Device, system and method for in-vivo detection of bleeding in the gastrointestinal tract

• US 9,795,330 B2
• Filed: 06/13/2014
• Issued: 10/24/2017
• Est. Priority Date: 12/15/2011
• Status: Active Grant

• Current Assignee: Given Imaging Limited (Medtronic Plc)
• Original Assignee: Given Imaging Limited (Medtronic Plc)
• Inventors: Pascal, Amit, Gilad, Zvika, Rabinovitz, Elisha, Birnboim, Yaniv
• Primary Examiner(s): Winakur, Eric
• Assistant Examiner(s): Fardanesh, Marjan
• Application Number:
  US14/304,690
• Publication Number:
  US 20140296666A1
• Time in Patent Office: 1,229 Days
• Field of Search: None
• CPC Class Codes: A61B 1/041 Capsule endoscopes for imaging
• CPC Class Codes: A61B 1/063 for monochromatic or narrow-band illumination
• CPC Class Codes: A61B 1/0684 using light emitting diodes [LED]
• CPC Class Codes: A61B 5/0084 for introduction into the body, e.g. by catheters A61B5/1459 takes precedence
• CPC Class Codes: A61B 5/073 Intestinal transmitters
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence

Abstract

In-vivo devices, systems and methods for the detection of blood within in-vivo bodily fluids. The methods include irradiating in-vivo fluids passing through a gap in a housing of an in-vivo device introduced to the GI tract of a subject with a plurality of illumination sources positioned on a first side of a gap; detecting with at least one light detector positioned on the opposite side of the gap and facing the illumination sources, light irradiated by the illumination sources; transmitting a plurality of values representing the light detected over time; converting these values to blood concentration values over time, and comparing the blood concentration values to a predetermined threshold value. Based on the comparison, the method includes determining the type of bleeding profile, such that if a plurality of blood concentration values measured consecutively is above the threshold value, the bleeding profile indicates bleeding.

Claims

1. A system for determining the type of a patient'"'"'s bleeding profile over time, said system comprising:

an in-vivo sensing device comprising;

a housing comprising a sensing head in the form of a gap, which remains in contact with bodily fluids and through which the fluids pass when the device is within the GI tract;

said sensing head comprising a plurality of illumination sources positioned on a first side of the gap, each illumination source for repeatedly irradiating the fluids within the gap at a different narrow band wavelength, and at least one light detector photodiode positioned on the opposite side of the gap and facing the illumination sources, for detecting light irradiated by the illumination sources and which passed through the fluids;

a transmitter for transmitting a plurality of values representing the light detected over time by the at least one light detector to an external receiver;

a memory unit for storing the values received by the external receiver;

a processing unit configured for processing the stored values and for;

converting the values to a series of blood concentration values measured consecutively over time, and

identifying a bleeding event based on the blood concentration values as a function of time and based on a comparison of the blood concentration values to a threshold.

2. The system according to claim 1, wherein the processor is configured to identify a bleeding event indicating major-active bleeding over time if the blood concentration values show a peak above the threshold value after which a plurality of blood concentration values measured consecutively are below the peak but are still above the threshold value.

3. The system according to claim 1, wherein the processor is configured to identify a bleeding event indicating major-non-active bleeding over time if the blood concentration values show a steady peak close to the threshold value.

4. The system according to claim 1, wherein the processor is configured to identify a bleeding event indicating minor bleeding over time if the blood concentration values show at least one peak below the threshold value.

5. The system according to claim 1, wherein the processor is configured to identify a bleeding event indicating no bleeding over time if the blood concentration values are below the threshold value with no distinct peak over time.

6. The system according to claim 1, wherein said memory unit and said processing unit are incorporated within said external receiver.

7. The system according to claim 1, wherein said sensing head comprises a cover placed over the gap, said cover comprising at least one hole located on an axis perpendicular to an axis along which the illumination sources and the light detector are located.

8. The system according to claim 7, wherein said at least one hole comprises holes located on opposite sides of the gap.

9. The system according to claim 7, wherein said cover is shaped as a flexible accordion, said cover defining a space within the sensing head, the space defined within the sensing head having an initial un-squeezed volume which is configured to be filled with in-vivo-bodily fluids through said at least one hole, wherein the cover has a spring constant which is:

soft enough so that the cover can be squeezed whenever peristaltic pressure is applied onto it thus causing the space defined by said cover to decrease and the in-vivo bodily fluids to exit from said sensing head through said at least one hole, and

strong enough to cause the space defined by the cover to return to its initial un-squeezed volume whenever the peristaltic pressure is no longer applied onto said cover, thus enabling new in-vivo bodily fluids to enter said sensing head through said at least one hole.

10. The system according to claim 9, wherein said hole is located in close proximity to a sensing area, said sensing area being located between said illumination sources and said at least one light detector.

11. The system according to claim 1, wherein said in-vivo sensing device further comprises an imaging head.

12. The system according to claim 11, wherein said imaging head is located at one end of said housing, opposite to the end of the housing comprising the sensing head.

13. The system according to claim 1, wherein said system further comprises a display unit for displaying a graph of the blood concentration values over time.

14. The system according to claim 1, wherein said plurality of illumination sources comprise at least three LEDs, wherein at least one LED is selected from each of the following three ranges:

a first range is between 400 nm to 600 nm, a second range is between 600 nm to 700 nm, and a third range is between 700 nm to 900 nm.

15. The system according to claim 14, wherein said plurality of illumination sources comprise six LEDs, wherein two are selected from the first range, three are selected from the second range and one is selected form the third range.

16. A method for determining the type of a patient'"'"'s bleeding profile over time, said method comprising:

irradiating in-vivo fluids passing through a gap in a housing of an in-vivo sensing device introduced to the GI tract of a subject with a plurality of illumination sources positioned on a first side of a gap, each illumination source for irradiating at a different narrow band wavelength;

detecting, with at least one light detector photodiode positioned on the opposite side of the gap and facing the illumination sources, light irradiated by the illumination sources;

transmitting a plurality of values representing the light detected over time;

converting said values to blood concentration values over time;

identifying a bleeding event based on the blood concentration values as a function of time and based on a comparison of the blood concentration values to a predetermined threshold value.

17. The method according to claim 16, wherein if the blood concentration values show a peak above the threshold value after which a plurality of blood concentration values measured consecutively are below the peak but are still above the threshold value, the bleeding event indicates major-active bleeding over time.

18. The method according to claim 16, wherein if the blood concentration values show a steady peak close to the threshold value, the bleeding event indicates a major-non-active bleeding over time.

19. The method according to claim 16, wherein if the blood concentration values show at least one peak below the threshold value, the bleeding event indicates minor bleeding over time.

20. The method according to claim 16, wherein if the blood concentration values are below the threshold value with no distinct peak over time, the bleeding event indicates no bleeding over time.