Systems and methods for electrical stimulation of biological systems

• US 10,406,356 B2
• Filed: 06/30/2017
• Issued: 09/10/2019
• Est. Priority Date: 10/09/2006
• Status: Active Grant

• Current Assignee: Paras Holdings LLC
• Original Assignee: EndoStim, Inc.
• Inventors: Sharma, Virender K., Policker, Shai
• Primary Examiner(s): Flory, Christopher A
• Application Number:
  US15/639,590
• Publication Number:
  US 20170361092A1
• Time in Patent Office: 802 Days
• Field of Search: 607 2, 607 40, 607116, 607133, 600593
• CPC Class Codes: A61B 5/03 Detecting, measuring or recording fluid pressure within the body other than blood pressure, e.g. cerebral pressure; Measuring pressure in body tissues or organs A61B5/205 takes precedence
• CPC Class Codes: A61B 5/14539 for measuring pH
• 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 1/3606 adapted for a particular treatment
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• 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

Abstract

Systems and methods for the treatment of gastroesophageal reflux disease (GERD) include at least one electrically stimulating electrode coupled to a pulse generator. Individuals with GERD are treated by implanting a stimulation device within and/or proximate the patient'"'"'s lower esophageal sphincter, gastric fundus, or other nearby gastrointestinal structures and applying electrical stimulation to the patient'"'"'s lower esophageal sphincter and/or fundus, in accordance with certain predefined protocols. Electrical stimulation provided by the disclosed systems results in an increase in the length of the high pressure zone of the LES and/or modulation of the receptive relaxation response of the fundus to decrease gastric pressure, creating a longer barrier to the reflux of gastric contents or increasing functional lower esophageal pressure respectively, thereby treating GERD.

Claims

1. A system for increasing a length of a high pressure zone of a lower esophageal sphincter (LES) of a patient, said system comprising:

at least one electrically stimulating electrode in electrical communication with the LES and adapted to be located in at least one of the LES, a gastric cardia of the patient, within 3 cm of the LES, or a stomach of the patient;

a waveform generator coupled to said at least one electrode; and

,

a controller configured to control the waveform generator repeatedly generate and apply an electrical pulse train through the at least one electrically stimulating electrode, wherein said electrical pulse train comprises a pulse width having a range of 30 μ

sec to 5 msec and a pulse amplitude having a range of 2 mAmp to 15 mAmp and wherein values for each of said pulse width and pulse amplitude are selected such that the length of said high pressure zone is increased above a threshold level which reduces at least one of a frequency of occurrence or an intensity of gastroesophageal reflux symptoms in said patient and a maximum pressure of the LES is not increased.

2. The system of claim 1, wherein said at least one electrode is adapted to be located within said LES.

3. The system of claim 1, wherein said at least one electrode is adapted to be located within a gastric cardia of said patient.

4. The system of claim 1, wherein said at least one electrode is adapted to be located in an area within 3 cm of said LES.

5. The system of claim 1, comprising at least two electrodes wherein at least one first electrode is adapted to be located within said LES and at least one second electrode is adapted to be located within a gastric cardia of said patient.

6. The system of claim 1, comprising at least two electrodes wherein at least one first electrode is adapted to be located within said LES and at least one second electrode is adapted to be located in an area within 3 cm of said LES.

7. The system of claim 1, comprising at least two electrodes wherein at least one first electrode is adapted to be located within a gastric cardia of said patient and at least one second electrode is adapted to be located in an area within 3 cm of said LES.

8. The system of claim 1, comprising at least three electrodes wherein at least one first electrode is adapted to be located within said LES, at least one second electrode is adapted to be located within a gastric cardia of said patient, and at least one third electrode is adapted to be located in an area within 3 cm of said LES.

9. The system of claim 1, wherein said high pressure zone has a baseline length prior to stimulation and said threshold level defines a length of said high pressure zone which is at least 10% greater than said baseline length.

10. A system for increasing a length of a high pressure zone of a lower esophageal sphincter (LES) of a patient, said system comprising:

at least one electrically stimulating electrode in electrical communication with the LES and adapted to be located in at least one of the LES, a gastric cardia of the patient, within 3 cm of the LES, or a stomach of the patient;

a waveform generator coupled to said at least one electrode;

a controller configured to control the waveform generator repeatedly generate and apply an electrical pulse train through the at least one electrically stimulating electrode, wherein said electrical pulse train comprises a pulse width having a range of 30 μ

sec to 5 msec and a pulse amplitude having a range of 2 mAmp to 15 mAmp and wherein values for each of said pulse width and pulse amplitude are selected such that the length of said high pressure zone is increased above a threshold level which reduces at least one of a frequency of occurrence or an intensity of gastroesophageal reflux symptoms in said patient, such that an average pressure within said high pressure zone is greater than 5 mm Hg, and such that the high pressure zone has a baseline length prior to stimulation and said threshold level defines a length of said high pressure zone which is at least 10% greater than said baseline length.

11. The system of claim 10, wherein said at least one electrode is adapted to be located within said LES.

12. The system of claim 10, wherein said at least one electrode is adapted to be located within a gastric cardia of said patient or within 3 cm of said LES.

13. The system of claim 10, further comprising at least one sensor for sensing at least one physiological parameter of said patient.

14. The system of claim 13, wherein said at least one sensor is configured to measure any one or combination of LES high pressure zone length, LES pressure, esophageal pH, inclinometer data, temperature, or accelerometer data.

15. The system of claim 14, wherein said controller is configured to electrically stimulate said area proximate said LES based on data sensed by said at least one sensor.

16. A method for increasing the length of a high pressure zone of a lower esophageal sphincter (LES) of a patient, said method comprising the steps of:

providing an electrical stimulation system, said system comprising;

at least one electrically stimulating electrode;

a waveform generator coupled to said at least one electrode; and

,

a controller configured to operate said waveform generator to transmit an electrical current to said at least one electrode;

implanting said at least one electrode in at least one of a stomach of the patient, the LES, within 3 cm of said LES or within a gastric cardia of said patient; and

operating said controller to control the waveform generator repeatedly generate and apply an electrical pulse train through the at least one electrically stimulating electrode, wherein said electrical pulse train comprises a pulse width having a range of 30 μ

sec to 5 msec and a pulse amplitude having a range of 2 mAmp to 15 mAmp and wherein values for each of said pulse width and pulse amplitude are selected such that the length of said high pressure zone is increased above a threshold level which reduces at least one of a frequency of occurrence or an intensity of gastroesophageal reflux symptoms in said patient.

17. The method of claim 16, wherein said at least one electrode is adapted to be located within said LES.

18. The method of claim 16, wherein an average pressure within said high pressure zone is greater than 5 mm Hg.

19. The method of claim 16, wherein said high pressure zone has a baseline length prior to stimulation and said threshold level defines a length of said high pressure zone which is at least 10% greater than said baseline length.

20. The method of claim 16, wherein said electrical stimulation system further comprises at least one sensor, said method further comprising the steps of:

sensing at least one physiological parameter of said patient via said at least one sensor; and

, modifying the operation of said controller to cause said at least one electrode to electrically stimulate an area proximate said LES based upon said at least one sensed physiological parameter.