WO2005062896A2 - Tissue dressing assemblies, systems, and methods formed from hydrophilic polymer sponge structures such as chistosan - Google Patents
Tissue dressing assemblies, systems, and methods formed from hydrophilic polymer sponge structures such as chistosan Download PDFInfo
- Publication number
- WO2005062896A2 WO2005062896A2 PCT/US2004/043147 US2004043147W WO2005062896A2 WO 2005062896 A2 WO2005062896 A2 WO 2005062896A2 US 2004043147 W US2004043147 W US 2004043147W WO 2005062896 A2 WO2005062896 A2 WO 2005062896A2
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- tissue
- tissue dressing
- hydrophilic polymer
- chitosan
- sponge structure
- Prior art date
Links
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
- A61F13/00—Bandages or dressings; Absorbent pads
- A61F13/02—Adhesive plasters or dressings
- A61F13/0276—Apparatus or processes for manufacturing adhesive dressings or bandages
-
- 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
-
- 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
- A61F13/00051—Accessories for dressings
- A61F13/00072—Packaging of dressings
- A61F13/00076—Packaging of adhesive dressings
- A61F13/0008—Packaging of adhesive dressings having means for facilitating the removal of the packaging and release liner
-
- 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
- A61F13/02—Adhesive plasters or dressings
-
- 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
- A61F13/02—Adhesive plasters or dressings
- A61F13/0203—Adhesive plasters or dressings having a fluid handling member
- A61F13/0213—Adhesive plasters or dressings having a fluid handling member the fluid handling member being a layer of hydrocoloid, gel forming material
-
- 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
- A61F13/02—Adhesive plasters or dressings
- A61F13/0246—Adhesive plasters or dressings characterised by the skin adhering layer
- A61F13/0253—Adhesive plasters or dressings characterised by the skin adhering layer characterized by the adhesive material
-
- 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
- A61F13/36—Surgical swabs, e.g. for absorbency or packing body cavities during surgery
-
- 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
- A61F15/00—Auxiliary appliances for wound dressings; Dispensing containers for dressings or bandages
-
- 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
- A61L15/28—Polysaccharides or their derivatives
-
- 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
-
- 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
- A61F2013/00089—Wound bandages
- A61F2013/00246—Wound bandages in a special way pervious to air or vapours
- A61F2013/00255—Wound bandages in a special way pervious to air or vapours with pores
-
- 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
- A61F2013/00314—Wound bandages with surface treatments
- A61F2013/00327—Wound bandages with surface treatments to create projections or depressions in surface
-
- 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
-
- 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
- A61F2013/00365—Plasters use
- A61F2013/0054—Plasters use for deep wounds
-
- 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
- A61F2013/00544—Plasters form or structure
- A61F2013/00582—Properties of backing
-
- 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
- A61F2013/00655—Plasters adhesive
- A61F2013/00676—Plasters adhesive hydrogel
-
- 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
- A61F2013/00655—Plasters adhesive
- A61F2013/00714—Plasters adhesive adhesives for mucosae
-
- 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
- A61F2013/00655—Plasters adhesive
- A61F2013/00719—Plasters adhesive adhesives for use on wounds
-
- 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
- A61F2013/00727—Plasters means for wound humidity control
- A61F2013/00731—Plasters means for wound humidity control with absorbing pads
- A61F2013/00744—Plasters means for wound humidity control with absorbing pads containing non-woven
-
- 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
- A61F2013/00855—Plasters pervious to air or vapours
- A61F2013/00863—Plasters pervious to air or vapours with pores
-
- 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
- A61F2013/00897—Plasters package for individual plaster
-
- 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
- A61F2013/0091—Plasters containing means with disinfecting or anaesthetics means, e.g. anti-mycrobic
-
- 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
- A61F2013/00931—Plasters containing means with biological activity, e.g. enzymes for debriding wounds or others, collagen or growth factors chitin
-
- 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
- the invention is generally directed to tissue dressings applied on a site of tissue injury, or tissue trauma, or tissue access to ameliorate bleeding, fluid seepage or weeping, or other forms of fluid loss, as well as provide a protective covering over the site.
- Background of the Invention The application of continuous pressure with gauze bandage remains a primary intervention technique used to stem blood flow, especially flow from severely bleeding wounds. However, this procedure neither effectively nor safely stanches severe blood flow. This has been, and continues to be, a major survival problem in the case of severe life- threatening bleeding from a wound.
- Hemostatic bandages such as collagen wound dressings or dry fibrin thrombin wound dressings or chitosan and chitosan dressings are available, such dressings are not sufficiently resistant to dissolution in high blood flow. They also do not possess enough adhesive properties to serve any practical purpose in the stanching of severe blood flow. These currently available surgical hemostatic bandages are also delicate and thus prone to failure should they be damaged by- bending or loading with pressure. They are also susceptible to dissolution in hemorrhagic bleeding. Such dissolution and collapse of these bandages may be catastrophic, because it can produce a loss of adhesion to the wound and allow bleeding to continue unabated. There remains a need for improved hemostatic dressings with robustness and longevity to resist dissolution during use.
- the invention provides tissue dressing assemblies, systems and methods formed from hydrophilic polymer sponge structures.
- the tissue dressing assemblies can be used, e.g., (i) to stanch, seal, or stabilize a site of tissue injury, tissue trauma, or tissue access; or (ii) to form an anti-microbial barrier; or (iii) to form an antiviral patch; or (iv) to intervene in a bleeding disorder; or (v) to release a therapeutic agent; or (vi) to treat a ucosal surface; or (vii) combinations thereof .
- the hydrophilic polymer sponge structure includes at least one of (i) micro-fracturing of a substantial portion of the structure by mechanical manipulation prior to use, or (ii) a surface relief pattern formed on a substantial portion of the structure prior to use, or (iii) a pattern of fluid inlet channels formed in a substantial portion of the structure prior to use.
- the tissue dressing assembly comprises at least one woven or non-woven or permeable membranous sheet present within the hydrophilic sponge structure.
- the tissue dressing assembly comprises an absorbent component secured to the hydrophilic sponge structure. The incorporation of one or more of these aspects imparts compliance, flexibility, and longevity to sponge structure.
- the hydrophilic polymer sponge structure includes a chitosan biomaterial .
- the hydrophilic polymer sponge structure is desirably densified by compression to a density of between 0.6 to 0.1 g/cm3.
- Fig. 1 is a perspective assembled view of a tissue dressing pad assembly that is capable of adhering to body tissue in the presence of blood, fluid, or moisture.
- Fig- 2 is a perspective exploded view of the tissue dressing pad assembly shown in Fig. 1.
- Fig. 3 is a perspective view of the tissue dressing pad assembly shown in Fig. 1 packaged in a sealed pouch for terminal irradiation and storage.
- Figs. 4 and 5 are perspective views of the sealed pouch shown in Fig. 3 being torn open to expose the tissue dressing pad assembly for use.
- Figs. 6 and 7 are perspective views of the tissue dressing pad assembly being held and manipulated by folding or bending prior to application to conform to the topology of a targeted tissue site.
- FIG. 8 to 10A/B are perspective views of the tissue dressing pad assembly being applied to a targeted tissue site to stanch bleeding.
- FIG. 11 is a perspective view of two tissue dressing pad assemblies being applied in an overlapping fashion to a targeted tissue site to stanch bleeding.
- Figs . 12 and 13 are perspective views of pieces of a tissue dressing pad assembly being cut and fitted to a targeted tissue site to stanch bleeding.
- Figs . 14 and 15 are perspective views of the tissue dressing pad assembly being held and manipulated by molding into a concave or cup shape to conform to a targeted tissue site.
- Fig. 16 is a diagrammatic view of the steps of a process for creating the tissue dressing pad assembly shown in Fig. 1.
- Fig. 16 is a diagrammatic view of the steps of a process for creating the tissue dressing pad assembly shown in Fig. 1.
- FIG. 17 is a partially diagrammatic view of a test fixture used to quantify acute adhesive and cohesive sealing properties of the tissue dressing pad assembly, shown in Fig. 1, in a simulated arterial wound environment .
- Figs. 18A to 18C are partially diagrammatic views showing the use of the test fixture in Fig. 17 being used to conduct a burst pressure test on a test sample of a tissue dressing pad assembly.
- Fig. 19 is a graph showing the difference in burst pressures, determined by use of the test fixture shown in Fig. 17, among hydrophilic polymer sponge structures manufactured at different freezing temperatures.
- Figs. 20, 21A/B, and 22A/B are perspective views of an embodiment of the steps for conditioning a hydrophilic polymer sponge structure to create micro-fractures, which provide improved flexibility and compliance.
- Figs. 23A and 23B are views of an embodiment of the steps for conditioning a hydrophilic polymer sponge structure by forming deep relief patterns, which provide improved flexibility and compliance.
- Figs. 24A to 24F are plane views of relief patterns that can be applied to condition a hydrophilic polymer sponge structure following the steps shown in Figs. 23A and 23B.
- Figs. 25A and 25B are graphs demonstrating the improvement in flexibility and compliance that the treatment steps shown in Figs. 23A and 23B can provide.
- Figs. 26A .and 26B are views of an embodiment of the steps for conditioning a hydrophilic polymer sponge structure by forming vertical channels (perforations) , which provide improved flexibility and compliance.
- Fig. 24A to 24F are plane views of relief patterns that can be applied to condition a hydrophilic polymer sponge structure following the steps shown in Figs. 23A and 23B.
- Figs. 25A and 25B are graphs demonstrating the improvement in flexibility and compliance that the treatment steps shown in
- FIG. 27 is a plane view of vertical (perforated) channels that can be applied to condition a hydrophilic polymer sponge structure following the steps shown in Figs. 26A and 26B.
- Fig. 28 is a graph demonstrating the improvement in flexibility and compliance that the treatment steps shown in Figs. 26A and 26B can provide.
- Fig. 29 is a perspective assembled view of a tissue dressing sheet assembly that is capable of adhering to body tissue in the presence of blood, fluid, or moisture.
- Fig. 30 is a perspective exploded view of the tissue dressing sheet assembly shown in Fig. 29.
- Fig. 31A is a perspective assembled view of tissue dressing sheet assemblies arranged in sheet form.
- Fig. 31B is a perspective assembled view of tissue dressing sheet assemblies arranged in roll form.
- FIG. 32 is a perspective view of the stuffing of a tissue dressing sheet assembly in roll form into a targeted tissue region to stanch bleeding.
- FIG. 33 is a diagrammatic view of the steps of a process for creating the tissue dressing sheet assembly shown in Fig. 29.
- Fig. 34 is a perspective view of the tissue dressing pad assembly shown in Fig. 29 packaged in a sealed pouch for terminal irradiation and storage.
- Fig. 35 is a graph demonstrating the flexibility and compliance of a tissue dressing sheet assembly, as shown in Fig. 29, compared to an untreated tissue dressing pad assembly shown in Fig. 1.
- Fig. 36A is a graph showing the simulated wound sealing characteristics of a tissue dressing sheet assembly, as shown in Fig. 29 prior to gamma-irradiation.
- Fig. 36A is a graph showing the simulated wound sealing characteristics of a tissue dressing sheet assembly, as shown in Fig. 29 prior to gamma-irradiation.
- Fig. 29 prior to gamma-
- FIG. 36B is a graph showing the simulated wound sealing characteristics of a tissue dressing sheet assembly, as shown in Fig. 29 before and after gamma- irradiation.
- Fig. 37 is a perspective assembled view of a composite tissue dressing assembly that is capable of adhering to body tissue in the presence of blood, fluid, or moisture.
- Fig. 38 is a perspective exploded view of the composite tissue dressing assembly shown in Fig. 37.
- Fig. 39 is a side section view of the composite tissue dressing assembly shown in Fig. 37.
- Fig. 40 is a perspective view of a composite tissue dressing assembly of the type shown in Fig. 37 that has been shaped and configured to form a gasket assembly to adhere about and seal an access site for an indwelling catheter.
- Fig. 37 is a perspective assembled view of a composite tissue dressing assembly that is capable of adhering to body tissue in the presence of blood, fluid, or moisture.
- Fig. 38 is a perspective exploded view of the composite tissue dressing assembly shown in
- Fig. 41 is a side section view of the gasket assembly shown in Fig. 40.
- Fig. 42 is a perspective view of a tissue dressing pad assembly of the type shown in Fig. 1 that has been shaped and configured to form a gasket assembly to adhere about and seal an access site for an indwelling catheter.
- Fig. 43 is a perspective view of a tissue dressing sheet assembly of the type shown in Fig. 29 that has been shaped and configured to form a gasket assembly to adhere about and seal an access site for an indwelling catheter.
- the Tissue Dressing Matrix 2. The Backing 3. The Pouch B. Use of the Tissue Dressing Pad Assembly Example 1
- FIG. 1 shows a tissue dressing pad assembly 10.
- the tissue dressing pad assembly 10 is capable of adhering to tissue in the presence of blood, or body fluids, or moisture.
- the tissue dressing pad assembly 10 can be used to stanch, seal, and/or stabilize a site of tissue injury, or tissue trauma, or tissue access (e.g., a catheter or feeding tube) against bleeding, fluid seepage or weeping, or other forms of fluid loss.
- the tissue site treated can comprise, e.g., arterial and/or venous bleeding, or a laceration, or an entrance/entry wound, or a tissue puncture, or a catheter access site, or a burn, or a suture.
- the tissue dressing pad assembly 10 can also desirably form an anti-bacterial and/or anti- microbial and/or anti-viral protective barrier at or surrounding the tissue treatment site.
- Fig. ' l shows the tissue dressing pad assembly 10 in its condition prior to use.
- the tissue dressing pad assembly 10 comprises a tissue dressing matrix 12 and a pad backing 14 that overlays one surface of the tissue dressing matrix 12.
- the tissue dressing matrix 12 and the backing 14 possess different colors, textures, or are otherwise visually and/or tactilely differentiated, to facilitate recognition by a caregiver.
- the size, shape, and configuration of the tissue dressing pad assembly 10 can vary according to its intended use.
- the pad assembly 10 can be rectilinear, elongated, square, round, oval, or a composite or complex combination thereof. Desirably, as will be described later, the shape, size, and configuration of pad assembly
- tissue dressing pad assembly ' 10 can be formed by cutting, bending, or molding, either during use or in advance of use.
- a representative configuration of the tissue dressing pad assembly ' 10 is shown that is very useful for the temporary control of external bleeding or fluid loss.
- its size is 10 cm x 10 cm x 0.55 cm. 1.
- the Tissue Dressing Matrix The tissue dressing matrix 12 is preferably formed from a low modulus hydrophilic polymer matrix, i.e., a inherently "uncompressed" tissue dressing matrix 12, which has been densified by a subsequent densification process, which will be described later.
- the tissue dressing matrix 12, preferably, includes a biocompatible material that reacts in the presence of blood, body fluid, or moisture to become a strong adhesive or glue.
- the tissue dressing matrix also possesses other beneficial attributes, for example, anti-bacterial and/or anti-microbial anti-viral characteristics, and/or characteristics that accelerate or otherwise enhance the body's defensive reaction to injury.
- the tissue dressing matrix 12 may comprise a hydrophilic polymer form, such as a polyacrylate, an alginate, chitosan, a hydrophilic polya ine, a chitosan derivative, polylysine, polyethylene imine, xanthan, carrageenan, quaternary ammonium polymer, chondroitin sulfate, a starch, a modified cellulosic polymer, a dextran, hyaluronan or combinations thereof.
- a hydrophilic polymer form such as a polyacrylate, an alginate, chitosan, a hydrophilic polya ine, a chitosan derivative, polylysine, polyethylene imine, xanthan, carrageenan, quaternary ammonium polymer
- the starch may be of amylase, amylopectin and a combination of amylopectin and amylase.
- the biocompatible material of the matrix 12 comprises a non-mammalian material, which is most preferably poly [ ⁇ - (1 ⁇ 4) -2-amino-
- the chitosan selected for the matrix 12 preferably has a weight average molecular weight of at least about 100 kDa, and more preferably, of at least about 150 kDa. Most preferably, the chitosan has a weight average molecular weight of at least about 300 kDa.
- the chitosan is desirably placed into solution with an acid, such as glutamic acid, lactic acid, formic acid, hydrochloric acid and/or acetic acid.
- hydrochloric acid and acetic acid are most preferred, because chitosan acetate salt and chitosan chloride salt resist dissolution in blood whereas chitosan lactate salt and chitosan glutamate salt do not.
- Larger molecular weight (Mw) anions disrupt the para-crystalline structure of the chitosan salt, causing a plasticization effect in the structure (enhanced flexibility) . Undesirably, they also provide for rapid dissolution of these larger Mw anion salts in blood.
- the matrix 12 comprises an "uncompressed" chitosan acetate matrix 12 of density less than 0.035 g/cm 3 that has been formed by freezing and lyophilizing a chitosan acetate solution, which is then densified by compression to a density of from 0.6 to 0.25 g/cm 3 , with a most preferred density of about 0.20 g/cm 3 .
- This chitosan matrix 12 can also be characterized as a compressed, hydrophilic sponge structure.
- the densified chitosan matrix 12 exhibits all of the above-described characteristics deemed to be desirable. It also possesses certain structural and mechanical benefits that lend robustness and longevity to the matrix during use, as will be described in greater detail later.
- the chitosan matrix 12 presents a robust, permeable, high specific surface area, positively charged surface.
- the positively charged surface creates a highly reactive surface for red blood cell and platelet interaction.
- Red blood cell membranes are negatively charged, and they are attracted to the chitosan matrix 12.
- the cellular membranes fuse to chitosan matrix 12 upon contact .
- a clot can be formed very quickly, circumventing immediate need for clotting proteins that are normally required for hemostasis. For this reason, the chitosan matrix 12 is effective for both normal as well as anti-coagulated individuals, and as well as persons having a coagulation disorder like hemophilia.
- the chitosan matrix 12 also binds bacteria, endotoxins, and microbes, and can kill bacteria, microbes, and/or viral agents on contact. Further details of the structure, composition, manufacture, and other technical features of the chitosan matrix 12 will be described later. 2.
- the tissue dressing pad assemble is sized and configured for manipulation by a caregiver's fingers and hand.
- the backing 14 isolates a caregiver's fingers and hand from the fluid-reactive chitosan matrix 12 (see, e.g., Fig. 8) .
- the backing 14 permits the chitosan matrix 12 to be handled, manipulated, and applied at the tissue site, without adhering or sticking to the caregiver's fingers or hand.
- the backing 14 can comprise low-modular meshes and/or films and/or weaves of synthetic and naturally occurring polymers .
- the backing 14 comprises a fluid impermeable polymeric material, e.g., polyethylene (3M 1774T polyethylene foam medical tape, 0.056 cm thick), although other comparable materials can be used.
- Other polymers suitable for backing use in temporary wound applications include, but are not limited to, cellulose polymers, polyethylene, polypropylene, metallocene polymers, polyurethanes , polyvinylchloride polymers, polyesters, polyamides or combinations thereof
- a resorbable backing may be used in hydrophilic sponge bandage forms.
- Synthetic biodegradable materials may include, but are not limited to, poly (glycolic acid), poly (lactic acid), poly(e- caprolactone) , poly ( ⁇ -hydroxybutyric acid), poly ( ⁇ - hydroxyvaleric acid), polydioxanone, poly (ethylene oxide), poly (malic acid), poly (tartronic acid), polyphosphazene, copolymers of polyethylene, copolymers of polypropylene, and the copolymers of the monomers used to synthesize the above-mentioned polymers or combinations thereof.
- Naturally occurring biodegradable polymers may include, but are not limited to, chitin, algin, starch, dextran, collagen and albumen. 3.
- the chitosan matrix 12 is desirably vacuum packaged before use with low moisture content, preferably 5% moisture or less, in an air-tight heat sealed foil-lined pouch 16.
- the tissue dressing pad assembly 10 is subsequently terminally sterilized within the pouch 16 by use of gamma irradiation.
- the pouch 16 is configured to be peeled opened by the caregiver (see Figs. 4 and 5) at the instant of use.
- the pouch 16 provides peel away access to the tissue dressing pad assembly 10 along one end.
- tissue dressing pad assembly 10 is immediately ready to be adhered to the targeted tissue site. It needs no pre- application manipulation to promote adherence. For example, there is no need to peel away a protective material to expose an adhesive surface for use.
- the adhesive surface forms in situ, because the chitosan matrix 12 itself exhibits strong adhesive properties once in contact with blood, fluid, or moisture.
- the tissue dressing pad assembly 10 is applied to the injury site within one hour of opening the pouch 16. As Fig.
- the tissue dressing pad assembly 10 can be pre-shaped and adapted on site to conform to the topology and morphology of the site.
- the tissue dressing pad assembly 10 can be deliberately molded into other configurations, e.g., into a cup-shape, to best conform to the particular topology and morphology of the treatment site. While shaping or otherwise manipulating the tissue dressing pad assembly 10 prior to placement on a treatment site, the caregiver should avoid contact between hand or finger moisture and the chitosan matrix 12. This could cause the chitosan matrix 12 to become sticky and difficult to handle.
- FIGS. 8 to 13 show the chitosan tissue dressing pad assembly 10 being applied for treating an arterial and/or venous bleeding injury.
- the tissue dressing pad assembly 10 should be placed with the chitosan matrix 12 laid against on the site of active bleeding or where adherence is otherwise desired.
- the backing 14 provides a non-stick surface for the caregiver to apply pressure in conventional fashion.
- the caregiver should avoid repositioning the tissue dressing pad assembly 10.
- firm pressure is applied for at least two minutes, to allow the natural adhesive activity of the chitosan matrix 12 to develop.
- the adhesive strength of the chitosan matrix 12 will increase with duration of applied pressure, up to about five minutes.
- tissue pad dressing assembly can also be cut to size on site (see Fig. 13) , fitted and adhered to the periphery of another pad assembly 10 to best approximate the topology and morphology of the treatment site. If the tissue pad dressing assembly fails to stick to the injury site, it can be removed and discarded, and another fresh dressing pad assembly 10 applied. In wounds with substantial tissue disruptions, with deep tissue planes or in penetrating wounds, peeling away the backing 14 and stuffing the chitosan matrix 12 into the wound, followed by covering the wound with a second dressing, has been shown to be very effective.
- a second conventional dressing e.g., gauze
- a water tight covering should be applied to prevent the dressing from becoming over-hydrated.
- the tissue dressing pad assembly 10 is removed within forty-eight hours of application for definitive surgical repair. The tissue dressing pad assembly 10 can be peeled away from the wound and will generally separate from the wound in a single, intact dressing.
- chitosan may remain, and this can be removed using saline or water with gentle abrasion and a gauze dressing.
- Chitosan is biodegradable within the body and is broken down into glucosamine, a benign substance. Still, it is desirable in the case of temporary dressings, that efforts should be made to remove all portions of chitosan from the wound at the time of definitive repair.
- biodegrable dressings can be formed for internal use.
- Example 1 Usage Action Reports Action reports by combat medics in operations in and during freedom operations in Afghanistan and Iraq have shown successful clinical utility for the dressing pad assemblies without adverse effects.
- the US Army Institute for Surgical Research at Fort Sam Houston in Texas evaluated the dressing pad assembly 10 in trauma models with severe life threatening bleeding and compared this dressing to standard 4 4 inch cotton gauze dressings.
- the tissue dressing pad assembly 10 significantly decreased blood loss and decreased resuscitative fluid requirements. Survival at one hour was increased in the group to which the tissue dressing pad assembly 10 was applied, compared to the cotton gauze survival group.
- Combat medics have successfully treated bullet wounds, shrapnel, land mine and other injuries, when conventional wound dressings have failed.
- C. Manufacture of the Tissue Dressing Pad Assembly A desirable methodology for making the tissue dressing pad assembly 10 will now be described. This methodology is shown schematically in Fig. 16. It should be realized, of course, that other methodologies can be used. 1.
- the chitosan used to prepare the chitosan solution preferably has a fractional degree of deacetylation greater than 0.78 but less than 0.97. Most preferably the chitosan has a fractional degree of deacetylation greater than 0.85 but less than 0.95.
- the chitosan selected for processing into the matrix has a viscosity at 25°C in a l%(w/w) solution of 1% (w/w) acetic acid (AA) with spindle LVI at 30 rpm, which is about 100 centipoise to about 2000 centipoise.
- the chitosan has viscosity at 25°C in a 1% (w/w) solution of l%(w/w) acetic acid (AA) with spindle LVI at 30 rpm, which is about 125 centipoise to about 1000 centipoise.
- the chitosan has viscosity at 25°C in a l%(w/w) solution of l%(w/w) acetic acid (AA) with spindle LVI at 30 rpm, which is about 400 centipoise to about 800 centipoise .
- the chitosan solution is preferably prepared at 25°C by addition of water to solid chitosan flake or powder and the solid dispersed in the liquid by agitation, stirring or shaking.
- the acid component is added and mixed through the dispersion to cause dissolution of the chitosan solid.
- the rate of dissolution will depend on the temperature of the solution, the molecular weight of the chitosan and the level of agitation.
- the dissolution step is performed within a closed tank reactor with agitating blades or a closed rotating vessel. This ensures homogeneous dissolution of the chitosan and no opportunity for high viscosity residue to be trapped on the side of the vessel.
- the chitosan solution percentage (w/w) is greater than 0.5% chitosan and less than 2.7% chitosan. More preferably the chitosan solution percentage (w/w) is greater than 1% chitosan and less than 2.3% chitosan. Most preferably the chitosan solution percentage is greater than 1.5% chitosan and less than 2.1% chitosan.
- the acid used is acetic acid.
- the acetic acid is added to the solution to provide for an acetic acid solution percentage (w/w) at more than 0.8% and less than 4%.
- the acetic acid is added to the solution to provide for an acetic acid solution percentage (w/w) at more than 1.5% (w/w) and less than 2.5%.
- the structure or form producing steps for the chitosan matrix 12 are typically carried out from solution and can he accomplished employing techniques such as freezing (to cause phase separation) , non-solvent die extrusion (to produce a filament) , electro-spinning (to produce a filament) , phase inversion and precipitation with a non-solvent (as is typically used to produce dialysis and filter membranes) or solution coating onto a preformed sponge-like or woven product.
- the filament can he formed into a non-woven sponge-like mesh by non-woven spinning processes. Alternately, the filament may he produced into a felted weave by conventional spinning and weaving processes. Other processes that may be used to make the biomaterial sponge-like product include dissolution of added porogens from a solid chitosan matrix 12 or boring of material from said matrix. 2.
- the chitosan biomaterial is degassed of general . atmospheric gases.
- degassing is removing sufficient residual gas from the chitosan biomaterial so that, on undergoing a subsequent freezing operation, the gas does not escape and form unwanted large voids or large trapped gas bubbles in the subject wound dressing product.
- the degassing step may be performed by heating a chitosan biomaterial, typically in the form of a solution, and then applying a vacuum thereto.
- degassing can be performed by heating a chitosan solution to about
- certain gases can be added back into the solution to controlled partial pressures after initial degassing.
- gases would include but are not limited to argon, nitrogen and helium.
- An advantage of this step is that solutions containing partial pressures of these gases form micro-voids on freezing. The microvoid is then carried through the sponge as the ice- front advances. This leaves a well defined and controlled channel that aids sponge pore interconnectivity. 3. Freezing the Aqueous Chitosan Solution Next (see Fig. 16, Step C) , the chitosan biomaterial -- which is typically now in acid solution and degassed, as described above -- is subjected to a freezing step.
- Freezing is preferably carried out by cooling the chitosan biomaterial solution supported within a mold and lowering the solution temperature from room temperature to a final temperature below the freezing point. More preferably this freezing step is performed on a plate freezer whereby a thermal gradient is introduced through the chitosan solution in the mold by loss of heat through the plate cooling surface.
- this plate cooling surface is in good thermal contact with the mold.
- the temperature of the chitosan solution and mold before contact with the plate freezer surface are near room temperature.
- the plate freezer surface temperature is not more than -10 °C before introduction of the mold + solution.
- the thermal mass of the mold + solution is less than the thermal mass of the plate freezer shelf + heat transfer fluid.
- the molds are formed from, but are not limited to, a metallic element such as iron, nickel, silver, copper, aluminum, aluminum alloy, titanium, titanium alloy, vanadium, molybdenum, gold, rhodium, palladium, platinum and/or combinations thereof.
- the molds may also be coated with thin, inert metallic coatings such as titanium, chromium, tungsten, vanadium, nickel, molybdenum, gold and platinum in order to ensure there is no reaction with the acid component of the chitosan solution and the chitosan salt matrix.
- Thermally insulating coatings or elements may be used in conjunction with the metallic molds to control heat transfer in the molds.
- the mold surfaces do not bind with the frozen chitosan solution.
- the inside surface of the mold is preferably coated with a thin, permanently-bound, fluorinated release coating formed from polytetrafluoroethylene (Teflon) , fluorinated ethylene polymer (FEP) , or other fluorinated polymeric materials.
- Teflon polytetrafluoroethylene
- FEP fluorinated ethylene polymer
- coated metallic molds are preferable, thin walled plastic molds can be a convenient alternative for supporting the solution.
- Such plastic molds would include, but not be limited to, molds prepared by injection molding, machining or thermoforming from polyvinylchloride, polystyrene, acrylonitrile-butadiene- styrene copolymers, polyesters, polyamides, polyurethanes and polyolefins .
- the metallic molds combined with local placement of thermally insulating elements is that they also provide opportunity for improved control of heat flow and structure within the freezing sponge. This improvement in heat flow control results from large thermal conductivity differences between thermally conducting and thermally insulating element placements in the mold. Freezing of the chitosan solution in this way enables the preferred structure of the wound-dressing product to be prepared.
- the plate freezing temperature affects the structure and mechanical properties of the final chitosan matrix 12.
- the plate freezing temperature is preferably not higher than about -10°C, more preferably not more than about -20°C, and most preferably not more than about -30°C.
- the structure of the uncompressed chitosan matrix 12 When frozen at -10°C, the structure of the uncompressed chitosan matrix 12 is very open and vertical throughout the open sponge structure. When frozen at -25°C, the structure of the uncompressed chitosan matrix 12 is more closed, but it is still vertical. When frozen at -40°C, the structure of the uncompressed chitosan matrix 12 is closed and not vertical. Instead, the chitosan matrix 12 comprises more of a reinforced, inter-meshed structure. The adhesive/cohesive sealing properties of the chitosan matrix 12 are observed to improve as lower freezing temperatures are used. A freezing temperatures of about -40°C forms a structure for the chitosan matrix 12 having superior adhesive/cohesive properties.
- the temperature may be lowered over a predetermined time period.
- the freezing temperature of a chitosan biomaterial solution may he lowered from room temperature to -45°C by plate cooling application of a constant temperature cooling ramp of between about -0.4°C/mm to about -0.8°C/mm for a period of about 90 minutes to about 160 minutes.
- the frozen chitosan/ice matrix desirably undergoes water removal from within the interstices of the frozen material (see Fig. 16, Step D) . This water removal step may he achieved without damaging the structural integrity of the frozen chitosan biomaterial.
- the ice in the frozen chitosan biomaterial passes from a solid frozen phase into a gas phase (sublimation) without the formation of an intermediate liquid phase.
- the sublimated gas is trapped as ice in an evacuated condenser chamber , at substantially lower temperature than the frozen chitosan biomaterial .
- the preferred manner of implementing the water removal step is by freeze-drying, or lyophilization. Freeze-drying of the frozen chitosan biomaterial can be conducted by further cooling the frozen chitosan biomaterial. Typically, a vacuum is then applied. Next, the evacuated frozen chitosan material may be gradually heated.
- the frozen chitosan biomaterial may be subjected to subsequent freezing preferably at about -15°C, more preferably at about -25°C, and most preferably at about -45°C, for a preferred time period of at least about 1 hour, more preferably at least about 2 hour, and most preferably at least about 3 hour.
- This step can be followed by cooling of the condenser to a temperature of less than about -45°C, more preferably at about -60°C, and most preferably at about -85°C.
- a vacuum in the amount of preferably at most about 100 mTorr, more preferably at most about 150 mTorr, and most preferably at least about 200 mTorr can be applied.
- the evacuated frozen chitosan material can be heated preferably at about -25°C, more preferably at about - 15°C, and most preferably at about -10°C, for a preferred time period of at least about I hour, more preferably at least about 5 hour, and most preferably at least about 10 hour. Further freeze drying, maintaining vacuum pressure at near 200 mTorr, is conducted at a shelf temperature of about 20 °C, more preferably at about 15°C, and most preferably at about 10°C, for a preferred time period of at least about 36 hours, more preferably at least about 42 hours, and most preferably at least about 48 hours. 5.
- the chitosan matrix before densification will be called an "uncompressed chitosan matrix.”
- This uncompressed matrix is ineffective in stanching bleeding since it rapidly dissolves in blood and has poor mechanical properties .
- the chitosan biomaterial is necessarily compressed (see Fig. 16, Step E) .
- Compression loading normal to the hydrophilic matrix polymer surface with heated platens can be used to compress the dry "uncompressed” chitosan matrix 12 to reduce the thickness and increase the density of the matrix.
- the compression step which will sometimes be called in shorthand “densification, " significantly increases adhesion strength, cohesion strength and dissolution resistance of the chitosan matrix 12.
- Appropriately frozen chitosan matrices 12 compressed above a threshold density do not readily dissolve in flowing blood at 37 °C.
- the compression temperature is preferably not less than about 60°C, more preferably it is not less than about 75 °C and not more than about 85 °C.
- the density of the matrix 12 can be different at the base ("active") surface of the matrix 12 (i.e., the surface exposed to tissue) than at the top surface of the matrix 12 (the surface to which the backing 14 is applied) .
- the mean density measured at the top surface can be significantly lower, e.g., at 0.05 g/cm 3 .
- the desired density ranges as described herein for a densified matrix 12, are intended to exist at are near the active side of the matrix 12, where exposure to blood, fluid, or moisture first occurs.
- the densified chitosan biomaterial is next preferably preconditioned by heating chitosan matrix 12 in an oven to a temperature of preferably up to about 75°C, more preferably to a temperature of up to about 80 °C, and most preferably to a temperature of preferably up to about 85°C (Fig.
- Preconditioning is typically conducted for a period of time up to about 0.25 hours, preferably up to about 0.35 hours, more preferably up to about 0.45 hours, and most preferably up to about 0.50 hours. This pre-conditioning step provides further significant improvement in dissolution resistance with a small cost in a 20-30% loss of adhesion properties.
- the backing 14 is secured to the chitosan matrix 12 to form the tissue dressing pad assembly 10 (see Fig. 16, Step G) .
- the backing 14 can be attached or bonded by direct adhesion with a top layer of chitosan matrix 12.
- tissue dressing pad assembly 10 can he subsequently packaged in the pouch 16 (see Fig. 16, Step H) , which is desirably purged with an inert gas such as either argon or nitrogen gas, evacuated and heat sealed.
- the pouch 16 acts to maintain interior contents sterility over an extend time (at least 24 months) and also provides a very high barrier to moisture and atmospheric gas infiltration over the same period.
- the processed tissue dressing pad assembly 10 is desirably subjected to a sterilizationstep (see Fig. 16, Step I).
- the tissue dressing pad assembly 10 can be sterilized by a number of methods.
- a preferred method is by irradiation, such as by gamma irradiation, which can further enhance the blood dissolution resistance, the tensile properties and the adhesion properties of the wound dressing.
- the irradiation can be conducted at a level of at least about 5 kGy, more preferably a least about 10 kGy, and most preferably at least about 15 kGy.
- the Arterial Wound Sealing Test Fixture The adhesive characteristics of any given hydrophilic polymer sponge structure, of which the tissue dressing pad assembly 10 is but one example, can be reliably tested and verified using a test fixture specially designed for the task.
- a representative test fixture 20 is shown in Fig. 17.
- the test fixture 20 provides a platform that simulates an arterial wound sealing environment.
- the test fixture 20 makes it possible to assess, for that environment and exposure period, the burst (or rupture) strength of a hydrophilic polymer sponge structure, such as the pad assembly 10, or a manufactured lot of such structure, in a reproducible and statistically valid way.
- the test fixture 20 can be implemented as part of an overall manufacturing process to validate, based upon prescribed, objective burst strength criteria, the relative adhesive and cohesive properties of a tissue dressing pad assembly 10, or a manufactured lot of pad assemblies, prior to final labeling and product release.
- the test fixture 20 provides burst strength data in reproducible way that statistically correlates with in vivo use.
- the test fixture 20 comprises a test block 22, which simulates an external arterial wound site.
- the test block 22 comprises a test surface 24 made of a material that simulates tissue.
- the test surface 24 can be made, e.g., from rigid polyvinyl chloride plastic.
- the test surface 24 includes an aperture 44 of about 4mm in diameter, which simulates the arterial wound entrance .
- the test surface 24 is treated to simulate tissue, e.g., by sanding the test surface 24 surrounding the aperture 44in small circular motions with 400 grit sandpaper.
- a load arm 26 is positioned over the test surface 24 in registry with the aperture.
- the load arm 26 is part of a pneumatic cylinder that is coupled to a source of pneumatic pressure 28.
- a controller 30 e.g., a programmed microprocessor
- Pneumatic pressure advances the load arm 26 toward the test surface 24 to apply a prescribed pressure.
- test-sized sample 32 of a hydrophilic polymer sponge structure e.g., a tissue dressing pad assembly
- a test fluid 34 is pre-soaked in a test fluid 34 and placed upon the test surface 24.
- the chitosan matrix 12 is situated over the aperture.
- the load arm 26 can then be operated (see Fig. 18A) to initially apply pressure upon the pre-soaked test-sized sample 32 on the test surface 24.
- the test fluid 34 comprises a fluid that activates the adhesive properties of the chitosan matrix 12.
- the test fluid 34 can comprise, for example, bovine whole blood which has been anti-coagulated (e.g., with citrate) .
- a supply conduit 36 is coupled to the test block 22.
- the supply conduit 36 is capable of conveying the test fluid 34 into the test block 22 and through the aperture 44 into contact with the chitosan matrix 12.
- the other end of the supply conduit 36 is coupled to a syringe drive pump 38.
- the syringe drive pump 38 is operated in draw and expel cycles by a motor 40.
- the motor 40 is, in turn, coupled to the controller 30. Through the motor 40, the controller 30 commands operation of the syringe drive pump 38 in synchrony with the source of pneumatic pressure.
- the motor 40 operates the syringe drive pump 38 to draw the test fluid 34 from a test fluid source 42 into the syringe drive pump 38.
- Back flow of blood from the test block 22 to the syringe drive pump 38 during the draw cycle is prevented by an in-line one-way check valve 46B.
- the motor 40 operates the syringe drive pump 38 to expel the test fluid 34 from the syringe drive pump 38 through the aperture 44 in the test surface 24.
- Back flow of the test fluid to the test fluid source 42 during the expel cycle is prevented by an in-line one-way check valve 46A.
- the controller 30 governs the rate at which the test fluid 34 is conveyed through the aperture 44 during the expel cycle.
- the test-sized sample 32 pre- soaked in the test fluid 34 (e.g., for no more than about 10 seconds), is placed on the test surface 24.
- the controller 30 operates the load arm 26 to apply pressure (e.g., about 60 kPa) to the test-sized sample 32 over the aperture.
- a prescribed load period is desirably observed to simulate actual use conditions, e.g., about 3 minutes.
- the controller 30 can operate the syringe drive pump 38 in a draw cycle to conduct the test fluid 32 into the syringe drive pump 38.
- the controller 30 releases pneumatic pressure on the load arm 26 and withdraws the load arm 26 from the test surface 24.
- the controller 30 immediately operates the syringe drive pump 38 in an expel cycle.
- the controller 30 ramps the citrated bovine whole blood pressure into the test block 22 at a prescribed rate, e.g., between 3 and 16 mmHg/s, and preferably 10 mmHg/s.
- the pressure within the supply conduit 36 is continuously monitored and recorded by the controller 30 over time.
- the controller 30 continues ramping blood pressure at the prescribed rate until ultimate failure of the test-sized sample occurs (see Fig. 18C) . Ultimate failure is indicated when the highest ramped pressure state is lost, indicating that the test-sized sample has lost adherence with the test surface 24 and can no longer withstand the pressure applied through the aperture.
- the controller 30 records the highest pressure state at which ultimate failure occurs for test-sized sample.
- This pressure is the burst strength of the pad assembly 10.
- the highest pressure state (burst strength) observed is compared to a prescribed "pass-fail” criteria.
- burst strengths greater than 750 mmHg indicate a "pass.”
- Burst strengths below 750 mmHg indicate a "fail.”
- This criteria imposes a strict "pass” standard, as it represents a pressure level that is generally six times greater than normal human blood systolic pressure.
- An alternative to ramping pressure continuously to ultimate failure is to ramp at between 3 and 16 mmHg/s
- tissue dressing pad assemblies can be validated using the above-described test fixture 20 and test methodology.
- test block 22s each with a dedicated load arm 26 and test fluid supply conduit 36, coupled by manifolds to a single source of pneumatic pressure and a syringe drive pump 38, can be operated in tandem using a single controller 30.
- the pass-fail criteria can be defined with a composite pass-fail rate for the entire lot. For example, ultimate burst strengths of 75% or more of the lot of greater than 750 mmHg can correlate to a statistically valid "pass" of the entire lot. Ultimate burst strengths of less than 75% of the lot below 750 mmHg can correlate to a statistically valid "fail" of the entire lot. 2.
- EXAMPLE 2 The Aging Phenomenon A procedure was initiated to retest lots that had failed initial testing, because an apparent increase in adhesive efficacy performance over time had been observed, including better performance at six and twelve months than immediately following production.
- the following data was derived from seven lots of tissue dressing pad assemblies that had failed final product testing and were retested after a minimum of two months aging.
- the "Pressure" in Tables 1 and 2 is the highest pressure state at which ultimate failure occurred for test samples (i.e., the burst strength), as described above. As Tables 1 and 2 show, six of seven lots demonstrated an increase in performance, which, for most of them, was a dramatic increase.
- the enhancement of performance of the tissue dressing pad assembly 10 over storage time is dramatic and real.
- the aging phenomenon demonstrates the robustness and longevity of resistance to dissolution of the chitosan matrix 12 composition described above, which improves over time. 3.
- Discernment of Adhesive/Cohesive Sealing Properties Among Different Tissue Dressing Pad Assembly Con igurations Using the test fixture 20 and methodology described above, the differences in densified tissue dressing pad assemblies manufactured in different ways can be discerned and quantified. For example, using the test fixture 20 and methodology described above, it can be discerned that the temperature at which the chitosan matrix 12 is frozen during manufacture affects the not only the structure of the matrix but its adhesive and cohesive properties, as well.
- the differences in the structure of the uncompressed chitosan matrix 12 frozen at different temperatures can be visually observed.
- the structure of the uncompressed chitosan matrix 12 has course, openly spaced and vertical lamella throughout the sponge structure.
- the structure of the uncompressed chitosan matrix 12 has less course, more closely spaced, but still vertical lamella.
- the structure of the uncompressed chitosan matrix 12 When frozen in Teflon coated, 5 cm diameter aluminum mold on a shelf at -40°C, the structure of the uncompressed chitosan matrix 12 has fine, most closely spaced lamella radiating from the mold edge toward the top middle portion of the sponge. In this later condition, the uncompressed chitosan matrix 12 comprises more of a reinforced inter- meshing structure that is better suited to the densification step where compression load is applied normal to the matrix surface .
- Fig. 35 is a graphical demonstration of the underlying data..
- Fig. 19 Three data sets are plotted in Fig. 19 along the x-axis by freezing temperature (-10°C, -25°C, and -40°C) , with the temperature decreasing to the right) and along the y- axis by burst pressure (in mmHg) as measured by the test fixture 20 and methodology described above.
- Fig. 19 also demonstrates that the test fixture 20 and methodology described above yield reproducible data that is sensitive enough to distinguish among "less effective” and “more effective” chitosan matrix 12es.
- E. Altering the Compliance Properties of a Hydrophilic Polymer Sponge Structure Immediately prior to use, the tissue dressing pad assembly 10 is removed from its pouch 16 (as shown in Figs. 4 to 6) .
- the tissue dressing pad assembly 10 upon removed from the pouch 16, can seem to be relatively inflexible and may not immediately mate well with curved and irregular surfaces of the targeted injury site. Bending and/or molding of the pad assembly 10 prior to placement on the targeted injury site has been already described and recommended. The ability to shape the pad assembly 10 is especially important when attempting to control strong bleeding, since apposition of the pad assembly 10 immediately against an injured vessel is necessary to control severe bleeding. Generally, these bleeding vessels are deep within irregularly shaped wounds.
- hydrophilic polymer sponge structure of which the pad assembly 10 is but one example
- the more flexible and compliant the structure is the more resistant it is to tearing and fragmentation as the structure is made to conform to the shape of the wound and achieve apposition of the sponge structure with the underlying irregular surface of the injury. Resistance to tearing and fragmentation is a benefit, as it maintains wound sealing and hemostatic efficacy.
- Compliance and flexibility provide an ability to load a hydrophilic polymer sponge structure (e.g., the pad assembly 10) against a deep or crevice shaped wound without cracking or significant pad assembly 10 dissolution. Improved flexibility and compliance by the use of certain plasticizing agents in solution with the chitosan may be problematic, because certain plasticizers can change other structural attributes of the pad assembly 10.
- chitosan glutamate and chitosan lactate are more compliant than chitosan acetate.
- glutamate and lactate chitosan acid salts rapidly dissolve in the presence of blood, while the chitosan acetate salt does not.
- improved compliance and flexibility can be offset by reduced robustness and longevity of resistance to dissolution.
- Improved compliance and flexibility can be achieved by mechanical manipulation of any hydrophilic polymer sponge structure after manufacture, without loss of beneficial features of robustness and longevity of resistance to dissolution.
- Controlled Micro-Fracturing of a Hydrophilic Polymer Sponge Structure Controlled micro-fracturing of the substructure of a hydrophilic polymer sponge structure such as the chitosan matrix 12 can be accomplished by systematic mechanical pre-conditioning of the dry pad assembly 10. This form of controlled mechanical pre-conditioning of the pad assembly 10 can achieve improved flexibility and compliance, without engendering gross failure of the pad assembly 10 at its time of use. Desirably, as Fig. 20 shows, pre-conditioning can be performed with the pad assembly 10 sealed within its pouch 16.
- Fig. 20 shows, maintaining the active face of the pad assembly 10 (i.e., the chitosan matrix 12) upright, manual repetitive digital impressions 48 of 1 to 1.5 mm depth can be applied over the entire surface.
- Fig. 21A shows, one edge of the square pad assembly 10, with active face remaining upright, can be attached to the side of a 7.5 cm diameter x 12 cm long cylinder 50.
- the cylinder 50 is then rolled onto the pad assembly 10 to produce a 7.5 cm diameter concave in the pad assembly 10.
- the cylinder 50 can be released and the pad assembly 10 rotated 90° (see Fig. 21B) to enable another 7.5 cm diameter concave to be formed into the pad assembly 10.
- the pad assembly 10 can be flipped
- the mechanical pre-conditioning described above is not limited to the pre-conditioning by digital probing and/or drawing over cylinders.
- the pre-conditioning may also include any technique which provides for mechanical change inside any hydrophilic polymer sponge structure resulting in enhanced sponge flexural modulus without significant loss of sponge hemostatic efficacy.
- Such preconditioning would include mechanical manipulations of any hydrophilic sponge structure including, but not limited to, mechanical manipulations by bending, twisting, rotating, vibrating, probing, compressing, extending, shaking and kneading.
- Bupivacaine was administered over the exposed femoral artery, prior to making the injury, as an analgesic, and also to reduce vasospasm.
- the pressure used to control the injury was just sufficient to stop arterial blood flow as observed by monitoring the pulse, distal to the injury. Pressure was released after 3 minutes with the 7.5 cm gauze roll left in place over the test piece. Time of hemostasis was recorded for each test piece. If the first test piece attempt did not achieve hemostasis within 30 minutes, a second test piece attempt with the same pad assembly 10 was allowed. If the second attempt was also unable to achieve and maintain hemostasis for at least 240 minutes, then the HCB or 48PG application was recorded as a failure. If 48PG had been used in the first application and it had been unsuccessful in the first 30 minutes, then the HCB pad assembly 10 could be used as a rescue pad assembly 10.
- flexural testing and acute in vitro simulated arterial wound seal test were performed on manipulated pad assemblies and non- manipulated pad assemblies. Two strips of 10 cm x 1.27 cm x 0.55 cm were removed from one half of each pad assembly 10. These were used to test flexural modulus in a three-. point bend test. Three point flexural testing on an Instron uniaxial mechanical tester, model number 5844; with a 50 N load cell was performed to determine flexural modulus for the 0.55 cm thick test pieces with span 5.8 cm and crosshead speed of 0.235 cm/s. The other halves of the pad assemblies were used in the SAWS test.
- the results of flexural testing are shown below in Table 7.
- the flexural testing demonstrates a significant improvement in flexibility with the mechanical pre- conditioning.
- the results of the SAWS testing are shown below in Table 8.
- the SAWS test results indicate that there is a 32.4% loss in mean resistance to rupture pressure from 1114 mmHg to 753.7 mmHg in the treated test samples compared to the untreated controls .
- This in vitro testing is on the flat test bed surface of the SAWS tester; however, on the irregular curved surface of an injury, as demonstrated in the femoral artery model, the treated sample exhibited a high level of efficacy.
- the 63% reduction in stiffness, afforded by the mechanical manipulation allows ready apposition of chitosan matrix 12 to injury; and this demonstrably offsets the 32.4% loss in SAWS efficacy.
- Controlled Macro-Texturing of a Hydrophilic Polymer Sponge Structure can achieve improved flexibility and compliance, without engendering gross failure of the pad assembly 10 at its time of use.
- the deep relief patterns can be formed either on the active surface of the chitosan matrix 12, or on the backing 14, or both sides.
- deep (0.25-0.50 cm) relief surface patterns 52 can be created in the pad assembly 10 by sponge thermal compression at 80 °C.
- the sponge thermal compression can be performed using a positive relief press platen 54, which includes a controlled heater assembly 56.
- Figs. 24A to 24D Various representative examples of the types of relief patterns 52 that can be used are shown in Figs. 24A to 24D.
- the relief pattern negative is formed from a positive relief attached to the heated platen 54.
- the purpose of the patterns 52 is to enhance dry pad assembly compliance by reduction in flexural resistance orthogonal to the relief 52, so that the relief pattern acts much like a local hinge to allow enhanced flexure along its length. It is preferred that this relief 52 is applied in the backing 14 of the pad assembly 10 and not in the chitosan .matrix 12 , whose role is to provide hemostasis by injury sealing and promoting local clot formation.
- Macro-textured deep relief patterns 52 in the base chitosan matrix 12 can provide for loss of sealing by providing channels for blood to escape through the chitosan matrix 12.
- alternative relief patterns 52 of the type shown in Fig. 24E and 24F may be used in a base relief, which would be less likely to cause loss of sealing. It is therefore possible that the relief 52 may be use in the base of the matrix, however this is still less preferred compared to its use in the backing 14 or top surface of the matrix.
- a single, deep relief is created by use of one positive relief in the top surface of the chitosan matrix 12, as Figs 18A and 18B show.
- Example 4 Mechanical flexure testing was carried out on a test pad assemblies (each 10 cm x 10 cm x 0.55 cm, with adherent backing 14 -- 3M 1774T polyethylene foam medical tape 0.056 cm thick).
- One pad assembly 10 (Pad 1) comprised a chitosan matrix 12 having a predominantly vertical lamella structure (i.e., manufactured at a warmer relative freezing temperature, as described above) .
- the other pad assembly 10 (Pad 2) comprised a chitosan matrix 12 having a predominantly horizontal, intermeshed lamella structure (i.e., manufactured at a colder relative freezing temperature, as described above) .
- Each Pad 1 and 2 was cut in half.
- Two halves (5 cm x 10 cm x 0.55 cm) of each compressed chitosan pads 1 and 2 were locally compressed at 80 °C to produce the relief pattern on the backing 14, in the form of Fig. 19A.
- the other halves of the pads 1 and 2 were left untreated to be used as controls.
- Three test pieces (10 cm x 1.27 cm x 0.55 cm) were cut from each half of the pad assembly 10 using a scalpel. These test pieces were subjected to three point flex testing.
- test pieces had relief indentations 0.25 cm deep and 0.25 cm wide at the top surface. Each indentation was separated from its neighbor by 1.27 cm.
- Three point flex testing on an Instron uniaxial mechanical tester, model number 5844, with a 50 N load cell was performed to determine flexural modulus for the 0.55 cm thick test pieces with span 5.8 cm and crosshead speed of 0.235 cm/s. Flexural load was plotted against mid-point flexural displacement for the two pads 1 and 2 (treated and untreated) and are shown, respectively, in Figs. 25A and 25B. Flexural moduli of treated versus untreated test pieces for Pads 1 and 2 (treated and untreated) are shown in Tables 9A and 9B, respectively. The flexural testing demonstrates a significant improvement in flexibility with controlled macro- texturing of either type of the dry pad assembly 10.
- a hydrophilic polymer sponge structure of which the chitosan matrix 12 is but one example, is desirable for improved initial structural compliance and also for longevity of resistance to structure dissolution.
- Controlled formation of vertical channels into a given hydrophilic polymer sponge structure can achieve improved flexibility and compliance, without engendering gross failure of the structure at its time of use.
- a controlled introduction of blood into, and through the bulk of a hydrophilic polymer sponge structure is desirable for improved initial compliance of the structure and also for longevity of resistance to dissolution of the structure.
- Improved absorption of blood into a hydrophilic polymer sponge structure can be accomplished by the introduction of vertical channels into the structure. Channel cross sectional area, channel depth and channel number density can be controlled to ensure an appropriate rate of blood absorption and distribution of blood absorption into the hydrophilic polymer sponge structure.
- chitosan matrix 12 typically, a 200% increase in chitosan matrix 12 mass associated with blood absorption from 5 g to 15 g can cause a flexural modulus reduction of near 72%, from 7 MPa to 2 MPa. Also, controlled introduction of blood into the chitosan matrix 12 can result in a more cohesive matrix. This improvement in the strength of a hydrophilic polymer matrix is a consequence of reaction of blood components, such as platelets and erythrocytes, with the same matrix.
- the subsequent sponge structure is resistant to dissolution in body fluids and cannot be dissolved readily, especially in the case of a chitosan acid salt matrix, by the introduction of saline solution.
- the introduction of saline causes rapid swelling, gelling and dissolution of the hydrophilic polymer sponge structure. Still, excessive introduction of blood into a given hydrophilic polymer sponge structure such as the chitosan matrix 12 can result in fluidized collapse.
- mean channel cross-sectional area, mean channel depth and channel number density should be controlled to ensure that rate of blood absorption does not overwhelm the structure of the hydrophilic polymer sponge structure.
- Controlled distribution of vertical channels in the hydrophilic polymer sponge structure can be achieved during the freezing step of the sponge structure preparation, or alternatively it may be achieved mechanically by perforation of the sponge structure during the compression (densification) step.
- vertical channels can be introduced in the freezing solution by super-saturation of the same solution with residual gas. The same gas nucleates bubbles at the base of the solution in the mold as it begins to freeze . The bubbles rise through the solution during the freezing step leaving vertical channels.
- channels may also be formed during the freezing step by the positioning of vertical rod elements in the base of the molds .
- the molds are formed from, but are not limited to, a metallic element such as iron, nickel, silver, copper, aluminum, aluminum alloy, titanium, titanium alloy, vanadium, molybdenum, gold, rhodium, palladium, platinum and/or combinations thereof.
- the metallic rod elements are preferably formed from, but not limited to, a metallic element such as iron, nickel, silver, copper, aluminum, aluminum alloy, titanium, titanium alloy, vanadium, molybdenum, gold, palladium, rhodium or platinum and/or combinations thereof.
- the molds may also be coated with thin, inert metallic coatings such as titanium, chromium, tungsten, vanadium, nickel, molybdenum, gold and platinum in order to ensure there is no reaction with the acid component of the chitosan solution and the chitosan salt matrix.
- Thermally insulating coatings or elements may be used in conjunction with the metallic molds and vertical rod elements to control heat transfer in the molds and in the vertical rod elements.
- metallic molds and vertical metallic rod elements are preferable, plastic molds and vertical plastic mold rod elements can be a convenient alternative for creating channels .
- An advantage of the metallic molds and their metallic rod elements combined with local placement of thermally insulating elements is that they also provide opportunity for improved control of heat flow and structure within the freezing sponge structure.
- a compression fixture 58 carries a pincushion geometrical patterned device 60 for placing short (2.5 mm depth) equally spaced perforations 62 in the base of the sponge structure (as shown in Fig. 27) .
- the intent of the perforations 62 is to allow local infiltration of blood at a slow controlled rate into and through the base of the hydrophilic polymer sponge structure.
- this infiltration is first to allow for a more rapid flexural change in the matrix by plasticization of the dry sponge with blood. Secondly, it is intended to provide for a more uniform dispersion and mixing of blood through the matrix in order to stabilize the matrix to resist subsequent dissolution agents present within the body cavity.
- the perforated base surface it is seen after 1, 6, 16 and 31 minutes that blood only penetrates superficially into the sponge structure ( ⁇ 1.5 mm depth) while in the presence of the perforations that blood penetrates from 1.8 to 2.3 mm depth after 31 minutes.
- Example 5 In vitro SAWS testing of both perforated and non- perforated chitosan matrixes, demonstrates that both matrix types are effective in sealing strong blood flow, as Table 10 demonstrates.
- the tissue dressing sheet assembly 64 is capable, in use, of adhering to tissue in the presence of blood or body fluids or moisture.
- the tissue dressing sheet assembly 64 can thus also be used to stanch, seal, and/or stabilize a site of tissue injury or trauma or access against bleeding or other forms of fluid loss.
- the tissue site treated by the tissue dressing sheet assembly 64 can comprise, e.g., arterial and/or venous bleeding, or laceration, or entrance/entry wound, or tissue puncture, or catheter access site, or burn, or suturing.
- the tissue dressing sheet assembly 64 can also form an anti-bacterial and/or anti-microbial and/or antiviral protective barrier at or about the tissue treatment site.
- Fig. 29 shows the tissue dressing sheet assembly 64 in its condition prior to use.
- the tissue dressing sheet assembly 64 comprises a sheet 66 of woven or non-woven mesh material enveloped between layers of a tissue dressing matrix 68.
- the tissue dressing matrix 68 impregnates the sheet 66.
- the tissue dressing matrix 68 desirably comprises a chitosan matrix 12 as described in connection with the tissue dressing pad assembly 10.
- other hydrophilic polymer sponge structures can be used.
- the size, shape, and configuration of the tissue dressing sheet assembly 64 can vary according to its intended use.
- the sheet assembly 64 can be rectilinear, elongated, square, round, oval, or composite or complex combinations thereof.
- the tissue dressing sheet assembly 64 achieves rapid compliance of the hydrophilic polymer sponge structure in a bleeding field.
- the tissue dressing sheet assembly 64 is preferably thin (compared to the pad assembly 10) , being in the range of between 0.5 mm to 1.5 mm in thickness.
- a preferred form of the thin reinforced structure of the sheet assembly 64 comprises a chitosan matrix 12 or sponge, at the typical chitosan matrix density of 0.10 to 0.20 g/cm3, reinforced by absorbable bandage webbing such as cotton gauze and the resultant bandage thickness is 1.5 mm or less .
- the sheet assembly 64 can be prepared as a compact sheet form (e.g. 10 cm 10 cm x 0.1 cm) for packaging in a multi-sheet flat form 70 (as Fig. 31A shows) or as an elongated sheet form (e.g.
- the sheet 66 provides reinforcement throughout the assembly 64, while also presenting significant specific hydrophilic polymer sponge structure surface area availability for blood absorption.
- the presence of the woven or non-woven sheet 66 also serves to reinforce the overall hydrophilic polymer sponge structure.
- the sheet 66 can comprise woven and non-woven mesh materials, formed, e.g., from cellulose derived material such as gauze cotton mesh. Examples of preferred reinforcing materials include absorbent low-modulus meshes and/or porous films and/or porous sponges and/or weaves of synthetic and naturally occurring polymers.
- Synthetic biodegradable materials may include, but are not limited to, poly (glycolic acid), poly(lactic acid), poly (e-caprolactone) , poly ( ⁇ -hydroxybutyric acid) , poly ( ⁇ -hydroxyvaleric acid), polydioxanone, poly (ethylene oxide), poly (malic acid), poly (tartronic acid), polyphosphazene, polyhydroxybutyrate and the copolymers of the monomers used to synthesize the above-mentioned polymers.
- Naturally occurring polymers may include, but are not limited to, cellulose, chitin, algin, starch, dextran, collagen and albumen.
- Non-degradable synthetic reinforcing materials may include but are not limited to polyethylene, polyethylene copolymers, polypropylene, polypropylene copolymers, metallocene polymers, polyurethanes, polyvinylchloride polymers, polyesters and polyamides .
- the thin sheet assembly 64 possesses very good compliance and allows for excellent apposition of the hydrophilic polymer sponge structure (e.g., the chitosan matrix 12) immediately against the injury site. Also the reinforcement of the sheet enables the overall assembly to resist dissolution in a strong bleeding field.
- the sheet assembly 64 accommodates layering, compaction, and/or rolling -- i.e., "stuffing" (as Fig.
- the hydrophilic polymer sponge structure e.g., the chitosan matrix 12
- the hydrophilic polymer e.g., chitosan
- the interaction of the blood with the hydrophilic polymer (e.g., chitosan) infused within the webbing provides advantages for the application when the wounds are particularly deep or otherwise apparently inaccessible.
- the stuffing of the sheet assembly 64 into a bleeding wound and its compression on itself provide for a highly adhesive, insoluble and highly conforming bandage form.
- a tissue dressing sheet assembly 64 (10 cm x 10 cm x 0.15 cm), with chitosan matrix 12 density near 0.15 gm/cm3, can be prepared by filling 11 cm x 11 cm x 2 cm deep aluminum mold with a two percent (2%) chitosan acetate solution (see Fig. 33, Step A) to a depth of 0.38 cm.
- the sheet 66 comprising, e.g., a layer of absorbent gauze webbing 10 cm x 10 cm - can be placed over the top of the solution in the mold and allowed to soak with chitosan.
- the chitosan impregnates the sheet 66 .
- Fig. 33 the sheet 66 comprising, e.g., a layer of absorbent gauze webbing 10 cm x 10 cm -
- a further 0.38 cm depth of chitosan can be poured over the top of the impregnated gauze sheet 66.
- the mold is placed in, e.g., a Virtis Genesis 25XL freeze dryer on a shelf at -
- Fig. 33 (Step E) shows, the resultant gauze reinforced sheet assembly 64 is pressed between platens at 80 °C to a thickness of 0.155 cm. The pressed sheet assembly 64 is then baked at 80 °C for thirty minutes
- Fig. 33, Step F The resulting sheet assemblies can sterilized in a manner previously described.
- One or more sheet assemblies can be packaged within in a heat sealed foil lined pouch 74 or the like (see Fig. 34) , either in sheet form or roll form for terminal sterilization and storage.
- Example 6 Flexural Characteristics of the Tissue Dressing Sheet Assembly Flexural three point bend testing of a tissue dressing sheet assembly 64 was performed. The three point flexural testing was performed on an Instron uniaxial mechanical tester, model number 5844, with a 50 N load cell to determine flexural modulus test pieces with span 5.8 cm and crosshead speed of 0.235 cm/s. The results are shown in Fig. 35. Fig.
- Example 7 Adhesion Characteristics of the Tissue Dressing Sheet Assembly Test pieces (5 cm x 5 cm x 0.15 cm) of the tissue dressing sheet assembly 64 were cut within ninety-six hours of their production. The sheet assembly 64 was not subjected gamma radiation sterilization before testing. The test pieces were soaked in citrated bovine whole blood for 10 seconds and immediately subjected to SAWS testing. During the test, three test pieces were layered together, presenting a composite chitosan density near 0.15 g/cm3. The result of this testing is shown in Fig. 36. As Fig.
- tissue dressing sheet assembly 64 held substantial physiological blood pressure of near 80 mmHg for an extended period (i.e., about 400 seconds). This indicates the presence of sealing and clotting. Based upon experience with the pad assemblies, better adhesion/cohesion properties were expected to result after the tissue dressing sheet assembly 64 underwent gamma irradiation.
- Fig. 36B confirms this: after gamma-irradiation, three layers of tissue dressing sheet assembly 64 performed significantly like a 0.55 cm thick chitosan tissue pad 10.
- a given compressed hydrophilic polymer sponge structure e.g., the chitosan matrix 12
- the control of bleeding represents but one indication where preservation of a body fluid is tantamount to preserving health and perhaps life. Another such indication is in the treatment of burns. Burns can occur by exposure to heat and fire, radiation, sunlight, electricity, or chemicals. Thin or superficial burns (also called first-degree burns) are red and painful.
- the dressing keeps air off the area, reduces pain and protects blistered skin.
- the dressing also absorbs fluid as the tissue burn heals.
- Anti-microbial creams or ointments and/or moisturizers are also used to prevent drying and to ward off infection.
- a hydrophilic polymer sponge structure e.g., a chitosan matrix 12 of the type already described
- the hydrophilic polymer sponge structure e.g., chitosan matrix 12
- the hydrophilic polymer sponge structure (e.g., the chitosan matrix 12) can also serve an anti- bacterial/anti-microbial protective barrier at the tissue burn region.
- the composite dressing assembly 76 includes a fluid absorbent component 78 or carrier and a hydrophilic polymer sponge structure (e.g., a chitosan matrix 12) that is carried by the fluid absorbent component 78.
- fluid absorbent component 78 examples include absorbent low-modulus meshes and/or porous films and/or porous sponges and/or weaves of synthetic and naturally occurring polymers.
- Synthetic biodegradable materials may include, but are not limited to, poly (glycolic acid), poly(lactic acid), poly(e- caprolactone) , poly ( ⁇ -hydroxybutyric acid), poly( ⁇ - hydroxyvaleric acid), polydioxanone, poly (ethylene oxide), poly (malic acid), poly (tartronic acid), polyphosphazene, polyhydroxybutyrate and the copolymers of the monomers used to synthesize the above-mentioned polymers.
- Naturally occurring polymers may include, but are not limited to, cellulose, chitin, algin, starch, dextran, collagen and albumen.
- Non-degradable synthetic reinforcing materials may include but are not limited to polyethylene, polyethylene copolymers, polypropylene, polypropylene copolymers, metallocene polymers, polyurethanes , polyvinylchloride polymers, polyesters and polyamides .
- the hydrophilic polymer sponge structure can, e.g., comprise a chitosan matrix 12 of the type previously described, which desirably has undergone densification. Still, other types of a chitosan structure or other forms of hydrophilic polymer sponge structures or tissue dressing matrixes in general can be used.
- the hydrophilic polymer sponge structure (e.g., the chitosan matrix 12) can be secured to the adsorbent component by, e.g., direct adhesion to the hydrophilic polymer sponge structure and/or adhesive, or fibrin glue, or cyanoacrylate glue.
- the primary function of the absorbent component 78 when placed in association with the hydrophilic polymer sponge structure (e.g., the chitosan matrix 12), is to absorb residual fluids at or near the tissue burn region (or other wound site) . In this way, the hydrophilic polymer sponge structure (e.g., the chitosan matrix 12) need not bear the full fluid retention function of the composite assembly. As Fig.
- the periphery of the fluid absorbent component 78 desirably extends beyond the periphery of the hydrophilic polymer sponge structure (e.g., the chitosan matrix 12), to increase the reach and capacity of the fluid absorption function of the absorbent component 78.
- the absorbent component 78 thereby complements and shares the fluid retention function of the hydrophilic polymer sponge structure (e.g., the chitosan matrix 12).
- the absorbent component 78 serves to moderate the fluid retention load of the hydrophilic polymer sponge structure (e.g., the chitosan material), so that the hydrophilic polymer sponge structure does not too quickly over-hydrate or become super-saturated with fluid or blood, thereby compromising its structural integrity.
- the hydrophilic polymer sponge structure e.g., the chitosan material
- the interface between the absorbent component 78 and the hydrophilic polymer sponge structure (e.g., the chitosan matrix 12) can be perforated 80 or otherwise rendered permeable, so that fluid retained within the hydrophilic polymer sponge structure can be readily transported into the absorbent component 78, thereby reducing the fluid-bearing load of the hydrophilic polymer sponge structure.
- the fluid absorbent component 78 can carry an adhesive to adhere to tissue.
- a second conventional dressing e.g., gauze
- a water tight covering should be applied to prevent the composite dressing assembly 76 from becoming over-hydrated.
- the focus of treatment becomes the prevention of ingress of bacteria and/or microbes through a tissue region that has been compromised, either by injury or by the need to establish an access portal to an interior tissue region.
- the latter situation include, e.g., the installation of an indwelling catheter to accommodate peritoneal dialysis, or the connection of an external urine or colostomy bag, or to accomplish parenteral nutrition, or to connect a sampling or monitoring device; or after the creation of an incision to access an interior region of the body during, e.g., a tracheotomy, or a laparoscopic or endoscopic procedure, or the introduction of a catheter instrument into a blood vessel.
- a tracheotomy or a laparoscopic or endoscopic procedure
- an antimicrobial gasket assembly 82 is shown.
- the gasket assembly 82 is sized and configured to be placed over an access site, and, in particular, an access site where an indwelling catheter 88 resides.
- the antimicrobial gasket assembly 82 includes a tissue adhering carrier component 84 , to which an anti-microbial component is secured.
- the anti-microbial component comprises the chitosan matrix 12 of the type previously described, which has undergone densification. Still, other types of a chitosan structure, or other hydrophilic polymer sponge structures, or tissue dressing matrixes in general can be used.
- the carrier component 84 desirably includes an adhesive surface 86, to attach the anti-microbial component (desirably, the chitosan matrix 12) over the access site.
- the anti-microbial component 12 and carrier 84 include a pass-through hole 90, which allows passage of the indwelling catheter 88 through it.
- the interior diameter of the pass-through hole 90 approximates the exterior diameter of the indwelling catheter 88, to provide a tight, sealed fit. It should be appreciated that, in situations where there is only an incision or access site without a resident catheter, the anti-microbial component will not include the pass-through hole.
- an alternative arrangement see Fig.
- a tissue dressing pad assembly 10 as previously described is sized and configured proportionate to the area of the access site to comprise an anti-microbial gasket assembly 82.
- the pad assembly 10 can be provided with a pass-through hole 90 to accommodate passage of an indwelling catheter, if present.
- a tissue dressing sheet assembly 64 as previously described is sized and configured proportionate to the area of the access site to comprise an anti-microbial gasket assembly 82. In this con iguration, the sheet assembly 64 can be provided with a pass-through hole 90 to accommodate passage of the indwelling catheter, if present.
- Example ⁇ Anti-Microbial Feature The densified chitosan acetate matrix and diverse forms of dressings that can incorporate the densified chitosan acetate matrix have anti-microbial efficacy as demonstrated by in vitro testing, as summarized in Table 11. TABLE 11: Results of USP 27 ⁇ 51> Testing of the Densified Chitosan Acetate Matrix.
- the excellent adhesive and mechanical properties of the densified chitosan matrix 12 make it eminently suitable for use in anti-microbial applications on the extremity (epidermal use) and inside the body. Such applications would include short to medium term (0-120 hour) control of infection and bleeding at catheter lead entry/exit points, at entry/exit points of biomedical devices for sampling and delivering application, and at severe injury sites when patient is in shock and unable to receive definitive surgical assistance.
- C. Antiviral Patches There are recurrent conditions that are caused by viral agents . For example, herpes simplex virus type 1 ("HSV1" ) generally only infects those body tissues that lie above the waistline. It is HSV1 that causes cold sores in the majority of cases.
- HSV1 herpes simplex virus type 1
- Cold sores are a type of facial sore that are found either on the lips or else on the skin in the area near the mouth.
- Some equivalent terminology used for cold sores is “fever blisters” and the medical term “recurrent herpes labialis”.
- Herpes simplex virus type 2 (“HSV2”) typically only infects those body tissues that lie below the waistline.” It is this virus that is also known as “genital herpes”. Both HSV 2 (as well as HSVl) can produce sores (also called lesions) in and around the vaginal area, on the penis, around the anal opening, and on the buttocks or thighs . Occasionally, sores also appear on other parts of the body where the virus has entered through broken skin.
- Figs. 44 and 45 show a representative embodiment of an anti-viral patch assembly.
- the anti-viral patch assembly 92 is sized and configured to be placed over a surface lesion of a type associated with HSVl or HSV2, or other forms of viral skin infections, such as molluscum contagiosum and warts.
- the anti-viral patch assembly 92 includes a tissue adhering carrier component 94 , to which an anti-viral component is secured.
- the antiviral component comprises the chitosan matrix 12 of the type previously described, which has undergone densification. Still, other types of a chitosan structure, or other hydrophilic polymer sponge structures, or tissue dressing matrixes in general can be used.
- the carrier component 94 includes an adhesive surface 96, to attach the anti-viral component (desirably, the chitosan matrix 12) over the lesion site.
- a tissue dressing pad assembly 10 or a tissue dressing sheet assembly 64 or a composite dressing assembly 76 as previously described can be sized and configured proportionate to the area of the lesion site to comprise an anti-viral patch assembly.
- the excellent adhesive and mechanical properties of the densified compressed chitosan matrix 12 make it eminently suitable for use in anti-viral applications on the extremity (epidermal use) and inside the body.
- the presence of the anti-viral patch assembly 92 can kill viral agents and promote healing in the lesion region. D.
- hemophilia is an inherited bleeding, or coagulation, disorder. People with hemophilia lack the ability to stop bleeding because of the low levels, or complete absence, of specific proteins, called "factors," in their blood that are necessary for clotting. The lack of clotting factor causes people with hemophilia to bleed for longer periods of time than people whose blood factor levels are normal or work properly.
- Idiopathic thrombocyt ⁇ penic purpura is another blood coagulation disorder characterized by an abnormal decrease in the number of platelets in the blood. A decrease in platelets can result in easy bruising, bleeding gums, and internal bleeding.
- a hydrophilic polymer sponge structure e.g., the chitosan matrix 12 incorporated into a tissue dressing pad assembly 10 or a tissue dressing sheet assembly 64 or a composite dressing assembly 76, all as previously described, can be sized and configured to be applied as an interventional dressing, to intervene in a bleeding episode experience by a person having hemophilia or another coagulation disorder.
- the presence of the chitosan matrix 12 attracts red blood cell membranes, which fuse to chitosan matrix 12 upon contact.
- a clot can be formed very quickly and does not need the clotting proteins that are normally required for coagulation.
- a hydrophilic polymer sponge structure (e.g., the chitosan matrix 12 as previously described) can provide a topically applied platform for the delivery of one or more therapeutic agents into the blood stream in a controlled release fashion.
- the therapeutic agents can be incorporated into the hydrophilic polymer sponge structure, e.g., either before or after the freezing step, and before the drying and densification steps.
- the rate at which the therapeutic agents are released from the hydrophilic polymer sponge structure can be controlled by the amount of densification. The more densified the hydrophilic polymer sponge structure is made to be, the slower will be the rate of release of the therapeutic agent incorporated into the structure.
- chitosan matrix 12 examples include, but are not limited to, drugs or medications, stem cells, antibodies, anti-microbials, anti-virals, collagens, genes, DNA, and other therapeutic agents; hemostatic agents like fibrin,- growth factors; and similar compounds.
- drug or medications include, but are not limited to, drugs or medications, stem cells, antibodies, anti-microbials, anti-virals, collagens, genes, DNA, and other therapeutic agents; hemostatic agents like fibrin,- growth factors; and similar compounds.
- the beneficial properties of chitosan matrix 12 includes adherence to mucosal surfaces within the body, such as those lining the esophagus, gastro-intestinal tract, urinary tract, the mouth, nasal passages and airways, and lungs.
- This feature makes possible the incorporation of the chitosan matrix 12, e.g., in systems and devices directed to treating mucosal surfaces where the adhesive sealing characteristics, and/or accelerated clotting attributes, and/or anti-bacterial/anti-viral features of the chitosan matrix 12, as described, provides advantages .
- Such systems and methods can include the anastomosis of bowels and other gastro-intestinal surgical procedures, repairs to esophageal or stomach function, sealing about sutures, etc. IV.
- hydrophilic polymer sponge structure like the chitosan matrix 12 can be readily adapted for association with dressings or platforms of various sizes and configurations -- in pad form, in sheet form, in composite form, in laminated form, in compliant form - such that a person of ordinary skill in the medical and/or surgical arts could adopt any hydrophilic polymer sponge structure like the chitosan matrix 12 to diverse indications on, in, or throughout the body. Therefore, it should be apparent that above- described embodiments of this invention are merely descriptive of its principles and are not to be limited. The scope of this invention instead shall be determined from the scope of the following claims, including their equivalents.
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Epidemiology (AREA)
- Hematology (AREA)
- Materials Engineering (AREA)
- Dispersion Chemistry (AREA)
- Surgery (AREA)
- Dermatology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Medicinal Chemistry (AREA)
- Manufacturing & Machinery (AREA)
- Materials For Medical Uses (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Prostheses (AREA)
Abstract
Description
Claims
Priority Applications (10)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
AU2004308415A AU2004308415A1 (en) | 2003-12-23 | 2004-12-22 | Tissue dressing assemblies, systems, and methods formed from hydrophilic polymer sponge structures such as chistosan |
NZ548079A NZ548079A (en) | 2003-12-23 | 2004-12-22 | Tissue dressing assemblies, systems, and methods formed from hydrophilic polymer sponge structures such as chitosan |
BRPI0417991-9A BRPI0417991A (en) | 2003-12-23 | 2004-12-22 | fabric assemblies, systems and methods of dressing formed by hydrophilic polymer sponge structures such as chitosan |
EP04815250A EP1699397A4 (en) | 2003-12-23 | 2004-12-22 | Tissue dressing assemblies, systems, and methods formed from hydrophilic polymer sponge structures such as chistosan |
MXPA06007343A MXPA06007343A (en) | 2003-12-23 | 2004-12-22 | Tissue dressing assemblies, systems, and methods formed from hydrophilic polymer sponge structures such as chistosan. |
KR1020067012470A KR101105081B1 (en) | 2003-12-23 | 2004-12-22 | Tissue Dressing Assemblies, Systems, and Methods Formed from Hydrophilic Polymer Sponge Structures such as Chitosan |
JP2006547315A JP4812630B2 (en) | 2003-12-23 | 2004-12-22 | Tissue coating assemblies, systems and methods formed from hydrophilic polymer sponge structures such as chitosan |
CA002548527A CA2548527A1 (en) | 2003-12-23 | 2004-12-22 | Tissue dressing assemblies, systems, and methods formed from hydrophilic polymer sponge structures such as chistosan |
IL176036A IL176036A0 (en) | 2003-12-23 | 2006-05-31 | A tissue dressing comprising a hydrophilic polymer sponge structure |
NO20062550A NO20062550L (en) | 2003-12-23 | 2006-06-02 | Bandages, systems and methods of hydrophilic polymer structures said as chitosan |
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US10/743,051 | 2003-12-23 | ||
US10/743,051 US20050137512A1 (en) | 2003-12-23 | 2003-12-23 | Wound dressing and method for controlling severe, life-threatening bleeding |
US10/743,052 US7371403B2 (en) | 2002-06-14 | 2003-12-23 | Wound dressing and method for controlling severe, life-threatening bleeding |
US10/743,052 | 2003-12-23 |
Publications (2)
Publication Number | Publication Date |
---|---|
WO2005062896A2 true WO2005062896A2 (en) | 2005-07-14 |
WO2005062896A3 WO2005062896A3 (en) | 2005-11-10 |
Family
ID=34743161
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US2004/043147 WO2005062896A2 (en) | 2003-12-23 | 2004-12-22 | Tissue dressing assemblies, systems, and methods formed from hydrophilic polymer sponge structures such as chistosan |
Country Status (10)
Country | Link |
---|---|
EP (1) | EP1699397A4 (en) |
JP (1) | JP4812630B2 (en) |
KR (1) | KR101105081B1 (en) |
AU (1) | AU2004308415A1 (en) |
CA (1) | CA2548527A1 (en) |
IL (1) | IL176036A0 (en) |
MX (1) | MXPA06007343A (en) |
NO (1) | NO20062550L (en) |
NZ (1) | NZ548079A (en) |
WO (1) | WO2005062896A2 (en) |
Cited By (42)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP1830755A2 (en) * | 2004-12-23 | 2007-09-12 | Hemcon, Inc. | Antimicrobial barriers, systems, and methods formed from hydrophilic polymer structures such as chitosan |
WO2007121912A2 (en) | 2006-04-20 | 2007-11-01 | Aesculap Ag | Layered wound dressing |
EP1945162A2 (en) * | 2005-10-28 | 2008-07-23 | Hemcon Medical Technologies, Inc. | Compostions, assemblies, and methods applied during or after a dental procedure to ameliorate fluid loss and/or promote healing, using a hydrophilic polymer sponge structrue such as chitosan |
DE102009053305A1 (en) * | 2009-11-12 | 2011-08-18 | medichema GmbH, 09112 | Process for producing a layered wound dressing |
CN103974679A (en) * | 2011-12-16 | 2014-08-06 | 凯希特许有限公司 | Sealing systems and methods employing a switchable drape |
US20140330227A1 (en) | 2010-03-16 | 2014-11-06 | Kci Licensing, Inc. | Delivery-and-fluid-storage bridges for use with reduced-pressure systems |
EP2812032A1 (en) * | 2012-02-06 | 2014-12-17 | Hyprotek, Inc. | Antiseptic applicators and packaging techniques |
US20150119831A1 (en) | 2013-10-30 | 2015-04-30 | Kci Licensing, Inc. | Condensate absorbing and dissipating system |
US9198995B2 (en) | 2006-09-20 | 2015-12-01 | Ore-Medix Llc | Conformable structured therapeutic dressing |
WO2017064495A1 (en) * | 2015-10-14 | 2017-04-20 | Selentus Science Limited | Haemostatic device |
WO2017120538A1 (en) * | 2016-01-07 | 2017-07-13 | Zeltiq Aesthetics, Inc. | Temperature-dependent adhesion between applicator and skin during cooling of tissue |
US9789005B2 (en) | 2009-09-02 | 2017-10-17 | Hyprotek, Inc. | Antimicrobial medical dressings and protecting wounds and catheter sites |
US9861532B2 (en) | 2011-12-16 | 2018-01-09 | Kci Licensing, Inc. | Releasable medical drapes |
US9925092B2 (en) | 2013-10-30 | 2018-03-27 | Kci Licensing, Inc. | Absorbent conduit and system |
US9956120B2 (en) | 2013-10-30 | 2018-05-01 | Kci Licensing, Inc. | Dressing with sealing and retention interface |
US10010656B2 (en) | 2008-03-05 | 2018-07-03 | Kci Licensing, Inc. | Dressing and method for applying reduced pressure to and collecting and storing fluid from a tissue site |
US10016544B2 (en) | 2013-10-30 | 2018-07-10 | Kci Licensing, Inc. | Dressing with differentially sized perforations |
US10117978B2 (en) | 2013-08-26 | 2018-11-06 | Kci Licensing, Inc. | Dressing interface with moisture controlling feature and sealing function |
US10271995B2 (en) | 2012-12-18 | 2019-04-30 | Kci Usa, Inc. | Wound dressing with adhesive margin |
US10299966B2 (en) | 2007-12-24 | 2019-05-28 | Kci Usa, Inc. | Reinforced adhesive backing sheet |
US10357406B2 (en) | 2011-04-15 | 2019-07-23 | Kci Usa, Inc. | Patterned silicone coating |
US10398604B2 (en) | 2014-12-17 | 2019-09-03 | Kci Licensing, Inc. | Dressing with offloading capability |
US10406266B2 (en) | 2014-05-02 | 2019-09-10 | Kci Licensing, Inc. | Fluid storage devices, systems, and methods |
US10561534B2 (en) | 2014-06-05 | 2020-02-18 | Kci Licensing, Inc. | Dressing with fluid acquisition and distribution characteristics |
US10568767B2 (en) | 2011-01-31 | 2020-02-25 | Kci Usa, Inc. | Silicone wound dressing laminate and method for making the same |
US10632020B2 (en) | 2014-02-28 | 2020-04-28 | Kci Licensing, Inc. | Hybrid drape having a gel-coated perforated mesh |
US10842707B2 (en) | 2012-11-16 | 2020-11-24 | Kci Licensing, Inc. | Medical drape with pattern adhesive layers and method of manufacturing same |
US10940047B2 (en) | 2011-12-16 | 2021-03-09 | Kci Licensing, Inc. | Sealing systems and methods employing a hybrid switchable drape |
US10946124B2 (en) | 2013-10-28 | 2021-03-16 | Kci Licensing, Inc. | Hybrid sealing tape |
US10973694B2 (en) | 2015-09-17 | 2021-04-13 | Kci Licensing, Inc. | Hybrid silicone and acrylic adhesive cover for use with wound treatment |
US11026844B2 (en) | 2014-03-03 | 2021-06-08 | Kci Licensing, Inc. | Low profile flexible pressure transmission conduit |
US11096830B2 (en) | 2015-09-01 | 2021-08-24 | Kci Licensing, Inc. | Dressing with increased apposition force |
US11246975B2 (en) | 2015-05-08 | 2022-02-15 | Kci Licensing, Inc. | Low acuity dressing with integral pump |
US11406771B2 (en) | 2017-01-10 | 2022-08-09 | Boston Scientific Scimed, Inc. | Apparatuses and methods for delivering powdered agents |
US11433223B2 (en) | 2016-07-01 | 2022-09-06 | Boston Scientific Scimed, Inc. | Delivery devices and methods |
US11642281B2 (en) | 2018-10-02 | 2023-05-09 | Boston Scientific Scimed, Inc. | Endoscopic medical device for dispensing materials and method of use |
US11701448B2 (en) | 2018-01-12 | 2023-07-18 | Boston Scientific Scimed, Inc. | Powder for achieving hemostasis |
US11766546B2 (en) | 2018-01-31 | 2023-09-26 | Boston Scientific Scimed, Inc. | Apparatuses and methods for delivering powdered agents |
US11833539B2 (en) | 2018-10-02 | 2023-12-05 | Boston Scientific Scimed, Inc. | Fluidization devices and methods of use |
US11918780B2 (en) | 2019-12-03 | 2024-03-05 | Boston Scientific Scimed, Inc. | Agent administering medical device |
US11931003B2 (en) | 2019-12-03 | 2024-03-19 | Boston Scientific Scimed, Inc. | Medical devices for agent delivery and related methods of use |
US11969318B2 (en) | 2020-08-24 | 2024-04-30 | Solventum Intellectual Properties Company | Releasable medical drapes |
Families Citing this family (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
GB2463523B (en) * | 2008-09-17 | 2013-05-01 | Medtrade Products Ltd | Wound care device |
AU2011207398B2 (en) | 2010-01-22 | 2014-11-20 | Hyprotek, Inc. | Antimicrobial agent comprising peroxide, alcohol and chelating agent |
KR200467691Y1 (en) * | 2011-03-18 | 2013-07-04 | 주식회사 제네웰 | Pad for medical treatment |
US20200246195A1 (en) * | 2017-08-02 | 2020-08-06 | Kci Licensing, Inc. | Systems and methods for wound debridement |
WO2019133936A1 (en) * | 2017-12-29 | 2019-07-04 | Tricol Biomedical, Inc. | Tissue adherent chitosan material that resists dissolution |
AU2020260448A1 (en) * | 2019-10-28 | 2021-05-13 | Chan, Laurence C. MR | Nonwoven Sponges, Nonwoven Sponge Pack And Their Applications |
Citations (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2003092756A1 (en) | 2002-04-30 | 2003-11-13 | Her Majesty The Queen, In Right Of Canada, As Represented By The Minister Of National Defence Of Her Majesty's Canadian Government | Multi-layer synthetic dressing with cooling characteristics |
Family Cites Families (13)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3849238A (en) * | 1972-04-07 | 1974-11-19 | S Ronel | Artificial skin |
US4460642A (en) * | 1981-06-26 | 1984-07-17 | Minnesota Mining And Manufacturing Company | Water-swellable composite sheet of microfibers of PTFE and hydrophilic absorptive particles |
EP0122085B1 (en) * | 1983-04-06 | 1987-06-24 | Smith and Nephew Associated Companies p.l.c. | Dressing |
CA2030593C (en) * | 1989-12-29 | 2002-03-26 | Donald H. Lucast | Multi-layered dressing |
US5387206A (en) * | 1993-08-27 | 1995-02-07 | Merocel Corporation | Mechanical treatment of dry sponge material to impart flexibility |
US5836970A (en) * | 1996-08-02 | 1998-11-17 | The Kendall Company | Hemostatic wound dressing |
FR2776518B1 (en) * | 1998-03-24 | 2002-11-29 | Oreal | ADHESIVE MATRIX PATCH |
GB2348136B (en) * | 1999-03-24 | 2003-06-04 | Johnson & Johnson Medical Ltd | Wound dressings having low adherency |
DE10009248C2 (en) * | 2000-02-28 | 2002-06-27 | Freudenberg Carl Kg | Medical dressings |
JP2002233542A (en) * | 2001-02-09 | 2002-08-20 | Shiseido Co Ltd | Wound coating material and method of manufacturing the same |
KR100953466B1 (en) * | 2001-06-14 | 2010-04-16 | 프로비던스 헬스 시스템-오레곤 | A method for preparing a wound dressing useful for secere, life-threatening bleeding |
US20050137512A1 (en) * | 2003-12-23 | 2005-06-23 | Campbell Todd D. | Wound dressing and method for controlling severe, life-threatening bleeding |
US7161365B2 (en) * | 2004-11-04 | 2007-01-09 | Infineon Technologies Ag | Apparatus and method for making ground connection |
-
2004
- 2004-12-22 KR KR1020067012470A patent/KR101105081B1/en active IP Right Grant
- 2004-12-22 JP JP2006547315A patent/JP4812630B2/en not_active Expired - Fee Related
- 2004-12-22 MX MXPA06007343A patent/MXPA06007343A/en unknown
- 2004-12-22 AU AU2004308415A patent/AU2004308415A1/en not_active Abandoned
- 2004-12-22 WO PCT/US2004/043147 patent/WO2005062896A2/en active Application Filing
- 2004-12-22 EP EP04815250A patent/EP1699397A4/en not_active Withdrawn
- 2004-12-22 NZ NZ548079A patent/NZ548079A/en unknown
- 2004-12-22 CA CA002548527A patent/CA2548527A1/en not_active Abandoned
-
2006
- 2006-05-31 IL IL176036A patent/IL176036A0/en unknown
- 2006-06-02 NO NO20062550A patent/NO20062550L/en not_active Application Discontinuation
Patent Citations (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2003092756A1 (en) | 2002-04-30 | 2003-11-13 | Her Majesty The Queen, In Right Of Canada, As Represented By The Minister Of National Defence Of Her Majesty's Canadian Government | Multi-layer synthetic dressing with cooling characteristics |
Cited By (78)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP1830755A4 (en) * | 2004-12-23 | 2012-12-19 | Hemcon Inc | Antimicrobial barriers, systems, and methods formed from hydrophilic polymer structures such as chitosan |
EP1830755A2 (en) * | 2004-12-23 | 2007-09-12 | Hemcon, Inc. | Antimicrobial barriers, systems, and methods formed from hydrophilic polymer structures such as chitosan |
EP1945162A4 (en) * | 2005-10-28 | 2012-03-28 | Hemcon Medical Technologies Inc | Compostions, assemblies, and methods applied during or after a dental procedure to ameliorate fluid loss and/or promote healing, using a hydrophilic polymer sponge structrue such as chitosan |
EP1945162A2 (en) * | 2005-10-28 | 2008-07-23 | Hemcon Medical Technologies, Inc. | Compostions, assemblies, and methods applied during or after a dental procedure to ameliorate fluid loss and/or promote healing, using a hydrophilic polymer sponge structrue such as chitosan |
JP2009534063A (en) * | 2006-04-20 | 2009-09-24 | アエスクラップ アクチェンゲゼルシャフト | Layered wound dressing |
WO2007121912A3 (en) * | 2006-04-20 | 2008-01-10 | Aesculap Ag & Co Kg | Layered wound dressing |
WO2007121912A2 (en) | 2006-04-20 | 2007-11-01 | Aesculap Ag | Layered wound dressing |
US9198995B2 (en) | 2006-09-20 | 2015-12-01 | Ore-Medix Llc | Conformable structured therapeutic dressing |
US10299966B2 (en) | 2007-12-24 | 2019-05-28 | Kci Usa, Inc. | Reinforced adhesive backing sheet |
US11020516B2 (en) | 2008-03-05 | 2021-06-01 | Kci Licensing, Inc. | Dressing and method for applying reduced pressure to and collecting and storing fluid from a tissue site |
US10010656B2 (en) | 2008-03-05 | 2018-07-03 | Kci Licensing, Inc. | Dressing and method for applying reduced pressure to and collecting and storing fluid from a tissue site |
US9789005B2 (en) | 2009-09-02 | 2017-10-17 | Hyprotek, Inc. | Antimicrobial medical dressings and protecting wounds and catheter sites |
DE102009053305A1 (en) * | 2009-11-12 | 2011-08-18 | medichema GmbH, 09112 | Process for producing a layered wound dressing |
US20140330227A1 (en) | 2010-03-16 | 2014-11-06 | Kci Licensing, Inc. | Delivery-and-fluid-storage bridges for use with reduced-pressure systems |
US10279088B2 (en) | 2010-03-16 | 2019-05-07 | Kci Licensing, Inc. | Delivery-and-fluid-storage bridges for use with reduced-pressure systems |
US11400204B2 (en) | 2010-03-16 | 2022-08-02 | Kci Licensing, Inc. | Delivery-and-fluid-storage bridges for use with reduced-pressure systems |
US10568767B2 (en) | 2011-01-31 | 2020-02-25 | Kci Usa, Inc. | Silicone wound dressing laminate and method for making the same |
US10357406B2 (en) | 2011-04-15 | 2019-07-23 | Kci Usa, Inc. | Patterned silicone coating |
US9861532B2 (en) | 2011-12-16 | 2018-01-09 | Kci Licensing, Inc. | Releasable medical drapes |
US11944520B2 (en) | 2011-12-16 | 2024-04-02 | 3M Innovative Properties Company | Sealing systems and methods employing a hybrid switchable drape |
US10940047B2 (en) | 2011-12-16 | 2021-03-09 | Kci Licensing, Inc. | Sealing systems and methods employing a hybrid switchable drape |
US10945889B2 (en) | 2011-12-16 | 2021-03-16 | Kci Licensing, Inc. | Releasable medical drapes |
CN103974679A (en) * | 2011-12-16 | 2014-08-06 | 凯希特许有限公司 | Sealing systems and methods employing a switchable drape |
US10265446B2 (en) | 2011-12-16 | 2019-04-23 | Kci Licensing, Inc. | Sealing systems and methods employing a switchable drape |
US9192443B2 (en) | 2012-02-06 | 2015-11-24 | Hyprotek, Inc. | Combined cap applicators |
US10617472B2 (en) | 2012-02-06 | 2020-04-14 | Hyprotek, Inc. | Adhesive patch with antimicrobial composition |
EP2812032A1 (en) * | 2012-02-06 | 2014-12-17 | Hyprotek, Inc. | Antiseptic applicators and packaging techniques |
EP2812032A4 (en) * | 2012-02-06 | 2015-10-14 | Hyprotek Inc | Antiseptic applicators and packaging techniques |
US10080620B2 (en) | 2012-02-06 | 2018-09-25 | Hyprotek, Inc. | Portable medical device protectors |
AU2013217602B2 (en) * | 2012-02-06 | 2016-11-10 | Hyprotek, Inc. | Antiseptic applicators and packaging techniques |
US11839529B2 (en) | 2012-11-16 | 2023-12-12 | Kci Licensing, Inc. | Medical drape with pattern adhesive layers and method of manufacturing same |
US10842707B2 (en) | 2012-11-16 | 2020-11-24 | Kci Licensing, Inc. | Medical drape with pattern adhesive layers and method of manufacturing same |
US11395785B2 (en) | 2012-11-16 | 2022-07-26 | Kci Licensing, Inc. | Medical drape with pattern adhesive layers and method of manufacturing same |
US10271995B2 (en) | 2012-12-18 | 2019-04-30 | Kci Usa, Inc. | Wound dressing with adhesive margin |
US11141318B2 (en) | 2012-12-18 | 2021-10-12 | KCl USA, INC. | Wound dressing with adhesive margin |
US10117978B2 (en) | 2013-08-26 | 2018-11-06 | Kci Licensing, Inc. | Dressing interface with moisture controlling feature and sealing function |
US10946124B2 (en) | 2013-10-28 | 2021-03-16 | Kci Licensing, Inc. | Hybrid sealing tape |
US11154650B2 (en) | 2013-10-30 | 2021-10-26 | Kci Licensing, Inc. | Condensate absorbing and dissipating system |
US11793923B2 (en) | 2013-10-30 | 2023-10-24 | Kci Licensing, Inc. | Dressing with differentially sized perforations |
US11964095B2 (en) | 2013-10-30 | 2024-04-23 | Solventum Intellectual Properties Company | Condensate absorbing and dissipating system |
US20150119831A1 (en) | 2013-10-30 | 2015-04-30 | Kci Licensing, Inc. | Condensate absorbing and dissipating system |
US11744740B2 (en) | 2013-10-30 | 2023-09-05 | Kci Licensing, Inc. | Dressing with sealing and retention interface |
US9925092B2 (en) | 2013-10-30 | 2018-03-27 | Kci Licensing, Inc. | Absorbent conduit and system |
US9956120B2 (en) | 2013-10-30 | 2018-05-01 | Kci Licensing, Inc. | Dressing with sealing and retention interface |
US10016544B2 (en) | 2013-10-30 | 2018-07-10 | Kci Licensing, Inc. | Dressing with differentially sized perforations |
US10849792B2 (en) | 2013-10-30 | 2020-12-01 | Kci Licensing, Inc. | Absorbent conduit and system |
US10967109B2 (en) | 2013-10-30 | 2021-04-06 | Kci Licensing, Inc. | Dressing with differentially sized perforations |
US10940046B2 (en) | 2013-10-30 | 2021-03-09 | Kci Licensing, Inc. | Dressing with sealing and retention interface |
US10398814B2 (en) | 2013-10-30 | 2019-09-03 | Kci Licensing, Inc. | Condensate absorbing and dissipating system |
US10632020B2 (en) | 2014-02-28 | 2020-04-28 | Kci Licensing, Inc. | Hybrid drape having a gel-coated perforated mesh |
US11026844B2 (en) | 2014-03-03 | 2021-06-08 | Kci Licensing, Inc. | Low profile flexible pressure transmission conduit |
US10406266B2 (en) | 2014-05-02 | 2019-09-10 | Kci Licensing, Inc. | Fluid storage devices, systems, and methods |
US11957546B2 (en) | 2014-06-05 | 2024-04-16 | 3M Innovative Properties Company | Dressing with fluid acquisition and distribution characteristics |
US10561534B2 (en) | 2014-06-05 | 2020-02-18 | Kci Licensing, Inc. | Dressing with fluid acquisition and distribution characteristics |
US10398604B2 (en) | 2014-12-17 | 2019-09-03 | Kci Licensing, Inc. | Dressing with offloading capability |
US11246975B2 (en) | 2015-05-08 | 2022-02-15 | Kci Licensing, Inc. | Low acuity dressing with integral pump |
US11950984B2 (en) | 2015-09-01 | 2024-04-09 | Solventum Intellectual Properties Company | Dressing with increased apposition force |
US11096830B2 (en) | 2015-09-01 | 2021-08-24 | Kci Licensing, Inc. | Dressing with increased apposition force |
US10973694B2 (en) | 2015-09-17 | 2021-04-13 | Kci Licensing, Inc. | Hybrid silicone and acrylic adhesive cover for use with wound treatment |
WO2017064495A1 (en) * | 2015-10-14 | 2017-04-20 | Selentus Science Limited | Haemostatic device |
CN108136080B (en) * | 2015-10-14 | 2022-06-24 | 赛兰特科学有限公司 | Hemostatic device |
GB2543307B (en) * | 2015-10-14 | 2020-12-09 | Selentus Science Ltd | Haemostatic device |
US20180303980A1 (en) * | 2015-10-14 | 2018-10-25 | Selentus Science Limited | Haemostatic device |
CN108136080A (en) * | 2015-10-14 | 2018-06-08 | 赛兰特科学有限公司 | Hemostasis device |
US10653821B2 (en) | 2015-10-14 | 2020-05-19 | Selentus Science Limited | Haemostatic device |
US10524956B2 (en) | 2016-01-07 | 2020-01-07 | Zeltiq Aesthetics, Inc. | Temperature-dependent adhesion between applicator and skin during cooling of tissue |
CN108472151B (en) * | 2016-01-07 | 2020-10-27 | 斯尔替克美学股份有限公司 | Temperature-dependent adhesion between applicator and skin during tissue cooling |
CN108472151A (en) * | 2016-01-07 | 2018-08-31 | 斯尔替克美学股份有限公司 | Temperature dependency between tissue cooling period applicator and skin adheres to |
WO2017120538A1 (en) * | 2016-01-07 | 2017-07-13 | Zeltiq Aesthetics, Inc. | Temperature-dependent adhesion between applicator and skin during cooling of tissue |
US11433223B2 (en) | 2016-07-01 | 2022-09-06 | Boston Scientific Scimed, Inc. | Delivery devices and methods |
US11406771B2 (en) | 2017-01-10 | 2022-08-09 | Boston Scientific Scimed, Inc. | Apparatuses and methods for delivering powdered agents |
US11701448B2 (en) | 2018-01-12 | 2023-07-18 | Boston Scientific Scimed, Inc. | Powder for achieving hemostasis |
US11766546B2 (en) | 2018-01-31 | 2023-09-26 | Boston Scientific Scimed, Inc. | Apparatuses and methods for delivering powdered agents |
US11642281B2 (en) | 2018-10-02 | 2023-05-09 | Boston Scientific Scimed, Inc. | Endoscopic medical device for dispensing materials and method of use |
US11833539B2 (en) | 2018-10-02 | 2023-12-05 | Boston Scientific Scimed, Inc. | Fluidization devices and methods of use |
US11931003B2 (en) | 2019-12-03 | 2024-03-19 | Boston Scientific Scimed, Inc. | Medical devices for agent delivery and related methods of use |
US11918780B2 (en) | 2019-12-03 | 2024-03-05 | Boston Scientific Scimed, Inc. | Agent administering medical device |
US11969318B2 (en) | 2020-08-24 | 2024-04-30 | Solventum Intellectual Properties Company | Releasable medical drapes |
Also Published As
Publication number | Publication date |
---|---|
KR20070001915A (en) | 2007-01-04 |
NZ548079A (en) | 2009-09-25 |
JP4812630B2 (en) | 2011-11-09 |
CA2548527A1 (en) | 2005-07-14 |
MXPA06007343A (en) | 2007-01-26 |
EP1699397A2 (en) | 2006-09-13 |
IL176036A0 (en) | 2006-10-05 |
AU2004308415A1 (en) | 2005-07-14 |
JP2007516051A (en) | 2007-06-21 |
WO2005062896A3 (en) | 2005-11-10 |
KR101105081B1 (en) | 2012-01-16 |
NO20062550L (en) | 2006-09-22 |
EP1699397A4 (en) | 2012-02-15 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
US20050147656A1 (en) | Tissue dressing assemblies, systems, and methods formed from hydrophilic polymer sponge structures such as chitosan | |
WO2005062896A2 (en) | Tissue dressing assemblies, systems, and methods formed from hydrophilic polymer sponge structures such as chistosan | |
ZA200605125B (en) | Tissue dressing assemblies, systems, and methods formed from hydrophilic polymer sponge structures such as chistosan | |
US20060004314A1 (en) | Antimicrobial barriers, systems, and methods formed from hydrophilic polymer structures such as chistosan | |
US8668924B2 (en) | Wound dressing and method for controlling severe, life-threatening bleeding | |
US8269058B2 (en) | Absorbable tissue dressing assemblies, systems, and methods formed from hydrophilic polymer sponge structures such as chitosan | |
US20070082023A1 (en) | Supple tissue dressing assemblies, systems, and methods formed from hydrophilic polymer sponge structures such as chitosan | |
US20070066920A1 (en) | Supple tissue dressing assemblies, systems, and methods formed from hydrophilic polymer sponge structures such as chitosan | |
EP2173293A1 (en) | Absorbable tissue dressing assemblies, systems, and methods formed from hydrophilic polymer sponge structures such as chistosan | |
EP2061413A2 (en) | Supple tissue dressing assemblies, systems, and methods formed from hydrophilic polymer sponge structures such as chitosan | |
IL184044A (en) | Antimicrobial barriers including a chitosan biomaterial and methods for the manufacture thereof | |
US20080128932A1 (en) | Supple tissue dressing assemblies, systems, and methods formed from hydrophilic polymer sponge structures such as chitosan |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
AK | Designated states |
Kind code of ref document: A2 Designated state(s): AE AG AL AM AT AU AZ BA BB BG BR BW BY BZ CA CH CN CO CR CU CZ DE DK DM DZ EC EE EG ES FI GB GD GE GH GM HR HU ID IL IN IS JP KE KG KP KR KZ LC LK LR LS LT LU LV MA MD MG MK MN MW MX MZ NA NI NO NZ OM PG PH PL PT RO RU SC SD SE SG SK SL SY TJ TM TN TR TT TZ UA UG US UZ VC VN YU ZA ZM ZW |
|
AL | Designated countries for regional patents |
Kind code of ref document: A2 Designated state(s): BW GH GM KE LS MW MZ NA SD SL SZ TZ UG ZM ZW AM AZ BY KG KZ MD RU TJ TM AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HU IE IS IT LT LU MC NL PL PT RO SE SI SK TR BF BJ CF CG CI CM GA GN GQ GW ML MR NE SN TD TG |
|
121 | Ep: the epo has been informed by wipo that ep was designated in this application | ||
DPEN | Request for preliminary examination filed prior to expiration of 19th month from priority date (pct application filed from 20040101) | ||
WWE | Wipo information: entry into national phase |
Ref document number: 176036 Country of ref document: IL Ref document number: 2004308415 Country of ref document: AU |
|
WWE | Wipo information: entry into national phase |
Ref document number: 2548527 Country of ref document: CA |
|
WWE | Wipo information: entry into national phase |
Ref document number: 2006/05125 Country of ref document: ZA Ref document number: 200605125 Country of ref document: ZA Ref document number: 548079 Country of ref document: NZ Ref document number: 2006547315 Country of ref document: JP |
|
ENP | Entry into the national phase |
Ref document number: 2004308415 Country of ref document: AU Date of ref document: 20041222 Kind code of ref document: A |
|
WWE | Wipo information: entry into national phase |
Ref document number: 1020067012470 Country of ref document: KR |
|
WWP | Wipo information: published in national office |
Ref document number: 2004308415 Country of ref document: AU |
|
WWE | Wipo information: entry into national phase |
Ref document number: PA/a/2006/007343 Country of ref document: MX |
|
NENP | Non-entry into the national phase |
Ref country code: DE |
|
WWW | Wipo information: withdrawn in national office |
Ref document number: DE |
|
WWE | Wipo information: entry into national phase |
Ref document number: 2004815250 Country of ref document: EP |
|
WWP | Wipo information: published in national office |
Ref document number: 2004815250 Country of ref document: EP |
|
WWP | Wipo information: published in national office |
Ref document number: 1020067012470 Country of ref document: KR |
|
ENP | Entry into the national phase |
Ref document number: PI0417991 Country of ref document: BR |