Composite for packaging a medical device and method of forming the same

Abstract

A composite for packaging a medical device has a first layer including an aromatic polyether polyurethane and a second layer. The first layer forms a base that has a plurality of walls extending therefrom to define a cavity for receiving the medical device. The second layer is disposed on the first layer opposite the cavity. The composite is formed from a method that includes the step of disposing the first layer on the second layer. The composite may also be included with a container to form a packaging system.

1 - 20 . (canceled) 
     
     
         21 . A packaging system for packaging a medical device, said packaging system comprising:
 a container receiving the medical device; and   a packaging disposed in said container and contacting the medical device, with said packaging comprising;
 a first layer comprising an aromatic polyether polyurethane, and 
 a second layer disposed on said first layer with said second layer comprising a material selected from silicones, halogenated plastics, polystyrenes, polyvinylchlorides, polyethylene terephthalate glycols, polychlorotrifluoroethylenes, low-density polyethylenes, high-density polyethylenes, polyethylene foams, polysulfones, fluorinated ethylene polypropylenes, ethylene-tetrafluoroethylenes, ethylene-chlorotrifluoroethylene copolymers, perfluoroalkyl plastics, cyclic olefin copolymers, and combinations thereof. 
   
     
     
         22 . Packaging for a medical device, wherein said packaging comprises:
 a first layer forming a base having a plurality of walls extending therefrom to define a cavity for receiving the medical device; and   a second layer disposed on said first layer opposite said cavity, wherein said second layer is an outermost layer of said packaging and comprises a material selected from silicones, halogenated plastics, polystyrenes, polyvinylchlorides, polyethylene terephthalate glycols, polychlorotrifluoroethylenes, low-density polyethylenes, high-density polyethylenes, polyethylene foams, polysulfones, fluorinated ethylene polypropylenes, ethylene-tetrafluoroethylenes, ethylene-chlorotrifluoroethylene copolymers, perfluoroalkyl plastics, cyclic olefin copolymers, and combinations thereof;   wherein said first layer comprises an aromatic polyether polyurethane and is an innermost layer of said packaging.   
     
     
         23 . Packaging as set forth in  claim 22  wherein the second layer is a high-density polyethylene, and wherein the high-density polyethylene is a cross-linked high-density polyethylene. 
     
     
         24 . Packaging as set forth in  claim 22  wherein said aromatic polyether polyurethane has a specific gravity of from 0.84 to 1.40 measured according to ASTM D-792. 
     
     
         25 . Packaging as set forth in  claim 22  wherein said aromatic polyether polyurethane has a shore A hardness of from 66.25 measured according to ASTM D-2240 to a shore D hardness of 70.00. 
     
     
         26 . Packaging as set forth in  claim 22  wherein said aromatic polyether polyurethane has:
 an ultimate tensile strength of from 7,500 to 12,500 psi; 
 an ultimate elongation of from 431.25% to 718.75%; 
 a 100% modulus of from 862.5 to 1437.5 psi; and 
 a 300% modulus of from 2025 to 3375 psi, each measured according to ASTM D-882. 
 
     
     
         27 . Packaging as set forth in  claim 22  wherein said aromatic polyether polyurethane has a tear resistance of from 375 to 625 pli measured according to ASTM D-1004. 
     
     
         28 . Packaging as set forth in  claim 22  wherein said aromatic polyether polyurethane has a minimum softening point of from 112.5 to 187.5° C. and a maximum softening point of from 127.5 to 212.5° C. measured according to ASTM E2347-04. 
     
     
         29 . Packaging as set forth in  claim 22  further defined as a blister that has a shape complementary to a shape of the medical device. 
     
     
         30 . Packaging as set forth in  claim 22  wherein the medical device is further defined as a medical implant. 
     
     
         31 . Packaging as set forth in  claim 22  wherein said second layer has a thickness of from 0.5 to 250 mils. 
     
     
         32 . A method of forming a packaging for a medical device, the packaging comprising a first layer including an aromatic polyether polyurethane and forming a base having a plurality of walls extending therefrom to define a cavity for receiving the medical device, and a second layer disposed on the first layer opposite the cavity with the second layer comprising a material selected from silicones, halogenated plastics, polystyrenes, polyvinylchlorides, polyethylene terephthalate glycols, polychlorotrifluoroethylenes, low-density polyethylenes, high-density polyethylenes, polyethylene foams, polysulfones, fluorinated ethylene polypropylenes, ethylene-tetrafluoroethylenes, ethylene-chlorotrifluoroethylene copolymers, perfluoroalkyl plastics, cyclic olefin copolymers, and combinations thereof, wherein the first layer is an innermost layer of the packaging and is disposed to contact the medical device and the second layer is an outermost layer of the packaging, and wherein said method comprises the step of disposing the second layer on the first layer. 
     
     
         33 . The method as set forth in  claim 32  wherein the step of disposing is further defined as thermoforming. 
     
     
         34 . A packaging system for packaging a medical device, said packaging system comprising:
 packaging comprising:
 a first layer forming a base having a plurality of walls extending therefrom to define a cavity for receiving the medical device; and 
 a second layer disposed on said first layer opposite said cavity, wherein said second layer is an outermost layer of said packaging and comprises a material selected from silicones, halogenated plastics, polystyrenes, polyvinylchlorides, polyethylene terephthalate glycols, polychlorotrifluoroethylenes, low-density polyethylenes, high-density polyethylenes, polyethylene foams, polysulfones, fluorinated ethylene polypropylenes, ethylene-tetrafluoroethylenes, ethylene-chlorotrifluoroethylene copolymers, perfluoroalkyl plastics, cyclic olefin copolymers, and combinations thereof; 
 wherein said first layer comprises an aromatic polyether polyurethane and is an innermost layer of said packaging; and 
   a container;   wherein said packaging is disposed in said container forming a double sterile barrier about the medical device.   
     
     
         35 . The packaging system as set forth in  claim 34  wherein said container comprises a pouch. 
     
     
         36 . The packaging system as set forth in  claim 34  wherein said aromatic polyether polyurethane has a specific gravity of from 0.84 to 1.40 measured according to ASTM D-792. 
     
     
         37 . The packaging system as set forth in  claim 34  wherein said aromatic polyether polyurethane has:
 an ultimate tensile strength of from 7,500 to 12,500 psi; 
 an ultimate elongation of from 431.25% to 718.75%; 
 a 100% modulus of from 862.5 to 1437.5 psi; and 
 a 300% modulus of from 2025 to 3375 psi, each measured according to ASTM D-882. 
 
     
     
         38 . The packaging system as set forth in  claim 34  wherein said aromatic polyether polyurethane has a tear resistance of from 375 to 625 pli measured according to ASTM D-1004. 
     
     
         39 . The packaging system as set forth in  claim 34  wherein said aromatic polyether polyurethane has a minimum softening point of from 112.5 to 187.5° C. and a maximum softening point of from 127.5 to 212.5° C. measured according to ASTM E2347-04. 
     
     
         40 . The packaging system as set forth in  claim 34  wherein said plurality of walls includes one or more projections for engaging the medical device. 
     
     
         41 . The packaging system as set forth in  claim 34  wherein said plurality of walls include a periphery and at least one flange extending from said plurality of walls and disposed about said periphery.