This disclosure relates generally to surgical instruments and, more particularly, to devices and methods that can be utilized for delivery of bone screws or other implantable assemblies.
Bone anchor assemblies can be used in orthopedic surgery to fix bone during healing, fusion, or other processes. In spinal surgery, for example, bone anchor assemblies can be used to secure a rod or other spinal fixation element to one or more vertebrae to rigidly or dynamically stabilize the spine. Bone anchor assembly implantation can require the use of specialized drivers to advance a threaded shank component into bone.
In some cases, fenestrated bone anchor assemblies can be utilized in combination with the delivery of bone cement or other flowable materials to aid in setting and/or securing the component driven into bone. Fenestrated bone anchor assemblies can include a threaded shank having a lumen extending at least part of its length with a distal and/or side opening to allow flowable material to escape from the lumen.
Fenestrated bone anchor assemblies can require specific alignment guides to enable delivery of cement or other flowable material. In some cases an alignment guide can be configured to drive in a screw in addition to receive a cement delivery device. In such prior devices, however, a combined device is often considered single-use and/or lacks compatibility or consistency with other pre-existing hardware.
Moreover, in many cases the use of prior driver and cement delivery devices has required the performance of device setup in the surgical field. It can be advantageous to minimize assembly operations required in the surgical field and enable, for example, setup of an assembly at a “back table” away from the immediate surgical field that can be passed to a surgeon or other user in a ready-to-use configuration.
Accordingly, there is a need for improved instrumentation for use in inserting bone screw assemblies and delivering bone cement or other flowable materials thereto. There is a need for such improved instrumentation that address shortcomings of prior designs, e.g., providing a reusable insertion device capable of delivering flowable materials, working with pre- existing cement delivery devices, permits assembly outside a surgical field, etc.
The present disclosure provides bone screw inserters and methods that address shortcomings in prior designs and provide unique advantages. Generally speaking, the devices disclosed herein can include bone screw drivers configured to apply torque to a threaded shank of a bone screw assembly and implant it into bone, as well as receive a cement delivery device to introduce bone cement or other flowable material through the threaded shank. Also disclosed are driver adapters that can be coupled to a driver in order to facilitate application of torque thereto during bone screw implantation. The driver adapter can be configured to accommodate a configuration of the driver necessary for coupling with a cement delivery device and can be configured to decouple or release from the driver after implanting a bone screw shank into bone in order to allow the subsequent use of a cement delivery device in combination with the driver. The disclosed drivers and driver adapters can be reusable and can employ a number of additional components to form various assemblies, including retaining and counter-torque sleeves, driving handles, etc. Further, the devices disclosed herein can be utilized in a manner that allows setup of a bone screw inserter assembly outside a surgical field, such that a completed assembly can be passed to a surgeon or other user for immediate use in driving a bone screw assembly into bone.
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 the proximal-most end of the driver to the 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 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.
Any of a variety of alternative or additional features can be included and are considered within the scope of the present disclosure. For example, in some embodiments, the driver adapter can include a lumen extending from a proximal-most end of the driver adapter to the distal-facing cavity. In certain embodiments, the lock can include one or more pivoting latches that interface with a groove formed on the driver. In some embodiments, the driver can include one or more flats formed on the proximal driver body that interface with one or more flats formed on an interior surface of the distal-facing cavity of the driver adapter.
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 interface with a bone screw receiver head. Moreover, in some embodiments, the retaining sleeve can include a lock configured to prevent separation of the retaining sleeve and 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 configured to be received between portions of a bone screw receiver head. In certain embodiments, the second sleeve can include a plurality of flexible extensions formed at a proximal end thereof configured to deflect and ride 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 a bone screw receiver head coupled to the retaining sleeve, and a proximal position, in which the second sleeve can rotate relative to the bone screw receiver head coupled to the retaining sleeve.
In some embodiments, the surgical assembly can include a driver handle coupled to the proximal torque-receiving end of the driver adapter. In certain embodiments, a surgical navigation array can be coupled to the driver adapter.
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 interfaces with a drive feature formed on a shank of a bone screw assembly. The method further includes coupling the retaining sleeve to a receiver head of the bone screw assembly, and coupling a driver adapter to the driver such that a proximal portion of the driver is received within a distal- facing cavity of the driver adapter and 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.
The methods disclosed herein can include any of a variety of additional or alternative steps that are considered 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 driver and the shank of the bone screw assembly can be relative to the retaining sleeve.
In some embodiments, the method can further include inserting the retaining sleeve through a lumen of a second sleeve. The method may further include inserting the retaining sleeve through the lumen of the second sleeve before coupling the retaining sleeve to the receiver head of the bone screw assembly. The method may further comprise moving the second sleeve between a distal position, in which the second sleeve is locked against rotation relative to the receiver head of the bone screw assembly, and a proximal position, in which the second sleeve can rotate relative to the receiver head of the bone screw assembly.
In certain embodiments, the method can further include coupling the retaining sleeve to the receiver head, inserting the driver through the lumen of the retaining sleeve, and coupling the driver adapter to the driver outside of a surgical field.
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.
In another aspect, a bone screw driver is disclosed that includes a distal tip and a proximal body. Further, a lumen extends from the proximal-most end of the bone screw driver to the distal-most end of the bone screw driver, and the tip is formed at a distal-most end of the bone screw driver and is configured to interface with a bone screw to impart torque thereto. Still further, the proximal body includes opposed flats formed thereon configured to allow application of torque to the bone screw driver, and the proximal body has a diameter greater than a distance between the opposed flats at a position distal to the opposed flats.
As with the various aspects and embodiments disclosed above, any of a variety of alternative or additional features can be included and are considered within the scope of the present disclosure. For example, in some embodiments, the bone screw driver can include a coupling feature formed at a location proximal to the opposed flats. The coupling feature can be configured to interface with a driver adapter in a manner that prevents axial separation of the bone screw driver and driver adapter. In certain embodiments, the coupling feature can include a groove formed around a circumference of the proximal body.
In some embodiments, the bone screw driver can include an intermediate portion extending between the distal tip and the proximal body portion, and the intermediate portion can have a diameter less 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 position distal to the first shoulder. In certain embodiments, the second shoulder can include a tapered distal-facing surface. In some embodiments, the distal tip can have a diameter less than that of the intermediate portion.
In certain embodiments, the lumen can include at least one portion along its length with a tapering diameter. In some embodiments, a 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.
In another aspect, a bone screw driver adapter is disclosed that includes a distal adapter body and a proximal torque-receiving end. The distal adapter body has a diameter greater than the proximal torque-receiving end and defines a distal-facing cavity configured to receive a proximal portion of a bone screw driver. The bone screw driver adapter further includes a distal-facing surface within the cavity that includes a protrusion extending distally therefrom that is configured to be received within a lumen of the bone screw driver and impart torque thereto. The distal adapter body also includes a lock configured to engage with the proximal portion of the bone screw driver when received within the cavity to prevent axial separation of the bone screw driver and the bone screw driver adapter.
As with the aspects and embodiments disclosed above, any of a variety of alternative or additional features can be included and are considered 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 allow application of torque to the bone screw driver adapter.
In certain embodiments, the bone screw driver 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 less than a diameter of the distal adapter body. In some embodiments, the bone screw driver adapter can include a lumen extending from a proximal-most end of the adapter to the distal-facing cavity.
In some embodiments, the lock can include one or more pivoting latches with a first end exposed along an outer surface of the distal adapter body and a second end extending into the distal-facing cavity. In some embodiments, the one or more pivoting latches can be biased to drive the second end radially inward within the distal-facing cavity.
In certain embodiments, the bone screw driver adapter can include a surgical navigation array mount disposed between the distal adapter body and the proximal torque-receiving end.
In some embodiments, the distal-facing cavity can include at least one opening formed therein 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 protrusion can include one or more flats formed thereon. In some embodiments, the protrusion can include a first portion having the one or more flats formed thereon and a second portion extending distal to the first portion and having a diameter less than a diameter of the first portion.
In another aspect, a bone screw driver is disclosed that includes a distal tip and a proximal body. Further, a lumen extends from the proximal-most end of the bone screw driver to the distal-most end of the bone screw driver. Still further, the tip is formed at a distal-most end of the bone screw driver and is configured to interface with a bone screw to impart torque thereto. The proximal-most portion of the lumen also includes one or more flat sidewall portions configured to allow application of torque to the bone screw driver.
As with the aspects and embodiments disclosed above, any of a variety of alternative or additional features can be included and are considered within the scope of the present disclosure. For example, in some embodiments, the diameter of the lumen can be greatest along the proximal-most portion having the one or more flat sidewall portions.
Any of the features or variations described herein can be applied to any particular aspect or embodiment of the present disclosure in a number of different combinations. The absence of explicit recitation of any particular combination is due solely to avoiding unnecessary length or repetition.
The aspects and embodiments of the present disclosure can be more fully understood from the following detailed description taken in conjunction with the accompanying drawings, in which:
Certain exemplary embodiments will now be described to provide an overall understanding of the principles of the structure, function, manufacture, and use of the devices, systems, and methods disclosed herein. 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. The features illustrated or described in connection with one embodiment may be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of the present disclosure. Additionally, to the extent that linear, circular, or other dimensions are used in the description of 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. Equivalents to such dimensions can be determined for different geometric shapes, etc. Further, like-numbered components of the embodiments can generally have similar features. Still further, sizes and shapes of the devices, and the components thereof, can depend at least on the anatomy of the subject in which the devices will be used, the size and shape of objects with which the devices will be used, and the methods and procedures in which the devices will be used.
Bone screw inserters and related methods are disclosed herein for implanting a bone screw or portion of a bone screw assembly into bone. In some embodiments, the devices disclosed herein can include bone screw drivers configured to apply torque to a threaded shank of a bone screw assembly and implant it into bone, as well as receive a cement delivery device to introduce bone cement or other flowable material through the threaded shank. Also disclosed are driver adapters that can be coupled to a driver in order to facilitate application of torque thereto during bone screw implantation. The driver adapter can be configured to accommodate a configuration of the driver necessary for coupling with a cement delivery device and can be configured to decouple or release from the driver after implanting a bone screw shank into bone in order to allow the subsequent use of a cement delivery device in combination with the driver. The disclosed drivers and driver adapters can be reusable and can employ a number of additional components to form various assemblies, including retaining and counter-torque sleeves, driving handles, etc. Further, the devices disclosed herein can be utilized in a manner that allows setup of a bone screw inserter assembly outside a surgical field, such that a completed assembly can be passed to a surgeon or other user for immediate use in driving a bone screw assembly into bone.
The bone screw inserter assembly 100 can be utilized to implant a bone screw assembly into bone. In the illustrated embodiment, the retaining sleeve 108 can be threadably coupled to the receiver head 114 of the bone screw assembly 102. The driver 104 can be inserted through the retaining sleeve 108 such that a distal driver tip engages with a drive feature formed on the proximal end of the threaded shank 112. A driver adapter 106 can couple with a proximal end of the driver 104 to facilitate delivery of torque thereto via, e.g., a driver handle or other instrument that can couple to the driver adapter. In addition, the second sleeve 110 can be utilized to facilitate handling and, in some embodiments, to provide counter-torque to the receiver head 114 when torqueing the threaded shank 112 to drive it into bone. As explained in greater detail below and shown in
The driver body 502 can further include a coupling feature to facilitate coupling and selectively securing another component relative to the driver 104. In the illustrated embodiment, the coupling feature can include a groove 510 formed around an outer circumference of the driver body 502 at a location proximal to the opposed flats. As explained in more detail below, the coupling feature can be utilized by a lock of the driver adapter 106 to secure the two components relative to one another, and similarly can be utilized 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 can also include a conical proximal-most portion 512 that includes a diameter that tapers toward the proximal-most end of the driver 104. This conical profile can be used to help position another component, such as the driver adapter 106 or a cement delivery device, when coupling with the driver 104. In some embodiments, the conical surface can also be utilized in conjunction with the groove 510 to facilitate securing components relative to one another.
The illustrated embodiment of a 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 varying 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 a length of the intermediate portion 514. The one or more transitions or shoulders can have tapered conical surfaces or stepped surfaces that are 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 at a position distal to the first shoulder. As explained in more detail below, the first and second shoulders 518, 520 define a length 519 of the intermediate portion 514 that can receive a lock of the retaining sleeve 108 in order to prevent unintended axial separation of the driver 104 and retaining sleeve 108 while permitting relative rotation therebetween. Further, the second shoulder 520 can include a tapered distal-facing surface and a stepped proximal-facing surface, which can facilitate the lock of the retaining sleeve 108 riding over the shoulder 520 as the driver 104 is inserted into the retaining sleeve but prevent separation without specific release of the retaining sleeve lock.
As noted 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 the delivery of the driver 104, and any bone screw assembly coupled thereto, over a guidewire. The lumen 504 have a variety of diameters based on intended application, and can also include one or more transitions 602 between different diameters along its length. As with the transitions or shoulders described above with regard to the outer surfaces of the driver 104, the transitions 602 can include conical or tapered surfaces, or stepped surfaces that form shoulders perpendicular to the sidewalls of the lumen 504. In some embodiments, the use of tapered or conical transition surfaces can help guide devices inserted through the lumen, such as an elongate tube associated with a cement delivery device, as described in more detail below and show in
The driver 104 allows for delivery of a bone screw shank using, for example, the driver adapter 106 prior to delivery of bone cement or any other flowable material. As explained in more detail below, the driver adapter 106 can facilitate the attachment of a driver handle or other drive actuator to the driver 104. After removing the driver adapter 106, the cannulated driver 104 can allow the delivery of cement therethrough without requiring removal of the device or positioning of any additional components to facilitate introduction of a cement delivery device.
The driver adapter 106 can also include a distal adapter body 706. The distal adapter body 706 can have a diameter greater than the proximal torque-receiving end 702 and can define a distal-facing cavity 708 that can 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 can also include one or more flats 710 formed on an outer surface thereof, which can be utilized in certain embodiments to aid in torqueing the driver adapter 106 or otherwise coupling other instrumentation thereto in a manner that prevents relative rotation therebetween. Still further, the adapter body 706 can include one or more openings 711 formed therein and extending between an outer surface of the adapter body and the distal-facing cavity 708. These openings can facilitate user visualization into the cavity 708 during coupling or release operations, as well as cleaning and sterilization of the driver adapter 106, etc.
The distal-facing cavity 708 can include interior sidewalls that feature one or more flats 712. In the illustrated embodiment, there are opposed flats 712 configured to interface with or abut against the opposed flats 508 formed on the portion of the driver 104 that can be received within the distal-facing cavity 708. The interface of the one or more flats 712, 508 on the driver adapter 106 and driver 104 can allow torque applied to the driver adapter to transfer to the driver and, in turn, torque a bone screw shank coupled to the driver by the driver tip 302.
The distal adapter body 706 of the driver adapter 106 can also include a lock configured to prevent axial separation of the driver and the driver adapter. For example, a lock can be configured to engage with a proximal portion of a bone screw driver when received within the cavity 708 to prevent removal of the driver from the cavity. Any of a variety of locks can be utilized, including locks making use of various latches, threads, grooves, magnetic or electromagnetic attraction forces, etc. The lock can include one or more pivoting latches 714, such as the opposed latches 714 shown in the illustrated embodiment. The one or more latches 714 can each be configured to pivot around a pin 716 and can each include a first end 718 exposed along an outer surface of the distal adapter body 706 and a second end 720 extending into the distal-facing cavity 708. The one or more latches 714 can each be biased to drive the second end radially inward within the distal-facing cavity in some embodiments. 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 that urges the second end 720 to pivot radially inward into the cavity 708. In use, as a proximal portion of the driver 104 is received in the distal-facing cavity 708 of the driver adapter 106, the second end 720 of each of the one or more latches 714 can ride over 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 free the second end from the groove.
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 less than the diameter of the distal adapter body 706. As explained in more detail below, in some embodiments the intermediate portion can include mounting points or other features configured to facilitate coupling with other components, such as surgical navigation arrays, etc.
In some embodiments, the driver adapter 106 can include a lumen 726 extending along a length thereof. For example, the lumen 726 can extend from a proximal-most end of the driver adapter 106 to the distal-facing cavity 708. Inclusion of such a lumen can allow, for example, the use of the inserter assembly 100 in combination with a guidewire, etc.
The driver handle 1100 can further include a user-graspable handle 1106 at a proximal end thereof to facilitate a user gripping the handle and applying torque thereto. Various shapes and sizes of handles can be utilized. In the illustrated embodiment, a T-handle shape is utilized. In addition, the driver handle 1100 can include a lumen 1108 formed from a proximal-most end thereof to the distal-facing cavity 1102. This can be utilized in connection with the lumens formed in other components described herein, to allow use of an inserter assembly 100 in connection with a guidewire, etc.
While a user-graspable handle 1100 is shown in
The retaining sleeve 108 can include a lumen 1210 extending from its proximal-most end to its distal-most end to facilitate passing one or more instruments, such as the driver 104, therethrough. The retaining sleeve 108 can further include a lock configured to prevent separation of the retaining sleeve and, e.g., a driver inserted through the lumen 1210. The lock can include a button 1212 disposed within the proximal portion 1206 and capable of radial translation. A coil spring 1302 or other bias element can urge the button 1212 in one direction and a pin 1214 extending through a sidewall of the proximal portion 1206 can ride within 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 that can be sized to receive the driver 104. As explained in more detail below and shown in
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 of diameter or size along its length. Such transitions can feature tapered or conical surfaces for a gradual change in diameter or size, or steps that form perpendicular shoulders and instant 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, a ridge 1218 can be formed around a circumference of the retaining sleeve 108 at a location that facilitates desired positioning of a second sleeve that can be disposed over the retaining sleeve, as explained in more detail below.
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 can allow the retaining sleeve 108 to be rotated into or out of engagement with the threads of the receiver member 114 while the driver 104 remains in contact with the shank 112. Alternatively, the retaining sleeve 108 can be threaded into the receiver member 114 while the driver 104 is held proximally relative thereto (e.g., such that a proximal face of the shoulder 520 abuts the button 1212), which will slowly bring the driver tip 302 of the driver into engagement with the drive recess 1604 as the retaining sleeve is threaded further into the receiver member. In other words, allowing some degree of axial translation between the retaining sleeve 108 and the driver 104 when coupled can allow assembly with a bone screw in either a “driver first” or “retaining sleeve first” manner, thereby providing flexibility to surgeons and other users working with the components.
Also shown in
In use, the second sleeve 110 can be disposed over a portion of the retaining sleeve 108 and can be moved between a distal position, as shown in
When the second sleeve 110 is not in use, it can be translated proximally from the position shown in
The various components of the inserter assembly 100 described above can enable a user to setup the assembly and couple it to a bone screw assembly 102 for implantation in bone. Advantageously, such assembly can be performed outside a surgical field, such as on a “back table” or other preparation area adjacent the surgical field. This can reduce complexity of operation and the number of people operating within the surgical field. For example, in some embodiments, a user can couple a driver 104 to a retaining sleeve 108 by inserting the driver 104 through the lumen 1210 of the retaining sleeve. If a second sleeve 110 is to be utilized, it can be disposed over the retaining sleeve 108. The user can also couple the retaining sleeve 108 to a bone anchor assembly 100 by engaging the threads 1204 of the retaining sleeve with the threads 1602 of the receiver member 114. In addition, the user can 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. Further, a user can couple a driver adapter 106 to the driver 104 by inserting the proximal end of the driver into the distal-facing cavity 708 of the driver adapter until the latches 714 engage to secure the components relative to one another. A user can also couple the driver handle 1100 to the proximal end of the driver adapter 106 by, for example, inserting the proximal end of the driver adapter into the distal-facing cavity 1102 of the driver handle 1100. Coupling these components can create an assembly that is ready to pass from a preparation or staging area to a user in the surgical field who can immediately utilize the assembly to drive the shank 112 into bone. Further, if introduction of the shank 112 into bone is to be done over a guidewire, the lumens provided through the assembly 100 can enable passing the guidewire through the device and proceeding with guided delivery.
Note that a number of variations in order of coupling are possible with the assembly 100, and it is possible to utilize only select components in some embodiments. For example, a user can elect to couple the driver handle 1100 to the driver adapter 106 at any time, and also to couple these components to the driver 104. Further, the retaining sleeve 108 can be coupled to the receiver member 114 prior to insertion of the driver 104 therethrough, or the driver 104 can be coupled to the retaining sleeve 108 prior to coupling with the receiver member and/or shank 112. Similarly, the driver 104 can be inserted into the drive feature of the shank 112 prior to threadably engaging the retaining sleeve 108 to the receiver member 114, or the opposite order of coupling can be employed.
Once a shank 112 of a bone screw assembly 102 is implanted into bone, it can be desirable in some embodiments to deliver bone cement or other flowable material through a lumen 1606 formed in the shank (see
With the proximal end of the driver 104 exposed, a cement delivery device 2102 can be inserted through the lumen 504 of the driver 104 such that a 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.
As shown in
The devices and methods disclosed herein can therefore provide a number of advantages over prior devices because a single driver can be utilized to both implant a bone screw assembly into bone and deliver bone cement or other flowable material without requiring the removal of the driver to replace with a different component. The modular driver adapters disclosed herein can allow a single driver that can interface with various cement delivery devices directly and with various torque drivers via the driver adapter. In addition, the devices disclosed herein can be reusable in nature, as they can be removed, disassembled, cleaned, and sterilized.
While the description above focuses on one embodiment of a bone screw inserter assembly 100, other embodiments are also envisioned that can include any of a variety of variations or modifications. For example, in some embodiments it can be possible to reverse the various device configurations shown and described above. In some embodiments, for example, a bone screw driver can include a cavity formed in a proximal end thereof that receives a distal portion of the driver adapter. Further, in some embodiments a proximal portion of the bone screw driver can include a lock configured to aid in coupling with a 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 particularly shown and described above are considered within the scope of this disclosure.
The driver 2702 can also include a lumen 2718 extending along its length. The lumen 2718 can facilitate use of a guidewire to insert bone screws, as well as the delivery of flowable materials in cases where the size of the lumen 2718 is acceptable and the advantages of the above-described modular and separable driver and driver adapter are not needed.
The instruments disclosed herein can be constructed from any of a variety of known materials. Example materials include those which are suitable for use in surgical applications, including metals such as stainless steel, titanium, nickel, cobalt-chromium, or alloys and combinations thereof, polymers such as PEEK, ceramics, carbon fiber, and so forth. Further, various methods of manufacturing can be utilized, including 3D printing or other additive manufacturing techniques, as well as more conventional manufacturing techniques, including molding, stamping, casting, machining, etc.
The instruments and methods disclosed herein can be used in minimally-invasive surgery and/or open surgery. While the instruments and methods disclosed herein are generally described in the context of surgery on a human patient, it will be appreciated that the methods and instruments disclosed herein can be used in any of a variety of surgical procedures with any human or animal subject, or in non-surgical procedures.
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 pieces, and subsequent reassembly. In particular, the device can be disassembled, and any number of the particular pieces or parts of the device can be selectively replaced or removed in any combination. Upon 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. Use of such techniques, and the resulting reconditioned device, are all within the scope of the present application.
Various devices or components described herein can be processed before use in a surgical procedure. For example, a new or used device or component can be obtained and, if necessary, cleaned. The device or component can be sterilized. In one sterilization technique, the device or component can be placed in a closed and sealed container, such as a plastic or TYVEK bag. The container and its contents can be placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or high-energy electrons. The radiation can kill bacteria on the device or component and in the container. The sterilized device or component can be stored in the sterile container. The sealed container can keep the device or component sterile until it is opened in the medical facility. Other forms of sterilization are also possible, including beta or other forms of radiation, ethylene oxide, steam, or a liquid bath (e.g., cold soak). Certain forms of sterilization may be better suited to use with different devices or components, or portions thereof, due to the materials utilized, the presence of electrical components, etc.
In this disclosure, phrases such as “at least one of” or “one or more of” may occur followed by a conjunctive list of elements or features. The term “and/or” may also occur in a list of two or more elements or features. Unless otherwise implicitly or explicitly contradicted by the context in which it is used, such a phrase is intended to mean any of the listed elements or features individually or any of the recited elements or features in combination with any of the other recited elements or features. For example, the phrases “at least one of A and B,” “one or more of A and B,” and “A and/or B” are each intended to mean “A alone, B alone, or A and B together.” A similar interpretation is also intended for lists including three or more items. For example, the phrases “at least one of A, B, and C,” “one or more of A, B, and C,” and “A, B, and/or C” are each intended to mean “A alone, B alone, C alone, A and B together, A and C together, B and C together, or A and B and C together.” In addition, use of the term “based on,” is intended to mean, “based at least in part on,” such that an un-recited feature or element is also permissible.
Further features and advantages based on the above-described embodiments are possible and within the scope of the present disclosure. Accordingly, the disclosure is not to be limited by what has been particularly shown and described. All publications and references cited herein are incorporated by reference in their entirety, except for any definitions, subject matter disclaimers or disavowals, and except to the extent that the incorporated material is inconsistent with the express disclosure herein, in which case the language in this disclosure controls.
Examples of the above-described embodiments can include the following:
1. A surgical assembly, comprising:
2. The 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 assembly of any of claims 1 to 2, wherein the lock includes one or more pivoting latches that interface with a groove formed on the driver.
4. The assembly of any of claims 1 to 3, wherein the driver includes one or more flats formed on the proximal driver body that interface with one or more flats formed on an interior surface of the distal-facing cavity of the driver adapter.
5. The assembly of any of claims 1 to 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 interface with a bone screw receiver head.
7. The assembly of any of claims 5 to 6, wherein the retaining sleeve includes a lock configured to prevent separation of the retaining sleeve and driver.
8. The assembly of any 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 configured to be received between portions of a bone screw receiver head.
10. The assembly of any of claims 8 to 9, wherein the second sleeve includes a plurality of flexible extensions formed at a proximal end thereof configured to deflect and ride over one or more surface features formed on the retaining sleeve.
11. The assembly of any of claims 8 to 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 receiver head coupled to the retaining sleeve, and a proximal position, in which the second sleeve can rotate relative to the bone screw receiver head coupled to the retaining sleeve.
12. The assembly of any of claims 1 to 11, further comprising a driver handle coupled to the proximal torque-receiving end of the driver adapter.
13. The assembly of any of claims 1 to 12, further comprising a surgical navigation array coupled to the driver adapter.
14. A surgical method, comprising:
15. The method of claim 14, wherein rotation of the driver and the shank of the bone screw assembly is relative to the retaining sleeve.
16. The method of any of claims 14 to 15, further comprising coupling a driver handle to a proximal end of the driver adapter.
17. The method of any of claims 14 to 16, further comprising locking the driver against axial separation from the retaining sleeve.
18. The method of any of claims 14 to 17, further comprising inserting the retaining sleeve through a lumen of a second sleeve.
19. The method of claim 18, wherein inserting the retaining sleeve through the lumen of the second sleeve is performed before coupling the retaining sleeve to the receiver head of the bone screw assembly.
20. The method of any of claims 18 to 19, further comprising moving the second sleeve between a distal position, in which the second sleeve is locked against rotation relative to the receiver head of the bone screw assembly, and a proximal position, in which the second sleeve can rotate relative to the receiver head of the bone screw assembly.
21. The method of any of claims 14 to 20, wherein the steps of coupling the retaining sleeve to the receiver head, inserting the driver through the lumen of the retaining sleeve, and coupling the driver adapter to the driver are performed outside of a surgical field.
22. The method of any of claims 14 to 21, further comprising:
23. A bone screw driver, comprising:
24. The device of claim 23, further comprising a coupling feature formed at a location proximal to the opposed flats, wherein the coupling feature is configured interface with a driver adapter in a manner that prevents axial separation of the bone screw driver and driver adapter.
25. The device of claim 24, wherein the coupling feature includes a groove formed around a circumference of the proximal body.
26. The device of any of claims 23 to 25, further comprising an intermediate portion extending between the distal tip and the proximal body portion, wherein the intermediate portion has a diameter less than a 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 at a position distal to the first shoulder.
28. The device of claim 27, wherein the second shoulder includes a tapered distal-facing surface.
29. The device of any of claims 26 to 28, wherein the distal tip has a diameter less than that of the intermediate portion.
30. The device of any of claims 23 to 29, wherein the lumen includes at least one portion along its length with a tapering diameter.
31. The device of any of claims 23 to 30, wherein a proximal-most portion of the proximal body has a conical outer surface with a diameter that tapers toward the proximal-most end of the driver.
32. A bone screw driver adapter, comprising:
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 screw driver adapter.
34. The device of any of claims 32 to 33, further comprising an intermediate portion extending between the distal adapter body and the proximal torque-receiving end, wherein the intermediate portion has a diameter less than a diameter of the distal adapter body.
35. The device of any of claims 32 to 34, wherein the bone screw driver adapter includes a lumen extending from a proximal-most end of the adapter to the distal-facing cavity.
36. The device of any of claims 32 to 35, wherein the lock includes one or more pivoting latches with a first end exposed along an outer surface of the distal adapter body and a second end extending into the distal-facing cavity.
37. The device of claim 36, wherein the one or more pivoting latches are biased to drive the second end radially inward within the distal-facing cavity.
38. The device of any of claims 32 to 37, further comprising a surgical navigation array mount disposed between the distal adapter body and the proximal torque-receiving end.
39. The device of any of claims 32 to 38, wherein the distal-facing cavity includes at least one opening formed therein that extends to an outer surface of the adapter body.
40. The device of any of claims 32 to 39, wherein the outer surface of the distal adapter body includes one or more flats formed thereon.
41. The device of any of claims 32 to 40, wherein the protrusion includes one or more flats formed thereon.
42. The device of claim 41, wherein the protrusion includes a first portion having the one or more flats formed thereon and a second portion extending distal to the first portion and having a diameter less than a diameter of the first portion.
43. A bone screw driver, comprising:
44. The device of claim 43, wherein a diameter of the lumen is greatest along the proximal-most portion having the one or more flat sidewall portions.
This application claims the benefit of U.S. Provisional Application No. 63/277,153, filed on Nov. 8, 2021. The entire content of this application is hereby incorporated by reference in its entirety.
Number | Date | Country | |
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63277153 | Nov 2021 | US |