Uterine tissue monitoring device and method

• US 20040193028A1
• Filed: 03/28/2003
• Published: 09/30/2004
• Est. Priority Date: 03/28/2003
• Status: Active Grant

• Current Assignee: Vascular Control Systems, Inc. (Johnson & Johnson)
• Original Assignee: Vascular Control Systems, Inc. (Johnson & Johnson)
• Inventors: Jones, Michael L., Burbank, Fred H., Altieri, Greig E., Uyeno, Jill
• Granted Patent: US 7,333,844 B2
• Time in Patent Office: Days
• US Class Current: 600/361
• 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 5/4325 of the uterine cavities, e.g. uterus, fallopian tubes, ovaries

Abstract

The invention provides a devices, methods and systems to measure and record uterine tissue environment components such as pH during the course of uterine artery occlusion. The uterus becomes ischemic due to the occlusion thereof, and its pH drops sharply within minutes of uterine artery occlusion and remains relatively low for a period of time. The return of normal pH is an indicator of return of blood to the ischemic tissue. In use, a catheter with a pH measuring tip is advanced through the patient'"'"'s vaginal canal and into the patient'"'"'s uterine cavity until the pH measuring active electrode on the distal end of the catheter contacts or penetrates the uterine fundus. The active electrode detects the pH and a signal representing pH is transmitted to a pH recording and monitoring device which preferably displays the pH. The signal may be transmitted through a conductor or by a radio transmitter. Components other than pH may be monitored such a pCO₂, and pO₂.

Claims

1. A transvaginal device for measuring the pH of a female patient'"'"'s uterine tissue, comprising:

a. an elongated introducer sheath which is configured to extend through a female patient'"'"'s vaginal canal, uterine cervix and into the uterine cavity of the female patient'"'"'s uterus and which has an elongated shaft, proximal and distal ends, a first port in the proximal end, a second port in the distal end and an inner lumen extending within the shaft in fluid communication with the first and second ports; and

b. a pH measuring catheter which is configured to be slidably disposed within the inner lumen of the introducer sheath and which has an elongated shaft with a proximal end and a distal end, which has an active electrode at the distal end of the shaft and which is configured to transmit a signal from the active electrode to a pH monitoring unit.

2. The transvaginal device of claim 1 including a biasing mechanism interconnecting the catheter and elongated sheath to urge the catheter distally with respect to the elongated sheath to ensure that the active electrode on the distal end of the catheter engages endometrial tissue within the uterine cavity.

3. The transvaginal device of claim 1 wherein the active electrode is a porous electrode.

4. The transvaginal device of claim 2 wherein the active electrode is an antimony based half cell electrode.

5. The transvaginal device of claim 1 including a reference electrode which is configured to be secured to an exterior location on the patient'"'"'s body.

6. The transvaginal device of claim 1 including a reference electrode which is located on the shaft proximal to the active electrode.

7. The transvaginal device of claim 1 wherein the pH catheter is electrically connected to a pH monitoring unit by an electrical conductor for transmitting an electrical signal representing the voltage sensed by the active electrode.

8. The transvaginal device of claim 7 including a reference electrode which is configured to be secured to an exterior location on the patient'"'"'s body and a connected signal transmitting member for transmitting a signal representing the voltage sensed by the reference electrode.

9. The transvaginal device of claim 1 wherein the pH catheter is provided with a transmitter to transmit a signal from the active electrode representing a uterine tissue parameter to the pH monitor which converts the signal to a pH value.

10. The transvaginal device of claim 8 wherein the pH monitor includes a manifold which develops a signal representing a difference between voltage sensed by the active electrode and voltage sensed by the reference electrode which is a measure of the pH of the uterine lining tissue.

11. The transvaginal device of claim 5 wherein the reference electrode is a silver/silver chloride half cell.

12. The transvaginal device of claim 1 wherein the sheath configured to provide access to the patient'"'"'s uterine cavity is configured to be secured at least in part to the patient.

13. The transvaginal device of claim 12 wherein the sheath is in part secured within the patient'"'"'s vaginal canal.

14. The transvaginal device of claim 2 wherein the biasing mechanism is configured to be releasably secured to the catheter shaft.

15. The transvaginal device of claim 14 wherein a Toughy-Borst adapter is provided on a proximal end of the biasing mechanism to releasably secure the proximal end of the biasing mechanism to the catheter shaft.

16. The transvaginal device of claim 2 wherein the biasing mechanism is a spring.

17. A method of monitoring the pH of tissue lining a female patient'"'"'s uterine cavity during a medical treatment which includes occluding one or more uterine arteries, comprising:

a. providing a pH measuring catheter having an elongated shaft with proximal and distal end and an active electrode on the distal end thereof;

b. advancing the pH measuring catheter through the patient'"'"'s vaginal canal, into the female patient'"'"'s uterine cavity;

c. urging the active electrode on the distal end of the pH measuring catheter into contact with uterine tissue; and

d. generating a signal representing a pH parameter of the uterine tissue environment.

18. The method of claim 17 wherein a pH signal is generated representing the difference between the signal representing the pH parameter of the body cavity and a signal received from a reference electrode secured to an exterior portion of the patient.

19. The method of claim 17 wherein the difference signal is transmitted to a monitoring unit which displays pH units.

20. The method of claim 17 wherein an introducer sheath is introduced through the patient'"'"'s vaginal canal and into the patient'"'"'s uterine cavity and is secured to the patient.

21. The method of claim 20 wherein a biasing spring is secured between the introducer sheath and the pH measuring catheter to urge the active electrode into contact with uterine tissue.

22. The method of claim 21 wherein the uterine tissue is endometrial tissue.

23. The method of claim 21 wherein the uterine tissue is myometrial tissue.

24. The method of claim 17 wherein the pH of the patient'"'"'s uterine lining tissue is monitored for at least 0.5 hour.

25. The method of claim 17 wherein the pH of the patient'"'"'s uterine lining tissue is monitored for a period of up to about 48 hours.

26. A device for monitoring a component of a female patient'"'"'s uterine tissue, comprising:

b. an elongated introducer sheath which is configured to extend through a female patient'"'"'s vaginal canal, uterine cervix and into the uterine cavity of the female patient'"'"'s uterus and which has an elongated shaft, proximal and distal ends, a first port in the proximal end, a second port in the distal end and an inner lumen extending within the shaft in fluid communication with the first and second ports; and

b. a component monitoring catheter which is configured to be slidably disposed within the inner lumen of the introducer sheath, which has an elongated shaft with a proximal end and a distal end, which has an active electrode at the distal end of the shaft, which is configured to transmit a signal representing the component concentration in the tissue environment the active electrode with a pH monitoring unit.

27. The device of claim 26 wherein a reference electrode is held in contact with the patient'"'"'s body to generate a reference signal by the reference electrode is compared with the signal representing the component concentration in the tissue environment.

28. The device of claim 27 wherein a manifold is provided to generate a difference signal between the reference signal and the signal from the active electrode.

29. The device of claim 28 wherein a conductor is provided to transmit the difference signal to the pH monitor.

30. A method of treating a female patient'"'"'s uterus, comprising:

a. occluding one or more of the patient'"'"'s uterine arteries, comprising;

b. detecting the concentration of a component of uterine tissue environment,

c. monitoring the concentration of the detected component;

d. re-establishing blood flow in the patient'"'"'s uterine artery after the concentration of the detected component returns to pre-occlusion levels or near pre-occlusion levels.

31. The method of claim 30 wherein the component is the hydrogen ion concentration.

32. The method of claim 31 wherein the hydrogen ion concentration is detected by a pH detecting electrode.

33. The method of claim 32 wherein a pH measuring catheter having an elongated shaft with proximal and distal end and an active electrode on the distal end thereof is advanced through the patient'"'"'s vaginal canal, into the female patient'"'"'s uterine cavity and the active electrode is urged into contact with uterine tissue.

34. The method of claim 33 wherein a signal is generated which represents a pH parameter of the uterine tissue environment.

35. The method of claim 34 wherein a pH signal is generated representing the difference between the signal representing the pH parameter of the body cavity and a signal received from a reference electrode secured to the patient

36. The method of claim 35 wherein the difference signal is transmitted to a monitoring unit which displays pH units relating to the signal received.

37. The method of claim 33 wherein an introducer sheath is introduced through the patient'"'"'s vaginal canal and into the patient'"'"'s uterine cavity and is secured to the patient.

38. The method of claim 37 wherein a biasing spring is secured between the introducer sheath and the pH measuring catheter to urge the active electrode into contact with uterine tissue.

39. The method of claim 33 the active electrode is urged against endometrial uterine tissue.

40. The method of claim 33 wherein the uterine tissue is myometrial tissue.

41. The method of claim 32 wherein the pH of the patient'"'"'s uterine lining tissue is monitored for at least 0.5 hour.

42. The method of claim 32 wherein the pH of the patient'"'"'s uterine lining tissue is monitored for a period of up to about 48 hours.