Ostomy bag

Abstract

An ostomy bag has a pair of opposing side walls, one of the side walls defining a stoma reception opening to, in use, receive a portion of a stoma into the ostomy bag, one or both side walls being formed of a polymeric film at least partially coated on an inner surface thereof with hydrophobic particles, the hydrophobic particles including: a metal oxide core; and a hydrocarbon chain having from 2 to 40 carbon atoms, wherein the hydrocarbon chain is chemically bonded to the metal oxide core.

Description

24 ostomy bag FIELD

[001] This descriptive report refers to ostomy bags and, in particular, to ostomy bags where at least a portion of an inner surface thereof is coated with hydrophobic particles to result in an inner surface with a water contact angle (WCA) of approximately 140° or greater. The hydrophobic particles described herein are non-toxic and adhere well to polymer films. In this way, the hydrophobic particles described herein are particularly well suited for use in ostomy. FUNDAMENTALS

[002] Ostomy bags are medical devices that provide a means for collecting bodily waste from a stoma. Ostomy bags are most commonly associated with colostomies, ileostomies, and urostomies. Ostomy bags generally include a collection bag and a baseplate (also known as a flange or pad). There are one-piece ostomy bags where the collection bag and baseplate are provided as a single item, and there are two-piece ostomy bags where the collection bag and baseplate are provided as separate items to be attached to each other.

[003] Ostomy bags can be divided into two basic types: open-end bags and closed-end bags. Open-end bags typically comprise a drainable opening for the removal of bodily waste, for example, into a toilet. The drainable opening may include a valve, or the drainable opening may be opened and closed with a clip or a strap fastener. Closed-end bags are typically removed from the patient when full. The closed-end bag can then be discarded or emptied and cleaned, ready for reuse. Petition 870210088819, dated 09 / 27 / 2021, page 11 / 44 / 24

[004] Ostomy bags, particularly closed-end bags, can suffer from the phenomenon of pancaking. This is where a vacuum occurs inside the bag and the inner surfaces of the side walls stick together. Consequently, bodily waste is prevented from falling to the bottom of the bag. Trapped bodily waste can contaminate the adhesive on the baseplate, which can cause the ostomy bag to detach from the patient.

[005] Open-end bags can be problematic when the drainable opening becomes clogged with bodily waste. In such circumstances, the open-end bag may be difficult to drain and may need to be removed for thorough cleaning. In certain circumstances, however, it may not be possible to sufficiently clean the drainable opening, which may mean that the open-end bag needs to be replaced.

[006] The use of hydrophobic materials to create surfaces that are difficult to wet, non-stick, self-cleaning and / or resistant to contamination is well known. Such hydrophobic materials typically include waxes, fluorinated polymers, for example, polytetrafluoroethylene (PTFE), organosilanes, etc.

[007] However, known hydrophobic materials are not always suitable for use in ostomy, because they often do not adhere well to polymer films, and / or may be toxic, for example, containing fluoride.

[008] There is a commercial need for improved ostomy bags that seek to overcome the problems described above. SUMMARY OF THE INVENTION

[009] The embodiments of the present invention seek to provide ostomy bags that are simple and quick to clean, address the issues of pancaking and drainage, while at the same time being durable and non-toxic.

[0010] According to a first aspect of the invention, it is provided Petition 870210088819, dated 09 / 27 / 2021, page 12 / 44 / 24 an ostomy bag with a pair of opposing side walls, one of the side walls defining a stoma reception opening to, in use, receive a part of a stoma, one or both side walls being formed of a polymeric film at least partially coated on an inner surface thereof with hydrophobic particles, the hydrophobic particles comprising: a metal oxide core; and a hydrocarbon chain containing from 2 to 40 carbon atoms, wherein the hydrocarbon chain is chemically bonded to the metal oxide core.

[0011] The lateral wall defining the stoma reception opening may be formed from the polymeric film, and may comprise a first region that at least partially surrounds or encircles the stoma reception opening, wherein the first region is coated with hydrophobic particles.

[0012] The first region may have a peripheral border located approximately 20 mm to approximately 80 mm (such as approximately 20 mm to approximately 60 mm, for example, 40 mm) from the center of the stoma reception opening.

[0013] The side wall that opposes the side wall defining the stoma reception opening may be formed of the polymeric film, and may comprise a second region that is substantially oriented towards the stoma reception opening, wherein the second region is coated with hydrophobic particles.

[0014] The diameter of the second region may be larger than the diameter of the stoma reception opening.

[0015] The diameter of the second region may be greater than, less than, or approximately equal to the diameter of the first region. Petition 870210088819, dated 09 / 27 / 2021, page 13 / 44 / 24

[0016] The ostomy bag may comprise a drainable opening at one lower end thereof, both side walls being formed of polymeric film and comprising a third region surrounding the drainable opening, wherein the third region is coated with hydrophobic particles.

[0017] The drainable opening may include a valve to control the flow of bodily waste from it.

[0018] The inner surface of the valve can be coated with hydrophobic particles.

[0019] Both side walls can be formed from the polymeric film, and the entire inner surfaces of the same can be coated with hydrophobic particles.

[0020] The average diameter of hydrophobic particles can be less than or equal to approximately 200 nm.

[0021] The average diameter of hydrophobic particles can be less than or equal to approximately 50 nm, for example, less than or equal to approximately 20 nm.

[0022] The average diameter of hydrophobic particles can be from approximately 8 nm to approximately 20 nm, as well as from approximately 8 nm to approximately 15 nm.

[0023] The metal oxide core may comprise one or a combination of aluminum oxide, iron oxide, zinc oxide and silicon oxide.

[0024] The hydrocarbon chain can be aliphatic.

[0025] The hydrocarbon chain can be straight or branched.

[0026] The hydrocarbon chain can have from 2 to 32 carbons.

[0027] The hydrocarbon chain can have from 6 to 32 carbons, as well as from 6 to 24 carbons. Petition 870210088819, dated 09 / 27 / 2021, page 14 / 44 / 24

[0028] The hydrocarbon chain can be covalently linked to the metal oxide core by means of a functional group, for example, an anionic functional group.

[0029] The functional group may comprise any one or a combination of hydroxide, carboxylate, phosphonate, phosphinate, thiolate and thiocarboxylate.

[0030] Hydrophobic particles can be fluorine-free.

[0031] The polymeric film may comprise a thermoplastic film. For example, the polymeric film may comprise any one or more of a polyolefin, vinyl polymer, polyester, and polyacetal film.

[0032] The polymeric film may comprise a coextruded bilayer or multilayer film. For example, the coextruded bilayer or multilayer film may comprise layers of any one or a combination of polyethylene (PE), polypropylene (PP), acetal, acrylic, polyamide, polyvinyl chloride (PVC), ethylene vinyl acetate (EVA), polyvinylidene chloride (PVDC), polystyrene (PS), acrylonitrile butadiene styrene (ABS), and polycarbonate (PC).

[0033] Hydrophobic particles can be deposited (e.g., sprayed) onto the polymer film. For example, hydrophobic particles can be mixed with a carrier, such as a volatile solvent, and the resulting mixture can be sprayed onto the polymer film. The mixture of hydrophobic particles and carrier can form a solution or suspension. The mixture can have a hydrophobic particle concentration of approximately 0.5% by weight to approximately 20% by weight, such as approximately 0.5% by weight to approximately 10% by weight, such as approximately 0.5% by weight to approximately 5% by weight, for example, 0.5% by weight or 1% by weight or 2% by weight or 3% by weight or 4% by weight or 5% by weight.

[0034] Hydrophobic particles can be at least partially Petition 870210088819, dated 09 / 27 / 2021, page 15 / 44 / 24 incorporated into the polymeric film.

[0035] The polymer film can be heated to allow hydrophobic particles to become at least partially incorporated into it, to form a three-dimensional hydrophobic surface. The incorporation of hydrophobic particles can be intensified by physical means, such as rolling the heated polymer film between rollers. During processing, the volatile solvent (when used) evaporates naturally, and as the polymer film cools, the hydrophobic particles remain attached to the polymer film in such a way that they are not removed by washing.

[0036] The temperature to which the polymer film is heated will vary depending on the type of polymer film used. In general, the polymer film is heated to a temperature at which it begins to deform plastically. It should be recognized that those skilled in the art will know this temperature, or will be able to determine this temperature through basic experimentation. For the five-layer coextruded thermoplastic film of EVA / EVA / PVDC / EVA / EVA used in the following examples, the plastic deformation temperature was between approximately 80 °C and approximately 90 °C.

[0037] The hydrophobic particles and the polymer film can be fixed to each other by an adhesive, such as an epoxy resin. For example, an adhesive can be deposited on the polymer film, followed by the hydrophobic particles. Alternatively, the hydrophobic particles can be deposited on the polymer film, followed by the adhesive. The hydrophobic particles can become at least partially incorporated into the polymer film, which can provide the bond between the polymer film and the hydrophobic particles. When the adhesive is cured, the result is a polymer film with a three-dimensional hydrophobic surface.

[0038] The hydrophobic particles and the adhesive can be mixed and Petition 870210088819, dated 09 / 27 / 2021, page 16 / 44 7 / 24 The resulting mixture can be deposited onto the polymer film.

[0039] Where hydrophobic particles and adhesive are mixed, the mass ratio of hydrophobic particles to adhesive can be from approximately 1.0:1.0 to approximately 2.0:1.0. Mass ratios of hydrophobic particles to adhesive in this range have been found to produce polymer films with particularly good hydrophobic surfaces, particularly when the metal oxide core comprises aluminum oxide.

[0040] The hydrophobic particles or the hydrophobic particle / adhesive mixture can be sprayed onto the polymer film using a carrier, for example, a volatile solvent, in the manner previously described.

[0041] In all methods of attaching hydrophobic particles to the polymer film, it was found that WCAs are not adversely affected, even after the polymer film is embedded in, or exposed to, a solvent. Such treatment may result in the removal of some of the hydrophobic particles from the polymer film, but the removal has a negligible effect on the WCA.

[0042] The hydrophobicity of the polymer film can be adjusted in different regions along its surface. This means that a first region of the polymer film may have an associated first WCA measurement, and a second (or more) region of the polymer film may have a second associated WCA measurement that differs from the first WCA measurement.

[0043] The hydrophobicity of the polymer film can be adjusted in numerous ways. For example, more layers of hydrophobic particles can be deposited in the first region than in the second region. In this way, the first region will typically exhibit a higher WCA measurement than the second region. Additionally or alternatively, a more concentrated mixture of hydrophobic particles Petition 870210088819, dated 09 / 27 / 2021, page 17 / 44 / 24, suggests that hydrophobic particles can be deposited in the first region rather than the second region. Therefore, the first region will typically show a higher WCA measurement than the second (or additional) region. The concentration of hydrophobic particles in the mixture can be adjusted by dilution with the solvent and / or a different species, for example, a hydrophilic particle and / or a non-functionalized metal oxide. Additionally or alternatively, different types of hydrophobic particles can be deposited in the respective first and second regions. Therefore, the first and second regions will typically show different WCA measurements.

[0044] The present invention provides ostomy bags made of self-cleaning polymeric films. At least a portion of the inner surface of the ostomy bag has a hydrophobic surface formed by the attachment of hydrophobic particles to a polymeric film.

[0045] The methods of attaching hydrophobic particles to the polymer film result in a polymer film with a three-dimensional surface structure, which can achieve a WCA of approximately 140° or greater. In this way, ostomy bags of the invention can offer better self-cleaning properties, be resistant to contamination and / or be easier to clean. Ostomy bags of the present invention are also considered more durable in terms of the same properties and, consequently, have a longer lifespan when compared to known ostomy bags, due to the better adhesion between the hydrophobic particles and the polymer film. BRIEF DESCRIPTION OF THE FIGURES

[0046] The modalities will now be described, by way of example, with reference only to the attached drawings, in which: Figure 1 is a representation of a hydrophobic particle; Figure 2 shows a polymeric film with hydrophobic particles at least partially incorporated into it; Petition 870210088819, dated 09 / 27 / 2021, page 18 / 44 / 24 Figure 3 shows a polymeric film comprising hydrophobic particles bonded to it by an adhesive; Figure 4 is a cross-sectional view of an ostomy bag according to a first embodiment of the invention; Figure 5 is a cross-sectional view of an ostomy bag according to a second embodiment of the invention; and Figure 6 is a cross-sectional view of an ostomy bag according to a third embodiment of the invention. DESCRIPTION OF THE MODALITIES

[0047] With reference to Figure 1, a hydrophobic particle is shown, generally represented by 1. The hydrophobic particle 1 comprises a metal oxide core 10 and six hydrocarbon chains 12. It should be recognized that in other embodiments the hydrophobic particle 1 may have more or fewer than six hydrocarbon chains 12. Each hydrocarbon chain 12 has from 2 to 40 carbon atoms. The hydrocarbon chains 12 are branched, although they may be straight.

[0048] The hydrocarbon chains 12 are chemically linked to the metal oxide core 10. In some embodiments, the hydrocarbon chains 12 may be covalently linked to the metal oxide core 10 by means of a functional group 14. Suitable metal oxide cores 10 include aluminum oxide, iron oxide, zinc oxide and silicon oxide.

[0049] The term “oxide”, as used herein, is intended to include oxide-hydroxides, hydroxides, and also oxides with multiple oxidation states of metal. For example, iron oxide may include Fe3O4 or Fe2O3 or a combination thereof.

[0050] In some embodiments, the hydrophobic particle 1 comprises a metal oxide core 10 with a hydrocarbon chain 12 covalently linked to it by a functional group. Petition 870210088819, dated 09 / 27 / 2021, page 19 / 44 / 24 carboxylate 14. In other embodiments, functional groups may be employed, provided that a stable covalent interaction is formed between the metal oxide core 10 and the hydrocarbon chain 12. Alternative functional groups 14 may comprise any one or a combination of hydroxide, phosphonate, phosphinate, thiolate and thiocarboxylate.

[0051] In some embodiments, the hydrocarbon chain 12 may be aliphatic. In particular, the hydrocarbon chain 12 may be chosen from any suitable alkyl organic group, in the manner defined by the formula CxHy, where x and y are integers ex is from 2 to 40. In some embodiments, the hydrocarbon chain 12 may have from 6 to 32 carbons, as well as from 6 to 24 carbons.

[0052] In some embodiments, the hydrocarbon chain 12 may be straight. For example, the hydrophobic particle 1 may be created by the reaction of octanoic acid (CH3(CH2)6CO2H) with a metal oxide core 10.

[0053] In some embodiments, the hydrocarbon chain 12 may be branched. For example, the hydrophobic particle 1 may be created by the reaction of either isostearic acid (CH3(CH2)16COOH) and 2-hexyldecanoic acid (CH3(CH2)7CH[(CH2)5CH3]CO2H) with the metal oxide core 10.

[0054] The creation of hydrocarbon chains 12 in the manner described herein may provide the advantage that the resulting hydrophobic particles 1 are fluorine-free. This means that the hydrophobic particles 1 of the invention offer environmental benefits, in that they are less toxic when compared to materials of the prior art.

[0055] With reference now to figure 2, a polymeric film 2 is shown with hydrophobic particles 1 at least partially incorporated therein.

[0056] In some embodiments, the polymeric film 2 is prepared by deposition, for example, by spraying, the hydrophobic particles 1 in Petition 870210088819, dated 09 / 27 / 2021, page 20 / 44 / 24 a heated surface thereof. The hydrophobic particles 1 can be dissolved or suspended in a solvent. The exposed surface of the polymer film 2 can be heated until it becomes soft, followed by deposition of the solution or suspension onto the softened surface. After the solvent evaporates naturally and the surface cools, the hydrophobic particles 1 become at least partially incorporated into the polymer film 2. The result is a polymer film 2 with a stable, textured hydrophobic surface. In some embodiments, the polymer film 2 can be heated by radiation (e.g., by infrared lamps) or by conduction (e.g., by placing the polymer film 2 on a heated plate or exposing it to heated air). It should be understood that any method that provides sufficient heating to soften the polymer film 2, without compromising its integrity, can be employed.

[0057] The choice of solvent is limited only by the need for the solvent to evaporate from the surface of the polymer film 2. Suitable solvents include, but are not limited to, isopropanol, toluene, and ethanol.

[0058] With reference now to figure 3, a polymeric film 20 is shown, where hydrophobic particles 1 are fixed to it by an adhesive 30.

[0059] In some embodiments, the adhesive 30 may be an epoxy resin. The adhesive 30 may be applied to the polymer film 20, followed by deposition of the solution or suspension containing the hydrophobic particles 1, or vice versa. The adhesive 30 is cured naturally, at which point the hydrophobic particles 1 become bonded to the polymer film 20, by virtue of being at least partially incorporated into the adhesive 30.

[0060] In some embodiments, the hydrophobic particles 1 and the adhesive 30 can be mixed, and the resulting mixture can be deposited, for example, by spraying, onto the polymeric film 20.

[0061] Spraying can be done by dissolving or suspending Petition 870210088819, dated 09 / 27 / 2021, page 21 / 44 / 24 the mixture in a solvent and using a propellant or compressor, as is well known in the industry. Materials

[0062] The polymer film may comprise a thermoplastic film, for example, a polyethylene copolymer. The polymer film used for all subsequent experiments was a five-layer co-extrusion of EVA / EVA / PVDC / EVA / EVA, with a thickness of 75 microns.

[0063] Aluminum oxide (Al2O3) particles with an average diameter of 13 nm were purchased from Sigma-Aldrich.

[0064] Iron oxide (Fe3O4) particles with an average diameter of 15 - 20 nm were purchased from Sigma-Aldrich.

[0065] Isostearic acid was purchased from Nissan Chemical Industries, and was used without further purification.

[0066] Toluene and isopropanol were supplied by VWR Chemicals.

[0067] Slow hardener 1 kg of multipurpose epoxy resin system SP106 was purchased from MB Fibreglass.

[0068] Spraycraft universal airbrush propeller was used for spray coating and was purchased from Axminster Tools and Machinery. Water contact angle (WCA) measurements

[0069] WCA measurements were used to study the wettability of polymer films. WCA measurements were obtained by depositing 4 μE drops of H2O onto the polymer films. The WCA values ​​reported here are the average of three measurements, recorded at different positions on the surfaces. Standard deviations are used to represent the uncertainties associated with these values. Comparative example 1

[0070] The WCA of the uncoated polymer film (i.e., the five-layer coextruded film of EVA / EVA / PVDC / EVA / clean EVA) was Petition 870210088819, dated 09 / 27 / 2021, page 22 / 44 / 24 88.3° ±1.7°. Comparative example 2

[0071] The polymer film was coated with non-functionalized Al2O3 particles. The deposition of the non-functionalized Al2O3 particles on the polymer film was achieved by spray coating with 2% by weight isopropanolic suspensions at room temperature. Three sprays were used to try to achieve maximum coverage of the polymer film by the non-functionalized Al2O3 particles.

[0072] Coating the polymer film with non-functionalized Al2O3 particles at room temperature resulted in its surface becoming super-hydrophilic. Therefore, it is not possible to accurately measure the WCA of the resulting polymer film. Comparative example 3

[0073] The polymer film was coated with non-functionalized Fe3O4 particles. The deposition of the non-functionalized Fe3O4 particles on the polymer film was achieved by spray coating with 2 wt% isopropanolic suspensions at room temperature. Three sprays were used to try to achieve maximum coverage of the polymer film by the non-functionalized Fe3O4 particles.

[0074] The WCA of the resulting polymer film was 107.2° ±3.4°. Example 1

[0075] Functionalized aluminum oxide (Al2O3) particles were synthesized as follows. Aluminum oxide (Al2O3) particles (d = 13 nm, 10.0 g, 98.0 mmol, 1.0 equiv.) were refluxed with isostearic acid (39.1 g, 137.3 mmol, 1.4 equiv.) in toluene (250 mL) for 24 hours. Once the reaction time had elapsed, the reaction mixture was collected and centrifuged at 5,000 rpm for one hour. The solid was then recovered and centrifuged at 5,000 rpm in isopropanol for one hour. Following this, the solid was centrifuged in ethanol at 5,000 rpm for one hour. Petition 870210088819, dated 09 / 27 / 2021, p. 23 / 44 / 24 three additional times, and then dried at 80 °C for six hours.

[0076] The polymer film was coated with functionalized Al2O3 particles. The deposition of the functionalized Al2O3 particles on the polymer film was achieved by spray coating with 2% by weight isopropanolic suspensions at room temperature. Three sprays were used to try to achieve maximum coverage of the polymer film by the functionalized Al2O3 particles.

[0077] The WCA of the resulting polymer film was 151.1° ±1.0°. Example 2

[0078] Functionalized iron oxide (Fe3O4) particles were synthesized as follows. Iron oxide (Fe3O4) particles (d = 15 - 20 nm, 5.0 g, 21.6 mmol, 1.0 equiv.) were refluxed in toluene (100 mL) with isostearic acid (18.4 g, 64.7 mmol, 3.0 equiv.) for approximately twenty-four hours, under mechanical stirring. Once the reaction time had elapsed, the mixture was centrifuged at 5,000 rpm for one hour. Following this, the solid was recovered and dried at 80 °C for six hours.

[0079] The polymer film was coated with functionalized Fe3O4 particles. The deposition of the functionalized Fe3O4 particles on the polymer film was achieved by spray coating with 2 wt% isopropanolic suspensions at room temperature. Three sprays were used to try to achieve maximum coverage of the polymer film by the functionalized Fe3O4 particles.

[0080] The WCA of the resulting polymer film was 151.9° ±2.1°. Example 3

[0081] The polymer film was heated and coated with the functionalized Al2O3 particles described in Example 1. The functionalized Al2O3 particles were spray-coated onto the polymer film once they had softened as a result of heating. The heating of the polymer film was carried out in the manner that Petition 870210088819, dated 09 / 27 / 2021, page 24 / 44 15 / 24 following. First, the polymer film was physically attached at its edges to the surface of a glass Petri dish. The purpose of this was to fix the polymer film in order to limit the extent to which it changed shape during the heating process. Heat was then applied to the Petri dish until physical deformation of the polymer film was observed. Once physical deformation of the polymer film was observed, deposition of the functionalized Al2O3 particles onto the polymer film was achieved through spray coating. The functionalized Al2O3 particles were spray-coated from a 2.0% by weight suspension. Five sprays were used to attempt to achieve maximum coverage of the polymer film by the functionalized Al2O3 particles. After each spray, the polymer film was continuously heated in order to accelerate the removal of isopropanol.Additional spray coating was performed on the polymer film when no liquid was observed on its surface. The temperature of the polymer film was not measured before spray coating. However, it was observed that the polymer film would begin to deform plastically when heated between 80 and 90 °C.

[0082] The WCA of the resulting polymer film was 142.0° ±3.9°.

[0083] Although this value is slightly lower than when the functionalized Al2O3 particles were deposited on the polymer film at room temperature (Example 1), it is noteworthy that water droplets would easily roll off the coated polymer film. In this way, this suggests that heating the polymer film during application of the hydrophobic particles does not overtly impair the desired hydrophobic nature of the resulting polymer film.

[0084] In order to determine how well the hydrophobic functionalized AI2O3 particles had bonded, the polymer film was sonicated in isopropanol for approximately ten minutes and the WCA was tested. Petition 870210088819, dated 09 / 27 / 2021, page 25 / 44 / 24 again.

[0085] After sonication, the WCA of the polymer film was 137.7° ±7.9°. It is evident that the WCA did not change significantly after sonication, which indicates a strong thermal incorporation of the functionalized hydrophobic Al2O3 particles into the polymer film. Example 4

[0086] The polymer film was heated and coated with the functionalized Fe3O4 particles described in Example 2 according to the method described in Example 3.

[0087] The WCA of the resulting polymer film was 151.9° ±2.7°.

[0088] In order to determine how well the functionalized hydrophobic Fe3O4 particles bonded, the polymer film was sonicated in isopropanol for approximately ten minutes and the WCA was tested again.

[0089] After sonication, the WCA of the polymer film was 90.3° ±0.5°. This represents a WCA close to that of the uncoated polymer film. This indicates that most of the functionalized hydrophobic Fe3O4 particles were removed by sonication. Without wanting to get stuck on any particular theory, it is understood that functionalized hydrophobic Fe3O4 particles form relatively large clusters on the surface, which are less strongly incorporated than, say, functionalized hydrophobic Al2O3 particles. In this way, functionalized hydrophobic Fe3O4 particles are more easily removed than functionalized hydrophobic Al2O3 particles. However, this does not mean that embodiments incorporating functionalized hydrophobic Fe3O4 particles are not commercially viable. The sonication test aims merely to replicate a highly destructive environment to determine the degree of bonding between the hydrophobic particles and the polymer film.Hydrophobic films are unlikely to experience a highly destructive environment in use. Petition 870210088819, dated 09 / 27 / 2021, page 26 / 44 / 24 normal. Examples 5 to 9

[0090] The bonding of functionalized Al2O3 particles to the polymer film by an epoxy resin was studied in examples 5 to 9.

[0091] In Example 5, 0.08 g of epoxy resin was added to 0.66 g of the functionalized Al2O3 particles described in Example 1 and suspended in 40 mL of isopropanol, such that the mass ratio of functionalized Al2O3 particles to epoxy resin was approximately 8.6:1.0. The deposition of the mixture onto the polymer film was carried out by spray coating at room temperature, as previously described. Spray coating this suspension onto the polymer film resulted in a polymer film with a WCA of 144.3° ±4.3°.

[0092] In examples 6 to 9, the ratio of functionalized Al2O3 particles and epoxy resin was adjusted.

[0093] The functionalized particle ratios of Al2O3 and epoxy resin, and the corresponding WCAs for the polymer films of Examples 5 to 9 are summarized in Table 1. Table 1 also shows the WCAs for the polymer films after being sonicated in isopropanol for approximately ten minutes. Example Functionalized Al2O3 particles:epoxy resin Water contact angle (°) Water contact angle (°) after sonication 5 8.6:1.0 144.3 ±4.3° 132.2 ±7.4° 6 2.0:1.0 149.9 ±1.1° 137.1 ±1.0° 7 1.5:1.0 150.7 ±1.2° 135.9 ±7.5° 8 1.0:1.0 149.0 ±7.8° 141.1 ±1.6° 9 1.0:1.4 138.1 ±10.4° 142.0 ±0.6° Table 1. Angle of contact with water (°) before and after sonication as a function of the ratio of functionalized particles of Al2O3 and epoxy resin.

[0094] Although all examples 5 to 9 achieved high WCAs, it is evident that polymer films with the best hydrophobicity were created when the ratio of functionalized Al2O3 particles to epoxy resin was approximately 1.0:1.0 (i.e., 149.0 ±7.8°) at Petition 870210088819, dated 09 / 27 / 2021, page 27 / 44 / 24 approximately 2.0:1.0 (that is, 149.9 ±1.1°), for example, 1.5:1.0 (that is, 150.7 ±1.2°).

[0095] Furthermore, as in example 3, it is evident that the WCAs of examples 5 to 9 did not change significantly after sonication. This seems to indicate a strong incorporation of the functionalized hydrophobic Al2O3 particles into the epoxy resin. Examples 10 to 14

[0096] The bonding of functionalized Fe3O4 particles to the polymer film by an epoxy resin was studied in examples 10 to 14. The polymer film was coated with a mixture of epoxy resin and functionalized Fe3O4 particles, as described in example 2. In these examples, the epoxy resin was added to the suspension of functionalized Fe3O4 particles. The deposition of the mixture onto the polymer film was carried out by spray coating at room temperature, as previously described.

[0097] The functionalized particle ratios of Fe3O4 and epoxy resin, and the corresponding WCAs for the polymer films of Examples 10 to 14 are summarized in Table 2. Table 2 also shows the WCAs for the polymer films after being sonicated in isopropanol for approximately ten minutes. Example: Functionalized isostearate particles Fe3O4:epoxy resin. Water contact angle (°) Water contact angle (°) after sonication 10 11.8:1.0 124.3 ±10.6° 92.7 ±8.3° 11 6.5:1.0 102.1 ±4.3° 85.3 ±14.5° 12 2.0:1.0 89.9 ±4.7° 84.4 ±5.9° 13 1.0:1.0 75.4 ±2.2° 81.4 ±3.0° 14 1.0:1.5 80.7 ±10.8° 81.8 ±2.5° Table 2. Angle of contact with water (°) before and after sonication as a function of the ratio of functionalized Fe3O4 particles to epoxy resin.

[0098] When compared with examples 5 to 9, the WCAs of examples 10 to 14 are not as high. However, there is a clear trend. Petition 870210088819, dated 09 / 27 / 2021, page 28 / 44 / 24, states that the WCA increases during the increase in the ratio of functionalized Fe3O4 particles to epoxy resin. Therefore, it is plausible that the WCA would exceed 140° in embodiments where the ratio of functionalized Fe3O4 particles to epoxy resin exceeds 15.0:1.0.

[0099] With reference now to Figure 4, an ostomy bag, generally indicated as 40, is shown, with a pair of opposing side walls 41, 42. The ostomy bag 40 shown in this figure is of the closed-end type. The side walls 41, 42 are formed of a polymeric film, such as a polymeric film composed of any plastic that can be sealed by suitable heat or a combination of plastics (for example, as a coextruded laminate) that is resistant, flexible, and impermeable to liquids and gases. In some embodiments, the side walls 41, 42 may be separate pieces of film, joined (for example, welded) at their respective edges 43. In other embodiments, the side walls 41, 42 may be formed from a single piece of film.

[00100] One of the side walls 41 defines a stoma reception opening 100 for, in use, receiving a portion of a stoma (not shown) into the ostomy bag 40. In some embodiments, the ostomy bag 40 may comprise a pad 44 for adhesively attaching the ostomy bag 40 to the peristomal skin surfaces of a patient. The stoma reception opening 100 may have a diameter of approximately 10 mm to approximately 50 mm to accommodate stomas of different sizes and shapes.

[00101] The ostomy bag 40 is at least partially coated on an inner surface thereof (for example, on an inner surface of one or both of the side walls 41, 42) with hydrophobic particles 1. As previously described, the hydrophobic particles 1 comprise a metal oxide core 10 and a hydrocarbon chain 12 having from 2 to 40 carbon atoms. The hydrocarbon chain 12 is chemically Petition 870210088819, dated 09 / 27 / 2021, page 29 / 44 / 24 attached to the metal oxide core 10. Any of the hydrophobic particles 1 described herein may be used in the ostomy bag 40.

[00102] In some embodiments, the lateral wall 41 defining the stoma reception opening 100 may comprise a first region 46 that surrounds the stoma reception opening 100. The first region 46 may have a peripheral border 46a, located approximately 40 mm from the center of the stoma reception opening 100. Therefore, the distance through the first region 46 may be approximately 80 mm. The first region 46 may be coated with hydrophobic particles 45.

[00103] In some embodiments, the first region 46 may only partially surround the stoma reception opening 100.

[00104] In some embodiments, the lateral wall 42 that opposes the lateral wall 41, defining the stoma reception opening 100, may comprise a second region 47 that is substantially oriented towards the stoma reception opening 100, and is coated with hydrophobic particles 1. The second region 47 may have a peripheral border 47a and the distance through the second region 47 may be approximately 80 mm. Thus, the diameter of the second region 47 may be greater than the diameter of the stoma reception opening 100. The diameter of the second region 47 may also be approximately equal to the diameter of the first region 46. In some embodiments, the diameter of the second region 47 may be greater than or less than the diameter of the first region 46.

[00105] In some embodiments, the entire inner surface(s) of one or both of the side walls 41, 42 may constitute the respective first and second region(s) 46, 47. Thus, in some embodiments, the entire inner surface(s) of one or both of the side walls 41, 42 may be coated with hydrophobic particles 1.

[00106] In use, body residue enters the ostomy bag 40 from Petition 870210088819, dated 09 / 27 / 2021, page 30 / 44 / 24 of the stoma (not shown) through the stoma reception opening 100. As a consequence of the hydrophobic particles 1 present in the first and / or second region(s) 46, 47, and their high WCA, substantial amounts of body residue do not become attached to the side walls 41, 42 or immediately adjacent to the stoma reception opening 100. Instead, by virtue of the self-cleaning nature of the hydrophobic particles 1, the body residue falls to the bottom of the ostomy bag 40. It has been found, particularly with regard to closed-end type ostomy bags, that the pancaking phenomenon is therefore substantially reduced. Consequently, the adhesive on tablet 44 does not become contaminated in such a way that tablet 44 does not detach from the patient.

[00107] With reference now to Figure 5, an ostomy bag, generally indicated as 50, is shown. The ostomy bag 50 shown in this figure is of the open-end type. The features of the ostomy bag 50 that are common with the ostomy bag 40 of Figure 4 are indicated with a corresponding reference number in the decimal place of 50, instead of in the decimal place of 40. For example, the side walls of the ostomy device 50 are indicated with reference numbers 51, 52, instead of 41, 42.

[00108] Embodiments of the open-end type bags may comprise a drainable opening, generally indicated as 101, at a lower end of the ostomy bag 50 for drainage thereof. In some embodiments, the side walls 51, 52 may comprise a third region 58 that surrounds the drainable opening 101, and is coated with hydrophobic particles 1.

[00109] In some embodiments, the drainable opening 101 can be opened and closed using retention means (not shown), such as a retaining clip or a hook and handle fastener. In such embodiments, the drainable opening 101 is typically closed by folding the side walls 51, Petition 870210088819, dated 09 / 27 / 2021, page 31 / 44 / 24 around each other, and opened by reversing the action. In other embodiments, the drainable opening 101 may be fitted with a valve (not shown). The inner surface of the valve may be coated with hydrophobic particles 1.

[00110] Due to the high WCA of hydrophobic particles 1, it was found that the drainable opening 101 is cleared of body residue. In this way, the drainable opening 101 is less likely to become clogged, which can extend the lifespan of the ostomy bag 50 and / or improve its hygiene.

[00111] In some open-end ostomy bag designs 50, one or both of the first and / or second regions 56, 57 coated with hydrophobic particles 1 may not be present. Thus, hydrophobic particles 1 may be present only in the third region 58.

[00112] Referring now to Figure 6, an ostomy bag, generally indicated as 60, is shown. The 60 ostomy bag shown in this figure is of the open-end type. Features of the 60 ostomy bag, which are common with the 40 ostomy bag in Figure 4, are indicated with a corresponding reference numeral in the decimal place of 60, instead of in the decimal place of 40. For example, the side walls of the 60 ostomy device are indicated with reference numerals 61, 62, instead of 41, 42.

[00113] The entire internal surfaces of the side walls 61, 62 are coated with hydrophobic particles 1 in the ostomy bag 60 of figure 6. However, ostomy bags of a closed-end type can also be configured with the entire internal surfaces coated with hydrophobic particles, without departing from the scope of the invention.

[00114] One advantage of coating the entire internal surfaces of an ostomy bag with hydrophobic particles is that the ostomy bag is generally easier to clean. Petition 870210088819, dated 09 / 27 / 2021, page 32 / 44 / 24

[00115] In summary, the present invention relates to ostomy bags 40, 50, 60, formed from polymeric films, which exhibit improved self-cleaning properties due to the attachment of hydrophobic particles 1 to them. It has been found that the surface energies of these polymeric films are very low and that the polymeric films are non-toxic. Thus, not only are the ostomy bags 40, 50, 60 better in terms of their self-cleaning properties, but they are also better because they are non-toxic. It is also evident that the adhesion of the hydrophobic particles 1 to the polymeric films is better when compared to solutions of the prior art. Therefore, it is understood that the ostomy bags 40, 50, 60 of the present invention will be more durable, specifically in terms of their hydrophobic nature.

[00116] It may be useful to fine-tune the WCA in different regions of the ostomy bag 40, 50, 60. In some modalities, the WCA of any one of the first region 46, 56, the second region 47, 57 or the third region 58 may differ from another region. One way to achieve this is by varying the concentration of hydrophobic particles that are deposited in the different regions. For example, a 4% by weight solution of hydrophobic Al2O3 particles can be deposited in the first and second regions 46, 56; 47, 57, and a 2% by weight solution of hydrophobic Al2O3 particles can be deposited in the third region 58. In this way, the first and second regions 46, 56; 47, 57 will exhibit a higher WCA than the third region 58, due to the high concentration of hydrophobic Al2O3 particles.

[00117] As used herein, the term “hydrocarbon chain” is intended to convey its common meaning, that is, a molecule consisting entirely of hydrogen and carbon.

[00118] Representative characteristics are set out in the following clauses, which are independent or may be combined, in any combination, with one or more characteristics described in the text and / or Petition 870210088819, dated 09 / 27 / 2021, page 33 / 44 / 24 drawings from the descriptive report.

[00119] When used in this descriptive report and claims, the terms “comprises” and “comprising,” and variations thereof, mean that the specified features, steps, or whole numbers are included. The terms should not be interpreted to exclude the presence of other features, steps, or components.

[00120] The features described in the preceding description, or in the following claims, or in the attached drawings, expressed in their specific forms, or in terms of a means for performing the described function, or a method or process for obtaining the disclosed result, in the appropriate manner, can, separately, or in any combination of such features, be used to carry out the invention in various forms.

[00121] Although certain exemplary embodiments of the invention have been described, the scope of the appended claims is not intended to be limited to those embodiments alone. The claims should be interpreted literally, intentionally, and / or to encompass equivalents. Petition 870210088819, dated 09 / 27 / 2021, pp. 34 / 44

Claims

1 / 4 CLAIMS 1. Ostomy bag with a pair of opposing side walls, one of the side walls defining a stoma reception opening for, in use, receiving a part of a stoma, one or both side walls being formed of a polymeric film at least partially coated on an inner surface thereof with hydrophobic particles, characterized in that the hydrophobic particles comprise: a metal oxide core; and a hydrocarbon chain having from 2 to 40 carbon atoms, wherein the hydrocarbon chain is chemically bonded to the metal oxide core.

2. Ostomy bag according to claim 1, characterized in that the lateral wall defining the stoma reception opening is formed of polymeric film and comprises a first region that at least partially surrounds or encircles the stoma reception opening, wherein the first region is coated with hydrophobic particles.

3. Ostomy bag according to claim 1 or 2, characterized in that the side wall opposite the side wall defining the stoma reception opening is formed of polymeric film and comprises a second region that is substantially oriented towards the stoma reception opening, wherein the second region is coated with hydrophobic particles.

4. Ostomy bag according to claim 3, characterized in that the diameter of the second region is larger than the diameter of the stoma receiving opening.

5. Ostomy bag according to claim 3 or 4, when dependent on claim 2, characterized in that the diameter of the second region is approximately equal to the diameter of the first region.

6. Ostomy bag according to the preceding claim, characterized in that it further comprises a drainable opening at one lower end thereof, both side walls being formed of polymeric film and comprising a third region surrounding the drainable opening, wherein the third region is coated with hydrophobic particles.

7. Ostomy bag according to claim 6, characterized in that the drainable opening includes a valve, wherein optionally the inner surface of the valve is coated with hydrophobic particles.

8. Ostomy bag according to any of the preceding claims, characterized in that both side walls are formed of polymeric film, and the entire inner surfaces thereof are coated with hydrophobic particles.

9. Ostomy bag according to any of the preceding claims, characterized in that the average diameter of the hydrophobic particles is less than or equal to approximately 200 nm.

10. Ostomy bag according to claim 9, characterized in that the average diameter of the hydrophobic particles is less than or equal to approximately 50 nm.

11. Ostomy bag according to claim 10, characterized in that the average diameter of the hydrophobic particles is from approximately 8 nm to approximately 20 nm.

12. Ostomy bag according to any of the preceding claims, characterized in that the metal oxide core comprises one or a combination of aluminum oxide, iron oxide, zinc oxide, and silicon oxide. Petition 870210088819, dated 09 / 27 / 2021, pp. 36 / 44 3 / 4 13. Ostomy bag according to any of the preceding claims, characterized in that the hydrocarbon chain is aliphatic.

14. Ostomy bag according to any of the preceding claims, characterized in that the hydrocarbon chain is straight or branched.

15. Ostomy bag according to any of the preceding claims, characterized in that the hydrocarbon chain has from 6 to 32 carbons.

16. Ostomy bag according to claim 15, characterized in that the hydrocarbon chain has from 6 to 24 carbons.

17. Ostomy bag according to any of the preceding claims, characterized in that the hydrocarbon chain is covalently linked to the metal oxide core by means of a functional group.

18. Ostomy bag according to claim 17, characterized in that the functional group comprises any one or a combination of hydroxide, carboxylate, phosphonate, phosphinate, thiolate and thiocarboxylate.

19. Ostomy bag according to any of the preceding claims, characterized in that the hydrophobic particles are fluoride-free.

20. Ostomy bag according to any of the preceding claims, characterized in that the polymeric film comprises a thermoplastic film.

21. Ostomy bag according to claim 20, characterized in that the thermoplastic film comprises polyolefin, vinyl polymer or polyacetal film. Petition 870210088819, dated 09 / 27 / 2021, page 37 / 44 4 / 4 22. Ostomy bag according to claim 20 or 21, characterized in that the thermoplastic film comprises a coextruded bilayer or multilayer film.

23. Ostomy bag according to any of the preceding claims, characterized in that hydrophobic particles are at least partially incorporated into the polymeric film.

24. Ostomy bag according to any one of claims 1 to 22, characterized in that the hydrophobic particles and the polymeric film are fixed to each other by an adhesive.

25. Ostomy bag according to claim 24, characterized in that the mass ratio of the hydrophobic particles and the adhesive is approximately 1.0:1.0 to approximately 2.0:1.

0. Petition 870210088819, dated 09 / 27 / 2021, pp. 38 / 44

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