Electrode package and method for sealing same

• US 6,048,640 A
• Filed: 05/27/1998
• Issued: 04/11/2000
• Est. Priority Date: 05/27/1998
• Status: Expired due to Term

• Current Assignee: Katecho, Inc.
• Original Assignee: Katecho, Inc.
• Inventors: Luhrs, Michael J., Walters, Warren R.
• Primary Examiner(s): Nuzzolillo, Maria
• Assistant Examiner(s): Martin, Angela J.
• Application Number:
  US09/085,901
• Time in Patent Office: 685 Days
• Field of Search: 429/121, 429/124, 429/127, 429/136, 29/623.2, 206/701
• US Class Current: 429/136
• 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 1/0488 Details about the lead
• CPC Class Codes: A61N 1/0492 Patch electrodes A61N1/0412, A61N1/0428 take precedence
• CPC Class Codes: Y10T 29/4911 including sealing

Abstract

An electrode package includes a pouch having pouch walls forming a sealed pouch enclosure. At least one electrode is within the pouch enclosure and includes an electrode wire having one end connected to the electrode within the pouch, an intermediate portion extending through the pouch walls, and a second end outside the pouch enclosure. A sealing joint is formed at the point where the intermediate portion of the wire extends through the pouch walls. The pouch walls have a plastic layer which surrounds and contacts the intermediate portion of the wire at the sealing joint to form an air tight seal. The invention also includes a method whereby heat and pressure are applied at the sealing joint to cause the plastic layer of the pouch walls to melt and fuse around the wires to create the seal.

Claims

1. A method for packaging and using an electrode having a conductive hydrogel adapted to be placed in contact with a patient'"'"'s skin and an electrical wire surrounded by a plastic insulation material, said electrical wire having a first end connected to said electrode, a second end connected to a plug, and an intermediate wire portion between said first and second ends of said wire, said method comprising:

placing said electrode within a pouch comprising at least first and second pouch walls which form a pouch enclosure that is completely enclosed except for an open sealing area between said first and second pouch walls, said pouch walls each having a plastic layer at said open sealing area;

extending said wire through said open sealing area to a position where said second end of said wire is outside said pouch enclosure, said first end of said wire is within said pouch enclosure and connected to said electrode, and said intermediate wire portion of said wire is positioned between said plastic layers of said first and second pouch walls at said sealing area;

fusing said plastic layers of said first and second pouch walls around and to said insulation material of said electrical wire to cause said electrode to be hermetically sealed within said pouch enclosure;

said fusing step comprising placing first and second dies on opposite sides of said sealing point with said walls of said pouch and said wire therebetween, compressing said first and second dies together with a predetermined pressure, and heating at least one of said first and second dies to a predetermined temperature so as to impart heat to said walls of said pouch and said wire during said compressing step;

plugging said plug into electrical apparatus at the time of use of said electrode while said intermediate portion of said wire is fused between said first and second pouch layers at said sealing area;

opening said pouch to gain access to said electrode within said pouch enclosure;

removing said electrode from said pouch;

placing said hydrogel of said electrode in contact with a patient'"'"'s skin after removal of said electrode from said pouch.

2. A method according to claim 1 wherein said opening step comprises tearing said pouch walls.

3. A method according to claim 1 wherein said compressing step further comprises using said first and second dies each of which have recesses shaped to conform to the shape of said wire with said insulation material thereon and sized to apply pressure to said wire and said insulation material during said compressing step.