Integrity testing method and apparatus for delivering vapor to the uterus
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.
1. A uterine ablation device, comprising:
a shaft adapted to be inserted into a uterus of a patient, the shaft including an outflow lumen and an inflow lumen;
a source configured to deliver gas or fluid through the inflow lumen of the shaft into the uterus;
an outflow valve configured to seal the outflow lumen of the shaft;
a flow meter that is fluidly coupled to the inflow lumen and configured to measure a flow rate of gas or fluid as it is delivered into the uterus; and
an electronic controller operatively coupled to the source, the outflow valve, and the flow meter, the electronic controller being configured to:
open the outflow valve only partially to remove gas or fluid from the uterus through the outflow lumen of the uterine ablation device while maintaining distension of a cavity of the uterus;
determine a flow rate of gas or fluid in the outflow lumen while the outflow valve is only partially opened and distension of the cavity of the uterus is maintained; and
determine that the uterine ablation device is not clogged or embedded in tissue if the flow rate of gas or fluid is above a threshold value.
2. The device of claim 1 , wherein the threshold value is 5 ml/min.
3. The device of claim 1 , wherein the electronic controller is configured to determine that the uterine ablation device is not clogged or embedded in tissue if the flow rate of gas or fluid measured by the flow meter is above the threshold value during a rolling patency test time window.
4. The device of claim 3 , wherein the rolling patency test time window is a 5 second time period.
5. The device of claim 1 , wherein the outflow valve is partially opened in a range of 20% to 50% open when the flow rate is determined.
6. The device of claim 1 , wherein the outflow valve comprises a balloon valve.
7. The device of claim 6 , wherein the outflow valve is partially opened by pulsing the opening of the outflow valve at a specified duty cycles.