Medical electrode packaging technology

• US 5,402,884 A
• Filed: 09/24/1992
• Issued: 04/04/1995
• Est. Priority Date: 09/24/1992
• Status: Expired due to Term

• Current Assignee: Cardiac Science Operating Company (Cardica Incorporated)
• Original Assignee: SurViva Link Corporation
• Inventors: Kroll, Karl J. F., Gilman, Byron L.
• Primary Examiner(s): Gehman, Bryon P.
• Assistant Examiner(s): Hilliard, Thomas P.
• Application Number:
  US07/950,823
• Time in Patent Office: 922 Days
• Field of Search: 206/331, 206/210, 206/328, 206/438, 206/363, 206/460, 206/461
• US Class Current: 206/701
• CPC Class Codes: A61N 1/046 Specially adapted for shock therapy, e.g. defibrillation
• CPC Class Codes: A61N 1/0472 Structure-related aspects
• CPC Class Codes: A61N 1/048 Electrodes characterised by a specific connection between lead and electrode
• CPC Class Codes: A61N 2001/37294 Means for testing medical devices within the package prior to implantation

Abstract

The invention provides a sealed package system for housing at least one medical electrode apparatus and for enabling the periodic testing thereof, comprising a thin, generally flat flexible envelope constructed and arranged to form an interior cavity for enclosing a conductive gel contact surface of an electrode apparatus, the envelope having at least one continuous layer of a homogeneous, non-conductive, polymeric material, the envelope further having first and second sides; and a structure for conducting current across the envelope to the interior cavity, the conductive structure being electrically connectible to the electrode conductive contact surface.

Claims

1. A sealed packaged medical electrode system for use with an electro-medical device and which permits easy periodic testing of electrode electrical viability without being opened, comprising:

(a.) a first disposable electrode for placement on a patient'"'"'s body and connection to the electro-medical device, including;

i) a flat, thin, non-conductive base layer;

ii) a conductive semi-liquid gel layer disposed on a side of said base layer, said gel layer being for contact with a patient; and

iii) conductive connection means communicatively connected to said gel layer;

(b.) a second disposable electrode for placement on a patient'"'"'s body and connection to the electro-medical device, including;

i) a flat, thin, non-conductive base layer;

ii) a conductive semi-liquid gel layer disposed on a side of said base layer, said gel layer being for contact with a patient; and

iii) conductive connection means communicatively connected to said gel layer;

(c.) a thin, generally flat flexible envelope constructed and arranged to form an interior cavity for enclosing said first and second electrodes, said envelope being constructed entirely of a non-gas permeable polymeric material, and

(d.) said first and second electrode connection means extending outwardly through said envelope, and said first and second electrode gel layers being oriented in a face to face relationship for electrical communication therebetween, so that current loop is formable between said first electrode connection means, said first electrode gel layer, said second electrode gel layer, and said second electrode connection means without opening said envelope.

2. The packaged electrode system of claim 1, wherein said first and second electrode connection means is an insulated wire, the conductive wire portion of which contacts said gel layer.

3. The packaged electrode system of claim 2, further comprising a resistive layer disposed between and contacting said gel layers, said resistive layer being constructed of a material having a predetermined resistance.

4. The packaged electrode system of claim 3, wherein said resistive layer further has a peripherally disposed non-conductive portion.

5. The packaged electrode system of claim 3, further comprising a conductive connection means communicatively connected to said resistive layer and extending outwardly through said envelope.

6. The packaged electrode system of claim 1, wherein said electrodes are defibrillation electrodes and wherein said electrode connection means conduct high voltage defibrillation currents.