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.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application claims priority to U.S. Patent Ser. No. 60/915,275, with a filing date of May 1, 2007, the contents of which are hereby incorporated by reference in its entirety. 
    
    
     TECHNICAL FIELD 
     This disclosure relates generally to securing a surgical site marker to prevent migration thereof within a biopsy site and a deployment device to be used in this endeavor. 
     BACKGROUND 
     In the diagnosis and treatment of breast cancer, it is often necessary to perform a biopsy to remove tissue samples from a suspicious mass. The suspicious mass is typically discovered during a preliminary examination involving visual examination, palpation, X-ray, magnetic resonance imaging (MRI), ultrasound imaging or other detection means. 
     When a suspicious mass is detected, a sample is taken by biopsy, and then tested to determine whether the mass is malignant or benign. This biopsy procedure can be performed by a variety of surgical techniques. 
     Regardless of the method or instrument used to perform the biopsy, subsequent examination of the surgical site may be necessary, either in a follow up examination or for treatment of a cancerous lesion. Treatment often includes a mastectomy, lumpectomy, radiation therapy, or chemotherapy procedure that requires the surgeon or radiologist to direct surgical or radiation treatment to the precise location of the lesion. Because this treatment might extend over days or weeks after the biopsy procedure, and the original features of the tissue may have been removed or altered by the biopsy, it is desirable to insert one or more site markers into the surgical site to serve as a landmark for future identification of the location of the lesion. 
     However, one problem that arises with site markers is migration. When the site markers are typically deployed to the biopsy site, the breast is still under compression. However, when the breast is released from compression, the site marker may migrate within the site or even out of the site through a needle tract created by the biopsy device, thereby preventing a surgeon or radiologist from easily locating the precise location of the lesion or biopsied area. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Features and advantages of the disclosure will be apparent from the following detailed description and the appended claims, taken in conjunction with the accompanying drawings, in which: 
         FIG. 1  is a partial cross-sectional view of a first embodiment of a securing agent deployment device. 
         FIG. 2  is a second embodiment of a securing agent and marker deployment device. 
         FIG. 3  is a third embodiment of a securing agent deployment device. 
     
    
    
     DETAILED DESCRIPTION 
     Referring now to the drawings, exemplary approaches are shown in detail. Although the drawings represent some exemplary approaches, the drawings are not necessarily to scale and certain features may be exaggerated to better illustrate and explain the present disclosure. Further, the approaches set forth herein are not intended to be exhaustive or to otherwise limit or restrict the disclosure to the precise forms and configurations shown in the drawings and disclosed in the following detailed description. 
     Overview of the Disclosure 
     In a typical biopsy procedure, such as a breast biopsy, a patient&#39;s breast may be placed in compression. Next, a target site is biopsied using any one of a variety of biopsy devices. After the biopsy procedure, a surgeon typically deploys a site marker into the biopsy site (sometimes referred to as a biopsy cavity) formed by the biopsy procedure. The marker may be deployed using a marker deployment system, examples of which are described in co-pending U.S. application Ser. Nos. 11/238,295 and 11/305,141, the contents of which are incorporated herein by reference in their entireties. 
     To secure the marker in a desired location within the biopsy site, an embodiment of this disclosure includes a method of using the body&#39;s own haem (blood) as a securing/gluing agent to attach or bond the marker to a specific biopsy site or location, thereby precluding and potentially eliminating migration of the marker away from the desired biopsy site or down a needle track created by the biopsy needle. 
     In connection with one exemplary embodiment of the method, a haemostatic agent is injected into the biopsy site shortly after the marker is deployed into the biopsy site. The haemostatic agent causes the blood within the site to clot, thereby locking and securing the marker and tissue into place. When the breast is released from compression after the biopsy procedure is completed, the marker will remain bonded in place. 
     One suitable haemostatic agent is sold under the trade name Arista™, which is manufactured by Medafor, Inc. In one exemplary arrangement, the haemostatic agent is provided in a powder or slurry form to allow for rapid clotting, though other forms of a haemostatic agent may also be used. 
     EXEMPLARY EMBODIMENTS 
       FIG. 1  is a cross-sectional view of a securing agent deployment device  10  that may be used to selectively deploy a securing agent  12 , such as a haemostatic agent, to a biopsy site. Deployment device  10  includes an elongated cannula  14  defining an inner lumen  16  therein. Cannula  14  is defined by a first end  18  and a second end  20 . In one arrangement, a normally closed valve  22  may be secured to first end  18 . In one exemplary embodiment, valve  22  is configured as a duckbill valve and is disposed around an exterior of cannula  14  at first end  18 . It is understood however, that other types of normally closed valves may also be employed. It is also understood that the valve  22  may be arranged at first end  18  in other manners than what is shown in  FIG. 1 . For example, valve  22  may be secured within the interior of cannula  14 . 
     An actuation portion  24  is connected to second end  20 . In one arrangement, actuation portion  24  is used to deliver air to inner lumen  16 , to be explained in further detail below. Positioned within inner lumen  16  is a predetermined amount of securing agent  12 . In one embodiment, securing agent  12  is provided in a powder form, although it is understood that securing agent may be provided in other forms as well. For example, securing agent  12  may be provided in a slurry form, a liquid, a gel, or as a pellet or plug. A filter element  30  (to be explained below in further detail) may also be provided to position securing agent  12  within inner lumen  16 . 
     In operation, first end  18  of deployment device  10  is inserted into a biopsy cavity. In one arrangement, elongated cannula  14  of deployment device  10  is inserted into a delivery cannula of a biopsy device or, alternatively, an introducer system that is in registration with the biopsy site. An exemplary introducer system may be found in commonly owned U.S. Pat. No. 7,347,829, the contents of which are incorporated herein by reference in its entirety. Deployment device  10  may include a mounting flange  26  from which one or more latching fingers  28  may extend. Latching fingers may be configured to cooperate with a portion of the biopsy device or a portion of the introducer system to selectively fix deployment device  10  thereto. 
     After first end  18  is positioned within the biopsy site, actuation portion  24 , which in one exemplary embodiment is configured as a bellows bulb, is activated (in the exemplary illustrated embodiment, depressed) in the direction of arrow A. The activation forces fluid, and in one embodiment, air, into cannula  14  at second end  20  and into contact with securing agent  12 . As the fluid moves through cannula  14 , normally closed valve  22  is forced open, and at least a portion of securing agent  12  is deployed into the biopsy site. In one embodiment, securing agent  12  is deployed currently with a site marker (to be explained below). In another embodiment, securing agent  12  is deployed shortly after site marker is deployed to the biopsy cavity. Once deployed, securing agent  12  accelerates clotting, such that the marker element becomes fixed into position within tissue of the biopsy site and is substantially prevented from migrating within, or out of, the biopsy site. 
     In one arrangement, to retain securing agent  12  within cannula  14  prior to deployment, deployment device  10  may further include a filter element  30  positioned between first end  18  and second end  20 . Securing agent  12  may be positioned between filter element  30  and first end  18 . Filter element  30  may be semi-permeable such that securing agent  12  is substantially prevented from passing therethough, but fluid is permitted to pass therethrough. In one embodiment, filter element  30  is an open cell foam material. 
     In another exemplary approach, both marker M and securing agent  12  may be deployed by a single deployment device  50 . Referring to  FIG. 2 , deployment device  50  will now be described. 
     Deployment device  50  includes an outer cannula  52  having an open distal end  54  and defining a lumen  56  therein. An inner cannula  58  is positioned within outer cannula  52 . Inner cannula  58  includes a distal end  60  to which a normally closed valve  62  (such as a duckbill valve) is secured. An actuation member  64 , which is selectively slidable within inner cannula  58 , is further provided. In one embodiment, a seal member  61  may be provided within inner cannula  58 , through which actuation member  64  passes. Seal member  61  serves to prevent securing material  12  from escaping through a proximal end of inner cannula  58 . 
     In operation, securing agent  12  is retained within inner cannula  58  and one or more markers M are positioned within lumen  56  of outer cannula  52 . Distal end  54  of outer cannula  52  is positioned at the target site. Outer cannula  52  may be delivered to the biopsy site through a biopsy delivery cannula or an introducer assembly, as described above. In one embodiment, marker M may be temporarily retained adjacent distal end  54  by a deformable retaining tab  66 . 
     To deploy securing agent  12  and marker M, actuation member  64  (which may be a plunger) is activated. Actuation member  64  is moved distally, pushing at least a portion of securing agent  12  through distal end  60  of inner cannula  58 , thereby opening normally closed valve member  62 . Actuation member  64  continues through inner cannula  58  and comes into contact with marker M, thereby pushing both securing agent  12  and marker M past retaining tab  66  and into the biopsy site with a single device and substantially simultaneously. 
     In another embodiment, securing agent  12  may be provided in plug form that is adhered to at least a portion of marker M. In this configuration, inner cannula  58  may not be needed. Instead, only actuation member  64  is used to eject marker M and attached securing agent  12  plug from outer cannula. In yet another embodiment, securing agent  12  is provided as a separate pellet from marker M. In this embodiment, actuation member  64  may push out both marker M and the separate pellet of securing agent  12  to the biopsy site. 
     In one arrangement, actuation member  64  is a plunger. It may be desirable that actuation member  64  be sized so as to extend a predetermined distance past distal end  54  of outer cannula  52  to insure that marker M and securing agent  12  are fully deployed into the biopsy site. 
     Another embodiment of a securing agent deployment device  100  is shown in  FIG. 3 .  FIG. 3  is a partial cross-sectional view of securing agent deployment device  100  that may be used to selectively deploy a securing agent  12 , such as for example, a haemostatic agent, to a biopsy site. Deployment device  100  includes an elongated cannula  102  defining an inner lumen  104  therein. Cannula  102  includes a first end  106  and a second end (not shown). 
     Attached to first end  106  is a film or cap member  108 . Film or cap member  108  temporarily closes first end  106 , as will be explained below. In one embodiment film or cap member  106  is constructed of a bioabsorbable material. In another embodiment, film or cap member  106  is a heat shrinkable material that is deformed around first end  106  to temporarily close of first end  106 . 
     Disposed within inner lumen  104  is an actuation device  110  having a distal end and proximal end. In one embodiment, actuation device  110  is a plunger having a piercing tip  112  disposed at the distal end and an actuation member  114  formed at the proximal end. Disposed adjacent to piercing tip  112  is a seal member  116  that is sized to have a size and shape that generally corresponds to inner lumen  104 , but permits actuation device  110  to slide within inner lumen  104 . While actuation device  110  is depicted with a piercing tip  112  at the distal end, it is understood that piercing tip  112  is optional. For example, piercing tip  112  may be eliminated entirely. 
     Prior to operation, actuation device  110  is in a retracted position (shown in  FIG. 3 ), whereby the distal end of actuation device  110  and the film or cap member  108  cooperate with inner lumen  104  to form cavity  118  into which securing material  12  is positioned. Next, the deployment device  100  is positioned such that a distal end thereof is positioned within the biopsy site. Similar to deployment devices  10  and  50 , deployment device  100  may be positioned in a delivery cannula or an introducer device to deliver distal end  106  to the biopsy site. 
     To deploy securing agent  12 , actuation device  110  is moved distally in the direction of arrow A by pressing on actuation member  114 . In the embodiment shown in  FIG. 3 , piercing tip  112  may cooperate with seal member  116  to push securing agent  12  towards film or cap member  108 . Actuation device  110  may be sized so as to be at least slightly longer than the length of cannula  102  such that when actuation device  110  is fully deployed, piercing tip  112  (or distal end of actuation device  110 ) will rupture or dislodge film or cap  108  from distal end  106  of cannula  102  and expel securing agent  12  into the biopsy site. In another embodiment wherein the film or cap  108  is heat shrunk onto distal end  106 , the body heat within the cavity will dislodge film or cap  108 . 
     In another embodiment, one or more site markers M ( FIG. 3 , shown in phantom) may also be positioned within cavity  118  such that when actuation device  110  is activated, both securing agent  12  and marker M will be deployed generally simultaneously to the biopsy site. 
     While the present disclosure has been particularly shown and described with reference to the foregoing embodiments, it should be understood by those skilled in the art that various alternatives to the embodiments of the disclosure described herein may be employed in practicing the disclosure without departing from the spirit and scope of the disclosure as defined in the following claims. It is intended that the following claims define the scope of the invention and embodiments within the scope of these claims and their equivalents be covered thereby. This description of the disclosure should be understood to include all novel and non-obvious combinations of elements described herein, and claims may be presented in this or a later application to any novel and non-obvious combination of these elements. The foregoing embodiments are illustrative, and no single feature or element is essential to all possible combinations that may be claimed in this or a later application.