Methods for evaluating the integrity of a uterine cavity

• US 8,343,078 B2
• Filed: 11/11/2009
• Issued: 01/01/2013
• Est. Priority Date: 11/11/2009
• Status: Active Grant

• Current Assignee: Minerva Surgical, Inc.
• Original Assignee: Minerva Surgical, Inc.
• Inventors: Toth, Akos
• Primary Examiner(s): Hoekstra, Jeffrey G
• Assistant Examiner(s): Leedy, Megan
• Application Number:
  US12/616,343
• Publication Number:
  US 20110112433A1
• Time in Patent Office: 1,147 Days
• Field of Search: 600/587, 600/591, 600/560, 604 65- 67
• US Class Current: 600/591
• 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 for detecting perforations in a patient'"'"'s uterus, said method comprising:

transcervically introducing a probe into a uterine cavity of the patient;

expanding an expandable-collapsible frame to expand a fluid-tight wall on the probe in the uterine cavity;

introducing a flow of a fluid into the uterine cavity in a region between an external surface of the fluid-tight wall and an interior wall of the uterus, wherein the fluid comprises a gas; and

measuring a flow rate of the fluid as it is being introduced into the uterine cavity, wherein a measured flow rate which drops to a level below a predetermined threshold minimum level indicates that the uterus is not perforated.

2. The method of claim 1, wherein the flow is introduced through the probe and the probe provides no outlet for flow from the uterine cavity.

3. The method of claim 1, further comprising generating a signal, responsive to the flow rate, that characterizes the uterine cavity as at least one of perforated or non-perforated.

4. The method of claim 1, further comprising generating a signal responsive to the flow rate not dropping below a predetermined level, that characterizes 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, further comprising generating a signal responsive to the flow rate dropping below a predetermined level, that characterizes 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 measuring comprises measuring the flow rate over a predetermined first time interval after initiation of the flow.

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

10. The method of claim 8, wherein the first time interval is in a range from 1 second to 60 seconds.

11. The method of claim 8, wherein the first time interval is in a range from 10 seconds to 30 seconds.

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

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

16. The method of claim 1, wherein measuring comprises providing a signal, responsive to the flow rate, 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 prevents a flow of the fluid out of the uterine cavity.

18. The method of claim 17, 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 probe has an energy-delivery surface on the fluid-tight wall for ablating uterine cavity tissue, and wherein the method further comprises disabling activation of the energy delivery surface responsive to the uterine cavity being characterized as perforated.

21. The method of claim 1, wherein the probe has an energy-delivery surface on the fluid-tight wall for ablating uterine cavity tissue, and wherein the method further comprises enabling activation of the energy delivery surface responsive to the uterine cavity being characterized as non-perforated.

22. The method of claim 21, further comprising, responsive to the uterine cavity being characterized as non-perforated, automatically activating the energy delivery surface.