Tissue localization device and method of use thereof

Abstract

Tissue localization devices and methods of localizing tissue using tissue localization devices are disclosed. The tissue localization device can comprise a handle comprising a delivery control, a delivery needle extending out from the handle, and a localization element within the delivery needle. The localization element can be deployed out of the delivery needle or retracted back into the delivery needle when the delivery control is translated in a first direction or a second direction, respectively. The localization element can be coupled to a flexible tracking wire.

1 .- 20 . (canceled) 
     
     
         21 . A localization marker, comprising:
 a distal end including a unitary proximal segment and a branched distal segment, the branched distal segment having two or more sharpened locator tips configured to securely anchor the localization marker at a tissue localization site within a patient's tissue; and   an elongated thread extending proximally from the proximal segment of the distal end.   
     
     
         22 . The localization marker of  claim 21 , wherein the branched distal segment has two sharpened locator tips diverging at an angle away from one another. 
     
     
         23 . The localization marker of  claim 21 , wherein the thread comprises a flexible wire. 
     
     
         24 . The localization marker of  claim 21 , wherein, when the branched distal segment is anchored at the tissue localization site, a portion of the thread is configured to extend outside the patient's tissue. 
     
     
         25 . The localization marker of  claim 24 , wherein, when the branched distal segment is anchored at the tissue localization site, the portion of the thread extending outside the patient's tissue is configured to be wound into a coiled segment. 
     
     
         26 . The localization marker of  claim 21 , further comprising a sheath enclosing at least a portion of the thread. 
     
     
         27 . The localization marker of  claim 26 , wherein the sheath extends proximally from the proximal segment of the distal end to enclose a distal portion of the thread. 
     
     
         28 . The localization marker of  claim 21 , wherein the proximal segment of the distal end includes an interlock element configured to detachably couple to a pusher slidably disposed within a lumen of a delivery needle and an eyelet having an aperture configured to receive the flexible thread in a plane perpendicular to a plane of the eyelet so that the flexible thread is not co-linear with the aperture. 
     
     
         29 . A method of localizing tissue using a localization marker, the method comprising:
 deploying the localization marker from a delivery needle of a tissue localization device into a tissue of a patient, the localization marker comprising a distal end and an elongated, flexible thread extending proximally from the distal end, wherein the distal end of the localization marker includes a unitary proximal segment and a branched distal segment having two or more sharpened locator tips;   anchoring the two or more sharpened locator tips into tissue at a localization site within the tissue of the patient to secure the distal end of the localization marker at the localization site;   retracting the delivery needle out of the tissue and proximally over the flexible thread to expose a portion of the flexible thread that extends outside the tissue of the patient; and   reducing a length of the exposed portion of the flexible thread.   
     
     
         30 . The method of  claim 29 , wherein anchoring the two or more sharpened locator tips into the tissue at the localization site comprises anchoring two sharpened locator tips that diverge at an angle away from one another into the tissue at the localization site. 
     
     
         31 . The method of  claim 29 , wherein reducing the length of the exposed portion of the flexible thread comprises winding the exposed portion of the flexible thread into a coiled segment. 
     
     
         32 . The method of  claim 31 , further comprising, after winding the exposed portion of the flexible thread into the coiled segment, attaching the coiled segment to the patient. 
     
     
         33 . The method of  claim 32 , wherein attaching the coiled segment to the patient comprises taping the coiled segment to a dermis of the patient. 
     
     
         34 . The method of  claim 29 , wherein deploying the localization marker from the delivery needle comprises deploying the localization marker into a partially-circular configuration within the tissue of the patient. 
     
     
         35 . The method of  claim 34 , wherein a distal portion of the flexible thread is configured to rotate relative to the distal end of the localization marker when the localization marker is deployed out of the delivery needle from a first alignment wherein the flexible thread is tangent to the partially-circular configuration of the localization marker to a deployed alignment wherein the flexible thread aligns secant to the partially-circular configuration of the localization marker. 
     
     
         36 . The method of  claim 29 , wherein the proximal segment of the distal end of localization marker includes an interlock element configured to detachably couple to a pusher slidably disposed within a lumen of the delivery needle, and
 wherein the method further comprises, when the pusher is at least partially extended out of the lumen, rotating the delivery needle and the pusher to detach the localization marker.   
     
     
         37 . The method of  claim 36 , further comprising translating a slidable delivery control of the tissue localization device in a longitudinal direction along a handle of the tissue localization device to move the pusher within the lumen and to deploy the localization marker out of the delivery needle. 
     
     
         38 . The method of  claim 37 , further comprising retracting the localization marker into the lumen of the delivery needle after at least part of the localization marker is deployed out of the delivery needle. 
     
     
         39 . The method of  claim 38 , wherein at least a section of the flexible thread resides within the lumen prior to deployment of the localization marker.