WO2025075847A1

WO2025075847A1 - Polymer compositions for ostomy patient attachment devices

Info

Publication number: WO2025075847A1
Application number: PCT/US2024/048379
Authority: WO
Inventors: Sean Xixian ZHOU; Fei He
Original assignee: Hollister Inc
Current assignee: Hollister Inc
Priority date: 2023-10-04
Filing date: 2024-09-25
Publication date: 2025-04-10
Anticipated expiration: 2026-04-04

Abstract

A polymeric material composition for ostomy pouch attachment devices, includes at least one stiffer polymer, at least one softer, polar polymer, and optionally at least one medium softness/stiffness polymer. The material composition is suitable for ostomy pouch flanges, ostomy convex plates and ostomy pouch closure members. The material composition has high durability and long life, high recovery properties, compression strength, flexibility, and elasticity, and is compatible to adhering to ostomy pouch films, woven and nonwoven fabrics by hot melt adhesives and heat sealing, exhibiting high seal strength.

Description

POLYMER COMPOSITIONS FOR OSTOMY PATIENT ATTACHMENT DEVICES

BACKGROUND

[0001] The following description relates to ostomy appliances, and more particularly to material compositions for patient attachment devices such as ostomy pouch flanges, convex plates, and pouch closure members.

[0002] Ostomy pouches for collecting bodily waste are used by individuals who have had surgery such as a colostomy, ileostomy, or urostomy. An ostomy pouch may be secured to a user via an ostomy barrier appliance that seals around the stoma and is attached to the peristomal skin surface and protects the peristomal surface from exposure to stomal effluent. The attachment to the user is via a skin-friendly adhesive.

[0003] There are two principal types of pouch systems, one-piece and two-piece pouch systems. In both types of systems, one side of the barrier appliance is attached or mounted to the user and the opposite side of the barrier appliance is directly or indirectly attached to the pouch. In a one-piece pouch system, the opposite side of the baffler appliance is attached directly (or indirectly via an intermediate member) to the pouch, and the barrier appliance and pouch cannot be separated from one another. In a two-piece pouch system, the opposite side of the barrier appliance includes a flange that mates with a flange on the ostomy pouch. In such two-piece systems, the flanges can be separated from one another to separate the pouch from the baffler appliance.

[0004] The various components or members in an ostomy pouch system may be formed from a wide variety materials selected for their specific characteristics. For example, the pouch material may be selected to provide liquid and effluent impermeability, odor baffler characteristics and the like. The barrier or wafer material may be selected to provide a high integrity seal between the peristomal skin and the pouch or a pouch attachment.

[0005] The materials for other components, such body and pouch side flanges, convexity members (such as inserts), and closure members may be selected for their durability, long life, relative flexibility (or conversely rigidity), and compatibility to adhering to a wide variety of other materials.

[0006] Accordingly, there is a need for a polymeric material for ostomy pouch attachment devices such as ostomy pouch flanges, convex plates and pouch closure members that has high durability and long life. Desirably, such a material has a high recovery property, compression strength, flexibility, and elasticity. More desirably, such a material is compatible to adhering to a wide variety of other materials used in the manufacture of ostomy pouches. More desirably still, such material is sealable to ostomy pouch films, woven and nonwoven fabrics by hot melt adhesives and heat sealing and exhibit high seal strength.

BRIEF SUMMARY

[0007] A polymeric material for ostomy pouch attachment devices such as ostomy pouch flanges, convex plates and pouch closure members has high durability and long life. Such a material has high recovery properties, compression strength, flexibility, and elasticity. More desirably, such a material is compatible to adhering to a wide variety of other materials used in the manufacture of ostomy pouches. More desirably still, such material is sealable to ostomy pouch films, woven and nonwoven fabrics by hot melt adhesives and heat sealing and exhibit high seal strength.

[0008] In one aspect, a polymeric material composition includes at least one stiffer polymer, at least one medium softness/stiffness polymer, and at least one softer, polar polymer. The polymeric material is suitable for one or more of for ostomy pouch flanges, ostomy convex plates and ostomy pouch closure members, and is sealable or can be adhered to ostomy pouch films, woven and nonwoven fabrics.

[0009] The stiffer polymer can be one or a combination of polypropylene homopolymers, polypropylene copolymers, high density polyethylene, crosslinked polyethylene, medium density polyethylene, olefin block copolymers, ionomers, grafted polyolefins, thermoplastic elastomers, propylene based elastomers, polylactic acids, and cyclic olefin copolymers.

[0010] The medium softness/stiffness polymer can be one or a combination of low density polyethylene, very low density polyethylene, medium density polyethylene, chlorinated polyethylene, crosslinked low density polyethylene, crosslinked very low density polyethylene, linear low density polyethylene, metallocene linear low density polyethylene, thermoplastic elastomers, and thermoplastic olefins.

[0011] The softer, polar polymer can be one or a combination of ethylene vinyl acetate copolymers, anhydride modified ethylene vinyl acetate, anhydride modified ethylene vinyl acetate, acrylate modified ethylene vinyl acetate, acid modified ethylene acrylate, ethylene methyl acrylate copolymers, ethylene acrylic acid copolymers, ethylene methyl acrylic acid copolymers, anhydride modified ethylene acrylate, anhydride modified ethylene methyl acrylate, anhydride modified low density polyethylene, and anhydride modified liner low density polyethylene.

[0012] In embodiments, the stiffer polymer is a polypropylene and high density polyethylene. In embodiments, the medium softness/stiffness polymer is one or a combination of low density polyethylene and linear low density polyethylene. In embodiments, the softer, polar polymer is an ethyl ene-methyl acrylate copolymer.

[0013] In embodiments, the polymeric material exhibits a shape recovery (R) of at least about 70 percent, and preferably at least about 85 percent where (R) in percent = [(Go - 0 ) / 0o] x 100, where 0o is the original angle before compression, and 0 is the angle after sample has recovered from compression.

[0014] The polymeric material can exhibit a compression peak force of at least about 0.5 pounds force/2 inches and preferably at least about 1.0 pound force/2 inches when tested on a tensile and compression testing device, such as an MTS® model No. Insight 2EL test system following an internal test protocol TMD-00066.

[0015] The polymeric material can exhibit a Shore D hardness of at least about 30 and preferably at least about 40, and a Shore A hardness of at least about 80 and preferably at least about 90 when measured in accordance with ASTM Standard D790, Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials.

[0016] The polymeric material can exhibit a flexural modulus of at least about 8000 and preferably at least about 10,000 when measured in accordance with ASTM Standard D2240, Standard Test Method for Rubber Property - Durometer.

[0017] The polymeric material can exhibit a seal strength of at least 2.5 pounds per inch and preferably at least about 4.0 pound per inch and a peel seal failure rate of zero.

[0018] In another aspect, an ostomy pouch flange, ostomy convex plate or an ostomy pouch closure member is formed from a polymeric material composition. [0019] The foregoing general description and the following detailed description are examples only and are not restrictive of the present disclosure. Other aspects, objectives and advantages will become more apparent from the following detailed description when taken in conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[0020] 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:

[0021] FIG. 1 illustrates the pouch portion of a two-piece ostomy pouch illustrating an ostomy pouch flange and pouch closure formed from an embodiment of a polymeric material composition and shown with an ostomy barrier.

DETAILED DESCRIPTION

[0022] 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.

[0023] A polymeric material composition for attachment devices for an ostomy pouch 10 (FIG. 1), such as ostomy pouch flanges 12, convex plates (not shown) and pouch closure members 14, has high durability and long life. Typically, the components are not subjected to stomal effluent.

[0024] Such a material has high recovery properties, compression strength, flexibility, and elasticity. Further, such a material is compatible to adhering to a wide variety of other materials used in the manufacture of ostomy pouches, and is sealable or can be adhered to ostomy pouch films, woven and nonwoven fabrics by hot melt adhesives and heat sealing, and exhibit high seal strength.

[0025] It has been found that a suitable polymer composition includes at least one stiffer polymer, and one softer, polar polymer. The composition can also include at least one medium softness/stiffness polymer.

[0026] Examples of stiffer polymers include one or a combination of polypropylene homopolymers, polypropylene copolymers, high density polyethylene, crosslinked polyethylene, medium density polyethylene, olefin block copolymers, ionomers, grafted polyolefins, thermoplastic elastomers, propylene based elastomers, polylactic acids, and cyclic olefin copolymers.

[0027] Examples of medium softness/stiffness polymers include one or a combination of low density polyethylene, very low density polyethylene, medium density polyethylene, chlorinated polyethylene, crosslinked low density polyethylene, crosslinked very low density polyethylene, linear low density polyethylene, metallocene linear low density polyethylene, thermoplastic elastomers, and thermoplastic olefins.

[0028] Examples of softer, polar polymers include one or a combination of ethylene vinyl acetate copolymers, anhydride modified ethylene vinyl acetate, anhydride modified ethylene vinyl acetate, acrylate modified ethylene vinyl acetate, acid modified ethylene acrylate, ethylene methyl acrylate copolymers, ethylene acrylic acid copolymers, ethylene methyl acrylic acid copolymers, anhydride modified ethylene acrylate, anhydride modified ethylene methyl acrylate, anhydride modified low density polyethylene, and anhydride modified liner low density polyethylene.

[0029] Various commercially available polymers were investigated. These include:

LOTRYL® 29MA03-T, an ethyl ene-methyl acrylate (EMA) copolymer (a softer polymer),

Dow 722, a low density polyethylene (LDPE) (a medium softness/stiffness polymer), Marlex® 3980, a crystalline polypropylene and high density polyethylene (HDPE) (a stiffer polymer).

[0030] Specifically desired properties, including recovery properties, compression strength, flexibility and elasticity can be achieved by adjusting the composition, i.e., the ratio of the stiffer polymer, the medium softness/stiffness polymer and softer polymer. In each of the below tables illustrating test results, the material tested is indicated with the specific polymer(s) and the percentage of that polymer in the composition. In some of the compositions, a colorant/dye was added to the composition.

[0031] For example a sample indicated as Lotryl® 29MA03- T/Marlex3980/Dow722/Color 44/42/10/4 % is 44% Lotryl® 29MA03-T, 42% Dow 722, 10% Marlex® 3980, and 4% colorant or dye. Where a single material is shown, that material was tested at 100%. All percentages are in percent by weight of the composition.

[0032] The recovery properties of various shapes of components made from an embodiment of a polymer composition were measured. A recovery of at least 70%, and preferably 85% or greater from its shape after deformation was considered acceptable. The shape recovery property was tested in accordance with an internal test method, TMD-00066 3.0 Provision 1.0, Plastics Compression and Recovery Test.

[0033] The test was conducted using an MTS® model No. Insight 2EL test system following an internal test protocol TMD-00066. The samples to be tested were 2 inch x 3 inch x 1/6 inch plaques (samples). An additional set up for the test consisted of a base platen, a sample holder, a clamp, a compressor head with sample stopper, and a protractor. The base plate is attached to the MTS® bottom clamp, a sample holder and clamp are attached to the base plate, and the compressor head is attached to MTS upper clamp.

[0034] The procedure was as follows: attach the base platen to the MTS machine base; attach the sample holder to the base platen; secure the compressor head to the load cell; attach the compressor head to MTS upper clamp; place the plaque sample onto the plate and slide into the sample holder; push down the clamp to secure the sample; lower the compressor head above the highest point of the clamp head; set the compression distance to 5 mm; align the origin of the protractor at 0.75 inches from the right edge of the sample holder, and secure on the back of the sample holder; bend the sample plaque over to touch the bottom of the compressor head; set the test speed at 5 inches per minute;

Start testing - the tester will stop at a 5 mm compression distance; wait for 10 second after the cross-head stops, return the cross-head, and release the sample from the compressor; and wait for 10 seconds, read the angle between the base platen and the bottom line of the sample plaque using the attached protactor and record the reading.

[0035] The shape recovery was calcaulated as follows:

Recovery (R) in % = [(0o - 0 ) / 0o] x 100% = [(180 - 0 ) / 180] x 100%, where 0o is the original angle, 180°, and 0 is the angle after sample has recovered from compression.

[0036] The results of recovery test data for selected polymers and polymer blends are shown in Table 1, below.

Table 1 - Shape Recovery Test Data for Various Polymer Compositions

[0037] The compression peak force of articles made from selected polymer compositions were tested. A compression peak force of at least above 0.5 lbf/2 inch was found to be acceptable; a preferable compression force is above about 1.0 Ibf/ 2 inch, tested in accordance with TMD-00066 3.0 Provision 1.0. The compression force was calculated by the MTS® model No. Insight 2EL test system internal software. The results of compression peak force for selected polymers and polymer blends are shown in Table 2, below.

Table 2 - Compression Peak Force Test Data for Various Polymer Compositions

[0038] The Shore A and Shore D hardness of the polymer composition were also tested. An acceptable Shore D hardness was found to be above 30, and preferably above 40. An acceptable Shore A hardness was found to be above 80, and preferably above 90. Shore hardness testing was conducted in accordance with ASTM D790, Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials. The test results are shown in Table 3, below.

Table 3 - Shore A and Shore D Hardness Test Data for Various Polymer Compositions

[0039] The flexural modulus of the polymer compositions was tested. It was found that a flexural modulus of greater than 8000 was acceptable. Preferably, the flexural modulus is greater than 10000 psi. Testing was conducted in accordance with ASTM D2240, Standard Test Method for Rubber Property - Durometer. The test results are shown in Table 4, below.

Table 4 - Flexural Modulus Test Data for Various Polymer Compositions

[0040] The polymer composition is to be heat sealable to ostomy pouch fdms, woven and non-woven fabrics and other ostomy pouch films and components. Sealing strength of the articles made from the polymer composition to pouch film was tested. A sealing strength of at least 2.5 Ibs/in and preferably at least 4.0 Ibs/in, with a peel seal failure rate of zero in any number of test samples was determined to be acceptable. Testing was conducted in accordance with an internal test method TMD-00127. Test results are provided in Table 5 below.

Table 5 - Sealing Strength to Pouch Film for Various Polymer Compositions

[0041] It can be seen from the test results above that a polymer composition of 38 to about 48 percent of a first relatively soft polymer, about 29 percent to about 48 percent of a second relatively soft polymer, about zero percent to about 29 percent of a relatively stiff polymer and optionally about zero percent to about percent of a colorant/dye provides a composition having the proper characteristics of shape recovery, compression force, hardness, flexural modulus and heat seal strength for any of a variety of for ostomy pouch attachment devices such as ostomy pouch flanges, convex plates and pouch closure members.

[0042] In embodiments, such a composition is about 38 percent to about 48 percent of an ethylene-methyl acrylate (EMA) copolymer, about 29 percent to about 48 percent of a low density polyethylene (LDPE), about zero percent to about 29 percent of a crystalline polypropylene and high density polyethylene (HDPE), and optionally about zero percent to about 4 percent of a colorant/dye.

[0043] In embodiments, the polymer composition is about 38 percent to about 48 percent of an ethylene-methyl acrylate (EMA) copolymer, such as Lotryl® 20MA03T , about 29 percent to about 48 percent of a low density polyethylene (LDPE) such as Dow 722, about zero percent to about 29 percent of a crystalline polypropylene and high density polyethylene (HDPE), such as Marlex® 3980, and optionally about zero percent to about 4 percent of a colorant/dye.

[0044] In embodiments, the polymer composition is about 48 percent of an ethylene-methyl acrylate (EMA) copolymer, such as Lotryl 20MA03T, about 48 percent of a low density polyethylene (LDPE) such as Dow 722, and optionally about zero percent to about 4 percent of a colorant/dye.

[0045] In other embodiments, the polymer composition is about 46 percent of an ethylene-methyl acrylate (EMA) copolymer, such as Lotryl® 20MA03T, about 25 of a low density polyethylene (LDPE) such as Dow 722, about 25 percent of a crystalline polypropylene and high density polyethylene (HDPE), such as Marlex® 3980, and optionally about zero percent to about 4 percent of a colorant/dye.

[0046] In still other embodiments, the polymer composition is about 38 percent of an ethylene-methyl acrylate (EMA) copolymer, such as Lotryl® 20MA03T, about 29 of a low density polyethylene (LDPE) such as Dow 722, about 29 percent of a crystalline polypropylene and high density polyethylene (HDPE), such as Marlex® 3980, and optionally about zero percent to about 4 percent of a colorant/dye. It will be appreciated that in the above example embodiments, as the percentage of the softer polymer is reduced, the percentage of the stiffer polymer increases.

[0047] It will be appreciated that embodiments of a polymeric material composition for ostomy pouch attachment devices such as ostomy pouch flanges, convex plates and pouch closure members, which composition includes at least one stiffer polymer, one medium softness/stiffness polymer and one softer, polar polymer has high durability and long life. Such materials have high recovery properties, compression strength, flexibility, and elasticity, and are compatible to adhering to a wide variety of other materials used in the manufacture of ostomy pouches. Further such material compositions are sealable or can be adhered to ostomy pouch fdms, woven and nonwoven fabrics by hot melt adhesives and heat sealing, and exhibit high seal strength.

[0048] All patents referred to herein, are hereby incorporated herein in their entirety, by reference, whether or not specifically indicated as such within the text of this disclosure.

[0049] In the present disclosure, 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.

[0050] From the foregoing it will be observed that numerous modifications and variations can be effectuated without departing from the true spirit and scope of the novel concepts of the present disclosure. It is to be understood that no limitation with respect to the specific embodiments illustrated is intended or should be inferred. The disclosure is intended to cover by the appended claims all such modifications as fall within the scope of the claims.

Claims

CLAIMS What is claimed is:

1. A polymeric material composition for ostomy pouch attachment devices, comprises: at least one stiffer polymer; and at least one softer, polar polymer, wherein the polymeric material composition is suitable for one or more of for ostomy pouch flanges, ostomy convex plates and ostomy pouch closure members, wherein the polymeric material composition is sealable or can be adhered to ostomy pouch films, woven and nonwoven fabrics, wherein the stiffer polymer is one or a combination of polypropylene homopolymers, polypropylene copolymers, high density polyethylene, crosslinked polyethylene, medium density polyethylene, olefin block copolymers, ionomers, grafted polyolefins, thermoplastic elastomers, propylene based elastomers, polylactic acids, and cyclic olefin copolymers, and wherein the softer, polar polymer is one or a combination of ethylene vinyl acetate copolymers, anhydride modified ethylene vinyl acetate, anhydride modified ethylene vinyl acetate, acrylate modified ethylene vinyl acetate, acid modified ethylene acrylate, ethylene methyl acrylate copolymers, ethylene acrylic acid copolymers, ethylene methyl acrylic acid copolymers, anhydride modified ethylene acrylate, anhydride modified ethylene methyl acrylate, anhydride modified low density polyethylene, and anhydride modified liner low density polyethylene.

2. The polymeric material composition of claim 1, further including wherein at least one medium softness/stiffness polymer.

3. The polymeric material composition of claim 2, wherein medium softness/stiffness polymers include one or a combination of low density polyethylene, very low density polyethylene, medium density polyethylene, chlorinated polyethylene, crosslinked low density polyethylene, crosslinked very low density polyethylene, linear low density polyethylene, metallocene linear low density polyethylene, thermoplastic elastomers, and thermoplastic olefins.

4. The polymeric material composition of any one of claims 1-3, wherein the polymeric material composition exhibits a shape recovery (R) of at least about 70 percent, and preferably at least about 85 percent where (R) in percent = [(0o - 0 ) / 0o] x 100, where 0o is the original angle before compression, and 0 is the angle after sample has recovered from compression.

5. The polymeric material composition of any one of claims 1-4, wherein the polymeric material composition exhibits a compression peak force of at least about 0.5 pounds force/2 inches and preferably at least about 1.0 pounds force/2 inches when tested on an MTS® model No. Insight 2EL test system.

6. The polymeric material composition of any one of claims 1-5, wherein the polymeric material composition exhibits a Shore D hardness of at least about 30 and preferably at least about 40, and a Shore A hardness of at least about 80 and preferably at least about 90 when measured in accordance with ASTM Standard D790, Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials.

7. The polymeric material composition of any one of claims 1-6, wherein the polymeric material composition exhibits a flexural modulus of at least about 8000 and preferably at least about 10,000 when measured in accordance with ASTM Standard D2240, Standard Test Method for Rubber Property - Durometer.

8. The polymeric material composition of any one of claims 1-7, wherein the polymeric material composition exhibits a seal strength of at least 2.5 pounds per inch and preferably at least about 4.0 pound per inch and a peel seal failure rate of zero.

9. The polymeric material composition of any one of claims 1-8, wherein the stiffer polymer is a polypropylene and high density polyethylene.

10. The polymeric material composition of any one of claims 1-9, wherein the softer, polar polymer is an ethyl ene-methyl acrylate copolymer.

11. The polymeric material composition of any one of claims 2-10, wherein the medium softness/stiffness polymer is one or a combination of low density polyethylene and linear low density polyethylene.

12. The polymeric material composition for ostomy pouch attachment devices according to any one of claims 1-11, wherein the ostomy pouch attachment device is an ostomy pouch flange.

13. The polymeric material composition for ostomy pouch attachment devices according to any one of claims 1-11, wherein the ostomy pouch attachment device is an ostomy convex plate.

14. The polymeric material composition for ostomy pouch attachment devices according to any one of claims 1-11, wherein the ostomy pouch attachment device is an ostomy pouch closure member.

15. An ostomy pouch flange, ostomy convex plate or an ostomy pouch closure member formed from the polymeric material composition of any one of claims 1-11.