Methods and systems for controlled deployment of needle structures in tissue
Inventors
Munrow, Michael A. • Uecker, Darrin • Placek, Brian • Kwan, Harry • Toub, David • Hinman, Cameron D. • Danitz, David J.
Assignees
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Publication Number
US-11890134-B2
Publication Date
2024-02-06
Expiration Date
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.
Core Innovation
The invention provides a controlled method for deploying a plurality of tines from a needle in tissue using real-time image guidance and projected virtual treatment and safety boundaries. A real-time image of the tissue including an anatomical feature to be treated is provided on a display, and at least one of a treatment boundary or a safety boundary is projected onto the display. The safety boundary comprises a minimum threshold distance beyond the treatment boundary where a risk of damaging tissue during the treatment is reduced.
After penetrating the needle into the tissue proximate the anatomical feature, the extent of tine deployment is adjusted to change a size and/or shape of the treatment and/or safety boundary projected onto the display. The treatment is delivered through the plurality of tines after adjusting the extent of tine deployment, such that the plurality of tines are positioned to provide the treatment within the projected boundary after the projected boundary has been adjusted. In related embodiments, a real time ultrasound image is used, and the probe is displayed as the probe is positioned near the anatomical feature.
User adjustment is used to change the size and/or position of the projected boundary, including user adjustment via a user interface or a first interface, and the deployed plurality of tines are displayed on the real time image as the plurality of tines is deployed. The plurality of tines is deployed from the probe by distal advancement of a slider on the handle of the probe or by operation of a second interface on the handle of the probe. The disclosed system further includes boundary adjustment workflow with fiducials/markers for verifying actual needle/tine placement, as well as interlocks that control correct actuation order to support matching deployment to confirmed boundaries.
Claims Coverage
The independent claims are clm-00001, clm-00019, and clm-00020. Across these claims, the coverage centers on real-time image guidance with projected treatment/safety boundaries, user adjustment of boundary size/position, and tine deployment arranged so treatment is delivered through the plurality of tines within the adjusted projected boundary, with the safety boundary defined by a minimum threshold distance.
Real-time image including anatomical feature and projected treatment/safety boundaries
Providing a real-time image of the tissue including an anatomical feature to be treated on a display and projecting at least one of a treatment boundary or a safety boundary onto the display, wherein the safety boundary comprises a minimum threshold distance beyond the treatment boundary where a risk of damaging tissue during the treatment is reduced.
Adjusting extent of tine deployment to change projected boundary
Adjusting an extent of tine deployment to change a size and/or shape of the treatment and/or safety boundary projected onto the display, wherein the treatment is delivered through the plurality of tines after adjusting the extent of tine deployment.
Real-time ultrasound image, user interface boundary adjustment, and display of deployed tines
Providing a real time ultrasound image of the tissue including an anatomical feature to be treated on a display; projecting an image of at least one of a treatment region for a treatment or a safety region on the real time image with the safety boundary comprising a minimum threshold distance beyond a boundary of the treatment region where a risk of damaging tissue during the treatment is reduced; adjusting a size and a position of a projected boundary by user adjustment of a user interface; and displaying the plurality of tines on the real time ultrasound image as the plurality of tines is deployed, wherein the plurality of tines is positioned to provide the treatment within the projected boundary after the projected boundary has been adjusted.
Real-time image with first interface boundary adjustment and second interface tine deployment
Providing a real time image of the tissue including an anatomical feature to be treated on a display; projecting an image of at least one of a treatment region for a treatment or a safety region on the real time image, wherein the safety boundary comprises a minimum threshold distance beyond a boundary of the treatment region where a risk of damaging tissue during the treatment is reduced; adjusting at least one of a size or a position of a projected boundary by user adjustment of a first interface; displaying the plurality of tines on the real time image as the plurality of tines is deployed from the probe; and deploying the plurality of tines from the probe by operation of a second interface on the handle of the probe.
The claim set focuses on projecting treatment and safety boundaries with the safety boundary defined by a minimum threshold distance, adjusting boundary size/shape or size/position via real-time image guidance and user interfaces, and deploying and displaying the plurality of tines such that treatment is delivered through the tines after the projected boundary has been adjusted, with deployment carried out via specified handle interfaces.
Stated Advantages
Reduces the risk of damaging tissue during the treatment by using a safety boundary that comprises a minimum threshold distance beyond the treatment boundary.
Supports adjusting and matching tine deployment so treatment is provided within the projected treatment boundary after boundary adjustment.
Documented Applications
Uterine fibroid treatment using a controlled needle/tine deployment system with real-time imaging display and adjustable virtual treatment and safety boundaries (fibroid/serosa example).
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