WO1997041900A1 - Hydrogels - Google Patents

Hydrogels Download PDF

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Publication number
WO1997041900A1
WO1997041900A1 PCT/GB1997/001244 GB9701244W WO9741900A1 WO 1997041900 A1 WO1997041900 A1 WO 1997041900A1 GB 9701244 W GB9701244 W GB 9701244W WO 9741900 A1 WO9741900 A1 WO 9741900A1
Authority
WO
WIPO (PCT)
Prior art keywords
hydrogel
sodium
coherent
product
fibres
Prior art date
Application number
PCT/GB1997/001244
Other languages
French (fr)
Inventor
Denis Keith Gilding
Yimin Qin
Original Assignee
Innovative Technologies Limited
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Innovative Technologies Limited filed Critical Innovative Technologies Limited
Priority to EP97920851A priority Critical patent/EP0901382B1/en
Priority to DE69727801T priority patent/DE69727801T2/en
Priority to JP09539660A priority patent/JP2000510718A/en
Priority to US09/180,171 priority patent/US6534083B2/en
Priority to AU27071/97A priority patent/AU2707197A/en
Publication of WO1997041900A1 publication Critical patent/WO1997041900A1/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L26/00—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
    • A61L26/0009—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form containing macromolecular materials
    • A61L26/0023—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
    • A61L26/00—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
    • A61L26/0061—Use of materials characterised by their function or physical properties
    • A61L26/008—Hydrogels or hydrocolloids
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/29—Coated or structually defined flake, particle, cell, strand, strand portion, rod, filament, macroscopic fiber or mass thereof
    • Y10T428/2913—Rod, strand, filament or fiber
    • Y10T428/2973—Particular cross section
    • Y10T428/2978—Surface characteristic

Definitions

  • the present invention relates to hydrogels, i.e. cross-linked macromolecular networks which are swollen with water or biological fluids.
  • the invention relates more particularly, but not exclusively, to such hydrogels that are useful as wound dressings.
  • hydrogel is a cross-linked macromolecular network swollen with water or biological fluids. It is known that hydrogels are useful as wound dressings, particularly because of their ability to donate fluid to a wound to maintain a moist "healing environment". There are however disadvantages with prior art hydrogel dressings (e.g. Clearsile) in that they can be weak and difficult to handle.
  • a method of producing a hydrogel product comprising impregnating a coherent fibrous structure (preferably sterilised) with an aqueous solution of a hydrogel precursor material (preferably sterilised), said fibres incorporating cations which are capable of cross- linking said precursor material to form a fibre reinforced hydrogel as the hydrogel product.
  • coherent fibrous structure we mean that the fibrous structure is comprised of fibres which are positively held together to maintain the overall coherency of the structure although obviously we do not preclude the possibility that individual fibres of the structure may become loose and detached. Such structures are to be distinguished from, for example, loose chopped fibres in which there is no mechanical forces holding the fibres together into the form of a structure.
  • coherent fibrous structures which may be used in accordance with the invention are knitted, woven, and non-woven products such as felts, matts and the like.
  • a preferred fibrous structure is a non-woven felt.
  • a particularly preferred fibrous structure is a non-woven felt made of calcium alginate fibres and having a basis weight of 30 to 200 gsm, more preferably 40 to 80 gsm, and most preferably about 60 gsm.
  • the method of the invention is effected by impregnating the fibrous structure with the solution of hydrogel precursor, preferably in ratio (by weight) of solution-fabric of (20-70): 1.
  • the method results in the production of a hydrogel which has been cross-linked (i.e. "set") by ions released from the fibres.
  • the fibrous structure provides, in effect, a reinforcement giving strength for easy handling ofthe hydrogel.
  • the hydrogel product may be autoclaved.
  • Hydrogels produced in accordance with the invention may be in the form of sheets typically having a thickness of 1 mm to 10 mm.
  • the hydrogels are in a hydrated form and are capable of donating moisture to a wound.
  • the hydrogels may be used for treating superficial wounds with low to medium levels of exudates
  • hydrogel precursor material examples include sodium alginate, sodium carboxymethyl cellulose, sodium pectinate, sodium O- carboxymethyl chitosan (OCC), sodium N,0-carboxymethyl chitosan (NOCC). sodium polyacrylate, and naturally occurring gums and synthetic polymers containing pendant carboxylic acid groups (hummectants).
  • the hydrogel precursor may consist wholly or partially of Ace Mannan (or other component of Alloe Vera) which is a natural polymer known to accelerate healing of wounds.
  • the Ace Mannan may, for example, provide up to 80% of the matrix.
  • the Ace Mannan may be clinical grade material obtainable from Carrington Laboratories, Dallas, Texas, U.S.A.
  • the hydrogel precursor may, if desired, incorporate an agent lo stimulate the healing of wounds.
  • agents include growth factors, e.g. whey growth factor extract (obtainable from GroPep Ltd. Australia) or Prczatidc copper acetate complex (obtainable from Procyte, U.S.A.).
  • the fibres which are used contain a di- or higher valent cation which is effective for cross-linking the hydrogel.
  • suitable cations include Ca , Zn , and cations which also act as enzyme cofactors.
  • Particular preferred examples of fibres which may be used are calcium alginate fibres.
  • the hydrogel precursor solution incorporates a bacteriostatic agent, preferably propylene glycol.
  • the hydrogel precursor e.g. an alginate
  • the hydrogel precursor e.g. an alginate
  • the resultant solution is then used to impregnate the coherent fibrous structure to form the hydrogel.
  • hydrogel precursor solution and coherent fibrous structure may be supplied separately whereby the method of the first aspect of the invention may ⁇ be effected in, for example, a surgery.
  • kits of parts for producing a hydrogel product comprising a container of a hydrogel precursor solution (preferably sterilised) and a coherent fibrous structure (preferably sterilised).
  • Hydrogel products obtained in accordance with the invention may be used in conjunction with hydrophilic films which have an increased breathability in the presence of liquid water as compared to moisture vapour alone.
  • the use of such a film over the hydrogel i.e. on the side remote from the wound) ensures that water is vented from the hydrogel through the film. Therefore the dissolution of the hydrogel may be controlled.
  • the breathable film will be of a material which, as a 50 micron film, has an MVTR in the presence of moisture vapour alone of 6,000 to 10,000 g m 24hr as measured by ASTM E96B and an MVTR in the presence of a liquid water (as measured by ASTM E96BW) of 6.000 to 10,000 g m "2 24hr " ' .
  • the breathable film will have a thickness of 30-70 microns, more preferably 40-60 microns, e.g. about 50 microns.
  • the breathable film may for example be of polyurethane. Suitable films are available from Alternative Technologies Limited under the designations IT325, IT425 and IT625.

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Materials Engineering (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Hematology (AREA)
  • Dispersion Chemistry (AREA)
  • Materials For Medical Uses (AREA)
  • Medicinal Preparation (AREA)

Abstract

A method of producing a hydrogel product comprises impregnating a coherent fibrous structure with an aqueous solution of a hydrogel precursor material, said fibres incorporating cations which are capable of cross-linking said precursor material to form a fibre reinforced hydrogel as the hydrogel product.

Description

HYDROGELS
The present invention relates to hydrogels, i.e. cross-linked macromolecular networks which are swollen with water or biological fluids. The invention relates more particularly, but not exclusively, to such hydrogels that are useful as wound dressings.
A hydrogel is a cross-linked macromolecular network swollen with water or biological fluids. It is known that hydrogels are useful as wound dressings, particularly because of their ability to donate fluid to a wound to maintain a moist "healing environment". There are however disadvantages with prior art hydrogel dressings (e.g. Clearsile) in that they can be weak and difficult to handle.
It is therefore an object of the present invention to obviate or mitigate the above disadvantages.
According to a first aspect of the present invention there is provided a method of producing a hydrogel product comprising impregnating a coherent fibrous structure (preferably sterilised) with an aqueous solution of a hydrogel precursor material (preferably sterilised), said fibres incorporating cations which are capable of cross- linking said precursor material to form a fibre reinforced hydrogel as the hydrogel product.
By "coherent fibrous structure" we mean that the fibrous structure is comprised of fibres which are positively held together to maintain the overall coherency of the structure although obviously we do not preclude the possibility that individual fibres of the structure may become loose and detached. Such structures are to be distinguished from, for example, loose chopped fibres in which there is no mechanical forces holding the fibres together into the form of a structure. Examples of coherent fibrous structures which may be used in accordance with the invention are knitted, woven, and non-woven products such as felts, matts and the like. A preferred fibrous structure is a non-woven felt. A particularly preferred fibrous structure is a non-woven felt made of calcium alginate fibres and having a basis weight of 30 to 200 gsm, more preferably 40 to 80 gsm, and most preferably about 60 gsm.
The method of the invention is effected by impregnating the fibrous structure with the solution of hydrogel precursor, preferably in ratio (by weight) of solution-fabric of (20-70): 1. The method results in the production of a hydrogel which has been cross-linked (i.e. "set") by ions released from the fibres. In the final hydrogel the fibrous structure provides, in effect, a reinforcement giving strength for easy handling ofthe hydrogel. If desired the hydrogel product may be autoclaved.
Hydrogels produced in accordance with the invention may be in the form of sheets typically having a thickness of 1 mm to 10 mm.
The hydrogels are in a hydrated form and are capable of donating moisture to a wound. The hydrogels may be used for treating superficial wounds with low to medium levels of exudates
Examples of hydrogel precursor material which may be used include sodium alginate, sodium carboxymethyl cellulose, sodium pectinate, sodium O- carboxymethyl chitosan (OCC), sodium N,0-carboxymethyl chitosan (NOCC). sodium polyacrylate, and naturally occurring gums and synthetic polymers containing pendant carboxylic acid groups (hummectants).
The hydrogel precursor may consist wholly or partially of Ace Mannan (or other component of Alloe Vera) which is a natural polymer known to accelerate healing of wounds. The Ace Mannan may, for example, provide up to 80% of the matrix. The Ace Mannan may be clinical grade material obtainable from Carrington Laboratories, Dallas, Texas, U.S.A.
The hydrogel precursor may, if desired, incorporate an agent lo stimulate the healing of wounds. Examples of such agents include growth factors, e.g. whey growth factor extract (obtainable from GroPep Ltd. Australia) or Prczatidc copper acetate complex (obtainable from Procyte, U.S.A.).
The fibres which are used contain a di- or higher valent cation which is effective for cross-linking the hydrogel. Examples of suitable cations include Ca , Zn , and cations which also act as enzyme cofactors. Particular preferred examples of fibres which may be used are calcium alginate fibres.
Preferably the hydrogel precursor solution incorporates a bacteriostatic agent, preferably propylene glycol.
In a preferred method of carrying out the invention, the hydrogel precursor (e.g. an alginate) is dissolved in a mixture of 75%-85% by weight water and 15%> to 25% by weight propylene glycol. The resultant solution is then used to impregnate the coherent fibrous structure to form the hydrogel.
It is possible for the hydrogel precursor solution and coherent fibrous structure to be supplied separately whereby the method of the first aspect of the invention may¬ be effected in, for example, a surgery. This affords the possibility of either using the coherent fibrous structure as a dressing per se or using it to produce a hydrogel product as discussed above.
Therefore according to a second aspect of the invention there is provided a kit of parts for producing a hydrogel product, the kit comprising a container of a hydrogel precursor solution (preferably sterilised) and a coherent fibrous structure (preferably sterilised).
Hydrogel products obtained in accordance with the invention may be used in conjunction with hydrophilic films which have an increased breathability in the presence of liquid water as compared to moisture vapour alone. The use of such a film over the hydrogel (i.e. on the side remote from the wound) ensures that water is vented from the hydrogel through the film. Therefore the dissolution of the hydrogel may be controlled.
Typically the breathable film will be of a material which, as a 50 micron film, has an MVTR in the presence of moisture vapour alone of 6,000 to 10,000 g m 24hr as measured by ASTM E96B and an MVTR in the presence of a liquid water (as measured by ASTM E96BW) of 6.000 to 10,000 g m"2 24hr"' . Typically the breathable film will have a thickness of 30-70 microns, more preferably 40-60 microns, e.g. about 50 microns. The breathable film may for example be of polyurethane. Suitable films are available from Innovative Technologies Limited under the designations IT325, IT425 and IT625.
The invention is illustrated with reference to the following non-limiting Example.
Example
A none-woven felt made of calcium alginate Ml' 1 -2 A felt, available from Innovative Technologies) having a weight/unit area of about 60 g/m" was treated with a 2% alginate (Protanol LF 10/60, ex-Pronava) dissolved in a 80/20 mixture of water and propylene glycol. The ratio of solution to felt was 40 to 1 . The solution was first spread out in a flat stainless steel dish having a size of about 30 cm x 30 cm and the felt was then placed in solution. The fibres interacted with the sodium alginate in the solution to form a sheet hydrogel. The resultant gel could be autoclaved to provide a hydrated sheet hydrogel for treating superficial wounds with low to medium level of exudate.

Claims

1. A method of producing a hydrogel product comprising impregnating a coherent fibrous structure with an aqueous solution of a hydrogel precursor material, said fibres incoφorating cations which are capable of cross-linking said precursor material to form a fibre reinforced hydrogel as the hydrogel product.
2. A method as claimed in claim 1 wherein the coherent fibre structure is a knitted, woven or non-woven product.
3. A method as claimed in claim 2 wherein the coherent fibre structure is a felt or matt.
4. A method as claimed in any one of claims 1 to 3 wherein the hydrogel precursor is sodium alginate, sodium carboxymethyl cellulose, sodium pectinate, sodium O-carboxymethyl chitosan (OCC), sodium N, O-carboxymethyl chitosan (NOCC), sodium polyacrylate, and naturally occurring gums and synthetic polymers containing pendant carboxylic acid groups (hummectants).
5. A method as claimed in any one of claims 1 to 3 wherein the hydrogel precursor consists wholly or partially of Ace Mannan (or other component of Alloc Vera).
6. A method as claimed in any one of claims 1 to 5 wherein the hydrogel precursor incorporates an agent to stimulate the healing of wounds.
7. A method as claimed in any one of claims 1 to 6 wherein said cations are Ca ,
Zn and/or cations which also act as enzyme cofactors.
8. A method as claimed in any one of the preceding claims wherein the fibres are calcium alginate fibres.
9. A method as claimed in any one of the preceding claims wherein the hydrogel precursor is dissolved in a mixture of 75% to 85%> by weight water and 15% to 25% by weight propylene glycol.
10. A method as claimed in any one of the preceding claims wherein the ratio by volume of the hydrogel precursor solution to the coherent fibre structure is (20 to 70): 1.
1 1. A hydrogel product which comprises a hydrogel and a reinforcement of a fibrous structure which is coherent per se.
12. A hydrogel product as produced by the method of any one of claims 1 to 10 or as claimed in claim 1 1 for use as a primary wound dressing for superficial wounds with low to medium levels of exudate.
13. A kit of parts for producing a hydrogel product, the kit comprising a container of a hydrogel precursor solution (preferably sterilised ) and a coherent fibrous structure (preferably sterilised).
PCT/GB1997/001244 1996-05-08 1997-05-08 Hydrogels WO1997041900A1 (en)

Priority Applications (5)

Application Number Priority Date Filing Date Title
EP97920851A EP0901382B1 (en) 1996-05-08 1997-05-08 Reinforced hydrogels
DE69727801T DE69727801T2 (en) 1996-05-08 1997-05-08 FIBER REINFORCED HYDROGEL
JP09539660A JP2000510718A (en) 1996-05-08 1997-05-08 Hydrogel
US09/180,171 US6534083B2 (en) 1996-05-08 1997-05-08 Hydrogels
AU27071/97A AU2707197A (en) 1996-05-08 1997-05-08 Hydrogels

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB9609474.3 1996-05-08
GBGB9609474.3A GB9609474D0 (en) 1996-05-08 1996-05-08 Hydrogels

Publications (1)

Publication Number Publication Date
WO1997041900A1 true WO1997041900A1 (en) 1997-11-13

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Application Number Title Priority Date Filing Date
PCT/GB1997/001244 WO1997041900A1 (en) 1996-05-08 1997-05-08 Hydrogels

Country Status (8)

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US (1) US6534083B2 (en)
EP (1) EP0901382B1 (en)
JP (1) JP2000510718A (en)
AU (1) AU2707197A (en)
DE (1) DE69727801T2 (en)
ES (1) ES2215226T3 (en)
GB (1) GB9609474D0 (en)
WO (1) WO1997041900A1 (en)

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WO2002102425A2 (en) * 2001-06-20 2002-12-27 Panayiotis Spyros Spyropoulos Compound hydrogel wound dressing
EP1607412A1 (en) * 2004-06-07 2005-12-21 First Water Limited Hydrogel Composites
US6998509B1 (en) 1999-10-07 2006-02-14 Coloplast A/S Wound care device
AU2004263062B2 (en) * 2003-07-15 2010-05-13 Rijksuniversiteit Groningen Prosthesis made of a fibre-reinforced hydrogel, method of manufacturing and use thereof
WO2010140146A2 (en) 2009-06-01 2010-12-09 Technion - Research & Development Foundation Ltd Sealants, manufacturing thereof, and applications thereof
JP2012006971A (en) * 1999-12-09 2012-01-12 Apimed Medical Honey Ltd Honey based medical dressing
US8377241B2 (en) 2005-07-29 2013-02-19 W. L. Gore & Associates, Inc. Method of making porous self-cohered web materials
US8597745B2 (en) 2005-07-29 2013-12-03 W. L. Gore & Associates, Inc. Composite self-cohered web materials
US8673354B2 (en) 2007-11-05 2014-03-18 Technion Research And Development Foundation Ltd. Adhesives and methods of applying the same
WO2014057254A1 (en) * 2012-10-08 2014-04-17 First Water Limited Hydrogel composites

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BR122018068450B8 (en) 2004-10-12 2021-07-27 Fmc Biopolymer As implantable device comprising alginate gel
JP5296531B2 (en) 2005-05-05 2013-09-25 センシエント フレイバーズ エルエルシー Production of β-glucan and mannan
US20070026039A1 (en) * 2005-07-29 2007-02-01 Drumheller Paul D Composite self-cohered web materials
BRPI0815977A2 (en) * 2007-08-28 2017-06-13 Fmc Corp dispersion, kit and composition for manufacturing same, methods for dispensing a delayed self-gelling alginate dispersion, for preparing an alginate gel and for preparing insoluble alginate / gelling ion particles, and insoluble ultrapure alginate / gelling ion particles.
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US20130123816A1 (en) 2011-11-10 2013-05-16 Gerald Hodgkinson Hydrophilic medical devices
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US20190241944A1 (en) 2018-01-31 2019-08-08 Bio-Rad Laboratories, Inc. Methods and compositions for deconvoluting partition barcodes
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Cited By (14)

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Publication number Priority date Publication date Assignee Title
US6998509B1 (en) 1999-10-07 2006-02-14 Coloplast A/S Wound care device
US7141714B2 (en) 1999-10-07 2006-11-28 Coloplast A/S Wound care device
JP2012006971A (en) * 1999-12-09 2012-01-12 Apimed Medical Honey Ltd Honey based medical dressing
WO2002102425A3 (en) * 2001-06-20 2007-11-08 Panayiotis Spyros Spyropoulos Compound hydrogel wound dressing
WO2002102425A2 (en) * 2001-06-20 2002-12-27 Panayiotis Spyros Spyropoulos Compound hydrogel wound dressing
AU2004263062B2 (en) * 2003-07-15 2010-05-13 Rijksuniversiteit Groningen Prosthesis made of a fibre-reinforced hydrogel, method of manufacturing and use thereof
EP1607412A1 (en) * 2004-06-07 2005-12-21 First Water Limited Hydrogel Composites
US8597745B2 (en) 2005-07-29 2013-12-03 W. L. Gore & Associates, Inc. Composite self-cohered web materials
US8377241B2 (en) 2005-07-29 2013-02-19 W. L. Gore & Associates, Inc. Method of making porous self-cohered web materials
US8673354B2 (en) 2007-11-05 2014-03-18 Technion Research And Development Foundation Ltd. Adhesives and methods of applying the same
WO2010140146A2 (en) 2009-06-01 2010-12-09 Technion - Research & Development Foundation Ltd Sealants, manufacturing thereof, and applications thereof
EP2638922A1 (en) 2009-06-01 2013-09-18 Technion Research & Development Foundation Ltd. Multi-components adhesives, manufacturing thereof, and applications thereof
US9216234B2 (en) 2009-06-01 2015-12-22 Technion Research & Development Foundation Ltd. Sealants, manufacturing thereof, and application thereof
WO2014057254A1 (en) * 2012-10-08 2014-04-17 First Water Limited Hydrogel composites

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Publication number Publication date
GB9609474D0 (en) 1996-07-10
JP2000510718A (en) 2000-08-22
EP0901382A1 (en) 1999-03-17
US6534083B2 (en) 2003-03-18
DE69727801T2 (en) 2004-12-02
AU2707197A (en) 1997-11-26
US20020009591A1 (en) 2002-01-24
ES2215226T3 (en) 2004-10-01
EP0901382B1 (en) 2004-02-25
DE69727801D1 (en) 2004-04-01

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