Method and device for uterine fibroid treatment

• US 20060189972A1
• Filed: 02/02/2006
• Published: 08/24/2006
• Est. Priority Date: 02/02/2005
• Status: Active Grant

• Current Assignee: Gynesonics, Inc.
• Original Assignee: Gynesonics, Inc.
• Inventors: Grossman, Jessica
• Granted Patent: US 7,918,795 B2
• Time in Patent Office: Days
• US Class Current: 606/32
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 2018/00559 Female reproductive organs
• CPC Class Codes: A61B 2018/143 multiple needles
• CPC Class Codes: A61B 2090/378 using ultrasound
• CPC Class Codes: A61B 2090/3782 transmitter or receiver in catheter or minimal invasive instrument
• CPC Class Codes: A61B 8/085 for locating body or organic structures, e.g. tumours, calculi, blood vessels, nodules
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00

Abstract

Methods and devices for both imaging and treating uterine fibroid tumors in one real-time system are provided. One minimally invasive method comprises introducing a sheath into a uterus and determining a location of a fibroid using a visualization element within or on the sheath. Upon identification, a portion of the sheath is steered to position at least one treatment needle at the determined location. The needle is then anchored in uterine tissue and the fibroid treated with the needle.

Claims

1. A method for minimally invasive treatment of uterine fibroids, said method comprising:

introducing a sheath into a uterus;

determining a location of a fibroid using a visualization element within or on the sheath;

steering a portion of the sheath to position at least one treatment needle at the determined location;

anchoring the needle in uterine tissue; and

treating the fibroid with the needle.

2. A method as in claim 1, wherein the sheath is introduced transcervically.

3. A method as in claim 1, wherein the visualization element is ultrasonic and produces a visual image.

4. A method as in claim 3, wherein anchoring comprises manually positioning and penetrating the treatment needle through an endometrium so as to engage the fibroid.

5. A method as in claim 4, further comprising steering, rotating, or deflecting the visualization element independent of the treatment needle.

6. A method as in claim 4, further comprising resisting displacement of the treatment needle.

7. A method as in claim 4, wherein anchoring further comprises deploying at least two treatment needles in a converging manner so as to pinch the fibroid therebetween.

8. A method as in claim 4, wherein anchoring further comprises deploying at least two treatment needles in a diverging manner so as to hook the fibroid therebetween.

9. A method as in claim 4, wherein anchoring further comprises deploying at least two treatment needles in a telescoping manner.

10. A method as in claim 1, wherein treating the fibroid comprises delivering ablative energy to the fibroid with the needle.

13. A method as in claim 1, wherein treating the fibroid comprises delivering at least one therapeutic agent to the fibroid with the needle.

14. A method as in claim 1, wherein treating the fibroid comprises morcelating the fibroid with the needle.

15. A method as in claim 1, further comprising imaging needle anchoring and treatment in real-time with the visualization element.

16. A method as in claim 1, further comprising monitoring tissue impedance.

17. A method as in claim 1, further comprising measuring a tissue temperature so as to aid in diagnosis, blood supply measurement, thermal signature, or tissue targeting.

11. A method as in claim 11, wherein the ablative energy comprises radiofrequency energy, microwave energy, laser energy, cryo energy, ultrasound energy, HIFU, or radiation.

12. A method as in claim 12, wherein the ablative energy comprises radiofrequency energy delivered in a bipolar or monopolar fashion.

18. Minimally invasive device for fibroid treatment, said device comprising:

a sheath adapted for transcervical introduction into a uterus;

a visualization element within or on a steerable portion of the sheath, the visualization element capable of determining a location of a fibroid on a wall of the uterus while the sheath is in the uterus; and

at least one self-anchoring treatment needle on or within the sheath, the needle being deployable against a fibroid whose position has been located by the visualization element.

19. A device as in claim 18, wherein the visualization element comprises an ultrasonic transducer.

20. A device as in claim 19, wherein the ultrasonic transducer comprises a phased array transducer having 64 elements or a mechanically scanned transducer.

21. A device as in any one of claims 18, wherein the treatment needle has a geometry which resists displacement.

22. A device as in claim 21, wherein the geometry is non-linear, helical, curved, co-axial, or everting.

23. A device as in claim 22, wherein the non-linear geometry is arcuate.

24. A device as in claim 18, wherein the treatment needle comprises an electrode, antenna, hollow tube, or cutting tube.

25. A device as in claim 18, wherein the treatment needle is formed from nitinol.

26. A device as in claim 18, wherein the treatment needle delivers ablative energy or at least one therapeutic agent to the fibroid.

27. A device as in claim 18, further comprising at least one other self-anchoring treatment needle on or within the sheath.

28. A device as in claim 18, wherein the sheath, visualization element, or treatment needle are integrally formed.

29. A device as in claim 18, wherein the sheath, visualization element, or treatment needle comprise separate, modular components.

30. A device as in claim 18, wherein the sheath, visualization element, or treatment needle is steerable, rotatable, deflectable, flexible, pre-shaped, or pre-formed.