System and method for detecting perforations in a body cavity

• US 20030191412A1
• Filed: 03/27/2003
• Published: 10/09/2003
• Est. Priority Date: 11/10/1999
• Status: Active Grant

• Current Assignee: Cytyc Surgical Products II Incorporated (Hologic Incorporated)
• Original Assignee: Cytyc Surgical Products II Incorporated (Hologic Incorporated)
• Inventors: Sampson, Russell M., OʼHara, Mike, Miller, Dean T., Truckai, Csaba
• Granted Patent: US 6,743,184 B2
• Time in Patent Office: Days
• US Class Current: 600/561
• CPC Class Codes: A61B 18/00 Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body eye surgery A61F9/007; ear surgery A61F11/00
• CPC Class Codes: A61B 2017/00292 mounted on or guided by flexible, e.g. catheter-like, means
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension

Abstract

A system and method for detecting perforations in a body cavity. In accordance with the method of the invention, a fluid (liquid or gas) is delivered into a body cavity to slightly pressurize the cavity. A pressure sensing system monitors the pressure within the cavity for a predetermined test period. If cavity pressure is not substantially sustained during the test period, the physician is alerted to further assess the cavity for perforations before initiating treatment within the cavity. In a preferred form of the system, a medical treatment system such as an RF ablation system is provided with perforation detection functionality. The system preferably includes an interlock that prevents RF power delivery unless a perforation detection procedure previously has been performed.

Claims

1. A method of detecting a perforation in a body cavity, comprising the steps of:

(a) inserting a medical device into a body cavity;

(b) passing an inflation medium through the medical device and into the body cavity;

(c) monitoring a pressure within the body cavity for a predetermined amount of time; and

(d) if the pressure monitored in step (c) rises and remains above a predetermined threshold level during the predetermined amount of time, providing feedback to the user that the body cavity is intact.

2. The method of claim 1, wherein the method further includes the step of, if the pressure monitored in step (c) fails to rise and remain above a predetermined threshold level during the predetermined amount of time, providing feedback alerting the user to the presence of a perforation in the body cavity.

3. The method of claim 1, wherein the method further includes the step of treating the body cavity using the medical device.

4. The method of claim 3 wherein the treating step includes delivering ablation energy to the body cavity.

5. The method of claim 4 wherein the ablation energy is RF energy.

6. The method of claim 4 wherein the ablation energy is thermal energy.

7. The method of claim 3, wherein the method includes the step of preventing use of the medical device to treat the body cavity until after steps (b) and (c) have been carried out.

8. The method of claim 7 wherein the method includes the step of preventing use of the medical device to treat the body cavity if the pressure monitored in step (c) fails to rise and remain above the predetermined threshold level during the predetermined amount of time.

9. The method of claim 7 wherein the treating step includes ablating tissue within the body cavity.

10. The method of claim 9 wherein the ablation step includes delivering RF energy to the body tissue.

11. The method of claim 9 wherein the ablation step includes delivering thermal energy to the body tissue.

12. The method of claim 8 wherein the method further includes the step of detecting an override signal from a user input device and permitting treatment of the body cavity using the medical device following detection of the override signal.

13. The method of claim 1, further including the steps of:

inserting a second medical device into the body cavity; and

using the second medical device to treat the body cavity.

14. The method of claim 13 wherein the method includes the step of, preventing use of the second medical device to treat the body cavity until after steps (b) and (c) have been carried out.

15. The method of claim 14 wherein the method includes the step of preventing use of the second medical device to treat the body cavity if the pressure monitored in step (c) fails to rise and remain above the predetermined threshold level during the predetermined amount of time.

16. The method of claim 15 wherein the method further includes the step of detecting an override signal from a user input device and permitting treatment of the body cavity using the second medical device following detection of the override signal.

17. The method of claim 1 wherein the inflation medium is a gas.

18. The method of claim 1 wherein the inflation medium is a liquid.

19. The method of claim 1 wherein the body cavity is a uterus.

20. The method of claim 19 wherein the predetermined threshold level is selected to be below the cracking pressure of fallopian tubes.

21. The method of claim 1, including the steps of:

providing a source of inflation medium and further providing a pressure detector;

in step (a), positioning the source and the pressure detector in series with the body cavity;

performing step (b) using the source; and

performing step (c) using the pressure detector.

22. The method of claim 1, wherein the predetermined threshold level and the predetermined amount of time are selected to detect perforations having diameters of 0.5 mm or larger.

23. The method of claim 1, further including the step of passing inflation medium through the medical device during step (a) so as to prevent blood and/or other body tissue from occluding the medical device.

24. The method of claim 1, wherein:

the medical device inserted in step (a) includes an open position and a closed position;

step (a) includes the step of inserting the medical device into the body cavity when in the closed position and then opening the medical device within the body cavity, and the method includes the steps of;

detecting whether the medical device is in the opened or closed position; and

if the medical device is detected to have been moved to the closed position after the pressure monitored in step (c) has risen and remained above the predetermined threshold level during the predetermined amount of time, preventing treatment of the body cavity using the medical device.

25. The method of claim 1, wherein step (b) includes passing inflation medium from a source of inflation medium through the medical device, and wherein the method further includes the steps of:

monitoring the amount of inflation medium in the source; and

providing feedback alerting a user when the amount has fallen below a predetermined level.

26. The method of claim 1 wherein step (a) includes providing a medical device having a seal, inserting the medical device through an entry to the body cavity, and causing the seal to seal the entry to the body cavity.

27. A method of treating a body cavity, comprising the steps of:

(a) inserting a medical device into a body cavity;

(b) using a pressure sensor fluidly coupled to the medical device, monitoring for the presence of a perforation in the body cavity; and

(c) using the medical device, treating the interior of the body cavity.

28. The method of claim 27 wherein step (c) includes ablating tissue within the body cavity.

29. The method of claim 28 wherein step (c) includes delivering RF energy to the tissue.

30. The method of claim 28 wherein step (c) includes delivering thermal energy to the tissue.

31. The method of claim 27 wherein step (b) includes:

passing an inflation medium through the medical device and into the body cavity; and

monitoring a pressure within the body cavity for a predetermined amount of time.

32. The method of claim 31, further including the step of:

if the pressure monitored in the monitoring step fails to rise and remain above a predetermined level during the predetermined amount of time, providing feedback alerting a user to the presence of a perforation in the body cavity.

33. The method of claim 27, further including the step of preventing performance of step (c) until after step (b) has been carried out.

34. The method of claim 32, further including the steps of:

preventing performance of step (c) if the pressure monitored in the monitoring step fails to rise and remain above a predetermined level during the predetermined amount of time;

detecting an override signal from a user input device; and

permitting treatment of the body cavity using the medical device following detection of the override signal.

42. The system of claim 31 wherein the ablation head includes means for conducting thermal energy to the tissue.

35. A system for detecting the presence of a perforation in a body cavity, the system including:

a source of inflation medium;

a medical device insertable into a body cavity, the medical device fluidly coupled to the source of inflation medium for delivery of inflation medium into the body cavity;

a pressure sensor positioned to detect a pressure of the body cavity; and

feedback means coupled to the pressure sensor to provide feedback to a user if the pressure monitored by the pressure sensor fails to rise and remain above a predetermined level during a predetermined amount of time.

36. The system of claim 35, wherein the feedback means is for providing auditory feedback to a user.

37. The system of claim 35 wherein the feedback means is for providing visual feedback to a user.

38. The system of claim 35 wherein the feedback means includes a processor electronically coupled to the pressure sensor, the processor configured to generate a feedback signal in the event the monitored pressure fails to rise and remain above a predetermined level during the predetermined amount of time;

and

a feedback device coupled to the processor, the feedback device responsive to the feedback signal for alerting a user to the presence of a perforation in the body cavity.

39. The system of claim 35 wherein the medical device includes a treatment element.

40. The system of claim 39 wherein the treatment element is an ablation head.

41. The system of claim 40 wherein the ablation head includes an ablation electrode.

43. The system of claim 39, further including:

interlock means preventing treatment of a body cavity using the treatment element until after the medical device has been used to monitor for the presence of a perforation in the body cavity.

44. A system for detecting the presence of a perforation in a body cavity and for treating the interior of the body cavity, the system including:

a souci of inflation medium;

a medical device insertable into a body cavity, the medical device fluidly coupled to the source of inflation medium for delivery of inflation medium into the body cavity, the medical device including a treatment element for treating the interior of a body organ;

a pressure sensor positioned to detect a pressure of the body cavity;

determining means coupled to the pressure sensor to determine whether pressure monitored by the pressure sensor fails to rise and remain above a predetermined level during a predetermined amount of time.

45. The system of claim 44 wherein the treatment element is an ablation head.

46. The system of claim 45 wherein the ablation head includes an ablation electrode.

47. The system of claim 46 wherein the ablation head includes means for conducting thermal energy to the tissue.

48. The system of claim 45, further including:

interlock means preventing treatment of a body cavity using the treatment element until after the medical device has been used to monitor for the presence of a perforation in the body cavity.

49. The system of claim 48, further including override means permitting treatment of a body cavity using the treatment element after the medical device has been used to monitor for the presence of a perforation in the body cavity, even if the determining means has determined that pressure monitored by the pressure sensor has failed to rise and remain above the predetermined level during the predetermined amount of time.