METHODS FOR NIPPLE FORMATION VIA COLLAPSIBLE DEVICES
Apparatus and methods for nipple and breast formation are described where devices precondition or expand a target nipple tissue to reduce the pressure exerted by the skin on an eventual implant. Generally, the apparatus comprises a mold having a contact surface which is curved in conformance with a breast upon which the mold is positionable, the contact surface having an adhesive for securement upon the breast, and the mold defining a cavity along the contact surface which conforms to a size of a nipple to be formed upon the breast and where the cavity further comprises the adhesive for securement to the nipple. A breast enlargement device comprises a cup larger than the target breast and further defines an inner surface which adheres to the breast when contacted.
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This application is a divisional of U.S. patent application Ser. No. 13/606,517 filed Sep. 7, 2012 (now U.S. Pat. No. 9,308,081), which claims the benefit of priority to U.S. Provisional Patent Application No. 61/532,734 filed Sep. 9, 2011, the content of each of which is incorporated herein by reference in its entirety.FIELD OF THE INVENTION
The present invention relates generally to medical devices and methods used for nipple reconstruction. More particularly, the present invention relates to apparatus and methods for nipple reconstruction utilizing devices which are mechanically simple to utilize.BACKGROUND OF THE INVENTION
In a majority of mastectomies, the nipple is not preserved. While breast implants are an option for women who would like to have their breasts reconstructed, nipple reconstruction is still a challenging problem which lacks good options. Currently, surgeons do their best to recreate a nipple, e.g., cinching skin together and/or implanting the nipple area with some filler or material such as a biomaterial or some allograft. The inherent challenge is that the skin, which is taut, tends to push any additive material into the body making the nipple appear flat.
Although techniques for nipple-saving mastectomies exist, in most cases, the nipple and areola tissue are removed. There is no established gold standard procedure for nipple reconstruction, however, with all techniques permanence of nipple projection is inconsistent or problematic, and therein is an unmet clinical need.
An example of a commercially available product that helps enlarge or precondition breasts prior to fat grafting is the BRAVA® (Brava, LLC, Miami, Fla.) which is typically worn at night by the user while sleeping.
However, the user is generally required to wear the device for a minimum of 10 hours per day for 10 to 14 consecutive weeks. This is usually very challenging given that a small pump must be worn in addition to the molds and a sports bra-like garment. Patient compliance is often a big challenge with BRAVA, and further it is not intended for or capable of nipple expansion.SUMMARY OF THE INVENTION
A nipple forming apparatus which may precondition, expand or maintain target nipple tissue may be utilized to reduce the pressure exerted by the skin on an implant. Generally, the apparatus may comprise a mold having a contact surface which is curved in conformance with a breast upon which the mold is positionable, the contact surface comprising an adhesive for securement upon the breast, and the mold defining a cavity along the contact surface which conforms to a size of a nipple to be formed or that has been formed by an implant upon the breast and where the cavity further comprises the adhesive for securement to the nipple.
In use, a first mold having a contact surface which is curved may be adhered upon a breast such that the mold conforms to a surface of the breast. The mold may further define a first cavity along the contact surface which will precondition or expand the skin on the breast that will eventually be formed into a nipple. This mold is adhered to a portion of the breast and is maintained upon the breast for a first period of time. The mold is then removed from the breast and a second mold having a contact surface is adhered upon the breast where the second mold defines a second cavity which is equal to or larger than the first cavity. The second mold is maintained upon the breast for a second period of time such that a size of the nipple is maintained when the second mold is removed from the breast. This process is repeated with subsequent molds as necessary to achieve the desired preconditioned or expansion.
When desired result is achieved, the mold can be removed and an implant placed in the newly formed nipple envelop. It may be desirable to adhere an appropriately sized mold after placing the implant within the nipple, which may hold the nipple in the desired conformation while some degree of settling takes place.
Generally, the cause of nipple flattening is multi-factorial and includes inadequate subcutaneous fat, internal pressure, external pressure, poor flap design, delayed healing, and tissue memory. Poor flap design, inadequate subcutaneous flu and delayed healing are more related to surgical technique. Permanent implants like ARTECOLL® (Artes Medical, Inc., San Diego, Calif.) or absorbable allografts like ALLODERM® (LifeCell Corp., Branchburg, N.J.) have been used to address the issues of internal and external pressure as well as tissue memory however these projections reduce over time. The devices and methods described herein address the internal and external pressures and tissue memory thereby making implants as described in U.S. Pat. No. 4,778,465, Surgically implantable areola and nipple prosthesis, more likely to persist.
Generally, the devices described herein precondition, expand or maintain the target nipple tissue (which is homogenous post-mastectomy) which reduces the pressure exerted on an implant by the skin. This can be done multiple ways where one variation may utilize an external mold that is adhered to the nipple target skin to create laxity in the skin prior to the implantation of a filler, whether fat or a biomaterial. Once the nipple skin is expanded, an implant such as ALLODERM® or a cylinder of hyaluronic acid threads or a chitosan sponge, for example, is surgically implanted. By creating a space, the forces acting on the nipple implant to drive it into the body may be minimized or rendered non-existent. In another variation designed to maintain nipple tissue, after implanting a filler to create the nipple shape, an external mold is adhered to the newly created nipple projection to reduce or eliminate the external pressure exerted by the skin on the implant while the skin remodels, allowing the nipple projection to be maintained.
Pressing the mold 1 on the top of the dome will invert the mold 1 to the configuration seen in
Once adhered to the target area on the breast tissue 7, the mold reversion process is initiated as shown in
In yet another variation, another embodiment may comprise stretching the breast tissue to form the nipple with the assistance of a suction or vacuum force. As shown in the partial cross-sectional side view of
When the device is released and allowed to revert back towards its relaxed configuration as seen in
Aside from the openings 3 for allowing fluid communication with a vacuum source, the openings 3 may also serve to allow for any sweat or fluid from the adhered skin to evaporate through the openings 3. Additionally and/or alternatively, the material forming the sides or walls of the nipple mold 4 may also define one or more openings therethrough to allow for sweat or fluids to evaporate from the underlying skin. Aside from the one or more openings, the material and/or adhesive may be permeable to fluid.
Clinical experience has shown that forming the nipple must be done gradually. Attempting to recruit skin too quickly creates high stress/strain concentrations in the skin that can lead to blisters, tears, infection and/or scarring. This can delay the process and complicate further nipple formation efforts. To minimize the risk, one or more molds may be utilized in progression where each subsequent mold may define a nipple mold which is progressively larger than the previous mold to subsequently stretch the nipple into a progressively larger size.
Once the progression of one or more is completed and the patient has reached the required nipple size, expansion may be stopped and an implant material or filler such as fat or a biomaterial may be inserted to permanently form the nipple as shown in
The applications of the disclosed invention discussed above are not limited to certain treatments or regions of the body, but may include any number of other treatments and areas of the body. Modification of the above-described methods and devices for carrying out the invention, and variations of aspects of the invention that are obvious to those of skill in the arts are intended to be within the scope of this disclosure. Moreover, various combinations of aspects between examples are also contemplated and are considered to be within the scope of this disclosure as well.
1. A method of forming a nipple, comprising:
- reconfiguring a mold into a first collapsed configuration and a mold skirt into a first extended configuration, where the mold skirt is attached to a portion of the mold;
- adhering the mold having a contact surface which is curvable onto a region of a breast where a nipple is to be formed;
- reconfiguring the mold into a second molding configuration such that the mold defines a receiving cavity and draws the adhered region of the breast into the mold and away from a remainder of the breast;
- reconfiguring the mold skirt into a second supporting configuration such that the mold skirt forms a smoothed surface relative to the mold in its second molding configuration.
2. A method of forming a nipple, comprising:
- adhering a first mold upon a breast such that the mold conforms to a surface of the breast, wherein the first mold has to contact surface which is curved and further has a first mold skirt attached to a portion of the first mold, and wherein the first mold defines a first cavity along the contact surface which conforms to a size of a nipple to be formed upon the breast;
- adhering a portion of the breast where a nipple is to be formed within the cavity
- maintaining the first mold upon the breast for a first period of time of at least one day;
- removing the first mold from the breast and adhering at least a second mold having a contact surface upon the breast, if needed, wherein the second mold has a second mold skirt attached, and wherein the second mold defines a second cavity which is larger than the first cavity; and
- maintaining the second mold upon the breast for a second period of time of at least one day such that a size of the nipple is maintained when the second mold is removed from the breast.
3. The method of claim 2 further comprising repeating additional applications of molds with subsequently larger cavities until a predetermined nipple size is achieved, if needed.
4. The method of claim 2 further comprising inserting an implant into the formed nipple to maintain a shape and size of the nipple.
5. The method of claim 4 further comprising reapplying a mold after the implant is inserted to allow an implant-tissue interface time to equilibrate.
6. The method of claim 2 wherein the first mold is invertible and a portion of the first cavity is adhered to the target nipple tissue while inverted, wherein reversion of the first mold back to its first configuration recruits and stretches tissue at the surface of the breast and secures the tissue in place within the cavity.
7. The method of claim 2 wherein adhering a first mold comprises actuating a vacuum pump in fluid communication with the first mold.
8. The method of claim 2 wherein adhering a first mold comprises adhering the surface of the breast within the first cavity via an adhesive.
Filed: Apr 8, 2016
Publication Date: Aug 4, 2016
Applicant: TauTona Group Research and Development Company, L.L.C. (Menlo Park, CA)
Inventors: Kenneth N. HORNE (San Francisco, CA), Sergio SALINAS (Redwood City, CA), Geoffrey C. GURTNER (Palo Alto, CA), Michael H. ROSENTHAL (Menlo Park, CA), Christopher S. JONES (Menlo Park, CA), Joseph RIMSA (Palo Alto, CA)
Application Number: 15/094,889