Ingestible device for delivery of therapeutic agent to the gastrointestinal tract
An ingestible device, includes a storage reservoir configured to store a dispensable substance and a pressurized chamber configured so that, when a restraining force is removed from the pressurized chamber, the dispensable substance exits the ingestible device via openings in the ingestible device.
1. An ingestible device, comprising:
a housing, comprising:
a housing body comprising a first housing part and a second housing part connected to the first housing part;
a reservoir in the first housing part and configured to hold a dispensable substance;
a nozzle extending through the first housing part;
a gas cylinder in the housing body;
a spring in the housing body;
a piercer in the housing body;
a piston in the housing body between the gas cylinder and the reservoir;
a member comprising a material that is degradable, erodible and/or dissolvable in the GI tract of a subject; and
a covering over an opening of the nozzle,
wherein:
the member prevents the spring from causing the piercer to pierce the gas cylinder;
after the member degrades, erodes and/or dissolves in the GI tract of the subject, the spring forces the piercer into the gas cylinder which causes gas in the cylinder to leave the cylinder and apply a force against the piston which causes the piston to apply a force against the dispensable substance in the reservoir; and
at least one of the following holds:
the member comprises a material that degrades, erodes and/or dissolves due to a change in pH in the GI tract;
the member comprises a material that degrades, erodes and/or dissolves due to a pH in the GI tract;
the member comprises a material that degrades, erodes and/or dissolves due to a presence of an enzyme in the GI tract; and
the member comprises a material that degrades, erodes and/or dissolves due to a change in concentration of an enzyme in the GI tract.
2. The ingestible device of claim 1 , wherein the member comprises an enteric material.
3. The ingestible device of claim 1 , wherein the member degrades, erodes and/or dissolves in the small intestine of the subject or in the large intestine of the subject.
4. The ingestible device of claim 1 , wherein at least one of the following holds:
the covering comprises a material that degrades, erodes and/or dissolves due to a change in pH in the GI tract;
the covering comprises a material that degrades, erodes and/or dissolves due to a pH in the GI tract;
the covering comprises a material that degrades, erodes and/or dissolves due to a presence of an enzyme in the GI tract; and
the covering comprises a material that degrades, erodes and/or dissolves due to a change in concentration of an enzyme in the GI tract.
5. The ingestible of device of claim 4 , wherein, after the covering degrades, erodes and/or dissolves and after the member degrades, erodes and/or dissolves, when the piston applies the force against the dispensable substance in the reservoir, the dispensable substance leaves the ingestible device via the opening of the nozzle.
6. The ingestible device of claim 5 , wherein the dispensable substance leaves the ingestible device as a liquid jet.
7. The ingestible device of claim 6 , wherein the liquid jet has a peak jet power of at least about 1.8 Watts.
8. The ingestible device of claim 6 , wherein the liquid jet has a peak jet velocity of from about 25 meters per second to about 45 meters per second.
9. The ingestible device of claim 1 , wherein an internal pressure of the ingestible device is from about 150 psig to about 400 psig.
10. The ingestible device of claim 1 , wherein a peak fluid pressure of the ingestible device is from about 225 psig to about 425 psig.
11. The ingestible device of claim 1 , wherein the covering comprises an enteric material.
12. The ingestible device of claim 1 , wherein the covering degrades, erodes and/or dissolves in the small intestine of the subject or in the large intestine of the subject.
13. The ingestible device of claim 1 , wherein the housing body is configured as a 000 capsule.
14. The ingestible device of claim 1 , wherein the reservoir has a volume of from about 20 microliters to about 800 microliters.
15. The ingestible device of claim 1 , wherein the dispensable substance comprises a therapeutic agent.
16. The ingestible device of claim 1 , wherein the ingestible device is configured to provide trans-epithelial delivery of the dispensable substance.
17. The ingestible of device of claim 1 , wherein, the force the piston applies to the dispensable substance causes at least part of the covering to leave the ingestible device so that the dispensable substance leaves the ingestible device via the opening of the nozzle.
18. The ingestible device of claim 17 , wherein the dispensable substance leaves the ingestible device as a liquid jet.
19. The ingestible device of claim 18 , wherein the liquid jet has a peak jet power of at least about 1.8 Watts.
20. The ingestible device of claim 18 , wherein the liquid jet has a peak jet velocity of from about 25 meters per second to about 45 meters per second.
21. The ingestible device of claim 17 , wherein an internal pressure of the ingestible device is from about 150 psig to about 400 psig.
22. The ingestible device of claim 17 , wherein a peak fluid pressure of the ingestible device is from about 225 psig to about 425 psig.
23. The ingestible device of claim 1 , wherein the member comprises a material that degrades, erodes and/or dissolves due to a change in pH in the GI tract.
24. The ingestible device of claim 1 , wherein the member comprises a material that degrades, erodes and/or dissolves due to a pH in the GI tract.
25. The ingestible device of claim 1 , wherein the member comprises a material that degrades, erodes and/or dissolves due to a presence of an enzyme in the GI tract.
26. The ingestible of device of claim 25 , wherein, after the covering degrades, erodes and/or dissolves and after the member degrades, erodes and/or dissolves, when the piston applies the force against the dispensable substance in the reservoir, the dispensable substance leaves the ingestible device via the opening of the nozzle.
27. The ingestible device of claim 1 , wherein the member comprises a material that degrades, erodes and/or dissolves due to a change in concentration of an enzyme in the GI tract.
28. The ingestible device of claim 27 , wherein the dispensable substance leaves the ingestible device as a liquid jet.
29. An ingestible device, comprising:
a housing, comprising:
a housing body comprising a first housing part and a second housing part connected to the first housing part;
a reservoir in the first housing part and configured to hold a dispensable sub stance;
a nozzle extending through the first housing part;
a gas cylinder in the housing body;
a spring in the housing body;
a piercer in the housing body;
a piston in the housing body between the gas cylinder and the reservoir;
a member comprising a material that is degradable, erodible and/or dissolvable in the GI tract of a subject; and
a covering over an opening of the nozzle,
wherein:
the member prevents the spring from causing the piercer to pierce the gas cylinder;
after the member degrades, erodes and/or dissolves in the GI tract of the subject, the spring forces the piercer into the gas cylinder which causes gas in the cylinder to leave the cylinder and apply a force against the piston which causes the piston to apply a force against the dispensable substance in the reservoir; and
the member comprises an enteric material.
30. The ingestible device of claim 29 , wherein the member degrades, erodes and/or dissolves in the small intestine of the subject or in the large intestine of the subject.
31. The ingestible device of claim 29 , wherein at least one of the following holds:
the covering comprises a material that degrades, erodes and/or dissolves due to a change in pH in the GI tract;
the covering comprises a material that degrades, erodes and/or dissolves due to a pH in the GI tract;
the covering comprises a material that degrades, erodes and/or dissolves due to a presence of an enzyme in the GI tract; and
the covering comprises a material that degrades, erodes and/or dissolves due to a change in concentration of an enzyme in the GI tract.
32. The ingestible device of claim 29 , wherein an internal pressure of the ingestible device is from about 150 psig to about 400 psig.
33. The ingestible device of claim 29 , wherein a peak fluid pressure of the ingestible device is from about 225 psig to about 425 psig.
34. The ingestible device of claim 29 , wherein the covering comprises an enteric material.
35. The ingestible device of claim 29 , wherein the covering degrades, erodes and/or dissolves in the small intestine of the subject or in the large intestine of the subject.
36. The ingestible device of claim 29 , wherein the reservoir has a volume of from about 20 microliters to about 800 microliters.
37. The ingestible device of claim 29 , wherein the dispensable substance comprises a therapeutic agent.
38. The ingestible device of claim 29 , wherein the ingestible device is configured to provide trans-epithelial delivery of the dispensable substance.
39. The ingestible of device of claim 29 , wherein, the force the piston applies to the dispensable substance causes at least part of the covering to leave the ingestible device so that the dispensable substance leaves the ingestible device via the opening of the nozzle.