Method and apparatus for detection of acid reflux
First Claim
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1. A device for determining the duration of exposure of a patient'"'"'s esophagus to pH levels clinically significant for gastroesophageal reflux disease comprising:
- a capsule containing a known amount of radioactive material, and being subject to pH-dependent degradation at pH less than about pH 4, and being of a size to be readily swallowable;
a cord, the cord having a proximal end and a distal end, the proximal end being connected to the capsule, whereby the cord allows positioning and retrieval of the capsule.
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Abstract
Methods and apparatus for monitoring gastrointestinal pH levels are disclosed. A gastroesophageal diagnostic device for determining the duration of exposure of a patient'"'"'s esophagus to pH levels clinically significant for gastroesophageal reflux disease is disclosed.
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Citations
18 Claims
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1. A device for determining the duration of exposure of a patient'"'"'s esophagus to pH levels clinically significant for gastroesophageal reflux disease comprising:
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a capsule containing a known amount of radioactive material, and being subject to pH-dependent degradation at pH less than about pH 4, and being of a size to be readily swallowable;
a cord, the cord having a proximal end and a distal end, the proximal end being connected to the capsule, whereby the cord allows positioning and retrieval of the capsule. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10)
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11. A method of detecting gastroesophageal reflux comprising:
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providing a gastroesophageal diagnostic device, said gastroesophageal diagnostic device comprising a capsule having a cord attached thereto, the capsule containing a known first level of radioactivity and being subject to pH-dependent degradation at pH levels less than about pH 4;
introducing the gastroesophageal diagnostic device into the esophagus of a patient;
positioning the gastroesophageal diagnostic device in the esophagus of the patient such that the capsule is positioned in the lower one-third of the esophagus;
leaving the gastroesophageal diagnostic device in the esophagus of the patient for a selected time, whereby the capsule degrades and looses radioactivity in a pH-dependent manner;
removing the gastroesophageal diagnostic device from the patient after the selected time;
determining a second level of radioactivity remaining in the capsule after the selected time, calculating the reduction in the amount of radioactivity from the first level of radioactivity in the capsule to the second level of radioactivity in the capsule; and
determining the percentage of the selected time during which the capsule was exposed to pH levels less than about pH 4, wherein the reduction in the amount of radioactivity is correlated to the percentage of the selected time during which the capsule was exposed to pH levels less than about pH 4, and wherein exposure of the capsule to pH levels less than about pH 4 for at least a determined percent of the selected time is indicative of gastroesophageal reflux disease. - View Dependent Claims (12, 13, 14, 15, 16, 17)
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18. A method of determining the duration of exposure of a patient'"'"'s gastrointestinal tract to pH levels less than about pH 4 comprising:
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providing a gastrointestinal diagnostic device, said gastrointestinal diagnostic device comprising a capsule having a cord attached thereto, the capsule containing a known first level of radioactivity and being subject to pH-dependent degradation at pH levels less than about pH 4;
introducing the gastrointestinal diagnostic device into the gastrointestinal tract of a patient;
positioning the gastrointestinal tract of a patient device in the gastrointestinal tract of the patient such that the capsule is positioned at a predetermined location in gastrointestinal tract of the patient;
leaving the gastrointestinal diagnostic device in the gastrointestinal tract of the patient for a selected time, whereby the capsule degrades and looses radioactivity in a pH-dependent manner;
removing the gastrointestinal diagnostic device from the patient after the selected time;
determining a second level of radioactivity remaining in the capsule after the selected time;
calculating the reduction in the amount of radioactivity from the first level of radioactivity in the capsule to the second level of radioactivity in the capsule; and
determining the percentage of the selected time during which the capsule was exposed to pH levels less than about pH 4, wherein the reduction in the amount of radioactivity is correlated to the percentage of the selected time during which the capsule was exposed to pH levels less than about pH 4.
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Specification