Electrode array structures and methods of use for cardiovascular reflex control

• US 8,620,422 B2
• Filed: 09/27/2007
• Issued: 12/31/2013
• Est. Priority Date: 09/28/2006
• Status: Active Grant

• Current Assignee: CVRx, Inc.
• Original Assignee: CVRx, Inc.
• Inventors: Kieval, Robert S., Rossing, Martin, Cates, Adam, Covalin, Alejandro
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): KIMBALL, JEREMIAH T
• Application Number:
  US11/862,508
• Publication Number:
  US 20080082137A1
• Time in Patent Office: 2,287 Days
• Field of Search: 607/2
• US Class Current: 607/2
• 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, comprising:

implanting a baroreflex activation device chronically within a patient, the device including a plurality of independently activatable electrodes and being implanted in or on a blood vessel such that the independently activatable electrodes are proximate one or more baroreceptors in a wall of the blood vessel;

delivering a sub-stimulation signal to a first pattern of one or more of the electrodes, the sub-stimulation signal having a voltage, current and/or frequency selected so as not to create a medically meaningful baroreflex response in the patient;

measuring one or more attributes of the sub-stimulation signal delivered to the first pattern of electrodes;

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

measuring one or more attributes of the second sub-stimulation signal delivered to the second pattern of electrodes;

comparing the attributes measured from the sub-stimulation signals to attributes of signals known to cause favorable baroreceptor activation; and

selecting at least one pattern of one or more electrodes for delivering a baroreflex therapy based on the measured attributes of the sub-stimulation signals.

2. The method of claim 1, further comprising delivering a baroreflex therapy with the at least one selected pattern, the baroreflex therapy including a stimulation-level signal configured to create a measurable patient response.

3. The method of claim 2, further comprising:

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

confirming or altering the selected pattern based on the measured one or more patient parameters indicative of a response.

4. The method of claim 1, further comprising:

storing a plurality of possible favorable patterns of electrodes;

implanting a medical device configured to deliver a baroreflex 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.

5. The method of claim 1, wherein measuring one or more attributes of the sub-stimulation signal comprises measuring one or more attributes selected from the group consisting of:

impedance, capacitance, current, power, and resistance.

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

manufacturing a baroreflex activation device and making it available to a user, the device having a plurality of independently activatable electrodes; and

providing instructions to the user for implanting the system, comprising;

implanting the baroreflex activation device chronically in or on a blood vessel such that the independently activatable electrodes are proximate one or more baroreceptors in a wall of the blood vessel;

delivering a sub-stimulation signal to a first pattern of one or more of the electrodes, the sub-stimulation signal having a voltage, current and/or frequency selected so as not to create a medically meaningful baroreflex response in a patient;

measuring one or more attributes of the sub-stimulation signal delivered to the first pattern of electrodes;

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

measuring one or more attributes of the second sub-stimulation signal delivered to the second pattern of electrodes;

comparing the attributes measured from the sub-stimulation signals to attributes of signals known to cause favorable baroreceptor activation; and

selecting at least one pattern of one or more electrodes for delivering a baroreflex therapy based on the measured attributes of the sub-stimulation signals.

7. The method of claim 6, wherein providing instructions further comprises:

delivering a baroreflex therapy with the at least one selected pattern, the baroreflex therapy including a stimulation-level signal configured to create a measurable patient response.

8. The method of claim 7, further comprising:

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

confirming or altering the selected pattern based on the measured one or more patient parameters indicative of a response.

9. The method of claim 6, the instructions further comprising:

storing a plurality of possible favorable patterns of electrodes;

implanting a medical device configured to deliver a baroreflex 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.

10. The method of claim 6, wherein measuring one or more attributes of the sub-stimulation signal comprises measuring one or more attributes selected from the group consisting of:

impedance, capacitance, current, power, and resistance.