WO2018081339A1

WO2018081339A1 - Combined protective packaging system and delivery device for pedicle screw of other implant

Info

Publication number: WO2018081339A1
Application number: PCT/US2017/058401
Authority: WO
Inventors: Faezah AGARWAL; Adam Macmillan; Aakash AGARWAL; Daniel MERMUYS; Marcel INGELS
Original assignee: Spinal Balance, Inc.
Priority date: 2016-10-26
Filing date: 2017-10-26
Publication date: 2018-05-03

Abstract

A combined protective container and delivery device for a surgical implant is provided. The combined protective container and delivery device for a surgical implant includes an outer package having a closed end and an open end covered by a cap. The outer package and the cap form a non- sterile exterior surface and a sterile internal cavity. An inner package is positioned within the cavity of the outer package. A surgical implant is positioned within the inner package. The inner package and the surgical implant positioned within the inner package form a sterile assembly within the sterile internal cavity.

Description

COMBINED PROTECTIVE PACKAGING SYSTEM AND DELIVERY DEVICE FOR PEDICLE SCREW OR OTHER IMPLANT

Inventors: Faezah Agarwal, Adam MacMillan, Askash Agarwal, Dan Mermuys, Marcel Ingels

RELATED APPLICATIONS

[0001] This application claims the benefit of United States Provisional Application No. 62/413,016, filed October 26, 2017, the disclosure of which is incorporated herein by reference.

BACKGROUND

[0002] This invention relates in general to a combined protective container and delivery device for a pedicle screw or other implant.

[0003] A variety of spinal fixation devices are known for treating scoliosis, spondylolisthesis, degenerative disc disease, vertebra fractures, and other spinal disorders or abnormalities. In many instances, such spinal fixation devices include one or more pedicle screws, which are individually secured to the vertebrae of the spine to provide anchor points that can then be connected together with a rod or other alignment or immobilization structure. A typical pedicle screw includes a threaded shaft portion having a yoke- shaped head portion extending therefrom. The threaded shaft portion is adapted to be secured to a vertebra of the spine, while the head portion is adapted to be connected to the rod or other alignment or immobilization structure.

[0004] As with all spinal fixation devices and other surgical implants and medical devices, it is important that the pedicle screw be sterilized prior to implantation within a patient. Thus, it is known to dispose a sterile pedicle screw within a container that is sealed until shortly before removal and use. However, to maintain sterility, it is also very important that the amount of manual handling of the pedicle screw that occurs from the unsealing of the container to the implantation of the pedicle screw within the patient be minimized. Known sterile pedicle screw containers require an undesirably large amount of manual handling of the pedicle screw from the unsealing of the container to the implantation of the pedicle screw within the patient.

[0005] It would be desirable to provide an improved protective packaging system for pedicle screws and other surgical implants that minimizes the amount of manual handling thereof that occurs from the unsealing of the packaging system to the implantation within the patient.

SUMMARY

[0006] It should be appreciated that this Summary is provided to introduce a selection of concepts in a simplified form, the concepts being further described below in the Detailed Description. This Summary is not intended to identify key features or essential features of this disclosure, nor is it intended to limit the scope of the programmable locking dispenser.

[0007] The above objects as well as other objects not specifically enumerated are achieved by a combined protective container and delivery device for a surgical implant. The combined protective container and delivery device for a surgical implant includes an outer package having a closed end and an open end covered by a cap. The outer package and the cap form a non- sterile exterior surface and a sterile internal cavity. An inner package is positioned within the cavity of the outer package. A surgical implant is positioned within the inner package. The inner package and the surgical implant positioned within the inner package form a sterile assembly within the sterile internal cavity.

[0008] Various aspects of the combined protective container and delivery device for an implant will become apparent to those skilled in the art from the following detailed description of the illustrated embodiments, when read in light of the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] Figure 1 is a front view, in elevation, of a first embodiment of a combined protective container and delivery device for a surgical implant.

[0010] Figure 2 is a front exploded view, of the combined protective container and delivery device of the surgical implant of Figure 1.

[0011] Figure 3 is a front view, partially disassembled, of the combined protective container and delivery device of the surgical implant of Figure 1.

[0012] Figure 4 is a front view of a portion of the combined protective container and delivery device of the surgical implant of Figure 1, illustrating use of a tool to extract a surgical implant.

[0013] Figure 5 is a front view of a portion of the combined protective container and delivery device of the surgical implant of Figure 1 , illustrating an extracted surgical implant through use of a tool.

[0014] Figure 6 is a front view, in elevation, of a second embodiment of a combined protective container and delivery device for a surgical implant.

[0015] Figure 7 is a front view of the combined protective container and delivery device of the surgical implant of Figure 6, illustrating a first step in the use of the device.

[0016] Figure 8a is a front view of the combined protective container and delivery device of the surgical implant of Figure 6, illustrating a second step in the use of the device.

[0017] Figure 8b is a front view of the combined protective container and delivery device of the surgical implant of Figure 6, illustrating a third step in the use of the device.

[0018] Figure 8c is a front view of the combined protective container and delivery device of the surgical implant of Figure 6, illustrating a fourth step in the use of the device. [0019] Figure 9a is a front view of a portion of the combined protective container and delivery device of the surgical implant of Figure 6, illustrating use of a tool to extract a surgical implant.

[0020] Figure 9b is a front view of a portion of the combined protective container and delivery device of the surgical implant of Figure 6, illustrating an extracted surgical implant through use of a tool.

[0021] Figure 10 is a front view, in elevation, of a third embodiment of a combined protective container and delivery device for a surgical implant.

[0022] Figure 11 is a front exploded view, of the combined protective container and delivery device of the surgical implant of Figure 10.

[0023] Figure 12a is a front view, in elevation, of an outer non-sterile package of the surgical implant of Figure 10 illustrating a specific geometry of the outer surface.

[0024] Figure 12b is a cross-sectional view, of the outer non-sterile package of

Figure 12b illustrating a specific geometry of the outer surface.

[0025] Figure 13 is a front view of the combined protective container and delivery device of the surgical implant of Figure 10, illustrating a first step in the use of the device.

[0026] Figure 14 is a front view of the combined protective container and delivery device of the surgical implant of Figure 10, illustrating a second step in the use of the device.

[0027] Figure 15 is a front view of the combined protective container and delivery device of the surgical implant of Figure 10, illustrating a third step in the use of the device.

[0028] Figure 16 is a front view of the combined protective container and delivery device of the surgical implant of Figure 10, illustrating the inner sterile package is available for use. [0029] Figure 17 is a front view of a portion of the combined protective container and delivery device of the surgical implant of Figure 10, illustrating use of a tool to extract a surgical implant.

[0030] Figure 18 is a front view of a portion of the combined protective container and delivery device of the surgical implant of Figure 10, illustrating an extracted surgical implant through use of a tool.

[0031] Figure 19 is a front view, in elevation, of a fourth embodiment of a combined protective container and delivery device for a surgical implant.

[0032] Figure 20 is a front exploded view, of the combined protective container and delivery device of the surgical implant of Figure 11.

[0033] Figure 21a is a front view, in elevation, of an outer non-sterile package of the surgical implant of Figure 19 illustrating a specific geometry of the outer surface.

[0034] Figure 21b is a cross-sectional view, of the outer non-sterile package of Figure 19 illustrating a specific geometry of the outer surface.

[0035] Figure 22 is a front view of the combined protective container and delivery device of the surgical implant of Figure 19, illustrating a first step in the use of the device.

[0036] Figure 23 a is a front view of the combined protective container and delivery device of the surgical implant of Figure 19, illustrating a second step in the use of the device.

[0037] Figure 23b is a front view of the combined protective container and delivery device of the surgical implant of Figure 19, illustrating a third step in the use of the device.

[0038] Figure 24a is a front view of a portion of the combined protective container and delivery device of the surgical implant of Figure 19, illustrating use of a tool to extract a surgical implant. [0039] Figure 24b is a front view of a portion of the combined protective container and delivery device of the surgical implant of Figure 19, illustrating an extracted surgical implant through use of a tool.

[0040] Figure 25 is a front view of an alternative combined protective container and delivery device of the surgical implant of Figure 19, illustrating displacement of inner sterile packages in multiple directions.

[0041] Figure 26 is a front view of an alternative inner sterile package of the combined protective container and delivery device of the surgical implant of Figure 1.

[0042] Figure 27 is a perspective view of the alternative inner sterile package of Figure 26.

[0043] Figure 28 is a perspective view of the alternative inner sterile package of

Figure 26, illustrating use of a tool to extract a surgical implant.

[0044] Figure 29 is a perspective view of the alternative inner sterile package of

Figure 26, illustrating use of a tool to engage a surgical implant.

[0045] Figure 30 is a perspective view of the alternative inner sterile package of

Figure 26, illustrating an extracted surgical implant through use of a tool.

[0046] Figure 31 is a front view of an alternative inner sterile package of the combined protective container and delivery device of the surgical implant of Figure 1 , illustrating a first internal position of a surgical implant.

[0047] Figure 32 is a front view of the alternative inner sterile package of Figure

31, illustrating a second internal position of a surgical implant.

[0048] Figure 33a is a front view of the alternative inner sterile package of Figure

31.

[0049] Figure 33b is a cross-sectional view of the alternative inner sterile package of Figure 31.

[0050] Figure 34 is a front view of an alternative inner sterile package of the combined protective container and delivery device of the surgical implant of Figure 1 , illustrating a first internal position of a surgical implant. [0051] Figure 35 is a front view of the alternative inner sterile package of Figure 34, illustrating a second internal position of a surgical implant.

[0052] Figure 36 is a front view of the alternative inner sterile package of Figure 34, illustrating placement against a desired anatomy.

[0053] Figure 37 is a front view of the alternative inner sterile package of Figure 34, illustrating placement of the surgical implant into the desired anatomy.

[0054] Figure 38 is a front view of an alternative inner sterile package of the combined protective container and delivery device of the surgical implant of Figure 1 , illustrating a plurality of perforated cuts.

[0055] Figure 39 is a front view of the alternative inner sterile package of Figure 38, illustrating a broken portion of the alternative inner sterile package.

[0056] Figure 40 is a front view of an alternative inner sterile package of the combined protective container and delivery device of the surgical implant of Figure 1 , illustrating an inserted guide wire.

[0057] Figure 41 is a front view of an alternative inner sterile package of the combined protective container and delivery device of the surgical implant of Figure 1 , illustrating a carrier member.

[0058] Figure 42 is a front view of an alternative inner sterile package of Figure 41, illustrating helical internal patterns configured to receive the carrier member.

[0059] Figure 44 is a front, exploded view of an alternative inner sterile package of the combined protective container and delivery device of the surgical implant of Figure 41.

[0060] Figure 45 is a front, exploded view of an alternative inner sterile package of the combined protective container and delivery device of the surgical implant of Figure 41, shown with the surgical implant in a deployed arrangement. DETAILED DESCRIPTION

[0061] The combined protective packaging system and delivery device for an implant (hereafter "packaging system") will now be described with occasional reference to the specific embodiments. The packaging system may, however, be embodied in different forms and should not be construed as limited to the

embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the packaging system to those skilled in the art.

[0062] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the packaging system belongs. The terminology used in the description of the packaging system herein is for describing particular embodiments only and is not intended to be limiting of the packaging system. As used in the description of the packaging system and the appended claims, the singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise.

[0063] Unless otherwise indicated, all numbers expressing quantities of dimensions such as length, width, height, and so forth as used in the specification and claims are to be understood as being modified in all instances by the term "about." Accordingly, unless otherwise indicated, the numerical properties set forth in the specification and claims are approximations that may vary depending on the desired properties sought to be obtained in embodiments of the packaging system. Notwithstanding that the numerical ranges and parameters setting forth the broad scope of the packaging system are approximations, the numerical values set forth in the specific examples are reported as precisely as possible. Any numerical values, however, inherently contain certain errors necessarily resulting from error found in their respective measurements.

[0064] Referring now to Fig. 1, a first embodiment of a packaging system is shown generally at 10. Generally, the packaging system houses a surgical implant in a manner that eliminates the need for direct handling of the surgical implant. The packaging system also facilitates the transfer of the surgical implant from a non- sterile environment to a sterile environment. The packaging system 10 includes an outer non- sterile package 12 and an inner sterile package 14. The inner sterile package 14 contains a surgical implant 16.

[0065] Referring now to Fig. 2, an exploded view of the packaging system 10 is illustrated. The outer non-sterile package 12 includes a lower portion 18 and a removable cap 20. With the lower portion 18 assembled to the cap 20, the outer non- sterile package 12 is configured to protects the inner sterile package 14 and the surgical implant 16 from damage during shipping in addition to providing a barrier to ensure the inner sterile package 14 and the surgical implant 16 inside remain clean, protected and sterile.

[0001] Referring again to Fig. 2, the lower portion 18 has an open upper end 22 and a closed lower end 24, thereby forming a cavity 25 therein. The cap 20 is disposed about the open upper end 22 of the lower portion 18. When the cap 20 is disposed about the open upper end 22 of the lower portion 18, the cap 20 engages (frictionally or otherwise as desired) an outer surface of a portion of the lower portion 18.

[0002] Referring again to Fig. 2, optionally a seal 26 can be positioned between the base lower portion 18 and the cap 20. The seal 26 is configured to seal the outer non- sterile package 12 such as to prevent the ingress of contaminants. In the illustrated embodiment, the seal 26 has the form of an O-ring and can be formed from any desired material sufficient to prevent the ingress of contaminants. In other

embodiments, the outer non-sterile package 12 can be sealed by other structures, mechanisms and devices, including the non-limiting example of a tamper-evident seal. The tamper-evident seal can be configured to prevent the removal, handling, and/or unauthorized return of the surgical implant 16 back into the outer non-sterile package 12. [0003] Referring again to Fig. 2, the inner sterile package 14 includes a lower segment 28 and an upper segment 30. The lower segment 28 has an open upper end 32 and a closed lower end 34, thereby forming a cavity 35 therein. The upper segment 28 has an open lower end 36 and a closed upper end 38, thereby forming a cavity 39 therein. The open lower end 36 of the upper segment 30 is disposed about the open upper end 32 of the lower segment 28 and internal threads (not shown for purposes of clarity) engage external threads 40 disposed at the open upper end 32 of the lower segment 28 (as shown by direction arrow Dl in Fig. 3). The attachment of the lower segment 28 to the upper segment 30 forms a sealed inner package 14, wherein the cavities 35, 39 and the surgical implant 16 can be sterilized. While the attachment of the lower section 28 to the upper section 30 has been described as a threaded connection, it should be appreciated that in other embodiments, the lower section 28 can be attached to the upper section 30 with other structures, mechanisms and devices sufficient to form a sealed inner package 14.

[0004] Referring again to the embodiment shown in Fig. 2, the surgical implant 16 has the form of a surgical/bone screw. The surgical implant 16 has a threaded shaft portion 42 and has a yoke- shaped head portion 44 extending therefrom. The threaded shaft portion 42 is secured to a vertebra of the spine, while the head portion 44 is connected to the rod or other alignment or immobilization structure (not shown).

However, in other embodiments, the surgical implant 16 can have other forms.

[0005] Referring again to Fig. 2, assembly of the packaging system 10 begins as a portion of the surgical implant 16 is received within the cavity 35 of the lower segment 28 of the inner sterile package 14. The upper segment 30 is positioned such that a portion of the surgical implant 16 is received with the cavity 39 of the upper segment 30 and the upper segment 30 is attached to the lower segment 28 as described above, thereby forming the inner sterile package 14. The inner sterile package 14 is configured to securely hold the surgical implant 16. In some designs, it is beneficial for the inner sterile package 14 to completely constrain the surgical implant 16 to prevent the surgical implant from any movement. In other designs, it may be beneficial to allow the surgical implant 16 some freedom to move.

[0006] Referring again to Fig. 2 in a next step, the inner sterile package 14 is inserted into the lower portion 18 of the outer non-sterile package 12. Finally, the cap

20 and optional seal 26 are secured to the upper open end 22 of the lower portion 18, thereby forming the packaging system 10 as shown in Fig. 1.

[0066] As shown in Fig. 3, when the surgical implant 16 is ready to be used, the inner sterile package 14 is opened by removing the upper segment 30, which breaks the sterile barrier. The contents of the inner sterile package 14 are sterile and can be dropped into a sterile environment.

[0067] Once the inner sterile package 14 is opened, the surgical implant 16 is sterile and can be handled by sterile personnel. Referring now to Fig. 4, it is further contemplated that the head portion 44 of the surgical implant 16 can then be engaged by a tool 46, such that the process of removing the surgical implant 16 from the lower portion 28 can be completed without any person making physical contact with the surgical implant 16. In the illustrated embodiment, the tool 46 is a screwdriver.

However, in other embodiments, the tool 46 can other forms sufficient to engage the head portion 44 of the surgical implant 16 without a person making physical contact with the surgical implant 16.

[0068] As shown in Fig. 5, the surgical implant 16 can then be removed from the lower section 28 of the inner sterile package 14 without human touching of the surgical implant 16 itself.

[0069] Referring now to Fig. 6, a second embodiment of a packaging system is shown generally at 110. Generally, the packaging system 110 houses a surgical implant in a manner that eliminates the need for direct handling of the surgical implant. The packaging system also facilitates the transfer of the surgical implant from a non- sterile environment to a sterile environment. The packaging system 110 differs from the packaging system 10, as shown in Fig. 1, in that the packaging system 110 includes features configured to prevent an inner sterile package from falling completely out of an outer non-sterile package by the force of gravity alone.

[0070] Referring again to Fig. 6, the packaging system 110 includes an outer non- sterile package 112, an inner sterile package 114 and a surgical implant 116. The outer non- sterile package 112 and the inner sterile package 114 can be the same as the outer non-sterile package 12 and the inner sterile package 14, described above and shown in Fig. 1, with the exception that the outer non- sterile package 112 and the inner sterile package 114 include mating features that are configured to prevent the inner sterile package 114 from falling completely out of an outer non- sterile package by the force of gravity alone.

[0071] Referring again to Fig. 6, the outer non-sterile package 112 includes an internal recess feature 148 at an open upper end 122 of the outer non-sterile package. The internal recess feature 148 forms a partial thread that extends to the open upper end 122. The inner sterile package 114 includes a projection 150 that extends from a closed lower end 134. The projection 150 is configured to be received by the internal recess feature 148 such that the inner sterile package 114 rotates as the projection 150 follows the path of the internal recess feature 148. The internal recess feature 148 and the projection 150 will be discussed in more detail below.

[0072] Referring now to Figs. 7, 8a-8c, 9a and 9b, the operation of the packaging system 110 will now be described. Referring first to Fig. 7, the outer non- sterile package 112 is opened by removing a cap 120 from the open upper end 122. By removing the cap 120, a sterile barrier formed between the cap 120 and the outer non- sterile package 112 is broken. In the illustrated embodiment, the cap 120 is removed from the outer non-sterile package 112 by rotating and removing the cap 120. In alternate embodiments, the non-sterile package 112 could be designed to open in a number of various methods.

[0073] Referring now to Fig. 8a in a next step, the outer non-sterile package 112 is then turned upside-down. In this orientation, the inner sterile package 114 containing the surgical implant 116 slides and or falls slightly from the outer non-sterile package 112 and become exposed.

[0074] Referring now to Fig. 8b in a next step, inner sterile package 114 containing the surgical implant 116 cannot fall completely out of the outer non-sterile package 112 by gravity alone. The projection 150 engages the inner portion of outer non- sterile package 112 at the open upper end 122, which prevents the inner sterile package 114 from falling completely from the outer non-sterile package 112. The inner sterile package 114 must be grasped and rotated slightly, thereby allowing the projection 150 to engage the internal recess feature 148, to allow it to be removed from the outer non-sterile package 112, as shown in Fig. 8c. As discussed above, the outer non-sterile package 112 is non-sterile and can be handled by non-sterile personnel. The inner sterile package 114 and the surgical implant 116 are sterile and can be handled by sterile personnel. The inner sterile package 114 houses the sterile surgical implant 116. This embodiment of the packaging system 110 transfers a sterile surgical implant from a non- sterile environment to a sterile environment.

[0075] Once the inner sterile package 114 is opened, the surgical implant 116 is sterile and can be handled by sterile personnel. Referring now to Fig. 9a, it is further contemplated that a head portion 144 of the surgical implant 116 can then be engaged by a tool 146, such that the process of removing the surgical implant 116 from the inner sterile package 114 can be completed without any person making physical contact with the surgical implant 116. In the illustrated embodiment, the tool 146 is a screwdriver. However, in other embodiments, the tool 146 can have other forms sufficient to engage the head portion 144 of the surgical implant 116 without a person making physical contact with the surgical implant 116.

[0076] As shown in Fig. 9b, the surgical implant 116 can then be removed from the inner sterile package 114 without human touching of the surgical implant 116 itself.

[0077] Referring now to Fig. 10, a third embodiment of a packaging system is shown generally at 210. Generally, the packaging system 210 houses a surgical implant in a manner that eliminates the need for direct handling of the surgical implant. The packaging system also facilitates the transfer of the surgical implant from a non- sterile environment to a sterile environment. The packaging system 210 differs from the packaging system 10, as shown in Fig. 1, in that the packaging system 210 includes features configured to drive an inner sterile package containing a surgical implant from the outer non-sterile package.

[0078] Referring again to Figs. 10 and 11, the packaging system 210 includes an outer non-sterile package 212, an inner sterile package 214, a surgical implant 216, a cap 220, a spring 252 and a carrier member 254. The outer non-sterile package 212 can be the same as the outer non-sterile package 12 described above and shown in Fig. 1, with the exception that the outer non-sterile package 212 includes a plurality of internal recess features 248a, 248b configured to receive mating structures on the carrier member 254. As will be explained in more detail below, the internal recess features 248a, 248b and the mating structures on the carrier member 254 cooperate to prevent the inner sterile package 214 from falling completely out of an outer non- sterile package by the force of gravity alone.

[0079] Referring again to Fig. 10, the internal recess features 248a, 248b extend from a closed lower end 224 of the outer non-sterile package 214 in a direction toward the open upper end 222. The internal recess features 248a, 248b form threads that are configured to receive mating projections 250 extending from the carrier member 254 such that the carrier member 254 and the inner sterile package 214 supported by the carrier member 254 rotate as the projections 250 follow the paths of the internal recess features 248a, 248b. In the embodiment shown in Fig. 10, the internal recess features 248a, 248b form helical paths configured to reduce the speed (increase the time) that it takes for the inner sterile package 214 to be exposed. However, it should be appreciated that in other embodiments, the internal recess features 248a, 248b can form other paths, such as the substantially straight paths as shown by the internal recess features 248a, 248b in Fig. 11. [0080] Referring now to Fig. 11, the carrier member 254 includes an internal cavity 256 configured to receive a closed lower end 234 of the inner sterile package 214. The carrier member 254 supports the inner sterile package 214 such that movement of the carrier member 254 results in movement of the inner sterile package 214.

[0081] Referring again to Fig. 11, the spring 252 is configured to urge the carrier member 254, and the inner sterile package 214 supported by the carrier member 254, in an axial direction. In the illustrated embodiment, the spring 252 has the form of a helical spring. However, in other embodiments, the spring 252 can have other forms sufficient to urge the carrier member 254, and the inner sterile package 214 supported by the carrier member 254, in an axial direction. In the assembled illustration as shown in Fig. 10, the spring 252 is in a compressed arrangement.

[0082] Referring now to Figs. 12a and 12b, the outer non-sterile package 212 is configured to protect its contents from damage during shipping in addition to providing a sterile barrier to ensure the products inside remain clean, protected and sterile. In certain embodiments, an outer surface 258 of the outer non-sterile package 212 can be configured with specific geometry to prevent the outer non-sterile package 212 from rolling on a flat or slightly inclined/declined surface. One non-limiting example of a specific geometry is shown in Fig. 12b. The outer surface 258 of the outer non-sterile package 212 includes a plurality of flat segments 260a-260c. The flat segments 260a-260c are configured to prevent the outer non-sterile package 212 from rolling on a flat or slightly inclined/declined surface. However, the outer surface 258 of the outer non-sterile package 212 can have other specific geometries configured to prevent the outer non-sterile package 212 from rolling on a flat or slightly

inclined/declined surface.

[0083] Referring now to Figs. 13-18, the operation of the packaging system 210 will now be described. Referring first to Fig. 13, the outer non-sterile package 212 is opened by removing the cap 220 from an open upper end 222. By removing the cap 220, a sterile barrier formed between the cap 220 and the outer non-sterile package 212 is broken. In the illustrated embodiment, the cap 220 is removed from the outer non-sterile package 212 by rotating and removing the cap 220. In alternate

embodiments, the non- sterile package 212 could be designed to open in a number of various methods.

[0084] Referring now to Fig. 14 in a next step, with the cap 220 removed, the compressed inner spring 252 is free to expand in an axial direction, which in turn drives the inner sterile package 214 containing the surgical implant 216 from the outer non-sterile package 212, thereby exposing the inner sterile package 214. The outer non-sterile package 212 is non-sterile as it is exposed to external elements; however, its contents are sterile. In another embodiment, the spring 252 could be activated using another mechanism like a button or twist to allow timed extraction of the inner sterile package 214. It is contemplated that in another embodiment, there could be helical path given to the inner stage/tube to reduce the speed (increase the time) that it takes the inner tube to be exposed. This packaging system advantageously allows non- sterile personnel to hold the outer package, remove its cap exposing the inner package and surgical screw and present it to a sterile individual. The sterile individual can grab the sterile inner package and remove it from the outer package, maintaining its sterility.

[0085] Referring now to Figs. 15 and 16 in a next step, the inner sterile package 214 is sterile and can be handled by sterile personnel. The inner sterile package 214 houses the sterile surgical implant 216. The outer non- sterile package 212 was non- sterile and could be handled by non-sterile personnel.

[0086] Once the inner sterile package 214 is released from the outer non-sterile package 212, the surgical implant 216 is sterile and can be handled by sterile personnel. Referring now to Fig. 17, it is further contemplated that a head portion 244 of the surgical implant 216 can then be engaged by a tool 246, such that the process of removing the surgical implant 216 from the inner sterile package 214 can be

completed without any person making physical contact with the surgical implant 216. In the illustrated embodiment, the tool 246 is a screwdriver. However, in other embodiments, the tool 246 can other forms sufficient to engage the head portion 244 of the surgical implant 216 without a person making physical contact with the surgical implant 216.

[0087] As shown in Fig. 18, the surgical implant 216 can then be removed from the inner sterile package 214 without human touching of the surgical implant 216 itself.

[0088] Referring now to Fig. 19, a fourth embodiment of a packaging system is shown generally at 310. Generally, the packaging system 310 houses a surgical implant in a manner that eliminates the need for direct handling of the surgical implant. The packaging system also facilitates the transfer of the surgical implant from a non- sterile environment to a sterile environment. The packaging system 310 differs from the packaging system 10, as shown in Fig. 1, in that the packaging system 210 includes features configured to drive an inner sterile package containing a surgical implant from the outer non-sterile package.

[0089] Referring now to Figs. 19 and 20, the packaging system 310 includes an outer non-sterile package 312, an inner sterile package 314, a surgical implant 316, a cap 320, and a carrier member 354. The outer non-sterile package 312 can be the same as the outer non-sterile package 12 described above and shown in Fig. 1, with the exception that the outer non- sterile package 312 includes a slot 362 configured to receive mating structures on the carrier member 354. As will be explained in more detail below, the slot 362 and the mating structures on the carrier member 354 cooperate to drive the inner sterile package 314 from the outer non- sterile package 312.

[0090] Referring again to Fig. 19, the slot 362 extends from a closed lower end 324 of the outer non-sterile package 314 in a direction toward an open upper end 322. The slot 362 configured to receive a mating projections 350 extending from the carrier member 354 such that the carrier member 354 and the inner sterile package 314 supported by the carrier member 354 are displaced in an axial direction as the projection 250 is urged along the path of the slot 362. In the embodiment shown in Fig. 10, the slot 362 forms a substantially straight line from the closed lower end 324 to the open upper end 322. However, it should be appreciated that in other

embodiments, the slot 362 can form paths having other shapes and can be configured to reduce the speed (increase the time) that it takes for the inner sterile package 314 to be exposed.

[0091] Referring now to Fig. 20, the carrier member 354 includes an internal cavity 356 configured to receive a closed lower end 334 of the inner sterile package 314. The carrier member 354 supports the inner sterile package 314 such that movement of the carrier member 354 results in movement of the inner sterile package 314.

[0092] Referring now to Figs. 21a and 21b, the outer non-sterile package 312 is configured to protect its contents from damage during shipping in addition to providing a sterile barrier to ensure the products inside remain clean, protected and sterile. In certain embodiments, an outer surface 358 of the outer non-sterile package 312 can be configured with specific geometry to prevent the outer non-sterile package 312 from rolling on a flat or slightly inclined/declined surface. One non-limiting example of a specific geometry is shown in Fig. 21b. The outer surface 358 of the outer non-sterile package 312 includes a plurality of flat segments 360a-360c. The flat segments 360a-360c are configured to prevent the outer non-sterile package 312 from rolling on a flat or slightly inclined/declined surface. However, the outer surface 358 of the outer non-sterile package 312 can have other specific geometries configured to prevent the outer non- sterile package 312 from rolling on a flat or slightly

inclined/declined surface.

[0093] Referring now to Figs. 22-18, the operation of the packaging system 310 will now be described. Referring first to Fig. 22, the outer non-sterile package 312 is opened by removing the cap 320 from an open upper end 322. By removing the cap 320, a sterile barrier formed between the cap 320 and the outer non- sterile package 312 is broken. In the illustrated embodiment, the cap 320 is removed from the outer non-sterile package 312 by rotating and removing the cap 320. In alternate

embodiments, the non- sterile package 312 could be designed to open in a number of various methods. As shown in Fig. 22, the projection 350 is located toward a closed lower end 324 of the outer non-sterile package 312.

[0094] Referring now to Figs. 23a and 23b in a next step, with the cap 220 removed, the carrier member 354 can be manually advanced along the path of the slot 362, thereby exposing the inner sterile package 314 and surgical implant 316. The packaging system 310 advantageously allows non-sterile personnel to hold the outer non- sterile package 312 and advance the inner sterile package 314, via the carrier member 354, to present the inner sterile package 314 and surgical implant 316 to a sterile individual. The sterile individual can grab the inner sterile package 314 and remove it from the outer non- sterile package 312, maintaining its sterility. Different mechanisms could be used to achieve this transfer by sliding: direct contact through deformable sealing barrier, magnetic force transfer etc. Another embodiment could include a push from the bottom/base, to release the sterile inner tube. The pushing platform will be non-sterile on the outside and sterile on the inside.

[0095] Once the inner sterile package 314 is released from the outer non-sterile package 312, the surgical implant 316 is sterile and can be handled by sterile personnel. Referring now to Fig. 24a, it is further contemplated that a head portion 344 of the surgical implant 316 can then be engaged by a tool 346, such that the process of removing the surgical implant 316 from the inner sterile package 314 can be completed without any person making physical contact with the surgical implant 316. In the illustrated embodiment, the tool 346 is a screwdriver. However, in other embodiments, the tool 346 can other forms sufficient to engage the head portion 344 of the surgical implant 316 without a person making physical contact with the surgical implant 316. [0096] As shown in Fig. 24b, the surgical implant 316 can then be removed from the inner sterile package 314 without human touching of the surgical implant 316 itself.

[0097] Referring now to Fig. 25, it is within the contemplation of the packaging system 310 that the outer non- sterile package 312 could house multiple inner sterile packages 314a, 314b, each having a surgical implant 316. In this embodiment, the carrier member 354 is multi-directional along slot 362. Accordingly, the carrier member 354 urges the inner sterile package 314a toward open upper end 322 and later urges the inner sterile package 314b toward an open lower end 364.

[0098] Referring now to Fig. 26, another embodiment of an inner sterile package is shown at 414. Generally, the inner sterile package 414 has a certain geometry and is configured to rigidly secure a surgical implant in a desired orientation. The geometry of the inner sterile package 414 facilitates mating of a tool with the surgical implant such that the tool and the surgical implant are indexed and aligned as desired.

[0099] Referring now to Figs. 26 and 27, the inner sterile package 414 has an open upper end 422, a closed lower end 424 and an internal cavity 425 formed therein. The cavity 425 is configured to receive a surgical implant 416. The open upper end 422 includes opposing legs 466a, 466b. Opposing recesses 468a, 468b are formed between the opposing legs 466a, 466b.

[00100] Referring again to Fig. 26, the surgical implant 416 is positioned in inner sterile package 414 by the manufacturer, thereby forming a sterile assembly 470 as shown in Fig. 27. The sterile assembly 470 is delivered to a user is the assembled arrangement.

[00101] Referring now to Fig. 27, the surgical implant 416 is rigidly secured within the inner sterile package 414 such that opposing legs 472a, 472b of the surgical implant 416 are disposed in the opposing recesses 468a, 468b of the open upper end 422 of the inner sterile package 414. The inner sterile package 414 is secured within the inner sterile package 414 such that the inner sterile package 414 prevents rotation of the surgical implant 416 and the opposing legs 472a, 472b of the surgical implant 416 are maintained in the opposing recesses 468a, 468b. In this position, the opposing legs 472a, 472b of the surgical implant 416 are exposed and accessible to connect to one or more mating instruments.

[00102] Referring now to Fig. 28, the sterile assembly 470 is illustrated with the opposing legs 472a, 472b of the surgical implant 416 exposed between the opposing legs 466a, 466b of the inner sterile package 414. An instrument 446 has opposing prongs 472a, 472b configured to engage the exposed portions of the opposing legs 472a, 472b of the surgical implant 416, as shown in Fig. 29. As shown in Fig. 29, the geometry of the open upper end 422 of the inner sterile package 414 helps facilitate alignment and attachment of instrument 446 to the surgical implant 416. The geometry of the open upper end 422 of the inner sterile package 414 functions as an indexing and aligning device this scenario.

[00103] As shown in Fig. 30, the geometry of the open upper end 422 of the inner sterile package 414 facilitates removal of the surgical implant 416 from the inner sterile package 414 without the need for anyone to physically touch the surgical implant 416. Contact is made with the inner sterile package 414 and instrumentation 446 only.

[00104] Referring now to Figs. 31 and 32, another embodiment of an inner sterile package 514 is illustrated. Generally, the inner sterile package 514 is used as an instrument for the delivery and implantation of a surgical implant 516. As a package, the inner sterile package 514 provides a sterile barrier for the implantable surgical implant 516. As an instrument, the inner sterile package 514 provides for tissue distraction, surgical implant 516 manipulation and a connection mechanism for interaction with other implants and instruments.

[00105] Referring now to Figs. 33a and 33b, the inner sterile package 514 has the form of a hollow tube 573. The hollow tube has a vertical slot 574 extending substantially the length of the hollow tube. The vertical slot is configured to permit other surgical implants and instruments to pass through the inner sterile package 514.

[00106] Referring now to Fig. 34, the surgical implant 516 is retained within the interior of the inner sterile package 514 until the surgical implant 516 is to be used. The surgical implant 516 may be held securely within the interior of the inner sterile package 514 in a number of different positions. As shown in Fig. 34, the surgical implant 516 can be secured in a bottom portion 575 of the tube 573. In other embodiments as shown in Fig. 35, the surgical implant 516 can be secured in a top portion 577 of the tube 573. Regardless of the position of the surgical implant 516 within the tube 573, the surgical implant 516 can be secured through several methods such as the non-limiting examples of locational interference fit, mating features, elastomeric interface sleeve, and the like.

[00107] Referring now to Fig. 36, when the surgical implant 516 is to be implanted, the inner sterile package 514 is navigated through soft tissue until a distal end 580 of the inner sterile package 514 makes contact with a desired anatomy, such as the non-limiting example of bony anatomy as shown schematically at 582. Upon contact with the desired anatomy, the inner sterile package 514 is configured to provide tissue distraction and tissue dilation to allow clear visualization of the surgical implant 516. The inner sterile package 514 is further configured to provide alignment functions for entry of the surgical implant 516 into the intended anatomy 582. The surgical implant 516 is then advanced through the inner sterile package 514 and into the intended anatomy 582.

[00108] Referring now to Figs. 37 and 38, it is within the contemplation of the packaging system that the inner sterile package 514 includes optional, integrated perforated cuts 584 at its distal end 580, which are configured to facilitate controlled breaking of the inner sterile package 514. As shown in Fig. 38, in operation, the inner sterile package 514 is removed from the surgical implant 516 by breaking the inner sterile package 514 at the perforated cuts 584 after the surgical implant 516 has been inserted into the desired anatomy. Alternatively, the surgical implant 516 can be designed to break by forces generated by features on the surgical implant on the final stages of insertion.

[00109] Referring now to Fig. 40 in another embodiment, the inner sterile package 614 is equipped with an optional guide wire 686. The guide wire 686 extends through the inner sterile package 614 and is configured as a guide for the surgical implant 616. In operation, the surgical implant 616 can traverse/travel to the end of the inner sterile package 614 by simple axial force from an associated instrument (not shown).

[00110] Referring now to Fig. 40, another embodiment of an inner sterile package 714 is illustrated. In this embodiment, the inner sterile package 714 includes a hollow tube 573 configured to receive a carrier member 588. The carrier member 588 is configured to carry a surgical implant 716 through the interior of the inner sterile package 714. The carrier member 788 is configured as a medium between the inner sterile package 714 and the surgical implant 716. In operation, the surgical implant 716 sits inside the carrier member 788 and the inner sterile package 714 facilitates the advancement of the carrier member 788 and the contained surgical implant 716.

[00111] Referring now to Figs. 42 and 43, it is within the contemplation of the packaging system that a carrier member 888 may include a plurality of projections 850 configured to mate with one or more internal threads 890 or internal helix patterns within the inner sterile package 814. The mating carrier member 888 and internal threads 890 are configured to facilitate the advancement of the carrier member 888 carrying the surgical implant 816 within the inner sterile package 814.

[00112] Referring now to Fig. 44, in operation as the carrier member 888 reaches a distal end 880 of the inner sterile package 814, the carrier member 888 is retained within the inner sterile package 814, but the surgical implant 816 is permitted to pass through and inserted into the desired anatomy. [00113] Referring now to the embodiments illustrated in Figs. 1-7, 8a-8c, 9a, 9b, 10-11, 12a, 12b, 13-20, 21a, 21b, 22, 23a, 23b, 24a, 24b, 25-32, 33a, 33b and 34-44, it is within the contemplation of the packaging system that the inner sterile package can include spaced apart structures, such as the non-limiting examples of apertures, configured for permeability. The apertures can be configured to allow gas sterilization processes, such as for example steam-based or ethylene oxide-based sterilization processes to penetrate the inner sterile package and access the surgical implant while the inner sterile package and the surgical implant are positioned within the outer non- sterile package. Advantageously, the inner sterile package and the surgical implant can be sterilized while positioned within the outer non-sterile package and without human contact.

[00114] The principle and mode of operation of the packaging system have been explained and illustrated in certain embodiments. However, it must be understood that the packaging system may be practiced otherwise than as specifically explained and illustrated without departing from its spirit or scope.

Claims

CLAIMS What is claimed is:

1. A combined protective container and delivery device for a surgical implant, comprising:

an outer package having a closed end and an open end covered by a cap, the outer package and the cap forming a non- sterile exterior surface and a sterile internal cavity;

an inner package positioned within the cavity of the outer package; and a surgical implant positioned within the inner package;

wherein the inner package and the surgical implant positioned within the inner package form a sterile assembly within the sterile internal cavity.

2. The combined protective container and delivery device for a surgical implant of Claim 1, wherein the surgical implant is a pedicle screw.

3. The combined protective container and delivery device for a surgical implant of Claim 1 , wherein the inner package has a lower segment threadably attached to an upper segment.

4. The combined protective container and delivery device for a surgical implant of Claim 1, wherein a seal is positioned between the outer package and the cap.

5. The combined protective container and delivery device for a surgical implant of Claim 1 , wherein a tool is used to extract the surgical implant from the inner package.

6. The combined protective container and delivery device for a surgical implant of Claim 5, wherein the tool is a screwdriver.

7. The combined protective container and delivery device for a surgical implant of Claim 1, wherein the outer package includes a plurality of internal recess features.

8. The combined protective container and delivery device for a surgical implant of Claim 7, wherein the plurality of internal recess features are displaced at an open upper end of the inner package.

9. The combined protective container and delivery device for a surgical implant of Claim 7, wherein the internal recess features are configured to receive projections extending from the inner package.

10. The combined protective container and delivery device for a surgical implant of Claim 9, wherein the projections are configured to follow the path of the internal recess features, thereby resulting in a turn of the inner package to release the inner package from the outer package.

11. The combined protective container and delivery device for a surgical implant of Claim 1, wherein a carrier member is positioned within the outer package and configured to receive a portion of the inner package.

12. The combined protective container and delivery device for a surgical implant of Claim 11, wherein the carrier member includes a plurality of projections.

13. The combined protective container and delivery device for a surgical implant of Claim 12, wherein the projections of the carrier member are configured to follow internal recess features, thereby resulting in a turn of the inner package to release the inner package from the outer package.

14. The combined protective container and delivery device for a surgical implant of Claim 13, wherein a spring is positioned to urge the carrier member and the inner package supported by the carrier member in an axial direction.

15. The combined protective container and delivery device for a surgical implant of Claim 1, wherein the outer package includes a slot extending substantially along a length of the outer package.

16. The combined protective container and delivery device for a surgical implant of Claim 15, wherein the slot is configured to receive a projection extending from a carrier member, the carrier member configured to receive the inner package, the projection extending outwardly from the slot and configured to manually advance the carrier member and the inner package along the path of the slot.

17. The combined protective container and delivery device for a surgical implant of Claim 1 , wherein the inner package includes a plurality of perforated cuts configured for breakage.

18. The combined protective container and delivery device for a surgical implant of Claim 1, wherein a guide wire is positioned within the inner package and configured to guide the surgical implant.

19. The combined protective container and delivery device for a surgical implant of Claim 1 , wherein the inner package is configured to align entry of the surgical implant into an intended anatomy.

20. The combined protective container and delivery device for a surgical implant of Claim 1, wherein the inner package is configured for tissue dilation and tissue distraction.