(12) United States Patent
`Sayre et al.
`
`(10) Patent N0.2
`(45) Date of Patent:
`
`US 6,826,257 B2
`Nov. 30, 2004
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`US006826257B2
`
`(54) DEVICE AND METHOD FOR MARGIN
`MARKING ()F RADIOGRAPHY SPECIMENS
`
`(75) Inventors: James Sayre, Farmington, CT (Us);
`(SItJeSvSIart Bober, West Hartford, CT
`
`(73) Assignee: Beekley Corporation, Bristol, CT (US)
`
`( * ) Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U'S'C' 154(k)) by 0 days‘
`
`(21) Appl- NOJ 10/243,352
`(22) Filed,
`Sep_ 13’ 2002
`
`(65)
`
`Prior Publication Data
`
`US 2004 0052333 A1 M . 18 2004
`/
`at
`’
`(51) Int. Cl.7 ................................................ .. H05G 1/28
`(52) US. Cl. ...................................... .. 378/163; 378/162
`(58) Field Of Search ............................... .. 378/162—164,
`378/985, 37
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`5,474,569 A 12/1995 Zinreich 6161. .......... .. 606/151
`5,640,438 A * 6/1997 Talluto et a1. ...... ..
`378/165
`5,702,128 A 12/1997 Maxim et al.
`283/81
`5,902,310 A
`5/1999 Foerster et a1. ........... .. 606/142
`4 Cited by examiner
`Primary Examiner—Craig E. Church
`Assistant Examiner—Jurie Yun
`(74) Attorney, Agent, or Firm—McCarter & English, LLP
`
`ABSTRACT
`(57)
`Amarking device for de?ning the margins and orientation of
`radiography specimens includes a plurality of visually dis
`tinctive markers joined by a base that holds the markers until
`the markers are secured to a specimen. The base serves as a
`holder for the individual markers as the markers are secured
`to a specimen With sutures or staples, at Which time the
`markers are disconnected from the base. One or more
`.
`markers may be secured to a specimen as needed to de?ne
`the orientation of the specimen. By securing markers to
`Speci?c locations on a Specimen, a Surgeon Can indicate I0
`radiologists and pathologists the specimen’s Orientation in
`the body before removal, thus aiding in future study of the
`specimen. Since the markers are made either Wholly or
`partially from radiopaque material, the markers are visible
`When radiographed.
`
`4,041,931 A
`
`8/1977 Elliott et a1. .............. .. 128/1 R
`
`30 Claims, 6 Drawing Sheets
`
`Bard Exhibit 1007 Page 1 of 12
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`U.S. Patent
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`Nov. 30, 2004
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`Sheet 1 6f 6
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`US 6,826,257 B2
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`Bard Exhibit 1007 Page 2 of 12
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`U.S. Patent
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`Nov. 30, 2004
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`Sheet 2 6f 6
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`US 6,826,257 B2
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`3:
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`Bard Exhibit 1007 Page 3 of 12
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`U.S. Patent
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`Nov. 30, 2004
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`Sheet 3 6f 6
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`US 6,826,257 B2
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`Bard Exhibit 1007 Page 4 of 12
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`Bard Exhibit 1007 Page 5 of 12
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`

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`U.S. Patent
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`Nov. 30, 2004
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`Sheet 5 6f 6
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`US 6,826,257 B2
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`Bard Exhibit 1007 Page 6 of 12
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`Bard Exhibit 1007 Page 7 of 12
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`

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`US 6,826,257 B2
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`1
`DEVICE AND METHOD FOR MARGIN
`MARKING OF RADIOGRAPHY SPECIMENS
`
`FIELD OF THE INVENTION
`
`The present invention relates to devices for marking
`radiography specimens, and in particular to devices that
`indicate the orientation of the specimen in a patient’s body
`prior to removal. The present invention further relates to
`radiographic markers that Will remain secured to specimens
`during manipulations accompanying radiography and
`pathology.
`
`BACKGROUND INFORMATION
`
`Radiologists frequently use markers that absorb xrays and
`cast an image When placed Within an xray ?eld to convey
`pertinent information on xray ?lm. For example, right and
`left markers are routinely used to designate the anatomical
`orientation of the patient or to identify a particular extremity
`being examined. These types of markers are often placed on
`the surface of the examination table or xray ?lm cassettes,
`Within the exposure ?eld but outside the image of the
`patient, to de?ne the patient’s physical orientation in rela
`tionship to the xray beam or the ?lm.
`Markers consisting of a radiopaque body and adhesive
`can be attached directly to the skin of patients. These
`markers give the radiologist a speci?c target for the xray
`and, since the radiopaque body Will appear on radiographs
`later taken, help pinpoint the location of the area in question
`When reading the developed ?lm. Some markers have been
`developed that can be inserted into the body to mark tissues
`or organs that require repeated xray monitoring. These types
`of markers are manufactured as staples or hooks (to attach
`to tissues), and even partial rings (to encircle grafted veins).
`All of the previously described devices, While useful for
`speci?c purposes, have not been ideal for marking speci
`mens removed from patients, as the described devices fail to
`address circumstances particular to specimen removal,
`radiography, and pathology. Successful removal of tumors
`from a patient’s body requires an accurate evaluation of the
`excised tissue boundaries. To ensure that the entire tumor is
`removed, an adequate amount of healthy tissue surrounding
`the tumor is also extracted. The success of the surgery and
`the patient outcome is directly related to resection of the
`entirety of the tumor With an adequate healthy tissue bound
`ary. For example, successful removal of breast tumors
`requires an accurate evaluation of the removed tissue bound
`aries to see if the tumor has effected the surrounding healthy
`tissue.
`In the case of biopsies, a specimen is marked by the
`surgeon during removal from the patient. This mark aids the
`radiographers and pathologists in identifying the orientation
`of the specimen as it Was present in the patient’s body.
`Permanent marking of the exact orientation of the specimen
`is critical because of the manipulations—specimens must be
`pressed ?at to properly xray—that take place during radi
`ography. Presently, a surgeon may mark a tissue specimen
`by attaching sutures of various lengths, colors, or number
`combinations. The lengths, colors, or number of sutures
`convey to the pathologist the orientation of the gross pathol
`ogy specimen in the patient’s body. Unfortunately, this
`process of suturing and knotting may not be regularly
`performed because it is time consuming and requires
`detailed oral and/or Written communications betWeen
`surgeons, radiologists, and pathologists Which can result in
`frustrations betWeen the three professionals. Additional con
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`fusion may arise due to the fact that there is no standard
`marking method in the medical profession, since each sur
`geon develops his or her oWn method of marking.
`Some radiopaque markers have been developed to address
`this problem, but still have some shortcomings. For
`example, existing markers can be attached to specimens by
`securing the markers With a clamping pair of pinchers, but
`these markers may release While the specimen is being
`radiographed and otherWise examined, and thus, the bene?t
`is lost. Also, because such existing markers have sliding
`components and locking points, they tend to be thicker and
`larger than ideal. Since specimens must lay ?at for proper
`radiography and pathology, a large, thick marker may
`obscure subtle pathology Within the specimen. While the
`simple solution to this problem Would be to decrease the
`marker siZe, if the marker is too small, it may be virtually
`impossible to hold While securing to a specimen. Existing
`devices also fail to standardiZe the method of marking
`specimens, thereby perpetuating the confusion and misin
`terpretation betWeen the surgeon removing the specimen and
`the pathologist studying the specimen.
`Accordingly, it is an object of the present invention to
`overcome the above-described draWbacks and disadvan
`tages of existing markers.
`
`SUMMARY OF THE INVENTION
`
`The present invention is directed to a device for marking
`the margins of radiography specimens. The device includes
`a base and a plurality of markers detachably connected to the
`base. The base alloWs a user to easily grip the device While
`securing the small individual markers to a specimen. The
`base can take many forms from Which the individual mark
`ers extend outWardly to facilitate attachment of the markers
`to specimens. The markers preferably include at least one
`aperture for receiving sutures, staples, or the like, Which are
`used to secure the markers to specimens. After a marker is
`secured to a specimen, it can be broken aWay from the base
`of the device, thereby remaining secured to the specimen
`during radiography and pathology. The markers de?ne
`distinctive, radiopaque marking indicia and/or shapes. The
`indicia (and/or the shapes of the markers themselves) are
`visible in a radiograph and indicate orientation of the
`specimen before the specimen Was removed from the body.
`One advantage of the present invention is that the device
`may standardiZe the marking system used to indicate the
`orientations of specimens, thereby eliminating confusion
`betWeen the different medical professionals involved in
`treatment. Another advantage is that the device may remain
`?xedly secured to specimens during radiography because the
`device can be attached to a specimen With a suture, staple,
`or like connecting means, rather than relying on any pinch
`ing or squeeZing elements that can accidentally release. Still
`another advantage is that the base of the device itself may be
`con?gured to be easily gripped during use, even though the
`markers themselves may be relatively small (so as to limit
`the amount of obstruction during x-ray). Yet another advan
`tage is that the device may be able to retain multiple markers
`With various indicia, Wherein one or more of the markers
`may be usable for the same or multiple specimens.
`Additionally, the device may be readily adaptable to mark all
`types of specimens and orientations.
`These and other features and advantages of the invention
`are more fully disclosed or rendered apparent from the
`folloWing detailed description of certain preferred embodi
`ments of the invention, that are to be considered together
`With the accompanying draWings.
`
`Bard Exhibit 1007 Page 8 of 12
`
`

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`US 6,826,257 B2
`
`3
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`FIG. 1 is a rendering of a ?rst embodiment of a device of
`the present invention for marking the margins of a specimen
`shoWn during use;
`FIG. 2 is a side vieW of the margin marking device;
`FIG. 2A is a front vieW of the margin marking device;
`FIG. 2B is a back vieW of the margin marking device;
`FIG. 2C is a perspective vieW of the margin marking
`device;
`FIG. 3 is a plan vieW of a second embodiment of the
`margin marking device of the present invention; and
`FIG. 4 is a plan vieW of a third embodiment of a margin
`marking device of the present invention.
`
`DETAILED DESCRIPTION OF THE
`PREFERRED EMBODIMENTS
`
`The present invention overcomes many of the problems
`that arise When other radiopaque markers are used to mark
`radiography specimens. The advantages, and other features
`of the disclosed device, Will become more readily apparent
`to those having ordinary skill in the pertinent art from the
`folloWing detailed description of certain preferred embodi
`ments taken in conjunction With the draWings Which set
`forth representative embodiments of the present invention
`and Wherein like reference numerals identify similar struc
`tural elements.
`In FIGS. 1, 2, and 2A—C, numeral 110 generally refers to
`a margin marking device. In FIG. 1, a marker 116 is being
`secured to a specimen 114 to mark the margins of the
`specimen. The marker 116 de?nes an aperture 126 siZed to
`accommodate sutures 118, staples, or like connecting means
`for securing the marker 116 to the specimen 114. The sutures
`118 may be any length, although longer lengths Will alloW
`the marker 116 to be moved aWay from the specimen 114
`during radiography, thereby reducing or eliminating possible
`obstruction of the specimen 114 caused by the image of the
`radiopaque marker 116. A user 130 grips (With ?ngers,
`forceps, pliers, or other means) the base 112 While securing
`the marker 116 to the specimen 114. Once attached, the
`marker 116, because of its distinctive shape and indicia 124,
`identi?es the orientation of the specimen 114 prior to
`removal from the patient’s body. The user 130 then discon
`nects the marker 116 from the base 112 by breaking the
`marker 116 at a frangible connection 122. The user 130 may
`then mark different areas of the specimen 114 With the
`remaining markers 120 and/or may dispose of the device
`110. Because the markers 116 are radiopaque, the markers
`116 Will appear on a radiograph of the specimen.
`Referring noW to FIGS. 2A—C, the base 112, frangible
`connections 122, and markers 116 are formed by photoetch
`ing a single piece of radiopaque material. For ease of
`handling the desirably small markers, each marker 116 is
`joined to the base 112 at a respective connection 122. The
`base 112 is of suf?cient siZe to alloW ease of handling the
`margin marking device 110, Whether a user is using forceps,
`?ngers, or other means to hold the base 112. The base 112
`is circular, but those With ordinary skill in the pertinent art
`Will notice that virtually any shape could be used for the base
`112 including hexagons, triangles, rods, ovals, stars and
`other shapes. The connection 122 is strong enough to
`prevent inadvertent breakage, but Weak enough to alloW a
`user to disconnect the marker 116 from the base 112 once the
`marker 116 is attached to a specimen. The connection 122
`can be a frangible connection (if the base and markers are
`constructed of a single piece of material, as shoWn), or can
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`be any of numerous other types of connections that Will
`alloW for easy disconnection of the marker 116 from the base
`112. Other such connections include, Without limitation,
`Wires, removable or breakable pins, hooks, adhesives, or the
`like.
`As can be seen, each marker 116 de?nes a distinctive
`shape Which, once attached to a specimen, indicates orien
`tation of the specimen prior to removal. Indicia 124, also
`photoetched from the radiopaque material, aid in indicating
`orientation of each marker 116. In the illustrated
`embodiment, the indicia 124 are letters de?ned by apertures
`photoetched through the respective marker. Since the mark
`ers 116 are formed from radiopaque material, the markers
`Will cast an image When radiographed, thus making the
`indicia 124 and/or distinctive shape of the marker 116
`visible. As shoWn, the markers 116 each indicate orientation
`preferably by including indicia 124 in the form of one of the
`folloWing Words: “cranial,” “caudal,” “medial,” “deep,”
`“lateral,” or “skin,” and each marker further de?nes a
`peripheral shape forming a graphical representation of the
`respective indicia.
`One of ordinary skill in the pertinent art Will recogniZe
`that the indicia 124 can be formed through processes other
`than photoetching. For example, indicia 124 also may be
`formed in the radiopaque markers 116 by stamping, laser
`cutting, or by other means. In FIGS. 2A—C, the indicia 124
`are de?ned by one or more apertures formed through the
`respective marker 116, those apertures de?ning the shapes of
`letters. Alternatively, the indicia can comprise distinctive
`shapes or other forms to provide unique identifying infor
`mation. One of ordinary skill in the pertinent art also Will
`recognize that the indicia themselves may be radiopaque.
`This method Would alloW the indicia to be mounted on or
`embedded in a non-radiopaque marker. In this case, indicia
`may be applied to each marker by printing the indicia
`thereon With a radiopaque ink or other suitable material.
`Radiopaque indicia could also be embedded Within non
`radiopaque markers While the markers are being formed
`(i.e., during casting, injection molding, or some other
`process).
`It Will be apparent to one of ordinary skill in the pertinent
`art that the markers 116, including the indicia 124 and/or the
`distinctive shapes of the markers, can de?ne virtually any
`information relevant to the marking of specimens.
`Additionally, the marking system indicated, While directed
`to breast specimens, can be utiliZed With obvious modi?ca
`tions to mark any type of specimen, from any body part, for
`any purpose. A non-exhaustive list of possible alternative
`indicia include the Words: “breast,” “?rst,” “second,” “left,”
`“right,” “malignant,” “base,” “testicle,” “anterior,” etc. In
`addition, each marker may de?ne a respective shape forming
`a graphical representation of the representative indicia or
`otherWise conveying desired information. Each marker 116
`de?nes an aperture 126 large enough to accommodate
`sutures, staples or other attachment elements as desired,
`Which alloW fast attachment of the marker 116 to a speci
`men.
`In the currently preferred embodiment of FIGS. 2A—C,
`the margin marking device 110 is approximately one inch in
`diameter, With each marker 116 de?ning a footprint of
`approximately 0.2 inches by 0.2 inches. The small siZe of the
`individual markers 116 alloWs for accurate marking of
`specimen margins and decreases the amount of specimen
`obstructed by the marker’s image during xray. The base 112
`and the markers 116 are both approximately 0.005 inch
`thick, Which reduces the possibility of markers 116 imped
`ing the required ?attening of a specimen during radiography.
`
`Bard Exhibit 1007 Page 9 of 12
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`

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`US 6,826,257 B2
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`5
`Those of ordinary skill in the pertinent art Will note that the
`thickness and siZe of the markers 116 can vary depending on
`any of numerous different factors, such as the siZe of the
`specimen to Which the markers 116 Will be af?xed (i.e.,
`larger markers can be attached to larger specimens).
`Those of ordinary skill in the pertinent art also Will
`recogniZe that the margin marking device 110 can be made
`from any of numerous different materials that are currently
`or later become knoWn for performing the function of the
`markers described herein. While FIG. 1 shoWs a marking
`device 110 made from a single piece of stainless steel, other
`radiopaque materials may be used, including platinum,
`titanium, lead, other metals or alloys, non-radiopaque mate
`rials With radiopaque coatings, or any combination of any of
`the foregoing. Additionally, non-radiopaque markers may be
`used With radiopaque indicia ?xed thereon. In addition, the
`markers could be made of partially radiopaque, partially
`radiolucent material as disclosed in Us. patent application
`Ser. No. 09/372,835, ?led Aug. 12, 1999, entitled “An
`intermediate density marker and a method for using such a
`marker for radiographic examination”, Which is assigned to
`the assignee of the present invention and is hereby expressly
`incorporated by reference as a part of the present disclosure.
`This material Would alloW the image of the marker to appear
`on a radiograph yet Would not obstruct any underlying
`structure of the specimen from being visible through the
`image of the marker on the radiograph.
`Photoetching is the currently preferred method of making
`the margin marker system, since this process is relatively
`cost-effective, produces a precise reproduction of the origi
`nal design, and produces a marking device that is burr and
`stress free. Photoetching also alloWs for a simple Way to
`manufacture the entire device (base, connections, and
`markers) as a single piece. Other manufacturing processes
`such as stamping, casting, injection-molding, laser-cutting,
`and the like equally may be used.
`Referring to FIG. 3, a margin marking device 310 de?nes
`a hexagonal base 312. As Will be appreciated by those of
`ordinary skill in the pertinent art, margin marking device
`310 utiliZes the same principles of the margin marking
`device 110 of FIGS. 1 and 2A—C. Accordingly, like refer
`ence numerals preceded by the numeral “3,” instead of the
`numeral “1,” are used to indicate like elements. Each base
`312 is connected to plate 316 at a respective connection 322.
`Each plate 316 is radiopaque and is photoetched With indicia
`324 de?ning a respective unique orientation. Each plate 316
`is connected to a respective Wire 328 Which is, in turn,
`connected to respective closed ring de?ning an aperture. The
`aperture 326 of each closed ring is siZed to accommodate
`sutures, staples, or like connecting means, and may be
`fabricated from any of numerous materials available in the
`art and those developed in the future.
`The length of each Wire 328 may be set as desired.
`Alternatively, the Wire 328 may be eliminated and each
`closed ring may be directly connected to the respective plate
`316. The presence of the Wire 328 is particularly useful for
`extremely small specimens, Where little or no obstruction of
`the radiograph by the plate 316 Would be acceptable. In this
`case, the closed ring can be ?xed to a specimen, and the
`respective plate 316 can be moved aWay from the specimen
`during xray procedures, thereby eliminating possible
`obstruction of relevant portions of the specimen by the
`radiopaque plate 316. The Wire 328 may be fabricated from
`radiopaque, non-radiopaque material, or partially
`radiopaque, partially radiolucent. A radiopaque Wire 328
`Would be particularly useful, as it Would be visible on a
`radiograph of the specimen, thereby de?ning a line from the
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`respective plate 316 to the point of connection on the
`specimen. This Would alloW those vieWing the radiograph to
`pinpoint the location of a particular point of interest on the
`specimen, Without blocking that point With a radiopaque
`plate 316.
`FIG. 4 shoWs a margin marking device 410 particularly
`Well-suited to knoWn methods of plastic construction. A
`rod-shaped base 412 is connected to markers 416 at fran
`gible connections 422. Each marker 416 de?nes unique
`indicia, shoWn typically at 424, indicative of a respective
`orientation. The indicia 424 may be de?ned by one or more
`apertures formed through the respective marker 416,
`Wherein the apertures de?ne the shapes of letters and/or
`other unique identifying information. Alternatively, the indi
`cia 424 may be applied to each marker 416 by printing the
`indicia thereon With a radiopaque ink or other suitable
`material. An aperture 426 is present in each marker 416 for
`attaching sutures, staples, or like attachment means. The
`margin marking device 410 can be molded as one piece of
`plastic or other suitable material. Each plastic marker 416
`may be suf?ciently radiopaque to mark the specimen.
`Alternatively, a radiopaque coating may be applied to each
`marker 416, or radiopaque material may be embedded or
`attached to the markers 416 in a manner knoWn to those of
`ordinary skill in the pertinent art.
`Although FIGS. 1 through 4 shoW margin marking
`devices having a plurality of markers connected to a base,
`one of ordinary skill in the pertinent art Will recogniZe that
`the markers individually are novel in their oWn right. While
`the small siZe of the markers necessitates the use of a base
`to hold the markers as those markers are being ?xed to
`specimens, this base is not necessary for larger markers,
`Which can be stored in a container until they are secured to
`a specimen. These larger markers could be used to mark the
`margins of larger specimens, specimens Where obstruction
`caused by the image of the marker during radiography is less
`of a concern, or for markers made of partially radiopaque,
`partially radiolucent material. The novelty of the present
`invention is not lost With an increase of marker siZe and the
`elimination of the base, as the advantages of a marker that
`remains secured to a specimen and standardiZes the method
`of marking specimens still exist.
`The skilled artisan also Will recogniZe that any or all
`components of the margin marking device of the present
`disclosure (including the base and markers) could be made
`from many materials presently available in the art or
`invented in the future. If a marker is made from radiopaque
`material (or non-radiopaque material coated With radio
`paque coating), indicia can be formed on the marker, either
`by photoetching, stamping or other means. The markers
`themselves also may de?ne a distinctive shape Without
`indicia, provided the markers are of such a shape as to
`clearly indicate a unique orientation or other requisite iden
`tifying information. Markers also may be completely non
`radiopaque, With radiopaque indicia printed or otherWise
`?xed thereon. It also Will be apparent to those of ordinary
`skill in the pertinent art that the base and markers may be
`manufactured from more than one piece of material or
`various combinations of materials. After manufacture, the
`markers could be attached to the base in any of numerous
`different Ways that alloW for disconnection during use. As
`indicated above, these points of connection betWeen the
`markers and the base may be formed by hooks, Wire, pins,
`frangible portions, or like connections.
`Although the invention has been described in terms of
`exemplary embodiments, it is not limited thereto. Rather, the
`appended claims should be construed broadly, to include
`
`Bard Exhibit 1007 Page 10 of 12
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`7
`other variants and embodiments of the invention, Which may
`be made by those skilled in the art Without departing from
`the scope and range of the equivalents of the invention as
`de?ned by the appended claims.
`What is claimed is:
`1. Adevice for margin marking of radiography specimens,
`comprising:
`a base for gripping during use; and
`a plurality of markers detachably connected to said base,
`Wherein each marker de?nes an aperture for attaching
`the marker to a specimen and indicia, and at least one
`of the marker and indicia is at least partially radiopaque
`and thereby visible When radiographed to indicate
`orientation of the specimen.
`2. The margin marking device set forth in claim 1,
`Wherein each marker is fabricated from radiopaque material.
`3. The margin marking device set forth in claim 2,
`Wherein a plurality of the markers each comprises a periph
`eral surface de?ning a unique shape.
`4. The margin marking device set forth in claim 1,
`Wherein each marker de?nes a unique orientation relative to
`the other markers.
`5. The margin marking device set forth in claim 1,
`Wherein each of the markers de?nes a unique orientation,
`including
`a ?rst marker de?ning a cranial orientation; (ii)
`a second marker de?ning a caudal orientation; (iii) a third
`marker de?ning a medial orientation; (iv) a fourth marker
`de?ning a deep orientation; (v) a ?fth marker de?ning a
`lateral orientation; and (vi) a siXth marker de?ning a skin
`orientation.
`6. The margin marking device set forth in claim 1,
`Wherein each of the markers comprises indicia de?ned by at
`least one aperture.
`7. The margin marking device set forth in claim 6,
`Wherein each indicia includes characters indicative of a
`unique orientation.
`8. The margin marking device set forth in claim 7,
`Wherein each of the markers comprises a peripheral surface
`de?ning a unique shape and indicative of orientation.
`9. A margin marker for radiography specimens compris
`ing:
`a base and at least one marker detachably connected to the
`base, Wherein the marker includes an aperture for
`attaching the marker to a specimen and indicia, and at
`least one of the marker and indicia is at least partially
`radiopaque and thereby visible When radiographed to
`indicate orientation of the specimen.
`10. The margin marker set forth in claim 9, Wherein the
`marker is fabricated from radiopaque material.
`11. The margin marker set forth in claim 10, further
`comprising a peripheral surface de?ning a unique shape
`indicative of orientation.
`12. The margin marker set forth in claim 9, Wherein the
`marker is radiopaque and de?nes an orientation consisting of
`at least one of the folloWing: cranial, caudal, medial, deep,
`lateral, and skin.
`13. The margin marker set forth in claim 12, further
`comprising indicia de?ned by at least one aperture.
`14. The margin marker set forth in claim 13, Wherein each
`indicia includes characters indicative of a unique orienta
`tion.
`15. A method of marking the margins of a radiography
`specimen comprising the steps of:
`providing a margin marking device having a base and at
`least one marker detachably connected to the base, and
`Wherein the at least one marker de?nes an aperture and
`is at least partially radiopaque;
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`20
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`25
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`30
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`35
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`40
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`45
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`50
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`US 6,826,257 B2
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`15
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`8
`gripping the base and holding the marker against or
`adjacent to a respective marginal portion of a specimen;
`securing the marker to the marginal portion of the speci
`men through the aperture and into the specimen; and
`disconnecting the marker from the base and leaving the
`marker secured to the marginal portion of the specimen
`to indicate the orientation of the specimen.
`16. The method of marking set forth in claim 15, Wherein
`10 the securing step is performed With at least one of a suture
`and a staple.
`17. A method of marking the margins of a radiography
`specimen comprising the steps of:
`providing a device including a base and at least one
`marker detachably connected to the base and having
`indicia visible on a radiograph and indicative of orien
`tation;
`securing the marker to a marginal portion of a specimen
`corresponding to the respective indicia disconnecting
`the marker and base;
`radiographing the specimen and marker attached thereto;
`displaying on the radiograph the indicia to thereby shoW
`the orientation of the specimen.
`18. The method of marking set forth in claim 17, Wherein
`the securing step is performed With at least one of a suture
`and a staple.
`19. The method of marking set forth in claim 18, further
`comprising at least one of the folloWing steps:
`(i) securing a marker With indicia indicative of caudal
`orientation to the caudal margin of the specimen;
`(ii) securing a marker With indicia indicative of medial
`orientation to the medial margin of the specimen;
`(iii) securing a marker With indicia indicative of deep
`orientation to the deep margin of the specimen;
`(iv) securing a marker With indicia indicative of lateral
`orientation to the lateral margin of the specimen;
`(v) securing a marker With indicia indicative of skin
`orientation to the skin margin of the specimen; and
`(vi) securing a marker With indicia indicative of cranial
`orientation to the cranial margin of the specimen.
`20. A device for margin marking of radiography
`specimens, comprising:
`?rst means for marking a marginal portion of the speci
`men;
`second means for supporting the ?rst means and for
`gripping during use;
`third means for visually indicating the orientation of the
`specimen on a radiograph;
`fourth means for detachably connecting the ?rst means to
`the second means; and
`?fth means for securing the marker to the marginal
`portion of the specimen, Wherein at least a portion of at
`least one of the ?rst and third means is at least partially
`radiopaque.
`21. The device for margin marking set forth in claim 20,
`Wherein the ?rst means is de?ned by a marker formed by a
`material that is at least partially radiopaque.
`22. The device for margin marking set forth in claim 20,
`Wherein the second means is de?ned by a base including at
`least one surface for gripping during use.
`23. The device for margin marking set forth in claim 20,
`Wherein the third means is de?ned by indicia.
`24. The device for margin marking set forth in claim 23,
`Wherein the indicia is de?ned by characters.
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`Bard Exhibit 1007 Page 11 of 12
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`US 6,826,257 B2
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`25. The device for margin marking set forth in claim 23,
`Wherein the indicia is de?ned by a peripheral shape.
`26. The device for margin marking set forth in claim 23,
`Wherein the indicia is de?ned by at least one aperture.
`27. The device for margin marking set forth in claim 20, 5
`Wherein the fourth means is de?ned by a frangible portion.
`28. The device for margin marking set forth in claim 20,
`Wherein the ?fth means is de?ned by at least one aperture for
`receiving at least one of a suture and a staple.
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`10
`29. The device for margin marking set forth in claim 28,
`Wherein the suture is suf?ciently long to alloW the ?rst
`means to lie ?at during a radiographic procedure.
`30. The device for margin marking set forth in claim 20,
`_
`_
`Wherem each of the ?rst means and Second means 15
`approximately Plan“
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`Bard Exhibit 1007 Page 12 of 12