System and method to diagnose bacterial growth

• US 5,507,289 A
• Filed: 03/23/1994
• Issued: 04/16/1996
• Est. Priority Date: 09/16/1993
• Status: Expired due to Fees

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Synectics Medical, Inc. (Medtronic Plc)
• Inventors: Essen-Moller, Anders
• Primary Examiner(s): Sykes, Angela D.
• Assistant Examiner(s): NASSER, ROBERT L
• Application Number:
  US08/216,588
• Time in Patent Office: 755 Days
• Field of Search: 204/403, 204/406-408, 204/412, 204/416, 128/635, 128/642, 128/644, 128/630
• US Class Current: 600/348
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• 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

Abstract

A system and a method for monitoring intragastrointestinal concentrations of ammonium, and urease, during short or prolonged periods is presented, as an indicator of the presence and activity of an intragastrointestinal Helicobacter Pylori ("HP") infection, and of other bacterial infections that are similarly located. Ambulatory monitoring is possible. This system and method may be used in the evaluation of treatments for HP and other bacterial infection in the patient. A method is also presented to increase the diagnostic accuracy of the system and method by ingesting urea immediately before or during the monitoring.

Claims

1. A system for monitoring a gastrointestinal presence of at least one of an urease producing bacterial strain and an ammonium producing bacterial strain comprising:

(a) an electronic recorder,

(b) a first catheter with a first sensor for detecting the gastrointestinal presence of the bacterial strain, the first sensor being a gastrointestinal ammonium sensing electrode, the first catheter being interconnected with the recorder, and the gastrointestinal ammonium sensing electrode communicating through the first catheter to the recorder, and

(c) a second catheter with a reference Ag/AgCl electrode near a distal end of said second catheter, the second catheter being interconnected with the recorder, and the reference Ag/AgCl electrode communicating, through the second catheter, with the recorder said recorder communicating with said sensor and said electrode to determine the gastrointestinal presence of said bacterial strain.

2. The invention in claim 1, wherein the electronic recorder is an ambulatory digital electronic recorder with RAM memory.

3. The invention in claim 1, wherein the gastrointestinal ammonium Sensing electrode is an ammonium sensitive glass gastrointestinal electrode.

4. The invention in claim 1, and further comprising a second sensor communicating through the first catheter with the recorder, said second sensor being selected from the group consisting of a pH sensor, a potential difference sensor, a pressure sensor, and a motility sensor and sensing a parameter other than gastrointestinal ammonium.

5. A system for monitoring a gastrointestinal presence of at least one of an urease producing bacterial strain and an ammonium producing bacterial strain comprising:

(a) an electronic recorder, comprising an ambulatory digital electronic recorder with RAM memory,

(b) a first catheter with a first sensor for detecting the gastrointestinal presence of the bacterial strain, the first sensor being a gastrointestinal ammonium sensing electrode, the first catheter being interconnected with the recorder, and the gastrointestinal ammonium sensing electrode communicating through the first catheter with the recorder, the gastrointestinal ammonium sensing electrode further comprising an ammonium sensitive glass gastrointestinal electrode,

(c) a second catheter with a reference Ag/AgCl electrode near a distal end of said second catheter, the second catheter being interconnected with the recorder, and the reference Ag/AgCl electrode communicating, through the second catheter, with the recorder, and

(d) a second sensor communicating through the first catheter with the recorder, said second sensor being selected from the group consisting of a pH sensor, a potential difference sensor, a pressure sensor, and a motility sensor and sensing a parameter other than gastrointestinal ammonium said recorder communicating with said first sensor, said second sensor, and said electrode to determine the gastrointestinal presence of said bacterial strain.

6. A system for monitoring a gastrointestinal presence of at least one of an urease producing bacterial strain and an ammonium producing bacterial strain comprising:

(a) an electronic recorder, and

(b) a catheter interconnected with the recorder, the catheter having (i) a first sensor for detecting the gastrointestinal presence of the bacterial strain, the first sensor being a gastrointestinal ammonium sensing electrode communicating, through the catheter, with the recorder, and (ii) a second sensor, the second sensor being a reference Ag/AgCl electrode communicating, through the catheter, with the recorder said recorder communicating with said first sensor and said second sensor to determine the gastrointestinal presence of said bacterial strain.

7. The invention in claim 6, wherein the electronic recorder is an ambulatory digital electronic recorder with RAM memory.

8. The invention in claim 6, wherein the gastrointestinal ammonium sensing electrode is an ammonium sensitive glass gastrointestinal electrode.

9. The invention in claim 6, and further comprising a third sensor communicating through the catheter with the recorder, said third sensor being selected from the group consisting of a pH sensor, a potential difference sensor, a pressure sensor, and a motility sensor and sensing a parameter other than gastrointestinal ammonium.

10. A system for monitoring a gastrointestinal presence of at least one of an urease producing bacterial strain and an ammonium producing bacterial strain comprising:

(a) an electronic recorder, comprising an ambulatory digital electronic recorder with RAM memory,

(b) a catheter interconnected with the recorder, the catheter having (i) a first sensor for detecting the gastrointestinal presence of the bacterial strain, the first sensor being a gastrointestinal ammonium sensing electrode communicating, through the catheter, with the recorder, and (ii) a second sensor, the second sensor being a reference Ag/AgCl electrode communicating, through the catheter, with the recorder, and

(c) a third sensor communicating through the catheter with the recorder, said third sensor being selected from the group consisting of a pH sensor, a potential difference sensor, a pressure sensor, and a motility sensor and sensing a parameter other than gastrointestinal ammonium said recorder communicating with said first sensor, said second sensor, and said third sensor to determine the gastrointestinal presence of said bacterial strain.

11. A method for diagnosing a presence of one of an urease producing bacterial strain and an ammonium producing bacterial strain infection in a patient, determining an effectiveness of a treatment for the infection and monitoring gastrointestinal ammonium levels, comprising the steps of:

(a) attaching an ammonium sensing catheter and a reference Ag/AgCl catheter to an electronic recorder,

(b) calibrating the ammonium sensing catheter with the reference Ag/AgCl catheter,

(c) inserting the ammonium sensing catheter into a gastrointestinal position in the patient,

(d) recording, in RAM memory in the electronic recorder, periodically, during a monitoring period, a plurality of ammonium concentration readings from the ammonium sensing catheter,

(e) uploading recorded ammonium concentration readings to one of an electronic computer and a printer,

(f) presenting graphically the recorded ammonium concentration readings,

(g) diagnosing the presence of the infection from said recorded ammonium concentration readings, and

(h) determining the effectiveness of the treatment from said recorded concentration readings.

12. The invention in claim 11, and further comprising the step of:

correlating the ammonium concentration readings with expected ammonium concentration readings of a particular infection.

13. The invention in claim 11, and further comprising the steps of:

(a) exposing the patient to a treatment for the infection while recording the ammonium concentration readings, and

(b) correlating the recorded ammonium concentration readings with expected ammonium concentration readings of an effective treatment of the infection.

14. A method for diagnosing a presence of a Helicobactor Pylori infection in a patient, determining an effectiveness of a treatment for the infection and monitoring gastrointestinal ammonium levels, comprising the steps of:

(a) attaching an ammonium sensing catheter and a reference Ag/AgCl catheter to an electronic recorder,

(b) calibrating the ammonium sensing catheter with the reference Ag/AgCl catheter,

(c) inserting the ammonium sensing catheter into a gastrointestinal position in the patient,

(d) recording, in RAM memory in the electronic recorder, periodically, during a monitoring period, a plurality of ammonium concentration readings from the ammonium sensing catheter,

(e) uploading recorded ammonium concentration readings to an electronic computer,

(f) correlating the ammonium concentration readings with expected ammonium concentration readings of the Helicobacter Pylori infection to obtain a correlation,

(g) diagnosing the presence of the Helicobacter Pylori infection based on whether the correlation is positive or negative, and

(h) determining the effectiveness of the treatment from said recorded concentration readings.

15. The invention in claim 14, and further comprising the step of:

presenting graphically the recorded ammonium concentration readings and the correlation.

16. The invention in claim 14, and further comprising the steps of:

(a) attaching a pH sensing catheter to the electronic recorder,

(b) inserting the pH sensing catheter into a gastrointestinal position in the patient,

(c) recording, in RAM memory in the electronic recorder, periodically, during a monitoring period, a plurality of pH readings from the pH sensing catheter,

(d) uploading, recorded pH readings to the electronic computer,

(e) correlating the pH readings with the ammonium concentration readings and with expected pH readings and ammonium concentration readings of the Helicobacter pylori infection to obtain a correlation, and

(f) indicating whether the correlation is positive or negative.

17. A method for diagnosing a presence of a Helicobacter Pylori infection in a patient, determining an effectiveness of a treatment for the infection and monitoring gastrointestinal ammonium levels, comprising the steps of:

(a) attaching an ammonium sensing catheter and a reference Ag/AgCl catheter to an electronic recorder,

(b) calibrating the ammonium sensing catheter with the reference Ag/AgCl catheter,

(c) inserting the ammonium sensing catheter into a gastrointestinal position in the patient,

(d) ingesting urea into the patient,

(e) recording, in RAM memory in the electronic recorder, periodically, during a monitoring period, a plurality of ammonium concentration readings from the ammonium sensing catheter,

(f) uploading recorded ammonium concentration readings to an electronic computer,

(g) correlating the ammonium concentration readings with expected ammonium concentration readings of the Helicobacter Pylori infection to obtain a correlation,

(h) diagnosing the presence of the Helicobacter Pylori infection based on whether the correlation is positive or negative, and

(i) determining the effectiveness of the treatment from said recorded concentration readings.

18. The invention in claim 17, and further comprising the step of:

presenting graphically the recorded ammonium concentration readings and the correlation.

19. The invention in claim 17, and further comprising the steps of:

(a) attaching a pH sensing catheter to the electronic recorder,

(b) inserting the pH sensing catheter into a gastrointestinal position in the patient,

(c) recording, in RAM memory in the electronic recorder, periodically, during a monitoring period, a plurality of pH readings from the pH sensing catheter,

(d) uploading recorded pH readings to the electronic computer,

(e) correlating the pH readings with the ammonium concentration readings and with expected pH readings and ammonium concentration readings of the Helicobacter Pylori infection to obtain a correlation, and

(f) indicating whether the correlation is positive or negative.

20. A system for monitoring a gastrointestinal presence of at least one of an urease producing bacterial strain and an ammonium producing bacterial strain comprising:

(a) an electronic recorder, and

(b) a catheter with a gastrointestinal ammonium sensing electrode for detecting the gastrointestinal presence of the bacterial strain, the catheter attached to the recorder, and the gastrointestinal ammonium sensing electrode communicating through the catheter to the attached recorder said recorder communicating with said electrode to determine the gastrointestinal presence of said bacterial strain.

21. The system defined by claim 20, wherein the electronic recorder is an ambulatory digital electronic recorder with RAM memory.

22. The system defined by claim 20, wherein the gastrointestinal ammonium sensing electrode is an ammonium sensitive glass gastrointestinal electrode.

23. The system defined by claim 20, and further comprising a second sensor communicating through the catheter with the recorder, said second sensor being selected from the group consisting of a pH sensor, a potential difference sensor, a pressure sensor, and a motility sensor and sensing a parameter other than gastrointestinal ammonium.

24. A system for monitoring a gastrointestinal presence of at least one of an urease producing bacterial strain and an ammonium producing bacterial strain comprising:

(a) an electronic recorder, comprising an ambulatory digital electronic recorder with RAM memory,

(b) a catheter with (i) a gastrointestinal ammonium sensing electrode for detecting the gastrointestinal presence of the bacterial strain, the catheter attached to the recorder, and the gastrointestinal ammonium sensing electrode communicating through the catheter to the recorder, the gastrointestinal ammonium sensing electrode further comprising an ammonium sensitive glass gastrointestinal electrode, and (ii) a second sensor, the second sensor communicating through the catheter to the recorder, the second sensor being one member selected from the group consisting of a pH sensor, a potential difference sensor, a pressure sensor, and a motility sensor and sensing a parameter other than gastrointestinal ammonium said recorder communicating with said electrode and said second sensor to determine the gastrointestinal presence of said bacterial strain.

25. A method for diagnosing a presence of a Helicobacter Pylori infection in a patient, determining an effectiveness of a treatment for the infection and monitoring gastrointestinal ammonium levels, comprising the steps of:

(a) attaching an ammonium sensing catheter to an electronic recorder,

(b) inserting the ammonium sensing catheter into a gastrointestinal position in the patient,

(c) recording, in RAM memory in the electronic recorder, periodically, during a monitoring period, a plurality of ammonium concentration readings from the ammonium sensing catheter,

(d) uploading recorded ammonium concentration readings to an electronic computer,

(e) correlating the ammonium concentration readings with expected ammonium concentration readings of the Helicobacter Pylori infection to obtain a correlation,

(f) diagnosing the presence of the Helicobacter Pylori infection based on whether the correlation is positive or negative, and

(g) determining the effectiveness of the treatment from said recorded concentration readings.

26. The invention in claim 25, and further comprising the step of:

presenting graphically the recorded ammonium concentration readings and the correlation.

27. The invention in claim 25, and further comprising the steps of:

(a) attaching a pH sensing catheter to the electronic recorder,

(b) inserting the pH sensing catheter into a gastrointestinal position in the patient,

(c) recording, in RAM memory in the electronic recorder, periodically, during a monitoring period, a plurality of pH readings from the pH sensing catheter,

(d) uploading recorded pH readings to the electronic computer,

(e) correlating the pH readings with the ammonium concentration readings and with expected pH readings and ammonium concentration readings of the Helicobacter Pylori infection to obtain a correlation, and

(f) indicating whether the correlation is positive or negative.

28. A method for diagnosing a presence of a Helicobacter Pylori infection in a patient, determining an effectiveness of a treatment for the infection and monitoring gastrointestinal ammonium levels, comprising the steps of:

(a) attaching an ammonium sensing catheter to an electronic recorder,

(b) inserting the ammonium sensing catheter into a gastrointestinal position in the patient,

(c) ingesting urea into the patient,

(d) recording, in RAM memory in the electronic recorder, periodically, during a monitoring period, a plurality of ammonium concentration readings from the ammonium sensing catheter,

(e) uploading recorded ammonium concentration readings to an electronic computer,

(f) correlating the ammonium concentration readings with expected ammonium concentration readings of the Helicobacter Pylori infection to obtain a correlation,

(g) diagnosing the presence of the Helicobacter Pylori infection based on whether the correlation is positive or negative, and

(h) determining the effectiveness of the treatment from said recorded concentration readings.

29. The invention in claim 28, and further comprising the step of:

presenting graphically the recorded ammonium concentration readings and the correlation.

30. The invention in claim 28, and further comprising the steps of:

(a) attaching a pH sensing catheter to the electronic recorder,

(b) inserting the pH sensing catheter into a gastrointestinal position in the patient,

(c) recording, in RAM memory in the electronic recorder, periodically, during a monitoring period, a plurality of pH readings from the pH sensing catheter,

(d) uploading recorded pH readings to the electronic computer,

(e) correlating the pH readings with the ammonium concentration readings and with expected pH readings and ammonium concentration readings of the Helicobacter Pylori infection to obtain a correlation, and

(f) indicating whether the correlation is positive or negative.