Sampling capsule and process

• US 5,395,366 A
• Filed: 01/10/1994
• Issued: 03/07/1995
• Est. Priority Date: 05/30/1991
• Status: Expired due to Term

• Current Assignee: Given Imaging Incorporated (Medtronic Plc), SmartPill Diagnostics, Inc. (Medtronic Plc), The Research Foundation for The State University of New York (State University of New York)
• Original Assignee: Gastrotarget Corporation, State University of New York
• Inventors: D'Andrea, David T., Schentag, Jerome J.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US08/179,502
• Time in Patent Office: 421 Days
• Field of Search: 128/630, 128/631, 128/654, 128/655, 128/737, 128/903, 604/67, 604/93, 604/113, 604/145, 604/890.1, 604/890.1, 604/892.1, 600/2, 600/3, 600/7
• US Class Current: 604/890.1
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 2010/0061 Alimentary tract secretions, e.g. biliary, gastric, intestinal, pancreatic secretions
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/073 Intestinal transmitters
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• 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

An ingestible capsule and process for sampling, particularly repeatable sampling, of fluids in the alimentary canal is disclosed wherein an essentially non-digestible capsule contains an electric energy emitting means, a radio signal transmitting means, a sampling storage means and a remote actuatable sampling means. The capsule signals a remote receiver as it progresses through the alimentary tract in a previously mapped route and upon reaching a specified site is remotely triggered to capture a fluid sample in the alimentary canal.

Claims

1. An ingestible capsule for removal of a fluid sample from the alimentary canal of an animal comprising, an electric power source;

a radio signal transmitting means in enabling circuitry with said power source, said transmitting means being suitable for transmitting a radio signal the location from which the transmission emanates being trackable through animal tissue;

a fluid sample storage compartment;

means for obtaining a fluid sample from said alimentary canal;

all encased in an essentially non-digestible outer shell that is configured to pass through said alimentary canal.

2. The capsule of claim 1 wherein said means for obtaining said fluid sample is actuatable remote from said capsule.

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

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

5. The capsule of claim 2 wherein said means for obtaining said fluid sample is actuatable by radio signal transmitted from a site exterior of the body of said animal.

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

7. The capsule of claim 1 comprising a passageway for the flow of fluid from the exterior of said capsule to the interior of said capsule.

8. The capsule of claim 7 comprising means arranged to resist the flow of fluid through said passageway.

9. The capsule of claim 8 wherein said means arranged to resist the flow of fluid comprises a one way flap means.

10. The capsule of claim 7 wherein said passageway comprises a closable opening through said outer shell to a storage compartment within said capsule, said closable opening comprising a spring assisted one way valve means.

11. The capsule of claim 1 wherein said means for obtaining a fluid sample comprises activating means arranged to initiate sampling activity of a sampling means.

12. The capsule of claim 11 wherein said activating means comprises means for receiving a radio signal transmitted from a site exterior of the body of said animal.

13. The capsule of claim 11 wherein said activating means comprises an initiator coil that is characterized by a detectable resonate frequency when activated.

14. The capsule of claim 12 comprising means for enabling the flow of electricity from said power source to said sampling means in response to receiving said radio signal from a site exterior said body.

15. The capsule of claim 14 wherein said sampling means comprises a filament, which is arranged to heat a thermal sensitive adhesive when the flow of electricity from said power source is enabled.

16. The capsule of claim 15 wherein said thermal sensitive adhesive is comprised in an arrangement which restrains a spring, and heating of said adhesive by said filament releases said restraint.

17. The capsule of claim 16 wherein said sampling means comprises a piston which is arranged in said sample storage compartment, release of said spring urges said piston from a first position in said compartment to a second position, and the movement of said piston creates a partial vacuum in a portion of said storage compartment which influences the flow of a fluid from said alimentary canal through a passageway in said capsule to said portion of said storage compartment.

18. The capsule of claim 17 wherein said filament breaks through movement of said piston and the flow of electricity therethrough is disconnected.

19. The capsule of claim 18 wherein breaking said filament changes the resonate frequency of said initiator coil.

20. The capsule of claim 1 wherein said sampling means comprises a movable piston adapted to influence the flow of a fluid from the alimentary canal into said capsule, through movement of said piston from a first position to a second position.

21. The capsule of claim 20 wherein said movement of said piston creates a pressure in a portion of said capsule.

22. The capsule of claim 21 comprising means for relieving said pressure in said portion of said capsule.

23. The capsule of claim 22 wherein said means for relieving said pressure comprises a pressure induced opening to the exterior of said capsule through which air can flow, and movement of the piston to a said second position restrains said flow of air through said opening.

24. The capsule of claim 23 wherein said piston comprises means for restraining the flow of fluid through said opening.

25. The capsule of claim 20 wherein said piston is arranged in said sample storage compartment and movement of said piston from said first position to a second position influences the flow of a fluid from the alimentary canal into said storage compartment.

26. The capsule of claim 25 wherein said movement of said piston creates a partial vacuum in a portion of said storage compartment which influences the flow of a fluid from said alimentary canal through a passageway from the exterior of said capsule into said portion of said storage compartment.

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

28. An ingestible capsule for removal of a fluid sample from the alimentary canal of an animal comprising, a non-digestible outer shell;

an electric power source;

a radio signal transmitting means; and

a fluid sample storage compartment comprising a piston means arranged for withdrawing a fluid sample from said alimentary canal in response to a signal from a signal means remote from the body of said animal.

29. An ingestible capsule for sampling a fluid from the alimentary canal of an animal comprising, a non-digestible outer shell;

an electric power source;

a first radio signal transmitting means;

a fluid sample storage compartment;

means for receiving a second radio signal; and

, a fluid sampling means responsive to the receipt of said second radio signal.

30. The capsule of claim 29 wherein said fluid sampling means withdraws fluid from said alimentary canal through differential pressure means.

31. The capsule of claim 29 comprising a fluid sample taken from said alimentary canal.

32. A process for the gathering of a fluid sample from a selected site in the alimentary canal of an animal comprising, providing an ingestible capsule containing a signal transmitting means and a remote actuatable fluid sampling means;

ingesting said capsule into the alimentary canal;

transmitting a signal, trackable through animal tissue, from said transmitting means contained in said capsule, said signal being suitable for determining location of said capsule;

receiving said transmitted signal exterior of the body of said animal;

comparing said signal to a pre-established model;

transmitting an actuating signal to said remote actuatable fluid sampling means contained in said capsule; and

gathering a fluid sample in said capsule in response to said actuating signal.

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

34. The process of claim 33 wherein said radio signal, transmitted from said transmitting means in said capsule, is converted to an intermediate frequency signal.

35. The process of claim 34 wherein an intermediate frequency signal is quantified as a DC voltage signal.

36. The process of claim 35 wherein a quantified DC voltage signal is digitized to provide input to a computer.

37. The process of claim 32 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.

38. The process of claim 37 wherein the output of said multiple receiving antennae is directed to time multiplexing means and said output is converted to time multiplexed output.

39. The process of claim 38 wherein a 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.

40. The process of claim 32 where digitized information from said transmitted signal is compared to digitized information from said pre-established model in a computer.

41. The process of claim 32 wherein said pre-established model comprises historic data obtained from the previous passage of a radio signal transmitting capsule through said alimentary canal.

42. The process of claim 32 wherein said pre-established model comprises digitized information having parameters comprising one of a rate of progress of said capsule through said canal, length of time of said capsule in said canal or normalized model.

43. The process of claim 32 wherein sampling of said fluid initiates a sampling indicator signal, by sampling indicator means comprised in said capsule, which is detectable exterior of the body of said animal.

44. The process of claim 32 wherein said transmitted signal is received exterior of the animal body, digitized and provided to a computer.

45. The process of claim 44 wherein said pre-established model comprises digitized historic data obtained from the previous passage of a capsule through said alimentary canal.

46. The process of claim 44 wherein said pre-established model comprises one of a rate of progress of said capsule through said canal, length of time of said capsule in said canal or normalized model.

47. The process of claim 44 wherein said computer is programmed to scan and compute variations from pre-programmed factors.

48. The process of claim 44 wherein transmission of said activating signal is operator controlled.

49. The process of claim 44 wherein said computer is programmed to initiate an actuating signal to the fluid sampling means of the capsule.

50. The process of claim 49 wherein sampling of said fluid initiates a sampling indicator signal, by sampling indicator means comprised in said capsule, which is detectable exterior of the body of said animal.

51. The process of claim 50 wherein said computer is programmed to re-initiate an activating signal when a sampling indicator signal is not received from said capsule after an actuating signal has been initiated by said computer.

52. The process of claim 32 comprising two or more capsules in the alimentary canal transmitting differential signals.

53. The process of claim 32 wherein a first ingestible capsule, containing a signal transmitting means, is ingested into said alimentary canal;

a signal transmitted from said first capsule is received exterior of said body and digitized in a computer; and

digitized data from said signal transmitted from said first capsule comprises said pre-established model.

54. A process for the collection of data for the sampling of a fluid at a selected site in the alimentary canal of an animal comprising, providing an ingestible capsule containing a radio signal transmitting means suitable for determining location of said capsule;

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 receiving antennae;

storing said digitized signal in computer recoverable, time sequence memory.

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