Foundation garments – Breast or chest – e.g. – brassieres
Reexamination Certificate
2001-04-10
2002-05-21
Hale, Gloria M. (Department: 3765)
Foundation garments
Breast or chest, e.g., brassieres
C450S003000, C450S054000
Reexamination Certificate
active
06390885
ABSTRACT:
TECHNICAL FIELD
The present invention relates generally to surgical appliances and supplies and, more specifically, to a garment worn by women who have undergone breast surgeries.
BACKGROUND ART
Each year, thousands of women undergo breast surgery. Of all the surgeries that a woman may experience, breast surgery, and particularly mastectomy or removal of a breast or breasts, is the most traumatic. A mastectomy is the most common surgical procedure performed when a malignant tumor is found. The type of surgery depends upon the staging of the tumor and the client's preferences. Although many women look for more conservative treatment and less destructive surgery than removal of the breast, mastectomy continues to be the preferred course of treatment to increase the likelihood of destroying the breast cancer. Mastectomy procedures include modified radical mastectomy (removal of the underlying muscle as well as the breast), simple mastectomy (removal of one breast), bilateral mastectomy (removal of both breasts) and lumpectomy (removal of a portion of the breast).
When the cancer involves the muscle or interpectoral node, substantially more muscle and tissue must be removed. Removal of auxiliary nodes and lymphatic channels predisposes the client to infection and lymphatic obstruction. Edema, an abnormal excess accumulation of serious fluid in connective tissue, is a frequent occurrence in breast surgeries unless positive steps are taken to prevent it. The body develops a collateral lymphatic drainage system usually within 3 to 4 weeks postoperatively. In the interim, lymphatic fluid production must be drained to prevent infection and promote healing.
Post operative drainage tubes are placed in the body to aid in lymphatic fluid drainage. Drainage tube systems are used not only for mastectomies but also for breast reconstructive surgery as well as for less radical surgeries for breast enlargement or breast reduction. The drainage tube system conventionally consists of one to two flexible tubes which exit the chest wall on one or both sides of the body in the area of the incision wound. The drainage tubes extend outside the body and a collection bulb or cup is installed on the end of the drainage tube to collect lymphatic fluids and tissue debris. The drainage tubes and collection bulbs are conventionally gathered together and pinned to the front of the patient's gown with a safety pin. The collection bulb must be emptied of lymphatic discharge on a regular basis, approximately every hour to promote free flow of discharge. The entire drainage system must be supported to prevent pain and inflammation resulting from the disruption and separation of the tubes from the chest wall.
Although the physical changes resulting from mastectomy and other breast surgeries require weeks or even months of recovery time, the psychological changes are even more difficult and require a much longer recovery time to overcome. In the time period immediately following surgery, a woman must overcome not only pain, limited mobility in the arms, and an extensive drainage system, but also a feeling of flatness and imbalance resulting from the loss of the weight of the breast. These physical changes often delay the beginning of psychological healing that is essential to recovery of total well-being in the patient. Doctors recommend that a mastectomy patient begin to wear a prosthesis as soon as possible to being this healing process. The sooner a woman can don a prosthesis and provide the body with a feeling of balance and wholeness, the sooner she will come to terms with the traumatic change in her body and the greater the chances of regaining mental well being.
The change in the physical appearance of the patient requires visual and uncomplicated relief as soon as possible. At times a patient will require a more customized fitting to achieve her pre-surgery appearance. The present invention allows the patient to achieve a womanly appearance in the interim until she is sufficiently recovered to face the search for a fitted bra, prosthesis and fitter to meet her needs.
BACKGROUND—DESCRIPTION OF PRIOR ART
It will be recognized that although there are a number of medically supported articles that are conventionally known and medically employed for post-operative recovery of surgeries in and around the breast area, none of the articles offer solutions for prosthetic applications which accommodate the fluid drainage systems used routinely in surgical practice for removal of fluids after breast surgery. To the contrary, conventionally known articles either address incision wounds to the chest wall in general or provide prosthetic support. Such articles do not provide a breast surgery patient with the ability to don a prosthetic brassiere which accommodates drainage systems in the days following her surgery.
Articles which generally accommodate chest wall surgeries include compression dressings and cardio-thoracic brassieres. One such article may be found by reference to U.S. Pat. No. 5,429,593 to Matory, a post surgical drainage accommodating, compression dressing and garment to be worn by a man or a woman after chest wall surgery to cover and compress at least one surgical incision site on the upper torso. The patent to Matory does not support prosthetic applications. Further, compression dressings can exacerbate breast surgery recovery because no allowance is made to accommodate shifting caused by differential heights between the remaining breast and the area where the breast was removed. Another example of an article designed to accommodate chest wall surgery maybe found by reference to U.S. Pat. No. 4,804,351 to Raml et al., a surgical brassiere for use by female patients following cardio-thoracic surgery which provides a ventilated panel over the mid sternal incisional line. The referenced design to Raml et al. does not provide for prosthesis use.
On the other hand, conventionally known mastectomy brassieres are directed primarily toward prosthesis use but may only be comfortably used several weeks after surgery when post-operative fluid drains are removed. Merely representative of such prior art articles are the following: a garment for use after breast surgery with enlarged arm openings and an elongated bodice portion to fit over the wearer's torso and assist in holding the garment in place as disclosed in U.S. Pat. No. 4,187,855 to Paulus et al.; a brassiere for supporting prosthesis that is cut low under the woman's arms to avoid sensitive surgical incisions that provides pockets to receive prosthesis as shown in U.S. Pat. No. 4,369,792 to Miller; and a reversible mastectomy brassiere which positions a prosthesis on the left breast of a mastectomy patient or alternatively on the right breast of the patient as described by U.S. Pat. No. 5,180,326 to Williams. The waist bands, side panels and elongated bodices of such articles make no accommodation for post-operative drains exiting the chest wall and often result in pain if used too soon after surgery.
Such prior art designs do not firmly hold the prosthesis in place. An example of one such design is the '792 patent to Miler. When a woman bends over, the prosthesis can readily fall out due to open top construction of the prosthetic support cup.
Further, the use of such articles can result in the disruption and separation of the drainage tubing from the chest wall. Because conventionally known prosthetic brassieres cannot be properly fitted around the drainage tubes, the brassiere often shifts out of place. At a time when the patient's psychological needs demand that the brassiere to fit as naturally as possible, drain tubes prevent proper use of the prosthesis. Drainage tubes typically remain in place for at least one month ???? after surgery. However, psychological healing should begin well before this time.
An additional burden during the initial weeks of recovery is the placement and storage of collection bulbs. The bulbs must be regularly emptied of fluid. For breast reconstruction surgery in partic
Hale Gloria M.
Manson, Attorney Kim S.
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