Systems and methods for treating gastroesophageal reflux disease

• US 8,831,729 B2
• Filed: 04/14/2012
• Issued: 09/09/2014
• Est. Priority Date: 03/04/2011
• Status: Active Grant

• Current Assignee: Paras Holdings LLC
• Original Assignee: EndoStim, Inc.
• Inventors: Policker, Shai, Sharma, Virender K.
• Primary Examiner(s): DIETRICH, JOSEPH M
• Application Number:
  US13/447,168
• Publication Number:
  US 20120265103A1
• Time in Patent Office: 878 Days
• Field of Search: 607/40
• US Class Current: 607/40
• 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 method of treating gastroesophageal reflux disease (GERD) in a patient having a lower esophageal sphincter (LES) comprising:

implanting a stimulation device proximate the LES wherein said stimulation device is programmable and provides electrical stimulation to the LES to produce a contraction of said LES;

measuring a pH in the patient'"'"'s esophagus and generating pH data;

transmitting said pH data to a processor housed within a computing device external to the patient and storing said pH data within said computing device;

obtaining information relating to the patient'"'"'s symptoms arising from the patient'"'"'s GERD;

analyzing said pH data in relation to said information to generate programming parameters; and

programming said stimulation device using said programming parameters wherein said programming step comprises establishing fixed start times for initiating said electrical stimulation and fixed end times for terminating said electrical stimulation.

2. The method of claim 1 wherein measuring said pH comprises implanting at least one pH sensor in the esophagus proximate the LES wherein said at least one pH sensor is configured to continually monitor the pH of the lower esophagus and is capable of transmitting sensed pH data.

3. The method of claim 2 wherein said pH sensor is adapted to be implanted endoscopically.

4. The method of claim 1 wherein the information includes answers to any one or more of questions relating to a timing of the patient'"'"'s GERD symptoms, a duration of the patient'"'"'s GERD symptoms, a severity of the patient'"'"'s GERD symptoms, the patient'"'"'s meal times, types of food ingested by the patient, types of liquid ingested by the patient, the patient'"'"'s sleep times, and the patient'"'"'s exercise regimens.

5. The method of claim 1 wherein programming said stimulation device comprises changing at least one operational parameter, wherein said at least one operational parameter comprises stimulation start time, stimulation duration, and/or stimulation amplitude.

6. The method of claim 1 wherein the information is obtained by electronically presenting questions related to the patient'"'"'s symptoms to the patient through a network to a computing device in the patient'"'"'s possession and electronically receiving answers to said questions from said computing device.

7. The method of claim 6 wherein the computing device is a mobile phone.

8. The method of claim 6 wherein the pH data, programming parameters, and answers are stored in a memory and in relation to a user account that is controlled by the patient and accessible using a network accessible computing device.

9. The method of claim 1 further comprising providing an online service that electronically receives said pH data through a network and stores said pH data.

10. The method of claim 9 wherein said online service electronically receives the information through the network and stores said information.

11. The method of claim 9 wherein said online service electronically receives other data representing at least one physiological value and wherein said physiological value includes at least one patient eating state, supine position, level of physical activity, or blood glucose level.

12. The method of claim 1 further comprising using a remote process to automatically program said stimulating device after generating said programming parameters.

13. The method of claim 9 wherein said online service further electronically transmits reminders and/or recommendations to the patient regarding diet and exercise regimens.

14. The method of claim 9 wherein said online service further electronically receives questions and appointment requests from the patient.

15. The method of claim 9 wherein said online service monitors the patient'"'"'s compliance with at least one of a treatment, diet, or exercise regimen or scheduled appointment, determines a degree of compliance, and generates a reward for the patient based on said degree of compliance.

16. The method of claim 1 further comprising providing a handheld patient input device, wherein said handheld patient input device is adapted to wirelessly charge said stimulation device.

17. The method of claim 16 wherein the handheld patient input device is adapted to monitor changes in tissue impedance.