Implant retainer

Abstract

Various implant retention systems are provided herein, and they include outer tubes, inner tubes and retainers. The implant retention system can be designed to keep various implants, such as the bone anchor used in spinal manipulation. For example, an embodiment of the implant retention system can have an outer tube, the inner tube that can be arranged in the outer tube and the implant retainer that can be arranged in the inner tube. The independent bone anchor with various configurations and size can be arranged in the retainer, and the retainer can engage the bone anchor to help maintain the orientation of the bone anchor relative to the retainer.

Description

Technical Field

[0001] The present disclosure generally relates to an implant holder. Background Art

[0002] During various surgical procedures, a sterile surgical environment must be maintained. Therefore, preparing for an operation requiring multiple tools and implants (such as a spinal operation in which multiple bone anchors may be used) can be very time-consuming because the user is required to sterilize many different implants. In addition, many bone anchors are provided to the user on large trays of various sizes and configurations. Even if a particular operation only requires a small number of bone anchors on a tray, the user is still required to sterilize the entire tray, and the user must pay for, maintain, and ensure appropriate training for any implant sterilization equipment.

[0003] Therefore, there remains a need for improved implant holders. Summary of the Invention

[0004] Generally speaking, separate implant holders and methods of use are provided.

[0005] In one embodiment, an implant retention system is provided, comprising an outer tube, an inner tube, a bone anchor, and a retainer. The outer tube has a sealed first outer end and an open second outer end, and the outer tube has a removable outer cap that selectively seals the second outer end. The inner tube is disposed within the outer tube, and the inner tube has a sealed first inner end that engages with the outer cap of the outer tube. The inner tube has an open second inner end and a removable inner cap that is configured to selectively seal the second inner end. The bone anchor has a drive head and a threaded shaft extending distally from the drive head. The retainer is disposed within the inner tube and has a longitudinal axis. The retainer has a receiving head that receives the drive head of the bone anchor and a collar that extends distally from the receiving head. The collar engages at least a portion of the threaded shaft of the bone anchor to maintain the orientation of the threaded shaft of the bone anchor relative to the longitudinal axis of the retainer when the bone anchor is received therein.

[0006] The system can have a variety of variations. For example, the receiving head can be configured to engage the driver head of the bone anchor to prevent axial rotation about the longitudinal axis of the retainer, and the receiving head can have an inner lumen extending distally through the receiving head and the collar so that the threaded shaft of the bone anchor can pass therethrough. In another example, the retainer can include a breakaway tab removably disposed at an end opposite the receiving head, and the breakaway tab is configured to be removed to change the length of the retainer along the longitudinal axis of the retainer. In some examples, the retainer can have at least two arcuately deformable legs configured to maintain the position of the retainer within the inner tube by frictionally engaging each of the legs with the inner surface of the inner tube. In another example, the retainer can have an alignment panel disposed along a distal portion thereof, and the alignment panel can be configured to engage the inner surface of the inner tube to resist axial rotation of the retainer about the longitudinal axis of the retainer. The alignment panel can also have a non-circular cross-section at a point along the longitudinal axis of the retainer. In yet another example, the retainer, outer tube, and inner tube can allow for visualization of the orientation of the bone anchor when the bone anchor is received in the retainer. In one example, when the retainer is disposed within the inner tube and the inner tube is disposed within the outer tube, the outer tube, inner tube, and retainer can be coaxial with each other along a longitudinal axis of the retainer.

[0007] In another embodiment, an implant retention system is provided, comprising an outer tube, an inner tube, a bone anchor, and a retainer. The outer tube has a sealed first outer end and an open second outer end, and the outer tube has a removable outer cap that selectively seals the second outer end. The inner tube is disposed within the outer tube, and the inner tube has a sealed first inner end that engages the outer cap of the outer tube. The inner tube has an open second inner end and a removable inner cap that selectively seals the second inner end. The bone anchor has a drive head. The retainer is disposed within the inner tube, and the retainer has a longitudinal axis extending between a first retainer end that engages the inner cap of the inner tube and an open second retainer end. An inner lumen extends at least partially through the retainer from the second retainer end toward the first retainer end, and the inner lumen receives at least a portion of the bone anchor therein. A plurality of alignment members extend at least partially into the inner lumen, and the plurality of alignment members engage the bone anchor to maintain the orientation of the bone anchor relative to the longitudinal axis of the retainer when the bone anchor is received in the inner lumen.

[0008] The system can have a variety of variations. For example, each of the multiple alignment members can be one of a longitudinal rectangular protrusion, a vertical protrusion, an arcuate arm, a curved arm, a spiral arm, and a flexible arm, so that multiple bone anchors of different lengths and diameters can be received in the inner cavity. In another example, the retainer can have one or more disconnected portions extending from the open second retainer end toward the first retainer end, and the one or more disconnected portions can be removed to change the length of the retainer along the longitudinal axis of the retainer. In some examples, the bone anchor can have a threaded shaft extending distally from the driver head, and the multiple alignment members can be arranged to extend radially into the inner cavity to correspond to the threads extending radially outward from the threaded shaft. In one example, when the retainer is engaged to the inner cap, the retainer can maintain a rotational position relative to the inner cap of the inner tube relative to the longitudinal axis of the retainer. The first retainer end can also have a non-circular cross-section at a point along the longitudinal axis of the retainer. In another example, the retainer, outer tube, and inner tube can allow visualization of the orientation of the bone anchor when it is received in the retainer. In one example, when the retainer is disposed within the inner tube and the inner tube is disposed within the outer tube, the outer tube, inner tube, and retainer can be coaxial with one another along a longitudinal axis of the retainer.

[0009] On the other hand, a kind of surgical method is provided, it is included in and is accommodated in outer tube and implant holder is arranged in inner tube when removing sealing cap from outer tube.The threaded shaft of bone anchor remains in first orientation in implant holder relative to the longitudinal axis of implant holder by engaging with the receiving head and collar of implant holder, and the inside, inner tube, implant holder and bone anchor of outer tube are aseptic.The method also comprises when the outer surface of non-polluted inner tube is passed to inner tube in aseptic area and removes lid from the inner tube in aseptic area.The method also comprises the implant holder in the inner tube in aseptic area and retrieves bone anchor, makes the threaded shaft of bone anchor remain in first orientation by engaging with the receiving head and collar of implant holder during retrieval.

[0010] This method can have many variations. For example, the method can also include visually inspecting the orientation of the bone anchor through the outer tube, the inner tube, and the implant holder during removal of the sealing cap from the outer tube. In another example, the bone anchor's driver head can engage the proximal end of the threaded shaft, and the bone anchor's driver head and threaded shaft can be maintained in the first orientation during removal of the sealing cap from the outer tube, transfer of the inner tube to the sterile field, and removal of the cap from the inner tube. In yet another example, the implant holder can hold a plurality of bone anchors of various lengths and diameters in the first orientation.

[0011] The details of one or more variations of the subject matter described herein are set forth in the accompanying drawings and the description below. Other features and advantages of the subject matter described herein will be apparent from the description and drawings, and from the claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] The present invention will be more fully understood through the following detailed description taken in conjunction with the accompanying drawings, in which:

[0013] Figure 1 is a perspective view of one embodiment of an implant holder and one embodiment of a bone anchor disposed within one embodiment of an inner tube aligned for placement within one embodiment of an outer tube;

[0014] Figure 2A yes Figure 1 A side view of an implant holder;

[0015] Figure 2B yes Figure 1 a side view of the implant holder with the breakaway tab removed;

[0016] Figure 3 yes Figure 1 A perspective view of an implant holder;

[0017] Figure 4 yes Figure 1 A perspective view of an implant holder;

[0018] Figure 5 yes Figure 1 A top view of an implant holder;

[0019] Figure 6 An embodiment of a bone anchor Figure 1 A perspective view of a top portion of an implant holder;

[0020] Figure 7A yes Figure 1 A bottom view of an implant holder;

[0021] Figure 7B Inserted into the inner tube Figure 1 A bottom view of an implant holder;

[0022] Figure 8A yes Figure 1 A perspective view of an implant holder;

[0023] Figure 8B yes Figure 1 A side view of an implant holder;

[0024] Figure 8C yes Figure 1 Another side view of the implant holder;

[0025] Figure 8D yes Figure 1 Front view of the implant holder;

[0026] Figure 8E yes Figure 1 Posterior view of the implant holder;

[0027] Figure 8F yes Figure 1 A bottom view of an implant holder;

[0028] Figure 8G yes Figure 1 A top view of an implant holder;

[0029] Figure 8H Is set in Figure 1 within the inner tube Figure 1 A perspective view of the implant holder, the inner tube is then placed in Figure 1 Inside the outer tube;

[0030] Figure 8I yes Figure 1 A side view of an implant holder, inner tube, and outer tube;

[0031] Figure 8J yes Figure 1 Another side view of the implant holder, inner tube and outer tube;

[0032] Figure 8K yes Figure 1 Front view of the implant holder, inner tube and outer tube;

[0033] Figure 8L yes Figure 1 Rear view of the implant holder, inner tube, and outer tube;

[0034] Figure 8M yes Figure 1 A bottom view of the implant holder, inner tube and outer tube;

[0035] Figure 8N yes Figure 1 A top view of the implant holder, inner tube and outer tube;

[0036] Figure 9 It is the use of Figure 1 Tools and bone anchor insertion Figure 1 A partially transparent side view of an implant holder in an inner tube;

[0037] Figure 10 Another embodiment of a bone anchor is Figure 1 A side view of an implant holder;

[0038] Figure 11 Another embodiment of a bone anchor is Figure 1 A side view of an implant holder;

[0039] Figure 12 Another embodiment of a bone anchor is Figure 1 A side view of an implant holder;

[0040] Figure 13 yes Figure 1 A perspective view of an implant holder and bone anchor;

[0041] Figure 14 yes Figure 11 A perspective view of an implant holder and bone anchor;

[0042] Figure 15 Inserted into the inner tube Figure 13 A perspective view of an implant holder and bone anchor;

[0043] Figure 16 yes Figure 15 A perspective view of an implant holder, bone anchor, and inner tube;

[0044] Figure 17 yes Figure 15 A perspective view of an implant holder, bone anchor, and inner tube;

[0045] Figure 18 A cap with an outer tube Figure 15 A perspective view of an implant holder, bone anchor, and inner tube;

[0046] Figure 19 is a perspective view of one embodiment of an outer tube;

[0047] Figure 20 Is a Figure 19 outer tube Figure 18 A perspective view of an implant holder, bone anchor, inner tube, and cap;

[0048] Figure 21 yes Figure 19 a perspective view of the outer tube;

[0049] Figure 22 yes Figure 19 a perspective view of the outer tube;

[0050] Figure 23 is used to Figure 20 A block diagram of one embodiment of the steps of delivering an inner tube into a sterile environment;

[0051] Figure 24 It is used to transfer the inner tube into the sterile environment Figure 20 Another block diagram of the steps;

[0052] Figure 25 is a perspective view of another embodiment of an implant holder;

[0053] Figure 26 Another embodiment of a bone anchor is Figure 25A perspective view of an implant holder;

[0054] Figure 27 Inserted into the inner tube Figure 25 A perspective view of an implant holder;

[0055] Figure 28 is a perspective view of another embodiment of an implant holder;

[0056] Figure 29 is a perspective view of another embodiment of an implant holder;

[0057] Figure 30 is a perspective view of another embodiment of an implant holder having another embodiment of a bone anchor;

[0058] Figure 31 is a perspective view of another embodiment of an implant holder;

[0059] Figure 32 is a perspective view of another embodiment of an implant holder;

[0060] Figure 33 yes Figure 32 A cross-sectional side view of an implant holder;

[0061] Figure 34 Is a tool and a stylet Figure 32 A cross-sectional side view of an implant holder;

[0062] Figure 35 is a perspective view of another embodiment of an implant holder;

[0063] Figure 36 is a perspective view of another embodiment of an implant holder;

[0064] Figure 37 is a perspective view of another embodiment of an implant holder;

[0065] Figure 38 is a perspective view of another embodiment of an implant holder;

[0066] Figure 39 is a perspective view of another embodiment of an implant holder;

[0067] Figure 40 is a perspective view of another embodiment of an implant holder;

[0068] Figure 41 is a perspective view of another embodiment of an implant holder;

[0069] Figure 42 yes Figure 41A cross-sectional side view of a retainer;

[0070] Figure 43 yes Figure 41 A partially transparent side view of the retainer;

[0071] Figure 44 is a perspective view of another embodiment of an implant holder;

[0072] Figure 45 yes Figure 44 A cross-sectional side view of a retainer;

[0073] Figure 46 yes Figure 44 A partially transparent side view of the retainer;

[0074] Figure 47 is a perspective view of another embodiment of an implant holder;

[0075] Figure 48 yes Figure 47 A cross-sectional side view of a retainer;

[0076] Figure 49 yes Figure 47 A partially transparent side view of the retainer;

[0077] Figure 50 is a perspective view of another embodiment of an implant holder;

[0078] Figure 51 yes Figure 50 A cross-sectional side view of a retainer;

[0079] Figure 52 yes Figure 50 A partially transparent side view of the retainer;

[0080] Figure 53 is a cross-sectional side view of another embodiment of an implant holder;

[0081] Figure 54 yes Figure 53 A perspective view of a retainer;

[0082] Figure 55 is a perspective view of another embodiment of an implant holder;

[0083] Figure 56 Inserted into the inner tube Figure 55 A perspective view of a retainer;

[0084] Figure 57 Inserted into the cap Figure 55 A perspective view of the retainer in FIG.

[0085] Figure 58 is a perspective view of one embodiment of an implant holder engaged with a cap;

[0086] Figure 59 Inserted into the inner tube Figure 58 A perspective view of the retainer in FIG; and

[0087] Figure 60 Inserted into the outer tube Figure 59 Perspective view of the retainer and inner tube in FIG. DETAILED DESCRIPTION

[0088] Certain exemplary embodiments will now be described to provide a comprehensive understanding of the principles of structure, function, manufacture, and use of the devices and methods disclosed herein. One or more examples of these embodiments are shown in the accompanying drawings. Those skilled in the art will understand that the devices and methods specifically described herein and shown in the accompanying drawings are non-limiting exemplary embodiments, and the scope of the present disclosure is limited only by the claims. Features shown or described in conjunction with one exemplary embodiment may be combined with features of other embodiments. Such modifications and variations are intended to be included within the scope of the present invention.

[0089] In addition, in the present disclosure, components with similar names in various embodiments generally have similar features, so in a specific embodiment, it is not necessary to fully set forth every feature of each component with similar names. In addition, to the extent that linear or circular dimensions are used in the description of the disclosed systems, devices and methods, such dimensions are not intended to limit the types of shapes that can be used in conjunction with such systems, devices and methods. Those skilled in the art will recognize that equivalent dimensions of such linear and circular dimensions can be readily determined for any geometric shape. The size and shape of the systems and devices and their components may depend at least on the anatomy of the subject in which the systems and devices will be used, the size and shape of the components with which the systems and devices will be used, and the methods and surgeries in which the systems and devices will be used. The same reference numerals in the various figures indicate the same elements.

[0090] The present disclosure as a whole relates to implant holders. When transporting various individual implants, maintaining the general orientation of the implants can help prevent the implants from being damaged during transport and minimize any difficulty in removing the implants from their transport containers during deployment. Additionally, sterilizing and packaging the individual implants in separate transport containers can be beneficial so that, when deployed, the user does not need to sterilize the implants and does not need to handle more than one implant at a time and potentially contaminate them.

[0091] Therefore, this paper provides various implant retention systems, which include outer tubes, inner tubes and retainers. The implant retention system can be designed to accommodate various implants of different types and sizes, such as the bone anchor used in spinal manipulation, and the retainer can engage the bone anchor arranged therein to help maintain the orientation of the bone anchor relative to the retainer. In other words, the retainer engages the bone anchor and is maintained in the inner tube under aseptic conditions. The inner tube is then maintained in the outer tube that does not need aseptic. Ideally, a single retention system has the versatility of handling any size of the bone anchor that may be used.

[0092] Additionally, one or more of the bone anchor, retainer, inner tube, and / or outer tube can be sterilized during assembly and packaging and maintained in a sterile state until the bone anchor is deployed. Typically, the bone anchor, retainer, and inner tube are sterilized prior to placement within the outer tube. This ensures that each bone anchor is sterilized and maintained within its own sterile housing, allowing for the use of as many different types and sizes of bone anchors as possible during a surgical procedure without compromising the sterility of any bone anchors that are not used during the procedure.

[0093] Figures 1 to 24 One embodiment of an implant retention system having an outer tube 100, an inner tube 150, and a retainer 200 is shown. Figure 1 100 and 150. The holder 200 receives the bone anchor 250 therein so that the orientation of the bone anchor 250 is maintained relative to the holder 200 during movement and transport of the system. As discussed further below, the holder 200 can be placed in the inner tube 150 and can maintain its position within the inner tube 150. The inner tube 150 can be placed in the outer tube 100 and can maintain its position within the outer tube 100. Thus, when being transported, for example, when being moved from a manufacturing or distribution facility to an operating environment where the bone anchor 250 will be deployed, the orientation of the bone anchor 250 can be maintained within the holder 200 and tubes 100, 150.

[0094] like Figures 2A to 4 As shown in FIG, the holder 200 has a receiving head 202, a collar 210, deformable legs 220, an alignment plate 230, and a breakaway tab 240. The receiving head 202 is located on the proximal end of the holder, and the collar 210 and the deformable legs 220 extend distally from the receiving head 202 along the longitudinal axis A1 of the holder 200. The deformable legs 220 extend distally on either side of the collar 210, and the legs 220 terminate in an alignment plate 230 formed at the distal end of the legs 220. The breakaway tab 240 is provided at the distal end of the holder 200.

[0095] The receiving head 202 receives the driving head 252 of the bone anchor 250 in the cavity 204 formed therein and maintains the orientation of the driving head 252 of the bone anchor 250. The receiving head 202 has two raised flat sides 202a and two lower flat sides 202b that define the cavity 204. Figure 5 and Figure 6 When the retainer is disposed within the inner tube 150, the flat sides 202a, 202b contact corresponding flat inwardly facing surfaces in the inner tube 150 to help prevent the retainer from rotating independently of the inner tube 150. The cavity 204 also has flat inwardly facing surfaces 204a, 204b. Thus, as Figure 6 As shown, which shows a cross-section of the drive head 252 in the receiving head 202 , the flat surfaces 204 a , 204 b may engage corresponding flat outwardly facing surfaces of the drive head 252 to help prevent the drive head 252 from rotating independently of the holder 200 .

[0096] Additionally, the receiving head 202 allows for visualization or observation of the orientation of the driver head 252 because the elevated side 202a and the lower side 202b form a generally U-shaped profile when viewed from a side of the holder 200. The cavity 204 has a distal or lower surface 205 that engages the lower surface of the driver head 252 of the bone anchor 250, and the receiving head 202 has an opening or lumen 208 through which the threaded shaft 254 of the bone anchor 250 can extend distally along the axis A1.

[0097] In some embodiments, a small gap can be designed between the bone anchor 250, the receiving head 202, and the sides of the inner tube 150 to allow for easier insertion and removal of the retainer 200 and bone anchor 250 while still maintaining a fixed orientation. Figure 5 As shown, flanges 206 and other surface features may also be formed within cavity 204 to facilitate engaging driver heads of various sizes and configurations, which may vary based on the intended use of the various bone anchors.

[0098] When the receiving head 202 maintains the orientation of the driving head 202, the collar maintains the orientation of the threaded shaft 254 of the bone anchor 250 relative to the axis A1. Figures 2A to 8G As shown, the collar 210 extends distally from the receiving head 202, and the lumen 208 extends through the collar 210 along the axis A1. Thus, when the threaded shaft 254 extends through the lumen 208, the collar 210 engages at least a portion of the threaded shaft 254, thereby maintaining the orientation or angle of the threaded shaft 254 in the retainer 200. Although the collar 210 has a circular or annular cross-section, a variety of different cross-sectional shapes may be used, such as hexagonal, octagonal, etc.

[0099] Additionally, the collar 210 allows for visualization and observation of the orientation of the threaded shaft 254 during movement of the holder 200. The collar 210 extends only partially along the longitudinal axis A1 of the holder 200, such that at least the distal-most portion 255 of the threaded shaft 254 protrudes beyond the collar 210, as shown. Figure 9 For example, the collar 210 can extend between about 5% and about 75% of the length of the threaded shaft 254 , and more preferably between about 5% and about 35% of the length of the threaded shaft 254 .

[0100] Therefore, if Figures 9 to 12 As shown, cavity 204, lumen 208, and collar 210 can be sized to accommodate bone anchors having a variety of different sized driver heads and threaded shafts. For example, Figures 9 to 12 Conventional bone anchors 250, 250b, 250c, 250d are shown having driver heads 252, 252b, 252c, 252d and threaded shafts 254, 254b, 254c, 254d of various sizes, lengths, dimensions, configurations, etc. Although several embodiments of bone anchors are shown, many types of bone anchors can be received in the holder 200, such as the various polyaxial and / or modular screws described in detail in U.S. Patent Application No. 2019 / 0150989, entitled “Bone Anchor Assemblies and Related Instrumentation,” filed November 7, 2018, to Biester et al., which is incorporated herein by reference in its entirety. Additionally, various fixation bone screws having a threaded shaft and driver head in a fixed orientation relative to each other, as well as one or more separate components of modular screws, such as only a threaded shaft, can be received in the holder 200.

[0101] Extending distally from the receiving head 202 and surrounding the collar 210, two legs 220 help maintain the orientation of the retainer 200 within the inner tube 150. The two legs 220 are deformable and are arched radially outward relative to the axis A1. Thus, each leg contacts the inward-facing surface of the inner tube 150 at its widest point, and the retainer 200 is coaxial with the inner tube 150. During placement of the retainer 200 in the inner tube 150, the legs 220 flex radially inward due to contact with the inward-facing surface of the inner tube 150, thereby experiencing frictional engagement with the inner tube 150. As force is applied distally along the axis A1 when the receiving head 254 of the bone anchor 250 is loaded onto the distal end of the tool 280, the distally applied force is received by the legs 220 and distributed outwardly from the legs 220 to the inner tube 150 to further increase engagement therebetween, as shown in FIG. Figure 9 The increased engagement allows for easier loading and retrieval of the bone anchor 250 from the holder 200.

[0102] Additionally, the legs 220 allow for visualization and observation of the orientation of the threaded shaft 254 during movement of the retainer 200 between the legs 220. Although two legs 220 are shown, in other embodiments more than two legs 220 may be used, such as from two to about twenty. Figures 1 to 4 Surface features 225 are shown that may take various forms and may serve various purposes, such as helping to increase engagement between the retainer 200 and the inner tube 150 , helping to provide engagement with molds during manufacture and forming of the retainer 200 , and the like.

[0103] An alignment panel 230 is provided at the distal end of the legs 220 and helps maintain the orientation of the retainer 200 within the inner tube 150. The alignment panel 230 has a non-circular cross-section taken at a point along the longitudinal axis A1 of the retainer 200. Thus, at least two sides 230a, 230b of the alignment panel 230 contact the inner surface 154b of the inner tube 150, as shown in FIG. Figure 7A and Figure 7B Because the alignment panel 230 is non-circular, the two sides 230a, 230b of the alignment panel 230 that contact the inner tube 150 resist rotation of the retainer 200 about the axis A1. Although the alignment panel 230 has an elliptical cross-section, other non-circular shapes such as square, triangle, hexagon, octagon, etc. can be used.

[0104] At the distal-most end of the retainer 200, the break-away tab 240 allows the overall length of the retainer along the longitudinal axis A1 to be changed. The break-away tab 240 can be removed from the retainer 200 before the retainer 200 is placed into the inner tube 150. Removing the break-away tab 240 creates additional distance between the receiving head 202 and the cap 162 of the inner tube 150. Thus, when the break-away tab 240 is removed, bone anchors 250c, 250d having larger drive heads 252c, 252d can be accommodated in the retainer 200 while the cap 162 can still enclose the inner tube 150 and the engagement interface 164 of the cap, discussed further below, can still engage the receiving head 200 and the drive heads 252c, 252d to prevent the bone anchor 250 from sliding proximally out of the retainer 200, such as if the retainer 200 is inverted. Thus, with the break-away tab 240 attached, as Figure 9 and Figure 10 As shown, the receiving head 202 of the holder 200 can accommodate various drive heads of various sizes, such as bone anchors 250, 250b having smaller or axially shorter drive heads 252, 252b. Similarly, with the breakaway tab 240 removed, as shown Figure 11 and Figure 12 As shown, the holder 200 can accommodate bone anchors 250c, 250d having larger or axially longer drive heads 252c, 252d.

[0105] The illustrated breakaway tab 240 is frangibly connected to the retainer 200 such that once the breakaway tab 240 is removed, it cannot be reengaged with the retainer 200. However, other embodiments may be reengageable, and in some embodiments, various spacers may be added to the inner tube 150 to help adjust the placement of the retainer 200 within the inner tube 150, in addition to or in lieu of the breakaway tab. Additionally, while one breakaway tab 240 is shown, other embodiments may have multiple breakaway tabs and / or tabs of different sizes to allow for further customization of the axial length of the retainer 200.

[0106] With and without the attached breakaway tab 240, the retainer 200 additionally has one or more feet 245 on the distal end of the retainer 200. The feet 245 help maintain the orientation along the axis A1 of the retainer 200 by providing a flat contact surface on which the retainer 200 can rest on the distal end of the inner tube 150 when the retainer 200 is positioned within the inner tube 150. Furthermore, the retainer 200 and its various components can be manufactured in a variety of ways and from a variety of materials. For example, the retainer 200 can be manufactured by injection molding, 3D printing, machining, etc., and the retainer 200 and / or individual components can be made from a variety of plastics, polymers, metals, etc.

[0107] like Figures 8H to 8N as well as Figures 15 to 22 As shown, the retainer 200 can be disposed within the inner tube 150, which in turn can be disposed within the outer tube 100. The inner tube 150 helps maintain the orientation of the retainer 200 within the inner tube 150. Thus, the inner tube 150 has an open end 156, a sealed or closed end 158, an inner lumen 160 extending therebetween into which the retainer 200 is to be inserted, and a cap 162 that closes the open end 156.

[0108] The cap 162 is removably engageable with the threads 156t on the open end 156 and has an engagement interface 164 on the cap 162 that faces the lumen 160 of the inner tube 150. While the illustrated embodiment utilizes the threads 156t to engage the cap 162, various engagement mechanisms may be used, such as a friction fit, adhesive, etc. When the cap 162 closes the distal end, the engagement interface 164 removably engages the driver head 252 of the holder 200 and the bone anchor 250. As described above, the engagement interface 164 can thereby help maintain the orientation of the bone anchor 150 within the holder 200.

[0109] Furthermore, as described above, the inner tube 150 has a flat inward-facing surface 154a that can contact the flat sides 202a, 202b of the receiving head 202, and a curved radially inward-facing surface 154b that can engage the sides 230a, 230b of the alignment panel 230 to help maintain the orientation of the retainer 200 therein. The inner tube 150 and its various components can be manufactured in various ways and from various materials. For example, the inner tube 150 and the cap 162 can be manufactured by injection molding, 3D printing, machining, etc., and the inner tube 150, the cap 162, and / or the individual components can be made from various plastics, polymers, metals, etc.

[0110] The inner tube 150 can also allow for visualization and observation of the orientation of the bone anchor 250 through the inner tube 150. At least a portion of the inner tube 150 can be made of an optically transparent material. Thus, the user can ensure that the correct orientation of the bone anchor 250 has been maintained during movement, and the user can confirm the contents of the inner tube 150 without having to open the cap 162, thereby maintaining any sterile environment within the inner tube 150.

[0111] The inner tube 150 also helps maintain the orientation of the inner tube 150 within the outer tube 100. The inner tube 150 has a flat outwardly facing surface 152a that contacts a corresponding flat inwardly facing surface on the outer tube 100 to maintain the orientation of the inner tube 150 within the outer tube 100.

[0112] like Figures 18 to 22 As shown, outer tube 100 can receive inner tube 150 therein to help maintain the orientation of inner tube 150. Outer tube 100 has an open end 106, a sealed or closed end 108, an inner lumen 110 extending therebetween into which inner tube 150 can be inserted, and a cap 112 closing open end 106.

[0113] The cap 112 is removably engageable with the threads 106t on the open end 106 and has an engagement interface 120 that protrudes from the surface of the cap 112 into the inner lumen 110 of the outer tube 100 when the cap 112 closes the open end 106. While the illustrated embodiment utilizes the threads 106t to engage the cap 112, various engagement mechanisms may be used, such as a friction fit, adhesive, etc. The engagement interface 120 removably engages the closed end 158 of the inner tube 150 before the cap 112 closes the open end 106. Thus, the inner tube 150 is held by the cap 112 and protrudes therefrom. An additional spacer 122 is also inserted into the inner lumen 110 against the inner surface of the closed end 108. The additional spacer 112 facilitates engagement with the cap 162 of the inner tube 150. Thus, the inner tube 150 is held between the spacer 122 on one end and the engagement interface 120 on the other end. Both the engagement interface 120 and the spacer 122 may engage the inner tube 150 by a friction fit or a press fit.

[0114] As described above, the outer tube 100 has a flat, inward-facing surface 102 that can contact a corresponding, flat, outward-facing surface 152a of the inner tube 150 to maintain the orientation of the inner tube 150. However, in some embodiments, the engagement mechanism 120 and / or the spacer 122 can contact the inner tube 150 without the inward-facing surface 102 of the outer tube 100 contacting the inner tube 150. The outer tube 100 and its various components can be manufactured in various ways and from various materials. For example, the outer tube 100 and the cap 112 can be manufactured by injection molding, 3D printing, machining, etc., and the outer tube 100, the cap 112, and / or the individual components can be made from various plastics, polymers, metals, etc.

[0115] Similar to the inner tube 150, the outer tube 100 can also allow for visualization and observation of the orientation of the bone anchor 250 passing therethrough. Thus, at least a portion of the outer tube 100 can be made of an optically transparent material. Thus, the user can ensure that the correct orientation of the bone anchor 250 has been maintained during movement, and the user can confirm the contents of the outer tube 100 without having to open the cap 112, thereby maintaining any sterile environment therein.

[0116] In use, the user can insert the bone anchor 250 into the retainer 200. Figure 13 and Figure 14 As shown, bone anchors having a variety of driver heads and a variety of threaded shafts can be used, and the user can remove the breakaway tabs 240 as needed to ensure that each driver head fits securely within the space between the receiving head 202 of the holder 200 and the cap 162 of the inner tube 150. Because the space between the receiving head 202 and the cap 162 can be customized to the particular driver head through the use of the breakaway tabs 240, each bone anchor can be retained in the holder 200 during movement of the inner tube 100 and the outer tube 150, even when the entire implant retention system is inverted.

[0117] like Figures 15 to 17 As shown, the retainer 200 is inserted into the open end 156 of the inner tube 150 and into the inner lumen 160, and the legs 220 of the retainer 200 engage the radially inwardly facing surface of the inner tube 150 to maintain the orientation of the retainer 200 when the retainer 200 has been fully inserted. The cap 162 is placed on the open end 156 of the inner tube 150 to enclose the retainer 200 and the bone anchor 250. Figures 18 to 22As shown, the closed end 158 of the inner tube 150 is placed to engage with the engagement mechanism 120 of the cap 112, and the spacer 122 can be inserted into the inner cavity 110 of the outer tube 100. The inner tube 150 and the engagement mechanism 120 are inserted into the open end 106 of the outer tube 100, and the cap 112 is placed on the open end 106 of the outer tube 100 to close the inner tube 150. Once the implant retention system has been assembled, the outer tube 100, the inner tube 150 and the retainer 200 can all be coaxial. Various labels, seals, anti-tamper closures 290, 292, 294, etc. can be applied to the outer tube 100, and the implant retention system is thus prepared for transportation and final deployment of the bone anchor 250.

[0118] In addition, one or more components of the system can be sterilized at various points throughout the assembly process. For example, the outer tube 100, the inner tube 150, the retainer 200, and the bone anchor 250 can be sterilized and assembled in a sterile environment. Thus, the retainer 200 and the bone anchor 250 can be placed in a sterile housing within the inner tube 150, and the inner tube 150 can then be placed within a sterile housing within the outer tube 100. When the outer tube 100 is transported to the deployment site (such as an operating room), the outer surface 104 of the outer tube may become contaminated and no longer sterile. However, the internal environment of the outer tube 100 and the inner tube 150, the retainer 200, and the bone anchor 250 remain sterile. Thus, during deployment, a sterile operating environment 300 can be prepared and an opening or passage 302 can be formed between the external non-sterile environment 304 and the sterile environment 300, as shown in FIG. Figure 23 and Figure 24 As shown. A user in a non-sterile environment 304 can open the outer tube 100 and transfer or deliver the inner tube 150 to the sterile environment 300 through the passage 302. The user in the sterile environment 300 can then open the inner tube 150 within the sterile environment 300 and remove the bone anchor 250 without having to sterilize the bone anchor 250 because the sterility of the inner tube 150, the holder 200, and the bone anchor 250 has been maintained. Thus, the user can use the exact number and type of bone anchors actually needed during a procedure without having to sterilize a large number of additional bone anchors and / or having to store, maintain, and utilize any excess sterilization equipment.

[0119] Additionally, because the holder 200 has maintained the orientation of the bone anchor 250 during transport, when the cap 162 is removed from the inner tube 150, the bone anchor 250 can be removed from the inner tube 150 and holder 200 by inverting the inner tube 150 or by using various tools without encountering an axially misaligned bone anchor 250 that may be difficult to remove. Various tools can be used, such as those discussed in U.S. Patent Application No. 2019 / 0150989 to Biester et al., which are further identified above and incorporated by reference.

[0120] While the retainer 200 provided above can maintain the orientation of the driver head and threaded shaft of various bone anchors together, other embodiments of the retainer can secure the threaded shaft or various modular elements of the driver head separately. For example, Figures 25 to 40 Many embodiments of retainers are shown that secure threaded shafts of various bone anchors having different lengths, diameters, and configurations.

[0121] Figures 25 to 27 A retainer 600 similar to retainer 200 is shown maintaining the orientation of a threaded shaft 654 of a bone anchor 650 relative to retainer 600. Retainer 600 is placed within an inner tube 550 similar to inner tube 150 and within an outer tube similar to outer tube 100.

[0122] Bone anchor 650 has a driver head 652 that can receive an additional modular head component thereon in use, similar to the bone anchors discussed above and incorporated herein. However, various other bone anchors, such as set screws, can also be used.

[0123] Retainer 600 has a closed first end 602 (with an engagement base 620), an open second end 604, and an inner cavity extending at least partially therebetween. Inner cavity 606 receives at least a portion of a threaded shaft 654 of a bone anchor 650. A plurality of alignment members 610 extend into inner cavity 606 to engage the threaded shaft 654 of the bone anchor 650, thereby maintaining the orientation of the threaded shaft 654 relative to the central longitudinal axis A2 of retainer 600. Alignment members 610 are rectangular structures that protrude from an inwardly facing surface 608 of inner cavity 606 toward axis A2. Members 610 also extend along the entire length of inner cavity 606, parallel to axis A2. When threaded shaft 654 is inserted into inner cavity 606, the ends of alignment members 610 closest to central axis A2 contact the threaded shaft 654 and are forced to bend and flex away from the threaded shaft 654. Thus, the threaded shaft 654 is retained within the lumen 606 by the alignment members 610 through a friction fit, such that the orientation of the threaded shaft 654 is maintained relative to the holder 600. The alignment members 610 and the holder 600 as a whole can be made of a variety of materials, such as various plastics, polymers, etc. Additionally, while the alignment members 610 are shown as being evenly distributed around the lumen 606, different distribution patterns and arrangements are possible. The lumen 606 of the holder 600 also has a circular cross-section, but various cross-sections are possible, such as triangular, rectangular, etc.

[0124] The inner lumen 606 terminates in a closed first end 602 having an engagement base 620. The engagement base 620 securely engages the retainer 600 with the engagement mechanism 564 of the cap 562 of the inner tube 550, similar to the engagement mechanism 164 of the cap 162. When the cap 562 closes the inner tube 550, as described below, the retainer 600 protrudes from the cap 562 and into the inner lumen 560 of the inner tube 550. When the cap 562 is removed from the inner tube 550, the engagement base 620 continues to maintain its engagement with the engagement mechanism 564. In this way, the retainer 600 maintains its orientation relative to the cap 562, including rotation about the axis A2 when the cap 564 is removed from the inner tube 550.

[0125] The engagement base 620 is inserted into the cavity of the engagement mechanism 564 on the cap 562 with a secure friction fit, and the base 620 has one or more flat, outwardly facing surfaces 622 that correspond to the flat, inwardly facing surfaces on the engagement mechanism 564. Thus, the retainer 600 is prevented from rotating about the axis A2 relative to the cap 562. However, in other embodiments, a variety of different engagement methods are possible, such as by clamps, hooks, adhesives, tabs, etc., and the engagement can be permanent or removable.

[0126] When the retainer 600 protrudes from the cap 562 of the inner tube 550, the retainer 600 can be inserted into the inner tube 550. The inner tube 550 has an inner cavity extending between a first open end 556 (in which the retainer 600 is inserted) and a second sealed or closed end 558. As described above, the cap 562 can be engaged with the inner tube 550 to close the open end 556 of the inner tube 550. The cap 562 engages threads on the open end 556, which are similar to the threads 156t of the inner tube 150 discussed above. However, a variety of different closure mechanisms can be used, such as a friction fit, hooks, adhesives, etc.

[0127] 562. The inner tube 550 thus does not contact the retainer 600 except through contact with the cap 562. However, the inner tube 550 has a flat, outward-facing surface that can engage with a radially inward-facing surface of an outer tube, such as tube 100. Additionally, the inner tube 550 can also be secured between the engagement mechanism 120 and the spacer 122. Similar to the inner tube 150, in some embodiments, the radially inward-facing surface of the outer tube 100 and the radially outward-facing surface of the inner tube 550 do not contact each other, and in some embodiments, the inner tube 550 can be secured within the outer tube 100 by the engagement mechanism 120 and the spacer 122.

[0128] In addition, the holder 600 and the inner tube 550 can allow for visualization of the bone anchor 650 because the holder 600 receives a portion of the bone anchor 650 that is less than the entire bone anchor 650, and at least a portion of the inner tube 550 can be made of an optically transparent material. In addition, the holder 600 and the inner tube 550 can be sterilized, loaded, shipped, and opened for deployment of the bone anchor 650 similar to the holder 200 and the inner tube 150.

[0129] As mentioned above, various alignment members may be used, such as through Figures 28 to 40 As shown, it can have different structures and joining methods, and it can be made of rigid or flexible materials such as metal, plastic, polymer, etc. depending on the embodiment.

[0130] For example, Figures 28 to 31 Embodiments of alignment members 702, 706, 710, 714 of retainers 700, 704, 708, 712 are shown having a similar rectangular configuration as alignment member 610. However, alignment members 702, 706, 710, 714 project to varying lengths toward the longitudinal axis of each retainer 700, 704, 708, 712, with some providing a greater amount of unobstructed space within the retainer for receiving a threaded shaft of a bone anchor, such as threaded shaft 718 of bone anchor 716, which has an increased diameter and, therefore, may require additional unobstructed space. Figures 32 to 34 Another embodiment of a retainer 720 is shown having an alignment member 722 extending proximally about the central longitudinal axis A3 of the retainer 720 and in the form of a rigid trapezoidal structure aligned to form interrupted ribs for engaging the threads on the threaded shaft. Thus, the threaded shaft 734 on the bone anchor 730 can be inserted into the lumen of the retainer 720 and securely engaged with the alignment member 722. Figure 33 and Figure 34 As shown, a cannula 728 is formed to extend at least partially through an engagement base 726, which is similar to the engagement base 620 described above and can be engaged with a cap 730. However, the cannula 728 can receive a stylet 734 through a threaded hollow shank 752 of a bone anchor 750 used with an inserter 740 (e.g., a Viper Prime inserter). In other embodiments, the cannula can be formed to receive the distal-most end of the bone anchor.

[0131] Figures 35 to 37Additional embodiments of retainers 800, 810, 820 are shown with alignment members 802, 812, 822. The alignment members 802, 812, 822 are generally rectangular structures that extend or project at a radially inward angle or slope from the corresponding engagement base 804, 814, 824 toward the central longitudinal axis of each retainer 800, 810, 820 and enter the lumen of the inner tube when the retainer 800, 810, 820 is engaged with the cap and inserted into the inner tube, such as the inner tube 550. The alignment members 802, 812, 822 are connected to the engagement base 804, 814, 824 on only one rectangular edge and are unattached on the other three rectangular edges. However, because the members 802, 812, 822 extend radially inward at an angle, they form engagement edges 806, 816, 826 that engage the threaded shafts 809, 819, 829 of the bone anchors 808, 818, 828 to secure the bone anchors 808, 818, 828 therein and maintain the orientation of the bone anchors 808, 818, 828 in the retainers 800, 810, 820.

[0132] Figure 38 Another embodiment of a retainer 900 is shown having an alignment member 902. The alignment member 902 is an arcuate or curved arm that curves toward the central longitudinal axis A4 and extends between an engagement base 904 having a partial sleeve 906 and an upper ring 910 through which the threaded shaft of the bone anchor is inserted. Figure 39 Yet another embodiment of an alignment member 922 of a retainer 920 is shown extending along an inner surface of an interior lumen 924 of the retainer 920, similar to the alignment member 610. However, the alignment member 922 protrudes into the interior lumen 924 in a spiral or helical pattern.

[0133] Additionally, a retainer configured to secure the threaded shaft of a bone anchor may have a variable longitudinal length, similar to the configuration of the breakaway tab 240 of retainer 200. Figure 40 As shown, a retainer 950 having an alignment member 952 and a longitudinal axis A5 can have one or more perforated rings 954 extending around the retainer 950 at various points along the axis A5 so that the retainer 950 is a series of sections frangibly engaged with each other. The length of the retainer 950 along the axis A5 can be shortened to better match the length of the threaded shaft of the bone anchor by removing one or more sections at the optional rings 954.

[0134] The holder can also fix the orientation of modular components of various bone anchors, where the driver head is similar to a fixed threaded shaft, such as Figures 41 to 60 For example, Figures 41 to 43One embodiment of a retainer 1000 is shown that receives a receiver member or driver head 1010 designed for use with various threaded shafts in one or more modular screw arrangements, such as those provided in U.S. Patent Application No. 2019 / 0150989 to Biester et al., further identified above and incorporated by reference. Retainer 1000 is similar to retainer 600 and can receive head 1010 in lumen 1006 of retainer 1000. Figure 42 As shown, a clamp 1008 extends into the inner cavity 1006 to removably engage the head 1010 and fix the orientation of the head 1010 relative to the holder 1000 . Figures 44 to 46 Another embodiment of a holder 1020 is shown having separate clamping arms 1024 for securing a drive head 1028. Figures 47 to 49 Another embodiment of a holder 1030 is shown having a wide clamp 1034 for securing a drive head 1038. Figures 50 to 52 Another embodiment of a retainer 1040 is shown having separate wide clamping arms 1044 for securing a drive head 1048. Figure 53 and Figure 54 Another embodiment of a retainer 1050 is shown having a notched arm 1054 for securing a drive head 1058. Figures 55 to 57 Another embodiment of a retainer 1060 is shown having a protrusion 1064 for securing a drive head 1068 within an inner tube 1070 and a cap 1072. Figures 58 to 60 Another embodiment of a retainer 1080 for securing a drive head 1088 within an inner tube 1090 and cap 1092 and an outer tube 1094 and cap 1096 is shown.

[0135] A full range of retainers for securing and maintaining the orientation of a threaded shaft or drive head therein can be used similarly to retainer 200, including by being placed within an inner tube similar to tube 100 and an outer tube 150 and by being sterilized and deployed such that the internal environment of the inner and outer tubes remains sterile until deployment to avoid contamination of the threaded shaft and / or drive head therein.

[0136] In the above description and in the claims, phrases such as “at least one of” or “one or more of” may appear after a conjunctive list of elements or features. The term “and / or” may also appear in a list of two or more elements or features. Unless otherwise implicitly or explicitly contradicted by the context in which it is used, such phrases are intended to mean any one of the listed elements or features alone or in combination with any of the other listed elements or features. For example, the phrases “at least one of A and B”; “one or more of A and B”; and “A and / or B” are each intended to mean “A alone, B alone, or A and B together.” A similar interpretation applies to lists of three or more items. For example, the phrases "at least one of A, B, and C"; "one or more of A, B, and C"; and "A, B, and / or C" are each intended to mean "A alone, B alone, C alone, A and B together, A and C together, B and C together, or A, B, and C together." Furthermore, the use of the term "based on" above and in the claims is intended to mean "based at least in part on," so that unlisted features or elements are also allowed.

[0137] Depending on the desired configuration, the subject matter described herein may be embodied in systems, devices, methods and / or articles. The specific implementations set forth in the foregoing description do not represent all specific implementations consistent with the subject matter described herein. Instead, they are merely some examples consistent with various aspects related to the described subject matter. Although some variations have been described in detail above, other modifications or additions are possible. Specifically, in addition to those set forth herein, additional features and / or variations may also be provided. For example, the specific implementations described above may involve various combinations and subcombinations of the disclosed features and / or combinations and subcombinations of several additional features disclosed above. In addition, the logical flows depicted in the accompanying drawings and / or described herein do not necessarily require the specific order or sequential order shown to achieve the desired results. Other specific implementations may be within the scope of the following claims.

Claims

1. An implant retention system comprising: an outer tube having a sealed first outer end and an open second outer end, the outer tube having a removable outer cap configured to selectively seal the second outer end; an inner tube configured to be disposed within the outer tube, the inner tube having a sealed first inner end configured to engage the outer cap of the outer tube, the inner tube having an open second inner end and a removable inner cap configured to selectively seal the second inner end; a bone anchor having a driver head and a threaded shaft extending distally from the driver head; as well as a retainer configured to be disposed within the inner tube and having a longitudinal axis, the retainer having a receiving head configured to receive the driver head of the bone anchor, the retainer having a collar extending distally from the receiving head, the collar configured to engage at least a portion of the threaded shaft of the bone anchor to maintain an orientation of the threaded shaft of the bone anchor relative to the longitudinal axis of the retainer when the bone anchor is received in the retainer.

2. The system according to claim 1, wherein: The receiving head is configured to engage the driver head of the bone anchor to prevent axial rotation about the longitudinal axis of the retainer, the receiving head having a lumen extending distally through the receiving head and the collar such that the threaded shaft of the bone anchor can pass therethrough.

3. The system according to claim 1, wherein: The retainer further includes a break-away tab removably disposed at an end opposite the receiving head, wherein the break-away tab is configured to be removed to change a length of the retainer along the longitudinal axis of the retainer.

4. The system according to claim 1, wherein: The retainer has at least two arcuately deformable legs configured to maintain a position of the retainer within the inner tube by frictional engagement between each of the legs and an inner surface of the inner tube.

5. The system according to claim 1, wherein The retainer has an alignment panel disposed along a distal portion thereof, and the alignment panel is configured to engage an inner surface of the inner tube to resist axial rotation of the retainer about the longitudinal axis of the retainer.

6. The system according to claim 5, wherein: The alignment panel has a non-circular cross-section at a point along the longitudinal axis of the retainer.

7. The system according to claim 1, wherein: The holder, the outer tube, and the inner tube are configured to allow visualization of the orientation of the bone anchor when the bone anchor is received in the holder.

8. The system according to claim 1, wherein: The outer tube, the inner tube, and the retainer are configured to be coaxial with one another along the longitudinal axis of the retainer when the retainer is disposed within the inner tube and the inner tube is disposed within the outer tube.

9. An implant retention system comprising: an outer tube having a sealed first outer end and an open second outer end, the outer tube having a removable outer cap configured to selectively seal the second outer end; an inner tube configured to be disposed within the outer tube, the inner tube having a sealed first inner end configured to engage the outer cap of the outer tube, the inner tube having an open second inner end and a removable inner cap configured to selectively seal the second inner end; a bone anchor having a driver head; and a retainer configured to be disposed within the inner tube, the retainer having a longitudinal axis extending between a first retainer end configured to engage the inner cap of the inner tube and an open second retainer end, and an inner lumen extending at least partially therethrough from the second retainer end toward the first retainer end, wherein the inner lumen is configured to receive at least a portion of the bone anchor therein, and wherein a plurality of alignment members extend at least partially into the inner lumen, the plurality of alignment members being configured to engage the bone anchor to maintain the orientation of the bone anchor relative to the longitudinal axis of the retainer when the bone anchor is received in the inner lumen.

10. The system according to claim 9, wherein: Each of the plurality of alignment members is one of a longitudinal rectangular protrusion, a vertical protrusion, an arcuate arm, a curved arm, a spiral arm, and a flexible arm, enabling a plurality of bone anchors having different lengths and diameters to be received in the lumen.

11. The system according to claim 9, wherein: The retainer has one or more break-away portions extending from the open second retainer end toward the first retainer end, the one or more break-away portions being configured to be removed to change the length of the retainer along the longitudinal axis of the retainer.

12. The system according to claim 9, wherein: The bone anchor has a threaded shaft extending distally from the driver head, and the plurality of alignment members are arranged to extend radially into the lumen to correspond to threads extending radially outward from the threaded shaft.

13. The system according to claim 9, wherein: The retainer is configured to maintain a rotational position of the inner cap with the inner tube relative to the longitudinal axis of the retainer when the retainer is engaged to the inner cap.

14. The system according to claim 13, wherein: The first retainer end has a non-circular cross-section at a point along the longitudinal axis of the retainer.

15. The system according to claim 9, wherein: The holder, the outer tube, and the inner tube are configured to allow visualization of the orientation of the bone anchor when the bone anchor is received in the holder.

16. The system according to claim 9, wherein: The outer tube, the inner tube, and the retainer are configured to be coaxial with one another along the longitudinal axis of the retainer when the retainer is disposed within the inner tube and the inner tube is disposed within the outer tube.

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