Thin film electrodes for sensing cardiac depolarization signals

• US 6,564,106 B2
• Filed: 12/13/2000
• Issued: 05/13/2003
• Est. Priority Date: 12/13/2000
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Guck, Beth Anne, Donders, Adrianus P.
• Primary Examiner(s): Walberg, Teresa
• Assistant Examiner(s): DAHBOUR, HENRY
• Application Number:
  US09/736,046
• Publication Number:
  US 20020072778A1
• Time in Patent Office: 881 Days
• Field of Search: 607/116, 607/119, 607/129, 607/142, 607/9, 607/32, 607/122, 607/36, 607/4, 600/373, 600/374, 600/375
• US Class Current: 607/116
• CPC Class Codes: A61N 1/08 Arrangements or circuits for monitoring, protecting, controlling or indicating for external stimulators A61N1/3603; for implantable neurostimulators A61N1/36128; for heart stimulators A61N1/37; for defibrillators A61N1/3925
• CPC Class Codes: A61N 1/3754 Feedthroughs
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators

Abstract

A subcutaneous electrode is structured to acquire electrocardiographic data and waveform tracings from an implanted pacemaker without the need for or use of surface (skin) electrodes. Thin film electrodes disposed on a top surface of a feedthrough are adapted to connect into an assembly at the peripheral edge of the implantable device. Each of the electrodes comprise an integral element of a subcutaneous electrode array or SEA which detects cardiac depolarizations that are communicable and displayable by a portable device programmer. The thin film electrode is a complete functional component with a hermetically attached weld ring adapted for direct welding into the implanted device casing. The distribution and dispersion of the electrodes around the perimeter of the pacemaker provide a maximum and equidistance setting of electrode pairs for either three or four preferred electrode configurations.

Claims

1. A data collection system implemented with a medical device for recording electrocardiographic data, the system comprising:

an hermetically sealed case; and

an array of subcutaneous thin film electrodes mounted on a surface of a feedthrough; and

signal processing circuitry inside the case coupled with the electrodes via the feedthrough.

2. The system of claim 1 wherein the electrodes are mounted on the surface of said feedthrough by thin film deposition and wherein the surface of the feedthrough is polished and ground prior to deposition of the thin film electrodes.

3. The system of claim 2 wherein the case includes walls into which body fluid is allowed to flow so that the body fluid is above and around the thin film electrodes, and is mounted on the surface of said feedthrough.

4. The system of claim 1 wherein said feedthrough includes a head and a pin assembly further comprising a ferrule and insulation.

5. The system of claim 4 wherein said ferrule is made from material selected from the group consisting of titanium, titanium 64, niobium, titanium/niobium alloy, stainless steel and equivalent laser weldable and brazeable alloys.

6. The system of claim 5 wherein said insulator is one of a single crystal sapphire and a polycrystalline aluminum oxide.

7. The system of claim 1 wherein said feedthrough includes a head having a conductive metal selected from the group of materials consisting of gold, gold alloys and niobium alloys, and equivalent metal alloys.

8. The system of claim 1 wherein said thin film electrode includes a sensing electrode attached to the feedthrough surface.

9. A method of attaching a thin film electrode to a hermetically sealed case, the method comprising:

forming a slightly flattened area on a perimeter surface of a hermetically sealed case; and

depositing the thin film electrode on a feedthrough; and

welding the feedthrough to the slightly flattened area on the perimeter surface of the case.

10. The method of claim 9 wherein said feedthrough includes a head and the thin film is deposited after grinding and polishing the head.

11. The method of claim 10 wherein said head is slightly indented after the grinding and polishing method.

12. The method of claim 9 wherein the thin film electrode is deposited including one of laser beam a metalization coating and spray techniques.

13. The method of claim 9 wherein the thin film electrode includes an underlying adhesion layer to ensure stabilizing the electrode and hermeticity.

14. A data collection system implemented with a medical device for recording electrocardiographic data including a thin film electrode scheme distributed about the perimeter of a hermetically sealed case, the electrode scheme in combination, comprising:

a hermetically sealed case; and

a plurality of subcutaneous thin film electrodes forming a distributed array spaced apart to optimally cover and receive signals from all directions and connected to signal processing circuitry inside the case coupled with the electrode via a feedthrough assembly in operable electrical contact with amplifiers in a microprocessor circuitry.

15. The thin film electrode scheme of claim 14 wherein one of three and four electrodes form the array in said spaced-apart relations therewith.