Abstract:
A system for packaging a medical implant may include a sleeve for housing the implant within a cavity in the sleeve, with at least a portion of the cavity conforming to the shape of the implant. A flexible material film may cover and substantially conform to the shape of the sleeve so as to aid in stabilizing the sleeve and implant within an outer package. An insertion instrument for inserting the implant within the body of a patient may also be provided with the system. In some embodiments, the sleeve, with the implant inserted in the cavity of the sleeve, is configured for manipulation by a user without contacting the implant, and the implant is connectable to the insertion instrument while in the sleeve.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    The present application is a divisional of U.S. patent application Ser. No. 13/438,302, filed Apr. 3, 2012, which is a continuation of U.S. patent application Ser. No. 12/655,369, filed Dec. 29, 2009, the disclosures of which are incorporated herein by reference. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    The present disclosure relates to apparatuses and methods for packaging a medical device. More specifically, the present disclosure relates to packages for holding a medical implant and processes for making said packages. 
         [0003]    Conventional implant packages rely on a void-filling approach to protect their contents. The void-filling approach entails stabilizing the contents within a rigid plastic package with a variety of foams and padding materials. The foam and padding materials essentially fill the void between the implant and the inner surfaces of the rigid plastic package. The rigid plastic package is then sealed with lidstock material. 
         [0004]    The void-filling approach requires the use of multiple foam components. These components are usually bulky and generate a considerable volume of package waste. Additionally, implants packed in foam can be difficult to remove without premature or accidental exposure to biological material on surgical gloves since the foams are intended to provide a tight fit to cushion the package and the implant. The void-filling approach also requires some manual processes, which are prone to error and typically result in a long packaging process time. 
         [0005]    Packages filled with foam also experience problems during transportation. As a package is transported, the foam contained within the package may compress due to the repeated motion experienced during shipping. As a consequence, heavy implants packed in foam must be packed very tightly. Compressed foam allows more implant motion within the package. This implant motion may damage the implant and/or the package and negate the sterile barrier. Once the sterile barrier of a package has been compromised, the medical implant contained within that package cannot be used in surgery. What&#39;s more, if a medical implant has been contaminated and the physician has no back-up medical implant on hand, surgery could be delayed. 
         [0006]    Foams used in void-filling packages may jeopardize the sterility of the medical implants in other ways. For instance, friction between the foam and the medical implant can abrade the foam and generate particulate. Moreover, when the medical implant is packed tightly with foam to reduce implant motion, the foam may occasionally adhere to the package lidstock during the sealing process. As a result of this improper adhesion, the foam may scorch or shear apart when the package is opened by the end user. Both of these situations may endanger the implant sterility. If the implant has been contaminated and no back-up implant is readily available, surgery could be delayed. 
         [0007]    Although implant packages like the void-filled implants packages are well known in the art, improvements are always possible. 
       BRIEF SUMMARY OF THE INVENTION 
       [0008]    The present disclosure relates to a packaging assembly for holding a medical implant. An embodiment of the presently disclosed packaging assembly includes a substantially rigid base having a cavity dimensioned to receive a medical implant, a sleeve positioned within the cavity of the substantially rigid base and defining an opening dimensioned to receive the medical implant, and a skin pack material sealed to the lid stock and collar to enclose and secure the sleeve in the cavity of the substantially rigid base. The sleeve has a shape substantially similar to a shape of the medical implant and substantially envelopes the medical implant when the medical implant is positioned in the opening of the sleeve. The skin pack lid has a geometry that substantially conforms to the shape of the sleeve. 
         [0009]    In another embodiment, the presently disclosed packaging assembly includes a substantially rigid base having a cavity dimensioned to receive a medical implant, a flexible pad positioned in the cavity of the substantially rigid base, a flexible cover placed over the outer surface of the medical implant, and a skin pack material sealed to the lid stock and collar to enclose and secure the medical implant enveloped by the flexible pad and the flexible cover within the cavity of the substantially rigid base. The flexible pad engages at least a portion of the lower or bottom surface of the medical implant. The flexible cover has a shape that substantially conforms to the shape of the outer surface of the medical implant. The skin pack lid has a geometry that substantially conforms to the shape of the medical implant. 
         [0010]    The present disclosure further relates to a method of packaging a medical implant. In one embodiment, this method includes the steps of inserting a medical implant inside a sleeve, placing the sleeve with the medical implant on a substantially rigid base, and sealing a skin film over the substantially rigid base using a skin packing process. 
         [0011]    The present disclosure further relates to another method of packing a medical implant, which includes the steps of wrapping a medical implant with a flexible cover and a flexible pad, placing the wrapped medical implant on a substantially rigid base, and sealing a flexible film over the substantially rigid base using a skin packing process. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0012]    Various embodiments of the presently disclosed packaging assembly are disclosed herein with reference to the drawings, wherein: 
           [0013]      FIG. 1  is an isometric view of a package in accordance with an embodiment of the present disclosure; 
           [0014]      FIG. 2  is an isometric exploded view of the packaging assembly, which includes the package shown in  FIG. 1 ; 
           [0015]      FIG. 3  is a side elevation view of a base of the package depicted in  FIG. 1 ; 
           [0016]      FIG. 4  is a top view of the base illustrated in  FIG. 3 ; 
           [0017]      FIG. 5  is a top view of a collar of the package shown in  FIG. 1 ; 
           [0018]      FIG. 6  is a side elevation view of the collar depicted in  FIG. 5 ; 
           [0019]      FIG. 7  is a top view of an embodiment of a sleeve for use with the package shown in  FIG. 1  in a sealed position; 
           [0020]      FIG. 8  is a side elevation view of the sealed sleeve depicted in  FIG. 7 ; 
           [0021]      FIG. 9  is a side elevation view of the sleeve of  FIG. 7  in an unsealed position; 
           [0022]      FIG. 10  is a top view of an embodiment of a sleeve for use with the package shown in  FIG. 1  in a sealed position; 
           [0023]      FIG. 11  is a side elevation view of the sealed sleeve illustrated in  FIG. 10 ; 
           [0024]      FIG. 12  is a top view of the sleeve of  FIG. 10  in an unsealed position; 
           [0025]      FIG. 13  is a top view of an embodiment of a sleeve for use with the package shown in  FIG. 1  in a sealed position; 
           [0026]      FIG. 14  is a side elevation view of the sealed sleeve illustrated in  FIG. 13 ; 
           [0027]      FIG. 15  is a top view of the sleeve of  FIG. 13  in an unsealed position; 
           [0028]      FIG. 16  is an isometric exploded view of an alternate embodiment of a package for use with an acetabular cup; 
           [0029]      FIG. 17  is a side exploded view of the package shown in  FIG. 16 ; and 
           [0030]      FIG. 18  is a top view of the lower flexible pad of the package shown in  FIG. 16 . 
       
    
    
     DETAILED DESCRIPTION 
       [0031]    With reference to  FIGS. 1 and 2 , the present disclosure relates to a package  10  for holding any suitable medical item such as an orthopaedic medical implant I. Package  10  is part of a packaging assembly  100  and generally includes a sleeve  12 , a substantially rigid base or tray  14 , a skin pack film or lid  16 , and a collar  15 . Base  14  defines a cavity  17  and may be wholly or partly made of a rigid polymer. Cavity  17  is dimensioned to receive medical implant I contained inside sleeve  12 . Sleeve  12  defines an opening  61  (see  FIG. 8 ) extending therethrough and prevents, or at least hinders, skin pack lid  16  from wrapping medical implant I too tightly. Opening  61  of sleeve  12  is adapted to receive medical implant I. In some embodiments, sleeve  12  is wholly or partly made of glycol-modified polyethylene terephthalate (“PETG”) or any other suitable thermoplastic. In certain embodiments, the shape of sleeve  12  is substantially similar to the shape of medical implant I. Consequently, when medical implant I is positioned inside sleeve  12 , sleeve  12  substantially envelopes medical implant I. During assembly, a sleeve  12  containing medical implant I is positioned within cavity  17  of base  14 . Skin pack lid  16  is sealed over collar  15  and base  14  to enclose and secure sleeve  12  inside cavity  17 . Skin pack lid  16  is then vacuum formed over sleeve  12 . As a consequence, skin pack lid  16  attains a geometry that substantially conforms to the shape of sleeve  12 . Although skin pack lid  16  is sealed over base  14 , skin pack lid  16  is actually adhered to collar  15 , which surrounds a periphery of base  14 . 
         [0032]    Referring to  FIGS. 3 and 4 , base  14  has a first end portion  25 , a second end portion  26 , and a central portion  27  located between first and second end portions  25 ,  26  and incorporates an exterior wall  22 , a cavity  17  located within the confines of exterior wall  22 , a rim  18  surrounding a periphery of the base  14 , a supporting surface  28  for supporting sleeve  12 , and means for retaining or locating sleeve  12  relative to base  14 , as discussed in detail below. Exterior wall  22  encloses cavity  17  and includes a first end  23  and a second end  24 . In some embodiments, exterior wall  22  has six sides joined by six rounded corners. In other embodiments, exterior wall has a substantially oblong shape. However, exterior wall  22  may have any suitable shape or configuration. Rim  18  is positioned around first end  23  of exterior wall  22  and extends outwardly from exterior wall  22 . Supporting surface  28  is oriented substantially parallel to rim  18  and is located adjacent to first end  23  of exterior wall  22 . In use, sleeve  12  ( FIG. 2 ) is placed on supporting surface  28 . Sleeve  12  is in turn secured to base by any suitable structure or means, as will be discussed below. 
         [0033]    In some embodiments, the means for retaining or locating sleeve  12  relative to base  14  includes first and second inner walls  29 ,  30  extending from supporting surface  28 . First inner wall  29  is located adjacent to first end portion  25  of base  14 , whereas second inner wall  30  is positioned adjacent to second end portion  26  of base  14 . When sleeve  17  is placed on supporting surface  28 , first and second inner walls  29 ,  30  limit the motion of sleeve  12  during shipping of package  10 . 
         [0034]    The means for retaining or locating sleeve  12  relative to base  14  may (additionally or alternatively) include a pin  19  for engaging one or more holes in sleeve  12  (see e.g., holes  49  and  50  in  FIG. 9 ). In some embodiments, pin  19  extends from second inner wall  30  past beyond second end  24  of exterior wall  22 , as seen in  FIG. 3 . As discussed in detail below, sleeve  12  has a hole dimensioned to securely receive pin  19 . When pin  19  engages the hole of sleeve  12 , sleeve  12  is secured to base  14 , thereby maintaining the location of sleeve  12  with respect to cavity  17 . 
         [0035]    Moreover, the means for retaining or locating sleeve  12  relative to base  14  may (additionally or alternatively) include at least one ridge ( 31  or  32 ) formed on supporting surface  28 . In the embodiment depicted in  FIG. 4 , base  14  includes first and second ridges  31 ,  32  for increasing the friction between sleeve  12  and supporting surface  28  when sleeve  12  is placed in base  14 . First ridge  31  has a twisted configuration and extends from a location adjacent to first inner wall  29  to central portion  27  of base  14 . Second ridge  32  also has a twisted configuration and extends from second end portion  26  of base  14  toward central portion  27  of base  14 . At least a portion of second ridge  32  is located adjacent to second inner wall  30 . 
         [0036]    In certain embodiments, base  14  incorporates at least one rib  21  for limiting the movement of sleeve  12  inside cavity  17 . In the embodiment shown in  FIG. 4 , base  14  includes two ribs  21  formed on supporting surface  28  at central portion  27  of base  14 . Although both ribs  21  are positioned in central portion  27 , ribs  21  are located on opposite sides of external wall  22 . On the side of supporting surface  28  facing cavity  17 , both ribs  21  have a raised profile configured to engage sleeve  12 . On the side of supporting surface  28  facing away from cavity  17 , each rib  21  defines a void adapted to receive a user&#39;s fingers. In use, the end user can place the fingers in these voids to grab base  14  and then separate base  14  from skin pack lid  16 . 
         [0037]    With reference to  FIGS. 5 and 6 , package  10  further includes a collar  15  configured to be positioned around a periphery of base  14 . Collar  15  defines a central opening  37  and includes an exterior wall  33  surrounding central opening  37 . Central opening is configured to receive base  14 . External wall  33  includes a first end  34  and a second end  35  and has a shape substantially similar to the shape of exterior wall  22  of base  14 . Consequently, collar  15  is adapted to form around a periphery of base  14 . A flange  36  extends outwardly from second end  35  of external wall  33 . Flange  36  has a generally planar shape. In several embodiments, collar  15  has six sides joined by six rounded corners. Collar  15 , however, may have any suitable shape or configuration so long as it fits around the periphery of base  14 . When package  10  is assembled, skin pack film or lid  16  is adhered to flange  36  of collar  15  rather than base  14 . As a result, an end user can separate base  14  from skin pack film or lid  16  without cutting package  10 . 
         [0038]      FIGS. 7-9  show an embodiment of sleeve  12 . This embodiment of sleeve  12  includes first and second sides  38 ,  39  coupled to each other and is made wholly or partly of a biocompatible flexible material. In one embodiment, sleeve  12  is made wholly or partly of a biocompatible polyurethane. The precise shape of sleeve  12  depends on the implant to be packed inside said sleeve  12 . For example, sleeve  12  can be designed to accommodate hip femoral implants, shoulder humeral implants, and other implants with a general oblong shape. In any event, sleeve has a shape substantially similar to the shape of medical implant I or any other suitable implant. 
         [0039]    In the embodiment shown in  FIGS. 7-9 , first and second sides  38 ,  39  have substantially similar shapes. First side  38  can be bent and sealed over second side  39  and vice-versa. In some embodiments, a living hinge  40  or any suitable structure or means connects first side  38  to second side  39 . In these embodiments, first side  38  can be bent over second side  39  along living hinge  40 . First side  38  includes an elongate portion  41  having a substantially triangular shape and a flange  42  extending from elongate portion  41 . Elongate portion  41  of first side  38  has a first end  43  and a second end  44  and includes a sealing area  51  extending between first and second ends  43 ,  44 . In use, elongate portion  41  covers an elongate portion of medical implant I, such as the stem of a hip femoral implant. First and second sides  38 ,  39  may be heat sealed along sealing areas  51 ,  52 , which are located along the borders of elongate portions  41 ,  45 . Flange  42  is connected to second end  44  of elongate portion  41  and has a hole  50  adapted to securely receive pin  19  ( FIG. 4 ) of base  14 . The secure engagement between pin  19  and hole  50  helps limit the motion of sleeve  12  within cavity  17  of base  14 . At least a portion of flange  42  has a rounded profile. The rounded profile of flange  42  assists in covering rounded features of medical implant I. 
         [0040]    Second side  39  also has an elongate portion  45  having a substantially triangular shape and a flange  46  extending from elongate portion  45 . Elongate portion  45  has a first end  47  and a second end  48  and includes a sealing area  52  extending between first and second ends  47 ,  48 . Sealing area  52  is positioned along a border of elongate portion  45 . As discussed above, the first and second sides  38 ,  39  may be heat sealed along sealing areas  51 ,  52  when first and second sides  38 ,  39  are bent over each other. Flange  46  is connected to second end  48  of elongate portion  45  and has a hole  49  adapted to securely receive pin  19  of base  14 . The secure engagement between pin  19  and hole  49  helps hinder the motion of sleeve  12  within cavity  17  of base  14 . Hole  49  is substantially aligned with hole  50  of first side  38  when first side  38  is bent over second side  39 . At least a section of flange  46  has a rounded profile, which assists in covering rounded features of medical implant I. 
         [0041]    When first side  38  is bent over second side  39 , sleeve  12  defines an opening  61  extending therethrough. Opening  61  is sized to receive medical implant I. When medical implant I is positioned in opening  61  of a sealed sleeve  12 , elongate portions  41 ,  45  of first and second sides  38 ,  39  can collectively envelop a portion of medical implant I, such as a stem of a hip femoral implant, and flanges  42 ,  46  can together enclose a portion of medical implant I, such as the cup and ball of a hip femoral implant. 
         [0042]    Referring to  FIGS. 10-12 , another embodiment of the sleeve is generally designated with reference number  112 . The structure and operation of sleeve  112  are similar to the structure and operation of sleeve  12 . However, the shape of flange  142  of first side  138  is different from the shape of flange  146  of second side  139 . In addition, flange  146  of second side  139  has a hole  149  adapted to securely receive pin  19  of base  14 , while flange  142  of first side  138  does not have a hole. Moreover, flange  146  is larger than flange  142 . Second side  139  further includes another bendable axis or ridge  148  formed on its outer surface. Ridge  148  extends along the entire length of the second side  139 . 
         [0043]      FIGS. 13-15  illustrate another embodiment of sleeve  212 . Sleeve  212  is substantially similar to sleeve  112  but does not include ridge  148 . 
         [0044]    Returning to  FIGS. 1 and 2 , during assembly, a skin packing machine is loaded with a roll or sheet of lidstock  53  and a roll of flexible seal material, which eventually turns into skin pack lid  16 . In an exemplary method, the manufacturers utilize an ASP Series skin packing machine sold by Starview Packaging Machinery, Inc. under the trademark STARVIEW. Lidstock  53  is made of any suitable medical grade packaging material. In one embodiment, lidstock  53  is made of the nonwoven material comprising of spunbond olefin fiber, which is sold by DUPONT under the trademark TYVEK. Base  14  is placed on a sheet of lidstock material  53  in a designated location. Medical implant I is inserted inside opening  61  of a sealed sleeve ( 12 ,  112 , or  212 ). Alternatively, medical implant I is placed on one side (e.g.,  38  or  39 ) of sleeve  12  (or any other sleeve described above) and then one side is sealed over the other side of sleeve  12  to enclose medical implant I within sleeve  12 . Once medical implant I has been enveloped by sleeve  12 , sleeve  12  (along with medical implant I) is placed in cavity  17  of base  14 . To secure sleeve  12  to base  14 , pin  19  of base  14  can be introduced through holes (e.g.,  49  and  50 ) of sleeve  12 . 
         [0045]    Before or after placing medical implant I inside base  308 , collar  15  is positioned around base  308 . Next, a piece of the flexible seal material is sealed over base  14  to form skin pack film or lid  16 . In some embodiments, the flexible seal material is wholly or partly made of a resin. Regardless of the particular material employed, the flexible seal material is placed over base  14  and sealed to collar  14  using a skin packing process. 
         [0046]    In one exemplary method, the skin packing process involves heating the flexible seal material to soften it. Once softened, the flexible film material can be stretched and placed over base  14  to cover the opening leading to cavity  17 . The flexible seal material, however, is adhered to collar  15 , which is positioned around base  14 . 
         [0047]    After placing the flexible film material over base  14 , a manufacturer employs vacuum forming to shape the flexible seal material and, therefore, form skin pack film or lid  16 . In one exemplary method, vacuum forming involves applying a vacuum between base  14  and the flexible seal material to mold the shape of the flexible seal material. As a result of this process, the flexible seal material forms a skin pack film or lid  16  having a geometry that substantially conforms to the shape of the sleeve  12  containing medical implant I. 
         [0048]    Then, skin pack film or lid  16  is adhered to collar  15 . Since skin pack lid  16  is adhered to collar  15  rather than base  14 , an end user can separate base  14  from skin pack film or lid  16  without cutting package  10 . Lidstock  53  is also adhered to collar  15 . 
         [0049]    Subsequently, a radiation or sterilization indicator  55  may be attached to an outer surface of skin pack lid  16 . Indicator  55  has a signal response to sterile processing conditions experienced by medical implant I and includes an ink having color-change response to exposure to sterilization processing to signal a history of sterile processing. In some embodiments, the ink is responsive to exposure to radiation or a sterilizing gas such as ethylene oxide. In certain embodiments, the ink is responsive to sterilizing steam or vapor, or organic agents such as formaldehyde. 
         [0050]    Following the assembly of package  10 , package  10  is positioned in an outer blister or tray  56 . Outer blister  56  is sealed with another lidstock  57 . Like lidstock  53 , lidstock  57  is made of any suitable medical grade packaging material. In one embodiment, lidstock  57  is made of the nonwoven material comprising of spunbond olefin fiber, which is sold by DUPONT under the trademark TYVEK. 
         [0051]    A label  58  is then attached to the outer surface of lidstock  57 . Once package  10  has been shipped to the end user, patient information may be printed on label  58 . A package insert  59  may be attached to the outer surface of label  59 . Usually, package insert  59  contains information required by regulatory agencies. 
         [0052]    The sealed outer blister  56  is then placed inside a box  60 . After closing box  60 , shrink wrap may be applied over box  60  to protect its contents. 
         [0053]    With reference to  FIGS. 16-18 , a package  300  is designed for holding generally hemispherical or spherical shaped implant Y. For illustration purposes only, the drawings shows a hip acetabular shell, but package  300  can retain many other kinds of implants such as knee femoral implants, knee tibial implants, hip acetabular heads, shoulder head implants, among others. Package  300  includes a base or tray  308 , a flexible cover  302 , a flexible pad  304 , a collar  312 , and a skin pack film or lid  306 . 
         [0054]    Base  308  is made wholly or partly of a substantially rigid material, such as a rigid plastic, and has a cavity  310  dimensioned to receive medical implant Y. One side of base  308  has a supporting surface adapted to support medical implant Y, and another side of base  308  has an opening leading to cavity  310 . 
         [0055]    A collar  312  is positioned around the periphery of base  308 . Specifically, collar  312  surrounds an external wall of base  308 . Accordingly, the shape of collar  312  is substantially similar to the shape of the external wall of base  308 . 
         [0056]    Package  300  may additionally include a structure or means for securing medical implant Y (along with flexible pad  304  and flexible cover  302 ) to base  308 . This means or structure may be substantially similar to the means for securing sleeve  12  to base  14  described above. 
         [0057]    During assembly, a skin pack film or lid  306  is sealed over base  308  and adhered to collar  312  after positioning medical implant I, flexible pad  304 , and flexible cover  302  inside cavity  310 . Flexible pad  304  and flexible cover  302  prevent, or at least inhibit, skin pack lid  306  from wrapping medical implant Y too tightly, preventing easy removal of medical implant Y. This arrangement allows the end user to separate skin pack film or lid  306  from base  308  without cutting package  300 . 
         [0058]    As seen in  FIG. 18 , flexible pad  304  includes at least one slit  326  extending from an exterior edge  314  to a central portion  320  thereof. Slit  326  enhances the flexibility of flexible pad  304 . In the depicted embodiment, flexible pad  304  features a circular shape and has six slits  326  spread around its superficial area. Nonetheless, flexible pad  304  may have any other suitable shape and may include more or fewer slits  326 . Irrespective of the specific number of slits  326 , flexible pad  304  is configured to wrap an inner surface of medical implant Y. 
         [0059]    Flexible cover  302  is substantially similar to flexible pad  304  but may have a different size than flexible pad  304 , as shown in  FIGS. 16 and 17 . In the depicted embodiment, flexible cover  302  is smaller than flexible pad  304 . The sizes of flexible cover  302  and flexible pad  304  would ultimately depend on the medical implant Y to be packed. Flexible cover  302  also has at least one slit  326  for enhancing its flexibility. Slit  326  extends from an outer edge  322  to a central portion  324  of flexible cover  302 . While  FIG. 16  shows flexible cover  302  with six slits  326  and featuring a circular superficial area, flexible cover  302  may include more or fewer slits  326  and may have other suitable shapes and configurations. In any case, flexible cover  302  is configured to wrap an external surface of medical implant Y. 
         [0060]    It is envisioned that flexible cover  302  and flexible pad  304  can be monolithically formed. Alternatively, flexible cover  302  and flexible pad  304  can be separate components. In any event, flexible cover  302  and flexible pad  304  collectively wrap around medical implant Y and maintain a sterile barrier around medical implant Y. 
         [0061]    During assembly, a skin packing machine is loaded with a roll of lidstock  318  and a roll of flexible seal material. Lidstock  318  is made of any suitable medical grade packaging material. In one embodiment, lidstock  318  is made of the nonwoven material comprising of spunbond olefin fiber sold by DUPONT under the trademark TYVEK. Base  308  is placed on a sheet of lidstock material  318  in a designated location. Medical implant Y is centered on flexible pad  304 . Then, the shape of flexible pad  304  is substantially conformed to the shape of an inner surface of medical implant Y. At this point, flexible pad  304  covers (entirely or substantially) the inner surface of medical implant Y. Flexible cover  302  is subsequently placed over medical implant Y to cover (entirely or substantially) the outer surface of medical implant Y. Once medical implant Y has been enveloped by flexible cover  302  and flexible pad  304 , medical implant Y (along with flexible cover  302  and flexible pad  304 ) is placed in cavity  310  of base  308 , with flexible pad  304  abutting the supporting surface of base  308 . 
         [0062]    Before or after placing medical implant Y inside base  308 , collar  312  is positioned around base  308 . Next, a flexible seal material is sealed over base  308  to form skin pack film or lid  306 . In some embodiments, the flexible seal material is made of resin. Regardless of the particular material employed, the flexible seal material is sealed over base  308  and adhered to collar  312  using a skin packing process. 
         [0063]    In one exemplary method, the skin packing process involves heating the flexible seal material to soften it. Once softened, the flexible seal material can be stretched and placed over base  308  to cover the opening leading to cavity  310  of base  308 . The flexible seal material, however, is adhered to collar  312 , which is positioned around base  308 . 
         [0064]    After placing the flexible seal material over base  308 , a manufacturer employs vacuum forming to shape the flexible seal material and, therefore, form skin pack film or lid  306 . In one exemplary method, vacuum forming involves applying a vacuum between base  308  and the flexible seal material to mold the shape of the flexible seal material. As a result of this process, the flexible seal material forms a skin pack film or lid  306  having a geometry that substantially conforms to the shape of the medical implant Y enveloped by flexible pad  304  and flexible cover  302 . 
         [0065]    Then, skin pack film or lid  306  is adhered to collar  312 . Since skin pack film or lid  306  is attached to collar  312  rather than base  308 , an end user can separate base  308  from skin pack film or lid  306  without cutting package  300 . Lidstock  318  is also adhered to collar  312 . Package  300  can also be contained in outer blister  56  and the packed in box  60 . 
         [0066]    In use, an end user may remove the implant from package ( 10  or  300 ) without contacting the implant surfaces. First, the user opens box  60  and removes outer blister  56  from box  60 . Then, the user peels back lidstock  57  from outer blister  56  to access package  10  or  300 . 
         [0067]    To remove the implant from either package  10  or  300 , the end user peels back sheet of lidstock  23  or  318  adhered to collar  15  or  312 . Subsequently, the end user separates base  14  or  308  from skin pack lid  16  or  306 . While separating base  14  or  308  from skin pack lid  16  or  306 , the end user should maintain a gentle grip on the implant through sleeve  12  or cover  302 . Then, the end user removes the implant from package ( 10  or  300 ). During removal and afterwards, the end user grabs the implant through sleeve  12  or cover  302  and pad  304 , without contacting the implant surface. No tool is required to remove the implant from the package ( 10  or  300 ). Once the end user has removed the implant from package ( 10  or  300 ), an insertion instrument can be attached to the implant without removing the implant from sleeve  12  or cover  302  and pad  304 . 
         [0068]    The processes described above results in substantially advantages over other known packaging processes. In particular, the use of sleeve  12  or cover  302  in conjunction with skin packaging greatly reduces the volume of package waste generated when an implant is consumed. Fewer components are required to package the implants, and the implant can be packed in multiples. Sleeve  12  allows the end user to grasp the sterile implant firmly without contacting the implant surface. Instruments required to place the implant in a patient body can be attached while the implant is being held by sleeve  12 , reducing the risk of premature contact with fluids. In addition, the skin package eliminates, or at least minimizes, motion within the packages ( 10  or  300 ). Neither sleeve  12  nor cover  302  and pad  304  substantially compress the implant, keeping the implant firmly positioned until opened by the end user. 
         [0069]    Moreover, sleeve  12  or cover  302  and pad  304  protect implant coatings and surface finish from damage. In turn, skin pack lid ( 16  or  306 ) is protected from implant coatings and sharp features. Additionally, sleeve  12  and cover  302  allow the end user to handle the implant without actually contacting the implant surface. Sleeve  12  and cover  302  also provide packages ( 10  or  300 ) with sleeker inner package profiles as compared with other implant packages. 
         [0070]    Further, the skin packing process described above results in substantial cost savings. Since the presently disclosed skin packaging processes do not entail the use of foams, the manufacturer may save time by using sleeves  12  or covers  302  and pads  304 , as opposed to foams. For example, the void-filling packaging approach, which entails the use of foam, typically requires manual packing. The use of sleeves  12  or covers  302  and pads  304  in a skin packing process, on the other hand, can be performed automatically by machines. Thus, the skin packing process allows the manufacturer to package the medical implant quicker than if foams were employed. 
         [0071]    Although the invention herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present invention. It is therefore to be understood that numerous modifications may be made to the illustrative embodiments and that other arrangements may be devised without departing from the spirit and scope of the present invention as defined by the appended claims.