Ingestible device for radioimaging of the gastrointestinal tract

• US 8,055,329 B2
• Filed: 01/22/2002
• Issued: 11/08/2011
• Est. Priority Date: 01/22/2001
• Status: Active Grant

• Current Assignee: Spectrum Dynamics Medical Ltd
• Original Assignee: Spectrum Dynamics LLC
• Inventors: Amrami, Roni, Antebi, Udi, Bouskila, Yona, Kimchy, Yoav
• Primary Examiner(s): Casler; Brian
• Assistant Examiner(s): Shahrestani; Nasir
• Application Number:
  US10/240,239
• Publication Number:
  US 20030139661A1
• Time in Patent Office: 3,577 Days
• Field of Search: 600/424, 600473-477, 600/130, 600/160, 600/103, 600/108, 600/109, 600/114, 600/172, 600/547, 600/153, 600/350, 600/593, 600/582, 600/101, 348/68, 348/76, 348/77, 348/301, 348/370
• US Class Current: 600/436
• CPC Class Codes: A61B 1/041 Capsule endoscopes for imaging
• 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 5/062 using magnetic field
• CPC Class Codes: A61B 5/067 using accelerometers or gyroscopes
• CPC Class Codes: A61B 5/073 Intestinal transmitters
• CPC Class Codes: A61B 5/411 Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
• CPC Class Codes: A61B 5/415 the glands, e.g. tonsils, adenoids or thymus
• 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 6/425 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 6/4423 related to hygiene or sterilisation
• CPC Class Codes: A61B 6/482 involving multiple energy imaging
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 8/4472 Wireless probes
• CPC Class Codes: A61B 8/56 Details of data transmission or power supply

Abstract

An ingestible device, adapted to travel in the gastrointestinal tract and perform a diagnostic image of tissue therein, is provided. The diagnostic image may comprise diagnostic information as a function of time, or diagnostic information as a function of distance traveled within the gastrointestinal tract. Specifically, the ingestible device may be arranged to perform a diagnostic image of nuclear radiation of a radiophamaceutical, scintillation of a scintillation liquid, responsive to nuclear radiation of a radiophamaceutical, optical fluorescence of a fluorescing-pharmaceutical or of bare gastrointestinal-tract tissue, infrared radiation of the gastrointestinal-tract tissue, temperature-differences along the gastrointestinal-tract, impedance, ultrasound reflection, magnetic resonance, and a combination thereof. The ingestible device may be adapted for general screening of a large population, on the one hand, and for specific diagnoses of suspected pathologies, on the other.

Claims

1. A method of performing tissue diagnosis within a gastrointestinal tract of a body, comprising:

providing a swallowable pill-like device having an overall size small enough for being fully ingested, the device comprising a probe, which comprises a plurality of nuclear radiation detectors, operative to perform, along said gastrointestinal tract, a diagnostic image by nuclear radiation of a radiopharmaceutical;

administrating said radiopharmaceutical;

swallowing said swallowable device, a predetermined time relative to said administrating said radiopharmaceutical;

producing diagnostic signals with said probe, as said ingestible device travels in said gastrointestinal tract, thus forming said diagnostic image; and

recording information of said diagnostic image.

2. The method of claim 1, wherein said nuclear-radiation detector is configured for detecting gamma and beta radiation.

3. The method of claim 1, wherein said probe further includes at least two solid-state nuclear radiation crystals.

4. The method of claim 3, and further including gating each of said crystals to a different narrow energy range, associated with a different radioisotope.

5. The method of claim 4, and further including identifying a pathological site, by an activity ratio of at least two radioisotopes.

6. The method of claim 3, wherein said at least two crystals are arranged a predetermined distance apart, in the direction of travel, and wherein said method further includes evaluating the distance traveled within said gastrointestinal tract, by cross correlating nuclear radiation striking said crystals at a time T and at a later time T+Δ

T.

7. The method of claim 1, wherein said probe further comprises a photodetector, wherein said method further includes administrating a scintillation liquid, a predetermined time after said administrating said radiopharmaceutical and a predetermined time before said swallowing said swallowable device, and wherein said producing diagnostic signals with said probe further includes detecting scintillation, produced by said scintillation liquid, responsive to nuclear radiation of said radiopharmaceutical, thus forming said diagnostic image.

8. The method of claim 7, wherein said probe further comprises at least two photo-sensing diodes, arranged a predetermined distance apart, in the direction of travel, and wherein said method further includes evaluating the distance traveled within said gastrointestinal tract, by cross correlating scintillation striking said photo-sensing diodes at a time T and at a later time T+Δ

T.

9. The method of claim 1, wherein said diagnostic image comprises diagnostic information as a function of time.

10. The method of claim 1, wherein said diagnostic image comprises diagnostic information as a function of distance traveled by said swallowable device.

11. The method of claim 1, wherein said recording further includes transmitting said information extracorporeally, and recording said information by extracorporeal apparatus.

12. The method of claim 1, wherein said recording further includes recording said information within said swallowable device.

13. The method of claim 1, and further including administrating a pharmaceutical a predetermined time prior to said swallowing said swallowable device.

14. The method of claim 1, and further including screening a large population.

15. The method of claim 14 and further including screening for gastrointestinal-tract neoplasm.

16. The method of claim 1, and further including diagnosing for a suspected pathology.

17. The method of claim 16, wherein said suspected pathology is malignant.

18. The method of claim 16, wherein said suspected pathology is nonmalignant.

28. The method of claim 1, wherein said nuclear-radiation detector is gated to a narrow energy range, associated with a particular radioisotope.

29. A method according to claim 1 wherein said plurality of radiation detectors comprise at least one solid-state nuclear radiation detector, selected from the group consisting of at least one Cadmium Zinc Telluride crystal and at least one Cadmium Telluride crystal.

30. A method according to claim 1, wherein said swallowable device is freely traveling in said gastrointestinal tract.

31. A method according to claim 1, wherein said swallowable device is about 2 cm in length.

35. A method according to claim 1, wherein swallowing said swallowable device, a predetermined time relative to said administrating said radiopharmaceutical comprises swallowing said swallowable device, a predetermined time after said administrating said radiopharmaceutical.

38. A method according to claim 1, wherein said swallowable device is about 1 cm in width.

19. A method of identifying a pathology, using a clock-like property of radioisotopes, comprising:

providing a swallowable pill-like device having an overall size small enough for being fully ingested, the device comprising a probe, which comprises a plurality of nuclear radiation detectors, wherein at least one of said plurality of nuclear radiation detectors is arranged for distinguishing between at least two forms of radiation, associated with at least two radioisotopes;

administering a radiopharmaceutical which includes said at least two radioisotopes;

swallowing said swallowable device, a predetermined time relative to said administrating said radiopharmaceutical;

performing diagnostic images by nuclear radiation for each of said at least two radioisotopes;

evaluating an activity ratio for said at least two radioisotopes; and

identifying said pathology, by an observed change in said activity ratio.

32. A method according to claim 19, wherein said swallowable device is about 2 cm in length.

36. A method according to claim 19, wherein swallowing said swallowable device, a predetermined time relative to said administrating said radiopharmaceutical comprises swallowing said swallowable device, a predetermined time after said administrating said radiopharmaceutical.

39. A method according to claim 19, wherein said swallowable device is about 1 cm in width.

20. A swallowable device, arranged for traveling within a gastrointestinal tract of a body, comprising:

a probe, which comprises a plurality of nuclear radiation detectors wherein at least one of said nuclear radiation detectors is optimized for detecting gamma particles, operative to perform, along said gastrointestinal tract, a diagnostic image by nuclear radiation of a gamma-emitting radiopharmaceutical;

data-handling apparatus, in signal communication with said probe, for receiving and handling imaging data, generated by said probe;

a power source, for powering said probe and data-handling apparatus; and

a shell, which encapsulates said probe, data-handling apparatus, and power source within, wherein said plurality of radiation detectors are arranged around said shell,

wherein the swallowable device is a swallowable pill-like device and has an overall size small enough for being fully ingested.

21. The swallowable device of claim 20, wherein said at least one nuclear radiation detector is gated to a preselected energy window, about an energy, which substantially matches a gamma energy of the gamma-emitting radiopharmaceutical.

22. The swallowable device of claim 20, wherein said probe further includes at least two nuclear radiation detectors, optimized for detecting gamma particles.

23. The swallowable device of claim 22, wherein each of said at least two nuclear radiation detectors is gated to a different narrow energy range, associated with a different gamma-emitting radiopharmaceutical, for differentiating between at least two different gamma-emitting radiopharmaceuticals, based on their distinctive gamma energies.

33. A swallowable device according to claim 20, wherein said swallowable device is about 2 cm in length.

40. A swallowable device according to claim 20, wherein said swallowable device is about 1 cm in width.

24. A method of performing tissue diagnosis within a gastrointestinal tract of a body, comprising:

providing a swallowable pill-like device having a size small enough for ingestion, the device comprising a probe, which comprises a plurality of nuclear radiation detectors, wherein at least one nuclear radiation detector is optimized for detecting gamma particles, operative to perform, along said gastrointestinal tract, a diagnostic image by nuclear radiation of a gamma-emitting radiopharmaceutical;

administrating said radiopharmaceutical;

swallowing said swallowable device, a predetermined time relative to said administrating said radiopharmaceutical;

producing diagnostic signals with said probe, as said swallowable device travels in said gastrointestinal tract, thus forming said diagnostic image; and

recording information of said diagnostic image.

25. The method of claim 24, wherein said at least one nuclear radiation detector is gated to a preselected energy window, about an energy, which substantially matches a gamma energy of the gamma-emitting radiopharmaceutical.

26. The method of claim 24, wherein said probe further includes at least two nuclear radiation detectors, optimized for detecting gamma particles.

27. The method of claim 26, wherein each of said at least two nuclear radiation detectors is gated to a different narrow energy range, associated with a different gamma-emitting radiopharmaceutical, for differentiating between at least two different gamma-emitting radiopharmaceuticals, based on their distinctive gamma energies.

34. A method according to claim 24, wherein said swallowable device is about 2 cm in length.

37. A method according to claim 24, wherein swallowing said swallowable device, a predetermined time relative to said administrating said radiopharmaceutical comprises swallowing said swallowable device, a predetermined time after said administrating said radiopharmaceutical.

41. A method according to claim 24, wherein said swallowable device is about 1 cm in width.