Miniature ingestible device
The present invention discloses multiple approaches to preventing the capsule walls and other material from interfering with the performance of an electronic device once the device is activated by surrounding fluid. In accordance with the teachings of the present invention, a miniature ingestible device (MID) may be created using excipients and films. The MID, in accordance with various aspects of the present invention, will have a coating or laminating surrounding an electronic device and separating and isolating the device from the pharmaceutical product or drug within the capsule once the capsule is ingested as well as from the capsule itself as the capsule walls begin to collapse during the disintegration process.
1. A unit including a pharmaceutical product, wherein the unit is ingestible and activated upon contact with a fluid, the unit comprising:
a capsule including a wall, wherein the capsule defines a cavity for holding the pharmaceutical product and wherein the wall loses its shape and disintegrates upon contact with the fluid; and
a device including a partial power source located within the cavity of the capsule, wherein the device is configured to encode information in a current flow, which occurs when the device is activated as the partial power source contacts the fluid, the device comprising:
a first surface with a first portion of the partial power source;
a second surface with a second portion of the partial power source; and
a control unit for encoding the information in the current flow, wherein the control unit is electrically coupled between the first and second portions of the partial power source; and
a material comprising a first part and a second part, the first part positioned over the first portion without contacting the first portion, and the second part positioned over the second portion of the partial power source without contacting the second portion, the first and second parts both having first and second ends, the first and second ends of the first part coupled to the first portion via an adhesive, and the first and second ends of the second part coupled to the second portion via the adhesive, wherein the adhesive disintegrates upon contact with the fluid to provide physical separation between the device and the disintegrating wall of the capsule;
wherein the material is a non-soluble film material that defines an opening at either end of the device such that when the device comes in contact with the fluid and expands, the non-soluble film material controls the direction of expansion.
2. The unit of claim 1 , wherein the material surrounds the device and is secured to itself to define a cavity between the material and the device.
3. The unit of claim 1 , wherein the material between the first and second ends of both the first part and the second part is molded to not touch the first portion and the second portion of the partial power source.
4. A device for placement within a capsule, comprising:
an ingestible unit comprising a first surface and a second surface opposite the first surface; and
a material comprising a first part and a second part and in physical communication with at least part of the ingestible unit, the first part positioned over the first surface without contacting the first surface, and the second part positioned over the second surface without contacting the second surface, the first and second parts both having first and second ends, the first and second ends of the first part coupled to the first surface via an adhesive, and the first and second ends of the second part coupled to the second surface via the adhesive, wherein the adhesive disintegrates upon contact with fluid such that the material facilitates physical separation of the ingestible unit from at least a portion of the capsule during a disintegration;
wherein the material is a non-soluble film material that defines an opening at either end of the ingestible unit such that when the ingestible unit comes in contact with the fluid and expands, the non-soluble film material controls the direction of expansion.
5. The device of claim 4 , wherein the ingestible unit comprises an ingestible event marker.
6. The device of claim 4 , wherein the material between the first and second ends of both the first part and the second part is molded to not touch the first surface and the second surface of the ingestible unit.
7. A system for tracking delivery of a pharmaceutical agent, the system comprising:
a capsule defining a cavity;
a miniature ingestible tablet located in the cavity of the capsule, the miniature ingestible tablet comprising:
an ingestible device comprising a first surface and a second surface opposite the first surface and that is activated upon contact with a fluid;
a tablet material in physical communication with at least part of the ingestible device; and
a material at least partially surrounding the miniature ingestible tablet, the material comprising a first part and a second part, the first part positioned over the first surface without contacting the first surface, and the second part positioned over the second surface without contacting the second surface, the first and second parts both having first and second ends, the first and second ends of the first part coupled to the first surface via an adhesive, and the first and second ends of the second part coupled to the second surface via the adhesive, wherein the adhesive disintegrates upon contact with fluid such that the tablet material facilitates physical separation of the ingestible device from at least a portion of the capsule during a disintegration process;
wherein the material is a non-soluble film material that defines an opening at either end of the miniature ingestible tablet such that when the tablet material comes in contact with the fluid and expands, the non-soluble film material controls the direction of expansion.
8. The system of claim 7 , wherein the material delays contact between the fluid and the ingestible device to delay activation.
9. The system of claim 7 , wherein the ingestible device includes a partial power source, and the ingestible device is configured to encode information in a current flow, which occurs when the ingestible device is activated as the partial power source contacts the fluid.
10. The system of claim 9 , wherein the ingestible device further comprises:
a first portion of the partial power source;
a second portion of the partial power source; and
a control unit for encoding the information in the current flow, wherein the control unit is electrically coupled between the first and second portions of the partial power source.
11. The system of claim 7 , wherein the material between the first and second ends of both the first part and the second part is molded to not touch the first surface and the second surface of the ingestible device.