Capsule and method for treating or diagnosing conditions or diseases of the intestinal tract

• US 20040162501A1
• Filed: 12/22/2003
• Published: 08/19/2004
• Est. Priority Date: 06/26/2001
• Status: Active Grant

• Current Assignee: Entrack, Inc.
• Original Assignee: Entrack, Inc.
• Inventors: Imran, Mir A.
• Granted Patent: US 8,005,536 B2
• Time in Patent Office: Days
• US Class Current: 600/547
• CPC Class Codes: A61B 1/00016 using wireless means
• CPC Class Codes: A61B 1/00082 Balloons
• CPC Class Codes: A61B 1/041 Capsule endoscopes for imaging
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 2018/00482 Digestive system
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00642 with feedback, i.e. closed loop control
• CPC Class Codes: A61B 2018/00702 Power or energy
• CPC Class Codes: A61B 2018/00821 measured by a thermocouple
• CPC Class Codes: A61B 2562/162 Capsule shaped sensor housings, e.g. for swallowing or implantation
• CPC Class Codes: A61B 5/002 Monitoring the patient using a local or closed circuit, e.g. in a room or building A61B5/0017 takes precedence
• CPC Class Codes: A61B 5/0084 for introduction into the body, e.g. by catheters A61B5/1459 takes precedence
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/036 by means introduced into body tracts A61B5/032 and A61B5/035 take precedence
• CPC Class Codes: A61B 5/0538 invasively, e.g. using a catheter
• 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 5/073 Intestinal transmitters
• CPC Class Codes: A61B 5/11 Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb for measuring pulse A61B5/02 ;A61B5/1038 takes precedence; motion detection to correct for motion artifacts in physiological signals A61B5/721
• CPC Class Codes: A61B 5/14503 : invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/14539 : for measuring pH
• CPC Class Codes: A61B 5/1459 : invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• 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 5/4233 : oesophagus
• CPC Class Codes: A61B 5/4255 : Intestines, colon or appendix
• CPC Class Codes: A61B 5/4839 : combined with drug delivery
• CPC Class Codes: A61B 5/6801 : specially adapted to be attached to or worn on the body surface
• CPC Class Codes: A61B 5/6873 : Intestine
• 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
• CPC Class Codes: A61M 5/172 : electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: A61M 5/1723 : using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61N 1/36007 : of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/37205 : Microstimulators, e.g. implantable through a cannula

Abstract

A device and method for mapping, diagnosing and treating inflammatory disorders (such as Crohn'"'"'s disease) or other diseases, disorders or conditions of the intestinal tract is provided using a capsule passing through the intestinal tract. Further, a capsule tracking system is provided for tracking a capsule'"'"'s location along the length of an intestinal tract as various treatment and/or sensing modalities are employed. In one variation, an acoustic signal is used to determine the location of the capsule. A map of sensed impedance and or temperature may be derived from the pass of a capsule to diagnose the disorder or disease. The capsule or subsequently passed capsules may treat, further diagnose or mark the intestinal tract at a determined location along its length.

Claims

1. A system for diagnosing a gastrointestinal disorder comprising:

an autonomous capsule sized to pass through the intestinal tract of a patient, the capsule comprising an impedance sensor configured to sense a first impedance at a first impedance location within the intestinal tract and a second impedance at a second impedance location within the intestinal tract;

a processor coupled to the impedance sensor to receive a signal representative of an impedance sensed by the impedance sensor, wherein the processor is configured to determine a change in impedance between the first impedance location and the second impedance location.

2. The system of claim 1 wherein the capsule further comprises a temperature sensor configured to sense a first temperature at the first temperature location and a second temperature at the second temperature location;

and wherein the processor is coupled to the temperature sensor to receive a signal representative of a temperature sensed by the temperature sensor, wherein the processor is configured to determine a change in temperature between the first location and the second location.

3. The system of claim 1 further comprising:

a capsule tracking system configured to track location of the capsule within an intestinal tract.

4. The system of claim 3 wherein the capsule tracking system is configured to track location of the capsule within a three-dimensional coordinate system.

5. The system of claim 4 wherein the processor is coupled to the capsule tracking system to receive information on the location of the capsule within the intestinal tract, and

wherein the processor is arranged to identify a location of a sensed impedance within the portion of the intestinal tract.

6. The system of claim 3 wherein the capsule tracking system is configured to track location of the capsule along a length of a portion of the intestinal tract.

7. The system of claim 6 wherein the processor is coupled to the capsule tracking system to receive information on the location of the capsule within the intestinal tract, and

wherein the processor is arranged to identify a location of a sensed impedance along a length of the portion of the intestinal tract.

8. The system of claim 6 further comprising a mapping element configured to map locations of the capsule along the length of the portion of the intestinal tract with respect to impedances sensed by the impedance sensor at corresponding locations along the length of the portion of the intestinal tract.

9. The system of claim 8 further comprising:

a display coupled to the processor, the display being configured to display a diagnostic map of sensed impedance of the intestinal tract along the length of the portion of the intestinal tract.

10. The system of claim 6 wherein the capsule tracking system is arranged to determine capsule location along the length the portion of the intestinal tract, from a determination of a plurality of locations of the capsule as the capsule passes through the portion of the intestinal tract.

11. The system of claim 3 wherein the capsule tracking system comprises:

an acoustic transducer transmitter and an acoustic transducer receiver,

wherein the acoustic transmitter is arranged to transmit a tracking signal from the acoustic transmitter to the acoustic receiver, between the autonomous capsule and a location external to a patient'"'"'s body, and

wherein in use, the acoustic transmitter is located at one of the autonomous capsule and the location external the patient'"'"'s body and the acoustic receiver is located at the other of the autonomous capsule and the location external the patient'"'"'s body.

12. The system of claim 3 wherein:

the capsule tracking system comprises;

a plurality of acoustic transducers at the capsule, each of the plurality of acoustic transducers being arranged to emit an acoustic signal detectable externally of a patient'"'"'s body as the capsule passes through at least a portion of the intestinal tract; and

at least one external acoustic receiver configured to sense the acoustic signal transmitted by the capsule,

wherein the acoustic signal of each of the plurality of acoustic transducers provides information from which the location of the capsule may be derived.

13. The system of claim 1 wherein the capsule further comprises:

a telemetry device arranged to transmit a telemetry signal corresponding to the impedance sensed by the impedance sensor, and a telemetry receiver for receiving the telemetry signal.

14. The system of claim 13 wherein the processor is located in an external device coupled to the telemetry receiver.

15. The system of claim 1 wherein the system comprises a capsule have a marking mechanism configured to mark an identified location of a disorder within the intestinal tract.

16. The system of claim 1 wherein the marking mechanism comprises a dye release mechanism.

17. The system of claim 1 wherein the marking mechanism comprises a position anchoring mechanism.

18. A system for diagnosing an inflammatory gastrointestinal disorder comprising:

an autonomous capsule sized to pass through the intestinal tract of a patient, the capsule comprising a temperature sensor configured to sense a first temperature at a first temperature location within the intestinal tract and a second temperature at a second temperature location within the intestinal tract;

a processor coupled to the temperature sensor to receive a signal representative of a temperature sensed by the temperature sensor, wherein the processor is configured to determine a change in temperature between the first location and the second location.

19. The system of claim 18 further comprising:

a capsule tracking system configured to track location of the capsule within an intestinal tract.

20. The system of claim 19 wherein the capsule tracking system is configured to track location of the capsule within a three dimensional coordinate system.

21. The system of claim 20 wherein the processor is coupled to the capsule tracking system to receive information on the location of the capsule within the intestinal tract, and

wherein the processor is arranged to identify a location of a sensed temperature within the portion of the intestinal tract.

22. The system of claim 19 wherein the capsule tracking system is configured to track location of the capsule along a length of a portion of the intestinal tract.

23. The system of claim 22 wherein the processor is coupled to the capsule tracking system to receive information on the location of the capsule within the intestinal tract, and

wherein the processor is arranged to identify the location of the sensed temperature along a length of the portion of the intestinal tract.

24. The system of claim 22 further comprising a mapping element configured to map locations of the capsule along the length of the portion of the intestinal tract with respect to impedances sensed by the impedance sensor at corresponding locations along the length of the portion of the intestinal tract.

25. The system of claim 24 further comprising:

a display coupled to the processor, the display being configured to display a diagnostic map of sensed impedance of the intestinal tract along the length of the portion of the intestinal tract.

26. The system of claim 19 wherein the capsule tracking system is arranged to determine capsule location along the length of the portion of the intestinal tract, from a determination of a plurality of locations of the capsule as the capsule passes through the portion of the intestinal tract.

27. The system of claim 19 wherein the capsule tracking system comprises:

an acoustic transducer transmitter and an acoustic transducer receiver,

wherein the acoustic transmitter is arranged to transmit a tracking signal from the acoustic transmitter to the acoustic receiver, between the autonomous capsule and a location external to a patient'"'"'s body, and

wherein in use, the acoustic transmitter is located at one of the autonomous capsule and the location external the patient'"'"'s body and the acoustic receiver is located at the other of the autonomous capsule and the location external the patient'"'"'s body.

28. The system of claim 19 wherein:

the capsule tracking system comprises;

a plurality of acoustic transducers at the capsule, each of the plurality of acoustic transducers being arranged to emit an acoustic signal detectable externally of a patient'"'"'s body as the capsule passes through at least a portion of the intestinal tract; and

at least one external acoustic receiver configured to sense the acoustic signal transmitted by the capsule,

wherein the acoustic signal of each of the plurality of acoustic transducers provides information from which the location of the capsule may be derived.

29. The system of claim 18 wherein the capsule further comprises:

a telemetry device arranged to transmit a telemetry signal corresponding to the temperature sensed by the temperature sensor, and a telemetry receiver for receiving the telemetry signal.

30. The system of claim 18 wherein the processor is located in an external device coupled to the telemetry receiver.

31. The system of claim 18 wherein the system comprises a capsule have a marking mechanism configured to mark an identified location of a disorder within the intestinal tract.

32. The system of claim 18 wherein the marking mechanism comprises a dye release mechanism.

33. The system of claim 18 wherein the marking mechanism comprises a position anchoring mechanism.

34. A system for diagnosing an inflammatory gastrointestinal disorder comprising:

a capsule tracking system configured to track the location of a capsule within an intestinal tract;

an autonomous capsule comprising a temperature sensor configured to sense a first temperature at a first temperature location within the intestinal tract and a second temperature at a second temperature location within the intestinal tract; and

an impedance sensor configured to sense a first impedance at a first impedance location and a second impedance at a second impedance location;

a processor coupled to the temperature sensor to receive a signal representative of a temperature sensed by the temperature sensor, and coupled to the impedance sensor to receive a signal representative of an impedance sensed by the impedance sensor, wherein the processor is coupled to the capsule tracking system, and wherein the processor is configured to determine a change in temperature between the first temperature location and the second temperature location, and a change in impedance between the first impedance location and the second impedance location.

35. The system of claim 34 wherein the processor is configured to diagnose a likelihood Crohn'"'"'s disease.

36. A system for treating or diagnosing the intestinal tract of a patient comprising:

capsule means for moving through a portion of an intestinal tract;

means for determining location of the capsule means within a portion of the intestinal tract;

impedance sensing means for sensing impedance of the intestinal tract;

tracking means for tracking the capsule means at a plurality of locations and for tracking sensed impedance at the plurality of locations; and

a processing means for determining a change in impedance within the portion of the intestinal tract.

37. The system of claim 36 wherein the means for determining location of the capsule means comprises an acoustic means for determining location.

38. The system of claim 36 wherein the means for determining location of the capsule means comprises means for determining location of the capsule means along a length of the portion of the intestinal tract.

39. The system of claim 36 further comprising:

temperature sensing means for sensing temperature of the intestinal tract, wherein the tracking means further comprises means for tracking temperature at a plurality of locations, and wherein the processing means comprises means for determining a change in temperature within the portion of the intestinal tract.

45. The method for diagnosing an inflammatory gastrointestinal disorder of claim 37 further comprising the steps of:

providing an autonomous capsule comprising a temperature sensor;

sensing with the temperature sensor, a temperature of a portion of a gastrointestinal tract at a first temperature location along a length of the gastrointestinal tract;

sensing with the temperature sensor, a temperature of a portion of a gastrointestinal tract at a second temperature location along a length of the gastrointestinal tract; and

determining whether the temperature at the first temperature location is different from the temperature at the second temperature location by a predetermined difference.

46. The method of claim 45 further comprising the steps of:

sensing the impedance at a plurality of impedance locations along a length of a portion of the inner wall of a gastrointestinal tract;

mapping sensed impedance with respect to each of the plurality of impedance locations along the length of the gastrointestinal tract;

sensing the temperature at a plurality of temperature locations along a length of a portion of the inner wall of a gastrointestinal tract; and

mapping sensed temperature with respect to each of the plurality of temperature locations along the length of the gastrointestinal tract.

40. A system for treating or diagnosing the intestinal tract of a patient comprising:

capsule means for moving through a portion of an intestinal tract;

means for determining location of the capsule means within a portion of the intestinal tract;

temperature sensing means for sensing impedance of the intestinal tract;

tracking means for tracking the capsule means at a plurality of locations and for tracking sensed temperature at the plurality of locations; and

a processing means for determining a change in temperature within the portion of the intestinal tract.

41. The system of claim 40 wherein the means for determining location of the capsule means comprises an acoustic means for determining location.

42. The system of claim 40 wherein the means for determining location of the capsule means comprises means for determining location of the capsule means along a length of the portion of the intestinal tract.

43. A method for diagnosing an inflammatory gastrointestinal disorder comprising the steps of:

providing an autonomous capsule comprising an impedance sensor;

sensing with the impedance sensor, an impedance of a portion of a gastrointestinal tract at a first impedance location along a length of the gastrointestinal tract

sensing with the impedance sensor, an impedance of a portion of a gastrointestinal tract at a second impedance location along a length of the gastrointestinal tract; and

determining whether the impedance at the first impedance location is different from the impedance at the second impedance location by a predetermined difference.

44. The method of claim 43 further comprising the steps of:

sensing the impedance at a plurality of locations along a length of a portion of the inner wall of a gastrointestinal tract; and

mapping sensed impedance with respect to each of the plurality of locations along the length of the gastrointestinal tract.

48. A method for diagnosing an inflammatory gastrointestinal disorder comprising the steps of:

providing an autonomous capsule comprising a temperature sensor;

sensing with the temperature sensor, a temperature of a portion of a gastrointestinal tract at a first temperature location along a length of the gastrointestinal tract

sensing with the temperature sensor, a temperature of a portion of a gastrointestinal tract at a second temperature location along a length of the gastrointestinal tract; and

determining whether the temperature at the first temperature location is different from the temperature at the second temperature location by a predetermined difference.

49. The method of claim 48 further comprising the steps of:

sensing the temperature at a plurality of locations along a length of a portion of the inner wall of a gastrointestinal tract; and

mapping sensed temperature with respect to each of the plurality of locations along the length of the gastrointestinal tract.