Foundation garments – Breast or chest – e.g. – brassieres
Reexamination Certificate
2002-12-17
2004-09-28
Hale, Gloria (Department: 3765)
Foundation garments
Breast or chest, e.g., brassieres
C450S038000
Reexamination Certificate
active
06796875
ABSTRACT:
BACKGROUND
This application relates to methods and apparatus for accurately sizing surgically implantable breast prostheses prior to implantation.
Surgical implantation of material in human female breasts has become fairly common, both for medical reconstructive and for cosmetic purposes. A key factor in such surgery is the proper selection of the size of the prosthetic implant. Currently, patients and physicians typically make their choices based on anatomic factors or using crude and unwieldy devices, such as tape measures.
One prior technique, disclosed in U.S. Pat. No. 4,024,856, uses a concave template of fixed size and shape placed around the breast and releasably sealed to the chest. A liquid is injected into the space between the breast and the template. From a measurement of the volume of liquid injected, the breast volume could be calculated. However, it has been found difficult to effect a perfect fluid-tight seal of the template to the chest.
Another technique, disclosed in U.S. Pat. No. 4,624,671, involves surgically implanting an empty, inflatable elastomeric balloon in the breast, filling the balloon with a liquid to the desired size, measuring the amount of liquid in the filled balloon and then removing the liquid from the balloon and removing the balloon from the breast. However, this technique must be performed at the time of surgical implantation of the prosthesis, or would require two separate surgical procedures.
The manufacturers of implantable prostheses provide “sizers,” which are essentially inflatable mock-ups of the implantable prostheses themselves, which can be inflated with air or water and inserted in the patient's own brassiere, these mock-ups respectively corresponding in size to the available sizes of implants. However, these mock-ups are relatively expensive and, in order to permit a patient to test various sizes at home, it would be necessary to provide the patient with a number of different-size mock-ups, and many patients are unwilling to incur that additional expense. It would be possible to “lend” the mock-ups to the patient, but this would raise sterility issues upon return of the mock-ups, which issues are of concern to many patients who would be unwilling to reuse a previously-used mock-up. It is also possible to perform the sizing test procedure in the physician's office, but this is undesirable because of time constraints. It is preferable that the patient be able to test different sizes at her leisure at home.
Applicant has attempted to minimize costs by instructing patients to utilize water-filled receivable plastic bags or rice-filled nylon stockings instead of the commercial “sizers.” These latter techniques have improved patient input in the implant decision-making process. However, due to the lack of sophistication of these techniques, outcomes may still be less than optimal.
SUMMARY
This application describes a technique for accurately sizing surgically implantable human breast prostheses which avoids the disadvantages of prior techniques while affording additional structural and operating advantages.
An aspect of the technique is that it is simple and economical.
In connection with the foregoing aspect, the technique uses low-cost, disposable apparatus.
Another aspect is that it affords precision without risk of fluid spillage and without discomfort or risk to the patient.
In an embodiment, there is provided an apparatus for sizing a surgically implantable human breast prosthesis comprising: a disposable brassiere-like garment including at least one elastic breast-receiving cup of a predetermined size and shape and having an inner surface, a pocket formed on the inner surface of the at least one cup, and at least one disposable, inflatable, flexible and resilient bladder removably receivable in the pocket and having a fluid inlet/outlet port for inflation and deflation of the bladder.
There is also provided a method of utilizing an apparatus of the type set forth, involving removably inserting a bladder into a pocket in a cup of a brassiere-like garment and introducing a fluid into the bladder for inflating the bladder.
Fluid may be introduced into and removed from the bladder by the use of a syringe coupled to the bladder via suitable fittings.
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