Method of evaluating constipation using an ingestible capsule

• US 8,945,010 B2
• Filed: 12/17/2010
• Issued: 02/03/2015
• Est. Priority Date: 12/23/2009
• Status: Active Grant

• Current Assignee: Given Imaging Incorporated (Medtronic Plc)
• Original Assignee: Covidien LP (Medtronic Plc)
• Inventors: Semler, John R
• Primary Examiner(s): Thomson, William
• Assistant Examiner(s): SANDS, DAVIN K
• Application Number:
  US12/971,989
• Publication Number:
  US 20110257490A1
• Time in Patent Office: 1,509 Days
• Field of Search: None
• US Class Current: 600/301
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• 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 5/14539 for measuring pH
• 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 5/6861 Capsules, e.g. for swallowing or implanting
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

A method for diagnosing constipation comprising the steps of providing an ingestible capsule (20) having a given density and a pH sensor (22) and a temperature sensor (24), having a subject ingest the capsule, recording pH measurements from the pH sensor as a function of time as the capsule moves through at least a portion of the gastrointestinal tract of the subject, transmitting the pH measurements to a processor (19) outside of the gastrointestinal tract of the subject, recording temperature measurements from the temperature sensor as a function of time as the capsule moves through at least a portion of the gastrointestinal tract of the subject, transmitting the temperature measurements to a processor (19) outside of the gastrointestinal tract of the subject, determining transit time of the capsule between a first location in the gastrointestinal tract of the subject and a second location in the gastrointestinal tract of the subject as a function of the pH measurements and the temperature measurements, providing a reference transit time that is a function of the density of the capsule, and comparing the determined transit time to the reference transit time to evaluate the subject for constipation.

Claims

1. A method of evaluating constipation in a subject having one or more symptoms of constipation, said subject having swallowed an ingestible capsule comprising a pH sensor and a temperature sensor, the method comprising the steps of:

recording pH and temperature measurements from said pH and temperature sensors, respectively, as a function of time as said capsule moves through at least a portion of the gastrointestinal tract of said subject;

transmitting said pH and temperature measurements to a processor outside of said gastrointestinal tract of said subject, wherein said processor is configured to;

determine said capsule'"'"'s location at a first position and at a second position in said gastrointestinal tract as a function of said measurements;

determine transit time between said first position and said second position to ascertain colonic transit time (CTT) and whole-gut transit time (WGTT);

provide a reference transit time; and

compare said CTT and said WGTT to said reference transit time to evaluate said subject for constipation, wherein said constipation is verified when said CTT and WGTT are slower compared to said reference transit time.

2. The method set forth in claim 1, wherein the processor is further configured to determine one or more of gastric emptying time (GET), small bowel transit time (SBTT), and small and large bowel transit time (SLBTT).

3. The method set forth in claim 1, wherein said reference transit time is a function of corresponding transit time of a capsule for a healthy control sample population.

4. The method set forth in claim 1, wherein said subject is identified as having normal transit constipation when said CTT is not slower than said reference transit time and said subject possesses a plurality of said symptoms of functional constipation selected from the group consisting of:

straining during at least 25% of defecations;

lumpy or hard stools in at least 25% of defecations;

sensation of incomplete evacuation for at least 25% of defecations;

sensation of anorectal obstruction/blockage for at least 25% of defecations;

manual maneuvers to facilitate at least 25% of defecations;

fewer than three defecations per week;

loose stools which are rarely present without the use of laxatives; and

insufficient criteria for irritable bowel syndrome.

11. The method set forth in claim 1, wherein said one or more symptoms of functional constipation are selected from the group consisting of:

straining during at least 25% of defecations;

lumpy or hard stools in at least 25% of defecations;

sensation of incomplete evacuation for at least 25% of defecations;

sensation of anorectal obstruction/blockage for at least 25% of defecations;

manual maneuvers to facilitate at least 25% of defecations;

fewer than three defecations per week;

loose stools which are rarely present without the use of laxatives; and

insufficient criteria for irritable bowel syndrome.

14. The method set forth in claim 1, wherein said capsule has a density from about 0.026 to about 0.029 grams/cm³.

5. A method of evaluating constipation in:

a subject having one or more symptoms of constipation,

said subject having swallowed an ingestible capsule comprising a pH sensor, a temperature sensor, and a pressure sensor, the method comprising the steps of;

recording pH, pressure and temperature measurements from said pH, pressure and temperature sensors, respectively, as a function of time as said capsule moves through at least a portion of the gastrointestinal tract of said subject;

transmitting said measurements to a processor outside of said gastrointestinal tract of said subject, wherein said processor is configured to;

determine said capsule'"'"'s location at a first position and at a second position in said gastrointestinal tract as a function of said measurements;

determine transit time between said first position and said second position to ascertain colonic transit time (CTT) and whole-gut transit time (WGTT);

provide a reference transit time; and

compare said CTT and WGTT to said reference transit time to evaluate said subject for constipation, wherein said constipation is verified when said CTT and said WGTT are slower compared to said reference transit time.

6. The method set forth in claim 5, wherein the processor is further configured to determine one or more of gastric emptying time (GET), small bowel transit time (SBTT), and small and large bowel transit time (SLBTT).

7. The method set forth in claim 5, wherein said reference transit time is a function of corresponding transit time for a healthy control sample population.

8. The method set forth in claim 5, wherein said subject is identified as having normal transit constipation when said CTT is not slower than said reference transit time and said subject possesses a plurality of said symptoms of functional constipation selected from the group consisting of:

straining during at least 25% of defecations;

lumpy or hard stools in at least 25% of defecations;

sensation of incomplete evacuation for at least 25% of defecations;

sensation of anorectal obstruction/blockage for at least 25% of defecations;

manual maneuvers to facilitate at least 25% of defecations;

fewer than three defecations per week;

loose stools which are rarely present without the use of laxatives; and

insufficient criteria for irritable bowel syndrome.

12. The method set forth in claim 5, wherein said one or more symptoms of functional constipation are selected from the group consisting of:

straining during at least 25% of defecations;

lumpy or hard stools in at least 25% of defecations;

sensation of incomplete evacuation for at least 25% of defecations;

sensation of anorectal obstruction/blockage for at least 25% of defecations;

manual maneuvers to facilitate at least 25% of defecations;

fewer than three defecations per week;

loose stools which are rarely present without the use of laxatives; and

insufficient criteria for irritable bowel syndrome.

15. The method set forth in claim 5, wherein said capsule has a density from about 0.026 to about 0.029 grams/cm³.

9. A method for determining the presence and severity of slow colonic transit constipation (SCTC) in a subject having one or more symptoms of constipation, said subject having swalloded an ingestible capsule comprising a temperature sensor and one or both of a pH sensor and a pressure sensor, the method comprising the steps of:

recording measurements from said temperature sensor and one or both of said pH sensor and said pressure sensor as a function of time as said capsule moves through said subject'"'"'s colon;

transmitting said measurements to a processor external to said subject, wherein said processor is configured to;

determine said capsule'"'"'s transit time based on a first colonic position and a second colonic position as a function of said measurements;

compare said measurements to a reference transit time;

diagnose the presence of said SCTC based on the comparison, wherein said subject is afflicted with said SCTC if said capsule'"'"'s transit time is slower than said reference transit time, wherein the slower the capsule'"'"'s transit time relative to the reference transit time, the more severe the SCTC.

10. The method set forth in claim 9, wherein said reference transit time is a function of corresponding transit time of a capsule for a healthy control sample population.

13. The method set forth in claim 9, wherein said one or more symptoms of functional constipation are selected from the group consisting of:

straining during at least 25% of defecations;

lumpy or hard stools in at least 25% of defecations;

sensation of incomplete evacuation for at least 25% of defecations;

sensation of anorectal obstruction/blockage for at least 25% of defecations;

manual maneuvers to facilitate at least 25% of defecations;

fewer than three defecations per week;

loose stools which are rarely present without the use of laxatives; and

insufficient criteria for irritable bowel syndrome.

16. The method set forth in claim 9, wherein said capsule has a density from about 0.026 to about 0.029 grams/cm³.