US 20060184100 A1
A breast implant injector device comprising a hollow guide cylinder having an open injection end and an opposed filling end, the cylinder having an elongated slot extending from the injection end toward the filling end, and an elongated plunger which can be pushed through the interior of the hollow cylinder. An unfilled breast implant can be inserted in the cylinder and a fill tube extending from the implant can extend from the interior of the cylinder through the elongated slot. Pushing the plunger through the cylinder pushes the implant through the open injection end, which can be directed into the open incision for injecting the implant therein. The filling end and the elongated slot are covered from the ambient environment by a flexible covering which allow passage of the implant through the filling end and the fill tube through the elongated slot.
1. A breast implant injector device comprising a hollow cylinder having opposed open ends, including a filling end and an injection end, said cylinder including an elongated slot extending from at least said injection end toward the filling end, an elongated plunger capable of passing through the interior of said cylinder, and a flexible cover means juxtaposed to said elongated slot and capable of closing and opening said slot to the ambient environment.
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11. A combination of a breast implant injector device and an unfilled breast implant containing a fill tube extending therefrom, said combination including a hollow cylinder having opposed open ends, including a filling end and an injection end, said cylinder including an elongated slot extending from said injection end toward said filling end, said breast implant lying within said hollow cylinder and said fill tube extending from the interior of said hollow cylinder through said elongated slot, a flexible cover means juxtaposed to said elongated slot and capable of closing said slot to the ambient environment and opening said slot to the ambient environment at the location the fill tube extends from said slot.
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This application is a Continuation-In-part of U.S. Ser. No. 10/789,030, filed Mar. 1, 2004.
The present invention relates to a device for injecting a breast implant into a surgically created body cavity.
Reconstruction of the human breast involves introducing a fixed or changeable-volume sac-like silicone rubber structure into a body cavity surgically created to receive such an implant. The implants and coverings therefore are described, by way of illustration and not by limitation, in: Braumann U.S. Pat. No. 4,648,880; Hamas U.S. Pat. No. 4,531,244; and Ledergerber U.S. Pat. No. 4,955,907.
The usual skin incision is on the order of 3-8 centimeters in length and is stretched open with retractors to facilitate the introduction of the implant. In various surgical procedures, a breast implant is placed within the surgically formed body cavity for subsequent inflation and/or deflation with a fluid.
In plastic and reconstructive surgery, when a breast implant or tissue expander is placed in the dissected pocket, it is typically filled via a fill connector coupled to fill tubing which is attached to a filling material (e.g. saline solution) source.
There are currently three basic types of fill connectors used to connect the fluid source to the implant, the choice of which often depends on the implant and the particular surgical approach used. The first is a permanent attachment of the fill tubing to the implant. A common means for this attachment is to make a small opening within the body or shell of the implant and insert the tubing securing it by means of connecting materials such as sleeves, patch assemblies, adhesives or vulcanizing compounds.
The other two common connectors are for temporary attachment of the fill tubing to the implant by means of a valve in the implant which seals after the fill tubing is removed. One of these two temporary attachment means is most commonly used with saline-fill breast implant devices that include a diaphragm valve within the shell. The valve has an opening that requires a rigid male implement to be inserted in the opening thus opening the valve and allowing fluid transfer. This male implement is the fill tip end of the fill connector, which has on the opposite end one or more barbs which accept the flexible (e.g. silicone or vinyl) fill tubing. In use, the fill connector and fill tubing attach to the implant normal to the implant surface.
Since breast implants are usually placed into the body through incisions considerably smaller than the implant, it has always been a challenge to introduce them. With greatly increased friction at the interface between the surface of newer texturized implants and the wound margins (body tissue), it has become correspondingly more difficult to introduce these implants. Increased manipulation of both implants and patient tissue often results in trauma to both implants and patient tissue, thereby increasing the risk associated with the procedure both in terms of immediate consequences as well as delayed structural failure and the implications deriving therefrom. Postoperative infection has also been a troublesome consequence of the need to manipulate the implant into place. It has become a matter of some urgency to be able to introduce breast implants atraumatically.
A novel breast implant introducer is provided which has as its object the alleviation of the difficulty of introducing breast implants, and thus limiting greatly both the damage to implants and trauma to patient tissues. The breast implant introducer greatly reduces the need to manipulate the breast implant in to place in the formed body cavity, and as a consequence greatly reduces postoperative infection.
The breast implant introducer is a modified syringe including a hollow guide cylinder open at opposite ends and having an internal area capable of receiving an unfilled breast implant. An elongated plunger sized to fit within the interior of the guide cylinder through an opened end thereof is used to push the breast implant into place in the surgically created body cavity. The hollow cylinder includes along one side thereof an elongated slot to allow the fill tube connected to the breast implant to extend outside of the guide cylinder and move with the breast implant without kinking and without inhibiting the movement of the breast implant as it is injected from the guide cylinder into the body cavity. The injection end of the cylinder and the elongated slot are closed by a flexible covering which opens once pressure is applied by the movement of the implant and fill tube through the guide cylinder. Inasmuch as the surgeon contacts only the outside surface of the guide cylinder and the top of the plunger and the cylinder is kept closed prior to insertion, risk of infection to the patient by transfer from the surgeon and/or the breast implant is substantially avoided.
Plunger 14 is an elongated rod having a diameter which can fit within the interior of guide cylinder 12. Typically, the plunger 14 will have a flattened end 26 capable of providing sufficient surface contact with the breast implant 20 so as to push the implant 20 down the length of the guide cylinder 12 and out through open injection end 18. Opposite flattened end 26, plunger 14 will include an end 28 which provides sufficient surface area to allow the surgeon to push plunger 14 through guide cylinder 12 such as by the thumb of the surgeon as the guide cylinder 12 is held between two fingers. Thus, end 28 preferably provides a flat surface, as shown in
In order to maintain excellent sanitary conditions prior to and during the breast implantation procedure, the guide cylinder 12 is provided with flexible coverings over elongated slot 22 and the open end 18 of guide cylinder 12. Referring again to
Placed against the open end 18 of guide cylinder 12 are a series of flexible tabs 36, 38, and 40 of similar or same material as flexible strips 23 and 25. Tabs 36, 38, and 40 are attached to, such as glued or inclusion-molded into, the injection end 18 of guide cylinder 12. When in the closed position, flaps 36, 38, and 40 entirely cover and seal the open bore that forms injection end 18 of guide cylinder 12 from the ambient environment. As specifically shown in
When mammoplasty is conducted using the present invention as illustrated in
With a novel configuration, the present invention allows a faster and more smooth operation compared to the prior art in mammoplasty involving the insertion of the implant. In addition to the major time saving, sanitary conditions remain throughout the procedure so as to avoid post-operation infection. The decrease in infection using the device described in parent application U.S. Ser. No. 10/789,030 has been quite remarkable. The improved flexible coverings on the guide cylinder 12 as described above provide even further protection against infection. The injector of the present invention can be disposable to completely rule out the infection problem due to repeated use which requires the disinfection in the prior art. It is contemplated that a kit 34 containing the guide cylinder 12 of this invention, and optionally containing the plunger 14, can be packaged together in a sanitary wrap 36 and opened during surgery.