ESOPHAGEAL ACTIVITY MODULATED OBESITY THERAPY

• US 20100268306A1
• Filed: 04/20/2010
• Published: 10/21/2010
• Est. Priority Date: 04/20/2009
• Status: Active Grant

• Current Assignee: Jeremy Maniak, Johann Neisz
• Original Assignee: Jeremy Maniak, Johann Neisz
• Inventors: Maniak, Jeremy, Neisz, Johann
• Granted Patent: US 8,321,030 B2
• Time in Patent Office: Days
• US Class Current: 607/62
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control

Abstract

Methods and devices for delivering electrical stimulation to the sympathetic nervous system in response to the onset of eating. In some methods, swallowing is detected which then initiates a dose of stimulation which can vary in intensity, frequency, or both over the dose length. In some methods, the dose length is between about one quarter hour and one hour. The dose frequency may increase, hold steady, then decrease over the dose duration so as to mimic the response of the gut stretch and nutrient receptors to receiving food. The dose can drive biomarkers indicative of eating, for example glucagon, glucose, FFA or glycerol to at least about half of their normal post eating levels and then stop so as to retain stimulation effectiveness for subsequent doses and to prolong battery life.

Claims

1. A method of modulating a component of the nervous system of a mammal, the method comprising:

providing a sensor, wherein the sensor is configured to produce a first sensor output signal associated with the onset of a period of nutrient consumption, and a second sensor output signal, associated with the end of a period of nutrient consumption;

providing a stimulator configured to output a first therapeutic signal in response to the first sensor output signal, and a second therapeutic signal in response to the second sensor output signal;

wherein applying the first therapeutic signal to a first component of the nervous system is effective to mimic satiety in the mammal; and

wherein applying the second therapeutic signal to a second component of the nervous system is effective to produce an increase in energy expenditure in the mammal.

2. The method of claim 1, wherein the sensor is configured to produce the first sensor output signal in response to at least one of swallowing, a blood glucose level, a neurological signal associated with olfaction, a stomach pH level, an electrical impedance of saliva, an electromyographic signal in the esophagus, and a change in intrathoracic pressure.

3. The method of claim 1, wherein the sensor is configured to produce the second sensor output signal in response to at least one of cessation of swallowing, a blood glucose level, a neurological signal associated with loss of an olfactory signal, a stomach pH level, an electrical impedance of saliva, an electromyographic signal in the esophagus, and a change in intra-thoracic pressure.

4. The method of claim 1, wherein the first therapeutic signal is applied to a component of the sympathetic nervous system.

5. The method of claim 1, wherein the component of the sympathetic nervous system comprises afferent nerve fibers of a splanchnic nerve.

6. The method of claim 1, wherein the second therapeutic signal is configured to modulate a component of the sympathetic nervous system.

7. The method of claim 6, wherein the component of the sympathetic nervous system comprises efferent fibers in a splanchnic nerve.

8. The method of claim 1, wherein the first therapeutic signal comprises at least one electrical pulse train;

wherein the at least one electrical pulse train is applied for a duration ranging from about 2.5 minutes to about 30 minutes;

wherein the at least one electrical pulse train is followed by a time interval ranging from about 2.5 minutes to about 30 minutes during which no electrical signal is applied to the component of the nervous system;

wherein the at least one electrical pulse train comprises a frequency ranging from about 0 Hz to about 20 Hz;

wherein the at least one electrical pulse train comprises a current ranging from about 1 to about 5 mA.

9. The method of claim 8, wherein the first therapeutic signal comprises a plurality of electrical pulse trains, wherein pulse trains are separated from each other by an interval comprising substantially no signal.

10-32. -32. (canceled)

33. A method of modulating a component of the nervous system of a mammal, the method comprising:

sensing the onset of eating in the mammal; and

stimulating a splanchnic nerve responsive to the eating sensing by applying at least one electrical stimulus dose,

in which the dose has a stimulation duration of at least about ¼

hour and has a frequency which varies much more than the intensity;

in which the method has a reduced intensity or no intensity interval after the dose at least about 1 hour in length.

34. The method of claim 33, in which the dose stimulation duration is less than about 1 hour.

35. The method of claim 34, in which the dose stimulation duration is less than about ½

hour.

36. The method of claim 33, in which the dose frequency increases at the beginning of the dose for at least about ⅕

of the dose and decreases at the end of the dose for at least about ⅕

of the dose.

37. The method of claim 36, in which the dose frequency remains substantially constant in the middle of the dose for at least about ⅕

of the dose.

38. The method of claim 33, in which the dose frequency increases and decreases over the dose in a pattern which mimics a normal eating response.

39. The method of claim 33, in which the dose frequency has a maximum frequency in the dose in between about 10 Hz and 20 Hz.

40. The method of claim 33, in which the dose stimulation intensity has a maximum intensity in between about ½

mSec-mA and about 2 mSec-mA.

41. The method of claim 33, in which the dose stimulation intensity and frequency are configured sufficient to raise biomarkers indicative of eating food to levels substantially the same or least half of the level indicative of eating food.

42. The method of claim 41, in which the dose stimulation duration is sufficient to raise biomarkers indicative of eating food to levels substantially the same or least half of the level indicative of eating food, and the stimulation stops or substantially reduces upon the biomarkers raising to the level indicative of eating food.

43-52. -52. (canceled)

53. A method of modulating a component of the nervous system of a mammal, the method comprising:

sensing the onset of eating in the mammal; and

stimulating a splanchnic nerve responsive to the eating sensing by applying at least one electrical stimulus first dose,

in which the first dose has a stimulation duration of at least about ¼

hour and has a frequency which varies much more than the intensity;

in which the method follows the varying frequency first dose with an increasing intensity second dose configured to stimulate more efferently than the first dose and to capture more fibers than the first dose.