Protective containers for sterile medical implants

Abstract

A protective container for sterile medical implants includes a base including a hollow body having a closed end and an open end. The base includes threads. A cover is fixed around the open end of the hollow body. The cover includes threads that cooperate with threads provided on the base so that relative rotation of the base and the cover causes relative axial movement of the base and the cover. Due to the relative axial movement of the base and the cover, a sealing member is compressed between the base and the cover to provide a seal therebetween.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of U.S. Provisional Application No. 62 / 630,997, filed February 15, 2018, the disclosure of which is incorporated herein by reference. Technical Field

[0003] The present invention relates generally to medical implants and other medical devices. In particular, the present invention relates to an improved structure for a protective container used to support sterile medical implants to prevent exposure to contaminants prior to installation in a human or animal body during a surgical procedure. Background Art

[0004] The current state of the art in sterile packaging of medical devices is limited to blister packs, trays, bags, and tubes that rely on stopper seals. Disadvantages of these known structures include cumbersome manufacturing processes, low-performance seals, poor stability during transport, and insufficient time and technology for aseptic transfer. It would be advantageous to provide an improved structure for a protective container used to support sterile medical implants to prevent exposure to contaminants prior to installation in a human or animal body during a surgical procedure. Summary of the Invention

[0005] A universal packaging tube is disclosed herein that has key utility properties related to tube sealing, support for an additional inner tube, containment stability during shipping, and providing good transfer from a non-sterile area to a sterile area. In its most basic embodiment, the present invention relates to a universal tubular container for sterilization and containment of sterile medical devices that incorporates a pressure sealant, medical device stabilization features, an ergonomic internal support and / or other barrier for use during exchange between non-sterile and sterile areas, and identification features such as see-through transparent and translucent color coding (tinting).

[0006] Various aspects of this invention will become apparent to those skilled in the art from the following detailed description of the preferred embodiment, when read in light of the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0007] Figure 1 FIG. 1 is an exploded perspective view of a protective container for sterile medical implants according to a first embodiment of the present invention.

[0008] Figure 2 yes Figure 1 A partially assembled, cross-sectional elevational view of the protective container of the first embodiment is shown.

[0009] Figure 3 yes Figure 1 and Figure 2An enlarged cross-sectional elevational view of a portion of the protective container of the first embodiment is shown.

[0010] Figure 4 yes Figure 3 An enlarged sectional front view of the assembled state of the parts of the protective container of the first embodiment is shown.

[0011] Figure 5 It can be with Figures 1 to 4 A perspective view of a first embodiment storage device used in conjunction with a first embodiment protective container is shown.

[0012] Figure 6 yes Figure 5 A cross-sectional elevational view of a first embodiment of a storage device shown supported on a Figures 1 to 4 The first embodiment is shown in a protective container.

[0013] Figure 7 It can be with Figures 1 to 4 Shown is a side elevation view of a second embodiment of a storage device for use with the first embodiment of a protective container.

[0014] Figure 8 yes Figure 7 A cross-sectional elevational view of a second embodiment of a storage device shown supported on a Figures 1 to 4 The first embodiment is shown in a protective container.

[0015] Figure 9 It can be with Figures 1 to 4 Shown is a side elevation view of a third embodiment of a storage device used in conjunction with the protective container of the first embodiment.

[0016] Figure 10 yes Figure 9 A cross-sectional elevational view of a third embodiment of a storage device shown supported on a Figures 1 to 4 The first embodiment is shown in a protective container.

[0017] Figure 11 It can be with Figures 1 to 4 A perspective view of a storage device according to a fourth embodiment is shown for use with the protective container according to the first embodiment.

[0018] Figure 12 yes Figure 11 An exploded perspective view of a storage device according to a fourth embodiment is shown.

[0019] Figure 13 yes Figure 11 and Figure 12 An exploded front view of a storage device according to a fourth embodiment is shown.

[0020] Figure 14 yes Figures 11 to 13 A cross-sectional elevational view of a fourth embodiment of a storage device shown supported on a Figures 1 to 4 The first embodiment is shown in a protective container.

[0021] Figure 15 It is along Figure 14 A cross-sectional front view taken along line 15-15.

[0022] Figure 16 It can be with Figures 1 to 4 A perspective view of a storage device according to a fifth embodiment is shown for use with the protective container according to the first embodiment.

[0023] Figure 17 yes Figure 16 An exploded perspective view of a storage device according to a fifth embodiment is shown.

[0024] Figure 18 yes Figure 16 and Figure 17 An exploded front view of a storage device according to a fifth embodiment is shown.

[0025] Figure 19 yes Figures 16 to 18 A cross-sectional elevational view of a fifth embodiment of a storage device shown supported on a Figures 1 to 4 The first embodiment is shown in a protective container.

[0026] Figure 20 It is along Figure 19 A cross-sectional elevation view taken along line 20-20.

[0027] Figure 21 It can be with Figures 1 to 4 A perspective view of a storage device according to a sixth embodiment is shown for use with the protective container according to the first embodiment.

[0028] Figure 22 It can be with Figures 1 to 4 A perspective view of a storage device according to a seventh embodiment is shown for use with the protective container according to the first embodiment.

[0029] Figure 23 is an exploded front view of a protective container according to a second embodiment of the present invention.

[0030] Figure 24 is a perspective view of a protective container according to a third embodiment of the present invention, shown in a closed state.

[0031] Figure 25 yes Figure 24 A perspective view of a protective container according to a third embodiment is shown, showing the container in an open state.

[0032] Figure 26 is a perspective view of a protective container according to a fourth embodiment of the present invention.

[0033] Figure 27 yes Figure 26 Exploded perspective view of a protective container according to a fourth embodiment shown in FIG.

[0034] Figure 28 is a perspective view of a protective container according to a fifth embodiment of the present invention.

[0035] Figure 29 yes Figure 28 An exploded perspective view of a protective container according to a fifth embodiment is shown.

[0036] Figure 30 yes Figure 28 and Figure 29 A cross-sectional front view of a protective container of a fifth embodiment is shown. DETAILED DESCRIPTION

[0037] Referring now to the accompanying drawings, Figures 1 to 4 A protective container for a medical implant according to a first embodiment of the present invention is shown, generally designated 10. As will be described in detail below, the protective container 10 serves as a sealed enclosure for a sterile medical implant to protect the medical implant from environmental contaminants and prevent damage to the medical implant during transport. However, the scope of the present invention is not intended to be limited to use with the specific configuration of medical implant described and illustrated, or with medical implants generally. Rather, as will become apparent below, the protective container 10 of the present invention may be used in any desired environment and for any desired purpose.

[0038] The protective container 10 of the first embodiment includes a base 11, a stabilizing member 12, a sealing member 13 and a lid 14, which, when assembled together, form a sealed enclosure. The illustrated base 11 is generally hollow cylindrical and includes a body 11a extending from a closed end 11b to an open end 11c. However, the base 11 may have any desired shape. Figure 2As shown, the closed end 11b of the base 11 is provided with a support structure 11d on its inner surface. In the embodiment shown, the support structure 11d is an annular ridge formed integrally with the closed end 11b of the base 11. However, the support structure 11d can have any desired shape and can be provided at any desired position on the base 11. An inner shoulder 11e is provided on the inner surface of the central area of ​​the body 11a of the base 11. Near the open end 11c, an annular groove 11f is provided on the outer surface of the base 11 adjacent to the body 11a of the base 11, and an external thread 11g is provided on the outer surface of the base 11 adjacent to the annular groove 11f of the base 11. The purpose of the support structure 11d, the inner shoulder 11e, the annular groove 11f and the external thread 11g will be explained below. Although any desired material can be used, the base 11 is preferably formed of a rigid plastic material.

[0039] The stabilizing member 12 shown is annular in shape and has an inner opening 12a and an outer shoulder 12b provided thereon. However, the stabilizing member 12 may have any desired shape. Although any material may be used, the stabilizing member 12 is preferably formed of an elastic elastomeric material such as rubber. The sealing member 13 shown is also annular in shape, but this is not required. Although any material may be used, the sealing member 13 is also preferably formed of an elastic elastomeric material such as rubber. The purposes of the stabilizing member 12 and the sealing member 13 will be described below.

[0040] The cap 14 is shown as being generally hollow cylindrical in shape and includes a body 14a extending from a closed end 14b to an open end 14c. However, the cap 14 may have any desired shape. Figures 2 to 4 As shown, the closed end 14b of the cap 14 is provided with a support structure 14d on its inner surface. In the embodiment shown, the support structure 14d is an annular ridge formed integrally with the closed end 14b of the cap 14. However, the support structure 14d can have any desired shape and can be provided at any desired location on the cap 14. An internal thread 14e is provided on the cap 14 adjacent to the open end 14c. The purpose of the support structure 14d and the internal thread 14e will be explained below. Although any desired material can be used, the cap 14 is preferably formed of a rigid plastic material.

[0041] The protective container 10 of the first embodiment can be assembled by first inserting the stabilizing member 12 into the base 11. To do so, the stabilizing member 12 can be moved axially through the open end 11c and into the interior of the base 11 until the outer shoulder 12b provided on the stabilizing member 12 engages with the inner shoulder 11e provided on the base 11, as shown in FIG. Figure 2 Preferably, the outer surface of the stabilizing member 12 is dimensioned to be as shown. Figure 2The illustrated positioning allows the outer surface of the stabilizing member 12 to frictionally engage the inner surface of the base 11, but this is not required. Thus, the stabilizing member 12 is clearly positioned within the base 11 and retained on the base 11.

[0042] Next, the sealing member 13 is inserted into the annular groove 11f provided around the open end 11c of the base 11. To this end, the sealing member 13 can be axially moved on the external thread 11g and into the annular groove 11f, as shown in FIG. Figure 2 Preferably, the sealing member 13 is sized so that it is received in the annular groove 11f in a snap-fit ​​relationship, but this is not required. Thus, the sealing member 13 is clearly positioned in and retained on the annular groove 11f.

[0043] Finally, the cover 14 is mounted on the base 11 to complete the protective container 10 of the first embodiment. To this end, the cover 14 is first axially aligned with the base 11 so that the external thread 11g provided on the base 11 is adjacent to the internal thread 14e provided on the cover 14, as shown in FIG. Figure 2 and Figure 3 Then, the cover 14 is moved axially relative to the body 11 so that the internal thread 14e engages with the external thread 11g. Then, the cover 14 is rotated relative to the body 11. Due to the engagement of the external thread 11g and the internal thread 14e, this rotation causes the cover 14 to further move axially relative to the body 11 to Figure 4 The lid 14 is positioned in the final orientation shown. During this movement toward this final orientation, the open end 14c of the lid 14 moves axially within the groove 11f housing the sealing member 13. Preferably, the outer diameter defined by the sealing member 13 is slightly larger than the inner diameter defined by the inner surface of the open end 14c of the lid 14. Therefore, when the lid 14 is in this final orientation relative to the body 11, the sealing member 13 is compressed radially inward by the inner surface of the open end 14c of the lid 14. Thus, the interior of the protective container 10 of the first embodiment is positively sealed to prevent the ingress of contaminants.

[0044] As mentioned above and Figure 2 As shown, support structure 11d is integrally formed with body 11, and support structure 14d is integrally formed with cover 14. However, if desired, one or both of these support structures 11d and 14d can be formed as separate components from body 11 and cover 14. In addition, one or both of these support structures 11d and 14d can be implemented as storage devices for sterile medical implants, as described below. Likewise, although Figures 1 to 4 The protective container 10 of the illustrated first embodiment includes both a support structure 11 d provided on the body 11 and a support structure 14 d provided on the lid 14 , but the present invention contemplates that one or both of these support structures 11 d and 14 d may be omitted.

[0045] Figure 5 A first embodiment of a storage device, generally designated 20, is shown, which may be used with Figures 1 to 4 The storage device 20 of the first embodiment is used in conjunction with the protective container 10 of the first embodiment shown. The storage device 20 of the first embodiment is a sealed container for supporting sterile medical implants (not shown) therein. The storage device 20 of the first embodiment is generally hollow cylindrical in shape (although this is not required) and includes an elongated hollow body portion 21 having a cover portion 22 removably supported thereon. Figure 6 As shown, the end of the elongated body portion 21 opposite the removable cover portion 22 is preferably sized and shaped so that the end can be received within the support structure 11d of the base 11 of the protective container 10 of the first embodiment. Figure 6 As shown, the removable cover portion 22 is preferably sized and shaped so as to be received within the support structure 14d of the cover 14 of the protective container 10 of the first embodiment.

[0046] The storage device 20 of the first embodiment (containing a sterile medical implant not shown) can be as Figure 6 The support shown is in the protective container 10 of the first embodiment. To this end, the stabilizing member 12 and the sealing member 13 are first arranged in the body 11a of the base 11 as described above. Then, the storage device 20 of the first embodiment is inserted axially through the open end 11c into the interior of the base 11. Thereby, the end of the slender body portion 21 is axially moved through the opening 12a of the stabilizing device 12 and engaged with the support structure 11d of the base 11 of the protective container 10 of the first embodiment. Therefore, the end of the slender body portion 21 is received in the support structure 11d of the base 11 of the protective container 10 of the first embodiment and is clearly supported on the support structure 11d of the base 11.

[0047] At the same time, the central region of the elongated body portion 21 extends through the opening 12a of the stabilizing device 12. Although not required, the central region of the elongated body portion 21 of the storage device 20 of the first embodiment is preferably sized and shaped so that the central region of the elongated body portion engages the inner surface defined by the opening 12a of the stabilizing device 12. Thus, the central region of the elongated body portion 21 of the storage device 20 of the first embodiment is received within the stabilizing device 12 and positively supported thereon.

[0048] Finally, as described above, the cover portion 14 is screwed onto the open end 11c of the body 11. Although not required, the size and shape of the cover portion 22 of the storage device 20 of the first embodiment are preferably designed to engage with the support structure 14d of the cover 14, as shown. Figure 6As shown. Thus, the cover portion 22 of the storage device 20 of the first embodiment is received within and explicitly supported on the support structure 14d of the cover 14 of the protective container 10 of the first embodiment. Because (1) the end of the elongated body portion 21 is received within and explicitly supported on the support structure 11d of the base 11; (2) the central area of ​​the elongated body portion 21 is received within and explicitly supported on the stabilizing device 12; and (3) the cover portion 22 is received within and explicitly supported on the support structure 14d of the cover 14, it can be seen that the storage device 20 of the first embodiment is firmly supported in the protective container 10 of the first embodiment to prevent relative movement therebetween. However, when it is desired to retrieve the sterilized medical implants from the interior of the storage device 20 of the first embodiment, the storage device 20 of the first embodiment can be quickly and easily removed from the protective container 10 of the first embodiment.

[0049] It should be understood that one or both of the support structures 11d and 14d can be implemented as a geometrically elongated portion or by appropriately determining the dimensions of the external components (i.e., the body 11 and the lid 14) and the internal components (i.e., the storage device 20 or the sterile medical device itself) so as to allow only limited axial movement or no axial movement. For example, the storage device 20 or the sterile medical device itself can be snugly fitted on the top and bottom or circumference of the protective container 10 of the first embodiment. In addition, some portions of the body 11 and / or the lid 14 can be provided with identification features, such as transparent and translucent color coding or coloring, to facilitate identification of the sterile medical device contained therein.

[0050] Figure 5 and Figure 6A single storage device 20 is shown as being supported within the protective container 10 of the first embodiment. However, it should be understood that a plurality of such storage devices 20 may be supported within the protective container 10 of the first embodiment. For example, two or more such storage devices 20 may be supported axially adjacent to one another within the protective container 10. In this case, a first storage device in the plurality of storage devices 20 may be supported on a support structure 11d provided on the base 11, while a second storage device in the plurality of storage devices 20 may be supported on a support structure 14d provided on the lid 14. The first and second storage devices in the plurality of storage devices 20 may be axially adjacent to one another to prevent movement relative to the protective container 10 of the first embodiment. Alternatively, a first storage device in the plurality of storage devices 20 may be supported on both the support structure 11d provided on the base 11 and the support structure 14d provided on the lid 14, and a second storage device in the plurality of storage devices 20 may be supported within the first storage device in the plurality of storage devices 20, similar to a matryoshka or Russian doll. Any number of such nested storage devices 20 may be supported in this manner within the protective container 10 of the first embodiment.

[0051] Figure 7 A second embodiment of a storage device is shown, generally indicated at 30, which can be used with Figures 1 to 4 The protective container 10 of the first embodiment shown is used in conjunction with a container for supporting sterilized medical implants MD therein. The storage device 30 of the second embodiment includes a body portion 31 having a first support portion 32 and a second support portion 33 disposed therein. The body portion 31 shown is formed from a generally flat rectangular sheet of material (such as plastic or cardboard), but this is not required. Each of the first support portion 32 and the second support portion 33 shown is generally semicircular in shape and is formed by cutting and bending a portion of the body portion 31 so that it extends generally perpendicular to the body portion. Each of the first support portion 32 and the second support portion 33 shown has an aperture 32a and 33a extending therethrough, respectively. However, the first support portion 32 and the second support portion 33 can be formed to have any desired shape or combination of shapes. Similarly, the body portion 31 of the storage device 30 of the second embodiment can be provided with a greater or lesser number of such support portions 32 and 33.

[0052] like Figure 7 and Figure 8As shown, the sterilized medical implant MD can be supported on the body portion 31 of the storage device 30 of the second embodiment by inserting the sterilized medical implant MD into the corresponding holes 32a and 33a of the first support portion 32 and the second support portion 33. In order to retain the sterilized medical implant MD on the body portion 31, the holes 32a and 33a can be formed to have a size slightly smaller than the size of the portion through which the sterilized medical implant MD extends. Alternatively, the holes 32a and 33a can be slightly offset relative to the sterilized medical implant MD extending therethrough.

[0053] The storage device 30 of the second embodiment can be as follows Figure 8 is supported in the protective container 10 of the first embodiment as shown. To this end, the sealing member 13 is first arranged in the groove 11f of the base 11 as described above (the stabilizing member 12 can be omitted in this embodiment). Then, the storage device 30 of the second embodiment is inserted axially through the open end 11c into the interior of the base 11. Thereby, the end of the main body portion 31 is axially moved to engage with the support structure 11d of the base 11 of the protective container 10 of the first embodiment. Thus, the end of the slender body 21 can be received in the support structure 11d of the base 11 of the protective container 10 of the first embodiment and is clearly supported on the support structure 11d of the base 11.

[0054] Finally, as described above, the cover portion 14 is screwed onto the open end 11c of the body 11. Although not required, the upper end of the body portion 31 of the storage device 30 of the second embodiment is preferably sized and shaped so that the upper end of the body portion is engaged by the support structure 14d of the cover 14, as shown in FIG. Figure 8 Thus, the upper end of the body portion 31 of the storage device 30 of the second embodiment is received within and positively supported on the support structure 14d of the lid 14 of the protective container 10 of the first embodiment.

[0055] Because the lower end of the body portion 31 is clearly supported on the support structure 11d of the base 11, and the upper end of the body portion 31 is clearly supported on the support structure 14d of the cover 14, it can be seen that the storage device 30 of the second embodiment is firmly supported in the protective container 10 of the first embodiment to prevent relative movement therebetween. However, when it is desired to retrieve the sterilized medical implant MD from the storage device 30 of the second embodiment, the storage device 30 of the second embodiment can be quickly and easily removed from the protective container 10 of the first embodiment.

[0056] Figure 9 A third embodiment of a storage device is shown, generally indicated at 40, which may be used with Figures 1 to 4The protective container 10 of the first embodiment shown is used in combination for supporting sterile medical implants MD therein. The storage device 40 of the third embodiment includes a body portion 41 having a first support portion 42 and a second support portion 43 arranged therein. The body portion 41 shown is formed by an elongated cylindrical column, but this is not required. The shape of each of the first support portion 42 and the second support portion 43 shown is designed to be generally in the form of a cylindrical disk, but this is not required. The first support portion 42 shown has a pair of holes (not shown) extending through it. However, if necessary, the first support portion 42 can be formed to have a greater or lesser number of such holes, and the second support portion 43 can be formed to have one or more similar holes.

[0057] like Figure 9 and Figure 10 As shown, a pair of sterile medical implants MD can be supported on the body portion 41 of the storage device 40 of the third embodiment by inserting the pair of sterile medical implants MD through corresponding holes in the first support portion 42. In order to retain the sterile medical implants MD on the body portion 41, the holes can be formed to have a size slightly smaller than the size of the sterile medical implants MD extending therethrough.

[0058] The storage device 40 of the third embodiment can be as follows Figure 10 As shown, the second support portion 43 of the body portion 41 is supported in the protective container 10 of the first embodiment. To this end, the sealing member 13 is first arranged in the groove 11f of the base 11 as described above (the stabilizing member 12 can be omitted in the present embodiment). Then, the storage device 40 of the third embodiment is inserted axially through the open end 11c into the interior of the base 11. Thereby, the second support portion 43 of the body portion 41 is axially moved to engage with the support structure 11d of the base 11 of the protective container 10. Therefore, the second support portion 43 can be received in the support structure 11d of the base 11 of the protective container 10 of the first embodiment and is clearly supported on the support structure 11d of the base 11.

[0059] Meanwhile, the first support portion 42 of the body portion 41 is disposed inside the base 11. The outer surface of the first support portion 42 is dimensioned so as to fit snugly within the inner surface of the interior of the base 11. Figure 10 This engagement of the outer surface of the first support portion 42 with the inner surface of the interior of the base 11 prevents or minimizes lateral movement of the storage device 40 of the third embodiment relative to the protective container 10 of the first embodiment.

[0060] Finally, as described above, the cover portion 14 is screwed onto the open end 11c of the body 11. Although not required, the size and shape of the upper end of the body portion 41 of the storage device 40 of the third embodiment are preferably designed so that the upper end of the body portion engages with the support structure 14d of the cover 14, as shown in FIG. Figure 10 Therefore, the upper end portion of the body portion 41 of the storage device 40 of the third embodiment is received in and positively supported on the support structure 14d of the cover 14 of the protective container 10 of the first embodiment.

[0061] Because (1) the second support portion 43 of the body portion 41 is clearly supported on the support structure 11d of the base 11; (2) the first support portion 42 of the body portion 41 engages the inner surface of the interior of the base 11; and (3) the upper end of the body portion 41 is clearly supported on the support structure 14d of the cover 14, it can be seen that the storage device 40 of the third embodiment is firmly supported within the protective container 10 of the first embodiment to prevent relative movement therebetween. However, when it is desired to retrieve the sterilized medical implant MD from the storage device 40 of the third embodiment, the storage device 40 of the third embodiment can be quickly and easily removed from the protective container 10 of the first embodiment.

[0062] Figures 11 to 15 A fourth embodiment of a storage device, generally designated 50, is shown, which may be used with Figures 1 to 4 The protective container 10 of the first embodiment is used in combination for supporting sterile medical implants MD therein. The storage device 50 of the fourth embodiment is designed to be generally in the form of a rectangular parallelepiped, but this is not required. The storage device 50 of the fourth embodiment includes a first cup-shaped body portion 51 and a second cup-shaped body portion 52, which cooperate to define an interior space in which the sterile medical implants MD can be arranged, such as Figure 12 and Figure 13 As shown in FIG. The first body portion 51 has a flange 51a extending around its open end. The flange 51a has extensions 51b at opposite ends of the first body portion 51. Similarly, the second body portion 52 has a flange 52a extending around its open end. The flange 52a has extensions 52b at opposite ends of the second body portion 52. The purpose of the flanges 51a and 52a and the associated extensions 51b and 52b will be explained below.

[0063] In use, the sterile medical implant MD is first placed inside the second body portion 52 of the storage device 50 of the fourth embodiment, as shown in FIG. Figure 12 and Figure 13 Then, as Figure 11As shown, the first body portion 51 is moved to engage with the second body portion 52. In this orientation, the flanges 51a and 52a (including respective extensions 51b and 52b) are disposed adjacent to and in engagement with each other. If desired, a retaining structure (not shown) may be provided to positively retain the first and second body portions 51, 52 in this orientation.

[0064] The storage device 50 of the fourth embodiment can be as follows Figure 14 and Figure 15 As shown, the protective container 10 of the first embodiment is supported. To this end, as described above, the sealing member 13 is first arranged in the groove 11f of the base 11 (in this embodiment, the stabilizing member 12 can be omitted). Then, the storage device 50 of the fourth embodiment is inserted into the interior of the base 11 through the open end 11c in the axial direction. Thereby, the first pair of extension portions 51b and 52b are moved axially to engage with the support structure 11d of the base 11 of the protective container 10 of the first embodiment. Therefore, the extension portions 51b and 52b can be received in the support structure 11d of the base 11 of the protective container 10 of the first embodiment and are clearly supported on the support structure 11d of the base 11.

[0065] At the same time, flanges 51a and 52a are provided inside the base 11. The outer surfaces of the flanges 51a and 52a are sized so as to fit snugly within the inner surface of the inner portion of the base 11. Figure 14 and Figure 15 This engagement of the flanges 51a and 52a with the interior surface of the interior of the base 11 prevents or minimizes lateral movement of the storage device 50 of the fourth embodiment relative to the protective container 10 of the first embodiment.

[0066] Finally, as described above, the cover portion 14 is screwed onto the open end 11c of the body 11. Although not required, the second pair of extensions 51b and 52b of the storage device 50 of the fourth embodiment are preferably sized and shaped so that the pair of extensions engage with the support structure 14d of the cover 14, as shown. Figure 14 As shown. Thus, the upper end of the storage device 50 of the fourth embodiment is received within and clearly supported on the support structure 14d of the lid 14 of the protective container 10. Thus, the storage device 50 of the fourth embodiment is securely supported within the protective container 10 of the first embodiment to prevent relative movement therebetween. However, when it is desired to retrieve the sterilized medical implants MD from the storage device 50 of the fourth embodiment, the storage device 50 of the fourth embodiment can be quickly and easily removed from the protective container 10 of the first embodiment.

[0067] Figures 16 to 20A fifth embodiment of a storage device, generally designated 60, is shown, which may be used with Figures 1 to 4 The protective container 10 of the first embodiment is shown for use in conjunction with the protective container 10 for supporting sterile medical implants MD therein. The storage device 60 of the fifth embodiment is largely similar to the protective container 10 of the first embodiment. Figures 11 to 15 The storage device 50 of the fourth embodiment shown is identical, and like reference numerals are used to denote like components. However, the storage device 60 of the fifth embodiment further includes a first positioning fin 51c provided on the first body portion 51 and a second positioning fin 52c provided on the second body portion 52. The first positioning fin 51c and the second positioning fin 52c extend substantially perpendicularly relative to the respective first flange 51a and second flange 52a, but this is not required. Figure 20 As best shown in FIG, the outer surfaces of the first and second positioning fins 51c and 52c are sized so that they fit snugly within the inner surface of the interior of the base 11. Similar to the first and second flanges 51a and 52a, the engagement of the first and second positioning fins 51c and 52c with the inner surface of the interior of the base 11 further prevents or minimizes lateral movement of the storage device 60 of the fifth embodiment relative to the protective container 10 of the first embodiment.

[0068] Figure 21 A sixth embodiment of a storage device is shown, generally indicated at 70, which may be used with Figures 1 to 4 The protective container 10 of the first embodiment is shown for use in conjunction with the protective container 10 for supporting sterile medical implants MD therein. The storage device 70 of the sixth embodiment is largely similar to the protective container 10 of the first embodiment. Figures 11 to 15 The storage device 50 of the fourth embodiment shown is identical, and like reference numerals are used to denote similar components. However, the storage device 70 of the sixth embodiment further includes a hinge 53 that pivotally connects the first body portion 51 to the second body portion 52. This clamshell arrangement facilitates handling and use of the storage device 70 of the sixth embodiment.

[0069] Figure 22 A seventh embodiment of a storage device is shown, generally designated 75, which may be used with Figures 1 to 4 The protective container 10 of the first embodiment is shown for use in conjunction with the sterile medical implant MD held therein. The storage device 75 of the seventh embodiment is largely similar to the protective container 10 of the first embodiment. Figures 16 to 20The storage device 60 of the fifth embodiment is shown to be identical, with like reference numerals used to indicate similar components. However, the storage device 75 of the seventh embodiment further includes a hinge 54 that pivotally connects the first body portion 51 to the second body portion 52. This clamshell arrangement facilitates handling and use of the storage device 75 of the seventh embodiment.

[0070] Figure 23 A protective container of a second embodiment is shown, generally indicated at 80. The protective container 80 of the second embodiment includes an outer container portion 81, an inner container portion 82 and a cover portion 83. The outer container portion 81 is shown to be generally hollow cylindrical in shape and includes a body 81a extending from a closed end 81b to an open end 81c. However, the outer container portion 81 can have any desired shape. An external thread 81d is provided on the outer surface of the body 81a adjacent to the open end 81c. Similarly, the inner container portion 82 is generally hollow cylindrical in shape and includes a body 82a extending from a closed end 82b to an open end 82c. However, the inner container portion 82 can have any desired shape. An external thread 82d is provided on the outer surface of the body 82a adjacent to the open end 82c.

[0071] The cap portion 83 shown in FIG. 1 includes a generally circular end wall having an outer skirt 83a hanging therefrom. The outer skirt 83a shown in FIG. 1 is generally in the shape of a hollow cylinder (but this is not essential), and is provided with an internal thread 83b thereon. The size and shape of the internal thread 83b provided on the outer skirt 83a are designed to match the internal thread of the outer skirt with the external thread 81d provided on the outer surface of the body 81a of the outer container portion 81. Therefore, the outer container portion 81 can be releasably fixed to the outer skirt 83a of the cap portion 83. Similarly, the circular end wall of the cap portion 83 shown in FIG. 1 also has an inner skirt 83c hanging therefrom. The inner skirt 83c shown in FIG. 1 is generally in the shape of a hollow cylinder (but this is not essential), and is provided with an internal thread 83d thereon. The size and shape of the internal thread 83d provided on the inner skirt 83c are designed to cooperate with the external thread 82d provided on the outer surface of the body 82a of the inner container part 82. Therefore, the inner container part 82 can be releasably fixed to the inner skirt 83c of the cover part 83.

[0072] In use, a sterile medical implant (not shown) is placed within the inner container portion 82. The inner container portion 82 is then screwed onto the inner skirt 83c of the cover portion 83 to maintain the sterile medical implant contained therein in a sterile environment. Next, the outer container portion 81 is screwed onto the outer skirt 83a of the cover portion 83 to protectively cover the inner container portion 82 and the sterile medical implant contained therein. To remove the sterile medical implant for use, these steps are reversed.

[0073] Figure 24 and Figure 25 A third embodiment of a protective container according to the present invention is shown, generally designated 90. The protective container 90 of the third embodiment includes a body 91 that is generally hollow cylindrical in shape and extends from a closed end 92 to an open end 93. A lid 94 is pivotally retained on the open end 93 of the protective container 90 of the third embodiment by a hinge 95 or any other conventional structure. Alternatively, the lid 94 may not be retained on the open end 93. The lid 94 also includes a pull tab 96 extending therefrom. The pull tab 96 shown includes an opening 96a to facilitate grasping and pulling the pull tab 96 to move the lid 94 from a closed position ( Figure 24 shown) to the open position ( Figure 25 shown).

[0074] In use, the lid 94 is initially in an open position relative to the body 91, thereby allowing a sterile medical implant (not shown) to be inserted into the body 91. The lid 94 is then moved to a closed position and sealed around the open end 93 of the body 91. Thus, the sterile medical implant is protectively contained within the protective container 90 of the third embodiment until it is needed for use. When that time arrives, the pull tab 96 is grasped and pulled to move the lid 94 from the closed position to the open position, thereby allowing access to the sterile medical implant contained within the body 91.

[0075] Figure 26 and 27A protective container according to a fourth embodiment of the present invention is shown, which is generally indicated at 100. The protective container 100 of the fourth embodiment includes a body 101, a seal 102, a closure 103 and an anti-tamper barrier 104. The body 101 shown is generally hollow cylindrical in shape, including an interior extending from a closed end 101a to an open end 101b. However, the body 101 can have any desired shape. The interior of the body 101 is suitable for supporting a sterile medical implant (not shown). After the sterile medical implant is placed in the interior of the body 101, the seal 102 is fixed to the open end 101b of the body 101. The seal 102 can be implemented as any conventional sealing structure. Next, the closure 103 is mounted on the body 101 to protectively cover the seal 102.

[0076] Finally, a tamper barrier 104 is mounted on the body 101 so as to extend around the closure 103. The tamper barrier 104 has one or more holes 104a extending therethrough, which allow a sterilant (such as, for example, ethylene oxide) to pass therethrough and into the protective container 100 of the third embodiment. Preferably, the holes 104a are positioned on the tamper barrier 104 in a manner that prevents direct linear access to the seal 102. In the embodiment shown, the holes 104a extend radially through a portion of the tamper barrier 104, while the seal 102 faces axially. Thus, direct linear access to the seal 102 through the holes 104a is prevented. If desired, the tamper barrier 104 may additionally have one or more conventional tamper-resistant or tamper-evident structures 104b disposed thereon.

[0077] Figure 28 、 Figure 29 and Figure 30 A protective container according to a fifth embodiment of the present invention is shown, generally indicated at 110. The protective container 110 of the fifth embodiment includes a body 111, a closure 112 including a seal 113, and an anti-tamper barrier 114. The body 111 is shown to be generally hollow cylindrical in shape, including an interior extending from a closed end 111a to an open end 111b. However, the body 111 can have any desired shape. The interior of the body 111 is suitable for supporting a sterile medical implant (not shown). After the sterile medical implant has been placed in the interior of the body 111, the closure 112 (including the seal 113) is secured to the open end 111b of the body 111. The seal 113 can be implemented as any conventional sealing structure. As Figure 29As shown, the closure 112 has one or more holes 112a that allow the sterilant to pass therethrough and enter the protective container 110 of the fifth embodiment. In the embodiment shown, four such holes 112a are spaced equidistantly from each other along the circumference of the circle of smaller diameter. However, any desired number of such holes 112a may be provided in any desired arrangement. Figure 30 As shown, the seal 113 extends over all of the plurality of apertures 112 a extending through the axial face of the closure 112 .

[0078] Finally, an anti-tamper barrier 114 is mounted on the closure 112. The anti-tamper barrier 114 has one or more holes 114a extending therethrough which also allow the sterilant to pass therethrough into the protective container 110 of the fifth embodiment. In the embodiment shown, six such holes 114a are spaced equidistant from one another along the circumference of a circle of larger diameter. However, any desired number of such holes 114a may be provided in any desired arrangement. Preferably, the holes 114a extending through the anti-tamper barrier 114 are not coaxially aligned with the holes 112a extending through the closure 112. Thus, direct linear access to the seal 113 through the holes 114a and 112a is prevented. If desired, the anti-tamper barrier 114 may additionally have one or more conventional tamper-proof or tamper-evident structures (not shown) provided thereon.

[0079] The principle and mode of operation of this invention have been described and illustrated in its preferred embodiments. However, it must be understood that the invention may be practiced otherwise than as specifically described and illustrated without departing from the spirit or scope of the invention.

Claims

1. A protective container for sterile medical implants, comprising: a base comprising a hollow body having a closed end and an open end; a cover secured around the open end of the hollow body; a sealing member compressed between the cover and the base to provide a seal between the base and the cover; and a first support structure disposed on the closed end of the base and a second support structure disposed on the cover, the first support structure and the second support structure each being adapted to support a sterile medical implant within the hollow body of the base; in The first support structure is an annular ridge disposed on the closed end of the base; The second support structure is an annular ridge disposed on the cover; An inner shoulder is provided on an inner surface of the hollow body of the base; an annular stabilizing member supported on the inner shoulder of the hollow body; An annular groove is provided on the base adjacent to the hollow body, and, The sealing member is disposed within the annular groove and is radially compressed between the cover and the base.

2. The protective container for sterile medical implants according to claim 1, further comprising a storage device for sterile medical implants arranged within the hollow body of the base.

3. The protective container for sterile medical implants according to claim 2, wherein: The storage device includes a first end supported on a first support structure and a second end supported on a second support structure.

4. The protective container for sterile medical implants according to claim 2, wherein: The support structure of the annular stabilization member engages the storage device.

5. The protective container for sterile medical implants according to claim 4, wherein: The support structure of the annular stabilization member includes an opening, and the storage device extends through the opening of the support structure of the annular stabilization member.

6. The protective container for sterile medical implants according to claim 2, wherein: The storage device includes a body portion that is generally hollow cylindrical in shape and has a removable cover portion supported on the body portion.

7. The protective container for sterile medical implants according to claim 2, wherein: The storage device includes a body portion that is generally flat and rectangular in shape and has one or more support portions that extend generally perpendicular to the body portion.

8. The protective container for sterile medical implants according to claim 7, wherein: Each of the support portions has a hole extending therethrough.

9. The protective container for sterile medical implants according to claim 5, wherein: The storage device comprises a body portion which is generally cylindrical in shape and comprises a first support portion and a second support portion which are each shaped in the form of a generally cylindrical disc.

10. The protective container for sterile medical implants according to claim 2, wherein: The storage device includes a first end supported on the first support structure and a second end supported on the second support structure, and wherein the annular stabilization member engages the storage device.

11. The protective container for sterile medical implants according to claim 10, wherein: The annular stabilizing member includes an opening, and wherein the storage device extends through the opening of the annular stabilizing member.

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