JP7227218B2 - Surgical Instrument for Expandable and Adjustable Spinal Lordosis Interbody Fusion System - Google Patents

Description

[0001] This invention relates to surgical procedures and devices for treating low back pain.

[0002] A lumbar fusion is a surgical procedure to correct problems associated with the human spine. Lumbar fusion generally involves removing the damaged intervertebral disc and bone from between the two vertebrae and inserting a bone graft material that promotes bone growth. As the bone grows, the two vertebrae join or fuse together. Fusing the bones together can help make that particular area of the back more stable and help reduce problems associated with nerve irritation at the site of the fusion. Fusions can occur in one or more segments of the spine.

[0003] Interbody fusion removes the nucleus pulposus and/or annulus fibrosis that make up the intervertebral disc at the site of the back problem, and shapes and reshapes the distance between adjacent vertebrae to restore the proper distance. It is a common procedure for replacement with a dimensioned cage. Surgical techniques for performing interbody fusions vary, and the patient's spinal column can be accessed through the abdomen or back. One other less invasive surgical method for achieving lumbar fusion may involve accessing the spinal column through a small incision on the side of the body. This procedure is known as a lateral pathway lumbar interbody fusion.

[0004] After an intervertebral disc is removed from the body during a lateral pathway lumbar interbody fusion, the surgeon generally pushes various trial implants between the vertebral endplates in specific areas to measure the distance between adjacent vertebrae. Determining the appropriate implant size to maintain Another consideration is maintaining the natural angle between the lumbar vertebral bodies to accommodate the lordosis or natural curvature of the spine. Therefore, both disc height and lordosis must be considered during the selection of a cage for implantation. Prior art fusion cages are often preconfigured to have top and bottom surfaces that are angled relative to each other to accommodate the natural curvature of the spine. It is unlikely that these values can be determined accurately preoperatively, which is a drawback of current procedures. Generally, the prepared bone graft is packed into the cage implant after the cage implant is properly sized and prior to insertion between the vertebral bodies.

[0005] Current lateral pathway interbody fusion cage devices are generally limited to providing height extension capabilities and do not provide lordosis adjustment capabilities. The patient is subjected to significant invasive activity in performing a trial and error approach to sizing the interbody fusion cage to its specific shape and fitting it within the area of interest. Bone graft material is generally added to and encapsulated within the fusion device after the desired height expansion has been completed and final adjustments made.

[0006] One embodiment of the device comprises an expandable housing constructed from opposing shell members. A tapered screw-like movable element having an external helical thread is disposed within the housing and operably engages the upper and lower shell members to force them apart so that the height of the housing is expanded. This feature allows adjustment of the distance (height) between adjacent vertebrae when in place. The tapered members angularly slope the exterior surface of the housing such that independent engagement of the tapered members along the side portions of the upper and lower shells when the wedge-shaped members are moved to different degrees. are arranged in a dual configuration to allow This feature allows adjustment of the angular relationship between adjacent vertebrae to aid in lordotic adjustment of the patient's spine. When these features of the device are used in combination by the surgeon, the device provides an effective tool for on-the-spot adjustments when performing lateral pathway lumbar interbody fusions.

[0007] One embodiment of the device further comprises a track arrangement within the housing for guiding the tapered helical externally threaded member into engagement with the upper and lower shell members. The track includes raised elements on the inner surfaces of each of the upper and lower shell members which interlock for lateral stability of the housing when in the retracted position. enable As the housing expands, the track area provides space for storing bone graft material. One embodiment includes an elastic membrane disposed around the housing to prevent bone graft material from seeping out of the cage and to provide a compressive force around the cage to provide structural stability to the housing. offer.

[0008] An embodiment of the device further comprises a drive shaft for operating the tapered helical externally threaded member. The drive shaft provides a tapered external helical threaded member through the use of assistive tools by the surgeon in controlling expansion of the housing and angular adjustment of the upper and lower shell members to fit the interbody fusion device in situ. Enables manipulating the operably moving shaft. A locking mechanism is provided to prevent rotation of the shaft when the tool is not engaged and after manipulation by the tool has been completed. The tool also facilitates the insertion of bone graft material into the fusion body during in situ preparation.

[0009] One embodiment of the present invention provides for expanding a fusion cage in situ during surgery on a patient, adjusting the lordosis angle of the fusion cage, and while the device is in place at the surgical site. provide the surgeon with the ability to introduce bone graft material at the Accordingly, this embodiment of the present invention provides a fusion cage with geometric variability to address the unique spinal conditions of each patient.

[0010] Accordingly, embodiments of the present invention combine the ability of height expansion to adjust the distance between adjacent vertebrae with lordosis adjustment to control the angular relationship between the vertebrae in a lateral pathway lumbar spine. An interbody cage device for use in an interbody fusion procedure is provided. Embodiments of the interbody cage device of the present invention further provide storage capacity for housing bone graft material within the interbody cage device, while adjusting disc height and lordosis on the fly. is done in

[0011] The present invention also provides devices that may be used in environments other than interbody fusion applications. The device can be used to create a spacing effect between adjacent elements and to create variable angular relationships between elements to which the device is applied.

[0012] One embodiment of a surgical instrument comprises a handle, a first drive shaft, a second drive shaft, and a gear assembly. A first drive shaft is operably connected to the handle. The gear assembly includes a first gear member received on the first drive shaft, a second gear member slidably received on the second drive shaft, and a lever member. A lever member engages the second gear member with the first gear member thereby coupling the second drive shaft with the first drive shaft and the handle engages the first drive shaft and the second drive shaft. or to disengage the second gear member from engagement with the first gear member, thereby rotating the second drive shaft. It is operable to provide a second mode of operation in which the shaft is decoupled from the first drive shaft and the handle operates to rotate only the first drive shaft.

[0013] One embodiment of a surgical instrument comprises a handle, a housing, first and second drive shafts, first and second tubular shafts, and a gear assembly. . A first drive shaft is operably connected to the handle and rotatably secured to the housing and includes a first portion received within the housing and a second portion extending from the housing. A second drive shaft is rotatably secured to the housing and has a first portion received within the housing and a second portion extending from the housing. A first tubular shaft surrounds the second portion of the first drive shaft and is rotatably secured to the housing. A second tubular shaft surrounds the second portion of the second drive shaft and is rotatably secured to the housing. A gear assembly is received within the housing and couples the second drive shaft with the first drive shaft and the handle is operable to rotate the first drive shaft and the second drive shaft together. A second drive shaft that operates to provide a first mode of operation or to decouple the second drive shaft from the first drive shaft and the handle rotates only the first drive shaft. It is operable to provide a mode of operation.

[0014] Embodiments of the present disclosure provide surgical instruments for expandable and adjustable spinal lordosis interbody fusion systems. This instrument provides an improved and more efficient method for connecting an interbody fusion implant device to a patient, physically implanting it, and further expanding the implant in situ to adjust the lordosis. This instrument allows for smoother, more efficient and forceful manipulation of the interbody fusion implant after the implant has been inserted into the patient. This instrument allows the surgeon to expand, lordotically adjust, and position the implant within the patient's intervertebral disc space with a smoother instrumentation interface, while avoiding instrument damage if necessary. It is also possible to deliver more force to the instrument without The instrument, when connected to the implant, is operable and can act as a distraction system capable of pushing or distracting two vertebral bodies apart from each other. This allows restoration of normal disc height anatomy for patients with degenerative disc disease (DDD), deformities, and tumors. This allows for a simpler and more efficient means of distracting the disc space. The human interface aspects of this instrument are more intuitive and allow for more seamless interaction between the surgeon and the instrument during surgery, ultimately making surgery easier and faster. The instrument is easier to assemble and disassemble after surgery, and allows the instrument to be cleaned and sterilized so that it can be reused for more surgeries.

[0015] One embodiment of a surgical instrument includes a housing, a chassis, first and second drive shafts, a gear assembly, a switch assembly, and a lock or bearing lock assembly. The first drive shaft and the second drive shaft each have a first portion supported by the chassis within the housing and a second portion extending from the housing. The gear assembly includes a first gear member fixedly received on the first portion of the first drive shaft and a second gear slidably received on the first portion of the second drive shaft. member. The switch assembly engages the second gear member with the first gear member thereby coupling the second drive shaft with the first drive shaft, the second drive shaft rotating with the first drive shaft. or to displace the second gear member out of engagement with the first gear member, thereby displacing the second drive shaft from the first drive shaft to provide the first mode of operation possible. to provide a second mode of operation in which the second drive shaft is not rotatable with the first drive shaft. The bearing lock assembly locks the first drive shaft and the second drive shaft to the chassis, thereby restricting the first drive shaft and the second drive shaft from sliding out of the housing and freeing the housing. or unlock the first drive shaft and the second drive shaft from the chassis so that the first drive shaft and the second drive shaft slide out of the housing. It is operable to allow

[0016] This Summary is provided to introduce a selection of embodiments in a simplified form and is not intended to identify key features or essential characteristics of the claimed subject matter. nor is it intended to be used as an aid in determining the scope of the claimed subject matter. The selected embodiments are presented merely to give the reader a brief overview of some forms that the invention can take, and are not intended to limit the scope of the invention. Other aspects and embodiments of the disclosure are described in the Detailed Description section.

[0017] These and other features of the present invention are described in detail below in the section entitled "Detailed Description."
[0018] One embodiment of the invention is described herein with reference to the following drawings, in which legibility is more important than scale.

[0019] Fig. 4 is a side view of the expandable shell device; [0020] Fig. 4 is a bottom perspective view of the expandable shell device; [0021] Fig. 4 is a plan view of the bottom of the expandable shell device; [0022] Fig. 3 is a plan view of the expandable shell device; [0023] FIG. 5 is a perspective view of a tapered helical externally threaded member; [0024] Fig. 4 is a side view of a tapered helical externally threaded member; [0025] Fig. 4 is a front side view of a tapered helical male threaded member; [0026] Figure 6 is a cross-sectional view of the device along line 6-6 of Figure 1; [0027] Fig. 4 is a side view of the device while the device is being expanded; Fig. 10 is a side view of the device while the device is being expanded; Fig. 10 is a side view of the device while the device is being expanded; [0028] Fig. 4 is a side view of the device showing expansion of the device to address the lordosis effect; [0029] Fig. 4 is an enlarged perspective view of a thrust bearing for the drive shaft; [0030] Fig. 4 is a perspective view of the drive shaft and thrust bearing; [0031] Fig. 4 is a plan view in cross section of the engagement region of the drive shaft with the thrust bearing; [0032] Fig. 4 is a side view of the housing when expanded; [0033] Fig. 4 is a plan view of another embodiment of a device; [0034] Fig. 4 is a plan view of another embodiment of a device; [0035] Fig. 4 is a plan view of the drive shaft disengaged by the locking mechanism; [0036] Fig. 4 is a plan view of the drive shaft engaged by the locking mechanism; [0037] Fig. 4 is a perspective view of the locking mechanism; [0038] Fig. 6 is a plan view including a cross-section of the drive shaft disengaged by the locking mechanism; [0039] Fig. 4 is a plan view including a cross-section of the drive shaft engaged by the locking mechanism; [0040] FIG. 11B is a view along line 14-14 in FIG. 11A; [0041] Fig. 10 is a side view from the end of the device while the device is being expanded, showing the lordosis effect; FIG. 10 is a side view from the end of the device while the device is being expanded, showing the lordosis effect; FIG. 10 is a side view from the end of the device while the device is being expanded, showing the lordosis effect; [0042] Fig. 4 is a perspective view of a manipulation tool; [0043] Fig. 7 illustrates the attachment of the manipulation tool to the drive shaft of the device; [0044] Fig. 5 is an exploded perspective view of the handle of the operating tool; [0045] Fig. 10 is a perspective view of the gears of the handle engaged for manipulation of both drive shafts; [0046] Fig. 10 is a perspective view of the gears of the handle disengaged for operation of a single drive shaft; [0047] FIGURE 3 is a cut-away perspective view of an exemplary surgical instrument according to an embodiment of the present disclosure; [0048] Fig. 21B is an exploded perspective view of the surgical instrument shown in Fig. 21A; [0049] Fig. 4 is a perspective view of a drive shaft according to an embodiment of the present disclosure; [0050] Fig. 22B is an enlarged perspective view of the distal end of the drive shaft shown in Fig. 22A; [0051] Fig. 22B is an enlarged plan view of a portion of the drive shaft shown in Fig. 22A; [0052] Fig. 4 is a perspective view of an exemplary lever member according to an embodiment of the present disclosure; [0053] Fig. 21B is a perspective view of a portion of the surgical instrument shown in Fig. 21A, more clearly showing the lever member in the extended position; [0054] Fig. 21B is a perspective view of a portion of the surgical instrument shown in Fig. 21A, showing more clearly the lever members in a lordosis position; [0055] Fig. 21B is a perspective view of a portion of the surgical instrument shown in Fig. 21A, more clearly showing the lever member in the locked position; [0056] Fig. 10 is a perspective view of an exemplary outer connecting shaft according to an embodiment of the present disclosure; [0057] Fig. 27B is a plan view of the outer connecting shaft shown in Fig. 27A; [0058] Fig. 27B is a plan view of the end portion of the outer connecting shaft shown in Fig. 27B; [0059] Fig. 10 is a perspective view of an exemplary handle according to an embodiment of the present disclosure; [0060] FIG. 28B is a side view of the handle shown in FIG. 28A. [0061] Fig. 28B is a cross-sectional view of the handle along line AA of Fig. 28B; [0062] FIG. 28B is an end view from the first end of the handle shown in FIG. 28A. [0063] FIG. 28B is an end view from the second end of the handle shown in FIG. 28A. [0064] FIG. 21B is a perspective view of a portion of the surgical instrument shown in FIG. 21A showing a better view of the housing, outer connecting shaft, and drive shaft; [0065] Fig. 10 is a perspective view of an exemplary adapter according to an embodiment of the present disclosure; [0066] Fig. 3 is a perspective view of an exemplary dial according to an embodiment of the present disclosure; [0067] Fig. 10 is a perspective view of an exemplary dial according to an embodiment of the present disclosure; [0068] Fig. 4 is an exploded view of an exemplary surgical instrument according to an embodiment of the present disclosure; [0069] FIG. 12 is a partial cross-sectional view of an exemplary surgical instrument according to an embodiment of the present disclosure; [0070] Fig. 10 is a perspective view of an exemplary surgical instrument according to an embodiment of the present disclosure; [0071] Fig. 2 is a perspective view of an exemplary surgical instrument according to an embodiment of the present disclosure; [0072] Fig. 12 is an exploded view of a housing including a housing cover according to an embodiment of the present disclosure; [0073] Fig. 10 is a schematic illustration of a housing enclosing a chassis according to an embodiment of the present disclosure; [0074] Fig. 4 is a perspective end view of a housing according to an embodiment of the present disclosure; [0075] Fig. 4 is a perspective front view of a housing according to an embodiment of the present disclosure; [0076] Fig. 12 is a perspective side view of a housing showing switch guide features according to an embodiment of the present disclosure; [0077] Fig. 10 is a perspective view of a switch gasket according to an embodiment of the present disclosure; [0078] Fig. 10 is a perspective view of an exemplary chassis according to an embodiment of the present disclosure; [0079] FIG. 10 is a perspective view of an exemplary chassis having a sleeve and drive shaft bearings, and other components disposed on the chassis, according to an embodiment of the present disclosure; [0080] FIG. 12 is a partial perspective view showing an exemplary chassis, locking assembly, and other components according to an embodiment of the present disclosure; [0081] Fig. 10 is a perspective view of an exemplary gear member according to an embodiment of the present disclosure; [0082] Fig. 10 is a perspective view of an exemplary toggle switch according to an embodiment of the present disclosure; [0083] Fig. 12 is a partial perspective view showing the gear assembly and switch assembly in a first operational setting according to an embodiment of the present disclosure; [0084] Fig. 12 is a partial perspective view showing the gear assembly and switch assembly in a second operational setting according to an embodiment of the present disclosure; [0085] Fig. 12 is a partial perspective view showing the gear assembly and switch assembly in a third operational setting according to an embodiment of the present disclosure; [0086] Fig. 10 is a perspective view of an exemplary gear lock according to an embodiment of the present disclosure; [0087] Fig. 12 is a partial perspective view showing a bearing lock assembly and other components of an exemplary surgical instrument according to an embodiment of the present disclosure; [0088] Fig. 10 is a schematic illustration of a bearing member that may be used as a drive shaft bearing or sleeve bearing according to an embodiment of the present disclosure; [0089] Fig. 10 is a partial cutaway of an exemplary surgical instrument showing a locking assembly including a retaining plate and other components according to an embodiment of the present disclosure; [0090] FIG. 12 is an isometric view of an exemplary surgical instrument including a slaphammer, according to an embodiment of the present disclosure; [0091] FIG. 56 is an isometric exploded view of the exemplary surgical instrument shown in FIG. 55, according to an embodiment of the present disclosure; [0092] FIG. 4 is an isometric view of an exemplary slap hammer according to an embodiment of the present disclosure;

[0093] Interbody fusion body devices according to various embodiments, including preferred embodiments, of the present invention are described, shown, and otherwise disclosed herein with reference to the drawings. An interbody fusion device 10 is shown generally in FIG. The interbody fusion device consists of a housing 12 having an upper shell 14 and a lower shell 16 . The entire housing can have a length of 50 mm and a width of 20 mm, as an example. The shell material may be composed of suitable materials such as titanium alloy (Ti-6AL-4V), cobalt chromium, or polyetheretherketone (PEEK). Other materials that can provide sufficient compositional integrity and have suitable biocompatible qualities may be suitable. The interior of the shell is configured with cascading step trackers 18, 20 arranged along their lateral edges. As shown in FIG. 2, step tracking 18 begins toward the midpoint of the inner surface of lower shell 16, and as tracking reaches the first end of lower shell 16, the height of successive track steps increases. increases. Similarly, the step tracking 20 begins toward the midpoint of the inner surface of the lower shell 16 and successive track steps increase in height as that portion of the tracking reaches the second end of the lower shell 16. . As shown in FIG. 3, step tracking 18 includes dual track runs 22,24 and step tracking 20 includes dual track runs 26,28. As shown in FIG. 4, the upper shell 14 is provided with corresponding step tracking 30,32. When the device is in its fully compressed state and upper shell 14 is adjacent lower shell 16, as shown in FIG. mesh with 32.

[0094] Each trackway includes a series of spaced apart risers or track steps that receive the threads of the tapered helical externally threaded member. The tapered helical external threaded member provides an intervening action to separate the upper and lower shells, thereby increasing the height of the housing and expanding between the vertebral bodies in which the device is placed. As shown in FIG. 4, trackway 22 receives a tapered helical external thread member 34, trackway 24 receives a tapered helical external threaded member 36, trackway 26 receives a tapered helical external threaded member 38, and trackway 28 receives a tapered helical external threaded member 38. receives a tapered helical male threaded member 40; The trackway 22 is collinearly aligned with the trackway 26 so that movement of the tapered helical male threaded members 34, 38 within their respective trackways is colinearly aligned. . The thread orientations of the tapered male threaded members 34, 38 are opposite each other so that their rotation results in opposite movement. As shown in FIG. 4, the drive shaft 42 extends along the co-linear extent of the trackways 22,26 and passes through the tapered helical externally threaded members 34,38. Shaft 42 has a square cross-sectional configuration for engaging and rotating each tapered helical external thread member. As shown in FIG. 5, the central axial opening 44 of the tapered helical externally threaded member is configured to receive and engage the shaft 42 . Alternatively, shaft 42 may have any shape to effectively create a spline, such as a hexagon, and central axial opening 44 may have a corresponding configuration to receive that shape. As the shaft 42 is rotated clockwise by its end 48, the tapered helical externally threaded members 34, 38 are also rotated, and their respective thread orientations cause the threads to extend along the trackways 22 and 26. move away from each other. Similarly, when shaft 42 is rotated counterclockwise by its end 48, tapered external helical threaded members 34, 38 move toward each other along trackway 22 and trackway 26, respectively.

[0095] Similarly, the trackway 24 is collinearly aligned with the trackway 28 so that the movement of the tapered external helical threaded members 36, 40 within the respective trackway is colinearly aligned. It is done in a state where The thread orientations of the tapered helical male threaded members 36, 40 are opposite each other so that their rotation results in opposite movement. Again, the shaft 46 passes through and engages the tapered male threaded members 36,40. However, the orientation of the tapered male threaded members 36,40 is reversed from the orientation of the tapered male threaded members 34,38. In this orientation, when the shaft 46 is rotated counterclockwise by its end 50, the tapered helical externally threaded members 36, 40 are rotated such that their respective thread orientations cause those threads to trackway 24 and trackway 24, respectively. They move apart from each other along track path 28 . Similarly, as shaft 46 is rotated clockwise by its end 50, tapered male threaded members 36, 40 move closer together along trackway 24 and trackway 28, respectively.

[0096] As shown in Figure 2, step tracking is configured with a series of cascading ridges of increasing height. For example, each trackway has ridges 52-60 as shown for step tracking 18 in FIG. As the threads of the tapered male threaded member move into the gap between the ridges 52 and 54, the height of the tapered male threaded member body supported on the ridges 52, 54 increases within the housing 12. do. As the tapered external helical threaded member continues to move along the trackway, its threads migrate from the gap between ridges 52 and 54 and into the gap between ridges 54 and 56, thereby tapering. The male helical threaded member body is supported on the ridges 54 , 56 and thus rises further within the housing 12 . As the tapered external helical thread member continues its travel along the remainder of the step ridges 58,60, its positional height further increases. As the tapered helical external thread member body increases in height, it pushes the upper shell 14 away from the lower shell 16 as shown in the series of FIGS. 7A-7C.

[0097] The combined effect of rotating these tapered external helical thread members and moving them toward the outer ends of their respective trackways causes housing 12 to expand, as shown in FIG. A fully expanded shell is shown in FIG. The housing 12 may be contracted by reversing the movement of the tapered external helical thread members such that they move along their respective track paths toward the midpoint of the housing and back. The housing will optimally provide expansion and contraction to give the implant device a height ranging from about 7.8 mm to 16.15 mm in this embodiment. The device of this embodiment of the invention may be adapted to provide different expansion dimensions.

[0098] In each of the co-linear double track paths, the pair of tapered male helical threaded members may be rotated independently from the pair of tapered male helical threaded members in the parallel track path. In this configuration, the degree of expansion of that portion of the housing in the collinear track path can be varied to adjust the lordosis effect of the device. As an example shown in FIG. 8, the tapered external helical threads 36, 40 are spread a certain distance along the trackways 24 and 28, respectively, to space the upper shell 14 from the lower shell 16 and The housing 12 is thereby expanded. The tapered external helical threaded members 34, 38 are spread a shorter distance along the parallel trackways 22, 26, respectively, to space the portion of the upper shell above the trackways 22, 26 from the lower shell to a lesser degree. . The series of FIGS. 15A-15C show that the tapered male threaded members 36, 40 are spread apart from each other by further increasing increments as an effect of the above, but the tapered male threaded members 34, 38 are spaced the same relative distance. Indicates when to maintain.

[0099] In FIG. 15A, the arrangement of each of the sets of tapered external helical threads 36-40 is substantially the same in their respective tracking as the sets of tapered external helical threads 34-38. In this position, upper shell 14 is essentially parallel to lower shell 16 . In FIG. 15B, the sets of tapered external helical threads 36-40 have moved further distally apart along their tracking, when the sets of tapered external helical threads 34-38 have moved further apart along their tracking. remain in the same position. In this setting, the side edges of the top shell 14 along which the tapered male threaded members 36, 40 travel are higher relative to the side edges of the upper shell 14 along which the tapered male threaded members 34, 38 travel. , giving the upper shell 14 an inclination with respect to the lower shell 16 . In FIG. 15C, the set of tapered external helical threads 36-40 are moved further distally apart along their tracking relative to the set of tapered external helical threads 34-38, allowing the upper shell 14 to engage the lower shell. 16 gives a larger slope. Through independent movement of each tapered helical external threaded member set, the device can achieve a lordosis effect between 0° and 35° in this embodiment. The device of this embodiment of the invention may be adapted to provide different lordotic slopes.

[00100] The tapered helical externally threaded member has a shape with a body profile having a minor diameter that increases from _Dr1 to _Dr2 as shown in FIG. Thread 33 has a pitch that matches the spacing between ridge elements 52-60 in the trackway shown in FIG. Threads 33 may have a square profile to match the configuration between the ridges, although other thread shapes may be used as appropriate. The increasing diameter and tapered surface of the male helical thread member causes the upper shell 14 and lower shell 16 to move apart as described above. Contact with the tops of ridges 52-60 is made at the smaller diameter of the helically externally threaded member.

[00101] Thrust bearings are provided to limit the axial movement of the drive shaft within the shell 12. As shown in FIG. As shown in FIG. 9A, the thrust bearing 62 comprises a two-piece yoke shape that is press fit together around the end of the shaft. An upper portion 64 of the thrust bearing yoke defines an opening for receiving a circular cross-sectional portion 66 of the shaft end. In FIG. 9C, the square shaft 42 has a circular cross-sectional portion 66 with a smaller diameter than the square cross-sectional portion of the shaft. A thrust bearing mating piece 65 engages the upper portion 64 and surrounds a circular cross-sectional portion 66 of the drive shaft 42 .

[00102] Pin elements 68 in upper portion 64 and lower portion 65 engage corresponding holes 69 in the mating portions to provide a press fit of the thrust bearing about the shaft. A journal groove 67 may be provided in the thrust bearing 62 . Shaft 42 may have an annular projection 63 around its circular cross-sectional portion 66 received in journal groove 67, as shown in FIG. 9C. A thrust bearing is provided at each end of the drive shaft, as shown in FIG. 9B. As shown in FIG. 6, the thrust bearing limits axial movement of the drive shaft within the housing.

[00103] A safety lock is provided at the proximal end of the device to prevent unintended rotation of the shaft. As shown in Figures 12A and 12B, a safety locking member 70 is provided that engages the proximal ends of the drive shafts 42,46. The opening 73 in the safety lock member 70 is configured to match the shape of the cross-sectional configuration of the drive shaft (see Figure 13A). A portion of the drive shaft has a narrowed circular cross-sectional portion 71 that allows the drive shaft to rotate freely while the circular cross-sectional portion of the shaft is aligned with the safety lock member opening 73 (FIG. 13C). reference). This relationship is shown between safety lock member 70, thrust bearing 62, and drive shafts 42, 46 in FIG. 12B. When the unconstricted portion 75 of the shaft is placed in alignment with the safety lock member opening 73, rotation of the shaft is prevented (see Figure 13B). This relationship is shown between safety lock member 70, thrust bearing 62, and drive shafts 42, 46 in FIG. 12A. A compression spring 77 may be positioned between the thrust bearing 62 and the safety lock member 70 to force the safety lock member back onto the square portion 75 of the drive shaft. 12B shows the locking disengagement when the safety locking member 70 is pushed forward out of alignment with the square portion 75 and placed in alignment with the circular cross-section portions 71 of the shafts 42,46. A post 79 can be positioned between the safety lock member 70 and the thrust bearing 62 and a compression spring 77 can be positioned thereon. A post 79 may be fixedly connected to the safety lock member 70 and provided with an opening in the thrust bearing 62 through which the post 79 slides. Post 79 includes a head 81 to limit rearward movement of safety lock member 70 against the compressive force of spring 77 .

[00104] The interaction of the tapered helical external thread member with step tracking contributes to self-locking under the power screw theory. Several factors are relevant when considering variables for promoting the self-locking properties of tapered threaded members. Specifically, these factors include the coefficient of friction of the material used, such as Ti-6Al-4V grade 5, the pitch length of the male helical thread, and the average diameter of the tapered member. The following equations describe the relationship between these factors in determining whether a tapered helical externally threaded member can self-lock as it moves along step tracking.

[00105]

[00106] The above equation determines the torque required to be applied to the drive shaft engaging the tapered helical externally threaded member to expand the shell member. This torque depends on the average diameter of the tapered external helical thread member, the load exerted by the adjacent vertebral bodies (F), the coefficient of friction of the work material (f), and the lead (l) or pitch in this embodiment of the external helical thread. Dependent. All of these factors convert rotational motion into a linear lifting force and determine the operating torque required to separate the shell members in achieving extension and lordosis.

[00107] The following equations describe the relationship between the factors related to the torque required to reverse the tapered helical male threaded member back to tracking.
[00108]

[00109] Under this equation, the torque (T _L ) required to lower the tapered helical male threaded member must be a positive value. When the value of (T _L ) is zero or positive, self-locking of the tapered helical externally threaded member within step tracking is achieved. When the value of (T _L ) becomes negative, the tapered helical externally threaded member no longer self-locks in step tracking. Factors that may contribute to the inability to self-lock include compressive loads from the vertebral bodies, improper pitch and average diameter of the male helical thread, and insufficient coefficient of friction of the material. Conditions for self-locking are given below.

[00110]

[00111] Under this condition, the product should be a multiple of lead or, in this particular application, a larger multiple than the pitch, as well as a sufficient average diameter size of the tapered members to allow the tapered members to self-lock in step tracking. It is necessary to select in combination with Based on an average value with the patient lying down, the lumbar cone cross-sectional area is approximately 2239 mm2 and the axial compressive force across that area is 86.35N. For the work material selected as Ti-6Al-4V, the operating torque to expand the shell housing 12 between L4-L5 of the spine is approximately 1.312 lb-in (0.148 N-m) and the spine The operating torque to retract the shell housing 12 between L4-L5 of is approximately 0.264 lb-in (0.029 N-m).

[00112] Alternate embodiments of the expandable shell housing provide for a variety of surgical procedures. FIG. 11A shows housing 100 for use when a surgeon approaches the lumbar area from the anterior aspect of the patient. The overall configuration of the tracking path for this embodiment is similar to that for device 10, but the drive shaft for moving the tapered helical externally threaded member has torque delivered from a vertical approach. Added. To this end, as shown in FIG. 14, two sets of worm gears 102, 104 transmit torque to drive shafts 106, 108, respectively.

[00113] Figure 1 IB shows a housing 200 for use when a surgeon approaches the lumbar area from the posterior aspect of a patient. The overall configuration of the tracking path for this embodiment is similar to that for device 10, but torque is applied to the drive shaft from an offset approach. To this end, two sets of bevel gears (not shown) can be used to transmit torque to the drive shafts 206,208.

[00114] The housing 12 includes a number of niches and open spaces within its surface and interior regions to accommodate stored bone graft material. The intervening spaces between the cascaded step-tracking ridges also provide space for receiving bone graft material. As an aid, a membrane may be provided around the housing 12 to help maintain compression against the upper and lower shells and retain the bone graft material. A tension spring element 78 may be provided to hold the upper member 14 and lower member 16 together as shown in FIG. These elements can also act to provide an initial tension in the opposite direction of expansion to the interbody fusion device. This allows the tapered externally threaded member to climb the ridge when contact between the outer shell and the vertebral bodies has not yet been made.

[00115] This embodiment of the interbody fusion device of the present invention thus provides support between the vertebral bodies and is able to expand to accommodate loads placed against that region. Further, the interbody fusion devices of the present invention are capable of achieving configurations that can provide the appropriate lordotic slope to the affected area. This device therefore provides a significant improvement in terms of patient-specific disc height adjustment.

[00116] The device includes tools for manipulating the interbody fusion device as it is adjusted in situ within the patient's spine. Manipulation tool 300 is shown generally in FIG. 16 and includes handle member 302, gear housing 304, and torque rod members 306,308. A torque rod member is connected to the drive shaft of the expandable shell 12 . One embodiment for connecting the torque rod member to the drive shaft of expandable shell 12 is shown in FIG. In this configuration, the ends 48, 50 of the drive shafts 42, 46 can be provided with hexagonal heads. The ends of the torque rod members 306,308 may be provided with correspondingly shaped receptacles for tightening about the ends 48,50.

[00117] Within gear housing 304, handle member 302 drives torque rod member 308 directly. Torque rod member 308 comprises a spur gear member 310 and torque rod member 306 comprises a spur gear member 312 . Spur gear member 312 is slidably received on torque rod member 306 and is moveable into and out of engagement with spur gear member 310 . A spur gear lever 314 engages spur gear 312 to move spur gear 312 into and out of engagement with spur gear member 310 . When torque rod member 308 is rotated by handle 302 and spur gear 312 is engaged with spur gear 310 , rotation is transferred to torque rod member 306 . In this state, torque rod member 308 rotates drive shaft 46 at the same time that torque rod member 306 rotates drive shaft 42, causing shell 12 to expand, as shown in FIGS. 7A-7C. Spur gear 312 may be moved out of engagement with spur gear 310 by retracting spur gear lever 314, as shown in FIG. With spur gear 312 out of engagement with spur gear 310 , rotation of handle 302 only rotates torque rod member 310 . In this condition, the torque rod member 308 rotates only the drive shaft 46 while the drive shaft 42 remains stationary and the tilting of the upper member of the shell 12 as shown in FIGS. 8 and 15A-15C. occurs and lordosis is achieved.

[00118] To achieve expansion of the device in the described embodiment, the operator rotates handle member 302 clockwise to apply torque. This applied torque then engages a compound reversible spur gear train composed of spur gear members 310,312. This series of gears then rotates the torque rod members 306, 308 in opposite directions. Torque rod member 310 (which engages handle member 302) rotates clockwise (to the right) and torque rod member 306 rotates counterclockwise (to the left). The torque rod member then rotates the drive shaft of the interbody fusion device 12 to expand it to the desired height.

[00119] To achieve lordosis, the operator pushes the spur gear lever 314 back towards the handle member 302. As shown in FIG. By doing so, spur gear 312 connected to torque rod member 306 is disengaged from the entire gear train, thereby disengaging torque rod member 306 . As a result, only torque rod member 308 is engaged with interbody fusion device 12 . This allows the operator to contract the posterior side of the implant device to create the desired degree of lordosis.

[00120] Referring now to Figures 21-32, various embodiments of surgical manipulation tools or instruments according to the present disclosure will now be described.
[00121] FIG. 21A is a cut-away perspective view of an exemplary manipulation tool or instrument according to an embodiment of the present disclosure. Figure 21B is an exploded perspective view of the manipulation tool or instrument shown in Figure 21A. As shown, the exemplary manipulation tool 400 generally comprises a handle 402, drive shafts 404,406, a gear assembly 408, and optionally outer connecting or tubular shafts 414,416. Gear assembly 408 may be received within housing 410 . Drive shafts 404 , 406 and optionally outer tubular shafts 414 , 416 may be rotatably secured to housing 410 .

[00122] The handle 402 may be any suitable handle that allows a user to apply torque to the drive shafts 404,406. Handle 402 can be shaped in a variety of configurations, including I-shaped or T-shaped configurations. Handle 402 may be a bi-directional ratchet handle that can be torqued by rotating both clockwise and counterclockwise. Handle 402 may be a torque-limiting ratchet handle that can limit the torque applied by the user so that damage to the workpiece (not shown) occurs. In some embodiments, the workpiece is the expandable and adjustable spinal implant device described above in conjunction with FIGS. 1-15 and the handle 402 is for expanding, contracting and/or tilting the spinal implant device. is a two-way torque-limiting ratchet handle. Torque-limiting ratchet handles are available from, for example, Bradshaw Medical, Inc. of Kenosha, Wisconsin. It is commercially available from

[00123] The drive shafts 404, 406 may include a first drive shaft 404 and a second drive shaft 406. As shown in FIG. A first drive shaft 404 is operably connected to handle 402 and can be rotated by handle 402 . A second drive shaft 406 can be operably coupled to or decoupled from the first drive shaft 404 via a gear assembly 408, which is described in more detail below. . When the second drive shaft 406 is operably coupled with the first drive shaft 404, the handle 402 can rotate the first drive shaft 404 and the second drive shaft 406 together. A first mode of operation is provided. A second mode of operation is provided in which the handle rotates 402 only the first drive shaft 404 when the second drive shaft 406 is uncoupled from the first drive shaft 404 .

[00124] The first drive shaft 404 and the second drive shaft 406 each have a first portion 404a, 406a received within the housing 410 and a second portion extending from the housing 410 when assembled. 404b, 406b. First drive shaft 404 and second drive shaft 406 may be rotatably secured to housing 410 via screws 418 keys, pins, etc., described in more detail below. First drive shaft 404 and second drive shaft 406 may have substantially the same length and cross-sectional geometry along that length. Alternatively, first drive shaft 404 and second drive shaft 406 may have different lengths and cross-sectional geometries. First drive shaft 404 may be connected to handle 402 via adapter 420, which is described in more detail below. Alternatively, first drive shaft 404 may extend its length from housing 410 and connect with handle 402 .

[00125] FIGS. 22A-22C illustrate exemplary drive shafts that can be used as first drive shaft 404 and/or second drive shaft 406. FIG. As shown, the exemplary drive shaft 404 may include a first portion 404a and a second portion 404b. The first portion 404a can be received within the housing 410 and the second portion 404b can extend from the housing 410 when the operating tool 400 is assembled. The first portion 404a and the second portion 404b may be machined together as a single component or may be machined separately and then assembled. The first portion 404a and the second portion 404b are generally cylindrically shaped and may have the same or different diameters.

[00126] The first portion 404a of the drive shaft 404 may include a portion 404d at the proximal end configured to receive a gear member, adapter, or dial described in more detail below. For example, portion 404d at the proximal end of first portion 404a may receive a gear member, adapter, or dial having channels, cutouts, or apertures with corresponding flattened and cylindrical surfaces. It may include structured flattened surfaces and residual cylindrical surfaces. The flattened surface prevents rotational movement of the gear member, adapter, or dial relative to drive shaft 404 when the gear member, adapter, or dial is received on portion 404d. At the distal end, first portion 404a of drive shaft 404 may include an undercut or groove forming a rounded portion 404e having a reduced diameter. The undercut or groove fits or seals a screw, key, pin, or the like within rounded portion 404e, thereby limiting drive shaft 404 from axial movement or slippage from housing 410, while the drive Provides space to allow shaft 404 to rotate freely.

[00127] The second portion 404b extends from the first portion 404a and includes a workpiece engaging tip 404c having features configured to engage a workpiece. As shown, workpiece engaging tip 404c has a Torx or hexalobular configuration. Other suitable configurations or features known in the art may be used to engage workpieces with corresponding engagement features. The workpiece may be the spinal implant device described above in conjunction with FIGS. 1-15. The work piece may be any other device operable to expand, contract or tilt by using a manipulation tool.

[00128] Returning to FIGS. 21A-21B, a gear assembly 408 couples the second drive shaft 406 to the first drive shaft 404 or connects the second drive shaft 406 to the first drive shaft 404. It acts to decouple from shaft 404 . In some embodiments, gear assembly 408 also engages second drive shaft 406 and first drive shaft 404 such that rotation of first drive shaft 404 and second drive shaft 406 is impeded. can be locked. As shown, the gear assembly 408 includes a first gear member 408a received on the first drive shaft 404, a second gear member 408b received on the second drive shaft 406, and a second gear member 408b. and a lever member 408c operable to engage and disengage the first gear member 408b with the first gear member 408a.

[00129] The first gear member 408a may be fixedly secured to the first drive shaft 404 via a screw, key, pin, or the like. A second gear member 408 b may be slidably received on the second drive shaft 406 . The lever member 408c may be coupled to a second drive shaft 406 configured to move the second gear member 408b along the second drive shaft 406, thereby driving the second gear member 408b. engages the first gear member 408a, disengages the first gear member 408a, or allows the first gear member 408a to be locked in a locked position described in more detail below. FIG. 23 shows an exemplary lever member 408c that can be used in manipulating tool 400. As shown in FIG. As shown, lever member 408c may include first and second annular rings 422a and 422b separated by a generally U-shaped structure 424 coupled with bar member 426, for example. When assembled, first ring 422 a and second 422 b of lever member 408 c are slidably received on second drive shaft 406 and rod member 426 projects from housing 410 . A second gear member 408b, which may be slidably received on the second drive shaft 406, is held between the first and second annular rings 422a, 422b and moved by the bar member 426. be.

[00130] FIGS. 24, 25 and 26 better show the gear assembly 408 within the housing 410. FIG. In FIG. 24, lever member 408c is disposed in a proximal or first position, which allows second gear member 408b to engage first gear member 408a, thereby allowing the second gear member 408b to engage first gear member 408a. Drive shaft 406 is operatively coupled with first drive shaft 404 . When second drive shaft 406 is operably coupled to first drive shaft 404, rotation of first drive shaft 404 by handle 402 causes second drive shaft 406 to rotate and For example, providing a first mode of operation in which an expandable spinal implant device can be expanded or contracted. In FIG. 25, lever member 408c is positioned in a distal or second position, which allows second gear member 408b to disengage first gear member 408a, thereby allowing the second gear member 408b to disengage first gear member 408a. drive shaft 406 from the first drive shaft 404 . When the second drive shaft 406 is uncoupled from the first drive shaft 404, the handle 402 rotates only the first drive shaft 404 while the second drive shaft 406 is uncoupled. It provides a second mode of operation that can be activated and tilt the spinal implant device, for example.

[00131] In some embodiments, the lever member 408c is configured such that the second gear member 406 and the first gear member 404 are locked within the housing 410 and the first drive shaft 404 and the second drive shaft 404 are locked. It can be placed in a third position where rotation of 406 is prevented. In FIG. 26, the lever member 408c is centered between the proximal and distal positions and the second gear member 408b is positioned between the first gear member 408a and the housing, as discussed in more detail below. Allows engagement with either of the toothed formations 428 built into 410 . When the second gear member 408a is in contact or engagement with the toothed formation 428, the rotation of the second gear member 408b is restricted so that the rotation of the first gear member 408a is also restricted to the second gear member. Limited by engagement with gear member 408b. When the lever member 408c is placed in the third position, the operating tool 400 is locked and rotation of the first drive shaft 404 and the second drive shaft 406 is prevented.

[00132] Returning to FIGS. 21A-21B, in some embodiments, the operational tool 400 includes outer connections or tubular shafts 414, 416 configured to connect the operational tool 400 to a workpiece, such as a spinal implant device. can include Outer connecting shafts 414 , 416 include a first tubular shaft 414 surrounding a second portion 404 b of first drive shaft 404 extending from housing 410 and a second tubular shaft 406 of second drive shaft 406 extending from housing 410 . and a second tubular shaft 416 surrounding portion 406b. First tubular shaft 414 and second tubular shaft 416 may be rotatably secured to housing 410 such that first tubular shaft 414 and second tubular shaft 416 are rotatably secured to housing 410, as described in more detail below. are prevented from sliding out of housing 410 while free to pivot or rotate independently of the rotation of first drive shaft 404 and second drive shaft 406, respectively.

[00133] FIGS. 27A-27C illustrate exemplary tubular shafts that can be used as the outer connecting shafts 414,416. As shown, exemplary tubular shaft 414 may be generally cylindrical with an inner diameter that is greater than the outer diameter of the second portion of drive shaft 404 . Tubular shaft 414 has a first end portion 414a configured to be rotatably secured to housing 410 and a second end portion 414b having features configured to interface with a workpiece. can include A finger grip 414c, which may be machined as an integral part of the tubular shaft, may be provided to interface with the workpiece to facilitate rotation or pivoting of the tubular shaft. As shown in detail in FIG. 27C, first end portion 414a of tubular shaft 414 may include an undercut or groove forming a rounded portion 414d having a reduced diameter. When assembled, the screw 419 (FIG. 21B), key, pin, etc. fits within the space within the undercut or groove or seals against the rounded portion 414d, thereby allowing axial movement of the tubular shaft 414. to prevent it from slipping or sliding out of the housing, while allowing the tubular shaft 414 to rotate freely. Second end portion 414b of tubular shaft 414 may include internal threads or other suitable features configured to connect with a workpiece such as a spinal implant device having corresponding connection features such as external threads.

[00134] Returning to Figures 21A-21B, the manipulator tool 400 receives or surrounds the gear assembly 408 to rotatably secure the drive shafts 404, 406 and, optionally, the outer connecting shafts 414, 416. may include a housing 410 configured to: 28A-28E show exemplary housings according to embodiments of the present disclosure. As shown, housing 410 may be ergonomically shaped to facilitate holding by a user. Housing 410 may also be designed in any other suitable shape or configuration. Housing 410 may include a proximal first end portion 410a of handle 402 and a distal second end portion 410b of handle 402 . A cavity 430 may be provided in the first end portion 410 a to receive the gear assembly 408 . A toothed formation 428 may be constructed in the interior surface of the housing to receive or lock the second gear member 408b. An opening 432 is provided in the side of housing 410 to receive rubber slide 409 and allow displacement of lever member 408c. Channels 434a, 434b may be provided to receive the first portions 404a, 406a of the first drive shaft 404 and the second drive shaft 406, respectively. Channels 436 a , 436 b may be provided in second end portion 410 b of housing 410 to receive first end portions 414 a , 416 a of first tubular shaft 414 and second tubular shaft 416 . A second end portion 410b of the housing 410 has an aperture or passage 438 for receiving a screw 418, pin, key, etc. (FIG. 21B) to rotatably secure the drive shafts 404, 406 to the housing 410. can be provided. Optionally, apertures or passages 440 may be provided to receive screws 419, pins, keys, etc. (FIG. 21B) to rotatably secure the outer connecting shafts 414, 416 to the housing 410.

[00135] FIG. 29 more clearly shows the drive shafts 404, 406 and the outer connecting shafts 414, 416 rotatably secured to the second end 410b of the housing 410. FIG. As shown, when assembled, screws 418, keys, pins, etc., may engage the reduced diameter round portions of first drive shaft 404 and second drive shaft 406 to provide a drive shaft. It prevents the shafts 404, 406 from axially sliding out of the housing 410, while allowing the drive shafts 404, 406 to pivot or rotate freely. Similarly, a screw 419 , key, pin, or the like may be fitted to the reduced diameter round portions of the first tubular shaft 414 and the second tubular shaft 416 such that the tubular shafts 414 , 416 axially extend into the housing 410 . while allowing tubular shafts 414, 416 to pivot or rotate freely.

[00136] Returning to FIGS. FIG. 30 shows an exemplary adapter 420 according to embodiments of the present disclosure. As shown, the adapter 420 can include a first end portion 420a and a second end portion 420b. A first end portion 420 a of adapter 420 may be shaped and sized to be received by handle 402 . Second end portion 420 b may include channel 442 configured to receive first drive shaft 404 . As shown, channel 442 allows end portion 404d (FIG. 22A) of first drive shaft 404 to slide freely into and out of channel 442 during assembly or disassembly. , may be shaped or configured to prevent drive shaft 404 from rotating relative to adapter 420 after end portion 404 d is received within channel 442 . An aperture or passageway 444 may be provided on the side of the second end portion 420b for receiving screws, keys, pins, etc. to secure the first drive shaft 404 to the adapter 420. As shown in FIG. The use of an adapter allows first drive shaft 404 and second drive shaft 406 to be of the same length and/or geometry. Therefore, the first drive shaft 404 and the second drive shaft 406 can be manufactured in the same style, reducing the number of parts required for manufacturing, thereby significantly reducing the cost of the operating tool 400. be able to.

[00137] Returning to FIGS. 21A-21B, the manipulation tool 400 may include a first dial 446 for providing information to the user about the rotation of the first drive shaft 404. As shown in FIG. In operation, first dial 446 is operably coupled to first drive shaft 404 and can be rotated therewith. FIG. 31 shows an exemplary dial that can be used as the first dial of the manipulation tool. As shown, the first dial 446 allows the dial rotation markings 448 to mate with the first drive shaft 404 or an adapter 420 coupled to the first drive shaft 404 . and an aperture 450 configured to. In use, first dial 446 rotates with first drive shaft 404 and indicia 448 on first dial 446 provide information to the user about rotation of first drive shaft 404 .

[00138] Referring to FIGS. 21A-21B, the manipulation tool 400 may also include a second dial 452 for providing information about the rotation of the second drive shaft 406 to the user. In operation, the second dial 452 is operably coupled to the second drive shaft 406 and can be rotated therewith. FIG. 32 shows an exemplary dial 452 that can be used as the second dial of the manipulation tool. As shown, the second dial 452 may include dial rotation markings 454 and a portion having a channel 456 configured to receive the second drive shaft 406 . In use, second dial 452 rotates with second drive shaft 406 and indicia 454 on second dial 452 provide information to the user about rotation of second drive shaft 406 . When in operation second drive shaft 406 is coupled to first drive shaft 404 by gear assembly 408 and handle 402 rotates first drive shaft 404 and second drive shaft 406 together. , the first dial 446 and the second dial 452 rotate together to provide an indication to the user about the first mode of operation of the manipulation tool. When second drive shaft 406 is uncoupled from first drive shaft 404 by gear assembly 408 and handle 402 rotates only first drive shaft 404, a Only the associated first dial 446 rotates to provide an indication to the user as to the second operational mode of the manipulator.

[00139] Referring to Figures 21A-21B, in use, the manipulation tool 400 may be connected to a workpiece such as a spinal implant device (not shown) via outer connections or tubular shafts 414,416. A user may pivot or rotate the outer connecting shafts 414, 416, for example, inwardly to thread the manipulation tool 400 onto the implant device. When connecting with the implant device, the user first places the lever member 408c in the locked position (eg, the central position in FIG. 26) so that the gear members 408a, 408b are locked within the housing 410 and the drive shaft Rotation of 404 , 406 may be prevented by handle 402 .

[00140] After the operating tool 400 has been connected with the implant device, to effect expansion of the implant device, the user places the lever member 408c in the expanded position (eg, the proximal position in FIG. 24) such that , the first gear member 408 a and the second gear member 408 b may be released from the locked position and engaged to couple the first drive shaft 404 and the second drive shaft 406 . The user may then rotate handle 402 in a direction, eg clockwise, to apply torque to first drive shaft 404 . Rotation of the first drive shaft 404 simultaneously causes rotation of the second drive shaft 406, thereby effecting expansion of the implant device in fine increments. If desired, the user may rotate handle 402 in the opposite direction, eg, counterclockwise, to retract or fine tune the level of expansion of the implant device. In some embodiments, gear members 408a, 408b are configured such that rotation of first drive shaft 404 in a first direction, eg, clockwise, rotates in a second direction opposite to the first direction, eg, counterclockwise. It may be configured to cause rotation of the second drive shaft 406 in a clockwise direction. Alternatively, gear members 408a, 408b may be configured such that rotating handle 402 causes first drive shaft 404 and second drive shaft 406 to rotate in the same direction.

[00141] To achieve lordosis, the user places lever 408c in a lordosis position (eg, the distal position in FIG. 25) such that first gear member 408a and second gear member 408 b may be disengaged, thereby uncoupling the second drive shaft 406 from the first drive shaft 404 . The user may then rotate handle 402 in a direction, eg, clockwise, applying torque to first drive shaft 404 only, as second drive shaft 406 becomes inactive. Rotating only the first drive shaft 404 tilts the implant device, thereby achieving lordosis. If desired, the user can rotate the handle 402 in the opposite direction, eg counterclockwise, to adjust or remove the level of lordosis.

[00142] To disconnect the operating tool 400 from the implant device, the user places the lever member 408c in the locked position and then pivots the outer connections or tubular shafts 414, 416, for example, outwardly to remove the operating tool 400 from the implant. It can be unscrewed from the device.

[00143] An embodiment of a surgical instrument has been described. Those skilled in the art will appreciate that various other modifications can be made within the spirit and scope of the invention. For example, although exemplary surgical instrument embodiments are described with drawings showing a straight drive shaft and a straight outer connecting shaft, in some embodiments the drive shaft and, optionally, the outer connecting shaft are , for example in the range of 0 to 90 degrees with respect to the straight portions of the drive shaft and the outer connecting shaft. An angled drive shaft allows the surgeon to reach the lumbar disc space in some patients where straight access is not possible. The angled and straight sections may be machined as a single drive or outer connecting shaft component, or may be machined separately and then assembled as the drive or outer connecting shaft. In some embodiments, the angled portion may be an adapter type piece that can be inserted or connected to an existing set of straight drive shafts or external connecting shafts. By way of example, the outer connecting shaft can be angled through ball joint variations that allow for perpendicular torqueing. The drive shaft can be angled through some variation of a ball joint, worm gear, or bevel gear arrangement that allows for orthogonal torqueing.

[00144] Various embodiments of surgical instruments will now be described with reference to Figures 33-57.
[00145] FIG. 33 is an exploded view of an exemplary surgical instrument 500 according to an embodiment of the present disclosure. 34 is a partial cross-sectional view of instrument 500. FIG. As shown, the instrument 500 generally includes a handle 502, a housing 540, a chassis 560, a pair of drive shafts 510, 512, a pair of sleeves 520, 522, a gear assembly 580, and a switch or switch assembly 610. and a lock or bearing lock assembly 630 . A handle 502 may be operably coupled to a pair of drive shafts 510, 512 through which to apply torque to a workpiece, such as an interbody fusion device (not shown), to expand, contract, and/or extend the fusion device. Allows to perform lordosis. Pair sleeves 520, 522, which enclose a portion of the pair of drive shafts 510, 512 outside housing 540, serve to connect instrument 500 to a workpiece, such as an interbody fusion device. Housing 540 surrounds and protects gear assembly 580 , bearing lock assembly 630 , portions of drive shafts 510 , 512 and sleeves 520 , 522 , and other components supported by chassis 560 . Chassis 560 serves as the foundation for instrument 500 and supports drive shafts 510 , 512 , sleeves 520 , 522 and housing 540 . Chassis 560 also serves as a partial housing for gear assembly 580 and other components. Switch assembly 610 operates in conjunction with gear assembly 580 to provide various operating modes of instrument 500 . Bearing lock assembly 630 operates to lock or unlock drive shafts 510 , 512 and sleeves 520 , 522 within housing 540 to chassis 560 . FIG. 35 is a perspective view of an assembled instrument 500 according to an embodiment of the present disclosure.

[00146] Referring to Figures 33 and 34, the handle 502 may be any suitable handle that allows a user to apply torque to the drive shafts 510,512. The handle 502 can be driven manually or by a motor or robot. Handle 502 can be shaped in a variety of configurations, including I-shaped or T-shaped configurations. Handle 502 may be a bi-directional ratchet handle that can be torqued by rotating both clockwise and counterclockwise. Handle 502 may be a torque-limiting ratchet handle that can limit the torque applied by the user so that damage to the workpiece does not occur. In some embodiments, the workpiece is an interbody fusion device, and the handle 502 is for expansion, contraction, lordosis, kyphosis, and/or coronal adjustment of the device. Bidirectional torque limiting ratchet handle. Torque-limiting ratchet handles are available, for example, from Bradshaw Medical, Inc. of Kenosha, Wisconsin. It is commercially available from

[00147] The handle 502 can be removed and replaced with a striking cap 503. FIG. 36 is a perspective view of an exemplary surgical instrument 500 including a striking cap 503 according to an embodiment of the present disclosure. The striking cap 503 can be made of stainless steel and allows the user to exert forward force through the instrument by striking the striking cap with, for example, a mallet. This feature of the instrument may, for example, help push or drive the interbody fusion device into the patient's vertebral space more easily. The striking cap 503 can avoid or reduce damage to instruments when hammering forces are applied during a surgical procedure.

[00148] In some embodiments, the handle 502 or striking cap 503 may be removed and replaced with a slap hammer. Following expansion and adjustment of the device, or perhaps even partial fixation of the device in secondary removal surgery, if the surgeon wishes to remove the implant, the slaphammer applies a pulling or removal force to the instrument 500 and It can help provide an interbody fusion device. FIG. 55 is an isometric view of an exemplary surgical instrument including a slap hammer 670 according to an embodiment of the present disclosure. 56 is an isometric exploded view of the exemplary surgical instrument shown in FIG. 55; FIG. FIG. 57 is an isometric view of an exemplary slap hammer according to embodiments of the present disclosure; As shown, slap hammer 670 may include elongated rod 672 and hammer weight 674 . Hammerweight 674 is configured to be grasped by a user and can slide along elongated rod 672 when a force is applied. A first or proximal end of the elongated rod 672 may be provided with a stop 676 to prevent the hammer weight 674 from falling off the elongated rod 672 . Stopper 676 may be removably coupled to rod 672 via a threaded connection, for example. A second or distal end of elongated rod 672 may be provided with a connection site 678 for coupling slap hammer 670 with instrument 500 . By way of example, connection site 678 may be configured to allow slap hammer 670 to be coupled to adapter 504 of instrument 500 via a threaded connection, a clip-on connection, a slotted "keyed" connection, or the like.

[00149] Referring to FIGS. 33-34, housing 540 encloses gear assembly 580, chassis 560, bearing lock assembly 630, drive shafts 510, 512 and portions of sleeves 520, 522, etc., to protect them from contamination by biomaterials. Protect the component and/or prevent outside objects from interfering with or interfering with component operation. Housing 540 may be constructed of a material that can withstand the high sterilizing steam temperatures many times and/or that provides mechanical strength to the instrument. Suitable materials for constructing the housing 540 include stainless steel, medical grade plastics such as Radel® R5500 polyphenylsulfone (PPSU), commercially available from Solvay Advanced Polymers of Brussels, Belgium. The housing 540 can be aesthetically shaped and/or ergonomically shaped for the user holding the instrument.

[00150] Referring to FIG. 37, housing 540 may include a proximal first end portion 542 of handle 502 and a distal second end portion 544 of handle 502. As shown in FIG. At the first end portion 542, the housing 540 can include two housing covers 546a, 546b. The housing covers 546a, 546b may be separate pieces that are secured to the chassis 560, eg, with screws 548, bolts, or the like. Housing covers 546a, 546b can be detached from chassis 560 to help clean the instrument more efficiently during cleaning and sterilization and to allow the interior of the instrument to dry quickly following sterilization. can be done. Removable housing covers 546a, 546b allow the gear assemblies, gear locks, and other components inside the chassis or housing to be exposed for faster and more efficient drying following sterilization. enable. The housing covers 546a, 546b can be constructed from medical grade plastic or metal such as stainless steel to add mechanical strength to the instrument. In some embodiments, housing covers 546a, 546b may each be configured to provide shoulders 550a, 550b for striking cap 503 to seat (FIGS. 33 and 36). As mentioned above, in some circumstances it may be desirable to exert an anterior force through the instrument, for example to help push or drive the interbody fusion device into the patient's vertebral space. By removing the handle 502 from the instrument and attaching the striking cap 503, the user can exert a forward force through the instrument by striking the striking cap with, for example, a mallet. Because the striking cap 503 sits on shoulders 550a, 550b of the housing 540 and is not connected to the drive shafts 510, 512 or other functional components, the striking force applied to the striking cap 503 is reduced to the body of the instrument. will be evenly distributed over the cross-sectional area of the instrument and will not damage the instrument. FIG. 38 shows a housing 540 enclosing a chassis 560 with housing covers 546a, 546b attached to the chassis 560 to provide shoulders 550a, 550b that allow the striking cap to sit.

[00151] At the second end portion 544 of the housing 540, the housing 540 includes an opening 552 configured to allow the main portion of the chassis 560 to be disposed therein. Housing 540 may sit on bottom base 567 of chassis 560, which may include a raised rim 571 surrounding the distal end of housing 560 (FIG. 43). Threads may be provided on the distal end of housing 560 to connect to chassis 560 . A gasket may be used to provide a tight fit and seal to prevent biomaterials and water from entering the housing. Two sub-housings or chambers 554a, 554b may be provided in the second end portion to accommodate the bearing lock assembly 630, as described in more detail below. The sub-housings 554a, 554b may be integrally formed with the main body of the housing and positioned opposite each other. The sub-housings 554a, 554b allow the retaining plates 652, 654 of the bearing lock assembly 630 (FIG. 54) to be inserted inside through a press fit and easily removed for cleaning and sterilization, as described below. can be configured to Apertures are provided in the sidewalls of the sub-housings 554a, 554b to allow access of a torquing tool to the fasteners and connection of the fasteners to the bearings of the bearing lock assembly 630, as described in more detail below. can be provided. 39 is a perspective end view of housing 540 showing opening 552 configured to receive the chassis and sub-housings 554a, 554b for bearing lock assembly 630. FIG. 40 is a perspective front view of housing 540. FIG.

[00152] Referring to FIG. Guide track 556 may include slots that correspond to different operating modes or settings when switched on. Markings 558 may be provided next to the guide track 556 to indicate various operating settings. In some embodiments, a gasket 559 (FIG. 42) may be coupled to guide track 556 to allow the user to operate the switch more smoothly and seamlessly. Gasket 559 may also help keep biomaterial from entering the inside of the housing through the switch site. FIG. 42 schematically illustrates an exemplary gasket 559. FIG. Gasket 559 may fit over hooks in guide track 556 by tension or by other suitable means. Gasket 559 may be made of a resilient material such as silicone rubber. The silicone rubber material allows the gasket to withstand high sterilization temperatures without melting or deforming.

[00153] Referring to FIGS. Chassis 560 supports drive shafts 510 , 512 , sleeves 520 , 522 and housing 540 . The top of chassis 560 may also serve as a partial housing for gear assembly 580 and other components and provide a fixing point for housing covers 546a, 546b. Chassis 560 may be constructed from metal, such as stainless steel, or medical-grade plastic, such as Radel® R5500 polyphenylsulfone (PPSU), to provide a sturdy surgical instrument so that it will not break if it falls to the floor. . Chassis 560, together with housing 540 and striking cap 503, allows the user to apply a hammering force to the instrument without damaging it. Including chassis 560 in instrument 500 simplifies assembly, disassembly, and cleaning of the instrument.

[00154] Figure 43 schematically illustrates an exemplary chassis 560 according to an embodiment of the present disclosure. As shown, chassis 560 may generally include a first or lower portion 561 and a second or upper portion 563 . Lower portion 561 may include a main body 562 that supports drive shafts 510,512 and sleeves 520,522. Upper portion 563 may include spaced apart arms 564 that define a partial housing 565 for gear assembly 580, gear lock 592, and switch assembly 610, as described in more detail below.

[00155] In the lower portion 561 of the chassis 560, the main body 562 may include a pair of elongated channels 566 extending between a bottom base 567 and an upper base 568. As shown in FIG. Pairs of elongated channels 566 may be provided parallel to each other along opposite sides of main body 562 . Channel 566 may be configured, for example, to have a generally arcuate surface to allow a generally cylindrical drive shaft or sleeve to fit and pivot. A plurality of ridges 569 may be provided on the channel surface to keep the drive shaft and sleeve tight against the chassis when tightened by the bearing lock assembly 630, as described in more detail below. Ridges 569 on the channel surface may keep the drive shaft and sleeve pressed tight against the chassis 562 to limit free axial movement of the drive shaft and sleeve when fastened. A divider 570 may be provided to divide the channel 566 into two sections. Partition 570 allows separate bearings to lock the draft shaft and sleeve to the chassis independently of each other. For example, drive shaft bearings 632, 634 may lock drive shafts 510, 512 to chassis 560 in the upper section of channel 566, while sleeve bearings 642, 644 may lock sleeves 520, 522 in the lower section of channel 566 ( 44 and 45) can be fixed to the chassis 560. FIG. Partition 570 may keep drive shaft bearings 632, 634 and sleeve bearings 642, 644 separate from one another during assembly and operation, allowing the bearings to rest on chassis 560 as a support structure. Bottom base 567 has a raised rim 571 to allow housing 540 to rest on chassis 560 . Apertures 572 provided in bottom base 567 allow drive shafts 510, 512 and sleeves 520, 522, respectively, to pass through channels 566 on chassis 560 and fit therein. Upper base 568 includes openings 573 to allow drive shafts 510 , 512 to pass through and extend into partial housing 565 defined by spaced apart arms 564 . Upper base 568 may also support gear assembly 580 and gear lock 592 while adding strength to the chassis or surgical instrument.

[00156] In an upper portion 563 of chassis 560, spaced apart arms 564 define a partial housing 565 for gear assembly 580, gear lock 592, and switch assembly 610. As shown in FIG. Arm 564 may also be configured to secure gear lock 592, as described in more detail below. For example, arm 564 may be configured with an inner surface contour that mates with the outer surface contour of gear lock 592 . By way of example, arm 564 may have a convex inner surface portion that mates with a concave outer surface portion of gear lock 592 so that gear lock 592 bends and/or slides into partial housing 565, When seated on upper base 568, gear lock 592 is fixed and will not rotate when torque is applied. Alternatively, arm 564 may have a concave inner surface portion that mates with a convex outer surface portion of gear lock 592 . Arms 564 may include features such as internally threaded holes 574 for securing housing covers 546a, 546b to chassis 560 (FIGS. 37 and 38).

[00157] FIG. 44 is a perspective view showing chassis 560 with drive shaft bearings 632, 634 and sleeve bearings 642, 644 located on main body 562 in lower portion 561, gear lock 592 and gear assembly. 580 is housed within a partial housing 565 within upper portion 563 . 45 is a partial perspective view showing chassis 560 with gear lock 592 and gear assembly 580 housed within a partial housing within upper portion 563 and pair of drive shafts 510, 512 (FIG. 44 shows a (not shown) and sleeves 520 , 522 are secured within lower portion 561 onto main body 562 by bearing lock assembly 630 . In FIG. 45, housing 560 has been removed to more clearly show the orientation between chassis 560 and bearing lock assembly 630, which are discussed in more detail below.

[00158] Referring to Figures 33 and 34, a pair of drive shafts 510, 512 are operably coupled to the handle 502 to apply torque to a workpiece (not shown). A pair of drive shafts 510 , 512 may include a first drive shaft 510 and a second drive shaft 512 . First drive shaft 510 may be operably connected to handle 502 via adapter 504, for example. Second drive shaft 512 may be coupled or uncoupled from first drive shaft 510 via gear assembly 580 . A first operation in which the handle 502 can rotate the first drive shaft 510 and the second drive shaft 512 together when the second drive shaft 512 is operably coupled with the first drive shaft 510 mode is provided. A second mode of operation is provided in which the handle 502 rotates only the first drive shaft 510 when the second drive shaft 512 is decoupled from the first drive shaft 510 .

[00159] The pair of drive shafts 510, 512 may be rotatably secured within the housing 540 to the chassis 560 by a bearing lock assembly 630, which is described in more detail below. Each pair of drive shafts 510, 512 may include a first portion 510a, 512a received within housing 540 and a second portion 510b, 512b extending from housing 540 when assembled. A first portion 510 a , 512 a of the pair of drive shafts 510 , 512 may be received within a pair of elongated channels 566 of chassis 560 and configured to be rotatably secured to chassis 560 . For example, the first portions 510a, 512a of the pair of drive shafts 510, 512 may include increased diameter sections and grooves 510c, 512c to provide space for the bearing notches to fit or seal; This restricts the drive shafts 510, 512 from sliding out of the housing 540 while allowing them to rotate freely. A first portion 510a, 512a of the pair of drive shafts 510, 512 may extend into a partial housing 565 of chassis 560 for receiving a gear member, dial, or adapter. For example, the first portions 510a, 512a are configured to receive gear members, adapters, or dials, which may include channels, cutouts, or apertures with corresponding flattened and cylindrical surfaces. It may include a flattened surface at the proximal end and a remaining cylindrical surface. When the gear member, adapter, or dial is received on the first portion 510a, 512a, the flattened surface is aligned with the drive shaft 510 of the gear member, adapter, or dial when secured with set screws or the like. , 512 is prevented. The pair of drive shafts 510, 512 may have substantially the same length and cross-sectional geometry along that length. Alternatively, the pair of drive shafts 510, 512 may have different lengths and cross-sectional geometries. For example, first drive shaft 510 may extend its length and connect directly to handle 502 without the need for an adapter.

[00160] The second portions 510b, 512b of the drive shafts 510, 512 include tips 510d, 512d having features configured to engage a workpiece. The workpiece engaging tip may have a Torx or Hexalobular or a modified Torx or Hexalobular configuration. Other suitable configurations or features known in the art may also be used to engage workpieces with corresponding engagement features. The workpiece may be an interbody fusion implant device as described in US Pat. No. 9,889,019, the entire disclosure of which is incorporated herein by reference in its entirety. The work piece may be any other device operable to expand, contract, or tilt through the use of surgical instruments.

[00161] Referring to Figures 33-34, a pair of sleeves or tubular shafts 520, 522 operate to connect the surgical instrument 500 to a workpiece such as an interbody fusion implant device. The pair of sleeves 520 , 522 includes a first sleeve 520 surrounding a second portion 510 b of first drive shaft 510 extending from housing 540 and a second portion 512 b of second drive shaft 512 extending from housing 540 . and a surrounding second sleeve 522 . The pair of sleeves 520, 522 may be rotatably secured to the chassis 560 via a bearing lock assembly 630, as described below, so that the sleeves 520, 522 are aligned with the pair of drive shafts 510, 512 during surgery. It is free to pivot or rotate independently of the rotation of the body and is restricted from sliding out of housing 540, but may be removed following surgery for cleaning and sterilization purposes.

[00162] The pair of sleeves 520,522 may be generally cylindrical having an inner diameter that is greater than the outer diameter of the second portions 510b, 512b of the drive shafts 510,512. Sleeves 520, 522 each have first end portions 520a, 522a configured to be rotatably secured to chassis 560 within housing 540 and features configured to interface with a workpiece. second end portions 520b, 522b. Finger grips 520c, 522c may be provided on sleeves 520, 522, respectively, to facilitate rotation or pivoting of the sleeves connected to the workpiece. A first end portion 520a, 522a of the pair of sleeves 520, 522 may be received within an elongated channel 566 of the chassis 560 and configured to be rotatably secured to the chassis. The first end portions 520a, 522a of the pair of sleeves 520, 522 may each include grooves 520d, 522d to provide space for the bearing notches to fit or seal, thereby allowing the sleeves 520, 522 to from sliding out of housing 540 while allowing sleeves 520, 522 to rotate freely. Second end portions 520b, 522b of sleeves 520, 522 may include internal threads or other suitable features configured to connect with a workpiece such as a spinal implant device having corresponding connection features such as external threads. .

[00163] Referring to FIGS. 33 and 34, a gear assembly 580 couples the second drive shaft 512 with the first drive shaft 510 or couples the second drive shaft 512 from the first drive shaft 510. It acts as a release and offers various modes of operation. In some embodiments, gear assembly 580 may lock second drive shaft 512 and first drive shaft 510 such that rotation of first drive shaft 510 and second drive shaft 512 is prevented. .

[00164] Gear assembly 580 may include a pair of spur gears having substantially parallel gear axes. A first gear member 581 may be received on the first drive shaft 510 and a second gear member 582 may be received on the second drive shaft 512 (FIGS. 48-50). The first gear member 581 may be fixedly secured to the first drive shaft 510 via screws, keys, pins, or the like. A second gear member 582 is slidably received on the second drive shaft 512 but is fixed against rotation relative to the second drive shaft via a set screw, key, pin, or the like. . Toggle switch 610 is received on and slidably movable on second drive shaft 512 to engage second gear member 582 with first gear member 581, as described in more detail below. and disengage.

[00165] FIG. 46 schematically illustrates an exemplary gear member 586 that may be used in gear assembly 580 according to embodiments of the present disclosure. As shown, gear member 586 includes a plurality of teeth 587 each having two opposite sides 588a, 588b extending between two end faces 590a, 590b. Tooth flanks 588a, 588b may be generally parallel to the axis of gear member 586 configured to engage teeth of a mating gear member. At least one end of gear member 586, or preferably both ends of gear member 586, end faces 590a, 590b of teeth 587 are beveled or chamfered. The surfaces between adjacent teeth at the end faces can also be beveled. A beveled or lofted cutting feature along one or both ends of the gear member teeth allows the gears to smoothly displace from each other and have a seamless transition when the user operates the switch 610. It allows you to mesh and return.

[00166] Referring to Figures 33 and 34, the switch assembly 610 allows the user to operate the instrument 500 smoothly and seamlessly via an intuitive interface. By way of example, the user may press a first position provided within the switch guide 556 (Fig. 41) that allows the second gear 582 and the first gear 581 to be engaged, e.g. Position switch assembly 610 to a second position that allows second gear 512 and first gear 510 to be disengaged, e.g., a "lordosis mode" position, or a second gear member. 512 may be placed in a third position, eg, a “lock mode” position, which allows 512 to engage both first gear member 510 and gear lock 592 .

[00167] FIG. 47 schematically illustrates a toggle switch 610 that may be used within surgical instrument 500 according to embodiments of the present disclosure. As shown, the toggle switch 610 has first and second ring structures 612 and 614 separated by a generally U-shaped structure 616 which may be coupled to a shield member 618 having a switch knob 620, for example. can contain. The first ring structure 612 and the second ring structure 614 can each have open ends. During assembly, the toggle switch 610 can be snapped onto the second drive shaft 512 through the open end, or it can be slide mounted from the top of the drive shaft 512 through the top opening of the housing 540. can do. Toggle switch 610 holds second gear member 582 between first ring structure 612 and second ring structure 614 and slides second gear member 582 on second drive shaft 512 . can move movably. The snap-on feature allows the toggle switch 610 to be easily attached or detached from the assembly, allowing for more effective cleaning and sterilization of the instrument as well as reuse for another surgical procedure. do. A shield 618 on the toggle switch 610 may more effectively prevent biomaterial from passing through the toggle switch and entering the inner portion of the surgical instrument.

[00168] FIGS. 48-50 more clearly illustrate the operation of switch assembly 610 and gear assembly 580. FIG. 48, toggle switch 610 enables second gear member 582 to engage first gear member 510, thereby enabling second drive shaft 512 to operate with first drive shaft 510. In FIG. is placed in a first or "extended mode" position that couples to the When the second drive shaft 512 is operably coupled with the first drive shaft 510, rotation of the first drive shaft 510 by the handle 502 causes rotation of the second drive shaft 512, e.g. provides a first mode of operation in which a flexible spinal implant device can be expanded or contracted. 49, toggle switch 610 allows second gear member 582 to disengage from first gear member 581, thereby coupling second drive shaft 512 from first drive shaft 510. In FIG. It is placed in a release second or "lordosis mode" position. When the second drive shaft 512 is uncoupled from the first drive shaft 510, the handle 502 rotates only the first drive shaft 510 while the second drive shaft 512 is deactivated. provides a second mode of operation in which, for example, the spinal implant device can be tilted or lordotically adjusted. 50, toggle switch 610 is placed in a third or "lock mode" position that allows second gear member 582 to engage both first gear member 581 and gear lock 592. It is Since the second gear member 582 is engaged with the gear lock 592, the rotation of the second gear member 582 is restricted so that the rotation of the first gear member 581 also rotates with the second gear member 582. is limited by the engagement of When switch 610 is placed in the third or "lock mode" position, instrument 500 is locked and rotation of first drive shaft 510 and second drive shaft 512 is prevented.

[00169] FIG. 51 is a perspective view of an exemplary gear lock 592 according to an embodiment of the present disclosure. As shown, the gear lock 592 can include a tubular member 594 having an internal contour such as a channel or slot that can accommodate the first gear member 581 and the second gear member 582 . On the side that receives the second gear member 582 , the inner surface of the gear lock 592 may include a tooth formation 596 configured to mate with the teeth of the second gear member 582 . A side of gear lock 592 may be opened to allow toggle switch 610 to slidably dispose or displace second gear member 582 so that the teeth on second gear member 582 engage gear lock 592 . Allows to engage or disengage upper teeth 596 . Aperture 598 also allows gear lock 592 to flex when positioned within partial housing 565 of chassis 560 . The outer surface of gear lock 592 may have a contour configured to mate with the contour of the inner surface of chassis arm 564 so that gear lock 592 fits within or with chassis arm 564 . It can mate and will not rotate when torque is applied.

[00170] Referring to FIGS. 33-34, the bearing lock assembly 630 operates to lock or unlock the drive shafts 510, 512 and sleeves 520, 522 to or from the chassis 560 within the housing 540. . The bearing lock assembly 630 is configured such that when the bearing lock assembly 630 is in the lock mode, the drive shafts 510, 512 and sleeves 520, 522 are not free to rotate axially, but are still free to rotate or pivot. designed to When bearing lock assembly 630 is in the unlocked mode, sleeves 520 , 522 and drive shafts 510 , 512 can slide out of housing 540 while the components of bearing lock assembly 630 remain within housing 540 . obtain. An exemplary bearing lock assembly 630 may include bearings 632, 634, 642, 644, fasteners 633, and retaining plates 652, 654 (FIG. 52).

[00171] FIG. 52 is a partial perspective view showing an exemplary bearing lock assembly 630 and other components of instrument 500 according to an embodiment of the present disclosure. In FIG. 52, housing 540 and chassis 560 have been removed to better show bearing lock assembly 630 in relation to other components of the instrument. As shown, the bearing lock assembly 630 includes a pair of drive shaft bearings 632, 634 configured to lock or unlock the drive shafts 510, 512 from the chassis 560, respectively. can include By way of example, drive shaft bearings 632, 634 may be in the form of curved plates having generally arcuate inner surfaces 635 (Fig. 53). Each of the drive shaft bearings 632 , 634 may be configured to be flush with the chassis main body 562 when assembled and tightened, with a passageway between the pair of drive shaft bearings 632 , 634 and the chassis main body 562 . forming a pair, allowing the pair of drive shafts 510, 512 to mate. Drive shaft bearings 632, 634 may each include a notch 636 (Fig. 53) on inner surface 635 configured to fit within a groove in each of the pair of drive shafts 510, 512. Notches 636 on the drive shaft bearings 632, 634 prevent the drive shafts 510, 512 from sliding out of the housing 540 when the bearing lock assembly 630 is in the locked mode, while allowing them to rotate freely. Or allow it to spin. Drive shaft bearings 632 , 634 may each include one or more ridges 638 on inner surface 635 . When the bearing lock assembly 630 is in the locked mode, the ridges 638 on the inner surface of the drive shaft bearings 632, 634 and the ridges 569 on the inner surface of the chassis 560 press against the drive shafts 510, 512 and lock the drive shafts 510, 512. from moving freely axially.

[00172] The drive shaft bearings 632, 634 may each include a bore 639 having internal threads. Fasteners 633 , which can be in the form of shoulder bolts or the like, can have external threads received within holes 639 of drive shaft bearings 632 , 634 . When torqued, fasteners 633 can enter threaded holes 639 and push drive shaft bearings 632 , 634 against chassis 560 , thereby tightening drive shafts 510 , 512 to chassis 560 . Rotating the fastener 633 in the opposite direction will loosen the drive shaft bearings 632 , 634 thereby unlocking the drive shafts 510 , 512 from the chassis 560 .

[00173] The bearing lock assembly 630 may include a pair of sleeve bearings 642, 644 configured to lock or unlock the sleeves 520, 522 to the chassis 560, respectively. Similar to drive shaft bearings 632 , 634 , sleeve bearings 642 , 644 may be in the form of curved plates having generally arcuate inner surfaces 635 . Each of the sleeve bearings 642 , 644 may be configured to be flush with the chassis main body 562 when assembled and tightened, providing a pair of passages between the pair of sleeve bearings 642 , 644 and the chassis main body 562 . , allowing the pair of sleeves 520, 522 to mate.

[00174] The sleeve bearings 642, 644 may each include a notch 636 on the inner surface 635 configured to fit within a groove in each of the pair of sleeves 520, 522. Notches 636 on the sleeve bearings 642, 644 prevent the sleeves 520, 522 from sliding out of the housing 540 while allowing them to pivot when the bearing lock assembly 630 is in the locked mode. do. In some embodiments, grooves 520d, 522d in sleeves 520, 522 provide a slight axial orientation of sleeves 520, 522, which may be required when surgical instrument 500 is connected, for example, with an interbody fusion device. The notches on the sleeve bearings 642, 644 may be machined slightly wider to allow movement. Sleeve bearings 642, 644 may also include one or more ridges on the inner surface. When the bearing lock assembly 630 is in the locked mode, the ridges 638 on the inner surface of the sleeve bearings 642, 644 and the ridges 569 on the inner surface of the chassis 560 press against the sleeves 520, 522 so that the sleeves 520, 522 are axially locked. to prevent free movement. This dynamic locking system allows for easy assembly and disassembly for cleaning and sterilization activities, so that instrument 500 can be reused for multiple surgical procedures while operating Provides a medium, strong assembly connection.

[00175] The sleeve bearings 642, 644, similar to the drive shaft bearings 632, 634, may include internally threaded holes 639 for connecting with fasteners 633. A fastener 633, which may be a shoulder bolt or the like, may have external threads to be received within the bore of the sleeve bearing. When torqued, the fastener 633 can enter the threaded bore and push the sleeve bearing flush with the chassis 560 . Rotating the fasteners in the opposite direction will loosen the sleeve bearings 642,644 from the chassis 560 and unlock the sleeves 520,522.

[00176] The bearing lock assembly 630 may include a pair of retaining plates 652, 654 for retaining the fastener 633 within the housing. Retaining plates 652, 654 include apertures 656 that allow a torque application tool to access fasteners 633 when tightening or loosening the bearings (FIG. 54). However, the retaining plates 652, 654 limit the movement of the fastener 633 outwardly or in the axial direction of the fastener, thereby preventing the fastener 633 from moving after torque is applied during bearing loosening. from coming loose from the entire assembly. Retaining plates 652, 654 allow sleeves 520, 522 and drive shafts 510, 512 to be removed from the assembly for cleaning, sterilization, or replacement without having to remove fastener 633 all the way from the assembly. This makes it easier for hospital personnel when they need to disassemble for replacement, cleaning, and sterilization. The retainer plate may include an O-ring of medical grade silicone to ensure that biomaterials or water do not enter the clearance of the bearing lock assembly.

[00177] The retaining plates 652, 654 may be configured to snap into the sub-housings 554a, 554b through a push fit or other suitable means (Fig. 54). Grooves are provided in the area adjacent aperture 656 for sealing gaskets, O-rings, etc., and thus to prevent water, debris, or biomaterial from entering the housing through the aperture. obtain. When needed, the holding plates 652, 654 can be easily removed for further cleaning and sterilization. FIG. 54 is a partial cutaway view of the surgical instrument showing retaining plates 652, 654 that can be snapped into and removed from sub-housings 554a, 554b.

[00178] Returning to Figures 33-34, the surgical instrument 500 may include a first dial 506 and a second dial 508 configured to provide information to the user about operation of the instrument. First dial 506 may be coupled to first drive shaft 510 . A second dial 508 may be coupled to a second drive shaft 512 . By way of example, first dial 506 may comprise an aperture configured to allow first drive shaft 510 or adapter 504 to mate. Second dial 508 may include a channel configured to receive or couple with second drive shaft 512 .

[00179] In use, the first dial 506 rotates with the first drive shaft 510, and indicia on the first dial 506 provide the user with information about the rotation of the first drive shaft 510. A second dial 508 rotates with the second drive shaft 512 and markings on the second dial 508 provide the user with information about the rotation of the second drive shaft 512 . As described above, when second drive shaft 512 is coupled to first drive shaft 510 by gear assembly 580, handle 502 moves first drive shaft 510 and second drive shaft 512 together. and thus both first dial 506 and second dial 508 are rotated to provide an indication to the user as to the first mode of operation of instrument 500 or as to the level of height extension. . When the second drive shaft 512 is uncoupled from the first drive shaft 510 by the gear assembly 580, the handle 502 rotates only the first drive shaft 510 and is thus coupled to the first drive shaft 510. Only the first dial 506 turned on rotates to provide an indication to the user about the second operating mode of the instrument 500 . The indication of the first dial when uncoupled and the second dial is equal to the additional angle of lordosis or kyphosis when the first drive shaft is driven unequal to the second drive shaft. .

[00180] In an embodiment of the present disclosure, instrument 500 manipulates an interbody fusion implant device in a surgical procedure, and indicia provided on first dial 506 and second dial 508 indicate that the user is can be configured to allow measuring the amount of expansion, contraction, and/or lordotic adjustment applied to the intervertebral disc space. For example, indicia may be provided on the first dial 506 to indicate added lordosis or allow it to be measured by the user. As an example, four degrees may equal one full rotation of dial 506, or two degrees may equal half a rotation of dial 506. Also, markings may be provided on the first dial 506 and/or the second dial 508 to indicate or allow the user to measure the added height or extension. As an example, 2.2 mm may equal one full rotation of the first and second dials 506,508, or 1.1 mm may equal one half rotation of the dials 506,508.

[00181] Referring to Figures 33-34, in use, the instrument 500 can be connected to a workpiece, such as a spinal implant device, via sleeves 520,522. A user may pivot or rotate the sleeves 520, 522, for example, inwardly to thread the instrument 500 onto the implant device. Prior to connecting with the implant device, the user first places the switch 610, for example, centrally within the switch guide so that the first gear member and the second gear member are locked and rotation of the drive shafts 510, 512 is prevented. Placement in position (FIG. 50) sets the instrument 500 to lock mode. Anterior force may be required in some situations when placing the implant device into the patient's vertebral space. When required, handle 502 of instrument 500 may be temporarily removed and replaced with striking cap 503 or slap hammer 670 . A forward force can then be exerted through the instrument 500 by striking the striking cap 503 using, for example, a mallet. After the implant device is properly positioned within the patient's vertebral space, striking cap 503 may be removed and replaced with handle 502 to manipulate the implant device. In some embodiments, handle 502 or striking cap 503 may be removed and slap hammer 670 may be connected to an instrument, eg, adapter 504 or top of housing 540 . Slaphammer 670 serves as an attachment to provide a removal or pulling force to the implant when the surgeon needs to remove the implant from the intervertebral disc space after insertion.

[00182] To effect expansion of the implant device, the user may place the switch 610 in the proximal position, releasing the first and second gear members from the locked position and disengaging the first drive. Allows shaft 510 and second drive shaft 512 to be coupledly engaged. The user may then rotate handle 502 in a direction, eg clockwise, to apply torque to first drive shaft 502 . Rotation of the first drive shaft 512 simultaneously causes rotation of the second drive shaft 51, thereby effecting expansion of the implant device in fine increments. If desired, the user may rotate the handle 502 in the opposite direction, eg counterclockwise, to contract or fine tune the expansion level of the implant device. Gear assembly 580 is such that rotation of first drive shaft 510 in a first direction, eg clockwise, rotates second drive shaft 512 in a second direction opposite to the first direction, eg counterclockwise. may be configured to cause rotation of the Alternatively, gear assembly 580 may be configured such that rotating handle 502 causes first drive shaft 510 and second drive shaft 512 to rotate in the same direction.

[00183] To achieve lordosis, the user places switch 610 in the distal position, allowing the first gear member and the second gear member to disengage, thereby Uncouple the second drive shaft 512 from the first drive shaft 510 . The user may then rotate handle 502 in a direction, eg, clockwise, and apply torque to first drive shaft 510 only, as second drive shaft 512 becomes inactive. Rotation of the first drive shaft 510 alone tilts the implant device, thereby achieving lordosis. If desired, the user can rotate handle 502 in the opposite direction, e.g., counterclockwise, to maintain lordosis while keeping first drive shaft 510 and second drive shaft 512 constrained against rotation. can be adjusted or removed. This constraint ensures that the drive shaft implant cannot be retracted while the instrument is decoupled from the implant.

[00184] To disconnect the surgical instrument 500 from the implant device, the user places the switch 610 in the center position, sets the instrument to the locked mode, and then pivots the sleeves 520, 522 outward, for example, so that the instrument 500 can be unscrewed from the implant device.

[00185] Various embodiments of surgical instruments have been described. It should be understood that the disclosure is not limited to particular embodiments described. Aspects described in conjunction with a particular embodiment are not necessarily limited to that embodiment, but can be implemented in any other embodiment.

[00186] Various embodiments are described with reference to the figures. Note that some figures are not necessarily drawn to scale. These diagrams are only intended to facilitate the description of particular embodiments and are not intended as an exhaustive description or as a limitation on the scope of the present disclosure. Moreover, the drawings and description may set forth specific details in order to provide a thorough understanding of the present disclosure. Those skilled in the art will appreciate that some of these specific details may not be used to implement embodiments of the present disclosure. In other instances, well-known components may not be shown or described in detail to avoid unnecessarily obscuring the embodiments of the present disclosure.

[00187] All technical and scientific terms used herein have the meaning commonly understood by one of ordinary skill in the art, unless otherwise defined. As used in the description and the appended claims, the singular forms "a," "an," and "the" include plural references unless the context clearly dictates otherwise. The term "or" refers to an inclusive "or" unless the context clearly indicates otherwise.

[00188] Those skilled in the art will appreciate that various other modifications may be made. All these and other variations and modifications are contemplated by and within the scope of the present invention.

Claims (39)

a handle;
a first drive shaft operably connected to the handle;
a second drive shaft;
A gear assembly comprising a first gear member received on said first drive shaft, a second gear member slidably received on said second drive shaft, and a lever member. said lever member engages said second gear member with said first gear member, thereby coupling said second drive shaft with said first drive shaft, and said handle engages said first drive shaft; or engaging said second gear member with said first gear member to provide a first mode of operation operable to rotate the first drive shaft and the second drive shaft together; a second mode of operation in which the handle is disengaged from the mating, thereby uncoupling the second drive shaft from the first drive shaft and the handle operates to rotate only the first drive shaft; a gear assembly operable to provide
A housing comprising a cavity configured to receive the gear assembly and first portions of the first drive shaft and the second drive shaft, the housing comprising: a housing from which a second portion of the drive shaft extends;
a first tubular shaft surrounding the second portion of the first drive shaft;
a second tubular shaft surrounding the second portion of the second drive shaft;
with
Said first tubular shaft and said second tubular shaft each comprise a first end portion rotatably fixed to said housing, whereby said first tubular shaft and said second tubular shaft are prevented from axially moving out of the housing, while the first tubular shaft and the second tubular shaft are prevented from rotating the first drive shaft and the second drive shaft, respectively. A surgical instrument that allows independent rotation . The first drive shaft and the second drive shaft are each rotatably secured to the housing such that the first drive shaft and the second drive shaft move axially from the housing. 2. The surgical instrument of claim 1 , preventing movement of the shaft while allowing the first drive shaft and the second drive shaft to rotate. The surgical instrument of claim 1, wherein the first tubular shaft and the second tubular shaft each comprise a workpiece connection end comprising female threads configured to be connected to a workpiece having corresponding male threads. . The surgical instrument of claim 1, wherein at least one of said first tubular shaft and said second tubular shaft comprises a finger grip. The lever member is operable to place the second gear member within the housing in a locked position such that rotation of the second drive shaft and the first drive shaft by the handle is prevented. 2. The surgical instrument of claim 1 , comprising: 6. The surgical instrument of Claim 5 , wherein an interior surface of the housing comprises a tooth configuration configured to mate with at least a portion of the second gear member in the locked position. The surgical instrument of claim 1 , further comprising a first dial operably coupled to said first drive shaft and indicative of rotation of said first drive shaft. 8. The surgical instrument of claim 7 , further comprising a second dial operably coupled to said second drive shaft and indicative of rotation of said second drive shaft. The surgical instrument of claim 1, further comprising an adapter connecting said first drive shaft with said handle. 10. The surgical instrument of claim 9 , wherein the first drive shaft and the second drive shaft have substantially the same length and cross-sectional geometry along the length. The first gear member and the second gear member are adapted to move the first gear member in a first direction by the handle when the first gear member and the second gear member are operatively engaged. 2. The surgical instrument of claim 1, wherein rotation of said drive shaft causes rotation of said second drive shaft in a second direction opposite said first direction. a handle;
a housing;
A first drive shaft operably connected to the handle, rotatably secured to the housing and comprising a first portion received within the housing and a second portion extending from the housing. a first drive shaft;
a second drive shaft rotatably secured to the housing and comprising a first portion received within the housing and a second portion extending from the housing;
a first tubular shaft surrounding the second portion of the first drive shaft and rotatably secured to the housing;
a second tubular shaft surrounding the second portion of the second drive shaft and rotatably secured to the housing;
a gear assembly received within the housing coupling the second drive shaft with the first drive shaft, the handle connecting the first drive shaft and the second drive shaft together; or decoupling said second drive shaft from said first drive shaft and said handle is operable to rotate only said first drive shaft; a gear assembly operable to provide a second mode of operation operable to rotate the
A surgical instrument comprising: 13. The surgical instrument of claim 12 , further comprising an adapter connecting said first drive shaft with said handle. 14. The surgical instrument of claim 13 , wherein said first drive shaft and said second drive shaft have substantially the same length and cross-sectional geometry along said length. 13. The surgical instrument of Claim 12, further comprising a first dial operably coupled to said first drive shaft and indicative of rotation of said first drive shaft. 16. The surgical instrument of Claim 15 , further comprising a second dial operably coupled to said second drive shaft and indicative of rotation of said second drive shaft. The gear assembly is further operable to lock the second drive shaft and the first drive shaft such that the second drive shaft and the first drive shaft are 13. The surgical instrument of claim 12 , which prevents rotation. 18. The claim of claim 17 , wherein an interior surface of said housing comprises a tooth configuration configured to mate with a portion of said gear assembly in locking said second drive shaft and said first drive shaft. Surgical instruments as described. The gear assembly is configured such that, in the first mode of operation, rotation of the first drive shaft by the handle in a first direction rotates the second drive shaft in a second direction opposite to the first direction. 19. The surgical instrument of claim 18 , configured to cause rotation of the drive shaft of the . a housing;
a chassis removably disposed in the housing ;
a first drive shaft and a second drive shaft each having a first portion supported by the chassis within the housing and a second portion extending from the housing;
a first gear member fixedly received on said first portion of said first drive shaft and a second gear member slidably received on said first portion of said second drive shaft; a gear assembly comprising a member;
engaging said second gear member with said first gear member thereby coupling said second drive shaft with said first drive shaft, said second drive shaft being coupled to said first drive shaft; or displacing said second gear member out of engagement with said first gear member, thereby displacing said second drive shaft a switch assembly operable to decouple from the first drive shaft and provide a second mode of operation in which the second drive shaft is not rotatable with the first drive shaft;
locking the first drive shaft and the second drive shaft to the chassis thereby restricting the first drive shaft and the second drive shaft from sliding out of the housing; or unlocking the first drive shaft and the second drive shaft from the chassis so that the first drive shaft and the second drive shaft are able to rotate freely; a bearing lock assembly operable to allow it to be slid out of the housing;
A surgical instrument comprising: 21. The surgical instrument of claim 20 , further comprising a handle connectable to said first drive shaft for applying torque. 21. The surgical instrument of Claim 20 , further comprising a striking cap configured for placement on the housing to receive a striking force. 21. The surgical instrument of Claim 20 , further comprising a slap hammer connectable to said surgical instrument for applying a pulling force to said surgical instrument. a gear lock disposed within the chassis, the switch assembly being further operable to engage the second gear member with both the gear lock and the first gear member; 21. The surgical instrument of claim 20 , thereby providing a third mode of operation in which rotation of said second drive shaft and said first drive shaft is restricted. The switch assembly comprises a pair of open ring structures, said pair of open ring structures snap or slide mounted on said second drive shaft and engage said second gear member with said 25. The surgical instrument of claim 24 , disposed between said pair of open ring structures. 26. The surgical instrument of Claim 25 , wherein the switch assembly further comprises a shield member configured to prevent debris or biomaterial from entering the housing. each of said first gear member and said second gear member comprising a plurality of teeth, each of said plurality of teeth having two end surfaces and two side surfaces extending between said two end surfaces; 21. The surgical instrument of claim 20 , wherein the two end faces are beveled to allow smooth engagement or disengagement of the first gear member and the second gear member. The gear assembly is such that, in the first mode of operation, rotation of the first drive shaft in a first direction rotates the second drive shaft in a second direction opposite to the first direction. 28. The surgical instrument of claim 27 , configured to cause rotation of the . said chassis having a first portion including a main body supporting said first drive shaft and said second drive shaft, and spaced apart arms defining partial housings for said gear assembly and said switch assembly; a second portion comprising: said main body comprising a pair of elongated channels along opposite sides of said main body configured to receive said first drive shaft and said second drive shaft; 21. A surgical instrument according to claim 20 . The main body of the chassis further comprises a base with a pair of openings at an end of the main body, the first drive shaft and the second drive shaft passing through the pair of openings in the base. 30. The surgical instrument of claim 29 , received within said pair of elongated channels and permitted to enter said partial housing defined by said spaced apart arms. 4. The main body of the chassis further comprising a partition dividing an elongated channel into two sections, the partition comprising a pair of openings aligned with the pair of openings in the base of the main body. Item 31. The surgical instrument according to Item 30 . The surgical instrument of Claim 31 , wherein the chassis is constructed from stainless steel or aluminum. 32. The surgical instrument of claim 31 , wherein the bearing lock assembly comprises a pair of bearings configured to lock or secure the first drive shaft and the second drive shaft to the main body of the chassis. . said pair of bearings comprising circumferential cutouts on respective inner surfaces of said pair of bearings, said cutouts being grooves in said first drive shaft and said second drive shaft, respectively; to limit the first drive shaft and the second drive shaft from sliding out of the housing when locked or secured. Each of said first and second pairs of said bearings further comprises one or more circumferential ridges on an inner surface of said pair of said bearings, said main body of said chassis extending from said pair of elongated ridges. Further comprising a plurality of ridges on respective inner surfaces of the channel, said ridges of said pair of bearings and said ridges of said main body of said chassis being aligned with said first drive shaft and said first drive shaft when locked or secured. 35. The surgical instrument of claim 34 configured to limit free axial movement of the two drive shafts. the bearing lock assembly comprising:
A first pair of fasteners configured to drive said pair of bearings, wherein rotation of said pair of fasteners causes said pair of bearings to move said first pair of fasteners within said pair of elongated channels of said chassis. a first pair of fasteners for tightening or loosening the drive shaft of and said second drive shaft;
a pair of retaining plates coupled to the housing configured to limit axial movement of the pair of fasteners;
34. The surgical instrument of claim 33 , further comprising: The housing comprises a first end portion surrounding at least the gear assembly and a second end portion surrounding at least the bearing lock assembly, the first end portion of the housing being connected to the chassis. 21. The surgical instrument of claim 20 , comprising a pair of removably attached housing covers, each of said pair of housing covers comprising a shoulder configured to support a striking cap. said housing having guide tracks for providing guidance in operating said switch assembly in at least said first and second modes of operation; and at least said first and second modes of operation. 38. The surgical instrument of claim 37 , comprising indicating indicia. Further comprising a guide gasket constructed from silicone, said guide gasket configured to smooth said operation of said switch assembly within a guide track while said switch assembly remains fixed in a selected mode of operation. 39. The surgical instrument of claim 38 , which helps to ensure that there is and/or prevent debris or biomaterial from entering the housing.

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