Methods for implanting electrodes and treating a patient with gastreosophageal reflux disease

• US 10,426,955 B2
• Filed: 10/24/2016
• Issued: 10/01/2019
• Est. Priority Date: 10/09/2006
• 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): Flory, Christopher A
• Application Number:
  US15/332,861
• Publication Number:
  US 20170036021A1
• Time in Patent Office: 1,072 Days
• Field of Search: 607 2, 607 40, 607116, 607133, 600593
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/42 Detecting, measuring or recording for evaluating the gastrointestinal, the endocrine or the exocrine systems A61B1/00, A61B5/4857, A61B5/486, A61B5/4866, A61B5/4869 take precedence
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/6852 Catheters
• CPC Class Codes: A61B 5/6861 Capsules, e.g. for swallowing or implanting
• CPC Class Codes: A61B 5/687 Oesophagus
• CPC Class Codes: A61N 1/0507 Electrodes for the digestive system
• 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 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36021 for treatment of pain
• CPC Class Codes: A61N 1/36125 Details of circuitry or electric components
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/36146 specified by the stimulation parameters
• CPC Class Codes: A61N 1/36171 Frequency
• CPC Class Codes: A61N 1/36175 Pulse width or duty cycle
• CPC Class Codes: A61N 1/37264 Changing the program; Upgrading firmware

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 implanting electrodes in a patient in order to treat gastroesophageal reflux disease, comprising:

implanting a first electrode in a stomach of the patient;

implanting a second electrode in the stomach of the patient, wherein the second electrode is positioned parallel to the first electrode;

connecting the first electrode and the second electrode to a pulse stimulator configured to supply a stimulation pulse to the first electrode and the second electrode;

programming the pulse stimulator to apply a train of stimulation pulses, wherein the pulse stimulator is not in data communication with an implanted sensor configured to sense a physiological state of the patient; and

operating the first electrode and the second electrode in combination to deliver the stimulation pulses to normalize a function of a lower esophageal sphincter (LES) of the patient post-stimulation.

2. The method of claim 1, wherein the stimulation pulses have a pulse amplitude equal to or less than 15 mAmp.

3. The method of claim 1, wherein the second electrode is separated from the first electrode by a distance equal to or less than 1.5 cm.

4. The method of claim 1, wherein the first electrode and the second electrode are each positioned more than 1 mm away from a vagal trunk of the patient.

5. A method of implanting a first electrode and a second electrode in a patient in order to treat gastroesophageal reflux disease, comprising:

implanting the first electrode in a stomach of the patient;

implanting the second electrode in a stomach of the patient, wherein the second electrode is positioned skew relative to the first electrode,

connecting the first electrode and the second electrode to a pulse stimulator configured to supply a stimulation pulse to the first electrode and the second electrode;

programming the pulse stimulator to apply a train of stimulation pulses, wherein the pulse stimulator is not in data communication with an implanted sensor configured to sense a physiological state of the patient; and

operating the first electrode and the second electrode in combination to deliver the stimulation pulses to normalize a function of a lower esophageal sphincter (LES) of the patient post-stimulation.

6. The method of claim 5, wherein the stimulation pulses have a pulse amplitude equal to or less than 15 mAmp.

7. The method of claim 5, wherein the second electrode is separated from the first electrode by a distance equal to or less than 1.5 cm.

8. The method of claim 5, wherein each of the first electrode and the second electrodes is positioned more than 1 mm away from a vagal trunk of said patient.