Device and Method for Radiosurgical Treatment of Uterine Fibroids

Abstract

Removable marker implants having fiducial markers disposed on multiple elongate members extend and splay laterally outward when deployed thereby providing improved 3D localization and tracking of a portion of the patient's body for stereotactic radiosurgery. Such an approach is particularly useful for tracking of the uterus during radiosurgery treatment of uterine fibroids. Such implants can include an outer sheath that contains the multiple elongate members during delivery into the portion of the body. The elongate members can be slidably disposed within the shaft and advanced into an expanded deployed position by advancement of an applicator shaft or rod within the sheath. Marker implant can also be integrally formed implants with flexible arms having fiducial markers thereon that can be constrained in a sheath for delivery and resiliently splay laterally outward when released from the shaft. Methods of delivery and deployment are also provided.

What is claimed is: 
     
         1 . A method of temporarily implanting fiducial markers in a portion of a patient's body, the method comprising:
 inserting a sheath of a marker device into the portion of the body, wherein the device includes a plurality of elongate members disposed within the sheath, each of the one or more elongate members having a fiducial marker at or near a distal portion thereof;   moving a base attached to the one or more elongate members within the sheath, wherein actuation of the base extends the plurality of elongate members from the sheath and splays the plurality of elongate members outward such that the fiducial markers are distributed about the portion of the body;   determining a location and/or movement of the body portion from the plurality of fiducial markers using visualization techniques;   delivering therapy to the portion of the body based on the determination of the location and/or tracking of the body portion;   retracting the plurality of elongate members into the sheath; and   removing the marker device.   
     
     
         2 . The method of  claim 1 , wherein the sheath is inserted into the portion of the body until a proximal flange of the sheath engages a proximally facing tissue near the portion of the body. 
     
     
         3 . The method of  claim 1 , further comprising:
 inserting an applicator into a lumen of the sheath positioned within the portion of the body and moving the base to facilitate deployment of the plurality of elongate members.   
     
     
         4 . The method of  claim 3 , wherein inserting the applicator comprises inserting an applicator shaft and mating corresponding coupling features of the applicator shaft and the sheath. 
     
     
         5 . The method of  claim 4 , wherein moving the base comprises advancing a rod through the applicator shaft and engaging the base with the rod. 
     
     
         6 . The method of  claim 5 , wherein engaging the base with the rod comprises mating corresponding coupling features of the rod and the base. 
     
     
         7 . The method of  claim 3 , wherein moving the base comprises distally advancing the rod thereby advancing the base within the sheath so as to extend the plurality of elongate members and splay the distal portions of the plurality of elongate members laterally outward thereby distributing the plurality of fiducial markers along the portion of the body. 
     
     
         8 . The method of  claim 7 , wherein retracting the plurality of elongate members comprises retracting the rod through the applicator shaft. 
     
     
         9 . The method of  claim 1 , wherein the portion of the body comprises a uterus. 
     
     
         10 . A device for deploying multiple fiducial markers into a portion of the human body, the device comprising:
 a means for setting an point of origin for deployment;   a means for deploying fiducial markers; and   a means for retracting fiducial markers;   wherein the device is configured to move the fiducial markers outward from a retracted position for positioning to an extended position for deployment.   
     
     
         11 . The device of  claim 10 , wherein the device is configured to return to the retracted position after deployment to facilitate removal from the body.