CA2112383C - Coextruded medical grade port tubing - Google Patents

Coextruded medical grade port tubing Download PDF

Info

Publication number
CA2112383C
CA2112383C CA002112383A CA2112383A CA2112383C CA 2112383 C CA2112383 C CA 2112383C CA 002112383 A CA002112383 A CA 002112383A CA 2112383 A CA2112383 A CA 2112383A CA 2112383 C CA2112383 C CA 2112383C
Authority
CA
Canada
Prior art keywords
port tubing
styrene
weight
medical grade
tubing
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
CA002112383A
Other languages
French (fr)
Other versions
CA2112383A1 (en
Inventor
Ying-Cheng Lo
Indrajit T. Patel
Lecon Woo
Y. Wilson Cheung
Michael T. K. Ling
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Baxter International Inc
Original Assignee
Baxter International Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=25381787&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA2112383(C) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Baxter International Inc filed Critical Baxter International Inc
Publication of CA2112383A1 publication Critical patent/CA2112383A1/en
Application granted granted Critical
Publication of CA2112383C publication Critical patent/CA2112383C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00—Layered products comprising a layer of synthetic resin
    • B32B27/06—Layered products comprising a layer of synthetic resin as the main or only constituent of a layer, which is next to another layer of the same or of a different material
    • B32B27/08—Layered products comprising a layer of synthetic resin as the main or only constituent of a layer, which is next to another layer of the same or of a different material of synthetic resin
    • 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
    • A61L29/041—Macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
    • 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
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/0045—Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B1/00—Layered products having a general shape other than plane
    • B32B1/08—Tubular products
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00—Layered products comprising a layer of synthetic resin
    • B32B27/30—Layered products comprising a layer of synthetic resin comprising vinyl (co)polymers; comprising acrylic (co)polymers
    • B32B27/304—Layered products comprising a layer of synthetic resin comprising vinyl (co)polymers; comprising acrylic (co)polymers comprising vinyl halide (co)polymers, e.g. PVC, PVDC, PVF, PVDF
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B7/00—Layered products characterised by the relation between layers; Layered products characterised by the relative orientation of features between layers, or by the relative values of a measurable parameter between layers, i.e. products comprising layers having different physical, chemical or physicochemical properties; Layered products characterised by the interconnection of layers
    • B32B7/04—Interconnection of layers
    • B32B7/12—Interconnection of layers using interposed adhesives or interposed materials with bonding properties
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L23/00—Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers
    • C08L23/02—Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers not modified by chemical after-treatment
    • C08L23/10—Homopolymers or copolymers of propene
    • C08L23/14—Copolymers of propene
    • C08L23/142—Copolymers of propene at least partially crystalline copolymers of propene with other olefins
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L53/00—Compositions of block copolymers containing at least one sequence of a polymer obtained by reactions only involving carbon-to-carbon unsaturated bonds; Compositions of derivatives of such polymers
    • C08L53/02—Compositions of block copolymers containing at least one sequence of a polymer obtained by reactions only involving carbon-to-carbon unsaturated bonds; Compositions of derivatives of such polymers of vinyl-aromatic monomers and conjugated dienes
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L53/00—Compositions of block copolymers containing at least one sequence of a polymer obtained by reactions only involving carbon-to-carbon unsaturated bonds; Compositions of derivatives of such polymers
    • C08L53/02—Compositions of block copolymers containing at least one sequence of a polymer obtained by reactions only involving carbon-to-carbon unsaturated bonds; Compositions of derivatives of such polymers of vinyl-aromatic monomers and conjugated dienes
    • C08L53/025—Compositions of block copolymers containing at least one sequence of a polymer obtained by reactions only involving carbon-to-carbon unsaturated bonds; Compositions of derivatives of such polymers of vinyl-aromatic monomers and conjugated dienes modified
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2270/00—Resin or rubber layer containing a blend of at least two different polymers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2535/00—Medical equipment, e.g. bandage, prostheses, catheter
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L2205/00—Polymer mixtures characterised by other features
    • C08L2205/03—Polymer mixtures characterised by other features containing three or more polymers in a blend
    • C08L2205/035—Polymer mixtures characterised by other features containing three or more polymers in a blend containing four or more polymers in a blend
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L23/00—Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers
    • C08L23/02—Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers not modified by chemical after-treatment
    • C08L23/04—Homopolymers or copolymers of ethene
    • C08L23/08—Copolymers of ethene
    • C08L23/0846—Copolymers of ethene with unsaturated hydrocarbons containing other atoms than carbon or hydrogen atoms
    • C08L23/0853—Vinylacetate
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L27/00—Compositions of homopolymers or copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and at least one being terminated by a halogen; Compositions of derivatives of such polymers
    • C08L27/02—Compositions of homopolymers or copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and at least one being terminated by a halogen; Compositions of derivatives of such polymers not modified by chemical after-treatment
    • C08L27/04—Compositions of homopolymers or copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and at least one being terminated by a halogen; Compositions of derivatives of such polymers not modified by chemical after-treatment containing chlorine atoms
    • C08L27/06—Homopolymers or copolymers of vinyl chloride
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L67/00—Compositions of polyesters obtained by reactions forming a carboxylic ester link in the main chain; Compositions of derivatives of such polymers
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/13—Hollow or container type article [e.g., tube, vase, etc.]
    • Y10T428/1352—Polymer or resin containing [i.e., natural or synthetic]
    • Y10T428/139—Open-ended, self-supporting conduit, cylinder, or tube-type article
    • Y10T428/1393—Multilayer [continuous layer]

Abstract

The present invention provides an improved coextruded medical port tubing. The medical port tubing provides characteris-tics that are desirable in the medical industry and therefore can be used as a medical port tubing in, for example, renal therapy or blood donor tubes. To this end, the present invention provides a coextruded medical grade port tubing comprising: an outer layer comprising a blend of polypropylene copolymer and styrene-ethylene-butylene-styrene copolymer; a tie layer; and a core layer comprising polivinyl chloride.

Description

~,~2~83 B p E C I F I C 11 T I O N
TT~TT.~R
"COEXTRUDED MEDICAL GRADE PORT TUBING"
- nA~x~ROLTND OF THE INVENTION
The present invention relates generally to materials for making medical grade products. More specifically, the present invention relates to medical grade port tubing.
It is known in the medical industry to house l0 products such as fluids that are administered to a patient in plastic containers.
- It is also known to use medical tubing, ports, to provide access either to a container or from a container.
Such port tubing serves other purposes besides accessing the container, for example, as a conduit to a patient from a fluid source. Such medical port tubing has uses in such therapies as renal and blood.
Examples of therapies wherein flexible containers including port tubing are used include intravenous therapy, continuous ambulatory dialysis (CAPD), and blood therapy. In CAPD, the container includes a dialysis fluid that can be infused into the peritoneal of the patient through a tube, poi't, fused to the container.
Typically, for medical uses, there are a variety of characteristics that a medical port tube should have.
Among the characteristics the port tube should exhibit is the ability to be RF (radio frequency) sealed to a material from which the'container may be constructed.
This allows the port tubing to be compatible with equipment used in certain of the medical industries. It is also desirable that the port tubing can be solvent bondable. For example, it is known in manufacturing containers with a port tubing to bond such tubings to a WO 93/2308 PC7"lUS93/04566 ~'11~383 _ 2 _ port closure (for example, PVC) using cyclohexanone to protect the sterility of the port tubing.
Furthermore, such port tubing should be sufficiently flexible as well as translucent. Additionally, the port .tubing, if it is coextruded, must not easily delaminate.
Although most medical containers have been constructed from PVC, recently, much attention has been focussed on constructing non-pvC containers. Such port tubing, if it is to be used with a non-PVC container, l0 must be compatible therewith.
BUl~ddARY OF THE INVENTION
The present invention provides an improved coextruded medical port tubing and materials for making same. The medical port tubing provides characteristics that are desirable in the medical industry and therefore can be used as a medical port tubing in, for example, renal therapy or blood donor tubes. Furthermore, the port tubing can be used with a non-PVC container.
To this end, the present invention provides a coextruded medical grade port tubing comprising: an outer layer comprising a blend of polypropylene copolymer and styrene-ethylene-butylene-styrene copolymer; a tie layer;
and a core layer comprising polyvinyl chloride.
In an embodiment, the tie layer comprises a blend of polyester, polypropylene copolymer, styrene-ethylene butylene-styrene copolymer, and ethylene vinyl acetate.
Preferably, the tie layer is a blend comprising:
approximately 30 to about 50~ by weight copolyester:
approximately 0 to about Z0~ by weight polypropylene copolymer: approximately 30 to about 60~ by weight styrene-ethylene-butylene-styrene copolymer; and approximately O~ to about 30x by weight ethylene vinyl acetate.

-3- 21 i 2383 In an embodiment, the outer layer of the port tube comprises approximately 40 to about 99% by weight polypropylene copolymer and approximately 1 to about 60% by weight styrene-ethylene-butylene-styrene copolymer.
In an embodiment, the present invention provides a coextruded medical grade port tubing comprising: an outer layer comprising a blend of polypropylene copolymer and styrene-ethylene-butylene-styrene copolymer;
a tie layer comprising a blend of polyester, polypropylene copolymer, styrene-ethylene-butylene-styrene copolymer, and ethylene vinyl acetate;
and a core layer of polyvinyl chloride. This structure allows the outer layer to be bonded to polyolefin surface layer film and allows the inner layer to be solvent bonded to PVC material.
In an embodiment, the layers of the port tubing have the following thickness ratios: outer layer approximately 2.5 to about 30%; tie layer approximately 2.5 to about 20%; and core layer approximately 50 to about 95%. Preferably, the outer and tie layer are thin enough to allow rapid and sufficient heat transfer from the PVC heat generation layer to the outer layer for welding.
Other aspects of this invention are as follows:
A coextruded medical grade port tubing comprising an outer layer comprising a blend of polypropylene copolymer and styrene-ethylene-butylene-styrene copolymer; a tie layer; and a core layer comprising polyvinyl chloride, characterised in that the layers have the following thickness ratios:
outer layer: 2.5 to 30% of the total cross-sectional thickness of the port tubing;
tie layer: 2.5 to 20 % of the total cross-sectional thickness of the port tubing; and core layer: 50 to 95% of the total cross-sectional thickness of the port tubing.
A non-PVC medical container for housing medical fluid including a coextruded medical grade port tubing of the type set out hereinabove.
Additional features and advantages of the present invention are described in, and will be apparent from, the detailed description of the presently preferred embodiments and from the drawings.
A

-3a- 2112383 BRIEF DESCRIPTION OF THE DRAWINGS
Figure 1 illustrates a cross-sectional view of a coextruded port tube constructed pursuant to an embodiment of the present invention.
Figure 2 illustrates a perspective view of a container including the port tubing of the present invention.
a ~O 93/13108 PCT/US93/04566 DETAILED DESCRIPTION' OF THE pRESENThY PREFERRED EMBODIMENTS
Ths present invention provides a coextruded medical grade port tubing and material for making same that achieves many of the characteristics that are desirable, in the medical industry, for such port tubing. For example, the port tubing, in an embodiment, exhibits RF
sealability, ability to solvent bond, flexibility, translucence, and ability to not delaminate after severe to bending or autoclaving.
Referring to Figure 1, the present invention provides a coextruded medical grade port tubing 10 comprising: an outer layer 12 comprising a blend of polypropylene copolymer and styrene-ethylene-butylene-styrene copolymer; a tie layer 14 comprising preferably a blend of polyester, polypropylene copolymer, styrene-ethylene-butylene-styrene copolymer, and ethylene vinyl acetate; and a core layer 16 of polyvinyl chloride.
The medical grade port tubing 10 is autoclavable and can be RF sealable to a non-PVC container having a polyolefin blend or polyolefin surfaces. Additionally, the composition can be solvent bonded to a PVC closure using cyclohexanone, MEK (methyl ethyl ketone) or other solvent. In this regard, the outer layer 12 is able to bond to a polyolefin surface layer film while the core layer 16 can be bonded to a PVC material.
preferably, the tie layer 14 is a blend of material comprising: approximately 30 to 60~ copolyester by weight, for example, Hytrel available from DuPont:
approximately 0 to 20~ by weight polypropylene copolymer (approximately 2-5~ by weight polyethylene):
approximately 30 to about Got by weight styrene-ethylene-butylsne-styrene copolymer, for example, Kraton; and -2~.1~~~3 approximately 0 to about 30% by weight ethylene vinyl acetate.
Preferably, the outer layer 12 comprises approximately 40 to 99% by weight polypropylene copolymer that includes approximately 2~ to 6% by weight polyethylene, and approximately 1 to 60% by weight styrene-ethylene-butylene-styrene copolymer, for example, Kraton.
The core layer 16 can comprise PVC plasticized with DEHP, or other material. Likewise, the core layer 16 can comprise non-plasticized PVC.
Preferably, the medical grade port tubing 10 has a structure so that it has the following ratio of layer thicknesses: the outer layer 12 comprises approximately 2.5% to about 30% of the total cross-sectional thickness of the port tube: the tie layer 14 comprises approximately 2.5% to 20% of the total cross-sectional thickness of the tube: and the core layer 16 of the structure comprises approximately 50% to 95% of the total cross-sectional thickness of the structure. By providing thin outer and tie layers 12 and 14, the port tubing 10 can be R.F. sealed to a plastic film..
The resultant medical grade port tubing 10 is flexible and translucent. Accordingly, when used as a medical tubing, one can see air bubbles or needles, for example, through the port tubing. Additionally, the port tubing 10 does not easily delaminate even after severe bending either. before or after~autoclaving.
The port tubing 10 of Figure 1 can be used with a medical container 20 illustrated in Figure 2. In a preferred embodiment, the container 20 is constructed from a non-PVC material. In a preferred embodiment, the container is constructed from a four layer film WO 93/23108 . PGT/U593/04566 ~1~2~~3 comprising: polypropylene copolymer,Kraton~/ethylene viriyl acetate/acid modified ethylene vinyl acetate/PCCE.
The port tubing 10 provides access to and away from an interior 22 of the container 20. The port tubing to of the present invention is believed to be particularly suitable for use in renal applications, especially CAPD.
However, the port tubing 10 can be used to construct other medical products.
By way of example, and not limitation, examples of l0 the present invention will now be given.
EZl~KPLE NQ. 1 Coextruded port tubings were constructed and evaluated as follows.
The following materials were used:
Core layer: DEHP Plasticized PVC:
Tie layer: 50 weight ~ Kraton G-1660 (Shell):
38 weight ~ Hytrel 4056 (DuPont);
l0 weight ~ L1E 697000 (Quantum): and 2 weight ~ Polypropylene copolymer 23M2 (E1 PaSO)s' Outer layer: 60 weight ~ Polypropylene copolymer-Fina 8473 (Fine):
and 40 weight ~t Styrene-ethylene-butylene-styrene - Kraton G-1652 (Shell).
The following processing conditions were used:
~ Nominal Setting .
:ore Lever i~s~ Davia Standard Tie Lever 1: Davi~.Standa=d Harrel zone ~ øg~~ ~Arre Eons ø Bet 3 Q 1 ) 325'F 1 ) 450'F
2) 325'F 2) ~50'F
3) 325'F 3) 150°F
4 ) 325°F

WO 93123108 PC1"/US93/04566 ~1 ~.23~3 _,_ Die Zone ~ ~ Die Zone 1 ) 325F 1 ) 450F

Adapter 325F

Screw R.P.M.s 60 AMPSs 12 Screw R.P.M.: 21 AMPS: 4 Screw Type: Pin Screw Type Maddox Screw Pack: 40-60-40 Sczew Pack: 40-60-40 Head Pressure: 5800 P.S.I. Head Pressure 180 P.S.I.

Cuter Laver 1" Davis-Standard Harrel Zone ~ tTri Die Set-UD) 1) 400F Die Pin O.D.: .300" O.D.

2) 400F Die Bushing: .375" I.D.

3 ) 400F

Die Zone ~ ~t (Vacuum Tank Set-Un) 1) 400F Sizer I.D.: .390"

Water Temp.: 53.8"

Vacuum: Pot. Setting 25.5 Dis to Tank: 1"

Screw R.P.M.: 18 AMPS: 4 Pull or Setting: 33 f.P.M.

Screw Type: Barrier 2 Screw Pack: 40-60-40 Head Pressure: N/A

The resultant port tubing included core layer a having a thickness of .71 mm, a tie layer .05 mm, and of an outer layer of .05 mm.

The port tubing was autoclaved. The port tubing characteristics were then evaluated, after autoclaving, and are set forth below in the table. The bonding force between the outer and tie layer was found to be strong.

An initial separation between the outer and tie layer 3o could not be initiated. The bonding force between the tie and core layer was 1r 1 to. 1.2 lbs./0.5inches.

PORT TUBING ~iATERIliI. EV11LU1~TION

Tubing Characteristics Post Autoclaving mina Materials Processing COMMENTS
Bond' Texture Bond' Texture 3 Example I1 Good 9 Smooth 9 Smooth Yery difficult to peel . g .
1. Assues bonding strength of PYC to PYC by eyelohsxarans fs 10. bats results are sub3eetive due to ~anuai testing. (~) Example No. 1 demonstrates that the port tubing of the present invention meets the necessary requirements of a port tubing. Indeed, the port tubing exhibits characteristics that are better than current PvC port tubing since a typical PvC port will not bond to a non-PVC container.
It should be understood that various changes and l0 modifications to the presently preferred embodiments described herein will be apparent to those s3cilled in the art: Such changes and modifications can be made without departing from the spirit and scope of the present invention and without diminishing its attendant advantages. It is therefore intended that such changes and modifications be covered by the appended claims.

Claims (10)

THE EMBODIMENTS OF THE INVENTION IN WHICH AN EXCLUSIVE
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:
1. A coextruded medical grade port tubing comprising an outer layer comprising a blend of polypropylene copolymer and styrene-ethylene-butylene-styrene copolymer; a tie layer; and a core layer comprising polyvinyl chloride, characterised in that the layers have the following thickness ratios:
outer layer: 2.5 to 30% of the total cross-sectional thickness of the port tubing;
tie layer: 2.5 to 20% of the total cross-sectional thickness of the port tubing; and core layer: 50 to 95% of the total cross-sectional thickness of the port tubing.
2. The coextruded medical grade port tubing of Claim 1 wherein the tie layer comprises a blend of polyester, polypropylene copolymer, styrene-ethylene-butylene-styrene copolymer, and ethylene vinyl acetate.
3. The coextruded medical grade port tubing of Claim 1 wherein the tie layer is a blend comprising:

30 to 60% by weight copolyester;
0 to 20% by weight polypropylene copolymer;
30 to 60% by weight styrene-ethylene-butylene-styrene copolymer;
and 0 to 30% by weight ethylene vinyl acetate.
4. The medical grade port tubing of Claim 3 wherein the polypropylene copolymer of the tie layer includes 2 to 6% by weight polyethylene.
5. The coextruded medical port tubing of any preceding claim wherein the outer layer comprises:
40 to 99% by weight polypropylene copolymer; and 1 to 60% by weight styrene-ethylene-butylene-styrene copolymer.
6. The coextruded medical port tubing of Claim 5 wherein the outer layer comprises 60% by weight polypropylene copolymer and 40% by weight styrene-ethylene-butylene-styrene.
7. The coextruded medical grade port tubing of any preceding claim wherein the polypropylene copolymer comprises 2 to 6% by weight polyethylene.
8. The coextruded medical grade port tubing of any preceding claim wherein the polyvinyl chloride includes a plasticizer.
9. The coextruded medical grade port tubing of any one of preceding Claims 1, 2, 3, 4, 5, 6 or 7 wherein the polyvinyl chloride does not include a plasticiser.
10. A non-PVC medical container for housing medial fluid including a coextruded medical grade port tubing according to any preceding claim.
CA002112383A 1992-05-14 1993-05-12 Coextruded medical grade port tubing Expired - Lifetime CA2112383C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US07/883,001 US5439454A (en) 1992-05-14 1992-05-14 Coextruded medical grade port tubing
US7/883,001 1992-05-14
PCT/US1993/004566 WO1993023108A2 (en) 1992-05-14 1993-05-12 Coextruded medical grade port tubing

Publications (2)

Publication Number Publication Date
CA2112383A1 CA2112383A1 (en) 1993-11-25
CA2112383C true CA2112383C (en) 2002-12-10

Family

ID=25381787

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002112383A Expired - Lifetime CA2112383C (en) 1992-05-14 1993-05-12 Coextruded medical grade port tubing

Country Status (17)

Country Link
US (1) US5439454A (en)
EP (1) EP0594842B1 (en)
JP (1) JP3234926B2 (en)
KR (1) KR100255283B1 (en)
AT (1) ATE155346T1 (en)
AU (1) AU659950B2 (en)
BR (1) BR9305524A (en)
CA (1) CA2112383C (en)
DE (1) DE69312211T2 (en)
DK (1) DK0594842T3 (en)
ES (1) ES2107039T3 (en)
MX (1) MX9302805A (en)
NO (1) NO305507B1 (en)
NZ (1) NZ253435A (en)
SG (1) SG67282A1 (en)
TW (1) TW270087B (en)
WO (1) WO1993023108A2 (en)

Families Citing this family (63)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6041826A (en) * 1993-06-03 2000-03-28 Elf Atochem S.A. Petrol supply tube
US5961765A (en) 1994-09-20 1999-10-05 Schneider (Europe) A. G. Method of making a catheter
US6659977B2 (en) 1993-10-27 2003-12-09 Schneider (Europe) A.G. Multilayer interventional catheter
ATE184799T1 (en) * 1993-10-27 1999-10-15 Schneider Europ Gmbh INTERVENTIONAL CATHETER
EP0803264B2 (en) 1996-04-26 2011-04-27 Schneider (Europe) GmbH Interventional catheter
US5935847A (en) 1994-10-28 1999-08-10 Baxter International Inc. Multilayer gas-permeable container for the culture of adherent and non-adherent cells
US5542834A (en) * 1994-11-10 1996-08-06 Lupke; Manfred A. A. Skinned double wall pipe and apparatus for making same
US6391404B1 (en) 1995-06-07 2002-05-21 Baxter International Inc. Coextruded multilayer film materials and containers made therefrom
US5954702A (en) * 1996-05-03 1999-09-21 Baxter International Inc. Interface geometry for adhesive bonds
US6187400B1 (en) 1996-05-03 2001-02-13 Baxter International Inc. Medical tubing and pump performance enhancement by ionizing radiation during sterilization
US6036676A (en) * 1996-05-03 2000-03-14 Baxter International Inc. Surface modified polymeric material formulation
US6129876A (en) * 1996-05-03 2000-10-10 Baxter International Inc. Heat setting of medical tubings
US6328716B1 (en) 1996-05-03 2001-12-11 Baxter International Inc. Method of using medical tubings in fluid administration sets
US6506333B1 (en) 1996-05-03 2003-01-14 Baxter International Inc. Method of surface modifying a medical tubing
US20030094736A1 (en) * 1996-05-03 2003-05-22 Chuan Qin Method of surface modifying a medical tubing
US5932307A (en) * 1996-05-03 1999-08-03 Baxter International Inc. Oriented medical tubing
US5741452A (en) * 1996-05-03 1998-04-21 Baxter International Inc. Orienting extrusion processes for medical tubing applications
US6127009A (en) * 1996-05-08 2000-10-03 Pactiv Corporation Dispenser unit, process for manufacturing the same and its use
US5851464A (en) * 1996-05-13 1998-12-22 Cordis Corporation Method of making a fuseless soft tip catheter
WO1998000286A1 (en) 1996-07-03 1998-01-08 Baxter International Inc. Method of sealing a port tube in a container
US6165166A (en) 1997-04-25 2000-12-26 Schneider (Usa) Inc. Trilayer, extruded medical tubing and medical devices incorporating such tubing
DE19727446A1 (en) * 1997-06-27 1999-01-07 Fresenius Medical Care De Gmbh Polymer material for the production of medical work equipment
US20020007145A1 (en) 1998-10-23 2002-01-17 Timothy Stivland Catheter having improved bonding region
US7947059B2 (en) * 2000-03-02 2011-05-24 Boston Scientific Scimed, Inc. Multilayer medical device
US6431219B1 (en) 2001-02-05 2002-08-13 Alaris Medical Systems, Inc. Coextruded tubing
TW480733B (en) * 2001-04-10 2002-03-21 Ind Tech Res Inst Self-aligned lightly doped drain polysilicon thin film transistor
US7914486B2 (en) * 2001-12-20 2011-03-29 Boston Scientific Scimed, Inc. Catheter having an improved balloon-to-catheter bond
US6923787B2 (en) * 2001-12-20 2005-08-02 Scimed Life Systems, Inc. Catheter having an improved balloon-to-catheter bond
US6913056B2 (en) 2002-01-31 2005-07-05 Baxter International Inc. Apparatus and method for connecting and disconnecting flexible tubing
WO2003077966A1 (en) 2002-03-20 2003-09-25 Gambro Lundia Ab Tube for medical applications and circuit incorporating such tube
US7275543B2 (en) * 2002-09-20 2007-10-02 Baxter International Inc. Coupler member for joining dissimilar materials
US6921363B2 (en) * 2002-10-03 2005-07-26 Koninklijke Philips Electronics N.V. Transesophageal endoscope with improved bite-through protection
US7488339B2 (en) * 2002-10-21 2009-02-10 Boston Scientific Scimed, Inc. Multilayer medical device
US6951675B2 (en) * 2003-01-27 2005-10-04 Scimed Life Systems, Inc. Multilayer balloon catheter
US6742952B1 (en) * 2003-02-28 2004-06-01 Bic Corporation Transparent or translucent tubular structure
US7722733B2 (en) 2004-03-29 2010-05-25 Baxter International Inc. Method for sterile connection of tubing
WO2006057370A1 (en) 2004-11-26 2006-06-01 Mitsui Chemicals, Inc. Medical tube
AU2005322136B2 (en) * 2004-12-23 2011-01-06 Hospira, Inc. Port closure system for intravenous fluid container
US8480797B2 (en) 2005-09-12 2013-07-09 Abela Pharmaceuticals, Inc. Activated carbon systems for facilitating use of dimethyl sulfoxide (DMSO) by removal of same, related compounds, or associated odors
WO2007033180A1 (en) 2005-09-12 2007-03-22 Abela Pharmaceuticals, Inc. Materials for facilitating administration of dimethyl sulfoxide (dmso) and related compounds
CA2622204C (en) 2005-09-12 2016-10-11 Abela Pharmaceuticals, Inc. Systems for removing dimethyl sulfoxide (dmso) or related compounds, or odors associated with same
WO2007033082A2 (en) 2005-09-12 2007-03-22 Abela Pharmaceuticals, Inc. Compositions comprising dimethyl sulfoxide (dmso)
US8936583B2 (en) 2007-09-28 2015-01-20 Hollister Incorporated Multi-layer catheter tubes with odor barrier
EP2203208B1 (en) 2007-09-28 2019-06-26 Hollister Incorporated Multi-layer odor barrier tube, and combination odor barrier tube and odor barrier collection bag
US8216498B2 (en) 2008-09-10 2012-07-10 Boston Scientific Scimed, Inc. Catheter having a coextruded fluoropolymer layer
TWI385330B (en) 2008-10-31 2013-02-11 Saint Gobain Performance Plast Multilayer flexible tubing
BRPI0921494A2 (en) 2008-11-03 2018-10-30 Prad Reasearch And Development Ltd method of planning a underground forming sampling operation, method of controlling a underground forming sampling operation, method of controlling a drilling operation for an underground formation, and method of sampling during the drilling operation.
WO2011053874A1 (en) 2009-10-30 2011-05-05 Tandem Abela Development Group Llc Dimethyl sulfoxide (dmso) and methylsulfonylmethane (msm) formulations to treat osteoarthritis
US8440090B2 (en) 2010-04-29 2013-05-14 Abbott Cardiovascular Systems Inc. Apparatus and method of making a variable stiffness multilayer catheter tubing
US9744332B2 (en) 2012-01-18 2017-08-29 Contech Medical, Inc. Lubricious extruded medical tubing
US9332998B2 (en) 2012-08-13 2016-05-10 Covidien Lp Apparatus and methods for clot disruption and evacuation
US9332999B2 (en) 2012-08-13 2016-05-10 Covidien Lp Apparatus and methods for clot disruption and evacuation
EP2916901B1 (en) 2012-11-12 2020-06-24 Hollister Incorporated Intermittent catheter assembly
WO2014077886A1 (en) 2012-11-14 2014-05-22 Hollister Incorporated Disposable catheter with selectively degradable inner core
EP3862031B1 (en) 2013-11-08 2023-08-09 Hollister Incorporated Oleophilic lubricated catheters
CA2923676C (en) 2013-12-12 2020-10-13 Hollister Incorporated Flushable catheters
US10420859B2 (en) 2013-12-12 2019-09-24 Hollister Incorporated Flushable catheters
EP3079752B1 (en) 2013-12-12 2020-04-01 Hollister Incorporated Flushable catheters
DK3079748T3 (en) 2013-12-12 2020-08-17 Hollister Inc EXCLUSIVE DECOMPOSITION CATHETER
EP3310404B1 (en) 2015-06-17 2024-03-13 Hollister Incorporated Selectively water disintegrable materials and catheters made of such materials
US10589060B2 (en) 2016-12-21 2020-03-17 Biosense Webster (Israel) Ltd. Extrusion with preferential bend axis
CN113692296A (en) * 2019-02-08 2021-11-23 R·C·怀特 Airway management device and method for manufacturing object
US20210113743A1 (en) * 2019-10-17 2021-04-22 Carefusion 303, Inc. Multilayer medical tubing with enhanced adhesion

Family Cites Families (35)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3561493A (en) * 1965-04-21 1971-02-09 Paul Maillard Composite tubes and method of manufacturing same
US3995084A (en) * 1973-07-09 1976-11-30 Allied Chemical Corporation Films and bags of nylon 6 - nylon 6,6 blends
US4087587A (en) * 1975-09-19 1978-05-02 Chemplex Company Adhesive blends
US4087588A (en) * 1975-09-22 1978-05-02 Chemplex Company Adhesive blends
US4233367A (en) * 1977-01-06 1980-11-11 American Can Company Coextruded multilayer film
US4327726A (en) * 1979-08-15 1982-05-04 Baxter Travenol Laboratories, Inc. Connector member for dissimilar materials
US4407888A (en) * 1979-12-07 1983-10-04 Raychem Limited Dimensionally recoverable article with adhesive portion
US4322465A (en) * 1980-08-08 1982-03-30 Baxter Travenol Laboratories, Inc. Clear, autoclavable, sealed container having good water vapor barrier properties and flex crack resistance
US4417753A (en) * 1981-05-21 1983-11-29 Baxter Travenol Laboratories, Inc. Method and apparatus for joining materials
JPS58129035A (en) * 1982-01-29 1983-08-01 Kishimoto Akira Resin composition having excellent drawability
AU565262B2 (en) * 1982-06-02 1987-09-10 Du Pont Canada Inc. Pouches of copolymer film
NL8202894A (en) * 1982-07-16 1984-02-16 Rijksuniversiteit POLYESTER FILAMENT MATERIAL.
US4479989A (en) * 1982-12-02 1984-10-30 Cutter Laboratories, Inc. Flexible container material
US4834755A (en) * 1983-04-04 1989-05-30 Pfizer Hospital Products Group, Inc. Triaxially-braided fabric prosthesis
US4724028A (en) * 1983-04-15 1988-02-09 Baxter Travenol Laboratories Method of manufacturing disc-shaped rubber articles, such as injection sites
US4707389A (en) * 1983-09-30 1987-11-17 Baxter Travenol Laboratories, Inc. Multilayer tube, assembly and method
EP0168755B1 (en) * 1984-07-16 1991-04-17 Sumitomo Bakelite Company Limited Container and method for storing blood
US4923470A (en) * 1985-04-25 1990-05-08 American Cyanamid Company Prosthetic tubular article made with four chemically distinct fibers
US4643926A (en) * 1985-04-29 1987-02-17 W. R. Grace & Co., Cryovac Div. Flexible medical solution pouches
EP0310143B1 (en) * 1985-04-29 1995-12-13 W.R. Grace & Co.-Conn. Flexible medical solution pouches
EP0203630A3 (en) * 1985-04-29 1988-04-06 Shell Internationale Researchmaatschappij B.V. Multiple-layer materials
FI73386C (en) * 1985-09-25 1987-10-09 Wihuri Oy A strong vapor-sterilizable multilayer film and packaging made of physiological solutions.
US4627844A (en) * 1985-10-30 1986-12-09 High Voltage Engineering Corporation Tri-layer tubing
DE3541478A1 (en) * 1985-11-23 1987-05-27 Beiersdorf Ag HEART VALVE PROSTHESIS AND METHOD FOR THE PRODUCTION THEREOF
US4778697A (en) * 1985-11-29 1988-10-18 American National Can Company Polymeric films
US4764404A (en) * 1985-11-29 1988-08-16 American National Can Company Films having a polypropylene blend layer
US4803102A (en) * 1985-11-29 1989-02-07 American National Can Company Multiple layer packaging films and packages formed therefrom
JPS62139626A (en) * 1985-12-13 1987-06-23 オリンパス光学工業株式会社 Flexible tube for endoscope
US4687688A (en) * 1986-02-18 1987-08-18 American Can Company Oriented multiple layer films and bags made therefrom
US4735855A (en) * 1986-08-04 1988-04-05 W. R. Grace & Co., Cryovac Div. Thermoformable laminate
US4734327A (en) * 1986-12-29 1988-03-29 Viskase Corporation Cook-in shrink film
US4948643A (en) * 1989-01-23 1990-08-14 W. R. Grace & Co.-Conn. Flexible medical solution tubing
US5096775A (en) * 1990-09-05 1992-03-17 Mitsubishi Petrochemical Co., Ltd. Resin laminate
US5085649A (en) * 1990-11-21 1992-02-04 Flynn Vincent J Torque controlled tubing
ZA931680B (en) * 1992-03-30 1993-10-05 Grace W R & Co Medical solution tubing

Also Published As

Publication number Publication date
NO305507B1 (en) 1999-06-14
DE69312211D1 (en) 1997-08-21
EP0594842A1 (en) 1994-05-04
MX9302805A (en) 1994-05-31
TW270087B (en) 1996-02-11
SG67282A1 (en) 1999-09-21
WO1993023108A3 (en) 1994-02-03
ES2107039T3 (en) 1997-11-16
DE69312211T2 (en) 1998-02-12
NO940121L (en) 1994-01-13
NZ253435A (en) 1997-02-24
AU4374693A (en) 1993-12-13
KR100255283B1 (en) 2000-05-01
AU659950B2 (en) 1995-06-01
CA2112383A1 (en) 1993-11-25
US5439454A (en) 1995-08-08
DK0594842T3 (en) 1997-09-08
JPH07507947A (en) 1995-09-07
NO940121D0 (en) 1994-01-13
BR9305524A (en) 1995-05-02
EP0594842B1 (en) 1997-07-16
WO1993023108A2 (en) 1993-11-25
ATE155346T1 (en) 1997-08-15
JP3234926B2 (en) 2001-12-04

Similar Documents

Publication Publication Date Title
CA2112383C (en) Coextruded medical grade port tubing
EP0597065B1 (en) Non-pvc coextruded medical grade port tubing
KR100439773B1 (en) Medical Non-PVC Multilayer Tubing and Its Manufacturing Process and Use
EP0564231B1 (en) Medical solution tubing
US4948643A (en) Flexible medical solution tubing
EP1373377B1 (en) Flexible monolayer elastromer films containing seps and bags for medical use
JPH049059B2 (en)
JPS58500751A (en) Method and apparatus for joining materials
JPH0649355B2 (en) Medical impact resistant film
JPH02180264A (en) Film for moistureproof treatment
US4490420A (en) Medical bag and method for manufacturing the same
JP2002282356A (en) Multiple layer tube and medical tool comprising multiple layer tube
JPH02209154A (en) Conduit tube for transfusion set
JPH0956808A (en) Tube for medical treatment
JPH10216225A (en) Peritoneal dialysis kit
JPH02209142A (en) Transfusion bag
JPS63110132A (en) Medical plastic vessel

Legal Events

Date Code Title Description
EEER Examination request