Implantable electroacupuncture system and method for treating dyslipidemia and obesity

• US 9,566,212 B2
• Filed: 09/18/2015
• Issued: 02/14/2017
• 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:
  US14/859,088
• Publication Number:
  US 20160008220A1
• Time in Patent Office: 515 Days
• US Class Current: 1/1
• 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 using a small implantable electroacupuncture device (IEAD) includes 1) implanting the IEAD below the skin surface of the patient at or near a target tissue location selected from the group of target tissue locations comprising acupoints ST36, SP4, ST37, ST40, SP6, SP9, K16, LR8 and their underlying nerves, the saphenous nerve and the peroneal nerve, and 2) enabling the IEAD to provide EA stimulation pulses in accordance with a stimulation regimen that provides a stimulation session having a duration of T3 minutes at a rate of once every T4 minutes, where the ratio of T3/T4 is no greater than 0.05, and wherein T3 is at least 10 minutes and no greater than 60 minutes.

Claims

1. A method of treating obesity or dyslipidemia of a patient using a small implantable electroacupuncture device (IEAD) powered by a small disc primary battery having a specified nominal output voltage of about 3 volts, and having an internal impedance of at least 5 ohms, the IEAD being configured, using electronic circuitry within the IEAD, to generate stimulation pulses in accordance with a specified stimulation regimen and apply the stimulation pulses through at least two electrodes located on an outside of a housing of the IEAD at a selected tissue location, the at least two electrodes comprising at least one cathode electrode and at least one anode electrode, the method comprising:

implanting the IEAD below the skin surface of the patient at or near a target tissue location selected from the group of target tissue locations comprising acupoints ST36, SP4, ST37, ST40, SP6, SP9, K16, LR8 and their underlying nerves, the saphenous nerve and the peroneal nerve; and

enabling the IEAD to provide EA stimulation pulses by way of the at least two electrodes located on the outside of the housing of the IEAD in accordance with a stimulation regimen that provides a stimulation session having a duration of T3 minutes at a rate of once every T4 minutes, where the ratio of T3/T4 is no greater than 0.05, and wherein T3 is at least 10 minutes and no greater than 60 minutes.

2. The method of claim 1, further comprising setting the stimulation pulses during the stimulation session to have a duration of T1 seconds, that occur at a rate of once every T2 seconds, wherein T1 is 0.1 to 2.0 milliseconds, and T2 is 100 to 1000 milliseconds.

3. The method of claim 2, wherein the time T2 varies during the stimulation session, whereby the frequency of the stimulation pulses varies during the stimulation session.

4. The method of claim 1, further including controlling the electronic circuitry within the IEAD to limit the instantaneous current drawn from the small disc primary battery so that the output voltage of the primary battery does not drop more than about 11% below the output voltage of the primary battery when current is being drawn from the primary battery, where the output voltage of the primary battery is equal to the specified nominal output voltage of the primary battery less the voltage drop caused by the instantaneous current flowing through the internal impedance of the primary battery.

5. The method of claim 4, wherein the electronic circuitry within the IEAD includes a boost converter circuit, and wherein the method of controlling the electronic circuits within the IEAD to limit the instantaneous current drawn from the battery comprises modulating the operation of the boost converter circuit between an ON state and an OFF state.

6. The method of claim 1, wherein the at least two electrodes are located on an outside surface of the housing of the IEAD.

7. The method of claim 6, wherein the at least two electrodes comprise a central electrode of a first polarity centrally located on a first surface of the housing of the IEAD located and an annular electrode of a second polarity and that is spaced apart from the central electrode.

8. The method of claim 7, wherein the annular electrode is a ring electrode placed around a perimeter edge of the housing of the IEAD.

9. The method of claim 7, wherein the annular electrode is located on the first surface of the housing.

10. The method of claim 1, wherein the enabling the IEAD to provide the EA stimulation pulses comprises applying the EA stimulation pulses to at least one of the saphenous nerve and the peroneal nerve.

11. An electroacupuncture device (IEAD) for treating obesity or dyslipidemia of a patient, comprising:

a housing configured to be implanted beneath a skin surface of the patient at or near a target tissue location selected from the group of target tissue locations comprising acupoints ST36, SP4, ST37, ST40, SP6, SP9, K16, LR8 and their underlying nerves, the saphenous nerve and the peroneal nerve;

a central electrode of a first polarity and centrally located on a first surface of the housing;

an annular electrode of a second polarity and that surrounds the central electrode on the first surface of the housing, the annular electrode being spaced apart from the central electrode; and

pulse generation circuitry located within the housing and electrically coupled to the annular and central electrodes, wherein the pulse generation circuitry

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

applies the stimulation sessions to the target tissue location by way of the central electrode and the annular electrode in accordance with the duty cycle,

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, 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.

12. The IEAD of claim 11, wherein T3 is at least 10 minutes and no greater than 60 minutes.

13. The IEAD of claim 11, wherein the pulse generation circuitry sets the stimulation pulses during the stimulation session to have a duration of T1 seconds, that occur at a rate of once every T2 seconds, wherein T1 is 0.1 to 2.0 milliseconds, and T2 is 100 to 1000 milliseconds.

14. The IEAD of claim 13, wherein the time T2 varies during the stimulation session, whereby the frequency of the stimulation pulses varies during the stimulation session.

15. The IEAD of claim 11, further comprising a disc primary battery having a specified nominal output voltage of about 3 volts, and having an internal impedance of at least 5 ohms.

16. The IEAD of claim 11, wherein the annular electrode is a ring electrode placed around a perimeter edge of the housing of the IEAD.

17. The IEAD of claim 11, wherein the annular electrode is located on the first surface of the housing.

18. The IEAD of claim 11, wherein the pulse generation circuitry applies the stimulation sessions to at least one of the saphenous nerve and the peroneal nerve.

19. A system for treating obesity or dyslipidemia of a patient, the system comprising:

means for implanting a coin-sized electroacupuncture device (IEAD) in the patient below the patient'"'"'s skin at at least one specified stimulation site;

means for enabling the IEAD to generate stimulation sessions at a duty cycle that is less than 0.05, each stimulation session comprising a series of stimulation pulses, wherein the duty cycle is the ratio of T3/T4, where T3 is the time or duration of each stimulation session, and T4 is the time between stimulation sessions; and

means for delivering the stimulation pulses of each stimulation session to the at least one specified stimulation site through a plurality of electrodes attached to an outside surface of the EA device.

20. The system of claim 19, wherein the at least one specified stimulation site comprises at least one of acupoint ST36, acupoint SP4, acupoint ST37, acupoint ST40, acupoint SP6, acupoint SP9, acupoint K16, acupoint LR8, a saphenous nerve, and a peroneal nerve.