内部に残置することがきることから強度も向上し、大口径の組織にも適用することが可能となる。 As described above, the biological tissue is guided to the opening portion of the outer member by embedding the base material composed of the structural member and the outer member according to the present invention in the living body and forming a tissue body on the surface. Since the intrusion and the outer member are embedded in the tissue body, the structural member and the outer member are integrated and embedded at the same time, so that the thickness of the tissue body in the opening is increased. Therefore, the independence of the connective tissue body consisting of the tissue body is improved, and the anastomosis operability with the living body is improved. Further, since the thickness of the connective tissue body is large and the outer member can be left inside the connective tissue body, the strength is improved and the structure can be applied to a large-diameter tissue.
形成される結合組織体の内面形状は、構造部材の表面形状と同等になる。従って、結合組織体の内面を平滑にすることができ、人工血管のように結合組織体の内面が平滑であることが望ましい組織にも適用することが可能となる。 The inner surface shape of the connective tissue formed is equivalent to the surface shape of the structural member. Therefore, the inner surface of the connective tissue body can be smoothed, and the present invention can be applied to a tissue where the inner surface of the connective tissue body is desired to be smooth, such as an artificial blood vessel.
外郭部材の開口部に侵入する組織には、毛細血管も形成されることから、生体内に移植された後の生体組織との適合性、生着性が良い。 Capillary blood vessels are also formed in the tissue that enters the opening of the outer member, so that the compatibility and engraftment with the living tissue after transplanted into the living body are good.
外郭部材を残置できない用途においては、外郭部材を生体吸収材料で作成することにより、容易に外郭部材を分解することができる。 In applications where the outer member cannot be left, the outer member can be easily disassembled by making the outer member from a bioabsorbable material.
さらには、人工血管の用途においては、棒状構造部材の表面に外郭部材を螺旋形に形成することにより、曲げにより開口部が潰れることが無くなり、曲げに強い構造を実現することができると同時に、棒状構造部材から組織体を剥離する際に棒状構造部材を回転させながら螺旋状外郭部材を抜き取ることにより、表面の組織体をねじのように容易に取り出すことが可能となる。 Furthermore, in the use of artificial blood vessels, by forming the outer shell member in a spiral shape on the surface of the rod-like structural member, the opening is not crushed by bending, and at the same time, a structure resistant to bending can be realized. By pulling out the spiral outer member while rotating the rod-shaped structural member when peeling the tissue body from the rod-shaped structural member, the surface tissue body can be easily taken out like a screw.
また、外郭部材を伸縮性を有する糸から形成することにより、あるいは、生体に吸収されて消滅する生体吸収材料からなる糸と生体非吸収材料からなる糸とを組み合わせて外郭部材を構成することにより、結合組織体を拡張自在とすることができる。 Further, by forming the outer member from a stretchable thread, or by configuring the outer member by combining a thread made of a bioabsorbable material that is absorbed by the living body and disappears, and a thread made of a bioabsorbable material. The connective tissue can be expandable.
以下、本発明に係る結合組織体形成基材およびそれを用いた結合組織体の製造方法を実施するための最良の形態について、小口径の人工血管に適用した例について図を参照して説明する。 Hereinafter, the best mode for carrying out the connective tissue body-forming substrate and the method for producing a connective tissue body using the same according to the present invention will be described with reference to the drawings with respect to an example applied to a small-diameter artificial blood vessel. .
図１は、本発明の結合組織形成用基材の側面図である。図２は、結合組織形成用基材の縦断面図である。図３は、図１に示す結合組織形成用基材の実際の基材の外観を示す図面（写真）である。 FIG. 1 is a side view of a connective tissue forming substrate of the present invention. FIG. 2 is a longitudinal sectional view of the connective tissue forming substrate. FIG. 3 is a drawing (photograph) showing the appearance of an actual substrate of the connective tissue forming substrate shown in FIG.
棒状構造部材１は、結合組織体形成用基材として生体内に埋入し、その表面に膜状の組織体を形成し、この組織体を剥離して結合組織体３を形成するためのものであり、その外径は２ｍｍで全長は約２０ｍｍである。外径により、人工血管として適用される血管の太さが決定される。棒状構造部材１の表面には、螺旋状に外郭部材２を巻き付けている。外郭部材２の径は、０．２ｍｍで、巻付間隔は、０．４ｍｍとした。外郭部材２は、棒状構造部材１に弾性による張力をもって巻き付けられているだけで接着はしていない。外郭部材２が棒状構造部材１に巻き付けられていない部分（開口部３）が螺旋状に形成される。 The rod-like structural member 1 is embedded in a living body as a base material for forming a connective tissue body, forms a membrane-like tissue body on its surface, and peels off this tissue body to form a connective tissue body 3 The outer diameter is 2 mm and the total length is about 20 mm. The thickness of a blood vessel to be applied as an artificial blood vessel is determined by the outer diameter. An outer shell member 2 is wound around the surface of the rod-like structural member 1 in a spiral shape. The diameter of the outer member 2 was 0.2 mm, and the winding interval was 0.4 mm. The outer member 2 is merely bonded to the rod-shaped structural member 1 with elastic tension and is not bonded. A portion (opening 3) where the outer member 2 is not wound around the rod-like structural member 1 is formed in a spiral shape.
棒状構造部材１の材料は、生体に埋入した際に大きく変形することが無い強度（硬度）を有しており、化学的安定性があり、滅菌などの負荷に耐性があり、生体を刺激する溶出物が無いまたは少ない必要がある。本実施形態においては、上記条件を満たす、シリコンゴムを使用している。 The material of the rod-shaped structural member 1 has strength (hardness) that does not greatly deform when implanted in a living body, has chemical stability, is resistant to loads such as sterilization, and stimulates the living body. There should be no or little eluate to be released. In the present embodiment, silicon rubber satisfying the above conditions is used.
外郭部材２の材料は、生体に埋入した際に大きく変形することが無い強度と形状を維持する弾性を有しており、化学的安定性があり、滅菌などの負荷に耐性があり、生体を刺激する溶出物が無いまたは少ない必要がある。本実施形態においては、上記条件を満たす、手術用縫合糸（ナイロン）を使用している。 The material of the outer member 2 has elasticity that maintains strength and shape that does not greatly deform when implanted in a living body, has chemical stability, is resistant to loads such as sterilization, There should be no or little eluate to irritate. In this embodiment, a surgical suture (nylon) that satisfies the above conditions is used.
結合組織形成用基材を埋入する生体は、ヒト、ヤギ、イヌ、ウサギなど動物界に分類される生物である。結合組織形成用基材の埋入部位としては例えば、結合組織形成用基材を受け入れる容積を有する腹腔内、あるいは四肢部、賢部又は背部、腹部などの皮下が好ましい。また、埋入には低侵襲な方法で行うことと動物愛護の精神を尊重し、十分な麻酔下で最小限の切開術で行うことが好ましい。 The living body into which the substrate for forming connective tissue is embedded is an organism classified into the animal kingdom such as human, goat, dog, and rabbit. The site for embedding the connective tissue-forming substrate is preferably, for example, the abdominal cavity having a volume for receiving the connective tissue-forming substrate, or the subcutaneous part of the extremity, the wise part or the back, the abdomen, or the like. In addition, it is preferable that the implantation is performed by a minimally invasive method and the spirit of animal welfare is respected, and is performed with a minimum of incision under sufficient anesthesia.
図４は、棒状構造部材１および外郭部材２の表面に形成された結合組織体の外観写真である。本実施形態では、ウサギの背部に結合組織形成用基材を２週間埋入した。結合組織形成用基材の表面全体にコラーゲンと繊維芽細胞からなる組織体が形成されており、一部は、組織体を透過して外郭部材２が見えている。しかし、表面は平滑になっており、外郭部材２が持つ螺旋状の突起構造は観察されない。 FIG. 4 is an external appearance photograph of the connective tissue formed on the surfaces of the rod-shaped structural member 1 and the outer shell member 2. In this embodiment, the connective tissue-forming substrate was embedded in the back of the rabbit for 2 weeks. A tissue body composed of collagen and fibroblasts is formed on the entire surface of the connective tissue-forming substrate, and a part of the tissue body is seen through the tissue body. However, the surface is smooth and the spiral protrusion structure of the outer shell member 2 is not observed.
図５は、結合組織体が表面に形成された結合組織形成用基材の断面図である。結合組織体４は、棒状構造部材１と外郭部材２の接触面に侵入し、外郭部材２の弾性力に打ち勝って外郭部材２を棒状構造部材１から隔離し、外郭部材２を完全に包埋している。 FIG. 5 is a cross-sectional view of a connective tissue forming substrate having a connective tissue body formed on the surface thereof. The connective tissue body 4 penetrates into the contact surface between the bar-shaped structural member 1 and the outer shell member 2, overcomes the elastic force of the outer shell member 2, isolates the outer shell member 2 from the bar-shaped structural member 1, and completely embeds the outer shell member 2 is doing.
図６は、結合組織体の断面図である。棒状構造部材１から結合組織体を剥離する際に棒状構造部材１を回転させながら外郭部材２を抜糸することにより、結合組織体４のみをネジのように容易に分離することが可能となる。また、剥離された結合組織体４の内面は、棒状構造部材１の表面に接しているので平滑になる。 FIG. 6 is a cross-sectional view of a connective tissue body. By pulling out the outer member 2 while rotating the rod-shaped structural member 1 when peeling the connective tissue from the rod-shaped structural member 1, only the connective tissue body 4 can be easily separated like a screw. In addition, the peeled inner surface of the connective tissue body 4 is in contact with the surface of the rod-shaped structural member 1 and thus becomes smooth.
図６より明らかなように、紐状の外郭部材２の間に対応する組織体４の厚みの厚い部分５と外郭材料２に対応する厚みの薄い部分６とが周期的に形成されている。 As is clear from FIG. 6, a thick portion 5 of the tissue body 4 corresponding to the cord-shaped outer member 2 and a thin portion 6 corresponding to the outer material 2 are periodically formed.
従って、厚みの厚い部分５が棒状構造部材１の螺旋状開口部３に沿って形成されることにより、棒状構造部材１の表面に形成される管状の結合組織体４においては、管の外壁に螺旋状に組織体の厚い部分５が形成される。耐圧試験によれば、生体の血管で圧力２０００ｍｍＨｇに対し、従来の平滑な棒状構造体では、１０００ｍｍＨｇと約１／２の強度であったが、本発明の棒状構造部材１を使用すると１６００〜２０００ｍｍＨｇとほぼ生体の血管に近い値が得られた。 Therefore, in the tubular connective tissue body 4 formed on the surface of the rod-like structural member 1 by forming the thick portion 5 along the spiral opening 3 of the rod-like structural member 1, it is formed on the outer wall of the tube. A thick part 5 of the tissue is formed in a spiral. According to the pressure resistance test, the strength of the conventional smooth rod-shaped structure in the blood vessel of the living body was 1000 mmHg and about ½ the strength. However, when the rod-shaped structure member 1 of the present invention is used, 1600 to 2000 mmHg. A value close to that of a living blood vessel was obtained.
また、結合組織体４が自立して管形状を維持することができることから、管状の結合組織体４を人工血管として生体と縫合する時に吻合部位が開孔した状態で、吻合操作が実施できる。 Further, since the connective tissue body 4 can stand up and maintain the tube shape, the anastomosis operation can be performed in a state where the anastomosis site is opened when the tubular connective tissue body 4 is sutured to the living body as an artificial blood vessel.
上記実施形態では、小口径の人工血管を例としたが、大口径の血管や大型の臓器に本発明を適用する場合には、外郭部材２の形状を網目状や格子状とし、結合組織体４の形成後に外郭部材２を剥離せずに使用すれば、結合組織体４の自立性と機械的強度を維持できる。 In the above embodiment, a small-diameter artificial blood vessel is taken as an example. However, when the present invention is applied to a large-diameter blood vessel or a large organ, the shape of the outer member 2 is a mesh shape or a lattice shape, and a connective tissue body is used. If the outer shell member 2 is used without being peeled after the formation of 4, the independence and mechanical strength of the connective tissue body 4 can be maintained.
あるいは、外郭部材２の材料として生体吸収材料（ＰＤＳ、モノクリル、ポリ乳酸、ポリグリコール酸など）を使用すれば、結合組織体４の形成後に外郭部材２を抜糸する必要が無くなる。さらに外郭部材２の生体吸収時間を結合組織体４の形成時間より長く選択すれば、結合組織形成用基材を生体から摘出後、棒状構造部材１から結合組織体４を剥離した時点では、外郭部材２により結合組織体４の形状が保たれる。従って、大口径の人工血管に適用する場合に自立性を維持しながら吻合操作が容易に行える。 Alternatively, when a bioabsorbable material (PDS, monoacryl, polylactic acid, polyglycolic acid, etc.) is used as the material of the outer member 2, it is not necessary to remove the outer member 2 after the connective tissue body 4 is formed. Furthermore, if the bioabsorption time of the outer member 2 is selected to be longer than the formation time of the connective tissue body 4, the external tissue is removed from the rod-like structural member 1 after the connective tissue forming substrate is removed from the living body. The shape of the connective tissue body 4 is maintained by the member 2. Therefore, when applied to a large-diameter artificial blood vessel, an anastomosis operation can be easily performed while maintaining independence.
また、外郭部材２の材料に内皮細胞増殖促進剤（例えば血管新生因子ＨＦＧ、ＶＥＧＦ、ｂＦＧＦなど）を埋入前に含浸させることにより、外郭部材２を薬剤の徐放材料として使用することができる。これにより、各種薬剤を徐々に生体組織に内部から浸透させることができる。 In addition, the outer member 2 can be used as a drug sustained-release material by impregnating the material of the outer member 2 with an endothelial cell growth promoter (eg, angiogenic factors HFG, VEGF, bFGF, etc.) before embedding. . Thereby, various chemical | medical agents can be osmose | permeated to a biological tissue from the inside gradually.
同様に、結合組織体４を形成後に外郭部材２を抜糸することにより形成された螺旋状の管腔部に薬剤を注入することができる。薬剤として、例えば、抗血液凝固剤を使用すれば、結合組織体４の内壁を透過して、血管内面において作用し、血栓の発生を防止することができる。 Similarly, the drug can be injected into the spiral lumen formed by removing the outer shell member 2 after forming the connective tissue body 4. If an anticoagulant, for example, is used as the drug, it can penetrate the inner wall of the connective tissue body 4 and act on the inner surface of the blood vessel to prevent thrombus generation.
また、図７に示すように、棒状構造部材１の外周側に形成する外郭部材７は、生体吸収材料からなる縦糸８と、生体非吸収材料からなる横糸９とから構成することもできる。このうち、縦糸８は、棒状構造部材１の表面かつ長さ方向に沿って配置されている。また、横糸９は、棒状構造部材１の周りに２周するごとに縦糸８に掛けて折り返すことにより、周方向に蛇行しつつ棒状構造部材１の表面に沿って配置されている。 Moreover, as shown in FIG. 7, the outer shell member 7 formed on the outer peripheral side of the rod-like structural member 1 can be composed of warp yarns 8 made of a bioabsorbable material and weft yarns 9 made of a bioabsorbable material. Among these, the warp 8 is arrange | positioned along the surface and the length direction of the rod-shaped structure member 1. FIG. The weft yarn 9 is arranged along the surface of the rod-shaped structural member 1 while meandering in the circumferential direction by being folded around the warp yarn 8 every time it makes two rounds around the rod-shaped structural member 1.
図８に示すように、結合組織形成用基材は、上記の実施形態と同様、例えばウサギの背部に２週間埋入することにより、表面に結合組織体１０が形成される。さらに、図９に示すように、結合組織体１０が形成されたときには、外郭部材７のうちの縦糸８が生体に吸収されて消滅し、蛇行状の横糸９のみが結合組織体１０に包埋されている。これにより、結合組織体１０は、横糸９によって機械的強度、自立性及び吻合操作性が高められつつ、拡張自在とされている。 As shown in FIG. 8, the connective tissue forming substrate 10 is formed on the surface of the connective tissue-forming substrate, for example, by embedding it in the back of a rabbit for two weeks, as in the above embodiment. Furthermore, as shown in FIG. 9, when the connective tissue body 10 is formed, the warp 8 of the outer shell member 7 is absorbed by the living body and disappears, and only the serpentine weft 9 is embedded in the connective tissue body 10. Has been. Thereby, the connective tissue body 10 is made expandable while the mechanical strength, self-supporting property and anastomosis operability are enhanced by the weft 9.
この結合組織体１０は、外郭部材７が棒状構造部材１の長さ方向に連続して形成されていることから、全長に渡って、機械的強度などが高められており、結合組織体１０を任意の部位で所望の長さに切断することができる。なお、外郭部材７を棒状構造部材１の長さ方向に間隔をあけて断続的に形成することにより、外郭部材７を形成する範囲を狭くすることもでき、この場合、外郭部材７を形成した部位で結合組織体１０を切断することにより、その長さを選択することができる。 In this connective tissue body 10, since the outer member 7 is formed continuously in the length direction of the rod-like structural member 1, the mechanical strength and the like are increased over the entire length. It can be cut to a desired length at any site. In addition, by forming the outer member 7 intermittently at intervals in the length direction of the rod-shaped structural member 1, the range in which the outer member 7 is formed can be narrowed. In this case, the outer member 7 is formed. The length can be selected by cutting the connective tissue body 10 at a site.
外郭部材７は、生体吸収材料からなる糸と生体非吸収材料からなる糸とを組み合わせて形成し、そのうちの生体吸収材料からなる糸を消滅させることにより、結合組織体１０を拡張自在とするものであればよく、生体非吸収材料からなる縦糸８を長さ方向に配置する代わりに螺旋状に配置することもできる。 The outer member 7 is formed by combining a thread made of a bioabsorbable material and a thread made of a bioabsorbable material, and extinguishing the thread made of the bioabsorbable material, thereby making the connective tissue body 10 expandable. The warp yarn 8 made of a non-bioabsorbable material may be arranged in a spiral shape instead of being arranged in the length direction.
また、図１０に示すように、外郭部材１１は、生体吸収材料からなる横糸１２と生体非吸収材料からなる縦糸１３とから構成することもできる。このうち、横糸１２は、棒状構造部材１の表面に沿って螺旋状に巻き付けられている。また、縦糸１３は、螺旋状の横糸１２のうちの隣り合う部位に掛け渡されるようにして、棒状構造部材１の長さ方向に蛇行しながら横糸１２に編み込まれつつ棒状構造部材１の表面かつ長さ方向周方向に沿って配置されている。 As shown in FIG. 10, the outer member 11 can also be composed of a weft thread 12 made of a bioabsorbable material and a warp thread 13 made of a bioabsorbable material. Among these, the weft 12 is wound spirally along the surface of the rod-shaped structural member 1. Further, the warp yarns 13 are hung on the weft yarns 12 while meandering in the longitudinal direction of the rod-like structural member 1 so as to be stretched over adjacent portions of the spiral weft yarns 12 and the surface of the rod-like structural member 1. It arrange | positions along the circumferential direction of a length direction.
この外郭部材１１を備えた結合組織形成用基材を、上記の実施形態と同様、例えばウサギの背部に２週間埋入することにより、表面に結合組織体が形成される。さらに、結合組織体が形成されたときには、外郭部材１１のうちの横糸１２が生体に吸収されて消滅し、蛇行状の縦糸１３のみが結合組織体に包埋される。これにより、結合組織体が、縦糸１３によって機械的強度、自立性及び吻合操作性を高められつつ、拡張自在とされる。 A connective tissue body is formed on the surface by embedding the connective tissue-forming substrate provided with the outer shell member 11 on the back of a rabbit for two weeks, for example, as in the above embodiment. Furthermore, when the connective tissue is formed, the weft 12 of the outer shell member 11 is absorbed by the living body and disappears, and only the meandering warp 13 is embedded in the connective tissue. Thereby, the connective tissue body can be expanded while the mechanical strength, the self-supporting property and the anastomosis operability are enhanced by the warp 13.
また、外郭部材は、生体吸収材料からなる網目状の掛け留め部材に、生体非吸収材料からなる糸を例えば蛇行させながら掛け留めして構成することもできる。これにより、結合組織体を形成するとき、掛け留め部材を生体に吸収させて、生体非吸収材料からなる例えば蛇行状の糸のみを結合組織体に包埋させることができ、結合組織体をその機械的強度、自立性及び吻合操作性を高めつつ拡張自在とすることができる。 In addition, the outer member can also be configured by hooking a thread made of a bioabsorbable material on a mesh-like hooking member made of a bioabsorbable material, for example, meandering. Thereby, when forming the connective tissue body, the hanging member can be absorbed by the living body and only the serpentine thread made of the non-biological absorbent material can be embedded in the connective tissue body. The mechanical strength, self-supporting property and anastomosis operability can be enhanced while being expandable.
さらに、外郭部材を伸縮性を有する糸から形成して結合組織体１０に残すことにより、結合組織体１０の機械的強度、自立性及び吻合操作性を高めつつ、結合組織体１０を拡張自在とすることもできる。 Further, by forming the outer shell member from a stretchable thread and leaving it in the connective tissue body 10, the connective tissue body 10 can be expanded while improving the mechanical strength, self-supporting property and anastomosis operability of the connective tissue body 10. You can also
以上に述べたように本発明に係わる結合組織形成用基材を使用すれば、従来でできる結合組織体と比較して、機械的強度を増加させることができる。従って、結合組織体を人工臓器として、生体に再移植する際に生体との吻合操作が容易になり、人工臓器を生体に移植する際の施術時間が短縮できることから、生体への負荷が軽減される。 As described above, when the connective tissue-forming substrate according to the present invention is used, the mechanical strength can be increased as compared with a connective tissue body that can be produced conventionally. Therefore, when the connective tissue body is used as an artificial organ, the anastomosis with the living body is facilitated when reimplanted into the living body, and the treatment time when the artificial organ is transplanted into the living body can be shortened. The
以上の利点から人工臓器の形成と移植の発展に寄与すると考えられる。 These advantages are thought to contribute to the development of artificial organs and transplantation.
１ 棒状構造部材
２、７、１１ 外郭部材
３ 開口部
４、１０ 結合組織体
５ 厚い部分
６ 薄い部分
８、１３ 縦糸
９、１２ 横糸
DESCRIPTION OF SYMBOLS 1 Bar-shaped structural member 2, 7, 11 Outer member 3 Opening part 4, 10 Connective tissue body 5 Thick part 6 Thin part 8, 13 Warp yarn 9, 12 Weft
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