Device with enhanced indication of use and prevention of re-use
In one aspect, the present invention is a medical device that reduces the likelihood of an operator improperly reusing it. The medical device includes (a) a device body; (b) a substrate comprising a contrast material that covers at least a portion of the device body; and (c) an outer layer comprising a hydrophilic material that covers at least a portion of the substrate. The outer layer comprising hydrophilic material is capable of absorbing water-soluble contaminants during clinical use that, once absorbed, are visible against the background of the substrate comprising the contrast material. In another aspect, the device includes (a) a device body and (b) an outer layer comprising a usage indicator reagent. In another aspect, the invention provides methods of preventing re-use of a single use medical device.
1 . A medical device that indicates prior use upon visual inspection, the medical device comprising:
(a) a device body;
(b) a substrate comprising a contrast material that covers at least a portion of the device body; and
(c) an outer layer comprising a hydrophilic material that covers at least a portion of the substrate;
wherein the hydrophilic material absorbs water-soluble contaminants during clinical use of the medical device; and wherein the absorbed contaminants are visible against the contrast material.
2 . The medical device of claim 1 , wherein the device body comprises a polymeric material.
3 . The medical device of claim 1 , wherein the contrast material is white.
4 . The medical device of claim 1 , wherein the hydrophilic material is covalently attached to the substrate.
5 . The medical device of claim 1 , wherein a usage indicator reagent is covalently attached to the substrate.
6 . The medical device of claim 1 , wherein the hydrophilic material is capable of becoming lubricous when contacted with an aqueous medium.
7 . The medical device of claim 6 , wherein the hydrophilic material is an acrylic acid-acrylamide copolymer.
8 . The medical device of claim 6 , wherein the hydrophilic material is a hydrogel.
9 . The medical device of claim 8 , wherein the hydrogel is capable of having a water content of at least 70%.
10 . The medical device of claim 1 , further comprising a sterile wrapper that is removed prior to use.
11 . The medical device of claim 1 , wherein the device is a single use endoscope.
12 . The single use medical device of claim 1 , wherein the hydrophilic material covers at least a distal tip of the endoscope.
13 . A method for reducing the likelihood of improper re-use of a single use medical device comprising:
visually inspecting the outer surface of a single use medical device for the presence of absorbed contaminants, wherein the single use medical device includes:
(a) a device body;
(b) a substrate comprising a contrast material that covers at least a portion of the device body; and
(c) an outer layer comprising a hydrophilic material that covers at least a portion of the substrate; and
disposing of a single use medical device that contains absorbed contaminants in the outer layer of the device.
14 . The method of claim 13 wherein the single use medical device is an endoscope.
15 . The method of claim 13 wherein the hydrophilic material is a hydrogel.
16 . A medical device that indicates prior use upon visual inspection, the medical device comprising:
(a) a device body; and
(b) an outer layer comprising a usage indicator reagent, wherein the outer layer covers at least a portion of the device body.
17 . The medical device of claim 16 wherein the outer layer further comprises a hydrophilic material.
18 . The medical device of claim 16 or 17 wherein the usage indicator reagent is an organic dye molecule.
19 . The medical device of claim 18 wherein the organic dye molecule changes color in an environment with a pH below pH 7.0.
20 . The medical device of claim 18 wherein the organic dye molecule changes color when complexed with protein.
21 . The medical device of claim 16 wherein the usage indicator reagent is a ferrous salt.
22 . The medical device of claim 21 wherein the ferrous salt is encapsulated in protein.