JP2023010189A - Tissue reinforcement material - Google Patents

Tissue reinforcement material Download PDF

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JP2023010189A
JP2023010189A JP2021114148A JP2021114148A JP2023010189A JP 2023010189 A JP2023010189 A JP 2023010189A JP 2021114148 A JP2021114148 A JP 2021114148A JP 2021114148 A JP2021114148 A JP 2021114148A JP 2023010189 A JP2023010189 A JP 2023010189A
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tissue
reinforcing material
nonwoven fabric
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tissue reinforcing
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晃 若杉
Akira Wakasugi
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Gunze Ltd
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Abstract

To provide a tissue reinforcement material capable of reinforcing more surely the tissue weakened by following the shape of the tissue, and having high adhesion to the tissue.SOLUTION: There is provided a tissue reinforcement material comprising a bioabsorbable nonwoven fabric. The tissue reinforcement material has such open holes penetrating the bioabsorbable nonwoven fabric in a thickness direction, that the average major axis is 500 μm or more and 3,500 μm or less, the average minor axis is 400 μm or more and 2,500 μm or less, and the density is one/cm2 or more and 10/cm2 or less.SELECTED DRAWING: Figure 1

Description

本発明は、組織の形状に追従して脆弱化した組織をより確実に補強できるとともに、組織への密着性が高い組織補強材に関する。 TECHNICAL FIELD The present invention relates to a tissue reinforcing material that conforms to the shape of the tissue, can more reliably reinforce weakened tissue, and has high adhesion to the tissue.

外科手術においては、手術部位である切除面の保護、体液リーク予防、縫合部位の補強を目的として、補強材を用いて組織を補強することがある。組織からの剥離を抑えて高い補強効果を得るためには、組織補強材を組織としっかり密着させる必要がある。組織補強材を組織としっかり密着させる方策としては、例えば、組織補強材に切り込みを入れることで伸縮性を向上させる方法が提案されている(例えば、特許文献1)。 BACKGROUND ART In surgical operations, a reinforcing material is sometimes used to reinforce tissues for the purpose of protecting the resected surface, which is a surgical site, preventing body fluid leakage, and reinforcing sutured sites. In order to suppress detachment from the tissue and obtain a high reinforcing effect, it is necessary to firmly adhere the tissue reinforcing material to the tissue. As a measure for firmly adhering the tissue reinforcing material to the tissue, for example, a method of improving stretchability by making a cut in the tissue reinforcing material has been proposed (eg, Patent Document 1).

特開2015-107198号公報JP 2015-107198 A

しかしながら、従来の組織補強材は伸縮性に優れるものの、組織との密着性についてはまだ充分とは言えなかった。組織補強材の組織に対する密着性が劣る場合は組織補強材の組織再生促進効果も低下することから、より密着性の高い組織補強材が求められていた。 However, although conventional tissue reinforcing materials are excellent in stretchability, their adhesion to tissue is still insufficient. If the adhesion of the tissue reinforcing material to the tissue is poor, the effect of the tissue reinforcing material on promoting tissue regeneration is also reduced. Therefore, a tissue reinforcing material with higher adhesion has been desired.

本発明は、組織の形状に追従して脆弱化した組織をより確実に補強できるとともに、組織への密着性が高い組織補強材を提供することを目的とする。 SUMMARY OF THE INVENTION An object of the present invention is to provide a tissue reinforcing material that follows the shape of the tissue, can more reliably reinforce the weakened tissue, and has high adhesion to the tissue.

本発明は、生体吸収性の不織布からなる組織補強材であって、前記組織補強材は、前記生体吸収性の不織布を厚み方向に貫通する平均長径500μm以上3500μm以下、平均短径400μm以上2500μm以下の貫通孔を1個/cm以上10個/cm以下の密度で有する組織補強材である。
以下に本発明を詳述する。
The present invention is a tissue reinforcing material made of a bioabsorbable nonwoven fabric, wherein the tissue reinforcing material penetrates the bioabsorbable nonwoven fabric in the thickness direction and has an average major axis of 500 μm or more and 3500 μm or less and an average minor axis of 400 μm or more and 2500 μm or less. through-holes at a density of 1/cm 2 or more and 10/cm 2 or less.
The present invention will be described in detail below.

本発明者らは鋭意検討を進めた結果、生体吸収性の不織布に特定の長径及び短径と密度の貫通孔を設けることで、組織の形状に追従し、脆弱化した組織をより確実に補強できるとともに、組織への密着性が高い組織補強材が得られることを見出し本発明を完成させるに至った。 As a result of intensive studies, the present inventors found that by providing through-holes with specific long and short diameters and densities in a bioabsorbable nonwoven fabric, it conforms to the shape of the tissue and more reliably reinforces weakened tissue. The present inventors have found that a tissue reinforcing material can be obtained and have high adhesion to tissue, and have completed the present invention.

本発明の組織補強材は、生体吸収性の不織布(以下、単に不織布ともいう)からなる。
組織補強材を生体吸収性の不織布とすることで、移植後に徐々に生体に吸収され、やがて消滅し自己組織に置換される。従って、慢性期の異物反応の軽減や感染の温床になるリスクが低減されることとなる。
The tissue reinforcing material of the present invention consists of a bioabsorbable nonwoven fabric (hereinafter simply referred to as nonwoven fabric).
By using a bioabsorbable nonwoven fabric as the tissue reinforcing material, it is gradually absorbed by the body after transplantation, and eventually disappears and is replaced by the autologous tissue. Therefore, foreign body reaction in the chronic stage is reduced and the risk of becoming a breeding ground for infection is reduced.

上記不織布を構成する生体吸収性材料は、例えば、ポリグリコリド、ポリラクチド(D、L、DL体)、グリコリド-ラクチド(D、L、DL体)共重合体、グリコリド-Ε-カプロラクトン共重合体、ラクチド(D、L、DL体)-Ε-カプロラクトン共重合体、ポリ(P-ジオキサノン)、グリコリド-ラクチド(D、L、DL体)-Ε-カプロラクトン共重合体等の合成吸収性高分子が挙げられる。これらは単独で用いられてもよく、2種以上が併用されてもよい。なかでも、適度の強度と柔軟性を発揮することができ、かつ、適度な生体反応を惹起して組織の修復を促進できることから、ポリグリコリド、ポリラクチド(L体)、ラクチド(D、L、DL体)-Ε-カプロラクトン共重合体が好適であり、適度な分解挙動を示すことから、ポリグリコリドがより好適である。
また、上記生体吸収性材料としては、シルクフィブロイン、コラーゲン、ゼラチン、キチン、キトサン、フィブリン等の天然吸収性高分子を用いることもできる。更に、上記合成吸収性高分子と上記天然吸収性高分子を併用してもよい。
Bioabsorbable materials constituting the nonwoven fabric include, for example, polyglycolide, polylactide (D, L, DL forms), glycolide-lactide (D, L, DL forms) copolymers, glycolide-Ε-caprolactone copolymers, Synthetic absorbable polymers such as lactide (D, L, DL forms)-Ε-caprolactone copolymers, poly(P-dioxanone), glycolide-lactide (D, L, DL forms)-Ε-caprolactone copolymers mentioned. These may be used alone or in combination of two or more. Among them, polyglycolide, polylactide (L form), lactide (D, L, DL )-E-caprolactone copolymer is preferred, and polyglycolide is more preferred because it exhibits moderate decomposition behavior.
As the bioabsorbable material, natural absorbable polymers such as silk fibroin, collagen, gelatin, chitin, chitosan, and fibrin can also be used. Furthermore, the synthetic absorbable polymer and the natural absorbable polymer may be used in combination.

上記生体吸収性材料としてポリグリコリド(グリコリドのホモポリマー又はコポリマー)を用いる場合、ポリグリコリドの重量平均分子量の好ましい下限は30000、好ましい上限は1000000である。上記ポリグリコリドの重量平均分子量が30000以上であると、組織補強材としての充分な強度を発揮でき、1000000以下であると、適度な生体反応を惹起して組織の修復を促進し、分解することで長期間の異物としての残存が無く速やかに生体組織に置き換わる。上記ポリグリコリドの重量平均分子量のより好ましい下限は50000、より好ましい上限は300000である。 When polyglycolide (a homopolymer or copolymer of glycolide) is used as the bioabsorbable material, the preferred lower limit of the weight average molecular weight of polyglycolide is 30,000, and the preferred upper limit is 1,000,000. When the weight-average molecular weight of the polyglycolide is 30,000 or more, it can exhibit sufficient strength as a tissue reinforcing material, and when it is 1,000,000 or less, it induces an appropriate biological reaction to promote tissue repair and decomposition. It is quickly replaced by living tissue without remaining as a foreign substance for a long period of time. A more preferable lower limit of the weight average molecular weight of the polyglycolide is 50,000, and a more preferable upper limit thereof is 300,000.

本発明の組織補強材がポリグリコリドからなる場合、ポリグリコリドのメルトフローレートの好ましい上限は15g/10min、好ましい下限は2g/10minである。上記ポリグリコリドのメルトフローレートがこの範囲内であると、組織補強材としての充分な強度を発揮できるとともに、適度な生体反応を惹起して組織の修復を促進し、分解することで長期間の異物としての残存が無く速やかに生体組織に置き換わる。上記ポリグリコリドのメルトフローレートのより好ましい上限は10g/10min、より好ましい下限は4g/10minである。 When the tissue reinforcing material of the present invention comprises polyglycolide, the preferred upper limit of the polyglycolide melt flow rate is 15 g/10 min, and the preferred lower limit is 2 g/10 min. When the melt flow rate of the polyglycolide is within this range, it is possible to exhibit sufficient strength as a tissue reinforcing material, induce an appropriate biological reaction to promote tissue repair, and decompose tissue for a long period of time. It does not remain as a foreign substance and is quickly replaced with living tissue. A more preferable upper limit of the melt flow rate of the polyglycolide is 10 g/10 min, and a more preferable lower limit is 4 g/10 min.

上記不織布の目付は特に限定されないが、好ましい下限は5g/m、好ましい上限は300g/mである。上記不織布の目付が5g/m未満であると、生体組織補強材としての強度が不足し、脆弱した組織を補強できないことがあり、300g/mを超えると、組織への接着性が悪くなることがある。上記不織布の目付のより好ましい下限は10g/m、より好ましい上限は100g/mである。 The basis weight of the nonwoven fabric is not particularly limited, but the preferred lower limit is 5 g/m 2 and the preferred upper limit is 300 g/m 2 . If the fabric weight of the non-woven fabric is less than 5 g/m 2 , the strength as a biological tissue reinforcing material may be insufficient, and fragile tissue may not be reinforced. can be. A more preferable lower limit of the basis weight of the nonwoven fabric is 10 g/m 2 , and a more preferable upper limit is 100 g/m 2 .

上記不織布の空隙率は特に限定されないが、好ましい下限は20%、好ましい上限は90%である。上記不織布の空隙率がこの範囲内であると、組織補強材としての充分な強度と、生体組織への接着性、再生組織侵入を両立することができる。上記不織布の空隙率のより好ましい下限は60%、より好ましい上限は80%である。 Although the porosity of the nonwoven fabric is not particularly limited, the preferred lower limit is 20% and the preferred upper limit is 90%. When the porosity of the nonwoven fabric is within this range, it is possible to achieve both sufficient strength as a tissue reinforcing material, adhesion to living tissue, and penetration into regenerated tissue. A more preferable lower limit of the porosity of the nonwoven fabric is 60%, and a more preferable upper limit thereof is 80%.

上記不織布を製造する方法は特に限定されず、例えば、エレクトロスピニングデポジション法、メルトブロー法、ニードルパンチ法、スパンボンド法、フラッシュ紡糸法、水流交絡法、エアレイド法、サーマルボンド法、レジンボンド法、湿式法等の従来公知の方法を用いることができる。 The method for producing the nonwoven fabric is not particularly limited, and examples thereof include an electrospinning deposition method, a melt blow method, a needle punch method, a spunbond method, a flash spinning method, a hydroentanglement method, an airlaid method, a thermal bond method, a resin bond method, A conventionally known method such as a wet method can be used.

本発明の組織補強材は、上記生体吸収性の不織布を厚み方向に貫通する平均長径500μm以上3500μm以下、平均短径400μm以上2500μm以下の貫通孔を有する。
従来の組織補強材は、貼り付ける際に空気を巻き込んでしまうことがあり、巻き込まれた空気は気泡として残るため、気泡の部分が浮き上がってしまい密着性が低下していた。本発明では組織補強材に貫通孔を設けることで、組織補強材の貼り付け時に生じた気泡を外部へ逃がすことができるため、浮きを抑えて高い密着性を発揮することができる。その結果、組織補強材が剥離し難くなるとともに、体液を溜まり難くすることができる。また、密着性が高まることにより、組織補強材の組織再生促進効果を充分に発揮することができる。更に、上記貫通孔の平均長径及び平均短径が上記範囲であることで、組織補強材としての性能を維持しつつも気泡を確実に外部へ逃がすことができる。
The tissue reinforcing material of the present invention has through holes having an average major axis of 500 μm or more and 3500 μm or less and an average minor axis of 400 μm or more and 2500 μm or less penetrating the bioabsorbable nonwoven fabric in the thickness direction.
Conventional tissue reinforcing materials sometimes entrain air when they are applied, and the entrained air remains as air bubbles, causing the air bubbles to float up and lowering the adhesiveness. In the present invention, by providing a through-hole in the tissue reinforcing material, air bubbles generated when the tissue reinforcing material is attached can escape to the outside, so that floating can be suppressed and high adhesion can be exhibited. As a result, it becomes difficult for the tissue reinforcing material to peel off, and it is possible to make it difficult for body fluids to accumulate. In addition, by increasing the adhesiveness, the effect of promoting tissue regeneration of the tissue reinforcing material can be sufficiently exhibited. Furthermore, by setting the average major axis and average minor axis of the through-holes within the above ranges, it is possible to reliably release air bubbles to the outside while maintaining the performance as a tissue reinforcing material.

上記貫通孔の平均長径は550μm以上であることが好ましく、1000μm以上であることがより好ましく、3300μm以下であることが好ましく、3000μm以下であることがより好ましい。また、上記貫通孔の平均短径は450μm以上であることが好ましく、800μm以上であることがより好ましく、2400μm以下であることが好ましく、2000μm以下であることがより好ましい。
なお、ここで平均長径及び平均短径とは、上記貫通孔10個の長径及び短径の平均のことを指す。また、上記貫通孔が真円である場合は上記平均長径及び平均短径は平均直径となる。
The average major axis of the through-holes is preferably 550 µm or more, more preferably 1000 µm or more, preferably 3300 µm or less, and more preferably 3000 µm or less. The average short diameter of the through-holes is preferably 450 μm or more, more preferably 800 μm or more, preferably 2400 μm or less, and more preferably 2000 μm or less.
Here, the average major axis and average minor axis refer to the average of the major axis and minor axis of the 10 through-holes. Moreover, when the through-hole is a perfect circle, the average major axis and the average minor axis are the average diameters.

上記貫通孔は1個/cm以上10個/cm以下の密度である。
上記貫通孔の密度が上記範囲であることで、気泡の数を充分に減らすことができ、高い密着性を発揮することができる。上記貫通孔の密度は、2個/cm以上であることが好ましく、3個/cm以上であることがより好ましく、8個/cm以下であることが好ましく、7個/cm以下であることがより好ましい。
The through-holes have a density of 1/cm 2 or more and 10/cm 2 or less.
When the density of the through-holes is within the above range, the number of air bubbles can be sufficiently reduced, and high adhesion can be exhibited. The density of the through-holes is preferably 2/cm 2 or more, more preferably 3/cm 2 or more, preferably 8/cm 2 or less, and 7/cm 2 or less. is more preferable.

上記貫通孔を形成する方法は特に限定されず、例えば、上記不織布に針を刺す方法や、上記不織布に切れ目(スリット)を入れた後に加熱する方法等が挙げられる。 The method of forming the through-holes is not particularly limited, and examples thereof include a method of inserting a needle into the nonwoven fabric, and a method of heating the nonwoven fabric after slitting.

ここで、本発明の貫通孔の写真を図1に示す。図1の貫通孔は不織布にスリットを入れた後に加熱する方法で形成されている。本発明の組織補強材は、上記範囲の大きさと密度を有する図1のような貫通孔を有することで、組織補強材の貼り付け時に生じた気泡を外部へ逃がすことができるため、浮きを抑えて高い密着性を発揮することができる。 Here, a photograph of the through hole of the present invention is shown in FIG. The through-holes shown in FIG. 1 are formed by slitting the nonwoven fabric and then heating the nonwoven fabric. Since the tissue reinforcing material of the present invention has through-holes as shown in FIG. 1 having the size and density within the above range, air bubbles generated when the tissue reinforcing material is attached can escape to the outside, thereby suppressing floating. can exhibit high adhesion.

本発明の組織補強材の厚みは特に限定されないが、30μm以上300μm以下であることが好ましい。
組織補強材の厚みが上記範囲であることで、強度と密着性とのバランスに優れた組織補強材とすることができる。上記組織補強材の厚みは、50μm以上であることがより好ましく、200μm以下であることがより好ましい。
Although the thickness of the tissue reinforcing material of the present invention is not particularly limited, it is preferably 30 μm or more and 300 μm or less.
By setting the thickness of the tissue reinforcing material within the above range, the tissue reinforcing material can have an excellent balance between strength and adhesiveness. The thickness of the tissue reinforcing material is more preferably 50 μm or more, and more preferably 200 μm or less.

本発明の組織補強材は、外科分野において損傷又は脆弱化した臓器、組織の止血、空気漏れ防止、体液漏れ防止のために用いる。とりわけ、呼吸器に好適に用いることができる。
本発明の組織補強材は、例えば、組織補強材を生理食塩水に浸漬してから患部にあてるだけで、容易に貼付することができる。また、患部に血液や体液がある場合には、これらを吸収することによっても接着力を発現することができる。また、本発明の組織補強材は上記貫通孔を有しているため、組織補強材を組織へ貼り付けた際に空気を巻き込んでしまったとしても、空気が貫通孔を通して抜けていくことから、組織補強材を充分に密着させることができ、組織をより確実に補強できる。
The tissue reinforcing material of the present invention is used for hemostasis, air leakage prevention, and body fluid leakage prevention for damaged or weakened organs and tissues in the surgical field. In particular, it can be suitably used for respiratory organs.
The tissue reinforcing material of the present invention can be easily applied by, for example, immersing the tissue reinforcing material in physiological saline and applying it to the affected area. In addition, when there is blood or body fluid in the affected area, the adhesive force can also be expressed by absorbing these. In addition, since the tissue reinforcing material of the present invention has the through-holes, even if air is entrained when the tissue reinforcing material is attached to the tissue, the air escapes through the through-holes. The tissue reinforcing material can be adhered sufficiently, and the tissue can be reinforced more reliably.

本発明によれば、組織の形状に追従して脆弱化した組織をより確実に補強できるとともに、組織への密着性が高い組織補強材を提供することができる。 According to the present invention, it is possible to provide a tissue reinforcing material that follows the shape of the tissue and can more reliably reinforce the weakened tissue and that has high adhesion to the tissue.

本発明の組織補強材の貫通孔の写真である。1 is a photograph of through-holes in a tissue reinforcing material of the present invention;

以下に実施例を挙げて本発明の態様を更に詳しく説明するが、本発明はこれら実施例にのみ限定されるものではない。 EXAMPLES The aspects of the present invention will be described in more detail below with reference to Examples, but the present invention is not limited to these Examples.

(実施例1)
厚み70μmのポリグリコリドからなる不織布(ネオベールナノ(NV-1010-D10G)、グンゼ社製)に、1mmのスリットを10個/cmの密度となるように入れた。その後、80℃10分の加熱処理を行うことで、平均長径0.55mm、平均短径0.46mmの楕円形の貫通孔を有する組織補強材を得た。
(Example 1)
A 70 μm-thick polyglycolide nonwoven fabric (Neovel Nano (NV-1010-D10G), manufactured by Gunze) was provided with 1 mm slits at a density of 10/cm 2 . Thereafter, heat treatment was performed at 80° C. for 10 minutes to obtain a tissue reinforcing material having elliptical through holes with an average major axis of 0.55 mm and an average minor axis of 0.46 mm.

(実施例2~7)
ポリグリコリドからなる不織布に表1に示す長さのスリットを入れ、表1に示す大きさ及び密度の貫通孔を形成した以外は実施例1と同様にして組織補強材を得た。
(Examples 2-7)
A tissue reinforcing material was obtained in the same manner as in Example 1, except that slits having the lengths shown in Table 1 were formed in the nonwoven fabric made of polyglycolide to form through holes having the sizes and densities shown in Table 1.

(比較例1)
スリットを入れず、貫通孔を設けなかった以外は実施例1と同様にして組織補強材を得た。
(Comparative example 1)
A tissue reinforcing material was obtained in the same manner as in Example 1, except that no slits were formed and no through holes were provided.

<評価>
実施例及び比較例で得られた組織補強材について以下の評価を行った。
<Evaluation>
The tissue reinforcing materials obtained in Examples and Comparative Examples were evaluated as follows.

(密着性の評価)
組織補強材の中央部を50mm×30mmに切り取り評価サンプルを作製した。次いで、評価サンプルをブタの肝臓の上に静置し、上から湿らせたガーゼ等でサンプルを濡らすように数回軽く押さえて密着させた。密着後の組織補強材を目視にて観察し、組織補強材に気泡による浮きが見られなかった場合を「○」、組織補強材に気泡による浮きが見られた場合を「×」として密着性を評価した。
(Evaluation of adhesion)
An evaluation sample was prepared by cutting the central portion of the tissue reinforcing material into a size of 50 mm×30 mm. Next, the evaluation sample was placed on the pig liver, and the sample was lightly pressed several times with wet gauze or the like so as to make the sample wet and adhered. The tissue reinforcing material after close contact was visually observed, and if no floating due to air bubbles was observed in the tissue reinforcing material, "○" was observed. evaluated.

Figure 2023010189000002
Figure 2023010189000002

本発明によれば、組織の形状に追従して脆弱化した組織をより確実に補強できるとともに、組織への密着性が高い組織補強材を提供することができる。

According to the present invention, it is possible to provide a tissue reinforcing material that follows the shape of the tissue and can more reliably reinforce the weakened tissue and that has high adhesion to the tissue.

Claims (1)

生体吸収性の不織布からなる組織補強材であって、
前記組織補強材は、前記生体吸収性の不織布を厚み方向に貫通する平均長径500μm以上3500μm以下、平均短径400μm以上2500μm以下の貫通孔を1個/cm以上10個/cm以下の密度で有する
ことを特徴とする組織補強材。
A tissue reinforcing material comprising a bioabsorbable nonwoven fabric,
The tissue reinforcing material has through-holes with an average major axis of 500 μm to 3500 μm and an average minor axis of 400 μm to 2500 μm that penetrate the bioabsorbable nonwoven fabric in the thickness direction at a density of 1 hole/cm 2 to 10 holes/cm 2 . A tissue reinforcement material comprising:
JP2021114148A 2021-07-09 2021-07-09 Tissue reinforcement material Pending JP2023010189A (en)

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