Device and implantation system for electrical stimulation of biological systems

• US 9,020,597 B2
• Filed: 05/03/2012
• Issued: 04/28/2015
• Est. Priority Date: 11/12/2008
• Status: Active Grant

• Current Assignee: Paras Holdings LLC
• Original Assignee: EndoStim, Inc.
• Inventors: Sharma, Virender K., Sofer, Edy, Goode, Paul V., Hogg, Bevil, Policker, Shai, Gani, Matthew Joseph, Miazga, Jay, Raby, Kaila
• Primary Examiner(s): DIETRICH, JOSEPH M
• Application Number:
  US13/463,803
• Publication Number:
  US 20130035740A1
• Time in Patent Office: 1,090 Days
• Field of Search: 607/40
• US Class Current: 607/40
• CPC Class Codes: A61B 5/0538 invasively, e.g. using a catheter
• CPC Class Codes: A61B 5/1116 Determining posture transitions
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61N 1/0517 Esophageal electrodes
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/3614 based on impedance measurement
• CPC Class Codes: A61N 1/36171 Frequency
• CPC Class Codes: A61N 1/36175 Pulse width or duty cycle
• CPC Class Codes: A61N 1/36178 Burst or pulse train parameters

Abstract

The present specification discloses devices and methodologies for the treatment of GERD. Individuals with GERD may be treated by implanting a stimulation device within the patient'"'"'s lower esophageal sphincter and applying electrical stimulation to the patient'"'"'s lower esophageal sphincter, in accordance with certain predefined protocols. The presently disclosed devices have a simplified design because they do not require sensing systems capable of sensing when a person is engaged in a wet swallow, have improved energy storage requirements, enable improved LES function while concurrently delivering additional health benefits, and enable improved LES function post stimulation termination.

Claims

1. A system for treating a patient with gastroesophageal reflux disease, comprising:

at least one electrode positioned within 3 cm above and 3 cm below the patient'"'"'s lower esophageal sphincter (LES);

a waveform generator operably coupled to said at least one electrode;

a controller configured to electrically stimulate the LES to increase a pressure of the LES from a first level to a second level or improve a function of the LES, wherein said controller controls the waveform generator to repeatedly;

a) generate and apply an electrical pulse train to the LES through the at least one electrode for a stimulation period, and

b) terminate the electrical pulse train for a rest period,

wherein said electrical pulse train comprises a pulse width having a range of 30 μ

sec to 5 msec, a pulse amplitude a range of 2 to 15 mAmp, and a duty cycle ranging from 1 to 100%, wherein values for each of said pulse width, pulse amplitude, and pulse frequency are selected such that said increase in pressure or improvement in function of the patient'"'"'s LES occurs at least five minutes after initiating an application of said electrical pulse train and maintains for at least 20 minutes after said electrical pulse train terminates.

2. The system of claim 1 wherein said second level is a pressure or function level that reduces at least one of a frequency or duration of occurrence or an intensity of acid reflux symptoms in the patient.

3. The system of claim 1 wherein the electrical pulse train is between 3 mA to 8 mA.

4. The system of claim 1 wherein the stimulation period is between 5 to 60 minutes in length.

5. The system of claim 1 wherein the controller is programmed to generate and apply an electrical pulse train to the LES for 4 to 24 stimulation periods per day, wherein each stimulation period is separated by a rest period.

6. The system of claim 1 wherein the controller is programmed to generate an on period of 0.1 seconds to 60 seconds and an off period of 0.1 seconds to 60 seconds within a cycle period of 24 hours or more.

7. The system of claim 1 wherein the controller is programmed to generate and apply an electrical pulse train to the LES for more than 11 stimulation periods per day, wherein each stimulation period is separated by a rest period and wherein each stimulation period consists of electrical pulses that are less than 3 mA.

8. The system of claim 1 wherein the stimulation period consists of electrical pulses that are less than 3 mA being applied for a period of time longer than 10 minutes.

9. The system of claim 1 further comprising an accelerometer coupled to the controller for sensing posture data of the patient, wherein said controller is configured to control the waveform generator to adjust parameters of the electrical pulse train applied to the LES based on an analysis of said posture data from said accelerometer.

10. The system of claim 9 wherein the controller is configured to switch from a first stimulation mode to a second stimulation mode when said posture data crosses a predetermined threshold value.

11. The system of claim 10 wherein said posture data comprises time spent in a supine position and said threshold value is set to 1, 5, 30, or 60 minutes.

12. The system of claim 10 wherein said posture data comprises level of inclination to a horizontal position and said threshold value is set to 140, 150, 160, or 170 degrees.

13. The system of claim 10 wherein said first stimulation mode comprises a dose mode which provides a pre-programmed stimulation session per time of day and said second stimulation mode comprises a cyclic mode which provides a stimulation session regularly spaced over a given period of time.

14. The system of claim 10 wherein the controller is configured to apply a block time after entering said second stimulation mode, wherein no further stimulations are applied during said block time and wherein any stimulation begun before entering said second stimulation mode is allowed to complete before initiating said block time.

15. The system of claim 9 wherein the controller is configured to switch from a second stimulation mode to a first stimulation mode when said posture data crosses a predetermined threshold value.

16. The system of claim 15 wherein the controller is configured to apply a block time after entering said first stimulation mode, wherein no further stimulations are applied during said block time and wherein any stimulation begun before entering said first stimulation mode is allowed to complete before initiating said block time.

17. The system of claim 1 further comprising an impedance sensor coupled to the controller for sensing impedance values in the LES, wherein said controller is configured to control the waveform generator to adjust parameters of the electrical pulse train applied to the LES based on said impedance values from said sensor.

18. The system of claim 17 wherein the system senses and analyzes said impedance values by recording more than two impedance measurements in succession prior to each stimulation session, discarding the high and low measurement values, checking for inappropriate values, and averaging the remaining values to modify stimulation parameters based on said average.

19. The system of claim 18 wherein the system modifies stimulation parameters by modifying stimulation voltage amplitude to deliver a consistent current (mA).

20. The system of claim 19 wherein the voltage amplitude is bound by a maximum stimulation amplitude, a minimum stimulation amplitude, and/or a maximum allowable change in stimulation amplitude.

21. The system of claim 17 wherein the system senses and analyzes said impedance values by recording more than two impedance measurements in succession prior to each stimulation session, discarding the high and low measurement values, checking for inappropriate values, averaging the remaining values, and retaking impedance measurements after a predetermined period of time if said four impedance measurements are determined to be too inappropriate.

22. The system of claim 21 wherein said predetermined period of time is 5 minutes.

23. The system of claim 1 further comprising a device external to the patient, wherein said device is capable of transmitting signals based on input from the patient, and an accelerometer coupled to the controller for receiving signals from the external device, wherein said controller is configured to control the waveform generator to adjust parameters of the electrical pulse train applied to the LES based on signals received by said accelerometer.

24. The system of claim 23 wherein said external device comprises a vibratory device having at least one patient operable button and configured to transmit signals comprising a multitude of vibratory signals of differing frequencies.

25. The system of claim 24 wherein said vibratory device comprises a first start/stop button for symptoms, a second start/stop button for drink times, and a third start/stop button for meal times.

26. The system of claim 24 wherein said external device is configured to transmit vibratory signals to said accelerometer when said external device is placed against the patient'"'"'s body proximate the implantation location of said IPG and activated to cause a transmission of signals from said external device to said accelerometer.

27. The system of claim 1 further comprising an accelerometer coupled to the controller for receiving vibratory signals generated by patient taps on the skin surface proximate the implantation location of the IPG, wherein one tap causes said device to generate a signal indicative of a drink time, two taps causes said device to generate a signal indicative of a meal time, and three taps causes said device to generate a signal indicative of symptoms.

28. The system of claim 1 wherein values for each of said pulse width, pulse amplitude, and pulse frequency are further selected such that swallowing of the patient is not hindered by said application of the electrical pulse train.

29. The system of claim 1 wherein the electrical pulse train is not modified based upon data from a sensor indicative of the patient engaging in swallowing.