WO1987007153A1 - Article hemostatique composite comprenant une couche d'agent hemostatique et procedes de preparation dudit article - Google Patents

Article hemostatique composite comprenant une couche d'agent hemostatique et procedes de preparation dudit article Download PDF

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Publication number
WO1987007153A1
WO1987007153A1 PCT/US1986/001134 US8601134W WO8707153A1 WO 1987007153 A1 WO1987007153 A1 WO 1987007153A1 US 8601134 W US8601134 W US 8601134W WO 8707153 A1 WO8707153 A1 WO 8707153A1
Authority
WO
WIPO (PCT)
Prior art keywords
hemostatic
agent
porous body
article
hemostatic agent
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.)
Ceased
Application number
PCT/US1986/001134
Other languages
English (en)
Inventor
Philip N. Sawyer
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.)
Interface Biomedical Laboratories Corp
Original Assignee
Interface Biomedical Laboratories 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 Interface Biomedical Laboratories Corp filed Critical Interface Biomedical Laboratories Corp
Priority to PCT/US1986/001134 priority Critical patent/WO1987007153A1/fr
Publication of WO1987007153A1 publication Critical patent/WO1987007153A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

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
    • A61L15/22—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
    • A61L15/32—Proteins, polypeptides; Degradation products or derivatives thereof, e.g. albumin, collagen, fibrin, gelatin
    • A61L15/325—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
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/00051—Accessories for dressings
    • A61F13/00063—Accessories for dressings comprising medicaments or additives, e.g. odor control, PH control, debriding, antimicrobic
    • 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
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/01—Non-adhesive bandages or dressings
    • A61F13/01034—Non-adhesive bandages or dressings characterised by a property
    • 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
    • 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
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/15—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
    • A61F13/84—Accessories, not otherwise provided for, for absorbent pads
    • A61F13/8405—Additives, e.g. for odour, disinfectant or pH control
    • 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
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F2013/00089—Wound bandages
    • A61F2013/00217—Wound bandages not adhering to the wound
    • 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
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F2013/00361—Plasters
    • A61F2013/00365—Plasters use
    • A61F2013/00463—Plasters use haemostatic
    • A61F2013/00472—Plasters use haemostatic with chemical means
    • 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
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F2013/00361—Plasters
    • A61F2013/00902—Plasters containing means
    • A61F2013/00927—Plasters containing means with biological activity, e.g. enzymes for debriding wounds or others, collagen or growth factors
    • 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

  • This invention relates to composite hemostatic articles and to methods of preparing the same.
  • a coating of a hemostatic agent to a porous body which is already impregnated with the same or a different hemostatic agent will have a number of advantages in clinical application over the hemostatic articles known previously.
  • the different porous materials in which hemostatic agents may be incorporated gauze, sponge, tissue, etc. — have different absorbencies and different effects on the healing rate of a wound to which the material may be applied.
  • the provision of a coating of a hemostatic agent which absorbs serum and plasma from an injured area on the surface of such materials will make the effects produced by use of the differing materials more uniform by mitigating any problems which may be encountered in dealing with a particular substrate in clinical use.
  • the hemostatic agent coating is more absorbent of serum and plasma from an injured area than is the material which it coats, the provision of such coating has been found to relieve pain in a patient more rapidly than will the materia without such coating.
  • a hemostatic agent as disclosed in my U.S. Patent 4,238,480 will have this effect.
  • the provision of a layer of hemostatic agent as a coat on the surface of a hemostatic material can have a comfort effect on a patient by acting as a cushion between the wound and the material.
  • a method comprising incorporating a first T hemostatic agent into a porous body to form a hemostatic material, preparing a second hemostatic agent with at least f portion thereof in liquid phase, affixing an onlay of said second hemostatic agent to said material by freezing the liquid portion of said second hemostatic agent to said material whereby to form an onlaid hemostatic article, and
  • the first and second hemostatic agents may be of the same or substantially the same chemical composition.
  • One or both ma preferably be prepared by modifying either a collagen or a
  • the hemostatic material is prepared by freezing the first hemostatic agent
  • the porous body may preferably be saturated with said first hemostatic agent.
  • the second hemostatic agent is prepared with at least a portion thereof in liquid phase by first freezing said secon
  • a hemostatic article and an apparatus for producing an improve hemostatic article prepared as indicated above.
  • Figs. 1-6 are schematic representations of a sequence o operations illustrating a method of the invention.
  • Fig. 7 is a diagrammatic view of an apparatus of the invention.
  • Fig. 8 is a diagrammatic view of another apparatus of the invention.
  • the hemostatic agent 2 is place in a vessel 4 in liquid phase.
  • the hemostatic agent may comprise a collagen substance or a collagen-like substance which has been modified by dissolving the substanc in water and modifying the thusly dissolved substance to render the surface charge thereof effectively more positive than prior to modification, in manners which are shown, for example, in my earlier Patent No. 4,238,430.
  • modified collagen or collagen-like substance may be prepared as taugh in said Patent 4,238,430 and may be freeze dried.
  • the thusl modified and freeze dried hemostatic agent may be dissolved in water for use as the hemostatic agent(s) of the present invention.
  • the hemostatic agent 2 in the vessel 4 may then be frozen into the solid phase.
  • Reference numeral 2 ' is used to designate the hemostatic agent in solid, as opposed to liquid, phase.
  • a porous body 6 incorporating a hemostatic agent 8 together form a hemostatic material 10 which is placed or prepared in a container 12.
  • the hemostatic agent 8 may be of the same or of substantially th same chemical composition as the hemostatic agent 2 shown in Fig. 1.
  • the hemostatic agent 8 may be prepared in accordance with the disclosure of, for example, U.S. Patent No. 4,238,480 by modifying a collagen or collagen-like substance by dissolving it in water and rendering the surface charge thereof effectively more positive than prior to modification.
  • Such hemostatic agent may be incorporated into a porous body such as, for example, a bandage, a small gauze sponge, a pad of surgical gauze, a laparotomy pad, a small sponge of natural or synthetic material or the like as shown, for example, in my earlier U.S. Patent No. 4,404,970.
  • the hemostatic agent 8 may be incorporated in the porous body by for example, freezing and drying or vacuum drying the agent in the porous body.
  • lyophilizer e.g., Vitrus model 100 SRC-7
  • lyophilizer e.g., Vitrus model 100 SRC-7
  • Gamma irradiation may be used for sterilization.
  • the following may alternatively be used for sterilization:
  • the porous body 6 will be saturated with hemostatic agent 8 in liquid phase.
  • the mixture of liquid hemostatic agent 8 porous body 6 may then be frozen as illustrated diagrammatically in Fig. 4.
  • Fig. 5 the frozen hemostatic materia 10 with hemostatic agent 8 incorporated thereinto is placed on top of frozen hemostatic agent 2 ' in vessel 4.
  • the surface of hemostatic agent 2' is melted (melted portion designated by reference numeral 2) by methods well known in the art.
  • the hemostatic agent 2 ' is then fused to the hemostatic material 10 by refreezing the melted portion 2 o hemostatic agent 2 ' to material 10.
  • the fused hemostatic material-hemostatic agent may then be freeze dried or vacuu dried to remove water from the resultant article.
  • Fig. 6 shows a completed freeze-dried composite article wherein th hemostatic agent 2 has been fused to the face of the hemostatic material 10 and subsequently freeze dried or vacuum dried.
  • the hemostatic agent 2 c be applied in liquid form to a strip of hemostatic material 28 by means, for example, of a spray applicator, indicated generally at reference numeral 20.
  • Spray applicator 20 comprises a vat 22 containing hemostatic agent 2 in liquid form.
  • the hemostatic agent may comprise from 0.25 to 1.5% of an aqueou solution of a collagen or collagen-like substance which has been modified to render the surface charge of such substance effectively more positive than prior to modification in accordance with the teachings of U.S. Patent 4,238,480.
  • the thickness of the onlay preferably is 2-3 mm.
  • the agent 2 is discharged through nozzle 26 to deposit a layer of said agen 27 onto strip 28.
  • Strip 28 comprises an already frozen, saturated mixture of hemostatic agent in, for example, a bandage. This preferably will be prepared in accordance wit the teachings of U.S. Patent No. 4,390,519 or U.S. Patent No 4,404,970.
  • a continuous layer of agent 2 may be deposited onto strip 28 by moving the strip relative to nozzle 26.
  • Valve 24 may be used for regulating the flow of hemostatic agent 2 through nozzle 26.
  • a liquid layer of hemostatic agent 2 which is deposited on strip 28 may then be fused to said strip by passing said strip through a freezer dryer as indicated diagrammatically at 30.
  • FIG. 8 An alternative apparatus for production of a continuous strip of a composite hemostatic article in accordance with the invention is shown in Fig. 8.
  • a strip of hemostatic material 46 comprising a frozen, saturated mixture of a hemostatic agent in a bandage is passed by a rotating cold wheel 42.
  • the wheel is rotated through a vessel 40 containing preferably 0.25 to 1.5% of an aqueous solution of hemostatic agent 2 which, for example, is prepared in accordance with the disclosure of U.S. Patent No. 4,238,480
  • the solution may alternatively comprise up to 10% of the agent 2.
  • the wheel comprises a liquid absorbent surface 44 which is a sponge or felt material or the like.
  • the sponge or felt material 44 of the surface picks up hemostatic agent from vessel 40 and brings it into contact with the surface o strip 46 where it is adsorbed by the surface of the frozen material, as shown at 48.
  • the strip of hemostatic material with an adsorbed layer of hemostatic agent is then advanced into a thin mouth, small volume, high energy, freeze dryer, as indicated diagrammatically at 50, to produce a composite bandage in a continuous strip.
  • Cutting means may also be supplied to cut the continuous strip into desired sizes.

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  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Materials Engineering (AREA)
  • Epidemiology (AREA)
  • Hematology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Dispersion Chemistry (AREA)
  • Materials For Medical Uses (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

On obtient un article hémostatique amélioré en faisant fusionner une couche d'agent hémostatique (27) sur un corps poreux (28), lequel est déjà imprégné par le même agent ou par un agent hémostatique différent. Le/les agent(s) hémostatique(s) (27) peut/peuvent comprendre du collagène ou une substance de type collagène, qu'on a modifiée en rendant sa charge en surface effectivement plus positive qu'avant la modification.
PCT/US1986/001134 1986-05-29 1986-05-29 Article hemostatique composite comprenant une couche d'agent hemostatique et procedes de preparation dudit article Ceased WO1987007153A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/US1986/001134 WO1987007153A1 (fr) 1986-05-29 1986-05-29 Article hemostatique composite comprenant une couche d'agent hemostatique et procedes de preparation dudit article

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US1986/001134 WO1987007153A1 (fr) 1986-05-29 1986-05-29 Article hemostatique composite comprenant une couche d'agent hemostatique et procedes de preparation dudit article

Publications (1)

Publication Number Publication Date
WO1987007153A1 true WO1987007153A1 (fr) 1987-12-03

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Country Status (1)

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Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2299026A (en) * 1938-02-23 1942-10-13 Carle J Merrill Method of and apparatus for coating paper
US3348964A (en) * 1964-05-01 1967-10-24 Minnesota Mining & Mfg Immersion coating of strip material
US3797453A (en) * 1970-08-21 1974-03-19 Afco Prod Inc Apparatus coating sheeted material with a tacky substance
US3818982A (en) * 1971-10-27 1974-06-25 Balzers Patent Beteilig Ag Device for cooling workpieces which are submitted to a vacuum treatment
US4051278A (en) * 1975-06-06 1977-09-27 Eastman Kodak Company Method for reducing mottle in coating a support with a liquid coating composition
US4233360A (en) * 1975-10-22 1980-11-11 Collagen Corporation Non-antigenic collagen and articles of manufacture
US4407787A (en) * 1980-10-03 1983-10-04 Dr. Ruhland Nachf. Gmbh Collagenous dressing
US4424208A (en) * 1982-01-11 1984-01-03 Collagen Corporation Collagen implant material and method for augmenting soft tissue
US4453939A (en) * 1981-02-16 1984-06-12 Hormon-Chemie Munchen Gmbh Composition for sealing and healing wounds

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2299026A (en) * 1938-02-23 1942-10-13 Carle J Merrill Method of and apparatus for coating paper
US3348964A (en) * 1964-05-01 1967-10-24 Minnesota Mining & Mfg Immersion coating of strip material
US3797453A (en) * 1970-08-21 1974-03-19 Afco Prod Inc Apparatus coating sheeted material with a tacky substance
US3818982A (en) * 1971-10-27 1974-06-25 Balzers Patent Beteilig Ag Device for cooling workpieces which are submitted to a vacuum treatment
US4051278A (en) * 1975-06-06 1977-09-27 Eastman Kodak Company Method for reducing mottle in coating a support with a liquid coating composition
US4233360A (en) * 1975-10-22 1980-11-11 Collagen Corporation Non-antigenic collagen and articles of manufacture
US4407787A (en) * 1980-10-03 1983-10-04 Dr. Ruhland Nachf. Gmbh Collagenous dressing
US4453939A (en) * 1981-02-16 1984-06-12 Hormon-Chemie Munchen Gmbh Composition for sealing and healing wounds
US4424208A (en) * 1982-01-11 1984-01-03 Collagen Corporation Collagen implant material and method for augmenting soft tissue

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