Optical capsule and spectroscopic method for treating and diagnosing the intestinal tract

• US 10,226,608 B2
• Filed: 09/24/2015
• Issued: 03/12/2019
• Est. Priority Date: 06/26/2001
• Status: Active Grant

• Current Assignee: Entrack, Inc.
• Original Assignee: Entrack, Inc.
• Inventors: Imran, Mir A.
• Primary Examiner(s): Towa, Rene
• Application Number:
  US14/863,762
• Publication Number:
  US 20160135720A1
• Time in Patent Office: 1,265 Days
• Field of Search: 600302, 600309-312, 600314-315, 600407, 600424, 600431, 600437, 600476, 600587, 600593
• 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 disorders or other diseases, disorders or conditions (e.g., bleeding, ischemic or necrotic tissue, and presence of certain chemicals or substances) of the intestinal tract is provided using a capsule passing through the intestinal tract and sensing optical characteristics as the capsule passes through. 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 optical characteristics 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 condition in an intestinal tract of a patient, the system comprising:

an autonomous capsule sized to pass through the intestinal tract of a patient, the autonomous capsule comprising;

a light source configured to emit light from the autonomous capsule so that the emitted light is reflected from intestinal tract tissue when the autonomous capsule is moving through the intestinal tract; and

a sensor configured to sense reflected light for at least one wavelength at a first location within the intestinal tract and to output a signal representative of light sensed by the sensor at the at least one wavelength, each at least one wavelength associated with a corresponding condition of intestinal tract tissue;

a processor operatively coupled to the sensor and configured to receive a signal representative of light sensed by the sensor, the processor further configured to associate each of the at least one wavelength with the corresponding condition of intestinal tract tissue, to select a gastrointestinal condition of intestinal tract tissue for detection, to control the emission of light from the light source for detecting the selected condition, to control wavelengths of light sensed by the sensor, and to determine a presence of the condition of intestinal tract tissue based at least in part on the received signal, the condition being at least one of a presence of a substance, an absence of a substance, or a condition of tissue of the intestinal tract; and

an autonomous capsule tracking system, the autonomous capsule tracking system including multiple ultrasound receivers and an acoustic reference receiver, wherein the multiple ultrasound receivers and the acoustic reference receiver are configured to establish multiple differential times between the multiple ultrasound receivers and the acoustic reference receiver; and

a treatment capsule configured to treat the condition determined to be present by the autonomous capsule, wherein the treatment capsule includes a first electrode located on a capsule body of the treatment capsule, and a second electrode located on an elongate member extending from the capsule body.

2. The system of claim 1, wherein the light source emits light at the at least one wavelength.

3. The system of claim 1, wherein the autonomous capsule further comprises a filter operatively coupled to the sensor, wherein the filter is configured to filter light of the at least one wavelength into the sensor.

4. The system of claim 1, wherein the autonomous capsule tracking system is configured to track a location of the autonomous capsule within a three-dimensional coordinate system.

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

wherein the processor is configured to identify a location of the selected gastrointestinal condition of intestinal tract tissue within a portion of the intestinal tract.

6. The system of claim 1, wherein the autonomous capsule tracking system is configured to track a location of the autonomous capsule along a length of a portion of the intestinal tract.

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

and

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

8. The system of claim 7, wherein the autonomous capsule tracking system is configured to determine autonomous capsule location along the length of the portion of the intestinal tract, from a determination of a plurality of locations of the autonomous capsule as the autonomous capsule passes through the portion of the intestinal tract.

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

10. The system of claim 9, further comprising:

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

11. The system of claim 1, wherein the autonomous capsule tracking system is further configured to define paraboloid planes for a first ultrasound receiver and the acoustic reference receiver, and a second ultrasound receiver and the acoustic reference receiver.

12. The system of claim 11, wherein:

the autonomous capsule tracking system is further configured to determine an intersection between the paraboloid planes to provide information from which a location of the autonomous capsule may be derived.

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

a telemetry device arranged to transmit a telemetry signal corresponding to the light sensed by the 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 operatively coupled to the telemetry receiver.

15. The system of claim 1, wherein the autonomous capsule further comprises a marking mechanism configured to mark an identified location of a condition within the intestinal tract.

16. The system of claim 15, wherein the marking mechanism comprises a substance release mechanism.

17. The system of claim 16, wherein the substance release mechanism comprises a dye release mechanism.

18. The system of claim 15, wherein the marking mechanism comprises a position anchoring mechanism.

19. The system of claim 1, wherein the presence of the condition comprises a presence of blood on a surface of the intestinal tract.

20. The system of claim 1, wherein the presence of the condition comprises an absence of blood in tissue.

21. The system of claim 1, wherein the presence of the condition comprises a presence of ischemic tissue.

22. The system of claim 1, wherein the presence of the condition comprises a presence of necrotic tissue.

23. The system of claim 1, wherein the presence of the condition comprises a presence of hemoglobin, or an absence of hemoglobin.

24. The system of claim 23, wherein at least one of the at least one wavelength is within a range between about 540 nanometers and about 620 nanometers.

25. The system of claim 1, wherein a surface area of the first electrode is less than a surface area of the second electrode so that a current density at the first electrode is greater than a current density at the second electrode, the first electrode being configured to cauterize or ablate a bleeding tissue in the intestinal tract.

26. The system of claim 1, wherein the treatment capsule further includes a treatment capsule tracking system configured to track a location of the treatment capsule and identify a location of the condition determined by the autonomous capsule.

27. The system of claim 26, wherein the treatment capsule further includes a tissue biopsy or content sampling device.