Systems and methods for performing endometrial ablation

• US 10,299,856 B2
• Filed: 06/12/2018
• Issued: 05/28/2019
• Est. Priority Date: 05/22/2014
• Status: Active Grant

• Current Assignee: Coopersurgical Incorporated (The Cooper Cos., Inc.)
• Original Assignee: Aegea Medical Inc. (The Cooper Cos., Inc.)
• Inventors: Chee, Uriel Hiram, Peliks, Robert Bilgor, Magen, Hugh Edward, Gurskis, Donnell William, Bacich, Steven Robert
• Primary Examiner(s): Fowler, Daniel W
• Assistant Examiner(s): Demie, Tigist S
• Application Number:
  US16/006,265
• Publication Number:
  US 20180289416A1
• Time in Patent Office: 350 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. A method of testing a uterine ablation device prior to a uterine procedure, comprising the steps of:

inflating at least one sealing balloon disposed on an elongate shaft of the uterine ablation device;

inflating a tip cover disposed over the at least one sealing balloon and a portion of the elongate shaft;

sensing a first pressure within the tip cover;

sensing a second pressure within a vapor generator of the uterine ablation device; and

comparing, with an electronic controller of the uterine ablation device, the first pressure within the tip cover to the second pressure within the vapor generator to determine if the at least one sealing balloon is leaking.

2. The method of claim 1, wherein the at least one sealing balloon comprises a distal sealing balloon, a central sealing balloon, and a proximal sealing balloon.

3. The method of claim 1, further comprising preventing, with the electronic controller, delivery of condensable vapor from the vapor generator if the at least one sealing balloon is leaking.

4. The method of claim 1, further comprising:

removing the tip cover from the uterine ablation device; and

delivering condensable vapor from the vapor generator through the uterine ablation device into a uterus of a patient.

5. The method of claim 1, further comprising prompting a user of the uterine ablation device if the at least one sealing balloon is leaking.

6. The method of claim 1, wherein the at least one sealing balloon is inflated up to approximately 30 psi.

7. The method of claim 1, wherein the at least one sealing balloon is inflated with air.

8. The method of claim 1, wherein the at least one sealing balloon is inflated with a fluid.

9. The method of claim 1, where in the inflating at least one sealing balloon step comprises inflating the at least one sealing balloon with an inflation source of the uterine ablation device.