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1. (WO1992021307) TELEMETRY CAPSULE AND PROCESS
Note: Text based on automatic Optical Character Recognition processes. Please use the PDF version for legal matters

WE CLAIM:

1. An ingestible capsule for delivery of a medicament to the alimentary canal comprising, an electric power source, a radio signal transmitting means, a medicament storage compartment, and a remote actuatable medicament releasing means, all encased in an essentially nondigestible outer shell.

2. The capsule of claim 1 wherein said electric power source comprises a battery.

3. The capsule of claim 1 wherein said transmitting means emits a detectable radio signal.

4. The capsule of claim 1 wherein said medicament storage compartment comprises a dosing means and a filling means.

5. The capsule of claim 4 wherein said filling means comprises a self sealing membrane.

6. The capsule of claim 4 wherein said dosing means comprises a removable plug.

7. The capsule of claim. 1 wherein said remote actuatable medicament releasing means comprises an activating means and a medicament releasing means.

8. The capsule of claim 7 wherein said activating means comprises an electric heating filament and means for activating said heating filament.

9. The capsule of claim 1 wherein said remote actuatable medicament releasing means comprises means for receiving a radio signal from a remote transmitting means.

10. The capsule of claim 7 wherein said activating means comprises an initiator coil that is characterized by a detectable resonate frequency when activated.

11. The capsule of claim 8 wherein said heating filament is detachably joined to a diaphragm by means of a thermal sensitive glue.

12. The capsule of claim 1 wherein said remote actuatable releasing means comprises a diaphragm, arranged to separate reactants that, upon contacting each other, will form a gas.

13. The capsule of claim 12 wherein said reactants comprise an acid and a base.

14. The capsule of claim 13 wherein said base comprises sodium bi-carbonate and said acid is an organic acid.

15. The capsule of claim 12 comprising means to rupture said diaphragm.

16. The capsule of claim 15 wherein said means to rupture said diaphragm comprises a rupture pin arranged to engage said diaphragm when said diaphragm is released from a distended position.

17. The capsule of claim 16, wherein said diaphragm is held in said distended position by distending means comprising an electric heating filament detachably joined, by thermal sensitive glue, to said diaphragm.

18. The capsule of claim 17 wherein said distending means comprise means for conducting electricity to said filament.

19. The capsule of claim 7 comprising a movable piston.

20. The capsule of claim 19 wherein said piston is adapted to cause medicament to be expelled from the capsule through movement of said piston.

21. The capsule of claim 19 comprising a trip wire arranged to be engaged with movement of said piston.

22. The capsule of claim 21 wherein said trip wire is arranged to break with defined movement of said piston.

23. The capsule of claim 21 wherein said trip wire is arranged to provide a means to remotely detect medicament dosing.

24. The capsule of claim 23 wherein said trip wire comprises a component of an initiator coil that is characterized by a detectable resonate frequency when activated.

25. The capsule of claim 24 wherein breaking said trip wire changes the resonate frequency of said initiator coil.

26. The capsule of claim 1 wherein said outer shell comprises a polycarbonate.

27. An ingestible capsule for delivery of a medicament to the alimentary canal comprising, a non-digestible outer shell; an electric power source; a radio signal transmitting means; a medicament storage compartment comprising a filling membrane and a dosing means; and, a remote actuatable medicament releasing means.

28. An ingestible capsule for delivery of a medicament to the alimentary canal comprising, a non-digestible outer shell; an electric power source; a radio signal transmitting means; a medicament storage compartment comprising a filling membrane and a dosing means; diaphragm means, arranged to separate reactants that upon contact generate a gaseous product; means to rupture said diaphragm; and piston means, arranged to move in response to generation of said gaseous product.

29. The capsule of claim 28 comprising means to receive a radio signal.

30. The capsule of claim 29 comprising a medicament.

31. A process for the delivery of a medicament to a selected site in the alimentary canal of an animal comprising, providing an ingestible capsule containing a signal transmitting means, medicament and a remote actuatable medicament releasing means; ingesting said capsule into the alimentary canal; transmitting a signal from said transmitting means contained in said capsule; receiving said transmitted signal exterior of said canal; comparing said signal to a predetermined standard and transmitting an actuating signal to said remote actuatable medicament releasing means contained in said capsule for releasing said medicament from said capsule.

32. The process of claim 31 wherein said signal is a radio signal.

33. The process of claim 31 wherein a radio signal is transmitted from said transmitting means in said capsule and is received at multiple antennae arranged about the exterior of the alimentary canal.

34. The process of claim 33 wherein the output of said multiple antennae is time multiplexed.

35. The process of claim 32. wherein said radio signal, transmitted from said transmitting means in said capsule, is converted to an intermediate frequency signal.

36. The process of claim 35 wherein an intermediate frequency signal is quantified as a DC voltage signal.

37. The process of claim 36 wherein a quantified DC voltage signal is digitized to provide input to a computer.

38. The process of claim 34 wherein a time multiplexed output of the multiple antennae is converted to an intermediate frequency signal, quantified as a DC voltage signal and digitized to provide input to a computer.

39. The process of claim 31 wherein digitized information from said transmitted signal is compared to said predetermined standard in a computer.

40. The process of claim 31 wherein said predetermined standard comprises historic data obtained from the previous passage of a capsule through said alimentary canal.

41. The process of claim 31 wherein said predetermined standard comprises one of a rate, time or normalized model.

42. The process of claim 31 wherein said transmitted signal is digitized and provided to a computer.

43. The process of claim 42 wherein said predetermined standard comprises digitized historic data obtained from the previous passage of a capsule through said alimentary canal .

44. The process of claim 42 wherein said predetermined standard comprises one of a rate, time or normalized model.

45. The process of claim 42 wherein said computer is programed to scan and compute variations from pre-programed factors.

46. The process of claim 42 wherein said computer is programed to initiate an activating signal to the medicament releasing means of the capsule.

47. The process of claim 42 wherein transmission of said activating signal is operator controlled.

48. The process of claim 31 wherein release of said medicament initiates a detectable dosing indicator signal.

49. The process of claim 46 wherein release of said medicament initiates a detectable dosing indicator signal.

50. The process of claim 49 wherein said computer is programed to re-initiate an activating signal when a dosing indicator signal is not detected.

51. The process of claim 31 comprising two or more capsules in the alimentary canal transmitting differential signals.

52. The process of claim 31 wherein a first ingestible capsule, containing a signal transmitting means, is ingested into said alimentary canal and digitized data from a signal transmitted from said first capsule, received exterior of said canal, comprises said predetermined standard.

53. A process for the collection of data for the delivery of a medicament to a selected site in the alimentary canal of an animal comprising, providing an ingestible capsule containing a radio signal transmitting means; ingesting said capsule into the alimentary canal; transmitting a radio signal from said transmitting means; receiving said transmitted signal exterior of said canal at multiple antennae arranged about said canal; digitizing said signal received by said multiple antennae; storing said digitized signal in computer recoverable, time sequence memory*

54. The process of claim 53 wherein said stored digitized signal is compared to digitized data from the passage of another capsule through said alimentary canal.

AMENDED CLAIMS
[received by the International Bureau on 12 November 1992 (12.11.92);
original claims 1-54 replaced by
amended claims 1-55 (10 pages)]

1. An ingestible capsule for delivery of a medicament to the alimentary canal comprising, an electric power source, a radio signal transmitting means in enabling circuitry with said power source, a medicament storage compartment, and a remote actuatable medicament releasing means for releasing medicament from said storage compartment, all encased in an essentially non-digestible outer shell.

2. The capsule of claim 1 wherein said electric power source comprises a battery.

3. The capsule of claim 1 wherein said transmitting means emits a radio signal, detectable exterior to said outer shell of said capsule, when enabled by said power source.

4. The capsule of claim 1 wherein said medicament storage compartment comprises a dosing means and a filling means.

5. The capsule of claim 4 wherein said filling means comprises a self sealing membrane arranged to be pierced for providing medicament to said storage compartment.

6. The capsule of claim.4 wherein said dosing means comprises a removable plug arranged to be expelled from said capsule at dosing.

7. The capsule of claim 1 wherein said remote actuatable medicament releasing means comprises an activating means and a medicament releasing means, said activating means being arranged to initiate medicament releasing activity of said medicament releasing means.

8. The capsule of claim 7 wherein said activating means comprises an electric heating filament, in enabling circuitry with said power source.

9. The capsule of claim 1 wherein said remote actuatable medicament releasing means comprises means for receiving a radio signal from a remote transmitting means positioned exterior of said outer shell of said capsule.

10. The capsule of claim 7 wherein said activating means comprises an initiator coil, in enabling circuitry with said power source, that is characterized by emitting a detectable resonant frequency when said activating means is activated.

11. The capsule of claim 8 wherein said medicament releasing means comprises a diaphragm, arranged between reactants and separating said reactants from contacting, and said heating filament is . detachably joined to said diaphragm by means of a thermal sensitive glue.

12. The capsule of claim 1 wherein said remote actuatable releasing means comprises a diaphragm, arranged between and separating reactants, that, upon contacting each other, will form a gas.

13. The capsule of claim 12 wherein said reactants comprise an acid and a base.

14. The capsule of claim 13 wherein said base comprises sodium bi-carbonate and said acid is an organic acid.

15. The capsule of claim 12 further comprising means to rupture said diaphragm to the extent that the separated reactants will contact.

16. The capsule of claim 15 wherein said means to rupture said diaphragm comprises a rupture pin arranged to engage said diaphragm when said diaphragm is released from a distended position.

17. The capsule of claim 16, wherein said diaphragm is held in said distended position by means comprising an electric heating filament detachably joined, by thermal sensitive glue, to said diaphragm.

18. The capsule of claim 17 wherein said means comprises enabling circuitry from said power source for conducting electricity to said filament.

19. The capsule of claim 7 wherein said medicament releasing means comprises a movable piston.

20. The capsule of claim 19 wherein said piston is adapted to cause medicament to be expelled from the capsule through movement of said piston forcing medicament stored in said medicament storage compartment to be expelled from said capsule.

21. The capsule of claim 20 comprising a trip wire arranged to be engaged with said movement of said piston.

22. The capsule of claim 20 wherein a trip wire is arranged to break with said movement of said piston.

23. The capsule of claim 21 wherein said trip wire is arranged to engage a means to remotely detect medicament dosing.

24. The capsule of claim 23 wherein said trip wire is an electrical conductor and engages an initiator coil in parallel circuitry that is characterized by a detectable resonant frequency when activated.

25. The capsule of claim 2.4 wherein breaking said trip wire modifies said parallel circuitry and changes the resonant frequency of said initiator coil.

26. The capsule of claim 1 wherein said outer shell comprises a polycarbonate.

27. An ingestible capsule for delivery of a medicament to the alimentary canal comprising, a non-digestible outer shell; an electric power source; a radio signal transmitting means in enabling circuitry with said power source; a medicament storage compartment comprising a filling membrane and a dosing means; and, a remote actuatable medicament releasing means.

28. An ingestible capsule for delivery of a medicament to the alimentary canal comprising, a non-digestible outer shell; an electric power source; a radio signal transmitting means in enabling circuitry with said power source; a medicament storage compartment comprising a filling membrane and a dosing means; diaphragm means, arranged to separate reactants that upon contact generate a gaseous product; means to rupture said diaphragm; and piston means, arranged to move in response to generation of said gaseous product.

29. The capsule of claim 28 comprising means to receive a radio signal.

30. The capsule of claim 2.9 containing a medicament in said medicament storage compartment.

31. A process for the delivery of a medicament to a selected site in the alimentary canal of an animal comprising, providing an ingestible capsule containing a signal transmitting means, medicament and a remote actuatable medicament releasing means; ingesting said capsule into the alimentary canal; transmitting a signal from said transmitting means contained in said capsule; receiving said transmitted signal exterior of the body of said animal; comparing said signal to a pre-established model and transmitting an actuating signal to said remote actuatable medicament releasing means contained in said capsule for releasing said medicament from said capsule, in response to the comparison.

32. The process of claim 31 wherein said signal is a radio signal.

33. The process of claim 31 wherein a radio signal is transmitted from said transmitting means in said capsule and is received at multiple receiving antennae arranged about the exterior of the body of said animal.

34. The process of claim 33 wherein the output of said multiple receiving antennae is directed to time multiplexing means and said output is converted to time multiplexed output.

35. The process of claim 32 wherein said radio signal, transmitted from said transmitting means in said capsule, is converted to an intermediate frequency signal.

36. The process of claim 35 wherein an intermediate frequency signal is quantified as a DC voltage signal.

37. The process of claim 36 wherein a quantified DC voltage signal is digitized to provide input to a computer.

38. The process of claim 34 wherein said time multiplexed output of the multiple receiving antennae is converted to an intermediate frequency signal, quantified as a DC voltage signal and digitized to provide input to a computer.

39. The process of claim 31 wherein digitized information from said transmitted signal is compared to digitized information from said pre-established model in a computer.

40. The process of claim 31 wherein said pre-established model comprises historic data obtained from the previous passage of a radio signal transmitting capsule through said alimentary canal.

41. The process of claim 31 wherein said pre- established model comprises digitized information having parameters comprising one of a rate, time or normalized model .

42. The process of claim 31 wherein said transmitted signal is received exterior of the animal body digitized and provided to a computer.

43. The process of claim 42 wherein said pre-established model comprises digitized historic data obtained from the previous passage of a capsule through said alimentary canal.

44. The process of claim 42 wherein said pre-established model comprises digitized information having parameters comprising one of a rate, time or normalized model .

45. The process of claim 42 wherein said computer is programed to scan and compute variations from pre-programed factors.

46. The process of claim 42 wherein said computer is programed to initiate an actuating signal to the medicament releasing means of the capsule.

47. The process of claim 42 wherein initiation of said actuating signal is operator controlled.

48. The process of claim 31 wherein release of said medicament initiates a dosing indicator signal, by a dosing indicator signal means comprised in said capsule, which is detectable exterior of the body of said animal.

49. The process of claim 46 wherein release of said medicament initiates a dosing indicator signal, by a dosing indicator signal means comprised in said capsule, which is detectable exterior of the body of said animal.

50. The process of claim 49 wherein said computer is programed to re-initiate an actuating signal when a dosing indicator signal is not received by said computer after it has initiated an actuating signal.

51. The process of claim 31 comprising two or more capsules in the alimentary canal transmitting differential signals.

52. The process of claim 31 wherein a first ingestible capsule, containing a signal transmitting means, is ingested into said alimentary canal; a signal transmitted from said capsule is received exterior of said body and digitized in a computer; and said digitized data from a signal transmitted from said first capsule comprises said pre-established model.

53. A process for the collection of data for the delivery of a medicament to a selected site in the alimentary canal of an animal comprising: providing an ingestible capsule containing a radio signal transmitting means; ingesting said capsule into the alimentary canal; transmitting a radio signal from said transmitting means; receiving said transmitted signal exterior of the body of said animal at multiple receiving antennae arranged about said canal; digitizing said signal received by said multiple antennae; and storing said digitized signal in computer recoverable, time sequence memory.

54. The process of claim 53 wherein said stored digitized signal is compared to digitized data derived from transmitted signals from the passage of another capsule through said alimentary canal.

55. The capsule of claim 1 wherein said enabling circuitry comprises a switching means.

CTATEME TUNDER ARTICLE 19

The reason for amending the claims is to clarify the recitation thereof and conform them to the recitation as amended in the prosecution of the United States priority application in order to expedite international examination.

The addition of claim 55 was occasioned by the clarifying amendment to claim 1. The amended claims do not go beyond the disclosure of the International Application as originally filed.
It is noted that none of the cited references disclose or suggest the combination of components contained within the essentially non-digestible shell of a capsule or the process as recited in the presently claimed invention.
Ellinwood, Jr. does not provide an ingestible capsule, does it comprise a radio signal transmitting means and does not appear as pertinent to use in the alimentary canal.
Kambara et al, does not provide a radio signal transmitting means and does not provide an electric power source.
Grozai does not disclose an ingestible capsule, a radio signal transmitting means nor a remote actuatable medicament dosing means.
A duplicate copy of this Amendment and Statement iε being filed in the United States Receiving Office together with a Demand for International Preliminary Examination under Article 31.