Patent Publication Number: US-2020297453-A1

Title: Braided fiducial metallic marker system

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is related to U.S. patent application Ser. No. 15/078,068, filed Mar. 23, 2016, which is a Divisional Application of U.S. patent application Ser. No. 13/348,965, filed Jan. 12, 2012, now U.S. Pat. No. 9,320,517, the entirety of each which is incorporated herein by reference. 
    
    
     BACKGROUND OF THE INVENTION 
     Field of the Invention 
     The present invention relates to the field of medical imaging and more particularly to a fiducial metal marker secured to a suture. 
     Description of the Related Art 
     A fiducial metal marker is a metallic object placed in the field of view of an imaging system which appears in the image produced, for use as a point of reference or a measure. In the context of medical imaging, a fiducial metal marker is a metallic reference point used to assist the health care provider in maintaining a target area within the field of view to ensure accurate results for the patient. More specifically, in the context of radiation therapy for cancer, a fiducial metal marker marks the tumor or tumor bed and facilitates precise delivery of radiation energy in treating the marked tumor or tumor bed while sparing surrounding healthy tissue from the effects of the radiation energy. 
     During use, one or more metal markers typically spheres or cylinders that may be gold, Platinum, Iridium, or other preferred metals, are inserted into the target tissue. Through the use of a suture on a needle or a needle injection system, these markers can be placed in a desired location. In many instances the insertion of the marker is done with the assistance of an image guided operation. If these markers are placed with a needle injection system, the needle system is removed leaving only the marker in place. If the suture marker system is used then the marker will be left behind as well as a portion of the suture holding it in place. Dense tissue will hold the marker in place so as to insure accurate targeting of a radiation beam, however less dense tissue and fatty tissue will not hold a loose marker accurately. If a suture marker system is used on the less dense tissue then it can be sutured into the tissue and tied so as not to move away from the desired location. A suture marker system that is tied into place is obviously a more reliable system. 
     To address the unique challenges presented by breast or fatty tissue in fiducial metallic marker placement, suture type marker system have been used quite effectively in targeted beam radiation therapy. In this regard, the intermediate suture is secured to the marker through a hollow channel defined within the marker. In this way the marker has been positioned at the desired location into the tissue. By sewing the marker in place we can prevent movement or migration of the metallic marker away from our desired location. Thus. limiting the amount of radiation exposure to adjacent healthy tissue and organs. 
     BRIEF SUMMARY OF THE INVENTION 
     The present invention describes an improvement to the suture marker system by way of attaching the marker to the suture in a new braided woven technique. In one embodiment of the system the metallic marker is contained within the braided suture, absorbable or non-absorbable fibers, in this way securing the marker inside of the suture. In this regard, the marker becomes secured inside to the woven suture threads and may be palpable along the suture thread or can alternatively be demarcated with a contrasting color. As well, the metallic marker (which is a cylinder) may contain radioactive material inside of it. As another option a single one of the multiplicity of the suture threads may extend through one end of the cavity to another end of the cavity so that the single one of the multiplicity of threads is braided with others of the multiplicity of suture threads. 
     In another embodiment of the invention, a method for assembling a braided suture fiducial metallic marker system includes inserting a metallic marker amongst a multiplicity of suture threads at a longitudinal focal point of the suture threads. The method further includes braiding the multiplicity of suture threads around the metallic marker so as to encapsulate the metallic marker. Finally, the method includes securing a needle to a distal end of the suture thread. Optionally, the method includes visually demarcating a portion of the braided multiplicity of suture threads wherein the metallic marker is encapsulated. 
     Additional aspects of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. The aspects of the invention will be realized and attained by means of the elements and combinations particularly pointed out in the appended claims. It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention, as claimed. 
    
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS 
       The accompanying drawings, which are incorporated in and constitute part of this specification, illustrate embodiments of the invention and together with the description, serve to explain the principles of the invention. The embodiments illustrated herein are presently preferred, it being understood, however, that the invention is not limited to the precise arrangements and instrumentalities shown, wherein: 
         FIG. 1  is perspective view of a braided suture fiducial metallic marker system; 
         FIG. 2  is cut-away side view of an encapsulating portion of the braided suture fiducial metallic marker system of  FIG. 1 ; and, 
         FIG. 3  is a pictorial illustration of a process for assembling the braided suture fiducial marker system of  FIG. 1 . 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     Embodiments of the invention provide for a braided suture fiducial metallic marker system. The system includes a marker affixed to a strand of suture thread such as an absorbable suture or a non-absorbable suture. The strand of suture thread is secured to additional strands of suture thread in a braid. Of importance, the braid wovenly encapsulates the marker. At least one end of the braid is then secured to a needle. Optionally, the marker includes a cavity that may include a radioactive material. As well, the outer portion of the braid may be denoted with a color that is different than the color of the suture thread so as to indicate the position of the marker encapsulated therein. 
     In further illustration,  FIG. 1  is perspective view of a braided suture fiducial metallic marker system. As shown in  FIG. 1 , a braided suture fiducial metallic marker system  100  includes a marker  140  encapsulated within an encapsulating portion  120  of a braided suture  110  formed from individual suture threads braided together. Each of the suture threads may be a “0” size suture, or alternatively a “1” size suture, a “2/0” suture, or a smaller “3/0” or “4/0” suture, or even a smaller “6/0” suture. The braided suture  110  in turn is coupled to a needle  130  at an end of the braided suture. Optionally, the encapsulating portion  120  of the braided suture  110  is visually demarcated with a contrasting color  150  so as to indicate a location in the braided suture  110  of the marker  140 . 
     Turning now to  FIG. 2 , a cut-away side view of an encapsulating portion of the braided suture fiducial metallic marker system of  FIG. 1  is provided. As can be seen in  FIG. 2 , the braided suture fiducial metallic marker system  220  has a braided suture  220  that encapsulates a metallic marker  210  formed from a metal such as pure gold. The marker  210  is affixed to a single suture thread  240  that is braided with other suture threads to form the braided suture  220 . A distal end of the single suture thread  240  is secured to a needle  230  as can be seen. Finally, the metallic marker  210  may be hollow, defining a cavity  250 . The cavity  250  then may include a radioactive material so as to facilitate visualization in an imaging system. To that end, the metallic marker  210  may have the dimensions of 0.040″+/−0.001″ outside diameter by 0.030″+/−0.001″ inside diameter by 0.175″+/−0.005″ length. The marker is metallic. In one aspect of the embodiment, the marker may be formed of pure gold. Alternatively, the marker may be formed of platinum or iridium, or a combination of gold and platinum, or gold and iridium, or platinum and iridium. 
     The braided suture fiducial metallic marker system  200  of  FIG. 2  may be assembled through a braiding process. In further illustration,  FIG. 3  pictorially shows a process for assembling the braided suture fiducial marker system of  FIG. 1 . As shown in  FIG. 3 , a marker  300  is inserted into a longitudinal focal point of a multiplicity of suture threads  320  surrounding the marker  300 . The multiplicity of suture threads  320  are then braided with one another so as to form an encapsulating portion  340  encapsulating the marker  300 . The final product is a braided suture fiducial metallic marker system  350 . 
     The corresponding structures, materials, acts, and equivalents of all means or step plus function elements in the claims below are intended to include any structure, material, or act for performing the function in combination with other claimed elements as specifically claimed. The description of the present invention has been presented for purposes of illustration and description, but is not intended to be exhaustive or limited to the invention in the form disclosed. Many modifications and variations will be apparent to those of ordinary skill in the art without departing from the scope and spirit of the invention. The embodiment was chosen and described in order to best explain the principles of the invention and the practical application, and to enable others of ordinary skill in the art to understand the invention for various embodiments with various modifications as are suited to the particular use contemplated. 
     Having thus described the invention of the present application in detail and by reference to embodiments thereof, it will be apparent that modifications and variations are possible without departing from the scope of the invention defined in the appended claims as follows: