JP5009591B2 - Surgical suture - Google Patents
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- JP5009591B2 JP5009591B2 JP2006298671A JP2006298671A JP5009591B2 JP 5009591 B2 JP5009591 B2 JP 5009591B2 JP 2006298671 A JP2006298671 A JP 2006298671A JP 2006298671 A JP2006298671 A JP 2006298671A JP 5009591 B2 JP5009591 B2 JP 5009591B2
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本発明は、生体適合性の熱可塑性樹脂からなる異形断面繊維で構成される、引張り強度、柔軟性が改善された取扱い性が良好な手術用縫合糸に関するものである。 The present invention relates to a surgical suture that is formed of a modified cross-section fiber made of a biocompatible thermoplastic resin and has improved handling properties with improved tensile strength and flexibility.
手術用縫合糸としては、外科手術時の操作性がよく、縫合や結紮がしやすい、また、結び目がほどけにくいものが求められており、例えば、絹からなる縫合糸や乳酸/ε−カプロラクトン共重合体等の生体吸収性ポリマーからなる糸(下記特許文献1参照)等が知られている。 Surgical sutures are required to have good operability at the time of surgery, easy to sew and ligate, and difficult to unknot. For example, sutures made of silk and lactic acid / ε-caprolactone A yarn made of a bioabsorbable polymer such as a polymer (see Patent Document 1 below) is known.
絹糸は、柔軟で結節保持力が優れているため、しばりやすく、取扱い性が良好であるという長所がある。しかしながら、絹糸はコストが高く引張り強度が低い等の問題点がある。特に、手術での使用状態である湿潤時において、外科結びされたときの強度が低いのが絹糸からなる縫合糸の本質的な問題点となっている。 Silk yarn has the advantages of being flexible and excellent in knot retention, so that it is easy to bind and easy to handle. However, silk yarn has problems such as high cost and low tensile strength. In particular, when wet, which is a state of use in a surgical operation, a low strength when surgically tied is an essential problem of a suture made of silk.
合成繊維からなる縫合糸として、靱性が約7ないし約8.5グラム/デニールであり、破断に至る伸長率が30%以下であり、沸騰水収縮率が約0.5ないし約3.0%である糸フィラメントから形成した「組みポリエステル縫合糸」と称する糸(下記特許文献2参照)や、脂肪族オキシカルボン酸単位0.02〜30モル%、脂肪族または脂環式ジオール単位35〜49.99モル%、脂肪族ジカルボン酸単位35〜49.99モル%からなる数平均分子量が1万〜20万の脂肪族ポリエステル共重合体からなる縫合糸(下記特許文献3参照)等が提案されているが、さらに柔軟性に優れ、適度な引張り強度、結節強度を併せ持った縫合糸が求められている。 As a suture made of synthetic fibers, the toughness is about 7 to about 8.5 grams / denier, the elongation to break is 30% or less, and the boiling water shrinkage is about 0.5 to about 3.0%. Yarns formed from yarn filaments (refer to Patent Document 2 below), aliphatic oxycarboxylic acid units 0.02 to 30 mol%, aliphatic or alicyclic diol units 35 to 49 And a suture made of an aliphatic polyester copolymer having a number average molecular weight of 10,000 to 200,000 consisting of .99 mol% and aliphatic dicarboxylic acid units of 35 to 49.99 mol% (see Patent Document 3 below), etc. However, there is a demand for a suture thread that is more flexible and has appropriate tensile strength and knot strength.
本発明の目的は、従来の縫合糸に比べ、引張り強度、柔軟性が改善され、取扱い性の良好な、新規な手術用縫合糸法を提供することにある。 An object of the present invention is to provide a novel surgical suture method which has improved tensile strength and flexibility as compared with conventional sutures and has good handleability.
すなわち、本発明は、生体適合性の熱可塑性樹脂からなり、単糸の横断面形状が2個所以上のくびれ部を有する扁平度が2〜5の扁平断面形状を有する異型断面の手術用縫合糸である。 That is, the present invention is a surgical suture having an irregular cross section having a flat cross-sectional shape with a flatness of 2 to 5 having a constricted portion with two or more narrow cross-sectional shapes of a single yarn made of a biocompatible thermoplastic resin. It is.
かかる手術用縫合糸において、上記生体適合性の熱可塑性樹脂がポリエステル類、ポリアミド類、ポリオレフィン類から選ばれる少なくとも1種の繊維形成性ポリマーであることが適当であり、特に、生体適合性の熱可塑性樹脂が芳香族ポリエステルであるのが好ましい。 In such a surgical suture, it is appropriate that the biocompatible thermoplastic resin is at least one fiber-forming polymer selected from polyesters, polyamides, and polyolefins. It is preferable that the plastic resin is an aromatic polyester.
また、上記手術用縫合糸を構成する糸がモノフィラメントであるか、または、縫合糸を構成する糸のフィラメントカウントが15以下であるマルチフィラメントが好ましい。
また、本発明に係る手術用縫合糸を構成する糸にあっては、引張り強度が1.5cN/dtex以上であり、結節強度が1.5〜6.0cN/dtexであることが好ましい。
Further, it is preferable that the thread constituting the surgical suture is a monofilament, or a multifilament in which the filament count of the thread constituting the suture is 15 or less.
Moreover, in the thread | yarn which comprises the surgical suture which concerns on this invention, it is preferable that tensile strength is 1.5 cN / dtex or more and knot strength is 1.5-6.0 cN / dtex.
本発明により、柔軟性に優れ、適度な引張り強度、結節強度を併せ持ち、生体への適用性を損なうことなく、取扱い性の良好な手術用縫合糸を提供することができる。 According to the present invention, it is possible to provide a surgical suture which is excellent in flexibility, has appropriate tensile strength and knot strength, and has good handleability without impairing applicability to a living body.
以下、本発明の実施形態について詳細に説明する。
本発明の手術用縫合糸を構成する生体適合性の熱可塑性樹脂としては、芳香族ポリエステル等のポリエステル類、ナイロン等のポリアミド類、ポリスチレンやポリビニルアルコール、ポリ(エチレン−ビニルアセテート)、ポリ(ヒドロキシエチルメタクリレート)等のポリオレフィン類やこれらのコポリマー類、ポリ(カーボネート)、ポリ(ウレタン)等の縮合系高分子類やこれらのコポリマー類、ポリ乳酸、ポリ乳酸−ポリグリコール酸共重合体、ポリヒドロキシ酪酸、ポリカプロラクトン、ポリエチレンアジペート、ポリブチレンアジペート等の生分解性脂肪族ポリエステル、ポリブチレンカーボネート、ポリエチレンカーボネート等の脂肪族ポリカーボネート等が挙げられる。
Hereinafter, embodiments of the present invention will be described in detail.
Examples of the biocompatible thermoplastic resin constituting the surgical suture of the present invention include polyesters such as aromatic polyester, polyamides such as nylon, polystyrene, polyvinyl alcohol, poly (ethylene-vinyl acetate), poly (hydroxy Polyolefins such as ethyl methacrylate) and copolymers thereof, condensation polymers such as poly (carbonate) and poly (urethane) and copolymers thereof, polylactic acid, polylactic acid-polyglycolic acid copolymer, polyhydroxy Examples include biodegradable aliphatic polyesters such as butyric acid, polycaprolactone, polyethylene adipate, and polybutylene adipate, and aliphatic polycarbonates such as polybutylene carbonate and polyethylene carbonate.
なかでも、ポリエステル類、ポリアミド類、ポリオレフィン類が好ましく、とりわけ芳香族ポリエステルが好ましい。芳香族ポリエステルとしては、ポリエチレンテレフタレート、ポリトリメチレンテレフタレート、ポリブチレンテレフタレート、ポリエチレンナフタレートおよびこれらを主たる繰返し単位し、これにイソフタル酸や5−スルホイソフタル酸金属塩等の芳香族ジカルボン酸やアジピン酸、セバシン酸等の脂肪族ジカルボン酸やε−カプロラクトン等のヒドロキシカルボン酸縮合物、ジエチレングリコールやトリメチレングリコール、テトラメチレングリコール、ヘキサメチレングリコール等のグリコール成分等を共重合した共重合ポリエステルが挙げられる。本発明では、特にポリエチレンテレフタレート、ポリトリメチレンテレフタレート、ポリブチレンテレフタレート、ポリエチレンナフタレートならびにイソフタル酸共重合率が20モル%以下のポリエチレンテレフタレートイソフタレート、ポリ(テトラメチレンテレフタレート・オキシテトラメチレンテレフタレート)共重合体等の芳香族ポリエステル類が好ましい。 Of these, polyesters, polyamides, and polyolefins are preferable, and aromatic polyesters are particularly preferable. Aromatic polyesters include polyethylene terephthalate, polytrimethylene terephthalate, polybutylene terephthalate, polyethylene naphthalate and their main repeating units, and aromatic dicarboxylic acids such as isophthalic acid and 5-sulfoisophthalic acid metal salts and adipic acid. And a copolyester obtained by copolymerizing an aliphatic dicarboxylic acid such as sebacic acid or a hydroxycarboxylic acid condensate such as ε-caprolactone, or a glycol component such as diethylene glycol, trimethylene glycol, tetramethylene glycol or hexamethylene glycol. In the present invention, in particular, polyethylene terephthalate, polytrimethylene terephthalate, polybutylene terephthalate, polyethylene naphthalate, polyethylene terephthalate isophthalate having an isophthalic acid copolymerization ratio of 20 mol% or less, and poly (tetramethylene terephthalate / oxytetramethylene terephthalate) copolymer Aromatic polyesters such as coalescence are preferred.
本発明の手術用縫合糸を構成するポリマーにおいて、生体適合性ポリマー以外の成分の含有は抑えることが好ましい。
本発明における手術用縫合糸は、繊維(単糸)の横断面形状が2個所以上のくびれ部を有する扁平度が2〜5の扁平断面形状を有する異形断面の縫合糸である。
In the polymer constituting the surgical suture of the present invention, it is preferable to suppress the inclusion of components other than the biocompatible polymer.
The surgical suture according to the present invention is a suture with a modified cross-section having a flat cross-sectional shape with a flatness of 2 to 5 in which the cross-sectional shape of the fiber (single yarn) has two or more constricted portions.
従来の合成繊維からなる手術用縫合糸は、断面が円形の丸断面糸からなるが、このような丸断面糸あるいは横断面形状におけるくびれ部が2個所未満の糸は、柔軟性がなく結びにくいという問題があったり、引っ張り強度、結節強度も低いという問題がある。また、繊維の扁平度が2未満では丸断面糸と同様の問題があり、一方、扁平度が5を超えると扁平すぎて結び難く手術時の取り扱い性が劣るという問題があるので、いずれも本発明の目的を達成できない。 Conventional surgical sutures made of synthetic fibers are made of round cross-section yarns with a circular cross section, but such round cross-section yarns or yarns with less than two constrictions in the cross-sectional shape are not flexible and difficult to bind. There are also problems such as low tensile strength and nodule strength. Further, when the flatness of the fiber is less than 2, there is a problem similar to that of the round cross section thread. On the other hand, when the flatness exceeds 5, there is a problem that it is too flat and difficult to tie, so that the handling property at the time of surgery is inferior. The object of the invention cannot be achieved.
なお、ここで言う扁平度とは、下記の式で求められる値である。
本発明の縫合糸では、その太さ等が特に制限されるものではないが、使用時の雑菌病巣になるか否かや、消毒を含めた衛生性の観点から、フィラメントカウントが少なく15フィラメント以下のマルチフィラメントもしくはモノフィラメントであることが好ましい。 In the suture of the present invention, the thickness or the like is not particularly limited. However, from the viewpoint of hygiene including use and disinfection, the filament count is small and 15 filaments or less. The multifilament or monofilament is preferably used.
本発明による好適な手術用縫合糸は、引張り強度が1.5cN/dtex以上である。引張り強度が1.5cN/dtex未満の場合には、手術用縫合糸としての強さが不十分であるため、好ましくない。本発明において、引張り強度は2.0〜7.0cN/dtexが好ましく、より好ましくは2.0〜6.0cN/dtexである。 A preferred surgical suture according to the present invention has a tensile strength of 1.5 cN / dtex or more. When the tensile strength is less than 1.5 cN / dtex, the strength as a surgical suture is insufficient, which is not preferable. In the present invention, the tensile strength is preferably 2.0 to 7.0 cN / dtex, more preferably 2.0 to 6.0 cN / dtex.
また、本発明による好適な縫合糸は、結節強度が1.5〜6.0cN/dtexである。結節強度が1.5〜6.0cN/dtexの範囲外であると、本発明が目指すような柔軟性のある、取扱い性が特に優れた縫合糸は得られない。結節強度の好ましい範囲は2.0〜5.0cN/dtexである。 A suitable suture according to the present invention has a knot strength of 1.5 to 6.0 cN / dtex. When the knot strength is out of the range of 1.5 to 6.0 cN / dtex, a flexible suture with particularly excellent handleability as aimed by the present invention cannot be obtained. A preferred range of knot strength is 2.0 to 5.0 cN / dtex.
本発明の手術用縫合糸は、モノフィラメントであってもよいが、複数のマルチフィラメントを合わせて、求められる引張り強度や結節強度を満たすような糸束として使用することもできる。また、糸の束を組みひも状に編込んだ糸とすることもできる。 The surgical suture of the present invention may be a monofilament, but a plurality of multifilaments can be combined and used as a yarn bundle that satisfies the required tensile strength and knot strength. Moreover, it can also be set as the thread | yarn knitted in the shape of a braid.
本発明の手術用縫合糸の製造方法としては、特に限定されるものではなく熱可塑性樹脂における通常の製糸方法でよい。ただし、上記の異形断面繊維を溶融紡糸する際には、例えば、図1および図2に例示する形状の紡糸孔を有する紡糸口金を使用し、繊維が所定の断面形状を保ったまま冷却固化するように紡糸する必要がある。 The method for producing the surgical suture of the present invention is not particularly limited, and may be a normal yarn production method using a thermoplastic resin. However, when melt spinning the above-mentioned irregularly shaped cross-section fiber, for example, a spinneret having a spin hole having the shape illustrated in FIGS. 1 and 2 is used, and the fiber is cooled and solidified while maintaining the predetermined cross-sectional shape. Need to be spun.
以下、実施例および比較例をあげて本発明をさらに具体的に説明する。ただし、本発明はこれらにより何ら限定されるものではない。なお、例中の各評価項目は下記の方法で測定した。 Hereinafter, the present invention will be described more specifically with reference to examples and comparative examples. However, the present invention is not limited by these. Each evaluation item in the examples was measured by the following method.
(1)引張り強度、伸度
室温(25℃)で、初期試料長を200mm、引っ張り速度を200mm/分とし、JIS L1013に示される条件で荷重−伸長曲線を求めた。そして、破断時の荷重値を初期の繊度で割った値を引張り強度とし、破断時の伸長値を伸度とした。
(1) Tensile strength and elongation At room temperature (25 ° C.), the initial sample length was 200 mm, the tensile speed was 200 mm / min, and a load-elongation curve was obtained under the conditions shown in JIS L1013. And the value which divided the load value at the time of a fracture | rupture by the initial fineness was made into tensile strength, and the elongation value at the time of a fracture | rupture was made into elongation.
(2)結節強度
該縫合糸のつかみ間隔の中央に本結びを1個作った状態で、上述の引張り強度試験法に準拠して結節強度を測定した。
(2) Knot strength The knot strength was measured in accordance with the tensile strength test method described above with one main knot made at the center of the interval between the sutures.
[実施例1]
285℃での溶融粘度が1200poiseのポリエチレンテレフタレートを、図1に示す異形断面紡糸孔を有し、孔数が2の紡糸口金を用いて285℃で溶融紡糸し、1000m/minで巻き取った。得られた未延伸糸を延伸温度60〜90℃でローラー延伸し、次いで150℃で熱セットして巻き取った。この際、延伸糸が95dtex/4fになるように紡糸吐出量を調整したところ、得られた糸条の繊維(単糸)の横断面形状は図1のように計2個所のくびれを有し、その扁平度は2であった。この糸の引張り強度は5.2cN/dtex、伸度は20%、結節強度は3.4cN/dtexであって、柔軟性があり、取扱い性の良好な手術用縫合糸が得られた。
[Example 1]
Polyethylene terephthalate having a melt viscosity of 1,200 poise at 285 ° C. was melt-spun at 285 ° C. using a spinneret having a modified cross-section spinning hole shown in FIG. 1 and wound up at 1000 m / min. The obtained undrawn yarn was subjected to roller drawing at a drawing temperature of 60 to 90 ° C, and then heat-set at 150 ° C and wound up. At this time, when the spinning discharge amount was adjusted so that the drawn yarn was 95 dtex / 4f, the cross-sectional shape of the obtained fiber (single yarn) had two necks as shown in FIG. The flatness was 2. The yarn had a tensile strength of 5.2 cN / dtex, an elongation of 20%, a knot strength of 3.4 cN / dtex, and had a flexible and easy-to-handle surgical suture.
[実施例2]
図2に示す異形断面紡糸孔を有する紡糸口金を使用し、繊維の横断面形状が図2に示す形状の繊維とした以外は、実施例1と同様にして繊維(単糸)の横断面形状に計4個所のくびれを有し扁平度3の糸を作製した。この糸の引張り強度は5.0cN/dtex、伸度は21%、結節強度は3.1cN/dtexであり、柔軟性があり、取扱い性の良好な手術用縫合糸が得られた。
[Example 2]
The cross-sectional shape of the fiber (single yarn) is the same as in Example 1 except that the spinneret having the irregular cross-section spinning hole shown in FIG. 2 is used and the cross-sectional shape of the fiber is the fiber shown in FIG. A thread with a flatness of 3 was prepared with a total of 4 necks. The tensile strength of this yarn was 5.0 cN / dtex, the elongation was 21%, the knot strength was 3.1 cN / dtex, and a surgical suture having flexibility and good handleability was obtained.
[比較例1]
繊維の横断面形状が丸断面の95dtexのモノフィラメントである以外は、実施例1と同様にして糸を作製した。糸の引張り強度は6.2cN/dtex、伸度は22%であったが、結節強度は2.8cN/dtexであり、柔軟性がなく、結びにくい糸となった。
[Comparative Example 1]
A yarn was produced in the same manner as in Example 1 except that the cross-sectional shape of the fiber was a 95 dtex monofilament having a round cross section. The tensile strength of the yarn was 6.2 cN / dtex and the elongation was 22%. However, the knot strength was 2.8 cN / dtex, and the yarn had no flexibility and was difficult to bind.
[比較例2]
繊維の横断面形状が丸断面の95dtexでフィラメントカウントが20のマルチフィラメントである以外は、実施例1と同様にして糸を作製した。糸の引張り強度は3.9cN/dtex、伸度は18%、結節強度は2.3cN/dtexであり、柔軟性があり取扱い性は良いが、強度が不十分な糸となった。
[Comparative Example 2]
A yarn was produced in the same manner as in Example 1 except that the cross-sectional shape of the fiber was a multifilament having a round cross section of 95 dtex and a filament count of 20. The yarn had a tensile strength of 3.9 cN / dtex, an elongation of 18%, and a knot strength of 2.3 cN / dtex. The yarn had flexibility and good handleability but had insufficient strength.
本発明による手術用縫合糸は、優れた引張り強度、柔軟性、取扱い性を有するため各種の手術において有効に使用される。 The surgical suture according to the present invention has excellent tensile strength, flexibility, and handleability, so that it is effectively used in various operations.
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JP6261909B2 (en) * | 2013-08-26 | 2018-01-17 | 松田医科工業株式会社 | Suture and manufacturing method thereof |
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