Application US20180353133

SWALLOWABLE CAPSULE, SYSTEM AND METHOD FOR MEASURING GASTRIC EMPTYING PARAMETERS
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US20180353133

1. A swallowable capsule for measurement of a gastric emptying parameter, the capsule comprising: (16) (8)

a capsule body sized to be swallowed and pass through the intestinal track of a patient, the capsule body having an outer surface and defining a capsule body interior;

at least a first, second and third electrode disposed on the capsule body outer surface;

an enteric coating disposed over a portion of the capsule body outer surface including 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;

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 between the first and second electrodes;

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 between the second and third electrodes;

a controller operatively coupled to the first and second circuits, the controller disposed within the capsule body interior and configured to generate a driver signal sent to the second electrode and receive the signals from the first and second circuits, and generate a first output signal in response to the first input signals and a second output signal in response to the first input signal;

a power source coupled to at least one of the controller, the first circuit or second circuits; and

wherein when the capsule reaches the stomach, the first and second electrodes electrically couple with stomach fluids to allow current flow between the first and second electrodes to generate the first input signal and when the capsule reaches the small intestine the enteric coating degrades allowing the second and third electrodes to couple with fluid in the small intestine to allow current flow between the second and third electrodes to generate the second input signal.

2. The capsule of claim 1, enteric coating comprises a EUDRAGIT coating. (0)

3. The capsule of claim 1, wherein the power source is a battery, a lithium battery, a lithium ion battery or an alkaline battery. (0)

4. The capsule of claim 1, wherein the driver signal is an AC signal. (0)

5. The capsule of claim 1, wherein the controller comprises a processor or microprocessor. (0)

6. The capsule of claim 1, wherein the first and second input signals comprise a voltage. (0)

7. The capsule of claim 1, wherein the first and second circuits include an operational amplifier (opamp). (1) (0)

9. The capsule of claim 1, wherein the first and second circuits include a resistor. (2) (0)

12. The capsule of claim 1, wherein the controller is configured to discontinue the first output signal after a selected period of time. (1) (0)

14. The capsule of claim 1, wherein the controller is configured to discontinue the second output signal after a selected period of time. (1) (0)

16. The capsule of claim 1, wherein an amplitude of the first output signal decreases after the controller starts generating the second output signal. (1) (0)

19. The capsule of claim 1, wherein the first output signal corresponds to a first chirp signal. (1) (0)

21. The capsule of claim 1, further comprising a transmitter coupled to the controller, the transmitter configured to transmit the first or second output signal. (3) (0)

25. The capsule of claim 1, wherein the controller includes logic to determine at least one of a start time of at least one of the first or second output signals or a gastric emptying parameter. (2) (0)

29. The capsule of claim 1, wherein the selected pH is above about 6. (1) (0)

31. The capsule of claim 1, wherein a density of the capsule is in a range from about 0.5 to about 1.5 gram/cc. (1) (0)

34. The capsule of claim 1, wherein a surface tension of the capsule body outer walls is in a range from about 30 to 45 dynes/cm. (1) (0)

27. The capsule of 25, where the gastric emptying time is determined based on the start time of the first and second output signals. (0)

36. A swallowable capsule for measurement of gastric emptying time, the capsule comprising: (2) (9)

a capsule body sized to be swallowed and pass through the intestinal track of a patient, the capsule body having an outer surface and defining a capsule body interior;

at least a first, second and third electrodes disposed on a capsule body outer surface; and

an enteric coating disposed over a portion of the capsule body outer surface including the third electrode, the coating configured to cover the third electrode while in the stomach and degrade in response to a selected pH in the small intestine to expose the 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 between the first and second electrodes;

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 between the second and third electrodes;

a controller coupled to the first and second circuits, the controller disposed within the capsule body interior and configured to generate a driver signal sent to the second electrode and receive the signals from the first and second circuits, and generate a first output signal in response to the first input signal and a second output signal in response to the first input signal;

a transmitter coupled to the controller for transmitting the first and second output signals;

a power source coupled to at least one of the controller, the first circuit or second circuits or the transmitter; and

37. The capsule of claim 36, wherein the transmitter is an RF transmitter. (0)

38. A system for measuring a gastric emptying parameter, the system comprising: (4) (2)

the capsule of claim 36; and

a receiver unit for receiving the transmitted first and second output signals.

39. The system of claim 38, wherein the receiver unit is configured to be worn by the patient. (1) (0)

43. The system of claim 38, further comprising a controller operatively coupled to the receiver unit, the controller configured to determine the gastric emptying parameter utilizing the first and second output signals. (0)

44. The system of claim 38, wherein the first and second output signals provide information on a location of the capsule in a GI tract at a moment in time. (0)

45. The system of claim 38, wherein determined gastric parameter is a gastric emptying time. (0)

46. A method for measuring a gastric emptying parameter in a patient, the method comprising: (9) (3)

transmitting the first or second electrical signals to outside of the patient's body; and

determining the gastric empting parameter utilizing information from the first and second electrical signals.

47. The method of claim 46, wherein determined gastric parameter is a gastric emptying time. (0)

48. The method of claim 46, wherein the location is at least one of the patient's stomach, small intestine, duodenum or jejunum. (0)

49. The method of claim 46, wherein the capsule includes at least a first, second and third electrode disposed on a capsule body outer surface, the third electrode covered by an insulative coating which remains in the stomach and degrades in response to a pH condition in the small intestine and wherein the first signal is initiated by current flow between the first and second electrodes in the patient's stomach and the second signal in is initiated by current flow between the second and third electrodes in the patient's small intestine. (1) (0)

50. The method of claim 49, further comprising: (0) (3)

51. The method of claim 46, wherein the first signal or second signal is stopped after a selected period of time. (1) (0)

53. The method of claim 46, further comprising: (2) (1)

administering a dose of a therapeutic agent to the patient utilizing information from the gastric emptying parameter.

54. The method of claim 53, wherein the gastric emptying parameter is a gastric emptying time. (0)

55. The method of claim 53, wherein the dose of therapeutic agent comprises a dose of a glucose regulating agent. (4) (0)

61. The method of claim 46, further comprising: (3) (2)

ingesting a test meal along with the swallowable capsule; the test meal having predetermined parameters including at least one of portion size or nutritional content, the parameters comprising test meal information; and

utilizing the test meal information along with information from the first and second signals to determine the gastric emptying parameter.

62. The method of claim 61, wherein the nutritional content includes at least one of protein, carbohydrate or fat content. (0)

63. The method of claim 61, wherein the gastric emptying parameter is a gastric emptying time. (1) (0)

64. The method of claim 61, wherein a determined gastric emptying time is increased or decreased based on the teat meal information. (0)

65. The method of claim 46, wherein the gastric emptying parameter is a gastric emptying time. (0)

67. The method of claim 46, wherein the gastric emptying parameter includes gastric emptying time, the method further comprising: (0) (1)

68. The method of claim 46, wherein the gastric emptying parameter includes gastric emptying time, the method further comprising: (0) (1)

69. A method for measuring a gastric emptying parameter in a patient, the method comprising: (1) (6)

ingesting a swallowable capsule configured to travel through the patient's intestinal tract and generate a first electrical signal when the capsule is in the stomach and a second electrical signal when the capsule is in the small intestine; the capsule includes at least a first, second and third electrode disposed on a capsule body outer surface, the third electrode covered by an insulative coating which remains in the stomach and degrades in response to a pH condition in the small intestine and wherein the first signal is initiated by current flow between the first and second electrodes in the patient's stomach and the second signal in is initiated by current flow between the second and third electrodes in the patient's small intestine.

generating the first signal by current flow between the first and second electrodes in the presence of fluids in the patient's stomach;

degrading the insulative coating in the patient's small intestine;

generating the second signal by current flow between the second and third electrodes in the presence of fluids in the patient's small intestine;

transmitting the first or second electrical signals to outside of the patient's body; and

determining the gastric empting parameter utilizing information from the first and second electrical signals.

70. The method of claim 69, wherein the gastric emptying parameter is a gastric emptying time. (0)

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Application US20180353133

SWALLOWABLE CAPSULE, SYSTEM AND METHOD FOR MEASURING GASTRIC EMPTYING PARAMETERS

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