Method and apparatus for phrenic stimulation detection

• US 9,555,253 B2
• Filed: 05/10/2016
• Issued: 01/31/2017
• Est. Priority Date: 02/14/2008
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Brooke, M. Jason
• Primary Examiner(s): Gedeon, Brian T
• Application Number:
  US15/150,853
• Publication Number:
  US 20160250479A1
• Time in Patent Office: 266 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 5/1107 Measuring contraction of parts of the body, e.g. organ, muscle apparatus for measuring work or force in general G01L
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/283 Invasive
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/4029 for evaluating the peripheral nervous systems A61B5/24 takes precedence
• CPC Class Codes: A61B 5/4848 Monitoring or testing the effects of treatment, e.g. of medication
• CPC Class Codes: A61N 1/3601 of respiratory organs
• CPC Class Codes: A61N 1/36585 controlled by two or more physical parameters
• CPC Class Codes: A61N 1/3684 for stimulating the heart at multiple sites of the ventricle or the atrium
• CPC Class Codes: A61N 1/36842 Multi-site stimulation in the same chamber
• CPC Class Codes: A61N 1/36843 Bi-ventricular stimulation
• CPC Class Codes: A61N 1/3706 Pacemaker parameters stimulation threshold A61N1/371
• 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
• CPC Class Codes: A61N 1/372 Arrangements in connection with the implantation of stimulators

Abstract

Approaches for characterizing a phrenic stimulation threshold, a cardiac capture threshold, a maximum device parameter, and a minimum device parameter are described. A plurality of cardiac pacing pulses can be delivered by using a cardiac pacing device, a pacing parameter of the plurality of cardiac pacing pulses being changed between delivery of at least some of the pulses. One or more sensor signals can be evaluated to detect stimulation of the phrenic nerve by one or more of the plurality of cardiac pacing pluses. The evaluation of the one or more sensor signals and the pacing parameter can be compared to determine if a phrenic stimulation threshold is at least one of higher than a maximum device parameter and lower than a minimum device parameter.

Claims

1. A method of controlling operation of a medical device, the method comprising:

delivering a pulse with a predetermined pulse energy as part of a cardiac capture threshold test;

determining if the delivered pulse produced phrenic stimulation;

continuing the capture threshold test when it is determined that the delivered pulse did not produce phrenic stimulation; and

halting the capture threshold test when detecting, using the medical device, that the delivered pulse did produce phrenic stimulation.

2. The method of claim 1, further including storing phrenic stimulation information in the medical device when detecting that the delivered pulse did produce phrenic stimulation.

3. The method of claim 2, wherein the storing the phrenic stimulation information includes storing a comparison of a phrenic stimulation threshold to one or both of a maximum device pulse amplitude and a minimum device pulse amplitude.

4. The method of claim 2, wherein the storing the phrenic stimulation information includes storing a comparison of a phrenic stimulation threshold to a capture threshold used in the capture threshold test.

5. The method of claim 1, wherein the predetermined pulse energy corresponds to a cardiac pacing device capability limit.

6. The method of claim 1, wherein the predetermined pulse energy corresponds to a programmed cardiac pacing device limit.

7. The method of claim 1, wherein a cardiac pacing device includes a plurality of electrode combinations where each electrode combination defines a pacing vector, the method comprising performing the method for each of two or more pacing vectors.

8. The method of claim 7, further comprising:

for each of the two or more pacing vectors, displaying on a display of a patient external device an indication of whether the pulse produced phrenic stimulation; and

for each of the two or more pacing vectors, displaying on the display of the patient external device an indication of a capture threshold as determined by the capture threshold test.

9. A medical apparatus, comprising;

a pulse generator for generating pulses at selectable pulse energy; and

a controller operatively coupled to the pulse generator, the controller configured to;

initiate delivery of a pace pulse with a predetermined pacing pulse energy as part of a cardiac capture threshold test;

determine when the delivered pulse produced phrenic stimulation;

continue the capture threshold test when it is determined that the delivered pulse did not produce phrenic stimulation; and

halt the capture threshold test when determining that the delivered pulse did produce phrenic stimulation.

10. The medical apparatus of claim 9, including a memory circuit integral to, or operatively coupled to the controller, wherein the controller is configured to store phrenic stimulation information in the memory circuit when detecting that the delivered pulse did produce phrenic stimulation.

11. The medical apparatus of claim 10, wherein the phrenic stimulation information includes a comparison of a phrenic stimulation threshold to one or both of a maximum device pulse amplitude and a minimum device pulse amplitude.

12. The medical apparatus of claim 10, wherein the phrenic stimulation information includes a comparison of a phrenic stimulation threshold to a capture threshold used in the capture threshold test.

13. The medical apparatus of claim 9, wherein the predetermined pulse energy corresponds to a cardiac pacing device capability limit.

14. The medical apparatus of claim 9, wherein the predetermined pulse energy corresponds to a programmed cardiac pacing device limit.

15. The medical apparatus of claim 9, including a plurality of electrodes configurable as a plurality of electrode combinations, wherein an electrode combination defines a pacing vector, and wherein the controller is configured to deliver a pace pulse to two or more pacing vectors and determining whether the delivered pulse produced phrenic stimulation.

16. The medical apparatus of claim 15, further comprising:

for the two or more pacing vectors, displaying on a display of a patient external device an indication of whether the delivered pulse produced phrenic stimulation, and an indication of a capture threshold as determined by the capture threshold test.

17. A method, comprising;

(a) selecting an electrode combination of a plurality of electrode combinations;

(b) delivering a pulse with a predetermined pacing pulse energy via the selected electrode combination;

(c) determining if the delivered pulse produced phrenic stimulation;

(d) continuing the capture threshold test when it is determined that the delivered pulse did not produce phrenic stimulation;

(e) halting the capture threshold test when detecting, using the medical device, that the delivered pulse did produce phrenic stimulation; and

(f) repeating steps (a)-(e) for at least one other electrode combination of the plurality of electrode combinations.

18. The method of claim 17, further comprising:

displaying a capture threshold as determined by the capture threshold test for the selected electrode combination on a display of a patient external device.

19. The method of claim 17, further comprising:

displaying a phrenic stimulation threshold for the selected electrode combination on a display of a patient external device when determining that the delivered pulse did produce phrenic stimulation.

20. The medical apparatus of claim 17, further comprising:

a switch for selectively connecting the pulse generator to a selected electrode combination of a plurality of electrode combinations; and

wherein the controller is configured to repeat (a)-(d) for at least one other electrode combination of the plurality of electrode combinations.