Method and apparatus for introducing a non-sterile component into a sterile device

Abstract

The invention is an apparatus and method for packaging a sterile device so that a non-sterile component of the device may be inserted into the device ( 10 ).

1 . An apparatus for aseptically assembling a sterile component and a non-sterile component comprising a sterile sleeve having a non-sterile aperture, and packaging material enclosing said sterile sleeve and having a non-sterile port communicating with said non-sterile aperture.  
     
     
         2 . The apparatus of  claim 1  wherein said sterile sleeve includes a non-sterile inside portion, said inside portion communicating with said non-sterile aperture.  
     
     
         3 . The apparatus of  claim 1  wherein said sterile sleeve further comprises a cover for closing said non-sterile aperture.  
     
     
         4 . The apparatus of  claim 1  wherein the sterile component and the non-sterile component comprise a medical device.  
     
     
         5 . The apparatus of  claim 4  wherein the medical device is a drill.  
     
     
         6 . The apparatus of  claim 5  wherein the drill comprises a sterile sleeve and a non-sterile motor adapted to communicate with an inside portion of said sterile sleeve.  
     
     
         7 . The apparatus of  claim 5  wherein the drill comprises a sterile sleeve and a non-sterile battery assembly adapted to communicate with an inside portion of said sterile sleeve.  
     
     
         8 . The apparatus of  claim 4  wherein the medical device is an endoscope.  
     
     
         9 . The apparatus of  claim 1  wherein the sterile component is disposable.  
     
     
         10 . The apparatus of  claim 1  wherein the non-sterile component is non-disposable.  
     
     
         11 . The apparatus of  claim 1  wherein the packaging material is openable.  
     
     
         12 . A method for packaging a device having a sterile component and a non-sterile component comprising providing a device having a sterile sleeve and a non-sterile aperture communicating with an inside portion of said sleeve; providing packaging material enclosing an outside portion of said sleeve, said packaging material having a port communicating with the inside portion of said sleeve; placing a non-sterile component of said device into the inside portion of said sleeve; closing said aperture; and opening said packaging.  
     
     
         13 . The method of  claim 12  wherein placing a non-sterile component of said device into the inside portion of said sleeve comprises maintaining an outside portion of said sleeve in a sterile condition.  
     
     
         14 . The method of  claim 12  wherein placing a non-sterile component of said device into the inside portion of said sleeve is conducted under non-sterile conditions.  
     
     
         15 . A method of assembling a device having a non-sterile component and a sterile component comprising providing a device having a sleeve, said sleeve comprising a sterile outer portion and a non-sterile inside portion; providing an enclosure adapted to communicate with said device and adapted to maintain the sterility of the outside portion of said sleeve, said enclosure having a port for communicating with an inside portion of said sleeve; and positioning said non-sterile component in said sleeve by passing said non-sterile component through said port.  
     
     
         16 . An aseptic packaging system comprising an openable package adapted to position an aseptic device in the package, said aseptic device comprising a sterile outer portion and a non-sterile inner portion; said package comprising a port adapted to communicate with the non-sterile inner portion of said device.