US3276448A - Collagen coated fabric prosthesis - Google Patents

Collagen coated fabric prosthesis Download PDF

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Publication number
US3276448A
US3276448A US244600A US24460062A US3276448A US 3276448 A US3276448 A US 3276448A US 244600 A US244600 A US 244600A US 24460062 A US24460062 A US 24460062A US 3276448 A US3276448 A US 3276448A
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US
United States
Prior art keywords
collagen
fabric
prosthesis
mesh
coated
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.)
Expired - Lifetime
Application number
US244600A
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English (en)
Inventor
Richard L Kronenthal
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.)
Ethicon Inc
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Ethicon Inc
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Filing date
Publication date
Application filed by Ethicon Inc filed Critical Ethicon Inc
Priority to US244600A priority Critical patent/US3276448A/en
Priority to GB49207/63A priority patent/GB1062876A/en
Priority to SE13929/63A priority patent/SE314159B/xx
Application granted granted Critical
Publication of US3276448A publication Critical patent/US3276448A/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0063—Implantable repair or support meshes, e.g. hernia meshes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/28—Materials for coating prostheses
    • A61L27/34—Macromolecular materials
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S623/00—Prosthesis, i.e. artificial body members, parts thereof, or aids and accessories therefor
    • Y10S623/92—Method or apparatus for preparing or treating prosthetic
    • Y10S623/921—Blood vessel

Definitions

  • This invention relates to prostheses adapted to be placed in the human body, and to a process for manufacturing the same. More particularly, the invention is directed to prostheses formed of porous, non-absorbable fabric coated with collagen.
  • Tendon collagen fibril means a thread-like collagen structure derived from beef tendon that is round in cross section. These fibrils in the completely dehydrated state measure about 500 to 2000 Angstroms in diameter.
  • Swollen tendon collagen fibril means a collagen fibril derived from beef tendon that has been swollen in acid solution.
  • the diameters of swollen collagen fibrils range from less than 5000 Angstroms to about 90,000 Angstroms.
  • Monofilament means a single thread of oriented collagen fibrils as extruded through a single orifice in a spinnerette.
  • Multifilament means a group :of individual separate collagen monofilaments extruded through a spinnerette. Further details are provided in related copending application Serial No. 216,247, filed August 10, 1962, and in Example XII of U.S. Patent No. 3,114,372.
  • Strand means a group of collagen monofilaments that have been united to form a unitary structure.
  • Tape means a group of individual collagen monofilaments that have been united to form a unitary structure that is ribbon-like in shape.
  • Non-absorbable fibers means those fibers, synthetic or natural, which are not absorbed in an animal body, particularly a human body, when present therein over an extended period of time.
  • a non-absorbable fabric is a fabric formed of non-absorbable fibers.
  • Associations of collagen and non-absorbable fibers means a combination of collagen filaments or strands and one or more non-absorbable fibers, formed by iweaving, knitting, braiding, crocheting, etc. the filaments or strands and fibers together into articles including tubes, which can be straight or Y-shaped.
  • tantalum gauze and inert fabrics have found considerable use, particularly in older patients who are recognized to have a reduced ability to rebuild tissue at the point of surgery. Tantalum gauze, however, has the undesirable property of work hardening and can curl up within the body, causing discomfort.
  • Inert fabric prostheses have the disadvantage that they do not become a part of the body tissue. During surgery, some surgeons have tried to overcome this disadvantage by knotting catgut sutures randomly throughout the fabric prosthesis. However, this does not result in a uniformly integrated fabric prosthesis. Many intert fabric inserts frequently remain surrounded by a pool of sera after the healing process.
  • a suitable prosthesis for strengthening the repair should be non-toxic, flexible and porous. The ideal prosthesis should retain its strength permanently in intimate contact with 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.
  • a primary object of the invention is to provide a porous, non-absorbable fabric compatible with an animal body, and coated with collagen.
  • a further object is to provide a porous, non-absorbable fabric which is coated with collagen and the pores of which are free of collagen.
  • Another object is the provision of prostheses comprised of the fabric so coated with collagen and promoting the growth of body tissue into and through the prostheses during the healing process.
  • Still another object is the provision of a process for manufacturing the prostheses of this invention. And another object is the provision of a process for pretreating the fabric in the manufacture of the prostheses.
  • an improved prostheses comprised of a porous, non-absorbable fabric coated with collagen, the pores of the fabric being free of collagen. It is an essential feature of the new prostheses that the pores thereof are open and not rendered blood tight by collagen fibrils. In this regard, they are distinct fromthose described by Artandi and Bechtol in related application Serial No. 92,620, filed March 1, 1961 (now abandoned), and application Serial No. 495,010 filed September 22, 1965.
  • the prostheses of this invention are formed by knitting, weaving, braiding, crocheting, etc. non-absorbable fibers into the shape or form desired.
  • the fibers are not absorbed by an animal body, as the human body, when present therein over extended time intervals, such as a decade.
  • Suitable materials are Vinyon-N, a resin manufactured by the Carbide and Carbon Corporation by copolymerizing vinyl chloride and acrylonitrile; Saran, a vinyl chloride polymer manufactured by the Dow Chemical Company; nylon, a polyamide resin made by polymerization of the hexamethylene diamine salt of adipic acid; Orlon, a synthetic fiber made from polyacrylonitrile; Dacron, a synthetic fiber made from terephthalic acid and ethylene glycol; Teflon, a tetrafluoroethylene polymer; polyolefins such as polyethylene and polypropylene; cotton and silk.
  • Nylon, Orlon, Dacron and Teflon are products of the E. I. du Pont de Nemours 8: Co. Preferred herein are Dacron, Teflon and polyolefins.
  • non-absorbable fibers used herein can be knitted, woven, braided, crocheted, etc. into forms suitable for porous implants, in any manner known in the art, since such does not form a part of this invention.
  • Collagen used herein to coat the non-absorbable fabric corresponds to the type of connective tissue normally laid down by the body during the healing process.
  • the collagen coating serves as a stimulus for body response during the post-operative period.
  • the porous character of the fabric allows for rapid in-growth of fibroblasts and endothelial cells. All such features combine in concert to make possible rapid and satisfactory attachment of the prosthesis to the host tissues.
  • Collagen can be prepared as described in United States Patent No. 2,920,000 of H. R. Hoohstadt and E. R. Lieberman. Since it is diflicult to prepare a collagen dispersion containing more than 2 percent collagen because of ex tremely high viscosities of more concentrated dispersions, the collagen dispersions used in this invention generally contain from 0.1 to 2 percent by weight of collagen.
  • the vehicle or liquid containing collagen can be one of a wide variety of materials, including: alcohols such as methanol; aqueous solutions of perfluoroacids, as shown in US. Patent Nos. 2,919,998 and 2,919,999; and aqueous cyanoacetic acid. Particularly preferred herein are collagen dispersions in a mixture of methanol and aqueous cyanoacetic acid.
  • the non-absorbable fabric as in film or mesh form, can be coated with collagen by a number of techniques.
  • the fabric can be immersed in a collagen dispersion for a suitable period of time, and the fabric can then be removed and allowed to drain and dry. Collagen is neutralized after the coated fabric is dry.
  • a dispersion of collagen can be sprayed onto the fabric, followed by draining of the sprayed fabric.
  • the fabric When the fabric is immersed in a collagen dispersion, the fabric is coated with collagen and is thereafter treated to remove collagen present in the pores thereof. This is accomplished advantageously by directing a stream of inert gas against the coated fabric, particularly through the coated fabric. The stream is so adjusted that collagen held in the pores of the coated fabric is removed, while collagen coating the fabric structure is retained. There is little danger that the collagen coat will be removed from the fabric, since a relatively strong bonding of collagen and the fabric obtains.
  • inert gases useful herein are air, nitrogen, and carbon dioxide. Since air is inexpensive and advantageous, it is preferred.
  • a fabric treated with collagen can be dried and then perforated to remove collagen from the pores thereof.
  • Temperatures of the impregnation step, draining (if such is used), neutralization and removal of collagen from the pores, are generally below about C. in each operation to avoid extensive degradation of collagen. Preferred for each operation are temperatures below about 25 C.
  • tanning agents for use with collagen can be used herein. Chromium, formaldehyde, polyhydroxyphenols, etc. can be used alone or in combination. Particularly preferred, however, are the tanning procedures described in related applications Serial Numbers 85,289 and 85,302, both filed January 27, 1961.
  • Solvents falling within category (A) include water and dilute aqueous solutions containing a detergent, among which are sulfates such as sodium lauryl sulfate, sulfonates such as sodium dodecyl benzene sulfonate, phosphates such as sodium tripolyphosphate, polyoxyalkylene derivatives of a hydroxy compound such as a condensate of 1 mol of nonyl phenol with 9 mols of ethylene oxide, quarternary ammonium compounds such as cetyltrimethylammonium chloride, etc.
  • a detergent among which are sulfates such as sodium lauryl sulfate, sulfonates such as sodium dodecyl benzene sulfonate, phosphates such as sodium tripolyphosphate, polyoxyalkylene derivatives of a hydroxy compound such as a condensate of 1 mol of nonyl phenol with 9 mols of ethylene oxide, quarternary am
  • solvents (B) are: alcohols, typified by methyl, ethyl, n-propyl, isopropyl, n-butyl, secondaryand tertiary-butyl, etc.; ketones, typified by acetone, methyl ethyl, methyl n-propyl, diethyl, etc.; ethers, typified by dimethyl, diethyl, ethyl methyl, etc.
  • Pretreatment is conducted at temperatures from about C. to about 100 C., for time intervals ranging from about 60 minutes to about 1 minute with each solvent, (A) and (B); preferred conditions are the approximate ranges of 6070 C., for 10-5 minutes.
  • Example I 4.33 grams of Dacron mesh (40 denier multifilament Dacron 12.5 inch square) was immersed in a gel prepared by diluting a collagen dispersion comprising 0.8 part of collagen, 0.4 part cyanoacetic acid, 49.4 parts water and 49.4 parts of methyl alcohol with an equal volume of methyl alcohol at room temperature (20 C.). The mesh was removed from the dispersion and allowed to drain vertically for about five minutes at room temperature. Compressed air was blown through the mesh to remove any collagenous film remaining across the interstices. If the orifice pressure is about 20 lbs. and the orifice is 4 mm. in diameter, a distance of approximately 3" between the orifice and the mesh is advantageous. Using the same orifice at 35 lbs.
  • Example II A piece of Dacron mesh (the same size and Weight as in Example I) was washed successively with 100 parts of hot water (60 C.), with 100 parts of isopropyl alcohol (25 C.) and 100 parts of acetone (25 C.). It was then dried in the air. The dried mesh was placed in a stainless-steel, Teflon coated tray measuring 15" x 9" x /2" containing a A;" layer of collagen dispersion containing 0.8 part of collagen fibrils and 49.4 parts of methyl alcohol, and 49.4 parts of water and 0.4 part of cyanoacetic acid, and another A2" layer of the same dispersion was placed on top of the fabric. The collagen dispersions and mesh were in contact for 24 hours at 25 C.
  • the resulting laminate then was neutralized with 100 parts of 10 percent aqueous ammonia. It was tanned with 100 parts of formaldehyde (1 percent) and removed from the tray. Edges of the mesh were trimmed to remove excess collagen. The laminate was strong, uniform and very resistant to separation. These characteristics continued when the film was wet with water. Only very severe stretching or deformation freed an edge of the collagen from the Dacron mesh and, once freed, it resisted further delarnination.
  • Dacron and collagen are more firmly bound by virtue of the pretreatment of Dacron, than when the pretreatment is omitted. In fact, pretreated Dacron and collagen are more firmly bound than when brought together by any other technique.
  • a surgical prosthesis comprising:
  • said fibers being coated with collagen fibrils throughout their area of contact only, whereby the pores 5 of the fabric are open to the rapid ingrowth of body tissue through the prosthesis.
  • porous fabric is a synthetic material made from terephthalic acid and ethylene glycol.
  • porous fabric is a synthetic material made of a tetrafluoroethylene polymer.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Biomedical Technology (AREA)
  • Vascular Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Cardiology (AREA)
  • Chemical & Material Sciences (AREA)
  • Dermatology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Treatment And Processing Of Natural Fur Or Leather (AREA)
  • Treatments For Attaching Organic Compounds To Fibrous Goods (AREA)
  • Materials For Medical Uses (AREA)
  • Prostheses (AREA)
US244600A 1962-12-14 1962-12-14 Collagen coated fabric prosthesis Expired - Lifetime US3276448A (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
US244600A US3276448A (en) 1962-12-14 1962-12-14 Collagen coated fabric prosthesis
GB49207/63A GB1062876A (en) 1962-12-14 1963-12-12 Surgical prosthesis
SE13929/63A SE314159B (enrdf_load_stackoverflow) 1962-12-14 1963-12-13

Applications Claiming Priority (1)

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US244600A US3276448A (en) 1962-12-14 1962-12-14 Collagen coated fabric prosthesis

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US3276448A true US3276448A (en) 1966-10-04

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GB (1) GB1062876A (enrdf_load_stackoverflow)
SE (1) SE314159B (enrdf_load_stackoverflow)

Cited By (90)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3366440A (en) * 1964-11-03 1968-01-30 Ethicon Inc Process for manufacturing a collagen fabric-film laminate
US3400719A (en) * 1963-06-11 1968-09-10 Albert O.L.J. Eckhart Buddecke Plastic graft material and method of making same
US3443261A (en) * 1967-09-01 1969-05-13 Fmc Corp Prosthetic structures from microcrystalline collagen
US3463158A (en) * 1963-10-31 1969-08-26 American Cyanamid Co Polyglycolic acid prosthetic devices
US3649347A (en) * 1966-05-27 1972-03-14 Fmc Corp Shaped structures having a self-adherent coating of a water-insoluble ionizable salt of a collagen
US3896806A (en) * 1971-01-08 1975-07-29 Ceskoslovenska Akademie Ved Implant for directed infusion of biologically active substances
EP0000949A1 (en) * 1977-08-26 1979-03-07 Philip Nicholas Sawyer Cardiac and vascular prostheses and methods of making the same
US4329743A (en) * 1979-04-27 1982-05-18 College Of Medicine And Dentistry Of New Jersey Bio-absorbable composite tissue scaffold
US4361552A (en) * 1980-09-26 1982-11-30 Board Of Regents, The University Of Texas System Wound dressing
FR2510394A1 (fr) * 1981-07-30 1983-02-04 Ceraver Ligament ou tendon prothetique, et procedes de fabrication de ceux-ci
US4411027A (en) * 1979-04-27 1983-10-25 University Of Medicine And Dentistry Of New Jersey Bio-absorbable composite tissue scaffold
US4512761A (en) * 1981-08-14 1985-04-23 Bentley Laboratories, Inc. Body implantable connector
US4512038A (en) * 1979-04-27 1985-04-23 University Of Medicine And Dentistry Of New Jersey Bio-absorbable composite tissue scaffold
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US4629459A (en) * 1983-12-28 1986-12-16 Shiley Inc. Alternate stent covering for tissue valves
EP0206025A3 (en) * 1985-06-06 1988-03-02 Thomas Jefferson University Coating for prosthetic devices
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US4772285A (en) * 1984-05-09 1988-09-20 The Board Of Trustees Of The Leland Stanford Junior University Collagen coated soft tissue prostheses
US4820626A (en) * 1985-06-06 1989-04-11 Thomas Jefferson University Method of treating a synthetic or naturally occuring surface with microvascular endothelial cells, and the treated surface itself
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US8460691B2 (en) 2010-04-23 2013-06-11 Warsaw Orthopedic, Inc. Fenestrated wound repair scaffold
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US9242026B2 (en) 2008-06-27 2016-01-26 Sofradim Production Biosynthetic implant for soft tissue repair
US9308068B2 (en) 2007-12-03 2016-04-12 Sofradim Production Implant for parastomal hernia
US9445883B2 (en) 2011-12-29 2016-09-20 Sofradim Production Barbed prosthetic knit and hernia repair mesh made therefrom as well as process for making said prosthetic knit
US9499927B2 (en) 2012-09-25 2016-11-22 Sofradim Production Method for producing a prosthesis for reinforcing the abdominal wall
US9510927B2 (en) 2012-06-28 2016-12-06 Sofradim Production Method of making a knit with barbs
US9526603B2 (en) 2011-09-30 2016-12-27 Covidien Lp Reversible stiffening of light weight mesh
US9554887B2 (en) 2011-03-16 2017-01-31 Sofradim Production Prosthesis comprising a three-dimensional and openworked knit
US9622843B2 (en) 2011-07-13 2017-04-18 Sofradim Production Umbilical hernia prosthesis
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US9750837B2 (en) 2012-09-25 2017-09-05 Sofradim Production Haemostatic patch and method of preparation
US9801705B2 (en) 2012-06-29 2017-10-31 Sofradim Production Hernia prosthesis
US9839505B2 (en) 2012-09-25 2017-12-12 Sofradim Production Prosthesis comprising a mesh and a strengthening means
US9877820B2 (en) 2014-09-29 2018-01-30 Sofradim Production Textile-based prosthesis for treatment of inguinal hernia
US9932695B2 (en) 2014-12-05 2018-04-03 Sofradim Production Prosthetic porous knit
US9931198B2 (en) 2015-04-24 2018-04-03 Sofradim Production Prosthesis for supporting a breast structure
US9980802B2 (en) 2011-07-13 2018-05-29 Sofradim Production Umbilical hernia prosthesis
US10076395B2 (en) 2010-07-16 2018-09-18 Sofradim Production Prosthesis having a radiopaque element
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US10159555B2 (en) 2012-09-28 2018-12-25 Sofradim Production Packaging for a hernia repair device
US10184032B2 (en) 2015-02-17 2019-01-22 Sofradim Production Method for preparing a chitosan-based matrix comprising a fiber reinforcement member
US10206769B2 (en) 2012-03-30 2019-02-19 Covidien Lp Implantable devices including a film providing folding characteristics
US10213283B2 (en) 2013-06-07 2019-02-26 Sofradim Production Textile-based prosthesis for laparoscopic surgery
US10327882B2 (en) 2014-09-29 2019-06-25 Sofradim Production Whale concept—folding mesh for TIPP procedure for inguinal hernia
US10363690B2 (en) 2012-08-02 2019-07-30 Sofradim Production Method for preparing a chitosan-based porous layer
US10405960B2 (en) 2013-06-07 2019-09-10 Sofradim Production Textile-based prothesis for laparoscopic surgery
US10549015B2 (en) 2014-09-24 2020-02-04 Sofradim Production Method for preparing an anti-adhesion barrier film
US10576187B2 (en) 2016-03-15 2020-03-03 University of Pittsburgh—of the Commonwealth System of Higher Education Layer by layer coated mesh for local release of bio-active proteins
US10646321B2 (en) 2016-01-25 2020-05-12 Sofradim Production Prosthesis for hernia repair
US10675137B2 (en) 2017-05-02 2020-06-09 Sofradim Production Prosthesis for inguinal hernia repair
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US10743976B2 (en) 2015-06-19 2020-08-18 Sofradim Production Synthetic prosthesis comprising a knit and a non porous film and method for forming same
US10865505B2 (en) 2009-09-04 2020-12-15 Sofradim Production Gripping fabric coated with a bioresorbable impenetrable layer
CN113481644A (zh) * 2021-06-03 2021-10-08 王剑 一种吸湿隔热烫金面料及其制备方法
US11471257B2 (en) 2018-11-16 2022-10-18 Sofradim Production Implants suitable for soft tissue repair
US12064330B2 (en) 2020-04-28 2024-08-20 Covidien Lp Implantable prothesis for minimally invasive hernia repair

Families Citing this family (2)

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CN116271259B (zh) * 2023-03-22 2025-07-25 苏州大学 一种复合丝素蛋白的改性涤纶血管支架覆膜及其制备方法

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