Integral indicators for single-procedure devices
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.
1. A method of manufacturing an integral indicator for a single-procedure device, comprising the steps of:
(a) selecting a resin and/or polymeric material possessing a melting temperature ranging from about 38-109° C., a melt flow rate ranging from about 2-600 g/10 minute, a tensile strength ranging from about 20-400 MPa, a tensile modulus ranging from about 4-1000 GPa, and a strain-at-break ranging from about 4-1000%; and
(b) forming said integral indicator with said resin and/or polymeric material, wherein said integral indicator is capable of being molded to a component of said single-procedure device and has 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 4-1000%; wherein the integral indicator is configured to irreversibly transition from an operative conformation to an inoperative conformation in response to an exposure after the single-procedure.
2. The method of claim 1 , wherein the integral indicator has said melting temperature, melt flow rate, tensile strength, tensile modulus, and strain-at-break following exposure to environmental conditioning and accelerated aging testing equivalent to one year at ambient conditions.
3. The method of claim 1 , wherein the exposure comprises subjecting the integral indicator to: (i) one or more steam sterilization cycles, or (ii) an average temperature sufficient to precipitate the irreversible transition, or both.
4. The method of claim 1 , wherein one or both of the resin and/or the polymeric material is/are 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.
5. The method of claim 1 , wherein the component comprises one or more non-indicator domains that: (i) are not composed of the resin or the polymeric material, or (ii) remain in the operative conformation in response to the exposure, or the combination of both (i) and (ii).
6. The method of claim 5 , 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.
7. The method of claim 1 , wherein the component and the integral indicator are configured as the single-procedure device, and wherein the single-procedure 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.