Automated phrenic nerve stimulation and pacing capture threshold test

• US 9,504,837 B2
• Filed: 10/25/2013
• Issued: 11/29/2016
• Est. Priority Date: 10/25/2013
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Demmer, Wade M, Sheldon, Todd J, Stadler, Robert W, Zhang, Xusheng
• Primary Examiner(s): DIETRICH, JOSEPH M
• Application Number:
  US14/063,766
• Publication Number:
  US 20150119950A1
• Time in Patent Office: 1,131 Days
• US Class Current: 1/1
• CPC Class Codes: A61N 1/3601 of respiratory organs
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/371 Capture, i.e. successful stimulation
• CPC Class Codes: A61N 1/3712 Auto-capture, i.e. automatic adjustment of the stimulation threshold

Abstract

A medical device system performs a method for determining pacing threshold data. Signals are received from a cardiac capture sensor and a phrenic nerve stimulation sensor. A cardiac capture threshold is determined from the cardiac capture sensor signal and a phrenic nerve stimulation threshold is determined from the phrenic nerve stimulation sensor signal for multiple pacing electrode vectors.

Claims

1. An automated method for determining pacing threshold data, comprising:

receiving a signal from a cardiac capture sensor;

receiving a signal from a phrenic nerve stimulation sensor;

determining a cardiac capture threshold from the cardiac capture sensor signal while detecting phrenic nerve stimulation from the phrenic nerve stimulation sensor signal for each of a plurality of pacing electrode vectors, the determining comprising;

delivering a stimulation pulse via a selected one of the plurality of pacing electrode vectors using a first pacing pulse output;

detecting from the phrenic nerve stimulation sensor signal whether phrenic nerve stimulation occurs in response to the first pacing pulse output;

adjusting the stimulation pulse by a first step to a second pacing pulse output in response to detecting the phrenic nerve stimulation;

detecting from the cardiac capture sensor signal whether cardiac capture occurs in response to the second pacing pulse output; and

adjusting the stimulation pulse output by a second step to a third pacing pulse output in response to detecting cardiac capture, the second step being less than the first step.

2. The method of claim 1, further comprising:

delivering a first number of pulses at the first pacing pulse output;

analyzing the phrenic nerve stimulation sensor signal for each of the first number of pulses for detecting the phrenic nerve stimulation; and

analyzing the cardiac capture sensor signal for less than the first number of pulses for detecting cardiac capture at the first pacing pulse output.

3. The method of claim 1, further comprising:

delivering a first number of pulses at the second pacing pulse output for detecting whether cardiac capture occurs without phrenic nerve stimulation; and

delivering a second number of pulses at the third pacing pulse output in response to detecting the cardiac capture without phrenic nerve stimulation, the second number of pulses being less than the first number of pulses.

4. The method of claim 1, wherein the first pacing pulse output comprises a maximum output amplitude and the first step is half of an output amplitude range to the second pacing pulse output comprising a mid-range output amplitude.

5. The method of claim 1, wherein the first step is at least a safety pacing margin.

6. The method of claim 1, further comprising:

detecting whether the cardiac capture occurs with phrenic nerve stimulation in response to the second pacing pulse;

repeating adjusting the stimulation pulse by the first step in response to detecting the cardiac capture with phrenic nerve stimulation;

detecting whether the cardiac capture occurs without phrenic nerve stimulation in response to each adjustment to the stimulation pulse; and

adjusting the stimulation pulse by the second step in response to detecting the cardiac capture without phrenic nerve stimulation.

7. The method of claim 1, further comprising:

detecting whether the cardiac capture occurs without phrenic nerve stimulation in response to the second pacing pulse;

repeating adjusting the stimulation pulse by the second step to determine a cardiac capture threshold in response to detecting the cardiac capture without phrenic nerve stimulation; and

adjusting the stimulation pulse upward from the second pacing pulse output to determine a phrenic nerve stimulation threshold in response to detecting the cardiac capture without phrenic nerve stimulation in response to the second pacing pulse.

8. The method of claim 7, wherein the adjusting the stimulation pulse upward from the second pacing pulse output comprises using a third step larger than the second step.

9. The method of claim 1, wherein the first step is to the second pacing pulse output and further comprising:

detecting whether the cardiac capture occurs with phrenic nerve stimulation in response to the second pacing pulse;

repeatedly adjusting the stimulation pulse by the second step in response to detecting the cardiac capture without phrenic nerve stimulation at the second pacing pulse until the cardiac capture threshold is determined; and

repeatedly adjusting the stimulation pulse by a third step in response to detecting the cardiac capture without phrenic nerve stimulation at the second pacing pulse until the phrenic nerve stimulation threshold is determined,

the third step being at least a safety pacing margin and greater than the second step.

10. The method of claim 1, further comprising selecting one of the plurality of electrode vectors for delivering an electrical stimulation therapy in response to the pacing threshold data.

11. A medical device system for determining pacing threshold data, comprising:

a cardiac capture sensor;

a phrenic nerve stimulation sensor;

a pulse generator selectively coupled to a plurality of electrode vectors;

a processor coupled to the cardiac capture sensor, the phrenic nerve stimulation sensor and the pulse generator and configured to determine a cardiac capture threshold from the cardiac capture sensor signal while detecting phrenic nerve stimulation from the phrenic nerve stimulation sensor signal for each of the plurality of pacing electrode vectors, the determining comprising;

controlling the pulse generator to deliver a stimulation pulse via a selected one of the plurality of pacing electrode vectors using a first pacing pulse output;

detecting from the phrenic nerve stimulation sensor signal whether phrenic nerve stimulation occurs in response to the first pacing pulse output;

adjusting the stimulation pulse by a first step to a second pacing pulse output in response to detecting the phrenic nerve stimulation;

detecting from the cardiac capture sensor signal whether cardiac capture occurs in response to the second pacing pulse output; and

adjusting the stimulation pulse output by a second step to a third pacing pulse output in response to detecting cardiac capture, the second step being less than the first step.

12. The system of claim 11, wherein processor is configured to:

control the pulse generator to deliver a first number of pulses at the first pacing pulse output;

analyze the phrenic nerve stimulation sensor signal for each of the first number of pulses for detecting the phrenic nerve stimulation; and

analyze the cardiac capture sensor signal for less than the first number of pulses for detecting cardiac capture at the first pacing pulse output.

13. The system of claim 11, wherein the processor is further configured to:

control the pulse generator to deliver a first number of pulses at the second pacing pulse output for detecting whether cardiac capture occurs without phrenic nerve stimulation and deliver a second number of pulses at the third pacing pulse output in response to detecting the cardiac capture without phrenic nerve stimulation, the second number of pulses being less than the first number of pulses.

14. The system of claim 11, wherein the first pacing pulse output comprises a maximum output amplitude and the first step is half of an output amplitude range to the second pacing pulse output comprising a mid-range output amplitude.

15. The device of claim 11, wherein the first step is at least a safety pacing margin.

16. The system of claim 11, wherein the processor is further configured to:

detect whether the cardiac capture occurs with phrenic nerve stimulation in response to the second pacing pulse;

repeat adjusting the stimulation pulse by the first step in response to detecting the cardiac capture with phrenic nerve stimulation;

detect whether the cardiac capture occurs without phrenic nerve stimulation in response to each adjustment to the stimulation pulse; and

adjust the stimulation pulse by the second step in response to detecting the cardiac capture without phrenic nerve stimulation.

17. The system of claim 11, wherein the processor is further configured to:

detect whether the cardiac capture occurs without phrenic nerve stimulation in response to the second pacing pulse;

repeat adjusting the stimulation pulse by the second step to determine a cardiac capture threshold in response to detecting the cardiac capture without phrenic nerve stimulation; and

adjust the stimulation pulse upward from the second pacing pulse output to determine a phrenic nerve stimulation threshold in response to detecting the cardiac capture without phrenic nerve stimulation in response to the second pacing pulse.

18. The system of claim 17, wherein the adjusting the stimulation pulse upward from the second pacing pulse output comprises using a third step larger than the second step.

19. The system of claim 11, wherein the first step is to the second pacing pulse output and the processor further configured to:

detect whether the cardiac capture occurs with phrenic nerve stimulation in response to the second pacing pulse;

repeatedly adjust the stimulation pulse by the second step in response to detecting the cardiac capture without phrenic nerve stimulation at the second pacing pulse until the cardiac capture threshold is determined; and

repeatedly adjust the stimulation pulse by a third step in response to detecting the cardiac capture without phrenic nerve stimulation at the second pacing pulse until the phrenic nerve stimulation threshold is determined,

the third step being at least a safety pacing margin and greater than the second step.

20. The system of claim 11, wherein the processor is further configured to select one of the plurality of electrode vectors for delivering an electrical stimulation therapy in response to the pacing threshold data.

21. A non-transitory, computer-readable storage medium storing instructions for causing a processor included in a medical device system to perform a method for determining pacing threshold data, the method comprising:

receiving a signal from a cardiac capture sensor;

receiving a signal from a phrenic nerve stimulation sensor;

determining a cardiac capture threshold from the cardiac capture sensor signal while detecting phrenic nerve stimulation from the phrenic nerve stimulation sensor signal for each of a plurality of pacing electrode vectors, the determining comprising;

delivering a stimulation pulse via a selected one of the plurality of pacing electrode vectors using a first pacing pulse output;

detecting from the phrenic nerve stimulation sensor signal whether phrenic nerve stimulation occurs in response to the first pacing pulse output;

adjusting the stimulation pulse by a first step to a second pacing pulse output in response to detecting the phrenic nerve stimulation;

detecting from the cardiac capture sensor signal whether cardiac capture occurs in response to the second pacing pulse output; and

adjusting the stimulation pulse output by a second step to a third pacing pulse output in response to detecting cardiac capture, the second step being less than the first step.

22. A system, comprising:

receiving means for receiving a signal from a cardiac capture sensor;

receiving means for receiving a signal from a phrenic nerve stimulation sensor;

output means for delivering stimulation pulses; and

processing means for determining a cardiac capture threshold from the cardiac capture sensor signal while detecting phrenic nerve stimulation from the phrenic nerve stimulation sensor signal for each of a plurality of pacing electrode vectors, the determining comprising;

delivering a stimulation pulse by the output means via a selected one of the plurality of pacing electrode vectors using a first pacing pulse output;

detecting from the phrenic nerve stimulation sensor signal whether phrenic nerve stimulation occurs in response to the first pacing pulse output;

adjusting the stimulation pulse by a first step to a second pacing pulse output in response to detecting the phrenic nerve stimulation;

detecting from the cardiac capture sensor signal whether cardiac capture occurs in response to the second pacing pulse output; and

adjusting the stimulation pulse output by a second step to a third pacing pulse output in response to detecting cardiac capture, the second step being less than the first step.