WO2023178027A1 - Matériaux adhésifs intelligents destinés à des applications de stomie - Google Patents

Matériaux adhésifs intelligents destinés à des applications de stomie Download PDF

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Publication number
WO2023178027A1
WO2023178027A1 PCT/US2023/064217 US2023064217W WO2023178027A1 WO 2023178027 A1 WO2023178027 A1 WO 2023178027A1 US 2023064217 W US2023064217 W US 2023064217W WO 2023178027 A1 WO2023178027 A1 WO 2023178027A1
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WO
WIPO (PCT)
Prior art keywords
skin
skin surface
adhesive
bio
smart
Prior art date
Application number
PCT/US2023/064217
Other languages
English (en)
Inventor
Abram D. Janis
Adrian P. DEFANTE
Clementene CLAYTON
Myra DADA
Nicholas THOM
Original Assignee
Hollister Incorporated
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 Hollister Incorporated filed Critical Hollister Incorporated
Publication of WO2023178027A1 publication Critical patent/WO2023178027A1/fr

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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
    • A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
    • A61L24/04—Surgical adhesives or cements; Adhesives for colostomy devices containing macromolecular materials
    • A61L24/08—Polysaccharides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
    • A61L24/001—Use of materials characterised by their function or physical properties
    • A61L24/0031—Hydrogels or hydrocolloids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
    • A61L24/04—Surgical adhesives or cements; Adhesives for colostomy devices containing macromolecular materials
    • A61L24/06—Surgical adhesives or cements; Adhesives for colostomy devices containing macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
    • A61L24/04—Surgical adhesives or cements; Adhesives for colostomy devices containing macromolecular materials
    • A61L24/10—Polypeptides; Proteins
    • A61L24/102—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
    • A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
    • A61L24/04—Surgical adhesives or cements; Adhesives for colostomy devices containing macromolecular materials
    • A61L24/10—Polypeptides; Proteins
    • A61L24/108—Specific proteins or polypeptides not covered by groups A61L24/102 - A61L24/106
    • 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
    • A61L2400/14—Adhesives for ostomy devices

Definitions

  • the present disclosure pertains to ostomy appliances, and more particularly to a hydrogel smart adhesive material for use with ostomy applications.
  • Ostomies are surgical procedures which involve the creation of a permanent or longterm opening in the abdominal cavity.
  • This opening, or stoma can allow for the expulsion of waste from the body into an ostomy device, a medical device which attaches to the stoma through an adhesive skin barrier and collects the waste in a disposable bag or pouch.
  • the skin barrier is typically comprised of a material that is in direct contact with the peristomal skin, the skin surrounding the stoma.
  • the pouch can interface with the skin barrier and serve to collect any waste that is expelled through the stoma.
  • Ostomy appliances, or pouches have advanced over the years and now exist in a variety of different forms and materials.
  • Atypical system consists of a skin barrier or wafer and a pouch.
  • the skin barrier also known as a faceplate or baseplate, is the piece of material that is in direct contact with the skin around the stoma (peristomial skin).
  • the waste collection pouch can exist in a closed-end one-piece or drainable two-piece form.
  • the skin barrier is directly attached to the pouch, while in the two-piece system, a mechanical coupling system called the flange interfaces between the barrier and pouch to allow for removal of the pouch without disturbance of the skin barrier.
  • a variety of adhesives, skin protectants, barrier rings, and powders are available to ostomy patients to help comfortably fit pouch systems to their unique stomas.
  • ostomy devices Following ostomy procedures, many patients aspire or expect to be able to return to typical activity levels; as such, there are several design requirements that ostomy devices must meet. For example, ostomy devices need to be comfortable and flexible enough to allow for regular exercise, including running and swimming, and travel. Pouches should remain intact and not leak under varying amounts of mechanical stress. Moreover, the adhesive used in the skin barrier should be strong enough to support the rest of the ostomy device, but not attach so firmly as to irritate the user’s peristomal skin upon removal. Because patients commonly live with a stoma for a time scale of years, it is essential that ostomy devices are easy to use and not interfere with their daily activities. In addition, infection or damage to the peristomal skin is one of the most common complications in ostomy patients. Accordingly, prevention of infection is of particular interest when considering ways to innovate and improve upon current ostomy appliances.
  • thermoresponsive microstructured block polymers with reversible hydrophobicity, hydrogels that swell or deswell upon exposure to different pH levels, and self-healing cross-linked polymers that restore chemical bonds after mechanical stress, to name a few.
  • Ostomies are inherently unique to each individual that undergoes the surgery and thus vary drastically across the patient population. Each stoma and the surrounding peristomial skin will look slightly different from patient to patient, and each patient will respond to ostomy appliances in a different way. This reality motivates an interest in a smart material-based ostomy appliance to allow for customization for each stoma system. The wide range of environments and conditions that ostomy appliances must perform in also necessitates a material that can adjust according to external cues.
  • the skin presents a of unique challenges one must take into account when it comes to designing adhesives, including a mixture of wet and dry environments, rough texture, mildly acidic conditions, and exposure to air.
  • Successful adhesives will closely match the elastic modulus of the peristomal tissue, exhibit sufficient fatigue resistance to remain adhered for at least 24 hours, resist degradation upon exposure to typical gut microbes, and dissipate applied mechanical stress at least equal to that of a full ostomy pouch.
  • Adherence of the flange, or skin barrier, of the ostomy appliance to the peristomal skin in a manner that maintains a sufficiently strong seal while still being able to be easily removed with no appreciable skin irritation or damage can also be critically important. This is not easily achieved, as seen with the skin stripping commonly observed in current commercial adhesives, and the ability of a soft material to “smartly” adhere/detach upon exposure to external stimulus would be a step closer to achieving such a delicate balance.
  • tissue adhesion examples include but are not limited to NHS esters, aldehydes, and cyanoacrylates.
  • An example of such is a tough NHS-ester hydrogel with instant triggerable benign detachment using a sodium bicarbonate and glutathione solution.
  • Chemical adhesives tend to demonstrate greater adhesion and tunability but run the risk of irritating the skin or reacting with gastrointestinal effluents.
  • ostomy adhesives utilize hydrocolloids, using polymers such as polyisobutylene or styrene-isoprene block copolymers, mixed with tackifiers, and paraffinic oils. Hydrocolloids also contain polymers with absorptive properties due to their hydrophilic nature, which is helpful in ensuring that the area around the stoma does not macerate. When designing adhesives for ostomy devices it is particularly important that the material has absorptive properties, minimizes irritation, and allows for easy removal.
  • Adhesive tape disks form a ring around the stoma which then allows the ostomy device to attach.
  • the other type is liquid adhesives, where some fluid is applied to the ostomy device, which is then attached to the body around the stoma.
  • Liquid adhesives are likely more tunable than tape disks, as there are a variety of different solutions that can be used.
  • a notable advantage of solvent-based adhesives is that they are often able to form a stronger bond.
  • ostomy device The ongoing presence and necessary maintenance of an ostomy device can result in certain common complications arising. Although the risk of complications declines after the first several years following the formation of a stoma, they can occur at any time. Possible complications of which ostomy patients must be aware include stomal necrosis, bleeding, and dehydration. However, the most common ostomy complications are related to the peristomal skin. In the United States, 20% of surgical ostomy revisions are due to peristomal skin conditions, and approximately two-thirds of ostomy patients experience peristomal skin problems at some point. Because ostomy pouches must be changed regularly and often do not fit properly, peristomal skin can become irritated or stripped. This is exacerbated by any leakage from the ostomy device, as the waste often contains harmful chemicals and enzymes capable of damaging the skin.
  • Embodiments presented herein are directed to a smart naturally derived bioadhesive material for application to a skin barrier of an ostomy appliance.
  • the smart bio-adhesive material can comprise a composition of a hydrogel comprising a biopolymer and a N- Hydroxysuccinimide (NHS) ester.
  • the biopolymer can comprise at least one of gum karaya, polysaccharides, chitosan, alginates, casein, collagen, cellulose and pectin.
  • the biopolymer can further comprise an acidic group to allow for adhesion through non-covalent adhesion on a skin surface.
  • the NHS ester can be configurable for adherence to the skin surface by temporary crosslinking a formation of covalent bonds between the ester and the skin surface.
  • the bioadhesive material can be configured for triggerable detachment from the skin surface by exposure to a chemical trigger. Non-covalent bonds can be disrupted by the chemical trigger and the covalent bonds can be cleaved upon exposure to the chemical trigger. Controlled adhesion of the smart naturally derived bio-adhesive material can be provided and defined by an on or an off state.
  • the acidic group of the biopolymer can comprise a carboxyl functional group.
  • the adhesive material can comprise a solvent-based liquid adhesive or a solvent-based adhesive tape disk.
  • the chemical trigger for non-covalent attachment can be a basic solution and the chemical trigger for covalent attachment mechanism can be at least one of a disruption of linkage between the NHS ester adhered to the skin surface and the ostomy appliance to disrupt S-S linkages in a polymer chain or a signal molecule for a self-immolating polymer.
  • the bio-adhesive material can be applied to an inner layer of the skin barrier between a backing layer and a removable release layer.
  • the acidic carboxylic can form non-covalent bonds to the skin and amine coupling groups of the ester can form covalent bonds with the skin surface.
  • Embodiments presented herein are further directed to an ostomy appliance skin barrier that can comprise an inner layer between a backing layer and a removable release layer.
  • the inner layer can comprise a smart bio-adhesive material.
  • the smart bioadhesive material can comprise a composition of a hydrogel having a biopolymer, acidic carboxylic group and a NHS ester.
  • the hydrogel can comprise at least one of gum karaya, polysaccharides, chitosan, alginates, casein, collagen, cellulose and pectin.
  • the biopolymer can further comprise an acidic group to allow for adhesion through non-covalent adhesion on a skin surface.
  • the acidic carboxylic group can be provided for adherence to the skin surface through non covalent adherence to the skin by temporary formation of physical bonds between the acidic carboxylic group and the skin surface.
  • the NHS ester can be configurable for adherence to a skin surface by temporary crosslinking a formation of covalent bonds between the ester and the skin surface.
  • the bio-adhesive material can be configured for triggerable detachment from the skin surface by exposure to a chemical trigger solution, where non-covalent bonds cause chemical dissociation and covalent bonds are cleaved upon exposure to the chemical trigger solution.
  • the ostomy appliance skin barrier can comprise an opening extending between opposing first and second sides of the skin barrier.
  • the opening can be generally centrally located on the skin barrier.
  • the inner layer and backing layer can be adjacent and surround the opening and extend outward therefrom.
  • the backing layer can extend beyond the inner layer to comprise an edge portion.
  • the inner layer can be exposed along the first side of the skin barrier.
  • the inner layer can be configured for adherence to the skin surface.
  • the adhesive material can comprise a solvent-based liquid adhesive.
  • the adhesive material can comprise a solvent-based adhesive tape disk.
  • the chemical trigger for non-covalent attachment can be a basic solution and the chemical trigger for covalent attachment mechanism can be at least one of a disruption of linkage between the NHS ester adhered to the skin surface and the ostomy appliance to disrupt S-S linkages in a polymer chain or a signal molecule for a self-immolating polymer.
  • Acidic coupling groups of the carboxylic group can form the non-covalent bonds with the skin surface.
  • Amine coupling groups of the ester can form the covalent bonds with the skin surface.
  • FIG. l is a perspective view of an ostomy barrier according to embodiments presented herein.
  • FIG. 2 is a partial cross-section view of the ostomy barrier of FIG. 1.
  • Embodiments presented here are generally directed to the use of materials with smart adhesive properties in ostomy devices, and more particularly to an ostomy adhesive, and/or ostomy skin barrier comprising an adhesive, formed from a smart hydrogel composition.
  • FIGS. 1 and 2 schematically illustrate a representative ostomy skin barrier 10 according to embodiments presented herein.
  • barrier 10 can be permanently attached to an ostomy bag or pouch (not shown) or may be configured for being removably attached to a pouch by way of a flange, coupling ring or other attachment member (not shown).
  • skin barrier 10 can have a first or proximal (body-facing) side 12 and a second, distal (pouch-facing) side 14.
  • Barrier 10 can comprise an inner layer 20 which includes an adhesive and a backing layer 3, which covers and extends beyond inner layer 20 to form an edge portion 40.
  • Barrier 10 can also include a release layer 42, which further includes a pull tab 44. As will be appreciated, the pull tab 44 may be utilized to remove the release layer 42 such that the barrier 10 may be adhered to the peristomal area of a user.
  • inner layer 20 with adhesive can be exposed along the first side 12 of the barrier whereupon the barrier can be placed or affixed to the user - the adhesive of the inner layer 20 securing the barrier to the user’s peristomal skin with the second pouch-facing side facing outward away from the user.
  • barrier 10 can further include a barrier hole or opening 22, which can be configured to be placed over a user's stoma, such that the stoma may extend through the opening 22 allowing the barrier 10 to be deployed.
  • opening 22 may range from 15 mm to 50 mm and is generally centered on the barrier 10.
  • barrier can be provided without an opening which may be created via a cutting tool prior to use.
  • Embodiments of the subject disclosure are directed to an adhesive composition
  • an adhesive composition comprising a hydrogel and a chemical solvent smart material with a triggering component that can respond dynamically to external stimuli to change adhesion on demand. It will be recognized that such capabilities can minimize peristomal skin irritation and reduce the likelihood of resulting complications.
  • adhesive compositions according to embodiments presented herein can be suitable for use in many medical or biomedical applications beyond ostomy care including, for example, wound care, e g., wound dressings, and the like, and may be suitable for use in both human and veterinary applications without limitation.
  • Embodiments presented herein include a smart bioadhesive comprising a hydrogel material having properties derived from different hydrogels of naturally derived biopolymers such as gum karaya, polysaccharides, chitosan, alginates, casein, collagen, cellulose and or pectin, having triggerable adhesion and detachment via an NHS ester (Chen et al., supra, Pan et al., supra).
  • naturally derived biopolymers such as gum karaya, polysaccharides, chitosan, alginates, casein, collagen, cellulose and or pectin
  • hydrogel materials were selected as proposed resources due to their strong adhesive characteristics, biocompatibility, capability of being made smart and triggerable and their ability to be multi-functionalized, meaning that adhesion control does not have to exist within a vacuum and can be integrated in concert with mechanical, absorption, self-healing, or other interesting smart properties.

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Dispersion Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Materials Engineering (AREA)
  • Orthopedics, Nursing, And Contraception (AREA)

Abstract

Un matériau bio-adhésif intelligent destiné à être appliqué sur une barrière cutanée d'un appareil de stomie. Le matériau bio-adhésif intelligent comprend une composition comprenant un matériau d'hydrogel, des groupes fonctionnels acides tels que l'acide carboxylique et un ester de N-Hydroxysuccinimide (NHS). Le matériau d'hydrogel est choisi dans un groupe de polymères d'origine naturelle tels que l'asgum karaya, les polysaccharides, le chitosane, les alginates, la caséine, le collagène, la cellulose et/ou la pectine. L'ester de NHS peut être conçu pour adhérer à une surface cutanée par réticulation temporaire par une formation de liaisons covalentes entre l'ester et la surface cutanée. Le matériau bio-adhésif est conçu pour un détachement de la surface cutanée déclenchable par une exposition à un déclencheur chimique lorsque les liaisons non covalentes et covalentes sont clivées lors de l'exposition au déclencheur.
PCT/US2023/064217 2022-03-14 2023-03-13 Matériaux adhésifs intelligents destinés à des applications de stomie WO2023178027A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US202263319672P 2022-03-14 2022-03-14
US63/319,672 2022-03-14
US202263324509P 2022-03-28 2022-03-28
US63/324,509 2022-03-28

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WO2023178027A1 true WO2023178027A1 (fr) 2023-09-21

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005116084A1 (fr) * 2004-05-24 2005-12-08 University Of Bath Processus
WO2017165490A1 (fr) * 2016-03-22 2017-09-28 President And Fellows Of Harvard College Adhésifs biocompatibles et leurs procédés d'utilisation
WO2021247262A1 (fr) * 2020-06-04 2021-12-09 Massachusetts Institute Of Technology Matériau adhésif à détachement à la demande déclenchable

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005116084A1 (fr) * 2004-05-24 2005-12-08 University Of Bath Processus
WO2017165490A1 (fr) * 2016-03-22 2017-09-28 President And Fellows Of Harvard College Adhésifs biocompatibles et leurs procédés d'utilisation
WO2021247262A1 (fr) * 2020-06-04 2021-12-09 Massachusetts Institute Of Technology Matériau adhésif à détachement à la demande déclenchable

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