DEVICE AND IMPLANTATION SYSTEM FOR ELECTRICAL STIMULATION OF BIOLOGICAL SYSTEMS

• US 20110307027A1
• Filed: 03/04/2011
• Published: 12/15/2011
• 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
• Granted Patent: US 8,712,529 B2
• Time in Patent Office: Days
• 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 GERD. Individuals with 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 increasing pressure of a patient'"'"'s lower esophageal sphincter (LES), comprising:

at least one electrode contacting the LES;

a waveform generator coupled to the electrodes; and

a controller configured to electrically stimulate the LES to increase the pressure of the LES, and maintain an average pressure of the LES above a pressure level which reduces at least one of a frequency of occurrence or an intensity of acid reflux symptoms in the patient both during and after stimulation by controlling the waveform generator to repeatedly;

a) generate and apply an electrical pulse train to the LES through the electrodes for a stimulation period, and

b) terminate the electrical pulse train for a rest period.

2. The system of claim 1, wherein the maintained average pressure does not induce dysphagia in the patient and allows the patient to swallow a bolus during both the stimulation period and rest period.

3. The system of claim 1, wherein the controller is configured to determine parameters of the electrical pulse train that maintain the average pressure of the LES above the pressure level during the rest period.

4. The system of claim 1, wherein the controller is configured to control the waveform generator to stimulate the LES based on a predetermined trigger of at least one of time of day and supine of the patient.

5. The system of claim 1, wherein the controller is configured to adjust a length of the stimulation period and a length of the rest period to maintain the average pressure of the LES above the pressure level.

6. The system of claim 1, including

a sensor coupled to the controller for sensing physiological data of the patient, the sensor sensing at least one of pH level at the LES and pressure of the LES,

wherein the controller is configured to control the waveform generator based on the sensed physiological data.

7. The system of claim 1, wherein the controller and the waveform generator are enclosed in a common housing and implanted in the patient.

8. The system of claim 1, including

an external programming device for configuring the controller to adjust at least one of the energy per stimulation period, duration of the stimulation period, frequency of the stimulation period, and a number of stimulation periods per day based on at least one of the frequency of occurrence or the intensity of acid reflux symptoms in the patient.

9. The system of claim 1, including

a disposable battery coupled to the waveform generator and the controller for powering the waveform generator and the controller.

10. The system of claim 1, wherein the controller is configured to control the waveform generator to set a pulse width of the electrical pulse train in a range from 1 μ

s to 1 second.

11. The system of claim 1, wherein the controller is configured to control the waveform generator to set a frequency of the electrical pulse train in a range from about 1 Hz to about 100 Hz.

12. The system of claim 1, wherein the controller is configured to control the waveform generator to set a current of pulses in the electrical pulse train in a range from 1 μ

Amp to 50 mAmps.

13. The system of claim 1, including

a sensor coupled to the controller for sensing physiological data of a patient;

and

a memory coupled to the controller for storing the sensed data of the patient,

wherein the controller is configured to control the waveform generator to adjust parameters of the electrical pulse train applied to the LES based on an analysis of the stored data.

14. The system of claim 1, including

at least one of an accelerometer and inclinometer coupled to the controller for sensing posture data of the patient,

wherein the controller is configured to control the waveform generator to adjust parameters of the electrical pulse train applied to the LES based on an analysis of the posture data.

15. The system of claim 1, including

an antenna coupled to the controller for wirelessly receiving instructions for instructing the controller to adjust parameters of the electrical pulse train applied to the LES,

wherein the instructions are set by at least one of the patient and a trained professional.

16. The system of claim 1, wherein the controller is configured to perform a diagnostic test on the patient by controlling the waveform generator to adjust an amount of electrical energy stimulating the LES over a treatment period based on at least one of the frequency of occurrence or the intensity of acid reflux symptoms in the patient.

17. A system for increasing pressure of a patient'"'"'s lower esophageal sphincter (LES), comprising:

at least one electrode contacting the LES;

a waveform generator coupled to the electrodes; and

a controller configured to control the waveform generator to generate and apply an electrical pulse train to the LES through the electrodes during a stimulation period to produce an increase in the pressure of the LES during a rest period after termination of the electrical pulse train, the pressure of the LES determined to increase during the rest period above a pressure level which reduces at least one of a frequency of occurrence or an intensity of acid reflux symptoms in the patient.

18. The system of claim 17, wherein, prior to stimulation, the controller is configured with a length of the stimulation period and an electrical current of the pulse train that increases the LES pressure above the pressure level during the rest period.

19. The system of claim 17, wherein, prior to stimulation, the controller is configured to determine a length of the rest period that allows the pressure of the LES to increase above the pressure level and does not allow the pressure of the LES to decrease below the pressure level.

20. The system of claim 17, wherein the controller is configured with parameters of the electrical pulse train that produce a first increase in LES pressure during the stimulation period, and a second increase in LES pressure during the rest period.

21. The system of claim 17, wherein the controller is configured to determine parameters of the electrical pulse train that produce an increase in the LES pressure at a first rate during the stimulation period and at a second rate during the rest period.

22. A system for increasing pressure of a patient'"'"'s lower esophageal sphincter (LES), comprising:

at least one electrode contacting the LES;

a waveform generator coupled to the electrodes; and

a controller configured to control the waveform generator to generate and apply an electrical pulse train to the LES through the electrodes to increase the pressure of the LES, and maintain an average pressure of the LES above a pressure level which reduces at least one of a frequency of occurrence or an intensity of acid reflux symptoms in the patient while allowing the patient to swallow during electrical stimulation.

23. The system of claim 22, wherein the bolus has a volume of greater than 1 cubic centimeter (cc).

24. The system of claim 22, wherein the controller is configured to control the waveform generator so that the increased pressure level of the LES is below a pressure level that prevents the patient from swallowing a bolus.

25. The system of claim 22, wherein the controller is configured to control the waveform generator so that the increased pressure level of the LES is below a pressure level that restricts the opening capacity of patient'"'"'s LES when swallowing a bolus.

26. The system of claim 22, wherein the controller is configured to control the waveform generator so that the electrical stimulation does not inhibit a patient'"'"'s esophageal motility.

27. A system for increasing pressure of a patient lower esophageal sphincter (LES), comprising:

at least one electrode contacting the LES;

a waveform generator coupled to the electrodes;

a battery powering the waveform generator; and

a controller configured to control the waveform generator to generate and apply an electrical pulse train to the LES through the electrodes to increase the pressure of the LES, the electrical pulse train being controlled by the controller so that an amount of electrical energy consumed from the battery when stimulating the LES is an energy amount that maintains an average pressure of the LES above a pressure level which reduces at least one of a frequency of occurrence or an intensity of acid reflux symptoms in the patient while maintaining at least a minimum charge on the battery to electrically power the waveform generator for a predetermined time period.

28. The system of claim 27, wherein the controller is configured to determine a stimulation time for stimulating the LES to reduce at least one of the frequency of occurrence or the intensity of acid reflux symptoms in the patient, and electrically power the waveform generator for the predetermined time period.

29. The system of claim 27, wherein the controller is configured to determine at least one of a pulse width, electrical current, frequency and energy of the electrical pulse train to reduce at least one of the frequency of occurrence or the intensity of acid reflux symptoms in the patient, and electrically power the waveform generator for the predetermined time period.

30. The system of claim 27, wherein the controller is configured to consume between 30 nano-amp hours and 3 micro-amp-hours of energy during a stimulation period to reduce the acid reflux symptoms in the patient for at least one hour, and does not consume more than 3 micro-amp hours of energy per stimulation period.

31. The system of claim 27, wherein the controller is configured to cumulatively consume between 300 nano-amp hours and 30 micro-amp-hours of energy over a plurality of stimulation periods to reduce the acid reflux symptoms in the patient for at least 24 hours, and does not consume more than 30 micro-amp hours of energy per day

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

(a) a pulse generator in electrical communication with at least one electrode;

(b) an energy storage component, wherein said pulse generator generates a pulse stream in accordance with a preset period and wherein said system does not include a sensor for sensing a physiological state of a patient.

58. The systems of claim 44, wherein energy delivered to the stimulator has a pulse width in a range of 1 μ

sec to 1 second.

59. The systems of claim 44, wherein energy delivered to the stimulator has a pulse frequency in a range of 1 Hz to 100 Hz.

60. The systems of claim 44, wherein energy delivered to the stimulator has a pulse amplitude in a range of 1 μ

Amp to 50 mAmp.

61. The systems of claim 44, wherein energy delivered to the stimulator has a pulse amplitude in a range of 1 μ

Amp to 50 mAmp.

62. The systems of claim 44, wherein, after cessation of stimulation, the LES has a normal physiological behavior.

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

(a) a pulse generator in electrical communication with at least one electrode;

(b) an energy storage component, wherein said pulse generator generates a pulse stream in accordance with a preset period and wherein said preset period is not dependent upon a physiological state of a patient.

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

(a) a pulse generator in electrical communication with at least one electrode;

(b) an energy storage component, wherein said pulse generator generates a pulse stream in accordance with a preset period and wherein said preset period is not lengthened or shortened based upon a feeding state of a patient.

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

(a) a pulse generator in electrical communication with at least one electrode;

(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 and wherein said on period is not lengthened or shortened based upon a feeding state of a patient.

48. 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 generates a pulse in accordance with a preset period and wherein said system does not include a sensor for sensing a physiological state of a patient.

49. 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 generates a pulse in accordance with a preset period and wherein said system does not include an implantable energy storage component.

50. 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 generates a pulse in accordance with a preset period and wherein said preset period is not dependent upon a physiological state of a patient.

51. 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 generates a pulse in accordance with a preset period and wherein said preset period is not lengthened or shortened based upon a feeding state of a patient.

52. 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 generates a pulse in accordance with an on period and wherein said on period is between 1 second and 24 hours and wherein said on period is not lengthened or shortened based upon a feeding state of a patient.

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

(a) a stimulator adapted to be implanted proximate to or within a LES of the patient;

(b) an energy receiver in electrical communication with the stimulator; and

(c) an energy transmitter, wherein said energy transmitter is adapted to be external to the patient'"'"'s body and configured to wirelessly transmit electrical energy to said energy receiver.

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

(a) a stimulator adapted to be implanted proximate to or within a LES of the patient;

(b) an energy receiver in electrical communication with the stimulator; and

(c) an energy transmitter, wherein said energy transmitter is adapted to be external to the patient'"'"'s body and configured to wirelessly transmit electrical energy to said energy receiver and wherein said energy transmitter transmits energy in accordance with a preset period and wherein said system does not include a sensor for sensing a physiological state of a patient.

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

(a) a stimulator adapted to be implanted proximate to or within a LES of the patient;

(b) an energy receiver in electrical communication with the stimulator; and

(c) an energy transmitter, wherein said energy transmitter is adapted to be external to the patient'"'"'s body and configured to wirelessly transmit electrical energy to said energy receiver and wherein said energy transmitter transmits energy in accordance with a preset period and wherein said preset period is not dependent upon a physiological state of a patient.

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

(a) a stimulator adapted to be implanted proximate to or within a LES of the patient;

(b) an energy receiver in electrical communication with the stimulator; and

(c) an energy transmitter, wherein said energy transmitter is adapted to be external to the patient'"'"'s body and configured to wirelessly transmit electrical energy to said energy receiver and wherein said energy transmitter transmits energy in accordance with a preset period and wherein said preset period is not lengthened or shortened based upon a feeding state of a patient.

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

(a) a stimulator adapted to be implanted proximate to or within a LES of the patient;

(b) an energy receiver in electrical communication with the stimulator; and

(c) an energy transmitter, wherein said energy transmitter is adapted to be external to the patient'"'"'s body and configured to wirelessly transmit electrical energy to said energy receiver and wherein said energy transmitter transmits energy in accordance with an on period and wherein said on period is between 1 second and 24 hours and wherein said on period is not lengthened or shortened based upon a feeding state of a patient.

63. A system for stimulating an anatomical structure within a patient, comprising:

(a) a stimulator adapted to be implanted into the patient; and

(b) a sensor adapted to be temporarily positioned within a lumen of the patient separate from said stimulator, wherein said sensor is configured to sense a physiological parameter of the patient and communicate data indicative of said physiological parameter to the stimulator and wherein said stimulator modifies at least one stimulation parameter based upon said data.

64. A system for collecting data from within a patient and transmitting the data outside the patient'"'"'s body, comprising:

(a) a logging device adapted to be implanted into the patient, wherein the logging device comprises a memory adapted to store a plurality of data; and

(b) a sensor adapted to be temporarily implanted into a lumen of the patient separate from said logging device, wherein said sensor is configured to sense a physiological parameter of the patient and communicate said sensed data to the logging device and wherein said logging device is capable of storing the sensed data and wirelessly transmitting sensed data to a receiver located outside the body.

65. The system of claim 64 wherein said stimulator comprises a structure that houses stimulating circuitry, a receiver to receive said data from the sensor, and a control unit that analyzes the received data and adjusts said at least one stimulation parameter.

66. The system of claim 65 wherein the stimulating circuitry comprises a power source and means for delivering stimulation.

67. The system of claim 66 wherein the means for delivering stimulation includes at least one of an electrical lead or electrical contact.

68. The system of claim 64 wherein the sensor is adapted to be temporarily located in the body for a duration less than one month

69. The system of claim 68 wherein the sensor is a pH capsule.

70. The system of claim 64 wherein the sensor is adapted to measure physiological pH and transmit pH data from within a lumen of the patient'"'"'s esophagus.

71. The system of claim 64 wherein the sensor comprises a pH sensor located within a nasogastric tube.

72. The system of claim 71 wherein the sensor transmits pH data to the stimulator via uni-directional or bi-directional communications.

73. The system of claim 64 wherein said stimulator comprises a controller that is adapted to execute a plurality of programmatic instructions to adjust said at least one stimulation parameter based upon said data, wherein said data is pH data.

74. The system of claim 73 wherein said pH data is continuously streamed to the stimulator from a pH capsule.

75. The system of claim 73 wherein said controller adjusts one or more stimulation parameters to increase a stimulation dose to the patient if, within a predefined period, the pH data is less than a first threshold value for a percentage of time higher than a second threshold value.

76. The system of claim 73 wherein said first threshold is 4.

77. The system of claim 73 wherein said second threshold is 5 percent.

78. The system of claim 73 wherein the stimulation parameters include at least one of number of stimulation events or size of each stimulation event.

79. The system of claim 75 wherein at least one of said stimulation parameters is bounded by a maximum value.

80. The system of claim 75 wherein at least one of said stimulation parameters is bounded by a minimum value.

81. The system of claim 73 wherein said controller adjusts one or more stimulation parameters to decrease a stimulation dose to the patient if, within a predefined period, the pH data is less than a first threshold value for a percentage of time less than a second threshold value.

82. The system of claim 81 wherein said first threshold is 4.

83. The system of claim 81 wherein said second threshold is 1 percent.

84. The system of claim 81 wherein the stimulation parameters include at least one of number of stimulation events or size of each stimulation event.

85. The system of claim 84 wherein at least one of said stimulation parameters is bounded by a maximum value.

86. The system of claim 84 wherein at least one of said stimulation parameters is bounded by a minimum value.

87. The system of claim 64 wherein said stimulator comprises a controller that is adapted to execute a plurality of programmatic instructions to adjust said at least one stimulation parameter based upon said data, wherein said data comprises at least one of pH data, accelerometer data, inclinometer data, impedance data or a combination thereof

88. The system of claim 87 wherein said data is transmitted from the stimulator to a device which is located external to the patient.

89. The system of claim 88 wherein said transmission occurs automatically when the patient and external device are within a predefined proximity.

90. The system of claim 89 wherein said transmission is enabled when the patient and external device are within a predefined proximity and only occurs when expressly authorized by the patient.

91. The system of claim 90 wherein said external device is adapted to receive data indicative of stimulation parameters from a second external device and communicate said data indicative of stimulation parameters to the stimulator within the patient.

92. The system of claim 64 wherein said stimulator comprises a controller that is adapted to monitor a status of said sensor.

93. The system of claim 92 wherein, if said sensor fails to respond to communicate attempts from said controller or fails a diagnostic test, the controller generates a signal indicative of a sensor failure state.

94. The system of claim 92 wherein, if said controller receives data indicating the sensor has migrated from a desired position to an undesired position, the controller generates a signal indicative of a sensor failure state.

95. The system of claim 94 wherein data indicating the sensor has migrated from a desired position to an undesired position includes pH less than a threshold value for greater than a predefined a period of time.

96. The system of claim 64 wherein said stimulator comprises a structure that houses stimulating circuitry, a receiving antenna to receive said data from the sensor, and a control unit that analyzes the received data and adjusts said at least one stimulation parameter.

97. The system of claim 96 wherein said receiving antenna can be additionally used to enable energy transfer to said stimulator.

98. The system of claim 64 wherein said sensor comprises a local energy source and is adapted to transfer energy from said sensor to the stimulator.

99. The system of claim 95 wherein said sensor is a pH capsule or is anchored in a nasogastric tube.

100. A method of treating a patient with acid reflux symptoms, wherein said patient has a lower esophageal sphincter (LES) and wherein said LES has a pressure, the method comprising:

maintaining an average pressure of the LES above a pressure level which reduces at least one of a frequency of occurrence or an intensity of the acid reflux symptoms both during and after stimulation by applying an electrical pulse train to the LES through electrodes for a stimulation period to increase the pressure of the LES above the pressure level, and terminating the electrical pulse train for a rest period.

32. A macrostimulator programmed, adapted to, or configured to perform the method of claim 100.

33. A macrostimulator comprising at least one electrode, an energy source, and a pulse generator in electrical communication with the at least one electrode and energy source, wherein said pulse generator is programmed, adapted to, or configured to perform the method of claim 100.

34. A macrostimulator implanted in a patient configured to perform the method of claim 100.

35. A macrostimulator implanted in a patient comprising at least one electrode, an energy source, and a pulse generator in electrical communication with the at least one electrode and energy source, wherein said pulse generator is programmed, adapted to, or configured to perform the method of claim 100.

36. A macrostimulator programmed, adapted to, or configured to perform the method of claim 100 wherein electrical stimulation is initiated, terminated or otherwise modified based upon sensed data.

37. A macrostimulator comprising at least one electrode, an energy source, and a pulse generator in electrical communication with the at least one electrode and energy source, wherein said pulse generator is programmed, adapted to, or configured to perform the method of claim 100 wherein electrical stimulation is initiated, terminated or otherwise modified based upon sensed data.

38. A macrostimulator implanted in a patient configured to perform the method of claim 100 wherein electrical stimulation is initiated, terminated or modified based upon sensed data.

39. A macrostimulator implanted in a patient comprising at least one electrode, an energy source, and a pulse generator in electrical communication with the at least one electrode and energy source, wherein said pulse generator is programmed, adapted to, or configured to perform the method of claim 100 wherein electrical stimulation is initiated, terminated, or otherwise modified based upon sensed data.

40. A macrostimulator programmed, adapted to, or configured to perform the method of claim 100 wherein electrical stimulation is initiated or terminated based upon sensed data and wherein the sensed data is at least one of LES pressure, esophageal pH, inclinometer data, temperature, or accelerometer data.

41. A macrostimulator comprising at least one electrode, an energy source, and a pulse generator in electrical communication with the at least one electrode and energy source, wherein said pulse generator is programmed, adapted to, or configured to perform the method of claim 100 wherein electrical stimulation is initiated or terminated based upon sensed data and wherein the sensed data is at least one of LES pressure, esophageal pH, inclinometer data, temperature, or accelerometer data.

42. A macrostimulator implanted in a patient configured to perform the method of claim 100 wherein electrical stimulation is initiated or terminated based upon sensed data and wherein the sensed data is at least one of LES pressure, esophageal pH, inclinometer data, temperature, or accelerometer data.

43. A macrostimulator implanted in a patient comprising at least one electrode, an energy source, and a pulse generator in electrical communication with the at least one electrode and energy source, wherein said pulse generator is programmed, adapted to, or configured to perform the method of claim 100 wherein electrical stimulation is initiated or terminated based upon sensed data and wherein the sensed data is at least one of LES pressure, esophageal pH, inclinometer data, temperature, or accelerometer data.

101. The method of claim 100, wherein the LES is repeatedly stimulated to maintain the average pressure of the LES in a pressure range which is above a first pressure level to at least one of the frequency of occurrence or the intensity of the acid reflux symptoms in the patient and below a second pressure level to allow the patient to swallow during both the stimulation period and rest period.

102. The method of claim 101, wherein a controller determines parameters of the electrical pulse train that maintain the average pressure of the LES above the pressure level during the rest period.

103. The method of claim 102, wherein the controller controls a waveform generator to stimulate the LES when the pressure of the LES decreases to a third pressure level during the rest period.

104. The method of claim 102, wherein the controller adjusts a length of the stimulation period and a length of the rest period to maintain the average pressure of the LES above the pressure level.

105. The method of claim 102, wherein the controller is configured to control the waveform generator to set a pulse width of the electrical pulse train in a range from about 1 μ

s to about 1 second.

106. The method of claim 102, wherein the controller is configured to control the waveform generator to set a frequency of the electrical pulse train in a range from about 1 Hz to about 100 Hz.

107. The method of claim 102, wherein the controller is configured to control the waveform generator to set a current of pulses in the electrical pulse train in a range from about 1 μ

Amp to about 50 mAmps.

108. The method of claim 102, wherein the controller is configured to perform a diagnostic test on the patient by controlling the waveform generator to vary parameters of the electrical pulse train to determine a pressure response of the LES based on different electrical stimulation.

109. The method of claim 100, wherein:

achieving said pressure level occurs after a minimum period selected from the group consisting of at least 5 minutes, 10 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 12 hours, 24 hours, or any time increment therein.

110. The method of claim 100, wherein:

said electrical stimulation is initiated prior to a predetermined time;

said predetermined time is associated with an acid reflux triggering event; and

said initiation occurs prior to said predetermined time by a minimum period selected from the group consisting of at least 5 minutes, 10 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 12 hours, 24 hours, or any time increment therein.

111. The method of claim 100, further comprising:

programming said stimulation device, wherein said programming is dependent upon a plurality of stimulation parameters that determine the application of electrical stimulation to the patient LES, and wherein said stimulation parameters are selected, at least in part, to treat acid reflux without inhibiting patient swallowing.

112. The method of claim 100, wherein electrical stimulation is applied to the patient LES while the patient swallows, during periods of esophageal motility, or during esophageal peristalsis.

113. The method of claim 100, wherein electrical stimulation is applied to the patient LES in accordance with a preset period and wherein said preset period is not dependent upon a physiological state of a patient.

114. The method of claim 100, wherein electrical stimulation is applied to the patient LES in accordance with a preset period and wherein said preset period is not dependent upon the patient swallowing, esophageal motility, esophageal peristalsis, or being in a feeding state.

115. The method of claim 100, wherein electrical stimulation is applied to the patient LES that is not dependent upon a physiological state of the patient.

116. The method of claim 100, wherein electrical stimulation is applied to the patient LES that is not dependent upon a sensed physiological state of the patient.

117. The method of claim 100, wherein electrical stimulation is applied to the patient LES that is not dependent upon the patient swallowing, esophageal motility, esophageal peristalsis, or being in a feeding state.

118. The method of claim 100, wherein sufficient electrical stimulation is applied to the patient LES to increase said pressure but not to inhibit patient swallowing, esophageal motility, or esophageal peristalsis.

119. The method of claim 100, wherein electrical stimulation is applied to the patient LES causing an increase in said pressure of at least 5% only after an elapsed period of time of at least one minute.

120. The method of claim 100, wherein said electrical stimulation normalizes lower esophageal function, normalizes LES pressure, or increases LES pressure to a normal physiological range only after an elapsed period of time of at least one minute.

121. The method of claim 100, wherein said stimulation causes a non-instantaneous or delayed increase in said pressure.

122. The method of claim 100, wherein said electrical stimulation causes a delayed increase in said pressure and wherein said delayed increase in the pressure normalizes LES function, normalizes LES pressure, increases LES pressure to a normal physiological range, or increases LES pressure by at least 3%.

123. The method of claim 100, wherein said electrical stimulation causes an increase in said pressure after said electrical stimulation is terminated.

124. The method of claim 100, wherein said electrical stimulation has a first level, wherein said stimulation causes an increase in said pressure after said electrical stimulation is decreased from said first level.

125. The method of claim 100, wherein said electrical stimulation is applied in accordance with at least one on period, wherein said on period is between 1 second and 24 hours and is not triggered by, substantially concurrent to, or substantially simultaneous with an incidence of acid reflux, and at least one off period, wherein said off period is greater than 10 seconds.

126. The method of claim 100, wherein said electrical stimulation is applied having a current from a single electrode pair ranging from about 1 mAmp to about 8 mAmp.

127. The method of claim 100, wherein said electrical stimulation has a pulse duration within a range of 5 μ

sec to 1 second.

128. The method of claim 100, wherein said electrical stimulation has a pulse duration of approximately 1 msec.

129. The method of claim 100, wherein said electrical stimulation has a pulse duration of approximately 200 μ

sec.

130. The method of claim 100, wherein the device incorporates an accelerometer or inclinometer to measure patient positional activity;

and

applying electrical stimulation based upon one or more of the following parameters as measured by said accelerometer or inclinometer;

time spent in the supine position or level of inclination.

131. A method of treating a patient with acid reflux symptoms, the method comprising:

(a) implanting a stimulation device in the patient to contact the patient LES, (b) applying electrical stimulation to the patient LES, and

(b) maintaining an average pressure of the LES above a pressure level both during and after electrical stimulation for a stimulation period to increase the pressure of the LES above the pressure level, and terminating the electrical stimulation for a rest period.

132. The method of claim 131, wherein:

achieving said pressure level occurs after a minimum period selected from the group consisting of at least 5 minutes, 10 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 12 hours, 24 hours, or any time increment therein.

133. The method of claim 131, wherein:

said electrical stimulation is initiated prior to a predetermined time;

said predetermined time is associated with an acid reflux triggering event; and

said initiation occurs prior to said predetermined time by a minimum period selected from the group consisting of at least 5 minutes, 10 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 12 hours, 24 hours, or any time increment therein.

134. The method of claim 131, further comprising:

programming said stimulation device, wherein said programming is dependent upon a plurality of stimulation parameters that determine the application of electrical stimulation to the patient LES, and wherein said stimulation parameters are selected, at least in part, to treat acid reflux symptoms without inhibiting patient swallowing.

135. The method of claim 131, wherein electrical stimulation is applied to the patient LES while the patient swallows, during periods of esophageal motility, or during esophageal peristalsis.

136. The method of claim 131, wherein electrical stimulation is applied to the patient LES in accordance with a preset period and wherein said preset period is not dependent upon a physiological state of a patient.

137. The method of claim 131, wherein electrical stimulation is applied to the patient LES in accordance with a preset period and wherein said preset period is not dependent upon the patient swallowing, esophageal motility, esophageal peristalsis, or being in a feeding state.

138. The method of claim 131, wherein electrical stimulation is applied to the patient LES that is not dependent upon a physiological state of the patient.

139. The method of claim 131, wherein electrical stimulation is applied to the patient LES that is not dependent upon a sensed physiological state of the patient.

140. The method of claim 131, wherein electrical stimulation is applied to the patient LES that is not dependent upon the patient swallowing, esophageal motility, esophageal peristalsis, or being in a feeding state.

141. The method of claim 131, wherein sufficient electrical stimulation is applied to the patient LES to increase said pressure but not to inhibit patient swallowing, esophageal motility, or esophageal peristalsis.

142. The method of claim 131, wherein electrical stimulation is applied to the patient LES causing an increase in said pressure of at least 5% only after an elapsed period of time of at least one minute.

143. The method of claim 131, wherein said electrical stimulation normalizes lower esophageal function, normalizes LES pressure, or increases LES pressure to a normal physiological range only after an elapsed period of time of at least one minute.

144. The method of claim 131, wherein said stimulation causes a non-instantaneous or delayed increase in said pressure.

145. The method of claim 131, wherein said electrical stimulation causes a delayed increase in said pressure and wherein said delayed increase in the pressure normalizes LES function, normalizes LES pressure, increases LES pressure to a normal physiological range, or increases LES pressure by at least 3%.

146. The method of claim 131, wherein said electrical stimulation causes an increase in said pressure after said electrical stimulation is terminated.

147. The method of claim 131, wherein said electrical stimulation has a first level, wherein said stimulation causes an increase in said pressure after said electrical stimulation is decreased from said first level.

148. The method of claim 131, wherein said electrical stimulation is applied in accordance with at least one on period, wherein said on period is between 1 second and 24 hours and is not triggered by, substantially concurrent to, or substantially simultaneous with an incidence of acid reflux, and at least one off period, wherein said off period is greater than 10 seconds.

149. The method of claim 131, wherein said electrical stimulation is applied having a current from a single electrode pair ranging from about 1 mAmp to about 8 mAmp.

150. The method of claim 131, wherein said electrical stimulation has a pulse duration within a range of 5 μ

sec to 1 second.

151. The method of claim 131, wherein said electrical stimulation has a pulse duration of approximately 1 msec.

152. The method of claim 131, wherein said electrical stimulation has a pulse duration of approximately 200 μ

sec.

153. The method of claim 131, wherein the device incorporates an accelerometer or inclinometer to measure patient positional activity;

and

applying electrical stimulation based upon one or more of the following parameters as measured by said accelerometer or inclinometer;

time spent in the supine position or level of inclination.

154. A method of treating a patient with acid reflux symptoms, the method comprising:

(a) implanting the stimulation device in the patient to contact the patient LES;

(b)

applying electrical stimulation to the patient LES;

(b) measuring one or more parameters selected from the group consisting of patient feed state including type of feed;

patient position;

patient activity;

patient reflux profile;

LES pressure;

LES electrical activity;

LES mechanical activity gastric pressure;

gastric electrical activity;

gastric chemical activity;

gastric temperature;

gastric mechanical activity;

patient intuition;

vagal neural activity; and

, splanchnic neural activity;

(c) inputting the collected data into an algorithm; and

(d) applying electrical stimulation based upon a summary score calculated by said algorithm to maintain an average pressure of the LES above a pressure level both during and after electrical stimulation for a stimulation period to increase the pressure of the LES above the pressure level, and terminating the electrical stimulation for a rest period.

155. A method of programming a stimulator wherein said stimulator is implanted proximate to a lower esophageal sphincter of a patient, comprising the steps of:

(a) causing said stimulator to stimulate the lower esophageal sphincter;

(b) monitoring a pressure level of said lower esophageal sphincter while said stimulator is stimulating the lower esophageal sphincter;

(c) recording a time when the pressure level of said lower esophageal sphincter exceeds a first threshold value;

(d) terminating said stimulation when the pressure level of said lower esophageal sphincter exceeds a first pressure value;

(e) monitoring the pressure level of said lower esophageal sphincter after terminating said stimulation;

(f) recording a time when the pressure level of said lower esophageal sphincter reaches a second pressure value; and

(g) programming the stimulator to operate for a fixed, preset period of time.

158. The method of claims 155, wherein said fixed, preset period of time is between 1 minutes and 12 hours.

159. The method of claim 155, wherein said fixed, preset period of time is not dependent on a feeding state of the patient.

160. The method of claim 155, wherein said fixed, preset period of time is not dependent on whether the patient is engaging in a swallow.

161. The method of claim 155, wherein said recording and monitoring steps are performed automatically by a system in data communication with a manometry measurement system.

162. The method of claim 155, wherein said energy input has a pulse frequency of approximately 20 Hz, a pulse duration of approximately 200 μ

sec, and a pulse amplitude in a range of 0.1 mAmp to 15 mAmp.

163. The method of claim 155, wherein said first pressure value is at least 20 mmHg.

164. The method of claim 155, wherein said second pressure value is at most 10 mmHg.

165. The method of claim 155, wherein said second pressure value is proportional to a baseline pressure level of the patient'"'"'s lower esophageal sphincter.

156. A method of programming a stimulator wherein said stimulator is implanted proximate to a lower esophageal sphincter of a patient, comprising the steps of:

(a) causing said stimulator to stimulate the lower esophageal sphincter;

(b) recording a time and an electrode impedance value when said stimulation is started;

(c) monitoring a pressure level of said lower esophageal sphincter while said stimulation is being applied;

(d) recording a time when the pressure level of said lower esophageal sphincter exceeds a first threshold value;

(e) recording an electrode impedance value when the pressure level of said lower esophageal sphincter exceeds the first threshold value;

(f) terminating said energy input to said stimulator when the pressure level of said lower esophageal sphincter exceeds a first pressure value;

(g) monitoring the pressure level of said lower esophageal sphincter after terminating said stimulation;

(h) recording a time when the pressure level of said lower esophageal sphincter reaches a second pressure value;

(i) recording an electrode impedance value when the pressure level of said lower esophageal sphincter reaches the second pressure value.

157. A method of programming a stimulator wherein said stimulator is implanted proximate to a lower esophageal sphincter of a patient, comprising the steps of:

(a) applying an energy input to said stimulator to cause said stimulator to stimulate the lower esophageal sphincter;

(b) recording a time and a electrode impedance value when said energy input is first applied to said stimulator;

(c) monitoring a pressure level of said lower esophageal sphincter while said energy input is being applied to said stimulator;

(d) recording a time when the pressure level of said lower esophageal sphincter exceeds a first threshold value;

(e) recording a electrode impedance value when the pressure level of said lower esophageal sphincter exceeds the first threshold value;

(f) terminating said energy input to said stimulator when the pressure level of said lower esophageal sphincter exceeds a first pressure value;

(g) monitoring the pressure level of said lower esophageal sphincter after terminating said energy input to said stimulator;

(h) recording a time when the pressure level of said lower esophageal sphincter reaches a second pressure value;

(i) recording a electrode impedance value when the pressure level of said lower esophageal sphincter reaches the second pressure value;

(j) programming the stimulator to operate for a fixed, preset period of time.