Methods and apparatus for the regulation of hormone release

• US 7,221,979 B2
• Filed: 04/30/2003
• Issued: 05/22/2007
• 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): Pezzuto; Robert
• Assistant Examiner(s): LEE, YUN HAENG NMN
• Application Number:
  US10/426,610
• Publication Number:
  US 20040220621A1
• Time in Patent Office: 1,483 Days
• Field of Search: 607 1- 3, 607/9, 607/58, 607/59, 607/6, 607/117, 607/118, 607/44, 607/45, 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;

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 renin.

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;

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 a renin.

3. The device of 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. 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 the hormone and at least one indicator of sympathetic tone.

6. The device of 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; 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.

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 therapy delivery, 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 a desired balanced condition of a hormone of the patient; and

delivering electrical stimulation therapy via the at least one electrode to increase or decrease the level of the hormone in the patient'"'"'s body to produce the desired balanced condition of the level of the hormone of the patient, and wherein said hormone is selected from the group consisting of;

adrenaline, noradrenaline, and a renin.

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

26. 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.

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

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

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

30. The method of claim 24, wherein the electrical stimulation therapy is delivered to effect a change in the sympathetic nervous system.

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

32. The method of claim 31, wherein the hormone is 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.

33. The method of claim 31, wherein the hormone concentrations consist of a renin, an angiotensin I, an angiotensin II, an aldosterone, a thyroid hormone, and a calcitonin gene-related peptide.

34. 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.

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

36. The method of claim 35, 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 adapted to be positioned at a region adjacent a patient'"'"'s neural tissue;

a controller adapted to deliver electrical stimulation therapy via the at least one electrode to increase or inhibit release of a hormone, wherein said controller modulates said electrical stimulation therapy to achieve a desired balance of the hormone, and wherein said hormone consists of;

adrenaline, noradrenaline, and a renin.

39. The device of claim 38, further comprising a driver circuit operatively coupled 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 cardiac pacing therapy.

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, wherein said biologically-active agent contributes to achieving the desired balance of the hormone.