JP2012205720A - Regeneration material for rotator cuff and shoulder intra-articular structure - Google Patents
Regeneration material for rotator cuff and shoulder intra-articular structure Download PDFInfo
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Abstract
Description
本発明は、損傷が広範に及ぶ肩関節内構成体や断裂サイズの大きな腱損傷の治癒に用いた場合に、組織再生を促しつつ組織再生の間の強度を保持し、かつ、機械的強度の高い肩関節内構成体や腱組織を菲薄化することなく再生できる腱板及び肩関節内構成体の再生材料に関する。 The present invention maintains the strength during tissue regeneration while promoting tissue regeneration when used for healing a wide range of injuries within the shoulder joint and tendon damage with a large tear size, and has a mechanical strength. The present invention relates to a rotator cuff that can be regenerated without thinning a high shoulder joint component and tendon tissue, and a regeneration material for the shoulder joint component.
腱板は、肩関節の安定化に重要な役割を果たしており、手を使う際等の上肢の運動全体に大きく係っている。腱板が損傷された場合には、安静時痛、運動時痛又は夜間痛等の疼痛や、可動域制限のために日常生活や仕事に大きな支障が生じる。また、肩関節には関節包や靭帯等に代表される肩関節内構成体が存在し、関節の安定性に寄与している。 The rotator cuff plays an important role in stabilizing the shoulder joint, and is largely involved in the entire upper limb movement such as when using the hand. When the rotator cuff is damaged, pains such as resting pain, exercise pain or night pain, and daily life and work are greatly hindered due to limited range of motion. In addition, there are shoulder joint components represented by joint capsules and ligaments in the shoulder joint, which contribute to the stability of the joint.
腱板損傷の治療方法としては、まず保存的治療法を行う。保存的治療法では治癒しない場合には、手術的治療法を行うのが一般的である。手術的治療法では、腱板の断裂サイズが小さい場合は、腱板断端を縫合する方法や、上腕骨に骨溝を作製して縫着する方法等の、いわゆる一次的修復が行われる。しかし、断裂サイズが大きい場合には、このような一次的修復の適用が困難となり、欠損部を大腿筋膜等、他の部位の生体組織で補填する方法（パッチグラフト法）等が用いられてきた。
しかしながら、パッチグラフト法では、自家組織を犠牲にするうえに、使用できる組織の大きさにも限界があった。また、再受傷した場合等には、更なる組織の採取に難渋した。そこで、自家組織を用いたパッチグラフト法に代わる、腱板損傷の治療方法が求められていた。
As a method for treating rotator cuff injury, first, a conservative treatment is performed. When conservative treatment does not cure, surgical treatment is generally performed. In the surgical treatment method, when the rotator cuff tear size is small, so-called primary repair is performed such as a method of suturing the rotator cuff stump and a method of creating and sewing a bone groove in the humerus. However, when the rupture size is large, it is difficult to apply such a primary repair, and a method (patch graft method) or the like for filling the defect with a living tissue of another part such as a thigh fascia has been used. It was.
However, the patch graft method has a limit on the size of the tissue that can be used in addition to sacrificing the autologous tissue. In the case of re-injury, it was difficult to collect more tissues. Therefore, there has been a demand for a method for treating rotator cuff damage in place of the patch graft method using autologous tissue.
肩関節内構成体の損傷の治療方法も同様であり、損傷部を一時的に修復する方法がまず行われる。しかし、損傷部が大きくなると一次修復が困難となる。そして、欠損部を他の部位の腱組織等で補填する方法（腱移行法）等が用いられてきた。しかしながら、欠損部を他の部位の腱組織等で補填する方法では、パッチグラフト法と同様に、自家組織を犠牲にするうえに、使用できる組織の大きさにも限界があった。また、再受傷した場合等には、更なる組織の採取に難渋した。そこで、自家組織を用いた方法に代わる、肩関節内構成体の損傷の治療方法が求められていた。 The same applies to the method of treating damage to the intra-shoulder component, and a method of temporarily repairing the damaged part is first performed. However, when the damaged part becomes large, primary repair becomes difficult. And the method (tendon transfer method) etc. which compensate a defect part with the tendon tissue of another site | part etc. have been used. However, in the method of filling a defect with a tendon tissue or the like at another site, there is a limit to the size of the tissue that can be used in addition to sacrificing the autologous tissue, as in the patch graft method. In the case of re-injury, it was difficult to collect more tissues. Therefore, there has been a demand for a method for treating damage to the components in the shoulder joint, in place of the method using the autologous tissue.
特許文献１には、絹繊維骨格のマトリックスを用い、当該マトリックス上で増殖及び分化して、生体外（ｅｘ ｖｉｖｏ）で腱を形成する多能性細胞を播種する方法が記載されている。しかしながら、現時点においては、臨床現場において細胞を播種し、培養する方法は現実的ではない。
特許文献２には、生体適合性マトリックス中に、血小板由来成長因子（ＰＤＧＦ）を含む溶液を配置した組成物を用い、腱の骨への付着を強化する方法が記載されている。しかしながら、高価な血小板由来成長因子（ＰＤＧＦ）を用いる方法は、現実的ではない。
特許文献３には、肩接合部の回旋筋腱板の断裂に対する外科的治療方法として短冊状部材を使用する方法が提案されている。しかしながら、この方法は治癒するまでの期間固定するだけの機能を有しているに過ぎず、積極的に組織を再生させるものではない。
これに対して本発明者らは、人工靭帯として市販されているポリエチレンテレフタレート（ＰＥＴ）繊維からなる織物を用いて、腱板の再生を試みた。当該ＰＥＴ繊維織物は充分な強度を有しており、これをパッチグラフトとして移植することにより、良好な腱組織の再生が認められた。しかしながら、断裂サイズの大きな腱損傷の治癒のために、４８００ｍｍ３以上のＰＥＴ繊維織物を移植した場合には、軽度の水腫が発生するという問題があった。 On the other hand, the present inventors tried to regenerate the rotator cuff using a woven fabric made of polyethylene terephthalate (PET) fibers commercially available as an artificial ligament. The PET fiber fabric has a sufficient strength, and when this was grafted as a patch graft, good tendon tissue regeneration was observed. However, there has been a problem that mild edema occurs when a PET fiber fabric having a size of 4800 mm 3 or more is implanted for healing tendon damage having a large tear size.
本発明者らは、更に、市販の生体吸収性のポリグリコリドからなる不織布を用いて、腱板の再生を試みた。その結果、腱骨付着部及び腱実質部が修復可能であることが確認された（非特許文献１）。ウサギの肩腱板にそのままでは修復されない大きさの欠損部を作製し、ポリグリコリド不織布シートを移植したところ、腱とポリグリコリド不織布シートとの適合性が良好で、充分な腱組織が再生されているのが確認された。更に、ポリグリコリド不織布シートと骨との接合部において、正常な解剖学的構造に近似した状態の腱が再生されることも確認された。
しかしながら、ポリグリコリド不織布シートをパッチグラフトとして移植して腱の再生を行った場合、４８００ｍｍ３程度の体積のシートを移植しても再生中の強度を保てず、また、再生された腱の機械的強度も正常な腱よりも低くなる傾向があるという問題があった。また、長期的には再生腱組織の一部が菲薄化してしまうことがあるという問題もあった。これを防止するために、８０００ｍｍ３以上の大量のポリグリコリド不織布シートを移植すると、菲薄化は防止できたものの、水腫と炎症とが発生してしまった。
そこで、組織再生を促しつつ再生の間の強度を保持し、かつ、機械的強度の高い組織を菲薄化することなく再生できる腱板及び肩関節内構成体の再生材料が求められていた。
The present inventors further attempted to regenerate the rotator cuff using a non-woven fabric made of a commercially available bioabsorbable polyglycolide. As a result, it was confirmed that the tendon attachment portion and the tendon parenchyma can be repaired (Non-Patent Document 1). When a defect part of a size that cannot be repaired as it is is prepared on the shoulder rotator cuff of a rabbit and transplanted with a polyglycolide nonwoven sheet, the compatibility between the tendon and the polyglycolide nonwoven sheet is good, and sufficient tendon tissue is regenerated. It was confirmed that Furthermore, it was confirmed that the tendon in a state approximating a normal anatomical structure was regenerated at the joint between the polyglycolide nonwoven fabric sheet and the bone.
However, when a polyglycolide non-woven sheet is transplanted as a patch graft to regenerate a tendon, the strength during regeneration cannot be maintained even if a sheet having a volume of about 4800 mm 3 is implanted, and the regenerated tendon machine There is a problem that the strength of the eye tends to be lower than that of a normal tendon. In addition, there has been a problem that a part of the regenerated tendon tissue may become thin in the long term. In order to prevent this, when a large amount of polyglycolide nonwoven fabric sheet of 8000 mm 3 or more was transplanted, although thinning could be prevented, edema and inflammation occurred.
Accordingly, there has been a demand for a regenerating material for a rotator cuff and a shoulder joint internal body that can maintain tissue strength during regeneration while promoting tissue regeneration and can regenerate a tissue having high mechanical strength without thinning.
本発明は、損傷が広範に及ぶ肩関節内構成体や断裂サイズの大きな腱損傷の治癒に用いる場合はもとより、限局的な損傷においても組織の再生が要求される場合に、組織再生を促しつつ組織再生の間の強度を保持し、かつ、機械的強度の高い肩関節内構成体や腱組織を菲薄化することなく再生できる腱板及び肩関節内構成体再生材料を提供することを目的とする。 The present invention promotes tissue regeneration not only when used for healing a wide range of damaged intra-shoulder components and tendon damage with large tear sizes, but also when tissue regeneration is required even in localized damage. It is an object of the present invention to provide a rotator cuff and a shoulder joint component regenerating material that can maintain the strength during tissue regeneration and can regenerate the mechanically strong shoulder joint component and tendon tissue without thinning. To do.
本発明は、生体吸収性材料からなる不織布層と、生体非吸収性材料からなる繊維構造体層との積層体からなることを特徴とする腱板及び肩関節内構成体再生材料である。
以下に本発明を詳述する。
The present invention is a rotator cuff and shoulder joint component regenerating material comprising a laminate of a nonwoven fabric layer made of a bioabsorbable material and a fiber structure layer made of a bioabsorbable material.
The present invention is described in detail below.
本発明者は、鋭意検討の結果、４８００ｍｍ３以上のパッチグラフトを要する断裂サイズの大きな腱板や肩関節内構成体の損傷の治癒において、生体吸収性材料からなる不織布層と、生体非吸収性材料からなる繊維構造体層との積層体をパッチグラフトとして移植して再生を行った場合には、組織再生を促しつつ再生の間の強度を保持し、かつ、機械的強度の高い腱組織及び肩関節内構成体組織を菲薄化することなく再生できることを見出し、本発明を完成した。 As a result of intensive studies, the present inventor has developed a nonwoven fabric layer made of a bioabsorbable material and a non-bioabsorbable material in healing damage to a large ruptured rotator cuff that requires a patch graft of 4800 mm 3 or more and a component in the shoulder joint. When regeneration is performed by transplanting a laminate with a fiber structure layer made of a material as a patch graft, tendon tissue having high mechanical strength while maintaining strength during regeneration while promoting tissue regeneration, and The present inventors have found that the body tissue in the shoulder joint can be regenerated without thinning, and the present invention has been completed.
上記生体吸収性材料からなる不織布層（以下、単に「不織布層」ともいう。）を構成する生体吸収性材料は特に限定されず、例えば、ポリグリコリド、ポリラクチド（Ｄ、Ｌ、ＤＬ体）、ポリカプロラクトン、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や、ゼラチン、コラーゲン又はフィブリン等の天然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、比較的高い強度と柔軟性、及び、適度な分解挙動を示すことから、ポリグリコリドが好適である。
上記ポリグリコリドからなる不織布は、例えば、グンゼ社製のネオベール（登録商標）等が市販されている。
The bioabsorbable material constituting the non-woven fabric layer (hereinafter also simply referred to as “nonwoven fabric layer”) made of the bioabsorbable material is not particularly limited. For example, polyglycolide, polylactide (D, L, DL body), poly Caprolactone, glycolide-lactide (D, L, DL) copolymer, glycolide-ε-caprolactone copolymer, lactide (D, L, DL) -ε-caprolactone copolymer, poly (p-dioxanone), Examples include synthetic absorbable polymers such as glycolide-lactide (D, L, DL form) -ε-caprolactone copolymer, and natural polymers such as gelatin, collagen, and fibrin. These may be used independently and 2 or more types may be used together. Among them, polyglycolide is preferable because it exhibits relatively high strength and flexibility and moderate decomposition behavior.
As the nonwoven fabric made of polyglycolide, for example, Neobale (registered trademark) manufactured by Gunze Co., Ltd. is commercially available.
上記生体非吸収性材料からなる繊維構造体層（以下、単に「繊維構造体層」ともいう。）を構成する生体非吸収性材料は特に限定されず、例えば、ポリエチレン、ポリプロピレン等のポリオレフィンや、ポリエチレンテレフタレート等のポリエステル等の生体不活性な合成高分子が挙げられる。なかでも、高い強度と柔軟性とを有することからポリエチレンテレフタレートが好適である。 The non-bioabsorbable material constituting the fiber structure layer made of the non-bioabsorbable material (hereinafter also simply referred to as “fiber structure layer”) is not particularly limited. For example, polyolefins such as polyethylene and polypropylene, Examples thereof include bioinert synthetic polymers such as polyesters such as polyethylene terephthalate. Among these, polyethylene terephthalate is preferable because it has high strength and flexibility.
上記繊維構造体層の構造は特に限定されず、例えば、織物、編物、不織布等が挙げられる。なかでも高い強度と柔軟性とを有することから、織物が好適である。
ポリエチレンテレフタレートの織物からなる繊維構造体は、例えば、ユフ精器社製、リーズケイオウ等が市販されている。
The structure of the said fiber structure layer is not specifically limited, For example, a woven fabric, a knitted fabric, a nonwoven fabric etc. are mentioned. Among them, a woven fabric is preferable because it has high strength and flexibility.
Examples of fiber structures made of polyethylene terephthalate fabrics are commercially available from Yufu Seiki Co., Ltd.
本発明の腱板及び肩関節内構成体再生材料は、上記不織布層と繊維構造体層との積層体からなる。
上記不織布層及び繊維構造体層は、各々１層のみからなっていてもよく、各々複数層からなっていてもよい。上記不織布層及び繊維構造体層が各々複数層からなる場合、上記不織布層同士、上記繊維構造体層同士を積層した後、これを不織布層積層体と繊維構造体層積層体とを積層してもよいし、上記不織布層と繊維構造体層とを交互に積層してもよい。
The rotator cuff and shoulder joint component regenerating material of the present invention comprises a laminate of the nonwoven fabric layer and the fiber structure layer.
Each of the nonwoven fabric layer and the fiber structure layer may be composed of only one layer, or may be composed of a plurality of layers. When the nonwoven fabric layer and the fiber structure layer are each composed of a plurality of layers, the nonwoven fabric layers and the fiber structure layers are laminated, and then the nonwoven fabric layer laminate and the fiber structure layer laminate are laminated. Alternatively, the nonwoven fabric layer and the fiber structure layer may be alternately laminated.
上記積層体は、縫合することにより結合されていることが好ましい。縫合することにより、移植時や移植後に、ずれたりすることがない。
上記積層体は、熱圧着により上記不織布層と繊維構造体層とが結合されてもよい。熱圧着することにより上記繊維構造体層の一部が溶融して上記不織布層に融着する。熱圧着法は、生産性の点で極めて優れる。なお、熱圧着による結合は、上記積層体の全面で行われてもよいが、例えば格子状等の形で上記積層体の一部で行われることが好ましい。
図１に、熱圧着法により上記不織布層と繊維構造体層とを融着させてなる本発明の腱板及び肩関節内構成体再生材料の一例を示す模式図を示した。図１は本発明の腱板及び肩関節内構成体再生材料を上方から見た図であり、格子状に熱プレスしたことにより、熱圧着部２において不織布層と繊維構造体層とが融着している。
It is preferable that the said laminated body is couple | bonded by sewing. By suturing, there is no slippage during or after transplantation.
In the laminate, the nonwoven fabric layer and the fiber structure layer may be bonded by thermocompression bonding. By thermocompression bonding, part of the fiber structure layer is melted and fused to the nonwoven fabric layer. The thermocompression bonding method is extremely excellent in terms of productivity. The bonding by thermocompression bonding may be performed on the entire surface of the laminated body, but is preferably performed on a part of the laminated body in a lattice shape or the like, for example.
FIG. 1 is a schematic view showing an example of the rotator cuff and shoulder joint component regenerating material of the present invention obtained by fusing the nonwoven fabric layer and the fiber structure layer by thermocompression bonding. FIG. 1 is a top view of a rotator cuff and a material for reconstructing a body part in a shoulder joint of the present invention as viewed from above, and the nonwoven fabric layer and the fiber structure layer are fused in the
本発明の腱板及び肩関節内構成体再生材料は、体積が４８００ｍｍ３以上であることが好ましい。本発明の腱板再生材料は、特に４８００ｍｍ３以上のパッチグラフトを要する断裂サイズの大きな腱損傷の治癒のために移植した場合に、組織再生を促しつつ再生の間の強度を保持し、かつ、機械的強度の高い腱組織を菲薄化することなく再生させることができる。なお、体積が４８００ｍｍ３未満であっても、原組織が残存して部分的な補強を行うためであれば、菲薄化した組織を再生し補強するのに有用である。 The rotator cuff and shoulder joint component regenerating material of the present invention preferably has a volume of 4800 mm 3 or more. The rotator cuff regeneration material of the present invention retains the strength during regeneration while promoting tissue regeneration, particularly when transplanted for healing a large-sized tendon injury requiring a patch graft of 4800 mm 3 or more, and Tendon tissue with high mechanical strength can be regenerated without thinning. Even if the volume is less than 4800 mm 3 , it is useful to regenerate and reinforce the thinned tissue if the original tissue remains and partial reinforcement is required.
本発明の腱板及び肩関節内構成体再生材料の構成のうち、上記不織布層の体積は、合計が６４００ｍｍ３以下であることが好ましい。上記不織布層の体積の合計が６４００ｍｍ３を超えると、腱組織の再生時に水腫や炎症が引き起こされることがある。
本発明の腱板及び肩関節内構成体再生材料の構成のうち、上記繊維構造体層の体積は、合計が４８００ｍｍ３以下であることが好ましい。上記不織布層の体積の合計が４８００ｍｍ３を超えると、腱組織の再生時に水腫や炎症が引き起こされることがある。
Among the constitutions of the rotator cuff and the shoulder joint component regenerating material of the present invention, the total volume of the nonwoven fabric layer is preferably 6400 mm 3 or less. If the total volume of the nonwoven fabric layer exceeds 6400 mm 3 , edema and inflammation may be caused during regeneration of tendon tissue.
Among the constitutions of the rotator cuff and the shoulder joint component regenerating material of the present invention, the total volume of the fiber structure layer is preferably 4800 mm 3 or less. If the total volume of the nonwoven fabric layer exceeds 4800 mm 3 , edema and inflammation may be caused during regeneration of tendon tissue.
本発明によれば、損傷が広範に及ぶ肩関節内構成体や断裂サイズの大きな腱損傷の治癒に用いる場合はもとより、限局的な損傷においても組織の再生が要求される場合に、組織再生を促しつつ組織再生の間の強度を保持し、かつ、機械的強度の高い肩関節内構成体や腱組織を菲薄化することなく再生できる腱板及び肩関節内構成体再生材料を提供することができる。本発明の腱板及び肩関節内構成体再生材料は、原組織が残存するも脆弱化あるいは菲薄化している場合にも、損傷された組織を再生し補強するのに有用である。 According to the present invention, tissue regeneration can be performed not only when used for healing a wide range of injuries within a shoulder joint or a tendon injury with a large tear size, but also when tissue regeneration is required even in localized damage. To provide a rotator cuff and a material for regenerating a body part in a shoulder joint, which can maintain the strength during tissue regeneration while being promoted, and can be regenerated without thinning the body part of the shoulder joint or the tendon tissue with high mechanical strength. it can. The rotator cuff and shoulder joint component regenerating material of the present invention is useful for regenerating and reinforcing damaged tissue even when the original tissue remains, but is weakened or thinned.
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。 Hereinafter, embodiments of the present invention will be described in more detail with reference to examples. However, the present invention is not limited to these examples.
（実施例１）
縦４０ｍｍ、横４０ｍｍ、厚さ１ｍｍのポリグリコリドからなる不織布（グンゼ社製、ネオベールシート０８、ＮＢ）を２枚積層した。該積層体の片側に、縦４０ｍｍ、横４０ｍｍ、厚さ１ｍｍのポリエチレンテレフタレート（ＰＥＴ）からなる織物シート（ユフ精器社製、リーズケイオウ、厚さ１ｍｍ、ＬＫ）を１枚を重ね、縫合固定して、縦４０ｍｍ、横４０ｍｍ、厚さ３ｍｍ（体積４８００ｍｍ３）の腱板再生基材を得た。
Example 1
Two non-woven fabrics made of polyglycolide having a length of 40 mm, a width of 40 mm, and a thickness of 1 mm (Gunze, Neobale Sheet 08, NB) were laminated. On one side of the laminate, a woven fabric sheet (manufactured by Yufu Seiki Co., Ltd., Leeds Keio, 1 mm thick, LK) made of polyethylene terephthalate (PET) 40 mm long, 40 mm wide and 1 mm thick is overlaid and secured by stitching. Thus, a rotator cuff regeneration base material having a length of 40 mm, a width of 40 mm, and a thickness of 3 mm (volume 4800 mm 3 ) was obtained.
（実施例２）
縦４０ｍｍ、横４０ｍｍ、厚さ１ｍｍのポリグリコリドからなる不織布（グンゼ社製、ネオベールシート０８、ＮＢ）を３枚積層した。該積層体の片側に、縦４０ｍｍ、横４０ｍｍ、厚さ１ｍｍのポリエチレンテレフタレート（ＰＥＴ）からなる織物シート（ユフ精器社製、リーズケイオウ、厚さ１ｍｍ、ＬＫ）を１枚重ね、縫合固定して、縦４０ｍｍ、横４０ｍｍ、厚さ４ｍｍ（体積６４００ｍｍ３）の腱板再生基材を得た。
(Example 2)
Three non-woven fabrics made of polyglycolide having a length of 40 mm, a width of 40 mm, and a thickness of 1 mm (manufactured by Gunze, Neobale Sheet 08, NB) were laminated. One woven sheet (Yufu Seiki Co., Ltd., Leeds Keio, 1 mm thick, LK) made of polyethylene terephthalate (PET) 40 mm long, 40 mm wide and 1 mm thick is stacked on one side of the laminate, and fixed by stitching. Thus, a rotator cuff regeneration substrate having a length of 40 mm, a width of 40 mm, and a thickness of 4 mm (volume 6400 mm 3 ) was obtained.
（実施例３）
縦４０ｍｍ、横４０ｍｍ、厚さ１ｍｍのポリグリコリドからなる不織布（グンゼ社製、ネオベールシート０８、ＮＢ）を２枚と、縦４０ｍｍ、横４０ｍｍ、厚さ１ｍｍのポリエチレンテレフタレート（ＰＥＴ）からなる織物シート（ユフ精器社製、リーズケイオウ、厚さ１ｍｍ、ＬＫ）を２枚とを交互に重ね、縫合固定して、縦４０ｍｍ、横４０ｍｍ、厚さ４ｍｍ（体積６４００ｍｍ３）の腱板再生基材を得た。
(Example 3)
A nonwoven fabric made of polyglycolide 40mm long, 40mm wide and 1mm thick (Gunze, Neobale Sheet 08, NB), and a woven fabric made of polyethylene terephthalate (PET) 40mm long, 40mm wide and 1mm thick. Two sheets of sheets (manufactured by Yufu Seiki Co., Ltd., Leeds Keio,
（実施例４）
縦４０ｍｍ、横４０ｍｍ、厚さ１ｍｍのポリグリコリドからなる不織布（グンゼ社製、ネオベールシート０８、ＮＢ）を３枚と、縦４０ｍｍ、横４０ｍｍ、厚さ１ｍｍのポリエチレンテレフタレート（ＰＥＴ）からなる織物シート（ユフ精器社製、リーズケイオウ、厚さ１ｍｍ、ＬＫ）３枚とを交互に重ね、縫合固定して、縦４０ｍｍ、横４０ｍｍ、厚さ６ｍｍ（体積９６００ｍｍ３）の腱板再生基材を得た。
Example 4
A nonwoven fabric made of polyglycolide 40mm long, 40mm wide, 1mm thick (Gunze, Neobale Sheet 08, NB), and a woven fabric made of polyethylene terephthalate (PET) 40mm long, 40mm wide, 1mm thick. 3 sheets of sheets (manufactured by Yufu Seiki Co., Ltd., Leeds Keio,
（実施例５）
縦４０ｍｍ、横４０ｍｍ、厚さ１ｍｍのポリグリコリドからなる不織布（グンゼ社製、ネオベールシート０８、ＮＢ）を２枚積層した。該積層体の片側に、縦４０ｍｍ、横４０ｍｍ、厚さ１ｍｍのポリエチレンテレフタレート（ＰＥＴ）からなる織物シート（ユフ精器社製、リーズケイオウ、厚さ１ｍｍ、ＬＫ）を１枚重ねた。次いで、２００℃に加熱した熱プレス機を用いて８ｍｍ角の格子状に、１５０Ｋｇｆにて１０分間、熱圧着することにより、積層体を融着固定して、縦４０ｍｍ、横４０ｍｍ、厚さ３ｍｍ（体積４８００ｍｍ３）の腱板再生基材を得た。
(Example 5)
Two non-woven fabrics made of polyglycolide having a length of 40 mm, a width of 40 mm, and a thickness of 1 mm (Gunze, Neobale Sheet 08, NB) were laminated. One sheet of a woven fabric sheet (manufactured by Yufu Seiki Co., Ltd., Leeds Keio,
（比較例１）
縦４０ｍｍ、横４０ｍｍ、厚さ１ｍｍのポリグリコリドからなる不織布（グンゼ社製、ネオベールシート０８、ＮＢ）を３枚重ね、縫合固定して、縦４０ｍｍ、横４０ｍｍ、厚さ３ｍｍ（体積４８００ｍｍ３）の腱板再生基材を得た。
(Comparative Example 1)
Three non-woven fabrics made of polyglycolide (length 40 mm, width 40 mm,
（比較例２）
縦４０ｍｍ、横４０ｍｍ、厚さ１ｍｍのポリグリコリドからなる不織布（グンゼ社製、ネオベールシート０８、ＮＢ）を４枚重ね、縫合固定して、縦４０ｍｍ、横４０ｍｍ、厚さ４ｍｍ（体積６４００ｍｍ３）の腱板再生基材を得た。
(Comparative Example 2)
4 non-woven fabrics made of polyglycolide 40mm long, 40mm wide and 1mm thick (Gunze Co., Neobale Sheet 08, NB) are stacked and secured, 40mm long, 40mm wide, 4mm thick (volume 6400mm 3 ) Rotator cuff regeneration base material was obtained.
（比較例３）
縦４０ｍｍ、横４０ｍｍ、厚さ１ｍｍのポリグリコリドからなる不織布（グンゼ社製、ネオベールシート０８、ＮＢ）を５枚重ね、縫合固定して、縦４０ｍｍ、横４０ｍｍ、厚さ５ｍｍ（体積８０００ｍｍ３）の腱板再生基材を得た。
(Comparative Example 3)
5 non-woven fabrics made of polyglycolide 40mm long, 40mm wide, 1mm thick (Gunze Co., Neobale Sheet 08, NB) are stacked and secured, 40mm long, 40mm wide, 5mm thick (volume 8000mm 3 ) Rotator cuff regeneration base material was obtained.
（比較例４）
縦４０ｍｍ、横４０ｍｍ、厚さ１ｍｍのポリエチレンテレフタレート（ＰＥＴ）からなる織物シート（ユフ精器社製、リーズケイオウ、厚さ１ｍｍ、ＬＫ）を３枚重ね、縫合固定して、縦４０ｍｍ、横４０ｍｍ、厚さ３ｍｍ（体積４８００ｍｍ３）の腱板再生基材を得た。
(Comparative Example 4)
40mm long, 40mm wide, 1mm thick polyethylene terephthalate (PET) woven sheet (Yuf Seiki Co., Ltd., Leeds Keio, 1mm thick, LK) is stacked, secured by sewing, 40mm long, 40mm wide A rotator cuff regeneration substrate having a thickness of 3 mm (volume 4800 mm 3 ) was obtained.
（比較例５）
縦４０ｍｍ、横４０ｍｍ、厚さ１ｍｍのポリエチレンテレフタレート（ＰＥＴ）からなる織物シート（ユフ精器社製、リーズケイオウ、厚さ１ｍｍ、ＬＫ）を４枚重ね、縫合固定して、縦４０ｍｍ、横４０ｍｍ、厚さ４ｍｍ（体積６４００ｍｍ３）の腱板再生基材を得た。
(Comparative Example 5)
40 mm long, 40 mm wide, 1 mm thick polyethylene terephthalate (PET) woven sheets (Yuf Seiki Co., Ltd., Leeds Keio, 1 mm thick, LK) are stacked and secured by sewing, 40 mm long, 40 mm wide A rotator cuff regeneration substrate having a thickness of 4 mm (volume 6400 mm 3 ) was obtained.
（比較例６）
縦４０ｍｍ、横４０ｍｍ、厚さ１ｍｍのポリエチレンテレフタレート（ＰＥＴ）からなる織物シート（ユフ精器社製、リーズケイオウ、厚さ１ｍｍ、ＬＫ）を５枚重ね、縫合固定して、縦４０ｍｍ、横４０ｍｍ、厚さ５ｍｍ（体積８０００ｍｍ３）の腱板再生基材を得た。
(Comparative Example 6)
40 mm long, 40 mm wide, 1 mm thick polyethylene terephthalate (PET) woven sheet (Yuf Seiki Co., Ltd., Leeds Keio, 1 mm thick, LK) is stacked and secured by sewing, 40 mm long, 40 mm wide A rotator cuff regeneration substrate having a thickness of 5 mm (volume 8000 mm 3 ) was obtained.
（評価）
ヒト肩腱板損傷の広範囲断裂症例に、実施例及び比較例で作製した腱板再生材を移植した。腱板断端とは腱板再生材の一部がオーバーラップするように縫合し、大結節へは骨溝を作製して縫合するか、アンカーを用いて縫合した。
移植後１、２、３、６、１２ヵ月で臨床所見（水腫形成、炎症所見）について評価し、あわせて移植後１２ヵ月でのＭＲＩ所見より腱板再生について評価した。
結果を表１に示した。
(Evaluation)
The rotator cuff regeneration material prepared in Examples and Comparative Examples was transplanted into a wide range of ruptured cases of human shoulder rotator cuff injury. The rotator cuff stump was sutured so that a part of the rotator cuff regeneration material overlapped, and a bone groove was created and sutured to the large nodule, or sutured using an anchor.
Clinical findings (edema formation, inflammation findings) were evaluated at 1, 2, 3, 6, and 12 months after transplantation, and rotator cuff regeneration was also evaluated based on MRI findings at 12 months after transplantation.
The results are shown in Table 1.
（１）水腫及び炎症の発生
移植後１、２、３、６、１２ヵ月で臨床所見（水腫形成、炎症所見）について評価し、水腫及び炎症が全く認められなかった場合を「○」、一部にでも認められた場合を「×」と評価した。
(1) Occurrence of edema and inflammation Evaluate clinical findings (edema formation, inflammatory findings) at 1, 2, 3, 6 and 12 months after transplantation. The case where even the part was recognized was evaluated as “x”.
（２）腱板の再生状態の評価
移植後１２ヵ月でのＭＲＩ所見より腱板再生について評価した。連続性が認められる場合を「○」、認められない場合を「×」と評価した。
(2) Evaluation of rotator cuff regeneration The rotator cuff regeneration was evaluated based on MRI findings 12 months after transplantation. The case where continuity was recognized was evaluated as “◯”, and the case where continuity was not recognized was evaluated as “x”.
本発明によれば、損傷が広範に及ぶ肩関節内構成体や断裂サイズの大きな腱損傷の治癒に用いる場合はもとより、限局的な損傷においても組織の再生が要求される場合に、組織再生を促しつつ組織再生の間の強度を保持し、かつ、機械的強度の高い肩関節内構成体や腱組織を菲薄化することなく再生できる腱板及び肩関節内構成体再生材料を提供することができる。本発明の腱板及び肩関節内構成体再生材料は、原組織が残存するも脆弱化あるいは菲薄化している場合にも、損傷された組織を再生し補強するのに有用である。 According to the present invention, tissue regeneration can be performed not only when used for healing a wide range of injuries within a shoulder joint or a tendon injury with a large tear size, but also when tissue regeneration is required even in localized damage. To provide a rotator cuff and a material for regenerating a body part in a shoulder joint, which can maintain the strength during tissue regeneration while being promoted, and can be regenerated without thinning the body part of the shoulder joint or the tendon tissue with high mechanical strength. it can. The rotator cuff and shoulder joint component regenerating material of the present invention is useful for regenerating and reinforcing damaged tissue even when the original tissue remains, but is weakened or thinned.
１ 腱板及び肩関節内構成体再生材料
２ 熱圧着部
３ 非熱圧着部
1 Rotator Cuff and Reconstruction Material in
Claims (7)
7. The rotator cuff and shoulder joint component regenerating material according to claim 1, wherein the nonwoven fabric layer and the fiber structure layer are bonded by thermocompression bonding.
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| CN114377211A (en) * | 2022-01-19 | 2022-04-22 | 复旦大学附属华山医院 | Artificial rotator cuff patch based on chitosan and preparation method thereof |
| CN114432501A (en) * | 2022-01-30 | 2022-05-06 | 上海松力生物技术有限公司 | Rotator cuff patch and preparation method thereof |
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