Device and implantation system for electrical stimulation of biological systems

• US 9,616,225 B2
• Filed: 03/23/2015
• Issued: 04/11/2017
• 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:
  US14/665,226
• Publication Number:
  US 20160001071A1
• Time in Patent Office: 750 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 said stimulator is operably coupled to at least one electrode and wherein said at least one electrode is in electrical communication with the lower esophageal sphincter of the patient, wherein said programming further comprises setting a first stimulation time in a range of 5 to 60 minutes, setting a first pulse amplitude in a range of 3 mA to 8 mA, and setting a first number of stimulations per day in a range of 3 to 24;

applying a plurality of stimulations defined by the first stimulation time, first pulse amplitude, and first number of stimulations;

waiting a period of time and assessing a state of the patient to determine if the patient can swallow during said plurality of stimulations; and

depending upon said assessing of the state of the patient, reprogramming said stimulator, wherein said reprogramming further comprises setting a second stimulation time in a range of 5 to 60 minutes, setting a second pulse amplitude in a range of 3 mA to 8 mA, and setting a second number of stimulations per day in a range of 3 to 24, wherein at least one of said first stimulation time is different from said second stimulation time, said first pulse amplitude is different from said second pulse amplitude, and said first number of stimulations per day is different from said second number of stimulations per day.

2. The method of claim 1 wherein assessing the state of the patient comprises determining whether the plurality of stimulations defined by the first stimulation time, the first pulse amplitude, and the first number of stimulations sufficiently minimizes adverse symptoms associated with the patient'"'"'s gastroesophageal reflux disease.

3. The method of claim 1 wherein assessing the state of the patient comprises determining whether the plurality of stimulations defined by the first stimulation time, the first pulse amplitude, and the first number of stimulations causes dysphagia.

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

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

6. The method of claim 5 wherein the period of time is up to an hour.

7. 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.

8. The method of claim 1 further comprising a second electrode, wherein the at least one electrode is implanted proximate to a left lateral wall of the patient'"'"'s esophagus and the second electrode is implanted proximate to a right lateral wall of the patient'"'"'s esophagus.

9. The method of claim 1 further comprising a second electrode, wherein the at least one electrode is implanted proximate to a left lateral wall of the patient'"'"'s esophagus and the second electrode is implanted proximate to an anterior proximal wall of the patient'"'"'s esophagus.

10. The method of claim 1 further comprising a second electrode, wherein the at least one electrode is implanted proximate to a right lateral wall of the patient'"'"'s esophagus and the second electrode is implanted proximate to an anterior proximal wall of the patient'"'"'s esophagus.

11. The method of claim 1 further comprising a second electrode, wherein the at least one electrode is implanted proximate to a left lateral wall of the patient'"'"'s esophagus and the second electrode is implanted proximate to an anterior distal wall of the patient'"'"'s esophagus.

12. The method of claim 1 further comprising a second electrode, wherein the at least one electrode is implanted proximate to a right lateral wall of the patient'"'"'s esophagus and the second electrode is implanted proximate to an anterior distal wall of the patient'"'"'s esophagus.

13. The method of claim 1 further comprising a second electrode, wherein the at least one electrode is implanted proximate to an anterior proximal wall of the patient'"'"'s esophagus and the second electrode is implanted proximate to an anterior distal wall of the patient'"'"'s esophagus.

14. The method of claim 1 wherein the first stimulation time, first pulse amplitude, and first number of stimulations are selected such that swallowing of the patient is not hindered by an application of a plurality of stimulations, via said stimulator and at least one electrode, defined by the first stimulation time, first pulse amplitude, and first number of stimulations.

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

16. The method of claim 1 further comprising applying a second plurality of stimulations defined by the second stimulation time, the second pulse amplitude, and the second number of stimulations and waiting a second period of time and assessing a second state of the patient.

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

18. The method of claim 1 wherein said plurality of stimulations defines at least one of a first stimulation mode and a second stimulation mode.

19. The method of claim 18 wherein the first stimulation mode is a dose mode which provides a pre-programmed stimulation session per time of day.

20. The method of claim 18 wherein the second stimulation mode is a cyclic mode which provides a stimulation session regularly spaced over a given period of time.