Device and implantation system for electrical stimulation of biological systems

• US 8,447,403 B2
• Filed: 03/04/2011
• Issued: 05/21/2013
• Est. Priority Date: 03/05/2010
• Status: Active Grant

• Current Assignee: Paras Holdings LLC
• Original Assignee: EndoStim, Inc.
• Inventors: Sharma, Virender K., Gani, Matthew Joseph, Goode, Paul V., Hogg, Bevil, Miazga, Jay, Policker, Shai, Raby, Kaila
• Primary Examiner(s): MANUEL, GEORGE C
• Application Number:
  US13/041,098
• Publication Number:
  US 20110295335A1
• Time in Patent Office: 809 Days
• Field of Search: 607/40
• US Class Current: 607/40
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/037 Measuring oesophageal pressure
• CPC Class Codes: A61B 5/0538 invasively, e.g. using a catheter
• CPC Class Codes: A61B 5/1116 Determining posture transitions
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/4211 Diagnosing or evaluating reflux
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• 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 1/36157 Current A61N1/3616 takes precedence
• 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
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer

Abstract

The present specification discloses devices and methodologies for the treatment of nocturnal GERD. Individuals with nocturnal GERD 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 system for treating a gastrointestinal condition of a patient, comprising:

(a) a pulse generator in electrical communication with at least one electrode, wherein said pulse generator is adapted to be implanted proximate to or within a LES of the patient;

(b) an energy storage component, wherein said pulse generator generates a pulse stream in accordance with a preset period, wherein said system comprises a non-volatile memory for storing programmatic code which, when executed by a processor, causes said pulse generator to generate the pulse stream for the preset period, wherein the programmatic code is not configured to modify the pulse stream based upon data from a sensor, and wherein at least one of an amplitude, frequency, or duration of said pulse stream is set such that functionality of the LES normalizes after at least five minutes from when stimulation is initiated.

2. The systems of claim 1, wherein energy delivered to the stimulator has a pulse width in a range of 1 .mu.sec to 1 second.

3. The systems of claim 1, wherein energy delivered to the stimulator has a pulse frequency in a range of 1 Hz to 100 Hz.

4. The systems of claim 1, wherein energy delivered to the stimulator has a pulse amplitude in a range of 1 .mu.Amp to 50 mAmp.

6. The systems of claim 1, wherein, after cessation of stimulation, the LES has a normal physiological behavior.

5. An implantable system for treating a gastrointestinal condition of a patient, comprising:

(a) a passive stimulator for receiving energy from a source;

(b) a pulse generator in electrical communication with said passive stimulator, wherein said pulse generator is adapted to be implanted proximate to or within a LES of the patient and wherein said pulse generator generates a pulse in accordance with a preset period, wherein said system does not include an implantable energy storage component, wherein said system comprises programmatic code which, when executed by a processor, causes said pulse generator to generate the pulse stream for the preset period, wherein the programmatic code is not adapted to modify the pulse stream based upon data from a sensor indicative of a feeding state of the patient, and wherein an amplitude, a frequency, and a duration of said pulse stream is set such that functionality of the LES normalizes after at least five minutes from when stimulation is initiated.

11. The systems of claim 5, wherein energy delivered to the stimulator has a pulse amplitude in a range of 1 .mu.Amp to 50 mAmp.

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

(a) a pulse generator in electrical communication with at least one electrode, wherein said pulse generator is adapted to be implanted proximate to or within a LES of the patient;

(b) an energy storage component, wherein said pulse generator generates a pulse stream in accordance with a preset period, wherein said system comprises programmatic code which, when executed by a processor, causes said pulse generator to generate the pulse stream for the preset period, wherein the programmatic code is not configured to modify the pulse stream based upon data from a sensor indicative of a physiological state of the patient, and wherein an amplitude, a frequency, and a duration of said pulse stream are set such that functionality of the LES normalizes after at least five minutes from when stimulation is initiated.

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

(a) a pulse generator in electrical communication with at least one electrode, wherein said pulse generator is adapted to be implanted proximate to or within a LES of the patient;

(b) an energy storage component, wherein said pulse generator generates a pulse stream in accordance with a preset period, wherein said system comprises programmatic code which, when executed by a processor, causes said pulse generator to generate the pulse stream for the preset period and wherein an amplitude, a frequency, and a duration of said pulse stream are defined such that functionality of the LES normalizes after at least five minutes from when stimulation is initiated.

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

(a) a pulse generator in electrical communication with at least one electrode, wherein said pulse generator is adapted to be implanted proximate to or within a LES of the patient;

(b) an energy storage component, wherein said pulse generator generates a pulse stream for an on period and wherein said on period is between 1 second and 24 hours, wherein said system comprises programmatic code which, when executed by a processor, causes said pulse generator to generate the pulse stream for the preset period and wherein an amplitude, a frequency, and a duration of said pulse stream are programmed such that pressure of the LES normalizes after at least five minutes from when stimulation is initiated.

10. An implantable system for treating a gastrointestinal condition of a patient, comprising:

(a) a passive stimulator for receiving energy from a source;

(b) a pulse generator in communication with said passive stimulator, wherein said pulse generator is adapted to be implanted proximate to or within a LES of the patient and wherein said pulse generator generates a pulse in accordance with a preset period wherein said system comprises a non-volatile memory for storing programmatic code which, when executed by a processor, causes said pulse generator to generate the pulse stream for the preset period, wherein the programmatic code is not adapted to modify the pulse stream based upon data from a sensor, and wherein at least one of an amplitude, frequency, or duration of said pulse stream is set such that functionality of the LES normalizes after at least five minutes from when stimulation is initiated.

12. An implantable system for treating a gastrointestinal condition of a patient, comprising:

(a) a passive stimulator for receiving energy from a source;

(b) a pulse generator in electrical communication with said passive stimulator, wherein said pulse generator is adapted to be implanted proximate to or within a LES of the patient and wherein said pulse generator generates a pulse in accordance with a preset period, wherein said system comprises a non-volatile memory for storing programmatic code which, when executed by a processor, causes said pulse generator to generate the pulse stream for the preset period, wherein the programmatic code is not adapted to modify the pulse stream based upon data from a sensor, and wherein at least one of an amplitude, frequency, or duration of said pulse stream is set such that functionality of the LES normalizes after at least five minutes from when stimulation is initiated.

13. An implantable system for treating a gastrointestinal condition of a patient, comprising:

(a) a passive stimulator for receiving energy from a source;

(b) a pulse generator in electrical communication with said passive stimulator, wherein said pulse generator is adapted to be implanted proximate to or within a LES of the patient and wherein said pulse generator generates a pulse in accordance with a preset period, wherein said system comprises programmatic code which, when executed by a processor, is adapted to cause said pulse generator to generate the pulse stream for the preset period, and wherein at least one of an amplitude, frequency, or duration of said pulse stream is defined such that pressure of the LES normalizes after at least five minutes from when stimulation is initiated.

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

(a) a passive stimulator for receiving energy from a source;

(b) a pulse generator in electrical communication with said passive stimulator, wherein said pulse generator is adapted to be implanted proximate to or within a LES of the patient and wherein said pulse generator generates a pulse in accordance with an on period, wherein said on period is between 1 second and 24 hours, and wherein said system comprises programmatic code which, when executed by a processor, is adapted to cause said pulse generator to generate the pulse stream for the preset period, and wherein an amplitude, a frequency, and a duration of said pulse stream are defined such that functionality of the LES normalizes after at least five minutes from when stimulation is initiated.