Systems and methods for performing endometrial ablation
View Patent ↗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. An endometrial vapor ablation system, comprising:
a vapor generator comprising a first pressure sensor;
a uterine ablation device coupled to the vapor generator, the uterine ablation device comprising:
a shaft configured to be inserted into a uterine cavity of a patient;
one or more lumens disposed in the shaft and coupled to the vapor generator;
a second pressure sensor; and
a tip cover disposed over a distal end of the shaft;
a control system coupled to the uterine ablation device and the vapor generator, the control system being configured to automatically perform a pre-procedural sterilization of the vapor generator and the uterine ablation device, the control system configured to prep the uterine ablation device for vapor delivery, the control system configured to test safety components of the uterine ablation device prior to and after insertion into the patient, the control system being configured to pressurize the tip cover and compare a sensed pressure of the first pressure sensor to a sensed pressure of the second pressure sensor, and, after removal of the tip cover, the control system being configured to monitor the application of vapor energy, monitor temperature reading at identified locations on the uterine ablation device, and implement shutdown of the vapor generator following vapor delivery.
2. The system of claim 1 , wherein the control system is configured to prompt an end user of the uterine ablation device if the pre-procedural sterilization fails to initiate or complete.
3. The system of claim 1 , wherein the control system is configured to prompt an end user of the uterine ablation device if the testing of the safety components indicates an error in the system.
4. The system of claim 1 , further comprising a distal anchor balloon, a central sealing balloon, and a proximal positioning balloon disposed on a shaft of the uterine ablation device.
5. The system of claim 4 , further comprising a temperature sensor positioned near the central sealing balloon and configured to measure a temperature inside an endocervix of the patient.
6. The system of claim 4 , further comprising one or more pressure sensors configured to measure a pressure of each of the distal anchor balloon, the central sealing balloon, and the proximal positioning balloon.
7. A method of providing vapor therapy to a uterus of a patient, comprising the steps of:
sensing a fluid level of a vapor generator;
heating the vapor generator to prepare a condensable vapor;
priming the condensable vapor through a uterine ablation device coupled to the vapor generator to sterilize the uterine ablation device;
pressurizing a tip cover disposed over a distal portion of the uterine ablation device;
comparing a pressure sensor value within the uterine ablation device to a pressure sensor value within the vapor generator;
verifying the integrity of a plurality of positioning and sealing balloons of the uterine ablation device;
removing the tip cover from the uterine ablation device;
delivering condensable vapor from the uterine ablation device into the uterus; and
during the delivering step, monitoring a temperature in a cervix of the patient and automatically terminating delivery of condensable vapor if the temperature exceeds a threshold value.
8. The method of claim 7 , wherein the threshold value comprises 44 degrees C.