Patent Publication Number: US-2020281626-A1

Title: Device for removal of implants and associated method of use

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     The present invention claims priority to U.S. provisional application Ser. No. 62/515,314, filed Jun. 5, 2017, the disclosure of which is herein incorporated by reference. 
    
    
     FIELD OF THE DISCLOSURE 
     The present invention relates, generally, to a device used to remove implants from a patient, and typically silicone breast implants. 
     DESCRIPTION OF THE RELATED ART 
     A breast implant is a prosthesis used to change the size, shape, and contour of a human breast. Breast implants are implanted under the breast tissue or under the chest muscle to increase breast size (augmentation), to rebuild breast tissue after mastectomy or other damage to the breast (reconstruction), or to correct congenital defects in the chest wall. They are also used in revision surgeries, which correct or improve the result of an original surgery. 
     Breast implants are available in many different forms. There are two types of breast implants approved for sale in the United States: saline-filled breast implants (i.e., saline breast implants), in which an implant shell is filled with sterile salt water, and silicone-filled breast implants (i.e., silicone breast implants), in which the implant shell is filled with a silicone gel. Both types have a silicone outer shell. They vary in size, shell thickness, shell surface texture, and shape (contour). 
     Ruptured silicone breast implants can result after placement into the human body. A rupture is a tear or hole in the outer shell of the breast implant. When this occurs in a saline breast implant, it deflates, meaning the saltwater (saline) solution leaks from the shell. Silicone gel is thicker than saline, so when a silicone gel-filled implant ruptures, the gel may remain in the shell or in the scar tissue that forms around the implant (intracapsular rupture). Silicone gel that leaks outside the capsule surrounding the implant may travel (migrate) away from the breast. The leaked silicone gel may cause lumps to form in the breast or in other tissue, most often the chest wall, armpit or arm. It may be difficult or impossible to remove silicone gel that has traveled to other parts of the body. Ruptured silicone breast implants can cause breast pain or changes in the contour or shape of the breast. Accordingly, the FDA (Food and Drug Administration of the United States) recommends removing both saline-filled and silicone gel-filled breast implants if they have ruptured. 
     In many instances, it is desirable to remove the ruptured silicone breast implant and the leaking silicone gel. Removal after rupture is a time consuming, tedious and difficult process. Typically, such removal is performed by manual extraction utilizing surgical sponges. 
     The present disclosure provides a simple, efficient device and associated method to address this problem. The device of the present disclosure is also appropriate for the removal of other types of implants from a patient, including un-ruptured silicone breast implants, saline breast implants, and buttocks implants and the like that include an outer shell that is filled with saline or silicone gel or another filling material. 
     SUMMARY OF THE INVENTION 
     The present disclosure is directed to an implant removal device, and a system including the implant removal device, and an associated method for removing an implant using the device and system. 
     The implant removal device comprises a hollow container extending between a first end and a second end along a longitudinal axis with a middle portion disposed between the first and second end for receiving and containing the implant. The hollow container has an interior container surface defining a volume therewithin. A connector port is coupled to the second end of the hollow container and is adapted for connection to the suction device. A nozzle is coupled to the first end of said hollow container and extends away from the first end along a nozzle axis and terminates at a nozzle opening defining a terminal end surface. 
     In certain embodiments, the nozzle opening includes at least one gripping portion and at least one recessed portion. The one or more gripping portions preferably are brought into contact with the shell of the implant when the device is inserted into the patient and aid in gripping or maintaining the shell in place during the removal process. In other embodiments, the nozzle axis is offset from the longitudinal axis such that the nozzle opening is offset from the middle portion of the hollow container for aligning with the implant during the removal process. In still further embodiments the device includes both sets of features. 
     To remove an implant from a patient, the implant removal device is coupled to a suction device and the device is inserted within an incision in the patient such that the nozzle is brought into proximity to the implant. The suction device is then actuated to create negative pressure in the volume of the hollow container through the connector port sufficient to draw out the shell and, in the case of silicone-filled implants, the silicone gel from the patient through the nozzle opening and into the volume of the hollow container. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Other advantages of the present invention will be readily appreciated, as the same becomes better understood by reference to the following detailed description when considered in connection with the accompanying drawings. 
         FIG. 1A  is a perspective view of the first end of the implant removal device according to one exemplary embodiment. 
         FIG. 1B  is a perspective view of the first end of the implant removal device according to another exemplary embodiment. 
         FIG. 2  is a perspective view of the implant removal device of  FIG. 1A  wherein the first end is coupled to the middle portion of the hollow container. 
         FIG. 3  is a close-up perspective view of the nozzle of  FIG. 2 . 
         FIG. 4  is a section view of an implant removal system including the implant removal device of  FIG. 2  prior to coupling the suction device; 
         FIG. 4A  is a close-up section view of the connector port of  FIG. 4 ; 
         FIG. 5  is a section view of an implant removal system including the implant removal device of  FIG. 2  after coupling the suction device; and 
         FIG. 6  is a partial section view of the use of the implant removal system of  FIG. 5  in removing an implant from a patient in an operating room. 
         FIG. 7  is a partial section view of the implant removal system after removal of an implant in which the shell and gel of the implant is contained within the hollow container. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     With reference to the Figures, an implant removal device  21  for use in an implant removal system  20  is disclosed herein that is configured for the removal of an implant, and in particular silicone gel-filled implants, from a patient during a surgical procedure. The disclosure also describes the use of the implant removal device  21  for removing an implant (shown as  80  in  FIGS. 6 and 7  below), and in particular a silicone gel filled implant such as a breast implant, but could also be used in the removal of other implants that include a shell (shown as  82  in  FIGS. 6 and 7  below) and a gel or other filling material (shown as silicone gel  84  in  FIGS. 6 and 7  below), such as a saline-filled implant, a buttocks implant, or the like. For ease of description, the description of the shell  82  and the gel  84  as used hereinafter, refers to any type of implant  80  that includes such components, including but not limited to silicone-filled implants  80  such as illustrated in  FIGS. 6 and 7 . 
     Referring first to  FIGS. 1-5 , the implant removal device  21  disclosed herein is in the form of a hollow container  22  having a middle portion  24  disposed between a first end  26  and a second end  28 . In certain embodiments, the hollow container  22  is generally bottle-shaped, with the middle portion  24  being substantially circular or oval-shaped in cross-section. However, in other embodiments, the hollow container  22  may be shaped different. By way of example, as opposed to being substantially circular or oval-shaped in cross-section, the middle section  24  may be rectangular or triangular in cross-section, with the respective shapes of the first end  26  and second end  28  modified so as to correspond to the shape of the modified middle portion  24 . 
     The middle portion  24 , first end  26 , and the second end  28  collectively have an interior container surface  30 , which further defines a volume  32 , and an exterior container surface  34  opposite the interior container surface  30 . The distance between the interior container surface  30  and the exterior container surface  34  defines a thickness of the hollow container  22  corresponding to the middle portion  24 , first end  26 , or the second end  28 . The volume  32  of the hollow container  22  should be sufficient to contain the entirety of the implant shell and silicone gel of the implant (respectively identified by reference numerals  82 ,  84  and  80  in  FIG. 6 ) removed during the surgical procedure. For example, in certain embodiments, the volume  32  may be between 100 and 5000 cubic centimeters, such as 1000 cubic centimeters, although in further embodiments smaller and larger volumes are contemplated. 
     In the embodiments illustrated, a longitudinal axis  25  may also be defined within the volume  32  that extends generally parallel to the length L 1  of the middle portion  24  in a direction from the first end  26  to the second end  28 . In embodiments wherein the middle portion  24  is symmetrical in cross-section, the longitudinal axis  25  may further defined as extending on a line that is equidistant from the interior container surface  30  of the middle portion  24 . 
     To aid in gripping the exterior container surface  34  of the device  21 , a series of one or more protrusions or recesses (shown here as protrusions  35 ) may be included on the exterior container surface  34  of the hollow container  22 , such as on one or more protrusions  35  or recesses on the exterior container surface  34  of the middle portion  24 , the first end  26 , and/or the second end  28  (shown in  FIGS. 1A, 1B, 2, 6 and 7 ) as being included on the middle portion  24 ). 
     A nozzle  40  is coupled to the first end  26  of the hollow container  22  which extends transversely in a direction away from the first end  26  and the second end  28 . The nozzle  40  is configured for interfacing with the implant  80  through the surgical incision  90  (see  FIG. 6 ) of a patient  95  during the surgical procedure to remove the implant  80 . In certain embodiments, the positioning of the nozzle  40  is offset from the longitudinal axis  25 , as will be described further below. 
     The nozzle  40  includes an interior nozzle surface  44  that extends outwardly from, or otherwise transitions outwardly from, the interior container surface  34  of the first end  26 . In addition, the nozzle  40  includes an exterior nozzle surface  46  that extends outwardly from, or otherwise transitions outwardly away from, the exterior container surface  34  of the first end  26 . 
     The interior container surface  44  of the nozzle  40  extends away from the first end  26  and terminates at a nozzle opening  50 . The nozzle opening  50  functions as the inlet port for the receipt of the ruptured breast implant shell  82  and silicone gel  84  to the volume  32  of the hollow container  22  during the surgical procedure. The nozzle opening  50  is open to the volume  32  of the hollow container  22 . The size of the nozzle opening  50  may vary depending upon the ultimate end use of the implant removal device  21 . In particular, the size of the nozzle opening  50  may be enlarged or diminished in cases where larger amounts of material, including the ruptured breast implant  80 , shell  82 , or gel  84 , is desired to be removed from the patient  95 . 
     As noted above, in certain embodiments, the nozzle  40  is coupled to the first end  26  such that it is offset relative to the longitudinal axis  25 . In particular, the nozzle  40  defines a nozzle axis  27  extending in a direction away from the first end  26 , and preferably away and transverse to the first end  26 , and in a direction that is parallel to, and radially spaced from, the longitudinal axis  25 . With this configuration, the nozzle  40  is more easily positioned such that it may be located in closer proximity to the incision  90  along the skin of the patient  95  when the device  21  is used to remove the implant  80  during the implant removal process as compared with a nozzle  40  aligned along the longitudinal axis  25 . 
     In certain embodiments, in addition to the nozzle opening  50  being offset from the longitudinal axis, the nozzle  40  is spaced from an exterior container surface  34  of the middle portion  24  toward said longitudinal axis  25 . 
     In certain embodiments, the nozzle opening  50  includes at least one recessed portion  52  and at least one gripping portion  56 . In further embodiments, the nozzle opening  50  includes a plurality of recessed portions  52  and a plurality of gripping portion  56 , with each of the gripping portions  56  separated from each other by one of the respective pair of recessed portions  52 , and vice versa. In the embodiments shown in  FIGS. 1-7 , the nozzle opening  50  includes a pair of recessed portions  52  and a pair of gripping portions  56 , with each of the pair of gripping portions  56  separated from each other by one of the respective pair of recessed portions  52 . 
     In certain embodiments, the gripping portions  56  define a terminal end surface  48  having an apex  58 , with the apex  58  of each of the gripping portions  56  spaced further away from the first end  26  than the recessed portions  52 . 
     Further, in certain embodiments, each of the recessed portions  52  are curved the gripping portions  56  so as to define a curved end surface  57 . In these embodiments, the recessed portions  52  have a vertex  54  between a respective apexes  58  of the gripping portions  56 . The distance between the apex  58  of the gripping portions  56  and the vertex  54  of the recessed portions  52  define a depth D 1  of the recessed portions  52 . 
     When the implant removal device  20  is used to remove the implant  80 , as will be described in further detail below with respect to the removal of a ruptured breast implant as illustrated in  FIG. 6 , the terminal end surface  48  corresponding to the apex  58  of each of the gripping portions  56  is brought into proximity with, and preferably brought into contact with, the shell  82  of the implant  80 , and functions to aid in holding or otherwise gripping the shell  82  of the implant  80  during the removal process. In order to aid in this function, it is preferable that the nozzle  40 , and in particular the gripping portions  56  of the nozzle opening  50 , is formed from a material and has dimension to have sufficient rigidity that they resist deformation when contacting the shell  82  (i.e., the curved gripping portions  56  in particular and the nozzle  40  in general do not bend or collapse when contacting the shell  82 ), and in particular being pressed against the shell  82 , during the process of removing the implant  80 . Further, the nozzle  40  and nozzle opening  50  also resist deformation while contacting the shell  82  as described above while negative pressure is applied to the device  21  during the process of removing the implant  80 . 
     It has been surprisingly and unexpectedly discovered that this offset positioning of the nozzle  40  relative to the longitudinal axis  25  and along the nozzle axis  27 , in combination with the rigidity of the nozzle  40 , and particularly in combination with the inclusion of one or more gripping portions  56  on the nozzle  40 , provides a maximum efficiency in the removal of the implant shell  82  and silicone gel  84  of the implant  80  during the removal process, as will be described in further detail below. 
     In certain embodiments, such as shown in the Figures herein, the first end  26  and the nozzle  40  are a one-piece structure, with the one-piece structure being is coupled to, or otherwise secured to, the distinct middle portion  24  to form the hollow container  22  prior to use. Stated another way, the nozzle  40  is integrally formed with the first end  26  as a one-piece structure which is distinct from the structure of the middle portion  24  and second end  28 . 
     In certain embodiments, the hollow container  22  includes a first cap  29  defining the first end  26 , with an outer peripheral end  42  of the first cap  29  being coupled to the middle portion  24 . In particular, the outer peripheral end  42  of the first cap  29  is positioned adjacent to, or is otherwise coupled or sealed to, a terminal end region  31  of the middle portion  24 . In embodiments described below, the first cap  29  is shown as being press fit and/or ultrasonically welded to the middle portion  24 . 
     In certain of these embodiments, as best shown in  FIGS. 1A, 4 and 5 , the outer peripheral end  42  of the first cap  29  includes a ledge  45  extending transverse from a shoulder  47 . The ledge  45  and shoulder  47  are shaped such that the outer surface  49  of the ledge  45  is press fit against the interior container surface  30  of the terminal end region  31  of the middle portion  24  and wherein the inward surface  51  of the shoulder  47  is adjacent to the outer terminal surface  33  of the middle portion  24 . 
     In certain alternative embodiments (not shown), as opposed to press fitting the ledge  45  of the first cap  29  to the interior container surface  30  of the middle portion  24 , the exterior container surface  34  of the middle portion  24  may be press fit to an inner surface  51  of the ledge  45  of the first cap  29 , with the inward surface  51  of the shoulder  47  still being adjacent to the outer terminal surface  33  (but wherein the shoulder  47  extends inwardly instead of outwardly. In certain related embodiments, in order to permanently secure the first cap  29  to the middle portion  24  in these alternative embodiments, an ultrasonic welding process may be performed, or an adhesive may be included, between the outer surface  49  and interior container surface  30  (or in the alternative arrangement between the inner surface  51  and the exterior container surface  34 ), and/or between the inward surface  51  and the outer terminal surface  33  to secure or otherwise affix the first cap  29  to the middle portion  24  if desired. 
     In another alternative embodiment of the first cap  29  as shown in  FIG. 1B , as opposed to a press fitting the outer peripheral end  42  of the first cap  29  to the middle portion  24 , an inward terminal surface  55  of the outer peripheral end  42  of the first cap  29  may simply be abutted to the outer terminal surface  33  of the outer terminal region  31  of the middle portion  24  and be secured thereto via ultrasonic welding or through the use of an adhesive. 
     In certain embodiments, a connector port  60  is coupled to the second end  28  of the hollow container  22 . The connector port  60 , as best shown in  FIG. 4A , includes a connector receiving region  62  that is adapted for connection to the suction device  100 . In particular, as further shown in  FIG. 5 , the connector interior region  62  is adapted to receive an external portion  102  of the suction device  100 . 
     In certain embodiments, the connector interior region  62  has an internal opening  63  that is open to, and forms a portion of, the volume  32  of the hollow container  22 . The internal opening  63  of the connector interior region  62  is also open with an internal opening  103  of the suction device  100  when the suction device  100  is coupled to the connector port  60 , with the internal opening  103  defined within the external portion  102 . As such, when negative pressure is actuated from the suction device  100 , suction is created (shown as arrow  200  in  FIG. 6 ) through the internal opening  103 , the internal opening  63 , and into the volume  32  of the hollow container  22  that is then used that draw the implant  80  (including the shell  82  and gel  84 ) through the nozzle opening  50  and into the volume  32 . 
     In certain embodiments, such as shown in  FIGS. 4 and 4A , the connector port  60  is integrally formed with the second end  28 . In these embodiments, the inner surface  64  of the connector receiving region  62 , which defines the internal opening  63 , extends outwardly from, or otherwise transitions outwardly from the interior container surface  30  of the second end  28  in an opposite direction from the middle portion  24  relative to the nozzle  40 . Similarly, the connector receiving region  62  includes an outer surface  66  that extends outwardly from, or otherwise transitions outwardly away from the exterior container surface  34  of the first end  26 . The outer surface  66  also includes a depressed region  69  that receives a corresponding flange  107  of the external portion  102  of the suction device  100  to secure the suction device  100  to the connector portion  60 . 
     The connector port  60  also defines a connector axis  65 . In particular, the connector axis  65  is defined within the internal opening  63  and is generally aligned parallel to the length of the inner surface  64  of the connector port  60 . 
     In certain embodiments, such as shown in the Figures, the connector axis  65  is parallel to the nozzle axis  27 . In further embodiments, the connector axis  65  is offset from the longitudinal axis  25 . Still further, in certain embodiments, the connector axis  65  is offset from the longitudinal axis  25  and is radially spaced from the nozzle axis  27  relative to the longitudinal axis  25 . 
     In still further embodiments, the connector port  60  is coupled to the second end  28  and extends in a direction transverse to the longitudinal axis  25 . In certain of these embodiments, the connector port  60  is coupled to the second end  28  and extends in a direction normal to the longitudinal axis  25 . 
     In still further embodiments, as opposed to being coupled to the second end  28 , the connector port  60  is coupled to the middle portion  24  and extends in a direction transverse to the longitudinal axis  25 . In certain of these embodiments, the connector port  60  is coupled to the middle portion  24  and extends in a direction normal to the longitudinal axis  25 . 
     In certain other embodiments, the connector port  60  is a separate structure that is coupled to the second end  28 . In certain of these embodiments, the outer surface  66  of the connector port  60  is coupled to the interior container surface  30  of the second end  28 , while in further alternative embodiments the inner surface  64  of the connector port  60  is coupled around the exterior container surface  34  of the second end  28 . In either of these embodiments, ultrasonic welding or an adhesive material may be introduced between the connector port  60  and the second end  28  to secure the connector port  60  to the first end  28 . In embodiments wherein the connector port  60  is coupled to the middle portion  24  and is a separate structure from the middle portion  24 , a similar kind of coupling and securing via ultrasonic welding or through an adhesive can occur. 
     In certain embodiments, the hollow container  22  includes a second cap  70  defining the second end  28 . In these embodiments, the second cap  70  is integrally formed with the middle portion  24  as a one-piece structure, such as best shown in  FIGS. 4 and 5 . 
     Alternatively, the second cap  70  may be coupled to another terminal end surface (not shown) of the middle portion  24  in a manner similar to the connection of the first cap  29  to the terminal end region  31  of the middle portion  24  as described above. 
     The hollow container  22 , in certain embodiments, is formed from a material having physical properties, particularly in terms of leakage prevention, durability and strength, appropriate for the temporary acceptance of the shell  82 , any silicone gel  84 , and associated medical waste from the patient  95 . Preferably, the hollow container  22  is transparent such that a doctor can confirm the acceptance of the breast implant shell  82 , any silicone gel  84 , and associated medical waste from the patient  95  during the surgical procedure. In certain embodiments, however, the separate first end  26  (including the nozzle  40 ) may be formed from an opaque material, such as an opaque plastic material. Still further, as noted above, the material used in the nozzle  40  should have sufficient rigidity to maintain its shape when pressed against the shell  82  of the implant  80  during the removal process. Yet still further, it is desirable that the material used in forming the hollow container  22  has sufficient rigidity and strength to withstand collapsing upon the introduction of negative pressure, in the range of 150-500 mm Hg (mercury), during the removal process. Even still further, it is desirable that such material retain their physical properties, including transparency, after a sterilization process such as through e-beam sterilization. 
     Exemplary materials for forming the hollow container  22 , or any component thereof (such as the nozzle  40 ), include, but are not limited, thermoplastic materials such as polycarbonate. In certain embodiments, the materials for each separate piece of the hollow container  22  are formed from the same exemplary material, while in other embodiments the separate pieces may be formed of different materials, or slightly different formulations of the same general thermoplastic material. For example, in embodiments, wherein the first end  26  is formed from an opaque material, while the middle portion  24  and second end  28  are formed from a transparent material, the difference in such materials could simply occur by adjusting the formulations to include additives (such as including a fillers or pigments in the first end  26  that are not present, or present in differing amounts, in the middle portion  24  or second end  28 ). Alternatively, the polymer composition of the thermoplastic materials may be different (such as through the use of a polycarbonate material in one instance and a polyurethane in another instance, or alternatively wherein the generally polycarbonate material is modified in some other manner (such as through changes in number average molecular weights or by modifying the structure to include additional chemical groups). Other materials, such as thermosetting polymeric materials or glass, may also form one or more of the separate components of the hollow container  22 . 
     In certain embodiments, a coating layer  110  is applied to the interior nozzle surface  44  of the nozzle  40 . The coating layer  110  is in the form of a low friction coating layer  110  formed from a low friction material, in which the outer surface  112  (shown in  FIG. 5 ) of the coating layer  110 , opposite the interior nozzle surface  44 , has lower surface friction than the corresponding surface friction of the interior nozzle surface  44 . In certain embodiments, in addition to forming a low surface friction outer surface, the coating material also is a hydrophilic coating, which is believed to provide the outer surface layer with an increased amount of lubricity. 
     The lower surface friction properties of the outer surface  112  of the coating layer  110 , alone or in combination with the increase in hydrophilicity, aids in preventing the implant  80  and any associated residual medical waste (such as blood, tissue, water etc.) from a patient from adhering onto the outer surface  112  during use of implant removal device  21  in removing the implant  80  as compared with an uncoated interior nozzle surface  44 , thereby increasing the efficiency of the implant removal process. 
     In still further embodiments, in addition to having the lower surface friction properties, the outer surface  112  of the coating layer  110  may also provide increased durability properties, or enhanced durability properties, as compared with devices  21  not include such a coating layer  110 . Further, the coating layers  110  provided have sufficient bonding strength to the interior nozzle surface  44  such that they are not removed, delaminated, or otherwise degrade during the implant removal process. 
     Exemplary, non-limiting coating compositions used to form the coating layer  110  include low friction, hydrophilic coating compositions sold under the tradename Serene™, commercially available from Surmodics, Inc. of Eden Prairie, Minn. and hydrophobic coating compositions sold under the tradename Hydak®, commercially available from Biocoat, Inc., of Horsham, Pa. However, other coating compositions for forming layers  110  having specific properties or combination of properties are also contemplated. 
     In even further embodiments, a flexible diaphragm may be provided that is positioned at the interface between the hollow container  22  and the suction device  100 , or within the interior of the hollow container  22  at a position near, along or adjacent to the connector port  60 , to separate the volume  32  of the hollow container  25  from the suction device  100 . The flexible diaphragm functions to limit contamination of the suction device  100  from the removed implant  80  during use, the flexible diaphragm also prevents the introduction of cross contamination into the volume  32  of the hollow container  22 , and into the patient  95  via the volume  32  of the hollow container  22 , from the outside environment. When included, the flexible diaphragm does not adversely impact the generation of negative pressure from the suction device  100  within the volume  32  of the hollow container  22 . 
     The present invention also is directed to an implant removal system  20 , including the afore-mentioned implant removal device  21 , and an associated method which is used in a surgical procedure to remove a ruptured silicone breast implant  80  from a patient  95 . In the implant removal system  20 , as shown in  FIG. 6 , the implant removal device  21  is coupled to a suction device  100 , such as a wall suction device  100  coupled to and extending from a wall  140  within an operating room  150  which when actuated provides negative pressure, in the range of 150-500 mm Hg, within the volume  32  of the hollow container  22  and through the nozzle opening  50  sufficient to facilitate the removal of the shell  82  and silicone gel  84  from the patient  95 . 
     The suction device  100  is conventional in nature and is of the type found in hospital or medical settings to provide a vacuum source for surgical procedures. The suction device  100  may be mounted in an operating room  150  of a medical facility, or alternatively may be mobile. 
     In particular, as best shown in  FIG. 6 , during the surgical procedure for removal on an implant, here shown as a ruptured silicone breast implant  80 , a small incision  90  is made in the skin of a patient  95  in order to access the ruptured implant  80 . 
     The device  21 , which has been sterilized before use such as through e-beam sterilization as described above, is then brought into proximity with the incision  90  and is utilized to remove the implant  80 . More particularly, the device  21  is positioned on the surface of the skin near the incision  90  between the ends of the incision  90 , with the nozzle opening  50  positioned in closest proximity to the skin of the patient  95  for easier insertion. The nozzle  40  is then inserted within the small incision  90  in the skin and brought into proximity to the implant  80 . The size of the small incision  90  is preferably roughly equal to the cross-sectional width of the nozzle  40  such that the nozzle  40  is surrounded by the tissue and skin of the patient  95  after insertion, although the size could be larger if desired based on the preference of the doctor. 
     Preferably, during the insertion process, the gripping portions  156  are brought into pressing contact with the shell  82  of the implant  80 . As noted above, the rigidity of the nozzle  40  and the gripping portions  156  allows the device  21  to maintain its internal position within the incision  90  of the patient  20  during the implant removal process. 
     The suction device  100  is coupled to the connector port  60  either prior to the insertion of the nozzle  40  or after the insertion of the nozzle  40 . Typically this is accomplished by inserting the external portion  102  of the suction device  100  into the connector receiving portion  62  and securing the flange  107  into the depressed portion  107  of the outer surface  66 . The suction device  100  is then actuated, thereby creating negative pressure (i.e., vacuum suction) within the volume  32  of the hollow container  22  (shown by arrow  200  in  FIG. 6 ) sufficient to draw out the breast implant shell  82  and cohesive silicone gel  84  through the nozzle opening  50  of the device  21  and into the volume  32  of the hollow container  22 . As illustrated in  FIG. 6 , a portion of the silicone gel  84  has been removed to the volume  32 , while the majority of the gel  84  contained in the shell  82  still remains in the patient  95 , such as immediately after actuation. As noted above, in certain embodiments, such negative pressure may be between 150 and 500 mm Hg. If needed, the negative pressure of the suction device  100  may be increased or decreased relative to the desired range. Because the middle portion  24  of the device  21  is transparent, the doctor can observe and confirm the introduction of the shell  82  and silicone gel  84  in the volume  32  of the hollow container  22  during the removal process as the negative pressure is actuated. 
     Upon confirmation, typically visual confirmation by the doctor, that a desired amount of the implant shell  82  and silicone gel  84  has been removed from the patient  95  and is visible through the transparent middle portion  24  in the volume  32 , the suction device  100  is turned off, and the device  21  is removed from the incision  90 , as shown in  FIG. 7 . The suction device  100  is then disconnected from the connector port  60 . Any residual silicone gel  84  or shell  82  of the implant  80  that was not removed by the device  21  can then be removed from the patient through the use of surgical sponges or other known manual extraction surgical techniques. 
     The device  21 , including the extravagated silicone gel  84  and shell  82  contained within the volume  32  of the hollow container  22  as best illustrated in  FIG. 7 , may be disposed of as medical waste. Alternatively, such materials may be removed from the device  21 , and the device  21  can be cleaned, sterilized, and reused as desired. 
     The claimed invention differs from what currently exists. There is no implant removal device  21  available which is able to be sterilized prior to use and will assist in removal of an implant  80  (or the shell or gel), such as a ruptured breast implant, as is described herein. This invention is an improvement on what currently exists. The device removes the vast majority of the extravagated silicone and the shell and traps it into an easily disposed unit which substantially expedites the process as well as limits contamination. 
     While the device  21  is ideally suited for the removal of silicone breast implants, and in particular ruptured silicone breast implants, the device  21  is also appropriate for use, in the method described above, for removal of other types of implants having a shell and material contained within a shell (such as silicone gel, saline, or some other filling material). 
     The invention has been described in an illustrative manner, and it is to be understood that the terminology which has been used is intended to be in the nature of words of description rather than of limitation. Many modifications and variations of the present invention are possible in light of the above teachings, and the invention may be practiced otherwise than as specifically described.