Highly conductive non-stringy adhesive hydrophilic gels and medical electrode assemblies manufactured therefrom

• US 4,989,607 A
• Filed: 03/30/1989
• Issued: 02/05/1991
• Est. Priority Date: 03/30/1989
• Status: Expired due to Term

• Current Assignee: Ludlow Corporation (Mallinckrodt plc)
• Original Assignee: Nepera, Inc.
• Inventors: Lennon, Linda, Keusch, Preston, Czap, Christine A., Murdock, Keith A.
• Primary Examiner(s): Cohen, Lee S.
• Application Number:
  US07/330,669
• Time in Patent Office: 677 Days
• Field of Search: 128/639-641, 128/798, 128/802, 128/803, 252/500
• US Class Current: 600/391
• CPC Class Codes: A61B 2018/00107 Coatings on the energy applicator
• CPC Class Codes: A61B 5/259 using conductive adhesive means, e.g. gels
• CPC Class Codes: A61L 15/58 Adhesives
• CPC Class Codes: A61L 24/001 Use of materials characterised by their function or physical properties
• CPC Class Codes: A61L 24/0031 Hydrogels or hydrocolloids
• CPC Class Codes: C08J 2300/10 Polymers characterised by the presence of specified groups, e.g. terminal or pendant functional groups
• CPC Class Codes: C08J 3/28 Treatment by wave energy or particle radiation
• CPC Class Codes: C08L 2666/02 Organic macromolecular compounds, natural resins, waxes or and bituminous materials
• CPC Class Codes: C08L 39/06 Homopolymers or copolymers of N-vinyl-pyrrolidones
• CPC Class Codes: C08L 71/02 Polyalkylene oxides
• CPC Class Codes: C09J 139/06 Homopolymers or copolymers of N-vinyl-pyrrolidones
• CPC Class Codes: C09J 171/02 Polyalkylene oxides
• CPC Class Codes: H01M 6/22 Immobilising of electrolyte

Abstract

The highly conductive hydrogels of this invention are comprised of a cohesive uniform mixture of poly(vinyl pyrrolidone), a viscosity-enhancing hydrophilic polymer, and an effective amount of an electrolyte. This polymeric mixture which is crosslinked by exposure to radiant energy provides a gel-like solid which is sufficiently tacky and adhesive to adhere to the subjects'"'"' skin and yet is substantially non-stringy and non-aggressive such that the use of such hydrogel imparts less discomfort to the user. In addition, the consumer utilizing the product of this invention would not experience the objectionable sticky, stringy sensation associated with existing conductive adhesive gels.

Claims

1. A highly conductive non-stringy adhesive hydrophilic gel comprising a cohesive uniform aqueous mixture of poly(vinyl pyrrolidone) (PVP), a viscosity-enhancing hydrophilic polymer having a weight average molecular weight in excess of about 100 kilodaltons (kD), and an amount of a water-soluble electrolyte effective to reduce the transverse electrical resistance of said aqueous mixture to an impedance at 60 Hz of less than about 1,000 ohms,

which aqueous mixture had been exposed to a dose of radiant energy effective to provide a highly conductive non-stringy adhesive hydrophilic gel which exhibits a sharp, substantially featureless force-displacement curve, having a force value of least about 180 grams and an Adhesion Energy Density (AED) of at least about 5 to less than about 50 g/cm.

2. The hydrophilic gel of claim 1 which further comprises an additive uniformly dispersed therein.

3. The hydrophilic gel of claim 1 which further comprises an additive uniformly dispersed therein selected from the group consisting of preservatives, stabilizers, fire retardants, pigments, refractive particles, bacteriacides, antibiotics, cosmetics, moisturizers, pharmaceuticals, and mixtures thereof.

4. The hydrophilic gel of claim 1 which further comprises a biocide uniformly dispersed therein.

5. The hydrophilic gel of claim 1 which further comprises a low area-weight scrim in intimate contact therewith.

6. The hydrophilic gel of claim 1 which further comprises a low area-weight scrim in intimate contact therewith, which scrim is manufactured from a synthetic water-insoluble polymer.

7. The hydrophilic gel of claim 1 in which said viscosity-enhancing hydrophilic polymer is of a synthetic origin.

8. The hydrophilic gel of claim 1 in which said viscosity-enhancing hydrophilic polymer is of a natural origin.

9. The hydrophilic gel of claim 1 in which said viscosity-enhancing hydrophilic polymer is crosslinked.

10. The hydrophilic gel of claim 1 in which said viscosity-enhancing hydrophilic polymer is water-soluble.

11. The hydrophilic gel of claim 1 in which said viscosity-enhancing hydrophilic polymer is selected from the group consisting of polyacrylamide, poly(vinyl alcohol), polyacrylate, poly(ethylene oxide), poly(ethylene imine), carboxymethylcellulose, methylcellulose, polyacrylamide sulfonic acid, polyacrylonitrile, mixtures, blends, and copolymers thereof.

12. The hydrophilic gel of claim 1 in which said viscosity-enhancing hydrophilic polymer is poly(ethylene oxide).

13. The hydrophilic gel of claim 1 in which said viscosity-enhancing hydrophilic polymer is a cellulose derivative.

14. The hydrophilic gel of claim 1 in which said viscosity-enhancing hydrophilic polymer is carboxymethylcellulose.

15. The hydrophilic gel of claim 1 in which said viscosity-enhancing hydrophilic polymer is selected from the group consisting of agar, dextran, dextrin, carrageenan, xanthan, guar, derivatives, and mixtures thereof.

16. The hydrophilic gel of claim 1 in which said water-soluble electrolyte is an inorganic salt.

17. The hydrophilic gel of claim 1 in which said water-soluble electrolyte is selected from the group consisting of potassium salts, sodium salts, magnesium salts, calcium salts, and mixtures thereof.

18. The hydrophilic gel of claim 1 in which said water-soluble electrolyte is selected from the group consisting of potassium chloride, sodium chloride, magnesium sulfate, magnesium acetate, and mixtures thereof.

19. The hydrophilic gel of claim 1 in which said aqueous mixture had been exposed to a dose of radiant energy equivalent to greater than about 0.5 Mrad to less than about 4 Mrad.

20. The hydrophilic gel of claim 1 in which said aqueous mixture had been exposed to a dose of radiant energy equivalent to about 0.5 Mrad to less than about 2 Mrad.

21. The hydrophilic gel of claim 1 in which said aqueous mixture had been exposed to a dose of radiant energy equivalent to about 0.7 Mrad to about 1 Mrad.

22. The hydrophilic gel of claim 1 in which said PVP is present at a concentration of about 10 to about 35 weight percent.

23. The hydrophilic gel of claim 1 in which said viscosity-enhancing hydrophilic polymer is present at a concentration of about 0.5 to about 5 weight percent.

24. The hydrophilic gel of claim 1 in which said water-soluble electrolyte is present at a concentration of about 0.1 to about 10 weight percent.

25. The hydrophilic gel of claim 2 in which said additive is present at a concentration of about 0.001 to about 3 weight percent.

26. The hydrophilic gel of claim 1 in which said PVP has a weight average molecular weight in the range of about 500 kD to about 2,000 kD.

27. The hydrophilic gel of claim 1 in which said aqueous mixture has a viscosity of at least about 8,000 cps.

28. The hydrophilic gel of claim 1 in which said transverse electrical resistance of said aqueous mixture is reduced to an impedance at frequencies between about 10 to about 60 Hz of less than about 100 ohms.

34. The hydrophilic gel of claim 1 having a force value of at least about 250 grams.

35. The hydrophilic gel of claim 1 having a force value of at least about 400 grams.

29. A conductive wound dressing comprising a conductive non-stringy adhesive hydrophilic gel, which gel comprises a cohesive uniform aqueous mixture of poly(vinyl pyrrolidone) (PVP), a viscosity-enhancing hydrophilic polymer having a weight average molecular weight in excess of about 100 kilodaltons (kD), and a sufficient amount of a water-soluble electrolyte,

which aqueous mixture had been exposed to a dose of radiant energy affective to provide a highly conductive non-stringy adhesive hydrophilic gel which exhibits a sharp, substantially featureless force-displacement curve, having a force value of at least about 180 grams and an Adhesion Energy Density (AED) of at least about 5 to less than about 50 g/cm.

30. A method of electrical wound healing which comprises (i) contacting an area of the body affected by a wound with the conductive wound dressing of claim 29 and (ii) applying an electrical impulse to said area with the aid of said conductive wound dressing for a period of time effective to promote healing.

36. The conductive wound dressing of claim 29 in which said hydrophilic gel has a force value of at least about 250 grams.

37. The conductive wound dressing of claim 29 in which said hydrophilic gel has a force value of at least about 400 grams.

31. An electrode comprising:

(a) a highly conductive non-stringy adhesive hydrophilic gel, which gel comprises a cohesive uniform aqueous mixture of poly(vinyl pyrrolidone) (PVP), a viscosity-enhancing hydrophilic polymer having a weight average molecular weight in excess of about 100 kilodaltons (kD), and an amount of a water-soluble electrolyte effective to reduce the transverse electrical resistance of said aqueous mixture to an impedance at 60 Hz of less than about 1,000 ohms,

which aqueous mixture had been exposed to a dose of radiant energy effective to provide a highly conductive non-stringy adhesive hydrophilic gel which exhibits a sharp, substantially featureless force-displacement curve, having a force value of at least about 180 grams and an Adhesion Energy Density (AED) of at least about 5 to less than about 50 g/cm; and

(b) a conductive member, in intimate contact with said gel, to which may be connected external electrical apparatus.

32. The electrode of claim 31 which is further characterized by its ability to provide an intimate uniform contact and a low impedance such that the occurrence of burns on the skin is minimized, which burns may result from the use of such electrode under conditions suitable for ESU applications.

33. The electrode of claim 31 in which the amount of water-soluble electrolyte ranges from about 5 to about 8 percent by weight of said aqueous mixture to provide an electrode having a DC offset suitable for EKG measurements.

38. The electrode of claim 31 in which said hydrophilic gel has a force value of at least about 250 grams.

39. The electrode of claim 31 in which said hydrophilic gel has a force value of at least about 400 grams.