Application US20180353133 AI Biotech/Diagnostics: Cardio

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Application US20180353133

Published 2018-12-13

Swallowable Capsule, System And Method For Measuring Gastric Emptying Parameters

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.

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5 Independent Claims

1. A swallowable capsule for measurement of a gastric emptying parameter, the capsule comprising: 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.
27. The capsule of 25, where the gastric emptying time is determined based on the start time of the first and second output signals.
36. A swallowable capsule for measurement of gastric emptying time, the capsule comprising: 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 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.
46. A method for measuring a gastric emptying parameter in a patient, the method comprising: 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; 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.
69. A method for measuring a gastric emptying parameter in a patient, the method comprising: 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.