High barrier elastomer fecal catheter or ostomy pouch

Abstract

A fecal catheter or ostomy pouch made of an odor barrier material including a thermoplastic elastomer, odor barrier modifier and an antiblocking agent.

Claims

1. A fecal catheter comprising an odor barrier material comprising: i) a thermoplastic elastomer selected from the group consisting of a styrenic block copolymer, a thermoplastic vulcanizate, or a polyolefin elastomer; ii) an odor barrier modifier selected from polyisobutene, polybutene, or an organoclay; and iii) at least 0.1% antiblocking agent selected from the group consisting of essentially inorganic fillers, including silica, talc, clay, and mica; and wherein the antiblocking agent imparts an interior rough surface having an arithmetic mean surface roughness (Ra) not less than 0.1 m, wherein the fecal catheter is non-blocking upon folding and packaging.

2. The fecal catheter of claim 1, wherein the styrenic block copolymer includes styrene-isoprene-styrene (SIS), styrene-butadiene-styrene (SBS), styrene-ethylene/butylene-styrene (SEBS), styrene-ethylene/propylene-styrene (SEPS), or a blend of above.

3. The fecal catheter of claim 1, wherein the thermoplastic vulcanizate includes a blend of curable rubber and a polyolefin.

4. The fecal catheter of claim 3, wherein said polyolefin is polyethylene and polypropylene, including homopolymers and copolymers thereof.

5. The fecal catheter of claim 3, wherein the curable rubber is selected from the group consisting of ethylene propylene diene monomer (EPDM), ethylene propylene rubber, santoprene, and blends thereof.

6. The fecal catheter of claim 1, wherein the polyolefin elastomer includes an olefin block copolymer wherein a crystalline phase of olefin block copolymer acts as hard blocks and an amorphous block copolymer acts as soft blocks.

7. The fecal catheter of claim 1, wherein the organoclay includes montmorillonite clay, smectite clay, intercalated clay, nanoclay, or a mixture of above.

8. The fecal catheter of claim 1, wherein the oxygen barrier transmission rate per ASTM D3985 is 1000 cc/m.sup.2/day or less at 23 C.

9. The fecal catheter of claim 1 having a Shore A hardness of 60 or less.

10. The fecal catheter of claim 1, wherein the surface of the fecal catheter can be bonded with an adhesive having an adhesive strength greater than 5 N/in.

11. The fecal catheter of claim 1, wherein the surface of the fecal catheter can be heat welded having a weld strength greater than 5 N/in.

12. A fecal catheter comprising an odor barrier material comprising: an elastomer selected from the group consisting of silicone, polyurethane, styrenic block copolymer, thermoplastic vulcanizate or polyolefin elastomer; a nanocomposite filler material coated on or present within said elastomer so as to provide an odor barrier; said elastomer and nanocomposite forming a soft catheter tube having a Shore A hardness of not more than 60; and wherein the fecal catheter comprises an interior rough surface having an arithmetic mean surface roughness (Ra) not less than 0.1 m, wherein the fecal catheter is non-blocking upon folding and packaging.

13. The fecal catheter of claim 12, wherein said catheter tube does not crack upon flexing.

14. The fecal catheter of claim 12, wherein said tube is extruded and may be converted both by welding and adhesive bonding.

15. A fecal catheter comprising an odor barrier material, comprising an elastomer substrate and zeolite, said elastomer and zeolite forming a soft catheter tube having a Shore A hardness of not more than 60; and wherein the fecal catheter comprises an interior rough surface having an arithmetic mean surface roughness (Ra) not less than 0.1 m, such that the fecal catheter is non-blocking upon folding and packaging.

16. The fecal catheter of claim 15, wherein the elastomer substrate is selected from the group consisting of silicone, polyurethane, styrenic block copolymer, thermoplastic vulcanizate and polyolefin elastomer.

17. The fecal catheter of claim 15, wherein the zeolite is incorporated into the elastomer substrate.

18. The fecal catheter of claim 15, wherein the fecal catheter resists cracking upon flexing.

19. The fecal catheter of claim 15, wherein the zeolite is incorporated in a coating on the elastomer substrate.

20. A fecal catheter comprising at least 0.1% antiblocking agent such that the antiblocking agent imparts a rough interior surface to prevent catheter blocking upon folding and packaging, and an interior surface with an arithmetic mean surface roughness (Ra) of not less than 0.1 m, wherein the fecal catheter is non-blocking.

21. The fecal catheter of claim 20, wherein the interior surface roughness is not less than 0.1 m and does not trap fecal material.

22. The fecal catheter of claim 20, wherein the antiblocking agent is selected from the group consisting of essentially inorganic fillers, including silica, talc, clay, and mica, and any combination thereof.

23. The fecal catheter of any one of claims 1, 12, 15, and 20, wherein the fecal catheter is at least 10 times better in odor barrier than a silicone catheter as measured by oxygen transmission rate per ASTM D3985.

24. The fecal catheter of claim 1, wherein the odor barrier material further comprises tortuous paths and sites to adsorb the odor-causing compounds.

Description

(1) A series of experiments were conducted as described below. A total of four different nanocomposites were evaluated, two from Southern Clay and two from Nanocor. Two types of coating matrix were used, silicone and polyurethane. The following is a summary of these findings:

Exp. #1: Silicone Coating Consisting of Nanocomposites:

(2) 2.5% of the following nanocomposites were added into a two-part silicone made by Nusil 6350, including

(3) (1) Southern Clay Cloisite Na+, Hydrated Aluminum Silicate,

(4) (2) Southern Clay Cloisite 15 A, Ammonium salts with Bentonite,

(5) (3) Nanocor 1.30 E (Octadecyl ammonium surface compatabilized montmorillonite), and

(6) (4) Nanocor 1.34 TCN (methyl, bis hydroxyethyl octadecyl ammonium surface compatabilized montmorillonite).

(7) The two-part silicone was applied onto the silicone catheter as a coating, and was then heat cured at 130 deg C for 30 minutes. The coated catheter was then tested for onion odor barrier per ISO 8670-3:2000. About 5 grams of onion was chopped and filled inside a 12 cm long coated silicone tubing (i.e., catheter).

(8) TABLE-US-00002 Nano- Cloisite Cloisite Nanocor Nanocor composite None NA+ 15A 1.30E 1.34TCN Coating Matrix, Silicone Silicone Silicone Silicone Silicone Nusil 6350 Substrate, Silicone Silicone Silicone Silicone Silicone Dow Corning C6-135 Onset of 5 45 45 90 60 Onion Smell minutes minutes minutes minutes minutes

(9) As can be seen, the addition of 2.5% nanocomposites in a silicone coating improves the onion odor barrier in the silicone tubing. The control with a silicone coating had an onset of onion odor outside of the closed silicone tubing at around 5 minutes. This is about the same as the silicone tube without any coating. After a silicone coating consisting of 2.5% nanocomposites was applied onto a silicone tube, the onset of the onion odor was extended to 45-90 minutes.

Exp. #2:Polyurethane Coating Consisting of Nanocomposites, Without Primer:

(10) 2.5% of the following nanocomposites were added into a two-part polyurethane made by Smooth-On, Vytaflex 30, including

(11) (1) Southern Clay Cloisite Na+, Hydrated Aluminum Silicate,

(12) (2) Southern Clay Cloisite 15 A, Ammonium salts with Bentonite,

(13) (3) Nanocor 1.30 E (Octadecyl ammonium surface compatabilized montmorillonite), and

(14) (4) Nanocor 1.34 TCN (Methyl, Bis Hydroxyethyl Octadecyl Ammonium Surface Compatabilized Montmorillonite).

(15) The two-part polyurethane was applied onto the silicone catheter as a coating, and was then room temperature cured for 6 hours. The coated catheter was then tested for onion odor barrier per ISO 8670-3:2000. About 5 grams of onion was chopped and filled inside a 12 cm long coated silicone tubing (i.e., catheter).

(16) TABLE-US-00003 Nano- Cloisite Cloisite Nanocor Nanocor composite None NA+ 15A 1.30E 1.34TCN Coating Poly- Poly- Poly- Poly- Poly- Matrix, urethane urethane urethane urethane urethane Vytaflex 30 Primer, No No No No No Dow Corning 1200 Substrate, Silicone Silicone Silicone Silicone Silicone Dow Corning C6-135 Onset of 30 6 6 >12 >12 Onion Smell minutes hours hours hours hours

(17) As can be seen, the addition of 2.5% nanocomposites significantly improves the onion odor barrier. The control with a polyurethane coating, but without any nanocomposites, was able to extend the onset of onion odor outside of the closed silicone tubing from 5 minutes to 30 minutes. After a polyurethane coating consisting of 2.5% nanocomposites was applied onto a silicone tube, the onset of the onion odor was extended to 6-12 hours. Despite of the odor barrier improvement, the coating adhesion was poor.

Exp. #3: Polyurethane Coating Consisting of Nanocomposites, with Primer:

(18) The same set of experiment as Exp. #2 was repeated with the use of a silane primer, Dow Corning 1200. The same level of onion odor improvement was observed. That is, after a polyurethane coating consisting of 2.5% nanocomposites was applied onto a silicone tube primed with a silane, the onset of the onion odor was extended from 30 minutes in the control without any nanocomposites to 6-12 hours. The polyurethane coating stuck well to the silicone tube, and was able to resist the flex.

(19) TABLE-US-00004 Nano- Cloisite Cloisite Nanocor Nanocor composite None NA+ 15A 1.30E 1.34TCN Coating Poly- Poly- Poly- Poly- Poly- Matrix, urethane urethane urethane urethane urethane Vytaflex 30 Primer, Yes Yes Yes Yes Yes Dow Corning 1200 Substrate, Silicone Silicone Silicone Silicone Silicone Dow Corning C6-135 Onset of 30 6.5 6 >12 >12 Onion Smell minutes hours hours hours hours

Exp. #4: Nanocomposites in a Silicone Slab:

(20) 2% of Nanocor 1.30 E was added to make into a 1 mm thick (i.e., 40 mil) silicone gel slab, Nusil 6350. Onion barrier was compared on silicone slab with and without the nanocomposite per ISO 8670-3:2000.

(21) TABLE-US-00005 1 mm thick silicone slab without nanocomposites 1 mm thick silicone slab (control) with 2% Nanocor 1.30E Onset of 5-10 minutes 60 minutes Onion Smell

(22) As a result, the addition of 2% of Nanocor 1.30 E improved the onion odor barrier of the silicone slab from 5 minutes to about 60 minutes.

(23) Another embodiment of the present invention is an improved odor barrier fecal catheter, having a Hardness of less than Shore A 60, comprising at least (a) one layer of a silane coupling agent, and (b) at least one layer of nanocomposite coating. This formulation, when applied onto a silicone fecal catheter, would result in an oxygen transmission rate no more than 20,000 cc/m2/day, or preferably, no more than 10,000 cc//m2/day, or more preferably no more than 5,000 cc/m2/day. A silicone tube without the use of silane coupling agent and without the nanocomposite coating has an oxygen permeation rate of around 37,500 cc/m2/day. A silicone with the nanocomposite coating, but without the silane coupling agent, has an oxygen permeation rate of close to 30,000-35,000 cc/m2/day due to the lack of bonding. Alternatively, the same formulation can be applied onto a thermoplastic elastomer (TPE) or a polyurethane tubing (PU), having a Hardness of less than Shore A 60, such that the gas barrier is improved to no more than 25,000 cc/m2/day, or preferably, no more than 10,000 cc/m2/day, or more preferably no more than 5,000 cc/m2/day.

(24) The materials described in this invention can be used as a fecal catheter. A fecal pouch is commonly connected to a fecal catheter in use. The same materials described for fecal catheter were used to make a fecal pouch. Similar odor barrier characteristics against oxygen transmission and onion odor shown in Table 1 were obtained in the lab. Thus, besides a fecal catheter, the same material construction could be used for an ostomy pouch.