US3588920A - Surgical vascular prostheses formed of polyester fiber paper - Google Patents

Surgical vascular prostheses formed of polyester fiber paper Download PDF

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US3588920A
US3588920A US3588920DA US3588920A US 3588920 A US3588920 A US 3588920A US 3588920D A US3588920D A US 3588920DA US 3588920 A US3588920 A US 3588920A
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polyester fiber
prostheses
paper
fiber paper
polyester
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Sigmund A Wesolowski
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Sigmund A Wesolowski
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    • DTEXTILES; PAPER
    • D21PAPER-MAKING; PRODUCTION OF CELLULOSE
    • D21HPULP COMPOSITIONS; PREPARATION THEREOF NOT COVERED BY SUBCLASSES D21C OR D21D; IMPREGNATING OR COATING OF PAPER; TREATMENT OF FINISHED PAPER NOT COVERED BY CLASS B31 OR SUBCLASS D21G; PAPER NOT OTHERWISE PROVIDED FOR
    • D21H13/00Pulp or paper, comprising synthetic cellulose or non-cellulose fibres or web-forming material
    • D21H13/10Organic non-cellulose fibres
    • D21H13/20Organic non-cellulose fibres from macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • D21H13/24Polyesters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION, OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14Macromolecular materials
    • A61L27/18Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds

Abstract

VASCULAR PROTHESES CHARACTERIZED BY A POROSITY OF FROM ABOUT 550 CC. TO 8,000 CC. PER MINUTE PER SQUARE CENTIMETER ARE CONSTRUCTED OF POLYESTER FIBER PAPER HAVING A THICKNESS OF FROM ABOUT 64 MICRONS TO ABOUT 25J MICRONS. THE MECHANICAL HANDLING PROPERTIES ARE EXCELLENT AND THE RESIDUAL PATENCY OF THE IMPLANTED PROSTHESE FOLLOWING HEALING IS SUPERIOR TO POLYESTER PROSTHESES HAVING A WOVEN OR KNIT STRUCTURE.

Description

June 29, 1971 s. A. WESOLOWSKI 3,588,920

SURGICAL VASCULAR PROSTHESES FORMED OF POLYESTER FIBER PAPER Filed Sept. 5, 1969 INVENTOR Java/v0 A M504 on snr/ BY M L's ATTORNEY United States Patent SURGICAL VASCULAR PROSTHESES FORMED 0F POLYESTER FIBER PAPER Sigmund A. Wesolowski, 44 Roosevelt Ave., East Rockaway, N.Y. 11518 Filed Sept. 5, 1969, Ser. No. 855,585 Int. Cl. A61f 1/24 US. Cl. 3-1 3 Claims ABSTRACT OF THE DISCLOSURE Vascular prostheses characterized by a porosity of from about 550 cc. to 8,000 cc. per minute per square centimeter are constructed of polyester fiber paper having a thickness of from about 64 microns to about 254 microns. The mechanical handling properties are excellent and the residual patency of the implanted prostheses following healing is superior to polyester prostheses having a woven or knit structure.

This invention relates to prostheses constructed to maintain an open lumen when placed in an animal body, particularly in the human body. More particularly, this invention relates to vascular implants for surgical use in the repair and replacement of vessels and tracts in human and animal bodies.

During the past decade considerable attention has been given to the development of artificial vascular parts or grafts as implants for animal bodies. Synthetic fibers such as Vinyon-N, nylon, Orlon, Dacron, Teflon, and Ivalon have been woven and knitted into tubes and other suitable shapes, for use as arteries, veins, ducts, esophagi and the like.

It has been recognized that an artificial graft must meet a number of standards in order to be of value. In particular, the graft must have certain physical properties such that it can be readily handled and manipulated during the specific surgery calling for its use. It must be flexible, for such is essential during an operation when time is critical and the graft must be accommodated to the artery, vein or the like to which it is being secured. It is sometimes necessary in surgery to bend a device or graft either around or under a body organ. An essential feature is that the graft be suificiently rigid, though bendable, to allow for flexing without collapse and closing of the lumen thereof. If the graft does not have such strength, there is ever present the danger that when bent or flexed acutely in the body the lumen would collapse, leading to fatality.

It has also been recognized that a suitable prostheses for the body should be non-toxic, flexible and porous. The ideal prostheses should retain its strength permanently in intimate contact with the body fluids and should be readily accepted and incorporated into the tissues. Porosity is an important characteristic of such a prosthesis to avoid the formation of fluid pockets and to promote the growth through the fabric of repair tissue. Proper merging of the fabric with the body structure is also essential.

It is an object of this invention to provide flexible implants in the form of a tube comprising an association of short polyester fibers of indefinite length that can be handled on conventional paper-making machinery, said fibers ranging from 10 to 15 microns in diameter. The fibers are randomly arranged and bonded together to form a non-woven, paper-like sheet. The structure may be stabilized by fusion of some of the polyester fibers to cause adhesion. Alternatively, various adhesives may be used for this purpose, i.e., a polyamide resin produced by the condensation of a polycarboxylic acid with polyamine (Versamid). If an adhesive is used, it must be applied sparingly to spot-weld the polyester fibers at spaced intervals throughout the area of the paper sheet so as not to decrease unduly the porosity of the fabric. When a polyamide resin is employed as an adhesive, it is heatcured to polymerize and set the adhesive.

A further object of the present invention is to provide a gossamer tube of high porosity. Still another object is to form artificial vascular parts for an animal body suitable for use as a replacement for damaged arteries.

The foregoing objects are realized by providing cylindrical articles of tubular shape comprising a polyester fiber paper. A better description of the vascular prostheses may be had from the following description read in conjunction with the accompanying drawings in which:

FIG. 1 is a perspective view of a Dacron paper tube embodying the invention;

FIG. 2 is a perspective view of the Dacron paper vascular implant of bifurcated form;

FIG. 3 is a cross-section of a vascular prostheses on the line 3--3 of FIG. 1;

FIG. 4 is a longitudinal cross-section on the line 4-4 of FIG. 1; and

FIG. 5 is a cross-section of the tube shown in FIGS. 1 and 4 when in a crimped condition.

The paper that is used to construct the prostheses of the present invention may consist essentially of polyester (polyethylene terephthalate) fibers of indefinite length. The paper is desirably between about 64 microns and 254 microns in thickness. To obtain bonding of the individual fibers throughout the paper sheet, one may include in the polyester fi-ber composition a small amount (1-4%) of a polyester fiber having a melting point that is substantially below the melting point of the polyester fibers that con stitute the major portion of the paper composition. To obtain bonding, the paper sheet, after formation, is heated for a short period of time to the fusion temperature of the low melting polyester fibers, but below the fusion temperature of the higher melting polyester fibers, and then cooled to room temperature.

The vascular prostheses of the present invention may be constructed, as best shown in FIG. 1, by rolling an oblong sheet to form a tube 10 and cementing the longitudinal seam 11 with a suitable adhesive. Adhesives that may be used for this purpose are the Z-cyanoacrylic esters such as methyl Z-cyanoacrylate and isobutyl Z-cyanoacrylate. Alternatively, the longitudinal seams may be secured by sewing with a polyester fiber thread, or by heat sealing.

Bifurcated structures of the type shown in FIG. 2 may be manufactured by making a small longitudinal cut 12 in the wall of a tube and joining thereto one end of a second tube 13 with an appropriate adhesive or by sewing, or heat sealing.

The tubes of the present invention may be crimped to allow for flexing and bending without collapse and closing of the lumen, by placing the uncrimped tube on a glass mandrel of slightly smaller diameter and compressing the tube longitudinally. The glass mandrel with the compressed tube thereon is then heat-set at a temperature slightly below the fusion temperature of the polyester fibers that are present in the paper, and permitted to cool to room temperature. After cooling, a crimped prostheses having the structure illustrated in FIG. may be removed from the mandrel.

Paper polyester fiber tubes constructed in accordance with the present invention exhibit excellent mechanical and physical properties and may be sutured quite like normal aorta. Tests have been performed by implantation into the thoracic aorta of growing pigs for periods of six months. The prostheses demonstrate in general excellent healing properties that compare well with the best healing prostheses of knitted and woven fabrications and show no incidence of obstruction that may sometimes result from the secondary deposition of thrombus upon the inner surface. The general observations with respect to fibrotic and cellular reaction, stenosis, and obstruction is summarized in the following table.

It appears to be an advantage of the polyester fiber paper tubes that the inner capsule is thinner than previously experienced with other prostheses that have been used.

As indicated above, the articles formed as described herein are useful as tubular grafts. They have desired characteristics as revealed by their maneuverability and flexing quality and capability of maintaining an open lumen when flexed. In addition, they have the desired feature of porosity as well as integrating Well with body tissue.

While the invention has been described in detail in accordance with the method of carrying out the process and yielding the products, it will be obvious to those skilled in the art that changes and modifications can be made without departing from the spirit or scope of the invention and it is intended in the appended claims to cover such changes and modifications.

TABLE I.-RELATIVE AOCEPTABILITY OF DACRON PAPER VASCULAR PROSTHESES Average rate in growing pig 1 If corrected for external constriction, residual patency 70.

What is claimed is:

1. A tubular vascular prosthesis formed from randomly arranged polyester fibers bonded together to form a polyester fiber paper implant suitable for implanting in the human or animal body, said prosthesis characterized by having a porosity to water of from about 550 cc. to 8,000 cc. per minute per square centimeter as measured on the Wesolowski scale and having a wall thickness of from about 64 microns to about 254 microns.

2. The vascular prostheses of claim 1 wherein the porosity is 8,000 cc. per minute per square centimeter and the wall thickness is 64 microns.

3. The vascular prostheses of claim 1 in crimped form.

References Cited UNITED STATES PATENTS 3,105,4 2 10/1963 Jeckel 128-334 3,3 16,557 5/1967 Liebig 3-1 3,317,924 5/1967 LeVeen 3l RICHARD A. GAUDET, Primary Examiner R. L. FRINKS, Assistant Examiner U.S. Cl. X.R.

US3588920A 1969-09-05 1969-09-05 Surgical vascular prostheses formed of polyester fiber paper Expired - Lifetime US3588920A (en)

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DE (1) DE2025358A1 (en)
FR (1) FR2060524A5 (en)
GB (1) GB1265246A (en)
NL (1) NL7009030A (en)

Cited By (30)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3843974A (en) * 1972-01-05 1974-10-29 Us Health Education & Welfare Intimal lining and pump with vertically drafted webs
US3878565A (en) * 1971-07-14 1975-04-22 Providence Hospital Vascular prosthesis with external pile surface
US3902198A (en) * 1974-05-20 1975-09-02 Gore & Ass Method of replacing a body part with expanded porous polytetrafluoroethylene
US3908201A (en) * 1972-06-30 1975-09-30 Ici Ltd Prosthetics
US4042978A (en) * 1972-06-30 1977-08-23 Imperial Chemical Industries Limited Prosthetics
US4130904A (en) * 1977-06-06 1978-12-26 Thermo Electron Corporation Prosthetic blood conduit
US4191218A (en) * 1975-05-07 1980-03-04 Albany International Corp. Fabrics for heart valve and vascular prostheses and methods of fabricating same
EP0043555A1 (en) * 1980-07-07 1982-01-13 Teijin Limited Paper-like polyester fiber sheet and process for producing the same
US4573471A (en) * 1984-07-09 1986-03-04 Rudner Merritt A Prosthetic apparatus for surgical anastomosis
US4671797A (en) * 1984-09-21 1987-06-09 Vrandecic Pedero Mario O Heterologous arterial biograft and biological material treating process
US4759748A (en) * 1986-06-30 1988-07-26 Raychem Corporation Guiding catheter
US4870966A (en) * 1988-02-01 1989-10-03 American Cyanamid Company Bioabsorbable surgical device for treating nerve defects
US5258027A (en) * 1991-01-24 1993-11-02 Willy Rusch Ag Trachreal prosthesis
US5697970A (en) * 1994-08-02 1997-12-16 Meadox Medicals, Inc. Thinly woven flexible graft
US5700287A (en) * 1992-12-11 1997-12-23 W. L. Gore & Associates, Inc. Prosthetic vascular graft with deflectably secured fibers
WO1999033403A1 (en) 1997-12-31 1999-07-08 Kensey Nash Corporation Bifurcated connector system for coronary bypass grafts
US6017352A (en) * 1997-09-04 2000-01-25 Kensey Nash Corporation Systems for intravascular procedures and methods of use
US6030395A (en) * 1997-05-22 2000-02-29 Kensey Nash Corporation Anastomosis connection system
US6063114A (en) * 1997-09-04 2000-05-16 Kensey Nash Corporation Connector system for vessels, ducts, lumens or hollow organs and methods of use
US6436135B1 (en) 1974-10-24 2002-08-20 David Goldfarb Prosthetic vascular graft
US20030093140A1 (en) * 1987-12-08 2003-05-15 W. Henry Wall Method of implanting a sleeve in a lumen
US20050113910A1 (en) * 2002-01-04 2005-05-26 David Paniagua Percutaneously implantable replacement heart valve device and method of making same
US20050267566A1 (en) * 2003-03-26 2005-12-01 Robert Rioux Longitudinally expanding medical device
US20090163936A1 (en) * 2007-12-21 2009-06-25 Chunlin Yang Coated Tissue Engineering Scaffold
US20100100170A1 (en) * 2008-10-22 2010-04-22 Boston Scientific Scimed, Inc. Shape memory tubular stent with grooves
US20100227096A1 (en) * 2009-03-09 2010-09-09 Georg Fischer Jrg Ag Method for producing a tubular hollow body, and tubular hollow body
US8361144B2 (en) 2010-03-01 2013-01-29 Colibri Heart Valve Llc Percutaneously deliverable heart valve and methods associated therewith
US9119738B2 (en) 2010-06-28 2015-09-01 Colibri Heart Valve Llc Method and apparatus for the endoluminal delivery of intravascular devices
EP3011936A1 (en) * 2011-01-06 2016-04-27 Humacyte Tissue-engineered constructs
US9737400B2 (en) 2010-12-14 2017-08-22 Colibri Heart Valve Llc Percutaneously deliverable heart valve including folded membrane cusps with integral leaflets

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB1527592A (en) * 1974-08-05 1978-10-04 Ici Ltd Wound dressing
US4340091A (en) * 1975-05-07 1982-07-20 Albany International Corp. Elastomeric sheet materials for heart valve and other prosthetic implants
GB1577221A (en) * 1976-02-04 1980-10-22 Ici Ltd Vascular prosthesis
DE2806030C2 (en) * 1978-02-14 1984-02-02 B. Braun Melsungen Ag, 3508 Melsungen, De
EP0130401B1 (en) * 1983-06-06 1989-05-17 Kanegafuchi Kagaku Kogyo Kabushiki Kaisha Artificial vessel and process for preparing the same
EP0128501B1 (en) * 1983-06-06 1989-03-29 Kanegafuchi Kagaku Kogyo Kabushiki Kaisha Artificial vessel and process for preparing the same
EP0157178B1 (en) * 1984-03-01 1988-11-30 Kanegafuchi Kagaku Kogyo Kabushiki Kaisha Artificial vessel and process for preparing the same
GB8422530D0 (en) * 1984-09-06 1984-10-10 Shirley Inst Production of porous tubes
DE3666530D1 (en) * 1985-08-26 1989-11-30 Kanegafuchi Chemical Ind Artificial vessel
JPS63209647A (en) * 1987-02-26 1988-08-31 Kanegafuchi Chemical Ind Artificial blood vessel
EP0349505B1 (en) * 1988-06-27 1998-09-16 Astra Aktiebolag A novel surgical material
US5641505A (en) * 1988-06-27 1997-06-24 Astra Tech Aktiebolag Porous flexible sheet for tissue separation
WO2004087012A1 (en) * 2003-03-31 2004-10-14 Teijin Limited Composite of support substrate and collagen, and process for producing support substrate and composite
EP2314739A1 (en) * 2009-10-22 2011-04-27 Gyeong-Man Kim Anti-migration casing for transponders

Cited By (56)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3878565A (en) * 1971-07-14 1975-04-22 Providence Hospital Vascular prosthesis with external pile surface
US3843974A (en) * 1972-01-05 1974-10-29 Us Health Education & Welfare Intimal lining and pump with vertically drafted webs
US3908201A (en) * 1972-06-30 1975-09-30 Ici Ltd Prosthetics
US4042978A (en) * 1972-06-30 1977-08-23 Imperial Chemical Industries Limited Prosthetics
US3902198A (en) * 1974-05-20 1975-09-02 Gore & Ass Method of replacing a body part with expanded porous polytetrafluoroethylene
US6436135B1 (en) 1974-10-24 2002-08-20 David Goldfarb Prosthetic vascular graft
US4191218A (en) * 1975-05-07 1980-03-04 Albany International Corp. Fabrics for heart valve and vascular prostheses and methods of fabricating same
US4130904A (en) * 1977-06-06 1978-12-26 Thermo Electron Corporation Prosthetic blood conduit
EP0043555A1 (en) * 1980-07-07 1982-01-13 Teijin Limited Paper-like polyester fiber sheet and process for producing the same
US4573471A (en) * 1984-07-09 1986-03-04 Rudner Merritt A Prosthetic apparatus for surgical anastomosis
US4671797A (en) * 1984-09-21 1987-06-09 Vrandecic Pedero Mario O Heterologous arterial biograft and biological material treating process
US4759748A (en) * 1986-06-30 1988-07-26 Raychem Corporation Guiding catheter
US20030093140A1 (en) * 1987-12-08 2003-05-15 W. Henry Wall Method of implanting a sleeve in a lumen
US6974475B1 (en) 1987-12-08 2005-12-13 Wall W Henry Angioplasty stent
US4870966A (en) * 1988-02-01 1989-10-03 American Cyanamid Company Bioabsorbable surgical device for treating nerve defects
US5258027A (en) * 1991-01-24 1993-11-02 Willy Rusch Ag Trachreal prosthesis
US5700287A (en) * 1992-12-11 1997-12-23 W. L. Gore & Associates, Inc. Prosthetic vascular graft with deflectably secured fibers
USRE40404E1 (en) 1994-08-02 2008-06-24 Maquet Cardiovascular, Llp Thinly woven flexible graft
US5697970A (en) * 1994-08-02 1997-12-16 Meadox Medicals, Inc. Thinly woven flexible graft
US6030395A (en) * 1997-05-22 2000-02-29 Kensey Nash Corporation Anastomosis connection system
US6036705A (en) * 1997-05-22 2000-03-14 Kensey Nash Corporation Anastomosis connection system and method of use
US6056762A (en) * 1997-05-22 2000-05-02 Kensey Nash Corporation Anastomosis system and method of use
US6402767B1 (en) 1997-05-22 2002-06-11 Kensey Nash Corporation Anastomosis connection system and method of use
US5922022A (en) * 1997-09-04 1999-07-13 Kensey Nash Corporation Bifurcated connector system for coronary bypass grafts and methods of use
US6063114A (en) * 1997-09-04 2000-05-16 Kensey Nash Corporation Connector system for vessels, ducts, lumens or hollow organs and methods of use
US20100217290A1 (en) * 1997-09-04 2010-08-26 Nash John E Surgical connector systems and methods of use
US6923820B1 (en) 1997-09-04 2005-08-02 Kensey Nash Corporation Surgical connector systems and methods of use
US20050245946A1 (en) * 1997-09-04 2005-11-03 Nash John E Surgical connector systems and methods of use
US6017352A (en) * 1997-09-04 2000-01-25 Kensey Nash Corporation Systems for intravascular procedures and methods of use
US8377080B2 (en) 1997-09-04 2013-02-19 Kensey Nash Corporation Surgical connector systems and methods of use
US7264624B2 (en) 1997-09-04 2007-09-04 Kensey Nash Corporation Surgical connector systems and methods of use
US20070293881A1 (en) * 1997-09-04 2007-12-20 Nash John E Surgical connector systems and methods of use
US7695483B2 (en) 1997-09-04 2010-04-13 Kensey Nash Corporation Surgical connector systems and methods of use
WO1999033403A1 (en) 1997-12-31 1999-07-08 Kensey Nash Corporation Bifurcated connector system for coronary bypass grafts
US9610158B2 (en) 2002-01-04 2017-04-04 Colibri Heart Valve Llc Percutaneously implantable replacement heart valve device and method of making same
US9554898B2 (en) 2002-01-04 2017-01-31 Colibri Heart Valve Llc Percutaneous prosthetic heart valve
US9186248B2 (en) 2002-01-04 2015-11-17 Colibri Heart Valve Llc Percutaneously implantable replacement heart valve device and method of making same
US20050113910A1 (en) * 2002-01-04 2005-05-26 David Paniagua Percutaneously implantable replacement heart valve device and method of making same
US9125739B2 (en) 2002-01-04 2015-09-08 Colibri Heart Valve Llc Percutaneous replacement heart valve and a delivery and implantation system
US8900294B2 (en) 2002-01-04 2014-12-02 Colibri Heart Valve Llc Method of controlled release of a percutaneous replacement heart valve
US8109995B2 (en) 2002-01-04 2012-02-07 Colibri Heart Valve Llc Percutaneously implantable replacement heart valve device and method of making same
US8790398B2 (en) 2002-01-04 2014-07-29 Colibri Heart Valve Llc Percutaneously implantable replacement heart valve device and method of making same
US20090030511A1 (en) * 2002-01-04 2009-01-29 David Paniagua Percutaneously implantable replacement heart valve device and method of making same
US8308797B2 (en) 2002-01-04 2012-11-13 Colibri Heart Valve, LLC Percutaneously implantable replacement heart valve device and method of making same
US20050267566A1 (en) * 2003-03-26 2005-12-01 Robert Rioux Longitudinally expanding medical device
US7842098B2 (en) * 2003-03-26 2010-11-30 Boston Scientific Scimed, Inc. Longitudinally expanding medical device
US20090163936A1 (en) * 2007-12-21 2009-06-25 Chunlin Yang Coated Tissue Engineering Scaffold
US20100100170A1 (en) * 2008-10-22 2010-04-22 Boston Scientific Scimed, Inc. Shape memory tubular stent with grooves
US9980806B2 (en) 2008-10-22 2018-05-29 Boston Scientific Scimed, Inc. Shape memory tubular stent with grooves
US9724883B2 (en) 2009-03-09 2017-08-08 Georg Fischer Jrg Ag Method for producing a tubular hollow body, and tubular hollow body
US20100227096A1 (en) * 2009-03-09 2010-09-09 Georg Fischer Jrg Ag Method for producing a tubular hollow body, and tubular hollow body
US8652605B2 (en) * 2009-03-09 2014-02-18 Georg Fischer Jrg Ag Method for producing a tubular hollow body, and tubular hollow body
US8361144B2 (en) 2010-03-01 2013-01-29 Colibri Heart Valve Llc Percutaneously deliverable heart valve and methods associated therewith
US9119738B2 (en) 2010-06-28 2015-09-01 Colibri Heart Valve Llc Method and apparatus for the endoluminal delivery of intravascular devices
US9737400B2 (en) 2010-12-14 2017-08-22 Colibri Heart Valve Llc Percutaneously deliverable heart valve including folded membrane cusps with integral leaflets
EP3011936A1 (en) * 2011-01-06 2016-04-27 Humacyte Tissue-engineered constructs

Also Published As

Publication number Publication date Type
NL7009030A (en) 1971-03-09 application
GB1265246A (en) 1972-03-01 application
FR2060524A5 (en) 1971-06-18 application
DE2025358A1 (en) 1971-06-16 application

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