METHODS AND DEVICES FOR NEUROMODULATION OF THE ADRENAL GLAND

• US 20180056062A1
• Filed: 08/22/2017
• Published: 03/01/2018
• Est. Priority Date: 08/23/2016
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Swanson, Lynne E., Stoffregen, William C., Clark, Bryan A., Govea, Michael X., Werner, Dennis B., Brill, Natalie A., Thakur, Pramodsingh H.
• Granted Patent: US 10,441,788 B2
• Time in Patent Office: Days
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• 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 5/02405 Determining heart rate variability
• CPC Class Codes: A61B 5/029 Measuring or recording blood output from the heart, e.g. minute volume A61B8/065 takes precedence
• CPC Class Codes: A61B 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/4227 endocrine glands, i.e. thyroid, adrenals, hypothalamic, pituitary
• CPC Class Codes: A61B 5/4561 Evaluating static posture, e.g. undesirable back curvature A61B5/1116 takes precedence
• CPC Class Codes: A61B 5/4809 Sleep detection, i.e. determining whether a subject is asleep or not
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61F 2007/0075 using a Peltier element, e.g. near the spot to be heated or cooled
• CPC Class Codes: A61F 2007/126 for invasive application, e.g. for introducing into blood vessels
• CPC Class Codes: A61F 7/007 characterised by electric heating
• CPC Class Codes: A61F 7/12 Devices for heating or cooling internal body cavities
• CPC Class Codes: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/3606 : adapted for a particular treatment
• CPC Class Codes: A61N 1/36135 : using physiological parameters
• CPC Class Codes: A61N 1/36171 : Frequency
• CPC Class Codes: A61N 1/36175 : Pulse width or duty cycle
• CPC Class Codes: A61N 1/36185 : Selection of the electrode configuration

Abstract

Aspects of the present disclosure are directed toward apparatuses, systems, and methods for delivering therapy to an adrenal gland of a patient. The apparatuses, systems, and methods may include a lead body that attaches to a portion of the adrenal gland of the patient; and a plurality of electrodes arranged along the lead body. In addition, one or more of the plurality of electrodes may deliver stimulation energy to modulate catecholamine release from chromaffin cells within the adrenal gland.

Claims

1. An apparatus for delivering therapy to an adrenal gland of a patient, the apparatus comprising:

a lead body including at least one attachment mechanism configured to attach to a portion of the adrenal gland of the patient, the lead body being configured to engage a capsule of the adrenal gland; and

a plurality of electrodes arranged along the lead body, the plurality of electrodes being configured to deliver stimulation energy through at least one of the plurality of electrodes to modulate catecholamine release from chromaffin cells within the adrenal gland.

2. The apparatus of claim 1, wherein the plurality of electrodes are arranged on a paddle component arranged at a distal end of the lead body.

3. The apparatus of claim 2, wherein the paddle component is configured to expand to a deployed configuration in response to deployment from a deployment system and fold and collapse to a delivery configuration in response to retraction within the deployment system.

4. The apparatus of claim 2, wherein the paddle component is flexible and configured to engage and attach to the portion of the adrenal gland or periadrenal connective tissue of the patient in the delivery configuration.

5. The apparatus of claim 1, further or alternatively comprising at least one thermoelectric element configured to cool the adrenal gland to modulate catecholamine release from chromaffin cells within the adrenal gland.

6. The apparatus of claim 1, wherein the plurality of electrodes are arranged on a paddle component arranged at a distal end of the lead body, and the least one thermoelectric element is arranged with the paddle component.

7. The apparatus of claim 1, wherein the lead body is configured to attach to at least one of:

periadrenal connective tissue, an exterior surface of the capsule of the adrenal gland, an interior surface of the capsule of the adrenal gland, and between the interior surface and the exterior surface of the capsule of the adrenal gland.

8. The apparatus of claim 1, wherein the lead body is configured to attach to the portion of the adrenal gland or the periadrenal connective tissue of the patient by at least one of mechanical attachment and adhesive attachment.

9. The apparatus of claim 8, wherein the lead body further comprises at least one of a barb, a suture tab, a helix, and a talon for mechanical attachment.

10. The apparatus of claim 8, further or alternatively comprising at least one of tissue glue, an adhesive, and a hydrogel for adhesive attachment of the lead body to the portion of the adrenal gland of the patient.

11. The apparatus of claim 1, wherein at least one of the plurality of electrodes is configured to penetrate into the adrenal gland to attach the lead body to the portion of the adrenal gland of the patient.

12. A system for delivering therapy to an adrenal gland of a patient, the system comprising:

a lead body configured to engage a capsule of the adrenal gland;

a plurality of electrodes arranged along the lead body, the plurality of electrodes being configured to deliver stimulation energy through at least one of the plurality of electrodes to modulate catecholamine release from chromaffin cells within the adrenal gland;

a physiological sensor configured to measure at least one physiological response of the patient; and

a controller operatively coupled to the lead and the physiological sensor, the controller configured to;

instruct delivery of the stimulation energy through the at least one of the plurality of electrodes,

receive a signal from the physiological sensor having data indicative of the at least one physiological response of the patient,

analyze the signal to calculate alteration of the stimulation energy, and

communicate with the lead to alter the stimulation energy based on analysis of the signal.

13. The system of claim 12, wherein the physiological sensor configured to measure at least one of:

heart rate of the patient, heart rate variability of the patient, respiration rate of the patient, activity level of the patient, catecholamine levels of the patient, catecholamine metabolites of the patient, normetanephrine level of the patient, metanephrine level of the patient, creatinine level in urine of the patient, cortisol metanephrine levels of the patient, position of the patient, body temperature of the patient, cardiac output of the patient, arterial pressure of the patient, a sleep status of the patient, and a depth of sleep of the patient.

14. The system of claim 12, wherein the controller is further configured to intermittently or continuously instruct delivery of the stimulation energy through different electrode sets of the plurality of electrodes.

15. The system of claim 12, wherein the controller is further configured to instruct delivery of the stimulation energy through the at least one of the plurality of electrodes on a duty cycle based on a metabolization time of catecholamine.

16. The system of claim 12, wherein the controller is further configured to instruct delivery of the stimulation energy through the at least one of the plurality of electrodes at a frequency between 2 Hz and 20 kHz.

17. A method of delivering therapy to an adrenal gland of a patient, the method comprising:

delivering a lead body to the adrenal gland of the patient;

attaching a portion of the lead body to a capsule of the adrenal gland or pericapsular connective tissue of the patient; and

delivering stimulation energy through at least one of a plurality of electrodes arranged along the lead body to modulate catecholamine release from chromaffin cells within the adrenal gland.

18. The method of claim 17, wherein attaching the portion of the lead body to the capsule comprises attaching the lead body to at least one of:

the pericapsular connective tissue, an exterior surface of the capsule of the adrenal gland, an interior surface of the capsule of the adrenal gland, and between the interior surface and the exterior surface of the capsule of the adrenal gland.

19. The method of claim 17, wherein attaching the portion of the lead body to the capsule comprises attaching the portion the lead body by at least one of mechanical attachment and adhesive attachment.

20. The method of claim 19, wherein mechanically attaching the portion of the lead body further includes attaching the lead body to the capsule using a barb, a suture tab, a helix, and a talon arranged with the portion of the lead body.