METHODS AND SYSTEMS FOR EVALUATING THE INTEGRITY OF A UTERINE CAVITY

• US 20130158428A1
• Filed: 01/30/2012
• Published: 06/20/2013
• Est. Priority Date: 02/04/2011
• Status: Active Grant

• Current Assignee: Minerva Surgical, Inc.
• Original Assignee: Minerva Surgical, Inc.
• Inventors: TOTH, Akos, BEK, Robin, FILLOUX, Dominique
• Granted Patent: US 9,655,557 B2
• Time in Patent Office: Days
• US Class Current: 600/560
• CPC Class Codes: A61B 18/042 using additional gas becoming plasma
• 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 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/00559 Female reproductive organs
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00821 measured by a thermocouple
• 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 2505/05 Surgical care
• CPC Class Codes: A61B 5/4325 of the uterine cavities, e.g. uterus, fallopian tubes, ovaries
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61M 13/003 Blowing gases other than for carrying powders, e.g. for inflating, dilating or rinsing
• 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

Methods, systems and devices for evaluating the integrity of a uterine cavity. A method comprises introducing transcervically a probe into a patient'"'"'s uterine cavity, providing a flow of a fluid (e.g., CO₂) through the probe into the uterine cavity and monitoring the rate of the flow to characterize the uterine cavity as perforated or non-perforated based on a change in the flow rate.

Claims

1. A method of characterizing a patient'"'"'s uterus, comprising:

positioning a probe within a patient'"'"'s cervical canal and uterine cavity;

introducing a flow of a gas through the probe into the uterine cavity; and

comparing a peak inflow rate to subsequent flow rate;

characterizing the uterine cavity as either perforated or non-perforated based at least in part on said comparison.

2. The method of claim 1, wherein introducing comprises transcervically introducing the probe into the uterine cavity and introducing the flow through the probe.

3. The method of claim 2 further comprising expanding an ablation device in the uterine cavity.

4. The method of claim 1 wherein introducing comprises introducing the gas at a pre-determined flow rate.

5. The method of claim 4 wherein introducing comprises introducing the gas at an initial flow rate ranging from 0.05 slpm to 0.2 slpm.

6. The method of claim 4 wherein introducing comprises introducing the gas at a pressure ranging from 0.025 psi to 1.0 psi.

7. The method of claim 1 wherein comparing comprises providing a signal responsive at least in part to determining whether the subsequent flow rate drops below the peak flow rate by at least 10%, 20%, 30%, 40% or 50%.

8. The method of claim 1 wherein comparing comprises providing a signal responsive at least in part to determining whether the subsequent flow rate drops to below a value in the range of 0.01 slpm to 0.05 slpm.

9. The method of claim 8 wherein comparing comprises providing the signal with a time interval in the range from 5 second to 30 seconds.

10. A method of characterizing a patient'"'"'s uterus, comprising:

positioning a probe within a patient'"'"'s cervical canal and uterine cavity;

introducing a flow of a gas through the probe into the uterine cavity for selected time interval; and

determining whether a gas flow rate during the interval is (i) below a peak flow rate by a selected amount and (ii) below a threshold flow rate to thereby characterize the uterine cavity as either perforated or non-perforated.

11. A method of characterizing a patient'"'"'s uterus, comprising:

positioning a probe working end in a patient'"'"'s uterine cavity, the working end comprising an inflated resilient structure;

introducing a flow of a gas through the probe into a uterine cavity exterior of the working end; and

measuring a flow of inflation media outward from the inflated resilient structure in response to the gas flow into the uterine cavity.

12. A method of characterizing a patient'"'"'s uterus, comprising:

positioning a probe working end in a patient'"'"'s uterine cavity, the working end comprising an inflated resilient structure;

introducing a flow of a gas through the probe into a uterine cavity exterior of the working end; and

measuring a change in volume of inflation media in the inflated resilient structure in response to the gas flow into the uterine cavity.

13. A method of characterizing a patient'"'"'s uterus, comprising:

positioning a probe working end is a patient'"'"'s uterine cavity, the working end comprising an inflated resilient structure;

introducing a flow of a gas through the probe into a uterine cavity exterior of the working end; and

measuring a change in pressure of inflation media in the inflated resilient structure in response to the gas flow into the uterine cavity.

14. A system for characterizing a patient'"'"'s uterus, said system comprising:

a probe;

means for introducing a flow of gas through the probe;

means for measuring a peak inflow rate through the probe when positioned in the uterus with a subsequent flow rate through the probe; and

means for determining whether the uterus cavity is perforated based at least in part on a comparison of the peak and subsequent flow rates.

15. A system as in claim 14, wherein the probe is adapted for transcervical introduction to the uterus.

16. A system as in claim 14, wherein the gas introducing means is adapted to deliver the gas at a pre-determined constant pressure.

17. A system as in claim 16, wherein the gas introducing means is adapted to introduce the gas at a pressure in the range from 0.025 psi to 1 psi.

18. A system as in claim 16, wherein the gas introducing means is adapted to deliver gas at a pre-determined initial flow rate.

19. A system as in claim 18, wherein the initial flow rate is in the range from 0.05 slpm to 0.2 slpm.

20. A system as in claim 18, wherein the determining means detects when the initial flow rate drops by at least 10%, 20%, 30%, 40%, or 50% of the initial flow rate.

21. A system as in claim 18, wherein the determining means detects when the initial flow rate drops to a value in the range from 0.01 slpm to 0.1 slpm.