System and method for mapping baroreceptors

• US 9,242,097 B2
• Filed: 06/17/2014
• Issued: 01/26/2016
• Est. Priority Date: 06/18/2013
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Mokelke, Eric A., Hammill, Eric Falbe
• Primary Examiner(s): Wieland, Robert N
• Application Number:
  US14/307,209
• Publication Number:
  US 20140371810A1
• Time in Patent Office: 588 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/024 Detecting, measuring or recording pulse rate or heart rate A61B5/0205, A61B5/021 take precedence
• CPC Class Codes: A61B 5/08 Detecting, measuring or recording devices for evaluating the respiratory organs A61B5/0205 takes precedence
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy
• CPC Class Codes: A61N 1/36117 for treating hypertension
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration

Abstract

An example of a method embodiment may place a set of stimulation electrodes on tissue containing the baroreceptor region, and may test bipolar configurations of the electrodes. Each of the bipolar configurations of the electrodes includes at least one of the electrodes configured to function as an anode and at least one other of the electrodes configured to function as a cathode. Testing the bipolar configurations may include stimulating the tissue using each of the bipolar configurations. For each of the tested bipolar configurations at least one physiological parameter may be monitored for a baroreflex response to stimulation of the tissue, and the baroreflex response may be recorded for each of the tested bipolar configurations.

Claims

1. A method, comprising:

placing a set of stimulation electrodes on tissue containing a baroreceptor region;

automatically mapping the baroreceptor region using a controller and at least one physiologic response sensor, including;

testing bipolar configurations of the electrodes, each of the bipolar configurations of the electrodes including at least one of the electrodes configured to function as an anode and at least one other of the electrodes configured to function as a cathode, wherein testing the bipolar configurations includes stimulating the tissue using each of the bipolar configurations;

for each of the tested bipolar configurations monitoring at least one physiological parameter for a baroreflex response to stimulation of the tissue; and

recording the baroreflex response for each of the tested bipolar configurations.

2. The method of claim 1, further comprising selecting a candidate therapy bipolar configuration, wherein the candidate therapy bipolar configuration is the tested bipolar configuration with a greatest baroreflex response to the stimulation of the tissue.

3. The method of claim 2, further comprising identifying a candidate therapy cathode for the candidate therapy bipolar configuration that provides a large baroreflex response to the stimulation of the tissue, wherein the large baroreflex response indicates that the candidate therapy cathode is proximate to a baroreceptor hotspot.

4. The method of claim 3, further comprising grouping the candidate therapy cathode with at least one adjacent cathode to provide a cathode cluster, stimulating the tissue using the cathode cluster, and monitoring for an increased baroreflex response when stimulating using the cathode cluster.

5. The method of claim 2, further comprising using the recorded baroreflex response to identify a backup candidate therapy bipolar configuration for use in response to a failure in the candidate therapy bipolar configuration.

6. The method of claim 1, wherein the at least one physiological parameter includes at least one of a heart rate parameter, a blood pressure parameter, or a respiration parameter.

7. The method of claim 1, wherein placing the set of stimulation electrodes includes suturing a patch over the tissue, the patch including the set of stimulation electrodes.

8. The method of claim 1, further comprising monitoring for undesired capture of adjacent tissue while testing each of the tested bipolar configurations, and identifying a candidate therapy bipolar configuration based on the monitored baroreflex responses and monitored undesired capture of adjacent tissue.

9. A method, comprising:

placing a set of stimulation electrodes on tissue containing a baroreceptor region; and

automatically mapping the baroreceptor region using a controller and at least one physiologic response sensor, including;

mapping one or more cathode clusters to confirm at least one of the cathode cluster is proximate to a baroreceptor hotspot, wherein each of the cathode clusters includes three or more of the stimulation electrodes connected to function as a cathode and wherein at least one other of the stimulation electrodes is connected to function as an anode;

for each cathode cluster confirmed to be proximate to the baroreceptor hotspot, conducting a secondary mapping to test at least two smaller cathode clusters to confirm at least one of the smaller cathode clusters is proximate to the baroreceptor hotspot;

for each smaller cathode cluster confirmed to be proximate to the baroreceptor hotspot, mapping individual cathode electrodes within the smaller cathode cluster to confirm at least one of the individual cathode electrodes is proximate to the baroreceptor hotspot.

10. The method of claim 9, further comprising:

for each smaller cathode cluster confirmed to be proximate to the baroreceptor hotspot, conducting another mapping of at least two subsets of the smaller cathode cluster to confirm at least one of the subsets is proximate to the baroreceptor hotspot, wherein mapping individual cathode electrodes within the smaller cathode cluster includes mapping individual cathode electrodes within one or more subsets confirmed to be proximate to the baroreceptor hotspot.

11. The method of claim 9, wherein mapping includes:

testing at least one bipolar configuration of the electrodes;

for each of the tested bipolar configurations monitoring at least one physiological parameter for a baroreflex response to stimulation of the tissue; and

recording the baroreflex response for each of the tested bipolar configurations.

12. The method of claim 9, further comprising selecting a candidate therapy electrode from the at least one of the individual cathode electrodes confirmed to be proximate to the baroreceptor hotspot.

13. The method of claim 12, further comprising grouping the candidate therapy cathode with at least one adjacent cathode to provide a cathode cluster, stimulating the tissue using the cathode cluster, and monitoring for an increased baroreflex response when stimulating using the cathode.

14. The method of claim 9, wherein placing the set of stimulation electrodes includes suturing a patch over the tissue, the patch including the set of stimulation electrodes.

15. A system for mapping a baroreceptor region, comprising:

stimulation electrodes for placement on tissue containing the baroreceptor region;

a stimulator, including a stimulation controller, a pulse generator, and switches, wherein the stimulation controller and switches are configured to connect different combination of the stimulation electrodes to the pulse generator to deliver bipolar stimulation of the tissue;

at least one physiologic response sensor configured to sense a physiologic response to stimulation of the tissue;

the controller including a stimulation protocol selector configured to select electrode configurations for testing, including control the switches to connect the pulse generator to the stimulation electrodes to provide selected electrode configurations for testing;

the controller including a physiologic feedback module to receive a signal from the at least one sensor, and a physiologic parameter analyzer configured to monitor a baroreflex response; and

the controller is configured to use the stimulation protocol selector and the physiologic feedback module to map the baroreceptor region, including;

stimulate the tissue using bipolar configurations of the electrodes to test the bipolar configurations, each of the bipolar configurations of the electrodes including at least one of the electrodes functioning as an anode and at least one other of the electrodes functioning as a cathode;

for each of the tested bipolar configurations monitor at least one physiological parameter for a baroreflex response to stimulation of the tissue; and

record the baroreflex response for each of the tested bipolar configurations.

16. The system of claim 15, further comprising a patch, wherein the stimulation electrodes are connected to the patch and the patch is configured to be sutured to the tissue.

17. The system of claim 15, wherein the controller is configured to select a candidate therapy cathode for the candidate therapy bipolar configuration that provides a large baroreflex response to the stimulation of the tissue, wherein the large baroreflex response indicates that the candidate therapy cathode is proximate to a baroreceptor hotspot.

18. The system of claim 17, wherein to map the baroreceptor region, the controller is configured to group the candidate therapy cathode with at least one adjacent cathode to provide a cathode cluster, stimulate the tissue using the cathode cluster, and monitor for an increased baroreflex response when stimulating using the cathode cluster.

19. The system of claim 17, wherein to map the baroreceptor region, the controller is configured identify a backup candidate therapy bipolar configuration using the recorded baroreflex response, the controller including programmed redundancy using the backup candidate therapy bipolar configuration to compensate for changes.

20. The system of claim 17, further comprising an accelerometer, wherein the controller is further configured to use the accelerometer to monitor for undesired capture of adjacent tissue while testing each of the tested bipolar configurations, and identify a candidate therapy bipolar configuration based on the recorded baroreflex responses and monitored undesired capture of adjacent tissue.