Intra-lumen polyp detection

• US 9,392,961 B2
• Filed: 06/29/2010
• Issued: 07/19/2016
• Est. Priority Date: 12/17/2003
• Status: Active Grant

• Current Assignee: Check-Cap Ltd.
• Original Assignee: Check-Cap Ltd.
• Inventors: Kimchy, Yoav, Klein, Yitzak, Baum, Gideon, Sommer, Rafi
• Primary Examiner(s): Chen, Tse
• Assistant Examiner(s): NGUYEN, HIEN NGOC
• Application Number:
  US12/825,797
• Publication Number:
  US 20100303200A1
• Time in Patent Office: 2,212 Days
• Field of Search: 378/44
• US Class Current: 1/1
• CPC Class Codes: A61B 5/036 by means introduced into body tracts A61B5/032 and A61B5/035 take precedence
• 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 6/4241 using energy resolving detectors, e.g. photon counting
• 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 6/482 involving multiple energy imaging

Abstract

An apparatus and a method for detecting clinically-relevant features of the gastrointestinal (GI) tract of a subject are disclosed. The apparatus includes a capsule to be swallowed by a subject and passing through the GI tract of the subject, a capsule housing, a radiation source emitting radiation, a rotatable collimator configured to rotate with respect to the housing and to collimate the radiation emitted by the radiation source, and a radiation detector configured to detect particles, such as photons, gamma radiation, beta radiation and electrons photons generated responsive to the emitted radiation. The apparatus also includes a control unit configured to analyze data regarding the photons. Movement of the capsule in the GI tract can be detected. The radiation source, radiation detector and control unit may advantageously be integrated inside a single housing.

Claims

1. An apparatus for detecting a polyp or cancer in a gastrointestinal (GI) tract of a subject, comprising:

a capsule with a capsule housing, said capsule adapted to be swallowed by a subject, said capsule comprising;

at least one radiation source emitting X-ray or gamma radiation and having at least one collimator configured to collimate radiation emitted by the at least one radiation source; and

at least one radiation detector configured to detect in a first energy window X-ray fluorescence radiation from a contrast agent composition consisting essentially of a stable and non-radioactive isotope and being excited by the emitted and collimated X-ray or gamma radiation, and to detect in a second energy window or additional energy windows, Compton-backscattered radiation from the contrast agent and the wall of the GI tract produced in response to the emitted and collimated X-ray or gamma radiation;

an accelerometer that is used to determine if the capsule is stationary or moving and determine a tilt angle of the capsule relative to the earth center of gravity;

the apparatus further comprising a control unit configured to distinguish between a gas bubble in the GI tract and a polyp or cancer at the specific location based on identifying one or more of the following;

a. a reduction in the count rate of Compton backscattered radiation at the location in all energy windows;

b. a reduction in the count rate of Compton backscattered radiation at the location in all energy windows and smaller changes in the difference between the count at high and low energies;

c. a reduction in the count rate of X-ray fluorescence radiation at the location;

d. the tilt angle of the capsule relative to center of gravity information to ascertain a relative location of the gas bubble or polyp or cancer; and

e. the surface of the detected gas bubble or polyp or cancer to determine if it is a gas bubble with a flat bottom surface or a polyp or cancer with bulging anatomical abnormalities.

2. The apparatus according to claim 1, wherein the control unit is integrated in or attached to the capsule.

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

4. The apparatus according to claim 1, wherein the control unit is configured to estimate a distance from a site of the capsule to a wall of the GI tract.

5. The apparatus according to claim 1, wherein the distance is estimated from an intensity measurement of the Compton backscattered radiation.

6. The apparatus according to claim 4, wherein the distance is estimated from an intensity measurement of the X-ray fluorescence (XRF) radiation generated responsive to the emitted radiation.

7. 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.

8. The apparatus according to claim 7, 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.

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

10. The apparatus according to claim 9, 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.

11. 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.

12. The apparatus according to claim 11, wherein the control unit includes means for activating the radiation detector and electronic circuitry upon relative movement between the capsule and the colon wall.

13. The apparatus according to claim 1, wherein the at least one radiation detector detects in response to the emitted radiation a first signal and a second signal inside a GI tract of the subject, and wherein the control unit processes the first signal to generate a first image of the GI tract of a region where the first signal was detected, and wherein the control unit processes the second signal to generate a second image of the GI tract of a region where the second signal was detected;

and detects movement of the capsule relative to the GI tract by comparing the first and second generated images.

18. The apparatus of claim 13, wherein the control unit computes an average of the processed first and second signals while the capsule is moving through the GI tract, and compares a new first signal with a magnitude of the computed average, and lengthens or shortens a time interval between acquisition of subsequent first and second signals depending if the magnitude of the computed average and the new first signal is smaller or greater than a predetermined threshold value.

20. The apparatus according to claim 1, wherein the at least one collimator is configured to rotate with respect to the housing.

14. An apparatus for detecting a polyp or cancer in a gastrointestinal (GI) tract of a subject, comprising:

a capsule with a capsule housing, said capsule adapted to be swallowed by a subject, said capsule comprising;

at least one radiation source emitting X-ray or gamma radiation;

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

an accelerometer that is used to determine if the capsule is stationary or moving and determine a tilt angle of the capsule relative to the earth center of gravity;

the apparatus further comprising a control unit configured to;

estimate a distance between the capsule and the wall of the GI tract from the Compton-backscattered radiation and the X-ray fluorescence radiation information; and

distinguish between a gas bubble in the GI tract and a polyp or cancer at the specific location based on identifying one or more of the following;

a. a reduction in the count rate of Compton backscattered radiation at the location in all energy windows;

b. a reduction in the count rate of Compton backscattered radiation at the location in all energy windows and smaller changes in the difference between the count at high and low energies;

c. a reduction in the count rate of X-ray fluorescence radiation at the location;

d. the tilt angle of the capsule relative to center of gravity information to ascertain a relative location of the gas bubble or polyp or cancer; and

e. the surface of the detected gas bubble or polyp or cancer to determine if it is a gas bubble with a flat bottom surface or a polyp or cancer with bulging anatomical abnormalities.

15. The apparatus of claim 14, further comprising at least two electrodes spaced on the capsule, with at least one electrode emitting electromagnetic pulses and at least one other electrode detecting a response signal responsive to the emitted electromagnetic pulses;

and wherein the electromagnetic pulses comprise RF pulses and the electrodes comprise antennae.

16. The apparatus of claim 14, further comprising at least two electrodes spaced on the capsule, with at least one electrode emitting electromagnetic pulses and at least one other electrode detecting a response signal responsive to the emitted electromagnetic pulses;

and wherein the electromagnetic pulses comprise low-voltage pulses and the electrodes comprise galvanic electrodes.

17. The apparatus of claim 14, wherein the control unit is integrated in or attached to the capsule.

21. The apparatus according to claim 14, wherein the control unit is configured to estimate the distance between the capsule and the wall of the GI tract based on an inverse relationship between the distance and photon flux of the detected Compton-backscattered radiation and a relationship between the detected X-ray fluorescence radiation and the distance between the capsule and the wall of the GI tract.

19. An apparatus for detecting a polyp or cancer in a gastrointestinal (GI) tract of a subject, comprising:

a capsule with a capsule housing, said capsule adapted to be swallowed by a subject, said capsule comprising;

at least one radiation source emitting X-ray or gamma radiation;

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

an accelerometer that is used to determine if the capsule is stationary or moving and determine a tilt angle of the capsule relative to the earth center of gravity;

the apparatus further comprising a control unit configured to distinguish between a gas bubble in the GI tract and a polyp or cancer at the specific location based on identifying one or more of the following;

a. a reduction in the count rate of Compton backscattered radiation at the location in all energy windows;

b. a reduction in the count rate of Compton backscattered radiation at the location in all energy windows and smaller changes in the difference between the count at high and low energies;

c. a reduction in the count rate of X-ray fluorescence radiation at the location;

d. the tilt angle of the capsule relative to center of gravity information to ascertain a relative location of the gas bubble or polyp or cancer; and

e. the surface of the detected gas bubble or polyp or cancer to determine if it is a gas bubble with a flat bottom surface or a polyp or cancer with bulging anatomical abnormalities.