Methods for detecting dehydration of a biomedical hydrogel

• US 4,717,378 A
• Filed: 03/31/1986
• Issued: 01/05/1988
• Est. Priority Date: 03/31/1986
• Status: Expired due to Fees

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Jordan, George, Perrault, James J.
• Primary Examiner(s): Cohen, Lee S.
• Application Number:
  US06/846,387
• Time in Patent Office: 645 Days
• Field of Search: 128/639-641, 128/798, 128/802, 128/803, 128/303.13, 128/660, 604/20, 604/111, 604/404, 604/318
• US Class Current: 116/201
• CPC Class Codes: A61L 31/14 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: G01N 31/221 for investigating pH value

Abstract

A visual (as opposed to mechanical or electronic) method for detecting the state of dehydration (or hydration) of a biomedical hydrogel is disclosed. The method contemplates incorporating a pH sensitive indicator into the hydrogel as it is prepared and applying the hydrogel to the skin-contacting surface of a biomedical device such as an electrode. Shortly before the biomedical device is to be used, the color of the hydrogel on the device is visually compared with its freshly-prepared color to determine the approximate state of dehydration of the gel.

Claims

1. A visual method for detecting the state of dehydration of a polymeric gel disposed on the skin-contacting surface of a biomedical device comprising the steps of:

selecting a weakly acidic or weakly basic, pH sensitive colored indicator;

preparing the gel by incorporating the selected indicator therein to produce a gel having a first color;

applying the first color gel to a skin-contacting surface of a biomedical device; and

shortly before the device is to be used, visually comparing the color of the gel just before used with its first color to determine the relative state of dehydration of the gel.

2. A method according to claim 1 wherein the gel is prepared by the steps of mixing the selected indicator with the gel raw materials.

3. A method according to claim 1 wherein after the first color gel is applied to the skin-contacting surface of the biomedical device a visually transparent humidity barrier is placed on a portion of the gel, and the visual comparison is between a covered and uncovered portion of the gel.

4. A method according to claim 1 wherein the gel has sodium acetate as an electrolyte.

5. A method according to claim 1 wherein the indicator is selected from the group consisting of FD&

C Blue #1, FD&

C Blue #2, FD&

C Green #3, D&

C Green #8 or D&

C Red #27.

6. A method according to claim 1 wherein the biomedical device is an iontophoresis electrode.

7. A visual method for detecting the state of dehydration of a conductive polymeric hydrogel disposed on the skin-contacting surface of a biomedical device comprising the steps of:

selecting a weakly acidic or weakly basic pH sensitive colored indicator selected from the group consisting of FD&

C Blue #1, FD&

C Blue #2, D&

C Green #3, D&

C Green #8 or D&

C Red #27;

preparing the hydrogel by incorporating the selected indicator therein thereby producing a hydrogel having a first color;

applying the first color hydrogel to a skin-contacting surface of the biomedical device; and

shortly before the device is to be used, visually comparing the color of the hydrogel just before use with its first color to determine the relative state of dehydration of the gel.

8. A method according to claim 7 wherein the hydrogel is prepared by the steps of mixing the selected indicator with the gel raw materials.

9. A method according to claim 7 wherein after the first color gel is applied to the skin-contacting surface of the biomedical device a visually transparent barrier having a low moisture vapor transmission rate is placed on a portion of the gel, and the visual comparison is between a covered and uncovered portion of the gel.

10. A method according to claim 7 wherein the gel comprises sodium acetate.