Multi-layered polymer based thin film structure for medical grade products
First Claim
1. A multiple layer thermoplastic structure:
- (1) a skin layer selected from the group consisting of polypropylene and polypropylene copolymers;
(2) a radio frequency susceptible layer adhered to the skin layer, the radio frequency susceptible layer having a dielectric loss greater than 0.05 at 1-60 MHz and at temperatures of ambient to 250°
C., the radio frequency susceptible layer having;
(a) a first polyolefin selected from the group consisting of polypropylene and polypropylene copolymers, (b) a second polyolefin selected from the group consisting of ethylene copolymers, ultra-low density polyethylene, polybutene, and butene ethylene copolymers;
(c) a radio frequency susceptible polymer selected from the group consisting of ethylene acrylic acid copolymers, ethylene methacrylic acid copolymers, polyimides, polyurethanes, polyesters, and polyureas, and (d) a compatibilizing agent of a styrene and hydrocarbon block copolymer;
wherein the structure has physical properties within the range a<
40,000 psi;
b>
=70%;
c<
30%;
d>
1.0;
e<
0.1%;
f<
0.1%;
g>
=0.05 h<
=60%;
i=0;
wherein;
a is the mechanical modulus of the composition measured according to ASTM D-882;
b is the percent recovery in length of the composition after an initial 20% deformation;
c is the optical haze of the composition processed into a film 9 mils in thickness measured in accordance to ASTM D-1003;
d is the loss tangent of the composition at 1 Hz measured at melt processing temperatures;
e is the elemental halogen content by weight of the composition;
f is the low molecular weight water soluble fraction of the composition;
g is the dielectric loss between 1 and 60 MHz and over temperatures of 25 to 250°
C. of the composition;
h is the sample creep measured at 121°
C. for a sample strip of the composition under 27 psi loading; and
, i the composition exhibits no strain whitening after being strained at moderate speeds of about 20 inches per minute to about twice the original length;
and wherein the multiple layer structure is capable of storing or collecting beneficial agents or transferring such agents to a patient, and wherein the multiple layer structure is capable of being thermoplastically recycled.
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Abstract
A multiple layer structure comprising a skin layer composed of a polypropylene copolymer with styrene ethylene-butene styrene block copolymer within a range of 0-20% by weight skin layer, and, a radio frequency (“RF”) susceptible layer adhered to the skin layer. The RF layer has a first component of a propylene based polymer, a second component of a nonpropylene polyolefin, a third component of a radio frequency susceptible polymer, and a fourth component of a polymeric compatibilizing agent wherein the radio frequency susceptible polymer is selected from the group consisting of ethylene acrylic acid copolymers, ethylene methacrylic acid copolymers, polyimides, polyurethanes, polyesters, and polyureas.
187 Citations
37 Claims
-
1. A multiple layer thermoplastic structure:
-
(1) a skin layer selected from the group consisting of polypropylene and polypropylene copolymers;
(2) a radio frequency susceptible layer adhered to the skin layer, the radio frequency susceptible layer having a dielectric loss greater than 0.05 at 1-60 MHz and at temperatures of ambient to 250°
C., the radio frequency susceptible layer having;
(a) a first polyolefin selected from the group consisting of polypropylene and polypropylene copolymers, (b) a second polyolefin selected from the group consisting of ethylene copolymers, ultra-low density polyethylene, polybutene, and butene ethylene copolymers;
(c) a radio frequency susceptible polymer selected from the group consisting of ethylene acrylic acid copolymers, ethylene methacrylic acid copolymers, polyimides, polyurethanes, polyesters, and polyureas, and (d) a compatibilizing agent of a styrene and hydrocarbon block copolymer;
wherein the structure has physical properties within the range a<
40,000 psi;
b>
=70%;
c<
30%;
d>
1.0;
e<
0.1%;
f<
0.1%;
g>
=0.05h<
=60%;
i=0;
wherein;
a is the mechanical modulus of the composition measured according to ASTM D-882;
b is the percent recovery in length of the composition after an initial 20% deformation;
c is the optical haze of the composition processed into a film 9 mils in thickness measured in accordance to ASTM D-1003;
d is the loss tangent of the composition at 1 Hz measured at melt processing temperatures;
e is the elemental halogen content by weight of the composition;
f is the low molecular weight water soluble fraction of the composition;
g is the dielectric loss between 1 and 60 MHz and over temperatures of 25 to 250°
C. of the composition;
h is the sample creep measured at 121°
C. for a sample strip of the composition under 27 psi loading; and
,i the composition exhibits no strain whitening after being strained at moderate speeds of about 20 inches per minute to about twice the original length;
and wherein the multiple layer structure is capable of storing or collecting beneficial agents or transferring such agents to a patient, and wherein the multiple layer structure is capable of being thermoplastically recycled.
-
-
2. A multiple layer thermoplastic structure suitable for manufacturing medical products comprising:
-
(1) a skin layer selected from the group consisting of polypropylene and polypropylene copolymers; and
,(2) a radio frequency susceptible layer adhered to the skin layer, the radio frequency susceptible layer having a dielectric loss greater than 0.05 at 1-60 MHz and at temperatures of ambient to 250°
C., the radio frequency susceptible layer comprising;
(a) a first polyolefin selected from the group consisting of polypropylene and polypropylene copolymers;
(b) a second polyolefin selected from the group consisting of ethylene copolymers, ultra-low density polyethylene, polybutene, and butene ethylene copolymers;
(c) a radio frequency susceptible polymer selected from the group consisting of ethylene acrylic acid copolymers, ethylene methacrylic acid copolymers, polyimides, polyurethanes, polyesters, and polyureas; and
(d) a first compatibilizing agent of a styrene and hydrocarbon block copolymer;
wherein the multiple layer structure has a mechanical modulus of less than 40,000 psi when measured according to ASTM D-882, the optical haze of the structure processed into a film 9 mils in thickness measured in accordance to ASTM D-1003 is less than 30%, the structure exhibits no strain whitening after being strained at moderate speeds of about 20 inches per minute to about twice the original length and the structure is capable of storing or collecting beneficial agents or transferring such agents to a patient, the structure has a sample creep measured at 121°
C. for a sample strip of the structure under 27 psi loading of less than or equal to 60%, and wherein the multiple layer structure is capable of being thermoplastically recycled.- View Dependent Claims (3, 4, 5, 6, 7, 8, 9)
a first core layer attached to the radio frequency susceptible layer and having;
(a) a third polyolefin selected from the group consisting of polypropylene and polypropylene copolymers, (b) a fourth polyolefin selected from the group consisting of ultra low density polyethylene, and polybutene-1 copolymers; and
(c) a second compatibilizing agent of a styrene and hydrocarbon block copolymer.
-
-
5. The structure of claim 4 wherein the first core layer is positioned between the radio frequency susceptible layer and the skin layer.
-
6. The structure of claim 4 further comprising
a beneficial agent contact layer attached to the radio frequency susceptible layer on a side opposite the skin layer, the contact layer comprises: -
(a) a polypropylene, (b) an ultra low density polyethylene, and, (c) a third styrene and hydrocarbon block copolymer.
-
-
7. The structure of claim 6 further comprising:
-
a first scrap layer comprising a first scrap material;
a first barrier layer; and
wherein the first core layer, first scrap layer and first barrier layer are attached together in any order and are together attached to the susceptible layer on a side opposite the skin layer.
-
-
8. The structure of claim 7 wherein the first core layer further includes a second scrap material.
-
9. The structure of claim 7 further comprising a second scrap material interposed between the first core layer and the radio frequency susceptible layer.
-
10. A multiple layer thermoplastic structure suitable for manufacturing medical products, the structure comprising:
-
(1) a skin layer from the group consisting of polypropylene and polypropylene copolymers; and
,(2) a radio frequency susceptible layer adhered to the skin layer, the radio frequency susceptible layer having a dielectric loss greater than 0.05 at 1-60 MHz and at temperatures of ambient to 250°
C. and comprising;
(a) a first polyolefin in an amount in a range of 30-60% by weight of the radio frequency susceptible layer and selected from the group consisting of polypropylene and polypropylene copolymers, (b) a second polyolefin in an amount within the range of 25-50% by weight of the radio frequency susceptible layer selected from the group consisting of ethylene copolymers, ultra-low density polyethylene, polybutene, and butene ethylene copolymers;
(c) a radio frequency susceptible polymer in an amount within the range of 3-40% by weight of the radio frequency susceptible layer selected from the group consisting of ethylene acrylic acid copolymers, ethylene methacrylic acid copolymers, polyimides, polyurethanes, polyesters, and polyureas, and (d) a compatibilizing agent of a styrene and hydrocarbon block copolymer in an amount within the range of 5-40% by weight of the radio frequency susceptible layer, and wherein the multiple layer structure has a mechanical modulus of less than 40,000 psi when measured according to ASTM D-882, the optical haze of the structure processed into a film 9 mils in thickness measured in accordance to ASTM D-1003 is less than 30%, the structure exhibits no strain whitening after being strained at moderate speeds of about 20 inches per minute to about twice the original length and the structure is capable of storing or collecting beneficial agents or transferring such agents to a patient, the structure has a sample creep measured at 121°
C. for a sample strip of the structure under 27 psi loading of less than or equal to 60%, and wherein the multiple layer structure is capable of being thermoplastically recycled.- View Dependent Claims (11, 12, 13, 14, 15)
from about 35% to about 45% polypropylene;
from about 35% to about 45% of the second polyolefin;
from about 7% to about 13% of the radio frequency susceptible polymer; and
,from about 7% to about 13% of a styrene and hydrocarbon block copolymer.
-
-
16. A multiple layer thermoplastic structure suitable for fabricating medical products comprising:
-
a skin layer selected from the group consisting of a polypropylene and polypropylene copolymers;
a core layer having a first side adhered to the skin layer and a second side; and
,a radio frequency susceptible layer having a first side adhered to the second side of the core layer comprising;
a first polyolefin selected from the group consisting of a polypropylene and polypropylene copolymers in an amount from 30-60% of the weight of the radio frequency susceptible layer, a second polyolefin in an amount from 25-50% of the weight of the radio frequency susceptible layer and selected from the group consisting of ethylene copolymers, ultra-low density polyethylene, polybutene, butene ethylene copolymers, ethylene copolymers with vinyl acetate having from 18-50% by weight vinyl acetate comonomer, ethylene methyl acrylate copolymers with methyl acrylate contents being from 20-40% by weight, ethylene n-butyl acrylate copolymers with n-butyl acrylate content from 20-40% by weight, and ethylene acrylic acid copolymers with the acrylic acid content of greater than approximately 15% by weight, a radio frequency susceptible polymer in an amount within the range of 3-40% by weight of the radio frequency susceptible layer and selected from the group consisting of ethylene acrylic acid copolymers, ethylene methacrylic acid copolymers, polyimides, polyurethanes, polyesters, and polyureas, and a first compatibilizing agent in an amount within the range of 5-40% by weight of the radio frequency susceptible layer and of a styrene and hydrocarbon block copolymer, and wherein the multiple layer structure has a mechanical modulus of less than 40,000 psi when measured according to ASTM D-882, the optical haze of the structure processed into a film 9 mils in thickness measured in accordance to ASTM D-1003 is less than 30%, the structure exhibits no strain whitening after being strained at moderate speeds of about 20 inches (50 cm) per minute to about 100% elongation (twice the original length) and the structure is capable of storing or collecting beneficial agents or transferring such agents to a patient, the structure has a sample creep measured at 121°
C. for a sample strip of the structure under 27 psi loading of less than or equal to 60%, and wherein the multiple layer structure is capable of being thermoplastically recycled.- View Dependent Claims (17, 18, 19, 20, 21)
wherein the first compatibilizing agent is selected from the group consisting of a styrene-ethylene-butene-styrene block copolymer, and a styrene-ethylene-butene-styrene block copolymer functionalized by a functional group selected from the group consisting of a maleic anhydride, epoxy and carboxylate; and wherein the core layer comprises;
(1) a third polyolefin selected from the group consisting of polypropylene and polypropylene copolymers;
(2) a fourth polyolefin selected from the group consisting of an ultra low density polyethylene and a polybutene copolymer; and
(3) a second compatibilizing agent of a styrene and hydrocarbon block copolymer.
-
-
19. The structure of claim 16 wherein the core layer further includes a scrap material.
-
20. The structure of claim 16 wherein the radio frequency susceptible polymer is a polyurethane.
-
21. The structure of claim 16 wherein the radio frequency susceptible polymer is a ethylene methacrylic acid copolymer.
-
22. A multiple layer thermoplastic structure of stacked layers suitable for manufacturing medical products comprising:
-
(1) a skin layer having a first side and being selected from a group consisting of a polypropylene and polypropylene copolymers;
(2) a radio frequency susceptible layer having second and third sides, the radio frequency susceptible layer comprising (a) a polypropylene in an amount from 30-60% of the weight of the radio frequency susceptible layer, (b) a first polyolefin in an amount from 25-50% of the weight of the radio frequency susceptible layer and selected from the group consisting of ethylene copolymers, ultra-low density polyethylene, polybutene, and butene ethylene copolymers, (c) a radio frequency susceptible polymer in an amount from 3-40% by weight of the radio frequency susceptible layer and selected from the group consisting of ethylene acrylic acid copolymers, ethylene methacrylic acid copolymers, polyimides, polyurethanes, polyesters, and polyureas, (d) a first compatibilizing agent of a styrene and hydrocarbon block copolymer in an amount from 5-40% by weight of the radio frequency susceptible layer; and
(e) wherein the radio frequency susceptible layer having a dielectric loss greater than 0.05 at 1-60 MHz and at temperatures of ambient to 250°
C.;
(3) a first core layer having fourth and fifth sides;
(4) scrap layer having sixth and seventh sides; and
wherein the multiple layer structure has a mechanical modulus of less than 40,000 psi when measured according to ASTM D-882, the optical haze of the structure processed into a film 9 mils in thickness measured in accordance to ASTM D-1003 is less than 30%, the structure exhibits no strain whitening after being strained at moderate speeds of about 20 inches per minute to about twice the original length and the structure is capable of storing or collecting beneficial agents or transferring such agents to a patient, the structure has a sample creep measured at 121°
C. for a sample strip of the structure under 27 psi loading of less than or equal to 60%, and wherein the multiple layer structure is capable of being thermoplastically recycled.- View Dependent Claims (23, 24, 25, 26)
a polyolefin selected from the group consisting of a polypropylene and a polypropylene copolymer;
a polyolefin selected from the group consisting of an ultra low density polyethylene and a polybutene copolymer; and
,a second compatibilizing agent of a styrene and hydrocarbon block copolymer.
-
-
27. A multiple layer thermoplastic structure suitable for manufacturing medical products comprising:
-
(1) a skin layer having a first side and being selected from a group consisting of a polypropylene and polypropylene copolymers;
(2) a radio frequency susceptible layer having sixth and seventh sides and comprising;
(a) a propylene-containing polymer in an amount in a range of 30-60% of the weight of the radio frequency susceptible layer, (b) a first polyolefin in an amount within the range of 25-50% of the weight of the radio frequency susceptible layer and selected from the group consisting of ethylene copolymers, ultra-low density polyethylene, polybutene, and butene ethylene copolymers;
(c) a radio frequency susceptible polymer in an amount within the range of 3-40% by weight of the radio frequency susceptible layer and selected from the group consisting of ethylene acrylic acid copolymers, ethylene methacrylic acid copolymers, polyimides, polyurethanes, polyesters, and polyureas;
(d) a compatibilizing agent of a styrene and hydrocarbon block copolymer in an amount within the range of 5-40% by weight of the radio frequency susceptible layer; and
(e) wherein the radio frequency susceptible layer having a dielectric loss greater than 0.05 at 1-60 MHz and at temperatures of ambient to 250°
C.;
(3) a first core layer having fourth and fifth sides and disposed between the skin layer and the radio frequency susceptible layer;
(4) a barrier layer having second and third sides adjacent to the core layer, and wherein the multiple layer structure has a mechanical modulus of less than 40,000 psi when measured according to ASTM D-882, the optical haze of the structure processed into a film 9 mils in thickness measured in accordance to ASTM D-1003 is less than 30%, the structure exhibits no strain whitening after being strained at moderate speeds of about 20 inches per minute to about twice the original length and the structure is capable of storing or collecting beneficial agents or transferring such agents to a patient, the structure has a sample creep measured at 121°
C. for a sample strip of the structure under 27 psi loading of less than or equal to 60%, and wherein the multiple layer structure is capable of being thermoplastically recycled.- View Dependent Claims (28, 29, 30, 31, 32, 33)
-
-
34. A multiple layer thermoplastic structure suitable for manufacturing medical products comprising:
-
(1) a skin layer comprising a polypropylene copolymer and a styrene and hydrocarbon block copolymer within a range of 0-20% by weight of the skin layer;
(2) a core layer adhered to the skin layer; and
,(3) a radio frequency susceptible layer adhered to the core layer comprising;
(a) a polypropylene having a melting point temperature greater than 130°
C. and a modulus less than 20,000 psi in an amount in a range of 30-60% of the weight of the radio frequency susceptible layer,(b) a radio frequency susceptible polymer in an amount within the range of 3-40% by weight of the radio frequency susceptible layer and is selected from the group consisting of ethylene acrylic acid copolymers, ethylene methacrylic acid copolymers, polyimides, polyurethanes, polyesters, and polyureas;
(c) a first compatibilizing agent of a styrene and hydrocarbon block copolymer in an amount within the range of 5-20% by weight of the radio frequency susceptible layer, and (d) wherein the radio frequency susceptible layer having a dielectric loss greater than 0.05 at 1-60 MHz and at temperatures of ambient to 250°
C.;
wherein the multiple layer structure has a mechanical modulus of less than 40,000 psi when measured according to ASTM D-882, the optical haze of the structure processed into a film 9 mils in thickness measured in accordance to ASTM D-1003 is less than 30%, the structure exhibits no strain whitening after being strained at moderate speeds of about 20 inches per minute to about twice the original length and the structure is capable of storing or collecting beneficial agents or transferring such agents to a patient, and wherein the multiple layer structure is capable of being thermoplastically recycled. - View Dependent Claims (35)
(a) a polyolefin selected from the group consisting of polypropylene and polypropylene copolymers;
(b) a second component selected from the group consisting of an ultra low density polyethylene and a polybutene-1 copolymer; and
(c) a second compatibilizing agent of a styrene and hydrocarbon block copolymer.
-
-
36. A multiple layer thermoplastic structure suitable for manufacturing medical products comprising:
-
(1) a skin layer selected from the group consisting of polypropylene and polypropylene copolymers; and
,(2) a radio frequency susceptible layer adhered to the skin layer, the radio frequency susceptible layer having a dielectric loss greater than 0.05 at 1-60 MHz and at temperatures of ambient to 250°
C., the radio frequency susceptible layer comprising;
(a) a first polyolefin selected from the group consisting of polypropylene and polypropylene copolymers;
(b) a second polyolefin selected from the group consisting of ultra-low density polyethylene, polybutene, and butene ethylene copolymers;
(c) a radio frequency susceptible polymer selected from the group consisting of ethylene acrylic acid copolymers, ethylene methacrylic acid copolymers, polyimides, polyurethanes, polyesters, and polyureas; and
(d) a first compatibilizing agent of a styrene and hydrocarbon block copolymer;
wherein the multiple layer structure has a mechanical modulus of less than 40,000 psi when measured according to ASTM D-882, the optical haze of the structure processed into a film 9 mils in thickness measured in accordance to ASTM D-1003 is less than 30%, the structure exhibits no strain whitening after being strained at moderate speeds of about 20 inches per minute to about twice the original length and the structure is capable of storing or collecting beneficial agents or transferring such agents to a patient, the structure has a sample creep measured at 121°
C. for a sample strip of the structure under 27 psi loading of less than or equal to 60%, and wherein the multiple layer structure is capable of being thermoplastically recycled.
-
-
37. A multiple layer thermoplastic structure suitable for manufacturing medical products comprising:
-
(1) a skin layer comprising a polypropylene copolymer and a styrene and hydrocarbon block copolymer within a range of 0-20% by weight of the skin layer;
(2) a radio frequency susceptible layer adhered to the skin layer comprising;
(a) a polypropylene having a melting point temperature greater than 130°
C. and a modulus less than 20,000 psi in an amount in a range of 30-60% of the weight of the radio frequency susceptible layer,(b) a radio frequency susceptible polymer in an amount within the range of 3-40% by weight of the radio frequency susceptible layer and selected from the group consisting of ethylene acrylic acid copolymers, ethylene methacrylic acid copolymers, polyimides, polyurethanes, polyesters, and polyureas;
(c) a first compatibilizing agent of a styrene and hydrocarbon block copolymer in an amount within the range of 5-20% by weight of the radio frequency susceptible layer, and (d) wherein the radio frequency susceptible layer having a dielectric loss greater than 0.05 at 1-60 MHz and at temperatures of ambient to 250°
C.; and
(3) wherein the multiple layer structure has a mechanical modulus of less than 40,000 psi when measured according to ASTM D-882, the optical haze of the structure processed into a film 9 mils in thickness measured in accordance to ASTM D-1003 is less than 30%, the structure exhibits no strain whitening after being strained at moderate speeds of about 20 inches per minute to about twice the original length and the structure is capable of storing or collecting beneficial agents or transferring such agents to a patient, the structure has a sample creep measured at 121°
C. for a sample strip of the structure under 27 psi loading of less than or equal to 60%, and wherein the multiple layer structure is capable of being thermoplastically recycled.
-
Specification