JP6466605B2 - Adipose tissue reconstruction material - Google Patents
Adipose tissue reconstruction material Download PDFInfo
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- JP6466605B2 JP6466605B2 JP2018018949A JP2018018949A JP6466605B2 JP 6466605 B2 JP6466605 B2 JP 6466605B2 JP 2018018949 A JP2018018949 A JP 2018018949A JP 2018018949 A JP2018018949 A JP 2018018949A JP 6466605 B2 JP6466605 B2 JP 6466605B2
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- Prior art keywords
- adipose tissue
- breast
- porous body
- polylactic acid
- sponge
- Prior art date
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- 210000000577 adipose tissue Anatomy 0.000 title claims description 56
- 239000000463 material Substances 0.000 title claims description 14
- 229920000747 poly(lactic acid) Polymers 0.000 claims description 27
- 239000004626 polylactic acid Substances 0.000 claims description 27
- 108010035532 Collagen Proteins 0.000 claims description 16
- 102000008186 Collagen Human genes 0.000 claims description 16
- 229920001436 collagen Polymers 0.000 claims description 16
- 210000001519 tissue Anatomy 0.000 claims description 15
- 239000002775 capsule Substances 0.000 claims description 13
- 230000007547 defect Effects 0.000 claims description 7
- 239000011148 porous material Substances 0.000 claims description 7
- 210000000481 breast Anatomy 0.000 description 50
- 239000000515 collagen sponge Substances 0.000 description 9
- 230000001172 regenerating effect Effects 0.000 description 7
- 206010006187 Breast cancer Diseases 0.000 description 6
- 208000026310 Breast neoplasm Diseases 0.000 description 6
- 238000000034 method Methods 0.000 description 6
- 238000001356 surgical procedure Methods 0.000 description 6
- 239000007943 implant Substances 0.000 description 5
- 229920001432 poly(L-lactide) Polymers 0.000 description 5
- 206010020751 Hypersensitivity Diseases 0.000 description 4
- JVTAAEKCZFNVCJ-REOHCLBHSA-N L-lactic acid Chemical compound C[C@H](O)C(O)=O JVTAAEKCZFNVCJ-REOHCLBHSA-N 0.000 description 4
- 230000007815 allergy Effects 0.000 description 4
- 208000015181 infectious disease Diseases 0.000 description 4
- 230000003902 lesion Effects 0.000 description 4
- 238000004519 manufacturing process Methods 0.000 description 4
- 230000008929 regeneration Effects 0.000 description 4
- 238000011069 regeneration method Methods 0.000 description 4
- 208000005623 Carcinogenesis Diseases 0.000 description 3
- 230000036952 cancer formation Effects 0.000 description 3
- 231100000504 carcinogenesis Toxicity 0.000 description 3
- 238000002513 implantation Methods 0.000 description 3
- 239000004677 Nylon Substances 0.000 description 2
- 208000026935 allergic disease Diseases 0.000 description 2
- 230000002950 deficient Effects 0.000 description 2
- 210000003195 fascia Anatomy 0.000 description 2
- 230000004927 fusion Effects 0.000 description 2
- 210000004013 groin Anatomy 0.000 description 2
- 230000014759 maintenance of location Effects 0.000 description 2
- 210000003205 muscle Anatomy 0.000 description 2
- 229920001778 nylon Polymers 0.000 description 2
- 230000035515 penetration Effects 0.000 description 2
- 241000283690 Bos taurus Species 0.000 description 1
- 206010006312 Breast swelling Diseases 0.000 description 1
- 102000004190 Enzymes Human genes 0.000 description 1
- 108090000790 Enzymes Proteins 0.000 description 1
- 206010061218 Inflammation Diseases 0.000 description 1
- 206010028980 Neoplasm Diseases 0.000 description 1
- 102000057297 Pepsin A Human genes 0.000 description 1
- 108090000284 Pepsin A Proteins 0.000 description 1
- 108091005804 Peptidases Proteins 0.000 description 1
- 239000004743 Polypropylene Substances 0.000 description 1
- 239000004365 Protease Substances 0.000 description 1
- 102100037486 Reverse transcriptase/ribonuclease H Human genes 0.000 description 1
- 241000282887 Suidae Species 0.000 description 1
- 230000002411 adverse Effects 0.000 description 1
- 108010045569 atelocollagen Proteins 0.000 description 1
- 201000011510 cancer Diseases 0.000 description 1
- 239000011248 coating agent Substances 0.000 description 1
- 238000000576 coating method Methods 0.000 description 1
- 230000000994 depressogenic effect Effects 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 229940088598 enzyme Drugs 0.000 description 1
- 238000011156 evaluation Methods 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 239000004744 fabric Substances 0.000 description 1
- 239000000835 fiber Substances 0.000 description 1
- 239000003102 growth factor Substances 0.000 description 1
- 230000004054 inflammatory process Effects 0.000 description 1
- 230000010354 integration Effects 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 230000003340 mental effect Effects 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 235000015097 nutrients Nutrition 0.000 description 1
- 229940111202 pepsin Drugs 0.000 description 1
- 230000002093 peripheral effect Effects 0.000 description 1
- -1 polypropylene Polymers 0.000 description 1
- 229920001155 polypropylene Polymers 0.000 description 1
- 229920001296 polysiloxane Polymers 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- XOJVVFBFDXDTEG-UHFFFAOYSA-N pristane Chemical compound CC(C)CCCC(C)CCCC(C)CCCC(C)C XOJVVFBFDXDTEG-UHFFFAOYSA-N 0.000 description 1
- 238000002271 resection Methods 0.000 description 1
- 230000000717 retained effect Effects 0.000 description 1
- 210000002435 tendon Anatomy 0.000 description 1
- 238000002054 transplantation Methods 0.000 description 1
- 239000002759 woven fabric Substances 0.000 description 1
Landscapes
- Prostheses (AREA)
Description
本発明は、脂肪組織再建用部材及びその製造方法に関する。具体的には、乳がんの病巣
組織を切除した乳房欠損部に埋入して乳房（脂肪組織）の再建に用いられる脂肪組織再建
用部材に関する。
The present invention relates to an adipose tissue reconstruction member and a method for producing the same. Specifically, the present invention relates to a member for reconstructing adipose tissue that is used for reconstructing a breast (adipose tissue) by embedding in a breast defect portion obtained by excising a lesion tissue of breast cancer.
乳がんの治療方法として、乳房にできたがんを手術により切除する方法（外科療法）が
採用されている。近年、患者のＱＯＬの観点から、乳房の病巣組織を部分的に切除する乳
房温存手術が普及してきているが、部分的切除であっても必然として患部に陥没が生じて
しまい、患者に精神的な負担を強いることに変わりはない。そのため、外科療法の後に乳
房再建術を受ける患者が増加している。
As a method for treating breast cancer, a method (surgical treatment) in which cancer formed in the breast is removed by surgery is employed. In recent years, from the viewpoint of QOL of patients, breast-conserving surgery for partially resecting the lesion tissue of the breast has become widespread, but even partial resection inevitably causes depression in the affected area, which makes the patient mentally There is no change in imposing a heavy burden. As a result, an increasing number of patients undergo breast reconstruction after surgery.
乳房再建術としては、シリコン製のインプラントが主に用いられているが、生体非吸収
性であるため感染を起こす可能性があり、また、接触によるアレルギー、発がん等の悪影
響も懸念されている。
Silicone implants are mainly used for breast reconstruction, but they may cause infection because they are non-absorbable in the body, and there are concerns about adverse effects such as allergies and carcinogenesis due to contact.
他の方法として、他部位から脂肪組織を採取し、それを陥没のある患部に移植する方法
もあるが、移植後速やかに吸収されてしまい再度陥没することがある。また、組織を採取
することで新たな創傷が生じＱＯＬの観点から必ずしも好ましくない。
As another method, there is a method in which adipose tissue is collected from another site and transplanted into an affected part having a depression, but it may be absorbed quickly after the transplantation and may be depressed again. In addition, a new wound is generated by collecting the tissue, which is not always preferable from the viewpoint of QOL.
そこで、乳房組織の部分的切除により生じた窪みや変形を整えて乳房を再建するために
、生体適合性の多孔質シートから形成される、内部空間を有する袋状部を備え、該袋状部
に基づいて弾性復元力を有する乳房メッシュインプラントが報告されている（特許文献１
及び２）。
Therefore, in order to reconstruct the breast by adjusting the depressions and deformations caused by partial excision of the breast tissue, the bag-like portion having an internal space formed from a biocompatible porous sheet is provided. A breast mesh implant having an elastic restoring force based on the above has been reported (Patent Document 1).
And 2).
しかし、当該乳房メッシュインプラントは袋状部により弾性復元力が付与されるもので
あるが、袋状部が生分解性（吸収性）の材料の場合には袋状部が経時的に消失してしまう
ため弾性復元力を長期間保持できないことになる。弾性復元力が付与され胸部の自然な乳
房の膨らみを長期間保持するためには、袋状部は非生分解性（非吸収性）の材料で構成さ
れている必要がある。特許文献１及び２の実施例では、袋状部の材料として非生分解性（
非吸収性）のポリプロピレン製のメッシュシートが推奨されている。
However, the breast mesh implant is provided with an elastic restoring force by the bag-like portion, but when the bag-like portion is a biodegradable (absorbable) material, the bag-like portion disappears with time. Therefore, the elastic restoring force cannot be maintained for a long time. In order to retain the natural breast bulge of the breast for a long period of time by applying an elastic restoring force, the bag-like portion needs to be made of a non-biodegradable (non-absorbable) material. In the examples of Patent Documents 1 and 2, non-biodegradable (
Non-absorbable) polypropylene mesh sheets are recommended.
このように、当該乳房メッシュインプラントは基本的に生体内で吸収されずに残るもの
であるため、生体にとっては異物であり、それに伴う感染やアレルギー等の問題が生じる
可能性があった。
As described above, since the breast mesh implant basically remains without being absorbed in the living body, it is a foreign body for the living body, which may cause problems such as infection and allergy.
本発明は、乳房の部分的切除後において、脂肪組織を再生することにより乳房を再建す
ることができる生分解性（吸収性）の脂肪組織再建用部材を提供することを課題とする。
具体的には、脂肪組織が再生し乳房が再建されるまでの期間は強度を保持し、脂肪組織再
生後に生体に吸収される乳房の脂肪組織再建用部材を提供することを課題とする。
An object of the present invention is to provide a biodegradable (absorbable) adipose tissue reconstruction member capable of reconstructing a breast by regenerating the adipose tissue after partial excision of the breast.
Specifically, an object of the present invention is to provide a member for reconstructing adipose tissue of a breast that retains strength during a period from the regeneration of the adipose tissue and the reconstruction of the breast, and is absorbed by the living body after the regeneration of the adipose tissue.
本発明者は、上記課題を達成すべく鋭意研究を重ねた結果、周囲からの圧迫に対し強度
を保持する生分解性材料（特に、ポリ乳酸）を含む多孔体と、乳房の脂肪組織を再生する
ための足場としてコラーゲンを含むスポンジとを組み合わせた部材が、上記課題を解決で
きることを見いだした。かかる知見に基づきさらに研究を重ねた結果、本発明を完成する
に至った。
As a result of intensive studies to achieve the above-mentioned problems, the present inventor regenerated a porous body containing a biodegradable material (particularly polylactic acid) that retains strength against pressure from the surroundings and adipose tissue of the breast. It has been found that a member combined with a sponge containing collagen as a scaffold for achieving this can solve the above-mentioned problems. As a result of further research based on this knowledge, the present invention has been completed.
本発明は、下記の乳房の脂肪組織再建用部材を提供する。 The present invention provides the following breast adipose tissue reconstruction member.
項１ 乳房再建用の脂肪組織再建用部材であって、コラーゲンを含むスポンジ及びポリ
乳酸を含む多孔体を含み、該多孔体が内部空間を有する袋形状を有し、その内部空間に該
スポンジが収容されてなる、部材。
Item 1 A fat tissue reconstruction member for breast reconstruction, comprising a sponge containing collagen and a porous body containing polylactic acid, wherein the porous body has a bag shape having an internal space, and the sponge is in the internal space. A member that is housed.
項２ 前記多孔体が、ポリ乳酸を含むメッシュシートを袋形状に固定した袋状物である
、項１に記載の乳房の脂肪組織再建用部材。
Item 2. The breast fatty tissue reconstruction member according to Item 1, wherein the porous body is a bag-like material in which a mesh sheet containing polylactic acid is fixed in a bag shape.
項３ 前記多孔体が、ポリ乳酸を含む多孔性カプセルである、項１又は２に記載の乳房
の脂肪組織再建用部材。
Item 3. The member for reconstructing breast adipose tissue according to Item 1 or 2, wherein the porous body is a porous capsule containing polylactic acid.
項４ 乳房の部分的切除によって生じた欠損部に埋設して用いられる、項１〜３のいず
れかに記載の乳房の脂肪組織再建用部材。
Item 4. The member for reconstructing adipose tissue of a breast according to any one of Items 1 to 3, which is used by being embedded in a defect part caused by partial excision of the breast.
項５ 前記多孔体の孔の大きさ及び個数が、袋形状の内部に脂肪組織が到達でき、かつ
、コラーゲンを足場にして脂肪組織が十分に再生できる程度である、項１〜４のいずれか
に記載の乳房の脂肪組織再建用部材。
Item 5 Any one of Items 1 to 4, wherein the size and number of pores of the porous body are such that adipose tissue can reach the inside of the bag shape and that the adipose tissue can be sufficiently regenerated using collagen as a scaffold. The member for reconstructing adipose tissue of the breast described in 1.
本発明の乳房の脂肪組織再建用部材は、乳房の脂肪組織を効果的に再生させて乳房を再
建することができる。具体的には、乳がんの外科療法として乳房を部分的に切除した後、
その患部に本発明の部材を埋入することにより、脂肪組織を効率的に再生させて乳房を再
建することができる。
The member for reconstructing the adipose tissue of the breast of the present invention can reconstruct the breast by effectively regenerating the adipose tissue of the breast. Specifically, after partly removing the breast as a surgical treatment for breast cancer,
By embedding the member of the present invention in the affected area, the adipose tissue can be efficiently regenerated and the breast can be reconstructed.
この部材は、ポリ乳酸を含む袋形状の多孔体の内部に、コラーゲンを含むスポンジを保
持しているため、該多孔体により弾性復元力が付与され胸部の自然な乳房の膨らみを長期
間保持することができ、同時に保持されたコラーゲンを含むスポンジが脂肪組織を再生で
きるため、乳房の再陥没を防ぐことができる。
Since this member holds a sponge containing collagen inside a bag-like porous body containing polylactic acid, an elastic restoring force is imparted by the porous body and the natural breast swelling of the breast is maintained for a long period of time. In addition, since the sponge containing collagen held at the same time can regenerate adipose tissue, re-depression of the breast can be prevented.
特に、本発明の部材は、該多孔体の材料にポリ乳酸を用いているため、長期間の形状保
持に必要な強度と生分解性速度を有している。該多孔体内に保持されたコラーゲンを含む
スポンジが脂肪組織を再生する足場として働くとともに、該スポンジで脂肪組織が再生す
るまで、該多孔体が周囲の組織からの圧迫に対して強度を保持する働きを有する。
In particular, since the member of the present invention uses polylactic acid as the material of the porous body, it has strength and biodegradability necessary for long-term shape retention. The sponge containing collagen held in the porous body serves as a scaffold for regenerating adipose tissue, and the porous body maintains strength against pressure from surrounding tissues until the adipose tissue is regenerated by the sponge. Have
また、本発明の部材は、生分解性材料（ポリ乳酸及びコラーゲン）からなり乳房再建後
は生体に吸収されるため、生体内に残留することで生じる不都合（炎症、感染症、アレル
ギー、発がん等）は生じない。
In addition, since the member of the present invention is made of biodegradable materials (polylactic acid and collagen) and is absorbed into the living body after breast reconstruction, inconveniences (inflammation, infection, allergies, carcinogenesis, etc.) caused by remaining in the living body. ) Does not occur.
従来の非生分解性材料を用いた乳房再建材料は、基本的に生体内に残留することで乳房
の形状を保持し弾力性を補完するものであるのに対し（例えば、特許文献１及び２）、本
発明の部材は、乳房の欠損部に脂肪組織を再生させて乳房を再建し、その役割を終えた後
は生体内に吸収され得るものである。これにより、患者のＱＯＬが飛躍的に向上する。
The conventional breast reconstruction material using a non-biodegradable material basically retains the shape of the breast by remaining in the living body and complements the elasticity (for example, Patent Documents 1 and 2). The member of the present invention can be absorbed into the living body after reconstructing the breast by regenerating the adipose tissue in the defective part of the breast and finishing its role. Thereby, a patient's QOL improves drastically.
以下、本発明について詳細に説明する。 Hereinafter, the present invention will be described in detail.
本明細書において、用語「含む」には「必須として含む」及び「のみからなる」の両方
の意味を包含する。
本発明の脂肪組織再建用部材は、乳がんの病巣組織を部分的に切除した乳房欠損部に埋
入して乳房（脂肪組織）を再建するために用いられる部材である。当該部材は、コラーゲ
ンを含むスポンジ及び生分解性材料（特に、ポリ乳酸）を含む多孔体を組み合わせたもの
であり、該多孔体が内部空間を有する袋形状を有し、その内部空間に該スポンジが収容さ
れていることを特徴とする。
In this specification, the term “comprising” includes both the meanings of “including as essential” and “consisting only of”.
The member for reconstructing adipose tissue of the present invention is a member used for reconstructing a breast (adipose tissue) by embedding in a breast defect part obtained by partially excising a lesion tissue of breast cancer. The member is a combination of a sponge containing collagen and a porous body containing a biodegradable material (particularly polylactic acid), and the porous body has a bag shape having an internal space, and the sponge is formed in the internal space. Is housed.
スポンジはコラーゲンを含み、コラーゲンを主成分として含むものが好ましく、スポン
ジ中にコラーゲンを５０質量％以上、６０質量％以上、７０質量％以上、８０質量％以上
、９０質量％以上、９５質量％以上、特に１００質量％含むものが好ましい。
The sponge contains collagen, and preferably contains collagen as a main component. The sponge contains 50% by mass, 60% by mass, 70% by mass, 80% by mass, 90% by mass, 95% by mass or more. In particular, those containing 100% by mass are preferable.
コラーゲンとしては特に限定はなく、牛、豚等の皮膚や腱等に由来するものを用いるこ
とができる。抗原性を排除してより安全性を高める観点から、コラーゲンをプロテアーゼ
やペプシン等の酵素で処理して、テロペプチドをできる限り除去したアテロコラーゲンが
好ましい。
Collagen is not particularly limited, and collagen derived from skin, tendon, etc. of cows and pigs can be used. From the standpoint of improving safety by eliminating antigenicity, atelocollagen in which telopeptides are removed as much as possible by treating collagen with an enzyme such as protease or pepsin is preferable.
コラーゲンスポンジの具体例として、例えば、ペルナック（スミス・アンド・ネフュー
ウンドマネジメント株式会社）、テルダーミス（テルモ株式会社）等が挙げられる。
Specific examples of the collagen sponge include Pernac (Smith & Newound Management Co., Ltd.), Teldermis (Terumo Co., Ltd.) and the like.
多孔体に含まれる生分解性材料としては、脂肪組織が再生し乳房が再建されるまで強度
を保持し、その後、生体内に吸収される材料であり、好ましくは、ポリ乳酸（Ｄ−、Ｌ−
、メソ体、それらの混合物）である。特にポリＬ−乳酸（ＰＬＬＡ）が好ましい。ポリ乳
酸の重量平均分子量は、通常、４０００〜２０００００程度である。重量平均分子量はＧ
ＰＣを用いて測定した値である。
The biodegradable material contained in the porous body is a material that retains strength until the adipose tissue is regenerated and the breast is reconstructed, and is then absorbed into the living body. Preferably, polylactic acid (D-, L −
, Meso form, and mixtures thereof). Poly L-lactic acid (PLLA) is particularly preferable. The weight average molecular weight of polylactic acid is usually about 4000 to 200000. The weight average molecular weight is G
It is the value measured using PC.
多孔体中にポリ乳酸（特に、ＰＬＬＡ）を５０質量％以上、６０質量％以上、７０質量
％以上、８０質量％以上、９０質量％以上、９５質量％以上、特に１００質量％含むもの
が好ましい。
The porous body preferably contains polylactic acid (particularly PLLA) in an amount of 50% by mass or more, 60% by mass or more, 70% by mass or more, 80% by mass or more, 90% by mass or more, 95% by mass or more, particularly 100% by mass. .
多孔体は、内部空間を有する袋形状を有していれば特に限定はない。例えば、ポリ乳酸
を含むメッシュシートを袋形状に固定した袋状物、ポリ乳酸を含む多孔性カプセル等の形
態が例示される。コラーゲンを含むスポンジが、該多孔体の内部空間に収容されている。
多孔体の孔は、脂肪組織がその孔を通り内部に存在する該スポンジに到達し得る程度の大
きさであれば特に限定はない。
The porous body is not particularly limited as long as it has a bag shape having an internal space. For example, forms such as a bag-like product in which a mesh sheet containing polylactic acid is fixed in a bag shape, a porous capsule containing polylactic acid, and the like are exemplified. A sponge containing collagen is accommodated in the internal space of the porous body.
The pores of the porous body are not particularly limited as long as the adipose tissue can be passed through the pores and reach the sponge present inside.
例えば、多孔体が上記のメッシュシートを袋形状に固定した袋状物である場合、メッシ
ュシートは、モノフィラメント又はマルチフィラメントから形成される網目状物（ネット
）、織物、編物等を挙げることができる。フィラメントの繊維の太さは特に限定はなく、
通常、０．０５〜０．５ｍｍ程度、好ましくは０．１〜０．４ｍｍ程度である。メッシュ
の伸縮性、弾性、保形性、脂肪組織の進入性等の観点から、モノフィラメントから形成さ
れる網目状又は編み状のメッシュシートが好ましい。メッシュ開口部の縦及び横のサイズ
が、それぞれ０．０１ｍｍ〜６ｍｍ程度、好ましくは０．０２ｍｍ〜５ｍｍ程度である。
言い換えれば、縦及び横のサイズが、０．０１ｍｍ×０．０１〜６ｍｍ×６ｍｍ程度、好
ましくは０．０２ｍｍ×０．０２ｍｍ〜５ｍｍ×５ｍｍ程度である。
For example, when the porous body is a bag-like product in which the mesh sheet is fixed in a bag shape, examples of the mesh sheet include a net-like product (net) formed from monofilaments or multifilaments, a woven fabric, a knitted fabric, and the like. . The thickness of the filament fiber is not particularly limited,
Usually, it is about 0.05 to 0.5 mm, preferably about 0.1 to 0.4 mm. From the viewpoint of mesh stretchability, elasticity, shape retention, adipose tissue penetration, and the like, a mesh or knitted mesh sheet formed from monofilaments is preferred. The vertical and horizontal sizes of the mesh openings are each about 0.01 mm to 6 mm, preferably about 0.02 mm to 5 mm.
In other words, the vertical and horizontal sizes are about 0.01 mm × 0.01 to 6 mm × 6 mm, preferably about 0.02 mm × 0.02 mm to 5 mm × 5 mm.
通常、メッシュシートを加工して開口部を有する袋形状とし、これにスポンジを収容し
た後、当該開口部を縫合、結紮、融着、接着等の任意の手段で固着して製造することがで
きる。具体的には、例えば、メッシュシートの筒状物にスポンジを収容した後、その両端
を固着して製造することができる。或いは、メッシュシートの筒状物の一方の開口部を固
着しこれにスポンジを収容した後、他方の開口部を固着して製造することができる。例え
ば、図１及び図２を参照。
Usually, a mesh sheet is processed into a bag shape having an opening, and after a sponge is accommodated in the bag, the opening can be fixed by any means such as stitching, ligation, fusion, and adhesion. . Specifically, for example, after a sponge is accommodated in a cylindrical member of a mesh sheet, it can be manufactured by fixing both ends thereof. Alternatively, it is possible to manufacture by fixing one opening of the cylindrical member of the mesh sheet and housing the sponge in the opening, and then fixing the other opening. For example, see FIGS.
多孔体がポリ乳酸を含む多孔性カプセルである場合、多数の孔を有するカプセルにスポ
ンジを収容した後、カプセルを固着して製造することができる。具体的には、例えば、多
数の孔を有するドーム状の２つのカプセルを用意し、この２つのカプセルでスポンジを収
容した後、カプセル同士を融着、接着等の任意の手段で固着することで製造することがで
きる。例えば、図３を参照。
When the porous body is a porous capsule containing polylactic acid, the capsule can be produced by adhering the sponge in a capsule having a large number of pores. Specifically, for example, by preparing two dome-shaped capsules having a large number of holes, and storing the sponge in these two capsules, the capsules are fixed to each other by any means such as fusion or adhesion. Can be manufactured. For example, see FIG.
多孔性カプセルの孔（開口部）のサイズは、脂肪組織の進入性等が確保されるものであ
れば特に限定はない。孔の径は、例えば、０．０１〜６ｍｍ程度、好ましくは０．０２〜
５ｍｍ程度である。
The size of the pores (openings) of the porous capsule is not particularly limited as long as the penetration property of adipose tissue is ensured. The diameter of the hole is, for example, about 0.01 to 6 mm, preferably 0.02 to
It is about 5 mm.
本発明の脂肪組織再建用部材の大きさ及び形状は特に限定はなく、通常、乳房欠損部に
埋入配置するのに適した大きさと形状に調製することができる。通常、多孔体の形状がこ
の部材の形状となる。例えば、部材の最長幅として、通常１〜１５ｃｍ程度、好ましくは
２〜１０ｃｍ程度、より好ましくは２〜８ｃｍ程度を挙げることができる。また、最短幅
として、通常１〜１０ｃｍ程度、好ましくは２〜１０ｃｍ程度、より好ましくは２〜８ｃ
ｍ程度を挙げることができる。
The size and shape of the adipose tissue reconstruction member of the present invention are not particularly limited, and can usually be prepared in a size and shape suitable for placement in a breast defect. Usually, the shape of the porous body is the shape of this member. For example, the longest width of the member is usually about 1 to 15 cm, preferably about 2 to 10 cm, more preferably about 2 to 8 cm. The shortest width is usually about 1 to 10 cm, preferably about 2 to 10 cm, more preferably 2 to 8 c.
m.
本発明の脂肪組織再建用部材は、乳がんの病巣組織を切除した乳房欠損部に埋入するこ
とで、乳房（脂肪組織）を再建することができる。乳房切除手術と同時に該部材を埋入で
きるため、患者の肉体的及び精神的苦痛を大きく低減することができる。また、切除した
欠損部の形状に応じて該部材の形状を調製することができる。
The member for reconstructing adipose tissue of the present invention can reconstruct a breast (adipose tissue) by embedding it in a breast defect part obtained by excising a lesion tissue of breast cancer. Since the member can be implanted simultaneously with the mastectomy, the physical and mental pain of the patient can be greatly reduced. In addition, the shape of the member can be prepared according to the shape of the excised defect.
この部材は、埋入後、三次元的に脂肪組織を再生する足場となる。スポンジが多孔体内
部に収容された構造を有しているため、当該孔を通して、周辺の脂肪組織が容易にスポン
ジに侵入することができ、スポンジに接着した脂肪組織へ充分な栄養を供給することが可
能となる。また、多孔体により部材の保形性を維持しつつ、スポンジにて脂肪組織を再生
することができる。さらに、全て生分解性材料で構成されているため乳房再建後に生体内
に吸収されることから、感染、アレルギー、発がん等の問題を生じることはない。このよ
うに、脂肪組織を効率的に再生することができることから、乳房再建用インプラントとし
て極めて有用である。
This member serves as a scaffold for regenerating three-dimensional adipose tissue after implantation. Since the sponge has a structure accommodated in the porous body, the peripheral adipose tissue can easily enter the sponge through the hole, and supply sufficient nutrients to the adipose tissue adhered to the sponge. Is possible. Further, the adipose tissue can be regenerated with a sponge while maintaining the shape retaining property of the member with the porous body. Furthermore, since it is composed entirely of biodegradable materials, it is absorbed into the living body after breast reconstruction, so that problems such as infection, allergy, and carcinogenesis do not occur. Thus, since a fat tissue can be efficiently regenerated, it is extremely useful as an implant for breast reconstruction.
本発明を、実施例を用いて具体的に説明するが、本発明はこれに限定されるものではな
い。
The present invention will be specifically described with reference to examples, but the present invention is not limited thereto.
実施例１
乳房にみたてたラットの鼠径部に種々の試料を導入して、一定期間後の脂肪組織の再生
の程度を評価した。
（１）試料の調製
ポリ乳酸（ＰＬＬＡ）で作られたメッシュシート（０．２〜０．２５ｍｍの糸で作製、
メッシュ開口部１×１ｍｍ〜２×２ｍｍ）でコラーゲンスポンジ（製品名：ペルナック、
スミス・アンド・ネフュー ウンドマネジメント社製）を被覆し、楕円状の部材Ａを製造
した。部材Ａの最長幅は２ｃｍであり、最短幅は１ｃｍであった。一方、コラーゲンスポ
ンジを用いないこと以外は、上記と同様にして、ポリ乳酸（ＰＬＬＡ）メッシュのみから
なる楕円状の部材Ｂを製造した。
（２）実験手順
細胞、成長因子を使用せずに、上記で得られた部材Ａ及びＢをラットの鼠径部へ埋入し
、脂肪組織の再生の程度を評価した。ラットの左右２カ所の鼠径部に部材Ａを埋入し、別
のラットの左右２カ所の鼠径部に部材Ｂを埋入して、それぞれ周囲（脂肪筋膜や筋）と軽
くナイロンで固定した。脂肪筋膜と筋をナイロンで縫合した。
（３）評価方法及び結果
上記ラットの鼠径部に埋入した後、３ヶ月後及び６ヶ月後の各部材を含む脂肪組織を採
取した。組織中のメッシュに相当する部分の断面を切り取り、断面における部材内部の面
積と、その部材内部の脂肪の面積を測定した（図４を参照）。その結果を表１及び表２に
示す。部材内部の面積及び部材内部の脂肪の面積は、画像統合ソフトウェアーNIS-Elemen
ts D (version 2,20：株式会社ニコン製)を用いて測定した。
Example 1
Various samples were introduced into the groin of a rat that had been seen in the breast, and the degree of regeneration of adipose tissue after a certain period was evaluated.
(1) Preparation of sample Mesh sheet made of polylactic acid (PLLA) (made with 0.2-0.25 mm thread,
Collagen sponge (product name: Pernac, with mesh opening 1x1mm-2x2mm)
(Smith & Nephew Management Co., Ltd.) was coated to produce an elliptical member A. The longest width of the member A was 2 cm, and the shortest width was 1 cm. On the other hand, an elliptical member B made of only a polylactic acid (PLLA) mesh was produced in the same manner as described above except that no collagen sponge was used.
(2) Experimental procedure Without using cells and growth factors, the members A and B obtained above were embedded in the groin of the rat, and the degree of regeneration of adipose tissue was evaluated. Member A was embedded in the left and right inguinal parts of the rat, and member B was embedded in the right and left inguinal parts of another rat, and the surroundings (fatty fascia and muscle) were lightly fixed with nylon. . The fat fascia and muscle were sutured with nylon.
(3) Evaluation method and results After embedding in the inguinal region of the rat, adipose tissue containing each member after 3 months and 6 months was collected. The cross section of the portion corresponding to the mesh in the tissue was cut out, and the area inside the member and the area of fat inside the member in the cross section were measured (see FIG. 4). The results are shown in Tables 1 and 2. The area inside the part and the area of fat inside the part are determined by the image integration software NIS-Elemen.
It was measured using ts D (version 2,20: manufactured by Nikon Corporation).
表１より、埋入後３ヶ月後において、コラーゲンスポンジがポリ乳酸のメッシュで被覆
されてなる部材Ａは、ポリ乳酸のメッシュのみからなる部材Ｂに比べて、部材内部の面積
が大きく、さらに６ヶ月経過後は更に面積が増大している。これは、部材Ａのスポンジを
収容したメッシュでは、埋入後でも形状が十分に保持されていることを示すものである。
From Table 1, after 3 months of implantation, the member A in which the collagen sponge is coated with the polylactic acid mesh has a larger area inside the member than the member B made of only the polylactic acid mesh. After a month, the area has further increased. This indicates that the shape of the mesh containing the sponge of member A is sufficiently retained even after embedding.
また、表２より、埋入後３ヶ月後において、部材Ａは部材Ｂに比べて、部材内部の脂肪
の面積が顕著に大きくなり、しかも６ヶ月経過後は、３倍近く脂肪面積が増大しているこ
とが分かる。これは、部材Ａの内部に収容されたコラーゲンスポンジが、部材Ｂと比べて
、脂肪組織を効率的に再生出来ていることを示すものである。
Also, from Table 2, after 3 months from the implantation, member A has a significantly larger fat area inside member than member B, and after 6 months, the fat area increases nearly three times. I understand that This indicates that the collagen sponge housed in the member A can regenerate the adipose tissue more efficiently than the member B.
これらの結果より、本発明の部材Ａは、乳房の欠損部に脂肪組織を再生させて乳房を再
建するための部材として有用であることが分かった。
From these results, it was found that the member A of the present invention is useful as a member for reconstructing the breast by regenerating the adipose tissue in the defective part of the breast.
本発明の乳房の脂肪組織再建用部材は、乳がんの外科療法として乳房を部分的に切除し
た後、その患部に本発明の部材を埋入することにより、脂肪組織を効率的に再生させて乳
房を再建することができる。
The member for reconstructing the adipose tissue of the breast according to the present invention can be obtained by efficiently regenerating the adipose tissue by embedding the member of the present invention in the affected part after partially excising the breast as a surgical treatment for breast cancer. Can be rebuilt.
１ コラーゲンスポンジ
２ ポリ乳酸のメッシュ
３ 脂肪組織再建用部材
４ 多孔性カプセル
５ 脂肪組織再建用部材
６ 脂肪組織再建用部材（メッシュ）内部の脂肪の面積
７ 脂肪組織再建用部材（メッシュ）内部の面積
８ 部材を構成するメッシュの糸の断面
1 Collagen sponge 2 Polylactic acid mesh 3 Adipose tissue reconstruction member 4 Porous capsule 5 Adipose tissue reconstruction member 6 Adipose tissue reconstruction member (mesh) fat area 7 Adipose tissue reconstruction member (mesh) area 8 Cross section of mesh thread
Claims (5)
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2018018949A JP6466605B2 (en) | 2018-02-06 | 2018-02-06 | Adipose tissue reconstruction material |
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|---|---|---|---|
| JP2015017678A Division JP6305357B2 (en) | 2015-01-30 | 2015-01-30 | Adipose tissue reconstruction material |
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| US6206930B1 (en) * | 1998-08-10 | 2001-03-27 | Charlotte-Mecklenburg Hospital Authority | Absorbable tissue expander |
| US6328765B1 (en) * | 1998-12-03 | 2001-12-11 | Gore Enterprise Holdings, Inc. | Methods and articles for regenerating living tissue |
| JP2001218829A (en) * | 2000-02-14 | 2001-08-14 | Univ Kyoto | Complex of basal membrane component for fat anagenesis and cell growth factor |
| JP4296399B2 (en) * | 2002-09-03 | 2009-07-15 | 真実 仁尾 | Breast mesh implant |
| US7537788B2 (en) * | 2003-07-25 | 2009-05-26 | Rubicor Medical, Inc. | Post-biopsy cavity treatment implants and methods |
| JP4296405B2 (en) * | 2003-11-04 | 2009-07-15 | 真実 仁尾 | Breast mesh implant |
| US9433489B2 (en) * | 2013-03-12 | 2016-09-06 | Soft Tissue Regeneration, Inc. | Absorbable synthetic braided matrix for breast reconstruction and hernia repair |
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