Securement for a surgical site marker and deployment device for same
Inventors
Mark, Joseph L. • Nicoson, Zachary R.
Assignees
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Publication Number
US-10159540-B2
Publication Date
2018-12-25
Expiration Date
Abstract
A method of securing a biopsy marker within a biopsy site includes depositing a marker element within a biopsy site and fixing the marker element within the biopsy site by injecting a securing agent within the biopsy site. Delivery devices for delivering the securing agent to the biopsy site are also disclosed.
Core Innovation
The disclosed subject matter relates to deploying a securing agent in a biopsy site. The securing agent comprises a material that accelerates clotting to substantially limit migration of a marker from the biopsy site. The deployment is performed using an apparatus having an elongate body with a proximal end, a distal end, and a lumen extending between the proximal and distal ends.
To control how the securing agent travels within the apparatus, the lumen includes a dividing element disposed in the lumen, or a filter element disposed in the lumen. The dividing element or filter element is configured to allow a fluid to pass from a proximal portion of the lumen into a distal portion of the lumen while the securing agent is substantially prevented from passing proximally through the dividing element or filter element. In described embodiments, the dividing element or filter element is configured as a semi-permeable filter, including an open-cell foam material.
The apparatus further includes a deployment arrangement intended to prevent substances external of the elongate body from entering the lumen through the distal end opening. In the described configuration, a duckbill valve is biased to prevent such external substances while allowing the securing agent to pass through the valve when subjected to a fluid force. In some embodiments, the deployment includes a mechanism that may also deliver the biopsy site marker into the biopsy cavity such that the marker becomes fixed when blood clotting occurs after compression is released.
Claims Coverage
The partial content includes three independent claims (clm-00001, clm-00010, clm-00015). Across these independent claims, the inventive features focus on deploying a clot-accelerating securing agent in a biopsy site while using a lumen divider/filter that allows fluid passage but substantially prevents proximal passage of the securing agent, and in at least one claim, using a duckbill valve biased to block external substances while allowing securing agent passage under fluid force.
Clot-accelerating securing agent to limit marker migration in a biopsy site
The apparatus includes a securing agent disposed in a distal portion of the lumen, wherein the securing agent comprises a material that accelerates clotting to substantially limit migration of a marker from the biopsy site.
Dividing element configured to pass fluid while preventing proximal passage of securing agent
The apparatus includes a dividing element disposed in the lumen so as to separate a proximal portion of the lumen from a distal portion of the lumen, wherein the dividing element is configured to allow a fluid to pass from the proximal portion of the lumen into the distal portion, while the securing agent is substantially prevented from passing proximally through the dividing element.
Filter element configured to allow fluid passage while substantially preventing proximal securing agent passage
The apparatus includes a filter element disposed in the lumen so as to separate a proximal portion of the lumen from a distal portion of the lumen, wherein the filter element is configured to allow a fluid to pass from the proximal portion of the lumen into the distal portion, while the securing agent is substantially prevented from passing proximally through the filter element.
Duckbill valve biased to block external substances while permitting securing agent passage under fluid force
The apparatus includes a duckbill valve disposed in the lumen proximate the distal end opening of the elongate body, wherein the valve is biased to prevent substances external of the elongate body from entering the lumen through the distal end opening, while allowing the securing agent to pass through the valve when subjected to a fluid force.
Collectively, the independent claims define an apparatus for deploying a clot-accelerating securing agent in a biopsy site to substantially limit migration of a marker, while using a lumen divider/filter that allows fluid passage but substantially prevents proximal movement of the securing agent, and in one independent claim, using a duckbill valve biased to prevent external ingress while allowing securing-agent passage when subjected to fluid force.
Stated Advantages
Substantially limits migration of a marker from the biopsy site.
Documented Applications
Securing a breast biopsy site marker to prevent migration by deploying a securing agent that accelerates clotting into a biopsy cavity.
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