Systems and methods for treating gastroesophageal reflux disease

• US 9,381,344 B2
• Filed: 07/21/2014
• Issued: 07/05/2016
• 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:
  US14/337,006
• Publication Number:
  US 20150018924A1
• Time in Patent Office: 715 Days
• US Class Current: 1/1
• 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 gastrointestinal reflux disease in a patient, comprising

implanting a device, having a plurality of dimensions, wherein the device is implanted such that the device is oriented between 45 degrees and 135 degrees within a standing patient in relation to a ground surface and wherein the device comprises

a housing;

a stimulator enclosed within the housing;

a plurality of electrodes wherein said electrodes are attached to the outer surface of the housing using conductors at least 1 mm in length wherein the electrodes are attached to the housing by insulated conductors; and

a controller configured to electrically generate, and transmit, an electrical pulse train to the LES through the plurality of electrodes, wherein the electrical pulse train is defined by a pulse width in a range of 30 μ

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

positioning the plurality of electrodes to be at least 1 mm from the patient'"'"'s main vagal trunk, to be at least 1 mm from the patient'"'"'s cardiac tissue and to be in electrical communication with the patient'"'"'s lower esophageal sphincter (LES).

2. The method of claim 1 wherein the electrodes are adapted to be placed in a right or left anterior quadrant of the LES.

3. The method of claim 1 wherein the housing comprises a needle having a length in the range of 5-50 mm and, more preferably, in the range of 10-25 mm, and wherein said needle is used to create a pathway for electrode implantation into the muscularis of the LES.

4. The method of claim 1 wherein the electrodes are of sufficient length to allow the plurality of electrodes to be placed entirely within the LES.

5. The method of claim 1 wherein the electrodes are of sufficient length to allow the plurality of electrodes to be placed proximate to the LES wherein the electrical field generated stimulates the LES.

6. The method of claim 1 wherein the dimensions are at least 6 mm long and no more than 10 cm long to minimize fibrosis within peritoneal cavity.

7. The method of claim 1 further comprising inserting the device into a laparoscopic trocar, wherein the device has a diameter of greater than 6 mm but less than 25 mm.

8. The method of claim 1 wherein said device has an energy source that is rechargeable.

9. The method of claim 8 wherein the device has a recharge frequency of no more than once per day for 6 hours.

10. The method of claim 1 wherein said device has an energy source that is a battery and wherein said battery is a solid state battery, lithium ion battery, or super capacitor battery.

11. The method of claim 1 further comprising anchoring an energy receiving unit to an abdominal wall of the patient to maximize coupling between energy transmitting and receiving units.

12. The method of claim 1 wherein said device is not rechargeable and has an implant life of at least 1 year.

13. The method of claim 1 wherein said plurality of electrodes are permanently attached to the housing by insulated conductors no longer than 65 cm.

14. The method of claim 1 wherein the plurality of electrodes are attached to the housing by insulated conductors which are detachable from the housing and are no longer than 65 mm.

15. The method of claim 1 further comprising attaching the device to an abdominal wall of the patient.

16. The method of claim 1 further comprising attaching the device to an outer surface or serosa of a stomach wall of the patient.

17. The method of claim 1 further comprising delivering and anchoring the device through a single port laparoscopic procedure.

18. The method of claim 1 further comprising delivering and anchoring the device using an articulated trocar in a laparoscopic procedure.

19. The method of claim 1 further comprising delivering the device into a peritoneal cavity of the patient through an incision that is created for a laparoscopic port.