The invention relates to a method for practicing augmentation mammaplasty, and for an assembly particularly adapted for filling of a silicone prosthesis with saline during augmentation mammaplasty. In recent years, the use of implants of silicone filled with saline has become extremely popular, however, the filling of the prosthesis with sterile fluid such as saline is normally a difficult and time-consuming procedure. It is common practice to repeatedly fill a 50 cc syringe until the desired amount of saline has been put into the prosthesis, however, in addition to being time-consuming, this procedure is not fail safe since one can easily miscount and place unequal volumes of saline in each breast prosthesis. Additionally, there can be problems associated with the sterile filling of the syringe with saline since the syringe used in augmentation mammaplasty does not have a needle, but rather merely a nipple providing an ingress/egress opening for liquid.
According to the present invention, a method and an assembly for practicing augmentation mammaplasty are provided that eliminate the problems inherent in the prior art. According to the method of the present invention, augmentation mammaplasty is practiced by implanting a silicone prosthesis beneath a breast and sequentially filling a syringe with saline or other fluid of sufficient volume to completely fill the silicone prosthesis, connecting up the syringe to the prosthesis, and completely filling the prosthesis with saline from the syringe without detachment of the syringe from connection with the prosthesis. The syringe has a volume of 300-400 cc. The step of filling the syringe with saline is accomplished by bringing the first end of a tubular connector releasably connected to the syringe into engagement with the saline bottle neck, filling the syringe with saline by expanding the volume of the syringe and releasing connection between the syringe and the tubular connector. The connection between the syringe and the tubular connector can be provided by screw threads having the opposite sense of screw threads for connecting the first end of the tubular connector to the saline bottle, or by a frangible connecting member, such as a shear-fracturable connecting member.
The assembly according to the present invention for sterile filling of the syringe from a container having a volume approximately larger than or equal to the volume of the syringe and having a neck portion screw-threaded in a first sense, comprises a syringe having a liquid ingress/egress nipple opening at a first end thereof; a generally tubular connecting means completely surrounding the syringe ingress/egress opening and for connecting the syringe to the container, the connecting means having a screw-threaded portion disposed at a first end thereof which screw-threaded portion has said first sense, and providing for connection of the container neck with the tubular connecting means; and releasable means for releasably connecting the tubular connecting means to the syringe so that once filled with liquid from the container, the syringe may be detached from the tubular connecting means while the tubular connecting means remains in screw-threaded engagement with the container. The releasable connecting means may comprise a screw-threaded portion of the tubular connecting means disposed at a second end thereof, opposite said first end, and having a second sense for the screw thread, and screw threads formed on the outside of a portion of the syringe adjacent the ingress/egress nipple opening thereof for cooperating with the second end screw-threaded portion of the tubular connecting means, and having a second sense. Since saline bottles conventionally come with right-hand screw sense, it is preferred that the first end of the tubular connecting means have a right-hand screw sense while the second end thereof (and the syringe) have left-hand screw sense. Alternatively, the releasable means may comprise a frangible connecting member, such as one that is fracturable upon the application of shear forces thereto.
It is the primary object of the present invention to provide an improved method and apparatus for practicing augmentation mammaplasty in particular, and for the sterile filling of syringes in general. This and other objects of the invention will become clear from an inspection of the detailed description of the invention and from the appended claims.
USPTO Backgrounds
USPTO Backgrounds