Prismatic source-indicating medical device packaging

Abstract

The present invention relates to a family of medical device packages designed and fabricated to provide instantaneous recognition as to the source and origin of a sterilized medical device stored therein and for passively retaining said medical device and related items in a desired manually accessible location within the package. The invention provides apparatus and methods for safely transporting, storing, identifying source and origin of, opening, packing and unpacking, evenly balanced packages containing sterilized implantable medical devices (IMDs). The packages and methods of the invention also are designed with features and structures that efficiently enhance the mechanical stability of one or more of the packages when stored in inventory at a clinic, in transport, and on an initial packaging site, and promote ease of handling and complement implant procedure efficiency in the operating room.

1 . A source-identifying package for transporting a sterilized medical device, comprising: 
 a first major cover having an exterior and an interior, wherein the interior has three walls and an open side wall location;    a minor cover member coupled to the first major cover with a first hinge at the open side wall location of the first major cover;    a second major cover having an exterior and an interior, wherein the interior has four wall members and the second major cover having a hinged coupling to the minor cover and wherein said four wall members are configured to slide inside the three walls of the first major cover;    a source-identifying color or indicia disposed on at least one of the first major cover, the second major cover and the minor cover member; and    at least a pair of cooperating interlocking structures disposed on one of the three walls and one of the four walls in opposing locations so that when the package is closed together the structures releasably retain the respective walls together.    
   
   
       2 . A package according to  claim 1 , further comprising: 
 an aperture formed in at least one of: the minor cover member, the first major cover, the second major cover.    
   
   
       3 . A package according to  claim 1 , further comprising: 
 a pair of rib members disposed on opposing ends of the minor cover member and configured to provide a biasing force to a corresponding one of the four side wall members.    
   
   
       4 . A package according to  claim 1 , wherein at least three of the four wall members are fabricating with between about one half of a degree and three degrees of draft.  
   
   
       5 . A package according to  claim 4 , further comprising: 
 at least two crowned regions located where at least two of the four wall members abut.    
   
   
       6 . A package according to  claim 1 , further comprising: 
 a manual access cut-out feature in one of the three side walls.    
   
   
       7 . A package according to  claim 6 , wherein the cut-out is disposed on the wide wall opposing the open side wall location.  
   
   
       8 . A package according to  claim 7 , wherein the cut-out is configured with one of a geometric configuration and an irregular configuration.  
   
   
       9 . A package according to  claim 1 , wherein the sterilized medical device comprises an implantable pulse generator (IPG).  
   
   
       10 . A package according to  claim 1 , wherein the sterilized medical device comprises an implantable cardioverter-defibrillator (ICD)  
   
   
       11 . A package according to  claim 10 , wherein the sterilized medical device further comprises at least one medical electrical lead for the ICD.  
   
   
       12 . A package according to  claim 1 , wherein the sterilized medical device comprises an implantable drug pump.  
   
   
       13 . A package according to  claim 1 , wherein the sterilized medical device comprises an implantable neurological stimulator.  
   
   
       14 . A package according to  claim 1 , wherein the sterilized medical device comprises an implantable stent.  
   
   
       15 . A package according to  claim 1 , wherein the sterilized medical device comprises an implantable orthopedic structure.  
   
   
       16 . A package according to  claim 1 , further comprising: 
 a mechanical impact sensor.    
   
   
       17 . A package according to  claim 1 , wherein the mechanical impact sensor comprises one of a single-axis accelerometer and a multiple-axis accelerometer and including wireless telemetry for conveying signals to a remote unit and wherein said remote unit includes data logging and impact memory storage.  
   
   
       18 . A package according to  claim 1 , wherein the sterilized medical device further includes a product information label having symbols that can be read with a machine vision device.  
   
   
       19 . A package according to  claim 1 , wherein the sterilized medical device comprises one of a wireless radio frequency (RF) identification circuitry and an optical scanner identification label.  
   
   
       20 . A source-identifying package for transporting a sterilized medical device, comprising: 
 a generally prismatic container devoid of protruding external surface features when in a closed configuration, said container including a major first cover and a major second cover each radially hinged to a minor cover disposed between the major first and second covers, and wherein the exterior of the container includes at least one indicia from the group: a trademark, a logo, a slogan, a trade dress feature, a service mark, a name of a commercial entity, a trade name, an icon;    wherein at least one of the first major cover, the second major cover, and the minor cover are predominantly colored consistent with a characteristic tradedress color of the owner of said at least one indicia; and    wherein when the container is disposed in an open configuration the major first and the major second cover and the intermediate cover assume a substantially coplanar relationship.