System and method of evaluating a subject with an ingestible capsule

• US 9,538,937 B2
• Filed: 06/12/2009
• Issued: 01/10/2017
• 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., Hwang, Kai-Sing J., Rohde, Bemina L.
• Primary Examiner(s): Natnithithadha, Navin
• Assistant Examiner(s): BLOCH, MICHAEL RYAN
• Application Number:
  US12/456,151
• Publication Number:
  US 20090318783A1
• Time in Patent Office: 2,769 Days
• Field of Search: 600/302
• US Class Current: 1/1
• 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 (207a or 207b, 218a or 218b, 237a or 237b) 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 method for determining a capsule transit time in the gastrointestinal tract comprising:

recording sensor measurements from an ingested capsule comprising at least one sensor, wherein said at least one sensor is selected from a pH sensor, a pressure sensor and a temperature sensor, as said capsule passes through said gastrointestinal tract, wherein said sensor measurements are related to a parameter of said gastrointestinal tract;

transmitting said measurements to a processor, and using said processor to;

condition said sensor measurements to provide sensor data, the sensor data including at least a pH data, a pressure data and/or a temperature data;

establish a baseline body temperature by determining an average body temperature of the temperature data;

define a physical swallow of the capsule as a pH minimum located between a beginning of the pH data and a boundary point, the boundary point being a maximum pH value located in pH data after a potential stomach entry point, the potential stomach entry point being a pH data point corresponding to a temperature data point at or above the baseline body temperature;

plot said sensor data on a display as a function of time to produce a plot representing the gastrointestinal tract parameter;

provide a suggested marker on said plot at a location identifying a gastrointestinal transition time;

receive input from a user in response to a query regarding the location of the suggested marker on said plot;

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

determine a capsule transit time in said gastrointestinal tract as a function of the location of said suggested marker as set on said plot.

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

transmitting said sensor measurements from said capsule to a receiver; and

downloading said sensor measurements from said receiver to said processor.

3. The method set forth in claim 1, wherein said step of conditioning said measurements to provide sensor data comprises steps of screening said sensor measurements to verify they are valid.

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

5. The method set forth in claim 1, wherein said step of providing a suggested marker comprises steps seeking confirmation from said user that said suggested marker is at a desired location.

6. The method set forth in claim 5, wherein said input comprises confirmation by said user that said suggested marker is at said desired location.

7. The method set forth in claim 1, wherein said step of providing a suggested marker comprises steps prompting said user to move said suggested marker by way of an input device communicating with said processor.

8. The method set forth in claim 7, wherein said input comprises movement of said suggested marker by said user with said input device.

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

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

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

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

13. 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.

14. The method set forth in claim 13, wherein said transit time is displayed on said display.

15. The method set forth in claim 1, and further comprising a step of using said processor to compare said transit time to a standard transit time.

16. The method set forth in claim 15, wherein a result of said compare step is displayed on said display.

17. The method set forth in claim 1, and further comprising a step of using said processor to compare said sensor data to a standard.

18. The method set forth in claim 17, 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.

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

using a receiver to record an event associated with said subject during transit of said capsule;

using said processor to correlate said event with said sensor data; and

using said processor to notate said event on said plot.

20. The method set forth in claim 19, 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.

21. The method set forth in claim 1, and further comprising a step of using said processor to receive a notation or comments associated with said plot.

22. The method set forth in claim 1, further comprising using said processor to define a final stomach entry point as a pH minimum located between the potential stomach entry point and the boundary point.

23. The method set forth in claim 1, further comprising using said processor to filter the pH data.

24. The method set forth in claim 23, further comprising using said processor to detect gastric emptying, wherein, after filtering the pH data:

detect a stomach-bowel transition point by traversing a pH data set from an end of the pH data to a beginning of the pH data to locate a demarcation between sustained pH values of a bowel area and a spike that immediately follows gastric emptying;

analyze the pH data from a post-emptying spike to a next sustained low pH reading for sustained drop in pH slope;

use a beginning point of the sustained drop as a point of gastric emptying; and

wherein said provide a suggested marker on said plot at a location includes providing said suggested marker at the point of gastric emptying.

25. A non-transitory computer-readable medium encoded with computer-executable instructions for performing a method comprising:

receiving measurements related to a gastrointestinal tract parameter of a subject recorded by at least one sensor, wherein said sensor is selected from a pH sensor, a pressure sensor and a temperature sensor, on a capsule ingested by said subject;

conditioning said measurements to provide sensor data, the sensor data including at least a pH data, a pressure data and/or a temperature data;

establishing a baseline body temperature by determining an average body temperature of the temperature data;

defining a physical swallow of the capsule as a pH minimum located between a beginning of the pH data and a boundary point, the boundary point being a maximum pH value located in pH data after a potential stomach entry point, the potential stomach entry point being a pH data point corresponding to a temperature data point at or above the baseline body temperature;

plotting said sensor data on a display as a function of time to produce a plot representing the gastrointestinal tract parameter;

providing a suggested marker on said plot at a location identifying a gastrointestinal transition time;

receiving, via an input device, input from a user in response to a query regarding the location of the suggested marker on said plot;

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

determining a capsule transit time in said gastrointestinal tract as a function of the location of said suggested marker as set on said plot.

26. The non-transitory computer readable medium set forth in claim 25, wherein said condition said measurements to provide sensor data comprises screening said measurements to verify that they are valid.

27. The non-transitory computer readable medium set forth in claim 25, wherein said plot is a graph.

28. The non-transitory computer readable medium set forth in claim 25, wherein said providing a suggested marker compresses seeking confirmation from said user that said suggested marker is at a desired location.

29. The non-transitory computer readable medium set forth in claim 28, wherein said input comprises confirmation by said user that said suggested marker is at said desired location.

30. The non-transitory computer readable medium set forth in claim 25, wherein said input comprises movement of said suggested marker by said user with said input device.

31. The non-transitory computer readable medium set forth in claim 25, wherein said providing a suggested marker comprises prompting said user to position the suggested marker at a desired location on said plot with said input device.

32. The non-transitory computer readable medium set forth in claim 25, wherein said sensor data is shown in a first color on said plot and said marker is shown on said plot in a second color different from said first color.

33. The non-transitory computer readable medium set forth in claim 25, wherein said location of said marker on said plot corresponds to a gastrointestinal event selected from a group consisting of ingestion, gastric emptying, colonic entry, and body exit.

34. The non-transitory computer readable medium set forth in claim 25, 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 non-transitory computer readable medium set forth in claim 34, wherein said transit time is displayed on said display.

36. The non-transitory computer readable medium set forth in claim 25, and further comprising comparing said transit time to a standard transit time.

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

38. The non-transitory computer readable medium set forth in claim 25, and further comprising comparing said sensor data to a standard.

39. The non-transitory computer readable 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 non-transitory computer readable medium set forth in claim 25, and further comprising receiving a recorded event associated with said subject during transit of said capsule via a receiver, correlating said event with said sensor data;

and notating said event on said plot.

41. The non-transitory computer readable 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 non-transitory computer readable medium set forth in claim 25, and further comprising entering a notation or comments associated with said plot.

43. The non-transitory computer readable medium set forth in claim 25, wherein the computer-executable instructions further comprise defining a final stomach entry point as a pH minimum located between the potential stomach entry point and the boundary point.

44. The non-transitory computer readable medium set forth in claim 25, wherein the computer executable instructions further comprise filtering the pH data.

45. The non-transitory computer readable medium set forth in claim 44, wherein the computer-executable instructions further comprise detecting gastric emptying, after filtering the pH data, by:

detecting a stomach-bowel transition point by traversing a pH data set from an end of the pH data to a beginning of the pH data to locate a demarcation between sustained pH values of a bowel area and a spike that immediately follows gastric emptying;

analyzing the pH data from a post-emptying spike to a next sustained low pH reading for a sustained drop in pH slope; and

using a beginning point of the sustained drop as a point of gastric emptying;

wherein said providing a suggested marker on said plot at a location includes providing said suggested marker at the point of gastric emptying.

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

an ingestible capsule having at least one sensor, wherein said at least one sensor is selected from a pH sensor, a pressure sensor and a temperature sensor, for recording measurements as said capsule passes through at least a portion of said subject'"'"'s gastrointestinal tract, said measurements are related to a parameter of the 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 sensor data, the sensor data including at least a pH data, a pressure data and/or a temperature data;

establish a baseline body temperature by determining an average body temperature of the temperature data;

define a physical swallow of the capsule as a pH minimum located between a beginning of the pH data and a boundary point, the boundary point being a maximum pH value located in pH data after a potential stomach entry point, the potential stomach entry point being a pH data point corresponding to a temperature data point at or above the baseline body temperature;

plot said sensor data on said display as a function of time to produce a plot representing the gastrointestinal tract parameter;

provide a suggested marker on said plot at a location identifying a gastrointestinal transition time;

receive input from said input device in response to a query regarding the location of the suggested marker on said plot;

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

determine a capsule transit time in said gastrointestinal tract as a function of the location of said suggested marker as set on said plot.

47. The system set forth in claim 46, wherein said conditioning said measurements to provide sensor data comprises screening said measurements to verify that they are valid.

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

49. The system set forth in claim 46, wherein said providing a suggested marker comprises seeking confirmation that said suggested marker is at a desired location.

50. The system set forth in claim 49, wherein said input comprises confirmation that said suggested marker is at said desired location.

51. The system set forth in claim 46, wherein said input comprises movement of said suggested marker with said input device.

52. The system set forth in claim 46, wherein said providing a suggested marker comprises allowing a user to position the suggested marker at a desired location on said plot with said input device.

53. The system set forth in claim 46, wherein said sensor data is shown in a first color on said plot and said marker is shown on said plot in a second color different from said first color.

54. The system set forth in claim 46, wherein said location of said suggested marker on said plot corresponds to a gastrointestinal event selected from a group consisting of ingestion gastric emptying, colonic entry, and body exit.

55. The system set forth in claim 46, 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.

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

57. The system set forth in claim 46, wherein said processor is programmed to compare said transit time to a standard transit time.

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

59. The system set forth in claim 46, wherein said processor is programmed to compare said sensor data to a standard.

60. The system set forth in claim 59, 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.

61. The system set forth in claim 46, wherein said processor is programmed to:

receive a recorded event associated with said subject during transit of said capsule via the receiver;

correlate said event with said sensor data; and

notate said event on said plot.

62. The system set forth in claim 61, 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.

63. The system set forth in claim 46, wherein said processor is programmed to receive from said input device and display a notation or comment associated with said plot.

64. The system set forth in claim 46, wherein the processor is further configured to define a final stomach entry point as a pH minimum located between the potential stomach entry point and the boundary point.

65. The system set forth in claim 46, wherein the processor is further configured to filter the pH data.

66. The system set forth in claim 65, wherein the processor is further configured to detect gastric emptying, wherein, after filtering the pH data, the processor is further configured to:

detect a stomach-bowel transition point by traversing a pH data set from an end of the pH data to a beginning of the pH data to locate a demarcation between sustained pH values of a bowel area and a spike that immediately follows gastric emptying;

analyze the pH data from a post-emptying spike to a next sustained low pH reading for a sustained drop in pH slope; and

use a beginning point of the sustained drop as a point of gastric emptying;

wherein said provide a suggested marker on said plot at a location includes to provide said suggested marker at the point of gastric emptying.