US3902497A - Body absorbable sponge and method of making - Google Patents

Body absorbable sponge and method of making Download PDF

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Publication number
US3902497A
US3902497A US454353A US45435374A US3902497A US 3902497 A US3902497 A US 3902497A US 454353 A US454353 A US 454353A US 45435374 A US45435374 A US 45435374A US 3902497 A US3902497 A US 3902497A
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United States
Prior art keywords
tissue
sponge
absorbable
polymer
absorbable polymer
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Expired - Lifetime
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US454353A
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English (en)
Inventor
Donald James Casey
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Wyeth Holdings LLC
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American Cyanamid Co
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Application filed by American Cyanamid Co filed Critical American Cyanamid Co
Priority to US454353A priority Critical patent/US3902497A/en
Priority to AR257766A priority patent/AR205109A1/es
Priority to CA219,627A priority patent/CA1045548A/en
Priority to GB6053/75A priority patent/GB1490425A/en
Priority to AU78222/75A priority patent/AU496185B2/en
Priority to IT8230/75A priority patent/IT1050278B/it
Priority to BR1268/75A priority patent/BR7531268A/pt
Priority to FR7509310A priority patent/FR2265412B1/fr
Priority to DE19752513159 priority patent/DE2513159A1/de
Priority to JP50035036A priority patent/JPS51116079A/ja
Application granted granted Critical
Publication of US3902497A publication Critical patent/US3902497A/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
    • 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
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/42—Use of materials characterised by their function or physical properties
    • A61L15/64—Use of materials characterised by their function or physical properties specially adapted to be resorbable inside the body
    • 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
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/42—Use of materials characterised by their function or physical properties
    • A61L15/425—Porous materials, e.g. foams or sponges
    • 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
    • A61L2400/00—Materials characterised by their function or physical properties
    • A61L2400/04—Materials for stopping bleeding

Definitions

  • ABSTRACT PP A conformable tissue absorbable surgical sponge is formed by dissolving a tissue absorbable polymer in 52 US. Cl 128/296; 260/25 E; 128/325 hexaflumoisopropyl alcohol or hexafluoroacetone [51] Int.
  • the sponge may be used to absorb blood or other liq- [56] References Cited uids during a surgical procedure or may be used as a UNITED STATES PATENTS hemostat and allowed to remam 1n aclos ed wound wlth the polymer belng absorbed by 11v1ng t1ssue. 3,297,033 l/l967 Schmitt et a1 Vietnamese 128/335.5 3,666,750 5/1972 Briskin et a1 128/325 6 Claims, 6 Drawing Figures PATENTEU SEP 2 YS SHEET 1 BF 3 PATENTS] SE?
  • Surgical sponges find many uses in which an absor bent sponge is desirable to soak up blood, serum, or other body fluids, which sponges are removed and discarded.
  • Cotton gauze sponges are used in many instances. When used internally, there is a problem of part of the sponge coming off and leaving threads or larger portions of the sponge in the wound. Concern over leaving a sponge in a patient complicates operating room practice and involves extremely rigorous counting procedures to insure that no sponge is accidentally left in a closed wound.
  • sutures and tieoffs can be used. In some instances it is highly desirable that additional methods of controlling bleeding be made available. More or less successful efforts have been made to se cure conformable hemostats which can be used to control bleeding and then left in the wound. The problem is well recognized and more acceptable devices are in constant demand.
  • U.S. Pat. No. 3,297,033, Schmitt and Polistina, Jan. 10, 1967, SURGICAL SUTURES discloses polyhydroxyacetic ester absorbable sutures.
  • the material is also called polyglycolic acid, and is disclosed as permitting small quantities of comonomers to be present, such as dl-lactic acid, its optically active forms, homologs and analogs.
  • a small quantity is recognized by the art as up to as shown by U.S. Pat. No. 2,668,162, Lowe, Feb. 2, 1954, PREPARATION OF HIGH MO LECULAR WEIGHT POLYHYDROXY-ACETIC ES- TER.
  • U.S. Pat. No. 3,783,093, Gallacher, Jan. 1, 1974, F1- BROUS POLYETHYLENE MATERIALS discloses a fibrillated material, mentioning poly(glycolic acid) among others, in which one resin is mixed and fibrillated with another, and one resin leached out to give the product, a web of oriented, interconnected direc tional fiber-like strands, membranes, ribbons, branched ribbons and fibrils. These can be used as bandages and for other medicalpurposes;
  • Example 15 shows 25 parts of poly(glycolic acid) and 75 parts of poly-(methyl methacrylate) leached with acetone.
  • an oxidized regenerated cellulose is available, as in a gelatin foam distributed in sheet form. Both of these are absorbable in tissues. Under some conditions, the gelatin foam causes bile cysts. It is desirably wetted with saline at the time of use.
  • a hemostat can be made by dissolving a tissue absorbable polymer in the very powerful solvents hexafluoroisopropyl alcohol or hexafluoroacetone sesquihydrate, preferably filtering the solution, freezing, and subliming off the solvent, yielding a sponge which is readily conformable to wound to pography, highly absorbent and versatile. It may be used in procedures in which the foam sponge is to be left in the wound and absorbed by body tissues and also sees great acceptance in sponges which are used to absorb blood, serum or other liquids with the sponge being removed and discarded. Because there is the ever present risk of part of the sponge falling off and being left in the wound or through inadvertence being closed in the wound, it is desirable that tissue absorbable sponges be used for general surgical use, wherever tissue may grow into the sponge.
  • a sponge should have high absorptive capacity, should absorb fluids, particularly blood, rapidly, should be strong enough to be readily handled in surgical procedures, and conformable enough that it fits into whatever topography and space that is available, and be soft enough so that it does not injure sensitive tissues.
  • the absorbability of the present sponges by the body reduces the risks from the inadvertent enclosure of portions of a hemostatic sponge in living tissue-because such portions are absorbed and removed by the tissue itself.
  • freeze drying is a well-known technique, it is usually drying of water from frozen compositions in which water is to be removed by sublimation; and the product is usually rather brittle and friable so that it is not readily conformable, and is easily broken.
  • the solvent which is removed by sublimation, is hexafluoroisopropyl alcohol or hexafluoroacetone sesquihydrate or a mixture of the two.
  • the residual foam is softer and more conformable than products usually secured from aqueous systems. It is, of course, not possible to use an aqueous system with the tissue absorbable polymer of this invention.
  • the polymers are not water soluble.
  • the absorbable sponge structure is more readily freed from other components than in a leach technique using a mixture of polymers in which one polymer is leached out, thus requiring elimination of not only the leached polymer, but also the leaching solvent.
  • freeze-drying sometimes implies an aqueous system
  • sublimation-drying is used in many places herein to accentuate that it is an organic solvent system which is being sublimed so that it could be called solvent-sublimation for sponge manufacture.
  • Products prepared in an aqueous system are generally friable. Using hexafluoroisopropyl alcohol or hexafiuoroacetone sesquihydrate as a solvent for polyglycolic acid, and other tissue absorbable compositions, yields a product which is readily flexible and tissue conformable.
  • homopolymeric polyglycolic acid is currently being used in sutures, has met with the approval of many government agencies in many countries, is commercially available, and is familiar to chemists, the present invention is primarily described in detail in relation to homopolymeric polyglycolic acid.
  • Polyglycolic acid containing up to of other units, such as lactic acid units, is considered within the term polyglycolic acid as used hereien unless specified as homopolymeric.
  • Other materials such as poly(N-acetyl-D-glucosamine) and polymers of 3-methyl-l ,4- dioxane-2,5-dione may be used.
  • Poly(N-acetyl-D- glycosamine) is described in US. Ser. No. 441,717, filed on or about Feb. I 1, 1974, Richard Carl Capozza, POLY( N-ACETYL-D-G LUCOSAMINE) PROD- UCTS.
  • the present invention is particularly useful with tissue absorbable polymers which are insoluble in common organic solvents.
  • the foam should conform to the surface of the tissue. Conformation comprises an assessment of the suppleness, resiliency, and foams ability to mimic the topography of the wound in such a fashion that there is a minimum gap between the tissue and the foam which minimizes air gaps and pools of liquid. If pools of liquid build up, whether of serum or blood, such pools may become sites for the growth of undesirable microorganisms, particularly for external dressings. If the foam conforms adequately to the surface of the wound, the bodys own defense mechanisms are effective up to the zone of contact with the foam, and bacterial contamination is minimized.
  • FIG. 1 shows a scanning electron microscope photomicrograph at 50 diameters magnification of the surface of a frozen and dried sample produced in accordance with Example 1.
  • FIG. 2 is a portion of the same structure at 300 diameters magnification.
  • FIG. 3 is a photomicrograph similar to FIG. 1 at 50 diameters magnification of the reverse side of the same structure.
  • FIG. 4 is the same surface as FIG. 3, but at 300 diameters magnification.
  • FIG. 5 is a razor cut cross section of the same sample as FIG. 1 at 50 diameters magnification.
  • FIG. 6 is the same razor cut cross section as FIG. 5 at 300 diameters magnification.
  • a scale on each photomicrograph shows relative sizes.
  • the polyglycolic acid forms ribbons and shows a fibrillar structure with the ribbons, sheets and fibers interconnected with many of the ribbons having considerable greater width than thickness.
  • the thickness in general is within the range of from about I to 5 microns.
  • the dried structure is spongy in character but resilient so as to be conformable to a wound surface and is not friable and brittle as are most frozen-dried solids in which the solids are dried from an aqueous system.
  • EXAMPLE 1 Polyglycolic Acid in Hexafluoroisopropyl Alcohol 10.3 Grams of low crystallinity homopolymeric polyglycolic acid was dissolved in ISO milliliters of hexa fluoroisopropyl alcohol by stirring at 36 to 37C. until solution resulted (about 3 hours). The resulting solution was freed from dust and inadvertent trace contaminants by filtration through a sintered glass filter, and transferred to a flat bottom dish. An additional milliliters of hexafluoroisopropyl alcohol was used to dilute the solution to about 4% concentration (wt/vol. The dish was surrounded by a solid carbon dioxideacetone mixture until the solution was solidly frozen.
  • the solvent free foam was placed in strippable packages, sterilized with 12% ethylene oxide in dichlorodifluoromethane and thus kept dry and sterile until time of use.
  • the foam As a hemostatic sponge, the foam conforms well to a wound and arrests the flow of blood immediately. The initial arresting of bleeding is largely mechanical. Blood then coagulates in the sponge. which both arrests the further flow of blood, and tends to hold the sponge in position.
  • the slices can be cut or broken into a size and shape adapted to cover a particular wound.
  • the foam is usable in a wound which is to be closed, such as, for example, on the surface of the liver with the foam being closed into the abdominal cavity, or it may be used on the surface of the body as protection, and allowed to remain until the wound is healed.
  • the foam may be used as an absorbent to absorb blood and other fluids at the site of a wound to dry the wound for subsequent suturing or closing as required by a particular surgical procedure.
  • the foam In test animals on sacrifice, the foam is found to be essentially absorbed within 90 days.
  • EXAMPLE 2 Polyglycolic Acid in Hexafluoroacetone Sesquihydrate 1.9 Grams of homopolymeric polyglycolic acid was dissolved in 45 ml. of hexafluoroacetone sesquihydrate by heating the mixture of 50C. with stirring for three hours, yielding a solution having a concentration of approximately 4.2% (wt./vol.). The solution was filtered through a sintered glass filter and transferred to a flat dish and the clear amber solution was set in a solid carbon dioxide-acetone mixture for about an hour until frozen completely solid.
  • the dish was then placed in a vacuum chamber and the hexafluoroacetone sesquihydrate was sublimed off at a reduced pressure of about 1 torr. After about 24 hours, the spongelike foam obtained was removed, sliced into Va inch thick slices, and again placed in a closed chamber evacuated at l torr. with heating to about 80C. for several days. The product was then essentially free from solvent. The slices were sealed in strippable packages, sterilized with ethylene oxide and kept dry until time for use, using techniques routinely employed for polyglycolic acid sutures.
  • the sponge was an effective absorbent for blood and served as an effective hemostat on wound surfaces.
  • the polymers herein described are named from the monomer or monomers from which the polymers can be considered as formed.
  • the key polymer, polyglycolic acid is so named whether made from glycolic acid or glycolide, even though the units in the chain could properly be described as glycolyl linkages.
  • such nomenclature is regarded as historically the most significant and the least ambiguous.
  • a method of making a hemostat comprising dissolving a tissue-absorbable polymer in hexafluoroisopropyl alcohol or hexafluoroacetone sesquihydrate, filtering to remove any insoluble contaminants, freezing the solution and subliming off the solvent, whereby an absorbable sponge structure is formed, which is essentially non-directional and is readily conformable to tissue surfaces.
  • tissue absorbable polymer comprises glycolic acid, having such a high glycolic acid content that it is insoluble in common organic solvents.
  • tissue absorbable polymer is homopolymeric polyglycolic acid.
  • a hemostatic surgical sponge of a tissue absorbable polymer comprising glycolic acid, having at least of the monomer units of glycolic acid, whereby it is insoluble in common organic solvents, in the form of a sheet having interconnected ribbons and ligaments of a single polymer which is essentially non-directional having a network of connecting elements, and which is sufficiently flexible to be readily conformable to a wound surface.
  • tissue absorbable polymer is homopolymeric polyglycolic acid.

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Materials Engineering (AREA)
  • Epidemiology (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Dispersion Chemistry (AREA)
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US454353A 1974-03-25 1974-03-25 Body absorbable sponge and method of making Expired - Lifetime US3902497A (en)

Priority Applications (10)

Application Number Priority Date Filing Date Title
US454353A US3902497A (en) 1974-03-25 1974-03-25 Body absorbable sponge and method of making
AR257766A AR205109A1 (es) 1974-03-25 1975-01-01 Un metodo para preparar un hemostato y el hemostato resultante
CA219,627A CA1045548A (en) 1974-03-25 1975-02-07 Tissue absorbable polymer sponge
GB6053/75A GB1490425A (en) 1974-03-25 1975-02-12 Surgical sponge
AU78222/75A AU496185B2 (en) 1974-03-25 1975-02-14 Sponge
IT8230/75A IT1050278B (it) 1974-03-25 1975-02-18 Procedimento per la produzione di spugne emostatiche e prodotto ottenuto
BR1268/75A BR7531268A (pt) 1974-03-25 1975-03-04 Processo para a producao de um hemostato e esponja cirurgica hemostatica
FR7509310A FR2265412B1 (fi) 1974-03-25 1975-03-25
DE19752513159 DE2513159A1 (de) 1974-03-25 1975-03-25 Blutstillende schwaemme und verfahren zu ihrer herstellung
JP50035036A JPS51116079A (en) 1974-03-25 1975-03-25 Tissueeabsorptive sponge and method of manufacturing same

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US454353A US3902497A (en) 1974-03-25 1974-03-25 Body absorbable sponge and method of making

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US3902497A true US3902497A (en) 1975-09-02

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US (1) US3902497A (fi)
JP (1) JPS51116079A (fi)
AR (1) AR205109A1 (fi)
BR (1) BR7531268A (fi)
CA (1) CA1045548A (fi)
DE (1) DE2513159A1 (fi)
FR (1) FR2265412B1 (fi)
GB (1) GB1490425A (fi)
IT (1) IT1050278B (fi)

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US4744365A (en) * 1986-07-17 1988-05-17 United States Surgical Corporation Two-phase compositions for absorbable surgical devices
US4840626A (en) * 1986-09-29 1989-06-20 Johnson & Johnson Patient Care, Inc. Heparin-containing adhesion prevention barrier and process
US4968317A (en) * 1987-01-13 1990-11-06 Toermaelae Pertti Surgical materials and devices
US5124103A (en) * 1984-03-06 1992-06-23 United States Surgical Corporation Two phase compositions for absorbable surgical devices
US5354290A (en) * 1989-05-31 1994-10-11 Kimberly-Clark Corporation Porous structure of an absorbent polymer
US5403870A (en) * 1989-05-31 1995-04-04 Kimberly-Clark Corporation Process for forming a porous particle of an absorbent polymer
US5403347A (en) * 1993-05-27 1995-04-04 United States Surgical Corporation Absorbable block copolymers and surgical articles fabricated therefrom
US5431679A (en) * 1994-03-10 1995-07-11 United States Surgical Corporation Absorbable block copolymers and surgical articles fabricated therefrom
US5475063A (en) * 1991-02-12 1995-12-12 United States Surgical Corporation Blends of glycolide and/or lactide polymers and caprolactone and/or trimethylene carbonate polymers and absorbable surgical devices made
US5502092A (en) * 1994-02-18 1996-03-26 Minnesota Mining And Manufacturing Company Biocompatible porous matrix of bioabsorbable material
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US5567612A (en) * 1986-11-20 1996-10-22 Massachusetts Institute Of Technology Genitourinary cell-matrix structure for implantation into a human and a method of making
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JPS61149160A (ja) * 1984-12-22 1986-07-07 株式会社　日本メデイカル・サプライ 生体分解吸収性スポンジ及びその製造法
DE4001833A1 (de) * 1990-01-23 1991-08-01 Juergen Dr Fischer Vorrichtung zur verhinderung von nachblutungen in knochenhohlraeume und beseitigung vorhandener fluessigkeitsvolumina
DE4034921C2 (de) * 1990-11-01 1994-09-08 Kulicke Werner Michael Prof Dr Verwendung eines Feuchtigkeit speichernden, watteförmigen Kunststoffs in Polsterungen und Matratzen

Citations (6)

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BR7531268A (pt) 1975-12-23
JPS51116079A (en) 1976-10-13
IT1050278B (it) 1981-03-10
AR205109A1 (es) 1976-04-05
FR2265412B1 (fi) 1978-10-06
FR2265412A1 (fi) 1975-10-24
AU7822275A (en) 1976-08-19
GB1490425A (en) 1977-11-02
CA1045548A (en) 1979-01-02
DE2513159A1 (de) 1975-10-09

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