Pharmaceutical dosages delivery system

• US 8,951,234 B2
• Filed: 07/02/2013
• Issued: 02/10/2015
• Est. Priority Date: 01/06/2009
• Status: Active Grant

• Current Assignee: Proteus Digital Health, Inc. (Otsuka Holdings Company Limited)
• Original Assignee: Proteus Digital Health, Inc. (Otsuka Holdings Company Limited)
• Inventors: Hafezi, Hooman, Moon, Gregory, Au-Yeung, Kityee, Duck, Robert, Holen, Maria Casillas
• Primary Examiner(s): Lucchesi, Nicholas
• Assistant Examiner(s): CHANDER, DIVA KAKAR
• Application Number:
  US13/934,054
• Publication Number:
  US 20140046147A1
• Time in Patent Office: 588 Days
• Field of Search: 604/19, 600/302
• US Class Current: 604/302
• CPC Class Codes: A61B 5/07 Endoradiosondes
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61J 3/071 into the form of telescopically engaged two-piece capsules
• CPC Class Codes: A61K 9/0097 Micromachined devices; Microelectromechanical systems [MEMS]; Devices obtained by lithographic treatment of silicon; Devices comprising chips intradermal microneedle arrays A61K9/0021; MEMS in general B81B7/02
• CPC Class Codes: A61M 31/00 Devices for introducing or retaining media, e.g. remedies, in cavities of the body A61M25/00 takes precedence ; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50

Abstract

Pharmaceutical delivery systems for delivering dosages according to the present invention include a carrier component and a cap configured to seal an internal volume of the carrier component, wherein the cap includes a device that produces a unique current signature. Dosages prepared to be delivered according to embodiments of the invention find use in a variety of different applications, including clinical trials.

Claims

1. A system comprising:

a carrier housing having a closed end and an open end, the carrier housing defining an internal volume, wherein the open end further comprises an engagement area on the inner wall of the carrier housing;

a cap comprising a top end and a bottom end, wherein the bottom end includes an insertion portion configured to couple with the engagement area of the open end of the carrier housing to seal the internal volume thereof, wherein the insertion portion and the engagement area are configured to seal the internal volume of the carrier when the cap and carrier housing are assembled, and release the cap from the carrier housing after the cap and carrier housing are ingested; and

at least one device secured to the cap, wherein each device is configured to produce an identifiable current signature for communicating information when the device comes into contact with an electrically conductive fluid as the carrier housing comes into contact with the conductive fluid.

2. The system of claim 1, wherein the cap comprises interlocking elements configured to operate with mating elements of the open end of the carrier housing in a sealing relationship.

3. The system of claim 2, wherein the interlocking elements are screw threads configured to sealingly engage the cap to the carrier housing.

4. The system of claim 2, wherein the interlocking elements are snap fit elements configured to sealingly engage the cap to the carrier housing.

5. The system of claim 1, wherein the bottom end of the cap is configured to pressure fit inside of the top end of the carrier housing in a sealing relationship.

6. The system of claim 5, wherein the bottom end of the cap is configured to pressure fit within the open end of the carrier housing.

7. The system of claim 6, wherein the bottom end of the cap is made of a rigid material having an outer diameter that is slightly larger than an inner diameter of the open end of the carrier housing.

8. The system of claim 7, wherein the open end of the carrier housing is made of an elastomeric material.

9. The system of claim 1, wherein the bottom end of the cap comprises a compressible compliant end.

10. The system of claim 1, wherein the at least one device comprises:

a frame;

a conductance control module secured to the frame and configured to produce the identifiable current signature representing the information;

a first material secured to the frame and electrically coupled to the conductance control module; and

a second material secured to the frame and electrically coupled to the conductance control module,

wherein the first material and the second material are separated by a non-conductive material and selected to produce a voltage potential when in contact with an electrically conductive fluid.

11. The system of claim 1, wherein the device is secured to a top portion of the cap.

12. The system of claim 1, wherein the carrier housing and the cap are configured to receive a dosage amount of one or more pharmaceutically active agent compositions to be sealed therein.

13. A system comprising:

a carrier housing having a closed end and an open end, the carrier housing defining an internal volume, wherein the open end further comprises an engagement area on the inner wall of the carrier housing;

an apparatus positioned within the internal volume defined by the housing for altering the buoyancy of the carrier housing;

a cap comprising a top end and a bottom end, wherein the bottom end includes an insertion portion configured to couple with the engagement area of the open end of the carrier housing to seal the internal volume thereof, wherein the insertion portion and the engagement area are configured to seal the internal volume when the cap and the carrier housing are assembled, and release the cap from the carrier housing after the cap and the carrier housing are ingested; and

at least one device secured to the cap, wherein each device is configured to produce an identifiable current signature for communicating information when the device comes into contact with an electrically conductive fluid as the carrier housing comes into contact with the conductive fluid.

14. The system of claim 13, wherein cap comprises interlocking elements configured to operate with mating elements of the open end of the carrier housing in a sealing relationship.

15. The system of claim 14, wherein the interlocking elements are screw threads configured to sealingly engage the cap to the carrier housing.

16. The system of claim 14, wherein the interlocking elements are snap fit elements configured to sealingly engage the cap to the carrier housing.

17. The system of claim 13, wherein the bottom end of the cap is configured to pressure fit inside of the top end of the carrier housing in a sealing relationship.

18. The system of claim 17, wherein the bottom end of the cap is configured to pressure fit within the open end of the carrier housing.

19. The system of claim 18, wherein the bottom end of the cap is made of a rigid material having an outer diameter that is slightly larger than an inner diameter of the open end of the carrier housing.

20. The system of claim 19, wherein the open end of the carrier housing is made of an elastomeric material.

21. The system of claim 13, wherein the bottom end of the cap comprises a compressible compliant end.

22. The system of claim 13, wherein the at least one device comprises:

a frame;

a conductance control module secured to the frame and configured to produce the identifiable current signature representing the information;

a first material secured to the frame and electrically coupled to the conductance control module; and

a second material secured to the frame and electrically coupled to the conductance control module,

wherein the first material and the second material are separated by a non-conductive material and selected to produce a voltage potential when in contact with an electrically conductive fluid.

23. The system of claim 13, wherein the device is secured to a top portion of the cap.

24. The system of claim 13, wherein the carrier housing and the cap are configured to receive a dosage amount of one or more pharmaceutically active agent compositions to be sealed therein.

25. A system comprising:

a dissolvable casing having a closed end and an open end, the dissolvable casing defining an internal volume, wherein the open end further comprises an engagement area on the inner wall of the carrier housing;

a cap comprising a top end and a bottom end, wherein the bottom end includes an insertion portion configured to couple with the engagement area of the open end of the dissolvable casing to seal the internal volume thereof, wherein the insertion portion and the engagement area are configured to seal the internal volume when the cap and the dissolvable casing are assembled, and release the cap from the dissolvable casing after the cap and the dissolvable casing are ingested; and

at least one device secured to the cap, wherein each device is configured to produce an identifiable current signature for communicating information when the device comes into contact with an electrically conductive fluid as the dissolvable casing comes into contact with the conductive fluid.

26. The system of claim 25, wherein the cap comprises interlocking elements configured to operate with mating elements of the open end of the dissolvable casing in a sealing relationship.

27. The system of claim 26, wherein the interlocking elements are screw threads configured to sealingly engage the cap to the dissolvable casing.

28. The system of claim 26, wherein the interlocking elements are snap fit elements configured to sealingly engage the cap to the dissolvable casing.

29. The system of claim 25, wherein the bottom end of the cap is configured to pressure fit inside of the top end of the dissolvable casing in a sealing relationship.

30. The system of claim 29, wherein the bottom end of the cap is configured to pressure fit within the open end of the dissolvable casing.

31. The system of claim 29, wherein the bottom end of the cap is made of a rigid material having an outer diameter that is slightly larger than an inner diameter of the open end of the dissolvable casing.

32. The system of claim 31, wherein the open end of the carrier housing is made of an elastomeric material.

33. The system of claim 25, wherein the bottom end of the cap comprises a compressible compliant end.

34. The system of claim 25, wherein the at least one device comprises:

a frame;

a conductance control module secured to the frame and configured to produce the identifiable current signature representing the information;

a first material secured to the frame and electrically coupled to the conductance control module; and

a second material secured to the frame and electrically coupled to the conductance control module,

wherein the first material and the second material are separated by a non-conductive material and selected to produce a voltage potential when in contact with an electrically conductive fluid.

35. The system of claim 25, wherein the device is secured to a top portion of the cap.

36. The system of claim 25, wherein the dissolvable casing and the cap are configured to receive a dosage amount of one or more pharmaceutically active agent compositions to be sealed therein.