Methods and apparatus for the regulation of hormone release

• US 7,650,190 B2
• Filed: 05/22/2007
• Issued: 01/19/2010
• Est. Priority Date: 04/30/2003
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Zhou, Xiaohong, Mullen, Thomas J., King, Gary W., Hill, Michael R. S.
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): LEE, YUN H
• Application Number:
  US11/751,813
• Publication Number:
  US 20080140150A1
• Time in Patent Office: 973 Days
• Field of Search: 607 1- 3, 607/6, 607/9, 607/58, 607/59, 607/117, 607/118, 600/301, 600/309, 600/322
• US Class Current: 607/44
• CPC Class Codes: A61N 1/205 for promoting a biological process
• CPC Class Codes: A61N 1/36021 for treatment of pain
• CPC Class Codes: A61N 1/36071 Pain

Abstract

A method and apparatus for delivering corrective therapy through hormone regulation is provided. Inhibition of sympathetic fibers by spinal cord stimulation is used to regulate the levels of hormones such as catecholamines, renin, and calcitonin gene-related peptide. The invention utilizes a closed or open loop feedback system in which physiological parameters such as the concentrations of hormones and sympathetic indicators such as heart rate and urine production are monitored and used to determine the appropriate level of neurostimulation. The site of electrical stimulation includes, but is not limited to, the spinal cord at levels T7-L2 and the associated neural fibers within a region of the T7-L2 dermatomes.

Claims

1. A device for regulating hormone levels through electrical stimulation comprising:

means for sensing at least one physiologic parameter of a patient, wherein said at least one physiologic parameter directly or indirectly indicates a current hormonal imbalance condition, said means for sensing comprising one of;

at least one spinal cord stimulating electrode bearing recording-type electrodes, a pressure sensor, an oxygen sensor, an activity sensor, a temperature sensor, a blood flow sensor;

means for providing stimulation to a portion of neural tissue of the patient in at least one predetermined site; and

means for controlling the stimulation means to provide stimulation to one of inhibit and increase release of a hormone when the at least one physiologic parameter indicates the hormonal imbalance condition, and wherein said means for controlling operates to at least partially alleviate said the hormonal imbalance condition, and wherein said hormone is selected from the group consisting of;

adrenaline, noradrenaline, and a rennin,

wherein the predetermined site consists of one of;

a portion of the spinal cord at levels T7-L2, a bundle of neural fibers within a region of the T7-L2 dermatomes, a volume of neural tissue nearest the kidneys, a neuronal ganglia.

2. A device for regulating hormone levels through electrical stimulation comprising:

a sensor adapted to detect at least one physiologic parameter relating to a hormonal imbalance condition of a patient, wherein said sensor sensing comprises one of;

at least one spinal cord stimulating electrode bearing recording-type electrodes, a pressure sensor, an oxygen sensor, an activity sensor, a temperature sensor, a blood flow sensor;

at least one electrode adapted to be positionable at a region adjacent a portion of neural tissue of the patient;

a controller adapted to generate electrical stimulation by the at least one electrode to be applied to the portion of neural tissue adjacent the at least one electrode to increase or inhibit release of a hormone to at least partially alleviate said hormonal imbalance condition, wherein at least one parameter of the electrical stimulation is controlled as a function of the sensed physiologic parameter, and wherein said hormone is selected from the group consisting of;

adrenaline, noradrenaline, and rennin.

3. A device according to claim 2, wherein the electrode is positionable for stimulating one of:

a portion of a spinal cord, a plurality of neural fibers near a region of the T7-L2 dermatome, a portion of neural tissue nearest a kidney of the patient.

4. A device according to claim 3, wherein the at least one electrode is adapted for stimulating the spinal cord in the T7-L2 vertebrae or in the associated dermatomes.

5. A device according to claim 2, wherein the sensor is adapted to detect concentrations of the hormone and at least one indicator of sympathetic tone.

6. A device according to claim 2, wherein the sensor is adapted to detect concentrations of hormones selected from the group consisting of a renin, an angiotensin II, an aldosterone, a thyroid hormone, and a calcitonin gene-related peptide.

7. A system for regulating a hormone level in a patient comprising:

at least one electrode adapted to stimulate neural tissue in a patient'"'"'s body in at least one predetermined site to regulate a hormone level if the patient'"'"'s body via electrical stimulation therapy;

at least one sensor to measure and provide information on at least one physiologic parameter related to the hormone level, wherein said sensor comprises at least one of;

at least one spinal cord stimulating electrode bearing recording-type electrodes, a pressure sensor, an oxygen sensor, an activity sensor, a temperature sensor, a blood flow sensor; and

a controller coupled to the sensor and the at least one electrode to control at least one parameter of the electrical stimulation therapy based on information provided by the sensor and to increase or inhibit the release of the hormone to regulate the hormone level, and wherein said hormone is selected from the group consisting of;

adrenaline, noradrenaline, and a renin.

8. The system of claim 7, wherein the controller includes a manual activation mechanism.

9. The system of claim 7, wherein the controller includes means for initiating the electrical stimulation therapy in response to the at least one physiologic parameter measured by the sensor.

10. The system of claim 7, wherein the at least one physiologic parameter is selected from the group consisting of one of a sympathetic and a parasympathetic indicator, a hemodynamic function indicator, and a physical activity indicator.

11. The system of claim 7, wherein the at least one physiologic parameter is the concentration of one or more hormones selected from the group consisting of a renin, an angiotensin I, an angiotensin II, an aldosterone, a thyroid hormone, and a calcitonin gene-related peptide.

12. The system of claim 7, wherein the at least one physiologic parameter is a sympathetic or parasympathetic indicator selected from the group consisting of heart rate, blood pressure, urine production, QT interval, atrioventricular interval, respiration and baroreflex sensitivity.

13. The system of claim 7, wherein the at least one physiologic parameter is a hemodynamic function indicator selected from the group consisting of blood pressure, cardiac output, contractility, and intracardiac pressure.

14. The system of claim 7, wherein the electrode stimulates one of a portion of a spinal cord and a dermatome associated with the spinal cord.

15. The system of claim 7, wherein the electrode is adapted to stimulate a plurality of sympathetic system neurons intrinsic to blood vessels or organs.

16. The system of claim 7, wherein the at least one electrode is adapted to be positioned external to the patient'"'"'s body.

17. The system of claim 7, wherein the at least one electrode is adapted to be positioned subcutaneously within a portion of the patient'"'"'s body.

18. The system of claim 7, wherein the at least one electrode is adapted to be implanted within the patient'"'"'s body.

19. The system of claim 7, wherein the at least one electrode is adapted to be positioned on or in the T7-L2 vertebrae or dermatomes associated therewith.

20. The system of claim 7, wherein the controller includes a microprocessor.