METHODS FOR EVALUATING THE INTEGRITY OF A UTERINE CAVITY

• US 20110112433A1
• Filed: 11/11/2009
• Published: 05/12/2011
• Est. Priority Date: 11/11/2009
• Status: Active Grant

• Current Assignee: Minerva Surgical, Inc.
• Original Assignee: Minerva Surgical, Inc.
• Inventors: Toth, Akos
• Granted Patent: US 8,343,078 B2
• Time in Patent Office: Days
• US Class Current: 600/560
• 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 18/042 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 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 2017/00115 with audible or visual output
• CPC Class Codes: A61B 2017/00119 alarm; indicating an abnormal situation
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/0225 flexible, e.g. fabrics, meshes, or membranes
• CPC Class Codes: A61B 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61B 2017/22062 to be filled with liquid
• CPC Class Codes: A61B 2017/4216 Operations on uterus, e.g. endometrium
• CPC Class Codes: A61B 2018/00505 Urinary tract
• CPC Class Codes: A61B 2218/007 Aspiration
• CPC Class Codes: A61B 5/035 Intra-uterine probes therefor
• CPC Class Codes: A61B 5/1076 for measuring dimensions inside body cavities, e.g. using catheters A61B3/1005 takes precedence
• CPC Class Codes: A61B 5/4325 of the uterine cavities, e.g. uterus, fallopian tubes, ovaries

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. If the flow rate drops to zero or close to zero, this indicates that the uterine cavity is intact and not perforated. If the flow rate does not drop to zero or close to zero, this indicates that a fluid flow is leaking through a perforation in the uterine cavity into the uterine cavity or escaping around an occlusion balloon that occludes the cervical canal.

Claims

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

introducing a flow of a fluid into a uterine cavity of a patient; and

monitoring the flow to characterize the uterine cavity as at least one of perforated or non-perforated based on a change in a rate of the flow.

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

3. The method of claim 1, wherein monitoring comprises providing a signal, responsive to the rate of flow, that characterizes the uterine cavity as at least one of perforated or non-perforated.

4. The method of claim 1, wherein monitoring comprises generating a signal responsive to the rate of flow not dropping below a predetermined level, the signal characterizing the uterine cavity as perforated.

5. The method of claim 4, wherein the predetermined level is 0.05 slpm.

6. The method of claim 1, wherein monitoring comprises generating a signal responsive to the rate of flow dropping below a predetermined level, the signal characterizing the uterine cavity as non-perforated.

7. The method of claim 6, wherein the predetermined level is 0.05 slpm.

8. The method of claim 1, wherein monitoring comprises monitoring a rate of flow after a predetermined first interval after initiation of the flow.

9. The method of claim 8, wherein the first interval is at least 5 seconds.

10. The method of claim 8, wherein the first interval is at least 15 seconds.

11. The method of claim 8, wherein the first interval is at least 30 seconds.

12. The method of claim 8, wherein monitoring comprises monitoring a rate of flow over a second predetermined interval after the first interval.

13. The method of claim 12 wherein the second interval is at least 1 second.

14. The method of claim 12 wherein the second interval is at least 5 seconds.

15. The method of claim 12 wherein the second interval is at least 10 seconds.

16. The method of claim 1, wherein monitoring comprises providing a signal, responsive to the rate of flow, that characterizes the uterine cavity as at least one of perforated or non-perforated, and wherein the signal is at least one of visual, aural and tactile.

17. The method of claim 1 further comprising, prior to introducing the flow, positioning a member within the cervical canal that substantially prevents a flow of the fluid out of the uterine cavity.

18. The method of claim 17, wherein introducing comprises transcervically introducing a probe into the uterine cavity, and introducing the flow through the probe, and wherein the member is positioned about an exterior of the probe.

19. The method of claim 18 wherein the member is expanded in the cervical canal.

20. The method of claim 1 wherein the fluid is a gas or a liquid.

21. The method of claim 1, wherein introducing comprises transcervically introducing a probe into the uterine cavity, and introducing the flow through the probe, and wherein the probe has a working end with an energy-delivery surface for ablating uterine cavity tissue, and further comprising, responsive to the uterine cavity being characterized as perforated, disabling activation of the energy delivery surface.

22. The method of claim 1, wherein introducing comprises transcervically introducing a probe into the uterine cavity, and introducing the flow through the probe, and wherein the probe has a working end with an energy-delivery surface for ablating uterine cavity tissue, and further comprising, responsive to the uterine cavity being characterized as non perforated, enabling activation of the energy delivery surface.

23. The method of claim 22, further comprising, responsive to the uterine cavity being characterized as non perforated, automatically activating the energy delivery surface.

24. A method of endometrial ablation, comprising:

introducing an ablation probe into a uterine cavity of a patient;

flowing a fluid from a fluid source through the probe into the uterine cavity;

monitoring the rate of the flow of the fluid into the uterine cavity to characterize the cavity as at least one of perforated or non-perforated based on a change in the flow rate; and

responsive the to the uterine cavity being characterized as non perforated, activating the ablation probe to ablate an interior of the uterine cavity.