Localization device for inserting localizer and methods of insertion
Inventors
LaViola, John • Defreitas, Kenneth F. • JAGENOW, Andrew L.
Assignees
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-12324604-B2
Publication Date
2025-06-10
Expiration Date
Abstract
A cannula defines a cannula axis and extends from the body of a localization device. An actuation system and a control rod are slidably and rotatably disposed within the body and the cannula. The control rod is operatively coupled to the actuation system for both slidable actuation and rotatable actuation.
Core Innovation
The invention provides an ultrasound-guided breast lesion localization device that includes a rigid cannula and a localization element that can be deployed after insertion. The device body has a first end and a second end, with the cannula extending from the second end and defining a cannula axis. An actuation system disposed on a lateral body portion enables movement relative to the cannula axis, including sliding along the cannula axis and rotation about the cannula axis.
A control rod is slidably and rotatably disposed within at least one of the body and the cannula. The control rod includes a first end and an opposite second end, where the first end of the control rod is disposed within the cannula and the second end of the control rod includes a spline coupled to a slidable actuator. The slidable actuator is configured to slide the control rod relative to a rotatable actuator and along the cannula axis, and the rotatable actuator is configured to rotate the control rod around the cannula axis.
The localization device includes a localization marker that is releasably coupled to the control rod and that moves with the control rod both along and relative to the cannula axis. The localization marker includes a localization element and flexible material coupled to the localization element, with the flexible material disposed at least partially within the control rod. The device further includes a wire latch with detents/ramps that provides controlled release and prevents accidental deployment, and fully extended positioning disengages the latch so the localization element remains in tissue after cannula withdrawal.
Claims Coverage
The document includes two independent claims, each centered on a rigid cannula-based localization device where a control rod is arranged to slide along and rotate about the cannula axis using an actuation system disposed on a lateral body portion.
Slidable and rotatable actuated control rod within rigid cannula
A localization device comprising a body with a rigid cannula extending from the second end of the body and defining a cannula axis; an actuation system on a lateral body portion including a slidable actuator configured to move along the cannula axis and a rotatable actuator configured to rotate about the cannula axis; and a control rod slidably and rotatably disposed within at least one of the body and the cannula, where the control rod includes a spline coupled to the slidable actuator and the rotatable actuator is slidably mounted at the spline such that the control rod slides and rotates relative to the cannula axis.
Single actuator in a slot configured for sliding and rotation of control rod
A localization device comprising a body defining a slot extending along a longitudinal axis on a lateral body portion; a rigid cannula extending from the second end and defining a cannula axis co-axial with the longitudinal axis; an actuation system on the lateral body portion including a single actuator disposed at least partially within the slot configured to both slidably move along the cannula axis and rotate about the cannula axis; and a control rod slidably and rotatably disposed within at least one of the body and the cannula, where the control rod is operatively coupled to the single actuator such that the control rod also both slides and rotates relative to the cannula axis.
Across the independent claims, the inventive coverage is directed to a rigid cannula-based breast lesion localization device in which a control rod both slides along the cannula axis and rotates about the cannula axis, implemented either with separate slidable and rotatable actuators or with a single actuator disposed in a slot.
Stated Advantages
Enables one-handed insertion of the localization device using ultrasound visualization.
Provides controlled release of the localization element to prevent accidental deployment.
Allows the localization element to remain in tissue after cannula withdrawal.
Documented Applications
Ultrasound-guided breast lesion localization using a cannula-based localization device and an ultrasound system with an ultrasound probe for B-mode imaging.
Interested in licensing this patent?