Ingestible device platform for the colon

• US 7,970,455 B2
• Filed: 05/19/2005
• Issued: 06/28/2011
• Est. Priority Date: 05/20/2004
• Status: Active Grant

• Current Assignee: Spectrum Dynamics Medical Ltd
• Original Assignee: Spectrum Dynamics LLC
• Inventors: Rousso, Benny, Halahmi, Izhar, Nagler, Michael, Zilberstein, Yoel
• Primary Examiner(s): Le; Long V
• Assistant Examiner(s): HOFFA, ANGELA MARIE
• Application Number:
  US11/132,320
• Publication Number:
  US 20050266074A1
• Time in Patent Office: 2,231 Days
• Field of Search: None
• US Class Current: 600/436
• CPC Class Codes: A61B 1/00156 using self propulsion
• CPC Class Codes: A61B 1/041 Capsule endoscopes for imaging
• CPC Class Codes: A61B 5/0077 Devices for viewing the surface of the body, e.g. camera, magnifying lens
• CPC Class Codes: A61B 5/073 Intestinal transmitters
• 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 5/205 Determining bladder or urethral pressure
• CPC Class Codes: A61B 5/415 the glands, e.g. tonsils, adenoids or thymus
• CPC Class Codes: A61B 5/4255 Intestines, colon or appendix
• CPC Class Codes: A61B 5/6861 Capsules, e.g. for swallowing or implanting
• 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
• CPC Class Codes: A61B 6/508 for non-human patients
• CPC Class Codes: A61B 6/5247 combining images from an ionising-radiation diagnostic technique and a non-ionising radiation diagnostic technique, e.g. X-ray and ultrasound
• 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 8/4416 related to combined acquisition of different diagnostic modalities, e.g. combination of ultrasound and X-ray acquisitions

Abstract

An ingestible pill platform for colon imaging is provided, designed to recognize its entry to the colon and expand in the colon, for improved imaging of the colon walls. On approaching the external anal sphincter muscle, the ingestible pill may contract or deform, for elimination. Colon recognition may be based on a structural image, based on the differences in diameters between the small intestine and the colon, and particularly, based on the semilunar fold structure, which is unique to the colon. Additionally or alternatively, colon recognition may be based on a functional image, based on the generally inflammatory state of the vermiform appendix. Additionally or alternatively, pH, flora, enzymes and (or) chemical analyses may be used to recognize the colon. The imaging of the colon walls may be functional, by nuclear-radiation imaging of radionuclide-labeled antibodies, or by optical-fluorescence-spectroscopy imaging of fluorescence-labeled antibodies. Additionally or alternatively, it may be structural, for example, by visual, ultrasound or MRI means. Due to the proximity to the colon walls, the imaging in accordance with the present invention is advantageous to colonoscopy or virtual colonoscopy, as it is designed to distinguish malignant from benign tumors and detect tumors even at their incipient stage, and overcome blood-pool background radioactivity.

Claims

1. An ingestible pill, adapted to recognize entry to a colon, comprising:

an ingestible-pill body, adapted to be swallowed by a living being and adapted for traveling down a gastrointestinal tract of the living being, the body including an expansion mechanism and an outer portion, wherein at least part of the outer portion is adapted to be moved by said expansion mechanism relative to an opposite part of the outer portion and wherein the part of the outer portion includes at least one radioactive-emission detector for detecting pathologies in the colon; and

a colon-recognition trigger mechanism, associated with the ingestible-pill body and configured to produce a colon-entry signal, when the ingestible-pill body enters the colon of the living being,

wherein the outer portion comprises a skin, and

wherein the at least one radioactive-emission detector contacts the skin.

2. The ingestible pill of claim 1, wherein the colon-recognition trigger mechanism is selected from the group consisting of:

an ultrasound sensor, configured to produce the colon-entry signal, based on the difference in structure between the small intestine and the colon,

an MRI sensor, configured to produce the colon-entry signal, based on the difference in structure between the small intestine and the colon,

a video camera, configured to produce the colon-entry signal, based on the difference in structure between the small intestine and the colon,

an ultrasound sensor, configured to produce the colon-entry signal, upon imaging the semilunar fold structure, which is unique to the colon,

an MRI sensor, configured to produce the colon-entry signal, upon imaging the semilunar fold structure, which is unique to the colon,

a video camera, configured to produce the colon-entry signal, upon imaging the semilunar fold structure, which is unique to the colon,

a radioactive-emission sensor, configured to produce the colon-entry signal, upon functional sensing the generally inflammatory state of the vermiform appendix,

an optical-fluorescence-spectroscopy sensor, configured to produce the colon-entry signal, upon functional sensing the generally inflammatory state of the vermiform appendix,

a pH sensor, configured to produce the colon-entry signal, upon sensing the pH environment of the colon, which is greater than 7,

an enzyme sensor, configured to produce the colon-entry signal, upon sensing the enzyme environment of the colon,

a chemical sensor, configured to produce the colon-entry signal, upon sensing the chemical environment of the colon,

a bacterial sensor, configured to produce the colon-entry signal, upon sensing the flora environment of the colon, and

a combination of the above.

3. The ingestible pill of claim 1, wherein the expansion mechanism is configured to expand the ingestible pill body into an expanded structure, having expanded length and width parameters, which are between a factor of two and a factor of five greater than the initial length and width parameters, so as to push the outside portion in an outward direction from the center of the body, when the colon-recognition trigger mechanism produces the colon-entry signal.

4. The ingestible pill of claim 3, wherein the ingestible pill expands generally uniformly.

5. The ingestible pill of claim 3, wherein the expanded structure has a shape, selected from the group consisting of an elliptical capsule, a plurality of loops, a star fish, and a plurality of spines.

6. The ingestible pill of claim 1, wherein the expansion mechanism is an absorption mechanism, selected from the group consisting of the absorption of gastrointestinal fluids by osmosis, the absorption of gastrointestinal fluids by a foam, the absorption of gastrointestinal fluids by guar gum, the absorption of gastrointestinal fluids by polyacrylic acid, the absorption of gastrointestinal fluids by a hydrogel, the absorption of gastrointestinal fluids by hydroxypropylmethylcellulose-HPMC, the absorption of gastrointestinal fluids by polyethylene oxide, the absorption of gastrointestinal fluids by Laminaria digitata, the absorption of gastrointestinal fluids by Laminaria japonica, a combination of the above.

7. The ingestible pill of claim 1, wherein the colon-recognition trigger mechanism is further operative as a detector for detecting pathologies in the colon.

8. The ingestible pill of claim 7, and further including another detector for detecting pathologies in the colon, wherein the at least one radioactive-emission detector and the another detector are of the same type.

9. The ingestible pill of claim 7, and further including another detector for detecting pathologies in the colon, wherein the at least one radioactive-emission detector and the another detector are of different types.

10. The ingestible pill of claim 9, wherein the another detector for detecting pathologies in the colon is selected from the group consisting of at least one optical fluorescence sensor, at least one ultrasound sensor, at least one MRI sensor, at least one still camera operative in a visible light range, at least one video camera, operative in a visible light range, at least one still camera operative in an infrared light range, at least one video camera, operative in an infrared light range, at least one temperature sensor, and at least one impedance sensor.

11. The ingestible pill of claim 7, wherein the another detector for detecting pathologies in the colon is further configured as an imager, for imaging pathologies in the colon, as a function of position along the colon.

12. The ingestible pill of claim 1, and further including another detector for detecting pathologies in the colon, wherein the at least one radioactive-emission detector and the another detector are of the same type.

13. The ingestible pill of claim 1, and further including another detector for detecting pathologies in the colon, wherein the at least one radioactive-emission detector and the another detector are of different types.

14. The ingestible pill of claim 13, wherein the another detector for detecting pathologies in the colon is selected from the group consisting of at least one optical fluorescence sensor, at least one ultrasound sensor, at least one MRI sensor, at least one still camera operative in a visible light range, at least one video camera, operative in a visible light range, at least one still camera operative in an infrared light range, at least one video camera, operative in an infrared light range, at least one temperature sensor, and at least one impedance sensor.

15. The ingestible pill of claim 1, wherein the at least one radioactive-emission detector for detecting pathologies in the colon is further configured as an imager, for imaging pathologies in the colon, as a function of position along the colon.

16. The ingestible pill of claim 1, configured for contracting under the pressure of the external anal sphincter muscle, for elimination of the ingestible pill from the living being.

17. The ingestible pill of claim 1, wherein the body further includes a core and the outer portion of the ingestible-pill body comprises a stretchable skin surrounding the core and expansion mechanism.

18. The ingestible pill of claim 1, wherein the at least one radioactive-emission detector is adapted to be moved by the expansion mechanism.

19. The ingestible pill of claim 1 wherein the at least one radioactive-emission detector comprises at least two detectors adapted to be moved away from each other by the expansion mechanism.

20. A method of colon recognition, by an ingestible pill, comprising:

providing an ingestible pill, which comprises;

an ingestible-pill body, adapted to be swallowed by a living being and adapted for traveling down a gastrointestinal tract of the living being, the body including an expansion mechanism and an outer portion including a part which includes at least one radioactive-emission detector for detecting pathologies in the colon, wherein the outer portion comprises a skin which contacts the at least one radioactive-emission detector; and

a colon-recognition trigger mechanism, associated with the ingestible-pill body and configured to produce a colon-entry signal, when the ingestible-pill body enters the colon of the living being;

administering the ingestible pill to the living being;

recognizing colon-entry by the colon-recognition trigger mechanism;

producing the colon-entry signal, upon the recognizing; and

expanding the expansion mechanism, thereby moving said part of said outer portion relative to an opposite part of the outer portion.

21. The method of claim 20, wherein the colon-recognition trigger mechanism is selected from the group consisting of:

an ultrasound sensor, configured to produce the colon-entry signal, based on the difference in structure between the small intestine and the colon,

an MRI sensor, configured to produce the colon-entry signal, based on the difference in structure between the small intestine and the colon,

a video camera, configured to produce the colon-entry signal, based on the difference in structure between the small intestine and the colon,

an ultrasound sensor, configured to produce the colon-entry signal, upon imaging the semilunar fold structure, which is unique to the colon,

an MRI sensor, configured to produce the colon-entry signal, upon imaging the semilunar fold structure, which is unique to the colon,

a video camera, configured to produce the colon-entry signal, upon imaging the semilunar fold structure, which is unique to the colon,

a radioactive-emission sensor, configured to produce the colon-entry signal, upon functional sensing the generally inflammatory state of the vermiform appendix,

an optical-fluorescence-spectroscopy sensor, configured to produce the colon-entry signal, upon functional sensing the generally inflammatory state of the vermiform appendix,

a pH sensor, configured to produce the colon-entry signal, upon sensing the pH environment of the colon, which is greater than 7,

an enzyme sensor, configured to produce the colon-entry signal, upon sensing the enzyme environment of the colon,

a chemical sensor, configured to produce the colon-entry signal, upon sensing the chemical environment of the colon,

a bacterial sensor, configured to produce the colon-entry signal, upon sensing the flora environment of the colon, and

a combination of the above.

22. The method of claim 20, wherein expanding the expansion mechanism comprises expanding the expansion mechanism, thereby expanding the ingestible pill body into an expanded structure, having expanded length and width parameters, which are between a factor of two and a factor of five greater than the initial length and width parameters, so as to push the outer portion in an outward direction from the center of the body, when the colon-recognition trigger mechanism produces the colon-entry signal.

23. The method of claim 22, wherein the expanded structure has a shape, selected from the group consisting of an elliptical capsule, a plurality of loops, a star fish, and a plurality of spines.

24. The method of claim 22, and further including detecting pathologies in the colon, by the expanded structure.

25. The method of claim 24, and further including imaging pathologies in the colon, as a function of position of the ingestible pill along the colon.

26. The method of claim 20, wherein the expansion mechanism is an absorption mechanism, selected from the group consisting of the absorption of gastrointestinal fluids by osmosis, the absorption of gastrointestinal fluids by a foam, the absorption of gastrointestinal fluids by guar gum, the absorption of gastrointestinal fluids by polyacrylic acid, the absorption of gastrointestinal fluids by a hydrogel, the absorption of gastrointestinal fluids by hydroxypropylmethylcellulose-HPMC, the absorption of gastrointestinal fluids by polyethylene oxide, the absorption of gastrointestinal fluids by Laminaria digitata, the absorption of gastrointestinal fluids by Laminaria japonica, a combination of the above.

27. The method of claim 20, wherein the ingestible pill expands generally uniformly.

28. The method of claim 20, and further including contracting under the pressure of the external anal sphincter muscle, for elimination of the ingestible pill from the living being.