Systems and methods for enabling appetite modulation and/or improving dietary compliance using percutaneous electrical neurostimulation

• US 10,154,922 B1
• Filed: 07/07/2016
• Issued: 12/18/2018
• Est. Priority Date: 02/24/2015
• Status: Active Grant

• Current Assignee: Elira, Inc.
• Original Assignee: Elira, Inc.
• Inventors: Perez, Raul E., Hong, Peter I., Diianni, Steven, Malave, Luis Jose, Stengel, Brad, Faul, John L.
• Primary Examiner(s): Schaetzle, Kennedy
• Application Number:
  US15/204,752
• Time in Patent Office: 894 Days
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/1118 Determining activity level
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/4848 Monitoring or testing the effects of treatment, e.g. of medication
• CPC Class Codes: A61B 5/4866 Evaluating metabolism A61B5/083 takes precedence
• CPC Class Codes: A61F 5/0026 Anti-eating devices using electrical stimulation
• CPC Class Codes: A61N 1/0502 Skin piercing electrodes
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36034 specified by the stimulation parameters
• CPC Class Codes: A61N 1/36085 Eating disorders or obesity
• CPC Class Codes: A61N 2001/083 Monitoring integrity of contacts, e.g. by impedance measurement

Abstract

A wearable, percutaneous device for suppressing appetite or hunger in a patient includes a microprocessor, electrical stimulator and at least one percutaneous electrode implanted and configured to deliver electrical stimulation through the patient'"'"'s skin. The percutaneous device includes a pad and at least one needle, in which the electrode is disposed, for secure placement of the device within the skin of a patient. The percutaneous device is adapted to provide electrical stimulation as per stimulation protocols and to communicate wirelessly with a companion control device configured to monitor and record appetite patterns of the patient. The control device is also configured to monitor, record, and modify stimulation parameters of the stimulation protocols.

Claims

1. An electrical stimulation system configured to modulate at least one of a patient'"'"'s appetite, hunger, level of satiety, or level of satiation comprising:

a percutaneous electrical dermal patch adapted to be adhered to the patient'"'"'s skin, wherein said electrical dermal patch comprises a controller, at least one electrode adapted to be implanted to a depth of 0.1 mm to 30 mm within said patient'"'"'s skin, a pulse generator in electrical communication with the controller and said at least one electrode; and

a transceiver in communication with at least one of said controller and pulse generator; and

a plurality of programmatic instructions, stored in a non-transient computer readable memory of a device physically separate from said percutaneous electrical dermal patch, wherein, when executed, said programmatic instructions acquire patient status data, generate a modulation signal based upon said patient status data, wherein said modulation signal comprises instructions for modulating at least one of a pulse width, a pulse amplitude, a pulse frequency, a pulse shape, a duty cycle, a session duration, and a session frequency, and wirelessly transmit said modulation signal from the device to the transceiver.

2. The electrical stimulation system of claim 1 further comprising a second electrode adapted to be positioned on a surface of the patient'"'"'s skin.

3. The electrical stimulation system of claim 1 further comprising a second percutaneous electrode adapted to be implanted to a depth of 0.1 mm to 30 mm within said patient'"'"'s skin.

4. The electrical stimulation system of claim 1 wherein the pulse generator is configured to generate a plurality of electrical pulses and a corresponding electrical field, wherein the electrical field is adapted to penetrate a range of 0.1 mm to 30 mm through the patient'"'"'s skin.

5. The electrical stimulation system of claim 4 wherein the electrical field is adapted to contact at least one of the patient'"'"'s T2 frontal and lateral thoracic dermatome, T3 frontal and lateral thoracic dermatome, T4 frontal and lateral thoracic dermatome, T5 frontal and lateral thoracic dermatome, T6 frontal and lateral thoracic dermatome, T7 frontal and lateral thoracic dermatome, T8 frontal and lateral thoracic dermatome, T9 frontal and lateral thoracic dermatome, or T10 frontal and lateral thoracic dermatome.

6. The electrical stimulation system of claim 4 wherein the electrical field is adapted to contact at least one of the patient'"'"'s T2 frontal and lateral thoracic dermatome, T3 frontal and lateral thoracic dermatome, T4 frontal and lateral thoracic dermatome, T5 frontal and lateral thoracic dermatome, T6 frontal and lateral thoracic dermatome, T7 frontal and lateral thoracic dermatome, T8 frontal and lateral thoracic dermatome, T9 frontal and lateral thoracic dermatome, or T10 frontal and lateral thoracic dermatome and is not positioned within a range of 0.1 mm to 25 mm from any one of the patient'"'"'s T2 posterior thoracic dermatome, T3 posterior thoracic dermatome, T4 posterior thoracic dermatome, T5 posterior thoracic dermatome, T6 posterior thoracic dermatome, T7 posterior thoracic dermatome, T8 posterior thoracic dermatome, T9 posterior thoracic dermatome, or T10 posterior thoracic dermatome.

7. The electrical stimulation system of claim 4 wherein the electrical field is adapted to contact at least one of the patient'"'"'s C8 anterior or posterior dermatome located on the patient'"'"'s hand, wrist, elbow, or fingers, C8 anterior or posterior dermatome located on the patient'"'"'s arm, C8 dermatome located on the patient'"'"'s upper trunk, T1 anterior or posterior dermatome located on the patient'"'"'s arm, T1 anterior or posterior dermatome located on the patient'"'"'s wrist, elbow, and hand, or T1 anterior or posterior dermatome located on the patient'"'"'s upper trunk is electrically stimulated.

8. The electrical stimulation system of claim 1 wherein the plurality of electrical pulses comprise a pulse width in a range of 10 μ

sec to 100 msec, a pulse amplitude in a range of 100 μ

A to 500 mA, and a pulse frequency in a range of 1 Hz to 10,000 Hz.

9. The electrical stimulation system of claim 1 wherein said patient status data comprises at least one of the patient'"'"'s hunger, the patient'"'"'s hunger appetite, the patient'"'"'s satiety level, the patient'"'"'s satiation level, and a degree of well-being being experienced by the patient.

10. The electrical stimulation system of claim 9 wherein said well-being level comprises at least one of a degree of nausea being experienced by the patient and a degree of dyspepsia being experienced by the patient.

11. The electrical stimulation system of claim 1 wherein, when executed, said programmatic instructions acquire a first stimulation protocol and use said first stimulation protocol to generate the modulation signal.

12. The electrical stimulation system of claim 11 wherein, when executed, said programmatic instructions acquire a second stimulation protocol, wherein said second stimulation protocol is different from the first stimulation protocol, and, using said second stimulation protocol, generate a second modulation signal, wherein said second modulation signal comprises instructions for modulating at least one of the pulse width, the pulse amplitude, the pulse frequency, the pulse shape, the duty cycle, the session duration, and the session frequency.

13. The electrical stimulation system of claim 12 wherein, when executed, said programmatic instructions wirelessly transmit said second modulation signal from the device to the electrical dermal patch.

14. The electrical stimulation system of claim 13 wherein the percutaneous electrical dermal patch is configured to use the second modulation signal to modify at least one of said pulse width, pulse amplitude, pulse frequency, pulse shape, duty cycle, session duration, and session frequency to yield a second pulse width, a second pulse amplitude, a second pulse frequency, a second pulse shape, a second duty cycle, a second session duration, or a second session frequency, wherein at least one of the second pulse width is different from the first pulse width, the second pulse amplitude is different from the first pulse amplitude, the second pulse frequency is different from the first pulse frequency, the second pulse shape is different from the first pulse shape, the second duty cycle is different from the first duty cycle, the second session duration is different from the first session duration, and the second session frequency is different from the first session frequency.

15. The electrical stimulation system of claim 1 wherein said controller, pulse generator, and transceiver are positioned in a first housing and the at least one electrode is positioned outside said first housing.

16. The electrical stimulation system of claim 15 wherein said first housing is covered by at least one polymer having a hardness measure of 30-70 on a subzero shore scale.

17. The electrical stimulation system of claim 15 wherein said first housing is encased in at least one polymer having a tensile modulus of 15 to 55 psi.

18. The electrical stimulation system of claim 1 wherein said controller and transceiver are positioned in a first housing and said pulse generator and the at least one electrode are positioned outside said first housing.

19. The electrical stimulation system of claim 1 further comprising an adhesive layer positioned on a bottom surface of the electrical dermal patch, such that when the adhesive layer is adhered to the patient'"'"'s skin, the electrical dermal patch has an average minimum peel strength in a range of 1.3 to 1.7 newtons.

20. The electrical stimulation system of claim 1 wherein at least one of said pulse width, said pulse amplitude, and said pulse frequency are defined such that, after receiving at least one stimulation session, the appetite of said patient is less than the appetite of said patient prior to receiving said at least one stimulation session.

21. The electrical stimulation system of claim 1 wherein the percutaneous electrical dermal patch further comprises a power source.

22. The electrical stimulation system of claim 1 wherein the percutaneous electrical dermal patch further comprises an impedance sensor configured to determine an electrode integrity of the at least one electrode.

23. The electrical stimulation system of claim 1 wherein the pulse generator is configured to generate a plurality of electrical pulses and a corresponding electrical field, wherein the electrical field is adapted to contact at least one of the patient'"'"'s C5, C6, C7, C8, T1, T2, T3, T4, T5, T6, T7, T8, T9, T10, T11, or T12 dermatomes.

24. The electrical stimulation system of claim 1 wherein the pulse generator is configured to generate a plurality of electrical pulses and a corresponding electrical field, wherein the electrical field is adapted to contact a portion of at least one of the patient'"'"'s C5, C6, C7, C8, T1, T2, T3, T4, T5, T6, T7, T8, T9, T10, T11, or T12 frontal or lateral dermatomes and wherein the electrical field is not adapted to contact any portion of the patient'"'"'s C5, C6, C7, C8, T1, T2, T3, T4, T5, T6, T7, T8, T9, T10, T11, and T12 posterior dermatomes.