Integral indicators for single-procedure devices

Abstract

Disclosed herein are single-use integral indicators and methods and systems for employing the same. Such indicators and their uses are directed toward identifying and rendering inoperable single-procedure medical devices after their intended—and only—use.

What is claimed is: 
     
         1 . An integral indicator for a single-procedure device, comprising a surgical device comprised of:
 (a) at least one integral indicator, wherein the integral indicator is composed of a polymeric material configured to irreversibly transition from a surgically operative conformation to a surgically inoperative conformation in response to an exposure after the single-procedure; and   (b) one or more non-indicator domains that: (i) are not composed of the polymeric material, or (ii) remain in the surgically operative conformation in response to the exposure, or the combination of both (i) and (ii).   
     
     
         2 . The integral indicator of  claim 1 , wherein the polymeric material possesses chemical and mechanical properties selected from the group consisting of a melting temperature ranging from about 50-121° C., a melt flow rate ranging from about 5-1000 g/10 minute, a tensile strength ranging from about 10-200 MPa, a tensile modulus ranging from about 2-500 GPa, and a strain-at-break ranging from about 2-500%, and combinations thereof. 
     
     
         3 . The integral indicator of  claim 1 , wherein the polymeric material is selected from the group consisting of polyolefins, polyethylene, polyolefin copolymers, poly(ethylene-co-acetate), poly(ethylene-co-acrylate), polyesters, polycaprolactone and aliphatic homopolymers thereof, polyethers, polyethyleneoxide, fluoropolymers, polypropyleneoxide, olyisoprene, polyamide, polystyrene, polysulphone, polyoxymethylene, polycarbonate, polyvinyl chloride, and acrylnonitrile butadiene styrene, and filled embodiments thereof, and combinations thereof. 
     
     
         4 . The integral indicator of  claim 1 , wherein the exposure comprises subjecting the surgical device comprised of the integral indicator to: (i) one or more steam sterilization cycles, or (ii) an average temperature sufficient to precipitate the irreversible transition, or both. 
     
     
         5 . The integral indicator of  claim 1 , wherein the exposure comprises: (i) subjecting at least 20% of the total surface area of the integral indicator to one or more steam sterilization cycles, or (ii) subjecting the total volume of the integral indicator to an average temperature sufficient to precipitate the irreversible transition, or both. 
     
     
         6 . The integral indicator of  claim 1 , wherein the surgical device comprises a proximal portion and a distal portion, and wherein the integral indicator constitutes at least a section of the proximal portion or the distal portion, or both. 
     
     
         7 . The integral indicator of  claim 1 , wherein the one or more non-indicator domains are composed of one or more materials selected from the group consisting of metals, metal alloys, shape memory alloys, titanium, nickel, copper, plastics, polymers, ceramic materials, composite materials, and stainless steel, and combinations thereof. 
     
     
         8 . The integral indicator of  claim 1 , wherein the surgical device is selected from the group consisting of reamers, awls, rod benders, drill guides, guide tubes, distance gages, inserters, implant holders, clamps, portals, screwdrivers, spacers, distracters, plate benders, broaches, fusion plates, fusion screws, spinal rods, spinal connectors, artificial discs, tissue-anchoring devices, fixation devices, dilators, joint spreaders, rasps, fusion cages, shavers, blades, burs, Kerrisons and Rongeurs, and combinations thereof. 
     
     
         9 . A single-procedure indicator system, comprising:
 (a) a medical device; and   (b) an integral indicator composed of a polymeric material configured to irreversibly transition from an operative conformation to an inoperative conformation in response to an exposure after the single-procedure,   (c) wherein the integral indicator is a contiguous component of the medical device.   
     
     
         10 . The system of  claim 9 , wherein the medical device further comprises one or more non-indicator domains that: (i) are not composed of the polymeric material, or (ii) remain in the operative conformation in response to the exposure, or the combination of both (i) and (ii). 
     
     
         11 . The system of  claim 9 , wherein the polymeric material possesses chemical and mechanical properties selected from the group consisting of a melting temperature ranging from about 50-121° C., a melt flow rate ranging from about 5-1000 g/10 minute, a tensile strength ranging from about 10-200 MPa, a tensile modulus ranging from about 2-500 GPa, and a strain-at-break ranging from about 2-500%, and combinations thereof. 
     
     
         12 . The system of  claim 9 , wherein the polymeric material is selected from the group consisting of polyolefins, polyethylene, polyolefin copolymers, poly(ethylene-co-acetate), polyethylene-co-acrylate), polyesters, polycaprolactone and aliphatic homopolymers thereof, polyethers, polyethyleneoxide, fluoropolymers, polypropyleneoxide, olyisoprene, polyamide, polystyrene, polysulphone, polyoxymethylene, polycarbonate, polyvinyl chloride, and acrylnonitrile butadiene styrene, and filled embodiments thereof, and combinations thereof. 
     
     
         13 . The system of  claim 9 , wherein the exposure comprises subjecting the medical device including the integral indicator to: (i) one or more steam sterilization cycles, or (ii) an average temperature sufficient to precipitate the irreversible transition, or both. 
     
     
         14 . The system of  claim 9 , wherein the medical device comprises a proximal portion and a distal portion, and wherein the integral indicator constitutes at least a section of the proximal portion or the distal portion, or both. 
     
     
         15 . The system of  claim 10 , wherein the one or more non-indicator domains are composed of one or more materials selected from the group consisting of metals, metal alloys, shape memory alloys, titanium, nickel, copper, plastics, polymers, ceramic materials, composite materials, and stainless steel, and combinations thereof. 
     
     
         16 . The system of  claim 9 , wherein the medical device is selected from the group consisting of reamers, awls, rod benders, drill guides, guide tubes, distance gages, inserters, implant holders, clamps, portals, screwdrivers, spacers, distracters, plate benders, broaches, fusion plates, fusion screws, spinal rods, spinal connectors, artificial discs, tissue-anchoring devices, fixation devices, dilators, joint spreaders, rasps, fusion cages, shavers, blades, burs, Kerrisons and Rongeurs, and combinations thereof.