Method and device for uterine fibroid treatment

• US 7,918,795 B2
• Filed: 02/02/2006
• Issued: 04/05/2011
• Est. Priority Date: 02/02/2005
• Status: Active Grant

• Current Assignee: Gynesonics, Inc.
• Original Assignee: Gynesonics, Inc.
• Inventors: Grossman, Jessica
• Primary Examiner(s): Winakur; Eric F
• Assistant Examiner(s): Laryea; Lawrence N
• Application Number:
  US11/347,018
• Publication Number:
  US 20060189972A1
• Time in Patent Office: 1,888 Days
• Field of Search: 600/439, 600/437, 600/462, 600/459, 600/210, 600/464, 601 1- 4, 606/170, 606/180, 606/45, 606/1, 606 13- 15, 606/40, 606/42, 606/41, 606/44, 604/113, 604/105, 604/19
• US Class Current: 600/439
• 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 having a uterine wall;

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 two treatment needles at the determined location above the uterine wall;

deploying said at least two treatment needles from a side of the sheath through the uterine wall and into uterine tissue at spaced-apart locations on the uterine wall such that the needles converge or diverge from said spaced-apart wall locations as they enter the tissue so that said needles anchor in the tissue;

treating the fibroid with the needles while the needles remain anchored and substantially immobile; and

withdrawing the needles entirely back into the sheath when the treatment is complete.

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 deploying comprises manually positioning and penetrating the treatment needles 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 1, wherein said at least two treatment needles are deployed in a converging manner so as to pinch the fibroid therebetween.

7. A method as in claim 1, wherein said at least two treatment needles are deployed in a diverging manner so as to hook the fibroid therebetween.

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

9. A method as in claim 8, wherein the ablative energy comprises radiofrequency energy, microwave energy, laser energy, cryo energy, ultrasound energy, HIFU, or radiation.

10. A method as in claim 8, wherein the ablative energy comprises radiofrequency energy delivered in a bipolar or monopolar fashion.

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

12. A method as in claim 1, wherein treating the fibroid comprises morcelating the fibroid with the needles.

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

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

15. 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.

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

a single sheath having a distal end, a proximal end, and an axis, wherein the distal end is adapted for transcervical introduction into a uterus;

a visualization element within or on a distal 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

a needle deployment array consisting of two self-anchoring treatment needles which are deployable from spaced-apart locations on a side of the sheath proximal of the visualization element to converge or diverge within tissue over a fibroid within the field of view of the visualization element, wherein the needles are adapted to be withdrawn entirely back into the sheath after use.

17. A device as in claim 16, wherein the visualization element comprises an ultrasonic transducer.

18. A device as in claim 17, wherein the ultrasonic transducer comprises a phased array transducer having 64 elements or a mechanically scanned transducer.

19. A device as in claim 16, wherein the treatment needle has an arcuate geometry which resists displacement.

20. A device as in claim 16, wherein the treatment needles each comprise an electrode, antenna, hollow tube, or cutting tube.

21. A device as in claim 16, wherein the treatment needle is formed from nitinol.

22. A device as in claim 16, wherein the treatment needle delivers ablative energy or at least one therapeutic agent to the fibroid.

23. A device as in claim 16, wherein the sheath, visualization element, and treatment needle are integrally formed.

24. A device as in claim 16, wherein the sheath, visualization element, and treatment needle comprise separate, modular components.

25. A device as in claim 16, wherein the sheath, visualization element, or treatment needle is steerable, rotatable, deflectable, flexible, pre-shaped, or pre-formed.