Method and apparatus for measuring of intestinal potential difference

• US 6,626,847 B1
• Filed: 04/06/2001
• Issued: 09/30/2003
• Est. Priority Date: 10/06/1998
• Status: Expired due to Fees

• Current Assignee: Hendevo AB
• Original Assignee: A+Science Invest AB
• Inventors: Sjövall, Henrik
• Primary Examiner(s): Walberg, Teresa
• Assistant Examiner(s): DAHBOUR, HENRY
• Application Number:
  US09/787,112
• Time in Patent Office: 907 Days
• Field of Search: 600/561, 600/526, 600/481, 600/480, 600/485, 600/547, 600/587, 600/593, 128/898
• US Class Current: 600/561
• CPC Class Codes: A61B 5/03 Detecting, measuring or recording fluid pressure within the body other than blood pressure, e.g. cerebral pressure; Measuring pressure in body tissues or organs A61B5/205 takes precedence
• CPC Class Codes: A61B 5/05 Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves impedance plethysmography A61B5/0295; measuring movement of the entire body or parts thereof A61B5/11; detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof A61B5/24
• CPC Class Codes: A61B 5/0538 invasively, e.g. using a catheter
• CPC Class Codes: A61B 5/392 Detecting gastrointestinal contractions
• CPC Class Codes: A61B 5/4035 Evaluating the autonomic nervous system
• 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 5/4255 Intestines, colon or appendix

Abstract

The present invention relates to a method and apparatus for producing a transmucosal potential different (PD) signal essentially being unaffected by intestinal motor activities. This is accomplished by reducing the PD signal based on time variations in the intraluminal pressure (IP) signal. The invention also relates to different applications of such a signal, such as measurement of the total peripheral resistance (TPR), detection of abnormalties in the enterical nervous system, detection of damages in the mucosal barrier.

Claims

1. A method for producing a preferably continuous transmucosal potential difference (PD) signal essentially being unaffected by intestinal motor activities, characterised by the steps of:

measuring the intestinal potential difference (PD);

measuring the intraluminal pressure (IP) in the intestine; and

reducing the PD signal based on the time variations in the IP signal.

2. A method according to claim 1, wherein the reduction is based on the duration of waves in the IP signal and the time between the waves.

3. A method according to claim 2, wherein the PD signal is based on a constant reduction for the duration of the waves, the constant reduction being determined by a predetermined limit value for the maximal PD enhancement.

4. A method according to claim 3, wherein two or more waves having a time distance between them that is shorter than a predetermined threshold value is considered as one single wave with a duration being the sum of the duration of the actual waves.

5. A method according to claim 2, wherein the reduction is diminished between the waves, preferably in the form of a monoexponential function.

6. A method according to claim 5, wherein the reduction is diminished, preferably following a monoexponential function, when the reduction is at or at least near the maximal reduction value.

7. A method according to claim 1, comprising the step of determining a maximal reduction value, beyond which no further reduction of the PD-signal should be made.

8. A method according to claim 1, wherein the reduction further is based on the mean value of the IP signal.

9. A method for measuring the total peripheral resistance (TPR), characterised by the steps of:

obtaining a transmucosal potential difference (PD) signal essentially without affection from intestinal motor activities, according to the method in claim 1;

obtaining, from this PD signal, a quantitative signal that reflects the TPR.

10. A method according to claim 9, including the initial step of measuring the mean arterial pressure (MAP) and the cardiac output (CO) and determine a calibration value for the TPR as MAP divided by CO.

11. A method for detecting abnormalities in the enterical nervous system, characterised by the steps of:

obtaining a transmucosal potential difference (PD) signal and analyze it according to the method defined in claim 1;

determine whether the connection between the PD signal and the IP signal is abnormal; and

in case of abnormality automatically give an alarm warning for abnormalities in the enterical nervous system.

12. Method according to claim 11, wherein the connection between the PD signal and the IP signal is considered abnormal when the potential difference (PD) signal essentially being reduced from affection from intestinal motor activities shows one or both of a negative value or top values exceeding a predetermined threshold value.

13. An apparatus for detecting abnormalities in the enterical nervous system, characterised by means for obtaining a transmucosal potential difference (PD) signal and analyzing it according to the method defined in claim 1, evaluating means for determining whether the connection between the PD signal and the IP signal is abnormal;

and alarm-means which are automatically activated by the evaluating means in case of abnormality to give an alarm warning for abnormalities in the enterical nervous system.

14. A method for detecting damages in the mucosal barrier, characterised by the steps of:

obtaining a transmucosal potential difference (PD) signal essentially without affection from intestinal motor activities, to the method in claim 1;

obtaining an artificial potential difference (APD) signal, likewise essentially without affection from intestinal motor activities, according to the method in claim 1, generated by a potential measurement with a perfusion with an ionic concentration different from that used in the PD-measurement, and preferably comprising sugar such as glucose or mannitol;

obtaining a mean difference value between the PD and the APD signal; and

detecting a damage in the mucosal barrier when said difference value is lower than a predetermined threshold value.

15. A method according to claim 14, comprising the additional step of in case of a detected damage automatically give an alarm.

16. An apparatus for detecting damages in the mucosal barrier, characterised by means for obtaining a transmucosal potential difference (PD) signal essentially without affection from intestinal motor activities, according to the method in claim 1;

means for obtaining an artificial potential difference (APD) signal, likewise essentially without affection from intestinal motor activities, according to the method in claim 1, with use of a perfusion with an ionic concentration different from that used in the PD-measurement, and preferably comprising sugar such as glucose or mannitol;

means for obtaining a mean difference value between the PD and the APD signal; and

means for detecting a damage in the mucosal barrier when said difference value is lower than a predetermined threshold value.

17. An apparatus according to claim 16, whereby the means for measuring the PD and the APD signal comprises one common catheter, comprising two separate channels debouching at some distance apart at the distal end of the catheterer, and preferably about 5 cm apart.

19. An apparatus according to claim 9, wherein the reduction is based on the duration of waves in the IP signal.

20. An apparatus according to claim 10, wherein the evaluation device is adapted to reduce the input PD signal based on a constant reduction for the duration of the waves, the constant reduction being determined by a predetermined limit value for the maximal PD enhancement.

21. An apparatus according to claim 19, wherein the reduction is diminished between the waves, preferably in the form of a monoexponential function.

18. An apparatus for producing a transmucosal potential difference (PD) signal essentially being unaffected by intestinal motor activities characterised in that it comprises a device for measuring the intestinal potential difference (PD), a device for measuring the intraluminal pressure (IP) in the intestine and an evaluation device, with inputs connected to the measuring devices, for reducing the PD signal based on the time variations in the IP signal, and with an output to supply the reduced PD signal.

22. An apparatus according to claim 18, whereby the evaluation device is adapted to have a maximal reduction value, beyond which no further reduction of the PD-signal should be made.

23. An apparatus according to claim 22, wherein the reduction is diminished, preferably following a monoexponential function, when the reduction is at or at least near the maximal reduction value.

24. An apparatus according to claim 18, wherein the reduction further is based on the mean value of the IP signal.

25. An apparatus for registering changes in the total peripheral resistance (TPR), characterised in that it comprises means for obtaining a transmucosal potential difference (PD) signal essentially without affection from intestinal motor activities, according to the apparatus in claim 18, and evaluating means for estimating, from the PD signal, the TPR.