Method of evaluating constipation using an ingestible capsule

#The present invention relates generally to ingestible capsules and, more particularly, to a process for evaluating a subject for constipation with an ingested capsule passing through the digestive tract of the subject.

#Ingestible capsules are well-known in the prior art. Such capsules are generally small pill-like devices that can be ingested or swallowed by a patient. It is known that such capsules may include one or more sensors for determining physiological parameters of the gastrointestinal tract, such as sensors for detecting temperature, pH and pressure.

#It is also known that certain physiological parameters may be associated with regions of the gastrointestinal tract. For example, a 1988 article entitled “Measurement of Gastrointestinal pH Profiles in Normal Ambulant Human Subjects” discloses pH measurements recorded by a capsule passing through the gastrointestinal tract. It is known that pH has been correlated with transitions from the stomach to the small bowel (gastric emptying) and from the distal small bowel to the colon (ileo-caecal junction).

#FIG. 1 is a sectional view of an embodiment of an ingestible capsule adapted to record pressure, pH and temperature measurements in the gastrointestinal tract.

#FIG. 2 is a schematic of an embodiment of a capsule system for evaluating a subject for constipation.

#FIG. 3 is a graph of pH versus time taken by a capsule passing through the gastrointestinal tract.

#At the outset, it should be clearly understood that like reference numerals are intended to identify the same structural elements, portions or surfaces consistently throughout the several drawing figures, as such elements, portions or surfaces may be further described or explained by the entire written specification, of which this detailed description is an integral part. Unless otherwise indicated, the drawings are intended to be read (e.g., cross-hatching, arrangement of parts, proportion, degree, etc.) together with the specification, and are to be considered a portion of the entire written description of this invention. As used in the following description, the terms “horizontal”, “vertical”, “left”, “right”, “up” and “down”, as well as adjectival and adverbial derivatives thereof (e.g., “horizontally”, “rightwardly”, “upwardly”, etc.), simply refer to the orientation of the illustrated structure as the particular drawing figure faces the reader. Similarly, the terms “inwardly” and “outwardly” generally refer to the orientation of a surface relative to its axis of elongation, or axis of rotation, as appropriate.

#A method is provided for evaluating a subject for constipation using an ingestible capsule as a function of pH readings taken by the ingested capsule, density and/or size of the ingested capsule and transit times. Capsule 20 is ingested by a subject and readings from sensors on the capsule are taken as the capsule passes through the gastrointestinal tract of the subject. Data from pressure sensor 23, pH sensor 22 and temperature sensor 24 are collected and analyzed to determine transit times, which are compared to one or more reference templates or criteria for the density and/or size of capsule 20 to evaluate the subject for constipation.

#Referring now to the drawings, and more particularly to FIG. 2 thereof, this invention provides a new method for evaluating constipation using an ingested capsule system, of which a first embodiment is generally indicated at 15. As shown in FIG. 2, capsule system 15 generally includes ingestible capsule 20, receiver 17, and computer workstation 19. Capsule 20 includes pressure sensor assembly 23, pH sensor 22 and temperature sensor 24 for taking measurements of pressure, pH and temperature, respectively, of a subject's gastrointestinal tract, power source 21, and transmitter 16 for transmitting the measurement data. Receiver 17 is configured to receive signals sent from transmitter 16. Computer workstation 19 includes processor 31 and is programmed to process measurements from pressure sensor 23, pH sensor 22 and temperature sensor 24.