NZ616754B2 - High barrier elastomer fecal catheter or ostomy pouch - Google Patents
High barrier elastomer fecal catheter or ostomy pouch Download PDFInfo
- Publication number
- NZ616754B2 NZ616754B2 NZ616754A NZ61675412A NZ616754B2 NZ 616754 B2 NZ616754 B2 NZ 616754B2 NZ 616754 A NZ616754 A NZ 616754A NZ 61675412 A NZ61675412 A NZ 61675412A NZ 616754 B2 NZ616754 B2 NZ 616754B2
- Authority
- NZ
- New Zealand
- Prior art keywords
- catheter
- fecal
- fecal catheter
- styrene
- silicone
- Prior art date
Links
- 230000002550 fecal Effects 0.000 title claims abstract description 47
- 229920001971 elastomer Polymers 0.000 title claims abstract description 32
- 239000000806 elastomer Substances 0.000 title claims abstract description 27
- 239000004927 clay Substances 0.000 claims abstract description 22
- 229910052570 clay Inorganic materials 0.000 claims abstract description 22
- 229920002725 Thermoplastic elastomer Polymers 0.000 claims abstract description 17
- 229920001400 block copolymer Polymers 0.000 claims abstract description 16
- 239000003795 chemical substances by application Substances 0.000 claims abstract description 13
- 229920000098 polyolefin Polymers 0.000 claims abstract description 11
- PPBRXRYQALVLMV-UHFFFAOYSA-N styrene Chemical compound C=CC1=CC=CC=C1 PPBRXRYQALVLMV-UHFFFAOYSA-N 0.000 claims abstract description 9
- 229920001169 thermoplastic Polymers 0.000 claims abstract description 9
- 239000004416 thermosoftening plastic Substances 0.000 claims abstract description 9
- 229920002367 Polyisobutene Polymers 0.000 claims abstract description 8
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims abstract description 8
- 239000003607 modifier Substances 0.000 claims abstract description 7
- 230000003746 surface roughness Effects 0.000 claims abstract description 6
- 239000011256 inorganic filler Substances 0.000 claims abstract description 5
- 229910003475 inorganic filler Inorganic materials 0.000 claims abstract description 5
- 239000010445 mica Substances 0.000 claims abstract description 5
- 229910052618 mica group Inorganic materials 0.000 claims abstract description 5
- 239000000454 talc Substances 0.000 claims abstract description 5
- 229910052623 talc Inorganic materials 0.000 claims abstract description 5
- 229920001083 Polybutene Polymers 0.000 claims abstract description 4
- 239000000377 silicon dioxide Substances 0.000 claims abstract description 4
- 239000000203 mixture Substances 0.000 claims description 16
- MYMOFIZGZYHOMD-UHFFFAOYSA-N oxygen Chemical compound O=O MYMOFIZGZYHOMD-UHFFFAOYSA-N 0.000 claims description 10
- 239000001301 oxygen Substances 0.000 claims description 10
- 229910052760 oxygen Inorganic materials 0.000 claims description 10
- 230000005540 biological transmission Effects 0.000 claims description 9
- KARVSHNNUWMXFO-UHFFFAOYSA-N dioxosilane;oxo(oxoalumanyloxy)alumane;hydrate Chemical compound O.O=[Si]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O.O=[Al]O[Al]=O KARVSHNNUWMXFO-UHFFFAOYSA-N 0.000 claims description 7
- 229910052901 montmorillonite Inorganic materials 0.000 claims description 7
- 150000001336 alkenes Chemical class 0.000 claims description 5
- 239000005060 rubber Substances 0.000 claims description 5
- FACXGONDLDSNOE-UHFFFAOYSA-N buta-1,3-diene;styrene Chemical compound C=CC=C.C=CC1=CC=CC=C1.C=CC1=CC=CC=C1 FACXGONDLDSNOE-UHFFFAOYSA-N 0.000 claims description 4
- -1 polyethylene Polymers 0.000 claims description 4
- 229920002943 EPDM rubber Polymers 0.000 claims description 3
- 239000000853 adhesive Substances 0.000 claims description 3
- 230000001070 adhesive Effects 0.000 claims description 3
- 239000004698 Polyethylene (PE) Substances 0.000 claims description 2
- 239000004743 Polypropylene Substances 0.000 claims description 2
- 229920003031 Santoprene Polymers 0.000 claims description 2
- 229920001519 homopolymer Polymers 0.000 claims description 2
- VSKJLJHPAFKHBX-UHFFFAOYSA-N 2-methylbuta-1,3-diene;styrene Chemical compound CC(=C)C=C.C=CC1=CC=CC=C1.C=CC1=CC=CC=C1 VSKJLJHPAFKHBX-UHFFFAOYSA-N 0.000 claims 2
- 229920000181 Ethylene propylene rubber Polymers 0.000 claims 1
- 229920000573 polyethylene Polymers 0.000 claims 1
- 229920001155 polypropylene Polymers 0.000 claims 1
- 239000000463 material Substances 0.000 abstract description 12
- 229920001296 polysiloxane Polymers 0.000 description 57
- 240000002840 Allium cepa Species 0.000 description 23
- 239000002114 nanocomposite Substances 0.000 description 23
- 235000002732 oignon Nutrition 0.000 description 23
- 239000004814 polyurethane Substances 0.000 description 19
- 229920002635 polyurethane Polymers 0.000 description 18
- 239000011248 coating agent Substances 0.000 description 15
- 238000000576 coating method Methods 0.000 description 15
- 239000010457 zeolite Substances 0.000 description 10
- 230000000903 blocking Effects 0.000 description 8
- 239000010410 layer Substances 0.000 description 7
- 239000000758 substrate Substances 0.000 description 7
- 230000001809 detectable Effects 0.000 description 6
- 238000009472 formulation Methods 0.000 description 6
- 239000000956 alloy Substances 0.000 description 5
- 229910045601 alloy Inorganic materials 0.000 description 5
- REDXJYDRNCIFBQ-UHFFFAOYSA-N aluminium(3+) Chemical class [Al+3] REDXJYDRNCIFBQ-UHFFFAOYSA-N 0.000 description 5
- 239000000945 filler Substances 0.000 description 5
- 150000002500 ions Chemical class 0.000 description 5
- 239000011159 matrix material Substances 0.000 description 5
- 229920000642 polymer Polymers 0.000 description 4
- 239000011527 polyurethane coating Substances 0.000 description 4
- 239000004447 silicone coating Substances 0.000 description 4
- 230000035943 smell Effects 0.000 description 4
- 239000006087 Silane Coupling Agent Substances 0.000 description 3
- 229940035295 Ting Drugs 0.000 description 3
- 239000000654 additive Substances 0.000 description 3
- 238000001125 extrusion Methods 0.000 description 3
- 239000007788 liquid Substances 0.000 description 3
- 239000004014 plasticizer Substances 0.000 description 3
- 239000002356 single layer Substances 0.000 description 3
- YGCMLNDQGHTAPC-UHFFFAOYSA-O 2-hydroxyethyl(octadecyl)azanium Chemical compound CCCCCCCCCCCCCCCCCC[NH2+]CCO YGCMLNDQGHTAPC-UHFFFAOYSA-O 0.000 description 2
- 210000003491 Skin Anatomy 0.000 description 2
- 150000003863 ammonium salts Chemical class 0.000 description 2
- 238000004630 atomic force microscopy Methods 0.000 description 2
- 239000002981 blocking agent Substances 0.000 description 2
- 150000001875 compounds Chemical class 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 239000007789 gas Substances 0.000 description 2
- 125000002496 methyl group Chemical group [H]C([H])([H])* 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 238000006011 modification reaction Methods 0.000 description 2
- 239000003921 oil Substances 0.000 description 2
- 229920003023 plastic Polymers 0.000 description 2
- 239000004033 plastic Substances 0.000 description 2
- BLRPTPMANUNPDV-UHFFFAOYSA-N silane Chemical compound [SiH4] BLRPTPMANUNPDV-UHFFFAOYSA-N 0.000 description 2
- 229910000077 silane Inorganic materials 0.000 description 2
- 238000003466 welding Methods 0.000 description 2
- PZZYQPZGQPZBDN-UHFFFAOYSA-N Aluminium silicate Chemical compound O=[Al]O[Si](=O)O[Al]=O PZZYQPZGQPZBDN-UHFFFAOYSA-N 0.000 description 1
- 241000282619 Hylobates lar Species 0.000 description 1
- HWKQNAWCHQMZHK-UHFFFAOYSA-N Trolnitrate Chemical compound [O-][N+](=O)OCCN(CCO[N+]([O-])=O)CCO[N+]([O-])=O HWKQNAWCHQMZHK-UHFFFAOYSA-N 0.000 description 1
- 238000004026 adhesive bonding Methods 0.000 description 1
- QGZKDVFQNNGYKY-UHFFFAOYSA-O ammonium Chemical compound [NH4+] QGZKDVFQNNGYKY-UHFFFAOYSA-O 0.000 description 1
- 239000000440 bentonite Substances 0.000 description 1
- 229910000278 bentonite Inorganic materials 0.000 description 1
- 238000010276 construction Methods 0.000 description 1
- 229920001577 copolymer Polymers 0.000 description 1
- 230000002708 enhancing Effects 0.000 description 1
- OTMSDBZUPAUEDD-UHFFFAOYSA-N ethane Chemical compound CC OTMSDBZUPAUEDD-UHFFFAOYSA-N 0.000 description 1
- 229920001903 high density polyethylene Polymers 0.000 description 1
- 239000004700 high-density polyethylene Substances 0.000 description 1
- REYJJPSVUYRZGE-UHFFFAOYSA-O hydron;octadecan-1-amine Chemical compound CCCCCCCCCCCCCCCCCC[NH3+] REYJJPSVUYRZGE-UHFFFAOYSA-O 0.000 description 1
- 238000003384 imaging method Methods 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- 239000002480 mineral oil Substances 0.000 description 1
- 235000010446 mineral oil Nutrition 0.000 description 1
- 238000004628 non contact atomic force microscopy Methods 0.000 description 1
- NLYAJNPCOHFWQQ-UHFFFAOYSA-N oxo-oxoalumanyloxy-[oxo(oxoalumanyloxy)silyl]oxysilane;dihydrate Chemical compound O.O.O=[Al]O[Si](=O)O[Si](=O)O[Al]=O NLYAJNPCOHFWQQ-UHFFFAOYSA-N 0.000 description 1
- 238000004806 packaging method and process Methods 0.000 description 1
- 229920002742 polystyrene-block-poly(ethylene/propylene) -block-polystyrene Polymers 0.000 description 1
- 229920000346 polystyrene-polyisoprene block-polystyrene Polymers 0.000 description 1
- 239000011347 resin Substances 0.000 description 1
- 229920005989 resin Polymers 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 238000009736 wetting Methods 0.000 description 1
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
- A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
- A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices
- A61F5/441—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices having venting or deodorant means, e.g. filters ; having antiseptic means, e.g. bacterial barriers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
- A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices
- A61F5/445—Colostomy, ileostomy or urethrostomy devices
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/60—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
- A61L2300/64—Animal cells
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2400/00—Materials characterised by their function or physical properties
- A61L2400/12—Nanosized materials, e.g. nanofibres, nanoparticles, nanowires, nanotubes; Nanostructured surfaces
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2420/00—Materials or methods for coatings medical devices
- A61L2420/04—Coatings containing a composite material such as inorganic/organic, i.e. material comprising different phases
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L28/00—Materials for colostomy devices
- A61L28/0007—Materials for colostomy devices containing macromolecular materials
- A61L28/0026—Mixtures of macromolecular compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L28/00—Materials for colostomy devices
- A61L28/003—Ingredients of undetermined constitution or reaction products thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L28/00—Materials for colostomy devices
- A61L28/0061—Materials for coating
- A61L28/0069—Macromolecular materials
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L28/00—Materials for colostomy devices
- A61L28/0073—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
- A61L28/008—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material with a macromolecular matrix
- A61L28/0092—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material with a macromolecular matrix containing inorganic fillers not covered by groups A61L28/0084 or A61L28/0088
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
- A61L29/02—Inorganic materials
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
- A61L29/04—Macromolecular materials
- A61L29/049—Mixtures of macromolecular compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
- A61L29/08—Materials for coatings
- A61L29/085—Macromolecular materials
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
- A61L29/12—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
- A61L29/126—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
- A61L29/14—Materials characterised by their function or physical properties, e.g. lubricating compositions
Abstract
Disclosed are fecal catheters made of an odor barrier material comprising; a thermoplastic elastomer selected from the group consisting of a styrenic block copolymer, a thermoplastic vulcanizate, or a polyolefin elastomer; an odor barrier modifier selected from polyisobutene, polybutene, or an organoclay; and an antiblocking agent selected from the group consisting of essentially inorganic fillers, including silica, talc, clay, and mica; wherein the fecal cathether comprises a surface having an arithmetic mean surface roughness (Ra) not less than 0.1 micron. oclay; and an antiblocking agent selected from the group consisting of essentially inorganic fillers, including silica, talc, clay, and mica; wherein the fecal cathether comprises a surface having an arithmetic mean surface roughness (Ra) not less than 0.1 micron.
Description
HIGH BARRIER ELASTOMER FECAL CATHETER OF OSTOMY POUCH
FIELD OF THE INVENTION
The present invention relates to an odor barrier material for a fecal catheter, a
fecal pouch, or an ostomy pouch.
BACKGROUND OF THE INVENTION
Fecal catheters have occasionally been criticized for the transmission of fecal
odor through the tubular walls.
A possible cause of the poor odor barrier is the silicone material of which these
devices are composed. The odor barrier of silicone is known to be one of the worst
among r materials. For example, the oxygen transmission rate of silicone has
been reported to be 775,000 cc mil/mZ/day. Therefore, a 20 mil thick silicone catheter
is about 3 orders of magnitude worse than a commonly used ostomy film having a
transmission rate of 50 day or less.
Another possible explanation for silicone fecal catheter having poor odor barrier
is that the extruded ne utilized in such devices is vely rough and as a result
could trap fecal components. The contours of the spots trapping the fecal material
provide ntial surface area, through which odor is transmitted.
The combination of high odor transmission rate and large surface area
contributes to the poor odor barrier teristics of the silicone used in fecal
catheters.
It would be desirable to develop a material to be used in a fecal catheter that
has the desirable teristics of silicone while providing an odor barrier
substantially better than that of silicone.
It would be ble to provide an odor barrier polymer having these
characteristics.
The sion of the background to the invention included herein including
reference to documents, acts, materials, s, articles and the like is included to
explain the context of the present invention. This is not to be taken as an admission
or a suggestion that any of the material referred to was published, known or part of the
common general knowledge in New Zealand or in any other y as at the priority
date of any of the claims.
SUMMARY OF INVENTION
Viewed from one aspect of the present invention, there is provided a fecal catheter
made of an odor r material, the fecal catheter comprising: i) a thermoplastic
elastomer selected from a group including a styrenic block copolymer, a thermoplastic
vulcanizate, and a polyolefin mer; ii) an odor r modifier selected from
polyisobutene, polybutene, and an organoclay; and iii) an antiblocking agent selected
from a group of essentially inorganic fillers, including silica, talc, clay, and mica, and
wherein the fecal catheter comprises a surface having an arithmetric mean surface
roughness (Ra) not less than 0.1 pm.
DESCRIPTION OF THE INVENTION
Thermoplastic elastomer (TPE) or curable elastomer is well known for use in
medical devices. r, these elastomers are not known to exhibit high odor
barrier properties. The present invention is the modification of elastomer to achieve a
high odor barrier while maintaining its softness, ability for post ion converting
ng and bonding) and non-blocking characteristics.
One embodiment of the present invention related to single layer of catheter
made from a high barrier elastomer such that the odor barrier measured by oxygen
ission rate per ASTM D3985 is not more than 50,000 cc mil/m2/day at 23°C,
or more preferably not more than 5,000 cc mil/mZ/day. Such a catheter is at least 10
times better in odor barrier than the silicone catheter.
US. Pat. No. 6,946,522, 7,056,971, and 7,060,753 disclosed the use of a
liquid polyisobutene oil plasticizer to improve the gas barrier of the TPE. However,
these formulations, especially when targeting a soft mer, i.e., Shore A less
than 60, s a blocking issue in which the surface of TPE catheter seals against
each other upon folding and packaging. The use of a higher amount of oil plasticizer
would allow a softer TPE, but it comes with an e effect in an oily surface,
resulting in poor post-extrusion converting (welding and bonding). in addition, the
TPE based on an olefin block copolymer (OBC, such as InfuseTM made by Dow) was
not sed. gh common approaches exist to minimize the blocking,
including adding mineral oil or slip additives. These approaches; however, have
drawbacks in that they prevent the parts from being further converted into a fecal
catheter due to their adverse effects on the surface bonding. U.S. Pat. No.
406 disclosed the use of an organoclay at a concentration less than 4% to
improve the barrier properties of high density hyelene (HDPE). However, the
use of organoclay in a TPE was not mentioned with a Shore A ss not more
than 60, or preferably not more than 50.
r embodiment of the present invention is related to a fecal catheter,
having a Shore A hardness not more than 60 and an oxygen transmission rate not
more than 2,500 cc/mZ/day or preferably not more than 1,000 cc/m2/day, comprising
(1) a thermoplastic elastomer, (2) odor barrier modifier, and (3) an antiblocking agent
of at least 0.1%, wherein thermoplastic elastomer is selected from the group
consisting of a styrenic block copolymer, a thermoplastic vulcanizate, or a polyolefin
elastomer, and n odor barrier modifier is selected from the group consisting of
polyisobutene, polybutene, or an organoclay, and wherein the antiblocking agent is
ed from the group consisting of an essentially inorganic fillers, such as ,
talc, clay, mica, etc. and blends thereof. It is noted organoclays can be used in one
embodiment as both the odor barrier modifier and as the antiblocking agent.
Organoclays include montmorillonite clay, smectite clay, intercalated clay, nanoclay,
or a mixture of above. Organoclay described in this invention includes
montmorillonite clay, made by Nanocor, which is the most common member of the
smectite clay family. Organoclay may consist of ay with a unique morphology
such that one ion is in the nanometer range. in addition, organoclay is
preferred to be intercalated with an organic intercaiant resulting in a clay-chemical
complex wherein the clay gallery spacing has increased due to the process of
surface modification. Under the proper conditions of temperature and shear, an
intercalate is capable of exfoliating in a resin matrix. Optionally, the following
additives can be used to facilitate the manufacturing of er extrusion, including
melt ity modifier, tackifier, detackifier, plasticizer, etc.
Styrenic block copolymer (880) based thermoplastic elastomer includes
e-isoprene-styrene (SIS), styrene-butadiene-styrene (SBS), styrene—
etheylene/butylene-styrene (SEBS), e—etheylene/propylene-styrene (SEPS),
and blends thereof. Thermoplastic vulcanizate (TPV) includes a blend of curable
rubber and a polyolefin (i.e., PP or PE, homopolymers and copolymers). Curable
rubbers include EPDM, EP rubber, santoprene, etc. A polyolefin elastomer includes
an olefin block copolymer (080), such as infuse made by Dow, where a crystalline
phase of a olefin block copolymer acted as hard blocks, and the amorphous block
copolymer acted as soft blocks within the same polymer . The following is a
summary of odor barrier as measured by oxygen transmission rate at 23°C per
ASTM D3985:
Table 1 - Odor Barrier Comparison of s Eiastomers t
Organoclays or zeolites
Silicone i SBC _“‘
TPV osc sec w/ sac w/
polyisobute polyisobutene
ne and clay
W0-7,500 i 3 4
2,500 1,000 250
cc/mZ/day, 4,500
mil thick
wail, ASTM
D3985
Onion Very poor, Poor, Poor, Poor, Better, God, not
Barrier, detectable detectable detectable detectable detectable detectable for 8
ISO 8670-3 in 10 in 60 in 60 in 60 in 120 hrs
minutes s minutes minutes minutes
When antiblocking agent, at least 0.1% or more preferably more than 0.5%,
was added to a high barrier elastomer formulation containing a SBC thermoplastic
elastomer and a liquid polyisobutene, an odor barrier in the range of around 1000
cc/mZ/day was achieved for making a non-blocking fecal catheter. This level of odor
barrier improvement was confirmed by an onion test per lSO 8670-3 such that the
onion odor breakthrough was longer than 120 minutes. Additional barrier
ement was seen in fecal catheter made from PTE containing a SBC
thermoplastic elastomer, a liquid polyisobutene, an organoclay. In this example,
onion odor breakthrough was longer than 8 hours. The results of both oxygen
barrier and onion barrier were shown in Table 1.
Another embodiment of the present invention is a fecal er based on a
multilayer structure, wherein at least one layer is selected from a high barrier
elastomer described above without any antiblocking agent, and at least another skin
layer is selected from the group ting of (1) same high barrier elastomer
bed above with at least 0.1% of antiblocking agent, or an elastomer alloy with
or without the use of antiblocking agent. An elastomer alloy is defined as a blend of
two polymer matrixes which are incompatible in a lar level. The advantage of
ocking agent is to impart a rough surface so that the catheter is not blocking.
The advantage of an elastomer alloy is that the incompatibility in a molecular level
s a roughness on the catheter surface, giving rise to a non-blocking catheter.
In addition, common materials to add for an elastomer alloy include, but not limited
to, plastic polyurethane (TPU). Due to a more polar structure in TPU, the
subsequent converting of an elastomer alloy is easier. Since the majority of the
catheter structure is ed by a high barrier elastomer, the odor barrier and the
softness is maintained based on the disclosure above. Because both the center
layer and the skin layer are elastomers based, the adhesion between the layers of a
fecal catheter is sufficiently good.
Besides the addition of anti-blocking agent, cold processing ions can be
3O utilized to enhance a rough surface of the catheter wall so that the catheter is not
blocking. The effect of anti-blocking agent and/or cold processing conditions is a
rough surface that could be characterized by surface roughness using a non-contact
e structure analyzer, such as Scanning White Light interferomtry ,
Atomic Force Microscopy (AFM), etc. A non-contact imaging surface structure
analyzer based on SWLl is made by Zygo NewView 7300. A non-contact atomic
force microscopy can be made by FEl. A typical parameter that has been used to
quantify the quality of a surface topography is the surface roughness, which is
represented by the arithmetic mean value, Ra. in this invention disclosure, a rough
surface with Ra not less than 0.1 pm or ably not less than 1 pm when
antiblocking agent is used with or without a cold processing temperature, resulted in
a non-blocking fecal catheter.
An important characteristic about the formulation described in this invention is
its ability to be post—extrusion converted, both by welding and adhesive bonding.
Greater than 5 N/in adhesive strength and heat weld strength was achieved.
Another embodiment of the present ion is related to the use of
clays and/or zeolites to improve the odor barrier of the mer catheter.
For example, a single layer of catheter can be made from an organoclay-containing
mer selected from the group consisting of silicone, polyurethane, styrenlc block
copolymer, thermoplastic vulcanizate, or polyolefin elastomer with a Shore A
hardness not more than 60, or more preferably not more than 50.
The use of nanocomposite (nanoclays) fillers to improve the odor barrier is not
new. The addition of nanocomposite fillers s the tortuous path for the odor
causing compounds; thus improving the odor barrier for the substrate. There are
various nanocomposite containing coating, additives, or polymers marketed by
various companies, such as Nanocor, Nanoresin, rn Clays, , lnmat,
etc. Since nanocomposites are mostly clay based, it is relatively rigid. Therefore,
the challenges of using nanocomposite fillers in FMS application are two fold, (1) the
difficulty in the wetting and adhesion of the nanocomposite fillers or coating onto the
silicone tubing, and (2) the odor barrier property upon flexing. ore, the
uniqueness of this invention is the formulation of a soft tube with a completely
covered, and/or relatively uniformly dispersed mposite containing catheter
which would not crack upon flexing. Such a soft nanoclay—containing catheter is
characterized with a Shore A hardness not more than 60, or more preferably not
more than 50.
Another embodiment of the present invention is related to single layer of
catheter made from a zeolite-containing elastomer selected from the group
ting of silicone, ethane, styrenic block copolymer, plastic
vulcanizate, or efin mer with a Shore A hardness not more than 60, or
more ably not more than 50.
The addition of zeolite creates the tortuous paths and sites to adsorb the odor
causing compounds; thus improving the odor barrier for the substrate. There are
various zeolites marketed by various companies, such as UOP. Since zeolites are
hard fillers, they produce rigidity when used. Therefore, the challenges of using
es in FMS application are two fold, (1) the difficulty in the g and adhesion
of the zeolite coating onto the silicone tubing, and (2) the odor barrier property upon
flexing. Therefore, the uniqueness of this invention is the formulation of a soft tube
with relatively uniform zeolite-containing elastomeric catheter which would not crack
upon flexing. Such a soft zeolite-containing catheter is characterized with a Shore A
hardness not more than 60, or more preferably not more than 50.
Another embodiment of the present invention is related to an organoclay—
containing coating onto an elastomer substrate selected from the group consisting of
silicone, polyurethane, styrenic block copolymer, thermoplastic vulcanizate, or
polyolefin elastomer with a Shore A ss not more than 60, or more ably
not more than 50.
Another embodiment of the t invention is related to a zeolite-containing
g onto an elastomer substrate selected from the group consisting of silicone,
polyurethane, styrenic block copolymer, thermoplastic vulcanizate, or polyolefin
elastomer with a Shore A hardness not more than 60, or more preferably not more
than 50.
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
ing is a summary of these findings:
Exg. #1: Silicone coating consisting of nanocomgosites:
2.5% of the following nanocomposites were added into a two-part silicone
made by Nusil 6350, including
(1) Southern Clay Cloisite Na+, Hydrated Aluminum Silicate,
(2) Southern Clay Cloisite 15A, Ammonium salts with ite,
(3) r 1.30E (Octadecyl ammonium surface compatabllized
montmorillonite), and
(4) Nanocor 1.34 TCN (methyl, bis hydroxyethyl octadecyl ammonium surface
compatabilized montmorillonite).
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
d and filled inside a 12 cm long coated silicone tubing (i.e., catheter).
[flocomposite None Cloisite TCloisite 1 r Nanocor
NA+ 15A 1.30E 1.34TCN
Coating Matrix, Silicone Silicone Silicone Silicone Silicone
Nusil 6350
Substrate, Silicone Silicone Silicone ne Silicone
Dow Corning C6-l35
Onset of Onion Smell l 5 minutes 45 minutes 45 minutes 90 minutes 60 minutes
As can be seen, the on 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 ting of 2.5% nanocomposites was applied onto a silicone tube,
the onset of the onion odor was extended to 45 — 90 minutes.
Exp. #22Polyurethane coating consisting of nanocomposites, t primer:
2.5% of the following nanocomposites were added into a two—part
polyurethane made by Smooth-On, Vytaflex 30, including
(1) Southern Clay Cloisite Na+, ed Aluminum Silicate,
(2) Southern Clay Cloisite 15A, Ammonium salts with Bentonite,
(3) Nanocor 1.30E ecyl ammonium surface compatabilized
montmorillonite), and
(4) Nanocor 1.34TCN (methyl, bis hydroxyethyl octadecyl ammonium e
compatabilized montmorillonite).
The two-part polyurethane was applied onto the silicone catheter as a coating,
and was then room ature cured for 6 hours. The coated catheter was then
tested for onion odor barrier per ISO 322000. About 5 grams of onion was
chopped and filled inside a 12 cm long coated silicone tubing (i.e., catheter).
mposite None Cloisite IflCloisite 15A Nanocor Nanocor
NA+ 1.3013 1.34TCN
Coating Matrix, Polyurethane [ Polyurethane Polyurethane Polyurethane Polyurethane
x 30 l ‘4 1 —_1
Primer, No No No No No
Dow Corning 1200
J d _
Substrate, Silicone ne Silicone Silicone Silicone
Dow Corning C6-
135 l
Onset of Onion 30 minutes 6 hours 6 hours > 12 hours > 12 hours
Smell i
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 s. 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 g consisting of nanocomposites, with primer:
The same set of experiment as Exp. #2 was repeated with the use of a silane
primer, Dow Coming 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.
Nanocornposite None Cloisite Cloisite 15A Nanocor Nanocor
NA+ 1.3013 1.34TCN
g Matrix, 4! Polyurethane Polyurethane Polyurethane Polyurethanel Polyurethane
LVytaflex 30 r
Primer, Yes Yes Yes Yes Yes
Dow Coming 1200
Substrate, Silicone rSilicone T
Silicone Silicone Silicone
Dow Corning C6—
Panet of Onion W
s 6.5 hours 6 hours > 12 hours > 12 hours j
Smell
Ex . #4: Nanocom osites in a silicone slab:
2% of Nanocor 1.30E was added to make into a 1 mm thick (Le, 40 mil)
silicone gel slab, Nusil 6350. Onion barrier was compared on silicone slab with and
without the nanocomposite per ISO 8670-3:2000.
1 mm thick silicone slab without 1 mm thick silicone slab with
nanocomposites (control) 2% Nanocor 1.3013
Onset of Onion Smell 5 - 10 minutes ‘ 60 minutes
As a result, the addition of 2% of r 1.30E improved the onion odor
r of the silicone slab from 5 s to about 60 minutes.
Another embodiment of the present ion 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/mZ/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
tion rate of close to 30,000 —- 35,000 cc/m2/day due to the lack of bonding.
Alternatively, the same formulation can be d 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
day.
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 al construction
could be used for an ostomy pouch.
Claims (11)
1. A fecal catheter made of an odor barrier al, the fecal catheter comprising: i) a thermoplastic elastomer selected from a group including a styrenic block copolymer, a thermoplastic vulcanizate, and a polyolefin elastomer; ii) an odor barrier modifier selected from polyisobutene, polybutene, or an organoclay; and iii) an antiblocking agent selected from a group of essentially inorganic fillers, ing silica, talc, clay, and mica, and 10 wherein the fecal catheter comprises a surface having an arithmetric mean surface roughness (Ra) not less than 0.1 pm.
2. The fecal catheter of claim 1 wherein the styrenic block copolymer includes styrene-isoprene-styrene (SIS), styrene-butadiene-styrene (SBS), styrene- etheylene/butylene-styrene (SEBS), styrene-etheylene/propylene-styrene (SEPS), or 15 a blend thereof.
3. The fecal catheter of claim 1 or 2 wherein the thermoplastic vulcanizate includes a blend of e rubber and a polyolefin.
4. The fecal catheter of claim 3 wherein said efin is polyethylene and polypropylene, including homopolymers and mers thereof. 20
5. The fecal catheter of claim 3 or 4 wherein the curable rubber is ed a group including ethylene propylene diene Monomer (EPDM), ethylene propylene rubber, and santoprene and blends thereof.
6. The fecal catheter of any one of claims 1 to 5 wherein the polyolefin elastomer includes an olefin block copolymer n a crystalline phase of olefin block 25 mer acts as hard blocks and an amorphous block copolymer acts as soft blocks.
7. The fecal catheter of any one of claims 1 to 6 n the clay includes montmorillonite clay, smectite clay, intercalated clay, nanoclay, or a e thereof.
8. The fecal catheter of any one of claims 1 to 7 wherein the oxygen barrier transmission rate per ASTM D3985 is 1000 cc/m2/day or less at 23C.
9. The fecal catheter of any one of claims 1 to 8 having a Shore A hardness of 60 or less.
10. The fecal catheter of any one of claims 1 to 9 wherein the surface of the fecal catheter can be bonded with an adhesive having an adhesive strength greater than 5 Win. 10
11. The fecal catheter of any one of claims 1 to 10 wherein the surface of the fecal catheter can be heat welded having a weld strength greater than 5 Win.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
NZ712149A NZ712149B2 (en) | 2011-03-17 | 2012-03-16 | High barrier elastomer fecal catheter or ostomy pouch |
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201161453667P | 2011-03-17 | 2011-03-17 | |
US61/453,667 | 2011-03-17 | ||
PCT/US2012/029375 WO2013043226A1 (en) | 2011-03-17 | 2012-03-16 | High barrier elastomer fecal catheter of ostomy pouch |
Publications (2)
Publication Number | Publication Date |
---|---|
NZ616754A NZ616754A (en) | 2015-10-30 |
NZ616754B2 true NZ616754B2 (en) | 2016-02-02 |
Family
ID=
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