Therapeutic payload delivery mechanism

An ingestible capsule, comprising:

• a housing, being a biocompatible indigestible housing including a therapeutic payload carrying compartment;
• a power supply;
• a release mechanism comprising a microcontroller and a release actuator;
• and a sensing mechanism, the sensing mechanism being sensitive to an environment external to the housing;
• the ingestible capsule being configured for passage through a gastrointestinal, GI, tract of a subject mammal, during which passage:
• the sensing mechanism is configured to output an output signal varying according to the GI tract environment external to the housing;
• wherein
• either
• A) the sensing mechanism comprises one or more from among a VOC gas sensor, a reflectometer formed by a transmission antenna of the ingestible capsule connected in series with a directional coupler configured to measure a reflected signal from the transmission antenna, and an accelerometer;
• and
• the microcontroller is configured:
• during an identification phase, on a rolling basis, to record a representation of the output signal for a most recent time period of duration t, and to process the recorded representation of the output signal for the most recent time period of duration t to identify presence of one or more ileocecal junction transition indicators, and
• upon identification of the presence of the one or more ileocecal junction transition indicators, to determine the release timing and based on the determined release timing to cause the release actuator to release the therapeutic payload from the therapeutic payload carrying compartment;
• and/or
• B) the sensing mechanism comprises one or more from among an accelerometer, a TCD gas sensor, and a reflectometer formed by a transmission antenna of the ingestible capsule connected in series with a directional coupler configured to measure a reflected signal from the transmission antenna;
• and
• the microcontroller is configured:
• during an identification phase, on a rolling basis, to record a representation of the output signal for a most recent time period of duration t, and to process the recorded representation of the output signal for the most recent time period of duration t to identify presence of one or more gastric-duodenal transition indicators, and
• upon identification of the presence of the one or more gastric-duodenal transition indicators, to determine the release timing and based on the determined release timing to cause the release actuator to release the therapeutic payload from the therapeutic payload carrying compartment.

A method comprising:

• providing an ingestible capsule to a subject mammal for ingestion, wherein the ingestible capsule comprises a therapeutic payload;
• processing an output signal from a sensing mechanism to determine a release timing of the therapeutic payload;
• causing the therapeutic payload to be released into a GI tract of the subject mammal at the determined release timing;
• wherein the ingestible capsule comprises:
• a housing, being a biocompatible indigestible housing including a therapeutic payload carrying compartment;
• a power supply;
• a release mechanism comprising a microcontroller and a release actuator;
• and a sensing mechanism, the sensing mechanism being sensitive to an environment external to the housing;
• the ingestible capsule being configured for passage through a gastrointestinal, GI, tract of a subject mammal, during which passage:
• the sensing mechanism is configured to output an output signal varying according to the GI tract environment external to the housing;
• wherein
• either
• A) the sensing mechanism comprises one or more from among a VOC gas sensor, a reflectometer formed by a transmission antenna of the ingestible capsule connected in series with a directional coupler configured to measure a reflected signal from the transmission antenna, and an accelerometer;
• and
• the microcontroller is configured:
• during an identification phase, on a rolling basis, to record a representation of the output signal for a most recent time period of duration t, and to process the recorded representation of the output signal for the most recent time period of duration t to identify presence of one or more ileocecal junction transition indicators, and
• upon identification of the presence of the one or more ileocecal junction transition indicators, to determine the release timing and based on the determined release timing to cause the release actuator to release the therapeutic payload from the therapeutic payload carrying compartment;
• and/or
• B) the sensing mechanism comprises one or more from among an accelerometer, a TCD gas sensor, and a reflectometer formed by a transmission antenna of the ingestible capsule connected in series with a directional coupler configured to measure a reflected signal from the transmission antenna;
• and
• the microcontroller is configured:
• during an identification phase, on a rolling basis, to record a representation of the output signal for a most recent time period of duration t, and to process the recorded representation of the output signal for the most recent time period of duration t to identify presence of one or more gastric-duodenal transition indicators, and
• upon identification of the presence of the one or more gastric-duodenal transition indicators, to determine the release timing and based on the determined release timing to cause the release actuator to release the therapeutic payload from the therapeutic payload carrying compartment.

A system comprising an ingestible capsule and a remote processing apparatus:

• the ingestible capsule, comprising:
• a housing, being a biocompatible indigestible housing including a therapeutic payload carrying compartment;
• a power supply;
• a release mechanism;
• and a sensing mechanism, the sensing mechanism being sensitive to an environment external to the housing;
• the ingestible capsule being configured for passage through a gastrointestinal, GI, tract of a subject mammal, during which passage:
• the sensing mechanism is configured to output an output signal varying according to GI tract environment external to the housing;
• wherein
• the release mechanism comprises a capsule transceiver and an actuator, and the capsule transceiver is configured, during an identification phase, to transmit a transmission signal representing the output signal to remote processing apparatus;
• the capsule transceiver being configured, upon receipt of a notification signal from the remote processing apparatus, to cause, immediately or at a predetermined delay, the therapeutic payload to be released from the therapeutic payload carrying compartment by the release actuator;
• and
• the remote processing apparatus comprising a remote processing apparatus transceiver configured to communicate with the capsule transceiver including to receive the transmission signal representing the output signal, and a processor configured to process the output signal to identify in real time either:
• A) one or more ileocecal junction transition indicators wherein the sensing mechanism comprises one or more sensors from among a VOC gas sensor, a reflectometer formed by a transmission antenna of the ingestible capsule connected in series with a directional coupler configured to measure a reflected signal from the transmission antenna, and an accelerometer;
• and/or
• B) one or more gastric duodenal transition indicators in the output signal, wherein the sensing mechanism comprises one or more from among an accelerometer, a TCD gas sensor, and a reflectometer formed by a transmission antenna of the ingestible capsule connected in series with a directional coupler configured to measure a reflected signal from the transmission antenna;
• and the processor is further configured:
• to cause the remote processing apparatus transceiver to transmit the notification signal to the capsule transceiver according to the identification of the one or more ileocecal junction transition indicators and/or the one or more gastric duodenal transition indicators.