US20210085820A1 - Hemostatic material and wound dressing containing same - Google Patents

Hemostatic material and wound dressing containing same Download PDF

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Publication number
US20210085820A1
US20210085820A1 US16/634,304 US201716634304A US2021085820A1 US 20210085820 A1 US20210085820 A1 US 20210085820A1 US 201716634304 A US201716634304 A US 201716634304A US 2021085820 A1 US2021085820 A1 US 2021085820A1
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US
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Prior art keywords
wound
cationized cellulose
hemostatic
cellulose
wound dressing
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Abandoned
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US16/634,304
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English (en)
Inventor
Kazuhiko Shibata
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Artisan Lab Co Ltd
Nipro Corp
Original Assignee
Artisan Lab Co Ltd
Nipro Corp
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Publication date
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Assigned to ARTISAN LAB CO., LTD., NIPRO CORPORATION reassignment ARTISAN LAB CO., LTD. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: SHIBATA, KAZUHIKO
Publication of US20210085820A1 publication Critical patent/US20210085820A1/en
Abandoned legal-status Critical Current

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    • 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
    • A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
    • A61L24/04—Surgical adhesives or cements; Adhesives for colostomy devices containing macromolecular materials
    • A61L24/08—Polysaccharides
    • 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
    • A61L15/44—Medicaments
    • 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
    • A61L15/46—Deodorants or malodour counteractants, e.g. to inhibit the formation of ammonia or bacteria
    • 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
    • A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
    • A61L24/001—Use of materials characterised by their function or physical properties
    • A61L24/0015—Medicaments; Biocides
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08B—POLYSACCHARIDES; DERIVATIVES THEREOF
    • C08B15/00—Preparation of other cellulose derivatives or modified cellulose, e.g. complexes
    • C08B15/05—Derivatives containing elements other than carbon, hydrogen, oxygen, halogens or sulfur
    • C08B15/06—Derivatives containing elements other than carbon, hydrogen, oxygen, halogens or sulfur containing nitrogen, e.g. carbamates
    • 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
    • A61L2300/23—Carbohydrates
    • A61L2300/232—Monosaccharides, disaccharides, polysaccharides, lipopolysaccharides
    • 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/404—Biocides, antimicrobial agents, antiseptic agents
    • 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
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/418—Agents promoting blood coagulation, blood-clotting agents, embolising agents
    • 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 present invention relates to a hemostatic material, and a wound dressing containing the hemostatic material.
  • Known skin wound healing mechanisms are such that (1) when the skin is damaged, platelets gather around and in the wound and coagulate the blood to stop bleeding, (2) neutrophils and macrophages gather around the wound to phagocytose and remove necrotic tissue and bacteria, (3) fibroblasts gather to shrink the wound, and (4) epidermal cells migrate and gather to epithelialize the wound.
  • cytokines For wound healing, various living cells are required to gather and function around and in the wound as described above. Many cytokines including growth factors summon cells required for wound healing to the wound. It is important for quick wound healing to maintain an environment where cells gathered around and in the wound by cytokines can actively function.
  • a wound dressing is a member that provides a moist environment by covering a wounded site and promotes wound healing.
  • Hydrogels which are widely used as components of wound dressings, have no effect in regard to as antibacterial and hemostatic properties and, it is not easy to degrade some kinds of hydrogels by microorganisms when buried in the soil. For this reason, some kinds of hydrogels are disposed by incineration or burying, and may generate dioxin if the temperature of a combustion furnace falls upon incineration. In the case of disposal by burying, securing of a burial place is becoming difficult, and thus a product causing no dioxin generation by incineration and having a small environmental burden is required.
  • chitosan could be an allergen leading to shellfish allergy, and the use of a hemostatic material or a wound dressing made of chitosan as a raw material may cause a severe allergic reaction in a person who is allergic to shellfish.
  • a formulation produced with chitosan as a raw material is used for wounds, and specifically, when such a formulation is prescribed for a person with a shellfish allergy, care should be taken and another formulation should be used if possible.
  • there is a potential risk of developing allergy since a person being prescribed may not be previously noticed that he/she has a shellfish allergy.
  • crab or shrimp crusts which are not originally sterile, are used as a raw material for mass production of chitosan.
  • endotoxins which are secreted by bacteria and harmful to human bodies, when chitosan is isolated.
  • pathological conditions induced by endotoxins include lethal shock, fever, activation of complements, activation of leukocytes, and damage to vascular endothelial cells, etc.
  • a first aspect of the present invention provides a hemostatic material comprising cationized cellulose.
  • Another aspect of the present invention provides a wound dressing comprising a hemostatic material containing cationized cellulose as a component.
  • Yet another aspect of the present invention provides a wound dressing comprising cationized cellulose.
  • Cellulose is a natural compound produced by plants in their bodies through photosynthesis.
  • wound dressings mainly made of cellulose such as Dermafill and XCell Cellulose Wound Dressings
  • wound dressings containing carboxymethyl cellulose which is a cellulose derivative
  • carboxymethyl cellulose which is a cellulose derivative
  • these products have water-holding capacity, but lack antibacterial and hemostatic properties. Therefore, wound dressings containing cellulose or carboxymethyl cellulose as a main component cannot suppress internal bacterial growth and bleeding complications when wounds are covered.
  • cationized cellulose has a positively charged functional group and thus has both hemostatic and antibacterial properties.
  • the hemostatic property was examined and confirmed using activated clotting time.
  • antibacterial property it was confirmed that cationized cellulose has an antibacterial property through culturing of skin indigenous bacteria of medical practitioners in an agar medium, followed by formation of a blocking circle around the filter paper impregnated with the gelled cationized cellulose during bacterial culture.
  • cationized cellulose is contained in a hemostatic material or a wound dressing that directly contacts a wound.
  • the hemostatic material or the wound dressing directly contacts bacteria at the wound site, whereby the cationized cellulose can exhibit antibacterial activity due to the positive charge of the cationized cellulose.
  • the above cationized cellulose may be of formula (1):
  • R 1 each represent —H, or —(CH 2 CH 2 O) n —H,
  • R 2 represents C 1-6 alkylene, C 2-6 hydroxyalkylene, —(CH 2 CH 2 O) l —, or a combination thereof,
  • l 1 or 2
  • n 1 or 2
  • R 3 , R 4 and R 5 each represent C 1-6 alkyl, C 1-6 alkenyl, O—C 1-6 alkyl, C a Y b heteroalkyl or heteroalkenyl, wherein Y represents a hetero atom, (a+b) ranges from 4 to 6, and a saturated or unsaturated 5- or 6-membered ring containing a nitrogen atom is formed upon binding with the nitrogen atom.
  • the at least one R 1 represents —CH 2 CH 2 O—CH 2 CH(OH)CH 2 —N + (R 3 ) (R 4 ) (R 5 ).
  • X ⁇ , and R 3 , R 4 and R 5 may represent a methyl or an ethyl group.
  • the at least one R 1 may represent —CH 2 CH(OH)CH 2 N + (R 3 ) (R 4 ) (R 5 ).
  • X ⁇ , and R 3 , R 4 and R 5 may each represent a methyl or an ethyl group.
  • the anionic group may be a halide ion, a phosphoric acid ester group, a carboxyl group, a sulfonic acid group, a sulfuric acid ester group or the like.
  • the halide ion may be a fluoride ion, a chloride ion, a bromide ion, or an iodide ion.
  • At least one of the other R 1 may also represent —(CH 2 CH 2 O) n H.
  • FIG. 1A is the image of a medium demonstrating the antibacterial property of cationized cellulose in one embodiment of the present invention.
  • FIG. 1B is the image of another medium demonstrating the antibacterial property of cationized cellulose in one embodiment of the present invention.
  • FIG. 1C is the image of yet another medium demonstrating the antibacterial property of cationized cellulose in one embodiment of the present invention.
  • hemostatic material and the wound dressing according to the present invention will be described.
  • the general formula representing cationized cellulose contained in the hemostatic material and the wound dressing according to the present embodiment is shown below. Any of the 2-, 4- and 6-position hydroxyl groups of glucose that forms cellulose is modified with a cationized functional group.
  • the cationized cellulose used in the present embodiment can be purchased as a commercial product, and can be synthesized by applying a general synthesis method employed for chemical modification of glucan.
  • 3-chloro-2-hydroxypropyltrimethylammonium chloride (2.3 g) as a cationizing agent is added to a solution prepared by dissolving 1.0 g of cellulose in 20 mL of a 1N sodium hydroxide aqueous solution, and then the solution is stirred at 30° C. to 50° C.
  • the resulting solution is neutralized with 4N acetic acid and then separated by dialysis membrane using distilled water.
  • the obtained solution is lyophilized, so that a desired product can be obtained.
  • Cellulose (2.0 g) is reacted with ethylene oxide under known conditions to synthesize hydroxyethyl cellulose.
  • Glycidyl trimethyl ammonium chloride (4.5 g) as a cationizing agent is added to a solution prepared by dissolving the obtained hydroxyethyl cellulose in 20 mL of a 1N sodium hydroxide aqueous solution, and then the solution is stirred at 30° C. to 50° C.
  • the resulting solution is neutralized with 4N acetic acid and then separated by dialysis membrane using distilled water.
  • the obtained solution is lyophilized, so that a desired product can be obtained.
  • FIGS. 1A to 1C The results of the experiment for confirmation of the antibacterial activity are shown in FIGS. 1A to 1C .
  • All of Medium 1 ( FIG. 1A ), Medium 2 ( FIG. 1B ) and Medium 3 ( FIG. 1C ) inhibition circles were observed around the discs impregnated with the cationized cellulose gel.
  • FIGS. 1A to 1C the results of using the filter paper impregnated with POIZ C-60H is shown on the left and the result of using the same impregnated with POIZ C-150L is shown on the right, and both groups of POIZ C-60H and POIZ C-150L exhibit equivalent antibacterial property.
  • results could confirm that the cationized cellulose has effects of promoting coagulation and stopping bleeding. Further, the results could also confirm that the cationized cellulose has hemostatic property higher than that of chitosan which is generally used for wound dressings.
  • KALTOSTAT registered trademark
  • alginic acid has a weak hemostatic function compared to chitosan (Syota Suzuki, Kazuhiko Shibata, Randomized Trial comparing New Chitosan-Based Bandage with Kaltostat Hemostatic Dressing to Control Bleeding from Hemodialysis Puncture Site, Nephrol. Dial.
  • chitosan has low water-holding ability, so neither is sufficient as bases for moist treatment.
  • a method that has been widely spread involves frequently replacing dressings attached to a wound site and cleaning the wound site every replacement. This is because a problem is becoming clear such that sealing the wound site by leaving a dressing applied to the wound site results in the formation of an environment suitable for the growth of bacteria present at the wound site, which in turn delays the healing of the wound site.
  • cationized cellulose can be gelled. Accordingly, a hemostatic material containing cationized cellulose can be applied directly to the wound site. Even if the wound is irregular in shape, the hemostatic is applied in this manner, so as to be able to ensure its contact with the wound surface. Moreover, the applied gel is covered and pressed with a gauze, a film or the like, so that hemostasis can be achieved. After confirmation of hemostasis, it is also possible to release the pressure and use continuously the gel as a wound dressing.
  • cationized cellulose has an antibacterial property. Therefore, even in a situation where cationized cellulose in the form of film or gel contacts directly the wound site, an antibacterial environment more suitable for healing can be maintained until wound healing.
  • a waterproof film may be replaced by a breathable film in case the amount of an exudate is further increased.

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
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  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
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US16/634,304 2017-08-01 2017-08-01 Hemostatic material and wound dressing containing same Abandoned US20210085820A1 (en)

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PCT/JP2017/027890 WO2019026177A1 (fr) 2017-08-01 2017-08-01 Matériau hémostatique et matériau pour pansement en contenant

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EP (1) EP3662937A4 (fr)
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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
USD944996S1 (en) * 2017-05-11 2022-03-01 Mölnlycke Health Care Ab Wound dressing

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US8852630B2 (en) * 2008-05-13 2014-10-07 Yale University Chimeric small molecules for the recruitment of antibodies to cancer cells
JPWO2021132663A1 (fr) * 2019-12-26 2021-07-01

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Publication number Priority date Publication date Assignee Title
USD944996S1 (en) * 2017-05-11 2022-03-01 Mölnlycke Health Care Ab Wound dressing

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Publication number Publication date
EP3662937A1 (fr) 2020-06-10
EP3662937A4 (fr) 2021-03-10
CN110997018A (zh) 2020-04-10
US11938230B2 (en) 2024-03-26
CN115475276A (zh) 2022-12-16
US20220378974A1 (en) 2022-12-01
WO2019026177A1 (fr) 2019-02-07

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