The present invention relates to a breast implant system that allows the shape of a breast implant to be varied after its implantation in the patient's body.
Breast implants are typically used to replace a natural breast that has been removed, e.g. due to cancer, or to increase the size of a natural breast, when the natural size is considered unsatisfactory. In general, people who desire to change the overall size and shape of the breast implants after implantation have to undergo major surgery. It would be desirable for the patient to adjust the size and shape of the breast implant easily, depending on current needs. For instance, as time goes by the patient might no longer be happy with the size or shape of the artificial breast. Alternatively, the patient might want to change the shape or size only temporarily. For instance, one might wish to reduce the height of the breast implant during sports activities or one might wish to enlarge the height for a particular event, such as a formal evening affair.
U.S. Pat. No. 6,875,233 B1 discloses a breast implant that allows the overall size and shape thereof to be changed once it has been surgically implanted. This breast implant includes an exterior shell and an inner bladder. The exterior shell is typically a bellows having a plurality of pleats, so that the outer size of the implant is variable. As the bladder is filled, the exterior shell expands in a manner that creates a lifting effect and a ballooning effect. A valve connected to both the exterior shell and the inner bladder can be used to fill the bladder external to the patient without the need for further surgery after the implant has been implanted in the patient. The bladder may be filled with a liquid, a gas, or a solid, and such filler can be added and removed through the valve as needed. The valve either remains external, so that it can be used without any further surgery, or it can be located under the patient's skin, in which case minor surgery must be performed to access the valve.
The options for changing the shape of this prior art breast implant are limited. In addition, it is inconvenient for the patient that the valve for accessing the inner bladder of the breast implant permanently penetrates the patient's skin or, where it is implanted subcutaneously, requires minor surgery to be accessed.
US 2003/0074084 A1 discloses a breast implant with a plurality of chambers. The chambers are differently pressurized in order to control the shape of the breast implant upon inflation thereof. Each chamber may be provided with a pair of conduits for alternatively delivering fluid to and removing fluid from the chambers. Terminal connectors of such conduits can be easily located by medical practitioners for delivery of fluid to or removal of fluid from a desired chamber either manually or assisted by machinery. Alternatively, fluid can be supplied or removed by inserting a hollow needle directly into the chambers of the breast implants.
While the options of changing the shape of this prior art breast implant are improved over the breast implant disclosed in U.S. Pat. No. 6,875,233 B1, a medical practitioner is still needed to achieve different sizes and shapes of the breast implant after its implantation.
In a simpler embodiment described in US 2003/0074084 A1, one-way valves are each disposed between two adjacent chambers for enabling a transfer of fluid from a first to a second of the adjacent chambers, upon application of an external compressive force to the first chamber. This way, the valves enable reshaping of the breast implant merely through manipulation. It is even suggested to automatically open and close the valves by wireless remote control.
PCT/EP2009/000622 also relates to a breast implant system comprising a plurality of chambers which are interconnected when implanted, such that fluid can be exchanged between them, so as to change their respective fluid content. Various embodiments are disclosed for: changing the shape but not the volume; for changing the shape, and also the volume without a change of the breast implant's mass (this being achieved by causing a gas-filled chamber to be compressed when liquid is exchanged between chambers of the breast implant); and for changing the shape, and also the volume of the breast implant involving a change of the breast implant's mass. It is further described that fluid exchange between the chambers can be achieved by manually compressing the one or the other fluid chamber, similar to the afore-mentioned US 2003/0074084 A1. However, preferred embodiments include a fluid reservoir implanted remotely from the breast implant in the patient's abdominal cavity, or inside the patient's chest area, such as outside the thorax under the minor pectoralis muscle, or between the major and the minor pectoralis muscles. A pump may be provided for pumping the fluid between the chambers of the breast implant, and/or between one or more chambers and the remotely implanted reservoir. The pump may be manually driven, for which purpose it is advantageously implanted subcutaneously. Alternatively, the pump may be driven by a motor, which may likewise be implanted. Pump and/or motor may be driven by energy wirelessly transmitted from outside the patient's body. A control unit for controlling the entire process, in particular wirelessly, may be further provided. The breast implant may further have a rigid back plate, to which at least one chamber is fixedly connected, to provide stiffness, giving the breast implant a basic contour which is maintained throughout any shape changes of the breast implant. Furthermore, in order to improve the overall appearance of the breast implant, the part of the breast implant's outer wall facing away from the patient's chest may comprise a compartment filled with a soft material, such as silicone.
Thus, the breast implant system disclosed in PCT/EP2009/000622 offers a great variety of options for changing the shape and the size of a breast implant after its implantation. The changes can be easily carried out and controlled by the patient without any medical practitioner being involved.
U.S. Pat. No. 5,356,429 suggests to place a liner material in a body pocket in which the breast implant is to be placed. The liner material may be formed of a single sheet or a number of sheets of elastomeric material and is smooth on one side and textured on the other side. The textured side will allow growth thereonto of tissue against which it is positioned, whereas the smooth side will not adhere or allow growth thereonto of tissue against which it is positioned. This way, since one side of the liner does not adhere to the body pocket wall, the breast implant is allowed to flow or move within the pocket easily. In a specific embodiment two of those liners are provided facing each other with their smooth sides allowing the breast implant to readily slight between them.