Implantable electroacupuncture system and method for treating cardiovascular disease

• US 8,996,125 B2
• Filed: 09/19/2012
• Issued: 03/31/2015
• Est. Priority Date: 09/23/2011
• Status: Active Grant

• Current Assignee: Valencia Bioscience, Inc.
• Original Assignee: Valencia Technologies Corporation
• Inventors: Greiner, Jeffrey H., Peterson, David K. L., Thenuwara, Chuladatta
• Primary Examiner(s): MALAMUD, DEBORAH LESLIE
• Application Number:
  US13/622,653
• Publication Number:
  US 20140214124A1
• Time in Patent Office: 923 Days
• Field of Search: 607 1- 2, 607/59, 607/61, 607115-116
• US Class Current: 607/61
• CPC Class Codes: A61H 2201/01 Constructive details
• CPC Class Codes: A61H 39/00 Devices for locating or stimulating specific reflex points of the body for physical therapy, e.g. acupuncture chiropodists' instruments A61B17/54; for radiation therapy A61N5/0619
• CPC Class Codes: A61H 39/002 Using electric currents electrotherapy A61N1/32
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• 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 1/37223 Circuits for electromagnetic coupling
• 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
• CPC Class Codes: A61N 1/3787 from an external energy source
• CPC Class Codes: Y10T 29/49002 Electrical device making

Abstract

An implantable electroacupuncture device (IEAD) treats cardiovascular disease through application of stimulation pulses applied at at least one of acupoints EX-HN1, BL14, HT7, HT5, PC6, ST36, LI11, LU7 and LU2. The IEAD comprises an implantable, coin-sized, self-contained, leadless electroacupuncture device having at least two electrodes attached to an outside surface of its housing. The device generates stimulation pulses in accordance with a specified stimulation regimen. Power management circuitry within the device allows a primary battery, having a high internal impedance, to be used to power the device. The stimulation regimen generates stimulation pulses during a stimulation session of duration T3 minutes applied every T4 minutes. The duty cycle, or ratio T3/T4 is very low, no greater than 0.05. The low duty cycle and careful power management allow the IEAD to perform its intended function for several years.

Claims

1. A method for treating cardiovascular disease in a patient comprising the steps of:

(a) implanting an electroacupuncture (EA) device in the patient below the patient'"'"'s skin at or near at least one specified acupoint;

(b) enabling the EA device to generate stimulation sessions at a duty cycle that is less than 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;

(c) delivering the stimulation pulses of each stimulation session to the at least one specified acupoint through a plurality of electrode arrays electrically connected to the EA device, where an electrode array comprises an array of n conductive contacts electrically joined together to function jointly as one electrode, where n is an integer from 1 to 30; and

(d) 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, and then treating cardiovascular disease by;

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

(ii) 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 (i) to automatically stop after T3(max) has elapsed;

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

(iv) repeating steps (ii) and (iii) for so long as the method for treating cardiovascular disease is to be continued, or aborting the treatment by manually shutting down the treatment.

2. The method of treating cardiovascular disease of claim 1 wherein the at least one specified acupoint at which the stimulation pulses are applied is selected from the group of acupoints that includes:

PC6 in the right or left forearm;

ST36 on the anterior aspect of the left or right leg, on the tibialis anterior muscle;

BL14 (also referred to as UB14), in the upper back region;

EX-HN1 (located approximately one centimeter from GV20, on the top of the head);

HT7 on the anteromedial aspect of the right or left wrist, radial to the flexor carpi ulnaris tendon, on the palmar wrist crease;

HT5 on the anteromedial aspect of the forearm, radial to the flexor carpi ulnaris tendon;

LI11 on the lateral aspect of the elbow;

LU2 on the anterior thoracic region, in the depression of the infraclavicular fossa; and

LU7 on the radial aspect of the forearm, between the tendons of the abductor pollicis longus and the extensor pollicis brevis muscles.

3. The method of treating cardiovascular disease of claim 1 further comprising attaching the plurality of electrode arrays to an outside surface of the EA device, with one electrode array of the plurality of electrode arrays comprising a central electrode array, and with another electrode array of the plurality of electrode arrays comprising an annular electrode array that surrounds the central electrode array, and wherein the spacing between the center of the central electrode array and the closest electrode contact within the annular electrode array comprises at least 5 mm.

4. The method of treating cardiovascular disease of claim 1further including setting the time T4, the time between stimulation sessions, to have a T4(min) of at least 720 minutes and a T4(max) of no longer than 20,160 minutes.

5. The method of treating cardiovascular disease of claim 4 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, wherein both T3₁ and T3₂ are greater than or equal to T3(min) and less than or equal to T3(max), with the value T3₁ being used every other stimulation session, whereby a time line of the method of treating cardiovascular disease follows a sequence T3₁-T4-T3₂-T4-T3₁-T4-T3₂-T4- . . . and so on.

6. The method of treating cardiovascular disease of claim 5 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.

7. The method of treating cardiovascular disease of claim 1 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 60 minutes if T4, the time period between stimulation sessions, is between 1,200 minutes [20 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 1,200 minutes [20 hours].

8. The method of treating cardiovascular disease 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, wherein both T4₁ and T4₂ are greater than or equal to T4(min) and less than or equal to T4(max), with the value T4₁ being used after every other stimulation session, whereby a time line of the method of treating cardiovascular disease follows a sequence T3-T4₁-T3-T4₂-T3-T4₁-T3-T4₂-T3-T4₁ . . . and so on.

9. The method of treating cardiovascular disease 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. A method for treating cardiovascular disease in a patient comprising the steps of:

(a) implanting an electroacupuncture (EA) device in the patient below the patient'"'"'s skin at or near at least one specified acupoint;

(b) enabling the EA device to generate stimulation sessions at a duty cycle that is less than 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;

(c) delivering the stimulation pulses of each stimulation session to the at least one specified acupoint through electrodes located on a case of the EA device; and

(d) controlling 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, and treating cardiovascular disease by;

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

(ii) stopping the stimulation session started in step (i) 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;

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

(iv) repeating steps (ii) and (iii) for so long as the method for treating cardiovascular disease is to be continued, or aborting the treatment by manually shutting down the treatment.