Patent Publication Number: US-2017360555-A1

Title: Breast implants

Description:
FIELD OF THE INVENTION 
     The present invention relates to breast implants, suitable inter alia for correcting breast sagging. 
     BACKGROUND 
     Breast implants have been in use since the early 1960&#39;s. Since the first generations, all implants are generally made of a silicone shell filled with silicone gel, saline, soybean oil or other filler materials which are non-compressible in nature. When such implants are introduced during breast surgery into a sub-mammary or sub-pectoral pocket, both projection and volume increase of the breast are obtained. Thus, projection and augmentation are two inseparable effects of current breast implants in breast surgery. 
     Women&#39;s breasts differ in their volume, tissue density, consistency, and amount of Cooper&#39;s ligaments that pack and hold the breast tissue together and are responsible for keeping the breast from sagging. In terms of projection, breasts may be voluminous and erect or voluminous and sagging. Typically, later in life, when skin and tissue elasticity are reduced, breast sagging becomes more prominent. Nowadays, breast reshaping procedures utilize breast implants and various surgical techniques for skin envelope reduction and re-draping the remaining breast tissue, with or without a breast implant. As noted above, when breast implants are used, both projection and augmentation of the breast are obtained. However, breast augmentation is not always desired in breast reshaping procedures. 
     There is still a need in the art for breast implants and surgical procedures that enable correction of breast sagging separately from breast augmentation, to improve the results and efficiency of breast reshaping procedures. 
     The foregoing examples of the related art and limitations related therewith are intended to be illustrative and not exclusive. Other limitations of the related art will become apparent to those of skill in the art upon a reading of the specification and a study of the figures. 
     SUMMARY OF INVENTION 
     The present invention provides, according to some aspects, breast implants that enable correction of breast sagging (known as breast ptosis) separately from breast augmentation. The breast implants, according to embodiments of the present invention, advantageously enable achieving breast projection without concomitant breast augmentation. The implant, according to some embodiments, acts as a resilient internal skeleton in the breast parenchyma, thus changing breast shape and maintaining it in a new contour. 
     According to one aspect, there is provided a breast implant (e.g., a three dimensional breast implant) comprising: a base having a first diameter, the base is configured to rest against a subject&#39;s chest wall when implanted; a dome having a second diameter, the dome is configured to be positioned within breast parenchyma underneath the nipple-areola complex when implanted; and an elongated projecting structure extending between the base and the dome, wherein the implant is configured to be inserted into a subject&#39;s breast as an internal supporting skeleton and to affect the projection of breast. 
     According to some embodiments, the elongated projecting structure may include a plurality of resilient elongated elements, one or more of the plurality of resilient elongated elements extend between the dome and the base. The elongated projecting structure may include one or more pillars. The elongated projecting structure may include at least one spring. The elongated projecting structure may include differently shaped projecting structures having different mechanical properties. 
     According to some embodiments, the implant or parts thereof may be formed of or comprise one or more resilient materials allowing natural movement of the breast. According to some embodiments, the elongated projecting structure may be formed of or comprise a resilient material. 
     According to some embodiments, the first diameter is larger than the second diameter. According to some embodiments, the elongated projecting structure and the dome may be integrally formed. According to some embodiments, at least one of the base, the projecting structure and the dome may be formed as a separate component, which is configured to be assembled with remaining component(s) to form the implant. 
     According to some embodiments, the implant may at least partially be made of human biocompatible materials. According to some embodiments, the implant may at least partially be coated with human biocompatible materials. 
     According to some embodiments, the dome may include one or more radial ribs. 
     According to some embodiments, the implant is configured to be assembled during surgery. According to some embodiments, the implant is variably configured to define projection of the breast during surgery. According to some embodiments, the implant is configured for altering the projection of the breast post-surgery. 
     According to some embodiments, an angle between the dome and the connecting projecting structure can be any angle. According to some embodiments, an angle between the base and the projecting structure can be any angle. According to some embodiments, these angels may variably be changed according to variable gravitational accelerations. 
     According to some embodiments, an angle between the dome and the projecting structure is changeable in response to applying external pressure by surrounding breast tissue. 
     According to some embodiments, an angle between the base and the projecting structure is changeable in response to applying external pressure by surrounding breast tissue. 
     According to some embodiments, the elongated projecting structure and the base are manufactured from materials having different mechanical and/or chemical properties. 
     According to some embodiments, the implant may further include a textured surface. According to some embodiments, the dome, the base, and the projecting structure include a body and an outer surface; the body and the outer surface are made from different materials. 
     According to some embodiments, the elongated projecting structure may be telescopic and may be configured to transiently change a distance between the dome and the base in response to pressure applied to the breast. 
     According to some embodiments, the implant includes a plurality of projecting structures, such that after implantation breast parenchyma is filling the space between at least two of the plurality of projecting structures. According to some embodiments, the elongated projecting structure may be changeable in response to pressure applied to it. According to some embodiments, the dome and the base may have different outer surface layer tactile feedback. According to some embodiments, the base may be substantially flat. According to some embodiments, the base may be substantially flat with its edges being curved downwardly. According to some embodiments, the base may be convex, having a smaller degree of convexity compared to the dome. According to some embodiments, the elongated projecting structure may be extending vertically between the base and the dome. 
     According to some embodiments, the implant may further include a torus structure configured to surround the projecting structure for further facilitating breast projection and for providing breast augmentation. According to some embodiments, the torus structure may be filled or fillable with a biocompatible material. The torus structure may be filled or fillable with a filler having specific gravity lower than 0.5 gr/cc. The torus structure may be filled or fillable with a filler having specific gravity lower than 0.4 gr/cc. The torus structure may be filled or fillable with a filler having specific gravity lower than 0.3 gr/cc. 
     According to some embodiments, the implant is a secondary implant for replacing a previous breast implant following extraction thereof, configured for placing inside a capsule formed in the breast around the previous breast implant. 
     According to another aspect, there is provided a breast implant kit comprising:
         (i) an internal skeleton comprising: a base having a first diameter, the base is configured to rest against a subject&#39;s chest wall when implanted; a dome having a second diameter, the dome is configured to be positioned within breast parenchyma underneath the nipple-areola complex when implanted; and an elongated projecting structure extending between the base and the dome; and   (ii) a torus structure configured to surround the projecting structure and at least partially fill a gap between the base and the dome.       

     According to some embodiments, the kit further includes a biocompatible material for filling the torus structure. 
     According to yet another aspect, there is provided a method of affecting the projection of a breast, the method comprising: (i) inserting into the breast an internal skeleton comprising: a base having a first diameter, the base is configured to rest against a subject&#39;s chest wall when implanted; a dome having a second diameter, the dome is configured to be positioned within breast parenchyma underneath the nipple-areola complex when implanted; and an elongated projecting structure extending between the base and the dome; and (ii) adjusting breast projection. 
     According to some embodiments, the method further includes assembling the base, the projecting structure and the dome. According to some embodiments, the assembling is performed during surgery. According to some embodiments, the method further includes inserting a torus structure surrounding the projecting structure for further adjusting breast projection and for providing breast augmentation. According to some embodiments, the method further includes filling the torus structure with a filler. 
     More details and features of the current invention and its embodiments may be found in the description and the attached drawings. 
     Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, suitable methods and materials are described below. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and not intended to be limiting. 
    
    
     
       BRIEF DESCRIPTION OF THE FIGURES 
       Exemplary embodiments are illustrated in referenced figures. Dimensions of components and features shown in the figures are generally chosen for convenience and clarity of presentation and are not necessarily shown to scale. It is intended that the embodiments and figures disclosed herein are to be considered illustrative rather than restrictive. The figures are listed below: 
         FIGS. 1A-R  are illustrations of various views of different embodiments of a breast implant according to the present invention.  FIG. 1A  and  FIG. 1B  are respectively a sectional side view and a pictorial top view of an implant according to one embodiment of the present invention.  FIG. 1C  and  FIG. 1D  are sectional side views of other embodiments, relating to design and composition of various parts of the breast implant.  FIG. 1E  and  FIG. 1F  are sectional side views of additional embodiments, providing solutions for various breast shapes and weights.  FIG. 1G  and  FIG. 1H  are respectively a sectional side view and a pictorial top view of an implant according to another embodiment, allowing in-growth of tissue into various parts of the implant.  FIG. 1I  and  FIG. 1J  are similarly a sectional side view and a pictorial top view of an implant allowing tissue in-growth, further showing scar tissue formed therein.  FIG. 1K  and  FIG. 1L  are respectively a sectional side view and a pictorial top view of an implant according to an additional embodiment, comprising a spring.  FIG. 1M  and  FIG. 1N  are respectively a sectional side view and a pictorial top view of an implant according to an additional embodiment, comprising a curved projecting structure.  FIG. 1O  and  FIG. 1P  are respectively a sectional side view and a pictorial top view of an implant according to an additional embodiment, comprising a projecting structure composed of a plurality of resilient elongated elements.  FIG. 1Q  and  FIG. 1R  are respectively a sectional side view and a pictorial perspective view of an implant according to an additional embodiment, comprising a projecting structure composed of a plurality of sub-structures of different designs and properties. 
         FIGS. 2A-J  are illustrations of lateral cross-sections of other embodiments of a breast implant according to the present invention comprising separate parts configured to assemble to one another.  FIG. 2A  and  FIG. 2B  illustrate a three-part implant design and assembly.  FIG. 2C  and  FIG. 2D  illustrate a three-part implant design and assembly, having a variable projection option.  FIG. 2E  and  FIG. 2F  illustrate an embodiment addressing breast tactility and consistency.  FIGS. 2G-2J  illustrate two embodiments of a collapsible projecting structure. 
         FIGS. 3A-D  are illustrations of lateral cross-sections of yet other embodiments of a breast implant comprising separate parts configured to assemble to one another.  FIG. 3A  and  FIG. 3B  illustrate a three-part implant design and assembly.  FIG. 3C  and  FIG. 3D  illustrate another embodiment of a three-part implant design and assembly. 
         FIG. 4  is a lateral cross section illustration of a breast implant according to another embodiment of the present invention, comprising added layers for improved tactility of the dome part and the base part of the implant. 
         FIG. 5  is a schematic lateral section of a human breast in need of correction of breast sagging. 
         FIG. 6  is a schematic lateral section of a human breast with a projecting implant implanted therein, according to some embodiments. 
         FIG. 7  is a schematic lateral section of a human breast with a projecting implant implanted therein, with the addition of a torus augmenting structure surrounding the central projecting structure of the projecting implant, the implant is implanted for primary augmentation procedure, according to some embodiments. 
         FIG. 8  is a schematic lateral section of a human breast with a projecting implant implanted therein, with the addition of a torus augmenting structure surrounding the central projecting structure of the projecting implant, the implant is implanted as a secondary implant after extraction of a previous breast implant, according to some embodiments. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     While a number of exemplary aspects and embodiments have been discussed above, those of skill in the art will recognize certain modifications, permutations, additions and sub-combinations thereof. It is therefore intended that the following appended claims and claims hereafter introduced be interpreted to include all such modifications, permutations, additions and sub-combinations as are within their true spirit and scope. 
     The following embodiments and aspects thereof are described and illustrated in conjunction with systems, tools and methods which are meant to be exemplary and illustrative, not limiting in scope. 
     In the description and claims of the application, each of the words “comprise” “include” and “have”, and forms thereof, are not necessarily limited to members in a list with which the words may be associated. 
     As used herein, the term “about”, when referring to a measurable value, is meant to encompass variations of +/−10%, more preferably +/−5%, even more preferably +/−1%, and still more preferably +/−0.1% from the specified value. 
     Reference is now made to  FIG. 1A  and  FIG. 1B , which illustrate, respectively, a sectional side view and a pictorial top view of a projecting breast implant  100  according to some embodiments of the present invention. The projecting breast implant shown in  FIGS. 1A-1B  includes three functional parts: a top breast supporting dome  110 , configured to be positioned within a subject&#39;s breast parenchyma underneath the nipple-areola complex when implanted, and to hold surrounding breast tissue and overlying skin in a new projecting configuration; a base  130 , configured to be in contact with the chest wall of the patient or with tissue adjacent to the chest wall and provide support; and an elongated projecting structure  120  connecting dome  110  and base  130 . As shown in  FIG. 1A , elongated projecting structure  120  is configured to define how far the breast extends forward from the chest wall, namely to define a new distance between the chest wall and the breast tissue supported and projected outwards by the implant. 
     In the illustrated embodiment, projecting structure  120  is in the form of a pillar connected on one side thereof to a center of projecting dome  110 , and in an opposing side thereof to a center of base  130 . In the illustrated embodiment, the diameter of dome  110  is smaller than the diameter of base  130 . According to other embodiments, the diameter of the dome may be the same as the diameter of the base. 
     The width of the projecting structure is smaller than the diameters of the dome and the base. In some embodiments, the width of the projecting structure may range from about 5 mm to about 20 mm. In some embodiments, the diameter of the dome may range from about 20 mm to about 70 mm. In some embodiments, the diameter of the base may range from about 40 mm to about 120 mm. 
     In some embodiments, thickness of each of the dome and base may range from about 2 mm to about 7 mm. In some embodiments, the dome, the base or both are of a uniform thickness. In other embodiments, the dome, the base or both are of varying thickness. In some embodiments, the dome and the base are of the same thickness. In other embodiments, the dome and the base are of different thicknesses. 
     In some embodiments, the length of projecting structure may range from about 40 mm to about 150 mm. 
       FIG. 1B  illustrates a pictorial top view of the projecting breast implant of  FIG. 1A , showing that projecting dome  110  has a smaller diameter than base  130 . According to some embodiments, projecting dome  110  may be asymmetrical. Projecting dome  110  is typically convex, but according to some embodiments it may be flat. According to some embodiments, projecting dome  110  or base  130  may be made of finger like projections rather than a full dome. This is only an example of one of the options related to the relative sizes and shapes of projecting dome  110  and base  130 . Various shapes and sizes may be used for projecting dome  110  and base  130  as desired and defined by a manufacturer and for different sizes and types of breast to be implanted with this projecting breast implant. 
     Reference is now made to  FIG. 1C  and  FIG. 1D , which illustrate sectional side views of some embodiments of projecting breast implant  100  where any of the three parts that constitute the projecting breast implant, namely, dome  110 , projecting structure  120  and base  130 , may be hollow or filled with a material different from the material forming the outer wall of the part. According to some embodiments, dome  110 , projecting structure  120  and base  130  may be integrally formed. According to other embodiments, dome  110 , projecting structure  120  and base  130  may be formed as separated parts that are configured to be assembled. 
     According to some embodiments, dome  110 , projecting structure  120  and base  130  may be made of the same material. According to other embodiments, dome  110 , projecting structure  120  and base  130  may be made of different materials. According to additional embodiments, each of dome  110 , projecting structure  120  and base  130  may be made of a combination of materials. Examples of materials suitable for the breast implant of the present invention include various silicone polymers, polyurethane and others known in the art. These different constructions/compositions can be used, for example, to give one of the implant&#39;s components different mechanical properties compared to the other components, to improve overall performance of the breast implant. 
     In  FIG. 1C , for example, projecting structure  120  has a core  140  (body) that is made of, or filled with, a material that is different from the material forming the outer wall (surface) of projecting structure  120 . In some embodiments, core  140  of projecting structure  120  may be filled with gas, e.g., air, or with closed-cell silicone foam or other foamy materials to reduce the weight of the breast implant. In other embodiments, core  140  of projecting structure  120  may be made of a substance that has a greater stiffness than the stiffness of the substance forming the outer wall of projecting structure  120 . Greater stiffness of core  140  may be advantageous in cases where stronger support is needed, for example with a relatively large and heavy breast. For example, core  140  may be made of silicone of higher stiffness, like a silicone having a higher Shore A Durometer, or another material as defined by the manufacturer. 
     In  FIG. 1D , each of dome  110 , projecting structure  120  and base  130  has a core ( 150 ,  140  and  145 , respectively) made of, or filled with, a material that is different from the material forming the outer wall of each part. In the embodiment illustrated in  FIG. 1D , each of core  150 , core  140  and core  145  is made of, or filled with, a different material. In some embodiments, core  150  of dome  110  may be filled with gas, e.g., air, or made from a material that is softer than the outer wall of dome  110 . Such filling may be used to render projecting dome lighter and/or softer, due to the damping effect of a softer filling material. In some embodiments, core  145  of base  130  may be filled with gas, e.g., air, or made from a material that is softer then the outer wall of base  130 , so base  130  can be lighter or can be softer due to the damping effect of a softer filling material  145 . 
     Reference is now made to  FIG. 1E  and  FIG. 1F , which illustrate sectional side views of additional embodiments of projecting breast implant  100 , where the implant is designed such that its shape is adjustable and changeable in response to pressure applied to it by surrounding breast tissue upon implantation, according to the size, shape, projection, weight and volume of the operated breast. 
     In  FIG. 1E , acute angle alpha ( 146 ) between base  130  and projecting structure  120  is set during the manufacturing process. Acute angle alpha typically ranges from about 60 degrees to about 85 degrees. Following insertion of breast implant  100  into a subject&#39;s breast, weight of surrounding breast parenchyma may push projecting dome  110  and projecting structure  120  such that acute angle alpha is changed into a less acute angle, until an equilibrium is reached between the pressure applied by projecting breast implant  100  and the counter-pressure applied by the operated breast. For example, acute angle alpha of 70 degrees (set during the manufacturing process) may change to about 85 degrees following insertion and application of pressure by surrounding tissue. 
       FIG. 1F  shows another embodiment of an adjustable projecting breast implant  100 . In the illustrated embodiment, an acute angle beta ( 147 ) is defined between dome  110  and projecting structure  120 , as well as acute angle alpha ( 146 ) between base  130  and projecting structure  120 . Both angles are set during the manufacturing process. In some embodiments, acute angle alpha and acute angle beta are the same. In other embodiments, acute angle alpha and acute angle beta are different. Acute angle beta typically ranges from about 60 degrees to about 85 degrees. This embodiment is designed to accommodate for a heavy breast once projecting breast implant is placed within breast parenchyma. In this embodiment there are two degrees of freedom to adopt to breast weight where the weight of breast tissue closer to the chest wall will have a higher impact on acute angle alpha, and the weight of breast tissue more distant from the chest wall will have a higher impact on acute angle beta. Upon implantation, acute angle alpha, acute angle beta or both change in response to the pressure applied to projecting breast implant  100  by surrounding tissue until an equilibrium is reached between the pressure applied to projecting breast implant  100  and the counter-pressure applied by projecting breast implant  100 . The result is a desired new projecting position of the breast post operatively. 
     Reference is now made to  FIG. 1G  and  FIG. 111 , which respectively illustrate a sectional side view and a top pictorial view of yet another embodiment of projecting breast implant  100 , in which projecting structure  120  is constructed of a plurality (at least two, e.g., two, three, four of more) of sub-structures constructing together a projecting structure according to mechanical properties defined by a manufacturer. In the illustrated embodiment, projecting structure  120  is composed of a plurality of spaced elongated elements. The elongated elements are circularly-arranged, each extending between dome  110  and base  130 , such that a cylindrical space is defined in-between. 
     Reference is now made to  FIG. 1I  and  FIG. 1J , which respectively illustrate a sectional side view and a top pictorial view of the projecting breast implant of  FIGS. 1G-111 , further showing scar tissue  121  generated within the cylindrical space between the sub-structures of projecting structure  120 . Once projecting implant  100  is placed inside an operated breast, the space between the sub-structures constructing projecting structure  120  is filled with breast parenchyma, and scar tissue  121  is generated during postsurgical healing processes. The combination of elastic and plastic properties of the post-operative scar tissue, and the mechanical properties of projecting breast implant  100 , defines a composite implant—breast tissue complex, characterized by properties that differ from the properties of each of the entities separately. 
     Reference is now made to  FIG. 1K  and  FIG. 1L , which respectively illustrate a sectional side view and a top pictorial view of another embodiment of projecting breast implant  100 . In the illustrated embodiment, projecting structure  120  is constructed from at least one spring  122  connecting between dome  110  and base  130 . Different spring mechanical properties, e.g., a harder or a softer spring, may define different resistance to breast weight once implanted in breast parenchyma, different response to pressure applied to the breast, and different response to changes in body posture and body movement such as during walking and running. The suitable implant will be selected by a surgeon according to need and patient&#39;s characteristics. Breast tissue and post-operative scar tissue filling the gaps in the spring structure will define a composite implant-breast tissue complex, characterized by new mechanical properties. 
     Reference is now made to  FIG. 1M  and  FIG. 1N , which respectively illustrate a sectional side view and a top pictorial view of another embodiment of projecting breast implant  100 . In the illustrated embodiment, projecting structure  120  is made of a resilient material manufactured in a bent structure at angle alpha ( 123 ), acting as a spring to hold a projected breast in a projecting position after implantation of projecting breast implant  100  in breast parenchyma. Angle alpha typically ranges from about 30 degrees to about 60 degrees. Following implantation, the presence of breast parenchyma filling the triangular space defined by acute angle alpha defines new combined properties to the combination of projecting breast implant  100  and breast parenchyma as a composite implant. The spring like properties of projecting structure  120  allows dynamic movement of the breast reflecting the action-reaction mechanism between the breast and projecting structure  120 . 
     Reference is now made to  FIG. 1O  and  FIG. 1P , which respectively illustrate a sectional side view and a top pictorial view of another embodiment of projecting breast implant  100 . In the illustrated embodiment, projecting structure  120  is made of at least two resilient elongated members  124  and  125 , each manufactured in a bent structure (acute angles delta′ and delta″, respectively). Elongated members  124 ,  125  act as springs to hold a projected breast in a projecting position after implantation of projecting breast implant  100  in breast parenchyma. Following implantation, the presence of breast parenchyma filling the triangular spaces defined by acute angles delta′ and delta″ defines new combined properties to the combination of projecting breast implant  100  and breast parenchyma as a composite implant. According to some embodiments, angles delta′ and delta″ may be identical. According to other embodiments, angles delta′ and delta″ may be different. Angles delta′ and delta″ typically range from about 30 degrees to about 60 degrees. The spring like properties of projecting structure  120  allows dynamic movement of the breast reflecting the action-reaction mechanism between the breast and projecting structure  120 . 
     Reference is now made to  FIG. 1Q  and  FIG. 1R , which respectively illustrate a sectional side view and a pictorial perspective view of yet another embodiment of projecting breast implant  100 . In the illustrated embodiment, projecting structure  120  comprises two sub-structures, namely a resilient angled structure  150  bent at an angle alpha ( 153 ) and a spring structure  155 . This is an example for a projecting structure that is made of different sub-structures rather than similar or identical sub-structures, as presented elsewhere in the description. In the illustrated embodiment, the two sub-structures  150  and  155  are each connected to base  130  and dome  110 . In other embodiments, a first sub-structure may be connected to both base  130  and dome  110 , and a second sub-structure may be connected to either dome  110  or base  130  on one end thereof, while an opposing end thereof is connected to the first sub-structure or remains free. Sub-structures  150  and  155  are configured to support dome  110  in different directions and allow the dome to withstand pressure from different directions simultaneously. Angled structure  150  may be made of a biocompatible resilient material like silicone that allows it to gradually bend such that angle alpha becomes more acute when pressure is applied to it, and gradually return to its original shape as pressure is reduced. Spring structure  155  is made of a biocompatible resilient material like silicone that allows it to gradually bend when pressure is applied to it and gradually return to original shape as pressure is reduced. In a spring like substructure, such as spring structure  155 , pressure is absorbed maximally when applied at a right angle to a center of dome  110 . Angled structure  150  may have various alpha angles as designed by a manufacturer to have different resiliency to pressure applied to it. According to some embodiments, angled structure  155  may be made of more than one polymer where each polymer has different mechanical properties giving angled structure  155  mechanical properties combining the different properties of each polymer. Angled structure  155  is designed to absorb pressure applied to dome  110  not only at a right angle but also laterally to spring structure  155 . 
     Reference is now made to  FIG. 2A  and  FIG. 2B , which illustrate sectional side views of a projecting breast implant  100  according to additional embodiments of the present invention. In the illustrated embodiment, the three parts that constitute projecting breast implant  100 , namely, dome  110 , projecting structure  120  and base  130 , are manufactured as separate parts configured to assemble to construct the complete projecting breast implant  100 . In the illustrated embodiment, projecting structure  120  is in the form of a pillar comprising a distal end configured to connect to base  130  and a proximal end configured to connect to dome  110 . 
       FIG. 2A  shows the three components separately. Dome  110  and the proximal end of projecting pillar  120  are configured to assemble via a dome-pillar locking mechanism, comprising a dome portion  220  and a pillar portion  210 . Base  130  and the distal end of projecting structure  120  are configured to assemble via a pillar-base locking mechanism, comprising a pillar portion  230  and a base portion  240 . 
     In  FIG. 2B  the three components of projecting breast implant  100  are shown when combined and locked in place as a functional projecting breast implant. The locking mechanisms displayed here are merely exemplary locking mechanisms between parts and any other suitable locking mechanism may be used. 
     Reference is now made to  FIG. 2C  and  FIG. 2D , which illustrate sectional side views of another embodiment of projecting breast implant  100 , wherein projecting structure  120  comprises a fixed element  222  and a replaceable element  221  that are configured to adjustably connect such that the length of projecting structure  120  is varied. Thus, the projection of the implant may be adjusted by a surgeon during operation. 
     In  FIG. 2C  projecting structure  120  includes a fixed element  222  in the form of a socket connected to base  130 , and a replaceable element  221 . Replaceable element  221  comprises an upper end configured to connect to dome  110  and a lower end configured to fit within fixed element  222 . Fixed element  222  and replaceable element  221  are shown in  FIG. 2C  in association with one another, where replaceable element  221  is partially accommodated in fixed element  222 . 
     During operation, a series of replaceable elements  221 A,  221 B, and  221 C of variable lengths may be provided. A surgeon may select a suitable replaceable element from among the series of replaceable elements, and connect it to dome  110  via the upper end of the replaceable element. The lower end may be fit within fixed element  222  and moved along fixed element  222  until the desired length of projecting structure  120  is obtained. 
     The design of projecting structure  120  may be changed such that the fixed element is the upper portion configured to connect to the projecting dome, and the replaceable element is the lower portion configured to connect to the supporting base. 
     In  FIG. 2D  projecting breast implant  100  is shown in an assembled configuration, ready for implantation in a subject&#39;s breast. Replaceable element  221  is placed inside fixed element  222 . Replaceable element  221  may be partially or fully accommodated in fixed element  222 , as needed to obtain a desired projection. In the illustrated embodiment, replaceable element  221  is partially accommodated in the socket such that a gap  225  is left at the bottom of the socket. Gap  225  indicates that a higher projection of projecting breast implant  100  was needed by the operating surgeon to get the desired breast projection, dictated inter alia by breast size, degree of ptosis and the patient&#39;s wish. Projecting implant  100  shown in  FIG. 2D  further comprises a sliding sleeve  224  configured to secure and lock replaceable element  221  in place and prevent it from sliding after its positioning within fixed element  222  to obtain a desired projection. In some embodiments, the sliding sleeve secures and locks the replaceable element by applying external pressure on the fixed element. Other means enabling changing the length of the projecting structure, and accordingly the projection of the projecting breast implant, may be used. Other designs may be included, for example springs, hydraulic pumps, pneumatic mechanisms and other mechanical designs known in the art. 
     Reference is now made to  FIG. 2E  and  FIG. 2F , illustrating sectional side views of other embodiments of projecting breast implant  100 . In the illustrated embodiments, projecting breast implant  100  is composed of separate dome  110 , base  130  and projecting structure  120  that are configured to assemble to construct projecting breast implant  100 , where projecting structure  120  includes a spring  226  configured to allow compression of projecting structure  120 . Spring  226  may be manufactured from a polymer material, e.g. silicone, or others known in the manufacturing of long term implantable devices. 
     In  FIG. 2E  projecting structure  120  comprises an internal lumen, and spring  226  is placed inside the internal lumen thereby providing support and defining new mechanical properties of projecting structure  120 . In  FIG. 2F  spring  226  is embedded within projecting structure  120 . Any other combinations and variations may be used to place a spring in the projecting structure, for example incorporating the spring into the wall of the projecting structure, or any other design. 
     Reference is now made to  FIG. 2G  and  FIG. 2H , illustrating sectional side views of another embodiment of projecting breast implant  100  where projecting structure  120  is telescopic and is configured to transiently change a distance between dome  110  and base  130  in response to pressure applied to the breast. In the illustrated embodiment, projecting structure  120  includes two springs of different diameters, namely first spring  226  and second spring  227 , where the diameter of first spring  226  is smaller than the diameter of second spring  227 . First spring  226  is connected on one end thereof to dome  110  and the other end thereof is partially located within second spring  227 . Second spring  227  is connected on one end thereof to base  130  and the other end accommodates a portion of first spring  226 . Projecting structure  120  further includes a breaking area  228  at the interface between the first and second springs that is configured to be responsive to pressure applied to the breast. When the pressure exceeds a certain threshold the breaking area allows collapse of projecting structure  120 , via sliding of first spring  226  into second spring  227 . In the collapsed state ( FIG. 2H ), a distance between dome  110  and base  130  is smaller than the distance at the extended state. When the pressure is reduced or removed, first spring  226  slides outside of second spring  227  to restore a full length projecting structure  120 . 
     Reference is now made to  FIG. 2I  and  FIG. 2J , illustrating sectional side views of an implant as shown in  FIGS. 2G-H , that further comprises a pin  245  and a bridging area  240 . Bridging area  240  and pin  245  hold projecting structure  120  in a full extended projection. Upon pressure applied to it that is larger than a threshold pressure pin  240  can hold, it breaks and first spring  226  slides into second spring  227 . Pin  245  then locks first and second springs in the new configuration. 
     Reference is now made to  FIG. 3A  and  FIG. 3B , illustrating sectional side views of an additional embodiment of projecting breast implant  100 , comprising integrally formed dome  110  and projecting structure  120  configured to assemble to base  130  via a snap-fit locking mechanism. 
     In the illustrated embodiment, base  130  comprises a cylindrical hollow holding member  300  extending upwardly from the center of base  130 , configured to accommodate the distal end of projecting structure  120 . Holding member  300  comprises an internal snap-in recess  320 , configured to receive and secure a matching protruding edge  315  on the distal end of projecting structure  120 . Projecting structure  120  comprises an opening  325  at its distal end configured to enable the distal end to resiliently deflect inwardly (i.e., towards the opening) upon engagement with snap-in recess  320 , until protruding edge  315  is secured within snap-in recess  320 . 
     Reference is now made to  FIG. 3C  and  FIG. 3D , illustrating sectional side views of an additional embodiment of projecting breast implant  100  where a different locking mechanism is used in the assembly between dome  110  and projecting structure  120 , manufactured as a single element, and base  130 .  FIG. 3C  shows the element composed of dome and projecting structure disassembled from the base. Projecting structure  120  comprises a plurality of circumferential apertures  330  at a distal end thereof. The distal end of projecting structure  120  is configured to engage within a cylindrical hollow accepting member  310  extending upwardly from the center of base  130 . Accepting member  310  similarly comprises a plurality of circumferential apertures  340 , matching circumferential apertures  330  of projecting structure  120  (at identical distances) such that upon engagement of projecting structure  120  and accepting member  310 , circumferential apertures  330  are aligned with circumferential apertures  340 . 
     In  FIG. 3D  dome  110  and projecting structure  120  are assembled with base  130 , and locked in place via locking pins  335  and compressing sleeve  360 . Locking pins  335  pass through apertures in the walls of compressing sleeve  360 , through circumferential apertures  340  in the wall of accepting member  340  and through circumferential apertures  330  in the distal end of projecting structure  120 . Insertion of locking pins  335  through the apertures of compressive sleeve  360  is advantageous in overcoming banding and to ease the sliding of locking pins  335  into position. This assembly and locking mechanism allows a surgeon to change the degree of projection of the projecting breast implant according to need during surgery. For example, in the illustrated embodiment, each of projecting structure  120  and accepting member  310  comprises three circumferential apertures, and when assembled, only the top two pairs of apertures are engaged and locked, resulting in a higher projection compared to a case where all three pairs of apertures are engaged and locked. 
     Reference is now made to  FIG. 4 , illustrating a sectional side view of a projecting breast implant in accordance with some embodiments of the present invention, which comprises outer surface covering layers. In the illustrated embodiment, the projecting breast implant comprises a covering layer on top of the dome, and a base layer underneath the support base. In the illustrated embodiment dome  110 , projecting structure  120  and base  130  are made from a first material, and the uppermost surface of dome  110  is covered with a top layer  400  made of a second material that is different from the first material. Top layer  400  is configured to change the tactility of projecting breast implant  100  through the subcutaneous tissues and skin covering it. The material forming top layer  400  may be, as an example, a material that is softer than the material forming the dome, projecting structure and base, such as a soft silicone polymer, closed-cell silicone foam, polyurethane or any other material known and approved for long-term implantation. Projecting breast implant  100  illustrated in  FIG. 4  further comprises a base layer  410  at the bottom surface of base  130 . The material forming base layer  410  may be softer than the material base  130  is made of. Base layer  410  may have a non-smooth, or textured, surface at the bottom to improve the contact and adherence to the chest wall and to reduce sliding of projecting breast implant  100  over the chest wall. 
     Reference is now made to  FIG. 5 , illustrating a schematic lateral cross section of a breast  500 . Chest wall  510  lies underneath the breast. Breast  500  includes covering skin  530  and breast parenchyma  520 . Breast  500  requires correction of sagging. 
     Reference is now made to  FIG. 6 , illustrating a schematic lateral cross section of breast  500  with a projecting breast implant  100  implanted in it, according to some embodiments. Projecting breast implant  100  lifts breast parenchyma  520  and overlying skin  530  to a desired position and shape. The projecting breast implant may be inserted into the breast through a skin incision placed in the infra-mammary fold  535  where a precise size pocket is developed in the sub-mammary plain; a vertical dissection is carried out through breast parenchyma  520  and a dissection plain is developed under skin and breast parenchyma leaving ample tissue coverage over projecting breast implant  100 . The dissection plain developed under skin and breast parenchyma leaving ample tissue coverage over projecting breast implant  100  can be performed through a skin incision at the skin-areola border  537 . 
     Reference is now made to  FIG. 7 , illustrating a schematic lateral cross section of breast  500  implanted with a projecting breast implant  100  according to some embodiments combined with a torus, ‘bagel-like’, structure  710 , thus providing both projection and augmentation of the breast. Torus structure  710  surrounds projecting structure  120 . Torus structure  710  is shown in its filled configuration, where it is filled with a biocompatible material. In the illustrated embodiment, torus structure  710  completely fills a space between the dome and base of projecting breast implant  100 . For insertion of the implant into a subject&#39;s breast, dissection of a pocket can be carried out through an infra-mammary skin incision  535  at a sub-mammary plain or sub-pectoral plain. The breast implant augments and adds to the projection of the breast as desired. 
     Reference is now made to  FIG. 8 , illustrating a schematic lateral cross section of breast  500  implanted with a projecting breast implant  100  according to some embodiments combined with a torus, ‘bagel-like’, structure  710 , implanted as a replacement breast implant after a previous implant has been removed. Through a sub-mammary skin incision  535  an old breast implant can be removed. A new breast implant combined of projecting breast implant  100  and a torus, ‘bagel-like’ augmenting structure  710  can then be inserted into a breast capsule  540  formed around the old breast implant. 
     Breast implants according to embodiments of the present invention may include a code identifier (label) on their surface or embedded therein, for non-invasively identifying the implants after they are implanted. According to one embodiment the code identifier may be printed during the manufacturing process. “Ink” materials may include, e.g., polymers, which can be distinguished and detected by optical, electro-optical, electromagnetic, ultrasonic detection means, or other detection means known in the art. For example, a printing material may include a radio-opaque material like barium sulfate, may contain gas bubbles to be detected by ultrasound, may contain a color different from the color of the implant layer on which it is printer or in which it is embedded to be detected optically, may contain magnetic material defining a different magnetic imprint for each code, or any combination of the above, but not limited to the above. According to another embodiment, the code may be cut by laser or any mechanical cutting device or method from a sheath made of the above described “ink” materials. The code may be generated by a computer, either randomly or according to a pre-determined algorithm. The code may be a printable character or any drawing or shape. The code may be saved to a computerized database to be retrieved when needed through a local network or over the web. The code can advantageously be retrieved non-invasively from the implant while the implant is still implanted in the patient, without the need to extract the implant by surgery. Once the code is retrieved some or all information regarding the implant, the patient and the operating physicians can be retrieved over the web or in any other method as allowed by authorities.