ELECTRODE ARRAY STRUCTURES AND METHODS OF USE FOR CARDIOVASCULAR REFLEX CONTROL

• US 20080082137A1
• Filed: 09/27/2007
• Published: 04/03/2008
• Est. Priority Date: 09/28/2006
• Status: Active Grant

• Current Assignee: CVRx, Inc.
• Original Assignee: CVRx, Inc.
• Inventors: Kieval, Robert S., Rossing, Martin
• Granted Patent: US 8,620,422 B2
• Time in Patent Office: Days
• US Class Current: 607/30
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0556 Cuff electrodes
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/36117 for treating hypertension

Abstract

A tissue stimulation device includes an electrode array having at least four independently switchable electrodes. In one embodiment, the electrode array comprises a flexible base to which the electrodes are fixed that flexes to encompass at least a portion of an artery or other elongate biological structure. The electrodes are electrically coupled to and energized by a signal generator coupled to a control system. In one embodiment, the array of electrodes are configured such that a suitable signal pattern for stimulation pulses between or among a set of the switchable electrodes may be determined without having to reposition the electrode assembly by using a series of signal patterns activating different combinations of switchable electrodes in response to sub-stimulation test signals to determine a signal pattern that provides suitable patient response. In another embodiment, the array of electrodes includes an array of selectively activatable multi-polar electrodes.

Claims

1. A method of implanting a medical device configured to deliver a tissue stimulation therapy, the method comprising:

locating a tissue stimulation device proximate an area of tissue of a patient desired to be stimulated, the tissue stimulation device having at least four independently activatable electrodes;

activating a first pattern of one or more of the electrodes using a sub-stimulation signal;

measuring one or more patient parameters indicative of a response to the activating of the first pattern;

activating a second pattern of one or more of the electrodes using a sub-stimulation signal, the second pattern differing from the first pattern;

measuring one or more patient parameters indicative of a response to the activating of the second pattern; and

selecting at least one pattern based on the responses of the patient to the activation of at least the first pattern and the second pattern as an initial pattern for delivering the tissue stimulation therapy.

2. The method of claim 1, wherein the tissue stimulation device comprises a baroreflex activation device, configured to deliver a baroreflex activation therapy.

3. The method of claim 1, further comprising delivering a therapy with the at least one selected pattern, the therapy including a stimulation-level signal.

4. The method of claim 3, further comprising:

measuring one or more patient parameters indicative of a response to the delivered therapy; and

selecting one or more patterns based on the measured patient response.

5. The method of claim 4, further comprising:

measuring one or more attributes of the sub-stimulation signal for a given pattern; and

correlating the sub-stimulation signal attribute to a measured patient response to the delivered therapy.

6. The method of claim 1, further comprising:

measuring and storing one or more signal attributes of a sub-stimulation signal associated with a pattern.

7. The method of claim 6, further comprising:

storing a plurality of possible favorable patterns of electrodes;

implanting a medical device configured to deliver a tissue stimulation therapy in a second patient;

activating the plurality of patterns individually with sub-stimulation signals;

measuring one or more attributes of the sub-stimulation signal for a specific pattern in the second patient;

accessing the stored one or more signal attributes;

correlating the one or more measured signal attributes in the second patient to the stored one or more signal attributes;

selecting one or more patterns for therapy based on the measured signal attributes and the stored signal attributes.

8. A method of providing a system for baroreflex activation therapy, comprising:

providing a tissue stimulation device having at least four independently activatable electrodes; and

providing instructions for implanting the system, comprising;

locating the tissue stimulation device proximate an area of baroreceptors of a patient;

activating a first pattern of one or more of the electrodes using a sub-stimulation signal;

measuring one or more patient parameters indicative of a response to the activating of the first pattern;

activating a second pattern of one or more of the electrodes using a sub-stimulation signal, the second pattern differing from the first pattern;

measuring one or more patient parameters indicative of a response to the activating of the second pattern; and

selecting at least one pattern based on the responses of the patient to the activation of at least the first pattern and the second pattern as an initial pattern for delivering the tissue stimulation therapy.

9. The method of claim 8, wherein the tissue stimulation device comprises a baroreflex activation device, configured to deliver a baroreflex activation therapy.

10. The method of claim 8, wherein providing instructions further comprises:

delivering a therapy with the at least one selected pattern, the therapy including a stimulation-level signal.

11. The method of claim 10, further comprising:

measuring one or more patient parameters indicative of a response to the delivered therapy; and

selecting one or more patterns based on the measured patient response.

12. The method of claim 11, further comprising:

measuring one or more attributes of the sub-stimulation signal for a given pattern; and

correlating the sub-stimulation signal attribute to a measured patient response to the delivered therapy.

13. The method of claim 8, further comprising:

measuring and storing one or more signal attributes of a sub-stimulation signal associated with a pattern.

14. The method of claim 13, further comprising:

storing a plurality of possible favorable patterns of electrodes;

implanting a medical device configured to deliver a tissue stimulation therapy in a second patient;

activating the plurality of patterns individually with sub-stimulation signals;

measuring one or more attributes of the sub-stimulation signal for a specific pattern in the second patient;

accessing the stored one or more signal attributes;

correlating the one or more measured signal attributes in the second patient to the stored one or more signal attributes;

selecting one or more patterns for therapy based on the measured signal attributes and the stored signal attributes.

15. A method of adjusting a tissue stimulation therapy, comprising:

providing a tissue stimulation device proximate an area of tissue of a patient desired to be stimulated, the tissue stimulation device having at least four independently activatable electrodes;

pre-selecting a first activation pattern of one or more electrodes using a sub-stimulation test signal;

pre-selecting a second activation pattern of one or more of the electrodes using a sub-stimulation signal, the second pattern differing from the first pattern;

delivering a therapy using the first activation pattern of electrodes; and

changing the therapy from the first activation pattern to the second activation therapy.

16. The method of claim 15, wherein the tissue stimulation device comprises a baroreflex activation device, configured to deliver a baroreflex activation therapy.

17. The method of claim 15, further comprising delivering a therapy with the at least one selected pattern, the therapy including a stimulation-level signal.

18. The method of claim 17, further comprising:

measuring one or more patient parameters indicative of a response to the delivered therapy; and

selecting one or more patterns based on the measured patient response.

19. The method of claim 18, further comprising:

measuring one or more attributes of the sub-stimulation signal for a given pattern; and

correlating the sub-stimulation signal attribute to a measured patient response to the delivered therapy.

20. The method of claim 15, further comprising:

measuring and storing one or more signal attributes of a sub-stimulation signal associated with a pattern.

21. The method of claim 20, further comprising:

storing a plurality of possible favorable patterns of electrodes;

implanting a medical device configured to deliver a tissue stimulation therapy in a second patient;

activating the plurality of patterns individually with sub-stimulation signals;

measuring one or more attributes of the sub-stimulation signal for a specific pattern in the second patient;

accessing the stored one or more signal attributes;

correlating the one or more measured signal attributes in the second patient to the stored one or more signal attributes;

selecting one or more patterns for therapy based on the measured signal attributes and the stored signal attributes.

22. A multi-polar electrode for use in tissue stimulation therapy, comprising:

a center portion, including at least two electrically conductive segments;

a first ring portion surrounding the center portion, the first ring including a plurality of non-contiguous electrically conductive segments; and

an outer ring surrounding the first ring portion, wherein the polarity of the center portion, inner ring portion, and outer ring can be selectively varied.

23. An implantable medical device, comprising:

a baroreflex activation device having an array of four or more independently selectively activatable electrodes;

a control system operably coupled to the baroreflex activation device, the control system configured to deliver sub-stimulation test signals to one or more unique patterns of one or more electrodes, the control system further configured to receive and record data indicative of a response of the patient to the unique patterns, and select and deliver a therapy signal to at least one or more unique patterns based on the data indicative of a response of the patient.

24. The medical device of claim 23, wherein the control system is further configured to measure and record signal attributes associated with the sub-stimulation signal.

25. The medical device of claim 24, wherein the control system is further configured to deliver a therapy signal to at least one or more unique patterns based on the signal attributes associated with the sub-stimulation signal.