Abstract:
The present invention relates to a customizable prosthesis, for instance a breast prosthesis, comprised of an outer shell, removable micro-compartments and flexible filling tubes formulated out of soft Poly (methyl 2-methylpropenoate) gel, wherein the removable micro-compartments of the prosthesis are arranged in a hierarchical layering scheme to create a prosthesis capable of undergoing modifications quickly, easily and with minimal invasiveness, while retaining a prosthesis with low specific gravity.

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
       [0001]    Not applicable. 
       FIELD OF THE INVENTION 
       [0002]    The field of the invention relates to medical prosthesis and, more particularly, to those medical prostheses used for breast, testicular, lips or buttocks. 
       BACKGROUND OF THE INVENTION 
       [0003]    Over the years, various implants have been designed to resemble the feel of a natural breast, or the shape and size of a natural breast. Breast augmentation surgeries have been performed in accordance with a plurality of procedures for decades by medical professionals in this field. In general, these procedures have consisted of inserting a singular sac into each breast and then volumizing the cavity with “fillers” such as silicone, saline, aqueous sugar solutions, aqueous solutions consisting of polyethylene glycol and other chemically inert, non-inflammatory, non-allergenic, and non-carcinogenic compositions. 
         [0004]    Silicone fillers in general provide more viscous characteristics and thus more closely resemble the look and feel of a natural breast. However, silicone compounds remain slightly reactive when implanted into one&#39;s body and as a result threaten the vitality of the body in the event the silicone implant leaks or ruptures. Under such circumstances, the silicone is capable of moving freely throughout the body and collecting in major bodily organs. The presence of free silicone in the body has incited autoimmune responses in many patients ultimately resulting in the patient&#39;s body reaching a severe debilitated state. 
         [0005]    Saline implants have provided additional flexibility to the size and symmetry of the breast (e.g., the amount of fluid injected will affect how large the implant or how small the implant would be). However, flexibility to change the size of the breast with time is not simple in these conventional implants and replacement of the implant may be necessary if a change is desired. Furthermore, the weight of the implant becomes an issue when electing to go with a larger implant. The additional weight resulting from the implantation of the larger implant presents an undue burden on the recipient and ultimately may cause ailments in the user (i.e., increased back pain resulting from the weight of a larger breast implant). 
       SUMMARY OF THE INVENTION 
       [0006]    An implant comprises a biologically proven inert material that encases compartments of fluid and/or gas to form a prosthesis of varied characteristics. The prosthesis contains at least one micro-compartment in a hierarchical layered formation each of which contain filler consisting of liquid, air, gas, gel or combination thereof. The amount of filler injected into each micro-compartment varies depending on the size and shape that the receiving individual seeks to achieve. Moreover, the removable nature of the micro-compartments facilitate one&#39;s ability to customize the prosthesis (i.e., if a smaller prosthesis is warranted, a medical examiner may extract filler from the prosthesis using a medical instrument, or even remove the micro-compartments to change the specific gravity of the prosthesis). Modifying the number of micro-compartments and amount of filler in the micro-compartments helps the receiving individual achieve an implant custom to their specific needs. 
         [0007]    The customizable prosthesis comprises a flexible outer shell made of soft Poly(methyl 2-methlypropenoate) gel (hereinafter “PMMA”) having at least one flexible filler tube for facilitating the traversal of injected fluids. Within the cavity of the outer shell, there is at least one micro-compartment arranged in a hierarchical layered scheme. The micro-compartments may be filled with fluids and inert gases or combination thereof. After the prosthesis has been placed into the surgically prepared implant site, the filler tube or tubes are drawn to a point that terminates adjacent to the arm pit. The input ports, through which fillers are injected, may be buried under the skin in the vicinity of the armpit at the end of the procedure. These input ports are accessible in the future for the purpose of modifying the structural characteristics and qualities of the prosthesis. For example, as the individual gets older, they may want to modify the size and shape of breast implant, therefore a lighter breast may be achieved by injecting multiple micro-compartment layers comprised of inert-gases behind the first micro-compartment, which can be comprised of a fluid-like solution. Injecting multiple micro-compartments with an inert gas creates an implant that possesses a lower specific gravity than an implant made of purely fluid fillers. As stated above, the injected fillers can be made of saline, silicone gel, PMMA gel, or other fluids and/or gases that are biologically tolerated (e.g., chemically inert compositions). Moreover, the injected filler may further comprise a fluorescent agent to serve as a visual aide for medical professionals when examining the implant in the dark under blue light (e.g., Ultra Violet Light). 
         [0008]    The fluorescent agent creates an incentive in the receiving individual to periodically follow up with their physician for check-ups because the examining physician will be able to determine whether the implant has shifted from the implant site or whether any leaks are present when viewed under blue light. The fluorescent agent found in the filler makes it easier to for a medical professional to examine the structure of the prosthesis as a whole with minimal invasiveness. Moreover, at any time after the surgery, the size, shape and/or consistency of the prosthesis may be altered via a simple procedure conducted at an office visit. A medical professional can make a small incision after locating the filler tube under blue light and simply inflate or deflate the prosthesis with a filler until the desired shape, size, weight and/or consistency of the individual is achieved. 
         [0009]    The soft PMMA materials have been shown to be biologically inert and have been proven to lack any adverse reactions within the body. PMMA has been a well respected and useful compound for those in the field of Ophthalmology. The physical properties (e.g., durable, light weight, and memory-like qualities) and chemical properties (e.g., inert compound) of PMMA have contributed to the ongoing use by medical professionals today. Today, the soft PMMA materials can be manufactured to conform to the various shapes and firmness values desired by the customer. The design of multiple micro-compartments implanted within the cavity of the outer shell of the prosthesis serves a novel feature in decreasing the total weight of the prosthesis, independent of its size, while simultaneously preserving the qualities of a natural breast. Controlling the specific gravity of the prosthesis is a major breakthrough in the field of cosmetic surgery because the recipient may modify the prosthesis as they get older. For example, as women age the glandular tissues of the breast start to breakdown, ultimately accounting for the cause to ptosis of the breasts. Other relevant factors leading to ptosis of the breasts include a women&#39;s body mass index (hereinafter “BMI”), number of pregnancies, whether they have ever breast fed, family history and overall weight. However, the apparatus and method of implementing a prosthesis with customizable features resolves the ptosis of the breasts dilemma. An individual with the implant may at anytime decrease the amount of aqueous filler in the first micro-compartment layer and increase the number of micro-compartment layers filled with inert gases as a means to decrease the specific gravity of the breast. Light weight and more supportive breasts are derived from decreasing the specific gravity of the prosthesis. As such, the present invention facilitates a user&#39;s ability to reduce their breast size, increase their breast size and “lift” their breasts via a minimally invasive procedure. 
         [0010]    These and other objects, features, and advantages of the present invention will become apparent from the following detailed description of illustrative embodiments thereof, which is to be read in connection with the accompanying drawings. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0011]    These and other features and advantages of the present invention will be better and more completely understood by referring to the following detailed description of example non-limiting embodiments in conjunction with the drawings, of which: 
           [0012]      FIG. 1  illustrates a perspective view of a customizable prosthesis in accordance with one or more embodiments of the present invention. 
           [0013]      FIG. 2  illustrates a perspective view of the micro-compartments of a customizable prosthesis in accordance with one or more embodiments of the present invention. 
       
    
    
     DETAILED DESCRIPTION 
       [0014]    Various aspects and embodiments of the present invention will now be described in detail with reference to the accompanying figures. Certain terminology is used herein for convenience only and is not to be taken as a limitation on the present disclosure. The terminology includes the words specifically mentioned, derivatives thereof and words of similar import. The embodiments illustrated below are not intended to be exhaustive or to limit the disclosure to the precise form disclosed. These embodiments are chosen and described to best explain the principle of the disclosure and its application and practical use and to enable others skilled in the art to best utilize the disclosure. 
         [0015]      FIG. 1  illustrates a perspective view of a customizable prosthesis  100  designed for surgical implantation into the soft tissue of an individual. Prosthesis  100  is further comprised of flexible implant tube  102 , injectable port  104 , outer shell  106  and prosthesis cavity  108 . 
         [0016]    Prosthesis  100  is surgically implanted into an individual at a small localized incision via a medical instrument. Outer shell  106  of prosthesis  100  is formulated out of a polymer (e.g., PMMA) that possesses memory-like and ductile qualities. The structural qualities embraced by outer shell  106  provide the surgeon with several alternative procedures in which to implant the prosthesis (e.g., prosthesis may be implant via a localized incision; prosthesis may be implanted via a medical instrument possessing an injectable means). Upon implantation of prosthesis  100 , the volume of prosthesis  100  may be modified in accordance with the patient&#39;s specifications. For example, a patient may increase the size of prosthesis  100  via an influx of filler (e.g., saline, PMMA, inert gas, silicone, etc.) injected by a medical instrument at injectable port  104 . The filler then traverses along implant tube  102  and empties in prosthesis cavity  108 . Alternatively, a patient may decrease the size of prosthesis  100  by retracting filler from prosthesis cavity  108 . A single filler or combination thereof may contribute to the volumization of prosthesis  100 . Prostheses cavity  108  may consist of a singular inflatable compartment or a plurality of micro-compartments arranged in a hierarchical layered scheme wherein each compartment possesses elastic and memory-like structural characteristics. 
         [0017]    Prosthesis  100  is not limited to purely augmentation mammoplasty procedures. An individual may have prosthesis  100  implanted for a plurality of cosmetic procedures including but not limited to lip enhancements, buttock augmentation and testicular implants. The procedures relating to the implant of prosthesis  100  is very similar regardless of the location of the implant itself. A localized incision is made, prosthesis  100  is then implanted at the site of the localized incision, prosthesis  100  is then maneuvered into the proper position, prosthesis fluid is injected by an individual at injectable port  104  via a medical instrument to achieve the desired size, shape and/or firmness and then injectable port  104  is clamped and stowed within the tissue of the individual upon completion. As described above, the filler&#39;s injected into prosthesis  100  for augmentation mammoplasty procedures may remain the same for every other cosmetic surgery performed using the described materials. 
         [0018]      FIG. 2  illustrates a perspective view of micro-compartments  204  incorporated within customizable prosthesis  200 . Micro-compartments  204  are designed to achieve the ideal shape and weight of prosthesis  200  Like outer shell  106 , micro-compartments  204  are manufactured from the polymer PMMA. Outer shell  206  is further comprised of at least one flexible implant tube  202  and corresponding injectable port wherein at least one removable micro-compartment  204  extends outward therefrom. Micro-compartments  204  are arranged in a hierarchical layered scheme therefore providing the recipient with a customizable prosthesis. For example, micro-compartment  204 - 1  represents the first layer of the layering scheme attributed to prosthesis  200 . Micro-compartment  204 - 1  is volumized by an aqueous filler (e.g., saline, PMMA, silicone, aqueous solution, etc.) in order to provide the recipient with the feel and look of a natural breast. Micro-compartments  204 - 2  . . .  204 - 10  are then filled with an inert gas to reduce the specific gravity of prosthesis  200  as a whole. 
         [0019]    Reducing the specific gravity of prosthesis  200  presents an entirely new novelty in the field of cosmetic surgery. For example, a light weight, natural looking and feeling prosthesis may be implanted into an individual without the unnecessary weight constraints imposed on by today&#39;s outdated technology. As described above, the hierarchical layered scheme of micro-compartments  204 - 1  . . .  204 - 10  contributes to the phenomena of reducing the specific gravity of prosthesis  200 . Similar to the description of prosthesis  100 , prosthesis  200  may be modified at any time. For example, a woman who initially received large breast implants may reduce the size of the implant as they get older in order to prevent ptosis of the breast. Implant tube  202  and injectable port  208  is clamped and stowed within the tissue of the individual upon completion. However, a medical professional can make a small incision after locating implant tube  202  under blue light and simply volumize or devolumize prosthesis  200  by injecting a liquid and/or gas until the desired shape, size, weight and/or consistency of the individual is achieved. 
         [0020]    An illuminating agent (e.g., fluorescein) is incorporated within implant tube  202  of prosthesis  200 . The illuminating agent creates an incentive in the receiving individual to periodically follow up with their physician for check-ups because the examining physician will be able to determine whether prosthesis  200  has shifted from the implant site or whether any leaks are present when viewed under blue light. Furthermore, the illuminating agent makes it easier for a medical professional to examine the structure of prosthesis  200  as a whole with minimal invasiveness. A medical professional can make a small incision after locating filler tube  202  while examining under blue light and simply inflate or deflate micro-compartments  204 - 1  . . .  204 - 10  of prosthesis  200  with a liquid and/or gas until the desired shape, size, weight and/or consistency of the individual is achieved. 
         [0021]    It should again be emphasized that the above-described embodiments of the invention are presented for purposes of illustration only. Many variations may be made in the particular arrangements shown. For example, although described in the context of particular augmentation mammoplasty procedures, the techniques are applicable to a wide variety of other types of prosthesis implantations. In addition, any simplifying assumptions made above in the course of describing the illustrative embodiments should also be viewed as exemplary rather than as requirements or limitations of the invention. Numerous other alternative embodiments within the scope of the appended claims will be readily apparent to those skilled in the art.