Device and implantation system for electrical stimulation of biological systems

• US 9,789,309 B2
• Filed: 05/08/2015
• Issued: 10/17/2017
• 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:
  US14/707,190
• Publication Number:
  US 20160059010A1
• Time in Patent Office: 893 Days
• 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 method of determining a plurality of stimulation parameters for an electrical stimulation device, wherein said electrical stimulation device comprises at least one electrode in electrical communication with a lower esophageal sphincter (LES) of a patient, a waveform generator coupled to the at least one electrode, and a controller configured to control the waveform generator, the method comprising:

applying a plurality of stimulation sequences, wherein each of said plurality of stimulation sequences is defined by a pulse frequency, pulse duration, and pulse amplitude and wherein each of said plurality of stimulation sequences is applied via said at least one electrode in electrical communication with the LES of the patient;

after each of said plurality of stimulation sequences, evaluating a pressure response of the LES of the patient; and

terminating said application of a plurality of stimulation sequences when the LES of the patient exhibits a pressure response of at least 20 mm Hg sustained for at least 5 minutes.

2. The method of claim 1 wherein a first of said plurality of stimulation sequences has a pulse frequency of 20 Hz, a pulse duration of 200 μ

sec, and a pulse amplitude of 5 mAmp.

3. The method of claim 2 wherein a second of said plurality of stimulation sequences has a pulse frequency of 20 Hz, a pulse duration of 200 μ

sec, and a pulse amplitude of 10-15 mAmp.

4. The method of claim 3 wherein a third of said plurality of stimulation sequences has a pulse frequency of 20 Hz, a pulse duration of 3 ms, and a pulse amplitude of 5-15 mAmp.

5. The method of claim 4 wherein a fourth of said plurality of stimulation sequences has a pulse frequency of 6 cycles/min, a pulse duration of 375 ms, and a pulse amplitude of 5 mAmp.

6. The method of claim 5 wherein a fifth of said plurality of stimulation sequences has a pulse frequency of 6 cycles/min, a pulse duration of 375 ms, and a pulse amplitude of 5-15 mAmp.

7. The method of claim 1 wherein, after terminating an application of the plurality of stimulation sequences, keeping said plurality of stimulation sequences off until a pressure of the patient'"'"'s LES drops to less than 10 mm Hg or to a baseline pressure of the patient'"'"'s LES, whichever is higher.

8. The method of claim 7 wherein, after the pressure of the patient'"'"'s LES drops to less than 10 mm Hg or to the baseline pressure of the patient'"'"'s LES, whichever is higher, applying another of said plurality of stimulation sequences via said at least one electrode in electrical communication with the LES of the patient.

9. The method of claim 8 further comprising recording periods during which the plurality of stimulation sequences are being applied and periods during which no stimulation is being applied.

10. A method of determining a plurality of stimulation parameters for an electrical stimulation device, wherein said electrical stimulation device comprises at least one electrode in electrical communication with a lower esophageal sphincter (LES) of a patient, a waveform generator coupled to the at least one electrode, and a controller configured to control the waveform generator, the method comprising:

applying a first of a plurality of stimulation sequences, wherein the first of a plurality of stimulation sequences is defined by a first pulse frequency, a first pulse duration, and a first pulse amplitude and wherein the first of a plurality of stimulation sequences is applied via said at least one electrode in electrical communication with the LES of the patient;

evaluating a pressure response of the patient'"'"'s LES;

terminating the first of the plurality of stimulation sequences when the LES of the patient exhibits a pressure response of at least 20 mm Hg sustained for at least 5 minutes;

waiting until a pressure of the patient'"'"'s LES decreases to less than 10 mm Hg or to a baseline pressure, whichever is higher; and

applying a second of the plurality of stimulation sequences, wherein the second of the plurality of stimulation sequences is defined by a second pulse frequency, a second pulse duration, and a second pulse amplitude and wherein the second of a plurality of stimulation sequences is applied via said at least one electrode in electrical communication with the LES of the patient.

11. The method of claim 10 further comprising recording an on period of the first of the plurality of stimulation sequences.

12. The method of claim 11 further comprising recording an off period between a termination of the first of the plurality of stimulation sequences and an application of the second of the plurality of stimulation sequences.

13. The method of claim 10 further comprising measuring an impedance of the at least one electrode using an impedance measurement device that is external to the patient.

14. The method of claim 10 further comprising measuring an impedance of the at least one electrode by measuring a voltage waveform generated during an application of an electrical stimulation pulse by the electrical stimulation device.

15. The method of claim 10 wherein the first pulse frequency is 20 Hz, the first pulse duration is 200 μ

sec, and the first pulse amplitude is 5 mAmp.

16. The method of claim 10 wherein the second pulse frequency is 20 Hz, the second pulse duration is 200 μ

sec, and the second pulse amplitude is 10-15 mAmp.

17. The method of claim 10 further comprising evaluating a pain level of the patient, and, if the patient experiences pain, decreasing a pulse amplitude of one of the plurality of stimulation sequences.

18. The method of claim 17 further comprising decreasing the pulse amplitude by 1 mAmp and re-evaluating the pain level of the patient.