Abstract:
A method of biological reconstruction and a device having a major chamber or compartment in the form of the desired anatomy with a shaped chamber inside the main chamber flipped up and held in place by one or more inflatable piston chambers. The inflatable piston chambers selectively hold the shaped chamber and are pressurized in order to support the shape of the device upon implantation. Valves are provided to allow filling the major chamber, the shaped chamber and the piston chambers with a biologically compatible fluid.

Description:
BACKGROUND OF THE INVENTION  
       [0001]     1. Field of the Invention  
         [0002]     This invention relates to a method for reshaping a portion of an organism through implantation of an expandable prosthesis and the prosthesis itself. This invention is particularly suitable for providing a female breast with a more desirable shape.  
         [0003]     2. Description of the Related Art  
         [0004]     For various reasons, including reconstructive surgery, implants have been used for many years to restore a natural size and shape to various parts of the anatomy, in particular to breasts. In particular, mammary implants are known in the prior art as evidenced in U.S. Pat. Nos. 2,636,182, 3,934,274, 4,605,412, 4,790,848 and 5,236,454.  
         [0005]     Methods used in the past often resulted in an unnatural appearance. One prior method included a silicone sac filled with saline and placed beneath the pectoral muscle. This bag is usually shaped in the form of a breast, but, unfortunately, the saline acts in accordance with the laws of fluids and gravity and, sometimes, over time as a scar forms around the bag (forming a capsule), it distributes itself into a spherical shape, resulting in an unnatural appearance of a ball placed beneath the skin rather than the shape of a natural breast. Another problem with prior attempts to reconstruct a natural shape is maintaining projection. Due to the redistribution of fluids within the sac, the top section of the prosthesis loses fluid, creating a flat or concave appearance on the top area of the breast, when a full, rounded shape is desired.  
         [0006]     U.S. Pat. No. 6,755,861 to Nakao describes a multi-chamber implantable device and is hereby incorporated by reference. The individual chambers are pressurized under computer control to control the shape upon implantation. This device has many smaller chambers, each having an interface to each other and the outer shell, producing an uneven feel and surface appearance.  
         [0007]     What is needed is an implant that will support the desired shape with an even surface texture and with a dependable shape that lasts. What is also needed is an implant that works well to lift minimally or moderately droopy breasts and one that helps prevent later-life drooping when implanted behind a youthful breast.  
       SUMMARY OF THE INVENTION  
       [0008]     In one embodiment, a breast implant is disclosed including a major chamber with a back wall and a shaped chamber located within an upper portion of the major chamber. At least two piston chambers are within the major chamber and are configured to flip up and hold the shaped chamber in place. A valve is associated with each chamber for admitting a biologically compatible fluid into the chamber with which it is associated.  
         [0009]     In another embodiment, a breast implant is disclosed including a major chamber having a back wall, the back wall with a top end configured to be positioned in the direction of a head of the person (cephalad) and a bottom end configured to be positioned in the direction of a waist of the person (caudal). Within the major chamber is a shaped chamber positioned towards the top end of the major chamber with a first end affixed to the back wall of the major chamber. There is at least one piston chamber within the major chamber configured to flip and hold the shaped chamber in place. A proximal end of the at least one piston chamber is affixed to a second end of the shaped chamber and a distal end of the at least one piston chamber is affixed to the back wall substantially near the bottom end. A valve is associated with each chamber for admitting fluid into the chamber with which it is associated.  
         [0010]     In another embodiment, a method of breast implantation is disclosed including inserting a breast implant through an incision in the breast, the breast implant having a major chamber with a back wall. Within an upper portion of the major chamber is a shaped chamber. There are at least two piston chambers within the major chamber for flipping and holding the shaped chamber in place. A valve is associated with each chamber for admitting a biologically compatible fluid into each chamber with which it is associated. Next, positioning the breast implant so the shaped chamber is positioned toward the top portion of the breast and then filling the major chamber and the shaped chamber with the biologically compatible fluid. Finally, inserting the biologically compatible fluid into the at least two piston chambers. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0011]     The invention can be best understood by those having ordinary skill in the art by reference to the following detailed description when considered in conjunction with the accompanying drawings in which:  
         [0012]      FIG. 1  is a schematic cross-sectional view of a breast prosthesis in accordance with the present invention.  
         [0013]      FIG. 2  is a cross-sectional view of the breast prosthesis of  FIG. 1 .  
         [0014]      FIG. 3  is a schematic front elevational view of the prosthesis of  FIG. 1 .  
         [0015]      FIG. 4  is a schematic side elevational view of a breast prosthesis of  FIG. 1  showing the injection of a fluid.  
         [0016]      FIG. 5  is an isometric view of a breast prosthesis of  FIG. 1  showing the injection of a fluid.  
         [0017]      FIG. 6  is a cross-sectional view of the breast prosthesis of  FIG. 1 . 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0018]     Reference will now be made in detail to the presently preferred embodiments of the invention, examples of which are illustrated in the accompanying drawings. Throughout the following detailed description, the same reference numerals refer to the same elements in all figures.  
         [0019]     Referring to  FIG. 1 , a schematic side elevational view of a breast prosthesis in accordance with the present invention will be described. The implant  8  has been surgically inserted under or behind the breast  50 , supported in the rear by other biological matter  52  such as muscle. The implant  8  is made from a soft, bendable, biologically compatible material such as silicone or silica. The implant  8  is made in various sizes to accommodate variations in breast sizes and desired target breast sizes and shapes. There are at least three chambers composed of this material. A major chamber  10  is a sac encapsulating the entire implant  8  and all other chambers. A valve  20  in the outer surface of the major chamber  10  allows introduction of a biologically compatible fluid such as saline or a soy-based solution. Within the major chamber  10  is a shaped chamber  12 . The shaped chamber  12  is positioned in an upper portion of the major chamber  10 . The shaped chamber  12  is attached to the top of the back wall  11  of the major chamber  10 , the top being the end of the back wall  11  that is positioned substantially in the direction of the person&#39;s head (cephalad). A valve  22  is provided for filling the shaped chamber with a biologically compatible fluid. The valve  22  interfaces with a surface of the major chamber  10  such that fluid can be injected into the shaped chamber without violating the integrity of the major chamber  10 . In some embodiments, the shaped chamber  12  is attached to the back wall  11  of the major chamber  10  by the valve  22 . All valves are on a surface of the implant  8  that is well within the body and in a location that permits filling the sacs from the outside after the implant  8  is inserted under the patient&#39;s breast. In some embodiments, the shaped chamber  12  is in the shape of a crescent-dome, a dome or a half-moon.  
         [0020]     Supporting the shaped chamber  12  is at least one sac in the shape of a piston  14 , preferably two pistons  14 . One end of the piston  14  is attached to the underside of the shaped chamber  12  near a distal end of its back surface (towards the front of the breast  50 ) and the opposite end is attached to the back wall  11  of the major chamber  10  at a point near the bottom of the back wall  11 . Valves  24  are provided for filling the piston(s)  14  with a biologically compatible fluid. The valves  24  interface with a surface of the major chamber  10  such that fluid can be injected into the piston(s)  14  without violating the integrity of the major chamber  10 . In some embodiments, the piston(s)  14  are attached to the back wall  11  of the major chamber  10  by the valve  24  while in other embodiments, the piston(s)  14  are affixed or are part of the back wall  11  of the major chamber  10 . The shape of the piston(s)  14  is not significant; it only needs to provide support to the shaped chamber  12 . Furthermore, in some embodiments some or all of the chambers or sacs are pre-filled with a volume of biologically compatible fluid.  
         [0021]     In most procedures, the implant  8  is inserted under the breast through a small incision made in a location medically recognized as an acceptable incision site for a breast augmentation such as in an existing scar, beneath the breast or around the lower portion of the areola. Once inserted and positioned so that the shaped chamber  12  is substantially in an upward position, the chambers are filled with a biologically compatible solution. The shaped chamber  12  is flipped-up and held in the upper portion of the breast by the piston(s)  14 , providing a superior lift to the overlying breast. The outer, major chamber  10  reduces ones ability to feel the other chambers within the breasts. The present invention works equally well on all types of breasts, but is very well suited for mildly droopy or moderately droopy breasts. Furthermore, the present invention works well on youthful breasts, possibly preventing future drooping with age.  
         [0022]     Referring to  FIG. 2 , a cross-sectional view of the breast prosthesis of  FIG. 1  will be described. There are at least three chambers. A major chamber  10  is a sac encapsulating the entire implant  8  and all other chambers. A valve  20  in the outer surface of the major chamber  10  allows introduction of a biologically compatible fluid such as saline or a soy-based solution. Within the major chamber  10  is a shaped chamber  12 . The shaped chamber  12  is positioned in an upper portion of the major chamber  10 . The shaped chamber  12  is attached to a top inside surface of the major chamber  10 , the top being the end of the back wall  11  that is positioned substantially in the direction of the patient&#39;s head when implanted (cephalad). A valve  22  is provided for filling the shaped chamber with a biologically compatible fluid. The valve  22  interfaces with a surface of the major chamber  10  such that fluid can be injected into the shaped chamber without violating the integrity of the major chamber  10 . In some embodiments, the shaped chamber  12  is attached to a surface of the major chamber  10  by the valve  22 . All valves are on a surface of the implant  8  that is well within the body and in a location that permits filling the sacs from the outside after the implant  8  is inserted under the patient&#39;s breast. In some embodiments, the shaped chamber  12  is in the shape of a crescent-dome, a dome or a half-moon.  
         [0023]     Supporting the shaped chamber  12  is at least one sac in the shape of a piston  14 . One end of the piston  14  is attached to the shaped chamber  12  near a distal end of its back surface and the opposite end is attached to an inside surface of the major chamber  10  at a point near the bottom of the back wall  11  (caudal). Valves  24  are provided for filling the piston(s)  14  with a biologically compatible fluid. The valves  24  interface with a surface of the major chamber  10  such that fluid can be injected into the piston(s)  14  without violating the integrity of the major chamber  10 . In some embodiments, the piston(s)  14  are attached to the back wall  11  of the major chamber  10  by the valve  24  while in other embodiments, the piston(s)  14  are affixed or are part of an inside surface of the major chamber  10 .  
         [0024]     Referring to  FIG. 3 , a schematic front elevational view of the prosthesis of  FIG. 1  will be described. In this example, there are four chambers. A major chamber  10  is a sac encapsulating the entire implant  8  and all other chambers. A valve  20  in the outer surface of the major chamber  10  allows introduction of a biologically compatible fluid such as saline or soy-based solution. Within the major chamber  10  is a shaped chamber  12 . The shaped chamber  12  is positioned in an upper portion of the major chamber  10 . The shaped chamber  12  is attached to a top inside surface of the major chamber  10 , the top being the end of the back wall  11  that is positioned substantially in the direction of the patient&#39;s head when implanted (cephalad). A valve  22  is provided for filling the shaped chamber with a biologically compatible fluid. The valve  22  interfaces with a surface of the major chamber  10  such that fluid can be injected into the shaped chamber without violating the integrity of the major chamber  10 . In some embodiments, the shaped chamber  12  is attached to the back wall  11  of the major chamber  10  by the valve  22 . All valves are on a surface of the implant  8  that is well within the body and in a location that permits filling the sacs from the outside after the implant  8  is inserted under the patient&#39;s breast. In some embodiments, the shaped chamber  12  is in the shape of a crescent-dome, a dome or a half-moon.  
         [0025]     Supporting the shaped chamber  12  are two sacs in the shape of a piston  14 / 16 . One end of the pistons  14 / 16  is attached to the shaped chamber  12  near a distal end of its back surface and the opposite end is attached to the back wall  11  or other inside surface of the major chamber  10  at a point near the bottom of the back wall  11  (caudal). Valves  24 / 26  are provided for filling the piston  14 / 16  with a biologically compatible fluid. The valves  24 / 26  interface with a surface of the major chamber  10  such that fluid can be injected into the piston  14 / 16  without violating the integrity of the major chamber  10 . In some embodiments, the piston  14 / 16  are attached to the back wall  11  of the major chamber  10  by the valve  24  while in other embodiments, the piston  14  are affixed or are part of an inside surface or the back wall  11  of the major chamber  10 .  
         [0026]     Referring to  FIG. 4 , a schematic side elevational view of a breast prosthesis of  FIG. 1  showing the injection of a fluid will be described. The implant  8  has been surgically inserted beneath the breast  50  through an incision  42  and is supported in the rear by other biological matter  52  such as muscle. The major chamber  10  is a sac encapsulating the entire implant  8  and all other chambers. A valve  20  in the outer surface of the major chamber  10  allows introduction of a biologically compatible fluid through an easy-to-disconnect tube  40  and may be filled with a syringe  60  or other pressurizing device. After filling each chamber, the tubes  40  are pulled off and away from their respective valve and discarded. Within the major chamber  10  is a shaped chamber  12 . The shaped chamber  12  is positioned in an upper portion of the major chamber  10 . The shaped chamber  12  is attached to an inside surface of the major chamber  10  near the top, the top being the end of the back wall  11  that is positioned substantially in the direction of the person&#39;s head (cephalad). A valve  22  allows introduction of a biologically compatible fluid by the easy-to-disconnect tube  40  and may be filled by a syringe  60  or other pressurizing device, then pulled off and away and discarded. The valve  22  interfaces with a surface of the major chamber  10  such that fluid can be injected into the shaped chamber without violating the integrity of the major chamber  10 . In some embodiments, the shaped chamber  12  is attached to the back wall  11  of the major chamber  10  by the valve  22 . All valves are on a surface of the implant  8  that is well within the body and in a location that permits filling the sacs from the easy-to-disconnect tubes  40  after the implant  8  is inserted into the patient&#39;s breast. In some embodiments, the shaped chamber  12  is in the shape of a crescent-dome, a dome or a half-moon.  
         [0027]     Supporting the shaped chamber  12  is at least one sac in the shape of a piston  14 . One end of the piston  14  is attached to the shaped chamber  12  near a distal end of the shaped chamber&#39;s  12  back surface (towards the front of the breast  50 ) and the opposite end is attached to the an inside surface or back wall  11  of the major chamber  10  at a point near the bottom of the back wall  11  (caudal). The valves  24  allow the introduction of a biologically compatible fluid through easy-to-disconnect tubes  40  using a syringe  60  or other pressurizing device. The valves  24  interface with a back wall  11  of the major chamber  10  such that fluid can be injected into the piston(s)  14  without violating the integrity of the major chamber  10 . In some embodiments, the piston(s)  14  are attached to the back wall  11  of the major chamber  10  by the valves  24  while in other embodiments, the piston(s)  14  are affixed or are part of a lower inside surface or the back wall  11  of the major chamber  10 .  
         [0028]     In most procedures, the implant  8  is inserted beneath the breast through a small incision  42  made in a location medically recognized as an acceptable incision site for a breast augmentation such as in an existing scar, beneath the breast or around the lower portion of the areola. Once inserted and positioned so that the shaped chamber  12  is substantially in an upward position, the chambers are filled with a biologically compatible solution through easy-to-disconnect tubes using a syringe  60  or other pressurizing device. The shaped chamber  12  is flipped-up and held in the upper portion of the breast by the piston(s)  14 , providing a superior lift to the overlying breast. The outer, major chamber  10  reduces ones ability to feel the other chambers within the breast.  
         [0029]     Referring to  FIG. 5 , an isometric view of a breast prosthesis of  FIG. 1  showing the injection of a fluid will be described. The major chamber  10  is a sac encapsulating the entire implant  8  and all other chambers and has a back wall  11 . A valve  20  in the outer surface of the major chamber  10  allows introduction of a biologically compatible fluid through an easy-to-disconnect tube using a syringe  60  or other pressurizing device.  
         [0030]     Referring to  FIG. 6 , a schematic side elevational view of a breast prosthesis in accordance with the present invention will be described. The implant  8  has been surgically inserted under or behind the breast  50 , supported in the rear by other biological matter  52  such as muscle. There are at least three chambers composed of this material. A major chamber  10  is a sac encapsulating the entire implant  8  and all other chambers. A valve  20  in the outer surface of the major chamber  10  allows introduction of a biologically compatible fluid such as saline or a soy-based solution. Within the major chamber  10  is a shaped chamber  12 . In this figure, the shaped chamber  12  is positioned in an unsupported position within the major chamber  10 . The shaped chamber  12  is attached to the top of the back wall  11  of the major chamber  10 , the top being the end of the back wall  11  that is positioned substantially in the direction of the person&#39;s head (cephalad). A valve  22  is provided for filling the shaped chamber with a biologically compatible fluid. The valve  22  interfaces with a surface of the major chamber  10  such that fluid can be injected into the shaped chamber without violating the integrity of the major chamber  10 . In some embodiments, the shaped chamber  12  is attached to the back wall  11  of the major chamber  10  by the valve  22 . All valves are on a surface of the implant  8  that is well within the body and in a location that permits filling the sacs from the outside after the implant  8  is inserted under the patient&#39;s breast. In some embodiments, the shaped chamber  12  is in the shape of a crescent-dome, a dome or a half-moon.  
         [0031]     Supporting the shaped chamber  12  is at least one sac in the shape of a piston  14 , preferably two pistons  14 . In this figure, the piston  14  is yet to be filled with the biologically compatible fluid and is shown in its relaxed state, allowing insertion. One end of the piston  14  is attached to the underside of the shaped chamber  12  near a distal end of its back surface (towards the front of the breast  50 ) and the opposite end is attached to the back wall  11  of the major chamber  10  at a point near the bottom of the back wall  11 . Valves  24  are provided for filling the piston(s)  14  with a biologically compatible fluid. The valves  24  interface with a surface of the major chamber  10  such that fluid can be injected into the piston(s)  14  without violating the integrity of the major chamber  10 . In some embodiments, the piston(s)  14  are attached to the back wall  11  of the major chamber  10  by the valve  24  while in other embodiments, the piston(s)  14  are affixed or are part of the back wall  11  of the major chamber  10 . The shape of the piston(s)  14  is not significant; it only needs to provide support to the shaped chamber  12 . Furthermore, in some embodiments some or all of the chambers or sacs are pre-filled with a volume of biologically compatible fluid.  
         [0032]     Equivalent elements can be substituted for the ones set forth above such that they perform in substantially the same manner in substantially the same way for achieving substantially the same result.  
         [0033]     It is believed that the system and method of the present invention and many of its attendant advantages will be understood by the foregoing description. It is also believed that it will be apparent that various changes may be made in the form, construction and arrangement of the components thereof without departing from the scope and spirit of the invention or without sacrificing all of its material advantages. The form herein before described being merely exemplary and explanatory embodiment thereof. It is the intention of the following claims to encompass and include such changes.