Intra-lumen polyp detection

• US 7,787,926 B2
• Filed: 12/16/2004
• Issued: 08/31/2010
• Est. Priority Date: 12/17/2003
• Status: Active Grant

• Current Assignee: Check-Cap Ltd.
• Original Assignee: Check-Cap Ltd.
• Inventors: Kimchy, Yoav
• Primary Examiner(s): Le; Long V
• Assistant Examiner(s): NGUYEN, HIEN NGOC
• Application Number:
  US10/596,065
• Publication Number:
  US 20070161885A1
• Time in Patent Office: 2,084 Days
• Field of Search: 600/407
• US Class Current: 600/407
• CPC Class Codes: A61B 5/073 Intestinal transmitters
• 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 6/4057 by using radiation sources located in the interior of the body A61B6/037 takes precedence
• CPC Class Codes: A61B 6/425 using detectors specially adapted to be used in the interior of the body
• CPC Class Codes: A61B 6/4258 for detecting non x-ray radiation, e.g. gamma radiation A61B6/037 takes precedence
• CPC Class Codes: A61B 6/481 involving the use of contrast agents
• CPC Class Codes: A61B 6/482 involving multiple energy imaging
• CPC Class Codes: A61B 6/483 involving scattered radiation
• CPC Class Codes: A61B 6/485 involving fluorescence X-ray imaging
• CPC Class Codes: A61B 6/547 involving tracking of position of the device or parts of the device

Abstract

Apparatus (40) is provided, including a capsule (50), adapted to be swallowed by a subject (54), the capsule (50) including (a) at least one radiation source (60), adapted to emit radiation having an energy of at least 10 keV, and (b) at least one photon detector (62), adapted to detect photons generated responsively to the emitted radiation, the photons having an energy of at least 10 keV. The apparatus (40) additionally includes a control unit (64), adapted to analyze data regarding the photons in order to generate information useful for identifying a clinically-relevant feature of a gastrointestinal (GI) tract (72) of the subject (54).

Claims

1. An apparatus for detecting a clinically-relevant feature of a gastrointestinal (GI) tract of a subject, comprising:

an oral contrast agent consisting essentially of a stable and non-radioactive isotope, adapted to be administered to the subject;

a capsule adapted to be swallowed by the subject, said capsule including;

at least one radiation source emitting X-ray or gamma radiation having an energy of at least 10 keV;

at least one radiation detector comprising at least one collimator configured to detect in a first energy window collimated X-ray fluorescence radiation from the X-ray contrast agent composition excited by the emitted radiation, and to detect in a second energy window Compton-backscattered radiation from the X-ray contrast agent and the wall of the GI tract produced in response to the emitted radiation; and

a control unit configured to analyze data regarding the detected X-ray fluorescence radiation and Compton-backscattered radiation to identify a distance between the capsule and a wall of the GI tract,

said control unit further configured to compute a ratio between the Compton-backscattered radiation and the X-ray fluorescence radiation signals for distinguishing between gas in the GI tract and the clinically-relevant feature.

2. The apparatus according to claim 1, wherein the contrast agent composition comprises an agent having a high Z adapted to be swallowed by the subject.

3. The apparatus according to claim 1, wherein the radiation source comprises a radioisotope.

4. The apparatus according to claim 1, wherein the radiation source comprises at least one collimator which collimates the radiation emitted by the radiation source.

5. The apparatus according to claim 1, wherein the clinically-relevant feature includes an estimate of a distance from a site of the capsule to a wall of the GI tract.

6. The apparatus according to claim 5, wherein the distance is estimated from an intensity measurement of the Compton backscattered radiation.

7. The apparatus according to claim 5, wherein the distance is estimated from an intensity measurement of the X-ray fluorescence (XRF) radiation generated responsive to the emitted radiation.

8. The apparatus according to claim 1, wherein the radiation source emits the radiation from the capsule only during a portion of a time that the capsule is in the GI tract.

9. The apparatus according to claim 8, wherein the capsule comprises a sensor, adapted to sense a parameter indicative of possible imminent motion of the capsule in the GI tract, and wherein the radiation source emits the radiation in response to sensing the parameter by the sensor.

10. The apparatus according to claim 1, wherein the capsule comprises an inflatable balloon, adapted to inflate around the capsule.

11. The apparatus according to claim 1, wherein the at least one radiation detector comprises a plurality of radiation detectors, arranged to detect radiation arriving from a plurality of respective detection directions.

12. The apparatus according claim 1, wherein the capsule comprises at least one radiation shield.

13. The apparatus according to claim 12, wherein the capsule comprises an actuator adapted to move at least one of the radiation source and the shield, such that the radiation shield does not block the radiation emitted from the radiation source during the portion of the time.

14. The apparatus according to claim 12, wherein the at least one radiation shield is configured to prevent radiation from being emitted from the radiation source in directions other than a single confined solid sector relative to a sphere surrounding the capsule.

15. The apparatus according to claim 1, wherein the clinically relevant feature includes a pathological abnormality of the GI tract.

16. The apparatus according to claim 15, wherein the pathological abnormality includes a polyp.

17. The apparatus according to claim 1, wherein the control unit is adapted to detect that the capsule has reached an area of clinical interest within the GI tract.

18. The apparatus according to claim 1, wherein the control unit includes means for activating the radiation detector and electronic circuitry upon movement of the colon wall.

19. The apparatus according to claim 17, wherein the capsule comprises a pressure sensor, and wherein the control unit detects that the capsule has reached the area responsively to a change in pressure detected by the pressure sensor.

20. The apparatus according to claim 1, wherein the capsule comprises at least one extending element, which, when extended, maintains the capsule at least a certain distance from a wall of the GI tract.

21. The apparatus according to claim 1, wherein the capsule comprises at least one extending element, which, when extended, orients a long axis of the capsule generally parallel to a longitudinal axis of the GI tract.

22. The apparatus according to claim 21, wherein the extending element comprises an expandable flexible chamber, wherein the flexible chamber comprises a super-absorbent hydrogel, and wherein the flexible chamber expands when the hydrogel absorbs liquids from the GI tract.

23. The apparatus according to claim 1, wherein X-ray contrast agent composition comprises a composition selected from a barium sulfate-based compound, an iodine-based compound, and a gadolinium-based compound.

24. The apparatus according to claim 1, wherein X-ray contrast agent composition comprises a composition selected from Tantalum, Gadolinium, Thorium, Bismuth, and compounds thereof.

25. The apparatus according to claim 14, wherein the at least one radiation detector is arranged for detection of Compton-backscattered radiation at an angle of 180°

±

30°

relative to the angle defined by the solid sector.

26. A method for detecting clinically-relevant features of a gastrointestinal (GI) tract of a subject, comprising:

orally administering to a subject a radiopaque X-ray contrast agent composition consisting essentially of a stable, non-radioactive isotope;

orally administering to a subject a capsule emitting X-ray or gamma radiation having an energy of at least 10 keV;

measuring, from within the GI tract, concurrently in a first energy window a first radiation signal generated responsively to the emitted X-ray or gamma radiation, said measured first radiation signal representing collimated Compton-backscattered radiation, and in a second energy window a second radiation signal representing X-ray fluorescence (XRF) radiation from the X-ray contrast agent;

computing a ratio between the first radiation signal and the second radiation signal for distinguishing between gas in the GI tract and a clinically-relevant feature.

27. The method of claim 26, wherein the clinically-relevant feature of the GI tract comprises a polyp or another comparable anatomical abnormality, further comprising identifying the polyp or anatomical abnormality from a decrease in the second radiation signal from the XRF radiation accompanied by an increase in the first radiation signal from the Compton-backscattered radiation.

28. The method of claim 26, further computing a ratio between the measured first radiation signal from Compton-scattered radiation and the measured second radiation signal from XRF radiation, and differentiating between gas pockets and polyps based on the computed ratio.

29. A capsule, adapted to be swallowed by a subject, for detecting clinically-relevant features of a gastrointestinal (GI) tract of a subject, comprising:

at least one radiation source emitting X-ray or gamma radiation having an energy of at least 10 keV;

at least one radiation detector comprising at least one collimator configured to detect a first energy window collimated X-ray fluorescence radiation from the X-ray contrast agent composition excited by the emitted radiation, and to detect a second energy window Compton-backscattered radiation from the X-ray contrast agent and the wall of the GI tract produced in response to the emitted radiation; and

a control unit configured to compute a ratio between the Compton-backscattered radiation and the X-ray fluorescence radiation signals for distinguishing between gas in the GI tract and a clinically-relevant feature.