System and method for detecting perforations in a body cavity

• US 6,743,184 B2
• Filed: 03/27/2003
• Issued: 06/01/2004
• Est. Priority Date: 11/10/1999
• Status: Expired due to Term

• Current Assignee: Cytyc Surgical Products II Incorporated (Hologic Incorporated)
• Original Assignee: Novacept Inc. (Hologic Incorporated)
• Inventors: Truckai, Csaba, Miller, Dean T., Sampson, Russel M., OʼHara, Mike
• Primary Examiner(s): MARMOR II, CHARLES ALAN
• Application Number:
  US10/400,823
• Publication Number:
  US 20030191412A1
• Time in Patent Office: 432 Days
• Field of Search: 600/560-562, 600/587, 600/591, 600/593, 600/101, 600/156, 600/158, 600/104, 600/105, 600/135, 600/153, 606/27, 606/40, 606/37, 606/41, 606/45, 606/46, 606/49, 607/63, 607/96, 607/101, 607/105, 607/113, 607/115, 607/116, 607/138, 604/20, 604/23, 604/26, 604/27, 604/65-67, 604/114, 604/118, 604/500, 604/515, 604/920
• US Class Current: 600/560
• 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 a pre-test lockout that prevents RF power delivery unless a perforation detection procedure previously has been performed.

Claims

1. A system for ablating tissue in a body cavity, the system including:

a source of inflation medium;

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

a source of ablation energy coupled to the ablation device;

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

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

2. The system of claim 1, wherein the feedback means is for activating an auditory notification signal.

3. The system of claim 2, further including:

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 pressure monitored by the pressure sensor has failed to remain above the predetermined level within the predetermined amount of time.

4. The system of claim 1, wherein the feedback means is for activating a visual notification signal.

5. The system of claim 1, 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 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.

6. The system of claim 5, further including:

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.

7. The system of claim 6 wherein the ablation device includes a closed position and an opened position, wherein the system includes means for detecting when the ablation device is in the closed position, and wherein the pre-test lockout means is further for preventing treatment of a body cavity using the ablation device until after the ablation device has been moved to an opened position and after the pressure sensor has been subsequently used to monitor for the presence of a perforation in the body cavity.

8. The system of claim 5, 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 remain above the predetermined level within the predetermined amount of time; and

override means for overriding the post-test lockout means, thereby 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 pressure monitored by the pressure sensor has failed to remain above the predetermined level within the predetermined amount of time.

9. The system of claim 1, wherein the ablation device includes an ablation electrode.

10. The system of claim 9, wherein the energy source is a source of RF energy.

11. The system of claim 9 further including a vacuum source fluid coupled to the ablation device, the vacuum source operable during ablation using the ablation electrode.

12. The system of claim 1, wherein the ablation device includes one or more electrodes formed of metallized fabric mesh.

13. The system of claim 1, further including a vacuum source fluidly coupled to the ablation device.

14. The system of claim 1 wherein the ablation device is an RF ablation device.

15. The system of claim 1 wherein the ablation device is a thermal ablation device.

16. The system of claim 15 wherein the ablation device includes an ablation element fluidly coupled to a source of heated fluid.

17. The system of claim 1 wherein the ablation device includes an ablation element having a bicornal shape to approximate the interior shape of a uterus.

18. The system of claim 1 wherein the inflation medium is a gas.

19. The system of claim 18 wherein the gas is carbon dioxide.

20. The system of claim 1 wherein the inflation medium is a liquid.

21. The system of claim 20 wherein the liquid is saline.

22. The system of claim 1 wherein the system is for uterine ablation and wherein the predetermined level is selected to be below a cracking pressure for fallopian tubes.

23. The system of claim 1 further including a collar assembly on the ablation device for sealing an opening to the body cavity.