Systems and methods for performing endometrial ablation

• US 9,993,290 B2
• Filed: 05/21/2015
• Issued: 06/12/2018
• Est. Priority Date: 05/22/2014
• Status: Active Grant

• Current Assignee: Aegea Medical Inc.
• Original Assignee: Aegea Medical Inc.
• Inventors: Chee, Uriel Hiram, Peliks, Robert Bilgor, Magen, Hugh Edward, Gurskis, Donnell William, Bacich, Steven Robert
• Primary Examiner(s): Stoklosa, Joseph
• Assistant Examiner(s): Demie, Tigist
• Application Number:
  US14/719,048
• Publication Number:
  US 20150335380A1
• Time in Patent Office: 1,118 Days
• CPC Class Codes: A61B 17/42 Gynaecological or obstetrical instruments or methods ligaturing clamps or clips for the umbilical cord A61B17/122; curettage A61B17/320708; dilators A61M29/00
• 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 18/1206 Generators therefor
• CPC Class Codes: A61B 18/1233 with circuits for assuring patient safety
• CPC Class Codes: A61B 18/1485 having a short rigid shaft for accessing the inner body through natural openings
• CPC Class Codes: A61B 2017/4216 Operations on uterus, e.g. endometrium
• 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 2018/0063 Sealing
• CPC Class Codes: A61B 2018/00648 using more than one sensed parameter
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/00821 measured by a thermocouple
• CPC Class Codes: A61B 2018/00898 Alarms or notifications created in response to an abnormal condition
• CPC Class Codes: A61B 2018/00982 combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes
• CPC Class Codes: A61B 2018/046 in liquid form
• CPC Class Codes: A61B 2018/1465 Deformable electrodes
• CPC Class Codes: A61B 2018/147 Electrodes transferring energy by capacitive coupling, i.e. with a dielectricum between electrode and target tissue
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension

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. 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.