Sense array intelligent patch lead for an implantable defibrillator and method

• US 5,476,503 A
• Filed: 03/28/1994
• Issued: 12/19/1995
• Est. Priority Date: 03/28/1994
• Status: Expired due to Fees

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: Yang, Min-Yaug
• Primary Examiner(s): Manuel, George
• Assistant Examiner(s): Getzow, Scott M.
• Application Number:
  US08/218,956
• Time in Patent Office: 631 Days
• Field of Search: 607/129, 607/130, 607/131, 607/5
• US Class Current: 607/129
• CPC Class Codes: A61N 1/0587 Epicardial electrode systems; Endocardial electrodes piercing the pericardium
• CPC Class Codes: A61N 1/39622 Pacing therapy

Abstract

An intelligent patch electrode having a plurality of sensor electrodes for use with an implantable defibrillator. The sensor electrodes are disposed in an array and connected to a microcircuit to sense a depolarization wave as it propagates through the ventricular tissue. The timing, direction of propagation, and point of initiation of successive depolarization waves can also be monitored.

Claims

1. A patch lead for use with an implantable defibrillator comprising:

a patch lead body having a first plurality of electrical conductors and a connector at a proximal end for electrically connecting said first plurality of electrical conductors to the implantable defibrillator;

a patch electrode affixed to a distal end of said patch lead body, said patch electrode including a wire mesh mounted on an insulation backing element, said patch electrode being electrically connected to one of said first plurality of electrical conductors;

a plurality of sense electrodes affixed to said patch electrode and electrically insulated from said wire mesh; and

microprocessor affixed to said patch electrode and electrically connected to said plurality of sense electrodes, said microprocessor being electrically connected to at least one of said first plurality of electrical conductors of said lead body, said microprocessor processing signals provided by said sense electrodes and producing at least one output signal indicative of cardiac electrical activity.

2. The patch lead of claim 1, wherein said

microprocessor is electrically connected to said plurality of sense electrodes by a plurality of second electrical conductors each having one end attached to one of said respective plurality of sense electrodes and opposite ends connected to said microprocessor.

3. The patch lead of claim 1, wherein said microprocessor affixed to said patch electrode is programmed with a sequence representing normal excitation of said plurality of sense electrodes in response to a normal cardiac depolarization wave.

4. The patch lead of claim 1 wherein said plurality of sense electrodes each comprise a conductive element having a surface projecting from the surface of said wire mesh.

5. The patch lead of claim 4, wherein said conductive elements are formed from materials selected from the group consisting of titanium, carbon, titanium nitrite and gold.

6. The patch lead of claim 1, wherein said plurality of sense electrodes each comprise a conductive element having a surface, and a projecting spike affixed to said surface of said conductive element, said projecting spike shaped to penetrate the epicardial tissue.

7. The patch lead of claim 6, wherein said conductive elements are formed from material selected from the group consisting of titanium, carbon, titanium nitrite and gold.

8. A patch electrode assembly for interconnection with an implantable defibrillator via a lead body having at least first and second electrical conductors, said patch electrode assembly comprising:

a shaped wire mesh, said shaped wire mesh electrically connected to the first electrical conductor of the lead body;

a backing sheet of biocompatible insulating material bonded to one surface of said shaped wire mesh;

a plurality of sense electrodes affixed to said shaped wire mesh;

means for insulating said plurality of sensor electrodes from said shaped wire mesh;

a plurality of electrical conductors each having one end attached to a respective one of said plurality of sense electrodes; and

a microprocessor for receiving electrical signals from said plurality of electrodes through said plurality of conductors, said microprocessor being connected to said second electrical conductor of the lead body.

9. The patch electrode assembly of claim 8, wherein said wire mesh is formed from titanium wires and said backing sheet is formed from silicone.

10. The patch electrode assembly of claim 8, wherein said sense electrodes are formed from a biocompatible conductive material.

11. A method of operating an implantable pacing and defibrillator system for monitoring and treating a heart, the defibrillator system including a patch lead having a wire mesh defibrillation electrode and a plurality of sense electrodes mounted on the surface of the heart, the method of operating the system comprising:

using said plurality of sensors for sensing cardiac electrical activity including depolarization occurrences and wave propagation;

determining the rate of depolarization occurrences and direction of propagation of depolarization waves to establish normal cardiac activity parameters and patterns thereof; and

monitoring the cardiac electrical activity for depolarization wave propagation patterns which do not coincide with the established normal parameters.

12. The method of operating the implantable pacing and defibrillator system of claim 11, further comprising:

delivering electrical stimulation charges to the heart through said plurality of sensor electrodes of said patch lead in a determinable sequence.

13. The method of operating the implantable pacing and defibrillator system of claim 12, wherein said electrical stimulation charges are delivered to said plurality of sensor electrodes in a sequence to create a pseudo-normal depolarization wave propagation.

14. The method of operating the implantable pacing and defibrillator system of claim 12, wherein said electrical stimulation charges are delivered to said plurality of sensor electrodes to cause cancellation of an abnormal depolarization wave propagation.

15. A method of operating an implantable pacing and defibrillator system for monitoring and treating a heart to which an intelligent patch electrode having a wire mesh electrode and a plurality of sensor electrodes is affixed, comprising the steps of:

sensing the cardiac electrical activity using the plurality of sensor electrodes to determine a pacing rhythm, a depolarization wave propagation pattern, and pacing rates to establish normal cardiac electrical activity patterns;

programming the defibrillator system with acceptable ranges for the established normal cardiac electrical activity patterns;

storing the normal cardiac electrical activity patterns and the acceptable ranges;

comparing subsequent cardiac electrical activity patterns to the stored normal cardiac electrical activity patterns and ranges; and

treating the heart using electrical stimulus when the subsequent cardiac electrical activity patterns deviate from the acceptable ranges.

16. The method of claim 15, wherein the step of monitoring cardiac electrical activity further comprises:

comparing depolarization wave propagation patterns sensed by said plurality of sensor electrodes with the established normal standards.

17. The method of claim 15, wherein the step of monitoring cardiac electrical activity further comprises:

monitoring the rate of cardiac electrical activity for the onset of tachycardia.

18. The method of claim 15, wherein the step of treating the heart using electrical stimulus further comprises delivering the electrical stimulus via said intelligent patch lead when subsequent cardiac electrical activity patterns deviate from the stored cardiac electrical activity patterns by more than a predetermined amount.

19. The method of claim 18, wherein the step of treating the heart using electrical stimulus further comprises delivering electrical stimulus via the plurality of sensor electrodes.

20. The method of claim 18, wherein the step of treating the heart using electrical stimulus further comprises delivering defibrillation stimulus via the wire mesh electrode.

21. A patch lead for use with an implantable defibrillator, said patch lead comprising:

a patch lead body having a first plurality of electrical conductors and a connector at a proximal end for electrically connecting said first plurality of electrical conductors to the implantable defibrillator;

a patch electrode affixed to a distal end of said patch lead body, said patch electrode including a wire mesh mounted on an insulation backing element, said patch electrode being electrically connected to one of said first plurality of electrical conductors; and

means for providing electrical sensing affixed to said patch electrode and electrically insulated from said wire mesh, said sensing means including means for sensing depolarization wave propagation.

22. The patch lead of claim 21, wherein said sensing means further includes means for determining the rate of depolarization.

23. The patch lead of claim 21, wherein said sensing means further includes means for determining the direction of propagation of depolarization waves.

24. The patch lead of claim 21, wherein said sensing means further includes means for determining when cardiac electrical activity does not coincide with predetermined normal parameters.

25. The patch lead of claim 24, wherein said predetermined normal parameters include a predetermined origination point.

26. The patch lead of claim 24, wherein said predetermined normal parameters include a predetermined direction of cardiac depolarization wave propagation.

27. The patch lead of claim 24, wherein said predetermined normal parameters include a predetermined speed of cardiac depolarization wave propagation.

28. The patch lead of claim 24, wherein said predetermined normal parameters include a predetermined sequence of excitation.

29. The patch lead of claim 21, wherein said sensing means includes a plurality of spaced apart electrodes.

30. The patch lead of claim 29, wherein said spaced apart electrodes include active fixation means.

31. A patch lead for use with an implantable defibrillator, said patch lead comprising:

a patch lead body having a first plurality of electrical conductors and a connector at a proximal end for electrically connecting said first plurality of electrical conductors to the implantable defibrillator;

a patch electrode affixed to a distal end of said patch lead body, said patch electrode including a wire mesh mounted on an insulation backing element, said patch electrode being electrically connected to one of said first plurality of electrical conductors;

means for sensing cardiac electrical activity affixed to said patch electrode and electrically insulated from said wire mesh, wherein said sensing means produces at least one output signal; and

signal processing means connected to said sensing means for receiving said at least one output signal from said sensing means and producing a processed output signal, said processed output signal corresponding to cardiac electrical activity.

32. The patch lead of claim 31, wherein:

said means for sensing cardiac electrical activity comprises a plurality of sense electrodes, wherein said at least one output signal comprises a corresponding plurality of output signals, each sense electrode producing a respective one of said plurality of output signals; and

said signal processing means comprises switching means electrically interconnected to said plurality of sense electrodes for selectively processing the output signal from each of the plurality of sense electrodes.

33. A patch lead for use with an implantable defibrillator, said patch lead comprising:

a patch lead body having a first plurality of electrical conductors and a connector at a proximal end for electrically connecting said first plurality of electrical conductors to the implantable defibrillator;

a shaped wire mesh, said shaped wire mesh electrically connected to a first one of said first plurality of electrical conductors of said lead body;

a backing sheet of biocompatible insulating material bonded to one surface of said shaped wire mesh;

a plurality of electrodes for sensing cardiac electrical activity affixed to said shaped wire mesh;

means for insulating said plurality of sensor electrodes from said shaped wire mesh;

a second plurality of electrical conductors each having one end attached to a respective one of said plurality of electrodes; and

signal processing means for receiving electrical signals from said plurality of electrodes through said second plurality of electrical conductors and producing an output signal indicative of cardiac electrical activity, said signal processing means being connected to a second one of said first plurality electrical conductor of said lead body.

34. A patch lead for use with an implantable defibrillator, said patch lead comprising:

a patch lead body having a first plurality of electrical conductors and a connector at a proximal end for electrically connecting said plurality of electrical conductors to the implantable defibrillator;

a patch electrode affixed to a distal end of said patch lead body, said patch electrode including a wire mesh mounted on an insulation backing element, said patch electrode being electrically connected to one of said plurality of electrical conductors; and

a plurality of means for sensing cardiac electrical signals.

35. The patch lead of claim 34, wherein said plurality of sensing means comprises a plurality of sense electrodes affixed to said wire mesh.

36. The patch lead of claim 34, further comprising signal processing means for receiving electrical signals from said plurality of means for sensing cardiac electrical signals and producing an output signal indicative of cardiac electrical activity, said signal processing means being connected to one of said plurality of electrical conductors.