US2015230926A1PendingUtilityA1

Method and device for reducing implant contamination from handling

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Assignee: BIOMET MFG LLCPriority: Feb 18, 2014Filed: Feb 18, 2014Published: Aug 20, 2015
Est. expiryFeb 18, 2034(~7.6 yrs left)· nominal 20-yr term from priority
A61F 2/0095A61F 2/34A61F 2/36A61F 2/30A61F 2/38A61F 2002/30718
49
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Claims

Abstract

An orthopedic implant has a removable handling cover coupled thereto which includes a thin-walled layer extending over a grasping portion of the outer surface. An outer container can sealingly house the orthopedic implant within a sterile environment and support the orthopedic implant in an orientation that presents the handling cover for grasping. A surgeon can manually grasp, handle and manipulate the implant into an implantation position, and remove the handling cover from the implant during implant surgery, and without the need to directly contact any surface of the orthopedic implant itself. Related methods of providing such an implant assembly and of reducing infection from contamination during implantation surgery are also disclosed.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . An orthopedic implant assembly providing reduced contamination from handling, comprising:
 an orthopedic implant having an outer surface including a grasping portion and a bone-facing portion;   a removable handling cover providing a thin-walled layer extending over the grasping portion of the outer surface;   an outer container sealingly housing the orthopedic implant within a sterile environment and supporting the orthopedic implant in an orientation that presents the handling cover for grasping upon opening the outer container;   wherein the removable handling cover provides a removable grasping portion for manually grasping, handling and manipulating the implant into an implantation position with the bone-facing surface facing an adjacent bone during implant surgery without the need to directly contact any of the outer surface of the orthopedic implant, and which removable handling cover is removable during surgery after the implant is moved into the implantation position.   
     
     
         2 . The orthopedic implant assembly of  claim 1 , wherein the removable handling cover covers a side of the orthopedic implant and a peripheral portion only of a surface adjacent the side of the orthopedic implant. 
     
     
         3 . The orthopedic implant assembly of  claim 1 , wherein the removable handling cover comprises a compliant film conforming over the grasping portion of the outer surface of the orthopedic implant. 
     
     
         4 . The orthopedic implant assembly of  claim 3 , wherein the compliant film comprises an adhesive film adhered to the grasping portion of the outer surface of the orthopedic implant. 
     
     
         5 . The orthopedic implant assembly of  claim 3 , wherein the compliant film comprises an naturally adherent film adhered to the grasping portion of the outer surface of the orthopedic implant. 
     
     
         6 . The orthopedic implant assembly of  claim 3 , wherein the compliant film comprises a material coated on the grasping portion of the outer surface of the orthopedic implant. 
     
     
         7 . The orthopedic implant assembly of  claim 3 , wherein the compliant film comprises a shrink wrap film. 
     
     
         8 . The orthopedic implant assembly of  claim 3 , wherein the compliant film comprises an elastic member at an opening, wherein the elastic member forms the compliant film around and captures the orthopedic implant. 
     
     
         9 . The orthopedic implant assembly of  claim 3 , wherein the compliant film comprises a grasping tab to facilitate removal of the compliant film from the orthopedic implant. 
     
     
         10 . The orthopedic implant assembly of  claim 3 , wherein the compliant film comprises a separation line to facilitate removal of the compliant film from the orthopedic implant. 
     
     
         11 . The orthopedic implant assembly of  claim 3 , wherein the compliant film comprises a bright color, a printed pattern, or both, causing the thin film cover to visibly stand out against the implant. 
     
     
         12 . The orthopedic implant assembly of  claim 1 , wherein the removable handling cover comprises a molded member forming the thin walled layer and coupled to the orthopedic implant over the grasping portion of the outer surface. 
     
     
         13 . The orthopedic implant assembly of  claim 12 , wherein the handling cover engages an edge of the orthopedic implant to cause the removable handling member to be resiliently coupled to the orthopedic implant. 
     
     
         14 . The orthopedic implant assembly of  claim 12 , wherein the handling cover comprises a molded protrusion that cooperates with the edge of the orthopedic implant to cause the removable handling member to be resiliently coupled to the orthopedic implant. 
     
     
         15 . The orthopedic implant assembly of  claim 12 , wherein the handling cover and orthopedic implant each comprise components of a snap-fit coupling to couple the handling cover into position over the grasping portion of the outer surface of the orthopedic implant. 
     
     
         16 . The orthopedic implant assembly of  claim 12 , wherein the handling cover comprises a curved spring-like configuration to resiliently couple the handling cover to the orthopedic implant. 
     
     
         17 . The orthopedic implant assembly of  claim 12 , wherein the molded member comprises a handle portion extending from the thin-walled layer. 
     
     
         18 . A method of providing an orthopedic implant with reduced contamination from handling comprising:
 covering a grasping portion of the orthopedic implant with a handling cover comprising a thin-walled, protective layer that is removable from the implant during implantation surgery;   supporting the orthopedic implant in an orientation within a container that presents the removable, thin-walled, protective layer to a user upon opening the container;   sealing the orthopedic implant in a sterile condition within a sterile environment of a container.   
     
     
         19 . The method of  claim 18 , further comprising, forming the thin-walled protective cover of a compliant film selected from at least one of adhesive film adhered to the grasping portion of the outer surface of the orthopedic implant, an naturally adherent film adhered to the grasping portion of the outer surface of the orthopedic implant, a material coated on the grasping portion of the outer surface of the orthopedic implant, a shrink wrap film, and an elastic member at an opening which forms the compliant film around and captures the orthopedic implant. 
     
     
         20 . The method of  claim 18 , further comprising, providing the thin-walled protective layer with at least one of:
 a grasping tab to facilitate removal of the compliant film from the orthopedic implant;   a separation line to facilitate removal of the compliant film from the orthopedic implant; and   a bright color, a printed pattern, or both, causing the thin film cover to visibly stand out against the implant   
     
     
         21 . The method of  claim 18 , further comprising, providing the thin-walled protective cover as a molded member snap-fit into position over the grasping portion of the outer surface;
 further comprising, engaging the molded member with an edge of the orthopedic implant to cause the handling cover to be snap-fit into position over the grasping portion of the outer surface; and   further comprising, providing a protrusion extending from the handling cover and forming the edge as part of an indent provided on the orthopedic implant.   
     
     
         22 . A method of reducing infection from contamination of an orthopedic implant during surgery comprising:
 opening a sterile container housing the orthopedic implant to present a removable thin-walled layer selectively covering a handling portion of the implant for easy grasping;   handling and manipulating the implant into an implantation position by manually grasping the presented removable thin-walled layer;   removing the removable thin-walled layer prior to closure during the implantation procedure.   
     
     
         23 . The method of  claim 22 , wherein removing the removable thin-walled layer comprises at least one of:
 peeling the thin walled layer from a surface of the implant;   disengaging an engagement portion of the thin-walled layer from an edge of the implant;   disengaging a snap-fit arrangement coupling the thin-walled member to the implant;   grasping and pulling a tab of the thin-walled layer; and   separating the thin-walled layer along a separation line of the thin-walled layer.   
     
     
         24 . The method of  claim 22 , further comprising applying adhesive to orthopedic implant prior to removing the thin-walled layer.

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