Ablation device with articulated imaging transducer

• US 8,206,300 B2
• Filed: 02/08/2011
• Issued: 06/26/2012
• Est. Priority Date: 08/26/2008
• Status: Active Grant

• Current Assignee: Gynesonics, Inc.
• Original Assignee: Gynesonics, Inc.
• Inventors: Deckman, Robert K., Placek, Brian, Munrow, Michael A., Gerbi, Craig
• Primary Examiner(s): ROZANSKI, MICHAEL T
• Application Number:
  US13/023,383
• Publication Number:
  US 20120035474A1
• Time in Patent Office: 504 Days
• Field of Search: 600/439, 600/459, 606/41
• US Class Current: 600/439
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 2018/0016 Energy applicators arranged in a two- or three dimensional array
• CPC Class Codes: A61B 2018/00559 Female reproductive organs
• CPC Class Codes: A61B 2018/143 multiple needles
• CPC Class Codes: A61B 2018/1475 Electrodes retractable in or deployable from a housing
• CPC Class Codes: A61B 2090/3782 transmitter or receiver in catheter or minimal invasive instrument
• CPC Class Codes: A61B 2090/3784 both receiver and transmitter being in the instrument or receiver being also transmitter
• CPC Class Codes: A61B 8/0833 involving detecting or locating foreign bodies or organic structures
• CPC Class Codes: A61B 8/0841 for locating instruments
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 8/445 Details of catheter construction
• CPC Class Codes: A61B 8/4461 Features of the scanning mechanism, e.g. for moving the transducer within the housing of the probe

Abstract

A system for imaging and treating tissue comprises a probe having a deflectable distal tip for carrying an imaging array and a delivery needle for advancement within a field of view of the imaging array. Optionally, the needle will carry a plurality of tines which may be selectively radially deployed from the needle. The imaging array will preferably be provided in a separate, removable component.

Claims

1. An imaging and therapeutic delivery system comprising:

a straight shaft having a distal end and a proximal end;

a needle reciprocatably coupled to the shaft so that a tissue-penetrating tip on the needle can be distally advanced from the shaft along an axial path;

a tip pivotally attached to the distal end of the shaft and movable between a position parallel to the axial path and a position at an acute or right angle relative to the axial path, wherein the pivotally attached tip includes a stop structure disposed thereon which prevents advancement of the needle when the pivotally attached tip is parallel to the axial path; and

an ultrasonic imaging array carried by the pivotally attached tip, wherein the pivotally attached tip can be oriented to align a field of view of the imaging array with the needle as the needle is advanced along the axial path so as to sweep the ultrasound field of view relative to the needle and anatomy to be imaged.

2. A system as in claim 1, wherein the pivotally attached tip is offset from the axial path of the needle.

3. A system as in claim 1, further comprising an imaging core which includes the imaging array near a distal end thereof, wherein the imaging core is removably positionable in the straight shaft so that the imaging array extends into the pivotally attached tip.

4. A system as in claim 3, wherein the straight shaft is relatively rigid and the imaging core is flexible, wherein the imaging core can bend at the point where the pivotally attached tip is pivotally attached to the shaft.

5. A system as in claim 3, wherein the straight shaft is relatively rigid and the imaging core is hinged at the point where the pivotally attached tip is pivotally attached to the shaft.

6. A system as in claim 1, wherein the needle comprises at least one tine.

7. A system as in claim 6, further comprising a plurality of tines carried by the needle, wherein the tines are reciprocatably attached to the needle.

8. A system as in claim 7, wherein the ultrasonic imaging array sweeps the ultrasound field of view relative to the anatomy, needle and plurality of tines.

9. A system as in claim 7, wherein the tines are arranged to radially diverge from the needle as they are advanced distally.

10. A system as in claim 9, wherein at least one additional tine is arranged to advance axially from the needle.

11. A system as in claim 7, wherein the needle is electrically non-conductive and the tines are electrically conductive.

12. A system as in claim 1, further comprising a handle attached to the proximal end of the straight shaft.

13. A system as in claim 12, wherein the handle includes a lever coupled to the pivotally attached tip by a pull rod, wherein the lever can be pivoted to pivot the pivotally attached tip.

14. A system as in claim 13, wherein the handle includes a first slide mechanism coupled to the needle, wherein the slide can be reciprocated to advance and retract the needle along the axial path.

15. A system as in claim 14, further comprising a plurality of tines carried by the needle, wherein the tines are reciprocatably attached to the needle to diverge from the needle as they are advanced distally, and further comprising a second slide mechanism on the slide to advance and retract the tines relative to the needle.

16. A system as in claim 1, wherein rotation of said ultrasonic imaging array is independent of movement of said needle.

17. A method for treating uterine fibroids, said method comprising:

introducing a straight shaft into a uterus, wherein a needle is reciprocatably coupled to the shaft so that a tissue-penetrating tip on the needle can be distally advanced from the shaft along an axial path;

locating a uterine fibroid using an ultrasonic imaging transducer carried by a pivotable tip attached to a distal end of the shaft, wherein the pivotable tip is movable between a position parallel to the axial path and a position at an acute or right angle relative to the axial path;

pivoting the ultrasonic transducer to reposition a field of view of the ultrasonic transducer, wherein the needle is blocked from advancing when the pivotable tip is disposed parallel to the axial path;

advancing a needle axially from the distal end of the shaft into tissue near the located uterine fibroid, wherein the needle is aligned in the field of view; and

imaging the needle and the fibroid using the ultrasound transducer.

18. A method as in claim 17, wherein introducing the shaft comprises transcervical introduction.

19. A method as in claim 17, wherein locating comprises manually rotating and translating the shaft to scan the uterine wall with the ultrasonic transducer.

20. A method as in claim 19, wherein imaging comprises rotating the ultrasound transducer independently of movement of said needle.

21. A method as in claim 17, wherein locating comprises pivoting the ultrasonic transducer relative to the shaft.

22. A method as in claim 21, further comprising releasing the needle to advance axially when the ultrasonic transducer is pivoted relative to the shaft.

23. A method as in claim 17, further comprising advancing a plurality of tines from the needle after the needle has been advanced into or near the uterine fibroid.

24. A method as in claim 23, wherein locating comprises pivoting the ultrasonic transducer for imaging the plurality of tines.

25. A method as in claim 23, further comprising delivering energy from the tines into the fibroid.

26. A method as in claim 25, wherein the energy is radiofrequency energy.

27. A method as in claim 25, wherein the needle remains electrically non-conductive while the energy is being delivered through the tines.

28. A method as in claim 25, further comprising blocking energy delivery if the tines are not fully advanced.

29. An imaging and therapeutic delivery system comprising:

a straight shaft having a distal end and a proximal end;

a delivery needle reciprocatably coupled to the shaft so that a tissue-penetrating tip on the delivery needle can be distally advanced from the shaft along an axial path;

at least one treatment needle deployable from said delivery needle wherein said treatment needle is reciprocatable within said delivery needle;

a tip pivotally attached to the distal end of the shaft and movable between a position parallel to the axial path and a position at an acute or right angle relative to the axial path, wherein the pivotally attached tip includes a stop structure disposed thereon which prevents advancement of the treatment needle when the pivotally attached tip is parallel to the axial path; and

an ultrasonic imaging array carried by the pivotally attached tip, wherein the pivotally attached tip can be oriented to align a field of view of the imaging array with the delivery needle as the delivery needle is advanced along the axial path, so as to sweep the ultrasound field of view relative to the delivery needle and anatomy to be imaged.

30. A system as in claim 29, wherein said at least one treatment needle comprises a plurality of tines.