Device and implantation system for electrical stimulation of biological systems

• US 9,561,367 B2
• Filed: 09/29/2014
• Issued: 02/07/2017
• 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
• Primary Examiner(s): Flory, Christopher A
• Application Number:
  US14/500,856
• Publication Number:
  US 20150057718A1
• Time in Patent Office: 862 Days
• Field of Search: 607/2, 607/40, 607/116, 607/133, 600/593
• US Class Current: 1/1
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• 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: 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 treating a patient with gastrointestinal reflux disease comprising:

implanting an electrical stimulator comprising an energy storage component, a non-volatile memory for storing programmatic code, and a pulse generator in electrical communication with at least one electrode, wherein said electrode is implanted such that said electrode is configured to be in electrical communication with a lower esophageal sphincter (LES) of the patient; and

programming said implanted electrical stimulator, wherein said electrical stimulator is programmed such that, when operated, the electrical stimulator generates a pulse stream, wherein said pulse stream 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, wherein values for each of said pulse width, pulse amplitude, and pulse frequency are defined such that swallowing of the patient is not hindered by said stimulation while said stimulation is occurring.

2. The method of claim 1, wherein the electrical stimulator comprises an accelerometer.

3. The method of claim 2, further comprising programming the electrical stimulator to have a stimulation mode adapted to automatically stimulate the LES during time periods in which the patient is in a supine position as determined by said accelerometer.

4. The method of claim 3, wherein said supine position is defined by a level of inclination relative to a vertical baseline and wherein said level is programmable and has a range of 50 to 80 degrees.

5. The method of claim 3, further comprising programming the electrical stimulator such that said automatic stimulation occurs after the patient has been in the supine position for a predetermined period of time and wherein said predetermined period of time has a range of 1 minute to 60 minutes.

6. The method of claim 3, further comprising programming the electrical stimulator such that said automatic stimulation occurs after a minimum percentage of data points occur within a predetermined period of time.

7. The method of claim 1, wherein said electrical stimulator is not in communication with a sensor to determine when the patient is swallowing and does not modify said pulse stream based on said swallowing.

8. A method of treating a patient with gastrointestinal reflux disease comprising:

implanting an electrical stimulator comprising an energy storage component, an accelerometer, a non-volatile memory for storing programmatic code, and a pulse generator in electrical communication with at least one electrode, wherein said electrode is implanted such that said electrode is configured to be in electrical communication with a lower esophageal sphincter (LES) of the patient; and

programming said implanted electrical stimulator, wherein said electrical stimulator is programmed such that, when operated, the electrical stimulator generates a pulse stream, wherein said pulse stream 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, wherein values for each of said pulse width, pulse amplitude, and pulse frequency are defined such that swallowing of the patient is not hindered by said stimulation while said stimulation is occurring.

9. The method of claim 8, further comprising programming the electrical stimulator to automatically stimulate the LES based on whether the patient is in a supine position, as determined by data from said accelerometer.

10. The method of claim 9, wherein said supine position is defined by a level of inclination relative to a vertical baseline and wherein said level is programmable and has a range of 50 to 80 degrees.

11. The method of claim 9, further comprising programming the electrical stimulator such that automatic stimulation occurs after the patient has been in the supine position for a predetermined period of time and wherein said predetermined period of time has a range of 1 minute to 60 minutes.

12. The method of claim 9, further comprising programming the electrical stimulator such that automatic stimulation occurs after a minimum percentage of data points occur within a predetermined period of time.