Patent Document

STATEMENT OF RELATED CASES 
     This case claims priority to U.S. Pat. App. 62/140,827 filed Mar. 31, 2015, which is incorporated by reference herein. 
    
    
     FIELD OF THE INVENTION 
     The present invention relates to brassieres in general and, more particularly, to a brassiere for use by women during and immediately after accelerated partial breast irradiation and other treatment techniques. 
     BACKGROUND OF THE INVENTION 
     Early stage breast cancer is not an uncommon problem in the United States. It is estimated that there will be about 300,000 such cases in 2015. Since 1998, the Federal government has required that women are presented with all options for surgery and reconstruction of their affected breasts. This includes lumpectomy (i.e., removal of the cancerous mass and surrounding tissue) followed by radiation or mastectomy (i.e., removal of the entire breast) with or without reconstruction and possibly radiation therapy as well. 
     There are many options for treatment with lumpectomy or partial mastectomy followed by radiation treatment to the breast. In most cases in which radiation therapy is provided, a “boost” dose of radiation is delivered to the tumor bed in addition to a longer course of treatment for the entire breast or portion thereof. The boost can be performed in a variety of ways, such as delivery through a linear accelerator of photons or electron fields, radiation in the operating room, electromagnetic generation or radiation delivered by an after-loaded catheter/brachytherapy device. 
     With respect to the latter approach, the radiation is delivered, for example, via a group of flexible after-loading catheters that are placed in the breast (multi-catheter interstitial brachytherapy), a balloon that is connected to a catheter (balloon-based brachytherapy), modified forms of balloon-based therapy using a balloon catheter with multiple ports (e.g., one for insertion of the radiation source, a second for inflating the balloon with saline, and a third for drainage of seroma fluid or air), and other approaches. These devices will be collectively referenced as “boost-treatment devices.” 
     Normally, patients are fitted with the boost-treatment devices in the operating room or physician&#39;s office, radiation dosimetry is thereafter planned, and then the patient is sent home for several days before beginning electromagnetic or radioactive after-loading. 
     During this time period, women cannot comfortably wear a conventional brassiere or conventional surgical bra because of the presence of the multiple catheters extending under the axilla (arm pit) region. This leads to pain—back pain as a consequence of the lack of support for the breasts, pain as a consequence of the heaviness of the breasts without support after surgery, and pain at the wound site due to the presence of the catheters—and an inability to wear clothes in public without embarrassment. The most common complications for patients include infection, seroma and hematoma in the tumor bed cavity, as well as rotation/movement of the boost-treatment device. 
     The latter complication—rotation or other movement of the boost-treatment device—can be quite serious, leading to failure of consistent dose delivery. In this situation, the boost-treatment device needs to be removed before the radiation course is completed or necrosis occurs. Movement of the catheter necessitates additional radiation planning and often results in delays in the course of treatment. Not only does this cost money and take an emotional toll on the patient, but there is risk to the patient of further progression of disease. 
     Existing post-surgical bras cannot address the problems presented by boost treatment devices. U.S. Pat. No. 5,429,593 to Matory and U.S. Pat. No. 6,390,885 to Brooks, which are representative of the art, disclose surgery recovery brassieres with drainage tube apertures and tab closures. The tab closures, which are oriented horizontally, are intended to close the aperture (Matory) or to reduce the size of the aperture to better secure the drainage tubes therein (Brooks) to further reduce the movement of the tubes. The use of the tab closure, horizontal or otherwise, will not prevent rotation of any tubes extending through the aperture. 
     SUMMARY OF THE INVENTION 
     The present invention provides a post-surgery brassiere for holding the tubes of a boost-treatment device securely against a patient&#39;s body in such a way as to prevent rotation, migration, or any movement thereof. The bra does not interfere with any surgical dressings or arm movement. 
     In accordance with the illustrative embodiment, the brassiere includes at least one side opening (“aperture”) through which the catheters/tubes of the boost device extend. The aperture(s) are disposed in the side panel/back band of the brassiere. 
     The aperture is preferably a placket; the placket preferably extends through the base band of the brassiere. In some embodiments, particularly those in which the opening extends through the base band, the brassiere further includes a closure to fasten the base band. In some embodiments, the closure is a tab or strip of material, such as can be formed from hook-and-loop fastener (e.g., VELCRO®, etc.). In some embodiments, the tab is oriented in line with the base band, such that the tab has a substantially horizontal orientation when the brassiere is worn. 
     In accordance with embodiments of the invention, the brassiere also includes a fixation element for immobilizing the catheters/tubes of the boost-treatment devices that protrude from the aperture. As used in this disclosure, the term “immobilize” and inflected forms thereof means to prevent rotation, migration, or any movement of an immobilized item, such as catheters, tubes, etc. 
     In the illustrative embodiment, the fixation element is distinct from the closure that fastens/tightens the aperture. In some embodiments, fixation element is a tab or strip of material, such as can be formed from hook-and-loop fastener (e.g., VELCRO®, etc.). There is no per se requirement that the fixation element be distinct from the closure. However, to the extent that a single element is intended to function as both a closure and a fixation element, it is must be capable of immobilizing the catheters/tubes protruding from the aperture. 
     In the illustrative embodiment, the fixation element is situated a short distance from the aperture and is oriented, as appropriate, to receive and immobilize the catheters/tubes. In embodiments in which the fixation element is a tab or strip of material, the tab is preferably oriented substantially parallel to the placket; that is, in such embodiments, the tab has a more or less vertical orientation, substantially orthogonal to the base band of the brassiere. 
     The fixation element reduces the discomfort otherwise experienced by patients. It also provides the critically important benefit of ensuring that physicians and dosimetrists can plan the radiation dose from the measurements obtained at the time of surgery (for implantation of the boost treatment devices) with confidence that the geometry and patient tissue position will be maintained since the boost-treatment device is immobilized. 
     In some embodiments, the closure for the base band includes indices, etc., for marking the closure position. This affords the physician with the ability to document and reproduce the fit of the brassiere to the patient. 
     In some embodiments, the brassiere is also physically adapted to accommodate drains, such as a JP drain. The drains are surgically implanted near each operative site to drain serous lymphatic fluid as well as some blood that accumulates after the mastectomy or breast surgery. Such drains include about a meter of flexible tubing that transports fluid from the surgical site to a bulbous reservoir (“collection bulb”). A perforated collection tube lies under the skin; most of the tubing and the collection bulb are extracorporeal. The tubing can extend through the same aperture as the tubes from the boost-device or through another aperture located on the same side or the opposite side of the brassiere. 
     The physical adaption(s) for accommodating the JP drain include: (i) a fastener that is capable of opening and closing, and, optionally, (ii) a piece of material, etc., by which the fastener couples to the bra. 
     In the illustrative embodiment, the fastener is in the form of a retaining ring or “circlip” (a portmanteau of “circle” and “clip”), preferably made of plastic. Non-limiting examples of suitable retaining rings include a spiral ring, snap ring, and the like. In preferred embodiments, the retaining ring is coupled to and hangs from a loop of material (ribbon, etc.) that is attached to and extends below the base band of the brassiere. 
     A patient or caregiver opens the retaining ring to engage the loop of plastic (a feature of all JP drains) that is attached to the collection bulb, and is then closed. The use of the openable/closable retaining ring avoids having to use a safety pin, etc., to attach the JP drain to a (closed) loop of material, etc., on the bra, as in some prior-art designs. 
     Thus, the collection bulb is fully supported by the bra without the use of pouches or external fasteners. Furthermore, this arrangement ensures that the collection bulb hangs below the heart, as is required for best fluid drainage via gravity and suction. 
     Also, because the collection bulb is attached to the brassiere near its bottom edge, and because the drain tubing remains hidden underneath the patient&#39;s blouse, it is very unlikely that the drain tubing could snag on anything that would otherwise cause tension/tugging on the sutured skin at the drain tube insertion site. Furthermore, the collection bulb is not forced into an ill-fitting pocket, as in a number of prior-art post-surgery garments. As a consequence, pain and discomfort are minimized and accidental dislodgement of the tubing is prevented. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  depicts a front perspective view of a post-surgery brassiere in accordance with the illustrative embodiment of the present invention. 
         FIG. 2  depicts a side view of the brassiere of  FIG. 1 . 
     
    
    
     DETAILED DESCRIPTION 
       FIG. 1  depicts post-surgery brassiere  100 . In the illustrative embodiment, bra  100  includes cups  102 A and  102 B, shoulder straps  104 A and  104 B, back band  108 , and base band  112 . 
     Cups  102 A and  102 B and back band  108  comprise a compressive fabric, such as, without limitation, Lycra® brand spandex fiber or Tencel® brand fiber. Using a compression-type material promotes healing and reduces the risk of seroma formation. In some embodiments, the compressive fabric includes an anti-stain treatment. In some further embodiments, the brassiere comprises a fabric liner that is resistant to serous and serosanguinous staining. In yet some additional embodiments, the brassiere comprises a removable fabric liner, which can be disposed of or washed. 
     Brassiere  100  is readily removable to provide for wound-site care and is capable of machine washing so that blood, bacteria, and fluids draining from the wound can be removed from the garment. This reduces the risk of bacteria harboring in the surgical garment. It also reduces the need for excess gauze and padding because the bra can be readily removed and washed. 
     Such removability is facilitated in brassiere  100  by one or more release points; the illustrative embodiment has three. One release point is medial closure  110 , which is disposed between cups  102 A and  102 B. In the illustrative embodiment, medial closure  110  is a hook-and-eye fastener; in some other embodiments, other fastening arrangements (e.g., hook-and-loop, etc.) may suitably be used. The other two release points are superior closures  106 A and  106 B, which are situated along respective shoulder straps  104 A and  104 B. In the illustrative embodiment, superior closures  106 A and  106 B comprise paired strips of hook-and-loop fastener, such as VELCRO® brand, available from Velcro Co. of Manchester, N.H. 
     In some alternative embodiments, superior closures  106 A and  106 B can be situated between each cup  102 A and  102 B and the respective shoulder strap  104 A and  104 B. 
     Base band  112  comprises an elastic material that is attached to the bottom edge of the cups  102 A and  102 B and back band  108 . By virtue of its elasticity, band  118  ensures that the bottom of the bra remains tight to the body. 
     Aperture  114  is disposed in back band  108 ; it is sited so that when the brassiere is in use, the aperture aligns with the side of the wearer underneath the axilla (i.e., arm pit). In the illustrative embodiment, aperture  114  is a placket, which is arranged to open through base band  112 . The aperture is closed by closure  116 , which in the illustrative embodiment is implemented as a strip of hook-and-loop fastener that couples to piece of hook-and-loop fastener disposed on base band  118 . Alternatively, base band  112  or a portion thereof can be formed of a “hook-compatible fabric” (i.e., VELCRO® receptive). In other words, closure  116 , when implemented as hook-and-loop fastener, will simply “stick” to the fabric. Such fabric is commercially available from Darlington Fabrics of Westerly, R.I., and others. In some other embodiments, other types of closure mechanisms known to those skilled in the art can suitably be used. 
     Although brassiere  100  depicts a single aperture  114 , in some other embodiments, a second aperture, typically in the form of a placket, is disposed on the opposite side of the brassiere. The second aperture is situated so that when the bra is worn, the second aperture aligns generally with a wearer&#39;s other axilla. 
     Aperture  114  enables the tubes from a boost-treatment device to pass through the brassiere. To the extent it is present, the flexible tubing of a drain, such as a JP drain, can pass through aperture  114  as well. The inventor recognized that using a placket, as opposed a hole through the side band, enables a user to put on or take off the brassiere without removing the drain&#39;s collection bulb. Also, if a discrete hole/opening is sized to permit passage of a collection bulb for a specific type of drain, it might be undersized to permit the passage of other bulbs from other drains. 
     The boost-treatment device tubes and JP drain tube extending from aperture  114  raise different concerns. As previously indicated, the boost-treatment tubes must be immobilized to prevent rotation or any movement thereof. The collection bulb and tubing of the JP drain, on the other hand, must simply be supported below the heart in as unobtrusive a manner as possible. 
     In accordance with embodiments of the invention, to address the boost-treatment device tubes, the brassiere includes fixation element  120  for immobilizing the catheters/tubes of the boost-treatment devices. In the illustrative embodiment, fixation element  120  is situated a short distance (e.g., typically ½ to 1½ inches) from aperture  114  and is oriented, as appropriate, to receive and fully immobilize the catheters/tubes. 
     In the illustrative embodiment, fixation element  120  comprises a first strip of material that is attached (e.g., sewn, etc.) to the back band. The first strip of material includes the female half of each of several (three in the illustrative embodiment) snaps  121 . The fixation element  120  also includes a second strip of material having the male half of each of several snaps  121 . The first and second strip of material can be snapped together. 
     The distance between adjacent snaps  121  is quite small, such that the tubes of boost-treatment devices, once positioned between adjacent snaps, are tightly compressed against one another so that they are effectively immobilized. In some other embodiments, the female and male portions of snaps can be replaced, for example, with several pieces of hook-and-loop fastener. 
     In the illustrative embodiment, fixation device  120  is oriented substantially parallel to aperture  114 . That is, in such embodiments, fixation device  120  has a generally vertical orientation, such that it is substantially orthogonal to base band  112  of the brassiere. This orientation places the tubes of boost-treatment devices exiting protruding from aperture  114  under the least amount of stress/tension (i.e., from bending), making it relatively easier to immobilize the tubes. 
     To support the extracorporeal portions of a JP drain, in the illustrative embodiment, brassiere  100  includes two loops  122  of material, such as ribbon, etc., one of which hangs from base band  112  below each cup  102 A and  102 B. One retaining ring  124  couples from each loop  122 . In the illustrative embodiment, retaining rings  124  comprises plastic. The retaining rings can be opened and closed to support the collection bulb and a drain and the associated tubing. 
     Markings  118 , which in the illustrative embodiment are a series of parallel vertical lines printed or otherwise appearing on base band  112 , serve as a scale for repeated, consistent positioning of closure  116 . 
       FIG. 2  depicts post-surgery brassiere  100  in use (patient&#39;s body is not depicted for clarity). Two boost-treatment-device tubes  230  and tube  232  of a JP drain are shown protruding from aperture  114 . Those skilled in the art will appreciate that a boost-treatment device and a JP drain would typically not be used in a patient at the same time; they are shown together in  FIG. 2  for convenience. 
     As depicted in  FIG. 2 , fixation element  120  immobilizes tubes  230  of a boost-treatment device against back band  108  of brassiere  100 . Drain tube  232  couples to collection bulb  234  of a JP drain. The collection bulb collects excess lymphatic fluid that is withdrawn from the body via tube  230 . Retaining ring  124  is coupled to loop  236  of collection bulb  234 . As previously discussed, to couple retaining ring  124  to loop  236 , the ring is opened, the loop  236  is positioned on the opened ring, and then the ring is closed. As appropriate, fixation element  120  can be used to provide additional support to tube  232  of the JP drain. 
     It is to be understood that the disclosure teaches just one example of the illustrative embodiment and that many variations of the invention can easily be devised by those skilled in the art after reading this disclosure and that the scope of the present invention is to be determined by the following claims.

Technology Category: 1