Implantable electroacupuncture system and method for treating dyslipidemia and obesity

• US 9,314,399 B2
• Filed: 01/07/2013
• Issued: 04/19/2016
• 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, Greiner, Stacy O.
• Primary Examiner(s): DIETRICH, JOSEPH M
• Application Number:
  US13/736,033
• Publication Number:
  US 20140214125A1
• Time in Patent Office: 1,198 Days
• Field of Search: 607/2, 607/59
• 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 Implantable ElectroAcupuncture System (IEAS) treats dyslipidemia or obesity through application of stimulation pulses applied at at least one of acupoints ST36, SP4, ST37, ST40, SP6, SP9, K16, or LR8, or underlying nerves saphenous or peroneal. The IEAS includes an hermetically-sealed implantable electroacupuncture (EA) device having at least two electrodes located outside of its housing. The housing contains a primary power source, pulse generation circuitry, and a sensor that wirelessly senses externally-generated operating commands. The pulse generation circuitry generates stimulation pulses as controlled, at least in part, by the operating commands sensed through the sensor. The stimulation pulses are applied to the specified acupoint or nerve through the electrodes in accordance with a specified stimulation regimen. Such stimulation regimen requires that the stimulation session be applied at a very low duty cycle not greater than 0.05.

Claims

1. A method for treating obesity or dyslipidemia of a patient using a small, thin, leadless, implantable electroacupuncture device (IEAD) powered by a small disc battery having an impedance of at least 5 ohms, the IEAD having a maximum linear dimension of no more than 25 mm in a first plane, and a maximum height of no more than 2.5 mm in a second plane orthogonal to the first plane, the IEAD being configured, using electronic circuitry housed within the IEAD, to generate electroacupuncture (EA) pulses in accordance with a specified stimulation regimen and apply the EA stimulation pulses through at least two electrodes/arrays located on a housing of the IEAD to the patient'"'"'s body tissue at or near at least one selected target tissue stimulation site, said at least two electrodes/arrays comprising at least one central electrode/array of a first polarity, having a maximum width of no more than 7 mm, centrally located on a first surface of the small IEAD housing, and at least one annular electrode/array of a second polarity spaced apart from the central electrode/array by at least 5 mm measured from the edge of the annular electrode/array closest to the central electrode/array to the center of the central electrode/array, said method comprising the steps of:

(a) implanting the IEAD below the skin surface of the patient at or near at least one selected target stimulation site, with the first surface of the IEAD facing inwardly into the patient'"'"'s body tissue at the selected target stimulation site; and

(b) enabling the EA device to generate stimulation sessions at a duty cycle that is less than or equal to 0.05, wherein each stimulation session comprises a series of stimulation pulses, wherein the duty cycle is the ratio of T3/T4, where T3 is the duration of each stimulation session, and T4 is the duration between stimulation sessions.

2. The method of treating obesity or dyslipidemia of claim 1 wherein the at least one selected target stimulation site at which the stimulation pulses are applied is selected from the group of target stimulation sites comprising acupoints ST36, SP4, ST37, ST40, SP6, SP9, K16, or LR8, or their underlying nerves.

3. The method of treating obesity or dyslipidemia of claim 1 further including setting the time T4, the time between stimulation sessions, to be at least 1440 minutes [1 day] but no longer than 20,160 minutes [14 days].

4. The method of treating obesity or dyslipidemia of claim 3 further including setting T3, the duration of the stimulation session, to toggle between a first value T3₁ for a first stimulation session duration and a second value T3₂ for a second stimulation session duration, with the value T3₁ being used every other stimulation session, whereby a time line of the method of treating obesity or dyslipidemia follows a sequence T3₁-T4-T3₂-T4-T3₁-T4-T3₂-T4- . . . and so on, where T4 is the time period between stimulation sessions.

5. The method of treating obesity or dyslipidemia of claim 4 where T3₁ is set to a value that ranges between 10 minutes and 40 minutes, and T3₂ is set to a value that ranges between 30 minutes and 60 minutes.

6. The method of treating obesity or dyslipidemia of claim 3 further including dividing T3, the duration of the stimulation session, into smaller segments of time, T31, T32, T33 . . . T3n, where n is an integer, such that T3=T31+T32+T33+ . . . T3n, and wherein during each segment of time the stimulus pulse is delivered at a different frequency than is delivered during the other segments of time, whereby over the total time of the stimulation session T3, the stimulation pulses are delivered at different frequencies.

7. The method of treating obesity or dyslipidemia of claim 1 further including setting the time T3, the duration of the stimulation sessions, to be at least 10 minutes but no longer than a maximum value, T3(max), where the value of T3(max) is adjusted, as needed, to maintain the duty cycle, the ratio of T3/T4, at a value no greater than 0.05, wherein T3(max) is equal to 72 minutes if T4, the time period between stimulation sessions, is between 1,440 minutes [24 hours] and 20,160 minutes [14 days];

and setting T3(max) to a value set by the equation T3(max)=0.05*T4 when T4 is between 720 minutes [½

day] and 1,440 minutes [24 hours].

8. The method of treating obesity or dyslipidemia of claim 7 further comprising setting T4, the time period between stimulation sessions, to toggle between a first value T4₁ and a second value T4₂, with the value T4₁ being used after every other stimulation session, whereby a time line of the method of treating obesity or dyslipidemia follows a sequence T3-T4₁-T3-T4₂-T3-T4₁-T3-T4₂-T3-T4₁ . . . and so on, where T3 is the duration of the stimulation sessions.

9. The method of treating obesity or dyslipidemia of claim 8 where T4₁ is set to a value that ranges between 720 minutes [½

day] and 10,080 minutes [1 week], and T4₂ is set to a value that ranges between 1,440 minutes [1 day] and 20,160 minutes [2 weeks].

10. The method of treating obesity or dyslipidemia of claim 1 further including manually starting and stopping the stimulation sessions within parameter boundaries that set a minimum duration, T3(min), for the stimulation session and a maximum duration, T3(max), for the stimulation session;

as well as a minimum time period, T4(min), between stimulation sessions and a maximum time period, T4(max), between stimulation sessions, the method comprising;

(a) manually starting a stimulation session at any time after an initialization event;

(b) manually stopping the stimulation session started in step (a) at any time after T3(min) has elapsed, or allowing the stimulation session started in step (a) to automatically stop after T3(max) has elapsed;

(c) manually starting a new stimulation session at any time after T4(min) has elapsed since the stopping of the stimulation in step (b), or allowing a new stimulation session to automatically start after T4(max) has elapsed;

(d) repeating steps (b) and (c) for so long as the method for treating obesity or dyslipidemia is to be continued, or aborting the treatment by manually shutting down the treatment.