JPS63260549A - Prosthesis material and its production - Google Patents

Prosthesis material and its production

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Publication number
JPS63260549A
JPS63260549A JP62092980A JP9298087A JPS63260549A JP S63260549 A JPS63260549 A JP S63260549A JP 62092980 A JP62092980 A JP 62092980A JP 9298087 A JP9298087 A JP 9298087A JP S63260549 A JPS63260549 A JP S63260549A
Authority
JP
Japan
Prior art keywords
amniotic membrane
human amniotic
medical device
prosthetic medical
sterile water
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
JP62092980A
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Japanese (ja)
Other versions
JPH034229B2 (en
Inventor
石川 統一
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Individual
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Individual
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Application filed by Individual filed Critical Individual
Priority to JP62092980A priority Critical patent/JPS63260549A/en
Publication of JPS63260549A publication Critical patent/JPS63260549A/en
Publication of JPH034229B2 publication Critical patent/JPH034229B2/ja
Granted legal-status Critical Current

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  • Materials For Medical Uses (AREA)
  • Prostheses (AREA)

Abstract

(57)【要約】本公報は電子出願前の出願データであるた
め要約のデータは記録されません。
(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

【発明の詳細な説明】 〔医療上の利用分野〕 本発明は出発原料としてヒト由来の羊膜を利用した、膀
胱・尿道・尿管の欠損部に対する補綴材料に関するもの
である。
DETAILED DESCRIPTION OF THE INVENTION [Field of Medical Application] The present invention relates to a prosthetic material for defects in the bladder, urethra, and ureter, which uses human-derived amniotic membrane as a starting material.

〔従来の技術〕[Conventional technology]

従来の技術として下記に列記するものがある。 Some of the conventional techniques are listed below.

(1)  生体自己組織である腸管などを用いる方丸(
2)  非生体非自己組織材料としてアクリル、テフロ
ン、シリコン・ラバーの成型物及びポリ[化ビニール、
ゼラチンのスポンヂの成型物を用いる方法。
(1) Square circles (
2) As non-living non-self-organizing materials, molded products of acrylic, Teflon, silicone rubber, polyvinyl chloride,
A method using gelatin sponge moldings.

(1)の技術を用いる場合、補綴材料を採取するために
健全なる生体部位に損傷を発生させなければならないと
いう重大な欠点がある。(2)の技術を用いる場合、何
れも異物反応が強く、成製、感染などを惹起し、所期の
医療目的をとげることができず、未だ完全なものは開発
されるに至っていない。
When using the technique (1), there is a serious drawback that damage must be caused to a healthy body part in order to collect the prosthetic material. When the technology (2) is used, all of them have a strong foreign body reaction, causing production and infection, making it impossible to achieve the intended medical purpose, and no perfect product has yet been developed.

〔発明が解決しようとする問題点〕[Problem that the invention seeks to solve]

膀胱、尿道、尿管などの欠損部に対する補綴材料として
備えていることが必要な特性としては次のようなもので
ある。
The following properties are necessary for a prosthetic material for defects in the bladder, urethra, ureter, etc.

(イ)容易に入手できて且つ安価な補綴材料であること
(a) Prosthetic materials that are easily available and inexpensive.

(嗜 健全な生体に損傷を発生させないため非自己組織
材料であること。
(It must be a non-self-organizing material so that it does not cause damage to healthy living organisms.)

(ハ) 成製が発生しないこと。(c) No molding occurs.

に)生体組織適合性が優れており異物反応等が発生しな
いこと。
2) Excellent bio-tissue compatibility and no foreign body reactions.

(ホ) 尿との親和性があること。(e) It has an affinity with urine.

(へ)手術し易い材料であること。例えば吻合において
縫合し易い物理的強度を保持すること。
(f) The material must be easy to operate on. For example, maintaining physical strength to facilitate suturing in anastomoses.

(ト)  消毒・滅菌が完全に行いうろこと。(g) Completely disinfected and sterilized scales.

(2)悪性腫瘍・感染症を惹起しないこと。(2) Do not cause malignant tumors or infectious diseases.

〔問題点を解決するための手段〕[Means for solving problems]

本発明の要旨とするところは前記した諸問題点の全てを
解決し得た補綴材料とその製造方法である。
The gist of the present invention is a prosthetic material and a method for manufacturing the same that can solve all of the problems described above.

出発原料であるヒト羊膜は、胎児を羊水を介在して包ん
でいる膜である。出産時所謂後産と′して胎盤と一体と
なって排出され癲棄物となる。
The starting material, human amniotic membrane, is a membrane that envelops the fetus with amniotic fluid interposed in it. At the time of childbirth, it is excreted together with the placenta as a so-called afterbirth and becomes a waste product.

従って安価に多量且つ容易に入手できるため生体系非自
己組織材料として容易に得ることができる。
Therefore, since it can be easily obtained in large quantities at low cost, it can be easily obtained as a biological non-self-organizing material.

尿管は腎で生−成された尿を膀胱にまで運ぶ排泄路であ
シ、膀胱はこの尿を一定量貯留し友後排泄する臓器であ
り、尿道は膀胱から尿を体外へ排泄する経路であるが男
性においては精液を射出する経路を兼ねている。
The ureter is an excretory route that carries urine produced in the kidneys to the bladder.The bladder is an organ that stores a certain amount of urine and excretes it, and the urethra is a route that excretes urine from the bladder to the outside of the body. However, in men, it also serves as a route for ejaculating semen.

これらの臓器が機能的に障害をうけ機能不全に陥入った
場合や、癌腫瘍を初めとする悪性腫瘍で一臓器摘除が行
われた場合には、これに代る臓器機能の代行又は補綴処
置がとられなければならない。弦に、膀胱・尿管・尿道
の組織機能を完全に代行する前記の問題点(ハ)、←)
、(ホ)、(へ)、(ト)、例を解決する人工補綴材料
の必要性が存在する。
When these organs become functionally impaired and malfunction, or when a single organ is removed due to malignant tumors such as cancer, alternative organ functions or prosthetic treatment may be required. must be taken. The above-mentioned problem (c), ←) where the strings completely take over the tissue functions of the bladder, ureter, and urethra.
There is a need for a prosthetic material that solves the following problems.

本発明においては問題点(ハ)を解決する手段として羊
膜の液体漏出阻止性能を利用し、更に成製阻止性能向上
の友め羊膜構成分子の分子間密度を高密度にする之めグ
ルタールアルデヒド又は紫外線を反応させ分子間に橋か
け反応を行つ友。
In the present invention, as a means to solve problem (c), we utilize the liquid leakage prevention ability of amniotic membrane, and further improve the formation prevention ability by increasing the intermolecular density of the constituent molecules of amniotic membrane using glutaraldehyde. Or a friend that reacts with ultraviolet rays and performs a cross-linking reaction between molecules.

問題点に)の解決手段としては、ヒト羊膜の利用、無菌
水による入念な繰返し洗浄、フィシン処理、及びグルタ
ールアルデヒド又は紫外線照射等による橋かけ化学反応
処理等である。
Solutions to this problem include the use of human amniotic membrane, careful repeated washing with sterile water, ficin treatment, and cross-linking chemical reaction treatment using glutaraldehyde or ultraviolet irradiation.

問題点(ホ)の対策は上記問題点(ハ)に)の手段で兼
備した。
The countermeasure for problem (e) was combined with the measures for problem (c) above.

問題点(へ)の対策手段としては上記問題点(/1の手
段で解決され分子間密度の向上、即ち物理的強度の向上
効果を生むことで解決された。より一層の強度向上が必
要な場合は羊膜を積層することで目的を果すことができ
る。
As a countermeasure for problem (f), the above problem (/1) was solved by improving the intermolecular density, that is, by producing an effect of improving physical strength. In this case, laminating amniotic membrane can serve the purpose.

問題点(ト)の対策手段としては本発明の補綴材料は、
加熱滅菌法、KOG滅菌法、放射線滅菌法、オゾン滅菌
法、アルコール消毒法等全ての滅菌消毒法の処理に耐え
得るので容易に解決できた。
As a countermeasure for problem (g), the prosthetic material of the present invention:
The solution was easy because it can withstand all sterilization methods such as heat sterilization, KOG sterilization, radiation sterilization, ozone sterilization, and alcohol disinfection.

問題点圀の対策手段としては上記諸問題点の解決手段に
より同時に解決される。
As a countermeasure for the problems, the above-mentioned problems can be solved at the same time.

下記に問題点を解決する手段を詳細に説明する。The means for solving the problem will be explained in detail below.

所謂後産として排出された胎盤と結合したヒト羊膜を、
排出直後無菌水にて洗浄・除血して直ちに、予め用意し
7!lニア5%エチールアルコール水溶液を満し友容器
中にて上記のアルコールに浸漬する。次に予め消毒滅菌
し北鋭利な刃物で、上記アルコール液中で、胎盤と羊膜
を切シ離し羊膜のみを別途用意した容器中の無菌水中に
投入する。この無菌水中にて羊膜を一層毎に剥離、遊浴
しアルコールその他可溶物を溶出洗浄する。
The human amniotic membrane combined with the placenta expelled as a so-called afterbirth,
Immediately after draining, wash and remove blood with sterile water and prepare in advance 7! Immerse in the above alcohol in a container filled with 5% ethyl alcohol aqueous solution. Next, the placenta and amniotic membrane are separated in the alcoholic solution using a previously sterilized and sharp knife, and the amniotic membrane alone is placed in sterile water in a separately prepared container. The amniotic membrane is peeled layer by layer in this sterile water and bathed to elute and wash alcohol and other soluble substances.

同条件下、無菌中にて、剥離された一層毎の羊膜を無菌
処理したガラス、セラミックス、金属、プラスチックの
平板状の支持板の上にシート状に拡げる。次に無菌処理
した上記支持板と同質材料で作られた角状、円状の枠で
羊膜の周辺を枠止め固持する。周辺を固体支持枠で固定
された羊膜シートは以後の加工処理操作を容易にするこ
とができるため本発明の補綴材料の製造コストを大幅に
低減することができるという特長tWし本発明の技術訴
求点となっている。
Under the same conditions and under sterile conditions, each layer of amniotic membrane that has been peeled off is spread into a sheet on a flat support plate made of sterilized glass, ceramics, metal, or plastic. Next, the periphery of the amniotic membrane is fixed and fixed with a square or circular frame made of the same material as the support plate which has been sterilized. The amniotic membrane sheet, whose periphery is fixed with a solid support frame, can facilitate subsequent processing operations, so the manufacturing cost of the prosthetic material of the present invention can be significantly reduced. It is a point.

この形状は最終製品に到る全工程に維持される。This shape is maintained throughout the process leading to the final product.

この枠組シートはフイ7ン酵素浴中に6)漬し、超音波
処理等の機械的洗浄処理の併用により、耐着細胞及び脂
質分を破壊・除去・洗浄する。
This framework sheet is 6) immersed in a fluorinated enzyme bath, and resistant cells and lipids are destroyed, removed, and washed by combined use of mechanical cleaning treatment such as ultrasonic treatment.

次に無菌水で入念に洗浄した後、グルタールアルデヒド
、紫外線等にょシ羊膜を構成するゴラーゲ7分子間に橋
かけ反応作用を行う。この化学的物理釣橋かけ反応によ
り羊膜シートの物理的強度が向上するのみならず、その
抗原性を不活性化し、望ましい生体適合性を有すること
になる。
Next, after carefully washing with sterile water, a cross-linking reaction is performed between the seven molecules of golage that make up the amniotic membrane using glutaraldehyde, ultraviolet light, etc. This chemical-physical bridge reaction not only improves the physical strength of the amniotic membrane sheet, but also inactivates its antigenicity and provides desirable biocompatibility.

次に無菌水にて十分水洗し次後、無菌環境下乾燥する。Next, wash thoroughly with sterile water, and then dry in a sterile environment.

乾燥させて羊膜7−トに適度の柔軟性を付与しない場合
は、可塑剤として局方グリセリンの適当量を上記の最終
の無菌水洗浄工程において、無菌水に添加し、その後乾
燥するこ′とにより目的を達成することができる。
If drying does not impart appropriate flexibility to the amniotic membrane, add an appropriate amount of pharmacopoeial glycerin as a plasticizer to the sterile water in the final sterile water washing step, and then dry it. The purpose can be achieved by

次に羊膜シートの積層体又は繊維メッシ二との複合体を
作ることを目的とする場合、シート層間又はシートと繊
維メッシス間の接着強度を向上する次めにフイプロネク
チン又は化学修飾フイプロネクチンを接着剤として用い
ることを本発明の特徴としている。
Next, when the purpose is to make a laminate of amniotic membrane sheets or a composite with fiber mesh, fibronectin or chemically modified fibronectin is used to improve the adhesive strength between the sheet layers or between the sheet and the fiber mesh. A feature of the present invention is that it is used as an adhesive.

フイプロネクチン又は化学修飾フイプロネクチンの使用
目的は上記の接着剤としての役割の外に本発明が解決し
ようとしてbる問題点である生体適合性のよシ一層の向
上効果を得るためにある。即ち、フイプロネクチン等が
本来有する細胞接着と細胞増殖と2つの効能を同時又は
個別に利用するものであシ、本発明の特徴点である。
The purpose of using fipronectin or chemically modified fipronectin is to obtain the effect of further improving biocompatibility, which is the problem that the present invention aims to solve, in addition to the above-mentioned role as an adhesive. . That is, it is a feature of the present invention that the two effects of cell adhesion and cell proliferation, which are inherent in fipronectin and the like, are utilized simultaneously or separately.

管状の補綴材を作る手段は、上記による手法で得九羊膜
シートを、パイプ状又は棒状のガラス、セラミックス、
金属、グラスチック等の芯材として、巻き取り、眉間剥
離を生じない状態で芯材を抜き取ることにより完成する
The means for making a tubular prosthetic material is to use the nine amniotic membrane sheets obtained by the above method to form pipe-shaped or rod-shaped glass, ceramics,
As a core material for metal, glass, etc., it is completed by winding it up and removing the core material without causing peeling.

以上記した補綴材は、日本粟局方基準の消毒・滅菌法を
適用して消毒・滅菌の手段とする。
The prosthetic materials described above are disinfected and sterilized by applying the disinfection and sterilization method based on the Japanese Millet Pharmacopoeia standards.

次に実施例に基づいて具体的に本発明を説明する。Next, the present invention will be specifically explained based on Examples.

実施例! ヒトの新鮮な羊膜を除血後局方75%エチルアルコール
液に50分間以上浸漬する。次に上記羊膜を無菌水を満
し比容量50リットルの1ラスチツク容器に入れ一層ご
とに剥離した後、別途用意し九角状、円板状のプラスチ
ック族の枠で、上記容器内の無菌水に浮遊する羊膜1枚
毎に適宜の形状に整え七の羊膜の周辺を上記グラスチッ
クの枠で固定し次。枠付けし次状態で羊膜を十分水洗し
てエチルアルコールを除去する。次に上記の枠付き羊膜
を別途用意し次容器中の001%のフィシン、リン酸緩
衝液(pH7,0)に24時間浸漬し次。次に、無菌水
にて水洗した後α5%グルタールアルデヒド液に浸漬し
羊膜構成物質コラーゲンの橋かけ反応を完結する。無菌
水にて余剰のグルタールアルデヒドを水洗除去する。
Example! After blood removal, fresh human amniotic membrane is immersed in a pharmacopoeial 75% ethyl alcohol solution for 50 minutes or more. Next, the amniotic membrane was placed in a plastic container with a specific capacity of 50 liters filled with sterile water and peeled off layer by layer. Each floating amnion is shaped into an appropriate shape, and the periphery of the seventh amniotic membrane is fixed with the above-mentioned plastic frame. After setting the frame, the amnion is thoroughly washed with water to remove ethyl alcohol. Next, the framed amniotic membrane was prepared separately and immersed in 001% ficin and phosphate buffer (pH 7.0) in a container for 24 hours. Next, it is washed with sterile water and then immersed in α5% glutaraldehyde solution to complete the cross-linking reaction of collagen, which is a component of the amniotic membrane. Wash away excess glutaraldehyde with sterile water.

その後5〜2ON局方グリセリン水溶液中に30分以上
浸漬した後無菌の東件下加熱乾燥する。
Thereafter, it is immersed in a 5-2ON pharmacopoeial glycerin aqueous solution for 30 minutes or more, and then heated and dried under a sterile atmosphere.

以上の結果、抗原性を極度に低減し次医療用生体材料基
準に合致し且つ柔軟性に富む強じんな膜材料を得ること
ができた。
As a result of the above, it was possible to obtain a highly flexible and strong membrane material that had extremely reduced antigenicity, met the standards for biomaterials for next-care medical use, and was highly flexible.

実施例2 前記実施例言により得られ几シート状の修飾されたヒト
羊膜を、シリコーン夷の直径510Iの−パイプに巻き
付け、その合わせ目を中心として、濃度0.5マイクロ
グラム/−以上のフイプロネクチンをコーティングして
貼り合わせる。
Example 2 The modified human amnion in the form of a sheet obtained in the above example was wrapped around a silicone pipe with a diameter of 510 mm, and a fiber having a concentration of 0.5 micrograms/- or more was wrapped around the seam. Coat with pronectin and bond.

その後シリコーン・パイプを抜きとることにより管状の
修飾ヒト羊膜チューブを得ることができだ。
Then, by pulling out the silicone pipe, a tubular modified human amniotic tube could be obtained.

実施例3 前記実施例1及び2において、ポリエステルm維め網状
シートをヒト羊膜と積層することによ!7′繊維強化修
飾ヒト羊膜のシート及びチューブを°得ることができた
Example 3 In Examples 1 and 2 above, by laminating the polyester fiber mesh sheet with human amniotic membrane! Sheets and tubes of modified human amniotic membrane reinforced with 7' fibers could be obtained.

〔発明の効果〕〔Effect of the invention〕

本発明が解決しようとする問題点は、全て解決する効果
を得次。従って、従来の技術が解決することができなか
ったため、停滞してい次膀胱、尿管、尿道の補綴術の進
歩向上及び普及を図ることができる。即ち医学・医術及
び医療福祉を画期的に進歩発展させる効果が期待できる
The problems that the present invention aims to solve are as follows. Therefore, it is possible to improve and popularize prosthetic techniques for the bladder, ureter, and urethra due to stagnation, which conventional techniques have not been able to solve. In other words, it can be expected to have the effect of dramatically advancing and developing medicine, medical technology, and medical welfare.

Claims (7)

【特許請求の範囲】[Claims] (1) ヒト羊膜の一層または多層のシートを原料とす
る膜状及び管状物とした膀胱、尿道、尿管用の生体適合
性に富む補綴用医療用具。
(1) A biocompatible prosthetic medical device for the bladder, urethra, and ureter in the form of a membrane or tube made from a single-layer or multi-layer sheet of human amniotic membrane.
(2) ヒト羊膜をエタノール、イソプロピールアルコ
ールに少なくとも30分以上浸漬し、次いで無菌水で洗
浄し、その後橋かけ結合処理し膜状及び管状物とするこ
とを特徴とする補綴用医療用具の製造方法。
(2) Production of a prosthetic medical device characterized by immersing human amniotic membrane in ethanol or isopropyl alcohol for at least 30 minutes, then washing with sterile water, and then subjecting it to crosslinking treatment to form a membrane-like and tubular product. Method.
(3) 無菌水による洗浄後の橋かけ結合処理としてグ
ルタールアルデヒド処理又は紫外線により橋かけ結合を
行うことを特徴とする特許請求の範囲第2項記載の補綴
用医療用具の製造方法。
(3) The method for manufacturing a prosthetic medical device according to claim 2, wherein the cross-linking treatment after washing with sterile water is performed by glutaraldehyde treatment or by ultraviolet rays.
(4) ヒト羊膜の無菌水による洗浄において、ヒト羊
膜シートを枠に固定して行なうことを特徴とする特許請
求の範囲第2項記載の補綴用医療用具の製造方法。
(4) The method for manufacturing a prosthetic medical device according to claim 2, wherein the washing of the human amniotic membrane with sterile water is carried out by fixing the human amniotic membrane sheet to a frame.
(5) ヒト羊膜シートを多層に形成する時、接着剤と
してフイプロネクチン又は化学修飾フイプロネクチンを
用いることを特徴とする特許請求の範囲第2項記載の補
綴用医療用具の製造方法。
(5) The method for manufacturing a prosthetic medical device according to claim 2, characterized in that when forming the human amniotic membrane sheet into multiple layers, fibronectin or chemically modified fibronectin is used as an adhesive.
(6) ヒト羊膜シートとして合成高分子繊維又は天然
繊維のメツシユにより補強したヒト羊膜を用いることを
特徴とする特許請求の範囲第1項記載の補綴用医療用具
(6) The prosthetic medical device according to claim 1, characterized in that the human amniotic membrane sheet is human amniotic membrane reinforced with a mesh of synthetic polymer fibers or natural fibers.
(7) ヒト羊膜シートとして合成高分子繊維又は天然
繊維のメツシユにより補強したヒト羊膜を用いることを
特徴とする特許請求の範囲第2項記載の補綴用医療用具
の製造方法。
(7) The method for producing a prosthetic medical device according to claim 2, characterized in that the human amniotic membrane sheet is a human amniotic membrane reinforced with a mesh of synthetic polymer fibers or natural fibers.
JP62092980A 1987-04-17 1987-04-17 Prosthesis material and its production Granted JPS63260549A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP62092980A JPS63260549A (en) 1987-04-17 1987-04-17 Prosthesis material and its production

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
JP62092980A JPS63260549A (en) 1987-04-17 1987-04-17 Prosthesis material and its production

Publications (2)

Publication Number Publication Date
JPS63260549A true JPS63260549A (en) 1988-10-27
JPH034229B2 JPH034229B2 (en) 1991-01-22

Family

ID=14069534

Family Applications (1)

Application Number Title Priority Date Filing Date
JP62092980A Granted JPS63260549A (en) 1987-04-17 1987-04-17 Prosthesis material and its production

Country Status (1)

Country Link
JP (1) JPS63260549A (en)

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2003532466A (en) * 2000-04-27 2003-11-05 ツァイ,レイ・ジュイ−ファン Proliferation method of epithelial stem cells
WO2008102847A1 (en) 2007-02-23 2008-08-28 National University Corporation University Of Toyama Medical substitute membrane, use thereof, and method for repair of membrane tissue in living body
JP2012101100A (en) * 1995-04-07 2012-05-31 Organogenesis Inc Peracetic acid crosslinked non-antigenic icl grafts
JP2014138590A (en) * 2002-03-26 2014-07-31 Anthrogenesis Corp Collagen biofabric and preparation method and use therefor
CN103977457A (en) * 2014-05-30 2014-08-13 国家纳米科学中心 Tubular tissue engineering scaffold and preparation method thereof
WO2020045608A1 (en) 2018-08-30 2020-03-05 淑子 吉田 Tendon/tendon sheath regeneration/restoration material, and use of same

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2012101100A (en) * 1995-04-07 2012-05-31 Organogenesis Inc Peracetic acid crosslinked non-antigenic icl grafts
JP2003532466A (en) * 2000-04-27 2003-11-05 ツァイ,レイ・ジュイ−ファン Proliferation method of epithelial stem cells
JP2014138590A (en) * 2002-03-26 2014-07-31 Anthrogenesis Corp Collagen biofabric and preparation method and use therefor
WO2008102847A1 (en) 2007-02-23 2008-08-28 National University Corporation University Of Toyama Medical substitute membrane, use thereof, and method for repair of membrane tissue in living body
US8414929B2 (en) 2007-02-23 2013-04-09 National University Corporation University Of Toyama Medical substitute membrane, use thereof, and method for repair of membrane tissue in living body
CN103977457A (en) * 2014-05-30 2014-08-13 国家纳米科学中心 Tubular tissue engineering scaffold and preparation method thereof
WO2020045608A1 (en) 2018-08-30 2020-03-05 淑子 吉田 Tendon/tendon sheath regeneration/restoration material, and use of same

Also Published As

Publication number Publication date
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