JPH03280960A - Artificial patch material and its manufacture - Google Patents

Artificial patch material and its manufacture

Info

Publication number
JPH03280960A
JPH03280960A JP2081045A JP8104590A JPH03280960A JP H03280960 A JPH03280960 A JP H03280960A JP 2081045 A JP2081045 A JP 2081045A JP 8104590 A JP8104590 A JP 8104590A JP H03280960 A JPH03280960 A JP H03280960A
Authority
JP
Japan
Prior art keywords
fluororesin
artificial
base material
blood
porous
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.)
Pending
Application number
JP2081045A
Other languages
Japanese (ja)
Inventor
Yuzo Ezaki
江嵜 祐造
Yoshihito Takano
高野 良仁
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Terumo Corp
Original Assignee
Terumo Corp
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Terumo Corp filed Critical Terumo Corp
Priority to JP2081045A priority Critical patent/JPH03280960A/en
Publication of JPH03280960A publication Critical patent/JPH03280960A/en
Pending legal-status Critical Current

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

Abstract

PURPOSE:To give an antithrombus character, and in the same time, enable to make the bore of an artificial blood vessel fine by coating at least the surface in contact with blood of a porous base material with a fluororesin to form an artificial patch material. CONSTITUTION:A fluororesin film is formed by the conventional method of dipping, spraying, coating, etc., with emulsion or organic solvent solution of fluororesin on at least the surface, in contact with blood of a base material, having porosity of a porous polyester or a porous polyurethane and the like. An artificial patch material is obtained by drying a pipe-shaped structure, in which the fluororesin film is formed, for about 1 to 30min at about 60 to 190 deg.C temperature. Further, concurrent use of a cross-linking agent or the like for firmly providing binding force between fluororesin and the base material and for improving durability is also effective for the emulsion or organic solvent solution of the fluororesin.

Description

【発明の詳細な説明】 〔産業上の利用分野〕 本発明は人工補綴材およびその製造法に関する。[Detailed description of the invention] [Industrial application field] The present invention relates to a prosthetic material and a method for manufacturing the same.

さらに詳しくは、本発明は、血液と接触すべき面にフッ
素樹脂被膜が形成されてなる人工補綴材およびその製造
法に関する。
More specifically, the present invention relates to a prosthetic material in which a fluororesin coating is formed on the surface to be in contact with blood, and a method for manufacturing the same.

本発明は抗血栓性および組織適合性に優れているので、
細口径人工血管、埋入型人工臓器の導管等に特に好適に
使用される。
Since the present invention has excellent antithrombotic properties and tissue compatibility,
It is particularly suitable for use in small-diameter artificial blood vessels, conduits for implantable artificial organs, and the like.

〔従来の技術及び発明か解決しようとする課題〕近年、
老齢化社会の到来とともに、閉塞性動脈疾患や瘤形成な
ど血管病変に起因する疾患が増加する一方、医療のめざ
ましい進歩により、バイパスグラフトcbypassg
rart)、経皮的バルーンによる血管形成術(pcr
cutaneous ballon angjopla
sty(PTBA))等が一般的に行なわれるようにな
り、さらに経皮的なレーザーによる血管形成術(per
cutaneous 1aser angioplas
ty(PTLA))も臨床段階へと入りつつある。
[Prior art and inventions or problems to be solved] In recent years,
With the arrival of an aging society, diseases caused by vascular lesions such as occlusive arterial disease and aneurysm formation are increasing.
rart), percutaneous balloon angioplasty (pcr
cutaneous ballon angjopla
sty (PTBA)), and percutaneous laser angioplasty (percutaneous laser angioplasty).
cutaneous 1aser angioplas
ty (PTLA)) is also entering the clinical stage.

しかしながら、PTBAは施術後の内膜の肥厚による再
閉塞が新たな問題となり、さらにPTLAは穿孔と隣接
組織への損傷、Caの決着による石灰化を伴う硬い病変
を焼灼することが困難である、高価な投資を要する等、
問題点がまだまだ多いのが現状である。一方、自家静脈
、あるいは人工血管による置換、バイパス術は広く一般
的に行なわれるようになり、その恩恵に多くの患者があ
ずかっている。しかしながら、これらの適用には、多く
の制限があり、またまだこれからの研究に負うところか
大きい。たとえば現状では人工血管の実用化はかなり太
い血管(口径が8m11以上)に限られており、それよ
りも細い血管では血栓による閉塞が問題となるため長期
開存が得られない。したがって、抗血栓性を有し、組織
修復性の優れた細口径人工血管が開発されれば適用部位
も大きく広がり、血管外科分野に大いなる福音を与える
ことになる。一方、将来的には人工肝、人工肝臓等が開
発され、それらを生体内に埋没する時には、必らず、導
管が必要となるが、ここでも細口径人工血管が必要とな
ってくる。
However, PTBA poses a new problem of re-occlusion due to post-procedure intimal thickening, and PTLA is difficult to cauterize hard lesions with perforation, damage to adjacent tissues, and calcification due to Ca settlement. Requires expensive investment, etc.
The current situation is that there are still many problems. On the other hand, replacement with autologous veins or artificial blood vessels, and bypass surgery have become widely practiced, and many patients are benefiting from them. However, there are many limitations to their application, and much remains to be done in future research. For example, at present, the practical use of artificial blood vessels is limited to fairly large blood vessels (diameter of 8 m11 or more), and long-term patency cannot be achieved in blood vessels smaller than that due to the problem of occlusion by thrombus. Therefore, if a small-diameter artificial blood vessel with antithrombotic properties and excellent tissue repair properties were developed, the range of applications would be greatly expanded, and this would bring great news to the field of vascular surgery. On the other hand, in the future, artificial livers, artificial livers, etc. will be developed, and when they are implanted in a living body, a conduit will be necessary, and a small-diameter artificial blood vessel will also be necessary here.

従来、人工血管としては、多孔性ポリエステルまたは微
孔性ポリテトラフルオロエチレンにより形成された口径
8+am以上のものが使用されている。
Conventionally, artificial blood vessels have been used that are made of porous polyester or microporous polytetrafluoroethylene and have a diameter of 8+am or more.

ポリエステル製の人工血管は、血管基材上に形成される
新生内膜細胞か有する天然の抗血栓性を利用している。
Polyester vascular grafts take advantage of the natural antithrombotic properties of neointimal cells that form on the vascular matrix.

これは、多孔性ポリエステルへの易組織侵入性を利用し
、さらに形成された新生内膜が人工血管内面に強固に成
育するため、その剥離が少なく、長期にわたる開存性を
期待するものである。一方、微孔性ポリテトラフルオロ
エチレンを用いた人工血管は、その材質の有する抗血栓
性を利用するものであり、初期の抗血栓性に対して優れ
た効果を有している。
This takes advantage of the easy tissue penetration of porous polyester, and furthermore, the formed neointima grows firmly on the inner surface of the artificial blood vessel, so it is expected to have less peeling and long-term patency. . On the other hand, artificial blood vessels using microporous polytetrafluoroethylene utilize the antithrombotic properties of the material, and have excellent initial antithrombotic effects.

しかし、前記の多孔性ポリエステルを用いた人工血管で
は、その内径か大きい場合には、植え込み直後より内面
に血栓が付着し、その後、新生内膜細胞が、その表面を
覆って天然の血管と同様な表面構造を形成する。このた
め、天然の抗血栓性を得ることができるが、その新生内
膜形成の程度および速度には現状では限界が知られてお
り、さらに致命的なのは、ポリエステルは抗血栓性に優
れていないことにより、細口径、特に口径5關以下の人
工血管では、付着した血栓により人工血管が閉塞し易く
、使用できないという問題点を有していた。
However, if the inner diameter of the artificial blood vessel using porous polyester is large, blood clots will adhere to the inner surface immediately after implantation, and neointimal cells will then cover the surface, similar to natural blood vessels. form a unique surface structure. For this reason, it is possible to obtain natural antithrombotic properties, but there are currently known limits to the degree and speed of neointimal formation, and even more fatally, polyester does not have excellent antithrombotic properties. Therefore, artificial blood vessels with a small diameter, particularly those with a diameter of 5 mm or less, have a problem that they are easily occluded by attached thrombi and cannot be used.

また微孔性ポリテトラフルオロエチレンを用いた人工血
管では、使用している材質が生体に不活性なものである
ことより、血液に対しては、ポリエステルと比較して抗
血栓性に優れているが、同時に細胞反応も非常に軽微な
ものとなることより、組織修復が非常に遅れる傾向にあ
ることか知られている。さらに微孔性であることより、
壁内に生体組織が入りにくく、したがって、新生内膜が
グラフト中央部に形成されに<<、器質化が遅れるとと
もに、外面側に形成される生体組織と内面側に形成され
る生体組織との結合も不十分なものとなり、たとえば、
透析用ブラッドアクセス使用時における血腫の原因とな
ったり、あるいは移植された人工血管の両端吻合部より
成育してきた、新生内膜が剥離しやすいものとなる。こ
の剥離物は、血栓形成の原因となる。また人工血管移植
後、血流末梢側噛合部付近で部分的に新生内膜のちりあ
がり(肥厚)が起こり、これが原因で長期的には閉塞す
ることがある等の、まだまだ解決すべき課題が多いのが
現状である。
In addition, artificial blood vessels using microporous polytetrafluoroethylene have superior antithrombotic properties to blood compared to polyester because the material used is inert to living organisms. However, at the same time, it is known that tissue repair tends to be extremely delayed as the cellular reaction becomes very slight. Furthermore, since it is microporous,
It is difficult for biological tissue to enter the wall, and therefore neointima is formed in the center of the graft, which delays organization and causes a difference between the biological tissue formed on the outer surface and the biological tissue formed on the inner surface. The coupling will also be insufficient, e.g.
This may cause hematoma when using a blood access for dialysis, or the neointima that has grown from the anastomosis at both ends of the transplanted artificial blood vessel may easily peel off. This detachment causes thrombus formation. Furthermore, after artificial blood vessel transplantation, neointimal dusting (thickening) occurs in areas near the occlusal site on the distal side of blood flow, which can lead to occlusion in the long term, and other issues that still need to be resolved. The current situation is that there are many.

一方、良好な生体適合性を示すことより、フッ素樹脂に
よる成形物が知られているが、加工し難いことから、多
孔性を持たせることが困難であり、前述のように、生体
組織との低結合性、等の欠点がある。
On the other hand, molded products made of fluororesin are known to exhibit good biocompatibility, but because they are difficult to process, it is difficult to make them porous, and as mentioned above, they are difficult to create with porosity. It has drawbacks such as low binding properties.

さらに、ポリウレタン弾性繊維不織布を管状に加熱成形
し、得られた多孔性の管状体の内面をフッ素化合物の低
温ガスプラズマ処理した人工血管が提案されている(特
開昭82−16758(1)。この人工血管は、内面が
フッ素化合物で被覆されているため、抗血栓性に優れて
いるが、他方、低温ガスプラズマ処理によりフッ素化合
物を人工血管に被覆するため、人工血管内面へのフッ素
化合物の固定が必ずしも十分ではなく、長期間の使用で
はフッ素化合物が人工血管内面から遊離し、血栓を生じ
るおそれがある。
Furthermore, an artificial blood vessel has been proposed in which a polyurethane elastic fiber nonwoven fabric is heated and formed into a tubular shape, and the inner surface of the resulting porous tubular body is treated with a low-temperature gas plasma of a fluorine compound (Japanese Patent Application Laid-Open No. 82-16758 (1)). This artificial blood vessel has excellent antithrombotic properties because its inner surface is coated with a fluorine compound, but on the other hand, since the artificial blood vessel is coated with fluorine compounds through low-temperature gas plasma treatment, the inner surface of the artificial blood vessel is coated with fluorine compounds. Fixation is not always sufficient, and when used for a long period of time, the fluorine compound may be released from the inner surface of the artificial blood vessel and cause thrombus formation.

〔課題を解決するための手段〕[Means to solve the problem]

本発明者等は上記問題点を解決すべく、鋭意研究した結
果、多孔性を有する基材の少なくとも血液と接触すべき
面にフッ素樹脂被覆を形成した人工補綴材が長期にわた
り、安定な抗血栓性および高い組織治癒性を示すことを
知り本発明を完成した。 従って本発明は下記の構成を
有する人工補綴材およびその製造法からなる。
In order to solve the above problems, the present inventors conducted intensive research and found that an artificial prosthesis material in which a fluororesin coating is formed on at least the surface of a porous base material that should come into contact with blood has a stable antithrombotic effect over a long period of time. The present invention was completed based on the knowledge that it exhibits high healing properties and tissue healing properties. Therefore, the present invention consists of a prosthetic material having the following configuration and a method for manufacturing the same.

1)多孔性を有する基材により形成され、かつ少なくと
も血液と接触すべき面にフッ素樹脂被膜が形成されてな
ることを特徴とする人工補綴材。
1) An artificial prosthetic material, characterized in that it is formed from a porous base material and has a fluororesin coating formed on at least the surface that should come into contact with blood.

2)前記人工補綴材が人工血管である1項に記載の人工
補綴材。
2) The prosthetic material according to item 1, wherein the prosthetic material is an artificial blood vessel.

3)多孔性を有する基材の少なくとも血液に接触すべき
面をフッ素樹脂エマルジョンまたはフッ素樹脂溶液で被
覆することを特徴とする人工補綴材の製造法。
3) A method for producing an artificial prosthetic material, which comprises coating at least the surface of a porous base material that is to come into contact with blood with a fluororesin emulsion or a fluororesin solution.

滲 前記被覆は前記基材をフッ素樹脂エマルジョンまた
はフッ素樹脂溶液に浸漬することにより行なわれる3項
に記載の人工補綴材の製造法。
Bleeding The method for producing a prosthetic material according to item 3, wherein the coating is performed by immersing the base material in a fluororesin emulsion or a fluororesin solution.

本発明で使用される基材には特に制限はなく、従来から
人工血管の材料として使用されていた多孔性ポリエステ
ルまたは多孔性ポリウレタン等が使用される。本発明に
おいては、これらの基Hの血液と接触すべき面、特に人
工血管に適用する場合には管の内面にフッ素樹脂被膜を
形成させる。
The base material used in the present invention is not particularly limited, and porous polyester, porous polyurethane, etc., which have been conventionally used as materials for artificial blood vessels, can be used. In the present invention, a fluororesin coating is formed on the surface of these groups H that is to come into contact with blood, particularly on the inner surface of the tube when applied to an artificial blood vessel.

フッ素樹脂のエマルジョンまたは有機溶媒溶液を用い、
浸漬法、スプレー法、コーティング法、パッドドライ法
等公知方法により基材の血液と接触すべき面にフッ素樹
脂被膜を形成させる。フッ素樹脂と基材との結合力を強
固にし、耐久性を向上させるために、架橋剤等を併用す
ることも有効である。フッ素樹脂被膜を形成された管状
構造物は80〜190℃の温度で1〜30分間乾燥して
、人工補綴材とされる。なお、本発明における人工補綴
材とは、血液に接触すべき部分を有する生体器管を補綴
するものならば人工血管に限定されるものではなく、パ
ッチ(血管を部分的に補綴するシート)、人工心臓、あ
るいは埋込型人工臓器の導管等に適用できる。
Using a fluororesin emulsion or organic solvent solution,
A fluororesin film is formed on the surface of the base material that is to be in contact with blood by a known method such as a dipping method, a spray method, a coating method, or a pad dry method. In order to strengthen the bond between the fluororesin and the base material and improve durability, it is also effective to use a crosslinking agent or the like in combination. The tubular structure coated with the fluororesin film is dried at a temperature of 80 to 190° C. for 1 to 30 minutes to obtain an artificial prosthetic material. In addition, the prosthetic material in the present invention is not limited to an artificial blood vessel as long as it prosthetes a biological vessel that has a part that should come into contact with blood, but it also includes patches (sheets that partially prosthesize blood vessels), It can be applied to artificial hearts or conduits for implantable artificial organs.

次に実施例および試験例を示して本発明をさらに具体的
に説明する。
Next, the present invention will be explained in more detail with reference to Examples and Test Examples.

実施例 1 ポリエステル繊維を用い、編み構造とし、直径3龍の管
状体Aを得た。上記管状体Aに、アサヒガードA G 
−710(旭硝子社製のフッ素樹脂商品名)の5%溶液
に30分間浸漬した後、温度120℃で3分間乾燥し、
160℃で5分間処理し、フ・ン素樹脂で被覆したポリ
エステル管状体Bを得た。
Example 1 A tubular body A having a diameter of 3 mm was obtained by using polyester fibers and having a knitted structure. Asahi Guard A G to the above tubular body A
-710 (fluororesin trade name manufactured by Asahi Glass Co., Ltd.) 5% solution for 30 minutes, and then dried at a temperature of 120°C for 3 minutes.
A polyester tubular body B coated with a fluorine resin was obtained by processing at 160° C. for 5 minutes.

試験例 (血管移植による評価) 上記管状体AおよびBをそれぞれエチレンオキサイドガ
ス滅菌し、プレクレット後、8−0血管縫合糸にて家兎
の腹部大動脈に移植した。さらに比較例として、直径3
mmのe −PTFE管状体Gore−TexO(Go
re−Tex社製)(管状体C)も同様に移植し、肉眼
的観察および組織学的観察を行なった。結果を表1に示
す。
Test Example (Evaluation by Blood Vessel Transplantation) The above-mentioned tubular bodies A and B were each sterilized with ethylene oxide gas, precletted, and then transplanted into the abdominal aorta of a domestic rabbit using an 8-0 vascular suture. Furthermore, as a comparative example, a diameter of 3
mm e-PTFE tubular Gore-TexO (Go
(manufactured by re-Tex) (tubular body C) was similarly transplanted, and macroscopic and histological observations were performed. The results are shown in Table 1.

表 ] 移 植 結 果 表1に示すように、管状体A(比較例)では3例中2例
が移植後5日と8日で完全閉塞し、18日で採取した残
り1例は血液接触面に8明な血栓付着が認められ、抗血
栓性に劣る所見が?!1られた。
Table] Transplant results As shown in Table 1, two out of three cases of tubular body A (comparative example) were completely occluded on the 5th and 8th day after transplantation, and the remaining 1 case, which was collected on the 18th day, was completely occluded on the blood contact surface. 8. Obvious thrombus adhesion was observed, indicating poor antithrombotic properties? ! I got 1.

一方、管状体B(本発明例)では、移植後7日および3
0口で観察したところ、血栓の付着は全く認められず、
抗血栓性に優れていることが明らかとなった。また残り
1例は60日以上経過後でも良好な開存性を示した。管
状体C(比較例)では5例中すべて開存していたが、赤
色血栓の何間が著聞に認められ、また、管状体と生体組
織との結合は不充分で組織治癒性で劣っていた。
On the other hand, in tubular body B (example of the present invention), 7 days and 3 days after transplantation.
When observed at 0 mouth, no thrombus was observed at all.
It was revealed that it has excellent antithrombotic properties. The remaining 1 case showed good patency even after 60 days or more. In tubular body C (comparative example), all of the five cases were patent, but several red blood clots were clearly observed, and the connection between the tubular body and living tissue was insufficient, resulting in poor tissue healing properties. was.

移植時の吻合性については、管状体Cは硬いため針の通
りが悪かったが、管状Bおよび管状体Aとも極めて良好
で全く問題は無かった。
Regarding anastomosis during transplantation, tubular body C was hard and had difficulty passing the needle through, but tubular body B and tubular body A were both extremely good and had no problems at all.

〔発明の効果〕〔Effect of the invention〕

本発明の人工補綴材は、多孔性を有する基材の血液と接
触すべき面にフッ素樹脂被膜を形成するものであるので
、合成高分子材料のもつ良好な物理的性質を保持しつつ
、多孔孔性であることにより生体組織との結合が強固と
なり、新生内膜の形成が良好となり安定化されることに
より長期開存性に優れるという性質を可能とするもので
ある。
Since the prosthetic material of the present invention forms a fluororesin coating on the surface of the porous base material that is to be in contact with blood, it maintains the good physical properties of the synthetic polymer material while maintaining porosity. The porous nature provides a strong bond with living tissue, and the formation of a neointima is favorable and stabilized, allowing for excellent long-term patency.

また、抗血栓性を有することより、特に人工血管に適用
した場合には細口径化を可能とし、多くの血管疾患をも
つ患者への治療の道を開くなど医学に寄与するところ大
である。また本発明の製造方法は管状に成形した後に、
フッ素樹脂の被膜を形成するものであるので、上記のよ
うな特徴を有する人工補綴材を容易に製造することがで
きる。
In addition, since it has antithrombotic properties, it makes it possible to make the caliber narrower, especially when applied to artificial blood vessels, making a great contribution to medicine by opening the way to treatment for patients with many vascular diseases. In addition, in the manufacturing method of the present invention, after forming into a tubular shape,
Since a fluororesin coating is formed, a prosthetic material having the above-mentioned characteristics can be easily manufactured.

Claims (1)

【特許請求の範囲】 1)多孔性を有する基材により形成され、かつ少なくと
も血液と接触すべき面にフッ素樹脂被膜が形成されてな
ることを特徴とする人工補綴材。 2)前記人工補綴材が人工血管である請求項1に記載の
人工補綴材。 3)多孔性を有する基材の少なくとも血液に接触すべき
面をフッ素樹脂エマルジョンまたはフッ素樹脂溶液で被
覆することを特徴とする人工補綴材の製造法。 4)前記被覆は前記基材をフッ素樹脂エマルジョンまた
はフッ素樹脂溶液に浸漬することにより行なわれる請求
項3に記載の人工補綴材の製造法。
[Scope of Claims] 1) An artificial prosthetic material, characterized in that it is formed from a porous base material and has a fluororesin coating formed on at least the surface that is to come into contact with blood. 2) The prosthetic material according to claim 1, wherein the prosthetic material is an artificial blood vessel. 3) A method for producing an artificial prosthetic material, which comprises coating at least the surface of a porous base material that is to come into contact with blood with a fluororesin emulsion or a fluororesin solution. 4) The method for manufacturing a prosthetic material according to claim 3, wherein the coating is performed by immersing the base material in a fluororesin emulsion or a fluororesin solution.
JP2081045A 1990-03-30 1990-03-30 Artificial patch material and its manufacture Pending JPH03280960A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2081045A JPH03280960A (en) 1990-03-30 1990-03-30 Artificial patch material and its manufacture

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
JP2081045A JPH03280960A (en) 1990-03-30 1990-03-30 Artificial patch material and its manufacture

Publications (1)

Publication Number Publication Date
JPH03280960A true JPH03280960A (en) 1991-12-11

Family

ID=13735460

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2081045A Pending JPH03280960A (en) 1990-03-30 1990-03-30 Artificial patch material and its manufacture

Country Status (1)

Country Link
JP (1) JPH03280960A (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7691460B2 (en) 2001-07-31 2010-04-06 Aesculap Ag & Co. Kg Covering element for veins, method for the production and use thereof in surgery

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7691460B2 (en) 2001-07-31 2010-04-06 Aesculap Ag & Co. Kg Covering element for veins, method for the production and use thereof in surgery

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