Stimulation paradigm to improve blood pressure dipping in an implantable electroacupuncture device

• US 8,942,808 B2
• Filed: 03/05/2013
• Issued: 01/27/2015
• Est. Priority Date: 03/12/2012
• Status: Active Grant

• Current Assignee: Valencia Bioscience, Inc.
• Original Assignee: Valencia Technologies Corporation
• Inventors: Peterson, David K. L., Greiner, Stacy O.
• Primary Examiner(s): Lavert, Nicole F
• Application Number:
  US13/786,447
• Publication Number:
  US 20140214116A1
• Time in Patent Office: 693 Days
• Field of Search: 607/44, 607/116, 606/204
• US Class Current: 607/44
• 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 2201/5041 control is restricted to certain individuals
• CPC Class Codes: A61H 2201/5097 wireless
• CPC Class Codes: A61H 39/002 Using electric currents electrotherapy A61N1/32
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system
• CPC Class Codes: A61N 1/36117 for treating hypertension
• CPC Class Codes: A61N 1/36135 using physiological parameters
• 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 1/3782 producing a voltage above the power source level

Abstract

A coin-sized implantable electroacupuncture (EA) device defines a stimulation paradigm, or stimulation regimen, that controls when EA stimulation pulses are applied to a selected acupoint, or other specified tissue location, to treat hypertension or nondipping. The stimulation regimen is applied when the patient is sleeping in order to minimize or mitigate the occurrence of nondipping or reverse dipping of the patient'"'"'s blood pressure. In one embodiment, medical personnel, set a timing reference marker at the time of implant that defines how much time should elapse before a nighttime stimulation window opens that allows an EA stimulation session to be applied to the patient. In another embodiment, the patient sets the time when the nighttime stimulation window opens or when the EA stimulation session begins. Typically, an EA stimulation session is applied to the patient at a low duty cycle, e.g., only once a week during the nighttime.

Claims

1. An implantable electroacupuncture (EA) device comprising a thin, leadless, disc-shaped housing having a diameter of 2-3 cm and a thickness of 2-4 mm, electrical stimulation circuitry on the inside of the housing and two electrodes formed on the outside of the housing, with one electrode comprising a central electrode positioned in the center of one side of the housing, and with the other electrode comprising a ring electrode positioned around the edge of the disc-shaped housing, and wherein the two electrodes on the outside of the housing are coupled to the stimulation circuitry on the inside of the housing, the stimulation circuitry being configured to generate EA stimulation pulses that are applied to the electrodes following a prescribed stimulation regimen, the prescribed stimulation regimen causing EA stimulation pulses to be generated during a stimulation session of T3 minutes, which stimulation session occurs only during nighttime hours and only once every T4 days, whereby the stimulation regimen restricts the timing of when the stimulation pulses are applied to the electrodes so that, when the EA device is implanted near a desired target location of a patient, stimulation pulses are applied to the desired target location only during a stimulation session of T3 minutes that occurs during nighttime hours no more than once every T4 days.

2. The implantable EA device of claim 1 wherein the EA device is configured to be implanted near a specified acupoint of a patient, and wherein the EA stimulation pulses are applied to the electrodes, and hence to the specified acupoint, for the purpose of treating hypertension.

3. The implantable EA device of claim 2 wherein the specified acupoint is selected from a group of acupoints comprising PC5, PC6, LI4, ST36, ST37, LI11, LR3, and GB34.

4. The implantable EA device of claim 1 wherein the EA stimulation pulses are applied to the electrodes for the purpose of minimizing nondipping, including reverse dipping, of the patient'"'"'s blood pressure.

5. The implantable EA device of claim 4, wherein the time period T3 comprises 15 to 120 minutes.

6. The implantable EA device of claim 5 wherein the time period T3 comprises 30 minutes.

7. The implantable EA device of claim 4, wherein the time period T4 comprises 2 to 14 days.