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05306271 - United States Patent[19 Zinreich et a1...

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Unformatted text preview: United States Patent [19] Zinreich et a1. lllllllllllllllllllllllllllIlllllllllllllllllllllllllllllllllllllllllllllll USOOS30627lA [11] Patent Number: 5,306,271 [45] Date of Patent: Apr. 26, 1994 [54] [75] [73] [21],. [22] [51] [52] [58] [56] RADIATION THERAPY SKIN MARKERS Inventors: Simion J. Zinreich; Eva S. Zinreich, both of Owings Mills, Md.; Earl F. Robinson, Lake Forest, Calif. Assignee: Izi Corporation, Owings Mill, Md. App]. No.: 848,269 Filed: Mar. 9, 1992 Int. Cl.5 .............................................. A6113 17/00 US. Cl. .......................................... 606/1; 378/20; 378/ 162;, 378/164; 428/43; 428/42; 606/116; 604/116; 128/659 Field of Search ................................ 378/ 162—164, 378/20; D5/63; 428/40, 42, 43, 79; 606/116, 130; 128/653.1, 659; 604/116; 40/299, 300, 594; 156/257, 267, 268, 250; D20/ll References Cited U.S. PATENT DOCUMENTS 3,542,022 11/1970 Bannik ................................ 604/116 3,547,121 12/1970 Cherry .. 4,117,337 9/1978 Sluts... 1.. 378/20 4,235,459 11/1980 Callahan 40/594 4,537,809 8/1985 Ang et a1. ..... 40/299 4,583,538 4/1986 Onik et a1. ........................ 128/6531 4,594,276 6/1986 Relyea. 4,652,239 3/1987 Brimberg. 4,680,210 7/1987 Corcoran. rrl'lrI-Inr‘ *— 240 4,710,875 12/1987 Nakajima et a1. ................... 378/162 4,838,265 6/1989 Cosman et a1. . 4,860,331 8/1989 Williams et al. . 4,918,715 4/1990 Krupnick et a1. . Primary Examiner—Stephen C. Pellegrino Assistant Examiner—Glenn K. Dawson Attorney, Agent, or Firm-Lyon & Lyon [57] ABSTRACT 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 is a set of radiation therapy skin markers which are releasably attached to a backing liner and include an adhesive surface such that the markers may be releasably attached to a patient’s skin surface. The markers include printed lines so as to facilitate radiation therapy treatments by more obvi- ously defining a radiation therapy portal area. The shape of the markers may vary including, for example, a marker of substantially circular shape with a ninety degree wedge cut therefrom such that the marker may - be used to outline a ninety degree corner and a marker of substantially circular shape with a circular cut-out center such that the marker is defined by a circular outer edge and a circular inner edge both of which circular edges share a common center point. 15 Claims, 5 Drawing Sheets 74a US. Patent Apr. 26, 1994 Sheet 1 of 5 5,306,271 “[7713 \‘I \‘l 340 25 75 I8 32 30 q 3617 250 36" 35 32b 22% f7 7 b 9- 34b 1‘79_ 7 c 440 20 44b 46a 42 46b 44d 40 44c Hg_ 7d F/g__ 7e & US. Patent Apr. 26, 1994 Sheet 2 of 5 5,306,271 . US. Patent Apr. 26, 1994 Sheet 3 of 5 5,306,271 78120 writ-1117‘?" :05; \‘I \‘I 72 I. 1. F521, M“! W US. Patent Apr. 25, 1994 Sheet 4 of 5 5,306,271 Fig_ 50’ US. Patent Apr. 26, 1994 Sheet 5 of 5 5,306,271 5,306,271 1 RADIATION THERAPY SKIN MARKERS 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- arres. 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. 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 10 15 20 25 30 35 45 55 65 2 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 THEADRAWINGS FIG. 1A shows a plan view of a preferred embodi- ment of a set of radiation therapy skin markers of the ‘ present invention. FIG. 18 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. 1E 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 lF-lF 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. SB 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. 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 3 being separated from each other after the backing card has been removed. FIG. 8 shows a perspective view of a bottom set of 5,306,271. markers from a third embodiment of a set of radiation ' ' therapy skin markersas 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 5 IO 15 FIG. 1B), line markers 18 (see also FIG. IC), isocenter V markers 20 (see also FIG. 1D), and set-up point markers 22 (see also FIG. 1B). 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 1n 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 28:: 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 comer 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 discemable 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 lengthof 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 square or rectangular radiation therapy portal (as shoWn in FIG. 3A and 3B). The printed lines 38 help create a discemable 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 20 25 30 35 45 50 55 6O 65 4 and is defined by a circular outer edge 40 and circular inner edge 42. Each isocenter marker 20 includes four printed lines 440—4411 extending radially from the circu- lar inner edge 42 to the circular outer edge 40. The printed lines 440—4411 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 44a and 44c would each be perpen- dicular to lines 44b and 4411'. The isocenter markers 20 are placed by a radiation therapist (described in more detail later) such that the printed lines 44a-44d define an isocenter of a specific radiation therapy portal as the point where the lines 44a-44d would intersect thereby assisting a radiation therapist perform radiation therapy treatments (see FIGS. 3A and 3B). As shown in FIG. 1B, a preferred set-up point marker 22 is octagonally shaped and includes two printed lines 46a and 46b. The printed lines 46a 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 46a 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 14a 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. 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 500 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 501: 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 corner markers 16 associated with each die cut 521: and 52b such that the liner strips 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 50a and 50b are removed. Application of the corner markers 16 is facili- tated because a larger bottom surface of the corner 5,306,271 5 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 visibility of the surface onto which the corner marker is 5 to be applied). The markers 16, 18, 20, and 22 are all applied as described above. FIGS. 5A, 5B, 5C, 5D, 6, 7, and 8 show views of a third embodiment of a set of radiation therapy skin markers 56. As shown in FIG. 5A, the configurations of 10 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 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 comer 15 markers 16 and the isocenter markers 20 after the back- ing card 62 is removed (as shown' in FIGS. 5A, 5B, and 6). In addition, the arrangement allows exposure of 20 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 applied2 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- . . . . . 3O ent invention, and all such modifications and equiva- lents are intended to be covered. What is claimed is: l. 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 corner boundary marker of substantially circular shape with a ninety degree wedge cut therefrom such that the corner bound— ary marker may be used to outline a ninety degree corner boundary of a radiation therapy portal and at least one of another corner boundary marker, a line boundary marker, an isocenter marker, or a set-up point marker configured 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 out such that a portion of the liner which is adhered to a portion of 50 at least one marker of the set may be removed without disturbing the set of markers from a re- 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. 2. The device of claim 1 wherein the markers are 35 4O 45 55 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 point of a radiation therapy portal. 6. The device of claim 1 wherein said corner bound- ary marker includes printed line on edges outlining the ninety degree comer, said printed lines delineating a 65 6 ninety degree corner boundary of a radiation therapy portal. 7. The device of claim 1 wherein the set of markers include a line marker of substantially rectangular shape wherein the length of the rectangle is multiple times the width of the rectangle with a substantially straight printed line thereon which extends along the length of said line marker, said printed line delinea...
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