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.

What is claimed is: 
     
         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° C. to 260° 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.