METHODS AND SYSTEMS FOR CONTROLLED DEPLOYMENT OF NEEDLE STRUCTURES IN TISSUE

• US 20140073910A1
• Filed: 03/13/2013
• Published: 03/13/2014
• Est. Priority Date: 09/07/2012
• Status: Active Grant

• Current Assignee: Gynesonics, Inc.
• Original Assignee: Gynesonics, Inc.
• Inventors: Munrow, Michael A., Uecker, Darrin, Placek, Brian, Kwan, Harry, Toub, David, Hinman, Cameron D., Danitz, David J.
• Granted Patent: US 9,861,336 B2
• Time in Patent Office: Days
• US Class Current: 600/424
• CPC Class Codes: A61B 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• CPC Class Codes: A61B 18/042 using additional gas becoming plasma
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 18/1485 having a short rigid shaft for accessing the inner body through natural openings
• CPC Class Codes: A61B 18/1815 using microwaves
• CPC Class Codes: A61B 2018/00559 Female reproductive organs
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00702 Power or energy
• CPC Class Codes: A61B 2018/00761 Duration
• CPC Class Codes: A61B 2018/00898 Alarms or notifications created in response to an abnormal condition
• CPC Class Codes: A61B 2018/00904 Automatic detection of target tissue
• CPC Class Codes: A61B 2018/00982 combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes
• CPC Class Codes: A61B 2018/0293 using an instrument interstitially inserted into the body, e.g. needle
• 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 2034/104 Modelling the effect of the tool, e.g. the effect of an implanted prosthesis or for predicting the effect of ablation or burring
• CPC Class Codes: A61B 2034/107 Visualisation of planned trajectories or target regions
• CPC Class Codes: A61B 2034/2063 Acoustic tracking systems, e.g. using ultrasound
• CPC Class Codes: A61B 2034/254 being adapted depending on the stage of the surgical procedure
• CPC Class Codes: A61B 2090/034 abutting on parts of the device itself
• CPC Class Codes: A61B 2090/0427 : Prevention of contact
• 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 2090/3784 : both receiver and transmitter being in the instrument or receiver being also transmitter
• CPC Class Codes: A61B 34/25 : User interfaces for surgical systems
• CPC Class Codes: A61B 5/066 : Superposing sensor position on an image of the patient, e.g. obtained by ultrasound or x-ray imaging
• 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 8/145 : characterised by scanning multiple planes
• CPC Class Codes: A61B 8/445 : Details of catheter construction
• CPC Class Codes: A61B 8/461 : Displaying means of special interest
• CPC Class Codes: A61B 8/463 : characterised by displaying multiple images or images and diagnostic data on one display composite display in devices for short-range imaging with acoustic waves G01S7/52074
• CPC Class Codes: A61B 8/467 : characterised by special input means
• CPC Class Codes: A61B 90/04 : Protection of tissue around surgical sites against effects of non-mechanical surgery, e.g. laser surgery protection of eyes against laser radiation A61F9/022
• CPC Class Codes: A61N 2007/025 : interstitial
• CPC Class Codes: F04C 2270/041 : Controlled or regulated

Abstract

A system for deploying needles in tissue includes a controller and a visual display. A treatment probe has both a needle and tines deployable from the needle which may be advanced into the tissue. The treatment probe also has adjustable stops which control the deployed positions of both the needle and the tines. The adjustable stops are coupled to the controller so that the virtual treatment and safety boundaries resulting from the treatment can be presented on the visual display prior to actual deployment of the system.

Claims

1. A method for deploying a needle structure in tissue, said method comprising:

positioning a probe having a deployable needle structure near an anatomical feature in the tissue;

providing a real time image of the tissue including the anatomical feature to be treated on a display connected to a controller;

projecting at least one of a treatment region and a safety region on the real time image prior to deploying the needle structure;

adjusting at least one of a size and a position of a boundary of the projected image of the treatment region and/or safety region on the real time image prior to deploying the needle structure; and

deploying the needle structure from the probe, wherein the needle structure is positioned relative to the probe and the tissue to provide treatment within the projected boundary after the projected boundary has been adjusted.

2. A method as in claim 1, wherein a position of the projected boundary is adjusted by manually repositioning the probe relative to the anatomical feature.

3. A method as in claim 1, wherein adjusting the size and/or position of the projected boundary comprises adjusting a user interface connected to the controller.

4. A method as in claim 3, wherein the interface comprises a keyboard, mouse, roller ball, or touch screen which is connected to the controller.

5. A method as in claim 3, wherein the interface is on the probe.

6. A method as in claim 5, wherein the interface on the probe also adjusts mechanically a needle deployment stop on the probe, wherein advancement of the needle to the needle deployment stop assures that the treatment region will be treated and that treatment will not extend beyond the safety region.

7. A method as in claim 6, wherein the needle structure further comprises a plurality of tines which are advanceable from the needle in a distally diverging pattern, wherein the extent of advancement of the tines at least partly determines the size of the treatment region and/or the safety region.

8. A method as in claim 7, wherein the size of the projected boundary is adjusted by manually positioning a tine stop element on the probe.

9. A method as in claim 8, wherein tine stop element provides a physical limit on advancing the plurality of tines so that when the tines are advanced to the tine stop element the tines will be located in tissue within the treatment region and/or safety region.

10. A method as in claim 1, wherein deploying the needles comprises driving a servo motor controlled by the controller to advance the needle structure.

11. A method as in claim 7, wherein deploying the tines comprises driving a servo motor controlled by the controller to advance the tines.

12. A method as in claim 1, further comprising delivering energy through the needle structure to target tissue.

13. A method as in claim 12, further comprising controlling at least one of treatment power or treatment time to limit the extent of tissue treatment to within the treatment region and/or safety region.

14. A method as in claim 1, further comprising projecting virtual needle structure location information onto the display.

15. A method as in claim 14, wherein the virtual needle structure location information comprises markers representing locations on the needle.

16. A method as in claim 14, wherein the virtual needle location information is updated on the display as the probe stops are adjusted.

17. A method as in claim 1, further comprising projecting actual needle structure location information onto the display.

18. A method as in claim 17, wherein the actual needle structure location information is derived from sensors on the probe which track needle structure deployment.

19. A method as in claim 17, wherein the virtual needle location information is updated on the display as the needle structure is deployed.

20. An imaging and therapeutic delivery system comprising:

an imaging component comprising an imaging shaft having a proximal end and a distal end and an imaging transducer at the distal end of the shaft;

a needle component comprising a needle shaft having a distal end and a proximal end and a needle structure reciprocally disposed on or within the shaft;

wherein the needle shaft is configured to removeably attach to the imaging shaft with the shafts lying side-by-side with their respective axes generally parallel.

21. A system as in claim 20, wherein the imaging transducer on the imaging shaft is pivotally attached at the distal end of the imaging shaft.

22. A system as in claim 21, wherein the distal end of the needle shaft is disposed proximally of the pivotally attached imaging transducer when the needle shaft is attached to the imaging shaft.

23. A system as in claim 20, wherein the needle structure in the needle shaft reciprocates distally along the axis of the needle shaft and wherein the imaging transducer pivots away from the axis of the needle shaft when the needle shaft is attached to the imaging shaft.

24. A system as in claim 22, wherein the imaging component further comprises an imaging handle section attached to a proximal end of the imaging shaft and the needle component further comprises a needle handle section attached to a proximal end of the needle shaft, wherein the imaging handle section and needle handle section together form a complete handle when the needle shaft is attached to the imaging shaft.

25. A system as in claim 24, wherein the imaging handle section has an interior which holds circuitry configured to connect the imaging transducer with an external imaging display and the needle handle section including mechanisms for advancing the tine needle structure.

26. A system as in claim 25, wherein the imaging handle section further comprises mechanisms for pivoting the imaging transducer relative to the imaging shaft.

27. A method for deploying a plurality of tines from a needle in tissue, said method comprising:

providing a real-time image of the tissue including an anatomical feature to be treated on a display;

penetrating the needle into the tissue proximate the anatomical feature;

deploying the tines from the needle, wherein at least one of a treatment boundary and a safety boundary are projected onto the display in response to the tine deployment; and

adjusting an extent of tine deployment to change a size and/or shape of the treatment and/or safety boundary projected on the display;

wherein a treatment is delivered through the tines after an acceptable size and/or shape of the treatment and/or safety boundary is achieved.

28. A method as in claim 27, wherein deployment of the tines is tracked via sensors in a needle/tine deployment mechanism.

29. A method as in claim 28, wherein penetrating the needle comprises advancing the needle from a probe which has been penetrated into the tissue.

30. A method as in claim 27, further comprising adjusting an extent of the needle deployment to a location of the treatment and/or safety boundary projected on the display.

31. A system for treating an anatomical feature in tissue, said system comprising:

a real-time display connected to a controller;

means for projecting and adjusting at least one of a treatment boundary and a safety boundary on the display;

a treatment probe having a deployable needle structure and an imaging transducer connectable to the controller and display; and

at least one servo drive motor on the treatment probe connected to the controller, wherein the controller is configured to drive the servo motor to position the needle structure to provide a treatment which covers the treatment boundary and which does not extend beyond the safety boundary.

32. A system as in claim 31, wherein the needle structure of the treatment probe comprises a needle and a plurality of tines advanceable from the needle in a distally diverging pattern.

33. A system as in claim 32, wherein the at least one servo motor comprises a first servo motor which drives the needle and a second servo motor which drives the plurality of tines.

34. A system as in claim 31, wherein the projecting means comprises a user interface configured to allow the user to virtually adjust a size and/or a position of the treatment and/or safety boundary on the display.

35. A system as in claim 34, wherein the interface is on the treatment probe.

36. A system as in claim 34, wherein the user interface comprises a keyboard, mouse, roller ball, or touch screen connected to the controller.