Patent Publication Number: US-2011076920-A1

Title: Novel enhanced filamentous silicone products and processes

Description:
This application is a continuation-in-part of U.S. application Ser. No. 11/171,900 filed on Jun. 30, 2005. 
    
    
     BACKGROUND OF THE DISCLOSURE 
     The present disclosure relates to novel siliceous products and fabrication processes. In particular, the present disclosure relates to silicone-based products heretofore unavailable, in the form of fibers, strands, threads, and other filamentous bodies, or by products made by further processing the same, and methods for generation of these novel products. 
     DESCRIPTION OF THE PRIOR ART 
     While thousands of finished silicon-based products are known, it is respectfully proposed that prior to the advent of the instant teachings longstanding needs remain. For example, prosthetic implants such as that discussed in U.S. Pat. No. 5,176,708 have been plagued by longstanding issues, and have not been improved in spite of tremendous demands in the marketplace. Many have been harmed by these products, particularly silicone breast implants which have leaked. Those skilled in the art understand the primary pitfalls in the area, so further details of these failures themselves are omitted from this discussion, which, it is respectfully proposed, focuses upon the teachings of the present disclosure which are believed to be a paradigm shifting improvement applicable to this field of art. 
     Likewise, fillers, such as those described in U.S. Pat. No. 6,013,234 and U.S. Pat. No. 3,383,172 have long been sought for many needs, yet fraught with issues of their own. Significant among these shortcomings are price, ease of manufacturability, consistency and general ability to be used for alternative types of applications. The search for substantially weightless, robustly tensile and memory-laden silicone constructions is ongoing. 
     Compositions of silicone-related materials and ways of making them ranging from U.S. Pat. No. 4,094,771 to U.S. Pat. No. 4,753,978 have long been sought to fill particular industrial needs. Each of the foregoing Letters Patent documents is herein expressly incorporated by reference as if fully set forth in this specification, yet none has pointed toward the teachings of the present disclosure, short of underscoring the clear needs for the objects of the teachings of the instant disclosure. 
     Aside from non-melanoma skin cancer, breast cancer is the most common form of cancer in women. Breast cancer is the number one cause of cancer death in Hispanic women. It is the second most common cause of cancer death in white, black, Asian/Pacific Islander, and American Indian/Alaska Native women. In 2006, 191,410 women were diagnosed with breast cancer and 40,820 women died from breast cancer. About 207,090 new cases of breast cancer will be diagnosed in women in the United States in 2010. 
     Mastectomy is the surgical removal of the entire breast. Some women have the option of mastectomy or lumpectomy (also called breast conserving surgery) plus radiation. Other women can only have mastectomy. Some women at high risk of getting breast cancer may consider mastectomy to try to prevent breast cancer (called prophylactic mastectomy). 
     As if haven&#39;t a mastectomy isn&#39;t stressful enough, there is the added stress for the patient following the surgery in deciding what steps to take next. When a patient chooses not to have reconstructive surgery, they may elect to use a prosthetic device to provide symmetry to their body. A mastectomy bra is a specially designed bra for use with a breast prosthesis. A breast prosthesis should be made to look and feel like mature breast tissue. But mastectomy bras in today&#39;s market require constant refitting because the filler material inserted in the bra cup is either liquid or semi-liquid based. In addition, regular mastectomy bras all come with two sewn-in pockets, which is one pocket too many for women who have had single breast surgeries. The instant disclosure provides a material wherein the elastic memory and tensile strength remain constant over time. 
     The teachings of the present disclosure have produced a new silicone end product different from those silicones known, industrially or commercially used or contemplated to date. 
     SUMMARY OF THE DISCLOSURE 
     Briefly stated filamentous bodies which are longitudinally extended and other film-like constructions are made by combining liquid siliceous precursors with air and extruding them. Distinct types or grades of fibers, strands, and other film-like constructions are produced which have a multiplicity of useful applications and indications for use owing to their inherent memory, compactability, tensile strength and density. Processes for making the novel enhanced filamentous bodies and products by the same can be optimized for uses ranging from safe and effective (“leak-free”) prosthetics to cushions, inserts, membranes, in a plurality of fields from consumer electronics to medical devices, and athletic or orthopedic shoe inserts. 
     According to features of the present disclosure there are provided novel enhanced prosthetic devices which comprise, in combination: a flexible container having a space for receiving a plurality of filamentous silicone members housed within the space in the container, wherein the filamentous silicone members exist within the flexible container without measurable compression within the space, and wherein the flexible container has elastic memory to form and maintain the shape of a woman&#39;s chest. 
     An additional feature of the present disclosure provides for an adhesive layer to be coated onto the exterior portion of the flexible container. It is disclosed that the adhesive layer attaches to an interior lining of a bra, a sports bra or a bathing suit. Further, the flexible container is removable from the bra. The flexible container may also be pigmented to match a user&#39;s skin tone. 
     According to features of the present disclosure there are provided a mastectomy garment comprising: a plurality of filamentous silicone members, a flexible container with a space for receiving the plurality of filamentous silicone members and the plurality of filamentous silicone members housed within the space in the container; and a bra having at least one bra cup in which the bra cup is adapted to receive the flexible container and the flexible container is housed within the bra cup. 
     Yet still another feature of the present disclosure defines the mastectomy garment described above wherein the bra cup is sealed to permanently house the flexible container. It is disclosed that the bra and the flexible container inside the bra cup are machine washable. In addition, the bra cup may be unsealed to allow for the flexible container to be refilled with filamentous silicone members. 
    
    
     
       BRIEF DESCRIPTION OF THE FIGURES 
       The above-mentioned features and objects of the present disclosure will become more apparent with reference to the following description taken in conjunction with the accompanying drawings wherein like reference numerals denote like elements and in which: 
         FIG. 1  shows a photograph of an embodiment of novel silicone filaments according to the teachings of the present disclosure; 
         FIG. 2  shows another photographic depiction of an additional embodiment of novel silicone fibers according to the teachings of the present disclosure; 
         FIG. 3  likewise illustrates strands of novel silicone products according to the teachings of the present disclosure; 
         FIG. 4  is a photograph of pieces of novel silicone products according to teachings of the present invention; 
         FIG. 5  photographically depicts finer pieces of novel silicone products, according to the disclosure; 
         FIG. 6  is a photograph of pieces of twine according to the present novel silicone products of the present disclosure; 
         FIG. 7  depicts photographically yet a finer grade of twine according to the teachings of the present disclosure; 
         FIG. 8  photographically illustrates an embodiment of silicone thread, according to the teachings of the present disclosure; 
         FIG. 9  shows an assembly including a silicone thread being packed into an exemplary holder for the same, according to embodiments of the teachings of the present disclosure; 
         FIG. 10  is a photograph of an assembly using threads and an implantable exemplary-prosthesis, according to teachings of the present disclosure; 
         FIG. 11  is a photograph of a thin sheet of silicone according to the present disclosure; 
         FIG. 12  shows an alternate ribbon like film of novel silicone according to the teachings of the present disclosure; 
         FIG. 13  shows an assembly used according to a process for making the instant disclosure; 
         FIG. 14  shows an assembly used according to a process for making the instant disclosure; 
         FIG. 15  shows an assembly used according to a process for making the instant disclosure; 
         FIG. 16  shows an assembly used according to an alternate process for making the instant disclosure; 
         FIG. 17  shows an assembly used according to an alternate process for making the instant disclosure; 
         FIG. 18A  through H each shows one step in an alternate process used according to the method for making the instant disclosure; 
         FIG. 19A  shows a side perspective view of the instant disclosure; 
         FIG. 19B  shows a rear perspective view of the instant disclosure; 
         FIG. 20  shows a schematic of a sleeve with an adhesion layer applied to the exterior of the sleeve. 
     
    
    
     DETAILED DESCRIPTION OF THE DISCLOSURE 
     The present inventor has discovered novel enhanced filamentous silicone strands, fibers, threads, and film-like constructions can be easily generated which have a multiplicity of useful applications. Heretofore uncontemplated, the products of the present disclosure allow for various usages that address, ameliorate and otherwise overcome longstanding needs, such as in the silicone prosthetic implant field, which filed is rife with issues currently. Other uses will become known to artisans in perusing the instant specification and studying the claims which are appended hereto. 
     Example 1 
     Referring now to  FIG. 1  silicone filament is shown which may be created from a combination of conventional silicone precursor elements as known to those skilled in the art from liquid silicone rubber parts A (catalyst: reinforced dimethyl methylvinyl siloxanes), Part B (crosslinking agent: reinforced dimethyl methylhydrogen) (For example, Rhodia-A LSR-4330 Silbione® HCA Part #V50131A-40 Lot 0409031, B LSR-10 Silbione® HC Part #V500004B-40 Lot 26776, Medical Grade available from Rhodia Europe/Rhodia SA, 26, quai Alphonse Le Gallo, 92512 Boulogne-Billancourt cedex and Rhodia Amerique du Nord/Rhodia Inc., 259 Prospect Plains Road, Conn. 7500, Cranbruy N.J. 08512-7500) which is then whipped, beaten and extruded through a die according to the teachings of the present disclosure. Likewise heat cured silicone rubbers are commercially available in 2 parts systems (A and B). These parts need to be precisely mixed to produce consistent product, requiring controlled pumping and mixing equipment. In 2004 Laur Silicone developed a ONE PART™ heat curable liquid silicone rubber using the EASY CURE™ technology (patent pending). This EASY CURE™ system greatly reduces the requirements for meter mix equipment. ONE PART™ liquid silicone can be supplied fully compounded and ready to use. 
     According to the teachings of the present disclosure, the aerated or fluffed emulsion cures, encapsulating gaseous elements which create heretofore unconstructed silicone products having many uses. 
     Extruding nozzles or screen assemblies and die plates may alternately be employed having aperture configurations which drive aspects of the specific tubular orientation desired to be achieved. Artisans understand that liquid silicone materials will not be altered in terms of physical properties until adequate temperatures are achieved, for example (once A and B are mixed, these materials have short pot lives that are inversely related to temperature) and the instant disclosure has used a heating chamber at 350 degrees Fahrenheit which circulates hot air to house the extrudate for drying. 
     Fabricators typically operate at vulcanization temperatures between 250° and 375° F. Actual results will depend on the design and size. According to this example, as the elongated filaments are extruded through the apertures or screen elements long strands hang curtain-like downward. 
     The curtain-like strands or threads, filaments, fibers, twines may be extruded directly from the die plate into the drying chamber, for example, the curtain-like group of filaments is deposited directly on a metal mesh that prevents sticking and allows for easy removal. The metal mesh itself is mounted on a moving belt that pushes the filaments outside of the heating chamber for easy removal, where they are reeled on a cocoon-like holding rod. A resulting product has diameter that varies between a few and several millimeters in diameter. 
     Example 2 
     Referring now to  FIG. 2  and  FIG. 3 , the process steps set forth above in the first example apply, however the diameters achieved are larger, here silicone fibers may be created also by mixing the silicone emulsion combining at least one of the ratios selected from the group consisting of 30/70, 40/60 and substantially equal aliquots of the two different liquid silicon precursors, of silicone A and B, medical grade (available also from Applied Silicone, Liquid Silicone Rubber, LSR 10, Part A, Lot 17689, and Silastic® Q7-4850 Lot hh 063161; Part B Silastic® Q7-48750 medical grade liquid silicone rubber). Medical grade silicone ingredients yield biocompatible product that may be used to fill containers used, for example for cosmetic facial enhancements, or as breast implants without any concerns about leakage, biocompatability, contamination, or many of the other problems which currently exist (see, for example  FIGS. 8-10 ). The process steps are similar to Example I, and different from the prior art by using a metal die, which is in its most rudimentary form simply a metal disc with apertures extending through it, following at least about ten minutes of mechanical agitation which suspends air into the mixture. 
     Referring specifically now to  FIG. 3 , strands of silicone having a larger diameter may also be mixed from at least one of the Dow Corning® brand of constituents, intermediates from GE Silicones® or the Walker-Chemie® brands of products. The silicone filaments, fibers and strands have elastic memory, tensile strength and a sufficiently high fill density in a compacted state rendering them effective for occupying a predetermined space over time without degrading, the diameter of the objects of this example are greater than several millimeters in diameter. 
     Example 3 
     Referring now to  FIG. 4  through  FIG. 6 , exemplary embodiments with varying diameters are shown, that have been subjected to additional chopping or cutting step during the finishing process. 
     As discussed above, a silicone emulsion was made by combining at least one of the ratios selected from the group consisting of 30/70, 40/60 and substantially equal aliquots of the two different liquid silicon precursors, substantially equal aliquots of silicones A and B, medical grade selected from the group consisting of 10, 20, 30, 40 and 50 type (manufacturer&#39;s suggestion for second-wise definitions of the optimal curing time for cross-linking to be achieved). The sources are as discussed in the first two examples. Mechanical agitations using a motor driven mixing machine were imparted to the mixture for approximately ten minutes. 
     The fluffed emulsion was then moved into a pressing machine having a die plate having a plurality of apertures through which it was extruded onto a rotating deposit plate into a drying chamber at 350° F. The resulting product was chopped into pieces, as shown in  FIG. 4 ,  FIG. 5 , and  FIG. 6 , as discussed above, curtain-like strands may be extruded directly from the die plate into the drying chamber, for example, the curtain-like group of filaments is deposited directly on a metal mesh that prevents sticking and allows for easy removal. The metal mesh itself is mounted on a moving belt. 
     Example 4 
     Referring now to  FIG. 7 , once again a silicone emulsion was made by combining substantially equal aliquots of silicones A and B, medical grade selected from the group consisting of 10, 20, 30, 40 and 50 type (manufacturer&#39;s suggestion for second-wise definitions of the optimal curing time for cross-linking to be achieved). (Rhodia-A LSR-4330 Silbione® HCA Part #V50131A-40 Lot 0409031, B LSR-10 Silbione® HC Part #V50000413-40 Lot 26776, Medical Grade available as discussed above). Mechanical agitations using a motor driven mixing machine were impacted to the mixture for approximately ten minutes. 
     The fluffed emulsion was then moved into a pressing machine having a die plate having a plurality of apertures through which it was extended onto a rotating plate into a drying chamber at 350° F. By sending the extruded filaments onto a round rotating dish, these exemplary embodiments were dried in under a minute. 
     The silicone is extruded at the same speed as the rotations of the drying or receiving plate which provides enough time for drying prior to another layer of silicone being deposited. 
     Example 5 
     Referring now to  FIG. 8 , a view is shown which photographically illustrates an embodiment of silicone thread, and by using smaller configuration of apertures, or a screen, a finer grade of filament is achieved. As in the above examples, a silicone emulsion was made by combining at least one of the ratios selected from the group consisting of 30/70, 40/60 and substantially equal aliquots of the two different liquid silicon precursors, substantially equal aliquots of silicones A and B, medical grade as discussed above. 
     Mechanical agitations using a motor driven mixing machine were impacted to the mixture for approximately ten minutes and then the fluffed emulsion was then moved into a pressing machine having a die plate having a plurality of apertures through which it was extended onto a rotating plate into a drying chamber at 350° F. By sending the extruded filaments onto a round rotating dish, these exemplary embodiments were dried in under a minute. The silicone was extruded at the same speed as the rotations of the drying or receiving plate which provided enough time for drying prior to another layer of silicone being deposited. 
     According to this example miniscule holes are located on the die plate or extrusion nozzles and as the silicone moves through the holes it forms strands which hang down in a curtain-like fashion. Finer threads are dried for shorter periods of time, and this range for this example is between roughly ⅓ and ⅔ of a minute, with a resulting novel aerated silicone filament defined by having at least one of a nano, pico, meso or millimeter scale longitudinally extended axis about a central plane defined by a cathetus. 
       FIG. 9  shows an assembly including a silicone thread being packed into an exemplary holder for the same, according to embodiments of the teachings of the present disclosure, those having a modicum of skill in the art will understand that both the container and the threads are biocompatible, and that none of the challenges of fluid filled media are present according to the teachings of the present invention. 
       FIG. 10  is a photograph of an assembly using threads and an implantable exemplary prosthesis such as one appropriate to use as a breast implant, according to teachings of the present disclosure. Those skilled in the art will appreciate that the threads of the instant teachings provide many design options and that they will work with, or in place of many aspects of conventional systems. 
     Referring now to  FIG. 11  and  FIG. 12  there are shown photographs of thin sheets of silicone according to the present disclosure, and an alternate ribbon like film of novel silicone according to the teachings of the present disclosure. These products are generated by processes similar to the example described above, as modified by the details according to the process in  FIG. 18  and its many sub-parts. Likewise, variations of the processes taught herein, such as, spreading a thin film of silicone emulsion onto a heating plate is done, as when one makes an omelet or crepe, and depending upon the thickness, the film-like construction cures extremely fast, in a matter of seconds. 
     Referring now to  FIG. 13  there is shown an assembly used according to a process for making the instant disclosure, illustrated in schematic form. Those skilled in the art will understand that motor  101  (for example available from B&amp;B Motoro &amp; Control Corp. of 96 Spring Street, N.Y., N.Y. 10012/Bodine Electric Company, 115 V, 60 HZ Model Number 728D2202/Type KCI-24A2) represents any conventional mixing mechanism connected to a blade or stirring arm or means  99  effective to stir, or mechanically agitate the mixture  22  of silicone emulsion was made by combining substantially equal aliquots of silicones A and B, medical grade as referenced above. 
     Air source  103  allows the mixture to have a grease-like viscosity by imparting aeration to the emulsion, as likewise would be understood by those having a modicum of skill in the art. At least about 10 minutes of mixing time is effective for use with the teachings of the present invention as discussed in the examples which are set forth above, and the claims defined below. 
       FIG. 14  further shows an assembly used according to a process for making the instant disclosure, whereby the steps of pressing the fluffed emulsion  22  through a pressing machine  105  equipped with a die plate, extruding silicone filaments  38  onto a belt  107  (likewise a plate or dish, not shown works), and drying the silicone filaments using a heat source  109  is done. 
       FIG. 15  shows another assembly used according to a process for making the instant disclosure whereby dual agitator motor assembly  102  (for example, including a 20 RPM motor at a top position, in communication with two 100 RPM motors, one with a clockwise rotation, and the other with a counterclockwise rotation) uses conventional mixing mechanisms connected to at least two blades or stirring arms  99  effective to stir, or mechanically agitate the mixture  22  of silicone emulsion was made by combining substantially equal aliquots of silicones A and B, medical grade as referenced above. 
     Air source  103  is connected with tubing for injection of air into the mixture, and allows the mixture to have a viscous paste-like consistency by imparting aeration to the emulsion, as likewise would be understood by those having a modicum of skill in the art. At least about 10 minutes of mixing time is effective for use with the teachings of the present invention as discussed in the examples which are set forth above, and the claims defined below. Output can be taken through port  17 , which may have conventional doors, valves or gating means associated therewith a would be known to those skilled in the art. 
     Referring now to  FIG. 16 , output from port  17  of  FIG. 15  may pass into  119 ,  125  as it is a sliding device using piston  122  to drive emulsion  22  (not shown) by way of reversible motor  115  driving shaft with center piece  117  back an forth, to leverage outputs  121  and  127  onto plate  129 , which carries a row of tiny holes. 
       FIG. 17  likewise picks up the exudate  38  and mechanically brings it through a drying chamber  111  at 350 degrees Fahrenheit, using heat source  109  and metallic wire mesh  113 . Filaments, fibers, strands  110  are thus dried for between 30 seconds and one and one-half minutes. 
       FIG. 18A  through H each shows one step in an alternate process used according to the method for making the instant disclosure, as will be clear to those skilled in the art, having read the above specification and studied the claims appended hereto. Not unlike the process disclosed in U.S. Pat. Nos. 6,612,823 and 6,585,504 each of which are expressly incorporated herein by reference as if fully set forth herein. 
     It will be appreciated that the silicon filamentous members may be easily inserted inside a silicone flexible pouch, sleeve or container. As it will become readily apparent to one of ordinary skill in the art, the filamentous members provide characteristics found to be desirable in a prosthetic device. However, unlike most prosthetic devices that are flexible and cannot maintain their breast-like shape when not being worn, the elastic memory of the filamentous members ideally conforms to the contours of a breast for a mastectomy patient and maintains its shape. 
     The shape and use of the prosthetic device may vary based on the woman&#39;s needs as well as the garment that is being worn: a woman&#39;s needs varying based upon the extent of the surgical procedure. The garments may range from a traditional mastectomy bra to a sports bra. Other garments in which the prosthetic device may be inserted include formal wear, bathing suits, nightgowns, etc. 
     Further, the filamentous fibers encapsulated in the flexible pouch may be worn, washed and stored in the same manner as a conventional bra. It is further contemplated by the present inventors that the sleeve can be color-coated to match the skin tone of the user. 
     Due to the unique properties of the instant disclosure, the filamentous members exist within the sleeve without measurable compression within that space. And, as stated previously, the elastic memory and tensile strength of the filamentous members remain constant over time such that load bearing is effectively done without perceptible decrease in the volume of the filaments. 
     Referring now to  FIGS. 19A and 19B , shown is a sleeve filled with filamentous members  200  inserted into a pocket of a bra. The pocket may be sewn shut for permanent fixture of the sleeve inside the bra cup. Because the silicone members have an elastic memory and load bearing has an insignificant effect on the volume of the filaments, the sleeve  200  holds its shape over time. The bra may be worn over and over again without significant changes to the sleeve&#39;s shape and its filamentous members&#39; volume. Thus, the instant disclosure provides a material that is long lasting. 
     In an alternative embodiment, the sleeve may be attached to a standard over-the-counter bra, without use of a pocket, by adhering it to the lining of the bra or along the bra&#39;s sides and rim. This embodiment provides for the removal of the sleeve. Upon removal of the sleeve, the bra may be washed without the sleeve. In addition, the sleeve may be re-stuffed with the filamentous members to compensate for any loss in volume. 
       FIG. 20  shows a sleeve  200  filled with filamentous members with an adhesion layer that is applied to the exterior of the sleeve. The adhesive layer provides a pasty-like attachment area  205  to be attached to the user&#39;s skin. The adhesion layer may be coated or sprayed onto the sleeve during the manufacturing process. The sleeve is then attached to the breast by adhesion. A bra provides additional support by maintaining the sleeve in its desired position. 
     While the apparatus and method have been described in terms of what are presently considered to be the most practical and preferred embodiments, it is to be understood that the disclosure need not be limited to the disclosed embodiments. It is intended to cover various modifications and similar arrangements included within the spirit and scope of the claims, the scope of which should be accorded the broadest interpretation so as to encompass all such modifications and similar structures. The present disclosure includes any and all embodiments of the following claims.