WO2001030405A1 - Feuilles flexibles pour therapie - Google Patents
Feuilles flexibles pour therapie Download PDFInfo
- Publication number
- WO2001030405A1 WO2001030405A1 PCT/GB2000/004157 GB0004157W WO0130405A1 WO 2001030405 A1 WO2001030405 A1 WO 2001030405A1 GB 0004157 W GB0004157 W GB 0004157W WO 0130405 A1 WO0130405 A1 WO 0130405A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- sheet
- bonding material
- tissue bonding
- tissue
- liquid tissue
- Prior art date
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
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/04—Macromolecular materials
- A61L31/043—Proteins; Polypeptides; Degradation products thereof
- A61L31/044—Collagen
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
- A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
- A61L15/22—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
- A61L15/32—Proteins, polypeptides; Degradation products or derivatives thereof, e.g. albumin, collagen, fibrin, gelatin
-
- 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
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/04—Macromolecular materials
- A61L31/043—Proteins; Polypeptides; Degradation products 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
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/04—Macromolecular materials
- A61L31/043—Proteins; Polypeptides; Degradation products thereof
- A61L31/047—Other specific proteins or polypeptides not covered by A61L31/044 - A61L31/046
Definitions
- This invention relates to therapeutic materials in the form of sheets suitable for topical administration to either an internal or external organ of the body, the sheets being secured by means of tissue bonding material.
- tissue bonding material as an adhesive to bond tissues together after surgery or to repair wounds, eg in place of suturing or the like, is known.
- tissue bonding material commonly comprises proteinaceous material which is applied to the tissues to be joined and then subjected to curing by the action of heat or light.
- WO 96/22797 describes such materials which consist substantially of albumin together with a chromophore which changes colour when the end point of the crosslinking process has been reached, thereby preventing the absorption of further energy.
- a sheet suitable for use in therapy comprising a material suitable for therapeutic use by topical administration, the sheet being flexible, hydratable and activatable so that it bonds to tissue whilst retaining its integrity, said sheet bearing on at least one side thereof a layer of liquid tissue bonding material.
- tissue bonding material a material which when applied to body tissues is capable of binding to those tissues and of causing the tissues to adhere to each other.
- the mechanism of such adhesion will normally involve curing by which the tissue bonding material molecules covalently bond to each other (cross- linking) and to the tissues.
- liquid tissue bonding material is meant a material of sufficient fluidity to be applied to the surface of the sheet.
- the material is preferably of sufficient viscosity to be retained at the locus to which it is applied.
- the material may thus be of the nature of a gel.
- the sheet itself comprises a tissue bonding material, incorporated in a solid matrix.
- the tissue bonding material may be applied over the whole surface of the sheet.
- the tissue bonding material may be applied to only part of the sheet, eg around the periphery of the sheet.
- the tissue bonding material may be applied to the tissue to which the sheet is to be attached, the sheet then being applied to the tissue bonding material.
- the invention thus also provides a method of attaching to a tissue a flexible, hydratable and activatable sheet, which method comprises applying to the sheet and/or to the tissue a tissue bonding material and then applying the sheet bearing the tissue bonding material to the tissue or applying the sheet to the tissue bonding material previously applied to the tissue.
- Both the sheet and the tissue bonding material applied to it will most commonly comprise a crosslinkable proteinaceous or other peptide material.
- the material may be selected from natural and synthetic peptides, enzymatically cleaved or shortened variants thereof and crosslinked derivatives thereof, as well as mixtures of any of the above. Included among the peptides are structural proteins and serum proteins. Examples of proteins are albumin, ⁇ -globulins, ⁇ -globulins, y- globulins, transthyretin, collagen, elastin and fibronectin and coagulation factors including fibrinogen, fibrin and thrombin.
- the tissue bonding material may be formulated in any suitable form for application to the sheet or to the tissue to which the sheet is to be applied.
- the formulation may be a liquid or low viscosity gel. A certain degree of viscosity may be desirable in order to aid retention of the material at the locus to which it is applied.
- Viscosity-modifying components which may be incorporated into the composition include hyaluronic acid and salts thereof such as sodium hyaluronate, hydroxypropylmethylcellulose, glycerine, dextrans, honey, sodium condroitin sulphate and mixtures thereof.
- the liquid tissue bonding material may be prepared by mixing the various components in appropriate proportions.
- the tissue bonding material may for example be dispersed or dissolved in water, together with any additional components such as viscosity-modifying agents.
- the liquid formulation most preferably also comprises a plasticiser to confer sufficient flexibility on the liquid tissue bonding material after curing.
- plasticisers include polyalcohols, eg glycerol, sorbitol etc.
- the sheet may comprise a single layer of mate ⁇ al.
- a carrier layer may be provided.
- Suitable materials for the carrier layer are biocompatible materials, eg polybutyrate, polysaccharides, polytetrafluoroethylene, polyesters, glycoproteins, polymer composites, collagen (including cross-linked collagen), pericardium, ethacrylate, polyurethane and derivatives thereof.
- Other materials include absorbable and non-absorbable suture materials, eg polypropylene, polyglactin, polylactic acid, polyglycolic acid, polydioxanone and polyglyconate.
- the sheet formulation preferably further comprises a plasticiser in order to ensure that the sheet has sufficient flexibility, even after polymerisation or cross-linking.
- plasticisers include polyalcohols, eg glycerol, sorbitol etc.
- the sheet preferably also comprises a synthetic structural polymer to confer strength and elasticity on the sheet.
- Suitable such polymers include water-soluble thermoplastic polymers, in particular selected from the group consisting of poly(vinyl alcohol), poly(ethylene glycol), poly(vinyl pyrrolidone), poly(acrylic acid), poly(acrylamide), copolymers of methylvinyl ether with maleic anhydride in the anhydride, acid, ester or mixed salt form, and similar materials.
- surfactant most preferably a non-ionic surfactant
- Suitable surfactants include block copolymers of ethylene oxide and propylene oxide, such as those sold under the trade mark Pluronic ® by BASF.
- the sheet may be manufactured by mixing the different components in aqueous solution as follows:
- tissue-bonding material 5 - 80%, more preferably 10 - 60 %, and most preferably 15 to 40%.
- structural polymer 0.01 - 20%, more preferably 1 - 10% , and most preferably
- surfactant 0.001 - 10%, more preferably 0.01 - 5%, and most preferably 0.1
- plasticiser 0.01 - 60%, more preferably 1 - 50%, and most preferably 10 - 40%
- the sheet may be prepared by casting the above solution into a suitable non-stick mould (e.g. of PTFE), and allowing it to set through evaporation.
- a suitable non-stick mould e.g. of PTFE
- the casting process used to achieve the desired thickness of the sheet may involve pouring, manual spreading or spraying of the component solutions.
- the sheet according to the invention may be 20 - 200 ⁇ m in thickness, and typically approximately 100 ⁇ m in thickness.
- the sheet will typically contain between 10% and 50% water by weight, and most preferably between 20% and 40%.
- the sheet may be partially or totally hydrated with a suitable aqueous medium at or following implantation (eg a body fluid or saline solution).
- the preferred material for use in the present invention is a soluble protein which is not part of the clotting cascade.
- Porcine albumin or porcine pericardium or any abundant non- thrombogenic protein, ie excluding collagen, may be used. Genetically or chemically modified versions of such proteins may also be suitable.
- Albumin is particularly suitable because of its chemical and physical properties.
- formulations of both the sheet and the liquid tissue bonding material are formulations comprising albumin.
- Mammalian albumin is preferred, particularly porcine albumin.
- the formulations most preferably further comprise glycerol as plasticiser.
- the tissue bonding material may, or may not, contain a thermochromic compound (which undergoes a colour change on the application of heat) and/or a photochromic compound (which undergoes a colour change on the application of light).
- the material may include a chromophore, such as methylene blue, which will change colour when the end point (when light activated) has been reached, as described in WO 96/22797.
- a visual colour change may provide the user with an indication that sufficient energy has been applied to ensure that curing of the tissue bonding material has occurred.
- the resultant colour change ensures that the material will absorb no further radiant energy. This provides protection against excess energy input.
- a light activated chromophore If a light activated chromophore is present it provides the user, ie normally a surgeon or veterinary surgeon, with means to determine whether or not adequate energy has been provided in the desired area, thereby preventing thermal damage as a result of the application of excessive energy.
- the sheet may also contain a thermochromic compound and/or a photochromic compound.
- the sheet preferably readily transmits energy applied to it to the coating of tissue bonding material.
- the sheet is preferably at least substantially transparent, at least at the relevant wavelengths.
- Therapeutic agents may be incorporated into the sheet, either by simple mixing during manufacturing or by covalent bonding to the materials making up the sheet.
- the sheet may be applied to a specific tissue (eg a tumour) in a simple surgical procedure.
- the therapeutic agents will be released from the sheet as it degrades.
- the rate at which the therapeutic agents are released may depend on the rate at which the sheet degrades and this in turn may be controlled by, for instance, adjusting the degree of crosslinking during the manufacturing process.
- the sheet may be applied externally to close an arterial puncture made for any one of a number of purposes.
- a sheet according to the invention may be applied to the surface of the bladder or part of the gastrointestinal tract in order to effect a repair.
- a sheet may be applied to a graft or the like which is applied to those tissues. This may increase the strength of the graft, reduce porosity and provide a biocompatible and anti-thrombogenic surface.
- the sheet according to the invention may be used as a form of dressing applied to the external surface of the skin to promote wound healing. Once the sheet begins to degrade fibroblasts will move in and begin to deposit components of the extra cellular matrix. Furthermore, factors such as growth factors and cAMP, which are known to promote the proliferation of skin cells, may be incorporated into the sheet to further assist in the healing process.
- factors such as growth factors and cAMP, which are known to promote the proliferation of skin cells, may be incorporated into the sheet to further assist in the healing process.
- the sheets according to the invention may be applied topically to promote wound closure, eg as an alternative to sutures. This may have beneficial effects in that it may reduce scarring, and may therefore be useful for cosmetic purposes during minor surgery.
- the sheet according to the invention may be used to provide additional support during the reinforcement of hernia repair procedures. It may be used on its own, or alternatively attached to an external mesh or support.
- porcine albumin 0.9g porcine albumin was dissolved in 3.0ml water for injection. To this solution 0.585g sorbitol was added and dissolved. The solution was then heated 50DC, left to cool for thirty minutes and then cast on a level PTFE-coated surface.
- the sheet so formed is cut into discs, eg of diameter 30mm, or into square or rectangular patches of similar dimension.
- Tissue adhesive such as described in Example 2 below may then be applied to one surface of the patches, either over the whole surface or in a band around the periphery.
- composition was made up by dissolving/dispersing the albumin, methylene blue and glycerol in the water for injection.
- Figure 1 shows schematically the manner in which a sheet prepared in accordance with Example 1 and coated on one side with the adhesive of Example 2 is applied to a tissue.
- the side of the sheet 1 with the coating of adhesive 2 is applied to the tissue 3.
- Full adhesion is then brought about by the application to the sheet of intense polychromatic light via a pencil-like handpiece 4 held by the surgeon.
- the handpiece 4 is connected by suitable means, eg an optical fibre (not shown), to a remote light source unit. Light from the handpiece 4 passes through the substantially transparent sheet 1 and is absorbed by the methylene blue in the adhesive coating 2 and dissipated within that coating as heat energy.
- This heat energy initiates crosslinking of the albumin molecules in the adhesive coating layer 2, to themselves and to the sheet 1 and the tissue 3. Once full crosslinking has occurred the methylene blue loses its blue colour, providing the surgeon with a visual indication of the completeness of the activation.
- sheet formulations to which the gel formulation of Example 2 may be applied are the following:
- porcine albumin 1.51g of porcine albumin, 0.1g of 80% hydrolysed polyvinyl alcohol, 1.42g of glycerol and 0.01 g of Pluronic 25R2 were dissolved in 2.02g of water for injection. 0.1 ml of this solution was poured onto a level PTFE surface, and spread to a thickness of approximately 50 ⁇ m. The solution was heated to 120°C for 10 minutes to evaporate off water and allowed to cool.
- porcine albumin 0.5g of 80% hydrolysed polyvinyl alcohol, 3.00g of glycerol and 0.02g of Pluronic 25R2 were dissolved in 3.53g of water for injection. 0.1 ml of this solution was poured onto a level PTFE surface, and spread to approximately 30 ⁇ m thick. The matrix was heated at 120°C for 20 minutes and allowed to cool.
- porcine albumin 1.53g of 80% hydrolysed polyvinyl alcohol, 8.98g of glycerol and 0.06g of Pluronic 25R2 were dissolved in 10.56g of water for injection. 0.3 ml of this solution was poured onto a level PTFE surface, and spread to a thickness of approximately 50 ⁇ m, and left at room temperature for 1 hour.
Abstract
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
AU10439/01A AU1043901A (en) | 1999-10-28 | 2000-10-27 | Flexible sheets for use in therapy |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
GB9925380.9 | 1999-10-28 | ||
GBGB9925380.9A GB9925380D0 (en) | 1999-10-28 | 1999-10-28 | Flexible sheets for use in therapy |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2001030405A1 true WO2001030405A1 (fr) | 2001-05-03 |
Family
ID=10863446
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/GB2000/004157 WO2001030405A1 (fr) | 1999-10-28 | 2000-10-27 | Feuilles flexibles pour therapie |
Country Status (3)
Country | Link |
---|---|
AU (1) | AU1043901A (fr) |
GB (1) | GB9925380D0 (fr) |
WO (1) | WO2001030405A1 (fr) |
Cited By (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2002034304A1 (fr) * | 2000-10-23 | 2002-05-02 | Tissuemed Limited | Matrice hydratable auto-adhesive a usage therapeutique topique |
WO2002092049A2 (fr) * | 2001-05-14 | 2002-11-21 | 3M Innovative Properties Company | Systeme d'administration d'agents cosmetiques et pharmaceutiques |
WO2004087227A1 (fr) * | 2003-04-04 | 2004-10-14 | Tissuemed Limited | Formulations pour adhesifs tissulaires |
WO2006013337A3 (fr) * | 2004-08-03 | 2006-09-14 | Tissuemed Ltd | Materiaux adhesifs tissulaires |
EP2014320A1 (fr) * | 2007-07-10 | 2009-01-14 | Christophe Lesca | Pansement durcissable par UV |
US10736769B2 (en) | 2013-07-18 | 2020-08-11 | Coloplast A/S | Touch mapping |
Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO1992014513A1 (fr) * | 1991-02-13 | 1992-09-03 | Interface Biomedical Laboratories Corp. | Matiere de remplissage utilisee pour le soudage de tissus |
US5292362A (en) * | 1990-07-27 | 1994-03-08 | The Trustees Of Columbia University In The City Of New York | Tissue bonding and sealing composition and method of using the same |
US5791352A (en) * | 1996-06-19 | 1998-08-11 | Fusion Medical Technologies, Inc. | Methods and compositions for inhibiting tissue adhesion |
WO2000010618A1 (fr) * | 1998-08-21 | 2000-03-02 | Tissuemed Ltd. | Feuille capable d'etre activee destinee a un usage topique et therapeutique |
-
1999
- 1999-10-28 GB GBGB9925380.9A patent/GB9925380D0/en not_active Ceased
-
2000
- 2000-10-27 AU AU10439/01A patent/AU1043901A/en not_active Abandoned
- 2000-10-27 WO PCT/GB2000/004157 patent/WO2001030405A1/fr active Application Filing
Patent Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5292362A (en) * | 1990-07-27 | 1994-03-08 | The Trustees Of Columbia University In The City Of New York | Tissue bonding and sealing composition and method of using the same |
WO1992014513A1 (fr) * | 1991-02-13 | 1992-09-03 | Interface Biomedical Laboratories Corp. | Matiere de remplissage utilisee pour le soudage de tissus |
US5791352A (en) * | 1996-06-19 | 1998-08-11 | Fusion Medical Technologies, Inc. | Methods and compositions for inhibiting tissue adhesion |
WO2000010618A1 (fr) * | 1998-08-21 | 2000-03-02 | Tissuemed Ltd. | Feuille capable d'etre activee destinee a un usage topique et therapeutique |
Cited By (9)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2002034304A1 (fr) * | 2000-10-23 | 2002-05-02 | Tissuemed Limited | Matrice hydratable auto-adhesive a usage therapeutique topique |
WO2002092049A2 (fr) * | 2001-05-14 | 2002-11-21 | 3M Innovative Properties Company | Systeme d'administration d'agents cosmetiques et pharmaceutiques |
WO2002092049A3 (fr) * | 2001-05-14 | 2003-04-03 | 3M Innovative Properties Co | Systeme d'administration d'agents cosmetiques et pharmaceutiques |
WO2004087227A1 (fr) * | 2003-04-04 | 2004-10-14 | Tissuemed Limited | Formulations pour adhesifs tissulaires |
WO2006013337A3 (fr) * | 2004-08-03 | 2006-09-14 | Tissuemed Ltd | Materiaux adhesifs tissulaires |
US8133504B2 (en) | 2004-08-03 | 2012-03-13 | Tissuemed Limited | Tissue-adhesive materials |
EP2014320A1 (fr) * | 2007-07-10 | 2009-01-14 | Christophe Lesca | Pansement durcissable par UV |
US10736769B2 (en) | 2013-07-18 | 2020-08-11 | Coloplast A/S | Touch mapping |
US11931286B2 (en) | 2013-07-18 | 2024-03-19 | Coloplast A/S | Method of monitoring pressure applied to adhere an ostomy appliance to skin |
Also Published As
Publication number | Publication date |
---|---|
AU1043901A (en) | 2001-05-08 |
GB9925380D0 (en) | 1999-12-29 |
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