Thermal Ablation System

• US 20090125014A1
• Filed: 11/13/2008
• Published: 05/14/2009
• Est. Priority Date: 11/14/2007
• Status: Abandoned Application

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Marsella, Andrew W., Gordon, Joseph M., Robson, David, MacLean, Brian, Bouthillier, Robert J., Keaney, Stephen S., Fusaro, Michael P., Shapeton, Boris
• Application Number:
  US12/270,401
• Publication Number:
  US 20090125014A1
• Time in Patent Office: Days
• US Class Current: 606/34
• CPC Class Codes: A61B 18/04 by heating by applying electromagnetic radiation A61B18/18; hyperthermia using electric or magnetic fields, radiation or ultrasound A61N
• CPC Class Codes: A61B 2017/00199 with a console, e.g. a control panel with a display
• CPC Class Codes: A61B 2017/4216 Operations on uterus, e.g. endometrium
• CPC Class Codes: A61B 2018/00035 with return means
• CPC Class Codes: A61B 2018/00559 Female reproductive organs
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/046 in liquid form

Abstract

A thermal ablation system comprises a fluid handling unit receiving fluid from a fluid source at a first pressure, the fluid handling unit including a heater heating the fluid to a desired temperature and a pump and an introducer including a sheath which, when in an operative position, is received within a hollow organ, the sheath including a delivery lumen introducing fluid heated by the heater to the hollow organ and a return lumen withdrawing fluid from the hollow organ and returning the withdrawn fluid to the console via a return lumen, wherein the pump increases a pressure of the fluid between the fluid source and the delivery lumen of the introducer.

Claims

1. A thermal ablation system comprising:

a fluid handling unit receiving fluid from a fluid source at a first pressure, the fluid handling unit including a heater heating the fluid to a desired temperature and a pump; and

an introducer including a sheath which, when in an operative position, is received within a hollow organ, the sheath including a delivery lumen introducing fluid heated by the heater to the hollow organ and a return lumen withdrawing fluid from the hollow organ and returning the withdrawn fluid to the console via a return lumens wherein the pump increases a pressure of the fluid between the fluid source and the delivery lumen of the introducer.

2. The system according to claim 1, wherein the fluid handling unit includes a reusable console and a disposable cartridge.

3. The system according to claim 1, wherein the pump increases the pressure of the fluid by a substantially constant amount.

4. The system according to claim 2, wherein a motor of the pump is located in the console and an impeller of the pump is located within the cartridge.

5. The system according to claim 4, wherein the motor drives the impeller via a magnetic coupling.

6. The system according to claim 2, wherein no fluid passes through the console.

7. The system according to claim 1 wherein the fluid handling unit is mounted on a variable height base.

8. The system according to claim 3, wherein the console includes a fluid bag mounting pole for mounting the fluid source a predetermined height above a fluid inlet of the fluid handling unit to achieve a desired substantially constant fluid pressure within the hollow organ.

9. The system according to claim 1, wherein the fluid handling unit includes a user interface including at least one of a display screen, a touch screen, a keypad and a speaker.

10. The system according to claim 1, wherein the fluid handling unit includes a height determining mechanism ensuring a desired height differential between the fluid source and the hollow organ.

11. The system according to claim 10, wherein the height determining mechanism provides a visual indication of a reference height relative to the hollow organ.

12. The system according to claim 11, wherein the height determining mechanism includes a light beam port projecting a light beam substantially horizontally.

13. The system according to claim 2, wherein the console includes a valve arrangement selectively opening and closing fluid circulation lumens in the cartridge.

15. The system according to claim 2, wherein the cartridge includes a filter arrangement filtering the fluid from the return lumen.

16. The system according to claim 2, wherein the cassette includes a reservoir storing the fluid and a level sensor outputting a signal corresponding to a level of the fluid within the reservoir.

17. The system according to claim 16, wherein the console includes a controller determining a fluid volume as a function of the signal.

18. The system according to claim 2, wherein the cartridge includes a drainage lumen emptying fluid from the return lumen into a drainage bag.

19. The system according to claim 1, wherein the introducer includes a grip having a sheath extending distally therefrom and a scope connector extending proximally therefrom.

20. The system according to claim 19, wherein the grip is sized and shaped for single-handed use.

21. The system according to claim 19, wherein the scope connector includes a lock for detachably coupling a visualization device to the introducer and a scope adapter adjusting a length of the introducer.

22. The system according to claim 19, wherein the sheath includes a seal disposed proximally of a distal end of the sheath.

23. The system according to claim 22, wherein the seal is radially expandable from the sheath.

24. The system according to claim 22, wherein a distance between the distal end of the sheath and a distal end of the seal is selected so that, when the distal end of the sheath is in a desired position within the hollow organ, the seal is located within a lumen through which the sheath is introduced into the hollow organ.

25. The system according to claim 24, wherein the hollow organ is a uterus and the distance is between 0 cm and 1.5 cm so that, when the distal end of the sheath is in a desired position within the uterus, the seal is located within a cervix.

26. The system according to claim 1, wherein the introducer includes a tenaculum stabilizer.

14. The system according to claim 14, wherein the valve arrangement includes at least one pincher valve.

27. A method, comprising:

aligning a fluid handling unit of a thermal ablation system to a desired height relative to a hollow organ to be treated;

heating a fluid in the fluid handling unit to a predetermined temperature;

pumping the fluid from the fluid handling unit via a fluid delivery lumen into an introducer inserted into the hollow organ; and

after the fluid has been circulated through the hollow organ, withdrawing the fluid from the tissue structure to the fluid handling unit via a fluid return lumen in the introducer.

28. The method according to claim 27, further comprising:

filtering the fluid received from the fluid return lumen; and

pumping the fluid back into the introducer via the fluid delivery lumen.

29. The method according to claim 27, further comprising:

monitoring a volume of the fluid circulating through the hollow organ; and

when the volume is outside a predetermined range, executing a safety procedure.