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05407440 - Usoos407440A United States Patent[191 1111...

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Unformatted text preview: HlllllllllllllllIllllllllllllllIllllllllllllllllllllllllIlllllllllllllllll . Usoos407440A United States Patent [191 1111 Patent Number: 5,407,440 . . =5: Zmrelch et a1. [45] Date of Patent: Apr. 18, 1995 [54] RADIATION THERAPY SKIN MARKERS 4,594,276 6/1986 Relyea ................................... 428/40 . _ . _ . . 4,710,875 12/1987 Nakajima etal. 128/6531 [75] Inventors: Smnon Zmrelch; Eva 5- Zmrelch, 5,008,947 4/1991 Yamada ....................... 378/162 both of Owings Mills, Md; Earl F. 5,070,861 12/1991 Einars 61 81. .. 128/6531 Robinson, Lake Forest, Calif. 5,210,783 5/1993 Wallace ............. 378/162 . . . ~,300,080 4 4 Cl . .................... 606 [73] Asmgnee: Izi Corporation, megs M1118, Md. 3 “99 aymafl 6t 81 A30 [ * ] Notice: The portion of the term of this patent subsequent to Apr. 26, 2011 has been Primary Examiner—Stephen C. Pellegrino Assistant Examiner—Glenn Dawson Attorney, Agent, or Firm—Lyon & Lyon disclaimed. [21] Appl. No: 177,528 [57] ABS CT [22] Filed- Jan 5 1994 A radiation therapy skin marking device which may be . . , used to delineate a radiation therapy portal area on a _ _ patient’s skin surface. The device includes a set of radia- Related U'S' Application Data tion therapy skin markers which are releasably attached [63] Continuation of Ser. No. 848,269, Mar. 9, 1992, Pat. to a backing liner and include an adhesive surface such NO- 5,306,271- that the markers may be releasably attached to a pa- [51] Int. 01.6 .............................................. A61B 17/00 tient’s skin surface The markers include Pfintéd lines SO [52] US. Cl. ....... 1 ................................ 606/1; 128/659; as to facilitate radiation therapy treatments by more 606/116 obviously defining a radiation therapy portal area. The [58] Field of Search ............... 434/363, 364, 430, 433; markers include various shapes including, for example, 606/1, 116, 130; 128/653.l—653.5, 659; a marker of substantially circular shape with a ninety 378/ 162—164, 20; D5 /63; D20/11; 604/ 116; degree wedge cut therefrom such that the marker may 40/299, 300, 594; 156/257, 267, 268, 250; be used to outline a ninety degree corner and a marker 428/40, 42, 43, 79 of substantially circular shape with a circular cut-out . center such that the marker is defined by a circular [56] References Cited outer edge and a circular inner edge both of which U-S' PATENT DOCUMENTS circular edges share a common center point. 4,235,459 11/1980 Callahan ............................... 428/42 4,537,809 8/1985 Ang et a1. ............................. 428/41 ' 10 Claims, 5 Drawing Sheets US. Patent 26 75 50 320 K2&7 52b . 28b Hg 7:; 440 20 42 4415 440/ 40 440 fig; / d Apr. 18, 1995 Sheet 1 of 5 5,407,440 540 78 5615 360 55 54b Hg 70 ‘ 460 ‘5‘ 46b 1|! 22 Fig; 76 Ma 240 75 72 ”fl. - ..-d~----.."~.-..-.4 .‘u‘ t '- 0 h... .-H..........-............. 24!)” Mb HQ if US. Patent Apr. 18, 1995 Sheet 2 of 5 5,407,440 fig; 5b US. Patent Apr. 18, 1995 Sheet 3 of 5 5,407,440 US. Patent Apr. 18, 1995 Sheet 4 of 5 5,407 ,440 US. Patent Apr. 18, 1995 Sheet 5 of 5 5,407,440 5,407,440 1 RADIATION THERAPY SKIN MARKERS This is a continuation of application Ser. No. 07/848,269, filed on Mar. 9, 1992, now US Pat. No. 5,306,271. INTRODUCTION The present invention relates to devices used to delin- eate radiation therapy portal areas of patients to be treated With radiation. BACKGROUND OF THE INVENTION In recent years the incidences of cancer in general has significantly increased. Concurrently the use of radia- tion therapy to treat cancer has also increased. Radia- tion therapy is used to treat cancer patients in two ways: for curative purposes and for palliative reasons. Virtually all radiation therapy centers are equipped with simulators—a fluoroscopic imaging unit equipped with all the characteristics and parameters found on the radiation treatment units. With the help of diagnostic imaging such as computerized x-ray tomography (CT) and magnetic resonance imaging (MRI), when com— bined with the fluoroscopic capability of the simulator, a radiation therapy portal (the area through which the treating radiation will be focussed) may be designed. Conventionally, the perimeter, isocenter, and set-up points of this radiation therapy portal are marked on the patients skin with magic markers, fuchsia color, and/ or tattoo markings. However, there are many problems with these conventional markers. The time between simulation and beginning treat- ment is usually zero to seven days. During this period, generally greater than one day, various types of mark- ings may be lost. For this reason, tattooing is often used to establish the portal boundaries with some perma- nency and reproducibility. However, there are several disadvantages to tattooing, even though it may seem to be the most optimal means to establish portal bound— aries. One problem is that tattoos are difficult to recognize on dark skin. Thus, tattoos too may be lost. An additional problem is that the tattooing process punctures the patient’s skin multiple times and, there- fore, exposes radiation therapy personnel to the pa- tient’s blood and the patient’s blood to out-side contami- nants. This exposure creates a risk that the radiation therapy personnel or the patient may be contaminated with various infectious organisms transmitted by blood exposure, especially the autoimmune virus. Two further problems are associated with the perma‘ nency of tattoos. First, a radiation therapy portal boundary tattoo is aesthetically unattractive. This is especially problematic when the tattoo is placed on skin surfaces which are not ordinarily covered by clothing. Second, but technically of equal importance, a radiation therapy portal boundary tattoo is inflexible. Initially, this may seem to be a benefit because it limits the risk that the portal boundary markings might inadvertently shift. However, a portal field for a particular patient is frequently changed throughout the course of treatment thereby requiring a shift in the portal boundary mark- ings. Once tattooing marks are established a re-tattooing is required to shift the portal boundaries thereby com- pounding the above described disadvantages. 5 10 15 20 25 30 35 4O 45 50 55 60 65 2 SUMMARY OF THE INVENTION To address the above described inadequacies of cur- rently used techniques to depict portal fields, a specially designed device is presented. This device is easy to apply to the patient’s skin. In addition, it is reliable in that it may retain its original position for up to seven days. Yet, it may be repositioned easily without risk to patient or personnel. Furthermore, it is removable with- out leaving any permanent traces on the patient’s skin. An exemplary embodiment of the device is shown and described herein. The device comprises flat, adhesive-coated tape-like structures in various shapes which are used to denote the perimeter, isocenter(s), and set-up points of radia— tion treatment portals on the skin of patients undergoing radiation therapy. In the preferred embodiment, the device includes pieces shaped such that they may be used to delineate the corners, the edges connecting the corners, the isocenter point(s), and any set-up points of the proposed radiation field. The pieces of the device are supplied arranged on a backing liner in a way which is conducive to their use. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1A shows a plan View of a preferred embodi— ment of a set of radiation therapy skin markers of the present invention. FIG. 1B shows a corner marker of the present inven— tion. FIG. 1C shows a line marker of the present invention. FIG. 1D shows a isocenter marker of the present invention. FIG. 1B shows a set-up point marker of the present invention. FIG. 1F shows a cross-section view of a preferred embodiment of a set of radiation therapy skin markers of the present invention taken from line 1F—1F in FIG. 1A. FIG. 2 shows a perspective view of the preferred embodiment of the present invention as a strip part of the backing liner is being removed. FIG. 3A shows a perspective View of the preferred embodiment of the present invention as the markers are used after a strip part of the backing liner has been removed. FIG. 3B shows a perspective View of the markers of the present invention after the markers have been ap- plied. FIG. 4A shows a plan view of a second embodiment of a set of radiation therapy skin markers. FIG. 4B shows a plan view of a second embodiment of a set of radiation therapy skin markers with both‘strip parts of the backing liner removed. FIG. 5A shows a plan View of a third embodiment of a set of radiation therapy skin markers of the present invention. FIG. 5B shows a plan View of a third embodiment of a set of radiation therapy skin markers after a backing card is removed. , FIG. 5C shows a plan View of a bottom set of markers from the third embodiment of a set of radiation therapy skin markers. FIG. 5D shows a plan View of a top set of markers from the third embodiment of a set of radiation therapy skin markers. 3 FIG. 6 shows a perspective view of the third embodi— ment. of a set of radiation therapy skin markers as the backing card is removed. FIG. 7 shows a perspective view of the third embodi- ment of a set of radiation therapy skin markers as the bottom set of markers and the top set of markers are being separated from each other after the backing card has been removed. FIG. 8 shows a perspective view of a bottom set of markers from a third embodiment of a set of radiation therapy skin markers as the markers are being applied. DESCRIPTION OF THE PREFERRED EMBODIMENT Turning to the drawings, FIG. 1A shows a plan view of the preferred embodiment of the present invention in the form of a set of radiation therapy skin markers 10. The set of skin markers 10 has various markers (de— scribed below), a backing liner 12, and two backing strips 14a and 14b. The markers comprise corner markers 16 (see also FIG. 1B), line markers 18 (see also FIG. 1C), isocenter markers 20 (see also FIG. 1D), and set-up point markers 22 (see also FIG. 1E). These markers are mounted on a backing liner 12 as shown in FIGS. 1A and IF. As described below, the corner markers 16 and the line markers 18 can be used, respectively, to mark the cor- ' ners and edges of a square or rectangle radiation ther- apy portal (as shown in FIG. 3B). The isocenter mark- ers 20 and the set-up point markers 22 can be used, respectively, to mark any isocenters and set-up points necessary to a particular radiation therapy treatment (as shown in FIG. 3B). The markers 16, 18, 20, and 22 have a top surface (shown in FIG. 1A) and a bottom surface (not shown). The markers 16, 18, 20, and 22 are made from a conventional breathable material, preferrably printable spunbonded nylon available from FLEXcon Company, Inc. as item number PBN—lOOO-W. In addi- tion, the markers 16, 18, 20, and 22 have adhesive, pref- errably skin contact adhesive available from FLEXcon Company, Inc. as item number H-566, applied to their ' entire bottom surface in a conventional manner. The 3M Company has material available which could be substituted for these preferred materials. As shown in FIG. 1B, a preferred corner marker 16 is defined by an arcuate edge 26 and two straight edges 28a and 28b. The straight edges 28a and 28b are perpen- dicular to each other thereby forming a two hundred seventy degree angle 30. The corner markers 16 are placed by a radiation therapist (described in more detail later) such that the two hundred seventy degree angle 30 of each corner marker 16 will outline a ninety degree angle of a corner of a specified square or rectangular radiation therapy portal (as shown in FIGS. 3A and 3B). In addition, the straight edges 28a and 28b include printing 32a and 32b to help create a discernable target for a radiation therapist performing radiation therapy treatments. As shown in FIG. 1C, a preferred line marker 18 is somewhat rectangular in shape and defined by short edges 34a and 34b and long edges 36a and 36b. The long edges 36a and 36b are multiple times the length of the short edges 34a and 34b. Each line marker 18 includes a printed line 38 extending between the short edges 34a and 34b and parallel to the long edges 36a and 36b. The line markers 18 are placed by a radiation therapist (de- scribed in more detail later) such that the printed lines 38 of each line marker 16 outline the edges of a specified 5,407,440 5 10 15 20 25 30 35 40 45 50 4 square or rectangular radiation therapy portal (as shown in FIG. 3A and 3B). The printed lines 38 help create a discernable target for a radiation therapist per- forming radiation therapy treatments. As shown in FIG. ID, a preferred isocenter marker 20 is circularly shaped with a circular cut-out center and is defined by a circular outer edge 40 and circular inner edge 42. Each isocenter marker 20 includes four printed lines 44a~44d extending radially from the circu- lar inner edge 42 to the circular outer edge 40. The printed lines 440—44d are further defined by the fact that if they were extended beyond the circular inner edge 42, they would intersect at a point which defines a com- mon center of circles defined by the circular outer edge 40 and the circular inner edge 42 and would intersect in such a way that lines 440 and 44c would each be perpen— dicular to lines 44b and 44d. The isocenter markers 20 are placed by a radiation therapist (described in more detail later) such that the printed lines 44a—44a' define an isocenter of a specific radiation therapy portal as the point where the lines 440-44d would intersect thereby assisting a radiation therapist perform radiation therapy treatments (see FIGS. 3A and 3B). As shown in FIG. 1E, a preferred set-up point marker 22 is octagonally shaped and includes two printed lines 460 and 46b. The printed lines 460 and 46b are posi- tioned such that they perpendicularly bisect each other. The set-up point markers 22 are placed by a radiation therapist (described in more detail later) such that the intersection of the printed lines 460 and 46b define a set-up point of a specific radiation therapy portal thereby assisting a radiation therapist perform radiation therapy treatments (see FIGS. 3A and 3B). As shown in FIG. 1A, the backing ‘liner 12 includes two die cuts 240 and 24b along its full length which define backing strips 140 and 14b. The die cuts 24a and 24b are designed in a way to facilitate the removal of backing strips 14a and 14b without disturbing the vari- ous markers 16, 18, 20, and 22 on the backing liner 12. FIG. 2 shows a perspective view of the present inven- tion as a backing strip 14a is being removed. FIG. 3A shows a perspective view of the present invention after the removal of backing strip 14a. As shown in FIGS. 2 and 3A, once the backing strip 140 has been removed, bottom surfaces of portions of the corner markers 16, the line markers 18, and the isocenter markers 20 are exposed. As described above, the entire bottom surface of the markers 16, 18, 20, and 22 include an adhesive coating. Thus, when the bottom surfaces are exposed, the adhesive coating is exposed which enables a radia- tion therapist to apply the markers onto the patient as - shown in FIG. 3A. 55 6O 65 FIGS. 4A and 4B show plan views of a second em- bodiment of a set of radiation therapy skin markers 48. FIG. 4A shows a complete second embodiment set 48. FIG. 4B shows a second embodiment set 48 with both backing strips 50a and 50b removed. This second em- bodiment set 48 includes the same markers as described above: corner markers 16, line markers 18, isocenter markers 20 and set-up point markers 22. The difference between the preferred embodiment 10 and this second embodiment set 48 are the shapes of the die cuts 520 and 52b in the backing liner 12 and, therefore, the shapes of the liner strips 50a and 50b. This difference comprises two pairs of extensions 54a and 54b (one pair on each die cut 52a and 52b). These extensions 54a and 54b occur directly below the comer markers 16 associated with each die cut 52a and 52b such that the liner strips 5,407,440 5 500 and 50b extend below each of the corner markers 16. The purpose of the extensions 54a and 54b is to facilitate the application of the corner markers 16 by the radiation therapist once the liner strips 500 and 5017 are removed. Application of the corner markers 16 is facili- 5 tated because a larger bottom surface of the corner markers 16 is exposed (thereby exposing a larger amount of adhesive) and because the ninety degree angle as outlined by the two hundred seventy degree angle 30 of the corner markers 16 is exposed (allowing 10 visibility of the surface onto which the corner marker is to be applied). The markers 16, 18, 20, and 22 are all applied as described above. FIGS. SA, 5B, 5C, 5D, 6, 7, and 8 show views of a third embodiment of a set of radiation therapy skin 15 markers 56. As shown in FIG. 5A, the configurations of the various markers 16, 18, 20, and 22, are as described above. The main difference between this third embodi- ment 56 and the preferred embodiment 10 is that the markers 16, 18, 20, and 22 are organized differently such 20 that they are arranged on a top backing liner 58, a bot- tom backing liner 60, and a backing card 62. This ar- rangement allows exposure of portions of the corner markers 16 and the isocenter markers 20 after the back- ing card 62 is removed (as shown in FIGS. 5A, 5B, and 25 6). In addition, the arrangement allows exposure of portions of the line markers 18 and the set-up point markers 22 when the top backing liner 58 and the bot- tom backing liner 60 are separated (as shown in FIGS. 5D and 7). The, markers 16, 18, 20, and 22 are all applied as described above (as shown in FIG. 8). Although particular and preferred embodiments of radiation therapy skin markers have been shown and described herein, it is to be understood that they can be modified without departing from the scope of the pres— ent invention, and all such modifications and equiva- 30 35 lents are intended to be covered. What is claimed is: 1. A device for marking skin surfaces to delineate a radiation therapy portal area comprising a set of thin flat markers comprising at least two surfaces including adhesive on one surface and including at least one isocenter marker of substan- tially circular shape with a circular cut-out center such that the isocenter marker is defined by a circu- lar outer edge and a circular inner edge both of which circular edges share a common center point, said isocenter marker including printed lines thereon which extend from the inner edge to the outer edge along imaginary lines extending radially from the common center point to the circular outer edge, such that said isocenter marker is configured to define an isocenter of a radiation therapy portal, said set further including at least one of a corner boundary marker, a line boundary marker, another isocenter marker, or a set-up point marker config- ured to be used to define and delineate a radiation therapy portal, and a thin flat backing liner comprising a surface onto which the set of markers is removably adhered, said backing liner including a die cut such that a portion of the liner which is adhered to a portion of at least one marker of the set may be removed without disturbing the set of markers from a re- 65 maining portion of the backing liner and thereby exposing at least a portion of the surface including adhesive of at least one of the markers of the set. 40 45 6O 6 2. The device of claim 1 wherein the markers are made of breathable material. 3. The device of claim 2 wherein the breathable mate- rial is printable spun—bonded nylon. 4. The device of claim 1 wherein the adhesive is skin contact adhesive. 5. The device of claim 1 wherein the markers include printed lines on at least one surface for delineating at least one of a corner boundary, a line boundary, an isocenter, or a set—up po...
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