Integrity testing method and apparatus for delivering vapor to the uterus

• US 9,662,060 B2
• Filed: 10/09/2012
• Issued: 05/30/2017
• Est. Priority Date: 10/07/2011
• Status: Active Grant

• Current Assignee: Coopersurgical Incorporated (The Cooper Cos., Inc.)
• Original Assignee: Aegea Medical Inc. (The Cooper Cos., Inc.)
• Inventors: Peliks, Robert Bilgor, Gurskis, Donnell William, Bacich, Steven Robert, Chee, Uriel Hiram
• Primary Examiner(s): Eiseman, Adam J
• Assistant Examiner(s): FERNANDES, PATRICK M
• Application Number:
  US13/648,132
• Publication Number:
  US 20130090572A1
• Time in Patent Office: 1,694 Days
• CPC Class Codes: A61B 18/04 by heating by applying electromagnetic radiation A61B18/18; hyperthermia using electric or magnetic fields, radiation or ultrasound A61N
• CPC Class Codes: A61B 2018/00285 Balloons
• CPC Class Codes: A61B 2018/00559 Female reproductive organs
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/048 in gaseous form
• CPC Class Codes: A61B 5/035 Intra-uterine probes therefor
• CPC Class Codes: A61B 5/4325 of the uterine cavities, e.g. uterus, fallopian tubes, ovaries
• CPC Class Codes: A61B 5/6847 mounted on an invasive device

Abstract

A method and system of providing therapy to a patient'"'"'s uterus is provided, which can include any number of features. The method can include the steps of inserting a uterine device into the uterus and performing a uterine integrity test to determine that the uterus is intact and not perforated. If it is determined that the uterus is not perforated, a patency test can be performed to determine that the uterine device is not clogged or embedded in tissue. If the uterus is intact and the device is not clogged or embedded in tissue, the uterus can be treated with the uterine device, e.g., uterine ablation. Systems for performing these methods are also disclosed.

Claims

1. A method of performing a procedure on a uterus of a patient, comprising:

performing a uterine integrity test comprising;

inserting a uterine device into the uterus of the patient;

delivering gas or fluid from an inflow lumen of the uterine device into the uterus;

measuring a flow rate of the gas or fluid as it is delivered into the uterus;

determining that the uterus is sealed if the flow rate decreases below a flow rate threshold value;

eliminating retrograde flow from the uterus back through the uterine device with a one way valve disposed in the inflow lumen; and

after performing the uterine integrity test and determining that the uterus is sealed, performing a patency test for the uterine device comprising;

delivering gas or fluid from the inflow lumen of the uterine device into the uterus;

removing gas or fluid from the uterus with an outflow lumen of the uterine device;

determining that the uterine device is not clogged or embedded in tissue if a flow rate of gas or fluid removed from the uterus is observed through the outflow lumen of the uterine device.

2. The method of claim 1 wherein the uterine device is a uterine ablation device.

3. The method of claim 1 wherein fluid flow is observed in a flow meter of the outflow lumen.

4. The method of claim 1 wherein the determining that the uterus is sealed step further comprises determining that the uterus is sealed if the flow rate decreases below a flow rate threshold value within a predetermined time period.

5. The method of claim 1 wherein the one way valve prevents retrograde flow and sinusoidal wave forms in response to uterine contractions.

6. The method of claim 1 wherein the determining that the uterus is sealed step further comprises determining that the uterus is sealed if the flow rate decreases to zero after the predetermined time period.

7. The method of claim 1 wherein the delivering steps further comprise delivering gas or fluid from the inflow lumen of the uterine device into the uterus at a constant pressure bounded by a safety threshold pressure.

8. The method of claim 7 wherein the safety threshold pressure is approximately 70 mm Hg.

9. The method of claim 1 where the flow rate threshold value is between 2 and 5 ml/min.

10. The method of claim 1 further comprising, during the patency test, determining that the uterine device is clogged or embedded in tissue if the return flow of gas or fluid is not observed in the outflow lumen of the uterine device.

11. The method of claim 1 further comprising, during the uterine integrity test, determining that the uterus has a perforation that is sealed at lower pressures and is opened at higher pressures if the flow rate oscillates between a low level and a high level.

12. The method of claim 1 wherein, during the uterine integrity test, the determining that a uterus is sealed step further comprises determining that the uterus is sealed if the flow rate averages approximately zero or the flow rate average is below a threshold value over a predetermined time period.

13. The method of claim 2 further comprising, after determining that the uterus is sealed and that the uterine ablation device is not clogged or embedded in tissue, delivering a heated condensable vapor to the uterus to ablate uterine tissue.

14. The method of claim 1 further comprising assessing a volume of gas or fluid delivered in the integrity test to estimate a size of the uterus.

15. The method of claim 1 further comprising assessing a volume of gas or fluid delivered in the integrity test to estimate a location of a distal tip of the uterine device within the uterus.

16. The method of claim 1 further comprising assessing a flow rate of gas or fluid delivered in the integrity test to estimate a location of a distal tip of the uterine device within the uterus.

17. The method of claim 15 wherein assessing the volume indicates that the distal tip is in a false passage.

18. The method of claim 16 wherein assessing the flow rate indicates that the distal tip is in a false passage.

19. The method of claim 15 wherein assessing the volume indicates that the distal tip is in the patient'"'"'s peritoneal cavity.

20. The method of claim 19 wherein assessing the flow rate indicates that the distal tip is in the patient'"'"'s peritoneal cavity.

21. The method of claim 1 wherein the delivering gas or fluid step of the uterine integrity test further comprises delivering gas or fluid from inflow and outflow lumens of the uterine device to the uterus.

22. The method of claim 1 wherein the performing a uterine integrity test step further comprises:

removing gas or fluid from the uterus with an outflow lumen of the uterine ablation device;

measuring an outflow flow rate of gas or fluid in the outflow lumen; and

comparing the flow rate of gas or fluid delivered into the uterus to the outflow flow rate of gas or fluid in the outflow lumen to provide a dynamic measurement for the presence of leaks in the uterus.

23. The method of claim 1 wherein the removing gas or fluid step of the patency test further comprises removing gas or fluid from the uterus with an outflow lumen of the uterine device positioned distally from the inflow lumen of the uterine device.

24. The method of claim 13 in which the delivery step is automatically initiated by module controller of the uterine ablation device.

29. The device of claim 1 wherein the inflow lumen is distinct from the outflow lumen.

32. The method of claim 1, wherein removing the gas or fluid with the outflow lumen is performed while delivering the gas or fluid with the inflow lumen.

25. A method of performing a procedure on a uterus of a patient, comprising:

performing a uterine integrity test comprising;

inserting a uterine ablation device into the uterus of the patient;

delivering fluid from an inflow lumen of the uterine ablation device into the uterus;

measuring a flow rate of the fluid as it is delivered into the uterus;

determining that the uterus is sealed if the flow rate decreases below a flow rate threshold value; and

eliminating retrograde flow caused by uterine contractions from flowing back through the inflow lumen with a one way valve disposed in the inflow lumen.

26. The method of claim 25 wherein the one way valve reduces noise in a flow meter of the inflow lumen caused by uterine contractions or relaxations, movements by the patient, or manipulations of the patient or inflow lumen by the physician or medical staff.

27. A method of performing a procedure on a uterus of a patient, comprising:

inserting a uterine ablation device into the uterus of the patient;

delivering fluid from an inflow lumen of the uterine ablation device into the uterus;

measuring a flow rate of the fluid as it is delivered into the uterus;

distending the uterus with the delivered fluid;

determining that the uterus is sealed if the flow rate decreases below a flow rate threshold value;

eliminating retrograde flow caused by uterine contractions from flowing back through the inflow lumen with a one way valve disposed in the inflow lumen;

determining that the uterine ablation device is not clogged or embedded in tissue if a return flow of fluid is observed through an outflow lumen of the uterine ablation device;

treating the uterus of the patient without reducing distension pressure with the uterine ablation device immediately following the step of determining that the uterine ablation device is not clogged and the uterus is sealed.

30. The device of claim 27 wherein the inflow lumen is distinct from the outflow lumen.

28. A method of performing a procedure on a uterus of a patient, comprising:

inserting a uterine ablation device into the uterus of the patient;

delivering fluid from an inflow lumen of the uterine ablation device into the uterus;

measuring a flow rate of the fluid as it is delivered into the uterus;

distending the uterus with the flow of fluid;

determining that the uterus is sealed if the flow rate decreases below a flow rate threshold value;

eliminating retrograde flow caused by uterine contractions from flowing back through the inflow lumen with a one way valve disposed in the inflow lumen;

determining that the uterine ablation device is not clogged or embedded in tissue if a return flow of fluid is observed through the outflow lumen of the uterine ablation device; and

treating the uterus of the patient with the uterine ablation device immediately following the step of determining that the uterine ablation device is not clogged and the uterus is sealed without reducing distension pressure in the uterus of the patient.

31. The device of claim 28 wherein the inflow lumen is distinct from the outflow lumen.