Device with enhanced indication of use and prevention of re-use

• US 20060069305A1
• Filed: 09/30/2004
• Published: 03/30/2006
• Est. Priority Date: 09/30/2004
• Status: Abandoned Application

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Zhong, Sheng-Ping, Couvillon, Lucien Alfred Jr., Banik, Michael S., Sahatjian, Ronald A.
• Application Number:
  US10/955,905
• Publication Number:
  US 20060069305A1
• Time in Patent Office: Days
• US Class Current: 600/117
• CPC Class Codes: A61B 1/00055 for alerting the user
• CPC Class Codes: A61B 1/00062 provided with means for preventing overuse
• CPC Class Codes: A61B 1/00103 designed for single use
• CPC Class Codes: A61B 2090/0814 Preventing re-use
• CPC Class Codes: A61B 2560/0276 Determining malfunction

Abstract

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.

Claims

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.