Uterine Therapy Device and Method

• US 20090054868A1
• Filed: 08/22/2008
• Published: 02/26/2009
• Est. Priority Date: 08/23/2007
• Status: Active Grant

• Current Assignee: Aegea Medical Inc.
• Original Assignee: Aegea Medical Inc.
• Inventors: Reyes, Ramiro, Sparks, Kurt D., Sharkey, Hugh R.
• Granted Patent: US 8,221,401 B2
• Time in Patent Office: Days
• US Class Current: 604/515
• 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 2017/3425 for internal organs, e.g. heart ports
• CPC Class Codes: A61B 2017/4216 Operations on uterus, e.g. endometrium
• CPC Class Codes: A61B 2017/4225 Cervix uteri
• CPC Class Codes: A61B 2018/00005 Cooling or heating of the probe or tissue immediately surrounding the probe
• CPC Class Codes: A61B 2018/00285 Balloons
• CPC Class Codes: A61B 2018/00559 Female reproductive organs
• CPC Class Codes: A61B 2018/048 in gaseous form

Abstract

A method and system of providing therapy to a patient'"'"'s uterus. The method includes the steps of inserting an access tool through a cervix and a cervical canal into the uterus; actively cooling the cervical canal; delivering vapor through the access tool lumen into the uterus; and condensing the vapor on tissue within the uterus. The system has an access tool with a lumen, the access tool being adapted to be inserted through a human cervical canal to place an opening of the lumen within a uterus when the access tool is inserted through the cervical canal; an active cooling mechanism adapted to cool the cervical canal, the active cooling mechanism having a coolant source; and a vapor delivery mechanism adapted to deliver condensable vapor through the access tool to the uterus, the condensable vapor being adapted to condense within the uterus.

Claims

1. A method of providing heat therapy to a patient'"'"'s uterus comprising:

inserting an access tool through a cervix and a cervical canal into the uterus, the access tool comprising a lumen;

actively cooling the cervical canal;

delivering vapor through the access tool lumen into the uterus; and

condensing the vapor on tissue within the uterus.

2. The method of claim 1 wherein the access tool comprises a coolant flowpath, the step of actively cooling comprising supplying a flow of coolant through the coolant flowpath.

3. The method of claim 2 wherein the access tool comprises an expandable member, the coolant flowpath being disposed within the expandable member, the method further comprising expanding the expandable member with the coolant.

4. The method of claim 3 wherein the expandable member comprises a balloon.

5. The method of claim 3 wherein the coolant flowpath comprises a coolant inlet communicating with a coolant source and a coolant outlet communicating with an interior volume of the expandable member, the supplying step comprising supplying coolant flow from the coolant inlet through the coolant outlet.

6. The method of claim 2 wherein the coolant flowpath comprises a coolant lumen formed in the access tool, the supplying step comprising supplying coolant flow from the coolant inlet through the coolant lumen.

7. The method of claim 1 further comprising sealing an interior cervical os after the inserting step.

8. The method of claim 7 wherein the sealing step comprises expanding an expandable member.

9. The method of claim 8 wherein the expandable member comprises a balloon.

10. The method of claim 9 wherein the expanding step comprises preferentially expanding a sealing portion of the balloon disposed at the interior cervical os prior to expanding an indicator portion of the balloon disposed proximal to the interior cervical os.

11. The method of claim 9 wherein the expanding step comprises supplying coolant to the balloon.

12. The method of claim 1 further comprising placing an expansion mechanism in contact with tissue within the uterus to move uterine tissue away from an opening in the lumen.

13. The method of claim 12 further comprising advancing the expansion mechanism distally prior to the placing step.

14. The method of claim 1 wherein the step of delivering vapor comprises inserting a vapor delivery tool through the access tool lumen.

15. The method of claim 1 further comprising exhausting vapor and vapor condensate from the uterus.

16. A uterine heat therapy system comprising:

an access tool comprising a lumen, the access tool being adapted to be inserted through a human cervical canal to place an opening of the lumen within a uterus when the access tool is inserted through the cervical canal;

an active cooling mechanism adapted to cool the cervical canal, the active cooling mechanism comprising a coolant source; and

a vapor delivery mechanism adapted to deliver condensable vapor through the access tool to the uterus, the condensable vapor being adapted to condense within the uterus.

17. The system of claim 16 wherein the access tool further comprises a coolant flowpath communicating with the coolant source.

18. The system of claim 17 wherein the access tool further comprises an expandable member, the coolant flowpath being disposed within the expandable member.

19. The system of claim 18 wherein the expandable member comprises a balloon.

20. The system of claim 18 wherein the coolant flowpath comprises a coolant inlet communicating with the coolant source and a coolant outlet communicating with an interior volume of the expandable member.

21. The system of claim 17 wherein the coolant flowpath comprises a coolant lumen formed in the access tool.

22. The system of claim 16 further comprising a seal disposed at a distal region of the access tool and adapted to seal against an interior cervical os.

23. The system of claim 22 wherein the seal comprises an expandable member.

24. The system of claim 23 wherein the expandable member comprises a balloon.

25. The system of claim 24 wherein the balloon comprises a distal sealing portion adapted to preferentially expand prior to a proximal indicator portion when the balloon is expanded with fluid.

26. The system of claim 16 further comprising an expansion mechanism adapted to contact tissue within the uterus to move uterine tissue away from the opening in the access tool lumen.

27. The system of claim 26 further comprising an advancement mechanism operatively connected to the expansion mechanism to move the expansion mechanism distally with respect to the access tool.

28. The system of claim 16 further comprising a vapor delivery tool adapted to be inserted through the access tool lumen.