Active implantable medical device with dynamic optimization of stimulation pulse energy

• US 9,925,383 B2
• Filed: 01/11/2016
• Issued: 03/27/2018
• Est. Priority Date: 01/12/2015
• Status: Active Grant

• Current Assignee: Sorin CRM USA (MicroPort Scientific Corp.)
• Original Assignee: Sorin CRM USA (MicroPort Scientific Corp.)
• Inventors: Makdissi, Alaa
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Piateski, Erin M
• Application Number:
  US14/992,677
• Publication Number:
  US 20160199654A1
• Time in Patent Office: 806 Days
• Field of Search: 607 7
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/3712 Auto-capture, i.e. automatic adjustment of the stimulation threshold
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula

Abstract

The disclosure relates to a device including a circuit for adjusting the energy of the stimulation pulses, independently controlling the pulse width and the voltage of each stimulation pulse. An iterative search algorithm for determining the optimum energy includes changing both the pulse width and voltage at each new pulse delivered, by setting a high energy value and a low energy value, and delivering a stimulation pulse with the low energy value. A capture test is then carried out. In the presence of a capture, a current iteration is complete and a new iteration is done with the current low energy as a new high energy value. In the absence of capture, the algorithm is terminated with selection of the last energy value that produced the capture as the value of optimum energy.

Claims

1. An active implantable medical device for stimulation, resynchronization, and/or defibrillation, comprising:

a stimulation circuit adapted to deliver stimulation pulses to an electrode in contact with a heart of a patient;

a capture test circuit adapted to detect a presence or an absence of a contraction of the heart subsequent to a stimulation pulse; and

an energy adjustment circuit adapted to adjust an energy of the stimulation pulses delivered by the stimulation circuit by independently controlling a stimulation voltage and a pulse width of the stimulation pulse for each stimulation pulse delivered;

wherein the energy adjustment circuit is configured to implement an iterative algorithm, wherein the iterative algorithm at each current iteration comprises testing to determine whether a contraction of the heart occurs at a plurality of energy values, wherein the testing comprises;

setting a value of high energy, wherein the value of high energy includes a first pulse width and a first stimulation voltage;

setting a value of low energy, wherein the value of low energy includes a second pulse width and a second stimulation voltage, wherein the second pulse width is less than the first pulse width, and wherein the second stimulation voltage is less than the first stimulation voltage;

delivering a stimulation pulse with the value of low energy; and

performing a capture test to detect the presence or the absence of a contraction of the heart; and

in the presence of a contraction;

ending the current iteration; and

transitioning to a new iteration, wherein the value of the delivered energy that produced the presence of a contraction is set as a new value of high energy; and

in the absence of a contraction;

applying consecutive counter-stimulation pulses of the first pulse width and the first stimulation voltage set for the value of high energy;

determining whether an end of the current iteration has been reached;

in response to determining the end of the current iteration has not been reached, continuing the current iteration with delivery of a stimulation pulse of increased energy and re-performing the capture test to detect the presence or the absence of a contraction of the heart; and

in response to determining the end of the current iteration has been reached, selecting a last energy value that produced the presence of a contraction as a selected energy value.

2. The device of claim 1, wherein the iterative algorithm at each current iteration further comprises:

defining a first intermediate energy value comprising the second pulse width and the first stimulation voltage;

defining a second intermediate energy value comprising the first pulse width and the second stimulation voltage;

defining a third intermediate energy value comprising a third pulse width between the first and second pulse widths and a third stimulation voltage between the first and second stimulation voltages;

ranking the first, second, and third intermediate energy values by decreasing energy value; and

wherein, in the absence of a contraction and in response to determining the end of the current iteration has not been reached, continuing the current iteration comprises delivering a stimulation pulse of the first, second, or third intermediate energy value, wherein the intermediate energy value of lowest rank that has not yet been delivered is selected as the intermediate energy value to be delivered.

3. The device of claim 2, wherein the third intermediate energy value is a value such that that the third pulse width is an average of the first and second pulse widths and the third stimulation voltage is an average of the first and second stimulation voltages.

4. The device of claim 1, wherein the energy values of the stimulation pulses delivered by the stimulation circuit are at most equal to an upper energy threshold value, wherein the first pulse width and the first stimulation voltage of the value of high energy of a first iteration of the algorithm is the upper energy threshold value.

5. The device of claim 1, wherein the energy values of the stimulation pulses delivered by the stimulation circuit are at least equal to a lower energy threshold limit value with a lower pulse width and a lower stimulation voltage, wherein the low energy value is a value such that the second pulse width is an average of the first pulse width and the lower pulse width and the second stimulation voltage is an average of the first stimulation voltage and the lower stimulation voltage.

6. The device of claim 1, wherein the energy values of the stimulation pulses delivered by the stimulation circuit are between an upper energy threshold value and a lower energy threshold value calculated before each first iteration of the algorithm.

7. The device of claim 6, wherein an upper pulse width and an upper stimulation voltage of the upper energy threshold value and a lower pulse width and a lower stimulation voltage of the lower energy threshold value are calculated by applying multiplication factors, respectively above and below unity, to a current pulse width and to a current stimulation voltage of the stimulation circuit before each first iteration of the algorithm.

8. A method for determining an energy for stimulation, resynchronization, and/or defibrillation, comprising:

implementing an iterative algorithm, wherein implementing each current iteration of the iterative algorithm comprises testing to determine whether a contraction of the heart occurs at a plurality of energy values, wherein the testing comprises;

setting a value of high energy, wherein the value of high energy includes a first pulse width and a first stimulation voltage;

setting a value of low energy, wherein the value of low energy includes a second pulse width and a second stimulation voltage and the second pulse width and second stimulation voltage are less than the first pulse width and first stimulation voltage;

delivering a stimulation pulse with the value of low energy; and

performing a capture test to detect a presence or an absence of a contraction of a heart of a patient; and

in the presence of a contraction;

ending the current iteration; and

transitioning to a new iteration, wherein the value of the delivered energy that produced the presence of a contraction is set as a new value of high energy; and

in the absence of a contraction;

applying consecutive counter-stimulation pulses of the first pulse width and the first stimulation voltage set for the value of high energy;

determining whether an end of the current iteration has been reached;

in response to determining the end of the current iteration has not been reached, continuing the current iteration with delivery of a stimulation pulse of increased energy and re-performing the capture test to detect the presence or the absence of a contraction of the heart; and

in response to determining the end of the current iteration has been reached, selecting a last energy value that produced the presence of a contraction as a selected energy value.

9. The method of claim 8, wherein implementing each iteration of the iterative algorithm further comprises:

defining a first intermediate energy value comprising the second pulse width and the first stimulation voltage;

defining a second intermediate energy value comprising the first pulse width and the second stimulation voltage;

defining a third intermediate energy value comprising a third pulse width between the first and second pulse widths and a third stimulation voltage between the first and second stimulation voltages;

ranking the first, second, and third intermediate energy values by decreasing energy value; and

wherein, in the absence of a contraction and in response to determining the end of the current iteration has not been reached, continuing the current iteration comprises delivering a stimulation pulse of the first, second, or third intermediate energy value, wherein the intermediate energy value of lowest rank that has not yet been delivered is selected as the intermediate energy value to be delivered.

10. The method of claim 9, wherein the third intermediate energy value is a value such that that the third pulse width is an average of the first and second pulse widths and the third stimulation voltage is an average of the first and second stimulation voltages.

11. The method of claim 8, wherein the energy values of the stimulation pulses delivered are at most equal to an upper energy threshold value, wherein the first pulse width and the first stimulation voltage of the value of high energy of a first iteration of the algorithm is the upper energy threshold value.

12. The method of claim 8, wherein the energy values of the stimulation pulses delivered are at least equal to a lower energy threshold value with a lower pulse width and a lower stimulation voltage, wherein the low energy value is a value such that the second pulse width is an average of the first pulse width and the lower pulse width and the second stimulation voltage is an average of the first stimulation voltage and the lower stimulation voltage.

13. The method of claim 8, wherein the energy values of the stimulation pulses delivered are between an upper energy threshold value and a lower energy threshold value calculated before each first iteration of the algorithm.

14. The method of claim 13, wherein an upper pulse width and an upper stimulation voltage of the upper energy threshold value and a lower pulse width and a lower stimulation voltage of the lower energy threshold value are calculated by applying multiplication factors, respectively above and below unity, to a current pulse width and to a current stimulation voltage before each first iteration of the algorithm.

15. An active implantable medical device for stimulation, resynchronization and/or defibrillation, comprising:

circuitry configured to;

deliver stimulation pulses to an electrode in contact with a heart of a patient;

detect a presence or an absence of a contraction of the heart subsequent to a stimulation pulse; and

adjust an energy of the stimulation pulses delivered by the circuitry by independently controlling a stimulation voltage and a pulse width of the stimulation pulse for each stimulation pulse delivered; and

determine a selected energy by applying a plurality of iterations, wherein each current iteration comprises testing to determine whether a contraction of the heart occurs at a plurality of energy values, wherein the testing comprises;

setting a value of high energy, wherein the value of high energy includes a first pulse width and a first stimulation voltage;

setting a value of low energy, wherein the value of low energy includes a second pulse width and a second stimulation voltage and the second pulse width and second stimulation voltage are less than the first pulse width and first stimulation voltage;

delivering a stimulation pulse with the value of low energy; and

performing a capture test to detect the presence or the absence of a contraction of the heart; and

in the presence of a contraction;

ending the current iteration; and

transitioning to a new iteration, wherein the value of the delivered energy that produced the presence of a contraction is set as a new value of high energy; and

in the absence of a contraction;

applying consecutive counter-stimulation pulses of the first pulse width and the first stimulation voltage set for the value of high energy;

determining whether an end of the current iteration has been reached;

in response to determining the end of the current iteration has not been reached, continuing the current iteration with delivery of a stimulation pulse of increased energy and re-performing the capture test to detect the presence or the absence of a contraction of the heart; and

in response to determining the end of the current iteration has been reached, selecting a last energy value that produced the presence of a contraction as a selected energy value.

16. The device of claim 15, wherein each current iteration further comprises:

defining a first intermediate energy value comprising the second pulse width and the first stimulation voltage;

defining a second intermediate energy value comprising the first pulse width and the second stimulation voltage;

defining a third intermediate energy value comprising a third pulse width between the first and second pulse widths and a third stimulation voltage between the first and second stimulation voltages;

ranking the first, second, and third intermediate energy values by decreasing energy value; and

wherein, in the absence of a contraction and in response to determining the end of the current iteration has not been reached, continuing the current iteration comprises delivering a stimulation pulse of the first, second, or third intermediate energy value, wherein the intermediate energy value of lowest rank that has not yet been delivered is selected as the intermediate energy value to be delivered.

17. The device of claim 16, wherein the third intermediate energy value is a value such that that the third pulse width is an average of the first and second pulse widths and the third stimulation voltage is an average of the first and second stimulation voltages.

18. The device of claim 15, wherein the energy values of the stimulation pulses delivered by the circuitry are at most equal to an upper energy threshold value, wherein the first pulse width and the first stimulation voltage of the value of high energy of a first iteration of the plurality of iterations is the upper energy threshold value.

19. The device of claim 15, wherein the energy values of the stimulation pulses delivered by the circuitry are at least equal to a lower energy threshold value with a lower pulse width and a lower stimulation voltage, wherein the low energy value is a value such that the second pulse width is an average of the first pulse width and the lower pulse width and the second stimulation voltage is an average of the first stimulation voltage and the lower stimulation voltage.

20. The device of claim 15, wherein an upper pulse width and an upper stimulation voltage of an upper energy threshold value and a lower pulse width and a lower stimulation voltage of a lower energy threshold value are calculated by applying multiplication factors, respectively above and below unity, to a current pulse width and to a current stimulation voltage of the circuitry before a first iteration of the plurality of iterations.