Swallowable capsule, system and method for measuring gastric emptying parameters

Abstract

Embodiments provide devices, systems and methods for measuring a gastric emptying (GE) parameter (GEP). Many embodiments provide a swallowable capsule having three electrodes one covered by a coating which remains in the stomach but is degraded in the small intestine (SI). The electrodes are coupled to circuitry such that when the capsule is in the stomach, current flow occurs between the first two electrodes generating a first signal and in the SI current flow occurs between the second and now uncovered third electrode generating a second signal. These two signals can be transmitted and analyzed externally or by an internal controller to determine a GEP e.g., GE time. The patient may wear an external device configured to receive and analyze the signals to determine GE time. Embodiments of the invention may be used to diagnose gastroparesis and provide patient's information on when to eat meals or administer insulin after eating.

1 . (canceled) 
     
     
         2 . A swallowable capsule for measurement of a gastric emptying parameter in a gastro-intestinal (GI) tract of a patient, the capsule comprising:
 a first, second, and third electrode;   a first circuit electrically coupled to the first and second electrodes, the first circuit configured to generate a first input signal based on a current flow between the first and second electrodes at a first location in the GI tract;   a second circuit electrically coupled to the second and third electrodes, the second circuit configured to generate a second input signal based on a current flow between the second and third electrodes at a second location in the GI tract different from the first location; and   a controller operatively coupled to the first and second circuits, wherein the controller is programmed to determine the gastric emptying parameter based on information relating to the first and second input signals.   
     
     
         3 . The capsule of  claim 2 , wherein the first location is the stomach and the second location is the small intestine. 
     
     
         4 . The capsule of  claim 3 , further comprising an enteric coating disposed over the third electrode, the coating configured to electrically insulate the third electrode while in the stomach and degrade in response to a selected pH in the small intestine to expose the third electrode. 
     
     
         5 . The capsule of  claim 2 , wherein the controller is further programmed to generate and transmit a driver signal to the second electrode so as to provide the current flow between the first and second electrodes and the current flow between the second and third electrodes. 
     
     
         6 . The capsule of  claim 5 , wherein the driver signal is an alternating current (AC) signal. 
     
     
         7 . The capsule of  claim 2 , further comprising a transmitter coupled to or integral with the controller. 
     
     
         8 . The capsule of  claim 7 , wherein the transmitter is a radiofrequency (RF) transmitter. 
     
     
         9 . The capsule of  claim 2 , wherein the information relating to the first and second input signals is a start time of the first input signal and a start time of the second input signal. 
     
     
         10 . The capsule of  claim 9 , wherein the controller is further programmed to determine a gastric emptying time based on a difference between the start time of the first input signal and the start time of the second input signal. 
     
     
         11 . A swallowable capsule for measurement of a gastric emptying parameter in a gastro-intestinal (GI) tract of a patient, the capsule comprising:
 a first, second, and third electrode;   a first circuit electrically coupled to the first and second electrodes, the first circuit configured to generate a first input signal based on a current flow between the first and second electrodes at a first location in the GI tract;   a second circuit electrically coupled to the second and third electrodes, the second circuit configured to generate a second input signal based on a current flow between the second and third electrodes at a second location in the GI tract different from the first location;   a controller operatively coupled to the first and second circuits, wherein the controller is programmed to generate a first output signal in response to the first input signal and a second output signal in response to the second input signal; and   a transmitter configured to transmit the first and second output signals to an external controller to determine the gastric emptying parameter based on information relating to the first and second output signals.   
     
     
         12 . The capsule of  claim 11 , wherein the controller is further programmed to generate and transmit a driver signal to the second electrode so as to provide the current flow between the first and second electrodes and the current flow between the second and third electrodes. 
     
     
         13 . The capsule of  claim 12 , wherein the driver signal is an alternating current (AC) signal. 
     
     
         14 . The capsule of  claim 11 , wherein the transmitter is a radiofrequency (RF) transmitter. 
     
     
         15 . The capsule of  claim 11 , wherein the first location is the stomach and the second location is the small intestine. 
     
     
         16 . A system for measuring a gastric emptying parameter, the system comprising:
 the capsule of  claim 11 ; and   a receiver unit for receiving the transmitted first and second output signals.   
     
     
         17 . The system of  claim 16 , wherein the receiver unit comprises the external controller of  claim 11 , and wherein information relating to the first and second output signals is a start time of the first output signal and a start time of the second output signal, respectively. 
     
     
         18 . The system of  claim 17 , wherein the external controller is programmed to determine a gastric emptying time based on a difference between the start time of the first output signal and the start time of the second output signal. 
     
     
         19 . A swallowable capsule for measurement of a gastric emptying parameter in a gastro-intestinal (GI) tract of a patient, the capsule comprising:
 a first, second, and third electrode; and   a first circuit electrically coupled to the first and second electrodes, the first circuit configured to generate a first input signal based on a current flow between the first and second electrodes at a first location in the GI tract;   a second circuit electrically coupled to the second and third electrodes, the second circuit configured to generate a second input signal based on a current flow between the second and third electrodes at a second location in the GI tract different from the first location; and   a controller programmed to:
 generate and transmit a driver signal to the second electrode so as to provide the current flow between the first and second electrodes and the current flow between the second and third electrodes; and 
 generate a first output signal in response to the first input signal and a second output signal in response to the second input signal. 
   
     
     
         20 . The capsule of  claim 19 , wherein the controller is further programmed to determine the gastric emptying parameter based on information relating to the first and second input signals. 
     
     
         21 . The capsule of  claim 19 , further comprising a transmitter configured to transmit the first and second output signals to an external controller to determine the gastric emptying parameter based on information relating to the first and second output signals.