Breast implant implantation method and apparatus

#The present invention relates to a breast implant implantation method and apparatus used in the method.

#More particularly, one aspect of the present invention relates to a method for implanting a breast implant into a subject, the method comprising: providing a sterile, flexible, elastic biodegradable bag sized to contain the breast implant; providing a sterile breast implant; inserting, using sterile handling, the sterile breast implant into the sterile bag to form a sterile breast implant assembly; closing the bag to fully enclose the implant within the bag; and implanting in a sterile manner the sterile breast implant assembly into the subject.

#Another aspect of the invention relates to a sterile bag, which may be provided in a kit, and preferably is used with one embodiment of the method. The bag includes first and second chambers connected by a channel for moving a breast implant from the first chamber through the channel to the second chamber without directly touching the implant. An incision dilator may also be included with the kit or provided separately for use in a preferred embodiment of the method.

#The foregoing summary, as well as the following detailed description of the preferred embodiments of the invention, will be better understood when read in conjunction with the appended drawings. For the purpose of illustrating the invention, there are shown in the drawings embodiments which are presently preferred. It should be understood, however, that the invention is not limited to the precise arrangements and instrumentalities shown.

#FIG. 1 is a vertical cross-sectional view of a first embodiment of a bag according to the present invention.

#FIG. 2 is a vertical cross-sectional view of the bag of FIG. 1 containing a breast implant, where the bag has been closed and sealed after the implant has been inserted.

#FIGS. 1 and 2 illustrate a first embodiment of a bag for use with the present invention for encasing a breast implant 10 to be implanted in a subject's body. As used herein, a “subject” typically refers to a human, and usually a woman, but also includes a man, where the implantation surgery and implantation generally uses standard breast reconstructive or augmentative surgical techniques, modified as described herein by the use of the bag containing the breast implant in a no touch procedure to assure sterility and reduce or prevent infection. However, the subject could also be any desired animal. Breast reconstruction usually occurs following complete mastectomy but can be also be done for a partial mastectomy usually in women, but also in men, as well as to correct or repair congenital deformities or traumatic injury to the breast. Breast augmentation is typically done by women for cosmetic reasons or by men regarding transgender surgery. A “no touch” procedure involves not touching the implant with any comtaminants, including without limitation surgical gloves, used surgical instruments, the skin surrounding the incision or the transected lacrimal ducts within the body. Nothing but the inside surface of the bag containing or to contain the implant should come into contact with the implant in a “no touch” procedure from the time the implant is removed from a sterile container until it is implanted into the subject. If and when gloves or implements contact any unsterile object in the operating theater, they are discarded or put aside for re-sterilization and new gloves and implements are used.

#With reference to the embodiment of FIGS. 1 and 2, a bag 12 includes a single chamber 14 for receiving and retaining the implant 10 through an opening 16. The opening 16 may be in the form of a slit, or a wider opening where the material around the opening can readily be overlapped to fully cover the implant so as to minimize and preferably prevent infection to an uncovered portion of the implant. Those of skill in the art can readily determine appropriate shapes, sizes and configurations for the openings or slits for a given size and shape of breast implant. The bag 12 is made of a flexible, elastomeric, biodegradable material, preferably a biodegradable polymer, which dissolves in the subject's body. After the implant 10 is sterilized and inserted preferably using a no touch procedure, the bag is closed, typically with sterile, biodegradable sutures 18 applied using a sterile needle. Alternatively or additionally, the closure may be made and/or sealed using biodegradable glue, such as fibrin glue, or a hydrogel glue made by mixing aldehyded dextran and ε-poly(l-lysine), as described in M. Araki, et al., J. Thorac. Cardiovasc. Surg., 2007; 134: 1241-1248 Any other biodegradable glue known to those in the art may also be used, if desired.

#Once encased within the bag 12, the implant 10 does not come into contact with anything other than the interior of the bag, thus assuring sterility and reducing or eliminating infection and foreign body contamination, as well as reducing the opportunity for adverse damage or weakening of the implant by direct handling. The implant encased within the bag forms a breast implant assembly. The term “breast implant assembly” as used herein also includes a bag supplied separately for encasing the implant and delivered to or available in the operating room for surgery, where the implant is encased within the bag to form the breast implant assembly at the time of the surgery. The bag may also be preassembled with the breast implant and supplied for surgery as a prepackaged breast implant assembly.