Pacemaker system and method with improved evoked response and repolarization signal detection

• US 6,067,472 A
• Filed: 01/22/1998
• Issued: 05/23/2000
• Est. Priority Date: 03/12/1997
• Status: Expired due to Term

• Current Assignee: Vitatron Medical BV (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: van Oort, Geeske, Vonk, Bernardus F. M.
• Primary Examiner(s): Schaetzle, Kennedy
• Application Number:
  US09/010,694
• Time in Patent Office: 852 Days
• Field of Search: 607/13, 607/27, 607/28
• US Class Current: 607/28
• CPC Class Codes: A61N 1/3712 Auto-capture, i.e. automatic adjustment of the stimulation threshold
• CPC Class Codes: A61N 1/3716 with reduction of residual polarisation effects

Abstract

There is provided a pacemaker system with capture verification and threshold testing, in which the pacemaker adjusts the post-stim pulse portion of a triphasic pulse to minimize polarization, and waits after each change in delivered pace pulses for a stabilization interval, in order to enhance capture verification. The threshold test utilizes a pace pulse pair, comprising a prior search pulse which is varied during the test, and the regular pacing pulse which is above threshold. When delivery of the pulse pairs is initiated, the search pulse is adjusted to optimize polarization, and the pacemaker waits for a predetermined stabilization period of time in order to allow for minimum polarization and to optimize capture detection. The search pulse is increased incrementally in output value toward threshold, and following each such increase the pacemaker waits for a stabilization interval. The pacemaker detects when capture is achieved by the search pulse, thereby providing an indication of threshold. The polarization minimization feature involves scanning the post-stim duration to find the optimal duration. The polarization minimization also enables detection of repolarization signals, and consequent pacemaker functions such as AAIR pacing and suppression of atrial tachycardia.

Claims

1. A pacemaker system for delivering pace pulses to a patient'"'"'s heart, comprising:

a controllable pulse generator for delivering pace pulses comprising a stimulus pulse portion of a first polarity and a post-stim portion of a second polarity;

control means for controlling the duration of said post-stim pace pulses;

a lead for delivering said pace pulses, said lead having at least one electrode at about its distal end;

sensing means for sensing signals at said electrode, and polarization level means for determining the level of polarization signals sensed at said electrode; and

said control means having program means for programming said post-stim pace pulse duration to a value at which the level of a said polarization signal following a delivered pace pulse is within predetermined limits, wherein said program means comprises means for adjusting said post-stim portion to different values in a predetermined sequence until said polarization signals are determined to be within said limits.

2. The system as described in claim 1, comprising cardiac signal means for recognizing cardiac signals sensed at said electrode, and evoked response means for determining when there has been an evoked response following a said delivered pace pulse.

3. The system as described in claim 2, comprising timing means for enabling said evoked response means after a first time duration following a delivered pace pulse.

4. The system as described in claim 3, wherein said program means has positive means for programming said post-stim duration to a value at which the level of polarization signals following delivered pace pulses is a positive value within said limits, and wherein said evoked response means comprises means for detecting a negative-going signal.

5. The system as described in claim 4, wherein said pulse generator means comprises triphasic means for generating and delivering pace pulses comprising a pre-stim positive portion, a negative stimulus portion, and a post-stim positive portion.

6. The system as described in claim 1, comprising threshold determining means for determining patient threshold to delivered pace pulses having said programmed post-stim pulse duration.

7. The system as described in claim 6, wherein said threshold means comprises means for determining that said post-stim polarization is within said limits following a predetermined number of consecutive said pacing pulses delivered at a predetermined stimulus level.

8. The system as described in claim 1, wherein said program means comprises means for setting said polarization signal limits at about 0.5 mV to 1.0 mV.

9. A method of generating stimulus pulses for delivery to an electrode positioned in proximity to a patient'"'"'s heart, each said stimulus pulse having a stimulus portion of a first polarity and a post-stim portion of an opposite polarity, comprising:

setting the magnitude and duration of said stimulus portion;

setting the magnitude and duration of said post-stim portion;

adjusting said post-stim duration and delivering stimulus pulses and determining the polarization level at said electrode following delivery of stimulus pulses, and continuing said adjusting and delivering and determining until the post-stim portion is optimally adjusted so that said polarization level is within predetermined limits; and

generating stimulus pulses having a said stimulus portion and a said optimally adjusted post-stim portion, comprising generating said stimulus portion with a negative polarity and said post-stim portion with a positive polarity, and initially setting said post-stim duration to a value selected so that thc polarization following delivery of a stimulus pulse is positive.

10. A method of generating stimulus pulses for delivery to an electrode positioned in proximity to a patient'"'"'s heart, each said stimulus pulse having a stimulus portion of a first polarity and a post-stim portion of an opposite polarity, comprising:

setting the magnitude and duration of said stimulus portion;

setting the magnitude and duration of said post-stim portion;

adjusting said post-stim duration and delivering stimulus pulses and determining the polarization level at said electrode following delivery of stimulus pules, and continuing said adjusting and delivering and determining until the post-stim portion is optimally adjusted so that said polarization level is within predetermined limits; and

generating stimulus pules having a said stimulus portion and a said optimally adjusted post-stim portion, comprising generating said stimulus portion with a negative polarity and said post-stim portion with a positive polarity, and initially setting said post-stim duration to a value selected so that the polarization following delivery of a stimulus pulse is positive, comprising determining when the polarization following delivery of a said stimulus pulse is positive and within a range of about 0.5 to 1.0 mV, determining the post-stim duration which results in polarization within said range, and thereafter generating said stimulus pulses with said determined post-stim duration.

11. A method of generating stimulus pulses for delivery to an electrode positioned in proximity to a patient'"'"'s heart, each said stimulus pulse having a stimulus portion of a first polarity and a post-stim portion of an opposite polarity, comprising:

setting the magnitude and duration of said stimulus portion;

setting the magnitude and duration of said post-stim portion;

adjusting said post-stim duration and delivering stimulus pulses and determining the polarization level at said electrode following delivery of stimulus pulses, and continuing said adjusting and delivering and determining until the post-stim portion is optimally adjusted so that said polarization level is within predetermined limits; and

generating stimulus pulses having a said stimulus portion and a said optimally adjusted post-stim portion, comprising generating said stimulus portion with a negative polarity and said post-slim portion with a positive polarity, and initially setting said post-stim duration to a value selected so that the polarization following delivery of a stimulus pulse is positive, comprising determining when the polarization following delivery of a said stimulus pulse is positive and within a range of about 0.5 to 1.0 mV, determining the post-stim duration which results in polarization within said range, and thereafter generating said stimulus pulses with said determined post-stim duration, further comprising detecting an evoked response following delivery of said stimulus pulse with said determined post-stim duration by sensing a negative signal.

12. A system for optimizing polarization following delivery of pacing pulses to a patient, said pacing pulses being triphasic and having a positive post-stim portion, comprising:

means for generating said triphasic pulses;

means for delivering said triphasic pulses to a pair of electrodes being positioned so that said pulses stimulate said patient'"'"'s heart;

means for sensing the polarization level at said electrodes following a delivered pacing pulse;

means for adjusting said post-stim portion to obtain a following polarization within predetermined limits; and

polarization optimization means for enabling said means for sensing and said means for adjusting, and program means for programming said polarization optimization means to operate at predetermined times, said program means is programmed to operate said polarization optimization means at a predetermined frequency, wherein said program means has means for lengthening the interval between operations after said system has been implanted for at least a predetermined time.

13. The system as described in claim 12, comprising means for determining when a negative signal occurs within a predetermined time window following a delivered pacing pulse, thereby determining when there has been an evoked response.