Uterine tissue monitoring device and method

• US 7,616,979 B2
• Filed: 04/28/2006
• Issued: 11/10/2009
• Est. Priority Date: 03/28/2003
• Status: Expired due to Fees

• 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
• Primary Examiner(s): Mallari; Patricia C
• Application Number:
  US11/413,260
• Publication Number:
  US 20060241337A1
• Time in Patent Office: 1,292 Days
• Field of Search: 600/361, 128/898, 604/515, 606/119
• 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 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 a proximal end, a distal end, and an active electrode on the distal end thereof for detecting a pH parameter;

b. advancing the pH measuring catheter through the patient'"'"'s vaginal canal until the distal end is located in 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 within the uterine cavity; and

d. generating a signal from the active electrode representing a pH parameter of the uterine tissue, wherein an introducer sheath having an inner lumen is introduced through the patient'"'"'s vaginal canal into the patient'"'"'s uterine cavity and is secured to the patient and the catheter is introduced through the inner lumen of the introducer sheath.

2. The method of claim 1 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.

3. The method of claim 2 wherein the difference signal is transmitted to a monitoring unit which displays pH units.

4. The method of claim 1 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.

5. The method of claim 4 wherein the uterine tissue is endometrial tissue.

6. The method of claim 1 wherein the pH parameter of the patient'"'"'s uterine lining tissue is monitored by the active electrode for at least 0.5 hour.

7. The method of claim 1 wherein the pH parameter of the patient'"'"'s uterine lining tissue is monitored for a period of up to about 48 hours.

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

a. detecting the concentration of a component of uterine tissue environment;

b. occluding one or more of the patient'"'"'s uterine arteries;

c. using a pH monitoring unit for monitoring the concentration of the detected component after occluding one or more of the patient'"'"'s uterine arteries; and

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.

9. The method of claim 8 wherein the detected component is the hydrogen ion concentration.

10. The method of claim 9 wherein the hydrogen ion concentration is detected by a pH detecting electrode.

11. The method of claim 8 wherein a pH measuring catheter having an elongated shaft with a proximal end and a 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 to detect a pH parameter.

12. The method of claim 11 wherein a signal is generated which represents the detected pH parameter.

13. The method of claim 12 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.

14. The method of claim 11 wherein the difference signal is transmitted to a monitoring unit which displays pH units relating to the signal received.

15. The method of claim 11 wherein an introducer sheath with an inner lumen is introduced through the patient'"'"'s vaginal canal into the patient'"'"'s uterine cavity and is secured to the patient and the pH measuring catheter is introduced through the inner lumen of the introducer sheath into the patient'"'"'s uterine cavity.

16. The method of claim 15 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.

17. The method of claim 16 wherein the active electrode is urged into contact with endometrial uterine tissue.

18. The method of claim 16 wherein the active electrode is urged into contact with myometrial uterine tissue.

19. The method of claim 8 wherein the concentration of the detected component is monitored for at least 0.5 hour.

20. The method of claim 8 wherein the concentration of the detected component is monitored for a period of up to about 48 hours.