Biomedical electrode having a secured one-piece conductive terminal

• US 5,406,945 A
• Filed: 05/24/1993
• Issued: 04/18/1995
• Est. Priority Date: 05/24/1993
• Status: Expired due to Term

• Current Assignee: Conmed Corporation (Jefferies Financial Group, Inc.)
• Original Assignee: NDM Acquisition Corporation
• Inventors: Wolf, Michael L., Riazzi, Timothy J., Allaire, Michael J.
• Primary Examiner(s): Cohen, Lee S.
• Application Number:
  US08/066,716
• Time in Patent Office: 694 Days
• Field of Search: 128/640, 128/641, 607/149, 607/152, 607/153
• US Class Current: 600/394
• CPC Class Codes: A61B 2018/00083 low, i.e. electrically insulating
• CPC Class Codes: A61B 2018/1467 using more than two electrodes on a single probe
• CPC Class Codes: A61B 2562/0217 Electrolyte containing
• CPC Class Codes: A61B 5/25 Bioelectric electrodes therefor
• CPC Class Codes: A61B 5/257 using adhesive means, e.g. adhesive pads or tapes
• CPC Class Codes: A61B 5/266 containing electrolytes, conductive gels or pastes

Abstract

A disposable biomedical electrode having a one-piece terminal secured therein without washers, retaining rings or other securement means is provided. The electrode also includes an electrolytic gel which exhibits greater patient comfort without any decrease in electrical performance. The gel layer is preferably a hydrogel material formed from an aqueous mixture of polyhydric alcohol, aliphatic diisocyanate terminated prepolymer, polyethylene oxide based polyamine, and sodium chloride.

Claims

1. A biomedical electrode comprising:

an electrolytic gel layer having first and second sides wherein said first side is adapted to contact a patient;

an anchoring layer having a perforated portion, a first side and a second side, and formed of a porous material having sufficient porosity such that said first side of said anchoring layer is secured to said second side of said gel layer;

a conductive terminal having a base portion integrally joined to a stud member, said base portion being mounted on said perforated portion of said second side of said anchoring layer;

a reinforcing strip having a first opening correspondingly sized with said stud member of said terminal, said reinforcing strip being mounted over said terminal such that said stud member protrudes through said first opening and said base portion is held against said second side of said anchoring layer; and

a top layer having first and second sides and a second opening correspondingly sized with said stud member of said terminal, wherein said second side of said top layer has first and second ends and a patient-contact adhesive coating, said top layer being adhesively mounted onto said reinforcing strip and said anchoring layer such that said stud member protrudes through said second opening and said first and second ends of said second side of said top layer are capable of being secured to said patient.

2. The biomedical electrode of claim 1 wherein said porous material comprises a foam material including silica and a polyolefin.

3. The biomedical electrode of claim 1 wherein said porous material has a porosity in range from about 30% to about 80%.

4. The biomedical electrode of claim 1 further comprising a support layer disposed within said gel layer.

5. The biomedical electrode of claim 1 wherein said gel layer is a hydrogel material formed from an aqueous mixture of polyhydric alcohol, aliphatic diisocyanate-terminated prepolymer, polyethylene oxide-based polyamine, and sodium chloride.

6. The biomedical electrode of claim 1 wherein said gel layer is a hydrogel material formed from an aqueous mixture comprising:

(a) from about 0% to about 90% by weight polyhydric alcohol;

(b) from about 6% to about 60% by weight aliphatic diisocyanate-terminated prepolymer;

(c) from about 4% to about 40% by weight polyethylene oxide-based polyamine;

(d) 0% to about 2% by weight sodium chloride; and

(e) the balance water.

7. The biomedical electrode of claim 6 wherein said polyhydric alcohol is selected from the group consisting of polypropylene glycol, polyethylene glycol and glycerine.

8. The biomedical electrode of claim 1 wherein said gel layer is a hydrogel material formed from an aqueous mixture comprising:

(a) from about 15% to about 30% by weight polyhydric alcohol;

(b) from about 8% to about 14% by weight isophoronediisocyanate-terminated prepolymer;

(c) from about 5% to about 10% by weight polyethylene oxide-based diamine;

(d) up to about 1% by weight sodium chloride; and

(e) the balance water.

9. The biomedical electrode of claim 1 wherein said gel layer is a hydrogel material formed from an aqueous mixture comprising:

(a) from about 16% to 17% by weight polypropylene glycol;

(b) from about 10% to 12% by weight isophoronediisocyanate-terminated prepolymer;

(c) from about 7% to 9% by weight polyethylene oxide-based diamine;

(d) about 0.5% to 1% by weight sodium chloride; and

(e) the balance water.

10. The biomedical electrode of claim 9 wherein said isophoronediisocyanate-terminated prepolymer is based on polyols containing more than about 40% polyethylene oxide and having an isocyanate content of about 3% by weight.

11. The biomedical electrode of claim 1 further comprising a release liner releasably secured to said first side of said gel layer for protection prior to use.