System and method for multisite steering of cardiac stimuli

• US 5,800,465 A
• Filed: 10/30/1996
• Issued: 09/01/1998
• Est. Priority Date: 06/18/1996
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Hrdlicka, Gregory A., Thompson, David L., King, Gary W.
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): LAYNO, CARL HERNANDZ
• Application Number:
  US08/755,797
• Time in Patent Office: 671 Days
• Field of Search: 607/4, 607/9, 607/11, 607/15, 607/122, 607/123, 607/129
• US Class Current: 607/9
• CPC Class Codes: A61N 1/368 comprising more than one electrode co-operating with different heart regions A61N1/3622, A61N1/3627 take precedence
• CPC Class Codes: A61N 1/3712 Auto-capture, i.e. automatic adjustment of the stimulation threshold
• CPC Class Codes: A61N 1/3714 Atrial capture
• CPC Class Codes: A61N 1/3918 characterised by shock pathway, e.g. by electrode configuration

Abstract

A system and corresponding method for steering stimulus pulses to one or more selected cardiac sites are disclosed. An apparatus and corresponding method permit improved capture and easy adjustment of the stimulus pulse when the threshold level changes, without simply increasing stimulus power or replacing the implanted lead. Substantially concurrent pulses may be delivered across one, two or more anode electrodes and a corresponding common or cathode electrode, where the pulse amplitude, pulse duration or pulse phase characteristics of each individual component pulse are adjusted to permit the resulting composite pulse to be steered or directed towards a desired target cardiac site. Different embodiments of the apparatus and corresponding method include those which permit the steering of pacing pulses in the left atrium or in multiple chambers, use of an improved single lead system having electrodes floating in the atrium, steering of atrial pulses to provide an enhancement of a VDD system, steering of atrial or ventricular defibrillation stimuli, and steering stimuli for arrhythmia prevention. In yet other embodiments, the steered pulse system is combined with capture detection and automatic adjustment of the steering parameters.

Claims

1. A pacing system for pacing in at least a patient'"'"'s left atrium, comprising:

a multiple electrode lead for pacing in the patient'"'"'s left atrium, said lead having a distal end and at least two anode electrodes and one cathode electrode positioned near said distal end, said electrodes being spaced from each other with a predetermined geometry, said lead having a proximal end for connecting to a pulse generator, and respective conductors connecting the respective electrodes to said proximal end,

pulse generator means for generating at least two pulse outputs and delivering a first of said outputs between a first of said anode electrodes and said cathode electrode, and for delivering a second of said outputs between the second of said anode electrodes and said cathode electrode, said pulse outputs having magnitude, polarity and phase parameters,

control means for controlling each of said pulse outputs with respect to at least one of said pulse parameters, and

steering means for selecting said at least one pulse parameter for each pulse output so as to generate pulses for steering the delivery of composite steering pulses to an effective site when said lead distal end is positioned in the patient'"'"'s left atrium.

2. The pacing system as described in claim 1, wherein said steering means has means for selecting relative pulse amplitudes for each of the pulse outputs.

3. The pacing system as described in claim 1, wherein said steering means has means for selecting pulse magnitude and pulse polarity for each of said pulse outputs.

4. The pacing system as described in claim 1, further comprising capture detection means for determining when a pair of pulse outputs delivered from said lead electrodes has captured the patient'"'"'s atrium.

5. The pacing system as described in claim 4, comprising adjusting means for controlling said steering means to adjust said at least one pulse parameter through a predetermined sequence of parameter values, and parameter reset means for resetting said at least one parameter as a function of whether capture is determined for each said parameter value.

6. The pacing system as described in claim 1, wherein said pulse generating means comprises a plurality of pulse generators controllable to generate respective pulse outputs, said lead comprises a plurality of electrodes, and further comprising switching means for switching predetermined ones of said generator outputs to selected ones of said electrodes.

7. The pacing system as described in claim 6, wherein said control means controls said generators to generate a plurality of composite pulses each cardiac cycle, each of said composite pulses being comprised of at least two substantially concurrent pulses controlled with respect to said pulse parameters.

8. The pacing system as described in claim 1, wherein said lead has a first set of electrodes for delivering steering pulses to a patient'"'"'s atrium and a second set of electrodes for delivering steering pulses to a patient'"'"'s ventricle.

9. The pacing system as described in claim 1, comprising sensing means for sensing patient natural cardiac signals at selected ones of said electrodes and further comprising sense switching means for switching respective ones of said electrodes to said sense switching means at controlled times.

10. A pacing system for dual chamber pacing of a patient, comprising:

pulse generator means for generating pacing pulses for delivery to the patient'"'"'s heart, having first pulse means for generating first pacing pulses, said first pulses having controllable respective first magnitude, polarity and phase values, and second pulse means for generating second pacing pulses substantially concurrently with said first pulses, said second pulses having controllable respective second magnitude, polarity and phase values;

a pacing lead connected to said pulse generator means to receive said first and second pulses, said lead having a distal end portion adapted for positioning proximate to or in the patient'"'"'s heart, said distal end portion having first and second active electrodes and a common electrode, and connecting means for connecting said first pacing pulses between said first electrode and said common electrode and for connecting said second pacing pulses between said second electrode and said common electrode; and

control means for controlling said pulse generator means to generate respective steered ventricular and atrial pacing pulses, each of which steered pulses is a combination of a said first and a said second pulse, and

steering means for controlling said first and second pulse means so as to select a first set of values of magnitude, polarity and phase for each of said first and second pulses when said pulse generator generates a ventricular pacing pulse, and a second set of values of magnitude, polarity and phase for each of said first and second pulses when said pulse generator generates an atrial pacing pulse.

11. The system as described in claim 10, wherein said control means comprises timing means for controlling the timing of respective generated ventricular and atrial pulses.

12. The system as described in claim 11, comprising sensing means connected to said active electrodes and said common electrode for sensing electrical signals from the patient'"'"'s heart, and wherein said timing means controls said timing as a function of said sensed electric signals.

13. The system as described in claim 12, comprising additional sensing means located apart from said lead distal end portion for sensing patient cardiac signals, and determining means for determining from said sensed cardiac signals whether they represent atrial or ventricular signals.

14. A pacing system for dual chamber pacing of a patient comprising:

pulse generator means for generating pacing pulses for delivery to the patient'"'"'s heart, having first pulse means for generating first pacing pulses, said first pulses having controllable respective first magnitude, polarity and phase values, and second pulse means for generating second pacing pulses substantially concurrently with said first pulses, said second pulses having respective second magnitude, polarity and phase values independently controllable from the first values;

a single pass pacing lead, said lead having a distal portion for positioning in a patient'"'"'s right ventricle and an intermediate portion positioned for floating in the patient'"'"'s right atrium, said intermediate portion having first and second active electrodes and a common electrode, and at least one pacing electrode positioned substantially at the distal portion of said lead, a proximal end for connecting to said pulse generator means, and connecting means for connecting said first pulse signals to said first electrode and said common electrode and said second pulse signals to said second electrode and said common electrode; and

steering means for controlling said first pulse means with a selected first set of values of magnitude, polarity, and phase and for controlling said second pulse means with a selected second set of values of magnitude, polarity and phase, thereby delivering a steered atrial composite pacing pulse to said patient'"'"'s right atrium.

15. The system as described in claim 14, further comprising control means for controlling said pulse generator means to generate ventricular pacing pulses, and ventricular connecting means for connecting said generated ventricular pacing pulses to said at least one distal electrode.

16. The system as described in claim 15, wherein said control means comprises timing means for controlling the timing of respective generated ventricular and steered atrial pulses.

17. The system as described in claim 14, further comprising capture detection means for determining when a delivered steered atrial pace pulse achieves atrial capture, and

threshold detecting means operative together with said capture detection means for determining capture threshold for said steered atrial pulses.

18. The system as described in claim 17, further comprising search means for varying at least one parameters of said first and second pacing pulses of said atrial pulse, and searching for a set of parameter values corresponding to optimum threshold for pacing the patient'"'"'s atrium.

19. A pacing system for generating and delivering steered composite pace pulses to at least a plurality of sites in a patient'"'"'s heart, comprising:

generator means, comprising a plurality of generators for delivering respective stimulus pulse components, each of said generators having outputs controllable with respect to at least the amplitude and polarity of its pulse component;

electrode means for providing a plurality of electrodes at different respective cardiac positions in the patient'"'"'s heart, said electrode means providing at least three electrodes constituting two active electrodes and one common electrode at each respective cardiac position;

a plurality of sense amplifiers for sensing natural heart beat signals from selected ones of said patient positions;

switch matrix means for connecting selected ones of said generator outputs to respective selected ones of said electrodes, and selected ones of said electrodes to selected ones of said sense amplifiers, said matrix connecting composite stimulus pulses consisting of plural pulse components to selected ones of said positions; and

pulse parameter and timing control means for controlling the connections made by said switch matrix means, whereby selected cardiac sites receive steered composite stimulus pulses and said composite stimulus pulses are timed as a function of sensed patient natural heartbeat signals.

20. The system as described in claim 19, comprising threshold detection means for detecting when a given one of said composite stimulus pulses results in cardiac capture, and means for controlling said component parameters as a function of said threshold detection.

21. A method of delivering a steered pacing stimulus to at least one site in a patient'"'"'s heart, comprising:

storing steering parameter data including at least amplitude and polarity data of at least two pulse components of a steered composite pulse having said at least two components, said at least two components being independently controllable and at least partially overlapping respecting times,

selecting parameters of said at least two pulse components;

delivering to said site a composite steered stimulus having said at least two component pulses;

determining when adjustment of said composite pulse can provide for more effective steering; and

adjusting said steered composite pulse by changing one or more of said selected pulse component parameters.

22. The method as described in claim 21, comprising initially positioning an array of electrodes within or proximate to the patient'"'"'s heart, and wherein said delivering step comprises delivering said steered composite pulse across said array of electrodes.

23. The method as described in claim 22, comprising positioning three electrodes within the patient'"'"'s subclavian vein, wherein said delivering step comprises delivering a two-component pulse, a first of said components being delivered between a first and second of said electrodes, and a second component pulse being delivered between said second and a third of said electrodes.

24. The method as described in claim 23, comprising selecting said pulse component parameters to steer a stimulus pulse to the patent'"'"'s left atrium.

25. The method as described in claim 22, comprising selecting stimulus parameter data for first and second steered stimulus pulses, and comprising delivering first and second steered stimulus pulses to respective different cardiac targets during a patient cardiac cycle.

26. The method as described in claim 21, comprising selecting said stimulus parameter data for delivering a pacing pulse to a selected one of the patient'"'"'s heart chambers.

27. The method as described in claim 26, comprising selecting said stimulus parameter data for delivering a defibrillation pulse to the patient'"'"'s right atrium.

28. The method as described in claim 26, comprising selecting said stimulus parameter data for delivering a defibrillation pulse to the patient'"'"'s right ventricle.

29. The method as described in claim 21, comprising positioning an array of floating electrodes in the patient'"'"'s atrium, and wherein said step of delivering a steered stimulus pulse comprises delivering said steered pulse to the patient'"'"'s atrium by delivering it across said array of floating electrodes.

30. The method as described in claim 21, comprising determining whether a delivered steered atrial stimulus pulse results in atrial capture, and further comprising adjusting said atrial stimulus pulse as a function of whether atrial capture has been sensed.

31. The method as described in claim 21, wherein said step of storing parameter data comprises storing parameter data corresponding to morphology specific therapies, and further comprising the steps of:

detecting a patient arrhythmia;

selecting a therapy as a function of said detected arrhythmia;

retrieving from said stored parameter data parameter data corresponding to the selected therapy; and

administering said selected therapy by delivering steered composite pulses having pulse components controlled with said parameter data.

32. An implantable system for delivering pacing stimulus pulses to at least one selected cardiac site in a patient, comprising:

generator means for generating a composite pulse having at least two pulse components;

a lead for delivering said two pulse components to an area in or proximate to the patient'"'"'s heart, and

control means for independently controlling the parameters of each of said pulse components for steering said composite pulse to said selected site, wherein said generator means has means for generating a composite pacing pulse, and said control means comprises parameter adjustment means for adjusting one or more of the amplitude, pulse width and phase of each of said pulse components.

33. The system as described in claim 32, wherein said parameter adjustment means comprises amplitude increment means for incrementing the amplitude of a said pulse component by a predetermined increment.

34. The system as described in claim 33, wherein said parameter adjustment means comprises pulse width means for incrementing the pulse width of a said pulse component by a predetermined increment.

35. The system as described in claim 34, wherein said parameter adjustment means comprises phase means for adjusting the phase of a said pulse component by a predetermined increment.

36. The system as described in claim 32, wherein said lead has at least three electrodes comprising at least two common electrodes and at least one active electrode, and conductor means for delivering a first of said pulse components across a first of said common electrodes and said active electrode and a second of said pulse components across the other of said common electrodes and said active electrode.

37. The system as described in claim 32, wherein said lead has at least three electrodes comprising at least two active electrodes and at least one common electrode, and conductor means for delivering a first of said pulse components across a first of said active electrodes and said common electrode, and a second of said pulse components across the other of said active electrodes and said common electrode.

38. The system as described in claim 37, wherein each of said electrodes is separated by a distance of at least 1 cm.

39. The system as described in claim 37, wherein said two active electrodes are separated by a distance of at least 2 cm.

40. An implantable pacing system, comprising:

a multiple electrode lead for pacing a patient'"'"'s heart having at least two anode electrodes and at least one cathode electrode positioned thereon, said electrodes being spaced from each other with a predetermined geometry, said lead having a proximal end for connecting to a pulse generator and respective conductors connecting the respective electrodes to said proximal end;

pulse generator means for generating at least two pulse outputs and delivering a first of said outputs between a first of said anode electrodes and said cathode electrode, and for delivering a second of said outputs between a second of said anode electrodes and said cathode electrode, said pulse outputs at least partially overlapping in respect of time and having magnitude, polarity and phase parameters;

control means for independently controlling each of said pulse outputs with respect to at least one of said pulse parameters, and

steering means for selecting said at least one pulse parameter for each pulse output so as to generate pulses for steering the delivery of composite steering pulses to an effective site when the electrodes are positioned in the patient'"'"'s heart.

41. A pacing system, comprising:

a multiple electrode lead for pacing a patient'"'"'s heart having at least two cathode electrodes and at least one anode electrode positioned thereon, said electrodes being spaced from each other with a predetermined geometry, said lead having a proximal end for connecting to a pulse generator and respective conductors connecting the respective electrodes to said proximal end;

pulse generator means for generating at least two pulse outputs and delivering a first of said outputs between a first of said cathode electrodes and said anode electrode, and for delivering a second of said outputs between a second of said cathode electrodes and said anode electrode, said pulse outputs at least partially overlapping in respect of time and having magnitude, polarity and phase parameters,

control means for independently controlling each of said pulse outputs with respect to at least one of said pulse parameters, and

steering means for selecting said at least one pulse parameter for each pulse output so as to generate pulses for steering the delivery of composite steering pulses to an effective site when the electrodes are positioned in the patient'"'"'s heart.

42. A pacing system, comprising:

a multiple electrode lead for pacing in a patient'"'"'s heart having at least three electrodes of alternating first and second polarities positioned thereon, at least two electrodes having the first polarity, at least one electrode having the second polarity, said electrodes being spaced from each other with a predetermined geometry, said lead having a proximal end for connecting to a pulse generator and respective conductors connecting the respective electrodes to said proximal end;

pulse generator means for generating at least two pulse outputs and delivering a first of said outputs between a first of said at least two first polarity electrodes and said at least one second polarity electrode, and for delivering a second of said outputs between a second of said at least two first polarity electrodes and said at least one second polarity electrode, said pulse outputs having magnitude, polarity and phase parameters;

control means for independently controlling each of said pulse outputs with respect to at least one of said pulse parameters, and

steering means for selecting said at least one pulse parameter for each pulse output so as to generate pulses for steering the delivery of composite steering pulses to an effective site when said electrodes are positioned in the patient'"'"'s heart.