Device and implantation system for electrical stimulation of biological systems

• US 10,272,242 B2
• Filed: 02/27/2017
• Issued: 04/30/2019
• Est. Priority Date: 05/18/2006
• 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:
  US15/443,983
• Publication Number:
  US 20170296813A1
• Time in Patent Office: 792 Days
• 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 method for treating a patient with gastroesophageal reflux disease, comprising:

programming a stimulator, wherein the stimulator is operably coupled to at least one electrode and wherein the at least one electrode is in electrical communication with the lower esophageal sphincter of the patient, wherein said programming further comprises setting a first pulse amplitude in a range of 3 mA to 8 mA;

applying a plurality of stimulations to the patient, wherein the plurality of stimulations is defined by the first pulse amplitude;

assessing a state of the patient to determine if adverse symptoms associated with the patient'"'"'s gastroesophageal reflux disease are minimized or if the patient experiences dysphagia; and

depending upon the assessing of the state of the patient, reprogramming the stimulator, wherein the reprogramming further comprises setting a second pulse amplitude in a range of 3 mA to 8 mA and wherein the first pulse amplitude is different from the second pulse amplitude.

2. The method of claim 1 wherein programming the stimulator further comprises setting a first number of stimulations per day in a range of 3 to 24 and wherein the plurality of stimulations is further defined by the first number of stimulations per day.

3. The method of claim 2 wherein reprogramming the stimulator further comprises setting a second number of stimulations per day in a range of 3 to 24 and wherein the first number of stimulations per day is different from the second number of stimulations per day.

4. The method of claim 1 wherein programming the stimulator further comprises setting a first stimulation time in a range of 5 to 60 minutes and wherein the plurality of stimulations is further defined by the first stimulation time.

5. The method of claim 4 wherein reprogramming the stimulator further comprises setting a second stimulation time in a range of 5 to 60 minutes and wherein the first stimulation time is different from the second stimulation time.

6. The method of claim 1 wherein the at least one electrode is placed in electrical communication with a fundus of the patient.

7. The method of claim 1 wherein the first pulse amplitude is selected such that a pressure of the lower esophageal sphincter increases, after a stimulation terminates, for a period of time and then decreases.

8. The method of claim 7 wherein the period of time is up to an hour.

9. The method of claim 1 wherein the stimulator and at least one electrode delivers an electrical pulse having both a higher frequency component and a lower frequency component.

10. The method of claim 1 wherein the first pulse amplitude is selected such that swallowing of the patient is not hindered by the application of the plurality of stimulations.

11. The method of claim 1 wherein the plurality of stimulations is not modified based upon data from a sensor indicative of the patient engaging in swallowing.

12. The method of claim 1 wherein the plurality of stimulations is defined by a first stimulation mode and a second stimulation mode.

13. The method of claim 12 wherein the first stimulation mode is a dose mode which provides a pre-programmed stimulation session per time of day.

14. The method of claim 13 wherein the second stimulation mode is a cyclic mode which provides a stimulation session regularly spaced over a given period of time.

15. The method of claim 1 further comprising applying a second plurality of stimulations to the patient, wherein the second plurality of stimulations is defined by the second pulse amplitude, waiting a second period of time, and assessing a second state of the patient.

16. The method of claim 15 further comprising, depending upon the assessing of the second state of the patient, reprogramming the stimulator, wherein the reprogramming further comprises setting at least one of a stimulation time in a range of 5 to 60 minutes, a third pulse amplitude in a range of 3 mA to 8 mA, and a number of stimulations per day in a range of 3 to 24.