Patent ID: 12201458

DETAILED DESCRIPTION

Certain exemplary embodiments will now be described to provide an overall understanding of the principles of the structure, function, manufacture, and use of the devices and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments and that the scope of the present invention is defined solely by the claims. The features illustrated or described in connection with one exemplary embodiment may be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of the present invention.

Further, in the present disclosure, like-named components of the embodiments generally have similar features, and thus within a particular embodiment each feature of each like-named component is not necessarily fully elaborated upon. Additionally, 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. A person skilled in the art will recognize that an equivalent to such linear and circular dimensions can easily be determined for any geometric shape. Sizes and shapes of the systems and devices, and the components thereof, can depend at least on the anatomy of the subject in which the systems and devices will be used, the size and shape of components with which the systems and devices will be used, and the methods and procedures in which the systems and devices will be used. Like reference symbols in the various drawings indicate like elements.

The present disclosure generally relates to implant holders. When various individual implants are transported, it can be helpful to maintain a general orientation of an implant to prevent the implant from being damaged during transportation and to minimize any difficulty in removing the implant from its transportation container during deployment. Additionally, it can be beneficial to sterilize and package individual implants in individual transportation containers so that, upon deployment, a user is not required to sterilize the implant and is not required to handle and potentially contaminate more than one implant at a time.

As such, various implant holding systems are provided herein that include an outer tube, an inner tube, and a holder. The implant holding systems can be designed to accommodate various implants of different types and sizes, such as bone anchors used in spinal operations, and the holder can engage a bone anchor disposed therein to assist in maintaining an orientation of the bone anchor relative to the holder. That is, the holder engages a bone anchor and is maintained within an inner tube in a sterile condition. the inner tube, in turn, is maintained within an outer tube, which need not be sterile. Ideally, a single holding system has the versatility to handle bone anchors of any size that are likely to be used.

Additionally, one or more of the bone anchor, the holder, the inner tube, and/or the outer tube can be sterilized during assembly packaging, and maintained in a sterile state until the bone anchor is to be deployed. Typically, the bone anchor, the holder, and the inner tube are sterilized before placement within the outer tube. This ensures that each bone anchor is sterilized and maintained within its own sterile enclosure, making it possible to use as many bone anchors of different types and sizes during a surgical procedure without compromising the sterility of any bone anchors that are not sued during the procedure.

FIGS.1-24illustrate one embodiment of an implant holding system that has an outer tube100, an inner tube150, and a holder200, as collectively illustrated inFIG.1. The holder200receives a bone anchor250therein so that an orientation of the bone anchor250is maintained relative to the holder200during movement and transport of the system. As discussed further below, the holder200can be placed in the inner tube150and can maintain a position within the inner tube150. The inner tube150can be placed in the outer tube100, and the inner tube150can maintain its position within the outer tube100. As such, an orientation of the bone anchor250can be maintained within the holder200and tubes100,150when it is transported, for example when being moved from a manufacturing or distribution facility to an operating environment in which the bone anchor250will be deployed.

As illustrated inFIGS.2A-4, the holder200has a receiving head202, a collar210, deformable legs220, an alignment plate230, and a break-off tab240. The receiving head202is on a proximal end of the holder, and the collar210and the deformable legs220extend distally from the receiving head202along a longitudinal axis A1of the holder200. The deformable legs220extend distally on either side of the collar210, and the legs220terminate in the alignment plate230that is formed at a distal end of the legs220. The break-off tab240is disposed at a distal end of the holder200.

The receiving head202receives a driver head252of the bone anchor250in a cavity204formed therein and it maintains an orientation of the driver head252of the bone anchor250. The receiving head202has two raised flat sides202aand two lower flat sides202bthat define the cavity204, as illustrated inFIGS.5and6. The flat sides202a,202bcontact corresponding flat inward-facing surfaces in the inner tube150when the holder is disposed within the inner tube150to assist in preventing rotation of the holder independent of inner tube150. The cavity204additionally has flat inward-facing surfaces204a,204b. As such, as illustrated inFIG.6showing a cross-section of the driver head252in the receiving head202, the flat surfaces204a,204bcan engage corresponding flat outward-facing surfaces of the driver head252to assist in preventing rotation of the driver head252independent of the holder200.

Additionally, the receiving head202allows one to visualize or observe an orientation of the driver head252because the raised sides202aand lower sides202bform an approximately U-shaped profile when viewed from a side of the holder200. The cavity204has a distal or lower surface205that engages a lower surface of the driver head252of the bone anchor250, and the receiving head202has an opening or lumen208through which a threaded shaft254of the bone anchor250can extend distally along the axis A1.

In some embodiments, small gaps can be designed between the sides of the bone anchor250, the receiving head202, and the inner tube150to allow for easier insertion and removal of the holder200and the bone anchor250while still maintaining a fixed orientation. As illustrated inFIG.5, ledges206and other surface features can also be formed within the cavity204to assist in engaging driver heads of various sizes and configurations, which can vary based on intended use(s) of various bone anchors.

While the receiving head202maintains an orientation of the driver head202, the collar maintains an orientation of the threaded shaft254of the bone anchor250relative to the axis A1. As illustrated inFIGS.2A-8G, the collar210extends distally from the receiving head202, and the lumen208extends through the collar210along the axis A1. The collar210thus engages at least part of the threaded shaft254when the threaded shaft254extends through the lumen208, thereby maintaining the orientation or angulation of the threaded shaft254in the holder200. While the collar210has a circular or annular cross section, a variety of different cross-sectional shapes can be used, such as a hexagon, an octagon, etc.

Additionally, the collar210allows one to visualize and observe an orientation of the threaded shaft254during movement of the holder200. The collar210extends only partially along the longitudinal axis A1of the holder200so that at least a distal-most portion255of the threaded shaft254protrudes beyond the collar210, as illustrated inFIG.9. For example, the collar210can extend between approximately 5% and approximately 75% along a length of the threaded shaft254, and more preferably between approximately 5% and approximately 35% along the length of the threaded shaft254.

Thus, as illustrated inFIGS.9-12, the cavity204, the lumen208, and the collar210can be sized to accept bone anchors with driver heads and threaded shafts of a variety of different sizes. For example,FIGS.9-12illustrate common bone anchors250,250b,250c,250dwith driver heads252,252b,252c,252dand threaded shafts254,254b,254c,254dof various sizes, lengths, dimensions, configurations, etc. While several embodiments of bone anchors are illustrated, numerous types of bone anchors can be received into the holder200, such as various polyaxial and/or modular screws detailed in U.S. Patent App. No. 2019/0150989 of Biester et al., entitled “Bone Anchor Assemblies and Related Instrumentation,” filed on Nov. 7, 2018, which is incorporated herein by reference in its entirety. Additionally, various fixed bone screws can be received in the holder200that have threaded shafts and driver heads in a fixed orientation with each other, as well as one or more individual components of a modular screw, such as only a threaded shaft.

Extending distally from the receiving head202and around the collar210, the two legs220assist in maintaining an orientation of the holder200within the inner tube150. The two legs220are deformable and bow radially outward relative to the axis A1. As such, each leg at its widest point contacts an inward-facing surface of the inner tube150, and the holder200is coaxial with the inner tube150. During placement of the holder200in the inner tube150, the legs220bend radially inward as a result of contact with the inward-facing surface of the inner tube150, thus experiencing frictional engagement with the inner tube150. As force is applied distally along the axis A1when the receiving head254of the bone anchor250is loaded onto a distal end of a tool280, the distally-applied force is received by the legs220and distributed outward from the legs220to the inner tube150to further increase engagement between the two, as illustrated by arrows inFIG.9. The increased engagement allows for easier loading and extraction of the bone anchor250from the holder200.

Additionally, the legs220allow one to visualize and observe an orientation of the threaded shaft254during movement of the holder200between the legs220. While two legs220are illustrated, more than two legs220can be used in other embodiments, such as from two to about twenty.FIGS.1-4illustrate surface features225that can take a variety of forms and can serve a variety of purposes, such as helping to increase engagement between the holder200and the inner tube150, helping to provide engagement with molds during manufacturing and formation of the holder200, etc.

The alignment panel230is disposed at a distal end of the legs220and assists in maintaining an orientation of the holder200within the inner tube150. The alignment panel230has a non-circular cross-section taken at a point along the longitudinal axis A1of the holder200. As such, at least two sides230a,230bof the alignment panel230contact inner surfaces154bof the inner tube150, as illustrated inFIGS.7A and7B. Because the alignment panel230is non-circular, the two sides230a,230bof the alignment panel230that contact the inner tube150resist rotation of the holder200about the axis A1. While the alignment panel230has an oval cross-section, other non-circular shapes can be used, such as squares, triangles, hexagons, octagons, etc.

At a distal-most end of the holder200, the break-off tab240can enable a total length of the holder along the longitudinal axis A1to be altered. The break-off tab240is removable from the holder200before placement of the holder200into the inner tube150. Removing the break-off tab240creates additional distance between the receiving head202and a cap162of the inner tube150. As such, when the break-off tab240is removed, bone anchors250c,250dwith larger driver heads252c,252dcan be accommodated in the holder200while the cap162can still close the inner tube150and an engagement interface164of the cap, discussed additionally below, can still engage the receiving head200and the driver heads252c,252dto prevent the bone anchor250from sliding proximally out of the holder200, for example if the holder200is inverted. As such, with the break-off tab240attached, as illustrated inFIGS.9and10, the receiving head202of the holder200can accommodate a variety of driver heads of various sizes, such as bone anchors250,250bwith smaller or axially shorter driver heads252,252b. Similarly, with the break-off tab240removed, as illustrated inFIGS.11and12, the holder200can accommodate bone anchors250c,250dwith larger or axially longer driver heads252c,252d.

The illustrated break-off tab240is frangibly connected to the holder200such that, once the break-off tab240is removed, it cannot be reengaged with the holder200. However, other embodiments can be reengageable, and in some embodiments, various spacers can be added to the inner tube150to assist in adjusting placement of the holder200within the inner tube150, either in addition to the break-off tab or instead of it. Additionally, while one break-off tab240is illustrated, other embodiments can have a plurality of break-off tabs and/or tabs of different sizes to allow further customization of the axial length of the holder200.

The holder200additionally has one or more feet245on distal ends of the holder200both with and without the break-off tab240attached. The feet245assist in maintaining an orientation along the axis A1of the holder200by providing a flat contact surface on which the holder200can rest on a distal end of the inner tube150when the holder200is disposed within the inner tube150. Furthermore, the holder200and its various components can be manufactured in a variety of ways and of a variety of materials. For example, the holder200can be manufactured through injection molding, 3D printing, machining, etc., and the holder200and/or individual components can be made from various plastics, polymers, metals, etc.

As illustrated inFIGS.8H-8N and15-22, the holder200can be disposed within the inner tube150, and the inner tube150in turn can be disposed within the outer tube100. The inner tube150assists in maintaining an orientation of the holder200within the inner tube150. As such, the inner tube150has an open end156, a sealed or closed end158, a lumen160extending therebetween into which the holder200is inserted, and the cap162that closes the open end156.

The cap162is removably engageable with threads156ton the open end156, and the cap162has the engagement interface164on the cap162facing the lumen160of the inner tube150. While the illustrated embodiment utilizes threads156tto engage the cap162, a variety of engagement mechanisms can be used, such as friction fit, adhesives, etc. The engagement interface164removably engages a distal end of the holder200and the driver head252of the bone anchor250when the cap162is closed. As discussed above, the engagement interface164can thus assist in maintaining the orientation of the bone anchor150within the holder200.

Furthermore, as discussed above, the inner tube150has flat inward-facing surfaces154athat can contact the flat sides202a,202bof the receiving head202and curved radially inward-facing surfaces154bthat can engage the sides230a,230bof the alignment panel230to assist in maintaining the orientation of the holder200therein. The inner tube150and its various components can be manufactured in a variety of ways and of a variety of materials. For example, the inner tube150and the cap162can be manufactured through injection molding, 3D printing, machining, etc., and the inner tube150, the cap162, and/or individual components can be made from various plastics, polymers, metals, etc.

The inner tube150can also allow one to visualize and observe an orientation of the bone anchor250through the inner tube150. At least a portion of the inner tube150can be made from an optically transparent material. As such, a user can ensure proper orientation of the bone anchor250has been maintained during movement, and the user can confirm the contents of the inner tube150without being required to open the cap162, thus maintaining any sterile environment within the inner tube150.

The inner tube150further assists in maintaining the orientation of the inner tube150within the outer tube100. The inner tube150has flat outward-facing surfaces152athat contact corresponding flat inward-facing surfaces on the outer tube100to maintain an orientation of the inner tube150within the outer tube100.

As illustrated inFIGS.18-22, the outer tube100can receive the inner tube150therein to assist in maintaining an orientation of the inner tube150. The outer tube100has an open end106, a sealed or closed end108, a lumen110extending therebetween into which the inner tube150can be inserted, and a cap112that closes the open end106.

The cap112is removably engageable with threads106ton the open end106, and the cap112has an engagement interface120that protrudes from a surface of the cap112into the lumen110of the outer tube100when the cap112closes the open end106. While the illustrated embodiment utilizes threads106tto engage the cap112, a variety of engagement mechanisms can be used, such as friction fit, adhesives, etc. The engagement interface120removably engages the closed end158of the inner tube150prior to the cap112closing the open end106. As such, the inner tube100is held by and protrudes from the cap112. An additional spacer122is also inserted into the lumen110against an inner surface of the closed end108. The additional spacer112assists in engaging the cap162of the inner tube15. As such, the inner tube150is held between the spacer122on one end and the engagement interface120on the other. Both the engagement interface120and the spacer122can engage the inner tube150through a friction or press fit.

As discussed above, the outer tube100has flat inward-facing surfaces102that can contact the corresponding flat outward-facing surfaces152aof the inner tube150to maintain an orientation of the inner tube150. However, in some embodiments, the engagement mechanism120and/or the spacer122can contact the inner tube150while the inward-facing surfaces102of the outer tube100do not contact the inner tube150. The outer tube100and its various components can be manufactured in a variety of ways and from a variety of materials. For example, the outer tube100and the cap112can be manufactured through injection molding, 3D printing, machining, etc., and the outer tube100, the cap112, and/or individual components can be made from various plastics, polymers, metals, etc.

Similar to the inner tube150, the outer tube100can also allow one to visualize and observe an orientation of the bone anchor250therethrough. Thus, at least a portion of the outer tube100can be made from an optically transparent material. As such, a user can ensure proper orientation of the bone anchor250has been maintained during movement, and the user can confirm the contents of the outer tube100without being required to open the cap112, thus maintaining any sterile environment therewithin.

In use, a user can insert the bone anchor250into the holder200. As illustrated inFIGS.13and14, bone anchors with various driver heads and various threaded shafts can be used, and a user can remove the break-off tab240as needed to ensure each driver head fits securely within a space between the receiving head202of the holder200and the cap162of the inner tube150. Because the space between the receiving head202and the cap162can be customized to a particular driver head through use of the break-off tab240, each bone anchor can remain in the holder200during movement of the inner and outer tubes100,150, even upon inversion of the entire implant holding system.

As illustrated inFIGS.15-17, the holder200is inserted into the open end156of the inner tube150and into the lumen160, and the legs220of the holder200engage the radially inward-facing surfaces of the inner tube150to maintain the orientation of the holder200when the holder200has been fully inserted. The cap162is placed on the open end156of the inner tube150to enclose the holder200and the bone anchor250. As illustrated inFIGS.18-22, the closed end158of the inner tube150is placed in engagement with the engagement mechanism120of the cap112, and the spacer122can be inserted into the lumen110of the outer tube100. The inner tube150and the engagement mechanism120are inserted into the open end106of the outer tube100, and the cap112is placed on the open end106of the outer tube100to enclose the inner tube150. The outer tube100, the inner tube150, and the holder200can all thus be coaxial once the implant holding system is assembled. Various labels, seals, tamper-proof closures, etc.290,292,294can be applied to the outer tube100, and the implant holding system is thus prepared for transportation and eventual deployment of the bone anchor250.

Furthermore, one or more components of the system can be sterilized at various points throughout the assembly process. For example, the outer tube100, inner tube150, holder200, and bone anchor250can be sterilized and assembled in a sterile environment. As such, the holder200and the bone anchor250can be placed in a sterile enclosure within the inner tube150, and the inner tube150can then be placed within a sterile enclosure within the outer tube100. As the outer tube100is transported to a deployment site, such as an operating room, outer surfaces104of the outer tube can be contaminated and no longer sterile. However, an interior environment of the outer tube100and the inner tube150, the holder200, and the bone anchor250are all still sterile. Thus during deployment, a sterile operating environment300can be prepared, and an opening or passageway302between an external, non-sterile environment304and the sterile environment300can be formed, as illustrated inFIGS.23and24. A user in the non-sterile environment304can open the outer tube100and pass or drop the inner tube150through the passageway302into the sterile environment300. A user in the sterile environment300can then open the inner tube150within the sterile environment300and extract the bone anchor250without having to sterilize the bone anchor250because the sterility of the inner tube150, the holder200, and the bone anchor250have all been maintained. The user can thus use an exact number and type of bone anchors actually needed during an operation without having to sterilize a large number of additional bone anchors and/or without having to store, maintain, and utilize any excess sterilization equipment.

Additionally, because the holder200has maintained an orientation of the bone anchor250during transportation, when the cap162is removed from the inner tube150, the bone anchor250can be removed from the inner tube150and the holder200by inverting the inner tube150or through use of various tools without encountering an axially misaligned bone anchor250that may be difficult to remove. Various tools can be used, such as the tools discussed in U.S. Patent App. No. 2019/0150989 of Biester et al., further identified and incorporated by reference above.

While the holder200provided above can maintain orientations of driver heads and threaded shafts of various bone anchors together, other embodiments of holders can secure either the threaded shaft or various modular elements of the driver head separately. For example,FIGS.25-40illustrate numerous embodiments of holders that secure threaded shafts of various bone anchors that have different lengths, diameters, and configurations.

FIGS.25-27illustrate a holder600similar to holder200that maintains an orientation of a threaded shaft654of a bone anchor650relative to the holder600. The holder600is placed within an inner tube550similar to inner tube150and within an outer tube similar to outer tube100.

The bone anchor650has a driver head652that can receive additional modular head components thereon in use, similar to the bone anchors discussed above and incorporated herein. However, various other bone anchors can be used, as well, such as fixed screws.

The holder600has a closed first end602with an engagement base620, an open second end604, and a lumen extending at least partially therebetween. The lumen606receives at least part of the threaded shaft654of the bone anchor650. A plurality of alignment members610extend into the lumen606to engage the threaded shaft654of the bone anchor650to maintain an orientation of the threaded shaft654relative to a central longitudinal axis A2of the holder600. The alignment members610are rectangular structures that protrude from an inward-facing surface608of the lumen606towards the axis A2. The members610also extend along an entire length of the lumen606parallel to the axis A2. As the threaded shaft654is inserted into the lumen606, ends of the alignment members610closest to the central axis A2contact the threaded shaft654and are forced to bend and flex away from the threaded shaft654. As such, the threaded shaft654is held in the lumen606by the alignment members610through a friction fit such that an orientation of the threaded shaft654is maintained relative to the holder600. The alignment members610and the holder600as a whole can be made from a variety of materials, such as various plastics, polymers, etc. Additionally, while the alignment members610are shown to be distributed evenly around the lumen606, different distribution patterns and arrangements are possible. The lumen606of the holder600also has a circular cross-section, but a variety of cross-sections are possible, such as triangular, rectangular, etc.

The lumen606terminates in the closed first end602with the engagement base620. The engagement base620securely engages the holder600with an engagement mechanism564of a cap562of inner tube550, similar to engagement mechanism164of cap162. When the cap562closes the inner tube550, discussed below, the holder600protrudes from the cap562and into a lumen560of the inner tube550. The engagement base620continues to maintain its engagement with the engagement mechanism564when the cap562is removed from the inner tube550. As such, the holder600maintains its orientation relative to the cap562, including rotating about the axis A2when the cap564is removed from the inner tube550.

The engagement base620is inserted into a cavity of the engagement mechanism564on the cap562in a secure friction fit, and the base620has one or more flat outward-facing surfaces622that correspond to flat inward-facing surfaces on the engagement mechanism564. As such, rotation of the holder600is prevented about the axis A2relative to the cap562. In other embodiments, various different engagement methods are possible, however, such as through clips, hooks, adhesives, tabs, etc., and engagement can be permanent or removable.

The holder600can thus be inserted into the inner tube550when the holder600protrudes from the cap562of the inner tube550. The inner tube550has a lumen extending between a first open end556into which the holder600is inserted and a second sealed or closed end558. As discussed above, the cap562is engageable with the inner tube550to close the open end556of the inner tube550. The cap562engages threads on the open end556similar to the threads156tof the inner tube150discussed above. However, a variety of different closure mechanisms can be used, such as friction fit, hooks, adhesive, etc.

Except through contact with the cap562, the inner tube550thus does not contact the holder600. However, the inner tube550has flat outward-facing surfaces that can engage with radially inward-facing surfaces of an outer tube, such as tube100. The inner tube550additionally can also be secured between the engagement mechanism120and the spacer122. Similar to inner tube150, in some embodiments, radially inward-facing and outward-facing surfaces of the outer and inner tubes100,550do not contact one another, and the inner tube550in some embodiments can be secured within the outer tube100by the engagement mechanism120and the spacer122.

Additionally, the holder600and the inner tube550can allow one to visualize the bone anchor650because the holder600receives a portion of the bone anchor650that is less than the entire bone anchor650and at least part of the inner tube550can be made of an optically clear material. Additionally, the holder600and the inner tube550can be sterilized, loaded, transported, and opened for deployment of the bone anchor650similar to the holder200and the inner tube150.

As referenced above, a variety of different alignment members can be used, as illustrated throughoutFIGS.28-40, that can have different structures and engagement methods and that can be made from rigid or flexible materials depending on the embodiment, such as metals, plastics, polymers, etc.

For example,FIGS.28-31illustrate embodiments of alignment members702,706,710,714of holders700,704,708,712that have similar rectangular structures to the alignment members610. However, the alignment members702,706,710,714protrude to different lengths towards a longitudinal axis of each holder700,704,708,712, with some alignment members providing greater amounts of unobstructed space within the holders for receiving threaded shafts of bone anchors, such as threaded shaft718of bone anchor716, that have increased diameters and thus may require additional unobstructed space.FIGS.32-34illustrate another embodiment of a holder720with alignment members722that extend proximal to a central longitudinal axis A3of the holder720and are in the form of rigid trapezoidal structures aligned to form broken ribbing to engage threading on threaded shafts. As such, a threaded shaft734on a bone anchor730can be inserted into the lumen of the holder720and into secure engagement with the alignment members722. As illustrated inFIGS.33and34, a cannula728is formed at least partially through an engagement base726that is similar to engagement base620above and can be engaged with a cap730. However, the cannula728can receive a stylet734through a threaded cannulated shank752of a bone anchor750for use with an inserter740, for example the Viper Prime Inserter. In other embodiments, a cannula may be formed to receive a distal-most end of a bone anchor.

FIGS.35-37illustrate additional embodiments of holders800,810,820with alignment members802,812,822. The alignment members802,812,822are generally rectangular structures that extend or protrude at a radially inward angle or slope from respective engagement bases804,814,824towards a central longitudinal axis of each holder800,810,820and into a lumen of an inner tube when the holders800,810,820are engaged with caps and inserted into an inner tube, such as the inner tube550. The alignment members802,812,822are joined only on one rectangular edge to the engagement bases804,814,824and are unattached on the other three rectangular edges. However, because the members802,812,822extend radially inward at an angle, they form engagement edges806,816,826that engage threaded shafts809,819,829of bone anchors808,818,828to secure the bone anchors808,818,828therein and maintain orientations of the bone anchors808,818,828in the holders800,810,820.

FIG.38illustrates another embodiment of a holder900with alignment members902. The alignment members902are bowed or curved arms that curve toward a central longitudinal axis A4and extend between an engagement base904with a partial cannula906and an upper ring910through which a threaded shaft of a bone anchor is inserted.FIG.39illustrates still another embodiment of alignment members922of a holder920that extend along an inner surface of a lumen924of the holder920, similar to the alignment members610. However, the alignment members922protrude into the lumen924in a helical or spiral pattern.

Additionally, holders configured to secure threaded shafts of bone anchors can have variable longitudinal lengths, similar in configuration to the break-off tab240of the holder200. As illustrated inFIG.40, a holder950with alignment members952and a longitudinal axis A5can have one or more perforated rings954extending around the holder950at various points along the axis A5such that the holder950is a series of portions that are frangibly engaged with each other. A length of the holder950along the axis A5can be shortened to better fit a length of a threaded shaft of a bone anchor by removing one or more portions at a selectable ring954.

Holders can also secure orientations of modular components of various bone anchors with driver heads similar to securing threaded shafts, as illustrated inFIGS.41-60. For example,FIGS.41-43illustrate one embodiment of a holder1000that receives a receiver member or driver head1010designed to be used with various threaded shafts in one or more modular screw arrangements, such as those provided in U.S. Patent App. No. 2019/0150989 of Biester et al., further identified and incorporated by reference above. The holder1000is similar to holder600and can receive the head1010in a lumen1006of the holder1000. As illustrated inFIG.42, clips1008extend into the lumen1006to removably engage the head1010and secure an orientation of the head1010relative to the holder1000.FIGS.44-46illustrate another embodiment of holder1020with separated clip arms1024for securing a driver head1028,FIGS.47-49illustrate another embodiment of holder1030with wide clips1034for securing a driver head1038,FIGS.50-52illustrate another embodiment of holder1040with separated wide clip arms1044for securing a driver head1048,FIGS.53and54illustrate another embodiment of holder1050with notched arms1054for securing a driver head1058,FIGS.55-57illustrate another embodiment of holder1060with protuberances1064for securing a driver head1068within an inner tube1070and a cap1072, andFIGS.58-60illustrate another embodiment of holder1080for securing a driver head1088within an inner tube1090and a cap1092and within an outer tube1094and a cap1096.

All of the proceeding holders for securing and maintaining an orientation of either a threaded shaft or a driver head therein can be used similarly to the holder200, including through being placed within inner and outer tubes similar to tubes100,150and by being sterilized and deployed such that inner environments of the inner and outer tubes remain sterile until deployment to avoid contamination of the threaded shafts and/or driver heads therein.

In the descriptions above and in the claims, phrases such as “at least one of” or “one or more of” may occur followed by a conjunctive list of elements or features. The term “and/or” may also occur 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 a phrase is intended to mean any of the listed elements or features individually or any of the recited elements or features in combination with any of the other recited 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 is also intended for lists including 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 and B and C together.” In addition, use of the term “based on,” above and in the claims is intended to mean, “based at least in part on,” such that an unrecited feature or element is also permissible.

The subject matter described herein can be embodied in systems, apparatus, methods, and/or articles depending on the desired configuration. The implementations set forth in the foregoing description do not represent all implementations consistent with the subject matter described herein. Instead, they are merely some examples consistent with aspects related to the described subject matter. Although a few variations have been described in detail above, other modifications or additions are possible. In particular, further features and/or variations can be provided in addition to those set forth herein. For example, the implementations described above can be directed to various combinations and subcombinations of the disclosed features and/or combinations and subcombinations of several further features disclosed above. In addition, the logic flows depicted in the accompanying figures and/or described herein do not necessarily require the particular order shown, or sequential order, to achieve desirable results. Other implementations may be within the scope of the following claims.