Systems and methods for treating gastroesophageal reflux disease

• US 10,420,934 B2
• Filed: 07/20/2018
• Issued: 09/24/2019
• Est. Priority Date: 03/05/2010
• Status: Active Grant

• Current Assignee: Paras Holdings LLC
• Original Assignee: EndoStim, Inc.
• Inventors: Sharma, Virender K, Policker, Shai
• Primary Examiner(s): Dietrich, Joseph M
• Application Number:
  US16/041,426
• Publication Number:
  US 20190076648A1
• Time in Patent Office: 431 Days
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61N 1/00 Electrotherapy; Circuits therefor A61N2/00 takes precedence; irradiation apparatus A61N5/00
• 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 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/37282 characterised by communication with experts in remote locations using a network
• CPC Class Codes: A61N 1/3787 from an external energy source
• CPC Class Codes: G16H 15/00 ICT specially adapted for medical reports, e.g. generation or transmission thereof
• CPC Class Codes: G16H 20/40 relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 20/60 relating to nutrition control, e.g. diets
• CPC Class Codes: G16H 30/20 for handling medical images, e.g. DICOM, HL7 or PACS
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass

Abstract

Systems and methods for treating gastroesophageal reflux disease (GERD) includes minimally invasively implanting a stimulating device in a patient'"'"'s esophagus in the region proximate the lower esophageal sphincter (LES). The patient is provided with a questionnaire related to his disease via an online service. The questionnaire is accessed on a mobile device, such as a cell phone, or on a computer with network access. The data from the sensors and the answers from the questionnaire are analyzed together by a health care provider using the online service. The data and answers are used to program the stimulating device, via the mobile device or computer, to optimize treatment.

Claims

1. A system for treating a gastrointestinal condition of a patient, comprising:

at least one electrode adapted to be implanted such that said electrode is configured to be in electrical communication with a lower esophageal sphincter (LES) of the patient to deliver a pulse stream in accordance with a plurality of stimulation parameters;

a pulse generator in electrical communication with the at least one electrode; and

a non-volatile memory for storing programmatic code which, when executed by a processor, causes the pulse generator to generate the pulse stream in accordance with the plurality of stimulation parameters,

wherein the plurality of stimulation parameters comprises at least one of a pulse width having a range of 5 μ

sec to 30 msec, a pulse amplitude having a range of 1 to 30 mAmp, a pulse frequency having a range of 1 to 100 Hz, wherein values for each of the pulse width, pulse amplitude, or pulse frequency are defined such that the gastrointestinal condition is treated, but swallowing of the patient is not hindered, when the pulse stream is delivered to the patient.

2. The system of claim 1, further comprising an accelerometer wherein the programmatic code comprises a pre-programmed stimulation mode adapted to automatically stimulate the LES during time periods in which the patient is in a supine position as determined by the accelerometer.

3. The system of claim 2, wherein the automatic stimulation occurs after the patient has been in the supine position for a predetermined period of time and wherein the predetermined period of time is programmable and is in a range of 1 minute to 60 minutes.

4. The system of claim 1, wherein the pulse generator is adapted to be implanted.

5. The system of claim 1, wherein the system does not have a sensor to determine when the patient is swallowing and does not modify the delivery of the pulse stream based on the swallowing.

6. The system of claim 1, wherein the plurality of stimulation parameters comprises a pulse width having a range of 30 μ

sec to 5 msec, a pulse amplitude having a range of 2 to 15 mAmp, and a pulse frequency having a range of 2 to 80 Hz.

7. A system for treating a gastrointestinal condition of a patient, comprising:

at least one electrode adapted to be implanted such that said electrode is configured to be in electrical communication with a lower esophageal sphincter (LES) of the patient to deliver a pulse stream in accordance with a plurality of stimulation parameters;

a pulse generator in electrical communication with the at least one electrode; and

a non-volatile memory for storing programmatic code which, when executed by a processor, causes the pulse generator to generate the pulse stream in accordance with the plurality of stimulation parameters,

wherein the plurality of stimulation parameters comprises at least one of a pulse width having a range of 5 μ

sec to 30 msec, a pulse amplitude having a range of 1 to 30 mAmp, a pulse frequency having a range of 1 to 100 Hz, wherein values for each of the pulse width, pulse amplitude, or pulse frequency are defined such that a function of the LES remains normalized after termination of the pulse stream.

8. The system of claim 7, further comprising an accelerometer wherein said programmatic code comprises a pre-programmed stimulation mode adapted to automatically stimulate the LES during time periods in which the patient is in a supine position as determined by the accelerometer and wherein the supine position is defined by a level of inclination relative to a vertical baseline, wherein 0 degrees is a vertical position and wherein the level is programmable and has a range of 50 to 80 degrees.

9. The system of claim 8, wherein the automatic stimulation occurs after the patient has been in the supine position for a predetermined period of time and wherein the predetermined period of time is programmable and is in a range of 1 minute to 60 minutes.

10. The system of claim 7, wherein the pulse generator is adapted to be implanted.

11. The system of claim 7, wherein the system does not have a sensor to determine when the patient is swallowing and does not modify the delivery of the pulse stream based on the swallowing.

12. The system of claim 7, wherein the plurality of stimulation parameters comprises a pulse width having a range of 30 μ

sec to 5 msec, a pulse amplitude having a range of 2 to 15 mAmp, and a pulse frequency having a range of 2 to 80 Hz.

13. The system of claim 7, wherein the function of the LES remains normalized for at least ninety minutes after termination of the pulse stream.

14. A system for treating a gastrointestinal condition of a patient, comprising:

at least one electrode adapted to be implanted such that said electrode is configured to be in electrical communication with a lower esophageal sphincter (LES) of the patient to deliver a pulse stream in accordance with a plurality of stimulation parameters;

a pulse generator in electrical communication with the at least one electrode; and

a non-volatile memory for storing programmatic code which, when executed by a processor, causes the pulse generator to generate the pulse stream in accordance with the plurality of stimulation parameters,

wherein the plurality of stimulation parameters comprises at least one of a pulse width having a range of 5 μ

sec to 30 msec, a pulse amplitude having a range of 1 to 30 mAmp, a pulse frequency having a range of 1 to 100 Hz, wherein values for each of the pulse width, pulse amplitude, or pulse frequency are defined such that a function of the LES normalizes after at least 5 minutes from an initiation of the pulse stream.

15. The system of claim 14, further comprising an accelerometer wherein the programmatic code comprises a pre-programmed stimulation mode adapted to automatically stimulate the LES during time periods in which the patient is in a supine position as determined by the accelerometer, the supine position being defined by a level of inclination relative to a vertical baseline wherein 0 degrees is a vertical position and wherein the level is programmable and is in a range of 50 to 80 degrees.

16. The system of claim 14, wherein the automatic stimulation occurs after the patient has been in the supine position for a predetermined period of time and wherein the predetermined period of time is programmable and is in a range of 1 minute to 60 minutes.

17. The system of claim 15, wherein said automatic stimulation occurs after a minimum percentage of data points are accumulated within said predetermined period of time and wherein said minimum percentage of data points is programmable and has a range of 50 to 90 percent.

18. The system of claim 14, wherein said system does not comprise a sensor to determine when the patient is swallowing.

19. The system of claim 18, wherein the system is not configured to modify the delivery of the pulse stream based on the swallowing.

20. The system of claim 14, wherein the pulse generator is adapted to be implanted.

21. The system of claim 14, wherein the plurality of stimulation parameters comprises a pulse width having a range of 30 μ

sec to 5 msec, a pulse amplitude having a range of 2 to 15 mAmp, and a pulse frequency having a range of 2 to 80 Hz.