Implantable nipple assembly

A nipple implant assembly and method for implanting the nipple implant are provided. The nipple implant assembly includes a nipple skeleton with or without areola made of metallic or non-metallic memory-shape bio-compatible material. The nipple implant assembly may consist of holes to allow growth of natural breast tissue into the implant for improved holding better attachment of the implant into the human's tissue. The nipple implant assembly may be coated by or cast in a polymeric coating.

BACKGROUND OF THE INVENTION

Nipple inversion is a common problem. Flat nipples and nipple inversion at women's breasts is a very common phenomena. Furthermore it is known that women with regular nipples are unhappy with their look. Women share a common desire of improving their nipples' shape and appearance by a cosmetic plastic procedure.

SUMMARY OF THE INVENTION

The present invention, in some embodiments thereof, relates to implantable nipples and implantable nipples with an integrated areola also denoted throughout the description of embodiments of the present invention ‘nipple assembly implant’, more particularly, but not exclusively, to components to be implanted in a human breast. Nipples and nipples with areola implantable components and a simple implantation method procedures are described, in which a prefabricated nipple and/or nipple with integrated areola is implanted in a human's breast.

According to an aspect of some embodiments of the present invention, including, for example, any of the embodiments described herein, there is provided a nipple and/or nipple with integrated areola built configuration consist of resilient material such as Silicone, plastic or polymer configured to be implanted under the existing Nipple and areola skin and may be coincided with the natural nipple and areola. The implant thus retains the natural nipple and areola in a projecting manner stretches the nipple natural skin and gives it a new fresh look while maintaining the softness of a human's tissue.

According to some embodiments of the invention, including, for example, any of the embodiments described herein, the implant may consists of a supporting structure, or skeleton, having a shape of a helix, a mesh-like skeleton or the like, optionally built from a memory shape material such as Nitinol, Titanium Alloy or similar material casted in or coated by a soft and flexible biomedical material such as Silicone, plastic or polymer. The implant skeleton may sustain its dimensions and shape at the body constant temperature while providing the necessary force for pushing the existing inverted nipple out to take the form and look of a natural and regular nipple, while the soft material covering the skeleton is adapted to follow the changes in form of the implant skeleton.

According to some embodiments of the invention, including, for example, any of the embodiments described herein, the implant may consist of a helix built from a shape memory and/or a temperature memory material thus the implant may be configured to change its shape and/or dimensions in accordance with the relative changes in temperature of the nipple and areola skin.

According to some embodiments of the invention, including, for example, any of the embodiments described herein, the implantable consists of a mesh configure to be built from a shape memory and/or a temperature memory material and may be covered with softer material such as Silicone, plastic or other polymer. Thus the configured built enhancing the hold of the implantable in its position under the breast skin preventing a movement, distortion or a distension of the implanted nipple and areola in the breast.

According to some alternative embodiments of the invention, including, for example, any of the embodiments described herein, the implant may consist of a support skeleton shaped as a helix, mesh or other fixture made of hard plastic, Silicone or Polymeric material. This internal fixture may also be cast in a soft plastic, Silicone or Polymeric material similarly to the costing of a metal skeleton described above.

According to some embodiments of the invention, including, for example, any of the embodiments described herein, the implant may consist of large flexible base and a nipple configure to be a hemisphere shape. Thus the base enhances the hold of the implant in its position under the skin. The base may be configured to be a circle shape with a 10-100 mm in diameter. The nipple and/or nipple with integrated areola may be configured to be an integral part of the base placed in the middle.

According to some embodiments of the invention, including, for example, any of the embodiments described herein, the implant base may be configured to be flat or hemisphere and consist openings thus allowing the natural breast tissue grow into the opening enabling a solid bonding of the implant into the existing nipple, areola and breast tissue.

According to some embodiments of the invention, including, for example, any of the embodiments described herein, the nipple and/or nipple with integrated areola implant and/or the base may consist of supporting biomedical material for example a metal such as medical grade stainless steel, Nitinol, Titanium alloy or similar materials.

According to some embodiments of the invention, including, for example, any of the embodiments described herein, the nipple and/or nipple with integrated areola implant may be configured to be in a hemisphere shape or a sleeve shape or a ball shape.

According to some embodiments of the invention, including, for example, any of the embodiments described herein, the nipple and/or nipple with integrated areola base may be configured to receive the natural shape of the breast shape.

According to some embodiments of the invention, including, for example, any of the embodiments described herein, the nipple and/or nipple with integrated areola implant base may be prefabricated to maintain its prefabricated shape in the breast.

According to some embodiments of the invention, including, for example, any of the embodiments described herein, the nipple and/or nipple with integrated areola implant base may consist of an opening slot stretched from the base circumference to center of the base in a wedge shape. The opening allows the insertion of the implantable in its place without interfering with the breast nerves and milk ducts and milk supply system to the nipple and/or nipple with integrated areola.

According to some embodiments of the invention, including, for example, any of the embodiments described herein, the thickness of the implantable base may vary between 0.1 mm to 25 mm.

According to some method of the invention, including, for example, any of the method described herein, the implantable may be implanted in its place by inserting through an incision in the skin near the intended position. The procedure may occur under local anesthesia. According to some method of the invention, including, for example, any of the method described herein, the natural nipple and areola may be removed if necessary then the implantable is placed in its place and the natural nipple and areola is then placed back in its natural position and stitched to the breast.

According to some embodiments of the present invention, the nipple assembly implant may contain an internal metal helix, a mesh structure or fixture as described throughout this application or may not have the metal part integrated.

According to some embodiments of the present invention, the nipple assembly implant may consist metal helix, or metal mesh or fixture without the addition of a soft cover such as Silicone, Plastic or Polymeric material.

According to some embodiments of the present invention, the nipple assembly implant may consist a non-metallic helix, mesh or fixture only without the addition of the soft Silicone, Plastic or Polymeric material. This nipple assembly implant may be made of hard Plastic, Silicone or other Polymeric material without the addition of metallic materials.

According to some embodiments a nipple assembly implant comprising a metal skeleton structure comprising which comprises a base portion, a tip and a support structure connecting said base with said tip a polymer coating surrounding said metal skeleton and wherein the metal skeleton is made of a memory-shape metal. According to further embodiments the memory-shape metal is made of Nitinol. According to yet further embodiments the coating is made of bio-compatible polymer and according to yet further embodiments the coating is made of Silicone.

DETAILED DESCRIPTION OF THE PRESENT INVENTION

The terms “comprises”, “comprising”, “includes”, “including”, “having” and their conjugates mean “including but not limited to”. The term “consisting of” means “including and limited to”. The term “consisting essentially of” means that the composition, method or structure may include additional ingredients, steps and/or parts, but only if the additional ingredients, steps and/or parts do not materially alter the basic and novel characteristics of the claimed composition, method or structure.

A broad aspect of some embodiments of the invention relates to nipple and/or nipple with integrated areola—commonly denoted ‘nipple assembly implant’—configurations. In some embodiments of the invention the implant may consist of a base with a nipple and/or nipple with integrated areola tip attached to it where the base and the nipple and/or nipple with integrated areola may be made from Silicone or other plastic or Polymeric material. The implant may be manufactured in molding technology known in the art. In some embodiments the implant may be configured to be the tip alone. In some embodiments, the implant may be enhanced with a supporting metal construction made of biomedical compatible material giving the implant strength and ability to sustain the prefabricated shape for a long duration through a large range of body rapidly changing parameters, such as body temperature. In some embodiments the implant may be of formed of a metal mesh or helix spring. The metal mesh may be covered with biomedical compatible Silicone, plastic or Polymeric material film. The mesh and the cover film together may give the implant strength and smoothness.

It should be noted that all materials presented here are biocompatible materials suitable for using in the body such as Nitinol and/or stainless steel grade316or other materials known in the art.

An aspect of some method of the invention relates to the insertion of the implant in the breast that may be done under local anesthesia. The relative small implant size, the flexibility yet having significant strength allow for simple clinical procedure.

It is to be understood that the invention is not necessarily limited in its application to the details of construction and the arrangement of the components and/or methods set forth in the following description and/or illustrated in the drawings. The scope of the invention extends to other embodiments or may be practiced or carried out in various other ways.

Reference is now made toFIG. 1, which is a simplified schematic view of an implant nipple with integrated areola2implanted in a female's breast1. The implanted nipple with integrated areola2is placed underneath the natural nipple and areola4thus stretching it to a forward prominent position. According to the exemplary embodiment of the present invention the implant nipple with integrated areola2may consists of openings3. Openings3may allow breast tissues to gradually grow into the implant2and thus to affix the implant strongly in its position.

Reference is now made toFIG. 1A, which illustrates an exemplary method of inserting an implant nipple with integrated areola12into a female's breast10. First an incision14may be made in the skin11. The incision14may partially be made along the circumference of nipple and areola16thus allowing the nipple and areola16remain partially connected to breast10. Natural nipple and areola16may then be partially separated from the breast tissue10thus creating a receiving pocket15. Implant nipple and/or nipple with integrated areola12may then be inserted in the direction indicated by arrow13into its place in pocket15underneath natural nipple and areola16. Bonding, such as stitches or biomedical glue, may be applied to close incision14. The implanted nipple and/or nipple with integrated areola12are now placed in its intended position as showed inFIG. 1.

Reference is now made toFIG. 1B, which illustrates another exemplary method of implementation of a nipple and/or nipple with integrated areola implant22in a female breast20. First natural nipple and areola23skin21is cut along its circumference and the natural nipple and areola23are removed in its entirety from breast20. Then implant nipple and/or nipple with integrated areola22are positioned in place of the natural nipple and areola23now removed. Natural nipple and areola are placed back24in its original position on breast20and is stitched to skin21. The implanted nipple and/or nipple with integrated areola23are now positioned in its place as showed inFIG. 1. The diameter of the implanted nipple and/or nipple with integrated areola23may be in the range of 5-100 mm. The diameter of the cut in skin21may be made to accommodate the specific implantable nipple and/or nipple with integrated areola23and may be, according to some embodiments, larger than that of the natural nipple and areola23by 0.5-10 mm Additionally, the thickness of the implantable nipple and/or nipple with integrated areola may be in the range of 0.2-10 mm. Accordingly, the thickness of the removed skin may include tissue section attached to it, that may be formed to accommodate the thickness of the implantable nipple23.

Reference is now made toFIG. 1C, which represents face view of a female anatomical breast structure37in which: milk ducts33, lobules32, areola36, fat35, and nervous34. Implant nipple and/or nipple with integrated areola30in this exemplary embodiment is showed placed in between areola36and nervous35layers and lobules32and milk duct33layers. Thus the implanted nipple and/or nipple with integrated areola30lies where the areola36in front of it and the nervous35, milk duct33and the lobules32are at its back. In some cases the milk ducts33, lobules32, areola36, fat35, and nervous34may be disconnected from the natural nipple and areola in order to allow the insertion of the implanted nipple and/or nipple with integrated areola30. In some other cases the breast tissue organs may left connected to the natural nipple and the implanted nipple and/or nipple with integrated areola30is inserted so that the relevant nipple organs are inserted via gap31of the implant.

Reference is now made toFIGS. 2 and 2A, which represent a tip implantable nipple that may configure to be a hemisphere shape or a tube.

FIG. 2shows an embodiment of a tip40made for example from flexible and resilient plastic material such as Silicone. The tip may consist of inner space41. The tip inner space41may be hollow. After implant tip40is placed under the natural nipple the hollow space41may be filled with breast tissue which may naturally grow in it thus to enable strong hold of the tip40in its intended implanted position.

FIG. 2Ashows an embodiment of an implant tip42that may consist of a slot43running from the tip43to the perimeter circumference of the open end of tip42. When implant tip42is implanted in its place under the natural nipple, slot43enables the tip42bypass over the breast organs connected to the natural nipple. It may be noted that slot43may prevent the necessity to cut the breast organs during placement. The implant tip42may further consist of hollow inner space44. The tip configuration may be tapered or straight tube or any other shape, as may be required to best fit the natural nipple.

Reference is now made toFIGS. 3-3Ewhich represent various embodiments of implantable nipple and/or nipple with integrated areolas configured to be consisted of a base and tip. The base diameter may be in the range of 5-100 mm and its thickness may be in the range of 0.2-10 mm. In some embodiments the base shape may be flat or hemisphere and the tip may be any hemisphere shape, as may be required to fit the shape of the respective natural nipple and breast. The plastic material may be biocompatible resilient flexible plastic such as Silicone or other material known in the art.

FIG. 3Ashows implantable nipple and/or nipple with integrated areola exemplary embodiment60consisting of base62and tip61. Base62and tip61may further consists of openings63. Openings63may allow breast tissue grow into the implanted nipple and/or nipple with integrated areola60thus preventing movement of the implantable60inside the breast.

FIG. 3Bshows implantable nipple and/or nipple with integrated areola exemplary configuration64consists of base65tip ring67slots66and tip ring opening68. Slots66and opening68may allow natural breast tissue to grow into the implant thus providing improved affixing of implantable nipple and/or nipple with integrated areola64to the natural breast's tissue.

FIG. 3Dshows implantable nipple and/or nipple with integrated areola exemplary embodiment53consisting of base54and tip55. Base54may further consist of bumpers, granulation or protrusions56made on the surface of implantable nipple and/or nipple with integrated areola53. The bumpers56may allow better holding of the implantable nipple and/or nipple with integrated areola53by the natural breast's tissue and prevent it from internal sliding.

FIG. 3Eshows implantable nipple and/or nipple with integrated areola exemplary embodiment70consisting of base71and tip73. The implantable nipple and/or nipple with integrated areola may also consist of slot72. Slot72may extend from the center of tip73to the outer circumference of base71. Slot72may allow the insertion of the implantable nipple and/or nipple with integrated areola70over the breast's organs such as milk ducts and nervous without harming them. The base71may further consist of holes69to allow the growth of natural breast tissue into the implant70for better holding of implantable nipple and/or nipple with integrated areola70in the breast.

Reference is now made toFIGS. 4-4C3, which represent exemplary embodiments of implantable nipples and/or nipples with integrated areolas consisting of metal skeleton. The metal skeleton may be covered with film of biocompatible plastic such as Silicone for smoothness or completely cast into the soft material to prevent harming the internal tissue. The metal skeleton may be made of shape memory material hence it May return to its prefabricated shape dependent on the ambient temperature. The metal may be of temperature shape memory material hence at constant body temperature of 37 degrees centigrade it may hold prefabricated shape and change its shape with body temperature changes. According to additional embodiments the metal may be of any other type known in the art. The cross section form of the metal skeleton may be of a flat bar or round wire or any other shape known in the art. Some exemplary dimension of a wire of which the metal skeleton may be formed may be in the range of 0.1-10 mm Some exemplary dimension of a flat bar of which the metal skeleton may be formed may be 0.5-10 mm in width and 0.2-5 mm in thickness.

FIG. 4presents an exemplary embodiment of implantable nipple80consisting of helical spring81. The helical spring81may be designed to constantly push the nipple in a forward position after it is inserted under the natural nipple.

FIG. 4Apresents an exemplary embodiment of implantable nipple82. The implantable nipple82may consist of shape-memory metal skeleton consisting of round base83connected by metal bars87to a tip metal ring85. Tip ring85and base83may further consist of slots86and84respectively which enable the insertion of implantable nipple82without disconnecting the breast organs such as milk ducts and nervous. The exemplary structure of implantable nipple82may constantly hold the nipple in a forward position. The base ring83may be of a larger diameter then tip ring85thus creating a tapered shape. The base ring83and tip ring85may be of the same diameter thus creating a straight cylindrical tube shape.

FIG. 4Bshows an exemplary configuration of implantable nipple88which consists of a mesh wire structure91. Implantable nipple88may further consist of base92and tip90. The mesh wire structure91may provide a stronger yet more flexible built of implant nipple88. Mesh wire structure91may further allow for natural breast tissue grow into the mesh openings thus creating a strong bonding between the implant and the breast.

FIGS.4C1-4C3present an exemplary configuration of implantable nipple metal skeleton100according to yet additional embodiment of the present invention, in3D view, front view and side view, respectively. Implantable nipple metal skeleton100may be formed of helix102formed as a cone with wide base104and narrow tip106. Base104may be placed on the breast tissue and narrow tip106may be placed under the natural nipple to support it. The helical structure of metal skeleton100of an implantable nipple may allow insertion of the structure around the breast nerves and milk ducts and milk supply system without having to cut or disconnect the natural nipple. Metal skeleton100of an implantable nipple may be made of a memory-shape metal as explained in details above.