Apparatus and Method for Sterilization and Organization of a Tamper Resistant Lock and Receptacle

Abstract

A multicompartment envelope or sterilization receptacle for receiving and storing medical instruments includes an adhesive flap for sealing multiple compartments within a single envelope. Individual compartments within the multicompartment enveloped can be opened while still keeping the seal of other compartments, thus keeping unused instruments sterilized. The multicompartment envelope or sterilization receptacle has an aperture for insertion of a heat-deforming color changing sterilization indicator device, where, after exposure to extreme heat, the sterilization indicator device deforms and cannot thereafter be inserted or removed from an aperture of a sterilization receptacle fitted for an unsterilized sterilization indicator device. Thus, the practitioner is assured of sterilized instruments in a sterilization receptacle, when an intact, color changed sterilization indicator device is within the aperture of the sterilization receptacle. Several multicompartment envelopes can further be organized within a binder by procedure or instrument type.

I claim: 
     
         1 . A sterilization indicator device made from a heat-deformable thermoplastic material capable of partial insertion through an aperture of a sterilization container in a closed position, comprising:
 a) a sterilization pin having,
 i) a proximal end having a tapered region for insertion through said aperture, said proximal end made from a heat-deformable thermoplastic; 
 ii) a distal end having an enlarged region of cross-sectional area greater than the diameter of said aperture, thereby preventing said enlarged region from passing through said aperture; 
 iii) a shaft forming a middle portion of said sterilization pin, connecting said proximal end and said distal end, wherein said shaft has a cross-sectional area less than the diameter of said aperture to allow said shaft to pass through said aperture; 
   b) a heat sensitive color changing composition, whereby said sterilization indicator device changes color after exposure to heat in an autoclave;
 wherein said proximal end deforms when heated, creating a deformed proximal end, said deformed proximal end having a cross-sectional region greater than the diameter of said aperture, thereby preventing said sterilization pin from being withdrawn from said aperture intact; and, 
 whereby an intact deformed sterilization indicator device having undergone a color change verifies that sterilization occurred, and that contents within said sterilization container have not been opened. 
   
     
     
         2 . The sterilization indicator device of  claim 1 , wherein said thermoplastic material is made of a polyvinyl chloride or polystyrene material. 
     
     
         3 . The sterilization indicator device of  claim 1 , wherein said shaft comprises a first region and a second region, said second region having a reduced thickness compared to said first region,
 whereby said area of reduced cross sectional area creates a weakened breakpoint to easily fracture said shaft at a predetermined position.   
     
     
         4 . The sterilization indicator device of  claim 1 , wherein said second region is a tapered region. 
     
     
         5 . The sterilization indicator device of  claim 1 , wherein said distal end comprises a handle for turning said sterilization indicator device. 
     
     
         6 . The sterilization indicator device of  claim 1 , further comprising:
 a pin locker having an aperture for insertion of said sterilization pin within said pin locker.   
     
     
         7 . The sterilization indicator device of  claim 6 , wherein said pin locker is a slidable pin locker capable coupling structures for sealing an open compartment when said pin locker is slid in a first direction. 
     
     
         8 . The sterilization indicator device of  claim 6 , further comprising a fracturing device for fracturing said sterilization indicator pin. 
     
     
         9 . The sterilization indicator device of  claim 8 , wherein said fracturing device is a blade. 
     
     
         10 . The sterilization indicator device of  claim 11 , wherein said sterilization pin locks into said pin locker when rotated within said pin locker. 
     
     
         11 . The sterilization indicator device of  claim 1 ,
 wherein said sterilization pin further comprises a ratcheting tooth or notch extending along a surface of said distal end of said sterilization pin; and,   said pin locker further comprises a region for engaging said ratcheting tooth or notch, whereby said sterilization pin is irretrievably locked within said pin locker when said sterilization pin is inserted within said pin locker and unintentional rotation of said sterilization pin is prevented from accidental rotation by engagement of said ratcheting tooth or notch with said region for engaging said ratcheting tooth or notch.   
     
     
         12 . A method of sterilizing instruments, comprising:
 a) placing unsterilized instruments into a sterilization receptacle;   b) sealing said sterilization receptacle;   c) inserting a sterilization indicator device through an aperture of said sterilization receptacle in a closed position; and,   d) exposing said sterilization receptacle to sterilizing heat conditions.   
     
     
         13 . The method of  claim 12 , wherein said sterilization indicator device comprises,
 a proximal end having a tapered region for insertion through said aperture, said proximal end made from a heat-deformable thermoplastic;   a distal end having an enlarged region of cross-sectional area greater than the diameter of said aperture;   a shaft forming a middle portion of said sterilization pin, connecting said proximal end and said distal end, wherein said shaft has a cross-sectional area less than the diameter of said aperture to allow said shaft to pass through said aperture;   wherein said proximal end deforms when heated, thereby creating a deformed proximal end, said deformed proximal end having a region of greater cross-sectional area greater than the diameter of said aperture, and thereby preventing said sterilization indicator device from being withdrawn from said aperture without fracturing said sterilization indicator device.