Method and device for uterine fibroid treatment

• US 9,808,310 B2
• Filed: 12/20/2010
• Issued: 11/07/2017
• Est. Priority Date: 02/02/2005
• Status: Active Grant

• Current Assignee: Gynesonics, Inc.
• Original Assignee: Gynesonics, Inc.
• Inventors: Grossman, Jessica
• Primary Examiner(s): Le, Long V
• Assistant Examiner(s): MCDONALD, KATHERINE M
• Application Number:
  US12/973,642
• Publication Number:
  US 20110087100A1
• Time in Patent Office: 2,514 Days
• Field of Search: 600439, 600437, 600462, 600459, 600210, 601 1- 4, 606170, 606180, 606 451, 606 13- 15, 606 40, 606 42, 606 41, 604113, 604105
• 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, said sheath having a longitudinal axis;

determining a location of a fibroid using a visualization element within or on the sheath, wherein the visualization element produces an imaging field transverse to the longitudinal axis of the sheath and wherein both the visualization element and the imaging field are deflectable with respect to the longitudinal axis of the sheath;

advancing a hollow needle from the sheath through a wall of the uterus and across the imaging field;

advancing a plurality of diverging needles from the hollow needle into the fibroid; and

treating the fibroid with the diverging needles, wherein the diverging needles remain within the limits of the imaging field during treatment, and

wherein determining the location of the fibroid comprises rotating the visualization element and the imaging field about the longitudinal axis of the sheath independently of the plurality of diverging needles after the hollow needle has been advanced through the wall of the uterus and across the imaging filed.

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 introducing comprises manually positioning and penetrating the plurality of diverging needles through an endometrium so as to engage the fibroid.

5. A method as in claim 1, wherein treating the fibroid comprises delivering ablative energy to the fibroid with the plurality of diverging needles.

6. A method as in claim 5, wherein the ablative energy comprises radiofrequency energy, microwave energy, laser energy, cryo energy, ultrasound energy, HIFU, or radiation.

7. A method as in claim 6, wherein the ablative energy comprises radiofrequency energy delivered in a bipolar or monopolar fashion.

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

9. A method as in claim 1, further comprising imaging advancing the hollow needle, advancing the plurality of diverging needles, and treatment in real-time with the visualization element.

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

11. 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.