WO2023183836A1 - Smart barrier materials for ostomy system - Google Patents

Abstract

An ostomy system includes an ostomy pouch, a skin barrier, and nanoparticles. The ostomy pouch can be configured to receive stoma effluent. The skin barrier can attach the ostomy pouch to a user's peristomal skin. The nanoparticles can be integrated into the skin barrier for neutralizing harmful enzymes in the stoma effluent

Description

TITLE

SMART BARRIER MATERIALS FOR OSTOMY SYSTEM

CROSS-REFERENCE TO RELATED APPLICATION

[0001] This application is based upon and claims priority to U.S. Provisional Application No. 63/322,917 filed on March 23, 2022, the entire content thereof is incorporated herein by reference in its entirety.

BACKGROUND

[0002] This disclosure is related to smart barrier materials for an ostomy system. More specifically, this disclosure is related to smart barrier materials used on a skin barrier.

[0003] Ostomy generally refers to the surgical procedure of creating an abdominal opening called a stoma that connects an internal organ to the skin surface, allowing for the external diversion of feces and urine. Ostomy surgery, in combination with the ostomy pouch system, a reservoir for storing waste outputs, can be a life-saving alternative for patients who suffer from either temporary or permanent disablement of bodily waste excretion from varying conditions. An ostomy pouch system device consists of a skin barrier and a collection pouch, and it can either be classified as a two-piece system or a one-piece system.

[0004] An ostomy procedure can be placed in three distinct categories, which include colostomy, ileostomy, and urostomy. The types of ostomies differ in where they redirect waste from. In the case of a colostomy, it is directed out of the colon, as well as in the type of waste they redirect, which can be urine or stool. Current products used by ostomates include ostomy skin barriers that attach around the stoma on the abdomen, and pouching systems, which connect to the skin barrier to collect bodily waste.

[0005] Currently, there are varying types of ostomy skin barriers compatible with the different ostomy pouching systems, but these do not provide sufficient levels of fluid absorption, adhesion, and mechanical response, specifically relating to the risks of acidic effluent leakage on the skin, the lifespan of the adhesive. Common ostomy complications, such as compromised skin integrity, irritant dermatitis, and leakage, can significantly affect the quality of life and further add financial burden to users. Skin damage can occur due to exposure to corrosive effluent, moisture accumulation, and local mechanical movement-induced friction, which significantly increases the susceptibility to skin infections and inflammation. Peristomal skin complications can include urostomy encrustation, inflammation of hair follicles, and dermatitis (skin irritation).

[0006] It is desirable to provide an improved ostomy skin barrier with smart functionality that can reduce peristomal skin complications by management of acidic effluent leakage that originates from stomal fluids.

BRIEF SUMMARY

[0007] Smart barrier materials for an ostomy system are provided according to various embodiments.

[0008] In one aspect, an ostomy system is provided. The ostomy system may include an ostomy pouch, a skin barrier, and nanoparticles. The ostomy pouch can be configured to receive stoma effluent. The skin barrier can attach the ostomy pouch to a user’s peristomal skin. The nanoparticles can be integrated into the skin barrier for neutralizing harmful enzymes in the stoma effluent.

[0009] In an embodiment, the nanoparticles may be composed of inorganic materials. In such embodiment, the inorganic materials may be iron oxide or copper sulfide.

[0010] In an embodiment, the nanoparticles may be composed of organic materials. In such an embodiment, the organic materials may include polymeric materials.

[0011] In an embodiment, the nanoparticles may be configured to be released into a stomatic channel for neutralizing enzymes in the stoma effluent.

[0012] In an embodiment, the nanoparticles may include pre-PEGylated iron oxide nanoparticles conjugated with alpha-1 antitrypsin. In such an embodiment, the nanoparticles may include iron oxide nanocomplexes conjugated with alpha- 1 antitrypsin.

[0013] In a second aspect, an ostomy barrier appliance is provided. The ostomy barrier appliance can include an inlet opening configured to receive a stoma, a skin barrier configured to attach to a user’s peristomal skin, and a polymer ring. The polymer ring may be located on the inlet opening and configured to expand around a stoma to provide intimate contact with the opening of the stoma.

[0014] In an embodiment, the polymer ring can be configured to expand around the stoma when activated by a threshold temperature. In such an embodiment, the polymer ring can be configured to deactivate when below a threshold temperature.

[0015] In an embodiment, the polymer ring can include polymeric temperature senstive materials.

[0016] In a third aspect, an ostomy barrier appliance is provided. The ostomy barrier appliance can include an inlet opening configured to receive a stoma, a skin barrier adhesive configured to attach to a user’s peristomal skin, at least one opening on a body side of the skin barrier, an absorption ring on a distal side of the skin barrier, and at least one fluid channel on the distal side of the skin barrier. At least one opening can be configured to intake stoma effluent. The absorption ring can be configured to absorb the stoma effluent. At least one fluid channel fluidly can connect the at least one opening to the absorption ring.

[0017] The foregoing general description and the following detailed description are examples only and are not restrictive of the present disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

[0018] The benefits and advantages of the present embodiments will become more readily apparent to those of ordinary skill in the relevant art after reviewing the following detailed description and accompanying drawings, wherein:

[0019] FIG. 1 is a front view of an ostomy system attached to a user, according to an embodiment.

[0020] FIG. 2 is a schematic view of a two-piece ostomy system, according to an embodiment.

[0021] FIG. 3 shows a skin barrier of FIG. 1 attached to a user.

[0022] FIG. 4 shows a prior art barrier ring.

[0023] FIG. 5A illustrates a lower critical solution temperature (LCST) for thermoresponsive polymers.

[0024] FIG. 5B shows an upper critical solution temperature (UCST) for thermoresponsive polymers.

[0025] FIG. 6A illustrates a distal side perspective view of an ostomy barrier appliance with a deactivated polymer ring.

[0026] FIG. 6B illustrates a distal side view of the ostomy barrier appliance of FIG. 5A with an activated polymer ring.

[0027] FIG. 7A illustrates a distal side view of an ostomy barrier appliance with fluid channels.

[0028] FIG. 7B illustrates a body side view of the ostomy barrier appliance of FIG. 6A with fluid channel openings.

[0029] FIG. 8 shows a cross-sectional view of the ostomy barrier appliance of FIG. 6A with microfluidic channels.

[0030] FIG. 9A shows a conjugation 2-step synthesis pathway.

[0031] FIG. 9B shows an example of PEGylation.

[0032] FIG. 10 shows aNMR spectroscopy example.

DETAILED DESCRIPTION

[0033] While the present disclosure is susceptible of embodiment in various forms, there is shown in the drawings and will hereinafter be described presently preferred embodiments with the understanding that the present disclosure is to be considered an exemplification and is not intended to limit the disclosure to the specific embodiments illustrated. The words “a” or “an” are to be taken to include both the singular and the plural. Conversely, any reference to plural items shall, where appropriate, include the singular. The words “first,” “second,” “third,” and the like may be used in the present disclosure to describe various information, such information should not be limited to these words. These words are only used to distinguish one category of information from another. The directional words “top,” “bottom,” up,” “down,” front,” “back,” and the like are used for purposes of illustration and as such, are not limiting. Depending on the context, the word “if’ as used herein may be interpreted as “when” or “upon” or “in response to determining.”

[0034] The present disclosure provides smart barrier materials for an ostomy system. The smart barrier material may be incorporated into a skin barrier of the ostomy system. Smart barrier materials can prevent leakage of stoma effluent in order to have an adaptable solution to keep peristomal skin healthy. The smart barrier material can include nanotechnology, thermoresponsive polymers, and or microfluidic channels. The ostomy system may include a one-piece pouch system or a two-piece pouch system.

[0035] Smart materials can be defined as materials that have properties that can be changed in a controlled fashion by stimuli, some of which include pH, temperature, chemicals, and moisture. In relation to a skin barrier, an example of a helpful smart material would be one that responds to the pH of leaking effluent and constricts around the stoma to prevent it from coming in contact with the skin.

[0036] Referring now to the figures, FIG. 1 illustrates an ostomy pouch system 10 mounted to a user. According to example embodiments shown in FIG. 1, the ostomy pouch system 10 can include an ostomy pouch 12, a skin barrier 14, and an inlet opening 16. The ostomy pouch system 10 can be attached to a user using an adhesive (See FIG. 2 and 3, adhesive 120) and surround a stoma with the inlet opening 16.

[0037] FIG. 2 illustrates an ostomy two-piece pouch system 110. According to example embodiments shown schematically in FIG. 2, the ostomy two-piece pouch system 110 can generally include an ostomy pouch 112 and an ostomy barrier appliance 114. The ostomy pouch 112 can include a flange 116. The ostomy barrier appliance 114 can include a coupling member 118 and an adhesive 120. The ostomy pouch 112 can be mounted on the ostomy barrier appliance 114 using the flange 116 and coupling member 118. The ostomy barrier appliance 114 can be mounted on a user using the adhesive 120. FIG. 3 illustrates the skin barrier 114 attached to a user’s skin 122 using an adhesive 120. The adhesive can include hydrogels, silicone, acrylic, and hydrocolloids.

[0038] In an embodiment, smart materials responsivity can engage to the environmental userspecific peristomal conditions, including the pH, temperature, chemicals, and moisture. Because every patient and his/her respective stoma condition is unique and even subject to its own alterations over time, a simple one-solution-fits-all approach of “plugging a leakage” by brute force is not effective, and there is a demand for a more sophisticated innovation in ostomy care, specifically for the skin barrier, that incorporates a smart property.

[0039] In an embodiment, smart material can be incorporated into an ostomy skin barrier. As mentioned previously, these smart material concepts rely on input stimuli in order to elicit a helpful response for the user. The new concepts all differ in input stimuli, an on / off switch to put it simply, which includes temperature, moisture detection, and the presence of enzymes from stoma effluent. Smart materials can include nanotechnology integration, specifically nanoparticles, thermoresponsive polymers, and/or microfluidic channels. The incorporation of at least one of these smart material concepts can prevent stoma peristomal skin damage from effluent leakage for users.

[0040] Thermoresponsive Polymer

[0041] Thermoresponsive polymers are materials that can change conformationally once a critical temperature is reached. The conformational changes can be from one to two-phase or two- phase to one. FIG. 5Aillustrates a lower critical solution temperature (LCST) for thermoresponsive polymers FIG. 5B shows an upper critical solution temperature (UCST) for thermoresponsive polymers. Upon reaching the critical (or threshold) temperature, polymers can either become more elastic or rigid depending on their design. The user can stretch the polymer around their stoma, then the user’s body heat would cause the polymer to reach its critical temperature. [0042] In an embodiment, once the critical temperature is reached, the polymer can contract around the stoma, forming a safe and tight seal. The seal can create a customized user solution preventing effluent leakage for any type of stoma.

[0043] FIG. 6A illustrates a distal side view of an ostomy barrier appliance 214 with a deactivated polymer ring 220. According to example embodiments shown schematically in FIG. 6A, the ostomy barrier appliance 214 can include an inlet opening 216, a coupling member 218, and the polymer ring 220. The polymer ring 220 can be an inner ring that can be located at the inlet opening and configured to activate and expand on or close the inlet opening 216 when activated by body heat.

[0044] FIG. 6B illustrates a distal side perspective view of the ostomy barrier appliance 214 with an activated polymer ring 220. According to example embodiments shown schematically in FIG. 6B, the ostomy barrier appliance 214 can include the polymer ring 220 activated by body heat and expanded on or closing the inlet opening 216.

[0045] In an embodiment, the thermoresponsive polymer can include the skin temperature around the stoma and the ability for a reversible conformational change. A potential material that could be used for this range would be Poly(N-alkylacrylamide), or PNIPAM. This concept could provide users with their own custom-molded stoma barrier through temperature control, effectively reducing the risk of effluent leakage.

[0046] Microfluidic Channels

[0047] In an embodiment, microfluidic channels can be embedded in the skin barrier to redirect leaking effluent away from the skin. Target specifications for integrating these microfluidic channels can be defined as such: homeostasis driven, and moisture detection. Using capillary action of the microfluidic channels, all liquids that come in contact with the channel’s openings along the skin interface will be drawn up and away from the skin, preventing the previously mentioned issues related to peristomal skin complications. The drawn-up fluid will then travel through the channels and be released into the absorbent ring.

[0048] The method for detecting enzymatic and pH changes may require the use of nanotechnology (see Nanotechnology Integration section). Moisture detection and uptake are nondiscriminant and will occur as the openings along the skin detect fluid due to the capillary action of the microfluidic channels and the absorbent ring around the outside of the barrier.

[0049] FIG. 7A illustrates a distal side view of an ostomy barrier appliance 314. According to example embodiments shown schematically in FIG. 7A, the ostomy barrier appliance 314 can include an inlet opening 316, a connecting member 318, one or more fluid channels 320, and a ring 322. The one or more fluid channels 320 can be configured to fluidly connect one or more openings 320 (FIG. 7B) to the ring 322. The ring 322 can be located at an edge of the ostomy barrier applieance 314 and can be made out of an absorbent material that can soak up a fluid. Stoma fluid can enter the one or more openings 320 and travel to the ring 322 through the one or more fluid channels 320.

[0050] FIG. 7B illustrates a body side view of the ostomy barrier appliance 314. According to example embodiments shown schematically in FIG. 7B, the ostomy barrier appliance 314 can include the one or more openings 320 and ring barrier 324. The one or more openings 320 can intake stoma fluid from the peristomal skin. The ring barrier 324 can be a barrier that seperates the absorbent material in the ring 322 to prevent the absorbed effluent from touching and irritating the peristomal skin. The fluid redirected from the peristomal skin can include both effluent and perspiration, as the one or more fluid channels 320 are non-discriminant with the up-drawn fluids. This is an advantage due to the possibility of prolonged contact of moisture on the skin causing skin irritation in addition to the corrosive enzymatic effluent, thus all fluids necessitate redirection. [0051] FIG. 8 shows a cross-sectional view of the ostomy barrier appliance with microfluidic channels. FIG. 8 includes microfluidic channel 410, hydrophobic polymer 412, skin barrier carrier material 414, skin adhesive 416, pathway for leaking effluent 418, absorbent material 420, and skin interface 422. In an embodiment, fluid can be intaked from the skin interface through the pathway for leaking effluent 418 to the absorbent material 420 through the microfluidic channel 410.

[0052] The microfluidic approach can have several advantages. Firstly, it is a well-established method of moving fluids in biomedical applications. Second, microfluidic channels can be made in a variety of ways. The third advantage is this is a simple and inexpensive method of redirecting effluent leakage, and the simplistic nature means it is easily combinable with other skin barrier improvement concepts.

[0053] Nanoparticles

[0054] In an embodiment, the smart barrier may include nanoparticles. For example, iron oxide nanoparticles can be used for skin barrier integration. Iron oxide nanoparticles are both inorganic and biochemically inert, meaning that they are unlikely to react with or be degraded by the stoma effluent. As a result, if they were to be strategically released into the stomatic channel, they could affect the stoma effluent without breaking down. Iron oxide nanoparticles also have easily modifiable surface properties, allowing for functional or targeting molecules to be added to the surface. Together, these two properties pave the way for the release of iron oxide nanoparticles into the stomatic channel to deliver an additional functional effect. The targeted release of functionalized iron oxide nanoparticles can neutralize harmful enzymes in the stoma effluent. This neutralization would greatly limit discomfort felt by patients who experience fluid leakage onto the skin. Iron oxide nanoparticle properties include specific targeting, drug release, fluorescent system, and biocompatibility.

[0055] Nanotechnology Integration

[0056] Nanotechnology integration can be a two-part process: first, the synthesis and functionalization of nanoparticles, and second, the integration of those nanoparticles into the skin barrier material interface. By integrating functional nanoparticles into the skin barrier material, the smart properties of those nanoparticles are inherited by the material.

[0057] FIG. 9A shows a conjugation 2-step synthesis pathway. FIG. 9B shows an example of PEGylation.

[0058] Iron oxide nanoparticles are both inorganic and biochemically inert, meaning that they are unlikely to react with or be degraded by the stoma effluent. As a result, if they were to be strategically released into the stomatic channel, they could affect the stoma effluent without breaking down. Iron oxide nanoparticles also have easily modifiable surface properties, allowing for functional or targeting molecules to be added to the surface. Together, these two properties pave the way for the release of iron oxide nanoparticles into the stomatic channel to deliver an additional functional effect. The targeted release of functionalized iron oxide nanoparticles can be used to neutralize harmful enzymes in the stoma effluent. This neutralization would greatly limit discomfort felt by patients who experience fluid leakage onto the skin.

[0059] FIG. 10 shows a nuclear magnetic resonance (NMR) spectroscopy example.

[0060] In one or more embodiments, iron oxide nanoparticles can be used for targeted release of antibiotics, strengthening the mechanical properties of the material barrier, and magnetic- mediated therapies.

Claims

CLAIMS What is claimed is:

1. An ostomy system comprising: an ostomy pouch, wherein the ostomy pouch is configured to receive stoma effluent; a skin barrier, wherein the skin barrier attaches the ostomy pouch to a user’s peristomal skin; and nanoparticles, wherein the nanoparticles are integrated into the skin barrier for neutralizing harmful enzymes in the stoma effluent.

2. The ostomy system of claim 1, wherein the nanoparticles comprise inorganic materials.

3. The ostomy system of claim 2, wherein the inorganic material comprises iron oxide or copper sulfide.

4. The ostomy system of claim 1, wherein the nanoparticles comprise organic materials.

5. The ostomy system of claim 4, wherein the organic materials comprise polymeric materials.

6. The ostomy system of claim 1, wherein the nanoparticles are configured to be released into a stomatic channel for neutralizing enzymes in the stoma effluent.

7. The ostomy system of claim 1 , wherein the nanoparticles comprise pre-PEGylated iron oxide nanoparticles conjugated with alpha-1 antitrypsin using a synthesis protocol.

8. The ostomy system of claim 7, wherein the nanoparticles comprise iron oxide nanocomplexes conjugated with alpha- 1 antitrypsin.

9. An ostomy barrier appliance comprising: an inlet opening configured to receive a stoma; a skin barrier adhesive configured to attach to a user’s peristomal skin; and a polymer ring, wherein the polymer ring is located on the inlet opening and configured to expand around the stoma.

10. The ostomy barrier appliance of claim 9, wherein the thermoresponsive polymer ring is configured to expand around the stoma when activated by a threshold temperature.

11. The ostomy barrier appliance of claim 10, wherein the polymer ring is configured to deactivate when below the threshold temperature.

12. An ostomy barrier appliance comprising: an inlet opening configured to receive a stoma; a skin barrier adhesive configured to attach to a user’s peristomal skin; at least one opening on a body side of the skin barrier, wherein the at least one opening is configured to intake stoma effluent; an absorption ring on a distal side of the skin barrier, wherein the absorption ring is configured to absorb the stoma effluent; and at least one fluid channel on the distal side of the skin barrier, wherein the at least one fluid channel fluidly connects the at least one opening to the absorption ring.

13. The ostomy barrier appliance of claim 12, further comprising: a ring barrier located on the body side of the skin barrier, wherein the ring barrier is configured to separate the absorption ring from the peristomal skin.

14. The ostomy barrier appliance of claim 12, wherein the at least one opening comprises a plurality of openings arranged in a circular pattern around the inlet opening.

15. The ostomy barrier appliance of claim 12, wherein the absorption ring is located on an outer edge of the skin barrier.