US3562820A - Tubular sheet and strip form prostheses on a basis of biological tissue - Google Patents

Tubular sheet and strip form prostheses on a basis of biological tissue Download PDF

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Publication number
US3562820A
US3562820A US661900A US3562820DA US3562820A US 3562820 A US3562820 A US 3562820A US 661900 A US661900 A US 661900A US 3562820D A US3562820D A US 3562820DA US 3562820 A US3562820 A US 3562820A
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United States
Prior art keywords
tissue
prostheses
prosthesis
layers
biological tissue
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US661900A
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English (en)
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Bernhard Braun
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Classifications

    • 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
    • A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
    • A61L27/3604—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
    • A61L27/3629—Intestinal tissue, e.g. small intestinal submucosa
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • 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
    • A61L27/14—Macromolecular materials
    • A61L27/22—Polypeptides or derivatives thereof, e.g. degradation products
    • A61L27/24—Collagen
    • 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
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A61F2310/00365—Proteins; Polypeptides; Degradation products thereof
    • 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
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/13—Hollow or container type article [e.g., tube, vase, etc.]
    • Y10T428/1348—Cellular material derived from plant or animal source [e.g., wood, cotton, wool, leather, etc.]

Definitions

  • the prosthesis itself comprises a unitary structure of alternating layers of natural tissue and collagen fibres.
  • the same is manufactured by applying a strip, sheet or tube of biological material onto a substantially rigid support, coating the exposed surface with a binder paste, as for example, a collagen fibre paste, or bringing about the swelling of the exposed surface, thereafter applying a second layer of natural material and repeating the procedure until the desired Wall thickness is obtained.
  • the multi-layer prosthesis is then dried and removed from the underlying support.
  • the invention described herein relates to tubular, strip and sheet form prostheses on a basis of biological tissue and to methods for manufacturing and using the same. More particularly this invention relates to a multi-layer prosthesis on a basis of biological tissue.
  • the prostheses of the invention are suitable for use as vascular, esophagus, bronchus, intestinal, ureter and cardiac valve prostheses and as other corrective parts of various organs such as liver.
  • the present invention overcomes the difficulties above mentioned and provides a prosthetic device for use in the replacement, repair and strengthening of living organs superior in effectiveness to anything previously known.
  • One of the objects of the invention is the provision of a prosthesis that is created from biological tissue which does not undergo deterioration after installation even after prolonged periods.
  • Another object is the provision of a prosthesis that is created from biological tissue that will allow for and facilitate tissue growth and organ regeneration at the site of installation.
  • a further object is the provision of a prosthesis that is created from biological tissue which can be simply and effectively installed using the conventional techniques.
  • Still a further object of the invention is the provision of a method by which such a prosthesis on a basis of biological tissue can be formed.
  • FIG. 1 is a longitudinal central section through an embodiment of a prosthesis in accordance with the invention
  • FIG. 2 is a diagrammatic view illustrating the method of forming the prosthesis of FIG. 1;
  • FIGS. 3 and 4 are diagrammatic perspective views illustrating two somewhat different forms of the prostheses embodying the invention.
  • a prosthesis in tubular, sheet or strip form which comprises at least two layers of biological tissue intimately joined and dried. More specific-ally the prosthesis comprises alternating layers of biological tissue and collagen fibers intimately joined and dried.
  • the biological prostheses are manufactured by placing over, i.e., applying onto the surface of a firm support a piece of tubular, sheet or strip form biological tissue, causing the exposed surface thereof to swell so as to produce thereon an adhesive or glue like effect and/ or the exposed surface is coated with a binder or bonding agent as for example a collagen fiber paste, a second piece of biological tissue is then applied to the first and the procedure repeated until a multi-layered structure of the desired wall thickness is obtained. The prosthesis is then dried and removed from the support.
  • a binder or bonding agent as for example a collagen fiber paste
  • the submucosa As natural tissue for use in the manufacture of the prostheses of the invention there are suitable in particular the submucosa, which can be obtained in pure form from the small intestine of sheep, goats and other animals, and the so-called goldbeaters skin, which is made up of the serosa taken from the intestines of cattle.
  • the submucosa which is obtained in the form of a fine, but high strength tube, is composed of diagonally disposed collagen fibres.
  • the mucosa and muscular tissue still adhering to the submucosa can easily be removed by the process as conventionally used in the manufacture of catgut.
  • the collagen fibre paste may be prepared, for example, by the process described in German patent specification No. 659,490. Furthermore, this layer of collagen fibres ensures that any holes, tears, and the like made in the tissue during the manufacture thereof, during the operation for installing the same, or a later time, will close easily. This can prevent hemorrhage, which hitherto has been highly dangerous.
  • the collagen fibre paste has a further advantage in that therapeutic substances may be incorporated therein. Thus, for example, heparin may be added to inhibit the clotting of blood, cartilage powder or chondroitin sulfate included to stimulate the formation of new collagen fibres for the vascular intima, as Well as other therapeutic substances.
  • a tubular core or a plate made of glass or a synthetic material as the firm, more or less rigid support.
  • synthetic materials include polyolefins as for example polyethylene or polypropylene etc.
  • any inert fairly firm material may be employed.
  • a lubricant as for example, glycerol or a silicone oil.
  • the tissue is then coated with a binder paste, preferably a collagen fibre paste, and, if necessary, the paste is allowed to dry slightly. Another piece of tissue is then applied, and the process is repeated until the desired thickness is obtained.
  • the finished prosthesis may contain, for example, about eight layers of tissue. The number of layers is generally determined by the thickness of the composite layers and by the ultimate use.
  • the prosthesis made by the process of the invention may be subjected to a hardening process to prevent premature absorption by the body tissues.
  • hardening agents there may be used physiologically acceptable vegetable or synthetic substances or, as for example, aldehydes. Instances of aldehydes that are suitable for this purpose are formaldehyde, glutardialdehyde and aldehydes of higher polyhydroxy compounds. The concentration of the hardening agent may be varied to produce the rate of absorption required.
  • fascia prostheses are obtained which are generally known as patches and which may be used to close defects in the tympanic membrane and the heart wall, for hollow-walled organs or as heart valves.
  • collagen patches in sheet form are also used to repair damage to parenchymatous soft tissue, for example, in the liver, kidney, spleen and pancreas. This can be effected in the following manner:
  • a so-called mattress suture is made, i.e., a large atrau matic needle threaded with a soft suture is passed through the parenchymatous tissue on one side of the wound and out of the other side.
  • the needle is then passed through a stiffened and perforated collagen patch from underneath.
  • the needle is then passed back through an adjacent perforation in the collagen patch at an appropriate distance from the point at which it emerged, through the organ and out the other side.
  • the length of the suture should be such that a second perforated collagen patch may be threaded onto the two ends. When the needle has been removed, the two ends of the suture are knotted together over the collagen patch.
  • Strips for surgical purposes may also be cut from sheets, i.e., membranes of the same material.
  • Tubular, flat or fluted prostheses may also be made by the process of the invention in addition to membranes and strips.
  • the tubular prostheses may be of uniform diameter throughout their length or their diameter may be widened or narrowed conically.
  • a tube made of synthetic material as, for example, a tube made of polyethylene or polypropylene and which has been provided with a plurality of threads 2 is thoroughly cleaned and, if necessary, treated with a silicone oil.
  • the submucosa 3 is thus provided with a thread 2' and is of a standardized size.
  • tissue is then coated with a binder paste, preferably a collagen fibre paste, the paste is allowed to dry slightly, and then another tube of tissue is drawn over the first one.
  • a synthetic filament is wound round it as before and the tissue is dried. This procedure may be repeated until the desired thickness of wall is obtained.
  • the multiple layers of tissue are firmly cemented together by the binder.
  • the threaded tube of tissue so obtained has the necessary strength, density and elasticity required of vascular prostheses, and it can be sutured and is puncture-proof.
  • the thread with which it is provided prevents it from kinking when it is moved after implantation in the host, thereby permitting an unhindered flow of blood. It is also extensible.
  • a smooth tubular prosthesis that is to say, without any thread or fluting, for example, as used for prosthetic repair of the cystic duct, the ureter, the esophagus or, in special cases, blood vessels
  • the same procedure as with the screw-threaded plastic tube may be followed, but without winding a filament round the tissue or allowing it to conform to the shape of the thread.
  • the elastic tube of tissue is drawn over the plastic tube and held taut over it by tying the tissue tube at both ends and allowing it to conform to the outer circumference of the plastic tube without complementing the shape of the thread.
  • a smooth plastic tube may be used as a support, for the layers of tissue.
  • Prostheses for example, for the esophagus, trachea and intestine, can be made by the process described above, with due regard to anatomical requirements, diameter and thickness of wall.
  • the strength of such prostheses can be considerably increased by placing layers of synthetic or natural tissue or even metallic clasps or spirals between the layers making up the actual prosthesis.
  • the synthetic tissue used may be made, for example, from polyamide or polyester fibres.
  • the natural tissue may be, for example, biological tissue, for exam ple, serosa tissue, or material made from natural fibres.
  • the serosa tissue may be wound round the prosthesis diagonally, first from left to right and then from right to left. If necessary, these layers of tissue may be pretreated, as for example, by stretching.
  • the process has a negative effect on the physical properties of the collagen fibre and neutralization is generally necessary afterwards, followed by washing out of the salts formed during neutralization.
  • Sterilization of the prostheses so obtained may be elfected by gamma-radiation, which process also reduces the antigenic properties of the collagen.
  • FIGS. 3 and 4 there are shown two somewhat ditferent forms of the prostheses in accordance with the invention.
  • FIG. 3 the embodiment comprising alternating layers of biological tissue 7 bonded together with a bond ing agent 8 is shown and in FIG. 4 the embodiment wherein the bonding is effected by swelling the layers 7 is set out.
  • the prostheses in accordance with the invention has been subjected to trial and has been observed and evaluated as a suitability, production of toxic symptoms, decomposition, detachment, secondary reactions such as abnormal tissue growth, etc.
  • the trials consisted in surgical implantation of the prostheses in otherwise normal animals, i.e., the requirement for the prostheses was surgically induced, observation of the thusly treated animals during the recovery period and for varying periods thereafter. During this time, numerous test procedures were carried out, the same including chemical, X-ray, electrocardiographic, etc., procedures. At the end of various predetermined time intervals certain of the animals were sacrificed and any of the animals possibly involved organs examined both microscopically and macroscopically. In every instance, the results of procedures and tests in both the living and sacrificed animals established the safety and suitability of the prosthetic devices for replacement and repair of damaged organs. It is to be noted that as experimental animals, there were employed cats, dogs and monkeys.
  • the device has been surgically implanted in human subjects, in each case where the subjects condition was indicative of such treatment. Almost all of the subjects are still under observation and to date there have not been observed any untoward results or happenings directly associated with the use of the herein disclosed prosthetic devices.
  • a tubular prosthetic device on a basis of biological tissue comprising at least two superimposed layers consisting of tubes of natural tissue applied in their natural tubular form prepared from the submucous layers of intestines of mammals, and said layers being bonded together by means of collagen fibers.
  • a prosthetic device according to claim 1 wherein said collagen fibres consist of a collagen fiber paste.
  • a prosthetic device according to claim 1 wherein at least one of said layers is a prehardened layer which has been prehardened by contacting the same with a hardening agent.
  • a prosthetic device according to claim 3 wherein said hardening agent is an aldehyde.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Veterinary Medicine (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Transplantation (AREA)
  • Dermatology (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Molecular Biology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Botany (AREA)
  • Zoology (AREA)
  • Urology & Nephrology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Pulmonology (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Biophysics (AREA)
  • Materials For Medical Uses (AREA)
  • Prostheses (AREA)
US661900A 1966-08-22 1967-08-21 Tubular sheet and strip form prostheses on a basis of biological tissue Expired - Lifetime US3562820A (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
AT795866A AT261800B (de) 1966-08-22 1966-08-22 Verfahren zur Herstellung von röhrenförmigen, glatten bzw. mit einem Gewinde versehenen Gewebe-Blutgefäß-Prothesen

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US3562820A true US3562820A (en) 1971-02-16

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AT (1) AT261800B (de)
DE (1) DE1617330B1 (de)
GB (1) GB1195992A (de)

Cited By (201)

* Cited by examiner, † Cited by third party
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AT261800B (de) 1968-05-10
GB1195992A (en) 1970-06-24

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