System and method of evaluating a subject with an ingestible capsule

• US 20090318783A1
• Filed: 06/12/2009
• Published: 12/24/2009
• Est. Priority Date: 06/18/2008
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Covidien LP (Medtronic Plc)
• Inventors: BIERL, CHRISTOPHER D., ROHDE, BEMINA L., HWANG, KAI-SING J.
• Granted Patent: US 9,538,937 B2
• Time in Patent Office: Days
• US Class Current: 600/302
• CPC Class Codes: A61B 2562/0247 Pressure sensors
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/06 Devices, other than using radiation, for detecting or locating foreign bodies for removing same A61B17/50 ; determining position of probes within or on the body of the patient
• CPC Class Codes: A61B 5/061 Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body A61B1/00158 takes precedence
• CPC Class Codes: A61B 5/065 Determining position of the probe employing exclusively positioning means located on or in the probe, e.g. using position sensors arranged on the probe
• CPC Class Codes: A61B 5/066 Superposing sensor position on an image of the patient, e.g. obtained by ultrasound or x-ray imaging
• CPC Class Codes: A61B 5/073 Intestinal transmitters
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/411 Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
• CPC Class Codes: A61B 5/42 Detecting, measuring or recording for evaluating the gastrointestinal, the endocrine or the exocrine systems A61B1/00, A61B5/4857, A61B5/486, A61B5/4866, A61B5/4869 take precedence
• CPC Class Codes: A61B 5/6861 Capsules, e.g. for swallowing or implanting

Abstract

A computerized method of analyzing measurements obtained from the gastrointestinal tract of subject comprising the steps of providing an ingestible capsule (20) having a sensor (22, 23, 24) for measuring a parameter of the gastrointestinal tract of a subject, having a subject ingest (118) the capsule, recording (130) measurements from the sensor as the capsule passes through the gastrointestinal tract of the subject, transmitting (131, 122) the measurements to a processor (31), conditioning (132) the measurements to provide data as a function of a time interval, plotting (133) the data on a display (32), providing a query (205, 216, 234), on the display, receiving input (207, 218, 237) from a user in response to the query, setting a marker (50-53) on the plot (40) at a location as a function of the input, and determining (238) a capsule transit time for a selected portion of the gastrointestinal tract as a function of the location of the marker.

Claims

1. A computerized method of analyzing measurements obtained from the gastrointestinal tract of a subject comprising the steps of:

providing an ingestible capsule having a sensor for measuring a parameter of the gastrointestinal tract of a subject;

having a subject ingest said capsule;

recording measurements from said sensor as said capsule passes through said gastrointestinal tract of said subject;

transmitting said measurements to a processor;

conditioning said measurements to provide data as a function of a time interval;

plotting said data on a display;

providing a query on said display;

receiving input from a user in response to said query;

setting a marker on said plot at a location as a function of said input; and

determining a capsule transit time for a selected portion of said gastrointestinal tract as a function of said location of said marker.

2. The method set forth in claim 1, wherein said sensor is selected from a group consisting of a pH sensor, a pressure sensor and a temperature sensor.

3. The method set forth in claim 1, wherein said step of transmitting said measurements to a processor comprises the steps of:

transmitting said measurements from said capsule to a receiver; and

downloading said measurements from said receiver to said processor.

4. The method set forth in claim 1, wherein said step of conditioning said measurements to provide data as a function of a time interval comprises the steps of screening said measurements to verify that they are valid.

5. The method set forth in claim 1, wherein said plot is a graph.

6. The method set forth in claim 1, wherein said step of providing a query comprises the steps of showing a suggested marker on said plot at a location and seeking confirmation from said user that said suggested marker is at a desired location.

7. The method set forth in claim 6, wherein said input comprises confirmation by said user that said suggested marker is at said desired location.

8. The method set forth in claim 1, wherein said step of providing a query comprises the steps of showing a suggested marker on said plot at a location and prompting said user to move said suggested marker by way of an input device communicating with said processor.

9. The method set forth in claim 8, wherein said input comprises movement of said suggested marker by said user with said input device.

10. The method set forth in claim 1, wherein said step of providing a query comprises the step of prompting said user to position a marker at a desired location on said plot with an input device communicating with said processor.

11. The method set forth in claim 10, wherein said input comprises placement of said marker by said user with said input device.

12. The method set forth in claim 1, wherein said data is plotted in a first color and said marker is shown on said plot in a second color different from said first color.

13. The method set forth in claim 1, wherein said location of said marker on said plot corresponds to an event selected from a group consisting of ingestion, gastric emptying, colonic entry, and body exit.

14. The method set forth in claim 1, wherein said transit time is selected from a group consisting of gastric emptying time, small bowel transit time, colonic transit time, whole gut transit time, and oral caecal transit time.

15. The method set forth in claim 14, wherein said transit time is displayed on said display.

16. The method set forth in claim 1, and further comprising the step of comparing said transit time to a standard transit time.

17. The method set forth in claim 16, wherein a result of said comparison is displayed on said display.

18. The method set forth in claim 1, and further comprising the step of comparing said data to a standard.

19. The method set forth in claim 18, wherein said standard is selected from a group consisting of stomach pH, pH rise from stomach to small bowel, pressure in a portion of said gastrointestinal tract, and a temperature fluctuation.

20. The method set forth in claim 1, and further comprising the steps of:

recording an event associated with said subject during transit of said capsule;

correlating said event with said data; and

notating said event on said plot.

21. The method set forth in claim 20, wherein said event is selected from a group consisting of said subject ingesting said capsule, ingesting food, ingesting liquid, experiencing pain, experiencing nausea, experiencing gas, experiencing bloating, exercising, moving actively, vomiting, resting, waking up, and experiencing a bowel movement.

22. The method set forth in claim 1, and further comprising the step of entering a notation or comments associated with said plot.

23. A computer-readable medium having computer-executable instructions for performing a method comprising:

receiving measurements of a parameter of a gastrointestinal tract of a subject recorded by a sensor on an ingestible capsule ingested by said subject;

conditioning said measurements to provide data as a function of a time interval;

plotting said data on a display;

providing a query on said display;

receiving input from a user in response to said query;

setting a marker on said plot at a location as a function of said input; and

determining a capsule transit time for a selected portion of said gastrointestinal tract as a function of said location of said marker.

24. The medium set forth in claim 23, wherein said sensor is selected from a group consisting of a pH sensor, a pressure sensor and a temperature sensor.

25. The medium set forth in claim 23, wherein said conditioning said measurements to provide data as a function of a time interval comprises screening said measurements to verify that they are valid.

26. The medium set forth in claim 23, wherein said plot is a graph.

27. The medium set forth in claim 23, wherein said providing a query comprises showing a suggested marker on said plot at a location and seeking confirmation from said user that said suggested marker is at a desired location.

28. The medium set forth in claim 27, wherein said input comprises confirmation by said user that said suggested marker is at said desired location.

29. The medium set forth in claim 23, wherein said providing a query comprises showing a suggested marker on said plot at a location.

30. The medium set forth in claim 29, wherein said input comprises movement of said suggested marker by said user with said input device.

31. The medium set forth in claim 23, wherein said providing a query comprises prompting said user to position a marker at a desired location on said plot with an input device.

32. The medium set forth in claim 23, wherein said data is plotted in a first color and said marker is shown on said plot in a second color different from said first color.

33. The medium set forth in claim 23, wherein said location of said marker on said plot corresponds to an event selected from a group consisting of ingestion, gastric emptying, colonic entry, and body exit.

34. The medium set forth in claim 23, wherein said transit time is selected from a group consisting of gastric emptying time, small bowel transit time, colonic transit time, whole gut transit time, and oral caecal transit time.

35. The medium set forth in claim 34, wherein said transit time is displayed on said display.

36. The medium set forth in claim 23, and further comprising comparing said transit time to a standard transit time.

37. The medium set forth in claim 36, wherein a result of said comparison is displayed on said display.

38. The medium set forth in claim 23, and further comprising comparing said data to a standard.

39. The medium set forth in claim 38, wherein said standard is selected from a group consisting of stomach pH, pH rise from stomach to small bowel, pressure in a portion of said gastrointestinal tract, and a temperature fluctuation.

40. The medium set forth in claim 23, and further comprising:

recording an event associated with said subject during transit of said capsule;

correlating said event with said data; and

notating said event on said plot.

41. The medium set forth in claim 40, wherein said event is selected from a group consisting of said subject ingesting said capsule, ingesting food, ingesting liquid, experiencing pain, experiencing nausea, experiencing gas, experiencing bloating, exercising, moving actively, vomiting, resting, waking up, and experiencing a bowel movement.

42. The medium set forth in claim 23, and further comprising entering a notation or comments associated with said plot.

43. A system for analyzing measurements obtained from the gastrointestinal tract of a subject comprising:

an ingestible capsule having a sensor adapted to record measurements as said capsule passes through at least a portion of a subject'"'"'s gastrointestinal tract;

a receiver adapted to receive said measurements when transmitted from said capsule;

a processor adapted to communicate with said receiver;

a display in communication with said processor;

an input device in communication with said processor;

said processor programmed to;

receive said measurements;

condition said measurements to provide data as a function of a time interval;

plot said data on said display;

provide a query on said display;

receive input from said input device in response to said query;

set a marker on said plot at a location as a function of said input; and

determine a capsule transit time for a selected portion of said gastrointestinal tract as a function of said location of said marker.

44. The system set forth in claim 43, wherein said sensor is selected from a group consisting of a pH sensor, a pressure sensor and a temperature sensor.

45. The system set forth in claim 43, wherein said conditioning said measurements to provide data as a function of a time interval comprises screening said measurements to verify that they are valid.

46. The system set forth in claim 43, wherein said plot is a graph.

47. The system set forth in claim 43, wherein said providing a query comprises showing a suggested marker on said plot at a location and seeking confirmation that said suggested marker is at a desired location.

48. The system set forth in claim 47, wherein said input comprises confirmation that said suggested marker is at said desired location.

49. The system set forth in claim 43, wherein said providing a query comprises showing a suggested marker on said plot at a location.

50. The system set forth in claim 49, wherein said input comprises movement of said suggested marker with said input device.

51. The system set forth in claim 43, wherein said providing a query comprises allowing said user to position a marker at a desired location on said plot with said input device.

52. The system set forth in claim 43, wherein said data is plotted in a first color and said marker is shown on said plot in a second color different from said first color.

53. The system set forth in claim 43, wherein said location of said marker on said plot corresponds to an event selected from a group consisting of ingestion, gastric emptying, colonic entry, and body exit.

54. The system set forth in claim 43, wherein said transit time is selected from a group consisting of gastric emptying time, small bowel transit time, colonic transit time, whole gut transit time, and oral caecal transit time.

55. The system set forth in claim 54, wherein said processor is programmed to display said transit time on said display.

56. The system set forth in claim 43, wherein said processor is programmed to compare said transit time to a standard transit time.

57. The system set forth in claim 56, wherein said processor is programmed to display a result of said comparison on said display.

58. The system set forth in claim 43, wherein said processor is programmed to compare said data to a standard.

59. The system set forth in claim 58, wherein said standard is selected from a group consisting of stomach pH, pH rise from stomach to small bowel, pressure in a portion of said gastrointestinal tract, and a temperature fluctuation.

60. The system set forth in claim 43, wherein said processor is programmed to:

record an event associated with said subject during transit of said capsule;

correlate said event with said data; and

notate said event on said plot.

61. The system set forth in claim 60, wherein said event is selected from a group consisting of said subject ingesting said capsule, ingesting food, ingesting liquid, experiencing pain, experiencing nausea, experiencing gas, experiencing bloating, exercising, moving actively, vomiting, resting, waking up, and experiencing a bowel movement.

62. The system set forth in claim 43, wherein said processor is programmed to receive from said input device and display a notation or comment associated with said plot.