PATENT ABSTRACT
A lip implant having first and second regions is described. The lip implant includes a first region formed of a liquid, solid, or a gas and a second region formed of a solid material. Also described is a lip implant having an elongated cross-section. A method for insertion of the implant is also described along with the instrumentation facilitating its insertion.

PATENT DESCRIPTION
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application is a continuation of application Ser. No. 11/929,267, filed on Oct. 30, 2007, which is a continuation of application Ser. No. 10/792,984, filed on Mar. 4, 2004, now U.S. Pat. No. 7,344,566, issued Mar. 18, 2008, which is a continuation-in-part of application Ser. No. 10/384,229, filed on Mar. 7, 2003, now U.S. Pat. No. 7,008,455, issued Mar. 7, 2006. 
     
    
     BACKGROUND 
       [0002]    The present disclosure relates generally to a lip implant, and more particularly to a lip implant, which may be used for lip augmentation or enhancement. 
         [0003]    Within the field of Plastic Surgery, soft tissue augmentation has long been in popular demand by people wishing to enhance their physical appearance. More recently, lip augmentation, i.e. increasing the fullness of the lips, has become a viable entity. 
         [0004]    Currently, there are a variety of materials and methods used for lip augmentation. Some of the current techniques provide for temporary lip augmentation via injection of various materials into the lip such as fat, collagen, hyaluronic acid, and particulated dermis or fascia. One of the disadvantages of such temporary techniques is the need for the patient to periodically undergo additional procedures to maintain the lip fullness. 
         [0005]    Other techniques, such as liquid silicone injections, provide a more permanent lip augmentation. However, liquid silicone injections may be complicated by skin ulceration, long-term nodularity and granuloma formation, and chronic cellulitis. Furthermore, it is inherently difficult to remove liquid silicone from the lips should a problem arise or should the patient desire removal. That is, reversibility is difficult or impossible. 
         [0006]    Another permanent lip augmentation technique is the implantation of expanded polytetraflouroethylene (PTFE) such as Gore-Tex® strips or tubular forms of PTFE such as Softform® and Ultrasoft™. Expanded PTFE utilizes the concept of tissue ingrowth into the porous wall of the implant. While beneficial in some areas of the body, implantation of such material into the lips can be complicated by tissue adherence to the implant. Tissue ingrowth may result in restriction of lip excursion and result in an abnormal appearance during facial expression. Furthermore, fluid may accumulate inside the tubular forms of PTFE, thereby resulting in an unacceptable incidence of postoperative surgical infection and subsequent loss of implant. 
         [0007]    Therefore, what is needed is a lip implant that eliminates, or at least significantly reduces, the above-described complications. Moreover, instrumentation and a method for insertion of this new lip implant are needed. Finally, a method that is easily reversible is needed. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0008]      FIG. 1  is a perspective view of a lip implant according to one embodiment of the present disclosure. 
           [0009]      FIG. 2  is a cross-sectional view of the lip implant of  FIG. 1  taken along the line  2 - 2 . 
           [0010]      FIG. 3  is a perspective view of a lip implant instrument according to one embodiment of the present disclosure. 
           [0011]      FIG. 4  is a side view of the lip implant instrument of  FIG. 3 . 
           [0012]      FIG. 5  is a cross-sectional view of the lip implant instrument of  FIG. 4  taken along the line  5 - 5 . 
           [0013]      FIG. 6  is a schematic view of a lip for receiving the lip implant according to the present disclosure. 
           [0014]      FIG. 7  is a perspective view of a lip implant according to another embodiment of the present disclosure. 
           [0015]      FIG. 8  is a perspective view of a lip implant according to yet another embodiment of the present disclosure. 
           [0016]      FIG. 9  is a perspective view of a lip implant according to yet another embodiment of the present disclosure. 
           [0017]      FIG. 10  is a perspective view of a lip implant according to yet another embodiment of the present disclosure. 
           [0018]      FIG. 11   a  is a sectional view of a lip implant according to yet another embodiment of the present disclosure. 
           [0019]      FIG. 11   b  is a sectional view of a lip implant according to yet another embodiment of the present disclosure. 
           [0020]      FIG. 11   c  is a sectional view of a lip implant according to yet another embodiment of the present disclosure. 
       
    
    
     DESCRIPTION 
       [0021]    Referring to  FIG. 1 , a lip implant for implantation into a lip of a patient (not shown) is generally referred to by reference numeral  10 . In one embodiment, the lip implant is integrally formed of medical grade silicone and is substantially solid as shown in the cross-section of  FIG. 2 . The implant can be manufactured by a variety of methods including, but not limited to, injection molding, cast molding, extrusion, or cutting from a larger, solid block. 
         [0022]    The lip implant  10  is formed to have a substantially uniform level of hardness as can be measured by the durometer A-scale rating. Of course, hardness can be measured in manners other than via durometer A-scale ratings. In one embodiment, the lip implant  10  has a durometer rating of ten (10) or less resulting in a relatively soft lip implant. In such an embodiment, the lip implant  10  may include a skin  12 , also formed of silicone, having a higher durometer rating to provide the lip implant with structural integrity and manageability. Accordingly, the provision of the skin  12  may aid in handling or manageability of the lip implant  10 . However, the provision for a skin  12  is not always necessary, and the lip implant  10  with a durometer rating of ten (10) or less may be used without the need for an external skin. Of course, the particular durometer rating of the lip implant  10  may vary depending on the particular firmness desired. Also, the lip implant  10  may have a varying durometer rating of 0 to 50, resulting in a lip implant having a non-uniform hardness. 
         [0023]    The lip implant  10  is shaped to have a substantially circular cross-section ( FIG. 2 ). The diameter of the lip implant  10  is substantially uniform along the longitudinal axis of a middle portion  14  of the lip implant. The diameter of the middle portion  14  of the lip implant  10  can vary depending on the desired thickness of the lip implant. For instance, the diameter of the lip implant  10  may be between 2-10 millimeters. 
         [0024]    The middle portion  14  of the lip implant  10  defines a pair of end portions  16 . The end portions  16  are tapered in diameter such that the diameter of the lip implant  10  along the end portions decreases from the middle portion  14  to the ends of the lip implant. The middle portion  14  and the end portions  16  of the lip implant  10  cooperate to define the length of the lip implant, which can vary depending on the desired length of the lip implant. For instance, the length of the lip implant  10  may be between 5-8 centimeters. 
         [0025]    Referring to  FIGS. 3-5 , a lip instrument for use in implanting the lip implant  10  is generally referred to by reference numeral  20 . The lip instrument  20  includes a pair of arms  22   a ,  22   b  coupled together at a pivot point  24  in any conventional manner to provide for relative pivotal movement of the arms about a pivotal axis P ( FIG. 4 ). Proximal to the pivotal axis P, the arms  22   a,    22   b  include a pair of integrally formed ring-like members  26   a,    26   b,  respectively, which define a pair of finger openings  28   a,    28   b.  A pair of protrusions  30   a,    30   b  extend towards one another from the ring-like members  26   a,    26   b,  respectively, to prevent over-rotation of the arms  22   a,    22   b.    
         [0026]    Distal to the pivotal axis P, the arms  22   a,    22   b  include a pair of integrally formed curved clamping members  32   a,    32   b,  respectively, which cooperate to grasp the lip implant  10  ( FIG. 1 ) as will be further described with respect to the method of insertion. Referring to  FIG. 5 , the clamping members  32   a,    32   b  include an outer generally convex surface  34   a,    34   b,  respectively, and a corresponding inner generally concave surface  36   a,    36   b.    
         [0027]    The inner surfaces  36   a,    36   b  of the clamping members  32   a,    32   b  face one another such that closing of the clamping members defines a generally circular area for grasping the lip implant  10  ( FIG. 1 ). The inner surfaces  36   a,    36   b  are formed of a non-crushing surface in order to prevent damage to the lip implant  10  ( FIG. 1 ) when squeezed between the clamping members. In one embodiment, the inner surfaces  36   a,    36   b  are formed of carbide. 
         [0028]    Referring to  FIG. 6 , a lip region  40  of a patient (not shown) to receive the lip implant is depicted. The lip region  40  includes an upper lip  42  and a lower lip  44 , which meet at a pair of commissures  46   a,    46   b.  The commissures  46   a,    46   b  are substantially equidistant from a midline M of the lip region  40 . A tunnel  48 , as is generally illustrated in phantom in  FIG. 6 , is formed through the lower lip  44  for reasons to be described with respect to the method for insertion. 
       Method for Insertion 
       [0029]    In operation, referring to  FIG. 6 , the lip region  40  is prepared for insertion of the implant by administering a local or regional anesthetic. Incisions are then made at each commissure  46   a,    46   b  of the lip region  40  via a conventional scalpel or scissors. For sake of clarity, the method of insertion will be described with respect to insertion of the lip implant  10  into the lower lip  44  although it will be understood that the lip implant can be inserted into the upper lip  42  as well. 
         [0030]    Initial formation of the tunnel  48  is then performed with conventional curved iris scissors (not shown). The iris scissors are inserted into the lower lip  44  via the incision at commissure  46   a  to dissect the tunnel  48  towards the midline M of the lip region  40 . In a like manner, the iris scissors are then inserted through the incision at commissure  46   b  on the opposite side of the lip region  40  to dissect the tunnel  48  towards the midline M of the lip region. Such dissection culminates in the initial formation of the tunnel  48  through the lower lip  44 . The tunnel  48  is then widened via manipulation of the iris scissors or lip instrument  20  to complete the formation of the tunnel. 
         [0031]    After establishing the tunnel  48 , the lip instrument  20  is inserted into the lower lip  44  via the incision at commissure  46   a  and the tunnel  48  such that the clamping members  32   a,    32   b  extend through the tunnel enabling a portion of the clamping members to extend outside of the incision at commissure  46   b.  The lip instrument  20  is then actuated to grasp the lip implant  10  between the clamping members  32   a,    32   b.  The lip implant  10  is then drawn into the lower lip  44  via the lip instrument  20  until it is positioned appropriately within the tunnel  48  whereupon the lip implant is released from the lip instrument. 
         [0032]    A conventional suture, such as a chromic or nylon suture, is then used to close the incisions at commissures  46   a,    46   b.  Antibiotic ointment may be applied to the incisions at commissures  46   a,    46   b  as a prophylaxis against infection. Ice may be applied indirectly to the lip region  40  to reduce swelling. 
         [0033]    Thus, as described, insertion of the lip implant  10  is accomplished simply and quickly and in an uninterrupted manner. Thus, many of the problems associated with previous lip augmentation techniques can be eliminated with the use of the lip implant  10 . Furthermore, this process is completely reversible if desired. 
       Alternates and Equivalents 
       [0034]    It is understood that a variety of alternative lip implants are contemplated by this disclosure. For example, and referring now to  FIG. 7 , a lip implant  70  substantially similar in all respects to the lip implant  10  of  FIGS. 1 and 2 , other than those features described below, has a middle portion  72  that includes a section  74  having a non-uniform diameter. 
         [0035]    In another alternative embodiment, and referring now to  FIG. 8 , a lip implant  80  substantially similar in all respects to the lip implant  10  of  FIGS. 1 and 2 , other than those features described below, includes a middle portion  82  having a non-uniform diameter along the entire length of the middle portion. 
         [0036]    In yet another alternative embodiment, and referring now to  FIG. 9 , a lip implant  90  substantially similar in all respects to the lip implant  10  of  FIGS. 1 and 2 , other than those features described below, is substantially non-uniform in diameter along the length of the implant. The lip implant  90  is reduced in diameter at a middle portion  92  thereof. 
         [0037]    In operation, the lip implants  70 ,  80  and  90  of  FIGS. 7 ,  8  and  9 , respectively, are inserted into the lower lip  44  ( FIG. 6 ) of the patient in a substantially similar manner as described above. Thus, the embodiments of  FIGS. 7 ,  8  and  9  enjoy the advantages of that of  FIG. 1  with respect to providing a structurally sound and safe lip implant for lip augmentation purposes. 
         [0038]    In yet another alternative embodiment, and referring now to  FIG. 10 , an alternative lip implant  100  substantially similar in all respects to the lip implant  10  of  FIGS. 1 and 2 , other than those features described below, is shaped to have a substantially elongated cross-section, which is substantially uniform in size along the length of the implant. In operation, the lip implant  100  is inserted into the lower lip  44  ( FIG. 6 ) of the patient in a substantially similar manner as described above. After insertion into the lower lip  44 , the lip implant  100  may be further sized to correspond to the shape of the lip. For example, the ends of the lip implant  100  may be cut in a tapered fashion such that the lip implant is customized to the particular shapes and contours of the lower lip  44 . 
         [0039]    As can be appreciated, the materials used in forming the lip implants of the present disclosure can be varied to include additional materials for use with silicone or alternative materials other than silicone. For example, the lip implants  10 ,  70 ,  80 ,  90 ,  100  and other embodiments of the lip implant of the present disclosure may alternatively be formed of urethane rather than silicone. 
         [0040]    Moreover, referring to  FIG. 11   a , an alternative lip implant  110   a  includes an inner core region  112   a  formed of expanded polytetraflouroethylene (PTFE) such as Gore-Tex®, and an outer shell  114   a  formed of silicone. The silicone used for the outer shell  114   a  provides the lip implant  110   a  with additional manageability. More importantly, the presence of the outer silicone shell  114   a  aids in preventing tissue-adherence associated with the use of expanded PTFE. 
         [0041]    It is understood that other types of outer shells are contemplated for the lip implant  110 . For example, in some embodiments, the outer shell  114   a  may be in the form of a polymer coating, such as Parylene™, which can be applied to the exterior of the inner core region  112   a  to provide structural integrity and manageability. Accordingly, any number of materials including but not limited to silicone, urethane, expanded PTFE, and biocompatible polymers, and any combination of such materials may be used to form the lip implant  110   a.    
         [0042]    In another embodiment, and referring to  FIG. 11   b , an alternative lip implant  110   b  includes an inner core region  112   b  formed of materials such as liquid silicone, silicone gel or beads, cohesive silicone gel or beads, biocompatible oil, saline or a biocompatible hydrogel material. The lip implant  110   b  further includes an outer shell  114   b,  which may be formed of a variety of materials including but not limited to silicone, urethane and biocompatible polymer (such as Parylene™). As can be appreciated, the outer shell  114   b  encloses the inner core region  112   b  and may be formed in an impermeable or semipermeable manner such that there is minimal or no leakage of the inner core region  112   b  through the outer shell. 
         [0043]    In still other embodiments, and referring to  FIG. 11   c , an alternative lip implant  110   c  includes an inner core region  112   c,  which may take the form of a hollow space defined by an outer shell  114   c.  In such an embodiment, the inner core region  112   c  can be filled with a gas such as air. Moreover, the outer shell  114   c  may be formed of a variety of materials including but not limited to silicone, urethane and biocompatible polymers. As can be appreciated, the outer shell  104   c  may be formed in an impermeable manner such that there is no leakage of gas from the inner core region  112   c  through the outer shell. 
         [0044]    While the invention has been particularly shown and described with reference to embodiments thereof, it is understood by those skilled in the art that various changes in form and detail may be made therein without departing from the spirit and scope of the invention. For example, although a plurality of shapes of the lip implant  10  is described, these shapes are merely representative of the variety of shapes that the lip implant may take. Thus, the lip implant  10  is not limited to the longitudinal or cross-sectional shapes as described. 
         [0045]    Moreover, the tapered end portions  16  of the lip implant  10  may be removed resulting in a lip implant having a rod-like shape. Still further, the degree of taper and the length of the end portions  16  may be varied to accommodate the various desires or needs of implant patients. 
         [0046]    Still further, the clamping members  32   a,    32   b  of the lip instrument  20  may be removable attached to the lip instrument such that various other clamping members may be used therewith. For instance, various degrees of curvature may be required of the clamping members resulting in the need to interchange the clamping members. 
         [0047]    Furthermore, the inner surfaces  36   a,    36   b  of the clamping members  32   a,    32   b  may be formed of a variety of materials other than carbide. 
         [0048]    Still further, during insertion of the lip implant  10  into the lower lip  44 , the incision may be made in the general commissure region on each side of the lip region  40  and such insertion is not limited to an exact commissure point. 
         [0049]    It is also understood that all spatial references, such as “diameter”, “longitudinal,” “increase,” and “decrease” are for illustrative purposes only and can be varied within the scope of the invention. Accordingly, all such modifications are intended to be included within the scope of this invention as defined in the following claims.