Systems and devices for evaluating the integrity of a uterine cavity

• US 8,394,037 B2
• Filed: 11/11/2009
• Issued: 03/12/2013
• 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): TOWA, RENE T
• Application Number:
  US12/616,318
• Publication Number:
  US 20110112432A1
• Time in Patent Office: 1,217 Days
• Field of Search: 600587-593, 600560-561, 604/19, 604 23- 30, 604/93.01, 606 32- 41
• 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 with imaging means A61B90/37, A61B34/20
• 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 system for characterizing a patient uterus, comprising:

a probe having a distal end;

an expandable member at the distal end of the probe, the expandable member having an expansible-collapsible frame which supports a fluid-tight wall and being adapted to occupy a uterine cavity when expanded;

a source of a pressurized flow of a fluid;

an integrity test lumen located in the probe, connected to the source, and configured to deliver the fluid from the source to a region surrounding an exterior of the fluid-tight wall of the expandable member when the expansible-collapsible frame is expanded in the uterine cavity of a patient;

a flow sensor for measuring a flow rate of the fluid from the lumen into the region surrounding the fluid-tight wall of the expandable member when expanded in the uterine cavity; and

a controller operatively coupled to the flow sensor and to the source of the pressurized fluid flow, said controller being configured to (1) initiate a flow of fluid from the fluid source through the lumen into the uterus to the region surrounding the exterior of the fluid-tight wall of the expandable member after the expandable-collapsible frame has been expanded to cause the expandable member to occupy the uterine cavity and before neutral gas is delivered to an interior of the expandable member to enable ablation, and (2) measure the flow rate of the flow of fluid into the uterus region surrounding the exterior of the fluid-tight wall of the expandable member using the flow sensor, and (3) determine if the measured flow rate of the fluid flow into the region drops below a predetermined minimum threshold rate within a predetermined period of lime in the range from 1 second to 60 seconds, wherein the controller generates a signal indicating that the uterus is perforated if the flow rate fails to fall below said predetermined minimum threshold rate within said predetermined time period.

2. The system of claim 1, wherein the signal is at least one of visual, aural and tactile.

3. The system of claim 1, wherein the flow sensor is a mass flow sensor.

4. The system of claim 1, wherein the controller generates a signal indicating that the uterus is not perforated if the flow rate drops below said predetermined minimum threshold rate within said predetermined period of time.

5. The system of claim 4, wherein the signal is at least one of visual, aural and tactile.

6. The system of claim 1, wherein the expandable member comprises a thin-wall dielectric which defines an energy-delivery surface for ablating uterine cavity tissue.

7. The system of claim 6, wherein the energy-delivery surface is configured to deliver RF energy to the tissue via capacitive coupling.

8. The system of claim 6, wherein the energy-delivery surface includes at least one electrode coupled to an RF generator.

9. The system of claim 6, wherein the controller is configured to disable activation of the energy-delivery surface if the flow rate fails to fall below said predetermined minimum threshold rate within said predetermined time period.

10. The system of claim 9, further comprising an override mechanism to override the disabling mechanism.

11. The system of claim 6, wherein the controller is configured to enable activation of the energy-delivery surface if the flow rate falls below said predetermined minimum threshold rate within said predetermined time period.

12. The system of claim 11, wherein the controller is configured to automatically activate the energy delivery surface if the flow rate falls below said predetermined minimum threshold rate within said predetermined time period.

13. The system of claim 8, further comprising a source of neutral gas, wherein the controller is configured to deliver the neutral gas through a neutral gas lumen in the probe to an interior volume defined by the wall of the expandable member after the expandable-collapsible frame has been expanded.

14. The system of claim 13, wherein the integrity test lumen in the probe provides the only flow path between the uterine cavity and a proximal end of the probe when the distal end of the probe is in the uterine cavity.