Implantable electroacupuncture system and method for treating dyslipidemia and obesity

• US 9,949,893 B2
• Filed: 01/31/2017
• Issued: 04/24/2018
• Est. Priority Date: 03/06/2012
• Status: Active Grant

• Current Assignee: Valencia Bioscience, Inc.
• Original Assignee: Valencia Technologies Corporation
• Inventors: Greiner, Jeffrey H., Peterson, David K. L., Thenuwara, Chuladatta, Chambliss, Stacy Greiner
• Primary Examiner(s): DIETRICH, JOSEPH M
• Application Number:
  US15/421,294
• Publication Number:
  US 20170135898A1
• Time in Patent Office: 448 Days
• CPC Class Codes: A61F 5/0026 Anti-eating devices using electrical stimulation
• CPC Class Codes: A61H 2201/50 Control means thereof
• CPC Class Codes: A61H 2201/5005 for controlling frequency distribution, modulation or interference of a driving signal
• CPC Class Codes: A61H 2201/5038 freely programmable by the user
• CPC Class Codes: A61H 2201/5097 wireless
• CPC Class Codes: A61H 39/002 Using electric currents electrotherapy A61N1/32
• CPC Class Codes: A61N 1/36085 Eating disorders or obesity
• CPC Class Codes: A61N 1/36117 for treating hypertension
• CPC Class Codes: A61N 1/36125 Details of circuitry or electric components
• CPC Class Codes: A61N 1/36153 Voltage A61N1/3616 takes precedence
• CPC Class Codes: A61N 1/36157 Current A61N1/3616 takes precedence
• CPC Class Codes: A61N 1/36175 Pulse width or duty cycle
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators
• CPC Class Codes: A61N 1/3758 Packaging of the components within the casing
• CPC Class Codes: A61N 1/3782 producing a voltage above the power source level
• CPC Class Codes: Y10T 29/49117 Conductor or circuit manufacturing

Abstract

An exemplary method of treating obesity or dyslipidemia of a patient includes 1) generating, by an electroacupuncture device implanted beneath a skin surface of the patient, stimulation sessions at a duty cycle that is less than 0.05, and 2) applying, by the electroacupuncture device in accordance with the duty cycle, the stimulation sessions to at least one of a saphenous nerve and a peroneal nerve of the patient by way of an electrode array located within the patient at an acupoint corresponding to at least one of the saphenous nerve and the peroneal nerve.

Claims

1. A method of treating obesity or dyslipidemia of a patient, comprising:

generating, by an electroacupuncture device implanted beneath a skin surface of the patient, stimulation sessions at a duty cycle that is less than 0.05, wherein

each stimulation session included in the plurality of stimulation sessions comprises a series of stimulation pulses,

the duty cycle is a ratio of T3 to T4,

each stimulation session included in the stimulation sessions has a duration of T3 minutes and occurs at a rate of once every T4 minutes, and

the electroacupuncture device is powered by a primary battery located within the electroacupuncture device and having an internal impedance greater than 5 ohms; and

applying, by the electroacupuncture device in accordance with the duty cycle, the stimulation sessions to at least one of a saphenous nerve and a peroneal nerve of the patient by way of an electrode array located within the patient at an acupoint corresponding to at least one of the saphenous nerve and the peroneal nerve.

2. The method of claim 1, wherein the primary battery located within the electroacupuncture device has a capacity of less than 60 milliamp-hours (mAh).

3. The method of claim 1, wherein:

a housing of the electroacupuncture device is coin-sized and coin-shaped; and

the primary battery located within the electroacupuncture device is a coin-cell battery.

4. The method of claim 1, wherein the primary battery located within the electroacupuncture device is not rechargeable.

5. The method of claim 1, wherein the acupoint comprises at least one of acupoints ST36, SP4, ST37, ST40, SP6, SP9, K16, and LR8.

6. The method of claim 1, wherein T3 is at least 10 minutes and less than 60 minutes, and wherein T4 is at least 1440 minutes.

7. The method of claim 1, further comprising:

receiving, by the electroacupuncture device from a device external to the electroacupuncture device, a control command that sets the times T3 and T4 to appropriate values configured to treat the obesity or the dyslipidemia;

wherein the generating of the stimulation sessions is performed in accordance with the control command.

8. The method of claim 7, wherein the receiving of the control command comprises detecting, with an electromagnetic field sensor included in the electroacupuncture device, a magnetic field generated by the device external to the electroacupuncture device.

9. The method of claim 1, wherein:

the electrode array comprises a central electrode of a first polarity centrally located on a first surface of a housing of the electroacupuncture device and an annular electrode of a second polarity and that is spaced apart from the central electrode; and

the applying of the stimulation sessions to at least one of the saphenous nerve and the peroneal nerve by way of the electrode array comprises applying the stimulation sessions to at least one of the saphenous nerve and the peroneal nerve by way of the central electrode and the annular electrode.

10. The method of claim 9, wherein the annular electrode is located on the first surface of the housing.

11. The method of claim 9, wherein the annular electrode comprises a ring electrode located around a perimeter edge of the housing.

12. The method of claim 1, wherein:

the electrode array comprises a plurality of electrodes located on a lead that is attached to the electroacupuncture device; and

the applying of the stimulation sessions to at least one of the saphenous nerve and the peroneal nerve by way of the electrode array comprises applying the stimulation sessions to at least one of the saphenous nerve and the peroneal nerve by way of the plurality of electrodes located on the lead.

13. A method of treating obesity or dyslipidemia of a patient, comprising:

generating, by an electroacupuncture device implanted beneath a skin surface of the patient, stimulation sessions at a duty cycle that is less than 0.05, wherein

each stimulation session included in the plurality of stimulation sessions comprises a series of stimulation pulses,

the duty cycle is a ratio of T3 to T4,

each stimulation session included in the stimulation sessions has a duration of T3 minutes and occurs at a rate of once every T4 minutes, and

the electroacupuncture device is powered by a primary battery located within the electroacupuncture device and having a capacity of less than 60 milliamp-hours (mAh); and

applying, by the electroacupuncture device in accordance with the duty cycle, the stimulation sessions to at least one of a saphenous nerve and a peroneal nerve of the patient by way of an electrode array located within the patient at an acupoint corresponding to at least one of the saphenous nerve and the peroneal nerve.

14. The method of claim 13, wherein the primary battery located within the electroacupuncture device has an internal impedance greater than 5 ohms.

15. The method of claim 13, wherein:

a housing of the electroacupuncture device is coin-sized and coin-shaped; and

the primary battery located within the electroacupuncture device is a coin-cell battery.

16. The method of claim 13, wherein the primary battery located within the electroacupuncture device is not rechargeable.

17. An electroacupuncture device for treating obesity or dyslipidemia of a patient, comprising:

a housing configured to be implanted beneath a skin surface of the patient,

pulse generation circuitry located within the housing, wherein the pulse generation circuitry

generates stimulation sessions at a duty cycle that is less than 0.05, and

applies, in accordance with the duty cycle, the stimulation sessions to at least one of a saphenous nerve and a peroneal nerve by way of an electrode array communicatively coupled to the pulse generation circuitry and located within the patient at an acupoint corresponding to at least one of the saphenous nerve and the peroneal nerve; and

a primary battery located within the housing and having an internal impedance greater than 5 ohms, the primary battery configured to provide operating power to the pulse generation circuitry;

wherein

each stimulation session included in the stimulation sessions comprises a series of stimulation pulses,

the duty cycle is a ratio of T3 to T4, and

each stimulation session included in the stimulation sessions has a duration of T3 minutes and occurs at a rate of once every T4 minutes.

18. The electroacupuncture device of claim 17, wherein the primary battery located within the housing has a capacity of less than 60 milliamp-hours (mAh).

19. The electroacupuncture device of claim 17, wherein:

a housing of the electroacupuncture device is coin-sized and coin-shaped; and

the primary battery located within the housing is a coin-cell battery.

20. The electroacupuncture device of claim 17, wherein the primary battery located within the housing is not rechargeable.