Capsule and method for treating or diagnosing the intestinal tract

• US 7,160,258 B2
• Filed: 06/26/2001
• Issued: 01/09/2007
• Est. Priority Date: 06/26/2001
• Status: Active Grant

• Current Assignee: Entrack, Inc.
• Original Assignee: Entrack, Inc.
• Inventors: Layman, Ted W., Lake, Sharon L., Colliou, Olivier K., Hughes, Timothy J., Imran, Mir A., TenHoff, Harm
• Primary Examiner(s): Hindenburg; Max F.
• Assistant Examiner(s): SZMAL, BRIAN SCOTT
• Application Number:
  US09/892,404
• Publication Number:
  US 20020198470A1
• Time in Patent Office: 2,023 Days
• Field of Search: 600/593, 600/587, 600/586, 600/561, 600/546, 600/547, 600/549, 600/407, 600/424, 600/459, 600/25, 600/437, 600/472, 600/101, 600/109, 600/117, 600/160, 600/438, 601/2, 601/46, 601/47, 601/55, 292/355, 381/150, 381/166, 594/0
• US Class Current: 600/593
• 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 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 information may be derived from the pass of a capsule. Capsules may be subsequently passed through to treat the intestinal tract at a determined location along its length. One variation uses an electrical stimulation capsule to treat and/or diagnose a condition in the intestinal tract.

Claims

1. A system for treating or diagnosing the intestinal tract comprising:

an autonomous capsule comprising an acoustic transducer, the transducer 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;

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

a reference generator arranged to generate a time reference from which the time of the acoustic signal generation is determined.

2. The system of claim 1 wherein the system comprises a plurality of external acoustic receivers configured to sense the acoustic signal transmitted by the capsule.

3. The system of claim 1 wherein the reference is a trigger signal arranged to trigger generation of the acoustic signal.

4. The system of claim 1 wherein the capsule comprises a plurality of acoustic transducers, each of the plurality of transducer being arranged to emit an acoustic signal detectable by the at least one acoustic receiver as the capsule passes through at least a portion of the intestinal tract, to provide information from which the orientation of the capsule may be derived.

5. The system of claim 1 wherein the at least one external acoustic receiver comprises a transducer for converting the acoustic signal to a representative electrical signal and an output for communicating the electrical signal.

6. The system of claim 5 further comprising:

a processor configured to communicate with the output of the at least one acoustic receiver, wherein the processor is arranged to determine location of the capsule on a coordinate system based at least in part on the electrical signal of the at least one acoustic receiver.

7. The system of claim 6 wherein the reference generator arranged to generate a reference signal at a predetermined time interval from transmission of the acoustic signal and at least one external reference signal receiver,

wherein the at least one external reference receiver is arranged to receive the reference signal and communicate the reference signal to the processor,

wherein the processor is arranged to use the reference signal to determine transmission time of the acoustic signal from the capsule to the at least one acoustic receiver and to determine the location of the capsule on the coordinate system.

8. The system of claim 7 wherein the reference signal generator is an RF telemetry device.

9. The system of claim 6 wherein the processor comprises a tracking system arranged to determine a location of the capsule along a length of the portion of the intestinal tract.

10. The system of claim 9 wherein the location along the length is based on the 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 1 wherein the capsule further comprises a sensor for sensing a characteristic of the intestinal tract adjacent the location of the capsule within the portion of the intestinal tract.

12. The system of claim 11 wherein the sensor comprises an electrode and wherein the characteristic comprises an electrical parameter of the intestinal tract.

13. The system of claim 12 wherein the electrical parameter comprises electrical impedance of an intestinal wall.

14. The system of claim 12 wherein the electrical parameter comprises an electrical potential over at least a portion of an intestinal wall.

15. The system of claim 14 wherein the electrical potential comprises a pacesetter potential.

16. The system of claim 14 wherein the electrical potential comprises inherent spike bursts.

17. The system of claim 14 wherein the electrical potential comprises an induced pacesetter potential.

18. The system of claim 14 wherein the electrical potential comprises an induced spike burst.

19. The system of claim 11 wherein the sensor comprises a pressure sensor.

20. The system of claim 11 wherein the sensor comprises an optical sensor.

21. The system of claim 11 wherein the sensor comprises a pH sensor.

22. The system of claim 11 wherein the sensor comprises a strain gauge.

23. The system of claim 22 wherein the strain gauge is arranged to measure contractile force.

24. The system of claim 16 wherein the sensor comprises a temperature sensing device.

25. The system of claim 11 wherein the sensor comprises a chemical sensor arranged to sense the presence of a chemical.

26. The system of claim 1 further comprising a sampling device for obtaining a sample from the intestinal tract.

27. The system of claim 11 wherein the capsule further comprises a telemetry circuit for transmitting a signal corresponding to the characteristic sensed by the sensor.

28. The system of claim 27 further comprising a telemetry receiver for receiving the telemetry signal.

29. The system of claim 28 wherein the telemetry receiver is coupled to the processor and wherein the processor is arranged to identify the location of the sensed characteristic within the portion of the intestinal tract.

30. The system of claim 29 wherein the processor is arranged to identify the location of the sensed characteristic along a length of the portion of the intestinal tract.

31. The system of claim 1 wherein the capsule comprises a treatment device for providing treatment to the intestinal tract.

32. The system of claim 31 wherein the treatment device comprises a therapeutic agent delivery device.

33. The system of claim 31 wherein the treatment device comprises an electrically stimulating electrode.

34. The system of claim 31 wherein the treatment device comprises a marker for identifying a location.

35. The system of claim 9 further comprising a second capsule wherein the second capsule comprises:

a treatment device for providing treatment to the intestinal tract.

36. The system of claim 35 wherein the second capsule further comprises:

a second acoustic transducer, the second acoustic transducer being arranged to emit a second acoustic signal detectable externally of a patient'"'"'s body as the second capsule passes through at least a portion of the intestinal tract.

37. The system of claim 36

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

wherein the at least one external acoustic receiver comprises a transducer configured to convert the second acoustic signal transmitted by the second capsule to a second representative electrical signal, and a second output configured to communicate the second representative electrical signal to the processor;

and

wherein the processor is arranged to determine a location of the second capsule along the length of the portion of the intestinal tract.

38. The system of claim 37 wherein the second capsule comprises a second telemetry device operatively coupled to the treatment device, and

wherein the processor is configured to control an external telemetry transmitter to transmit a control signal to the second capsule, the control signal being received by the telemetry device, wherein the control signal causes the treatment device to provide treatment to the intestinal tract at a selected location along the length of the portion of the intestinal tract.

39. A system for treating or diagnosing the intestinal tract comprising:

an autonomous capsule comprising an acoustic transducer, the transducer 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

a reference signal generator arranged to generate a signal from which the time of the acoustic signal generation is determined.

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

first capsule means for passing through the intestinal tract of a patient;

means for tracking the first capsule means, the means for tracking located external to the patient'"'"'s body;

an acoustic signal means for transmitting a signal between the first capsule means as it is passing through the intestinal tract of a patient, and the means for tracking; and

a location determining means for determining the location of the first capsule on a coordinate system, wherein the location determining means comprises a time differential means for determining the transmission time of the acoustic signal means between the external means and the capsule means.

41. The system of claim 40 wherein the location determining means comprises a reference means for determining the time of origin of the acoustic signal means.

42. The system of claim 40 wherein the location determining means is configured to determine at least one location of the first capsule means at a location along the length of a portion of an intestinal tract.

43. The system of claim 42 further comprising second capsule means for passing through the intestinal tract and means for tracking the second capsule means along the length of the portion of the intestinal tract at at least one tracked location, wherein the means for tracking the second capsule means includes means for correlating the at least one tracked location of the second capsule means with the at least one location of the first capsule means.

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

a capsule means for emitting a detectable acoustic signal as it passes through at least a portion of the intestinal tract; and

receiver means for receiving the acoustic signal external to the patient, the receiver means comprising at least one acoustic sensor;

processor means for determining the location of the capsule on a coordinate system based on the acoustic signal received at the receiver means; and

reference means for determining the time lag between emitting the detectable acoustic signal and receiving the acoustic signal at the at least one acoustic sensor.