Methods and apparatus for the regulation of hormone release

• US 20040220621A1
• Filed: 04/30/2003
• Published: 11/04/2004
• Est. Priority Date: 04/30/2003
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Mullen, Thomas J., Zhou, Xiaohong, King, Gary W., Hill, Michael R.S.
• Granted Patent: US 7,221,979 B2
• Time in Patent Office: Days
• US Class Current: 607/2
• 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;

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

means for controlling the stimulation means to provide stimulation to inhibit or increase release of at least one hormone when the at least one physiologic parameter indicates a hormonal imbalance.

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

a sensor adapted to detect at least one physiologic parameter;

at least one electrode positionable at a region adjacent a patient'"'"'s neural tissue;

a controller adapted to generate electrical stimulation by the at least one electrode to be applied to neural tissue adjacent the at least one electrode to increase or inhibit release of at least one hormone, wherein at least one parameter of the electrical stimulation is controlled as a function of the sensed physiologic parameter.

3. The device of claim 2, wherein the electrode is positionable for stimulating a spinal cord or an associated dermatome.

4. The device of 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. The device of claim 2, wherein the sensor is adapted to detect concentrations of hormones or sympathetic indicators.

6. The device of claim 2, wherein the sensor is adapted to detect concentrations of hormones selected from the group consisting of catecholamines, renin, angiotensin II, aldosterone, thyroid hormones, and 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 the patient'"'"'s body in at least one predetermined site;

at least one sensor to measure and provide information on at least one physiologic parameter; and

a controller coupled to the sensor and the electrode to control at least one parameter of electrical stimulation delivered by the electrode based on information provided by the sensor and to increase or inhibit the release of one or more hormone to regulate the hormone levels.

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 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 concentration of one or more hormones, sympathetic or parasympathetic indicators, hemodynamic function indicators, and physical activity indicators.

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 catecholamines, renin, angiotensin I, angiotensin II, aldosterone, thyroid hormones, and 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 a spinal cord or a dermatome associated therewith.

15. The system of claim 7, wherein the electrode stimulates sympathetic system neurons intrinsic to blood vessels or organs.

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

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

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

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

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

21. The system of claim 7, wherein the controller utilizes an algorithm for processing the information from the sensor.

22. The system of claim 7, wherein the at least one parameter of the electrical stimulation is selected from the group consisting of pulse amplitude, pulse width, pulse frequency, pulse frequency duty cycle, pulse polarity, and pulse waveform.

23. The system of claim 7, further including a storage device coupled to the controller to store results of past electrical stimulation;

and wherein the controller includes means for performing future electrical stimulation based on the results of past electrical stimulation.

24. A method for regulating levels of one or more hormones through electrical stimulation comprising:

locating at least one electrode in a region associated with neural tissue in a patient'"'"'s body;

coupling the at least one electrode to a controller;

generating a sensor signal related to the level of the one or more hormones being regulated; and

applying electrical stimulation via the at least one electrode to increase or decrease the level of one or more hormones in the patient'"'"'s body.

25. The method of claim 24, wherein the at least one electrode is located in a spinal cord or the dermatomes associated therewith.

26. The method of claim 24, further comprising positioning the at least one electrode externally to the patient'"'"'s body.

27. The method of claim 24, further comprising positioning the at least one electrode subcutaneously within the patient'"'"'s body.

28. The method of claim 24, further comprising implanting the at least one electrode within the patient'"'"'s body.

29. The method of claim 25, wherein the at least one electrode is positioned on or in the T7-L2 vertebrae or in dermatomes associated therewith.

30. The method of claim 24, wherein the electrical stimulation is administered to the sympathetic nervous system.

31. The method of claim 24, wherein the one or more hormones being regulated is one or more of the hormones involved in cardiovascular disease.

32. The method of claim 31, wherein the one or more hormones are selected from the group consisting of catecholamines, renin, angiotensin I, angiotensin II, aldosterone, thyroid hormones, and calcitonin gene-related peptide.

33. The method of claim 24, wherein a sensor measures a physiological signal and generates the sensor signal, which is used by the controller to vary the delivery of electrical stimulation.

34. The method of claim 33, wherein the physiological signal is based on one or more of the group consisting of concentrations of hormones and sympathetic or parasympathetic indicators.

35. The method of claim 34, wherein the hormone concentrations comprise concentrations of hormones selected from the group consisting of catecholamines, renin, angiotensin I, angiotensin II, aldosterone, thyroid hormones, and calcitonin gene-related peptide.

36. The method of claim 34, wherein the sympathetic or parasympathetic indicators are selected from the group consisting of heart rate, blood pressure, urine production, atrioventricular interval, QT interval, and baroreflex sensitivity.

37. The method of claim 24, further including providing a storage device coupled to the controller to store results of past electrical stimulation.

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

at least one electrode positionable at a region adjacent a patient'"'"'s neural tissue;

a controller adapted to generate electrical stimulation by the at least one electrode to be applied to neural tissue adjacent the at least one electrode to increase or inhibit release of at least one hormone.

39. The device of claim 38, further comprising a driver circuit associated with the controller, wherein the driver circuit is connected to at least one electrode positionable within the cardiovascular system in the patient'"'"'s body.

40. The device of claim 39, wherein the driver circuit includes a circuit to deliver pacing pulses.

41. The device of claim 38, further comprising a drug-delivery device controlled by the controller to provide a biologically-active agent to the patient.