NZ615607B2 - Radiation treatment brassiere - Google Patents

Abstract

bra to accommodate and position a woman’s breasts when receiving radiation treatment to ensure precise and reproducible radiation is delivered to a target area during each treatment session includes two breast cups (102A, 102B); a medial window (108); two shoulder straps (104A, 104B) and a back band. The medial window (108) is visually transparent and is disposed between the two breast cups (102A, 102B). The two shoulder straps (104A, 104B) support the two breast cups (102A, 102B). The back band couples the shoulder straps (104A, 104B) and the two breast cups (102A, 102B). The breast cups (102A, 102B), medial window (108), shoulder straps (104A, 104B) and back band, by virtue of the materials of construction, do not scatter or substantially attenuate treatment radiation. The bra is configured so that when worn, no portion of a vertical midline of a wearer’s chest is obscured by the bra so that a light field can be projected through the medial window (108) onto a wearer’s chest and viewed without obstruction. nd. The medial window (108) is visually transparent and is disposed between the two breast cups (102A, 102B). The two shoulder straps (104A, 104B) support the two breast cups (102A, 102B). The back band couples the shoulder straps (104A, 104B) and the two breast cups (102A, 102B). The breast cups (102A, 102B), medial window (108), shoulder straps (104A, 104B) and back band, by virtue of the materials of construction, do not scatter or substantially attenuate treatment radiation. The bra is configured so that when worn, no portion of a vertical midline of a wearer’s chest is obscured by the bra so that a light field can be projected through the medial window (108) onto a wearer’s chest and viewed without obstruction.

Description

RADIATION TREATMENT BRASSIERE Statement of Related Cases This case claims priority of U.S. Provisional Patent ation 61/446,278 filed February 24, 2011 and which is incorporated by reference herein.

Field of the Invention The present invention relates to radiation oncology in general and, more particularly, to a way to precisely and ucibly position a breast cancer patient for a radiation treatment session. ound of the Invention In 2010, approximately 250,000 women developed invasive or in- situ breast cancer in the United States. The majority of those women sought medical treatment for their disease. Women diagnosed with early stage breast cancer have several options for treatment. The surgical options include mastectomy, with or t reconstruction, or lumpectomy followed by radiation y and possibly chemotherapy.

Women ng lumpectomy and radiation therapy undergo -conserving surgery followed by approximately three to six weeks of radiation therapy. The radiation is intended to kill any tumor cells remaining in the breast after surgical removal of the primary tumor. A specialist physician (i.e., radiation oncologist) works in conjunction with a team of physicists, dosimetrists, and radiation-therapy-machine operators apists”) to plan and deliver the radiation treatment.

It is particularly important that radiation is delivered to the affected tissue (1) precisely and (2) in reproducible fashion. In particular, the nergy s must be delivered to the same planned volume of tissue —the “target”— each session. Care must be taken to avoid ating tissues surrounding the target, most importantly lung and heart tissue. Since multiple radiation treatment sessions are required, a reproducible set-up is necessary to ensure that the target site receives the intended cumulative dose of radiation. Receiving the full cumulative dose reduces the patient's risk of developing a local recurrence of the cancer in the d breast or metastatic spread of the disease.

As such, the best outcomes are achieved when (a) precise radiation ent parameters are followed, (b) a favorable breast geometry is attained, and (c) a reproducible set-up is established. Satisfying requirements (b) and even more so, (c), can be challenging, as discussed further below.

A woman’s breast geometry will change at each time she is on the treatment table. That is, particularly for a large-breasted woman, the shape of the breast is altered as a function of how the breast lies on her chest (e.g., falling off to the side, lying flat, etc.). This complicates the ability to precisely reproduce, during actual treatment, the position/geometry of the breast during the al radiation-planning scan. As a uence, during an actual treatment, the ent machine —a very valuable resource— must be idled while time is spent ing the patient’s position on the treatment table to try, with varying success, to reproduce the original breast geometry and position.

The majority of patients are treated in a supine position with the arm on the affected side “chicken—winged” out of the radiation field over their head.

The affected breast can therefore be ed and treated. The ideal breast geometry for treatment is akin to a tight compact breast mound with no folds of skin.

Women with large, pendulous, ptotic breasts pose challenges for the radiation oncology team. Because of the anatomical shape of the treatment volume and frequent dose variations, acute skin ty occurs in “hot spots” such as the axillary tail and the inframammary folds. In addition, breast overhang both in the inferior and/or lateral directions often requires enlargement of the radiation field, which disadvantageously captures larger areas of normal tissue in the radiation tangential fields. Dry and moist desquamation (i.e., raw, peeling areas of skin) can develop in hot spots and in areas where tissue folds upon itself. These problems can necessitate treatment breaks until the skin recovers. These treatment breaks compromise the efficacy of the radiation in killing cancer cells.

Furthermore, if a large, pendulous breast falls superiorly, ians may need to use an inclined breast board d board) to shift the breast. This board must be moved on and off the treatment table before and after each treatment session.

Another treatment strategy for breasted women is to place them in the lateral decubitus position with a wedge. Yet a further approach is to have the patient in a prone position wherein their ptotic breast hangs through a "breast board.” For many patients, this is a difficult position to achieve and maintain. More importantly, when a patient is in this on, there can be a tradeoff in terms of adequate treatment of the chest wall. Elderly and obese women find the prone set-up position difficult for other health s. Additionally, polyvinyl rings are mes ed to large breasts to attain a desired geometry, but it is not possible to reliably reproduce such a set-up. All of these alternative strategies/approaches/positions consume valuable time on the treatment table.

Women with widely spaced, large, pendulous breasts also pose challenges for homogenous treatment. Often, higher-energy radiation is required to achieve homogeneity.

Unfortunately, many radiation centers do not have nergy machines. Moreover, the higherenergy radiation s in a higher skin dose, which often causes increased skin reaction.

Currently, immobilization devices for women on the treatment table include cradles, plastic molds and netting. There are drawbacks to all such forms of immobilization. Simply put, exact, reproducible, comfortable set-up devices do not exist.

With current treatment regimens, a patient is tely exposed from the waist up while receiving treatment. For many women, this loss of privacy adds to feelings of re and vulnerability.

Object of the Invention [0013a] It is the object of the present invention to substantially overcome or at least ameliorate one or more of the above disadvantages.

Summary of the Invention [0013b] There is disclosed herein a bra comprising: two breast cups; a medial window disposed between the two breast cups, wherein the medial window is ly transparent; two shoulder straps for supporting the two breast cups; a back band that couples to the shoulder straps and the two breast cups; and further wherein: (i) the breast cups, medial window, shoulder , and back band, by virtue of the materials of construction thereof, do not scatter or substantially attenuate treatment radiation; and AH26(9425151_1):KEH (i) (ii) the bra is configured so that, when worn, no n of a vertical midline of a wearer’s chest is obscured by the bra so that a light field is projectable through the medial window onto a wearer’s chest and viewed without obstruction.

A preferred embodiment provides a way to precisely and reproducibly obtain a desired breast geometry, treatment position, and patient-to-machine ent for radiation therapy while also enabling the non-affected breast to be moved out of the treatment field.

Some embodiments of the invention e a radiation treatment brassiere (“bra”) that is worn during a radiation treatment session. In the illustrative embodiment, the bra includes a clear medial window (or both clear medial and lateral windows), sheer substantially “see- through” cup material, and multiple adjustment elements. The bra is devoid of metal and uses hook and loop fastener (e.g., VELCRO®, etc.). The bra can be worn for use with all treatment machines without causing bolus . The bra is undetectable during CT scan.

The clear medial and lateral s enable the physician and therapist to view and mark tattoos, as well as the midline and treatment parameters, as created by the light field that is projected by the treatment e onto the patient’s chest. The sheer cup material allows the ian and AH26(9425151_1):KEH therapists to mark the bra, as necessary (e.g., using indelible marker, etc.) and to view the breast, scars, or ent wires and tattoos.

Multiple adjustable elements, which can be (but are not necessarily) implemented as closures, enable the position of the breast to be adjusted to achieve a desired reference breast geometry during a radiation treatment planning session. This is achieved by appropriately tightening or loosening the various adjustable elements, thereby establishing a “reference setting” for each such adjustable element. In some embodiments, the able elements e: (1) a medial (central) t, disposed between the breast cups; (2) two lateral elements, disposed at the interface of each cup and the cooperating end of the back band; and (3) two superior elements, ed within each shoulder strap. In some other embodiments, fewer adjustable elements are used.

In the illustrative ments, the adjustable elements are closures, at least one of which is released to enable the bra to be removed or put- on. For the one or more closures that are to be released, the previously ished reference setting, which is indicated via some type of measurement tool, scale, etc., is memorialized (e.g., ed in the patient’s chart, etc.). This enables a technician to reset all released closures to their established reference settings prior to a radiation treatment n. Since the reference setting for each adjustable element establishes the reference breast geometry, the reference breast geometry is re-established for each radiation treatment n by simply resetting each released able closure to its reference setting.

In some further embodiments, the bra includes a closure that is not intended to establish the reference breast ry but, rather, is used to remove the bra or put it on. For such embodiments, once the bra is appropriately adjusted via the adjustable elements, the closure is used for taking the bra off or putting it on (e.g., for the next treatment session). As a consequence, the adjustable ts need not be closures, and if they are closures, they do not need to be re-set (since they do not to be released to remove the bra). In some embodiments, this closure is located near the mid-point of the back-band.

Thus, a radiation treatment bra in accordance with the present teachings can reliably reproduce the desired breast geometry prior to each radiation treatment session. The radiation treatment bra also provides an ability to move the non-treated breast laterally to avoid, to extent possible, placing medial tissue of the contralateral breast in the treatment field.

Some other embodiments of the invention e a method for ion therapy that includes establishing a reference breast geometry using a radiation treatment bra in accordance with the present invention.

Brief Description of the Drawings ] A preferred embodiment of the present invention will now be described, by way of an example only, with reference to the accompanying drawings wherein: depicts a front view of radiation ent bra 100 in accordance with the illustrative embodiment of the present invention. depicts a back view of radiation treatment bra 100. depict radiation treatment bra 200, n the bra includes adjustable elements that are embedded as closures. depicts further detail of the medial adjustable element of bra 200, wherein the adjustable element comprises a scale that provides an indicium of fit in accordance with the present ion. depicts further detail of the lateral adjustable element of bra 200, wherein the adjustable element comprises a scale that provides an um of fit in accordance with the t invention. depicts r detail of the superior adjustable element of bra 200, wherein the able element comprises a scale that provides an indicium of fit in accordance with the present invention. depicts radiation treatment bra 400, wherein the bra further includes a nonparticipating closure. depicts radiation treatment bra 500, including an alternative configuration for the medial window and medial adjustable elements.

AH26(9425151_1):KEH depicts radiation ent bra 600, including an alternative configuration for the medial window and medial adjustable elements. depicts radiation treatment bra 700, including an alternative configuration for the medial window and non medial adjustable elements. s radiation treatment bra 800, including lateral windows. depicts radiation treatment bra 900, including breast-supporting slings.

AH26(9425151_1):KEH depicts an alternative embodiment of a sling for use with the embodiment of . depicts a flow diagram of a method in accordance with the present invention for establishing a reference breast geometry for a breast cancer patient undergoing radiation therapy. depicts a flow diagram of a method for radiation therapy incorporating the method of .

Detailed Description FIGs. 1A and 18 depict respective front and back views of radiation treatment bra 100 in accordance with the illustrative embodiment of the t invention. Like virtually all bras, embodiments of the radiation treatment bra disclosed herein include breast cups 102A and 1023, shoulder straps 104A and 104B, and back band 106.

For use in conjunction with the present invention, cups 102A and 1023 advantageously comprise a sheer stretch material, such as, without limitation, a sheer version of LYCRA® brand spandex fiber. The material is preferably iently sheer so that features on the breast (e.g., scars, tattoos, etc.) are visible. Shoulder straps 104A and 1043 comprise a resilient, elastic material, such as, t limitation, LYCRA® brand spandex fiber. Back band 106 ses a resilient, elastic material, such as, without tion, LYCRA® brand x fiber. Other als, known to those d in the art, may suitably be used for the cups, shoulder straps and back band. It is important, however, that the materials do not e anything that will scatter or otherwise substantially attenuate the radiation treatment beam or add bolus .

It is to be understood that the tions of radiation treatment bra 100 shown in FIGs. 1A and 18, as well as the proportions of the various embodiments of the bras depicted in other Figures, are provided by way of ration, not limitation. For example, deviations from the width of shoulder straps 104A and 104B, the width of back band 106, the coverage provided by cups 102A and 102B, etc., are acceptable as long as they do not compromise the functionality of the radiation treatment bra, as disclosed herein. Furthermore, it is to be understood that the radiation treatment bras disclosed herein can incorporate industry-standard features and design elements, such as a “racer-back” configuration for the shoulder straps, etc., as long as such features and design elements do not compromise radiation-treatment-bra functionality, as disclosed herein.

The radiation treatment bra depicted in FIGs. 1A and 18 further includes medial window 108, lateral windows 116, medial adjustment t(s) 110, lateral adjustment element(s) 112, superior ment element(s) 114, and non-participating closure 118. Not all of the various features depicted in FIGs. 1A and 18 are present in all embodiments of the radiation treatment bra. Specific embodiments of bras ing some or all these features are described later in this specification in conjunction with FIGs. 2 and 4-8. A radiation ent bra showing additional features is discussed in conjunction with FIGs. 9A and 9B.

With continued reference to FIGs. 1A and 1B, medial window 108 is disposed between cups 102A and 1023. Medial window 108 comprises a clear/transparent material that is free of metals or other tuents that will r or ntially attenuate the radiation ent beam or cause bolus effect. In some embodiments, medial window 108 comprises a clear thermoplastic material, such as Clear-Fit TPU brand thermoplastic polyurethane, commercially available from Fulflex, Inc. of Brattleboro, Vermont.

Medial window 108 enables a light field, which originates from the radiation treatment machine, to be projected onto a patient’s chest and viewed.

During a ion planning session, using the light field is used as a guide, temporary and then permanent marks (i.e., tattoos) are placed on the patient’s chest to establish the ite alignment with respect to the treatment machine.

The tattoos are later used to re-establish the requisite alignment for actual radiation treatment sessions. When the material used for medial window 108 is suitably selected, the tattoos can be made through the medial window without damaging the window or compromising the alignment. One such suitable material is the aforementioned Fit TPU brand thermoplastic ethane.

The width of medial window 108 is at least about 3 centimeters, which will accommodate the lateral extent of the light field projected by the radiation treatment machine. The light field may extend downward from the patient’s clavicular depression for about 25 centimeters along the mid-line of the torso. For this reason, a radiation treatment bra in accordance with the present ion does not obscure a View of the patient’s skin along the midline of the torso. As shown in , a portion of the light field would be obscured if not for the presence of medial window 108.

The radiation treatment bra depicted in FIGs. 1A and 1B also includes left and right lateral s 116. One window is disposed between cup 102A and an end of back band 106; the other is disposed between cup 1023 and the other end of back band 106. The lateral windows are situated so that when the bra is in use, the lateral windows are oned beneath the patient’s axilla (i.e., arm pits). The lateral windows extend at least about 5 centimeters “back” from the lateral edge of each cup. The purpose for the lateral windows is to enable radiation treatment personnel to create and view alignment tattoos on the skin in those regions. Like the medial , the lateral windows se a transparent material that will not scatter or ntially attenuate the radiation beam.

As noted in the Background section of this specification, it is particularly important that treatment radiation is delivered to the same planned volume of tissue during each ion treatment session. Doing so is complicated by the fact that a woman’s breast geometry can change somewhat each time she is on the treatment table. Also, over the three— to ek course of therapy, there can be swelling and weight gain or loss that might shift the breast and change its volume. This is particularly problematic for a large-breasted woman, wherein the shape of the breast is altered as a function of how the breast lies on her chest.

This ility in breast geometry complicates the ability to precisely reproduce, during actual treatment, the position/geometry of the breast as it existed during the original radiation-planning scan.

Adjustable elements 110, 112, and 114 are used adjust the geometry and position of a breast to establish a ucible reference breast geometry for use during radiation treatment sessions. More particularly, during the radiation planning session, adjustable ts 110, 112, and 114 are adjusted (e.g., tightened or ed, etc.) until breast geometry/position is considered to be at a practical optimum for treatment. That practical optimum, which is determined by oncology/radiation sionals in conjunction with radiation simulations, is a position/shape for the breast that provides the best mise between irradiating the target tissue and not surrounding tissues. As used in this specification and the included claims, the term “reference breast geometry” refers to this practical optimum for the position/shape of the breast. As used in this specification and the included claims, the terms “adjustable element" or “adjustable closure” mean a fixture, arrangement, etc., that is capable of adjusting the geometry and position of a breast by changing the force applied by parts of the bra, such as the er straps, the back band, etc., on the breast cups. The adjustable elements/closures are also used to on the non-affected breast out of the treatment field, to the extent possible.

As depicted in FIGs. 1A and 1B, medial adjustable element(s) 110 are disposed proximal to cups 102A and 1023. l adjustable element(s) 112 are disposed proximal to each of back band 106. Superior adjustable element(s) 114 are situated along shoulder straps 104A and 1043 such that when the bra is in use, these elements lie near the top of a wearer’s shoulder.

As previously indicated, the best outcomes for radiation treatment are ed when the reference breast geometry is reproduced for each radiation treatment n. Reference breast ry is re-established in any one of several ways, the choice of which depends, in part, on the form of the able elements. In ular, in some embodiments, adjustable elements 110, 112, and 114 are embodied as “closures” that can be released to enable a patient to remove the bra. In some other embodiments, the adjustable elements are not embodied as closures, but rather as a feature that simply provides an adjustment function, such as the well known table slider," etc. Regardless of its structure, the adjustable element must comprise a material that will not scatter the treatment radiation or cause a bolus effect.

In ments in which the adjustable elements are closures, at least some of which are used to “open” the bra to remove it or put it on, the adjustable elements include a measurement tool (e.g., scale, etc.) that es an indicium of fit. As used in this specification, including the claims, the term “indicium of fit” refers to a measure or indication of the tightness or snugness of each adjustable element, as determined from a measurement tool, scale, etc., that is associated with the adjustable element.

Once the reference breast geometry is attained by adjusting the adjustable elements, the g for each adjustable element that ishes the reference breast geometry —which is known as the “reference setting”— is read from the scale that provides the indicium of fit and can be noted, as required, in the patient’s chart, etc. This enables a technician or patient to re-establish the reference breast geometry by simply adjusting each adjustable element to its reference setting before each treatment n, as necessary.

Another way to reproduce the reference breast geometry, once established, is to use a e, such as closure 118, which is not used to establish the reference breast geometry. In bra 100 depicted in FIGs. 1A and 1B, closure 118 (hereinafter nced as a “non—participating closure”) is disposed near the mid-point of back band 106. Non—participating closure 118, which can be (but is not necessarily) non-adjustable, permits bra 100 to be removed without having to release any of the adjustable (and hence reference—breast-geometry-establishing) elements 110, 112, and 114, to the extent such adjustable elements are embodied as closures.

Consider, for e, an embodiment in which the adjustable ts are embodied as “closures,” and are the only closures on the bra, as in bra 200 depicted in To remove this bra, or put it on, one or more of the closures would have to be released and then necessarily reset for the next radiation treatment session. But when the bra includes non—participating closure 118, the adjustable “closures,” once set to establish the reference breast geometry, need not be ed. Rather, using non—participating closure 118, every time the patient puts the bra on before a treatment session, the reference breast geometry will be “automatically” re-established; no re—setting of the adjustable elements is required. As used in this specification, including the claims, the term “non- participating closure” refers to a closure that is not involved in establishing the reference breast geometry. Rather, such a closure is used to simply open the bra to enable a patient to remove it after a radiation treatment session.

It will be appreciated that the use of non-participating closure 118 enables adjustable element(s) 110, 112, and 114 to be embodied as something other than closures.

Although a non-participating closure is not involved in establishing the nce breast geometry through adjustment, that closure can be an adjustable closure (as long as the closure can be released without altering its state of adjustment). After reading this disclosure, those skilled in the art will know how to add a non-participating closure in other ons on a ion treatment bra in accordance with the present teachings. For example, the non—participating e can be situated between the cups (i.e., in place of adjustable closure 110). In such an embodiment, the non-participating closure must not obscure the medial window.

After g the t disclosure, those d in the art will know how to orate adjustable elements, for obtaining a reference breast geometry, which are not es. For example, an adjustable slider can be used. s radiation treatment bra 200 in accordance with the present invention. Radiation treatment bra 200 es breast cups, shoulder straps, and a back band. In bra 200, adjustable ts 110, 112, and 114 (see FIGs. 1A and 18) are embodied as adjustable closures. In particular, they are ed as adjustable medial closure 210, adjustable lateral closures 212A and 212B, and adjustable superior closures 214A and 214B.

As depicted in the embodiment shown in shoulder straps 104A and 104B each comprise two segments; an anterior segment that couples to one of the breast cups and a posterior segment that s to back band 106. In preferred embodiments, the anterior segment overlies the posterior segment when brought together to “close” closure 214A and 214B. (See, e.g., .) In radiation treatment bra 200, each of the adjustable closures comprise paired strips of hook—and—loop fastener, such as VELCRO® brand hook- and-loop fastener, available from Velcro Co. of Manchester, New ire. In other ments, other types of fastening systems may be used, as long as the fastening systems comprise materials that will not scatter radiation.

Since bra 200 does not include non-participating e 118, at least some of the adjustable closures must be released to remove the bra. As a consequence, it is important that the reference setting is alized for at least those closures that will be released (to remove the bra).

Figs. 3A through 3C depict an embodiment of a scale that provides an indicium of fit for use with respective medial adjustable closure 210, lateral adjustable closures 212A and 2123 and superior adjustable closures 214A and 214B. These adjustable closures comprise two portions, wherein each closure n comprises a material that ts a strip of hook-and-loop fastener 324.

The segment of hook-and-loop fastener 324 on one of the closure portions is ed in FIGs. 3A and 3B.

In Figs. 3A h 3C, the scale that provides the indicium of fit comprises a plurality of lines 320, which is disposed on one of two closure portions.

A single line 322, which acts as an indicator, is disposed on the other of the two closure portions.

Each line 320 has associated with it an identifier, such as a number or letter (not depicted). When the two closure portions are brought together to engage one another, the indicator line 322 on one of the closure portions will align with one of the lines 320 in the scale. The particular line 320 that aligns with line 322 provides the “setting” of the adjustable closure. When the adjustable es 210, 212A/2123, and 214A/214B are set such that they provide the reference breast geometry, the setting is the “reference setting.” The identifier associated with the respective “aligned” line 320 is recorded in the patient’s chart.

In other embodiments, rather than using an indicator line 322 on one of the closure portions, the g edge of that closure element is used as an indicator. After reading the present disclosure, those skilled in the art will be able to devise other measurement arrangements suitable for ing a setting that identifies the relative positions of the two closure elements.

As an alternative to using two paired sections of hook-and-Ioop fastener, one n of such material can be used in conjunction with a “hookcompatible fabric” (i.e., VELCRO® receptive). In other words, the hook-and-loop fastener will simply “stick” to the fabric. Such fabric is commercially available from Darlington Fabrics of Westerly, Rhode Island, and others. The measurement tool (e.g., scale, etc.) can be printed directly onto the fabric.

Another approach for establishing a reproducible, reference breast geometry, which is especially useful when the adjustable elements are embodied as es, is to place a “mark” on the closure portions of the adjustable closures after they are set to provide the reference breast geometry. The mark, which is placed on one or both portions of each adjustable closure, records the amount of overlap of the two closures. The mark(s) can be made, for example, with indelible marker. This enables the reference breast ry to be reproduced each time the bra is worn by simply adjusting the adjustable elements in ance with the marks. In this approach, there is no scale, per se; rather, only an tion that provides the reference setting. Furthermore, the act of “marking” simultaneously creates the reference setting and memorializes (i.e., “notes” or s) it.

Regardless of the approach taken, what is important is that state (i.e., the reference setting) of the adjustable closure can be reliably reproduced.

It will be appreciated that in the ments ed in FIGs. 3A through 3C, the scale is simply a measure of the extent to which the two e portions overlap one another. To the extent the adjustable elements have a different structure, the form of the scale that provides the indicium of fit may be different. After reading the present disclosure, those skilled in the art will be able to p an appropriate scale as a function of the structure/arrangement of the adjustable element. depicts radiation treatment bra 400. This bra is structured similar to bra 200, and includes breast cups, shoulder straps, back band, medial window 108, a medial adjustable element 110, lateral adjustable ts 112, and superior adjustable elements 114.

Unlike bra 200, ion treatment bra 400 includes non- participating closure 118, which is disposed near the mid—point of back band 106.

Since bra 400 includes non-participating closure 118, the adjustable elements need not be (but can be) closures (e.g., like adjustable closures 210, 123, and 214A/2143) since they do not need to be released to remove the bra. The non-participating closure can comprise a plastic clasp, hook-and-Ioop fastener, etc.

Regardless of structure, the non—participating closure will preferably not scatter treatment radiation. depicts radiation treatment bra 500. This bra is structured similar to bra 200 and includes breast cups, shoulder straps, back band, a medial adjustable element, lateral adjustable elements, and superior adjustable ts, wherein the adjustable elements are configured as closures.

Since, in the embodiment depicted in bra 500 does not include a non-participating closure, the adjustable elements are configured as closures. The lateral and superior adjustable closures of bra 500 are the same as those for bra 200 and 200, but medial adjustable closure 510 of bra 500 is configured differently than medial adjustable element 210 of bra 200.

In particular, medial adjustable element 510 comprises two spaced-apart, horizontally-oriented strips 530A and 5303 of transparent al that will not scatter or substantially attenuate the radiation beam. The strips are attached to inner edge 526 of cup 102A. Strip 530A is attached relatively nearer to the top of inner edge 526 and strip 5303 is attached relatively nearer to the . A section of hook-and-loop fastener (not depicted) is disposed at the free end of each of strips 530A and 5303. Adjustable element 510 includes two further sections of hook-and-loop fastener, which are each disposed near inner edge 528 of cup 1023, one section closer to the top of the inner edge and the other closer to the . These two sections of nd-Ioop er are positioned to receive and engage the sections of nd-loop-fastener that are ed near the respective free ends of strips 530A and 5303.

Medial window 508 is defined between strips 530A and 5303.

Like the various medial windows ed for other embodiments of the radiation treatment bra, medial window 508 permits projecting the light field onto the midline of a patient’s chest, g the light field, and creating tattoos, as well as viewing any such tattoos or other marks that are placed along the midline of the chest in the region between the cups. Unlike bra 200, which includes a medial window that is formed of a transparent material, in bra 500, medial window 508 is simply open space (i.e., no material). The distance between inner edges 526 and 528 of respective cups 102A and 1023 is at least about 3 centimeters, which will accommodate the lateral extent of the light field projected by the radiation treatment machine.

In some further embodiments of radiation bra 500, a scale that provides an indicium of fit, such as depicted in FIGS. 3A through 3C, is used in conjunction with adjustable elements of bra 500, including medial able element 510. In some additional embodiments, radiation bra 500, with or without such a scale, includes rticipating closure 118, which may be situated along the mid-point of back band 106 as depicted in bra 400, or situated elsewhere. In embodiments that include non—participating closure 118, the able elements need not (but can) be configured as closures; that is, they need not be releasable. depicts radiation treatment bra 600. This bra is structured similar to bra 500, and includes breast cups, shoulder straps, back band, a medial adjustable element, l able elements, and superior adjustable elements.

Since, in the ment depicted in bra 600 does not include a rticipating closure, the adjustable elements are configured as closures. The lateral and superior adjustable closures of bra 600 are the same as those for bra 500, but medial adjustable closure 610 of bra 600 is configured differently than medial adjustable closure 510 of bra 500.

The lateral and superior adjustable elements of bra 600 are the same as those for bra 400, but medial adjustable closure 610 of bra 600 is configured differently than medial adjustable closure 510 of bra 500. In fact, medial adjustable closure 610 includes medial window 608.

Medial adjustable element 610 ses two strips 632 and 634 of hook-and—loop fastener, which are ed near respective inner edges of cups 102A and 1023. As indicated above, medial able element 610 also includes medial window 608, which comprises a transparent material that will not scatter or substantially attenuate the radiation treatment beam. Two strips of hook-and-loop er (not depicted) are attached to one face of medial window 608, near the edges thereof. The strips of hook—and-loop fastener on medial window 608 are positioned to engage strips 632 and 634 of hook-and-loop fastener that are disposed near the inner edges of the cups.

When medial able closure 610 is closed, the distance between the inner edges of respective cups 102A and 102B is at least about 3 centimeters to odate the lateral extent of the light field projected by the ent machine.

In some further embodiments of radiation bra 600, a scale that provides an indicium of fit, such as ed in FIGs. 3A through 3C, is used in conjunction with the adjustable elements of bra 600, including medial adjustable element 410. In some additional embodiments, radiation bra 600, with or without the scale, includes non—participating closure 118. The non-participating closure can be ed near the mid—point of back band 106 as in bra 400, or disposed elsewhere. In ments that include non—participating closure 118, the adjustable elements need not (but can) be ured as closures; that is, they need not be releasable. depicts radiation treatment bra 700. This bra is structured similar to bra 600, and includes breast cups, shoulder straps, back band, lateral adjustable elements, and superior adjustable elements. Since, in the embodiment depicted in bra 700 does not include a non-participating closure, the adjustable elements are configured as closures. Unlike bra 600 and other bras disclosed herein, radiation bra 700 does not include a medial adjustment element, embodied as a closure or ise.

Radiation bra 700 includes medial window 708, which is ed between the inner edges of cups 102A and 102B. Medial window 708 comprises a transparent material that will not scatter or ntially attenuate the radiation beam or cause a bolus effect. Like the various medial windows depicted for other embodiments of the radiation treatment bra, medial window 708 permits projecting the light field onto the midline of a patient’s chest, viewing the light field, and creating tattoos, as well as viewing any such tattoos or other marks that are placed along the midline of the chest in the region between the cups. The width of medial window 708 (i.e., the distance between the inner edges of cups 102A and 1023) is at least about 3 centimeters for that purpose.

In some further embodiments of radiation bra 700, a scale ing an indicium of fit, such as depicted in FIGs. 3A through 3C, is used in conjunction with the lateral and superior adjustable elements. In some additional embodiments, radiation bra 700, with or without such a scale, includes nonparticipating closure 118, which may be disposed near the mid-point of back band 106 as in bra 400, or disposed elsewhere. In embodiments that include non- participating closure 118, the adjustable ts need not (but can) be configured as closures; that is, they need not be releasable. depicts radiation ent bra 800. This bra is structured similar to other embodiments of the radiation treatment bra, and includes breast cups, shoulder , and a back band. And bra 800 includes any version of superior adjustable elements 114 and any version of medial adjustable t 110 (e.g., 210, 510, 610, etc.) and any version of medial window 108 (e.g., 208, 508, 608, 708, etc.). But unlike bras 200 and 400 through 700, radiation bra 800 includes two lateral windows 116A and 1163. Window 116A is disposed between cup 102A and an end of back band 106. Window 1163 is disposed between cup 1023 and an end of back band 106.

The lateral windows are situated so that when the bra is in use, the lateral windows are positioned beneath the axilla (i.e., arm pits). The lateral s extend at least about 5 centimeters “back” from the lateral edge of each cup. The purpose for the lateral windows is to enable radiation treatment personnel to create and view alignment tattoos on the skin in those regions. The alignment process is similar to that previously discussed, except that rather than projecting the light field onto a patient’s chest, it is projected onto a side of the patient’s torso through one of the l windows. Like the medial windows usly discussed, lateral windows 116A and 1163 comprise a transparent material that will not scatter or substantially attenuate the radiation beam. When the al is ly selected, such as the aforementioned Clear-Fit TPU brand thermoplastic polyurethane, tattoos can be created through the lateral s. ion treatment bra 800 also includes lateral adjustment elements 812A and 8123, which are ed along back band 106 al to the lateral windows. The lateral adjustment elements can be configured like lateral adjustment elements 212A and 2123 of bra 200, for example, but shifted along the back-band away from the lateral edge of the cups to accommodate the presence of the lateral windows.

In some r embodiments of radiation bra 800, a scale that provides an indicium of fit, such as depicted in FIGs. 3A through 3C, is used in conjunction with the medial, lateral, and superior adjustable elements. In some additional embodiments, radiation bra 800, with or without such a scale, includes rticipating closure 118, which may be disposed near the mid-point of back band 106 as in bra 400, or disposed elsewhere. In embodiments that include non- participating closure 118, the adjustable elements need not (but can) be configured as closures; that is, they need not be releasable.

It is notable that even in embodiments of the radiation ent bra that do not include a non-participating closure, some of the adjustable elements can be configured as closures and some not. For example, in some embodiments, the medial able element is configured as a closure but the lateral and superior adjustable elements are not. In some other embodiments, the superior adjustable elements are configured as a e but the lateral and medial are not. And so forth. depicts radiation treatment bra 900. This bra is ured similar to other embodiments of the radiation treatment bra, and es breast cups, shoulder straps, and a back band. And bra 900 es any version of superior adjustable elements 114 and any version of medial adjustable element 110 (e.g., 210, 510, 610, etc.) and any version of medial window 108 (e.g., 208, 508, 608, 708, etc.). Bra 900 further includes lateral closures, which in the embodiment ed in , are embodied as adjustable lateral es 212A and 2123 of Bra 200 (see, .

Bra 900 also es one or more slings 942 and 946 that detachably couple to either of cups 102A and 1023 and serve a purpose similar to an wire;” that is, they provide “lift.” A metal underwire cannot be used in the radiation treatment bras disclosed herein because it would scatter treatment radiation. A plastic “underwire” could be used, but, as will become apparent, the use of slings provides greater adjustability.

In the illustrative embodiment, bra 900 includes sections 936A, 936B, 937A, 937B, 938A, 938B, 940A, and 940B of hook-compatible fabric.

Sections 936A, 937A and 938A are disposed on cup 102A and sections 936B, 9373, and 938B are disposed on cup 1023. Furthermore, section 940A is ed near the end of back band 106 proximal to lateral closure 212A and section 9403 is disposed near the end of back band 106 proximal to lateral closure 2123. These sections of ompatible fabric can be sewn on to the bra or attached via other appropriate techniques. depicts two slings: sling 942 and sling 946. Sling 942 is the longer of the two slings, having a length of about 18 to about 25 centimeters.

Sling 946 has a length of about 8 to about 18 centimeters. The slings have a width of about 25 millimeters. In some embodiments, the slings comprise a strip of arent material that will not scatter or substantially attenuate the radiation beam, such as Clear-Fit TPU brand plastic polyurethane. Strips 944A and 9443 of hook-and-look fastener are disposed at each end of sling 942. Strips 948A and 9483 of hook-and-look fastener are disposed at each end of relatively shorter sling 946. The slings couple to the bra by mating the strips of hook-and- loop fastener on the sling to the sections of hook—compatible fabric on the bra.

In use, and using cup 1023 as an example, a sling (of appropriate length) will typically be oriented in one of the following ways: medial (9373) to lateral (9403); inferior (9363) to lateral (9403); and inferior (9363) to superior (9383).

A sling, such as sling 942 or 946, can be coupled anywhere along inferior section 9363 or medial section 9373 of ompatible , providing effectively continuous variability in the location of the “origin” of the sling.

An example of a medial-to—lateral connection is depicted in “phantom” in wherein sling 942 is coupled, at one end, to section 9373 proximal to a superior location. The other end of the sling is coupled to section 9403. An example of an inferior—to—superior tion is depicted in phantom in wherein sling 946 is coupled, at one end, to n 9363 proximal to its mid-point and at the other end to section 9383. In both cases, the slings are pulled taut; that is, placed under tension, to provide an appropriate amount of support for the breast.

The use of one or both of these slings allows for highly-localized adjustments to breast geometry and an ability to ensure that there are no folds in breast tissue, as might otherwise occur for a woman with large, pendulous breasts. depicts an alternative embodiment of a sling, wherein strips 9523 and 9523’ of hook—and—loop er are attached to both sides of one end of sling 950. Strip 952A of hook—and—loop fastener is attached to one side of the other end of sling 950. Using cup 102A as an example, the end of sling 950 that includes one strip 952A of nd-loop fastener couples to section 937A of hook-compatible fabric. The other of the sling is positioned between closure 212A.

Strip 9523 of hook-and-loop fastener will couple to the hook-and-look fastener on one portion of closure 212A and strip 9523' will couple to the hook-and-loop fastener on the other portion of closure 212A. Closures 212A/B were included in bra 900 to illustrate the use of sling 950. In embodiments in which sling 950 is not used, a different type of lateral closure may suitably be used.

The slings ed in conjunction with radiation treatment bra 900 can be used in conjunction with any of the bras sed herein.

In some less preferred embodiments, the radiation ent bra will include s adjustable elements, but neither medial nor lateral windows.

For example, a radiation bra in accordance with some less- preferred embodiments of the present teachings includes: a medial adjustable t, a lateral adjustable element, and a superior adjustable element, wherein both the medial and lateral adjustable elements are configured as closures. For the radiation treatment planning session, the patient would put on the bra and lie on the treatment table. Since neither the medial nor lateral windows are present, the medial able closure is opened to separate the breast cups to enable the light field to be ted onto the chest for ent/tattooing, etc. Likewise, the lateral adjustable closure is opened to project the light field onto the side(s) of the patient for alignment/tattooing. Even though both the medial and lateral closures are released, the breasts remain substantially d by the cups, maintaining some modicum of privacy for the t. After alignment is complete, the medial and l adjustable closures, as well as the superior able element (which can be a closure, but need not be) are ed to establish the reference breast geometry. For regular radiation treatment sessions, the alignment is re-established with the medial and lateral closures released so that the tattoos (created during the planning session) can be aligned with the light fields. The medial and lateral closures are then adjusted, in accordance with the reference setting, to e the reference geometry.

It should be clear from the foregoing disclosure and accompanying drawings that the t invention encompasses numerous different embodiments of a radiation treatment bra. A non—limiting list of embodiments in accordance with the present teachings includes a radiation treatment bra comprising: (i) a medial ; (ii) a medial window and at least one adjustable element configured as a closure; (iii) a medial window and at least one adjustable element configured as a closure and comprising a measurement tool that provides an indicium of fit; (iv) a medial window and at least one adjustable element and a non- participating closure; (v) a medial window and two lateral windows; (vi) a medial window, two lateral windows, and at least one adjustable element configured as a closure; (vii) a medial window, two lateral windows, and at least one adjustable element and a non—participating closure; (viii) a medial adjustable element that comprises a medial ; (ix) a sling for providing additional t and positioning capability; and (X) a medial adjustable closure and a lateral adjustable closure, wherein both closures comprise a measurement tool that provides an um of fit. depicts method 1000 for establishing a reference breast geometry for a breast cancer patient undergoing radiation therapy.

Operation 1002 of method 1000 recites fitting a radiation treatment bra, such as ion treatment bras 100, 200, and 400 through 900, to a patient. This involves ing a radiation treatment bra having an appropriate cup size and back sizing (e.g., 36D, etc.). ion 1004 of method 1000 recites simulating a radiation treatment session for the patient. In this ion, the patient undergoes low- energy x-ray planning or CT tion while in the treatment bra. During the simulation, iso-center check, and port-film verification (and while g up each radiation treatment session), a light field is projected onto the patient’s chest.

(See, e.g., .) This operation also es making temporary marks on the patient’s chest to ish a reference alignment of the patient with respect to the light field, and hence the treatment machine.

Operation 1006 of method 1000 recites adjusting the plural adjustable elements (e.g., the medial adjustment element if present, lateral adjustment elements, and superior adjustment elements) to establish a reference breast geometry and alignment in ance with the light field projected onto the patient’s chest.

Optional operation 1008 of method 1000 recites memorializing (e.g., recording, marking, etc.) a reference g for each adjustable element. In embodiments in which the radiation bra incorporates a non-participating closure, such as closure 118, which enables the bra to be removed/put-on without releasing the adjustable elements, operation 1008 is not required.

After the nce breast geometry and patient’s alignment with respect to the treatment machine are confirmed, e.g., through a simulated radiation treatment session, the rary” marks are replaced by small alignment tattoos. This ensures that the patient will be positioned the same with respect to the treatment machine for each radiation treatment session. Depending upon the choice of material for the medial (and lateral) windows, tattoos can be made directly h the clear material without damaging the material or mising tattoo on. depicts method 1100, which is a method for radiation therapy that incorporates method 1000 for establishing a reference breast geometry, in accordance with the present invention.

Operation 1102 of method 1100 recites establishing, during simulated radiation treatment, a reference breast geometry for a patient using a radiation treatment bra, such as bras 100, 200, and 400 through 900. In some embodiments, this ion ses method 1000; that is, operations 1002 through 1006 (and optionally 1008).

Operation 1104 of method 1100 recites re-establishing, in preparation for a radiation treatment session, the reference breast geometry of the patient using the ion treatment bra. In some embodiments, this operation is performed by simply placing the radiation treatment bra on the patient and closing non-participating closure 118. In some other embodiments, this operation involves adjusting the adjustment elements, when they are embodied as closures, in accordance with their reference settings.

Operation 1106 of method 1100 recites ating the target tissue of the patient.

It is to be tood that although the sure teaches many examples of embodiments in accordance with the present teachings, many additional variations of the invention can easily be devised by those skilled in the art after reading this disclosure. As a consequence, the scope of the present invention is to be ined by the following claims.

I

Claims (15)

/WE CLAIM:

1. A bra comprising: two breast cups; a medial window disposed between the two breast cups, wherein the medial window is visually arent; two shoulder straps for supporting the two breast cups; a back band that couples to the shoulder straps and the two breast cups; and further n: (i) the breast cups, medial window, shoulder straps, and back band, by virtue of the materials of construction thereof, do not scatter or substantially attenuate treatment radiation; and (ii) the bra is configured so that, when worn, no portion of a vertical e of a wearer’s chest is obscured by the bra so that a light field is projectable through the medial window onto a wearer’s chest and viewed without obstruction.

2. The bra of claim 1 and further comprising a medial adjustable element disposed between the two breast cups, wherein the medial adjustable element: (i) establishes, at least in part, a nce breast geometry; and (ii) by virtue of the material of construction thereof, does not scatter or substantially attenuates treatment radiation.

3. The bra of claim 2 and r n the medial adjustable element is configured as a closure.

4. The bra of claim 2 or claim 3 and further wherein the medial adjustable element comprises the medial window.

5. The bra as in any one of claims 1-4 and further comprising a first lateral able element and a second lateral adjustable element, n: the first lateral adjustable element is disposed between a first end of the back band and one of the two breast cups; AH26(9425151_1):KEH the second l able element is disposed between a second end of the back band and the other of the two breast cups; and further wherein the first and second lateral adjustable (i) establish, at least in part, a reference breast geometry; and (ii) by virtue of the material of uction thereof, do not scatter or substantially attenuate treatment radiation.

6. The bra of claim 5 and further wherein the first lateral adjustable element and the second lateral adjustable element are configured as closures.

7. The bra as in any one of claims 1-6 further comprising a first superior adjustable element and a second superior adjustable element, and wherein: the first superior adjustable t: (i) is disposed along one of the two shoulder straps; (ii) establishes, at least in part, a reference breast geometry; and (iii) by virtue of the al of construction thereof, does not r or substantially attenuate treatment radiation; and the second superior adjustable element: (i) is disposed along a second of the two er straps; (ii) establishes, at least in part, the reference breast geometry; and (iii) by virtue of the material of construction thereof, does not r or substantially attenuate treatment radiation.

8. The bra of claim 7 and further wherein the first and second superior adjustable elements are configured as es.

9. The bra as in any one of claims 2-4 and further wherein the medial adjustable element further comprises a measurement tool that provides an indicium of fit.

10. The bra of claim 5 or claim 6 wherein the first lateral adjustable element and the second lateral adjustable element each comprise a measurement tool that provides an indicium of fit.

11. The bra of claim 7 or claim 8 wherein the first superior adjustable element and the second superior adjustable element each comprise a measurement tool that es an indicium of fit. AH26(9425151_1):KEH

12. The bra as in any one of claims 1-11 and further comprising a first lateral window and a second lateral window, wherein the first and second l window are ly transparent for enabling a skin marking to be viewed therethrough, wherein the first and second lateral windows are disposed beneath a wearer’s left and right axilla when the bra is worn.

13. The bra as in any one of claims 1-12 and further comprising a non-participating closure by which the bra is d but not adjusted.

14. The bra as in any one of claims 1-13 and further comprising a sling, wherein the sling ses a strip of a material that does not scatter or substantially attenuate treatment radiation, wherein a first end of the sling couples to one of the breast cups near a bottom or medial edge thereof and, in use, the sling is placed under tension to provide additional support for a wearer’s breast and establishes, at least in part, a reference breast geometry.

15. The bra of claim 1 and further sing: at least one adjustable element configured as a closure; and a sling, wherein a first end of the sling couples to one of the breast cups near a bottom or medial edge thereof and, in use, the sling is placed under n to provide onal support for a wearer’s breast, and further wherein the adjustable element and the sling: (i) establish, at least in part, a reference breast ry; and (ii) by virtue of the material of construction thereof, do not scatter or substantially attenuate treatment radiation.