Claims
- 1. A diagnostic device for detection of urease producing Helicobacter pylori within a subject's stomach comprising:a soluble container, said container containing a combination of: (1 ) a pharmaceutically acceptable first pH indicator with a pH range from about 5.5 to about 9.0, said first pH indicator having a first indicium to indicate an alkaline pH and a second indicium to indicate an acidic pH, (2) a pharmaceutically acceptable second pH indicator wcombination, said second pH indicator combination including a second pH indicator with a pH range of from about 5.5 to about 9.0 and having a first indicium to indicate an acidic pH and a third indicium to indicate an alkaline pH range, and a reagent, said reagent reacting with urease to generate ammonia, said first pH indicator first indicium and said second pH indicator combination first indicium having the same indicium, and said first pH indicator second indicium and said second pH indicator combination third indicium having different indicium from one another and from said first pH indicator first indicium and said second pH indicator first indicium, said first pH indicator and said second pH indicator combination reacting to a presence or absence of urease producing Helicobacter by change, or lack of change, of indicium, wherein: both said first pH indicator and said second pH indicator combination indicating an acidic pH indicates an absence of said Helicobacter and said stomach is acidic and there is an absence of urease producing Helicobacter; said first pH indicator second indicium and said second pH indicator combination third indicium indicating an alkaline pH range indicates said stomach is alkaline and no determination regarding a gastrointestinal disorder can be made; and said first pH indicator first indicium indicating an acidic pH and said second pH indicator combination third indicium indicating an alkaline pH indicates the presence of ammonia and the presence of urease producing Helicobacter.
- 2. The diagnostic device of claim 1, further comprising:a first dense carrier, said first dense carrier being pharmaceutically acceptable, soluble in gastric fluids, and having a density sufficient to cause said first carrier to descend through stomach fluids to said stomach's gastric mucosa; a second dense carrier material, said second dense carrier being pharmaceutically acceptable, soluble in gastric fluids, and having a density sufficient to cause said second carrier to descend through stomach fluids to said stomach's gastric mucosa; said first dense carrier being combined with said first pH indicator, and said second dense carrier being combined with said second pH indicator combination.
- 3. The diagnostic device of claim 1, wherein said indicium is color, said first pH indicator first indicium being a first color at an acidic pH and said second indicium being a second color at an alkaline pH and said second pH indicator combination first indicium being said first color at an acidic pH and said second indicium being a third color at an alkaline pH, each of said first pH indicator first indicium and said second pH indicator combination first indicium can be the same color and said first pH indicator second pH indicium and said second indicator combination third indicium being different colors from one another and from said first pH indicator first indicium and said second pH indicator combination first indicium.
- 4. The diagnostic device of claim 1, wherein said container is a soluble capsule, said soluble capsule containing said first carrier and said second carrier combination and being soluble in gastric fluids.
- 5. The diagnostic device of claim 2, wherein said first dense carrier material and said second dense carrier material are pharmaceutically acceptable products which sorb said indicators and dissolve in said gastric fluids in about five minutes after reaching said stomach's gastric mucosa.
- 6. The diagnostic device of claim 2, wherein said first dense carrier material and said second dense carrier material are in the form of beads, thereby facilitating dispersal of said indicators over the mucosa.
- 7. The diagnostic device of claim 1 wherein said reagent is urea.
CROSS-REFERENCE TO RELATED PATENT APPLICATION
This application is a continuation in part of patent application Ser. No. 08/832,332 filed on Mar. 26, 1997, now U.S. Pat. No. 6,228,605 which is a continuation of Ser. No. 08/489,816 filed on Jun. 13, 1995, now abandoned the disclosures of which are incorporated herein by reference as though recited in full.
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Continuation in Parts (1)
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08/832332 |
Mar 1997 |
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Child |
09/824870 |
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