System and method for detecting perforations in a body cavity

• US 6,554,780 B1
• Filed: 11/10/2000
• Issued: 04/29/2003
• Est. Priority Date: 11/10/1999
• Status: Expired due to Term

• Current Assignee: Cytyc Surgical Products, LLC (Hologic Incorporated)
• Original Assignee: Novacept Inc. (Hologic Incorporated)
• Inventors: Truckai, Csaba, OʼHara, Mike, Miller, Dean T., Sampson, Russell M.
• Primary Examiner(s): MARMOR II, CHARLES ALAN
• Application Number:
  US09/710,102
• Time in Patent Office: 900 Days
• Field of Search: 600/560, 600/561, 600/562, 600/587, 600/591, 600/593, 600/101, 600/156, 600/158, 600/104, 600/105, 600/135, 600/153, 606/27, 606/40, 606/41, 606/49, 606/37, 606/45, 606/46, 607/96, 607/101, 607/63, 607/105, 607/113, 607/115, 607/138, 607/116, 604/20, 604/23, 604/26, 604/27, 604/65-67, 604/114, 604/118, 604/500, 604/515, 604/920
• US Class Current: 600/587
• 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. 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 a pre-test and post-test lockout system. The lockout system prevents RF power delivery unless, during a predetermined test period, the pressure sensing system determines that no perforation exists, or unless a previously performed perforation detection procedure determined a perforation was present but the lockout system was subsequently overridden by the physician.

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; and

(d) if the pressure monitored in step (c) fails to rise and remain above a predetermined threshold level within a predetermined amount of time, activating a notification signal providing feedback to a user alerting the user to the presence of a perforation in the body cavity.

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

3. The method of claim 2 wherein the treating step includes delivering ablation energy to the body cavity.

4. The method of claim 3 wherein the ablation energy is RF energy.

5. The method of claim 3 wherein the ablation energy is thermal energy.

6. 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.

7. The method of claim 6 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.

8. The method of claim 7 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 within the predetermined amount of time.

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

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

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

12. The method of claim 11 wherein the predetermined threshold level is selected to be below a cracking pressure of fallopian tubes.

13. 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.

14. 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 or other body tissue from occluding the medical device.

15. 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.

16. 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.

17. 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; and

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

18. 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;

(d) if the pressure monitored in step (c) fails to rise and remain above a predetermined threshold level within a predetermined amount of time, providing feedback to a user alerting the user to the presence of a perforation in the body cavity;

(e) treating the body cavity using the medical device; and

(f) preventing use of the medical device to treat the body cavity until after steps (b) and (c) have been carried out.

19. The method of claim 18 wherein the method includes the step of (g) 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 within the predetermined amount of time.

20. The method of claim 19 wherein the step of providing feedback in step (d) includes the preventing step of step (g).

21. The method of claim 18 wherein the treating step includes ablating tissue within the body cavity.

22. The method of claim 21 wherein the ablation step includes delivering RF energy to the body tissue.

23. The method of claim 21 wherein the ablation step includes delivering thermal energy to the body tissue.

24. 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; and

(d) if the pressure monitored in step (c) fails to rise and remain above a predetermined threshold level within a predetermined amount of time, providing feedback to a user alerting the user to the presence of a perforation in the body cavity

(e) treating the body cavity using the medical device;

(f) preventing use of the medical device to treat the body cavity until after steps (b) and (c) have been carried out;

(g) 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 within the predetermined amount of time; and

(h) after step (f) or (g), 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.

25. The method of claim 24 wherein the step of providing feedback in step (d) includes the preventing step of step (g).

26. 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; and

(d) if the pressure monitored in step (c) fails to rise and remain above a predetermined threshold level within a predetermined amount of time, providing feedback to a user alerting the user to the presence of a perforation in the body cavity

(e) inserting a second medical device into the body cavity;

(f) using the second medical device to treat the body cavity

(g) preventing use of the second medical device to treat the body cavity until after steps (b) and (c) have been carried out;

(h) 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 within the predetermined amount of time; and

(i) after step (h), 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.

27. 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; and

(d) if the pressure monitored in step (c) fails to rise and remain above a predetermined threshold level within a predetermined amount of time, providing feedback to a user alerting the user to the presence of a perforation in the body cavity, wherein the predetermined threshold level and the predetermined amount of time are selected to detect perforations having diameters of 0.5 mm or larger.

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

(a) providing a medical device having an open position and a closed position, inserting the medical device into a body cavity when in the closed position and then opening the medical device to the opened position within the body cavity;

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

(c) monitoring a pressure within the body cavity; and

(d) if the pressure monitored in step (c) fails to rise and remain above a predetermined threshold level within the predetermined amount of time, providing feedback to the user alerting the user to the presence of a perforation in the body cavity

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

(f) 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 within the predetermined amount of time, preventing treatment of the body cavity using the medical device.

29. 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.

30. The method of claim 29 wherein step (c) includes ablating tissue within the body cavity.

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

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

33. The method of claim 29 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.

34. The method of claim 33, 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.

35. The method of claim 34, 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.

36. The method of claim 29, further including the step of preventing performance of step (c) untlafter step (b) has been carried out.

37. 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 within the body cavity; and

feedback means coupled to the pressure sensor for activating notification signal to alert a user if the pressure detected by the pressure sensor fails to rise and remain above a predetermined level within a predetermined amount of time.

38. The system of claim 37, wherein the feedback means is for activating an auditory notification signal.

39. The system of claim 37, wherein the feedback means is for activating a visual notification signal.

40. The system of claim 37 wherein the feedback means includes electronics electronically coupled to the pressure sensor, the electronics configured to generate a feedback signal in the event the detected pressure fails to rise and remain above a predetermined level within the predetermined amount of time;

and

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

41. The system of claim 37 wherein the medical device includes a treatment element.

42. The system of claim 41 the treatment element is an ablation device.

43. The system of claim 42 wherein the ablation device includes an ablation electrode.

44. The system of claim 43 wherein the ablation device includes means for conducting energy to tissue.

45. The system of claim 41, further including:

pre-test lockout means for preventing treatment of a body cavity using the treatment element until after the pressure sensor has been used to monitor for the presence of a perforation in the body cavity.

46. The system of claim 41, further including:

post-test lockout means for preventing treatment of a body cavity using the treatment element if the pressure monitored by the pressure sensor has failed to rise and remain above the predetermined level within the predetermined amount of time.

47. The system of claim 46, further including override means for permitting a user to override the post-test lockout means, activation of said override means permitting treatment of a body cavity using the treatment element after the pressure sensor has been used to monitor for the presence of a perforation in the body cavity, and after the pressure monitored by the pressure sensor has failed to rise and remain above the predetermined level within the predetermined amount of time.

48. 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 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, 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;

feedback means coupled to the pressure sensor for activating a notification signal to alert a user as to whether pressure monitored by the pressure sensor fails to rise and remain above a predetermined level within a predetermined amount of time.

49. The system of claim 48 wherein the treatment element is an ablation device.

50. The system of claim 49 wherein the ablation device includes an ablation electrode.

51. The system of claim 50 wherein the ablation device includes means for conducting energy to tissue.

52. The system of claim 48, further including:

pre-test lockout means for preventing treatment of a body cavity using the treatment element until after the pressure sensor has been used to monitor for the presence of a perforation in the body cavity.

53. The system of claim 48, further including post-test lockout means for preventing treatment of a body cavity using the treatment element if the pressure monitored by the pressure sensor has failed to rise and remain above the predetermined level within the predetermined amount of time.

54. The system of claim 53, further including override means for permitting a user to override the post-test lockout means, activation of said override means permitting treatment of a body cavity using the treatment element after the pressure sensor has been used to monitor for the presence of a perforation in the body cavity, and after the pressure monitored by the pressure sensor has failed to rise and remain above the predetermined level within the predetermined amount of time.

55. 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 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, the medical device including an ablation device for treating the interior of a body organ;

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

electronic means coupled to the pressure sensor for determining whether pressure monitored by the pressure sensor fails to rise and remain above a predetermined level within a predetermined amount of time;

pre-test lockout means for preventing treatment of a body cavity using the ablation device until after the pressure sensor has been used to monitor for the presence of a perforation in the body cavity; and

override means for permitting a user to treat a body cavity using the ablation device after the pressure sensor has been used to monitor for the presence of a perforation in the body cavity, and after the electronic means has determined that pressure monitored by the pressure sensor has failed to rise and remain above the predetermined level within the predetermined amount of time.

56. The system of claim 55, further including post-test lockout means for preventing treatment of a body cavity using the ablation device if the pressure monitored by the pressure sensor has failed to rise and remain above the predetermined level within the predetermined amount of time, wherein the override means is further for overriding the post-test lockout means.