Patent Application
20200029632
One in eight women are diagnosed with breast cancer at some point in their lives. Many of them will choose to undergo a mastectomy, a procedure in which the affected breast tissue is removed to prevent cancer progression. The procedure damages lymph nodes and lymphatic vessels, which can lead to fluid buildup in the upper limbs and trunk. Surgeons may also do a second procedure called lymph node resection in order to check if the breast cancer has metastasized, again creating holes in the lymphatic system that allow fluid to pool. Both procedures can lead to a condition called lymphedema and, if left untreated, can cause painful and disfiguring swelling. Its occurrence in the trunk area is specified as truncal lymphedema, which has a 35% chance of development following a mastectomy.
Truncal lymphedema is incurable, though it can be managed. Furthermore, several preventative methods already exist, one of which involves the steady application of compression to block the fluid from pooling. Women who undergo unilateral mastectomies are at a disadvantage because the resulting asymmetry across the chest does not allow for the use of a simple, flat, compression garment designed for bilateral mastectomy patients.
Current prevention methods for lymphedema aim to compress the body and keep the lymph fluid from pooling in the truncal region. This compression also encourages the lymph to drain into the central lymphatic drainage sink found along the centerline of the body. It should be noted that there is no current cure for lymphedema, so when a patient develops the secondary complication they will receive treatment for the rest of their lives.
Currently, unilateral mastectomy patients are prescribed bras that compress their residual breast. Attempting to compress both the residual breast and the mastectomized site with a continuous compression layer can leave gaps in compressive forces in the transition areas between the protruding residual breast and relatively flat mastectomized site. Referring to
Other approaches to the problem suffer from additional deficiencies. Some are concerned with aesthetics that attempt to match the shape of the residual breast to that of a reconstruction. Such bras do not address the problem of attaining uniform compression. Another approach is the JoviPak Bellisse Pad. It is manufactured as an auxiliary component to the Bellisse Bra. A thick foam pad fits inside the bra over the surgical site and around the affected axilla. It is sewn to direct lymph from the surgical area towards the ducts in the middle of the chest. While the pad has been successful in preventing fluid buildup, it is a clunky and awkward solution, with potential for human error in placement. There are additional undergarments made to be worn directly post-surgery. These are compressive on the patient's surgical site and are constructed to house post-surgical drains. Some have fasteners in the front and on the arm straps for adjustability and comfort. However, no known bra addresses the problem of obtaining uniform compression in the manner of the present invention as disclosed below.
The present invention provides a bra structure for use in reducing the risk of truncal lymphedema after unilateral mastectomies. In one embodiment, the structure includes a compressive layer that provides compression (a) around the residual breast via a hole in the layer, (b) the mastectomized site, (c) the back, and (d) the left and right axillae. Preferably the compressive layer applies from about 20 to about 40 mmHg pressure. The structure also preferably includes a fabric overlay on top of the compressive layer that includes a cup to hold the residual breast. In addition, the structure may include a prosthesis for the mastectomized site between the compressive layer and the fabric overlay.
The front of the proposed bra is compressive on the surgical side and has a hole for the residual breast. This allows the breast to pass through the compressive layer without creating a pocket between the fabric and sternum where lymph fluid could pool. That portion of material above the sternum could have foam between the bra's layers. In addition, preferably a fabric overlay will support both the residual breast and a prosthesis. Another unique feature that can be included is an educational piece that aims to increase patient knowledge of lymphedema, which should in turn boost compliance.
For a more complete understanding of the present invention and for further advantages thereof, reference is now made to the following description taken in conjunction with the accompanying drawings in which:
The main goal of the invention is to diminish the risk of truncal lymphedema in women that undergo unilateral mastectomies. Therefore, one of the important functions of the bra is its compressive quality. Increased compression will further reduce swelling and fluid buildup. However, as with any medical device, the safety of the patients is a top priority. To ensure safety, breathing and blood circulation must not be obstructed by the bra. Since the lower end of blood pressure typically sits around 60 mmHg, it is preferred that compression should not exceed 40 mmHg, allowing for a safety buffer in case of low patient blood pressure. As a result, it is currently preferred that the bra specifically being able to apply about 20-40 mmHg of uniform pressure. This specific pressure range is believed to be able to provide sufficient compression to reduce swelling and fluid build-up by 90%. It also matches other medical-grade compression garments already in use.
The material selected for the bra needs to be able to provide the required compression and should preferably also provide adequate breathability in order to provide comfort to the user. The amount of compression that can be generated using a given material can be theoretically calculated using the Hoop Stress equation. Preferably, the maximum amount of compression that can be generated using a given material when stretched to its maximum is physically determined using a Tekscan flexiforce sensor placed between the fabric stretched to its max deformation and a curved surface. While any material that is able to create the desired amount of consistent compression across the entire bra can be used, it is currently preferred to use a material similar to those currently being used in medical grade compression stockings, such as a blend of about 63% polyamide and about 37% elasthan fabric.
In addition to the material being used, the sizing of the bra to the individual user will also have an effect on the amount of compression that is provided. It is contemplated that a modified version of the fitting protocol for current truncal compression garments can be used. This involves taking certain preoperative measurements around the user's chest, axialar, and waist regions, but would also include a measurement of the underbust and overbust to account for the residual breast. These measurements can be used by the manufacturer to generate a custom fit for a user that would generate the desired uniform compression. A user would need at least two of the inventive bras, as compression fabric needs to be washed after being worn to reset the material memory and regain its compression ability.
The next set of functional requirements were established with the common goal of increasing patient compliance, since the bra will only be effective if it is worn. Comfort was first among these, which was defined as no skin irritation from the garment. Since the bra will be worn for long periods of time, the fabric must be breathable, accommodating for minimal sweating during daily activities. Wearing the bra must also allow for normal range of movement, not inhibiting normal arm and trunk movement.
To encourage patients to wear the bra, ease of putting it on and taking it off is an important consideration, particularly since some patients may not have access to someone who can help them get dressed every day. Aesthetics were also considered in the design of the bra. One difficult aspect of mastectomies is the abnormal anatomy that results from the removal of breast tissue, so having a bra that helps the patients look and feel like they did before surgery helps restore normalcy. Ease of use also aids in education of the patient regarding the benefits of its use as compared to the dangers of truncal lymphedema.
One embodiment of the invention is shown in
A fabric blend of 63% polyamide and 37% elasthan was used for this embodiment. This blend was chosen because of its compressive qualities (it applies compression within the specified 20-40 mmHg), and because it is already used for other compression garments.
The bra is fastened with Velcro along the midline of the front of the torso. Velcro is easy to fasten and unfasten due to its low resistance to normal stress, but its shear strength makes it suitable for holding the garment closed. The placement of the fastener was decided with the goal of making the bra easy to use for patients with limited mobility. Since patients can have reduced shoulder mobility after surgery, it could be difficult to fasten the bra from the back. The Velcro also goes from the top edge of the garment to its bottom, making sure that the whole trunk is under the same compression. Preferably, the soft side of the Velcro faces down toward the skin in order to prevent possible irritation. A zipper can also be used in conjunction with the Velcro to provide a double fastener system that is easy to fasten and unfasten while ensuring the compression remains constant at the point of attachment.
Because lymphedema will not occur in the breast itself, a hole was designed to make sure compression was applied all around the breast without constricting it. As shown in
To make the bra more aesthetically appealing and help women regain some normalcy in their lives, the design of the bra includes a fabric overlay, shown in
This application claims the benefit of U.S. Provisional Patent Application No. 62/712,020 filed on Jul. 30, 2018.
| Number | Date | Country | |
|---|---|---|---|
| 62712020 | Jul 2018 | US |
