Bone screw inserter
Patent Information
- Application Number
- JP2024526886
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2021-11-08
- Filing Date
- 2022-11-08
- Publication Date
- 2025-08-22
AI Technical Summary
Conventional bone screw assembly devices lack compatibility and consistency with existing hardware, require assembly setup in the surgical field, and are often single-use, making them inefficient and cumbersome for delivering bone cement or flowable materials.
A reusable bone screw inserter system comprising a driver and adapter that allows for the delivery of bone cement through a threaded shank, compatible with existing cement delivery devices, and can be assembled outside the surgical field, featuring components like retaining and counter-torque sleeves for efficient bone screw implantation.
Enables efficient, reusable, and compatible delivery of bone cement or flowable materials with existing devices, reducing surgical complexity by allowing assembly outside the surgical field and improving the efficiency of bone screw implantation.
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Abstract
Description
[Technical field]
[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of U.S. Provisional Patent Application No. 63 / 277,153, filed November 8, 2021, the entire contents of which are incorporated herein by reference in their entirety.
[0002] FIELD OF THEINVENTION The present disclosure relates generally to surgical instruments and, more particularly, to devices and methods that may be utilized for the delivery of bone screws or other implantable assemblies. [Background technology]
[0003] Bone anchor assemblies can be used in orthopedic surgery to secure bone during healing, fusion, or other processes. For example, in spinal surgery, bone anchor assemblies can be used to secure rods or other spinal fixation elements to one or more vertebrae to rigidly or dynamically stabilize the spine. Implantation of the bone anchor assembly can require the use of a specialized driver to advance the threaded shank component into the bone.
[0004] In some cases, the fenestrated bone anchor assembly may be utilized in combination with delivery of bone cement or other flowable material to aid in cementing and / or securing the driven component into the bone. The fenestrated bone anchor assembly may include a threaded shank having a lumen extending at least a portion of its length, with distal and / or side openings allowing the flowable material to escape the lumen.
[0005] Fenestrated bone anchor assemblies may require specific alignment guides to allow for delivery of cement or other flowable materials. In some cases, the alignment guides may be configured to drive screws in addition to accepting a cement delivery device. However, with such conventional devices, the combined devices are often considered single use and / or lack compatibility or alignment with other existing hardware.
[0006] Moreover, in many cases, the use of conventional drivers and cement delivery devices has required the performance of device setup at the surgical field. It would be advantageous to minimize the assembly actions required at the surgical field, for example, to allow for the setup of the assembly at a "back table" away from the immediate surgical field, where it can be handed over to a surgeon or other user in a ready-to-use configuration. Summary of the Invention [Problem to be solved by the invention]
[0007] Thus, there is a need for improved instrumentation for use in inserting bone screw assemblies and delivering bone cement or other flowable materials thereto, which addresses shortcomings of conventional designs, such as providing a reusable insertion device capable of delivering flowable materials, cooperating with existing cement delivery devices, and allowing for assembly outside the surgical field. [Means for solving the problem]
[0008] The present disclosure provides bone screw inserters and methods that address shortcomings in conventional designs and provide unique advantages. Generally speaking, the devices disclosed herein can include a bone screw driver configured to apply torque to a threaded shank of a bone screw assembly and embed it into bone, and to receive a cement delivery device to introduce bone cement or other flowable material through the threaded shank. Also disclosed is a driver adapter that can be coupled to the driver to facilitate application of torque to the driver during embedding of the bone screw. The driver adapter can be configured to accommodate the configuration of the driver required to be coupled to the cement delivery device, and can be configured to be uncoupled or released from the driver after embedding the bone screw shank into bone to enable subsequent use of the cement delivery device combined with the driver. The disclosed drivers and driver adapters can be reusable and can employ several additional components to form various assemblies, including retention and counter torque sleeves, drive handles, etc. Additionally, the devices disclosed herein may be utilized in a manner that allows for setup of a bone screw inserter assembly outside the surgical field, such that a completed assembly may be provided to a surgeon or other user for immediate use in driving the bone screw assembly into bone.
[0009] In one aspect, a surgical assembly is disclosed that includes a driver having a distal tip configured to couple with another component in a manner that prevents rotation therebetween and a proximal driver body with a lumen extending from a proximal-most end of the driver to a distal-most end of the driver. The surgical assembly further includes a driver adapter having a distal adapter body and a proximal torque-receiving end. The driver adapter is coupled to the driver such that a portion of the proximal driver body is received within a distal-facing cavity of the distal adapter body. The driver adapter is also configured to impart a rotational force to the driver, and the distal adapter body includes a lock configured to prevent axial separation of the driver and the driver adapter.
[0010] Any of a variety of alternative or additional features may be included and are considered to be within the scope of the present disclosure. For example, in some embodiments, the driver adapter may include a lumen extending from a proximal-most end of the driver adapter to a distally-facing cavity. In certain embodiments, the lock may include one or more pivoting latches that mate with grooves formed on the driver. In some embodiments, the driver may include one or more flats formed on a proximal driver body that mate with one or more flats formed on an interior surface of a distally-facing cavity of the driver adapter.
[0011] In some embodiments, the surgical assembly can further include a retaining sleeve disposed over a portion of the driver. In certain embodiments, the retaining sleeve can include a threaded distal end configured to mate with the bone screw receiving head. Moreover, in some embodiments, the retaining sleeve can include a lock configured to prevent separation of the retaining sleeve and the driver. The surgical assembly can further include a second sleeve disposed over a portion of the retaining sleeve. In some embodiments, the second sleeve can include a plurality of rigid extensions formed at a distal end thereof and configured to be received between portions of the bone screw receiving head. In certain embodiments, the second sleeve can include a plurality of flexible extensions formed at a proximal end thereof and configured to deflect over one or more surface features formed on the retaining sleeve. The second sleeve can be configured to move between a distal position in which the second sleeve is locked against rotation relative to the bone screw receiving head coupled to the retaining sleeve and a proximal position in which the second sleeve can rotate relative to the bone screw receiving head coupled to the retaining sleeve.
[0012] In some embodiments, the surgical assembly can include a driver handle coupled to a proximal torque-receiving end of the driver adapter, hi certain embodiments, a surgical navigation array can be coupled to the driver adapter.
[0013] In another aspect, a surgical method is provided that includes inserting a driver through a lumen of a retaining sleeve such that a tip formed at a distal-most end of the driver mates with a drive feature formed on a shank of a bone screw assembly. The method further includes coupling the retaining sleeve to a receiving head of the bone screw assembly and coupling a driver adapter such that a proximal portion of the driver is received within a distal-facing cavity of the driver adapter such that the driver adapter is locked against axial separation from the driver. The method further includes rotating the driver adapter to impart corresponding rotation of the driver and the shank of the bone screw assembly.
[0014] The methods disclosed herein can include any of a variety of additional or alternative steps deemed within the scope of the present disclosure. In some embodiments, for example, the method can further include coupling a driver handle to a proximal end of the driver adapter. In certain embodiments, the method can further include locking the driver against axial separation from the retaining sleeve. In some embodiments, rotation of the shank of the driver and bone screw assembly can be relative to the retaining sleeve.
[0015] In some embodiments, the method can further include inserting a retaining sleeve through the lumen of the second sleeve. The method can further include inserting the retaining sleeve through the lumen of the second sleeve prior to coupling the retaining sleeve to the receiving head of the bone screw assembly. The method can further include moving the second sleeve between a distal position where the second sleeve is locked against rotation relative to the receiving head of the bone screw assembly and a proximal position where the second sleeve can rotate relative to the receiving head of the bone screw assembly.
[0016] In certain embodiments, the method can further include coupling a retaining sleeve to the receiving head outside the surgical field, inserting a driver through the lumen of the retaining sleeve, and coupling a driver adapter to the driver.
[0017] In some embodiments, the method can further include separating the driver adapter from the driver, coupling a bone cement delivery device to the driver, and delivering bone cement through the driver and the shank of the bone screw assembly.
[0018] In another aspect, a bone screwdriver is disclosed that includes a distal tip and a proximal body, further comprising a lumen extending from a proximal-most end of the bone screwdriver to a distal-most end of the bone screwdriver, a tip formed at the distal-most end of the bone screwdriver and configured to interface with a bone screw to apply torque to the bone screw, and further comprising opposing flats formed thereon and configured to enable application of torque to the bone screwdriver, the proximal body having a diameter distal to the opposing flats that is greater than a distance between the opposing flats.
[0019] As with the various aspects and embodiments disclosed above, any of a variety of alternative or additional features may be included and are considered to be within the scope of the present disclosure. For example, in some embodiments, the bone screwdriver may include a mating feature formed at a location proximal to the opposing flats. The mating feature may be configured to mate with the driver adapter in a manner that prevents axial separation of the bone screwdriver and the driver adapter. In one particular embodiment, the mating feature may include a groove formed around the circumference of the proximal body.
[0020] In some embodiments, the bone screwdriver can include an intermediate portion extending between the distal tip and the proximal body portion, the intermediate portion can have a diameter smaller than a diameter of the proximal body portion. In some embodiments, a first shoulder can be formed along the intermediate portion and a second shoulder can be formed along the intermediate portion at a location distal to the first shoulder. In certain embodiments, the second shoulder can include a tapered distally facing surface. In some embodiments, the distal tip can have a diameter smaller than a diameter of the intermediate portion.
[0021] In certain embodiments, the lumen can include at least one portion along its length having a tapered diameter, hi some embodiments, the proximal-most portion of the proximal body can have a conical outer surface with a diameter that tapers toward the proximal-most end of the driver.
[0022] In another aspect, a bone screwdriver adapter is disclosed that includes a distal adapter body and a proximal torque receiving end. The distal adapter body has a larger diameter than the proximal torque receiving end and defines a distally facing cavity configured to receive a proximal portion of a bone screwdriver. The bone screwdriver adapter further includes a distally facing surface within the cavity, the distally facing surface including a protrusion extending distally therefrom that is configured to be received within the lumen of the bone screwdriver and to apply torque to the bone screwdriver. The distal adapter body also includes a lock configured to engage the proximal portion of the bone screwdriver when received within the cavity to prevent axial separation of the bone screwdriver and the bone screwdriver adapter.
[0023] As with the aspects and embodiments disclosed above, any of a variety of alternative or additional features can be included and are considered to be within the scope of the present disclosure. For example, in some embodiments, the proximal torque receiving end can include one or more flats configured to enable application of torque to the bone screwdriver adapter.
[0024] In certain embodiments, the bone screwdriver adapter can further include an intermediate portion extending between the distal adapter body and the proximal torque-receiving end. Further, the intermediate portion can have a diameter smaller than a diameter of the distal adapter body. In some embodiments, the bone screwdriver adapter can include a lumen extending from a proximal-most end of the adapter to a distally-facing cavity.
[0025] In some embodiments, the lock can include one or more pivoting latches having a first end exposed along an outer surface of the distal adapter body and a second end extending into the distal-facing cavity, hi some embodiments, the one or more pivoting latches can be biased to drive the second end radially inwardly into the distal-facing cavity.
[0026] In certain embodiments, the bone screwdriver adapter can include a surgical navigation array mount disposed between the distal adapter body and the proximal torque-receiving end.
[0027] In some embodiments, the distally facing cavity can include at least one opening formed in the distally facing cavity that extends to an outer surface of the adapter body. In certain embodiments, the outer surface of the distal adapter body can include one or more flats formed thereon. In certain embodiments, the projection can include one or more flats formed thereon. In some embodiments, the projection can include a first portion having one or more flats formed thereon and a second portion extending distally of the first portion and having a diameter smaller than a diameter of the first portion.
[0028] In another aspect, a bone screwdriver is disclosed that includes a distal tip and a proximal body. Further, a lumen extends from a proximal-most end of the bone screwdriver to a distal-most end of the bone screwdriver. Still further, a tip is formed at the distal-most end of the bone screwdriver and is configured to interface with a bone screw to apply torque to the bone screw. The proximal-most portion of the lumen also includes one or more flat sidewall portions configured to enable application of torque to the bone screwdriver.
[0029] As with the aspects and embodiments disclosed above, any of a variety of alternative or additional features can be included and are considered to be within the scope of the present disclosure. For example, in some embodiments, the diameter of the lumen can be greatest along a proximal-most portion having one or more flat sidewall portions.
[0030] Any of the features or variations described herein may be applied to any particular aspect or embodiment of the present disclosure in several different combinations, and there is no explicit recitation of any particular combination, but this is simply to avoid unnecessary length or repetition. [Brief description of the drawings]
[0031] Aspects and embodiments of the present disclosure can be more fully understood from the following detailed description taken in conjunction with the accompanying drawings. [Figure 1] FIG. 1 is a perspective view of one embodiment of a bone screw inserter assembly according to the present disclosure coupled with one embodiment of a bone screw assembly. [Diagram 2] FIG. 2 is an exploded view of the bone screw inserter assembly of FIG. 1. [Diagram 3] FIG. 2 is a perspective view of selected components of the bone screw inserter assembly of FIG. 1. [Figure 4] FIG. 4 is an exploded view of selected components shown in FIG. 3. [Figure 5A] FIG. 2 is a rear perspective view of the bone screwdriver of the assembly shown in FIG. 1. [Figure 5B] FIG. 5B is a front perspective view of the bone screwdriver of FIG. 5A. [Figure 5C] FIG. 5B is a side view of the bone screwdriver of FIG. 5A. [Figure 6] FIG. 5B is a longitudinal cross-sectional view of the bone screwdriver of FIG. 5A. [Figure 7A] 2 is a rear perspective view of the driver adapter of the assembly shown in FIG. 1. [Figure 7B] FIG. 7B is a front perspective view of the driver adapter of FIG. 7A. [Figure 7C] 7B is another front perspective view of the driver adapter of FIG. 7A. [Figure 8] FIG. 7B is an exploded view of the driver adapter of FIG. 7A. [Figure 9] 7B is a longitudinal cross-sectional view of the driver adapter of FIG. 7A. [Figure 10] 7B is another longitudinal cross-sectional view of the driver adapter of FIG. 7A, offset 90° from the view of FIG. 9. [Figure 11] FIG. 1 is a perspective view of one embodiment of a driver handle according to the present disclosure. [Figure 12A] 2 is a rear perspective view of the retaining sleeve of the assembly shown in FIG. 1. [Figure 12B] FIG. 12B is a front perspective view of the retaining sleeve of FIG. 12A. [Figure 13] FIG. 12B is a longitudinal cross-sectional view of the retaining sleeve of FIG. 12A. [Figure 14] FIG. 12B is an exploded view of the retaining sleeve of FIG. 12A. [Figure 15] FIG. 2 is a perspective view of selected components of the bone screw inserter assembly of FIG. 1. [Figure 16] 16 is a longitudinal cross-sectional view of selected components shown in FIG. 15, also showing a second sleeve of the assembly of FIG. 1; [Figure 17A] 2 is a rear perspective view of a second sleeve of the assembly shown in FIG. 1. [Figure 17B] FIG. 17B is a front perspective view of the second sleeve of FIG. 17A. [Figure 18] FIG. 17B is a longitudinal cross-sectional view of the second sleeve of FIG. 17A. [Figure 19] 2 is a side view of selected components of the bone screw inserter assembly of FIG. 1 with the second sleeve in a distal position. FIG. [Figure 20] 2 is a side view of selected components of the bone screw inserter assembly of FIG. 1 with the second sleeve in a proximal position. FIG. [Figure 21] FIG. 2 is a front perspective view of a bone screwdriver of the assembly shown in FIG. 1 coupled to one embodiment of a cement delivery device. [Figure 22] FIG. 2 is a side view of the bone screwdriver and retaining sleeve of the assembly shown in FIG. 1 coupled to one embodiment of a cement delivery device. [Diagram 23] FIG. 2 is a rear perspective view of selected components of the assembly shown in FIG. 1 coupled to one embodiment of a cement delivery device. [Figure 24A] FIG. 2 is a partially transparent rear perspective view of the threaded bone anchor shank and bone screwdriver of the assembly shown in FIG. 1 coupled to one embodiment of a cement delivery device. [Figure 24B] FIG. 24B is a partially transparent front perspective view of the components shown in FIG. 24A. [Diagram 25] FIG. 1 is a side view of one embodiment of a navigated bone screwdriver and driver adapter assembly in accordance with the present disclosure; [Figure 26] FIG. 26 is a side exploded view of the navigated bone screwdriver and driver adapter of FIG. 25. [Figure 27A] FIG. 1 is a rear perspective view of one embodiment of a bone screwdriver according to the present disclosure; [Figure 27B] FIG. 27B is a front perspective view of the driver of FIG. 27A. [Figure 28] FIG. 27B is a longitudinal cross-sectional view of the driver of FIG. 27A. [Figure 29] FIG. 1 is a side exploded view of one embodiment of an assembly according to the present disclosure including a bone screwdriver, a retaining sleeve, and a second sleeve. [Diagram 30] FIG. 13 is a side exploded view of another embodiment of an assembly according to the present disclosure including a bone screwdriver, a retaining sleeve, and a second sleeve. [Diagram 31] FIG. 31 is a side view of another embodiment of a bone screwdriver that may be utilized in connection with the assembly of FIG. 30 . [Diagram 32] FIG. 1 is a perspective view of one embodiment of a bone screw inserter assembly according to the present disclosure; [Diagram 33] FIG. 33 is an exploded view of the bone screw inserter assembly shown in FIG. 32. [Diagram 34] FIG. 33 is a perspective view of a retaining sleeve of the assembly shown in FIG. 32. [Diagram 35] FIG. 35 is a partially transparent perspective view of the retaining sleeve shown in FIG. 34. [Diagram 36] FIG. 33 is a perspective view of a bone screwdriver of the assembly shown in FIG. 32. [Figure 37] FIG. 37 is a detailed rear perspective view of the bone screwdriver shown in FIG. 36. [Figure 38] FIG. 33 is a rear perspective view of the driver adapter of the assembly shown in FIG. 32. [Figure 39] FIG. 39 is a front perspective view of the driver adapter shown in FIG. 38. [Diagram 40]FIG. 1 is a perspective view of one embodiment of a bone screw inserter assembly according to the present disclosure; [Diagram 41] FIG. 41 is a perspective view of the bone screwdriver and driver adapter shown in FIG. 40 in a coupled configuration. [Diagram 42] FIG. 42 is a perspective view of the bone screwdriver and driver adapter shown in FIG. 41 in a separated configuration. [Diagram 43] FIG. 41 is a front view of the driver adapter shown in FIG. 40. [Diagram 44] FIG. 44 is a front perspective view of the driver adapter shown in FIG. 43. [Diagram 45] 44 is a partially transparent longitudinal cross-sectional view of the driver adapter shown in FIG. 43. [Figure 46] FIG. 41 is a rear perspective view of the bone screwdriver shown in FIG. 40. [Figure 47] FIG. 47 is a longitudinal cross-sectional view of the bone screwdriver shown in FIG. 46. [Figure 48] FIG. 41 is a longitudinal cross-sectional view of the assembly shown in FIG. 40. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0032] Certain exemplary embodiments will now be described so that the principles of the structure, function, manufacture, and use of the devices, systems, and methods disclosed herein can be generally understood. One or more examples of these embodiments are illustrated in the accompanying drawings. The devices, systems, and methods specifically described herein and illustrated in the accompanying drawings are non-limiting embodiments. Features illustrated or described in connection with one embodiment may be combined with features of other embodiments. Such modifications and variations are intended to be included within the scope of the present disclosure. Additionally, to the extent that linear, circular, or other dimensions are used in describing the disclosed devices and methods, such dimensions are not intended to limit the types of shapes that can be used in conjunction with such devices and methods. Dimensions equivalent to such dimensions can be determined for different geometries, and the like. Moreover, like-numbered components of the embodiments may generally have similar characteristics. Still further, the size and shape of the device and its components may depend at least on the anatomy of the subject with which the device is used, the size and shape of the object with which the device is used, and the method and procedure with which the device is used.
[0033] Disclosed herein is a bone screw inserter and associated method for embedding a bone screw or a portion of a bone screw assembly into bone. In some embodiments, the device disclosed herein can include a bone screw driver configured to apply torque to a threaded shank of the bone screw assembly and embed it into bone, and to receive a cement delivery device to introduce bone cement or other flowable material through the threaded shank. Also disclosed is a driver adapter that can be coupled to the driver to facilitate application of torque to the driver during embedding of the bone screw. The driver adapter can be configured to accommodate the configuration of the driver required to couple with the cement delivery device, and can be configured to decouple or release from the driver after embedding the bone screw shank into bone to enable subsequent use of the cement delivery device combined with the driver. The disclosed drivers and driver adapters can be reusable and can employ several additional components to form various assemblies, including retention and counter torque sleeves, drive handles, etc. Additionally, the devices disclosed herein may be utilized in a manner that allows for setup of a bone screw inserter assembly outside the surgical field, such that a completed assembly may be provided to a surgeon or other user for immediate use in driving the bone screw assembly into bone.
[0034] 1 and 2 show an embodiment of a bone screw inserter assembly 100 according to the present disclosure coupled to an embodiment of a bone screw assembly 102. The bone screw inserter assembly 100 can include a bone screw driver 104, a driver adapter 106, a retaining sleeve 108, and a second sleeve 110. The bone screw assembly 102 can be, for example, a polyaxial bone screw having a threaded implantable shank 112 and a receiving head 114 coupled to the shank and configured for polyaxial movement relative to the shank. Other embodiments can utilize uniplanar bone screw assemblies in which the receiving head can move in a single plane relative to the shank. Additionally, some embodiments can utilize monoaxial bone screws in which the receiving head is locked against movement relative to the shank or is integrally formed with the shank such that movement between the receiving head and the shank portion of the screw is not possible. Any of a variety of bone screws or bone screw assemblies may be utilized with the inserters disclosed herein, with the illustrated bone screw assembly 102 being one example. Further details regarding various bone screws and bone screw assemblies may be found in U.S. Patent Nos. 7,087,057, 9,155,580, 10,039,578, 10,299,839, and 10,980,574, the entire contents of each of which are incorporated herein by reference.
[0035] The bone screw inserter assembly 100 can be utilized to embed the bone screw assembly into bone. In the illustrated embodiment, a retaining sleeve 108 can be threadably coupled to a receiving head 114 of the bone screw assembly 102. A driver 104 can be inserted through the retaining sleeve 108 such that a distal driver tip engages a drive feature formed on a proximal end of a threaded shank 112. A driver adapter 106 can be coupled to a proximal end of the driver 104 to facilitate delivery of torque to the driver, for example, via a driver handle or other instrument that can be coupled to the driver adapter. Additionally, a second sleeve 110 can be utilized for ease of handling and, in some embodiments, to provide a counter torque to the receiving head 114 when the threaded shank 112 is torqued to drive into bone. As described in more detail below and shown in Figures 21-24B, the driver adapter 106 can be decoupled from the driver 104 and a cement delivery device can be coupled to the driver to deliver bone cement or other flowable material through a lumen formed in the threaded shank 112 of the bone anchor assembly 102.
[0036] 3 and 4 illustrate selected components of the bone screw inserter assembly of FIG. 1. In particular, these figures feature the driver 104, the driver adapter 106, and the retaining sleeve 108. FIGS. 3 and 4 also show the driving tip 302 formed at the distal-most end of the driver 104 and the threads 304 formed at the distal end of the retaining sleeve 108. Depending on the particular application and bone screw utilized, it may be possible to utilize an inserter assembly featuring all of the components illustrated in FIGS. 1 and 2, or a subset thereof, such as the assembly illustrated in FIGS. 3 and 4. For example, in some situations, it may be possible to utilize only the driver 104 and the adapter 106, such as when driving an implantable threaded shank of a bone anchor assembly, where the receiving head 114 is coupled to the shank at the surgical site after implantation.
[0037] 5A-6 illustrate the driver 104 in further detail. While various shapes and configurations are possible, in the illustrated embodiment, the driver 104 includes a distal driver tip 302 and a proximal driver body 502. Additionally, there is a lumen 504 that extends through the driver 104 from its proximal-most end to its distal-most end. The driver body 502 can have a generally cylindrical shape having a varying diameter. For example, in the illustrated embodiment, the driver body 502 can include a proximally extending reduced diameter section 506 that includes one or more flats 508 formed thereon, such as the opposing flats shown in the figures. In some embodiments, the one or more flats 508 can extend the entire length of the driver body without being divided into different sections of varying diameters. An exemplary embodiment of such a configuration is shown in FIGS. 32-39 and described in more detail below. As described in more detail below, the driver adapter 106 may include a distally facing cavity configured to receive the reduced diameter section 506 therein and one or more inwardly facing flats within the cavity that may mate with the one or more flats 508 to enable the driver adapter 106 to apply torque to the driver 104. In other embodiments, any of a variety of drive features may be integrated into the proximal driver body 502 to facilitate delivery of torque to the proximal driver body 502. For example, in some embodiments, a large drive feature such as a Torx® drive recess or other recess having one or more flats may be formed at the proximal end of the driver body 502, for example, surrounding the lumen 504. In such embodiments, a complementary drive feature may be formed on the driver adapter 106 to facilitate delivery of torque to the driver 104 when the two components are coupled together. An exemplary embodiment of such a configuration is shown in FIGS. 40-48 and described in more detail below.
[0038] The driver body 502 may further include a mating feature to facilitate coupling and selectively securing another component to the driver 104. In the illustrated embodiment, the mating feature may include a groove 510 formed around the circumference of the driver body 502 at a location proximal to the opposing flats. As described in more detail below, the mating feature may be utilized by a lock on the driver adapter 106 to secure the two components to one another, as well as by a cement delivery device to couple with the driver 104 for delivery of cement through the lumen 504 of the driver. The driver body 502 may also include a conical-shaped proximal-most portion 512 that includes a diameter that tapers toward the proximal-most end of the driver 104. This conical profile may be used to aid in positioning another component, such as the driver adapter 106 or a cement delivery device, when mating with the driver 104. In some embodiments, the conical surface may also be utilized in conjunction with the groove 510 to facilitate securing the components to one another.
[0039] The illustrated embodiment of the driver 104 also includes an intermediate portion 514 extending between the distal driver tip 302 and the proximal body 502. The intermediate portion 514 can have a generally cylindrical shape and can have various diameters and lengths according to the particular application, etc. In the illustrated embodiment, for example, there can be one or more transitions or shoulders 516 formed by different diameters along the length of the intermediate portion 514. The one or more transitions or shoulders can have tapered conical surfaces or stepped surfaces perpendicular to one another. For example, in the illustrated embodiment, a first shoulder 518 is formed along the intermediate portion 514 along with a second shoulder 520 distal to the first shoulder. As described in more detail below, the first shoulder 518 and the second shoulder 520 define a length 519 of the intermediate portion 514 that can receive a lock of the retaining sleeve 108 to prevent unintended axial separation between the driver 104 and the retaining sleeve 108 while allowing relative rotation therebetween. Additionally, the second shoulder 520 can include a tapered distal-facing surface and a stepped proximal-facing surface that can facilitate locking of the retaining sleeve 108 over the shoulder 520 when the driver 104 is inserted into the retaining sleeve, but can prevent separation without specific release of the retaining sleeve lock.
[0040] 5B illustrates the driver tip 302 in further detail. In the illustrated embodiment, the driver tip 302 is a T27 shape configured to be received within a complementarily shaped drive recess formed in the proximal end of the threaded shank 112 of the bone anchor assembly 102. However, in other embodiments, any of a variety of alternative driver tip shapes may be utilized. Also, in the illustrated embodiment, the driver tip 302 has a smaller diameter than the intermediate portion 514 and the proximal body portion 502.
[0041] As mentioned above, the driver 104 is cannulated and includes a lumen 504 extending along its length to facilitate delivery of bone cement or other flowable material therethrough. The lumen 504 can also facilitate delivery of the driver 104 and any bone screw assembly coupled thereto over a guidewire. The lumen 504 can have a variety of diameters based on the intended use and can also include one or more transitions 602 between the different diameters along its length. Similar to the transitions or shoulders described above with respect to the outer surface of the driver 104, the transitions 602 can include a conical or tapered surface, or a stepped surface that forms a shoulder perpendicular to the sidewall of the lumen 504. In some embodiments, the use of a tapered or conical transition surface can help guide a device being inserted through the lumen, such as an elongated tube associated with a cement delivery device, as described in more detail below and shown in FIGS. 21-24B.
[0042] The driver 104 allows for delivery of a bone screw shank, for example, using a driver adapter 106, prior to delivery of the bone cement or any other flowable material. As described in more detail below, the driver adapter 106 can facilitate attachment of a driver handle or other drive actuator to the driver 104. After removal of the driver adapter 106, the cannulated driver 104 can allow delivery of cement therethrough without requiring removal of the device or positioning of any additional components to facilitate introduction of the cement delivery device.
[0043] 7A-10 illustrate the driver adapter 106 in further detail. The driver adapter 106 can include a proximal end 702 configured to receive torque from a drive handle or other drive actuator. The proximal end 702 can include one or more flats 704 that can be utilized to apply torque to the driver adapter 106 and any components coupled thereto, such as, for example, the driver 104. In the illustrated embodiment, the proximal end 702 includes two pairs of opposing flats 704 that form a square drive feature, although other configurations are possible in other embodiments. The proximal end can also include a groove 705 formed about its circumference. As described in more detail below, this can be utilized in some embodiments to facilitate securing a driver handle or other drive actuator to the driver adapter 106.
[0044] The driver adapter 106 may also include a distal adapter body 706. The distal adapter body 706 may have a larger diameter than the proximal torque-receiving end 702 and may define a distally-facing cavity 708 that may be configured to receive a portion of the driver 104, such as the reduced diameter proximal portion 506 of the driver body 502. The adapter body 706 may also include one or more flats 710 formed on an outer surface thereof, which in certain embodiments may be utilized to torque the driver adapter 106 or otherwise aid in coupling other instruments to the driver adapter in a manner that prevents relative rotation therebetween. Still further, the adapter body 706 may include one or more openings 711 formed therein and extending between the outer surface of the adapter body and the distally-facing cavity 708. These openings may facilitate user visualization into the cavity 708, such as during coupling or uncoupling operations, as well as during cleaning and sterilization of the driver adapter 106.
[0045] The distally facing cavity 708 can include an interior sidewall characterized by one or more flats 712. In the illustrated embodiment, there are opposing flats 712 configured to mate or abut opposing flats 508 formed on a portion of the driver 104 that can be received within the distally facing cavity 708. The junction of the one or more flats 712, 508 on the driver adapter 106 and the driver 104 can allow torque applied to the driver adapter to be transferred to the driver and in turn impart torque to a bone screw shank coupled to the driver by the driver tip 302.
[0046] The distal adaptor body 706 of the driver adaptor 106 may also include a lock configured to prevent axial separation of the driver and the driver adaptor. For example, the lock may be configured to engage a proximal portion of the bone screwdriver when received within the cavity 708 to prevent the driver from being removed from the cavity. Any of a variety of locks may be utilized, including locks using various latches, threads, grooves, magnetic or electromagnetic attraction, and the like. The lock may include one or more pivoting latches 714, such as the opposing latches 714 shown in the illustrated embodiment. The one or more latches 714 may each be configured to pivot about a pin 716 and each may include a first end 718 exposed along an outer surface of the distal adaptor body 706 and a second end 720 that extends into the distal-facing cavity 708. In some embodiments, the one or more latches 714 may each be biased to drive the second end radially inward within the distal-facing cavity. For example, a coil spring 722 or other biasing element can apply a force to each of the one or more latches 714 in a direction urging the second end 720 to pivot radially inward into the cavity 708. In use, when the proximal portion of the driver 104 is received within the distally-facing cavity 708 of the driver adapter 106, the second end 720 of each of the one or more latches 714 can overcome the conical surface 512 and ultimately extend into the groove 510. This can secure the driver 104 against axial separation from the adapter 106 until a user urges the first end 718 of each of the one or more latches radially inward to release the second end from the groove.
[0047] The driver adapter 106 can also include an intermediate portion 724 extending between the proximal torque-receiving end 702 and the distal adapter body 706. The intermediate portion 724 can have a variety of lengths, shapes, and diameters. In the illustrated embodiment, the intermediate portion 724 is a generally cylindrical body having a diameter smaller than that of the distal adapter body 706. As described in more detail below, in some embodiments, the intermediate portion can include attachment points or other features configured to facilitate coupling with other components, such as a surgical navigation array.
[0048] In some embodiments, the driver adapter 106 can include a lumen 726 extending along its length. For example, the lumen 726 can extend from the proximal-most end of the driver adapter 106 to the distally-facing cavity 708. The inclusion of such a lumen can enable the use of the inserter assembly 100 in combination with, for example, a guidewire or the like.
[0049] FIG. 11 illustrates one embodiment of a driver handle 1100 that may be coupled to a proximal torque receiving end 702 of the driver adapter 106 to allow a user to apply torque to the driver adapter, as well as the driver 104 and bone screw shank 112 that may be coupled thereto. The driver handle 1100 may have a distal end defining a distally facing cavity 1102 configured to receive the proximal end of the driver adapter 106. The cavity 1102 may include one or more flats complementary in shape to one or more flats 704 formed on the driver adapter 104 to facilitate the transfer of torque therebetween. The driver handle 1100 may also include a lock 1104 formed along a distal portion thereof, which may be utilized to secure the coupling between the driver handle and the driver adapter. For example, the lock 1104 may include a radially translatable pin that may be forced into a groove 705 formed near the proximal end of the driver adapter 106 to prevent unintentional separation of the components.
[0050] The driver handle 1100 may further include a user-graspable handle 1106 at its proximal end to facilitate a user gripping and applying torque thereto. Handles of various shapes and sizes may be utilized. In the illustrated embodiment, a T-handle shape is utilized. Additionally, the driver handle 1100 may include a lumen 1108 formed from its proximal-most end to the distally facing cavity 1102. This may be utilized in conjunction with lumens formed in other components described herein to enable use of the inserter assembly 100 in conjunction with a guidewire, or the like.
[0051] Although a user-gripable handle 1100 is shown in FIG. 11, any of a variety of other driver actuators may be coupled to the proximal end of the driver adapter 106 to impart torque thereto. For example, an alternative driver such as a ratchet or a power driver such as a drill / driver may be coupled to a square drive or other drive feature formed in the proximal end of the driver adapter 106. In certain embodiments, the user-gripable handle or other driver components may be integrated into the driver adapter to create a single component with these features that cannot be separated from one another.
[0052] 12A-14 illustrate the retaining sleeve 108 in further detail. The retaining sleeve 108 may be a generally elongated cylindrical body and may include a distal end 1202 having threads 1204 formed thereon configured to engage threads formed on an inner surface of the receiving head 114 of the bone screw assembly 102. The retaining sleeve 108 may also include a proximal portion 1206 having a larger diameter than the distal end 1202. The proximal portion 1206 may include a series of ridges 1208 or other surface features to facilitate a user gripping and applying torque to the retaining sleeve, for example, when coupling or uncoupling the retaining sleeve with the bone screw receiving head 114.
[0053] The retaining sleeve 108 can include a lumen 1210 extending from its proximal-most end to its distal-most end to facilitate the passage of one or more instruments, such as the driver 104. The retaining sleeve 108 can further include a lock configured to prevent separation of the retaining sleeve and, for example, a driver inserted through the lumen 1210. The lock can include a radially translatable button 1212 disposed within the proximal portion 1206. A coil spring 1302 or other biasing element can urge the button 1212 in one direction, and a pin 1214 extending through a sidewall of the proximal portion 1206 can ride in a slot 1402 formed in the button 1212 to limit its range of motion. The button 1212 can include a through hole 1304 formed therein, which can be sized to receive the driver 104. As described in more detail below and shown in FIG. 16 , the button 1212 can ride over a shoulder 520 of the driver 104 as the driver is inserted through the lumen 1210 of the retaining sleeve 108. After clearing the shoulder 520, the button 1212 can be urged away by the spring 1302 in a manner that prevents separation of the driver 104 and the retaining sleeve 108 unless a user depresses the button 1212 against the biasing force of the spring 1302.
[0054] Similar to other components described herein, the retaining sleeve 108 can include an intermediate portion 1216 extending between the distal end 1202 and the proximal portion 1206. The intermediate portion 1216 can have a variety of shapes, lengths, and sizes and can include one or more transitions in diameter or size along its length. Such transitions can be characterized by tapered or conical surfaces that gradually change in diameter or size, or steps that form vertical shoulders and abrupt changes in diameter or size. In addition, the intermediate portion can include one or more surface features that can be utilized to couple with additional components. For example, ridges 1218 can be formed around the circumference of the retaining sleeve 108 at locations that facilitate desired positioning of a second sleeve that can be disposed over the retaining sleeve, as described in more detail below.
[0055] 15 and 16 illustrate selected components of the inserter assembly 100 of FIG. 1. For example, FIG. 15 illustrates the coupling of the retaining sleeve 108 to the receiving head 114 of the bone screw assembly 102, and the coupling of the driver 104 to the retaining sleeve and the threaded shank 112 of the bone screw assembly. FIG. 16 illustrates a cross-sectional view of the components shown in FIG. 15, but also illustrates the second sleeve 110 of the assembly 100. As can be seen in these figures, the retaining sleeve 108 can be coupled to the receiving head 114 of the bone anchor assembly 102 using threads 1602 formed on an inner surface of the receiving head and threads 1204 formed on the distal end 1202 of the retaining sleeve 108. The retaining sleeve 108 can be disposed over a portion of the driver 104 such that the driver tip 302 of the driver is received within a complementary shaped drive recess 1604 formed in the threaded shank 112 of the bone anchor assembly 102. Additionally, the driver 104 may be restrained against the retaining sleeve 108 by a locking button 1212 positioned along the length 519 of the driver between shoulders 518, 520. Separation of the driver 104 from the retaining sleeve 108 is prevented until the locking button 1212 is moved against the biasing force of the spring 1302 to allow the shoulder 520 to pass through a bore formed in the button.
[0056] The length 519 of the driver between the shoulders 518, 520 can be greater than the length of the lock button 1212, as in the illustrated embodiment, to facilitate some axial translation between the driver 104 and the retaining sleeve 108 when coupled. This allows the driver 104 to remain in contact with the shank 112 while the retaining sleeve 108 is rotated to engage or disengage the threads of the receiving member 114. Alternatively, the retaining sleeve 108 can be threaded into the receiving member 114 while the driver 104 is held proximally relative to the receiving member 114 (e.g., such that the proximal face of the shoulder 520 abuts the button 1212), which slowly engages the driver tip 302 of the driver with the drive recess 1604 as the retaining sleeve is threaded further into the receiving member. In other words, by allowing some axial translation between the retaining sleeve 108 and driver 104 when coupled, it is possible to assemble with the bone screw in either a "driver first" or "retaining sleeve first" manner, thereby providing flexibility to surgeons and other users working with the components.
[0057] Also shown in FIG. 16 is a second sleeve 110. This sleeve is illustrated in more detail in FIGS. 17A-20. The second sleeve 110 is a generally cylindrical body configured to be disposed over a portion of the retaining sleeve 108. The second sleeve 110 includes a lumen 1702 extending between its proximal and distal ends. In some embodiments where a sleeve is utilized to provide counter torque when driving the screw, the second sleeve 110 can include one or more rigid extensions 1704 or tangs formed at its distal end. In the illustrated embodiment, there are two opposing rigid extensions 1704. The rigid extensions 1704 can be configured to extend into a U-shaped recess formed between opposing portions of the receiving head 114 of the bone anchor assembly 102. At the proximal end of the second sleeve 110 are one or more flexible extensions 1706 configured to deflect over one or more surface features formed on the outer surface of the retaining sleeve 108. In the illustrated embodiment, the four flexible extensions 1706 are formed by four relief slots 1708 cut into the sidewall of the second sleeve 110. Additionally, a groove 1710 may be formed along the inner circumference of the second sleeve 110 and may be configured to receive a surface feature formed on the outer surface of the retaining sleeve 108, such as the ridge 1218 discussed above. In the illustrated embodiment, the groove 1710 is formed along the inner circumference of the lumen 1702 across each of the flexible extensions near the proximal end of the second sleeve 110.
[0058] In use, the second sleeve 110 may be disposed over a portion of the retaining sleeve 108 and may be moved between a distal position as shown in FIG. 19 and a proximal position as shown in FIG. 20. In the distal position of FIG. 19, the rigid extension 1704 may extend into a U-shaped recess formed by an opposing portion of the receiving member 114, or if no rigid extension is present, the distal end of the sleeve 110 may abut the proximal end of the receiving member. In embodiments including a rigid extension, disposing the sleeve 110 in a distal position may lock the sleeve against rotation relative to the receiving member due to interference between the rigid extension 1704 and the receiving member 114. In such a configuration, a user may grasp the second sleeve 110 and use it to apply a counter torque in one direction when applying torque to the driver 104 (e.g., via the driver adapter 106 and the driver handle 1100 coupled thereto) in a second direction.
[0059] The second sleeve 110 can be translated proximally from the position shown in FIG. 19 to the position shown in FIG. 20 when not in use. In the position shown in FIG. 20, the rigid extension 1704 (if present) can be withdrawn proximally beyond the proximal-most end of the receiving member 114, thereby allowing it to rotate relative to the receiving member 114 without interference. Additionally, in the position of FIG. 20, a groove 1710 formed on an inner surface of the flexible extension 1706 can be disposed over the ridge 1218, thereby holding the second sleeve 110 in a proximal position until a sufficient force is applied by the user to deflect the flexible extension over the ridge and advance distally. In other embodiments, the second sleeve 110 can be rotatably coupled to the retaining sleeve 108, such as by use of threads formed on an inner surface of the sleeve that can mate with threads formed on an outer surface of the retaining sleeve.
[0060] The various components of the inserter assembly 100 described above may allow a user to set up the assembly and couple it to the bone screw assembly 102 for implantation into bone. Advantageously, such assembly may be performed outside the surgical field, such as on a "back table" or other preparation area adjacent to the surgical field. This may reduce the complexity of the surgery and the number of people operating within the surgical field. For example, in some embodiments, a user may couple the driver 104 to the retaining sleeve 108 by inserting the driver 104 through the lumen 1210 of the retaining sleeve. A second sleeve 110, if utilized, may be disposed over the retaining sleeve 108. A user may also couple the retaining sleeve 108 to the bone anchor assembly 100 by engaging the threads 1204 of the retaining sleeve with the threads 1602 of the receiving member 114. Additionally, a user may couple the driver 104 to the threaded shank 112 by inserting the driver tip 302 of the driver into the drive recess 1604 of the shank 112. Additionally, a user may couple the driver adapter 106 to the driver 104 by inserting the proximal end of the driver into the distally facing cavity 708 of the driver adapter until the latch 714 engages and secures the components relative to one another. A user may also couple the driver handle 1100 to the proximal end of the driver adapter 106, for example, by inserting the proximal end of the driver adapter into the distally facing cavity 1102 of the driver handle 1100. Coupling these components may create an assembly ready to be passed from a preparation or staging area to a user in the surgical field where the assembly may be immediately utilized to drive the shank 112 into the bone. Additionally, if introduction of the shank 112 into the bone is performed over a guidewire, the lumen provided through the assembly 100 may allow the guidewire to be threaded through the device and guided delivery to proceed.
[0061] It should be noted that the assembly 100 allows for some variation in the coupling sequence, and in some embodiments, may utilize only selected components. For example, a user may choose to couple the driver handle 1100 to the driver adapter 106 at any time, and also couple these components to the driver 104. Additionally, the retaining sleeve 108 may be coupled to the receiving member 114 prior to inserting the driver 104 therein, or the driver 104 may be coupled to the retaining sleeve 108 prior to coupling with the receiving member and / or shank 112. Similarly, the driver 104 may be inserted into the drive features of the shank 112 prior to threadably engaging the retaining sleeve 108 with the receiving member 114, or the opposite coupling sequence may be employed.
[0062] Once the shank 112 of the bone screw assembly 102 is embedded in the bone, in some embodiments it may be desirable to deliver bone cement or other flowable material through a lumen 1606 (see FIG. 16) formed in the shank. The bone cement or other flowable material may flow out of the shank 112 through an opening 1608 formed in its distal end and / or through one or more openings (not shown) formed in the sidewall of the shank. In such embodiments, a cement delivery device 2102 may be coupled to the driver 104 as shown in FIGS. 21-24B. The proximal portion of the driver 104 may be configured to engage the cement delivery device 2102 using features that also facilitate coupling with the driver adapter 106, such as a groove 510 or other coupling feature and / or a conical surface 512. Thus, to deliver bone cement or other flowable material after embedding the bone screw shank 112, the user can uncouple the driver adapter 106 from the driver 104, for example, by firmly pressing the first end 718 of the pivot latch 714, releasing the second end 720 from the groove 510 and allowing the driver adapter 106 to be withdrawn proximally relative to the driver 104.
[0063] With the proximal end of the driver 104 exposed, the cement delivery device 2102 can be inserted through the lumen 504 of the driver 104 such that the distal cement delivery cannula 2104 of the device 2102 extends beyond the distal end of the driver and into the lumen 1606 of the shank 112. FIG. 21 illustrates the cement delivery device 2102 and driver 104 separately, while FIG. 22 illustrates the cement delivery device 2102 and driver 104 in combination with the retaining sleeve 108. FIG. 23 illustrates the components of FIG. 22 in addition to the bone screw assembly 102 and second sleeve 110. FIGS. 24A and 24B illustrate the cement delivery device, driver 104, and shank 112 separately and partially transparent to show the positioning of the cement delivery cannula and the flow path of the bone cement or other flowable material.
[0064] As shown in FIGS. 21-24B, the cement delivery device 2102 can be mated with the driver 104 using an elastic clip 2106 that engages with a groove 510 formed in the driver as well as a latch 714 on the driver adapter 106. The cement delivery device 2102 also includes an inlet 2106 that can be coupled to a syringe or other device to introduce cement or other flowable material through the cement delivery cannula 2104, into the lumen 1606 of the shank 112, and out one or more openings 1608 formed in the shank. One advantage of the devices and methods disclosed herein is that they can be configured for use with existing cement delivery devices such that no modifications or special adapters are required during surgery. For example, the devices and methods disclosed herein can be compatible with cement delivery devices utilized to deliver Vertecem® and Confidence® bone cements from DePuy Synthes. Additional details regarding cement delivery devices such as those that may be utilized in connection with the devices and methods disclosed herein can be found in U.S. Pat. No. 9,265,548, the entire contents of which are incorporated herein by reference.
[0065] Thus, the devices and methods disclosed herein may provide several advantages over conventional devices since a single driver may be utilized to both embed the bone screw assembly into the bone and deliver the bone cement or other flowable material without requiring removal of the driver to replace it with a different component. The modular driver adapters disclosed herein may allow for a single driver that can interface directly with a variety of cement delivery devices and with a variety of torque drivers via the driver adapters. Additionally, the devices disclosed herein may be inherently reusable since they may be removed, disassembled, cleaned, and sterilized.
[0066] 25 and 26 illustrate an alternative embodiment of a driver adapter 2502 that may be coupled to the driver 104. The driver adapter 2502 may operate similarly to the driver adapter 106 described above. In addition, however, the driver adapter 2502 may include a surgical navigation array mount 2602 disposed along an intermediate portion 2504 between the proximal torque receiving end 2506 and the distal adapter body 2508. The surgical navigation array mount may facilitate a rigid coupling of the surgical navigation array 2510 to the driver adapter 2502, such that a surgical navigation system may track the three-dimensional position of the surgical navigation array to track the three-dimensional position of the driver adapter 2502. Providing a navigated driver adapter 2502 and coupling it to the remainder of an inserter assembly, such as the assembly 100 described above, may enable surgically navigated implantation of a bone screw assembly, with all the attendant advantages in precision and accuracy of placement associated therewith. The surgical navigation array mount 2602 can utilize any of a variety of surgical navigation array mount configurations and can be positioned anywhere along the driver adapter 2502 depending on clearance requirements of other components, etc.
[0067] Although the above description focuses on one embodiment of the bone screw inserter assembly 100, other embodiments are contemplated that may include any of a variety of variations or modifications. For example, in some embodiments, it may be possible to reverse the various device configurations shown and described above. In some embodiments, for example, the bone screwdriver may include a cavity formed in its proximal end that receives the distal portion of the driver adapter. Furthermore, in some embodiments, the proximal portion of the bone screwdriver may include a lock configured to aid in coupling with the distal portion of the driver adapter and preventing axial separation of the driver and the driver adapter. Any such variations or modifications to the embodiments specifically shown and described above are deemed to be within the scope of the present disclosure.
[0068] 27A-31 illustrate alternative embodiments of bone screw inserters that do not utilize the modular separable driver and driver adapter configuration described above. These embodiments may utilize a single or integrated bone screwdriver in conjunction with the remainder of the components described above, such as the retaining sleeve, counter torque sleeve, and driver handle discussed in conjunction with the assembly 100. FIGS. 27A-28 illustrate in detail one embodiment of a driver 2702. The driver 2702 may have a generally elongated cylindrical shape and may include a distal driver tip 2704 and a proximal torque receiving end 2706. These components may be substantially similar to the driver tip 302 of the driver 104 and the proximal torque receiving end 702 of the driver adapter 106 discussed above. The driver 2702 may also include an intermediate portion extending between its proximal and distal ends, the intermediate portion having a variable length and including one or more surface features formed thereon, including diameter changes, ridges, shoulders, flats, and the like. In the illustrated embodiment, the driver 2702 includes three shoulders 2708, 2710, 2712 formed thereon. The shoulders can define two lengths 2714, 2716 that can receive locks on a retaining sleeve to constrain the relative position of the driver 2702 with respect to the retaining sleeve, as described in more detail below.
[0069] The driver 2702 can also include a lumen 2718 extending along its length. The lumen 2718 can facilitate the use of a guidewire to insert the bone screw, as well as delivery of the flowable material when the size of the lumen 2718 is acceptable and the advantages of the modular and separable driver and driver adapter described above are not required.
[0070] 29 illustrates the driver 2702 in association with a retaining sleeve 2902 and a second sleeve 2904. The retaining sleeve 2902 can be substantially similar to the retaining sleeve 108 discussed above, and the second sleeve 2904 can be substantially similar to the second sleeve 110 discussed above. The lengths of the driver 2702, retaining sleeve 2902, and second sleeve 2904 can be adjusted to provide the desired operation. This drawing view also highlights how the lock 2906 of the retaining sleeve 2902 can be received within any of the lengths 2714, 2716 defined by the various shoulders 2708, 2710, and 2712. In some embodiments, the size and location of the lengths 2714, 2716 can be configured to allow the driver 2702 to work in association with different types of bone screw assembly receiving heads. In particular, the lengths 2714, 2716 can be positioned to allow the driver 2702 to precisely mate with a threaded shank when the retaining sleeve 2902 is coupled to either a standard height receiving head, such as the receiving head 114 discussed above, or a receiving head having an extended reduction tab that extends the length of the threads formed on the receiving head. Further details regarding one embodiment of such a receiving head can be found in U.S. Patent No. 10,463,402 (e.g., FIG. 5A), the entire contents of which are incorporated herein by reference.
[0071] 30 illustrates another embodiment of an assembly including a driver 3002, a retaining sleeve 3004, and a second sleeve 3006. These components may be substantially similar to those shown in FIG. 29, but may have different lengths. Any of a variety of different lengths, diameters, or other shapes may be utilized in forming the various components of the bone screw inserter assembly depending on the particular bone screw to be inserted, the anatomical area to be accessed, or other particular application parameters.
[0072] 31 illustrates yet another embodiment of a driver 3102 that may be similar to either of the drivers 2702, 3002, but may further include a surgical navigation array mount 3104 disposed along its length. The surgical navigation array mount 3104 may be positioned along a proximal portion of the driver 3102 such that the driver remains proximal to the retaining sleeve when inserted therethrough. The surgical navigation array mount 3104 may be similar to the surgical navigation array mount 2602 discussed above and may facilitate coupling with a surgical navigation array 3106 to enable navigated insertion of a bone screw assembly.
[0073] 32-39 illustrate another exemplary embodiment of a bone screw inserter assembly 3200 according to the present disclosure. The assembly 3200 may be similar in many respects to the assembly 100 described above, and the following description provides details regarding certain differences between these embodiments. It should be noted that any of the various features illustrated in connection with any embodiment disclosed herein may be combined with other embodiments. The assembly 3200 includes a driver 3202, a driver adapter 3204, a retaining sleeve 3206, and a second sleeve 3208.
[0074] 34 and 35 illustrate the retaining sleeve 3206 in further detail. The retaining sleeve 3206 operates similarly to the retaining sleeve described above, including the use of a lock 3502 to couple the retaining sleeve to the driver. In addition, the retaining sleeve 3206 includes one or more recesses 3402 formed along its outer sidewall. The one or more recesses 3402 can receive an end of a shaft or a portion of another leverage multiplier to facilitate separation of the retaining sleeve 3206 from the receiving member when removal by directly grasping the body is difficult.
[0075] 36 and 37 illustrate the driver 3204 in further detail. The driver 3202 operates similarly to the drivers described above. However, in the illustrated embodiment, the driver 3202 includes a low profile proximal body 3602 having one or more flats 3604 formed thereon. In particular, the body 3602 can have an outer surface having a constant diameter along its length on which the one or more flats 3604 are formed. This can provide a continuous surface 3702 of a single diameter along the length of the proximal body 3602, for example, along the area between adjacent edges of the one or more flats 3604. Additionally, while the one or more flats 3604 in the illustrated embodiment are shown extending partway along the length of the proximal body 3602, in some embodiments, the one or more flats can be formed to extend along the entire length of the proximal body.
[0076] 38 and 39 illustrate the driver adapter 3204 in further detail. The driver adapter 3204 operates similarly to the driver adapters described above. The interior of the distally facing cavity 3902 of the driver adapter 3204 can include one or more flats 3904 configured to mate with one or more flats 3604 of the driver when the two components are coupled together.
[0077] 40-48 illustrate another exemplary embodiment of a bone screw inserter assembly 4000 according to the present disclosure. The assembly 4000 may be similar in many respects to the assembly 100 described above, and the following description provides details regarding certain differences between these embodiments. It should be noted that any of the various features illustrated in connection with any embodiment disclosed herein may be combined with other embodiments. The assembly 4000 includes a driver 4002, a driver adapter 4004, a retaining sleeve 4006, and a second sleeve 4008. FIG. 40 illustrates the assembly 4000 also coupled to a bone screw assembly 102.
[0078] 41 and 42 illustrate the driver 4002 and driver adapter 4004 in further detail. FIG. 41 shows the two components coupled together such that one or more latches 4102 lock the two components against axial separation and the driver adapter 4004 can be utilized to apply torque to the driver 4002. FIG. 42 shows the driver 4002 axially separated from the driver adapter 4004. Also visible is a protrusion 4202 extending from a distally facing cavity 4204 of the driver adapter 4004 that can be utilized to align the two components and apply torque between them, as described in more detail below.
[0079] 43-45 illustrate the driver adapter 4004 in further detail. The driver adapter 4004 may be similar in many respects to the driver adapters described above. However, as noted above, the driver adapter 4004 may include a protrusion 4202 extending from a distal-facing surface 4302 of the driver adapter's distal-facing cavity 4204. The protrusion 4202 may be utilized to either align the driver adapter 4004 with the driver 4002 or to apply torque thereto. In particular, in some embodiments, the protrusion 4202 may include a first portion 4304 having one or more flats 4306 formed thereon and a second portion 4308 extending distally of the first portion. In some embodiments, the second portion 4308 may have a diameter smaller than the diameter of the first portion 4304. The protrusion 4202 and its various portions can have any of a variety of cross-sectional shapes, for example, in the illustrated embodiment, the first portion 4303 has a hexagonal cross-sectional shape while the second portion 4308 has a cylindrical or circular cross-sectional shape. However, in other embodiments, any of a variety of shapes can be utilized for the various portions (e.g., a Torx® drive shape, a curved drive shape, a keyed drive shape, etc.). In some embodiments, the protrusion 4202 can include only one of the portions described herein. In embodiments in which the protrusion includes only a profile such as that of the second portion 4308, the distally facing cavity 4202 can include one or more flats formed along the other portions to impart torque between the driver adapter and the driver, as described above. In embodiments in which the protrusion includes a feature configured to impart torque to the driver, such as a first portion 4304 having one or more flats 4306, the distally-facing cavity 4204 can have a substantially cylindrical outer sidewall, as shown in FIGS. 43 and 44.
[0080] 46 and 47 illustrate the driver 4002 in further detail. The driver 4002 may be similar in many respects to the drivers described above. However, the driver 4002 may include a lumen 4602 having a proximal-most portion with one or more flat sidewall portions 4604. Additionally, in some embodiments, the diameter of the lumen along the proximal-most portion with the one or more flat sidewall portions 4604 may be larger than the diameter along other portions of the lumen. The proximal-most portion of the lumen 4602 may be configured to receive, for example, a first portion 4304 of a protrusion of the driver adapter 4004, thereby coupling the two components in a manner that allows for the transfer of torque between the two components (e.g., prevents relative rotation between the components along their longitudinal axes). Additionally, in some embodiments, a portion of the lumen 4602 distal to the proximal-most portion described above may be configured to receive a second portion 4308 of the protrusion 4202 of the driver adapter 4004. Extending the length of the first or second portion of the protrusion 4202 into a complementary lumen of the driver 4002 can aid in more precise alignment between the components. Additionally, in the illustrated embodiment, the proximal body 4606 of the driver 4002 can have a more rounded outer surface profile, such as a cylindrical outer surface or a surface having a small flat portion formed thereon. This is because the outer surface of the proximal body 4606 is not utilized to transmit torque between the driver adapter 4004 and the driver 4002.
[0081] 48 illustrates the coupling of the driver 4002 to the driver adapter 4004 and retaining sleeve 4006. This includes a lock 3502 that can selectively prevent axial separation of the driver 4002 and retaining sleeve 4006, and a lock 4102 that can prevent axial separation of the driver and driver adapter 4004. Also visible is the interaction between a protrusion 4202 formed on the driver adapter 4004 and a lumen 4602 of the driver 4002, including a proximal-most portion of the lumen that receives a first portion 4303 of the protrusion 4202 and a more distal portion of the lumen that receives a second portion 4308. Coupling the two components in this manner can allow for improved alignment therebetween, as well as the transfer of torque between the components (e.g., they can be locked against relative rotation with respect to one another).
[0082] The instruments disclosed herein may be constructed from any of a variety of known materials. Exemplary materials include materials suitable for use in surgical applications, including metals such as stainless steel, titanium, nickel, cobalt chrome, or alloys and combinations thereof, polymers such as PEEK, ceramics, carbon fiber, etc. Additionally, a variety of manufacturing methods may be utilized, including 3D printing or other additive manufacturing techniques, as well as more traditional manufacturing techniques including molding, stamping, casting, machining, etc.
[0083] The instruments and methods disclosed herein may be used in minimally invasive and / or open surgery. Although the instruments and methods disclosed herein are generally described in the context of surgery on a human patient, it will be understood that the methods and instruments disclosed herein may be used in any of a variety of surgical procedures or in non-surgical procedures with any human or animal subject.
[0084] The devices disclosed herein can be designed to be disposed of after a single use, or they can be designed to be used multiple times. In either case, however, the device can be reconditioned for reuse after at least one use. Reconditioning can include any combination of the steps of disassembly of the device, followed by cleaning or replacement of particular parts, and subsequent reassembly. Specifically, the device can be disassembled, and any number of particular parts or portions of the device can be selectively replaced or removed in any combination. After cleaning and / or replacement of particular parts, the device can be reassembled for subsequent use either at a reconditioning facility, or by a surgical team immediately prior to a surgical procedure. Reconditioning of a device can utilize a variety of techniques for disassembly, cleaning / replacement, and reassembly. The use of such techniques, and the resulting reconditioned device, are all within the scope of the present application.
[0085] Various devices or components described herein may be processed before being used in a surgical procedure. For example, new or used devices or components may be obtained and cleaned as necessary. The devices or components may be sterilized. In one sterilization technique, the devices or components may be placed in a closed and sealed container, such as a plastic bag or a TYVEK bag. The container and its contents may be placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or high energy electrons. The radiation may kill bacteria on the device or component and in the container. The sterilized device or component may be stored in a sterile container. The sealed container may keep the device or component sterile until it is opened in the medical facility. Other forms of sterilization are also possible, including beta radiation or other radiation, ethylene oxide, steam, or liquid baths (e.g., cold immersion). Certain forms of sterilization techniques may be more suitable for use with different devices or components or portions thereof due to the materials utilized, the presence of electrical components, etc.
[0086] In this disclosure, phrases such as "at least one of" or "one or more of" may be used with a conjunctive list of the elements or features that precede it. The term "and / or" may also be used with 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 of the listed elements or features individually, or any of the listed elements or features 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 is also intended for lists containing 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." Additionally, use of the phrase "based on" is intended to mean "based at least in part on," such that unrecited features or elements are acceptable.
[0087] Further features and advantages based on the above-described embodiments are possible and are within the scope of the present disclosure. Therefore, the present disclosure is not limited by what has been specifically shown and described. All publications and references cited herein are incorporated herein by reference in their entirety, except for any definitions, subject disclaimers or negations, and except where the incorporated material contradicts the explicit disclosure of the present specification (in which case the language of the present disclosure shall prevail).
[0088] Examples of the embodiments described above may include the following. 1. A surgical assembly comprising: a driver having a distal tip configured to mate with another component in a manner that prevents rotation therebetween, and a proximal driver body having a lumen extending from a proximal-most end of the driver to a distal-most end of the driver; a driver adapter having a distal adapter body and a proximal torque-receiving end; the driver adapter is coupled to the driver such that a portion of the proximal driver body is received within a distal-facing cavity of the distal adapter body; A surgical assembly, wherein the driver adapter is configured to impart a rotational force to the driver, and the distal adapter body includes a lock configured to prevent axial separation of the driver and the driver adapter. 2. The assembly of claim 1, wherein the driver adapter includes a lumen extending from a proximal-most end of the driver adapter to a distally-facing cavity. 3. An assembly as claimed in claim 1 or 2, wherein the lock includes one or more pivoting latches that mate with grooves formed on the driver. 4. An assembly as described in any one of claims 1 to 3, wherein the driver includes one or more flats formed on the proximal driver body that mate with one or more flats formed on an interior surface of the distally-facing cavity of the driver adapter. 5. The assembly of any one of claims 1-4, further comprising a retaining sleeve disposed over a portion of the driver. 6. The assembly of claim 5, wherein the retaining sleeve includes a threaded distal end configured to mate with a receiving head of a bone screw. 7. The assembly of claim 5 or 6, wherein the retaining sleeve includes a lock configured to prevent separation of the retaining sleeve and the driver. 8. The assembly of any one of claims 5 to 7, further comprising a second sleeve disposed over a portion of the retaining sleeve. 9. The assembly of claim 8, wherein the second sleeve includes a plurality of rigid extensions formed at a distal end thereof and configured to be received between portions of the bone screw receiving head. 10. The assembly of claim 8 or 9, wherein the second sleeve includes a plurality of flexible extensions formed on a proximal end thereof that are configured to deflect over and overcome one or more surface features formed on the retaining sleeve. 11. The assembly of any one of claims 8-10, wherein the second sleeve is configured to move between a distal position in which the second sleeve is locked against rotation relative to a bone screw receiving head coupled to the retaining sleeve, and a proximal position in which the second sleeve can rotate relative to a bone screw receiving head coupled to the retaining sleeve. 12. The assembly of any one of claims 1-11, further comprising a driver handle coupled to the proximal torque-receiving end of the driver adapter. 13. The assembly of any one of claims 1-12, further comprising a surgical navigation array coupled to the driver adapter. 14. A surgical method comprising: inserting a driver through the lumen of the retaining sleeve such that a tip formed on a distal-most end of the driver mates with a drive feature formed on a shank of the bone screw assembly; coupling the retaining sleeve to the receiving head of the bone screw assembly; coupling a driver adapter to the driver such that a proximal portion of the driver is received within a distally facing cavity of the driver adapter such that the driver adapter is locked against axial separation from the driver; and rotating the driver adapter to impart corresponding rotation of the driver and the shank of the bone screw assembly. 15. The method of claim 14, wherein rotation of the shank of the driver and bone screw assembly is relative to a retaining sleeve. 16. The method of claim 14 or 15, further comprising coupling a driver handle to a proximal end of the driver adapter. 17. The method of any one of claims 14-16, further comprising locking the driver against axial separation from the retaining sleeve. 18. The method of any one of claims 14-17, further comprising inserting a retaining sleeve through the lumen of the second sleeve. 19. The method of claim 18, wherein inserting the retaining sleeve through the lumen of the second sleeve is performed prior to coupling the retaining sleeve to the receiving head of the bone screw assembly. 20. The method of claim 18 or 19, further comprising moving the second sleeve between a distal position in which the second sleeve is locked against rotation relative to the receiving head of the bone screw assembly and a proximal position in which the second sleeve can rotate relative to the receiving head of the bone screw assembly. 21. The method of any one of claims 14 to 20, wherein the steps of coupling the retaining sleeve to the receiving head, inserting a driver through the lumen of the retaining sleeve, and coupling a driver adapter to the driver are performed outside the surgical field. twenty two. Separating the driver adapter from the driver; coupling a bone cement delivery device to a driver; 22. The method of any one of claims 14 to 21, further comprising delivering bone cement through the shank of the driver and bone screw assembly. 23. A bone screwdriver comprising: a distal tip; and a proximal body; a lumen extending from a proximal-most end of the bone screwdriver to a distal-most end of the bone screwdriver; a tip portion formed at a distal-most end of the bone screwdriver and configured to mate with the bone screw and apply torque to the bone screw; the proximal body includes opposing flats formed thereon configured to enable application of torque to the bone screwdriver; A bone screwdriver, wherein the proximal body has a diameter distal to the opposing flats that is greater than the distance between the opposing flats. 24. The device of claim 23, further comprising a mating feature formed at a location proximal to the opposing flats, the mating feature configured to mate with the driver adapter in a manner that prevents axial separation of the bone screwdriver and the driver adapter. 25. The device of claim 24, wherein the coupling feature comprises a groove formed around a circumference of the proximal body. 26. The device of any one of claims 23-25, further comprising an intermediate portion extending between the distal tip and the proximal body portion, the intermediate portion having a diameter smaller than the diameter of the proximal body portion. 27. The device of claim 26, further comprising a first shoulder formed along the intermediate portion and a second shoulder formed along the intermediate portion distal to the first shoulder. 28. The device of claim 27, wherein the second shoulder includes a tapered distally-facing surface. 29. The device of any one of claims 26-28, wherein the distal tip has a diameter smaller than the diameter of the intermediate portion. 30. The device of any one of claims 23-29, wherein the lumen includes at least one portion along its length having a tapered diameter. 31. The device of any one of claims 23-30, wherein the proximal-most portion of the proximal body has a conical outer surface having a diameter that tapers toward the proximal-most end of the driver. 32. A bone screwdriver adapter, comprising: a distal adaptor body; a proximal torque receiving end, the distal adapter body has a larger diameter than the proximal torque-receiving end; the distal adapter body defines a distally facing cavity configured to receive a proximal portion of a bone screwdriver; the distally facing surface within the cavity includes a protrusion extending distally from the distally facing surface configured to be received within the lumen of the bone screwdriver and to apply torque to the bone screwdriver; A bone screwdriver adapter, wherein the distal adapter body includes a lock configured to engage a proximal portion of the bone screwdriver when received within the cavity to prevent axial separation of the bone screwdriver and the bone screwdriver adapter. 33. The device of claim 32, wherein the proximal torque receiving end includes one or more flats configured to allow application of torque to the bone screwdriver adapter. 34. The device of claim 32 or 33, further comprising an intermediate portion extending between the distal adapter body and the proximal torque-receiving end, the intermediate portion having a diameter smaller than a diameter of the distal adapter body. 35. The device of any one of claims 32-34, wherein the bone screwdriver adaptor includes a lumen extending from a proximal-most end of the adaptor to a distally-facing cavity. 36. A device as described in any one of claims 32-35, wherein the lock includes one or more pivoting latches having a first end exposed along an outer surface of the distal adapter body and a second end extending into a distally-facing cavity. 37. The device of claim 36, wherein the one or more pivoting latches are biased to drive the second end radially inwardly within the distally-facing cavity. 38. The device of any one of claims 32-37, further comprising a surgical navigation array mount disposed between the distal adapter body and the proximal torque-receiving end. 39. A device as described in any one of claims 32-38, wherein the distally-facing cavity includes at least one opening formed within the distally-facing cavity that extends to an outer surface of the adapter body. 40. The device of any one of claims 32-39, wherein an outer surface of the distal adapter body includes one or more flats formed thereon. 41. The device of any one of claims 32-40, wherein the protrusion includes one or more flats formed thereon. 42. The device of claim 41, wherein the projection includes a first portion having one or more flats formed thereon and a second portion extending distally of the first portion and having a diameter smaller than the diameter of the first portion. 43. A bone screwdriver comprising: a distal tip; and a proximal body; a lumen extending from a proximal-most end of the bone screwdriver to a distal-most end of the bone screwdriver; a tip portion formed at a distal-most end of the bone screwdriver and configured to mate with the bone screw and apply torque to the bone screw; A bone screwdriver, wherein the proximal-most portion of the lumen includes one or more flat sidewall portions configured to allow application of torque to the bone screwdriver. 44. The device of claim 43, wherein the diameter of the lumen is greatest along its most proximal portion having one or more flat sidewall portions.
[0089] [Embodiment] (1) A surgical assembly comprising: a driver having a distal tip configured to mate with another component in a manner that prevents rotation therebetween, and a proximal driver body having a lumen extending from a proximal-most end of the driver to a distal-most end of the driver; a driver adapter having a distal adapter body and a proximal torque-receiving end; the driver adapter is coupled to the driver such that a portion of the proximal driver body is received within a distal-facing cavity of the distal adapter body; A surgical assembly, wherein the driver adapter is configured to impart a rotational force to the driver, the distal adapter body including a lock configured to prevent axial separation of the driver and the driver adapter. (2) The assembly of embodiment 1, wherein the driver adapter includes a lumen extending from a proximal-most end of the driver adapter to the distal-facing cavity. (3) The assembly of claim 1, wherein the lock includes one or more pivoting latches that mate with grooves formed on the driver. (4) The assembly of embodiment 1, wherein the driver includes one or more flats formed on the proximal driver body, the flats mating with one or more flats formed on an inner surface of the distally-facing cavity of the driver adapter. (5) The assembly of claim 1, further comprising a retaining sleeve disposed over a portion of the driver.
[0090] (6) The assembly of claim 5, wherein the retaining sleeve includes a threaded distal end configured to mate with a bone screw receiver head. (7) The assembly of claim 5, wherein the retaining sleeve includes a lock configured to prevent separation of the retaining sleeve and the driver. (8) The assembly of claim 5, further comprising a second sleeve disposed over a portion of the retaining sleeve. (9) The assembly of claim 8, wherein the second sleeve includes a plurality of rigid extensions formed at a distal end thereof and configured to be received between portions of a receiving head of a bone screw. (10) The assembly of embodiment 8, wherein the second sleeve includes a plurality of flexible extensions formed at a proximal end thereof and configured to deflect over and overcome one or more surface features formed on the retaining sleeve.
[0091] (11) The assembly of claim 8, wherein the second sleeve is configured to move between a distal position in which the second sleeve is locked against rotation relative to a bone screw receiving head coupled to the retaining sleeve and a proximal position in which the second sleeve can rotate relative to the bone screw receiving head coupled to the retaining sleeve. (12) The assembly of claim 1, further comprising a driver handle coupled to the proximal torque-receiving end of the driver adapter. (13) The assembly of claim 1, further comprising a surgical navigation array coupled to the driver adapter. (14) A bone screwdriver adapter, a distal adaptor body; a proximal torque receiving end, the distal adapter body has a larger diameter than the proximal torque-receiving end; the distal adapter body defines a distally facing cavity configured to receive a proximal portion of a bone screwdriver; a distally facing surface within the cavity including a protrusion extending distally therefrom configured to be received within a lumen of the bone screwdriver and to apply a torque to the bone screwdriver; a distal adapter body including a lock configured to engage the proximal portion of the bone screwdriver when received within the cavity to prevent axial separation of the bone screwdriver and the bone screwdriver adapter. (15) The device of embodiment 14, wherein the proximal torque receiving end includes one or more flats configured to enable application of torque to the bone screwdriver adapter.
[0092] (16) The device of claim 14, further comprising an intermediate portion extending between the distal adapter body and the proximal torque-receiving end, the intermediate portion having a diameter smaller than a diameter of the distal adapter body. (17) The device of embodiment 14, wherein the bone screwdriver adaptor includes a lumen extending from a proximal-most end of the adaptor to the distal-facing cavity. (18) The device of embodiment 14, wherein the lock includes one or more pivoting latches having a first end exposed along an outer surface of the distal adapter body and a second end extending into the distal-facing cavity. (19) The device of embodiment 18, wherein the one or more pivot latches are biased to drive the second end radially inward within the distal-facing cavity. (20) The device of embodiment 14, further comprising a surgical navigation array mount disposed between the distal adapter body and the proximal torque-receiving end.
[0093] (21) The device of embodiment 14, wherein the distally-facing cavity includes at least one opening formed therein that extends to an outer surface of the adapter body. (22) The device of embodiment 14, wherein the outer surface of the distal adapter body includes one or more flats formed thereon. (23) The device of embodiment 14, wherein the protrusion includes one or more flat portions formed thereon. (24) The device of embodiment 23, wherein the protrusion includes a first portion having the one or more flats formed thereon, and a second portion extending distally of the first portion and having a diameter smaller than a diameter of the first portion. (25) A bone screwdriver comprising: a distal tip; and a proximal body; a lumen extending from a proximal-most end of the bone screwdriver to a distal-most end of the bone screwdriver; the tip is formed at a distal-most end of the bone screwdriver and is configured to interface with a bone screw to apply torque to the bone screw; the proximal body includes opposing flats formed thereon configured to enable application of torque to the bone screwdriver; A bone screwdriver, wherein the proximal body has a diameter distal to the opposing flats that is greater than the distance between the opposing flats.
[0094] (26) The device of claim 25, further comprising a mating feature formed at a location proximal to the opposing flats, the mating feature configured to mate with the driver adapter in a manner that prevents axial separation of the bone screwdriver and the driver adapter. (27) The device of embodiment 26, wherein the coupling feature comprises a groove formed around a circumference of the proximal body. (28) The device of embodiment 25, further comprising an intermediate portion extending between the distal tip and the proximal body portion, the intermediate portion having a diameter smaller than a diameter of the proximal body portion. (29) The device of embodiment 28, further comprising a first shoulder formed along the intermediate portion and a second shoulder formed along the intermediate portion distal to the first shoulder. (30) The device of embodiment 29, wherein the second shoulder includes a tapered distally-facing surface.
[0095] (31) The device of embodiment 28, wherein the distal tip has a diameter smaller than a diameter of the intermediate portion. (32) The device of embodiment 25, wherein the lumen includes at least one portion along its length having a tapered diameter. (33) The device of embodiment 25, wherein the proximal-most portion of the proximal body has a conical outer surface having a diameter that tapers toward the proximal-most end of the driver. (34) A bone screwdriver comprising: a distal tip; and a proximal body; a lumen extending from a proximal-most end of the bone screwdriver to a distal-most end of the bone screwdriver; the tip is formed at a distal-most end of the bone screwdriver and is configured to interface with a bone screw to apply torque to the bone screw; A bone screwdriver, wherein the proximal-most portion of the lumen includes one or more flat sidewall portions configured to allow application of torque to the bone screwdriver. (35) The device of embodiment 34, wherein the diameter of the lumen is greatest along the proximal-most portion having the one or more flat sidewall portions.
Claims
1. 1. A surgical assembly comprising: a driver having a distal tip configured to couple with another component in a manner that prevents rotation therebetween, and a proximal driver body having a lumen extending from a proximal-most end of the driver to a distal-most end of the driver; a driver adapter having a distal adapter body and a proximal torque-receiving end; the driver adapter is coupled to the driver such that a portion of the proximal driver body is received within a distal-facing cavity of the distal adapter body; A surgical assembly, wherein the driver adapter is configured to impart a rotational force to the driver, and the distal adapter body includes a lock configured to prevent axial separation of the driver and the driver adapter.
2. The surgical assembly of claim 1 , wherein the driver adapter includes a lumen extending from a proximal-most end of the driver adapter to the distal-facing cavity.
3. The surgical assembly of claim 1 , wherein the lock includes one or more pivoting latches that mate with grooves formed on the driver.
4. 2. The surgical assembly of claim 1, wherein the driver includes one or more flats formed on the proximal driver body that mate with one or more flats formed on an interior surface of the distally-facing cavity of the driver adapter.
5. The surgical assembly of claim 1 , further comprising a retaining sleeve disposed over a portion of the driver.
6. The surgical assembly of claim 5 , wherein the retaining sleeve includes a threaded distal end configured to mate with a bone screw receiving head.
7. The surgical assembly of claim 5 , wherein the retaining sleeve includes a lock configured to prevent separation of the retaining sleeve and the driver.
8. The surgical assembly of claim 5 further comprising a second sleeve disposed over a portion of the retaining sleeve.
9. The surgical assembly of claim 8, wherein the second sleeve includes a plurality of rigid extensions formed at a distal end thereof configured to be received between portions of a bone screw receiving head.
10. 9. The surgical assembly of claim 8, wherein the second sleeve includes a plurality of flexible extensions formed on a proximal end thereof configured to deflect over and overcome one or more surface features formed on the retaining sleeve.
11. 9. The surgical assembly of claim 8, wherein the second sleeve is configured to move between a distal position in which the second sleeve is locked against rotation relative to a bone screw receiving head coupled to the retaining sleeve and a proximal position in which the second sleeve can rotate relative to the bone screw receiving head coupled to the retaining sleeve.
12. The surgical assembly of claim 1 , further comprising a driver handle coupled to the proximal torque-receiving end of the driver adapter.
13. The surgical assembly of claim 1 , further comprising a surgical navigation array coupled to the driver adapter.
14. A bone screwdriver adapter comprising: a distal adapter body; a proximal torque-receiving end; the distal adapter body has a larger diameter than the proximal torque-receiving end; the distal adapter body defines a distally facing cavity configured to receive a proximal portion of a bone screwdriver; a distally facing surface within the distally facing cavity including a protrusion extending distally therefrom configured to be received within a lumen of the bone screwdriver and to apply torque to the bone screwdriver; a bone screwdriver adapter, wherein the distal adapter body includes a lock configured to engage the proximal portion of the bone screwdriver when received within the distal-facing cavity to prevent axial separation of the bone screwdriver and the bone screwdriver adapter.
15. 15. The bone screwdriver adapter of claim 14, wherein the proximal torque-receiving end includes one or more flats configured to allow application of torque to the bone screwdriver adapter.
16. 15. The bone screwdriver adapter of claim 14, further comprising an intermediate portion extending between the distal adapter body and the proximal torque-receiving end, the intermediate portion having a diameter smaller than a diameter of the distal adapter body.
17. 15. The bone screwdriver adapter of claim 14, wherein the bone screwdriver adapter includes a lumen extending from a proximal-most end of the bone screwdriver adapter to the distally-facing cavity.
18. 15. The bone screwdriver adapter of claim 14, wherein the lock includes one or more pivoting latches having a first end exposed along an outer surface of the distal adapter body and a second end extending into the distal-facing cavity.
19. 19. The bone screwdriver adapter of claim 18, wherein the one or more pivotal latches are biased to drive the second end radially inward within the distally facing cavity.
20. The bone screwdriver adapter of claim 14, further comprising a surgical navigation array mount disposed between the distal adapter body and the proximal torque-receiving end.
21. The bone screwdriver adaptor of claim 14 , wherein the distally facing cavity includes at least one opening formed therein that extends to an outer surface of the distal adaptor body.
22. 22. The bone screwdriver adaptor of claim 21, wherein the outer surface of the distal adaptor body includes one or more flats formed thereon.
23. 15. The bone screwdriver adapter of claim 14, wherein the protrusion includes one or more flats formed thereon.
24. 24. The bone screwdriver adapter of claim 23, wherein the protrusion includes a first portion having the one or more flats formed thereon, and a second portion extending distally of the first portion and having a diameter smaller than a diameter of the first portion.
25. A bone screwdriver, comprising: a distal tip; and a proximal body; and a lumen extending from a proximal-most end of the bone screwdriver to a distal-most end of the bone screwdriver; the distal tip is formed at the distal-most end of the bone screwdriver and is configured to interface with a bone screw to apply torque to the bone screw; the proximal body includes opposing flats formed thereon configured to allow application of torque to the bone screwdriver; A bone screwdriver, wherein the proximal body has a diameter distal to the opposing flats that is greater than the distance between the opposing flats.
26. 26. The bone screwdriver of claim 25, further comprising a mating feature formed at a location proximal to the opposing flats, the mating feature configured to mate with the driver adapter in a manner that prevents axial separation of the bone screwdriver and driver adapter.
27. 27. The bone screwdriver of claim 26, wherein the coupling feature comprises a groove formed around the circumference of the proximal body.
28. 26. The bone screwdriver of claim 25, further comprising an intermediate portion extending between the distal tip and the proximal body, the intermediate portion having a diameter smaller than a diameter of the proximal body.
29. 29. The bone screwdriver of claim 28, further comprising a first shoulder formed along the intermediate portion and a second shoulder formed along the intermediate portion distal to the first shoulder.
30. 30. The bone screwdriver of claim 29, wherein the second shoulder includes a tapered distally facing surface.
31. 29. The bone screwdriver of claim 28, wherein the distal tip has a diameter smaller than the diameter of the intermediate portion.
32. 26. A bone screwdriver according to claim 25, wherein the lumen includes at least one portion along its length having a tapered diameter.
33. 26. The bone screwdriver of claim 25, wherein the proximal-most portion of the proximal body has a conical outer surface with a diameter that tapers towards the proximal-most end of the bone screwdriver.