WO2017196287A1 - Pansement à gel hydraulique pour traiter des brûlures et des ulcères trophiques et procédé de sa fabrication - Google Patents

Pansement à gel hydraulique pour traiter des brûlures et des ulcères trophiques et procédé de sa fabrication Download PDF

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Publication number
WO2017196287A1
WO2017196287A1 PCT/UA2016/000095 UA2016000095W WO2017196287A1 WO 2017196287 A1 WO2017196287 A1 WO 2017196287A1 UA 2016000095 W UA2016000095 W UA 2016000095W WO 2017196287 A1 WO2017196287 A1 WO 2017196287A1
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WO
WIPO (PCT)
Prior art keywords
hydrogel
dressing
mesh
gel
burn wounds
Prior art date
Application number
PCT/UA2016/000095
Other languages
English (en)
Russian (ru)
Inventor
Владимир Викторович ТАВОКИН
Original Assignee
Владимир Викторович ТАВОКИН
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from UAU201605222U external-priority patent/UA109212U/uk
Priority claimed from UAU201605223U external-priority patent/UA109213U/uk
Application filed by Владимир Викторович ТАВОКИН filed Critical Владимир Викторович ТАВОКИН
Priority to DE212016000276.7U priority Critical patent/DE212016000276U1/de
Publication of WO2017196287A1 publication Critical patent/WO2017196287A1/fr

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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
    • A61F13/00051—Accessories for dressings
    • A61F13/00063—Accessories for dressings comprising medicaments or additives, e.g. odor control, PH control, debriding, antimicrobic
    • A61F13/01017—
    • 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
    • A61L15/24—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds; Derivatives thereof
    • 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
    • A61L15/60—Liquid-swellable gel-forming materials, e.g. super-absorbents
    • 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
    • A61F2013/00157—Wound bandages for burns or skin transplants
    • 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
    • A61L2400/12—Nanosized materials, e.g. nanofibres, nanoparticles, nanowires, nanotubes; Nanostructured surfaces
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B82—NANOTECHNOLOGY
    • B82Y—SPECIFIC USES OR APPLICATIONS OF NANOSTRUCTURES; MEASUREMENT OR ANALYSIS OF NANOSTRUCTURES; MANUFACTURE OR TREATMENT OF NANOSTRUCTURES
    • B82Y5/00—Nanobiotechnology or nanomedicine, e.g. protein engineering or drug delivery

Definitions

  • Hydrogel dressing for the treatment of burn wounds and trophic ulcers and a method for its manufacture.
  • the present invention relates to medicine, namely to dressings for the treatment of burn wounds and trophic ulcers, mainly at the stages of granulation tissue formation and epithelization, and to methods for their manufacture.
  • a hydrogel dressing for the treatment of burn wounds and trophic ulcers which contains a gel-forming composition based on acrylamide and water fixed on the grid [Patent for invention N ° 2157243, RF, IPC 7 A61 L15 / 22, Publ. 10.10.2000].
  • the gel-forming composition is poured or placed on a mesh lining.
  • the mentioned dressing has insufficient strength, and therefore is destroyed when it is removed from the wound, which does not exclude additional injury to the wound and pain in patients.
  • a method of manufacturing a hydrogel dressing for the treatment of burn wounds and trophic ulcers which includes the manufacture of a gel-forming composition based on acrylamide and water, and its connection with the mesh [Patent for invention JV ° 2157243, RF, IPC 7 A61L15 / 22, Publ. 10.10.2000].
  • the gelling composition is poured or placed on a mesh lining.
  • the dressing obtained by the aforementioned method has insufficient strength, and therefore is destroyed when it is removed from the wound, which does not exclude additional injury to the wound and pain in patients.
  • the basis of the proposed inventions is the task of creating such a hydrogel dressing for the treatment of burn wounds and trophic ulcers and a method for its manufacture, which would make it possible to obtain hydrogel dressings of greater strength with an extended residence time on the wound, and which could have or acquire before use certain defined by the treating person by a doctor for a particular patient (patient), the properties, in particular, could be painkillers and / or hemostatic, for the purpose of their use, for example, in working with Ora medical care, for example, to assist the victims in the accident.
  • the problem is solved by creating conditions for increasing the strength of the dressing and increasing its duration by forming hydrogels with a polymer frame attached to planar polymer surfaces of the heat-treated mesh of synthetic fibers, and also due to the possibility of obtaining additional positive qualities of the dressing, namely, reduced humidity in the initial state during its storage and transportation, but with the possibility of its impregnation with medicinal and / or pharmaceutical liquids for increasing its moisture content and acquiring properties determined by the attending physician immediately before applying it to a wound or ulcer.
  • the proposed like the well-known hydrogel dressing for the treatment of burn wounds and trophic ulcers, contains a gel-forming composition based on acrylamide and water fixed on a grid, and, according to the invention, the grid is made of heat-treated threads based on synthetic, for example polypropylene, fibers.
  • a feature of the proposed hydrogel dressing is that the outer surfaces of the dressing are saturated with healing clays, for example, silicite and / or bentonite nanoparticles.
  • a feature of the proposed hydrogel dressing is that it has a moisture content of 75-95%, is impregnated with the drug and placed in a sealed sterile package.
  • a feature of the proposed hydrogel dressing is that it is made with the possibility of saturation with solutions of drugs, has a thickness of 0.5-3.0 mm and a moisture content of 9-12%.
  • the proposed, as well as the known method of manufacturing a hydrogel dressing for the treatment of burn wounds and trophic ulcers includes the manufacture of a gel-forming composition based on acrylamide and water, and their connection with a mesh, and, according to the invention, a mesh is knitted from synthetic threads, for example polypropylene fibers, they are cleaned of impurities, placed on the frame in a stretched state and heat treated by heating the grid in a thermostat to a temperature of +40 - + 140 ° C, withstanding the grid and this temperature for 20 to 45 minutes and then cool it to room temperature together with a thermostat, and perform its activation in the medium of either peroxide, or ozone, or chromium oxide, or acid, the resulting grid on the frame is placed in a plane-parallel form, into which the gel-forming composition is poured, air is removed from the mold and the mold is kept with the gel-forming composition and the net inside the mold for 14-15 hours at a temperature of 75-85 ° C until the formation of the hydro
  • a feature of the proposed method is that before use, the hydrogel dressing is saturated either with medicinal solutions, or emulsions, or with distilled water, by immersing the hydrogel dressing in an appropriate solution or emulsion or distilled water and the dressing is kept until its moisture content reaches 75-95%.
  • Another feature of the proposed method is that before use, the outer surfaces of the hydrogel dressing are saturated with healing clays, for example, silicite and / or bentonite nanoparticles.
  • the proposed hydrogel dressing is more durable than the dressing made by the prototype method.
  • Elasticity is the ability of a material to reverse deformations and stretch.
  • the gel-forming composition of the dressing made by the proposed method is directed to the formation of hydrogels with a polymer skeleton attached to planar polymer surfaces of a mesh of synthetic fibers.
  • a gelling composition includes acrylamide, bisacrylamide, potassium acrylate, potassium persulfate, polyethylene glycol and water with this ratio of components (in May.%):
  • the proposed composition has been determined experimentally and is aimed at increasing the time for the gel to dry, increasing its ability to saturate with medicinal substances, and reducing the likelihood of the hydrogel dressing sticking to the wound surface even after the end of the period prescribed by the attending physician for its stay on the wound.
  • Acrylamide is the main component of the construction of the polymer macromolecule.
  • Bisacrylamide is a binder component of polymer macromolecules.
  • Potassium acrylate is an integral part of the construction of polymer macromolecules, which gives them stability.
  • Polyethylene glycol - gives the bandage elasticity and atraumatism.
  • Potassium persulfate is the initiator of the polymerization reaction.
  • composition and ratio of ingredients can be adjusted depending on the technological capabilities of the manufacturer.
  • the optimal composition and the ratio of ingredients is selected empirically. In doing so, pay attention to the following:
  • composition of the gel-forming composition in addition to the above, creates conditions for its saturation with solutions of substances that have painkillers, or hemostatic, or anti-inflammatory, or anti-inflammatory, or anesthetic and healing properties, which make it possible to prolong the release of a medicinal or pharmaceutical substance from a dressing to a wound.
  • Using the proposed method allows you to create dressings that provide a flexible implementation of the healing properties of substances that saturate or cover the gel-forming composition, which makes it possible to create the optimal composition of the medicinal substance for a particular patient immediately before using the dressing and, by means of the gel-forming composition of the proposed composition, increase the time of its exit to the wound.
  • Saturation of the external surfaces of the dressing with healing clays increases its sorbing, anti-inflammatory and healing properties and at the same time increases the drying time of the gel, which extends the healing time of the dressing on the wound, reduces the dressability of the dressing as during application to the wound , and during its removal from the wound.
  • healing clays for example, silicite and / or bentonite nanoparticles
  • the technical result obtained as a result of the implementation of the invention consists in the possibility of obtaining a dressing increased strength, with the ability to soak it before using medicinal and / or pharmaceutical fluids to increase its moisture content and to acquire the properties set by the attending physician for a particular patient.
  • the proposed hydrogel dressing for the treatment of burn wounds and trophic ulcers consists of known structural elements, and the method for its manufacture includes currently known technological methods, tools and materials.
  • the proposed hydrogel dressing for the treatment of burn wounds and trophic ulcers can be used in various sectors of the economy, in medicine, cosmetology and for the prevention of various diseases, and therefore we can conclude that the proposed solutions meet the criteria of the invention "industrial applicability".
  • a hydrogel dressing was prepared for the treatment and anesthesia of trophic ulcers of the lower leg, which arose as a recurring complication of deep varicose veins of the legs.
  • Pre-made knitted mesh from synthetic - polypropylene thread cleaned the mesh from contamination.
  • the mesh was fixed by heating it in a thermostat to a temperature of 40–140 ° ⁇ , kept at this temperature for 20–45 minutes, and cooled to room temperature with a thermostat.
  • the polyperoxide activation method was used.
  • Mesh activation can also be performed either with ozone, or chromium oxide, or with the acid activation method [Kuleznev V.N., Shershnev V. A. Chemistry and physics of polymers.
  • the activation of the mesh allows the polypropylene mesh to covalently bond with the gel-forming composition and create a strong gel plate with a strong and at the same time elastic frame.
  • the gelling composition included acrylamide, bisacrylamide, potassium acrylate, polyethylene glycol, potassium persulfate and water with this ratio of components (in May.%):
  • the listed components were mixed and poured into a plane-parallel form with a heat-treated mesh made of threads based on polypropylene fibers.
  • the air was removed from the mold and the mold was heated with the composition and the net inside for 14-15 hours at a temperature of 75-85 ° C.
  • the formed hydrogel was purified from low molecular weight compounds by washing the gel with a 40-60% ethanol gel, dehydrated to a predetermined moisture content of the composition 9-12% and a plate with a thickness of 0.5-3.0 mm was obtained.
  • the manufactured plate was sterilized and a hydrogel dressing was obtained, which can be stored in an airtight container for a long period of use.
  • the hydrogel dressing was removed from the sealed package and saturated at the first stage of anesthesia and treatment of trophic ulcers of the lower leg with a solution of lidocaine hydrochloride in distilled water. For this, a calculated amount of a 3% solution of lidocaine hydrochloride was prepared. The plate was immersed in said solution and kept for 30-40 minutes. During this time, the hydrogel dressing absorbed the indicated solution and the value of its moisture increased to 85-95%. Then, the outer surfaces of the dressing were saturated with healing clay nanoparticles, for example, silicite and / or bentonite. The bandage prepared for use was applied without pressing against a trophic ulcer and fixed for 3-5 days.
  • the hydrogel dressing can be saturated, for example, with a 2% solution of lidocaine hydrochloride in distilled water with epinephrine (1: 50,000 - 1: 100,000). Moreover, in a 2% solution of lidocaine hydrochloride, epinephrine was added at the rate of 1 drop 0, 1% ”- epinephrine solution per 10 ml of a 2% solution of lidocaine. At the same time, epinephrine slows down the absorption of lidocaine and prolongs its effect. It is also possible to saturate the hydrogel dressing with a microcid.
  • the proposed hydrogel dressing was located on the ulcer twice as long without drying out - 1 10 - 120 hours (almost 5 days), which allowed, due to the prolonged duration of the action and the reduction of the ulcer injury both during its application and during its removal, to obtain a positive result is to significantly reduce the patient’s pain for the duration of the bandage.
  • the fact of an increase in the epithelium from the edge of the ulcer was recorded 5-7 days after the hydrogel dressing was located on the ulcer.
  • the proposed hydrogel dressing for the treatment of burn wounds and trophic ulcers unlike the prototype dressing, has greater strength and longer duration due to the use of a high-strength mesh in it.
  • This dressing has increased elasticity and is easily modeled in deep wounds and on wounds with complex surface relief.
  • the present invention can be applied to the manufacture of dressings intended for the effective treatment of wounds from a variety of wounds, including wounds such as "diabetic foot", pressure sores, etc.
  • hydrogel dressings with a moisture content of 75-95% impregnated with a certain medicinal product and placed in hermetic sterile packaging, which for use can only be removed from the package and fixed on the wound, are especially valuable and effective in emergency medical conditions.
  • the proposed invention allows the creation of hydrogel dressings with a flexible implementation of the healing properties of the substances that saturate them, and with the possibility of their immediate use even in the field.

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Materials Engineering (AREA)
  • Epidemiology (AREA)
  • Hematology (AREA)
  • Medicinal Chemistry (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Dispersion Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Materials For Medical Uses (AREA)
  • Medicinal Preparation (AREA)

Abstract

L'invention concerne la médecine. Le pansement à gel hydraulique pour le traitement de brûlures et des ulcères trophiques comprend, fixées sur la grille, une composition en forme de gel à base d'acrylamide et d'eau. La grille est préparée par traitement thermique à partir de fils à base de fibres synthétiques, notamment de fibres en polypropylène. Le pansement possède une meilleure résistance mécanique, une plus longue durée de vie sur la blessure et une élasticité préprogrammée qui diminue l'effet blessant sur la plaie. Le procédé de fabrication d'un pansement à gel hydraulique comprend la fabrication d'une composition de gel hydraulique et la connexion d'une composition avec une grille. La grille est préalablement nettoyée, disposée à l'état étendu et soumise à un traitement thermique grâce à un réchauffement à 40-140°C pendant 20-45 min, puis refroidie et soumise à une activation dans un milieu de peroxyde, d'ozone, d'oxyde de chrome ou d'acide. La grille est ensuite placée dans un moule dans lequel on fait couler une composition gélifiante, on évacue l'air du moule et on le retient pendant 14-15 heures à 75-85°C jusqu'à la formation d'une plaquette qui est rincée, déshydratée et stérilisée pour obtenir un pansement.
PCT/UA2016/000095 2016-05-13 2016-07-29 Pansement à gel hydraulique pour traiter des brûlures et des ulcères trophiques et procédé de sa fabrication WO2017196287A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
DE212016000276.7U DE212016000276U1 (de) 2016-05-13 2016-07-29 Hydrogelverband zur Behandlung von Brandwunden und trophischen Geschwüren

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
UAU201605222U UA109212U (uk) 2016-05-13 2016-05-13 Гідрогелева пов'язка для лікування опікових ран та трофічних виразок
UAU201605222 2016-05-13
UAU201605223U UA109213U (uk) 2016-05-13 2016-05-13 Спосіб виготовлення гідрогелевої пов'язки для лікування опікових ран та трофічних виразок
UAU201605223 2016-05-13

Publications (1)

Publication Number Publication Date
WO2017196287A1 true WO2017196287A1 (fr) 2017-11-16

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Family Applications (1)

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PCT/UA2016/000095 WO2017196287A1 (fr) 2016-05-13 2016-07-29 Pansement à gel hydraulique pour traiter des brûlures et des ulcères trophiques et procédé de sa fabrication

Country Status (2)

Country Link
DE (1) DE212016000276U1 (fr)
WO (1) WO2017196287A1 (fr)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1988006894A1 (fr) * 1987-03-13 1988-09-22 Ed Geistlich Söhne A.G. Für Chemische Industrie Pansements
US5292328A (en) * 1991-10-18 1994-03-08 United States Surgical Corporation Polypropylene multifilament warp knitted mesh and its use in surgery
RU2157243C1 (ru) * 1999-07-01 2000-10-10 Пищуров Александр Николаевич Гидрогелевая композиция и перевязочные средства из нее для лечения ран различной этиологии
WO2011160862A1 (fr) * 2010-06-21 2011-12-29 Closed Stock Company "Institute Of Applied Nanotechnology" Bandage pour plaies à propriétés antimicrobiennes

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1988006894A1 (fr) * 1987-03-13 1988-09-22 Ed Geistlich Söhne A.G. Für Chemische Industrie Pansements
US5292328A (en) * 1991-10-18 1994-03-08 United States Surgical Corporation Polypropylene multifilament warp knitted mesh and its use in surgery
RU2157243C1 (ru) * 1999-07-01 2000-10-10 Пищуров Александр Николаевич Гидрогелевая композиция и перевязочные средства из нее для лечения ран различной этиологии
WO2011160862A1 (fr) * 2010-06-21 2011-12-29 Closed Stock Company "Institute Of Applied Nanotechnology" Bandage pour plaies à propriétés antimicrobiennes

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