2002-08-07 Application filed by Foerster Seth A., Burbank Fred H., Ritchart Mark A., Zerhouni Elias A. filed Critical Foerster Seth A.
2010-12-07 First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=23192532&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=US20020193815(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Other devices are known for marking external regions of a patients skin. For example, U.S. Pat. No. 5,192,270 to Carswell, Jr. discloses a syringe which dispenses a colorant to give a visual indication on the surface of the skin of the point at which an injection has or will be given. Similarly, U.S. Pat. No. 5,147,307 to Gluck discloses a device which has patterning elements for impressing a temporary mark in a patient's skin, for guiding the location of an injection or the like. It is also known to tape or otherwise adhere a small metallic marker, e.g. a 3 millimeter diameter lead sphere, on the skin of a human breast in order to delineate the location of skin calcifications (see Homer et al,  The Geographic Cluster of Microcalcifications of the Breast, Surgery, Gynecology, & Obstetrics, December 1985). Obviously, however, none of these approaches are useful for marking and delineating internal tissue abnormalities, such as lesions or tumors.
In operation, the tube  54 of the marking instrument is inserted into the patient's body in the direction of the arrow 58, as shown in FIG. 4, until the distal end 20 of the center wire 18 approaches the desired location, adjacent to or in the abnormal tissue or lesion. Because direct visual access to the targeted tissue is impossible, an aided visualization device, such as the stereotactic guidance system described above, is used to guide the distal portion of the marking instrument to the targeted tissue. Then, if the biopsy instrument shown in FIGS. 1-3 is utilized to deploy the markers, the targeted tissue 51 a (FIG. 5) is vacuumed into the tissue receiving port 42. Referring particularly to FIG. 5, once the distal end 20 of the center wire reaches the targeted, vacuumed tissue, the ring 24 is pulled away from the tissue in the direction of the arrow 60. This action deploys the marker attachment members 14 and 16 as they are forced into a die formed in the tip 62 of the tube. This die may take any desired form, depending upon the desired deployed configuration of the attachment members 14, 16.
Now referring to FIG. 7, even after the attachment members  14 and 16 have been filly deployed, the pull ring 24 is pulled to further increase tension in the direction of the arrow 70, until the center wire 18 is sheared at a point of weakness or detent 72 (see FIGS. 4-6) which is established in the center wire 18 proximally of the tip 20. Once failure has occurred, the pull ring 24 and the proximal portion 18′ of the center wire may be discarded as they are severed from the marker element 12 and remaining distal portion 18″ of the center wire.
The FIG. 9 embodiment is substantially similar to the FIG. 4 embodiment, in that the marking instrument includes a tube  54 a which has a lumen 56 a, and may utilize a cannula, needle, or imaging instrument (i.e. endoscope, laparoscope, or the like) for access to a delivery site within the body and to aid in delivery. Again, as is the case for all succeeding embodiments, it is preferred that the tube 54 a utilize the hollow outer piercing needle 38 of the biopsy instrument shown in FIGS. 1-8, though any other instrument which is capable of delivering a marker percutaneously or through a body orifice from a location outside the patient's body may be utilized. A center wire 18 a runs longitudinally through the lumen 56 a At the proximal end of the center wire 18 a is a deployment actuator or pull ring 24 a At the distal end of the center wire is the marker element 12 a.
There are two primary differences between the embodiments of FIGS. 4 & 9 and that of FIG. 12. First, in the FIG. 12 embodiment, a plurality of marker elements  12 b (two are shown though any number may be employed) may be preloaded into the tube 54 b, each comprising a pre-formed spring which is deployed through the tube's distal region 90 in an axial direction. Second, the nature of the deployment mechanism utilizes a compressive rather than tensile force. It may further be noted that, though end deployment of the marker elements in the FIG. 12 embodiment is illustrated, they may be similarly deployed radially through a side port (not shown) in tube 54 b, or at any other angle, to accommodate delivery through an existing instrument (i.e. cannula, needle, endoscope, laparoscope, or the like). In being deployed radially, the distal region 90 is not used for passage of the marker element and could be utilized to house a piercing element (not shown) similar to that shown in FIGS. 1-3. Armed with the piercing element, this marker delivery system would not be dependent on a positioning system as described in FIGS. 1-3 for placement at the tissue site and could be used alone in conjunction with a commercially available stereotactic or other guidance system. This concept may be applied to all subsequent embodiments except that illustrated in FIG. 16.
In actuality, the FIG. 13 embodiment is substantially identical to that of FIG. 12, except for the shape of each spring  12 c, and is employed in precisely the same manner. Thus, to deploy a marker element 12 c, the mandrel 98 c is utilized to push the spring 12 c through the center lumen 56 c and out through the distal open end 90 c of the tube. As in the FIG. 12 embodiment, the marker element travels in the direction of the arrow 100 c, until the attachment members 94 c and 96 c extend outwardly sufficiently to anchor themselves to the target tissue. Also, the FIG. 13 embodiment is similar to the FIG. 12 embodiment in that the instrument may be re-positioned to immediately deploy another marker element without re-loading, and marker elements may be deployed radially through a side port in tube 54 c (not shown), or any other angle, to accommodate delivery through an existing instrument (i.e. cannula, needle, endoscope, laparoscope, or the like).
In this embodiment, each marker element  12 e is deployed distally through the open distal region 90 e of the tube 54 e by a mandrel 98 e, much as in the previous embodiments shown in FIGS. 12, 13, and 14. The primary difference, however, between this embodiment and the previous embodiments is that, while the marker elements in the previous embodiments rely largely on the barbed nature of the spring to secure themselves in the tissue, in this embodiment, the springs are secured simply because of their significant expansion upon exit from the tube. This embodiment particularly lends itself to marking the boundaries of a biopsy or other desired site by defining the perimeter of the site. The expansion of the spring 12 e causes the blunt edges 102 e and 104 e to press outwardly against the selected tissue, thereby wedging the spring securely into position.
Still another alternative embodiment of the marking instrument  10 is shown in FIG. 16. In this embodiment, the marking instrument 10 f comprises a tube 54 f. Wire segments 106 of any desired length are preloaded into the lumen 56 f, which runs along substantially the entire length of the tube 54 f Once the needle is properly positioned, the marker elements 12 f are deployed by pushing them out of the tip of the needle, through the side exit port 108. A curved portion 110 of the lumen 56 f comprises a die portion, and is adapted to form the wire segments 106 into helical marker elements 12 f as they pass therethrough, pushed by a mandrel (not shown) or other known means from the tip of the needle through the exit port 108. The nature of the curve or curves in the die portion 110 and preformed curves imparted into the wire segments determine the final shape (which resembles a partial or whole helix) and dimensions of the marker element.
Marker elements of many other materials and configurations may be used as well. For example, one such multi-appendaged jack-shaped marker  12 h is illustrated in FIG. 18. Additionally, small beads 12 i (FIG. 19) of calcium carbonate or other radiodense materials, which are highly visible by mammographic imaging, could be deployed as marker elements. One such application would be to place a plurality of such beads or pellets (each having a diameter of about 500 μ) around the entirety of a breast lesion prior to the extraction procedure, which would then serve as guides to ensure that all of the margins had been removed. During subsequent imaging procedures, they would function to denote the location of the previous biopsy for reference purposes.