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Publication Number
US-8298211-B2
Publication Date
2012-10-30
Expiration Date
Abstract
A site marker deployment device includes a housing defining a first portion, an outer cannula at least partially interposed within the first portion and having a proximal end and a distal end defined by an outer cannula aperture, an inner member at least partially interposed within the outer cannula, a first biasing portion, a second biasing portion, wherein the second biasing portion will selectively urge the outer cannula to move proximally relative to the inner member, and a site marker selectively disposed within the outer cannula adjacent the inner member, near the distal end of the outer cannula. The first biasing portion will selectively urge a site marker at least partially within the outer cannula.
Core Innovation
The disclosure describes a site marker deployment device having a housing, an outer cannula, and an inner member, in which a site marker is selectively retracted from outside of the outer cannula to at least partially inside of the outer cannula and retained at least partially within the outer cannula. A first actuator selectively releases a first biasing portion to retract the site marker via a retracting portion, while a second biasing portion selectively urges the outer cannula to move proximally relative to the inner member and the site marker.
The device deployment operation produces an ejection of the site marker and allows the marker to spring into a deployed, imaging-visible configuration, based on a spring-and-disengagement mechanism in which restraint arms release upon actuation. The marker filament architecture is described with a deployed configuration versus a retracted configuration, including elastically deformed filament members when interposed within inner cannula components, supporting conversion between configurations during use.
The disclosure further describes sterilizing the deployment device with the site marker not fully interposed within the outer cannula, such that the marker is in a partially retracted, less-deformed state. The deployment is described for use with an introducer and biopsy workflow at a biopsy site, lesion, or biopsy cavity, while enabling imaging compatibility of the deployed marker.
Claims Coverage
The document includes three independent claims, centered on selectively retracting and retaining a site marker in an outer cannula and then urging the outer cannula proximally relative to an inner member so that the marker becomes deployed and imaging-visible. The main inventive features across the independent claims are the coordinated actuator and biasing arrangement, the retracting-and-retaining relationship, the use of axial movement driven by a second biasing portion, and sterilization with the site marker not fully interposed within the outer cannula.
Coordinated actuator releases for selective marker retraction and retention
A first actuator is configured to at least partially release a first biasing portion to selectively retract a site marker from outside of the outer cannula to at least partially within the outer cannula, such that the site marker is retained at least partially within the outer cannula; a second biasing portion is configured to selectively urge the outer cannula to move proximally relative to the inner member and the site marker.
Retracting member coupled to retracting portion for marker selective retraction
Coupling a retracting biasing portion to the retracting portion such that a first actuator configured to at least partially release the retracting biasing portion causes movement of at least a portion of the retracting portion to selectively retract a site marker from outside of the outer cannula to at least partially inside of the outer cannula, such that the marker is retained at least partially within the outer cannula.
Sterilizing while the marker is not fully interposed within the outer cannula
Sterilizing the deployment device with a site marker not fully interposed within the outer cannula.
Deploying by sequential actuator actuation to retract marker then retract outer cannula
Actuating a first actuator to at least partially release a first biasing portion to selectively retract a site marker from outside of the outer cannula to at least partially inside of the outer cannula, inserting at least a portion of the outer cannula within a desired site marker location, and actuating a second actuator to at least partially release a second biasing portion to retract the outer cannula such that a distal end of the outer cannula is moved toward a proximal end of the site marker deployment device relative to the site marker.
Overall, the claims focus on a two-biasing and actuator arrangement that selectively retracts and retains a site marker within an outer cannula, uses a second biasing portion to urge proximal axial movement of the outer cannula relative to an inner member, and performs sterilization while the site marker is not fully interposed within the outer cannula.
Stated Advantages
Improves placement accuracy in a biopsy workflow.
Reduces tissue damage.
Provides an imaging-visible deployed marker configuration, including MRI compatibility, X-ray, and ultrasound.
Documented Applications
Deployment of a site marker for breast biopsy, including use within an introducer and biopsy workflow at a biopsy site, lesion, or biopsy cavity.
Imaging of the deployed marker using MRI, X-ray, and ultrasound.
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