Endometrial Ablation catheter

• US 20080281317A1
• Filed: 05/10/2007
• Published: 11/13/2008
• Est. Priority Date: 05/10/2007
• Status: Abandoned Application

• Current Assignee: Kimberly-Clark Worldwide Incorporated (Kimberly-Clark Corporation)
• Original Assignee: Kimberly-Clark Worldwide Incorporated (Kimberly-Clark Corporation)
• Inventors: Gobel, Fred
• Application Number:
  US11/801,645
• Publication Number:
  US 20080281317A1
• Time in Patent Office: Days
• US Class Current: 606/41
• 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 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61B 2017/22062 to be filled with liquid
• CPC Class Codes: A61B 2017/4216 Operations on uterus, e.g. endometrium
• CPC Class Codes: A61B 2018/046 in liquid form
• CPC Class Codes: A61B 2018/048 in gaseous form
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61M 2025/109 having balloons for removing solid matters, e.g. by grasping or scraping plaque, thrombus or other matters that obstruct the flow
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00

Abstract

An apparatus for ablating tissue with the uterine cavity is provided. The apparatus includes an ablation catheter and an expansible member. The expansible member is attached to the ablation catheter and it has a residual volume greater than the volume of the uterine cavity and exhibits residual dimensions greater than the anatomical dimensions of the uterine cavity.

Claims

1. An apparatus for ablating tissue in a uterine cavity, the apparatus comprising:

a catheter comprising a distal end, a proximal end, a catheter body, a catheter tip, one or more openings on the catheter body, and one of more fixation points; and

an expansible member comprising an outer surface, an interior surface, a distal end, and a proximal end, wherein upon introduction of inflation media into the expansible member, the expansible member defines a volume;

wherein the expansible member is adapted to attach to the catheter at the one or more fixation points so that under inflation, the distal end of the expansible member encloses the catheter tip; and

wherein the expansible member has a residual volume greater than the volume of the uterine cavity and exhibits residual dimensions greater than the anatomical dimensions of the uterine cavity.

2. The apparatus of claim 1 wherein the expansible member is inflated through the one or more openings of the catheter.

3. The apparatus of claim 2 wherein the inflation of the expansible member is accomplished by the introduction of gas, heated liquid, or a combination of both through the one or more openings.

4. The apparatus of claim 1, wherein the expansible member, upon inflation, does not enter a state of distension.

5. The apparatus of claim 1, wherein, upon inflation, the outer surface of the expansible member generates substantially even pressure against all interior portions of the uterine cavity including corneal areas.

6. The apparatus of claim 1, wherein the catheter is at least partially enclosed by a hysteroscope or is adjacent to a hysteroscope.

7. The apparatus of claim 1, wherein the expansible member further comprises a puls-oximeter sensor on its outer surface.

8. The apparatus of claim 1, wherein the catheter comprises one or more lumens.

9. The apparatus of claim 1, wherein upon inflation, pressure ranging from about 120 mmHg to about 200 mmHg is exerted upon the interior surface of the expansible member.

10. The apparatus of claim 9, wherein upon the inflation, pressure ranging from about 150 mmHg to about 180 mmHg is exerted upon the interior surface of the expansible member.

11. The apparatus of claim 1, wherein the expansible member is conically, cylindrically, or spherically shaped.

12. The apparatus of claim 1, wherein the expansible member has a shape corresponding to the shape of the uterine cavity.

13. The apparatus of claim 1, wherein the one or more fixation points comprise one of more distal fixation points and one or more proximal fixation points.

14. The apparatus of claim 1, wherein the expansible member comprises polyurethane material.

15. The apparatus of claim 1, wherein the thickness of the expansible member ranges from about 5 microns to about 30 microns.

16. The apparatus of claim 1, wherein the expansible member is a balloon.

17. The apparatus of claim 1, wherein the expansible member is pre-shaped prior to attachment to the catheter.

18. The apparatus of claim 1, wherein the expansible member, upon inflation, expands zero percent.

19. The apparatus of claim 1, wherein the expansible member has a residual volume between about 20% and about 60% greater than the volume of the uterine cavity and exhibits residual dimensions between about 20% and about 60% greater than the anatomical dimensions of the uterine cavity.

20. A method for ablating tissue in a uterine cavity, the method comprising:

Inserting a catheter into the uterine cavity, the catheter comprising a distal end;

a proximal end;

a catheter body;

a catheter tip;

one or more openings on the catheter body; and

one of more fixation points, the catheter further comprising an expansible member connected thereto at the one or more fixation points, the expansible member comprising an outer surface;

an interior surface;

a distal end; and

a proximal end, the expansible member having a residual volume greater than the volume of the uterine cavity and exhibiting residual dimensions greater than the anatomical dimensions of the uterine cavity;

Introducing a fluid into the proximal end of the catheter so that the fluid travels through the one or more openings into the expansible member so that the expansible member defines a volume which results in inflation of the expansible member without distension of the expansible member, wherein the outer surface of the expansible member exerts sufficient pressure against the uterine tissue to prevent blood from flowing into the uterine tissue; and

Deflating the expansible member and removing the catheter from the uterine cavity between about 5 and about 20 minutes after completion of introduction of fluid into the proximal end of the catheter.

21. The method of claim 20, wherein a hysteroscope, which partially encloses or is adjacent to a the catheter, is used to visualize the cessation of blood flow into the tissues of the uterine cavity.

22. The method of claim 20, wherein a puls-oximeter sensor is present on the outer surface of the expansible member and is used to measure the cessation of blood flow into the tissues of the uterine cavity

23. The method of claim 20, wherein upon inflation, pressure ranging from about 120 mmHg to about 200 mmHg is exerted upon the interior surface of the expansible member.

24. The method of claim 20, wherein the fluid is a gas.

25. The method of claim 20, wherein the fluid is a heated liquid.

26. A method for providing a system for ablating tissue in a uterine cavity, the method comprising:

Providing an apparatus comprising

a catheter comprising a distal end, a proximal end, a catheter body, a catheter tip, one or more openings on the catheter body, and one of more fixation points; and

an expansible member comprising an outer surface, an interior surface, a distal end, and a proximal end, wherein upon introduction of inflation media into the expansible member, the expansible member defines a volume;

wherein the expansible member is adapted to attach to the catheter at the one or more fixation points so that under inflation, the distal end of the expansible member encloses the catheter tip; and

wherein the expansible member has a residual volume greater than the volume of the uterine cavity and exhibits residual dimensions greater than the anatomical dimensions of the uterine cavity;

Providing instructions for inserting the catheter into the uterine cavity;

Providing means for introduction of fluid into the proximal end of the catheter so that the fluid travels through the one or more openings into the expansible member so that the expansible member defines a volume which results in inflation of the expansible member without distension of the expansible member, wherein the outer surface of the expansible member exerts sufficient pressure against the uterine tissue to prevent blood from flowing into the uterine tissue; and

Providing means for deflating the expansible member and removing the catheter from the uterine cavity between about 5 and about 20 minutes after completion of introduction of fluid into the proximal end of the catheter.

27. The method of claim 26, wherein a hysteroscope is provided for visualizing cessation of blood flow into the tissues of the uterine cavity.

28. The method of claim 26, wherein a puls-oximeter sensor is provided for measuring the cessation of blood flow into the tissues of the uterine cavity.