Device and implantation system for electrical stimulation of biological systems

• US 9,061,147 B2
• Filed: 03/07/2014
• Issued: 06/23/2015
• Est. Priority Date: 03/05/2010
• Status: Active Grant

• Current Assignee: Paras Holdings LLC
• Original Assignee: EndoStim, Inc.
• Inventors: Sharma, Virender K., Gani, Matt Joseph, Goode, Paul V., Hogg, Bevil, Miazga, Jay, Policker, Shai, Raby, Kaila
• Primary Examiner(s): DIETRICH, JOSEPH M
• Application Number:
  US14/201,645
• Publication Number:
  US 20140249594A1
• Time in Patent Office: 473 Days
• Field of Search: 607/40
• US Class Current: 1/1
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/037 Measuring oesophageal pressure
• 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 5/14539 for measuring pH
• CPC Class Codes: A61B 5/4211 Diagnosing or evaluating reflux
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/3606 adapted for a particular treatment
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/36157 Current A61N1/3616 takes precedence
• CPC Class Codes: A61N 1/3616 Voltage density or current density
• CPC Class Codes: A61N 1/36171 Frequency
• CPC Class Codes: A61N 1/36175 Pulse width or duty cycle
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer

Abstract

The present specification discloses devices and methodologies for the treatment of transient lower esophageal sphincter relaxations (tLESRs). Individuals with tLESRs 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 and have improved energy storage requirements.

Claims

1. A system for increasing pressure of a patient'"'"'s lower esophageal sphincter (LES), comprising:

at least one electrode configured to contact a region comprising the LES, wherein the region consists of tissue within a distance of 3 cm from the LES;

a waveform generator coupled to the electrodes; and

a controller configured to electrically stimulate the LES to increase an average pressure of the LES above a baseline such that at least one of a frequency of occurrence or an intensity of acid reflux symptoms in the patient is reduced during and/or after stimulation by controlling the waveform generator to repeatedly;

a) generate and apply an electrical pulse train to the LES through the electrodes 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 of 2 to 15 mAmp, an on period ranging from 1 second to 23 hours, 59 minutes, and 59 seconds, an off period ranging from 1 second to 23 hours, 59 minutes, and 59 seconds, a duty cycle ranging from 1 to 100% and a pulse frequency defined such that pressure of the LES normalizes after at least five minutes from when stimulation is initiated.

2. The system of claim 1, further comprising an accelerometer wherein said system includes a pre-programmed stimulation mode adapted to automatically stimulate the patient'"'"'s LES during time periods in which the patient is in a supine position as determined by said accelerometer, said supine position being defined by a level of inclination relative to a vertical baseline wherein 0 degrees is a vertical position and wherein said level is programmable and has a range of 50 to 80 degrees.

3. The system of claim 2, wherein said automatic stimulation occurs after the patient has been in the supine position for a predetermined period of time and wherein said predetermined period of time is programmable and has a range of 1 minute to 60 minutes.

4. The system of claim 3, wherein said automatic stimulation occurs after a minimum percentage of data points occur within said predetermined period of time and wherein said minimum percentage of data points is programmable and has a range of 50 to 90 percent.

5. The system of claim 1 wherein the system does not comprise a sensor to determine when the patient is swallowing.

6. A system for normalizing functionality of a patient'"'"'s lower esophageal sphincter (LES), comprising:

at least one electrode configured to contact a region comprising the LES, wherein the region consists of tissue within a distance of 3 cm from the LES;

a waveform generator coupled to the electrodes; and

a controller configured to control the waveform generator to generate and apply an electrical pulse train to the LES through the electrodes during a stimulation period to produce said normalization of function in the LES during and/or after the stimulation period,

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

sec to 5 msec, a pulse amplitude of 2 to 15 mAmp, an on period ranging from 1 second to 23 hours, 59 minutes, and 59 seconds, an off period ranging from 1 second to 23 hours, 59 minutes, and 59 seconds, a duty cycle ranging from 1 to 100% and a pulse frequency defined such that swallowing of the patient is not hindered by said stimulation.

7. The system of claim 6, further comprising an accelerometer wherein said system includes a pre-programmed stimulation mode adapted to automatically stimulate the patient'"'"'s LES during time periods in which the patient is in a supine position as determined by said accelerometer, said supine position being defined by a level of inclination relative to a vertical baseline wherein 0 degrees is a vertical position and wherein said level is programmable and has a range of 50 to 80 degrees.

8. The system of claim 7, wherein said automatic stimulation occurs after the patient has been in the supine position for a predetermined period of time and wherein said predetermined period of time is programmable and has a range of 1 minute to 60 minutes.

9. The system of claim 8, wherein said automatic stimulation occurs after a minimum percentage of data points occur within said predetermined period of time and wherein said minimum percentage of data points is programmable and has a range of 50 to 90 percent.

10. The system of claim 6 wherein the system does not comprise a sensor to determine when the patient engages in said swallowing.

11. A system for normalizing a function of a patient'"'"'s lower esophageal sphincter (LES), comprising:

at least one electrode configured to contact a region comprising the LES, wherein the region consists of tissue within a distance of 3 cm from the LES;

a waveform generator coupled to the electrodes; and

a controller configured to control the waveform generator to generate and apply an electrical pulse train to the LES through the electrodes to normalize the function of the LES, which reduces at least one of a frequency of occurrence or an intensity of acid reflux symptoms in the patient,

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

sec to 5 msec;

a pulse amplitude of 2 to 15 mAmp;

a pulse frequency of 2 to 80 Hz;

an on period ranging from 1 second to 23 hours, 59 minutes, and 59 seconds;

an off period ranging from 1 second to 23 hours, 59 minutes, and 59 seconds; and

a duty cycle ranging from 1 to 100% and a pulse frequency defined such that said function of the LES normalizes after at least five minutes from when stimulation is initiated and such that swallowing of the patient is not hindered by said stimulation.

12. The system of claim 11, further comprising an accelerometer wherein said system includes a pre-programmed stimulation mode adapted to automatically stimulate the patient'"'"'s LES during time periods in which the patient is in a supine position as determined by said accelerometer, said supine position being defined by a level of inclination relative to a vertical baseline wherein 0 degrees is a vertical position and wherein said level is programmable and has a range of 50 to 80 degrees.

13. The system of claim 12, wherein said automatic stimulation occurs after the patient has been in the supine position for a predetermined period of time and wherein said predetermined period of time is programmable and has a range of 1 minute to 60 minutes.

14. The system of claim 13, wherein said automatic stimulation occurs after a minimum percentage of data points occur within said predetermined period of time and wherein said minimum percentage of data points is programmable and has a range of 50 to 90 percent.

15. The system of claim 11 wherein the system does not comprise a sensor to determine when the patient engages in said swallowing.

16. A system for increasing pressure of a patient'"'"'s lower esophageal sphincter (LES), comprising:

at least one electrode configured to contact a region comprising the LES, wherein the region consists of tissue within a distance of 3 cm from the LES;

a waveform generator coupled to the electrodes;

a battery powering the waveform generator; and

a controller configured to control the waveform generator to generate and apply an electrical pulse train to the LES through the electrodes to increase an average pressure of the LES, the electrical pulse train being controlled by the controller so that an amount of electrical energy consumed from the battery when stimulating the LES is an energy amount that increases said average pressure of the LES above a baseline such that at least one of a frequency of occurrence or an intensity of acid reflux symptoms in the patient is reduced while maintaining at least a minimum charge on the battery to electrically power the waveform generator for a predetermined time period,

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

sec to 5 msec;

a pulse amplitude of 2 to 15 mAmp;

a pulse frequency of 2 to 80 Hz;

an on period ranging from 1 second to 23 hours, 59 minutes, and 59 seconds;

an off period ranging from 1 second to 23 hours, 59 minutes, and 59 seconds; and

a duty cycle ranging from 1 to 100% and a pulse frequency defined such that the increased pressure level of the LES is below a pressure level that prevents the patient from swallowing a bolus.

17. The system of claim 16, further comprising an accelerometer wherein said system includes a pre-programmed stimulation mode adapted to automatically stimulate the patient'"'"'s LES during time periods in which the patient is in a supine position as determined by said accelerometer, said supine position being defined by a level of inclination relative to a vertical baseline wherein 0 degrees is a vertical position and wherein said level is programmable and has a range of 50 to 80 degrees.

18. The system of claim 17, wherein said automatic stimulation occurs after the patient has been in the supine position for a predetermined period of time and wherein said predetermined period of time is programmable and has a range of 1 minute to 60 minutes.

19. The system of claim 18, wherein said automatic stimulation occurs after a minimum percentage of data points occur within said predetermined period of time and wherein said minimum percentage of data points is programmable and has a range of 50 to 90 percent.

20. The system of claim 16 wherein the system does not comprise a sensor to determine when the patient engages in said swallowing.