Method of making a hydratable bioelectrode

• US 5,281,287 A
• Filed: 03/12/1993
• Issued: 01/25/1994
• Est. Priority Date: 07/21/1989
• Status: Expired due to Term

• Current Assignee: Encore Medical Asset Corporation (Enovis Corp.)
• Original Assignee: Iomed, Inc. (Enovis Corp.)
• Inventors: Jacobsen, Stephen C., Petelenz, Tomasz J., Beck, Jon E., Lloyd, Lindsay B.
• Primary Examiner(s): Aftergut, Jeff H.
• Application Number:
  US08/031,260
• Time in Patent Office: 319 Days
• Field of Search: 604/20, 204/400, 204/415, 607/149, 156/80, 156/83, 156/191, 156/230, 156/234, 156/247, 156/250, 156/269, 156/292, 156/284, 156/296, 156/305, 156/276
• US Class Current: 156/80
• CPC Class Codes: A61N 1/0436 Material of the electrode
• CPC Class Codes: A61N 1/0468 Specially adapted for promoting wound healing
• CPC Class Codes: Y10T 156/1052 with cutting, punching, tearing or severing

Abstract

A hydratable iontophoretic bioelectrode includes a plurality of layers of material capable of absorbing and holding an ionized fluid when placed in contact with the fluid. Adjacent layers are maintained at least partially out of contact from one another by disposition between the layers of spacing elements such as sugar or other dissolvable particles or cellulose. The edges of the layers may be crimped to maintain the layers in a stack for assembly with an electrode sheet; such a sheet would be provided for receiving an electrical current to thereby produce an electric field and cause a migration of ions of the ionized fluid away from the electrode sheet and into the skin or tissue of a person or animal against which the bioelectrode is placed.

Claims

1. A method of producing a hydratable bioelectrode from a mass of hydrogel comprising the steps of

(a) forming the mass of hydrogel into sheets of hydrogel,

(b) drying the sheets of hydrogel,

(c) disposing the dried sheets in a swelling solution to cause the sheets to absorb solution, swell and expand laterally,

(d) drying the sheets of swollen hydrogel,

(e) distributing granules/fibers onto the sheets, and

(f) arranging the sheets into a stack where adjacent sheets are at least partially maintained apart by the granules/fibers.

2. A method as in claim 1 further comprising the step of

(g) cutting the stack, from top to bottom, into two or more parts.

3. A method as in claim 1 wherein step (a) comprises

(h) placing the mass of hydrogel on the exterior surface of a roller,

(i) rolling the roller with hydrogel over the surface of a cooled tray to thereby cool an outer layer of gel as it contacts the tray, causing it to freeze superficially, adhere to the tray and pull away from the hydrogel mass remaining on the roller, thereby forming a sheet of hydrogel.

4. A method as in claim 3 wherein the tray is cooled to a temperature below the freezing point of the hydrogel.

5. A method as in claim 3 wherein the roller is rolled at a substantially constant rate.

6. A method as in claim 1 wherein step (b) comprises drying the sheets of hydrogel in a convection oven at an elevated temperature.

7. A method as in claim 6 wherein the convention oven is heated to a temperature of about 55°

C.

8. A method as in claim 1 wherein step (c) comprises

(j) placing the sheets of hydrogel on a screen, and

(k) immersing the screen with hydrogel sheets in a solution of water and stiffening agent to cause the sheets to swell and ultimately stiffen.

9. A method as in claim 8 wherein the stiffening agent is sugar.

10. A method as in claim 1 wherein step (e) comprises

(l) moving the sheets of hydrogel under a granule/fiber dispensing mechanism to deposit granules/fibers onto the sheets, and

(m) applying water mist or vapor to the sheets and granules/fibers to moisten the granules/fibers to facilitate holding them in place on the sheets.

11. A method as in claim 10 wherein said granules/fibers are sugar crystals.

12. A method as in claim 2 wherein step (g) further comprises crimping together corresponding edges on opposite sides of the sheets.

13. A method as in claim 12 wherein step (g) further comprises crimping the resulting adjacent edges formed by the cutting.

14. A method as in claim 13 wherein step (g) comprises press-cutting the stack along one or more generally parallel first lines, and slicing the press-cut parts along lines generally perpendicular to the first lines.