WO2024256844A1 - Dispositif de modèle de plaie et procédé - Google Patents

Dispositif de modèle de plaie et procédé Download PDF

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Publication number
WO2024256844A1
WO2024256844A1 PCT/GB2024/051544 GB2024051544W WO2024256844A1 WO 2024256844 A1 WO2024256844 A1 WO 2024256844A1 GB 2024051544 W GB2024051544 W GB 2024051544W WO 2024256844 A1 WO2024256844 A1 WO 2024256844A1
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WIPO (PCT)
Prior art keywords
gum
model device
wound model
agarose
wound
Prior art date
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Ceased
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PCT/GB2024/051544
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English (en)
Inventor
Alan Smith
Jessica SENIOR
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University of Huddersfield
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University of Huddersfield
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 University of Huddersfield filed Critical University of Huddersfield
Priority to EP24737148.7A priority Critical patent/EP4728500A1/fr
Publication of WO2024256844A1 publication Critical patent/WO2024256844A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • G—PHYSICS
    • G09—EDUCATION; CRYPTOGRAPHY; DISPLAY; ADVERTISING; SEALS
    • G09B—EDUCATIONAL OR DEMONSTRATION APPLIANCES; APPLIANCES FOR TEACHING, OR COMMUNICATING WITH, THE BLIND, DEAF OR MUTE; MODELS; PLANETARIA; GLOBES; MAPS; DIAGRAMS
    • G09B23/00—Models for scientific, medical, or mathematical purposes, e.g. full-sized devices for demonstration purposes
    • G09B23/28—Models for scientific, medical, or mathematical purposes, e.g. full-sized devices for demonstration purposes for medicine
    • G09B23/30—Anatomical models

Definitions

  • the present invention relates to a wound model for debridement training and other educational purposes.
  • the invention also provides a method for manufacturing such a model.
  • the invention further provides a composition that can be manufactured using natural sustainable materials without the incorporation of animal-based products.
  • Current wound models that are used for debridement training and educational purposes on today’s market are often costly and poorly resemble the appearance and textures of real-life wounds.
  • Current practice involves the use of orange peel or pig’s feet. Although, orange peel may superficially resemble the texture of some types of necrotic wound tissue, it does not accurately simulate the complex biological and physiological properties or the variety of wound types that clinicians may encounter in practice.
  • pig’s feet is perhaps more realistic anatomically, however, there are several problems associated with their use that include ethical concerns around the use of animal tissue for teaching, infection risk, a limited range of wound types (as pigs feet can only simulate a limited range of wound types), lack of realism and difficulty in sourcing in some regions, limiting their availability and cost - especially if they need to be purchased in large quantities or shipped from a remote location. There are also synthetic models which look very realistic, but they are not training devices and can’t be debrided as they are designed for observational purposes only.
  • a wound model device comprising at least two layers, at least one of said layers is a base layer that mimics healthy skin wherein the base layer is a biopolymer.
  • the device comprises two or more layers wherein the base layer comprises a gel forming biopolymer.
  • the device includes a sloughy layer and/or a necrotic layer.
  • the device includes a base layer, a sloughy layer and a necrotic layer.
  • the base layer includes a biopolymer and at least one dye or pigment.
  • the base layer is made of biopolymer and can be dyed to match a range of different skin colours and tones.
  • the base layer comprises any one or any combination of agarose, agar, gellan gum, xanthan gum, carrageenan, methylcellulose hydroxypropylmethyl cellulose, chitosan, polysaccharide of tamarind seed, pectin, curdlan, gelatin, furcellaran, agarose sulphate, alginates, guar gum, locust bean gum, tara gum, gum Arabic, ghatti gum, Khaya grandifolia gum, tragacanth gum, karaya gum, arabinan, starch, konjac mannan, galactomannan, funoran, acetan, welan, rhamsan, succinoglycan, scleroglycan, schizophyllan, pullulnan, dextran and dextran sulphate.
  • the gel forming biopolymer substantially forming the base layer is agarose.
  • the amount of agarose used in the base layer is preferably greater than 0.5 wt%, more preferably greater than 1 wt%.
  • the amount of agarose is preferably below 4 wt%, more preferably less than 3 wt%.
  • pink dye paste and/or brown dye paste can be added to agarose.
  • the dye is added to agarose solution prior to solidification to obtain different skin colour tones.
  • the sloughy layer comprises a viscoelastic biopolymer.
  • the sloughy layer is a granular gel.
  • the sloughy layer comprises any one or any combination of custard powder, casein, whey protein, gluten, or polysaccharide based granular gels.
  • the slough is prepared from custard powder.
  • the amount of custard powder used in the slough is preferably greater than 5 wt%, more preferably greater than 10 wt%.
  • the amount of custard powder is preferably below 30 wt%, more preferably less than 20 wt%.
  • the sloughy layer is located subtantially above the base layer.
  • the sloughy layer is a layer of loosely adherent yellow slough that can be removed using mechanical debridement.
  • the model includes exudate.
  • Typica lly the exudate is prepared from a fluid gel materials. Further typically the exudate is prepared from any one or any combination of agarose, agar, gellan gum, xanthan gum, carrageenan, methylcellulose hydroxypropylmethyl cellulose, chiotosan.
  • exudate gel forming biopolymer is agarose.
  • gel forming biopolymer is agarose.
  • the amount of agarose used in the skin base is preferably greater than 0.5 wt%, more preferably greater than 1 wt%.
  • the amount of agarose is preferably below 4 wt%, more preferably less than 3 wt%.
  • black dye paste is added to agarose solution prior to solidification to obtain deep black colouration.
  • a plasticiser can also be added.
  • the plasticiser can include any one or any combination of glycerol, propylene glycol, propylene glycol, sorbitol, mannitol, sucrose, trehalose, glucose, dextrose, urea, polyethylene glycol, polycarbonates and polyphosphoesters.
  • the plast iciser is glycerol.
  • the amount of glycerol used is preferably greater than 5% wt%, more preferably greater than 10% wt%.
  • the amount of glycerol is preferably below 50% wt%, more preferably below 30% wt%.
  • a preservative can also be added. Tpically the preservat ive can be any one or any combination of diazolidinyl urea, sodium benzoate, potassium benzoate, benzoic acid, methyl paraben, propyl paraben, butyl paraben, sodium azide, sodium metabisulphite, sorbic acid, potassium sorbate.
  • Preprepared preservative systems can be used such as Germaben II.
  • coloured dye paste can be added to agarose solution prior to solidification to obtain different skin colour tones.
  • Typica lly additional appendages can also be added such as hair, tendon, bone blood vessels for a more realistic appearance.
  • a method of forming a wound model device said device including at least two layers, at least one of said layers is a base layer that mimics healthy skin wherein the base layer is a biopolymer.
  • the compositions comprising the base layer are prepared from agarose. Typically low EEO grade agarose. Further typically pink and/or brown dye paste is included.
  • the agarose powder was dispersed in a small amount of cold deionised water. Typically around 10% of water content.
  • the rest of the deionised water was added was added hot (>80 °C) to create a 2% w/w agarose solution.
  • 20 % glycerol is added followed by the remaining deionised water.
  • the mixture was stirred and heated to ⁇ 85 °C and a homogenous solution was evident.
  • the solution is then cooled to around 50 °C and a preservative system added.
  • Germaben II was used at a concentrations between 0.5% and 1% w/v.
  • a sufficient quantity of dye paste is added until solution became opaque. For different skin tones different quantities and colours can be added. This provided the healthy skin base material.
  • the hot agarose solution was then poured into a mould that defines the shape and dimensions of the required wound. Further typically the mould is a 3D printed mould.
  • the composition is then allowed to set at room temperature. Additional appendages such as hair can be added prior to the biopolymer or agarose fully setting.
  • the sloughy layer is produced by weighing the appropriate quantity of custard powder for a 15% w/w solution then was added to a beaker of cold deionised water. Typically the solution is heated to fully solubilise the custard powder.
  • the composition is typically allowed to thicken and solidify. In one embodiment, once solidified the sloughy layer composition is placed at 4 °C to cool.
  • artificial exudate is prepared by dispersing agarose in deionised water.
  • Typical ly artificial exudate is prepared by dispersing 0.5% wt agarose in deionised water at around 90°C and then once fully dissolved cooling to 20 °C under a shear. Further typically the shear is constant at around 700 rpm.
  • the necrotic eschar layer composition is prepared from agarose and a dye. Typically the dye is black dye paste.
  • the agarose powder is dispersed in a small amount of cold deionised water, typically around 10% of water content.
  • the rest of the deionised water is added hot (>80 °C) to create a 2% w/w agarose solution.
  • the mixture is stirred and heated to ⁇ 85 °C until the material was fully hydrated and a homogenous solution was evident. Further typically a sufficient quantity of black dye paste is added until solution is opaque. This provides the necrotic eschar material.
  • the hot agarose solution was then poured into a mould that contains the shape and dimensions of the required necrotic eschar. This was then allowed to set at 4 °C. The remaining black agarose solution can then be stored in the fridge at 4 °C and reused.
  • the material is heated in a microwave for ⁇ 30 seconds until the agarose gel has melted and can be poured.
  • the wound model device is assembled by removing the base layer from the mould and any imperfections trimmed away around the edges using a scalpel.
  • a drop of red food colouring is added to the wound cavity and carefully spread evenly taking care to prevent ‘bleed’ into the small channels at the edges of the cavity. Further typically a second drop of red food colouring was added into the centre of the wound cavity to make a darker red colour at the centre.
  • the slough layer is then added to fill the cavity. Typically the slough layer is added until flush with the base layer or healthy skin region.
  • the necrotic layer or gelled agarose eschar was is removed from the mould and placed on the artificial slough. Typically the layer is cut in half before being placed on the slough layer and gently pressed into the slough until flush with the healthy skin region base layer. In one embodiment artificial exudate is added onto the surface of the slough. Typical ly then the gelled agarose eschar is then removed from the mould and cut in half and placed on the artificial slough and exudate. Further typically the eschar is gently pressed into the slough until flush with the healthy skin region.
  • the top of the necrotic layer eschar is then cauterized from the edge towards the centre until a thin film is visible on the surface and the edges are bound to the healthy skin region of the base layer.
  • a wound model based on a composition containing a biopolymer gel base and a viscoelastic biopolymer for the sloughy tissue. Typical ly a solid leathery biopolymer necrotic eschar is included. Further tpyically other minor ingredients such as colouring agents, plasticisers and/or preservatives can be included. Typically the remainder of the composition is water.
  • a 3D printed mould is used to cast the base of the skin mimic, within which the wound void is situated.
  • the base layer is made of biopolymer and can be dyed to match a range of different skin colours and tones. It features a smooth, skin-like appearance at the surface that surrounds a wound void with red, rough granulation tissue lining the wound bed (Fig 1A). Above the granulation tissue is a layer of loosely adherent yellow slough that can be removed using mechanical debridement (Fig 1B).
  • the uppermost layer of the wound region exhibits leathery black necrotic eschar that requires a scalpel to facilitate removal (Fig 1C) - as is often the case in real- life wounds.
  • the mechanical properties of the model layers have been matched to be similar to those in human tissue.
  • the present invention relates to a wound model based on a composition containing a biopolymer gel base, viscoelastic biopolymer for the sloughy tissue, a solid leathery biopolymer necrotic eschar and other minor ingredients such as colouring agents plasticisers and preservatives.
  • the remainder of the composition being water.
  • the skin base polymer can be a gel forming biopolymer, such as agarose, agar, gellan gum, xanthan gum, carrageenan, methylcellulose hydroxypropylmethyl cellulose, chitosan, polysaccharide of tamarind seed, pectin, curdlan, gelatin, furcellaran, agarose sulphate, alginates, guar gum, locust bean gum, tara gum, gum Arabic, ghatti gum, Khaya grandifolia gum, tragacanth gum, karaya gum, arabinan, starch, konjac mannan, galactomannan, funoran, acetan, welan, rhamsan, succinoglycan, scleroglycan, schizophyllan, pullulnan, dextran and dextran sulphate.
  • a gel forming biopolymer such as agarose, agar, gellan gum, xanthan gum, carrage
  • gel forming biopolymer is agarose.
  • the amount of agarose used in the skin base is preferably greater than 0.5 wt%, more preferably greater than 1 wt%.
  • the amount of agarose is preferably below 4 wt%, more preferably less than 3 wt%.
  • a plasticiser can also be added such as glycerol, propylene glycol, propylene glycol, sorbitol, mannitol, sucrose, trehalose, glucose, dextrose, urea, polyethylene glycol, polycarbonates and polyphosphoesters.
  • glycerol is preferred.
  • the amount of glycerol used is preferably greater than 5% wt%, more preferably greater than 10% wt%.
  • the amount of glycerol is preferably below 50% wt%, more preferably below 30% wt%.
  • a preservative can also be added such as diazolidinyl urea, sodium benzoate, potassium benzoate, benzoic acid, methyl paraben, propyl paraben, butyl paraben, sodium azide, sodium metabisulphite, sorbic acid, potassium sorbate.
  • preprepared preservative systems can be used such as Germaben II. Coloured dye paste can be added to agarose solution prior to solidification to obtain different skin colour tones Fig 2A. Additional appendages can also be added such as hair, tendon, bone blood vessels for a more realistic appearance.
  • the sloughy tissue can be prepared from materials such as custard powder, casein, whey protein, gluten, or polysaccharide based granular gels.
  • the slough is prepared from custard powder.
  • the amount of custard powder used in the slough is preferably greater than 5 wt%, more preferably greater than 10 wt%.
  • the amount of custard powder is preferably below 30 wt%, more preferably less than 20 wt%.
  • Exudate Composition Exudate can be prepared from a fluid gel materials such as agarose, agar, gellan gum, xanthan gum, carrageenan, methylcellulose hydroxypropylmethyl cellulose, chiotosan.
  • a fluid gel materials such as agarose, agar, gellan gum, xanthan gum, carrageenan, methylcellulose hydroxypropylmethyl cellulose, chiotosan.
  • gel forming biopolymer is agarose.
  • the amount of agarose used should be greater than 0.1% wt% preferably greater than 0.3% wt%.
  • the amount of agarose is also preferably below 3% and more preferably below 1 %. In this embodiment the concentration of agarose used is 0.5% wt.
  • Necrotic Layer composition The necrotic layer can be prepared from a gel forming biopolymer such as agarose, agar, gellan gum, xanthan gum, carrageenan, methylcellulose hydroxypropylmethyl cellulose, chiotosan.
  • gel forming biopolymer is agarose.
  • the amount of agarose used in the skin base is preferably greater than 0.5 wt%, more preferably greater than 1 wt%.
  • the amount of agarose is preferably below 4 wt%, more preferably less than 3 wt%.
  • Black dye paste should be added to agarose solution prior to solidification to obtain deep black colouration.
  • the agarose powder was dispersed in a small amount of cold deionised water (10% of water content) and once dispersed, 20% glycerol was added followed by the remaining deionised water added hot (>80 °C) to create a 2% w/w agarose solution.
  • the mixture was stirred and heated to ⁇ 85 °C using a heated magnetic stirrer set to ⁇ 700 rpm until the material was fully hydrated and a homogenous solution was evident.
  • the solution was then cooled to 50°C and the preservative system was added.
  • Germaben II was used at a concentrations between 0.5% and 1% w/v. A sufficient quantity of pink dye paste was gently added until solution became opaque.
  • the hot agarose solution was then poured into a 3D printed mould that contains the shape and dimensions of the required wound. This was then allowed to set at room temperature. Additional appendages such as hair could be added prior to the agarose fully setting.
  • Preparation of Artificial Sloughy Tissue The artificial sloughy tissue composition was prepared by weighing the appropriate quantity of custard powder for a 15% w/w solution then was added to a beaker of cold deionised water ⁇ 25 ml per model. The solution was heated to fully solubilise the custard powder, then it was allowed to thicken and solidify. Once solidified it was placed at 4 °C to cool.
  • the agarose powder was dispersed in a small amount of cold deionised water (10% of water content) and once dispersed, the rest of the deionised water was added was added hot (>80 °C) to create a 2% w/w agarose solution.
  • the mixture was stirred and heated to ⁇ 85 °C using a heated magnetic stirrer set to ⁇ 700 rpm until the material was fully hydrated and a homogenous solution was evident. A sufficient quantity of black dye paste was gently added until solution became opaque. This provided the necrotic eschar material.
  • the hot black agarose solution was then poured into a 3D printed mould that contains the shape and dimensions of the required necrotic eschar. This was then allowed to set at 4 °C.
  • the remaining black agarose solution can then be stored in the fridge at 4 °C and reused (to reuse once cooled, the material should be heated in a microwave for ⁇ 30 seconds until the agarose gel has melted and can be poured).
  • Wound Model Assembly The wound bed was gently removed from the mould and any imperfections trimmed away around the edges using a scalpel. A drop of red food colouring was added to the wound cavity and carefully spread evenly taking care to prevent ‘bleed’ into the small channels at the edges of the cavity. A second drop of red food colouring was added into the centre of the wound cavity to make a darker red colour at the centre, then was left for 5 min (Fig 3A). Artificial slough was then added to fill the cavity using a spatula, until flush with the healthy skin region.

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Abstract

L'invention concerne un dispositif de modèle de plaie ainsi qu'un procédé de préparation. Le dispositif comprend au moins deux couches, au moins l'une desdites couches étant une couche de base qui imite une peau saine, la couche de base étant un biopolymère.
PCT/GB2024/051544 2023-06-15 2024-06-17 Dispositif de modèle de plaie et procédé Ceased WO2024256844A1 (fr)

Priority Applications (1)

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EP24737148.7A EP4728500A1 (fr) 2023-06-15 2024-06-17 Dispositif de modèle de plaie et procédé

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GB202308954 2023-06-15
GB2308954.3 2023-06-15

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TW200918109A (en) * 2007-10-16 2009-05-01 Ind Tech Res Inst Tissue mimicking phantom
CA2882131A1 (fr) * 2012-08-14 2014-02-20 Chd Bioscience, Inc. Produits de soin de plaies renfermant des compositions de peracide
US20170345339A1 (en) * 2016-05-26 2017-11-30 Cari JoAnn Normand Wound Debridement Model

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TW200918109A (en) * 2007-10-16 2009-05-01 Ind Tech Res Inst Tissue mimicking phantom
CA2882131A1 (fr) * 2012-08-14 2014-02-20 Chd Bioscience, Inc. Produits de soin de plaies renfermant des compositions de peracide
US20170345339A1 (en) * 2016-05-26 2017-11-30 Cari JoAnn Normand Wound Debridement Model
US9972218B2 (en) 2016-05-26 2018-05-15 Cari Normand Wound debridement model

Non-Patent Citations (6)

* Cited by examiner, † Cited by third party
Title
MALHOTRA ET AL.: "Linear viscoelastic and microstructural properties of native male human skin and in vitro 3D reconstructed skin models", J. MECH. BEHAV. BIOMED. MATER., vol. 90, 2019, pages 644 - 654
NORMAND CA, WOUND DEBRIDEMENT MODEL, 2018
NOSRATI HAMED ET AL: "Cationic, anionic and neutral polysaccharides for skin tissue engineering and wound healing applications", INTERNATIONAL JOURNAL OF BIOLOGICAL MACROMOLECULES, ELSEVIER BV, NL, vol. 192, 9 October 2021 (2021-10-09), pages 298 - 322, XP086848640, ISSN: 0141-8130, [retrieved on 20211009], DOI: 10.1016/J.IJBIOMAC.2021.10.013 *
SENIOR JESSICA J. ET AL: "Development of a bio-inspired wound model for debridement training", IN VITRO MODELS, 29 April 2024 (2024-04-29), pages 81 - 89, XP093203914, ISSN: 2731-3441, Retrieved from the Internet <URL:https://pure.hud.ac.uk/en/publications/development-of-a-bio-inspired-wound-model-for-debridement-trainin> [retrieved on 20240911], DOI: 10.1007/s44164-024-00071-6 *
SZYCHER MLEE SJ.: "Modern wound dressings: a systematic approach to wound healing", J. BIOMATER. APPL., vol. 7, no. 2, October 1992 (1992-10-01), pages 142 - 213
ZHANG MENGDE ET AL: "Advances in 3D skin bioprinting for wound healing and disease modeling", RESEARCH CENTER FOR TISSUE REPAIR AND REGENERATION AFFILIATED TO THE MEDICAL INNOVATION RESEARCH DEPARTMENT, PLA GENERAL HOSPITAL AND PLA MEDICAL COLLEGE , 28 FU XING ROAD , BEIJING 100853, CHINA, 17 January 2023 (2023-01-17), pages 1 - 20, XP093203920, ISSN: 2056-3426, Retrieved from the Internet <URL:https://watermark.silverchair.com/rbac105.pdf?token=AQECAHi208BE49Ooan9kkhW_Ercy7Dm3ZL_9Cf3qfKAc485ysgAAA20wggNpBgkqhkiG9w0BBwagggNaMIIDVgIBADCCA08GCSqGSIb3DQEHATAeBglghkgBZQMEAS4wEQQMIn9H3zno_R6UHF3AAgEQgIIDIIO6bMusv7xe_hMCxMb6L-cv7iP6D4nXzNPzxboSmDygCKbhzYEeZX2k6YHToLZwKgaoflZ-5wGv77JTZZcyZrLvr96Q> [retrieved on 20240911], DOI: 10.1093/rb/rbac105 *

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