U.S. patent application number 12/859972 was filed with the patent office on 2012-02-23 for recycled resin compositions and disposable medical devices made therefrom.
This patent application is currently assigned to Becton, Dickinson and Company. Invention is credited to Lourdes Pia L. Amora, Mildred Calistri-Yeh, Richard Giddes, Ankur S. Kulshrestha.
Application Number | 20120046411 12/859972 |
Document ID | / |
Family ID | 44513200 |
Filed Date | 2012-02-23 |
United States Patent
Application |
20120046411 |
Kind Code |
A1 |
Kulshrestha; Ankur S. ; et
al. |
February 23, 2012 |
Recycled Resin Compositions And Disposable Medical Devices Made
Therefrom
Abstract
Compositions including recycled resin components and medical
devices and components made from such compositions are disclosed.
The compositions and medical devices are characterized as
biocompatible and sterilization stable. In one or more embodiments,
the compositions include a recycled resin component and may include
one or more of an anti-oxidant component, slip additive component,
anti-static component, impact modifier component, colorant
component, acid scavenger component, X-ray fluorescence agent
component, radio opaque filler component, surface modifier
component, melt stabilizer component, clarifier component,
processing aid component and reinforcing agent component. Methods
of forming medical articles and components are also disclosed.
Inventors: |
Kulshrestha; Ankur S.;
(Hillsborough, NJ) ; Calistri-Yeh; Mildred;
(Florham Park, NJ) ; Amora; Lourdes Pia L.;
(Morristown, NJ) ; Giddes; Richard; (Edison,
NJ) |
Assignee: |
Becton, Dickinson and
Company
Franklin Lakes
NJ
|
Family ID: |
44513200 |
Appl. No.: |
12/859972 |
Filed: |
August 20, 2010 |
Current U.S.
Class: |
524/528 |
Current CPC
Class: |
B29L 2031/753 20130101;
A61L 29/04 20130101; B29C 45/0001 20130101; A61L 31/14 20130101;
C08L 23/12 20130101; A61L 31/048 20130101; A61L 31/04 20130101;
A61L 29/14 20130101; B29K 2023/12 20130101; B29C 48/475 20190201;
A61L 29/04 20130101; C08L 23/12 20130101; A61L 31/048 20130101;
C08L 23/12 20130101 |
Class at
Publication: |
524/528 |
International
Class: |
C08L 23/12 20060101
C08L023/12 |
Claims
1. A medical device formed from a sterilization-stable recycled
resin composition.
2. The medical device of claim 1, wherein the medical device is
capable of withstanding sterilization comprising exposure to gamma
rays in the range from about 5 kGys to about 75 kGys.
3. The medical device of claim 1, wherein the medical device is
capable of withstanding sterilization comprising exposure to an
electron beam in the range from about 40 kGys to about 100
kGys.
4. The medical device of claim 1, wherein the medical device is
capable of withstanding sterilization comprising exposure to X-ray
radiation.
5. The medical device of claim 1, wherein the medical device is
capable of withstanding sterilization comprising exposure to
ethylene oxide gas, autoclaving, plasma sterilization.
6. The medical device of claim 1, wherein the recycled resin
composition is biocompatible.
7. The medical device of claim 1, wherein the recycled resin
composition comprises from about 0.1% to about 100% by weight
recycled resin selected from one of post-industrial recycled resin,
post-consumer recycled resin and combinations thereof.
8. The medical device of claim 1, wherein at least a portion of the
medical device comprises a fluid path contact medical device.
9. The medical device of claim 1, wherein the recycled resin
composition further comprises one or more of a virgin resin
component and/or a biobased resin component.
10. The medical device of claim 7, wherein the recycled resin
composition further comprises one or more of an antioxidant
component, slip additive component, anti-static component, impact
modifier component, colorant component, acid scavenger component,
x-ray fluorescence agent component, radio opaque filler component,
surface modifier component, processing aid component, melt
stabilizer, clarifiers and reinforcing agent component.
11. The medical device of claim 1, wherein the medical device
comprises one of a plunger rod, needle shield, handle, safety
shield.
12. The medical device of claim 1, wherein the medical device
comprises a plunger rod with functional performance acceptable to
users including clinicians.
13. The medical device of claim 12, exhibiting a functional
performance that is the same or greater than the functional
performance exhibited by plunger rods formed from a non-recycled
resin composition.
14. A composition for molding a medical device comprising: a
recycled resin sourced from a traceable source; and one or more of
an antioxidant component, slip additive component, anti-static
component, impact modifier component, colorant component, acid
scavenger component, x-ray fluorescence agent component, radio
opaque filler component, surface modifier component, processing aid
component, melt stabilizer component, clarifier component,
nucleating agents and reinforcing agent component, wherein the
composition is biocompatible.
15. The composition of claim 14, wherein the composition is capable
of withstanding exposure to gamma rays in the range from about 5
kGys to about 75 kGys.
16. The composition of claim 14, wherein the composition is capable
of withstanding exposure to electron beams in the range from about
30 kGys to about 100 kGys.
17. The composition of claim 14, wherein the composition is capable
of withstanding exposure to one of X-ray radiation, ethylene oxide
gas, autoclaving and plasma sterilization.
18. The composition of claim 14, wherein the medical device
exhibits a functional performance acceptable to
users/clinicians.
19. The composition of claim 14, comprising a flexural modulus in
the range from about 70 kpsi to about 350 kpsi.
20. The composition of claim 14, comprising a melt flow range in
the range from about 3 dg/minute to about 80 dg/minute.
21. The composition of claim 14, comprising a heat deflection
temperature from about 60.degree. C. to 260.degree. C.
22. The composition of claim 14, comprising notched izod impact
strength in the range from about 0.1 ft-lb/in to about 4.0
ft-lb/in.
23. The composition of claim 14, further comprising one or more of
a virgin resin component and a biobased resin component.
24. A method of forming a medical device comprising: providing a
melt blend composition including a 50% to 99% recycled resin
component; stabilizing the composition to withstand exposure to
gamma rays, electron beams, X-ray radiations, ethylene oxide gas,
autoclave, plasma sterilization; and solidifying the composition in
a pre-selected shape.
25. The method of claim 24, wherein providing a melt blend
composition comprises feeding a recycled resin component and one or
more of an antioxidant component, slip additive component,
anti-static component, impact modifier component, colorant
component, acid scavenger component, nucleating agents, clarifiers,
x-ray fluorescence agent component, radio opaque filler component,
surface modifier component, processing aid component and
reinforcing agent component into a melt compounding extruder.
26. The method of claim 24, wherein solidifying the composition
comprises one of injection molding the composition, extruding the
composition, blow molding the composition and rotational molding
the composition.
27. The method of claim 24, wherein the pre-selected shape
comprises one of a plunger rod, a syringe barrel, a catheter, a
blood collection device, a surgical blade handle, a needle shield,
safety shield, catheter wings, catheter flow control plugs and a
needle hub, sharps containers, body fluid collection devices,
tubing, adapters and drainage tubes.
28. The method of claim 24, further comprising stabilizing the
composition to withstand exposure to gamma rays in the range from
about 5 kGys to about 75 kGys.
Description
TECHNICAL FIELD
[0001] The present invention relates to recycled resin
compositions, medical devices formed from recycled resin
compositions and methods for manufacturing medical devices from
recycled resin compositions.
BACKGROUND
[0002] Plastics form a significant component of majority of
disposable medical devices, non-disposable medical devices, medical
device packaging as well as other non-medical device applications
including automotive and commodity applications. These
thermoplastics include polymers such as polypropylene,
polyethylene, polystyrene, polyethyleneterephthalate and
polycarbonate among others. Increasing use of plastics over the
past decades has resulted in increased impact on landfill capacity
and the depletion of fossil fuel-based resources. The increasing
use of plastics or plastic material has also resulted in increasing
level of environmental pollution and associated carbon
footprint.
[0003] In light of above, there has been an increased interest in
the utilization of recycled thermoplastic polymeric materials,
which may be obtained from a variety of sources. The increased
interest in utilizing recycled thermoplastic polymeric materials is
driven by a number of factors, including increased customer
awareness and concern for protection of the environment,
environmentally preferred purchasing policies developed by
customers, recognition of benefits of environmental stewardship in
marketing by brand owners, development of new regulations and
environmental policies intended to reduce the carbon footprint, and
a desire to reduce the increasing costs of storage and/or landfill
space coupled with more stringent regulations for disposal and
incineration. The increased interest in utilizing recycled
thermoplastic polymeric materials is also driven by the improved
capabilities of recyclers to consistently produce high quality
recycled resins. These factors have already resulted in extensive
use of recycled plastics in automotive and food packaging
applications. For example, Ford Motor Company has developed ways to
increase the use of recycled materials in its vehicle
manufacturing. Two exemplary outcomes of this development include
Visteon Automotive Systems' recycling of thermoplastic scrap from
automobile bumpers and E. I. du Pont de Nemours and Company
recycling of scrap into automobile air cleaners. Recycled PET or
polyethylene terephthalate is extensively used in food and
packaging applications including beverage bottles.
[0004] In order to enhance the environmental stewardship of medical
devices and ability of healthcare agencies to satisfy environmental
targets, for example, the LEED system while reducing the impact on
landfills, without sacrificing safety, there is a growing emphasis
on manufacturing medical devices made from recycled plastics.
Previous attempts to use recycled resins in manufacturing of
medical devices or their components have encountered obstacles such
as lack of biocompatibility, lot-to-lot variability in properties,
and undesirable changes to the appearance during the sterilization
process. Furthermore, when recycled resin compositions are used to
form fluid path contact medical devices, there is a concern that
the recycled resin compositions will interfere with the material
being transmitted, carried or delivered through the medical
device.
[0005] Accordingly, there is a need in the industry for
thermoplastic compositions comprised of recycled resin compositions
that are biocompatible, sterilization-stable and are useful for
medical device applications. Such recycled resin compositions are
not limited to medical device applications and would apply to any
industry that may utilize such compositions that are
sterilization-stable.
SUMMARY
[0006] A first aspect of the present invention pertains to a
medical device. In one or more embodiments, the medical device is
formed from a sterilization-stable recycled resin composition. In a
more specific embodiment, the medical device is capable of
withstanding sterilization that includes exposure to gamma rays in
the range from about 5 kGys to about 75 kGys. The medical device
may be capable of withstanding sterilization that includes exposure
to an electron beam in the range from about 40 kGys to about 100
kGys or exposure to X-ray radiation, exposure to ethylene oxide
gas, autoclaving, plasma sterilization and other types of
sterilization. At least a portion of the medical device of one or
more embodiments may include a fluid-path contact medical device or
medical device that is in contact with fluid.
[0007] In one or more embodiments, the recycled resin composition
is biocompatible, as defined above. The composition may include
recycled resin that may be present in an amount in the range from
about 0.1% to about 100% by weight. The recycled resin may include
one of post-industrial recycled resin, post-consumer recycled resin
and combinations thereof. In one or more embodiments, the recycled
resin composition may include one or more of a virgin resin
component and/or a biobased resin component.
[0008] The recycled resin composition may also include one or more
of an antioxidant component, slip additive component, anti-static
component, impact modifier component, colorant component, acid
scavenger component, x-ray fluorescence agent component, radio
opaque filler component, surface modifier component, processing aid
component, melt stabilizer, clarifiers and reinforcing agent
component. The anti-oxidant component may include one or more of
hindered phenols and hindered amines and may optionally be present
in an amount in up to about 10% by weight of the recycled resin
composition. The impact modifier component utilized in one or more
embodiments may include one or more of ethylene-butene copolymer
and ethylene octane copolymer. The acid scavenger component may
include one or more of calcium stearate, dihydro talcite, calcium
lactate and monopotassium citrate. The radio opaque filler may
include one or more of barium sulfate, bismuth subcarbonate,
bismuth trioxide, bismuth oxychloride and tungsten, while the
colorant component may include organic dyes, inorganic pigments,
carbon black, channel black and titanium dioxide. The processing
aid component utilized in one or more embodiments may include one
or more of a fatty acid ester, fatty acid amide, wax and oxidized
polyethylene. The reinforcing agent component may include one or
more of glass fibers, cinderash, natural fibers and minerals,
carbon fibers, ceramic fillers, which may be provided as
nanoparticles or nanofibers.
[0009] The medical device of one or more embodiments may include a
plunger rod, needle shield, handle, safety shield. In embodiments
in which the medical device is a plunger rod, it exhibits
functional performance that is acceptable to users including
clinicians. In other words, the plunger rod may exhibit functional
performance that is the same or greater than the functional
performance exhibited by plunger rods formed from a non-recycled
resin composition. The medical devices described herein may be
formed by molding or extruding.
[0010] A second aspect of the present invention pertains to a
composition for molding a medical device. The composition includes
a recycled resin sourced from a traceable source and may optionally
include one or more of an antioxidant component, slip additive
component, anti-static component, impact modifier component,
colorant component, acid scavenger component, x-ray fluorescence
agent component, radio opaque filler component, surface modifier
component, processing aid component, melt stabilizer component,
clarifier component, nucleating agents and reinforcing agent
component, as otherwise described above. In one or more
embodiments, the composition is capable of withstanding exposure to
gamma rays in the range from about 5 kGys to about 75 kGys. In
another variant, the composition is capable of withstanding
exposure to electron beams in the range from about 30 kGys to about
100 kGys. The composition may also optionally be capable of
withstanding exposure to one of X-ray radiation, ethylene oxide
gas, autoclaving and plasma sterilization.
[0011] The composition may be utilized to form the medical devices
described herein. The composition may include one or more of a
virgin resin component and a biobased resin component.
[0012] A third aspect of the present invention pertains to a method
of forming a medical device. In one or more embodiments, the method
includes providing a melt blend composition including a 50% to 99%
recycled resin component, stabilizing the composition to withstand
exposure to gamma rays, electron beams, X-ray radiations, ethylene
oxide gas, autoclave, plasma sterilization and solidifying the
composition in a pre-selected shape. In one or more embodiments,
the method includes stabilizing the composition to withstand
exposure to gamma rays in the range from about 5 kGys to about 75
kGys.
[0013] In one or more embodiments, the step of providing a melt
blend composition includes feeding a recycled resin component and
one or more of an antioxidant component, slip additive component,
anti-static component, impact modifier component, colorant
component, acid scavenger component, nucleating agents, clarifiers,
x-ray fluorescence agent component, radio opaque filler component,
surface modifier component, processing aid component and
reinforcing agent component into a melt compounding extruder. The
step of solidifying the composition may include injection molding
the composition, extruding the composition, blow molding the
composition and rotational molding the composition.
[0014] In one or more embodiments, the composition may be
solidified in a pre-selected shape that includes one of a plunger
rod, a syringe barrel, a catheter, a blood collection device, a
surgical blade handle, a needle shield, safety shield, catheter
wings, catheter flow control plugs and a needle hub, sharps
containers, body fluid collection devices, tubing, adapters and
drainage tubes.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] FIG. 1 illustrates an exploded view of a syringe assembly of
one or more embodiments of the present invention; and
[0016] FIG. 2 illustrates a perspective view of a scalpel and
scalpel shield according to one or more embodiments.
DETAILED DESCRIPTION
[0017] Before describing several exemplary embodiments of the
invention, it is to be understood that the invention is not limited
to the details of construction or process steps set forth in the
following description. The invention is capable of other
embodiments and of being practiced or being carried out in various
ways.
[0018] As used herein, the term "medical device" shall include all
devices and components used in conjunction with other components in
devices that are used in all medical and/or laboratory purposes,
excluding waste collection containers such as sharps collection
containers. Medical devices include syringe assemblies, including
syringe barrels, plunger rods, catheters, needle hubs and needle
shields, safety shields, surgical blades, surgical handles, sharps
containers, body fluid collection devices, tubing, adapters,
shunts, drainage tubes, guidewires, stents, petri dishes, culture
bottles, centrifuge tubes, blood collection devices and the like.
As indicated, as used herein "medical devices" excludes waste
collection containers such as sharps collection containers.
[0019] As used herein, the term "biocompatible" shall mean any
substance that is not toxic to the body or biological environment
or does not produce an undesirable biological response during the
period of exposure to the human body. A composition is
biocompatible if the composition, and any degradation products of
the composition, are non-toxic to the recipient or biological
environment and also present no significant deleterious effects on
the biological environment. A medical device is biocompatible if
the medical device, and any degradation products of the medical
device, are non-toxic to the recipient or biological environment
and also present no significant deleterious effects on the
biological environment.
[0020] In addition, as used herein, the term "sterilization-stable"
shall mean the ability of a medical device or component to
withstand sterilization without significant loss of functional
performance and mechanical properties. Sterilization includes
exposure to radiation, for example, gamma rays and/or X-rays,
during the sterilization process. Medical devices or components
thereof that are capable of withstanding radiation sterilization
without significant loss of functional performance may be referred
to as "radiation stable." An example of a sterilization process may
include exposure of a medical device to high energy photons that
are emitted from an isotope source, for example Cobalt 60, which
produces ionization or electron disruptions throughout the medical
device. Sterilization may also include ethylene oxide
sterilization, electron bean sterilization, autoclave (steam
sterilization), plasma sterilization, dry heat sterilization, and
X-ray beam sterilization.
[0021] As used herein, "fluid path contact medical devices" are
medical devices wherein at least a portion of the medical device
comes into contact or interacts with fluids and/or solids, for
example, medications, solutions of medications, drug containing
solutions, flush solutions, body fluids, human tissue, or any
material that is intended to be isolated to prevent contamination.
As used herein, reference to a medical device "formed from a
sterilization-stable recycled resin composition" means that the
device is manufactured, for example, shaped from a resin obtained
from recycled resin. Accordingly, a medical device "formed from a
sterilization-stable recycled resin composition" does not include a
medical device that is used, and then reprocessed by cleaning or
sterilization of a part of or the entire device by radiation or in
an autoclave. Such reuse of medical device is often referred to as
"reprocessing", and reprocessed medical devices are not within the
scope of a device formed from a sterilization-stable recycled resin
composition because such reprocessing does not include shaping or
other manufacturing process to form a device from a resin
composition
[0022] A first aspect of the present invention pertains to
compositions for use in molding a medical device that includes a
recycled resin from a traceable source. A second aspect of the
present invention pertains to a medical device that is formed from
a recycled resin composition. A third aspect of the present
invention pertains to a method of forming a medical device.
[0023] The recycled resin compositions of one or more embodiments
of the first aspect may include a post-industrial recycled resin.
The amount of post-industrial recycled resin may be present in the
recycled resin composition in the range from about 0.1% to about
100% by weight of the recycled resin composition. In one or more
embodiments, the recycled resin composition includes
post-industrial recycled resin in an amount in the range from about
50% to about 99% by weight. In one or more specific embodiments,
the recycled resin composition may include post-industrial recycled
resin in an amount in the range from about 20% to about 80% by
weight. In a more specific embodiment, the lower limit of the
amount of post-industrial recycled resin may include 25%, 30%, 35%,
40%, 45% and 50% by weight of the recycled resin composition and
all ranges and sub-ranges therebetween. The upper limit of the
amount of post-industrial recycled resin may include 75%, 70%, 65%,
60%, 55% and 50% by weight of the recycled resin composition and
all ranges and sub-ranges therebetween.
[0024] The recycled resin compositions of one or more embodiments
of the first aspect may include a post-consumer recycled resin. The
resin may be provided in any suitable form, such as in the form of
flakes, chips, pellets and the like. In one variant, the recycled
resin compositions may include post-consumer recycled resin and
post-industrial recycled resin. The amount of post-consumer
recycled resin may be present in the recycled resin composition in
the range from about 0.1% to about 100% by weight of the recycled
resin composition. In one or more embodiments, the recycled resin
composition includes post-consumer recycled resin in an amount in
the range from about 50% to about 99% by weight. In one or more
specific embodiments, the recycled resin composition may include
post-consumer recycled resin in an amount in the range from about
20% to about 80% by weight. In a more specific embodiment, the
lower limit of the amount of post-consumer recycled resin may
include 25%, 30%, 35%, 40%, 45% and 50% by weight of the recycled
resin composition and all ranges and sub-ranges therebetween. The
upper limit of the amount of post-consumer recycled resin may
include 75%, 70%, 65%, 60%, 55% and 50% by weight of the recycled
resin composition and all ranges and sub-ranges therebetween.
[0025] Examples of suitable post-industrial recycled resins and
post-consumer recycled resins include polypropylene,
polycarbonates, nylons, polyethyleneterphthalates, polyesters,
polyethylenes, polystyrenes, poly lactic acid,
polyhyroxyalkanoates, bioderived polyolefins including polyethylene
and polypropylene and other resins known in the art that are
recyclable and combinations thereof. The recycled resins may have
been recovered or otherwise diverted from the solid waste stream,
either during the manufacturing process (pre-consumer), or after
consumer use (post-consumer).
[0026] In one or more embodiments, the recycled resin composition
may also include one or more of the optional additives. These
optional additives are selected from the group consisting of
anti-oxidants, slip additives, anti-static agents, impact
modifiers, a colorants, acid scavengers, X-ray fluorescence agents,
radio opaque fillers, surface modifiers, processing aids including
melt stabilizers, nucleating agents including clarifiers, flame
retardants, inorganic fillers other than finely powdered talc,
organic fillers and other polymers and reinforcing agents.
[0027] In one or more embodiments, the recycled resin composition
includes an anti-oxidant component. The anti-oxidant component may
include chemical compounds that inhibit oxidation via chain
terminating reactions. In one or more embodiments, the anti-oxidant
component may be present in the recycled resin composition in an
amount up to about 10% by weight of the recycled resin composition.
In one or more specific embodiments, the recycled resin composition
may include an anti-oxidant component in an amount of up to about
5% by weight or, more specifically, an amount of up to about 1% by
weight of the recycled resin composition. In one or more specific
embodiments, the anti-oxidant component may be present in an amount
in the range from about 1% by weight to about 5% by weight of the
recycled resin composition. In an even more specific embodiment,
the anti-oxidant component may be present in an amount in the range
from about 0.1% to about 1% by weight of the recycled resin
composition. The upper limit of the amount of the anti-oxidant
component may include 0.9%, 0.8%, 0.7%, 0.6% and 0.5% and all
ranges and sub-ranges therebetween.
[0028] In one or more embodiments, the anti-oxidant component is
present in an amount sufficient to inhibit oxidation reactions
during sterilization and over the shelf life and/or use-phase of
the product.
[0029] Non-exclusive examples of suitable anti-oxidant components
include hindered phenols, hindered amines, phosphites and/or
combinations thereof. Hindered phenols include chemical compounds
that act as hydrogen donors and react with peroxy radicals to form
hydroperoxides and prevent the abstraction of hydrogen from the
polymer backbone. Suitable hindered phenols include buylated
hydroxytoluene. Other suitable hindered phenols are available under
the trademark Irganox.RTM. 1076, Irganox.RTM. 1010, and
Irganox.RTM.E 201, from Ciba, Inc., now part of BASF Corporation of
Ludwigshafen, Germany. Other examples of hindered phenols include
BNX.RTM.1010 and BNX.RTM.1076TF from Mayzo Inc. or Norcross, Ga.,
U.S.A. Suitable hindered phenols are also available under the
trademark Ethanox.RTM.330 and Ethanox.RTM.376 from Albemarle
Corporation of Baton Rouge, La., U.S.A.
[0030] Hindered amines include chemical compounds containing an
amine functional group surrounded by a steric environment. They are
extremely efficient stabilizers against light-induced degradation
of most polymers. Examples of suitable hindered amines include
bis(1,2,2,6,6-pentamethyl-4-piperidinyl)-2-n-butyl-2-(3,5-di-tert-butyl-4-
-hydroxybenzyl)malonate;
bis(2,2,6,6-tetramethyl-4-piperidinyl)sebacate,
bis(1,2,3,6,6-pentamethyl-4-piperidinyl)sebacate and
bis(1,2,2,6,6-pentamethyl-4-piperidinyl)sebacate. These are
commonly referred to as Tinuvin 144, Tinuvin 770, Tinuvin 292 and
Tinuvin 765 respectively and are available from the Ciba-Geigy
Corporation, now part of BASF Corporation of Ludwigshafen, Germany.
Other examples of suitable hindered amines are available under the
tradenames Uvasorb HA-88 from 3V Sigma SpA of Bergamo, Italy, and
Chimassorb 944 and Chimassorb 994 from BASF Corporation of
Ludwigshafen, Germany.
[0031] In specific embodiments, the recycled resin composition
includes a slip additive component. The slip additive component may
include chemical compounds reduce the surface coefficient of
friction of polymers and are used to enhance either processing or
end applications. The slip additive component may be present in the
recycled resin composition in an amount in the range from about
0.001% to about 5% by weight of the recycled resin composition and
all ranges and sub-ranges therebetween. In one or more specific
embodiments, the slip additive component is present in an amount in
the range from about 1% to about 2% by weight of the recycled resin
composition. The upper limit of the amount of the slip additive
component may include 4.5%, 4.0%, 3.5%, 3.0%, and 2.5% by weight of
the recycled resin composition and all ranges and sub-ranges
therebetween. The lower limit of the amount of the slip additive
component may include 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%,
0.8%, and 0.9% by weight of the recycled resin composition and all
ranges and sub-ranges therebetween. Examples of suitable slip
additive components include oleamides, erucamide, Oleyl
palmitamide, Stearyl erucamide, Ethylene-bis-oleamide, waxes and
combinations thereof.
[0032] The recycled resin composition optionally includes an
anti-static component. The anti-static component may include
chemical compounds that prevent or reduce the accumulation of
static electricity. The anti-static component acts to permit the
body or surface of the material to be static dissipative,
preventing the formation of static charges and hindering the
fixation of dust. The anti-static component may be incorporated in
the material before molding, or applied to the surface after
molding and function either by being inherently static dissipative
or by absorbing moisture from the air. The anti-static component
may be present in the recycled resin composition in an amount in
the range from about 0.01% to about 5% by weight of the recycled
resin composition and all ranges and sub-ranges therebetween. In
one or more specific embodiments, the anti-static component is
present in an amount in the range form about 0.1% to about 3.0% by
weight of the recycled resin composition and all ranges and
sub-ranges therebetween. The upper limit of the amount of the
anti-static component may include 4.5%, 4.0%, 3.5%, 3.0% and 2.5%
by weight of the recycled resin composition and all ranges and
sub-ranges therebetween. The lower limit of the amount of the
anti-static component may include 0.1%, 0.2%, 0.3%, 0.4%, 0.5%,
0.6%, 0.7%, 0.8%, 0.9% and 1.0% by weight of the recycled resin
composition and all ranges and sub-ranges therebetween. Examples of
anti-static agent components are long-chain aliphatic amines and
amides, phosphate esters, quaternary ammonium salts, polyethylene
glycols, polyethylene glycol esters, ethoxylated long-chained
aliphatic amines and combinations thereof. Other examples of
suitable anti-static agents are available under the trade name
Pelestat 230 and Pelestat 300 from Toyota Tsusho Corporation of
Nagoya, Japan, Atmer.TM. 163 from Uniqema, now part of Croda
International Plc of Yorkshire, England, U.K, Entira.TM. MK 400
from E.I DuPont de Nemours and Company of Wilmington, Del., U.S.A
and Nourymix.RTM. AP 375 and 775 from Akzo Nobel N.V. of Amsterdam,
the Netherlands.
[0033] The recycled resin composition optionally includes an impact
modifier component. The impact modifier component may include
chemical compounds for improving the impact resistance of finished
articles or devices. The impact modifier component may be present
in the recycled resin composition in an amount in the range from
about 0.1% to about 30% by weight of the recycled resin
composition. In one or more specific embodiments, the impact
modifier component is present in an amount in the range form about
0.5% to about 5% by weight of the recycled resin composition and
all ranges and sub-ranges therebetween. The upper limit of the
amount of impact modifier component may include 4.5%, 4.0%, 3.5%,
3.0%, 2.5% and 2.0% by weight of the recycled resin composition and
all ranges and sub-ranges therebetween. The lower limit of the
amount of impact modifier component may include 0.75%, 1.0%, 1.25%,
1.5%, 1.75% and 2.0% by weight of the recycled resin composition
and all ranges and sub-ranges therebetween. Examples of suitable
impact modifier components include ethylene-butene copolymers,
ethylene octene copolymers, ethylene-propylene copolymers,
methacrylate butadiene-styrene core shell impact modifiers and
combinations thereof. Examples of suitable impact modifier agents
are available under the trade name Elvaloy.RTM. EAC3427 from E.I
DuPont de Nemours and Company of Wilmington, Del., U.S.A.,
Engage.TM. and Versify.TM. from the Dow Chemical Company of
Midland, Mich., U.S.A. and Clearstrength.TM. from Arkema Inc. of
Philadelphia, Pa., U.S.A.
[0034] When present, the impact modifier component can be present
in an amount sufficient to meet the impact requirements of the
fabricated medical article.
[0035] The recycled resin composition optionally includes an acid
scavenger component. The acid scavenger component may include
chemical compounds for preventing discoloration or premature aging
of the polymer as well as the fabricated medical article from the
acidic impurities during the course of manufacturing, processing,
sterilization, shelf life or use phase. For example, such chemical
compounds may neutralize halogen anions found in resin compositions
that may be formed due to the influence of heat and shear during
processing. The acid scavenger component scavenges these halogenic
acids to prevent polymer degradation or corrosion. The acid
scavenger component may be present in the recycled resin
composition in an amount in the range from about 0.01% to about 1%
by weight of the recycled resin composition. In one or more
specific embodiments, the acid scavenger component is present in an
amount in the range form about 0.1% to about 0.5% by weight of the
recycled resin composition and all ranges and sub-ranges
therebetween. The upper limit of the amount of acid scavenger
component may include 0.6%, 0.7%, 0.8%, and 0.9% by weight of the
recycled resin composition and all ranges and sub-ranges
therebetween. The lower limit of the amount of acid scavenger
component may include 0.01%, 0.02%, 0.03%, 0.04%, 0.05%, 0.06%,
0.07%, 0.08% and 0.09% by weight of the recycled resin composition
and all ranges and sub-ranges therebetween. Examples of suitable
acid scavenger components include metal salts of long chain
carboxylic acids like calcium, zinc or sodium stearates, lactates,
natural or synthetic silicates like hydrotalcites, metal oxides
(e.g. magnesium oxide, calcium oxide, zinc oxide), metal carbonates
(e.g. calcium carbonate) or metal hydroxides (see e.g. A Holzner, K
Chmil in H. Zweifel, Plastic Additives Handbook, 5.sup.th Ed.,
Hanser Publisher, Munich 2001, Chapter 4 Acid Scavengers). Suitable
examples of acid scavengers include calcium stearate, dihydro
talcite, calcium lactate, mono potassium citrate and combinations
thereof.
[0036] When present, the acid scavenger component can be present in
the recycled resin composition in an amount sufficient to inhibit
discoloration and prevent degradation caused by acidic impurities
during manufacturing, processing, storage, shelf life or use phase
of polymer and medical article fabricated therefrom.
[0037] Another optional component of the recycled resin composition
is a radio opaque filler component. The radio opaque filler
component may include chemical compounds for that cause medical
devices formed from the resin composition to be visible under
fluoroscopy or x-ray imaging. The radio opaque filler component may
be present in the recycled resin composition in an amount in the
range from about 10% to about 48% by weight of the recycled resin
composition and all ranges and sub-ranges therebetween. In one or
more specific embodiments, the radio opaque filler component is
present in an amount in the range from about 22% to about 25% by
weight of the recycled resin composition and all ranges and
sub-ranges therebetween. The upper limit of the amount of the radio
opaque filler component may include 26%, 28%, 30%, 32%, 34%, 36%,
38%, 40%, 42%, 44% and 46% by weight of the recycled resin
composition and all ranges and subranges therebetween. The lower
limit of the amount of the radio opaque filler component may
include 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19% and 20% by
weight of the recycled resin composition and all ranges and
subranges therebetween. Higher percentages of radio opaque filler
component may also be used. For example, the amount of the radio
opaque filler component may be more than about 50% by weight of the
recycled resin composition. Examples of suitable radio opaque
filler components include barium sulfate, bismuth subcarbonate,
bismuth trioxide, bismuth oxychloride, tungsten and combinations
thereof.
[0038] The radio opaque filler component can be present in an
amount sufficient to enable visibility of the medical devices using
x-ray and other radiology imaging techniques.
[0039] The recycled resin composition further optionally includes a
surface modifier component. The surface modifier component may
include chemical compounds or materials which tailor the surface of
the fabricated component(s) to meet or enhance adhesion, lubricity
and/or physical properties. The surface modifier component may be
present in the recycled resin composition in an amount in the range
from about 0.1% to about 10% by weight of the recycled resin
composition. In one or more specific embodiments, the surface
modifier component is present in an amount in the range form about
0.5% to about 5%, more preferably between 0.2 to 1% by weight of
the recycled resin composition and all ranges and sub-ranges
therebetween. The upper limit of the amount of the surface modifier
component may include 1.5%, 2.0%, 3.0%, 3.5%, 4.0% and 4.5% and all
ranges and sub-ranges therebetween. The lower limit of the amount
of the surface modifier component may include 0.3%, 0.35%, 0.4% and
0.45% by weight of the recycled resin composition and all ranges
and sub-ranges therebetween. In one or more embodiments, higher
percentages of surface modifiers may also be used. Examples of
suitable surface modifier components include diatomaceous earth,
talc, calcium carbonate, organosilanes, titanates, maleated
polyolefins, powdered PTFE and combinations thereof.
[0040] The surface modifier can be present in the recycled resin
composition in an amount sufficient to impart desirable surface
property to the surface of the fabricated medical device.
[0041] In one or more embodiments, the recycled resin composition
includes a colorant component. The colorant component may be
present in the recycled resin composition in an amount in the range
from about 0.01% to about 5% by weight of the recycled resin
composition. In one or more specific embodiments, the colorant
component(s) are present in an amount in the range form about 0.5%
to about 3% by weight of the recycled resin composition and all
ranges and sub-ranges therebetween. The upper limit of the amount
of colorant component may include 3.25%, 3.5%, 3.75%, 4.0%, 4.25%,
4.5% and 4.75% by weight of the recycled resin composition and all
ranges and sub-ranges therebetween. The lower limit of the amount
of the colorant component may include 0.1%, 0.15%, 0.2%, 0.25%,
0.3%, 0.35%, 0.4% and 0.45% by weight of the recycled resin
composition and all ranges and sub-ranges therebetween. Examples of
suitable colorant components include organic dyes, inorganic
pigments, carbon black, channel black, titanium dioxide and
combinations thereof. Organic dyes may include Phthalocyanine blue
and Phthalocyanine green, and FD&C colorants. Exemplary
inorganic pigments include ultramarines and iron oxides.
[0042] Another optional component of the recycled resin composition
includes a processing aid component. The processing aid component
may include chemical compounds which improve the processability of
high molecular weight polymers, reduces the cycle time and help
improve quality of finished products. The processing aid component
may be present in the recycled resin composition in an amount in
the range from about 0.05% to about 5% by weight of the recycled
resin composition and all ranges and sub-ranges therebetween. In
one or more specific embodiments, the processing aid component is
present in an amount in the range form about 0.1 to about 3% by
weight of the recycled resin composition and all ranges and
sub-ranges therebetween. The upper limit of the amount of colorant
component may include 3.25%, 3.5%, 3.75%, 4.0%, 4.25%, 4.5% and
4.75% by weight of the recycled resin composition and all ranges
and sub-ranges therebetween. The lower limit of the amount of the
colorant component may include 0.06%, 0.07%, 0.08% and 0.09% by
weight of the recycled resin composition and all ranges and
sub-ranges therebetween. Higher percentages of processing aid may
also be used. Examples of suitable processing aid components
include fatty acid esters, fatty acid amines, waxes, oxidized
polyethylenes, colloidal fumed silica particles and combinations
thereof. Colloidal fumed silica particles are available under the
tradename Nan-O-Sil ASD from Energy Strategy Associates, Inc. of
Old Chatham, N.Y., USA. Glycerol monostearates and bisstearaamides
are suitable fatty acid esters and fatty acid amides.
[0043] The recycled resin composition may optionally include a
nucleating agents and/or clarifier component. Nucleating agents may
include chemical compounds that enhance resin performance
properties such as stiffness and heat resistance. A clarifier may
also be added to enhance the aesthetic appeal of a formed product
by making it more transparent. In one or more embodiments, the
nucleating and/or clarifier component is present in an amount in
the range from about 0.005% to about 3% by weight of the recycled
resin composition. Higher percentages of nucleating and/or
clarifying agents may be used but generally provide no perceived
advantages. In one or more specific embodiments, the clarifier
component is present in an amount in the range from about 0.05 to
about 0.5% by weight of the recycled resin composition and all
ranges and sub-ranges therebetween. The upper limit of the amount
of the clarifier component may include 1.0%, 1.5%, 2.0% and 2.5% by
weight of the recycled resin composition and all ranges and
sub-ranges therebetween. The lower limit of the amount of the
clarifier component may include 0.01%, 0.015%, 0.02%, 0.025%,
0.03%, 0.035%, 0.04% and 0.045% by weight of the recycled resin
composition and all ranges and sub-ranges therebetween. Examples of
clarifier components include dibenzylidene sorbitol as described in
U.S. Pat. No. 4,016,118, which is incorporated herein by reference,
substituted dibenzylidene sorbitol as described in U.S. Pat. No.
4,371,645, which is incorporated herein by reference, and
dibenzylidene sorbitol thioether derivatives as described in U.S.
Pat. No. 4,994,552, which is incorporated herein by reference.
[0044] When present, the clarifiers can be present in an amount
sufficient such that the size of the size of the crystals in the
resulting resin composition is smaller than the wavelength of
visible light to prevent light scattering, which causes
opacity.
[0045] The recycled resin composition optionally includes a
reinforcing agent component. The reinforcing agent component may be
present in the recycled resin composition in an amount in the range
from about 1% to about 35% by weight of the recycled resin
composition. In one or more specific embodiments, the reinforcing
agent component(s) are present in an amount in the range from about
5% to about 30% by weight of the recycled resin composition and all
ranges and sub-ranges therebetween. The upper limit of the amount
of the reinforcing agent component may include 30.5%, 31%, 31.5%,
32%, 32.5%, 33%, 33.5%, 34% and 34.5% by weight of the recycled
resin composition and all ranges and sub-ranges therebetween. The
lower limit of the amount of the reinforcing agent component may
include 1.5%, 2%, 2.5%, 3%, 3.5%, 4% and 4.5% by weight of the
recycled resin composition and all ranges and sub-ranges
therebetween. Examples of suitable reinforcing agent components
include glass fibers, cinderash, natural fibers and minerals,
carbon fibers, ceramic fibers, and combinations thereof. Examples
of natural fibers include flax fibers and kenaf fibers and fillers.
The reinforcing agent component may be present in the recycled
resin composition in the form of nanofibers and/or
nanoparticles.
[0046] The recycled resin composition according to one or more
embodiments may optionally include a melt stabilizer component. The
melt stabilizer component may include chemical compounds for
adjusting the viscosity of the recycled resin composition during a
melting process.
[0047] The recycled resin composition may also optionally
incorporate a non-recycled resin component. Examples of a
non-recycled resin component include virgin resin components,
biobased resin components and combinations thereof. Virgin resin
components are resin compositions that do not include a significant
amount of recycled resin. In one or more embodiments, virgin resin
components are free of recycled resin. Virgin resin components may
also include "fossil fuel-based polymers" or "petroleum based
polymers," which shall be used interchangeably, and include,
without limitation, polymers formed from non-renewable sources such
as fossil fuel sources. Such polymers include polypropylene,
polyethylene not derived from sugar or other renewable resources,
polycarbonate.
[0048] The term "biobased" may be used interchangeably with the
terms "bioformed" and "bioderived." The biobased component includes
polymers that are derived, produced or synthesized in whole or in
significant part, from biological sources or renewable domestic
agricultural materials (including plant, animal, and marine
materials) or forestry materials. The biobased component includes
polymers in which carbon is derived from a renewable resource via
biological processes such as microbiological fermentation. The
biobased component may also include polymers with cellulose-based
materials of different grades. The biobased component may also
include polymers are that substantially free of materials derived
from fossil fuel or non-renewable resources as determined by ASTM
D6866-08.
[0049] The biobased component used herein may include polymers
which are derived from biological sources, such as plants, and
include polysaccharide-derived polymers, such as starch- or
carbohydrate-derived polymers, and sugar-derived polymers. The
starch used to form bioformed polymers may be derived from corn,
potatoes, wheat, cassava, rice and other plants. An example of a
composition containing bioformed polymer derived from starch is
available from Cereplast Inc., Hawthorne, Calif., U.S.A., under the
trademarks and trade names Cereplast Hybrid Resins.RTM.,
Bio-polyolefins.RTM., or Biopropylene 50.TM.. The sugar used to
form such bioformed polymers may be derived from sugar cane. Such
sugar-derived polymers include polyethylene, which may be produced
from ethanol derived from sugar cane, which is then used to produce
ethylene and polymers are available from Novamount S.P.A., Novara,
Italy under the trademark MATER-BI.RTM.. Other examples of
bioformed polymers are described in U.S. Pat. No. 7,393,590, U.S.
Patent Application Publication Nos. 2008/0113887 and 2008/0153940,
PCT Application Publication Nos. WO07/099,427 and WO07/063,361 and
European Patent No. 1725614, each of which is incorporated herein
in their entirety by reference. A specific example of a bioformed
polymer includes "poly(lactic acid)" or "PLA," which may include a
synthetic polymer produced from cane sugar or cornstarch. PLA is
available from NatureWorks LLC, Minnetonka, Minn., U.S.A., under
the trade name Ingeo.TM.. Embodiments utilizing PLA may also
include an ethylene copolymer. Ethylene copolymers are available
from E. I. du Pont de Nemours and Company, Wilmington, Del.,
U.S.A., under the trademark BIOMAX.RTM..
[0050] Biobased component includes polymers may also be produced
from microbes. Microorganisms produce substances, including
polymers, by growth on feedstock, including sugar feedstock. The
production of these polymers may also involve bacterial
fermentation of sugar or lipids. The biobased component may be
further treated or synthesized from natural products. Examples of
such produced and/or synthesized biobased polymers include
polyhydroxyalkanoates The term "polyhydroxyalkanoate" or "PHA"
includes linear polyesters produced in nature by bacterial
fermentation of sugar or lipids. Examples of PHAs include
poly(hydroxybutyrate) and poly(hydroxyvalerate) or "PHBV." PHAs may
exhibit properties such as elasticity. PHAs are available from
Metabolix, Inc., Cambridge, Mass., U.S.A., under the trademark
MIREL.RTM..
[0051] Recycled resin compositions according to one or more
embodiments, are biocompatible, as defined herein. In one or more
embodiments, the recycled resin composition is capable of
withstanding exposure to gamma rays, electron beams, X-rays,
ethylene oxide gas, dry heat, peroxide gas plasma, peracetic acid,
steam autoclave and other means of sterilization. In one or more
embodiments, the recycled resin composition is radiation stable and
capable of withstanding exposure to gamma rays in the range from
about 5 kGys to about 75 kGys, or more specifically, in the range
from about 25 kGys to about 50 kGys. In one or more embodiments,
the recycled resin composition is capable of withstanding exposure
to electron beams in the range from about 30 kGys to about 80 kGys,
or, more specifically, in the range from about 40 kGys to about 70
kGys.
[0052] The recycled resin composition according to one or more
embodiments has a melt flow rate in the range from about 3
dg/minute to about 80 dg/minute. In one or more specific
embodiments, the recycled resin composition has a melt flow rate in
the range from about 8 dg/minute to about 40 dg/minute. In even
more specific embodiments, the recycled resin composition has a
melt flow rate in the range from about 11 dg/minute to about 30
dg/minute. As used herein, the term "melt flow rate" refers to the
ease of flow of the melt of the recycled resin compositions
described herein.
[0053] The recycled resin compositions described herein may have a
flexural modulus in the range from about 70 kpsi to 350 kpsi and
all ranges and subranges therebetween as measured according to ASTM
D790 test method. In one or more specific embodiments, the recycled
resin compositions have a flexural modulus in the range from about
100 kpsi to about 300 kpsi. In even more specific embodiments, the
recycled resin compositions exhibits a flexural modulus in the
range from about 130 kpsi to about 270 kpsi.
[0054] The recycled resin composition may be characterized by
having notched izod impact strength in the range from about 0.1
ft-lb/in. to about 4.0 ft-lb/in and all ranges and subranges as
measured according to ASTM D256 test method. In one or more
embodiments, the recycled resin composition may have notched izod
impact strength in the range from about 0.2 ft-lb/in. to about 1.5
ft-lb/in. In one or more specific embodiments, the recycled resin
composition may have a notched izod impact strength in the range
from about 0.3 ft-lb/in. to about 1.0 ft-lb/in. As used herein, the
term "notched izod impact strength" refers to the ASTM standard
method of determining impact strength.
[0055] One or more embodiments of the recycled resin composition
described herein may be characterized by having a heat deflection
temperature in the range from about 60.degree. C. to about
260.degree. C. As used herein, the term "heat deflection
temperature" includes a measure of a polymer's resistance to
distortion under a given load at elevated temperature. The heat
deflection temperature is also known as the `deflection temperature
under load` (DTUL), deflection temperature, or `heat distortion
temperature` (HDT). The two common loads used to determine heat
deflection temperature are 0.46 MPa (66 psi) and 1.8 MPa (264 psi),
although tests performed at higher loads such as 5.0 MPa (725 psi)
or 8.0 MPa (1160 psi) are occasionally encountered. The common ASTM
test is ASTM D 648 while the analogous ISO test is ISO 75. The test
using a 1.8 MPa load is performed under ISO 75 Method A while the
test using a 0.46 MPa load is performed under ISO 75 Method B. In
one or more specific embodiments, the recycled resin composition
may have a heat deflection temperature in the range from about
68.degree. C. to about 140.degree. C. In even more specific
embodiments, the recycled resin composition may have a heat
deflection temperature in the range from about 70.degree. C. to
about 95.degree. C. In one or more embodiments which utilize a
post-industrial recycled resin component comprising polycarbonate,
the recycled resin composition has a heat deflection temperature of
about 140.degree. C. at a load of 0.46 MPa and 130.degree. C. at a
load of 1.8 MPa. In one or more embodiments which utilize a
post-industrial recycled resin component comprising nylon and a
reinforcing agent component including glass fibers, the recycled
resin composition has a heat deflection temperature of about
220.degree. C. at a load of 0.46 MPa and 200.degree. C. at a load
of 1.8 MPa. In embodiments which utilize a post-industrial recycled
resin component comprising PET and a reinforcing agent component
including glass fibers, the recycled resin composition has a heat
deflection temperature of about 250.degree. C. at a load of 0.46
MPa and 230.degree. C. at a load of 1.8 MPa.
[0056] Preparation of the Recycled Resin Compositions of this
Invention can be accomplished by any suitable blending or mixing
means known in the art. The blending step should, at least
minimally, disperse the components amongst each other. The
components may be blended together in a one-step process or a
multi-step process. In the one-step process, all the components are
blended together at the same time. In the multiple-step process,
two or more components are blended together to form a first mixture
and then one or more of the remaining components are blended with
the first mixture. If one or more components still remain, these
components may be blended in subsequent mixing steps. In one or
more embodiments, all the components are blended in a single
step.
[0057] In one or more alternative embodiments, the recycled
polypropylene composition may be prepared by dry blending the
individual components and subsequently melt mixing, either directly
in the extruder used to make the finished article, or premixing in
a separate extruder. Dry blends of the composition may also be
directly injection molded without pre-melt mixing.
[0058] The recycled resin compositions disclosed herein are
utilized to mold, extrude or otherwise form a medical device. In
one or more embodiments, the medical device is disposable. For
example, the medical devices may be formed from the recycled resin
compositions described herein may be used in injection, infusion,
blood collection, surgical applications and other applications
known in the art. Specific examples of medical devices that may be
formed form the recycled resin compositions described herein
include syringes (including syringe barrels, needle hub parts,
plunger rods, needle shields and the like), safety syringes,
catheters, blood collection devices, surgical blades or scalpels
and other such devices and components. In one or more alternative
embodiments, the medical device may be entirely or partially molded
from a recycled resin composition. For example, the inside surface
of a syringe barrel may be formed from a resin composition that is
not recycled while the outside surface of the syringe barrel or the
finger flanges of the syringe barrel are made from a recycled resin
composition. In one or more alternative embodiments, the scalpel
handle or needle shield are formed from a recycled resin
composition.
[0059] In one or more embodiments, the medical devices formed from
the recycled resin compositions described herein may be
characterized as non-fluid path contact components or medical
devices. As such, the medical devices and components do not
interact or come into contact with fluids and/or solids, for
example, medications, solutions of medications, drug containing
solutions, flush solutions, body fluids, human tissue, or any
material that is intended to be isolated to prevent contamination.
Examples of such devices include syringe plunger rods of a
three-piece syringe, needle shields, safety shields of injection
devices and the finger flanges of a syringe barrel, handle of
peripheral IV catheter, catheter wings, catheter flow control plug
etc. Medical devices and components formed from recycled resin
compositions may also be characterized as fluid path contact
medical devices. Such medical devices or medical device components
may include syringe barrels, needle hubs, surgical blade handles,
valve housings, syringe stopper, plunger rod of a two piece
syringe.
[0060] Non-limiting examples of medical devices are illustrated in
FIGS. 1 and 2. FIG. 1 illustrates a syringe assembly 100 including
a syringe barrel 110 with an inside surface defining a chamber, a
plunger rod 120 disposed within the chamber, a needle hub 130
including a needle cannula 140 for attachment to the syringe
barrel. FIG. 1 also illustrates an optional needle shield 150 to be
attached to the needle hub 130 to protect and cover the needle
cannula 140. The plunger rod 120 may include a separate stopper 125
attached to one end of the plunger rod 120 for forming a fluid
tight seal with the inside surface of the syringe barrel, as shown
in FIG. 1. In one or more alternative embodiments, the plunger rod
120 may include a sealing portion (not shown) that functions as a
stopper, and may be integrally molded with the plunger rod 120 and
thus formed form the same material as the plunger rod 120. The
syringe barrel 110 shown in FIG. 1 also includes a luer fitting 112
at one end of the syringe barrel 110 and a finger flange 114 at the
opposite end of the syringe barrel 110.
[0061] In one variant, the syringe barrel may be entirely formed
from the recycled resin compositions disclosed herein.
Alternatively, the luer fitting 112 and/or the finger flanges 114
may be formed from the recycled resin compositions disclosed
herein, while the syringe barrel 110 is formed from known resin
compositions that may include virgin resin components and/or
biobased resin components, and are free of any recycled resin. In
one or more alternative configurations, the inside surface of the
syringe barrel 110 may be coated with known a resin composition(s)
that may include virgin resin components and/or biobased resin
components, and are free of any recycled resin, while the remainder
of the syringe barrel 110 is formed form one or more of the
recycled resin compositions described herein.
[0062] In one variant, the plunger rod 120 may be formed from the
recycled resin compositions described herein. In embodiments which
incorporate a sealing edge (not shown) into the plunger rod 120,
the sealing edge (not shown) may also be formed from the recycled
resin compositions described herein. In one or more embodiments,
the stopper 125 may be formed from elastomeric or other known
materials, while the plunger rod is formed from the recycled resin
compositions and is attached to the stopper 125.
[0063] In one or more embodiments, the needle hub 130 may be formed
from the recycled resin compositions described herein, while the
needle cannula 140 is made from known materials in the art. In one
or more alternative configurations, the needle shield 150 may also
be formed from the recycled resin compositions disclosed
herein.
[0064] FIG. 2 illustrates a scalpel 200 that includes an elongate
handle 210 and blade holder 220 for attaching a blade (not shown)
to the elongate handle. The scalpel 200 also includes a blade
shield 230 that is removably attached to the elongate handle 210
and/or the blade holder 220 to protect the blade (not shown). In
one or more embodiments, the elongate handle 210, blade holder 220
and/or the blade shield 230 may be formed from the recycled resin
compositions described herein.
[0065] In one or more embodiments, medical devices formed from the
recycled resin compositions described herein do not change color
after being sterilized which may be measured in terms of yellowness
index. For example, the medical devices may be sterilized, as
described above, and undergo no change in color or appearance.
[0066] The medical devices may be formed using various methods
known in the art. For example, such methods include injection
molding, blow molding, extrusion and/or roto or rotational molding.
Other methods known in the art may also be utilized to form the
medical devices or components.
[0067] The medical devices formed from the recycled resin
composition described may include a plunger rod that exhibits
functional performance acceptable to users and/or clinicians.
[0068] In one or more embodiments, a plunger rod formed from the
recycled resin compositions described above exhibit the same
functional performance as plunger rods formed from non-recycled
resin compositions or compositions that do not include any recycled
content.
[0069] A third aspect of the present invention pertains to a method
for forming medical devices and components. In one or more
embodiments, the method includes providing a melt blend composition
of the recycled resin compositions described herein. The method
includes stabilizing the melt blend composition and solidifying the
composition in a pre-selected shape, which may include a plunger
rod, a syringe barrel, a catheter, a blood collection device, a
surgical bland handle, a needle shield and a needle hub. In one or
more embodiments, stabilizing the melt blend composition includes
stabilizing the melt blend composition to withstand exposure to
gamma rays, electron beams, X-ray radiation and ethylene oxide gas
without compromising functional performance and/or aesthetic appeal
of the finished product.
[0070] According to one embodiment, the step of providing a melt
blend composition comprises feeding a recycled resin component and
one or more of an antioxidant component, a slip additive component,
an anti-static component, an impact modifier component, a colorant
component, an acid scavenger component, a melt blend component, a
clarifier component, a X-ray fluorescence agent component, a radio
opaque filler component, a surface modifier component, a processing
aid component and a reinforcing agent component into a melt
compounding extruder. The step of solidifying the composition
comprises one of injection molding the composition, extruding the
composition and rotational molding the composition.
[0071] The recycled resin compositions, medical devices and
components made from such compositions and the methods of making
such medical devices and components provide a unique supply chain
system which reduces the impact on landfills.
[0072] The present invention will be further understood by
reference to the following non-limiting examples; however, the
scope of the claims is not to be limited thereby.
EXAMPLES
[0073] The Inventive Formulations 1-6 were prepared by mechanically
mixing recycled polypropylene resins with virgin polypropylene
resins, wherein the virgin polypropylene resins further comprised
of antioxidants, acid scavengers and melt-stabilizer.
[0074] Inventive Formulation 1 included 60% by weight of recycled
polypropylene component A and 40% by weight of a virgin
polypropylene component A. Virgin polypropylene component A
included up to 0.8% by weight of an anti-oxidant component and a
melt-stabilizer component and up to 0.3% by weight of an acid
scavenger component.
[0075] Inventive Formulation 2 included 70% by weight of a recycled
polypropylene component B and 30% by weight of virgin polypropylene
component A, as described above.
[0076] Inventive Formulation 3 included 50% by weight of a recycled
polypropylene component C and 50% by weight of a virgin
polypropylene component A. as described above
[0077] Inventive Formulation 4 included 60% by weight of recycled
polypropylene component A and 40% by weight of a virgin
polypropylene component B. Virgin polypropylene component B
included up to 0.3% by weight of an anti-oxidant component and up
to 0.2% by weight of an acid scavenger component.
[0078] Inventive Formulation 5 included 50% by weight of recycled
polypropylene component B and 50% of virgin polypropylene component
B, as described above.
[0079] Inventive Formulation 6 included 60% by weight of a recycled
polypropylene component D and 40% by weight of virgin polypropylene
component A, as described above.
[0080] The physical properties of each of Inventive Formulations
1-6 were analyzed. Specifically, the flexural modulus, tensile
strength @ yield, tensile strength @ break, tensile elongation @
yield, tensile elongation @ break, tensile modulus, Izod impact
strength and heat deflection temperature of Inventive Formulations
1-6 are evaluated and provided below in Table 1. For comparison,
typical ranges for the physical properties of virgin polypropylene
components are provided in Table 2.
[0081] The flexural modulus was measured according to ASTM D790-03.
The tests were carried out on five specimens of each of the
Inventive Formulations 1-6. The tests were carried out using a 0.05
in/min crosshead speed and a 2 inch support span length on an
instrument provided by Instru-Met Corp., of Rahway, N.J., U.S.A.
The specimens were formed using an injection molding process and
conditioned at 23.degree. C. and 50% relative humidity (RH) for 40
hours before the testing was performed. The average flexural
modulus measurement of each of the five samples for Inventive
Formulations is provided in Table 1.
[0082] The tensile properties of Inventive Formulations 1-6 were
evaluated according to ASTM D638-03. The tests were carried out on
five specimens of each of the Inventive Formulations 1-6. The tests
were carried out using a cross-head speed of 2.0 in/min on an
instrument provided by Instru-Met Corp., of Rahway, N.J., U.S.A.
The type I tensile bar specimens were formed using an injection
molding process and conditioned at 23.degree. C. and 50% RH for 40
hours before the testing was performed. The average tensile
strength @ yield, tensile strength @ break, tensile elongation @
yield, tensile elongation @ break and tensile modulus measurements
of each of the five samples for Inventive Formulations is provided
in Table 1.
[0083] The Izod impact strength of Inventive Formulations 1-6 were
evaluated according to ASTM D256-02. The tests were carried out on
ten specimens of each of the Inventive Formulations 1-6. The
average Izod impact strength measurements for Inventive
Formulations 1-6 are provided in Table 1.
[0084] The heat deflection temperature of Inventive Formulations
1-6 were evaluated according to ASTM D648-06 using an HDT/Vicat
instrument available from Tinius Olsen, Inc. of Horsham, Pa.,
U.S.A. under a load of 66 psi. The average heat deflection
temperature for Inventive Formulations 1-6 are provided in Table
1.
TABLE-US-00001 TABLE 1 Physical Properties of Inventive
Formulations 1-6. Inventive Formulation 1 2 3 4 5 6 Flexural
Modulus (psi) Average 174345 148373 207247 187735 159857 157830
Standard 2153 1288 4749 4200 2629 1385 Deviation Tensile Strength @
Yield (psi) Average 4694 4372 4959 4919 4737 4408 Standard 77 74
100 42 41 56 Deviation Tensile Strength @ Break (psi) Average 2228
2665 4044 4058 2740 2798 Standard 304 81 779 162 81 84 Deviation
Tensile Elongation @ Yield (%) Average 9.67 11.1 8.37 7.87 9.27
8.41 Standard 0.750 0.558 0.255 0.515 0.436 0.939 Deviation Tensile
Elongation @ Break (psi) Average 116 254 24.8 23.2 165 241 Standard
141 121 15.3 3.50 40.5 62.3 Deviation Tensile Modulus (psi) Average
238539 205376 264521 251694 234553 234458 Standard 7031 11233 6799
9940 11561 2841 Deviation Izod Impact Strength (ft-lbs/in) Average
0.46 0.51 0.53 0.53 0.44 0.51 Heat Deflection Temperature (.degree.
C.) Average 84.6 77.8 109.3 92.2 96.1 104.9
TABLE-US-00002 TABLE 2 Typical Physical properties of Virgin
polyolefin resins. Physical Properties Flexural Modulus 145037.7
psi (1000 MPa)-290075.4 psi (2000 MPa) Tensile strength 3625.9 psi
(25 MPa)-6526.7 psi (45 MPa) @yield Tensile elongation 6%-15%
@yield Tensile Modulus 145037.7 psi (1000 MPa)-61067.9 psi (1800
MPa) Notched Izod 0.3 ft-lb/in-1.0 ft-lb/in Impact Strength Heat
Deflection 70.degree. C.-110.degree. C. Temperature
[0085] The physical properties of the Inventive Formulations 1-6
are comparable to the physical properties of virgin polyolefin
resins, shown in Table 2. Accordingly, the recycled resin
compositions described herein achieve the goals of utilizing
recycled resins that are biocompatible and useful for medical
device applications, without compromising the physical properties
of the resulting devices.
[0086] Inventive Formulations 1-6 were also analyzed for
biocompatibility. Specifically, each of Inventive Formulations 1-6
was analyzed in accordance with ANSI/AAMI/ISO 10-993-5 and the
United States Pharmacopeia Biological Tests and Assays, Biological
Reactivity Tests, in Vitro <87>. The United States
Pharmacopeia Biological Reactivity Tests, in Vitro <87> are
designed to determine the biological reactivity of mammalian cell
cultures following contact with elastomeric plastics and other
polymeric materials with direct or indirect patient contact or of
specific extracts prepared from the materials under test. The
elution test described in United States Pharmacopeia Biological
Reactivity Tests, in Vitro <87> was carried out on Inventive
Formulations 1-6.
[0087] Each of Inventive Formulations 1-6 passed or met the
standard for the cytotoxicity tests with a United States
Pharmacopeia score of zero, thereby meeting the criteria for
preclinical toxicological safety evaluation established by United
States Pharmacopeia and ISO 10-993-5. All of the biocompatibility
tests were conducted in accordance with Good Laboratory Practice or
GLP principles following procedures known in the art.
[0088] Reference throughout this specification to "one embodiment,"
"certain embodiments," "one or more embodiments" or "an embodiment"
means that a particular feature, structure, material, or
characteristic described in connection with the embodiment is
included in at least one embodiment of the invention. Thus, the
appearances of the phrases such as "in one or more embodiments,"
"in certain embodiments," "in one embodiment" or "in an embodiment"
in various places throughout this specification are not necessarily
referring to the same embodiment of the invention. Furthermore, the
particular features, structures, materials, or characteristics may
be combined in any suitable manner in one or more embodiments.
[0089] Although the invention herein has been described with
reference to particular embodiments, it is to be understood that
these embodiments are merely illustrative of the principles and
applications of the present invention. It will be apparent to those
skilled in the art that various modifications and variations can be
made to the method and apparatus of the present invention without
departing from the spirit and scope of the invention. Thus, it is
intended that the present invention include modifications and
variations that are within the scope of the appended claims and
their equivalents.
* * * * *