Integrity testing method and apparatus for delivering vapor to the uterus

• US 10,179,019 B2
• Filed: 05/21/2015
• Issued: 01/15/2019
• 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): Marlen, Tammie K
• Application Number:
  US14/719,037
• Publication Number:
  US 20150335373A1
• Time in Patent Office: 1,335 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 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00115 with audible or visual output
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/4216 Operations on uterus, e.g. endometrium
• CPC Class Codes: A61B 2018/00559 Female reproductive organs
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 2090/0807 Indication means
• 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
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2210/1433 Uterus
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 31/00 Devices for introducing or retaining media, e.g. remedies, in cavities of the body A61M25/00 takes precedence ; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008

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 patency test for a uterine ablation device, comprising:

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

closing an outflow valve to seal an outflow lumen of the uterine ablation device;

delivering gas or fluid from an inflow lumen of the uterine ablation device into the uterus to achieve uterine cavity distension;

opening the outflow valve only partially to remove gas or fluid from the uterus with the outflow lumen of the uterine ablation device while maintaining uterine cavity distension;

determining a flow rate of gas or fluid in the outflow lumen while the outflow lumen is only partially opened;

comparing the flow rate of gas or fluid in the outflow lumen to a threshold value; and

determining that the uterine ablation device is not clogged or embedded in tissue if the flow rate of gas or fluid is above the threshold value.

2. The method of claim 1, wherein the opening step further comprises:

pulsing the outflow valve a specified duty cycle until a uterine pressure decreases.

3. The method of claim 1, wherein the opening step further comprises:

pulsing the outflow valve at a first duty cycle, then pulsing the outflow valve at a second duty cycle that is lower than the first duty cycle when flow of gas or fluid through the outflow lumen begins.