CN110996858B - Surgical operating instrument for an expandable and adjustable lordotic interbody fusion system - Google Patents

Abstract

An operating device includes a casing, a bottom frame, a first drive shaft and a second drive shaft, a gear assembly, a switching assembly and a bearing locking assembly. The first drive shaft and the second drive shaft each have a first portion supported in the housing by the chassis 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 member slidably received on the first portion of the second drive shaft. The shift assembly is operable to place the second gear member into engagement with the first gear member thereby coupling the second drive shaft with the first drive shaft to provide a first mode of operation in which the second drive shaft is capable of rotates with the first drive shaft, or the shift assembly is operable to displace the second gear member out of engagement with the first gear member thereby disengaging the second drive shaft from the first drive shaft to provide the second mode of operation, In the second mode of operation, the second drive shaft cannot rotate together with the first drive shaft. The bearing lock assembly is operable to lock the first drive shaft and the second drive shaft to the chassis whereby the first drive shaft and the second drive shaft are restricted from sliding out of the housing and are able to rotate freely, or the bearing lock assembly is operable to lock the first and second drive shafts to the chassis. The first drive shaft and the second drive shaft are unlocked from the chassis to allow the first drive shaft and the second drive shaft to slide away from the housing.

Description

Surgically operated instruments for expandable and adjustable lordotic interbody fusion systems

technical field

The present invention relates to surgical procedures and devices for treating low back pain.

Background technique

Lumbar fusion is a surgical procedure used to correct problems related to the human spine. Lumbar fusion usually involves removing damaged disc and bone from between 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 to stabilize specific areas of the back and help reduce problems related to nerve irritation at the fused site. Fusions can be performed at one or more segments of the spine.

Interbody fusion is a fusion performed to remove the nucleus pulposus and/or annulus that make up the disc at a problem point on the back and to use a fusion cage configured in shape and size to restore the distance between adjacent vertebrae to the proper state (cage) A common procedure to replace the nucleus pulposus and/or annulus fibrosus. The surgical approach used to accomplish intervertebral fusion varies, and the patient's spine can be accessed through the abdomen or back. Another surgical method for accomplishing lumbar fusion in a less invasive manner involves accessing the spine through a small incision on the side of the body. This procedure is called a lateral lumbar interbody fusion.

When removing the intervertebral disc from the body during lateral lumbar interbody fusion, surgeons typically force the insertion of different trial implants between the vertebral endplates in specific areas to determine the distance between adjacent vertebrae the appropriate size of the implant. Another consideration is to maintain the natural angle between the lumbar vertebrae to accommodate the lordotic 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 cages are typically pre-configured with top and bottom surfaces angled to each other to accommodate the natural curvature of the spine. These values are unlikely to be precisely determined prior to the procedure, which is a shortcoming in current surgery. Typically, once prepared the bone graft is properly sized and packaged into a cage implant before being inserted between the vertebral bodies.

Current lateral interbody fusion devices are generally limited to providing a high degree of expansion, but not lordosis accommodation. The patient is subject to significant invasive maneuvers while implementing the trial and error method of sizing and fitting the interbody cage into the target area for that patient's particular geometry. Bone graft material is typically added and encapsulated into the fusion device after the desired height has been expanded and final adjustments have been made.

Contents of the invention

One embodiment of the device includes an expandable housing formed from opposing housing members. A movable tapered screw-like element having an external helical thread is disposed in the housing and is operatively engaged against the top and bottom case members, forcing the top case The body member and bottom shell member are separated to cause expansion of the height of the housing. This feature allows adjustment of the distance (height) between adjacent vertebrae when in position. The tapered members are arranged in a dual arrangement such that independent engagement of the tapered members on the lateral portions of the top and bottom shells causes a tilt relative to the outer surface of the housing when the wedge members are moved to different degrees angle. This function allows adjustment of the angular relationship between adjacent vertebrae and facilitates lordotic adjustment of the patient's spine. When used in conjunction with the functionality of the device by the surgeon, the device provides an effective tool for in situ adjustment when performing lateral lumbar interbody fusion.

One embodiment of the device also includes a track formation within the housing for guiding engagement of the tapered external helical threaded member with the top and bottom housing members. The track includes a raised element on each of the inner surface of the top housing member and the inner surface of the bottom housing member that, when in the retracted position, allows interlocking engagement for the sides of the housing. towards stability. The rail region provides space for storage of bone graft material as the housing expands. One embodiment may provide an elastic membrane to be positioned around the housing to prevent leakage of bone graft material from the cage and to provide a compressive force around the cage, thereby providing structural stability to the housing.

An embodiment of the device also includes a drive shaft for operating the tapered external helical threaded member. The drive shaft allows the surgeon to manipulate the shaft, which operatively moves the tapered external helical threaded member to control the expansion of the shell and the angular adjustment of the top and bottom shell members for vertebral In situ fitting of interbody fusion devices. A locking mechanism is provided for preventing rotation of the shaft when the tool is not engaged and after manipulation by the tool is complete. The tool also facilitates the insertion of bone graft material into the fusion during in situ adjustment.

One embodiment of the present invention provides the surgeon with the ability to expand the cage and adjust the lordosis angle of the cage in situ during manipulation of the patient, as well as the ability to introduce bone graft material at the operative site while the device is in place . Thus, this embodiment of the invention provides a fusion cage with geometric variability to accommodate each patient's unique spinal condition.

Accordingly, embodiments of the present invention provide an interbody fusion cage device for lateral lumbar interbody fusion that combines height expansion for adjusting the distance between adjacent vertebrae and control for The angular relationship between the vertebrae regulates the function of the lordosis. The interbody fusion device of embodiments of the present invention also provides storage capacity for containing bone graft material in the interbody fusion device while disc height and lordosis adjustments are in situ.

The present invention also provides a device that can also be used in settings other than in interbody fusion applications. The device can generally be used to impart a spacing effect between adjacent elements and to impart a variable angular relationship between the elements to which it is applied.

Embodiments of the operating instrument include a handle, a first drive shaft, a second drive shaft, and a gear assembly. The first drive shaft is operatively 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. The lever member is operable to place the second gear member into engagement with the first gear member to couple the second drive shaft with the first drive shaft to provide a first mode of operation in which the handle is operated to cause the first Both the drive shaft and the second drive shaft rotate, or the lever member is operable to dispose the second gear member out of engagement with the first gear member thereby disengaging the second drive shaft from the first drive shaft to provide the second mode of operation , in the second mode of operation, the handle is operated to rotate only the first drive shaft.

Embodiments of the operating instrument include 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, the first drive shaft is rotatably fixed to the housing, and the first drive shaft includes a first portion received in the housing and a second portion extending from the housing. The second drive shaft is rotatably fixed to the housing, and the second drive shaft includes a first portion received in the housing and a second portion extending from the housing. A first tubular shaft surrounds the second portion of the first drive shaft, and the first tubular shaft is rotatably fixed to the housing. A second tubular shaft surrounds the second portion of the second drive shaft, and the second tubular shaft is rotatably fixed to the housing. A gear assembly is received in the housing and is operable to couple the second drive shaft with the first drive shaft to provide a first mode of operation in which the handle is operated to cause both the first drive shaft and the second drive shaft to The rotation, or gear assembly, is operable to disengage the second drive shaft from the first drive shaft to provide a second mode of operation in which the handle is operated to rotate only the first drive shaft.

Embodiments of the present disclosure provide a surgical instrumentation for an expandable and adjustable lordotic interbody fusion system. This device provides an improved and more efficient way to connect and physically implant an interbody fusion implant into a patient and further dilate and lordotically adjust the implant in situ. into things. The instrument allows for smoother, more efficient and more secure manipulation of the interbody fusion implant once the implant has been inserted into the patient. The device enables the surgeon to take advantage of a smoother device interface for implant expansion, lordosis adjustment and positioning in the patient's disc space, while also being able to deliver more instrumentation without damaging the device if desired. much force. The instrument may be operable when connected to the implant and act as a distraction system, wherein two vertebral bodies may be forced away from each other or distracted away from each other. This allows patients with degenerative disc disease (DDD), deformities and tumors to restore normal disc height anatomy. This allows for a more streamlined and effective device for distracting the disc space. The human-machine interface aspect of the device is more intuitive, allowing for a more seamless interaction between the surgeon and the device during surgery, which ultimately makes surgery easier and faster. The device enables easier assembly and disassembly after surgery, allowing the instruments to be cleaned and sterilized so they can be reused for more procedures.

Embodiments of a surgical operating instrument include a housing, a chassis, a first drive shaft and a second drive shaft, a gear assembly, a shift assembly, and a lock assembly or a bearing lock assembly. The first drive shaft and the second drive shaft each have a first portion supported in the housing by the chassis 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 member slidably received on the first portion of the second drive shaft superior. The shift assembly is operable to place the second gear member into engagement with the first gear member thereby coupling the second drive shaft with the first drive shaft to provide a first mode of operation in which the second drive shaft is capable of co-rotating with the first drive shaft, or the shift assembly is operable to displace the second gear member out of engagement with the first gear member thereby disengaging the second drive shaft from the first drive shaft to provide the second mode of operation, In the second mode of operation, the second drive shaft cannot rotate together with the first drive shaft. The bearing lock assembly is operable to lock the first drive shaft and the second drive shaft to the chassis whereby the first drive shaft and the second drive shaft are restricted from sliding out of the housing and are able to rotate freely, or the bearing lock assembly is operable to lock the first and second drive shafts to the chassis. The first drive shaft and the second drive shaft are unlocked from the chassis to allow the first drive shaft and the second drive shaft to slide away from the housing.

This summary is provided to introduce selected embodiments in a simplified form, it is not intended to identify key features or essential features 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 provide the reader with a brief summary of certain forms the invention might take, and not to limit the scope of the invention. Other aspects and embodiments of the disclosure are described in the Detailed Description section.

These and other features of the invention are described in more detail in the section below entitled Detailed Description of the Invention.

Description of drawings

Embodiments of the invention are described herein with reference to the following drawings, wherein emphasis has been placed on clarity rather than scale:

Figure 1 is a side view from the side of the expandable housing device.

Figure 2 is a perspective view of the bottom portion of the expandable housing.

Figure 3 is a top plan view of the bottom portion of the expandable housing.

Figure 4 is a top plan view of the expandable housing device.

Figure 5 is a perspective view of a tapered external helical threaded member.

Figure 5A is a side view from the side of a tapered external helical threaded member.

Figure 5B is a side view from the front of the tapered external helical threaded member.

6 is a cross-sectional view of the device taken along line 6-6 in FIG. 1 .

7A-7C are a series of side views of the device as it undergoes expansion.

Figure 8 is a side view of the device showing its expansion to accommodate the lordotic effect.

Figure 9A is an enlarged perspective view of a thrust bearing for a drive shaft.

Figure 9B is a perspective view of the drive shaft and thrust bearing.

9C is a cross-sectional top plan view of the engagement region of the drive shaft and thrust bearing.

Figure 10 is a side view of the housing when expanded.

Figure 1 IA is a top plan view of another embodiment of the device.

Figure 1 IB is a top plan view of yet another embodiment of the device.

12A is a top plan view of the drive shaft disengaged by the locking mechanism.

12B is a top plan view of the drive shaft engaged by the locking mechanism.

Figure 13A is a perspective view of the locking mechanism.

13B is a top plan cross-sectional view of the drive shaft with the locking mechanism disengaged.

13C is a top plan cross-sectional view of a drive shaft engaged by a locking mechanism.

FIG. 14 is a view taken along line 14-14 in FIG. 11A.

Figures 15A-15C are a series of side views taken from the end of the device showing the lordotic effect as the device undergoes expansion.

Fig. 16 is a perspective view of an operating tool.

Fig. 17 is a view showing the manner in which the operating tool is attached to the drive shaft of the device.

Fig. 18 is an isolated perspective view of the handle of the operating tool.

Figure 19 is a perspective view of the gears located in the handle engaged for operation of the two drive shafts.

20 is a perspective view of the gears located in the handle disengaged for operation of a single drive shaft.

21A is a cut-away perspective view of an exemplary procedure instrument according to an embodiment of the present disclosure.

Fig. 21B is an exploded perspective view of the operating instrument shown in Fig. 21A.

22A is a perspective view of a drive shaft according to an embodiment of the disclosure.

22B is an enlarged perspective view of the tip portion of the drive shaft shown in FIG. 22A.

Figure 22C is an enlarged plan view of a portion of the drive shaft shown in Figure 22A.

23 is a perspective view of an exemplary rod member according to an embodiment of the disclosure.

24 is a perspective view of a portion of the procedure instrument shown in FIG. 21A more clearly illustrating the rod member in an expanded position.

25 is a perspective view of a portion of the procedure instrument shown in FIG. 21A more clearly illustrating the rod member in a lordotic position.

26 is a perspective view of a portion of the procedure instrument shown in FIG. 21A more clearly illustrating the lever member in a locked position.

27A is a perspective view of an exemplary outer coupling shaft according to an embodiment of the disclosure.

Figure 27B is a plan view of the outer connecting shaft shown in Figure 27A.

Figure 27C is a plan view of the end portion of the outer connecting shaft shown in Figure 27B.

28A is a perspective view of an exemplary handle according to an embodiment of the disclosure.

Figure 28B is a side view of the handle shown in Figure 28A.

Figure 28C is a cross-sectional view of the handle taken along line A-A in Figure 28B.

Figure 28D is an end view from the first end of the handle shown in Figure 28A.

Figure 28E is an end view from the second end of the handle shown in Figure 28A.

29 is a perspective view of a portion of the procedure instrument shown in FIG. 21A more clearly illustrating the housing, outer connecting shaft, and drive shaft.

30 is a perspective view of an exemplary adapter according to an embodiment of the disclosure.

31 is a perspective view of an exemplary dial according to an embodiment of the disclosure.

32 is a perspective view of an exemplary dial according to an embodiment of the disclosure.

33 is an exploded view of an exemplary surgical operating instrument according to an embodiment of the present disclosure.

34 is a partial cross-sectional view of an exemplary surgical operating instrument according to an embodiment of the present disclosure.

35 is a perspective view of an exemplary surgical operating instrument according to an embodiment of the present disclosure.

36 is a perspective view of an exemplary surgical operating instrument according to an embodiment of the present disclosure.

37 is an exploded view of a housing including a housing cover according to an embodiment of the disclosure.

Figure 38 schematically illustrates a housing enclosing a chassis according to an embodiment of the disclosure.

39 is a perspective end view of a housing according to an embodiment of the disclosure.

40 is a perspective front view of a housing according to an embodiment of the disclosure.

41 is a perspective side view of the housing showing the toggle guide feature, according to an embodiment of the disclosure.

42 is a perspective view of a shift washer according to an embodiment of the disclosure.

43 is a perspective view of an exemplary chassis according to an embodiment of the disclosure.

44 is a perspective view of an exemplary undercarriage with sleeve and drive shaft bearings and other components positioned on the undercarriage according to an embodiment of the disclosure.

45 is a partial perspective view illustrating an exemplary chassis, locking assembly, and other components according to an embodiment of the disclosure.

46 is a perspective view of an exemplary gear member according to an embodiment of the disclosure.

47 is a perspective view of an exemplary toggle switch according to an embodiment of the disclosure.

48 is a partial perspective view showing the gear assembly and shift assembly in a first operational setting according to an embodiment of the disclosure.

49 is a partial perspective view showing the gear assembly and shift assembly in a second operating setting according to an embodiment of the disclosure.

50 is a partial perspective view illustrating the gear assembly and shift assembly in a third operational setting according to an embodiment of the disclosure.

51 is a perspective view of an exemplary gear lock according to an embodiment of the disclosure.

52 is a partial perspective view showing a bearing lock assembly and other components of an exemplary surgical operating instrument according to an embodiment of the present disclosure.

Figure 53 schematically illustrates a bearing member that may be used as a drive shaft bearing or sleeve bearing, according to an embodiment of the disclosure.

54 is a partial cross-sectional view of an exemplary surgical operating instrument showing a locking assembly including a retaining plate and other components in accordance with an embodiment of the present disclosure.

55 is an isometric view of an exemplary surgical instrument including a hammer in accordance with an embodiment of the present disclosure.

FIG. 56 is an exploded isometric view of the exemplary surgical operating instrument shown in FIG. 55 in accordance with an embodiment of the present disclosure.

FIG. 57 is an isometric view of an exemplary hammer in accordance with an embodiment of the present disclosure.

Detailed ways

With reference to the accompanying drawings, an interbody fusion device is herein described, illustrated and otherwise disclosed in accordance with various embodiments of the present invention, including a preferred embodiment. An interbody fusion device 10 is generally shown in FIG. 1 . The interbody fusion device 10 includes a housing 12 having a top shell 14 and a bottom shell 16 . As an example, the entire housing may have a length of 50mm and a width of 20mm. The housing material can consist of suitable materials such as titanium alloy (Ti-6AL-4V), cobalt chrome or polyether ether ketone (PEEK). Other materials that provide sufficient compositional integrity and have suitable biocompatibility are also suitable. The interior of the housing is constructed with cascading stepped rails 18 and 20 positioned along the side edges of the housing. As shown in FIG. 2 , the stepped track 18 begins toward the midpoint of the inner surface of the bottom shell 16 with a continuous track step having a height extending to the first end of the bottom shell 16 as the track extends. department increases. Correspondingly, the stepped track 20 begins towards the midpoint of the inner surface of the bottom shell 16 with a continuous track step having the height of the continuous track step extending to the opposite second side of the bottom shell 16 as this portion of the track extends. increase at the end. As shown in FIG. 3 , stepped track 18 includes dual track runs 22 and 24 , while stepped track 20 includes dual track runs 26 and 28 . As shown in FIG. 4 , corresponding stepped rails 30 and 32 are provided on the top case 14 . When the device is in the fully compressed state of the device wherein the top case 14 rests adjacent to the bottom case 16, as shown in FIG. The rails 32 engage with each other.

The respective orbiting portion includes a series of spaced risers or rail steps for receiving the threads of the tapered external helical threaded member. The tapered external helical threaded member provides a wedging action for separating the top shell from the bottom shell, thereby increasing the height of the shell to allow expansion between the vertebral bodies for device placement. As shown in FIG. 4 , orbiting portion 22 receives a tapered external helical thread member 34 , orbiting portion 24 receives a tapered external helical threading member 36 , orbiting portion 26 receives a tapered external helical threading member 38 , and The orbiting portion 28 receives a tapered external helical threaded member 40 . The orbiting portions 22 are in collinear alignment with the orbiting portions 26 such that the travel of the tapered external helical threaded members 34 and 38 within the respective orbiting portions occurs within this collinear alignment. The thread orientations of the tapered external helical threaded members 34 and 38 are opposite to each other such that rotation of the tapered external helical threaded members 34 and 38 will result in movement in opposite directions relative to each other. As shown in FIG. 4 , the drive shaft 42 extends along the collinear span of the orbiting portions 22 and 26 and passes through the tapered external helical threaded members 34 and 38 . Shaft 42 has a square cross-sectional configuration for engaging and rotating the tapered male helical threaded member. As shown in FIG. 5 , the central axial opening 44 of the tapered external helical threaded member is configured to receive and engage the shaft 42 . Alternatively, shaft 42 may comprise any shape effective to form a spline, such as a hexagon, and central axial opening 44 may comprise a corresponding formation for receiving that shape. When the shaft 42 is rotated in a clockwise direction through its end 48, the tapered external helical threaded members 34 and 38 rotate and the respective thread orientations of the tapered external helical threaded members 34 and 38 cause the screws, respectively, to orbit Section 22 and orbiting section 26 travel away from each other. Accordingly, when shaft 42 is rotated in a counterclockwise direction through end 48 thereof, tapered external helical threaded members 34 and 38 are caused to travel toward each other along orbiting portion 22 and orbiting portion 26 , respectively.

Similarly, orbiting portion 24 is in collinear alignment with orbiting portion 28 such that travel of tapered external helical threaded members 36 and 40 within the respective orbiting portions occurs within this collinear alignment. The thread orientations of the tapered external helical threaded members 36 and 40 are opposite to each other such that rotation of the tapered external helical threaded members 36 and 40 will result in movement in opposite directions relative to each other. Additionally, a shaft 46 passes through and engages the tapered external helical threaded members 36 and 40 . However, the orientation of the tapered external helical thread members 36 and 40 is opposite to the orientation of the tapered external helical thread members 34 and 38 . In this orientation, when the shaft 46 is rotated in the counterclockwise direction through its end 50, the tapered external helical threaded members 36 and 40 rotate and the corresponding thread orientation of the tapered external helical threaded members 36 and 40 causes the screw The rail runs 24 and 28 respectively travel away from each other. Accordingly, when shaft 46 is rotated in a clockwise direction through end 50 thereof, tapered external helical threaded members 36 and 40 are caused to travel toward each other along orbiting portion 24 and orbiting portion 28 , respectively.

As shown in Figure 2, the stepped track is constructed with a series of cascading risers of increasing height. For example, each rail run has risers 52 to 60 as shown for the stepped track 18 in FIG. 2 . When the thread of the tapered external helical threaded member advances to the gap between the standpipe 52 and the standpipe 54, the position height of the tapered external helical threaded member body is in the shell due to being supported on the standpipe 52 and the standpipe 54. In vivo 12 increases. As the tapered male helical threaded member continues to travel along the rail run, the threads of the tapered male helical threaded member pass from the gap between standpipe 52 and standpipe 54 and into the gap between standpipe 54 and standpipe 56. This allows the tapered male helically threaded member body to rise further within the housing 12 as the tapered male helically threaded member body bears on the standpipes 54 and 56. As the tapered male helical threaded member continues to travel along the remainder of the stepped risers 58 and 60, the location height of the tapered male helical threaded member further increases. As shown in the series of FIGS. 7A-7C , the tapered male helical threaded member forces the top shell 14 away from the bottom shell 16 as the position height of the tapered male helical threaded member body increases.

As shown in FIG. 7 , the combined effect of rotating the tapered external helical threaded member to move it toward the outer end of the respective orbiting portion causes the housing 12 to expand. The fully expanded shell is shown in FIG. 10 . The housing 12 may be retracted by reversing the movement of the tapered male helical threaded members so that the tapered male helical threaded members travel back along their respective orbiting portions towards the midpoint of the housing. In this embodiment, the housing will optimally provide expansion and contraction to give the implant a height in the range of approximately 7.8 mm to 16.15 mm. The device of this embodiment of the invention may be adapted to provide different expanded sizes.

The pair of tapered external helical threaded members in each collinear dual rail run is rotatable independently of the pair of tapered external helical threaded members in the parallel rail run. In this arrangement, the degree of expansion of the portion of the housing on each collinear orbiting portion can be varied to adjust the lordotic effect of the device. As shown in the example of FIG. 8 , tapered external helical thread members 36 and 40 have been extended to a certain distance along orbiting portion 24 and orbiting portion 28 respectively, causing separation of top case 14 from bottom case 16 , The housing 12 is thereby expanded. The tapered external helical threaded members 34 and 38 have been extended to a smaller distance along the parallel orbiting portions 22 and 26, respectively, so that the portion of the top housing on the orbiting portions 22 and 26 is in contact with the bottom housing. separated into smaller degrees. This effect is illustrated in the series of Figures 15A to 15C in which tapered external helical thread members 36 and 40 extend apart from each other in further increasing increments wherein tapered external helical thread members 34 and 38 Maintain the same relative distance with respect to each other.

In FIG. 15A, the respective positioning of the set of tapered external helical threaded members 36 and 40 is substantially the same as the set of tapered external helical threaded members 34 and 38 in their respective tracks. In this position, the top case 14 is generally parallel to the bottom case 16 . In FIG. 15B , the set of tapered external helical thread members 36 and 40 tapers along the set while the set of tapered external helical thread members 34 and 38 remains in their same position as in FIG. 15A . The tracks of the external helical threaded members 36 and 40 move further apart distally. In this setting, the side edges along which the tapered external helical thread members 36 and 40 of the top case 14 travel relative to the side edges along which the tapered external helical thread members 34 and 38 of the top case 14 travel. The side edges of the top case 14 are moved higher, giving the top case 14 an inclination relative to the bottom case 16 . In FIG. 15C , the set of tapered external helical thread members 36 and 40 tracks along the set of tapered external helical thread members 36 and 40 compared to the set of tapered external helical thread members 34 and 38 along the trajectory. The tracks of the set of tapered external helically threaded members 34 and 38 are moved further apart distally, giving the top shell 14 a greater inclination relative to the bottom shell 16 . In this embodiment, the device can achieve a lordotic effect of between 0° and 35° through independent movement of the respective sets of tapered external helical threaded members. The device of this embodiment of the invention may be adapted to provide different lordotic slope sizes.

As shown in FIG. 5 , the tapered external helical threaded member has a configuration comprising a body profile with a minor diameter increasing from D _r1 to D _r2 . As shown in Figure 4, the threads 33 have a pitch to match the spacing between the riser elements 52-60 in the rail run. The threads 33 may have a square profile to match the configuration between the risers, but other thread shapes may be used as appropriate. The increased diameter and tapered aspect of the helical thread member causes the top shell 14 and bottom shell 16 to move apart as described above. The contact at the top of the standpipes 52 to 60 is made at the small diameter of the helical threaded member.

Thrust bearings are provided to limit movement of the drive shaft in the axial direction within the housing 12 . As shown in FIG. 9A , the thrust bearing 62 comprises a two-piece yoke configuration that fits together and is press fit around the end of the shaft. The top portion 64 of the thrust bearing yoke defines an opening for receiving a circular portion 66 of the shaft end. In FIG. 9C, the square shaft 42 has a circular portion 66 of smaller diameter than the diameter of the square portion of the shaft. A thrust bearing fit 65 engages the top portion 64 to encircle a circular portion 66 of the drive shaft 42 .

Pin elements 68 in the top portion 64 and bottom portion 65 engage corresponding holes 69 in the fittings to provide a press fit of the thrust bearing around the shaft. A journal groove 67 may also be provided in the thrust bearing 62 . As shown in FIG. 9C , the shaft 42 may have an annular ridge 63 surrounding a circular portion 66 of the shaft 42 that is received in a journal groove 67 . As shown in Figure 9B, thrust bearings are provided at each end of the drive shaft. As shown in Figure 6, thrust bearings limit the axial movement of the drive shaft within the housing.

A safety lock is provided at the proximal end of the device for preventing undesired rotation of the shaft. As shown in FIGS. 12A and 12B , a safety lock member 70 is provided for engagement with the proximal ends of the drive shafts 42 and 46 . The opening 73 in the safety lock member 70 is configured to have the shape of the cross-sectional configuration of the drive shaft (see FIG. 13A ). A portion of the drive shaft has a narrower circular configuration 71 so that the drive shaft can rotate freely when the circular portion of the shaft is aligned with the safety lock member opening 73 (see FIG. 13C ). FIG. 12B illustrates this relationship between safety lock member 70 , thrust bearing 62 , and drive shafts 42 and 46 . When the non-narrow portion 75 of the shaft is positioned in alignment with the safety lock member opening 73, then rotation of the shaft is prevented (see Figure 13B). FIG. 12A illustrates this relationship between safety lock member 70 , thrust bearing 62 and drive shafts 42 and 46 . A compression spring 77 may be positioned between the thrust bearing 62 and the safety lock member 70 to urge the safety lock member back onto the square portion 75 of the drive shaft. FIG. 12B shows the locking disengagement when safety lock member 70 is pushed forward out of alignment with square portion 75 and placed in alignment with circular portion 71 of shafts 42 and 46 . Between the safety lock member 70 and the thrust bearing 62 a post 79 may be arranged, on which a compression spring 77 may be seated. Post 79 may be fixedly connected to safety lock member 70 and an opening may be provided in thrust bearing 62 through which post 79 may slide. The post 79 is provided with a head 81 to limit the rearward movement of the safety lock member 70 due to the compression force of the spring 77 .

According to the power screw theory, the interaction of the tapered external helical threaded member with the stepped track contributes to self-locking. Certain factors are relevant when considering variables for promoting self-locking of tapered threaded members. In particular, these factors include the coefficient of friction of the materials used, such as Ti-6Al-4V grade 5, the pitch length of the helical threads, and the average diameter of the tapered members. The following equation explains the relationship between these factors in determining whether a tapered male helically threaded member is self-locking as it travels along a stepped track:

The above equations determine the torque required to be applied to the drive shaft engaged with the tapered external helical threaded member to expand the housing member. This torque depends on the average diameter of the tapered external helical threaded member, the load (F) applied by the adjacent vertebral bodies, the coefficient of friction of the working material (f) and the lead (l) or in this embodiment the helical The pitch of the thread. All of these factors determine the operating torque required to convert rotational motion into linear lift to separate the housing members in accomplishing dilation and lordosis.

The following equation describes the relationship between the factors related to the torque required to back a tapered external helical threaded member back along the track direction:

In this equation, the torque (T _L ) required to lower the tapered male helical threaded member must be positive. When the value of (T _L ) is zero or positive, the self-locking of the tapered external helical thread member in the stepped track is realized. If the value of (T _L ) drops to a negative value, the tapered male helical threaded member no longer self-locks within the stepped track. Factors that may cause self-locking failure include compressive loads from the vertebral bodies, insufficient pitch and mean diameter of the helical threads, and insufficient material coefficient of friction. The conditions for self-locking are as follows:

πfd _m >l

In this case, it is necessary to choose a suitable combination of tapered members with sufficient average diameter size and product material that is much larger than the lead or pitch in this particular application, so that the tapered members can be in the stepped track. Internal self-locking. The cross-sectional area of the lumbar vertebral body is approximately 2239mm ² based on the average patient lying on their side, and the axial compressive force at this area is 86.35N. With the working material chosen to be Ti-6Al-4V, the operating torque to expand the shell shell 12 between L4 and L5 of the spine is about 1.312 Ib-in (0.148 Nm), and to make the shell The operating torque for retraction of body shell 12 between L4 and L5 of the spine is approximately 0.264 Ib-in (0.029 Nm).

Alternative embodiments of the expandable housing shell provide different surgical approaches. FIG. 11A shows the housing 100 for use where the surgeon is approaching the lumbar region from the frontal aspect of the patient. The overall configuration of the orbiter for this embodiment is similar to that for the device 10, but the drive shaft used to move the tapered external helical threaded member is applied with torque transmitted from the vertical path . To this end, as shown in Figure 14, two sets of worm gears 102 and 104 transmit torque to drive shafts 106 and 108, respectively.

FIG. 11B shows the housing 200 for use where the surgeon is accessing the lumbar region from the foraminal aspect of the patient. The overall configuration of the orbiter for this embodiment is also similar to that for device 10, but torque is applied to the drive shaft from an offset route. To this end, two sets of bevel gears (not shown) may be used to transmit torque to drive shafts 206 and 208 .

The housing 12 is provided with a number of cutouts and open areas in its surface and interior area to accommodate storage of bone graft material. The void space between the risers of the cascading stepped tracks also provides an area for receiving bone graft material. A membrane may be provided around the shell 12 as a supplement to help maintain compression on the top and bottom shells and retain bone graft material. As shown in FIG. 10 , tension spring elements 78 may be provided to hold the top member 14 and bottom member 16 together. These elements can also be used to provide an initial tensile force in the opposite direction against expansion of the interbody fusion device. This allows the tapered external helical threaded member to climb up the riser without contact between the outer shell and the vertebral body yet being made.

Thus, this embodiment of the interbody fusion device of the present invention is capable of expanding to provide support between the vertebral bodies and to accommodate loads placed on this region. Furthermore, the interbody fusion device of the present invention enables a configuration that can provide a suitable lordotic tilt to the affected area. Thus, the device provides a significant improvement with respect to patient-specific disc height adjustment.

The device is provided with tools for manipulating the interbody fusion device during in situ adjustment of the interbody fusion device in the patient's spine. Operating tool 300 is shown generally in FIG. 16 and includes handle member 302 , gear housing 304 , and torque rod members 306 and 308 . The torque rod member is connected to the drive shaft of the expandable housing 12 . One embodiment of a drive shaft for connecting the torque rod member to the expandable housing 12 is shown in FIG. 17 . In such an arrangement, the ends 48 and 50 of the drive shafts 42 and 46 may be provided with hexagonal heads. The ends of torque rod members 306 and 308 may be provided with correspondingly shaped receivers for clamping around ends 48 and 50 .

Within gear housing 304 , handle member 302 directly drives torque rod member 308 . The torque rod member 308 is provided with a spur gear member 310 and the torque rod member 306 is provided with a spur gear member 312 . Spur gear 312 is slidably received on torque rod member 306 and is movable into and out of engagement with spur gear 310 . Spur gear lever 314 engages spur gear 312 for moving spur gear 312 into and out of engagement with spur gear 310 . When torque rod member 308 is rotated by handle 302 and spur gear 312 is engaged with spur gear 310 , the rotation is transferred to torque rod member 306 . In this case, torque rod member 308 rotates drive shaft 46 while torque rod member 306 rotates drive shaft 42 to achieve expansion of housing 12 as shown in FIGS. 7A-7C . As shown in FIG. 20 , spur gear 312 can be moved out of engagement with spur gear 310 by retracting spur gear lever 314 . With the spur gear 312 disengaged from the spur gear 310 , rotation of the handle 302 only rotates the torque rod member 308 . In this case, the torque rod member 308 only rotates the drive shaft 46 and the drive shaft 42 remains inactive to achieve tilting of the top member relative to the housing 12 as shown in FIGS. 8 and 15A-15C. , thereby achieving lordosis.

To achieve expansion of the device in the described embodiment, the operator will turn the handle member 302 clockwise to engage twisting. This applied torque will then activate the compound counter-inverting spur gear train comprising spur gear members 310 and 312 . This series of gears will then rotate torque rod members 306 and 308 in opposite directions from each other. Torque rod member 308 (aligned with handle member 302 ) will rotate clockwise (to the right), and torque rod member 306 will rotate counterclockwise (to the left). The torque rod member then rotates the drive shaft of the interbody fusion device 12, thereby expanding the interbody fusion device 12 to a desired height.

To achieve lordosis, the operator moves the spur gear lever 314 back toward the handle member 302 . By doing so, the spur gear 312 connected to the torque rod member 306 disengages the entire gear train, which in turn disengages the torque rod member 306 . Thus, the torque rod member 308 will be the only member engaged with the interbody fusion device 12 . This will allow the operator to retract the posterior side of the implant to create the desired degree of lordosis.

Referring to FIGS. 21-32 , surgical tools or instruments according to various embodiments of the present disclosure will now be described.

21A is a cut-away perspective view of an exemplary operating tool or instrument according to an embodiment of the present disclosure. 21B is an exploded perspective view of the operating tool or instrument shown in FIG. 21A. As shown, the exemplary operating tool 400 generally includes a handle 402 , drive shafts 404 , 406 , a gear assembly 408 and optional outer connecting or tubular shafts 414 , 416 . Gear assembly 408 may be received in housing 410 . Drive shafts 404 , 406 and optional outer tubular shafts 414 , 416 may be rotatably fixed to housing 410 .

The handle 402 may be any suitable handle by which a user may apply torque to the drive shafts 404 , 406 . The handle 402 may be shaped in various configurations including I-shaped or T-shaped configurations. The handle 402 may be a bi-directional ratchet handle that can apply torque by both clockwise and counterclockwise rotation. Handle 402 may be a torque limiting ratchet handle that may limit torque applied by a user so that damage to a workpiece (not shown) does not occur. In some embodiments, the workpiece is an expandable and adjustable spinal implant as described above in connection with FIGS. Limit ratchet handle. Torque limiting ratchet handles are commercially available, for example, from Bradshaw Medical, Inc. of Kenosha, Wisconsin.

The drive shafts 404 , 406 may include a first drive shaft 404 and a second drive shaft 406 . The first drive shaft 404 can be operatively connected to the handle 402 and rotated by the handle 402 . The second drive shaft 406 may be operably coupled to or decoupled from the first drive shaft 404 via a gear assembly 408 that will be described in more detail below. When the second drive shaft 406 is operably coupled with the first drive shaft 404 , a first mode of operation is provided in which the handle 402 can rotate both the first drive shaft 404 and the second drive shaft 406 . When the second drive shaft 406 is disengaged from the first drive shaft 404 , a second mode of operation is provided in which the handle 402 only rotates the first drive shaft 404 .

The first drive shaft 404 and the second drive shaft 406 may each include a first portion 404a, 406a received in the housing 410 when assembled and a second portion 404b, 406b extending from the housing 410 . The first drive shaft 404 and the second drive shaft 406 may be rotatably fixed to the housing 410 via screws 418 or keys, pins, etc. as will be described in more detail below. The first drive shaft 404 and the second drive shaft 406 may have approximately the same length and the same cross-sectional geometry along the length. Alternatively, first drive shaft 404 and second drive shaft 406 may have different lengths and cross-sectional geometries. The first drive shaft 404 may be connected to the handle 402 via an adapter 420 which will be described in more detail below. Alternatively, first drive shaft 404 may extend its length beyond housing 410 to connect with handle 402 .

22A-22C illustrate example drive shafts that may be used as first drive shaft 404 and/or second drive shaft 406 . As shown, the example drive shaft 404 may include a first portion 404a and a second portion 404b. When operating tool 400 is assembled, first portion 404a may be received in housing 410 and second portion 404b may extend from housing 410 . The first portion 404a and the second portion 404b may be integrally machined as a single component, or alternatively, the first portion 404a and the second portion 404b may be machined separately and then assembled. The first portion 404a and the second portion 404b may be generally cylindrical in shape and have the same or different diameters from each other.

The first portion 404a of the drive shaft 404 may include a portion 404d at a proximal end configured to receive a gear member, an adapter, or a dial as will be described in more detail below. For example, a portion 404d at the proximal end of the first portion 404a may include a flat surface configured to receive a gear member, adapter, or dial having a corresponding flat surface and a remaining cylindrical surface. and channels, cutouts or holes in cylindrical surfaces. The flat surface prevents rotational movement of the gear member, adapter or dial relative to the drive shaft 404 when the gear member, adapter or dial is received on portion 404d. At the distal end, the first portion 404a of the drive shaft 404 may include an undercut or groove forming a circular portion 404e having a reduced diameter. The undercut or groove provides room for a screw, key, pin, etc. to fit in or flush against the circular portion 404e, thereby constraining the drive shaft 404 while allowing it to rotate freely. Move or slide axially away from housing 410 .

The second portion 404b extends from the first portion 404a, and the second portion 404b includes a workpiece engaging tip 404c having features configured to engage a workpiece. As shown, the workpiece engaging tip 404c has a quincunx or six-lobed configuration. Other suitable configurations or features known in the art may also be used to join workpieces with corresponding joining features. The workpiece may be a spinal implant device as described above in connection with FIGS. 1-15. The workpiece may also be other medical devices that can be manipulated to expand, contract or tilt by using the manipulation tool.

Returning to FIGS. 21A-21B , the gear assembly 408 is used to couple the second drive shaft 406 to the first drive shaft 404 or to decouple the second drive shaft 406 from the first drive shaft 404 . In some implementations, the gear assembly 408 can also lock the second drive shaft 406 and the first drive shaft 404 such that rotation of the first drive shaft 404 and the second drive shaft 406 is prevented. As shown, the gear assembly 408 can include: 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 lever member 408c operable to place the second gear member 408b into engagement with or out of engagement with the first gear member 408a.

The first gear member 408a may be fixedly fastened to the first drive shaft 404 via screws, keys, pins, or the like. The second gear member 408b can be slidably received on the second drive shaft 406 . The lever member 408c can be coupled to a second drive shaft 406 configured to move the second gear member 408b along the second drive shaft 406, thereby allowing the second gear member 408b to engage the first gear member 408a, allowing the second gear member 408b to The second gear member 408b disengages from the first gear member 408a, or allows the second gear member 408b to be locked in a locked position which will be described in more detail below. FIG. 23 depicts an exemplary lever member 408c that may be used in the operating tool 400 . As shown, the rod member 408c may include a first annular ring 422a and a second annular ring 422b spaced apart, for example, by a generally U-shaped structure 424 coupled to a rod member 426 . When assembled, the first and second turns 422a, 422b of the rod member 408c are slidably received on the second drive shaft 406 with the rod member 426 extending out of the housing 410 . A second gear member 408 b , which may be slidably received on the second drive shaft 406 , is held between the first annular ring 422 a and the second annular ring 422 b and moved by the rod member 426 .

24 , 25 and 26 more clearly illustrate the gear assembly 408 in the housing 410 . In FIG. 24, the lever member 408c is disposed in a proximal or first position, which allows the second gear member 408b to engage the first gear member 408a, thereby operatively coupling the second drive shaft 406 to the first drive shaft 404. connect. When the second drive shaft 406 is operatively coupled with the first drive shaft 404, rotation of the first drive shaft 404 through the handle 402 causes rotation of the second drive shaft 406, thereby providing a device in which, for example, an expandable spinal implant can First mode of operation for expansion or contraction. In FIG. 25, the lever member 408c is disposed in a distal or second position, which allows the second gear member 408b to disengage from the first gear member 408a, thereby disengaging the second drive shaft 406 from the first drive shaft 404. . When the second drive shaft 406 is disengaged from the first drive shaft 404, the handle 402 only rotates the first drive shaft 404 while the second drive shaft 406 becomes inactive, thereby providing a second drive shaft in which, for example, the spinal implant device can be tilted. operating mode.

In some embodiments, the lever member 408c can be positioned in a third position where the second gear member 406 and the first gear member 404 are locked in the housing 410 and rotation of the first drive shaft 404 and the second drive shaft 406 is prevented. . In FIG. 26, the lever member 408c is disposed in an intermediate position between the proximal and distal positions, thereby allowing the second gear member 408b to engage the first gear member 408a and the components built into the housing 410 which will be described in more detail below. Both toothed configurations 428 are described. When the second gear member 408a is in contact or engaged with the toothed formation 428, the rotation of the second gear member 408b is restricted, and thus, the rotation of the first gear member 408a is also restricted due to engagement with the second gear member 408b. . When the lever member 408c is placed in the third position, the operating tool 400 is locked, wherein rotation of the first drive shaft 404 and the second drive shaft 406 is prevented.

Returning to FIGS. 21A-21B , in some embodiments, the operating tool 400 can include an outer connecting or tubular shaft 414, 416 configured to couple the operating tool 400 to a workpiece, such as a spinal column. implanted device. The outer connecting shafts 414, 416 may include a first tubular shaft 414 surrounding the second portion 404b of the first drive shaft 404 extending from the housing 410 and a tube surrounding the second portion 406b of the second drive shaft 406 extending from the housing 410. Second tubular shaft 416 . The first tubular shaft 414 and the second tubular shaft 416 may be rotatably fixed to the housing 410 as will be described in more detail below such that the first tubular shaft 414 and the second tubular shaft 416 operate independently of the first drive shaft. 404 and second drive shaft 406 are free to rotate or rotate while being prevented from sliding away from housing 410 .

27A-27C illustrate exemplary tubular shafts that may be used as outer connecting shafts 414 , 416 . As shown, the exemplary tubular shaft 414 may be generally cylindrical in shape with a larger inner diameter than the outer diameter of the second portion of the drive shaft 404 . Tubular shaft 414 may include a first end portion 414a configured to be rotatably secured to housing 410 and a second end portion 414b having features configured to couple with a workpiece. A finger grip 414c, which may be machined as an integral part of the tubular shaft, may be provided to facilitate rotation or rotation of the tubular shaft when coupled to a workpiece. As shown in detail in FIG. 27C, the first end portion 414a of the tubular shaft 414 may include an undercut or groove forming a circular portion 414d having a reduced diameter. When assembled, screws 419 (FIG. 21B), keys, pins, etc. may fit into the spaces in the undercuts or grooves or sit flush against the circular portion 414d, thereby preventing tubular shaft 414 from rotating freely while allowing free rotation of the tubular shaft 414d. Shaft 414 moves or slides axially away from the housing. The second end portion 414b of the tubular shaft 414 may be provided with internal threads or other suitable features configured to couple with a workpiece, such as a spinal implant having corresponding coupling features such as external threads.

Returning to FIGS. 21A-21B , operating tool 400 may include a housing 410 configured to receive or enclose gear assembly 408 , rotatably secure drive shafts 404 , 406 and optional outer coupling shafts 414 , 416 . 28A-28E illustrate exemplary housings according to embodiments of the disclosure. As shown, housing 410 may be ergonomically shaped for easy handling by a user. The housing 410 can also be designed in any other suitable shape or configuration. Housing 410 may include a first end portion 410a proximate to handle 402 and a second end portion 410b distal to handle 402 . In the first end portion 410a, a cavity 430 may be provided for receiving the gear assembly 408 . A toothed formation 428 may be built into the inner surface of the housing for receiving or locking the second gear member 408b. An opening 432 may be provided in the side of the housing 410 for receiving the rubber slider 409 and allowing displacement of the lever member 408c. Channels 434a, 434b may be provided for receiving the first portions 404a, 406a of the first drive shaft 404 and the second drive shaft 406, respectively. Channels 436a, 436b may be provided in the second end portion 410b of the housing 410 for receiving the first end portions 414a, 416a of the first tubular shaft 414 and the second tubular shaft 416 . Apertures or channels 438 may be provided at the second end portion 410b of the housing 410 for receiving screws 418 , pins, keys, etc. ( FIG. 21B ) to rotatably secure the drive shafts 404 , 406 to the housing 410 . Optionally, apertures or channels 440 may be provided for receiving screws 419 , pins, keys, etc. ( FIG. 21B ) to rotatably secure the outer connecting shafts 414 , 416 to the housing 410 .

FIG. 29 more clearly shows the drive shafts 404 , 406 and the outer coupling shafts 414 , 416 rotatably secured to the second end 410 b of the housing 410 . As shown, when assembled, the screws 418, keys, pins, etc. may sit flush against the reduced diameter circular portions of the first drive shaft 404 and the second drive shaft 406, thereby allowing the drive shafts 404, 406 to The drive shafts 404 , 406 are prevented from sliding away from the housing 410 in an axial direction while freely turning or rotating. Likewise, a screw 419, key, pin, etc. may sit flush against the reduced diameter circular portions of the first tubular shaft 414 and the second tubular shaft 416, thereby allowing the tubular shafts 414, 416 to spin or rotate freely. The tubular shafts 414, 416 are prevented from sliding away from the housing 410 in the axial direction.

Returning to FIGS. 21A-21B , the operating tool 400 may include an adapter 420 configured to couple the first drive shaft 404 with the handle 402 . FIG. 30 illustrates an example adapter 420 according to an embodiment of the disclosure. As shown, adapter 420 may include a first end portion 420a and a second end portion 420b. The first end portion 420a of the adapter 420 may be shaped and dimensioned to be received by the handle 402 . The second end portion 420b may be provided with a channel 442 configured to receive the first drive shaft 404 . As shown, the channel 442 can be shaped or configured to allow the end portion 404d ( FIG. 22A ) of the first drive shaft 404 to freely slide into or out of the channel 442 during assembly or disassembly, and once the end portion 404d is received in the channel 442 prevents drive shaft 404 from rotating relative to adapter 420 . Apertures or channels 444 on the side of the second end portion 420b may be provided for receiving screws, keys, pins, etc. to secure the first drive shaft 404 to the adapter 420 . The use of an adapter allows the first drive shaft 404 and the second drive shaft 406 to be made to the same length and/or geometry. In this way, the cost of operating the tool 400 can be significantly reduced because the first drive shaft 404 and the second drive shaft 406 can be manufactured in the same manner and the number of parts required in manufacture is reduced.

Returning to FIGS. 21A-21B , the operating tool 400 may include a first dial 446 for providing the user with information regarding the rotation of the first drive shaft 404 . The first scale 446 may be operably coupled to and rotate with the first drive shaft 404 in operation. FIG. 31 illustrates an exemplary dial that may be used as a first dial of the operating tool. As shown, first dial 446 may include: indicia 448 indicating rotation of the dial; and aperture 450 configured to allow movement of first drive shaft 404 or coupled to first drive shaft 404 Adapter 420 fits therein. In use, the first dial 446 rotates with the first drive shaft 404 , and markings 448 on the first dial 446 provide the user with information regarding the rotation of the first drive shaft 404 .

Referring to FIGS. 21A-21B , the operating tool 400 may also include a second dial 452 for providing the user with information regarding the rotation of the second drive shaft 406 . The second dial 452 may be operably coupled to and rotate with the second drive shaft 406 in operation. FIG. 32 illustrates an exemplary dial 452 that may be used as a second dial of the operating tool. As shown, the second dial 452 may include markings 454 indicating rotation of the dial and a portion having a channel 456 configured to receive the second drive shaft 406 . In use, the second dial 452 rotates with the second drive shaft 406 and the markings 454 on the second dial 452 provide the user with information regarding the rotation of the second drive shaft 406 . The first dial 446 and the second Dials 452 both rotate, providing an indication to the user of the first mode of operation of the operating tool. When the second drive shaft 406 is decoupled from the first drive shaft 404 by the gear assembly 408 in a situation where the handle 402 only rotates the first drive shaft 404, only the first dial 446 coupled to the first drive shaft 404 rotates , thereby providing the user with an indication of the second mode of operation of the operating tool.

Referring to FIGS. 21A-21B , in use, the operating tool 400 may be coupled to a workpiece, such as a spinal implant (not shown), via external connecting or tubular shafts 414 , 416 . A user may, for example, turn or rotate the outer connecting shafts 414, 416 inwardly to thread the operating tool 400 onto the implant device. When connecting with the implant device, the user can first place the lever member 408c in the locked position (e.g., the neutral position in FIG. Rotation of handle 402 is prevented.

Once the operating tool 400 is connected to the implant device, in order to achieve expansion of the implant device, the user can place the rod member 408c in the expanded position (e.g., the proximal position in FIG. 24 ) such that the first gear member 408a and the second gear member 408a Member 408b disengages the locked position and engages to couple first drive shaft 404 and second drive shaft 406 . A user may then rotate handle 402 in, for example, a clockwise direction 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 enabling expansion of the implant device in small increments. If desired, the user may rotate the handle 402 in the opposite direction, eg, counterclockwise, to retract or fine-tune the level of expansion of the implant device. In some embodiments, the gear members 408a, 408b can be configured such that rotation of the first drive shaft 404 in a first direction, eg, clockwise, causes the second drive shaft 406 to rotate in a second direction opposite the first direction, eg, counterclockwise. Rotation in the clockwise direction. Alternatively, the gear members 408a, 408b may be configured such that rotating the handle 402 causes the first drive shaft 404 and the second drive shaft 406 to rotate in the same direction.

To achieve lordosis, the user can place lever 408c in a lordotic position (e.g., the distal position in FIG. Shaft 406 is separate from first drive shaft 404 . The user may then rotate the handle 402 in, for example, a clockwise direction, applying torque only to the first drive shaft 404 as the second drive shaft 406 becomes inactive. Only rotation of the first drive shaft 404 causes the implant device to tilt, thereby achieving lordosis. If desired, the user may rotate the handle 402 in the opposite direction, eg, counterclockwise, to adjust or remove the level of lordosis.

To disconnect the operating tool 400 from the implant device, the user can place the lever member 408c in the locked position and then rotate the outer connecting shafts or tubular shafts 414, 416, for example, outwardly to unscrew the operating tool 400 from the implant device. out.

Embodiments of the manipulation instrument have 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 manipulation instrument embodiments have been described in conjunction with figures depicting a straight drive shaft and a straight outer connection shaft, in some embodiments the drive shaft and optional outer connection shaft may comprise The straight portions of the drive shaft and the outer connecting shaft form an angle, for example an angled portion ranging from 0° to 90°. The angled drive shaft allows the surgeon to reach segments of the lumbar disc space that in some patients are inaccessible by the straight drive shaft. The angled and straight portions may be machined as a single drive shaft or outer connecting shaft component, or alternatively, the angled and straight portions may be machined separately and then assembled as a drive shaft or outer connecting shaft. In some embodiments, the angled portion can be an adapter type that can be plugged into or connected to an existing set of straight drive shafts or male coupling shafts. As an example, the outer link axis may be angled by a variation of a ball joint that allows vertical twisting. The drive shaft can be angled by some variation of a ball joint, worm gear, or bevel gear configuration that allows vertical twisting.

Referring to Figures 33-57, various embodiments of surgical operating instruments will now be described.

FIG. 33 is an exploded view of an exemplary surgical operating instrument 500 in accordance with an embodiment of the present disclosure. FIG. 34 is a partial cross-sectional view of instrument 500 . As shown, the instrument 500 may generally include 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, a switch or switch assembly 610, and a locking assembly. Or bearing lock assembly 630. The handle 502 can be operatively coupled to the pair of drive shafts 510, 512, thereby allowing torque to be applied to a workpiece, such as an interbody fusion device (not shown), through the drive shafts to effect expansion, contraction and/or anterior spinal fusion of the fusion device. Convex adjustment. The pair of sleeves 520, 522 surrounding a portion of the pair of drive shafts 510, 512 that are external to the housing 540 are used to couple the instrument 500 to a workpiece, such as an interbody fusion device. Housing 540 encloses 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 . Base frame 560 serves as a base for instrument 500 , providing support for drive shafts 510 , 512 , sleeves 520 , 522 and housing 540 . The chassis 560 may also serve as a partial housing for the gear assembly 580 and other components. Switch assembly 610 in combination with gear assembly 580 operates to provide various modes of operation of instrument 500 . Bearing lock assembly 630 operates to lock or unlock drive shafts 510 , 512 and sleeves 520 , 522 to and from chassis 560 inside housing 540 . Figure 35 is a perspective view of an instrument 500 assembled in accordance with an embodiment of the present disclosure.

Referring to FIGS. 33 and 34 , the handle 502 may be any suitable handle by which a user may apply torque to the drive shafts 510 , 512 . The handle 502 can be manually actuated or driven by a motor or robot. The handle 502 can be shaped in various configurations including I-shaped or T-shaped configurations. The handle 502 may be a bi-directional ratchet handle that can apply torque by both clockwise and counterclockwise rotation. The handle 502 can 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 a bi-directional torque limiting ratchet handle for expansion, retraction, lordosis, kyphosis, and/or coronal adjustment of the device. Torque limiting ratchet handles are commercially available, for example, from Bradshaw Medical, Inc. of Kenosha, Wisconsin.

The handle 502 can be removed and replaced with a shock cap 503 . FIG. 36 is a perspective view of an exemplary procedure instrument 500 including an impact cap 503 according to an embodiment of the disclosure. Impact cap 503, which may be made of stainless steel, allows the user to apply a forward force through the instrument by striking the impact cap with, for example, a mallet. This feature of the instrument may help to more easily push or wedge, for example, an interbody fusion device into a patient's spinal space. The impact cap 503 can prevent or reduce damage to the instrument when hammer force is applied during surgery.

In some embodiments, the handle 502 or impact cap 503 can be removed and replaced with a paddle hammer. If the surgeon desires to remove the implant after device expansion and adjustment in a secondary removal procedure, or possibly even after partial fusion of the device, a hammer can be helpful for proper alignment of the instrument 500 and the vertebral body. The fusion device provides pulling or removal force. FIG. 55 is an isometric view of an exemplary surgical instrument including a hammer 670 in accordance with an embodiment of the disclosure. FIG. 56 is an isometric exploded view of the exemplary surgical operating instrument shown in FIG. 55 . FIG. 57 is an isometric view of an exemplary hammer in accordance with an embodiment of the present disclosure. As shown, the hammer 670 may include an elongated rod 672 and a weight 674 . The weight 674 is configured to be grasped by a user and can slide along the elongated rod 672 when force is applied. A stop 676 may be provided at the first or proximal end of the elongated rod 672 to prevent the weight 674 from falling off the elongated rod 672 . Stop 676 may be removably coupled to rod 672 via, for example, a threaded connection. At a second or distal end of the elongate rod 672 a connection location 678 may be provided to couple the hammer 670 to the instrument 500 . As an example, connection site 678 may be configured such that hammer 670 may be coupled to adapter 504 of instrument 500 via a threaded connection, a clip-on connection, a slotted "key-like" connection, or the like.

R5500聚苯砜(PPSU)，该医用级塑料能够从比利时布鲁塞尔的苏威先进聚合物公司(Solvay Advanced Polymers)商购购得。外壳540可以定形状成给予美学吸引力，并且/或者定形状成符合人体工程学以供用户抓握器械。Referring to FIGS. 33-34 , the housing 540 encloses the gear assembly 580 , the chassis 560 , the bearing lock assembly 630 , a portion of the drive shafts 510 , 512 , and a portion of the sleeves 520 , 522 , etc., protecting the components from contamination by biological material, And/or prevent foreign objects from obstructing or interfering with the operation of the component. Housing 540 may be constructed of a material capable of withstanding high sterilizing steam temperatures over many cycles and/or providing mechanical strength to the instrument. Suitable materials for constructing housing 540 include stainless steel, medical grade plastics such as

R5500 Polyphenylsulfone (PPSU), a medical grade plastic commercially available from Solvay Advanced Polymers, Brussels, Belgium. Housing 540 may be shaped for aesthetic appeal and/or ergonomically shaped for a user to grip the instrument.

Referring to FIG. 37 , the housing 540 may include a first end portion 542 proximate the handle 502 and a second end portion 544 remote from the handle 502 . In the first end portion 542, the housing 540 may include two housing covers 546a, 546b. The housing covers 546a, 546b may be separate components secured to the chassis 560 with, for example, screws 548, bolts, or the like. The housing covers 546a, 546b can be detached from the chassis 560 during cleaning and sterilization to facilitate more efficient cleaning of the instruments and to allow the interior of the instruments to dry more quickly after sterilization. Removable housing covers 546a, 546b allow exposure of the gear assembly, gear locks and chassis or other components inside the housing, which in turn allows for quick and more efficient drying after sterilization. To add mechanical strength to the instrument, the housing covers 546a, 546b may be constructed of medical grade plastic or metal such as stainless steel. In some embodiments, housing covers 546a, 546b may each be configured to provide shoulders 550a, 550b for seating on impact cap 503 (FIGS. 33 and 36). As noted above, in some instances it may be desirable to apply a forward force through the instrument to help push or wedge, for example, an interbody fusion device into the patient's spinal space. By removing the handle 502 from the instrument and placing the impact cap 503 on the instrument, the user can apply a forward force through the instrument by striking the impact cap with, for example, a mallet. Because the impact cap 503 sits on the shoulders 550a, 550b of the housing 540 and is not coupled to the drive shafts 510, 512 or other functional components, the hammering force applied to the impact cap 503 will allow the force to be evenly distributed across the instrument. the entire cross-sectional area of the body of the instrument and will not further damage the instrument. Figure 38 shows the housing 540 enclosing the chassis 560, wherein housing covers 546a, 546b attached to the chassis 560 provide shoulders 550a, 550b to allow the shock cap to sit.

In a second end portion 544 of the housing 540, the housing 540 is provided with an opening 552 configured to allow the main part of the chassis 560 to be seated inside. The housing 540 may sit on a subbase 567 of the chassis 560, which may include a raised rim 571 to surround the distal end of the housing 560 (FIG. 43). Threads may be provided on the distal end of the housing 560 for connection to the chassis 560 . Gaskets can be used to provide a tight fit and seal to prevent biological material and water from entering the housing. Two sub-housings or chambers 554a, 554b may be provided at the second end portion for housing a bearing lock assembly 630 which will be described in more detail below. The sub-housings 554a, 554b may be integrally formed with the main body of the housing and disposed opposite to each other. The sub-housings 554a, 554b may be configured to allow the retention plates 652, 654 (FIG. 54) of the bearing lock assembly 630, described below, to be inserted inside by a press fit and easily removed for cleaning and disinfection. Apertures may be provided in the side walls of the sub-housings 554a, 554b to allow access of a torque applying tool to the fasteners and connection of the fasteners to the bearings of the bearing lock assembly 630 as will be described in more detail below. 39 is a perspective end view of the housing 540 showing the opening 552 configured to receive the chassis and sub-housings 554a, 554b for the bearing lock assembly 630. FIG. FIG. 40 is a perspective front view of housing 540 .

Referring to FIG. 41 , the housing 540 may include a toggle guide track 556 for guiding a user through the toggle or toggle assembly 610 to operate the instrument. The guide track 556 may include slots corresponding to different modes of operation or settings when the toggle is positioned. Markings 558 may be provided near guide track 556 to indicate various operating settings. In some embodiments, a washer 559 (FIG. 42) may be coupled to guide track 556 to allow a user to operate the toggle more smoothly and seamlessly. Gasket 559 may also help keep biological material from entering the interior of the housing through the switch site. FIG. 42 schematically illustrates an exemplary gasket 559 . Washers 559 may fit over hooks in guide tracks 556 by tension or by other suitable means. Gasket 559 may be made of elastic material, such as silicone rubber. The silicone rubber material allows the gasket to withstand high sterilization temperatures without melting or deforming.

R5500聚苯砜(PPSU)的医用级塑料制成，从而提供了坚固的操作器械使得在器械掉落于地板上时不会破裂。与外壳540和冲击帽503结合的底架560允许用户在不损坏器械的情况下对器械施加锤击力。在器械500中包括底架560简化了器械的组装、拆卸和清洁。Referring to FIGS. 33 to 34 , the base frame 560 serves as a main base of the operating instrument 500 . Base frame 560 provides support for drive shafts 510 , 512 , sleeves 520 , 522 and housing 540 . The upper portion of the chassis 560 may also serve as a partial housing for the gear assembly 580 and other components and provide attachment points for the housing covers 546a, 546b. Chassis 560 may be made of metal such as stainless steel or such as

Made of R5500 polyphenylsulfone (PPSU) medical grade plastic, which provides a sturdy handling instrument that will not break if dropped on the floor. Chassis 560 in combination with housing 540 and impact cap 503 allows the user to apply hammering force to the instrument without damaging the instrument. Including chassis 560 in instrument 500 simplifies assembly, disassembly, and cleaning of the instrument.

FIG. 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 body 562 that provides support for drive shafts 510 , 512 and sleeves 520 , 522 . Upper portion 563 may include spaced apart arms 564 that define a portion of housing 565 for gear assembly 580, gear lock 592, and shift assembly 610, as described in greater detail below.

In the lower portion 561 of the chassis 560 , the main body 562 may be provided with a pair of elongated channels 566 extending between a lower base 567 and an upper base 568 . The pair of elongated channels 566 may be disposed parallel relative to each other along opposite sides of the 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 rotate therein. A plurality of ridges 569 may be provided on the channel surface to hold the drive shaft and sleeve tightly against the chassis when secured by the bearing lock assembly 630 which will be described in more detail below. Ridges 569 on the channel surface can hold the drive shaft and sleeve tightly pressed against the chassis body 562 when tightened to limit free movement of the drive shaft and sleeve in the axial direction. A divider 570 may be provided to divide the channel 566 into two parts. The divider 570 allows for separate bearings to lock the traction 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 at an upper portion of channel 566, while sleeve bearings 642, 644 may secure sleeves 520, 522 at a lower portion of channel 566 to chassis 560 (Figures 44 and 45). Divider 570 may keep drive shaft bearings 632, 634 and sleeve bearings 642, 644 separated from each other and allow the bearings to rest on chassis 560 as a support structure during assembly and operation. The bottom base 567 has raised edges 571 to allow the housing 540 to rest on the chassis 560 . An opening 572 provided in the bottom base 567 allows the drive shafts 510 , 512 and sleeves 520 , 522 respectively to pass through and fit into the channel 566 on the bottom chassis 560 . The upper base 568 is provided with an opening 573 allowing the drive shafts 510 , 512 to pass through and extend into the portion of the housing 565 defined by the spaced apart arms 564 . Upper base 568 may also provide support for gear assembly 580 and gear lock 592 while adding strength to the chassis or operating implement.

In the upper portion 563 of the chassis 560 , spaced apart arms 564 define a partial housing 565 for the gear assembly 580 , gear lock 592 and switch assembly 610 . The arm 564 may also be configured to secure a gear lock 592 which will be described in more detail below. For example, arm 564 may be configured to have an inner surface contour that mates with an outer surface contour of gear lock 592 . As an example, arm 564 may have a convex inner surface portion that mates with a concave outer surface portion of gear lock 592 such that when gear lock 592 flexes and/or slides into partial housing 565 and seats on upper base 568 , the gear lock 592 is fixed and will not turn 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 . The arms 564 may be provided with features such as internally threaded holes 574 for securing the housing covers 546a, 546b to the chassis 560 (FIGS. 37 and 38).

44 is a perspective view showing the chassis 560 with the drive shaft bearings 632, 634 and the sleeve bearings 642, 644 seated on the main body 562 in the lower portion 561 and with the gear lock 592 and the gear assembly 580 in the upper portion 563 is accommodated in a partial housing 565. 45 is a partial perspective view showing chassis 560, wherein gear lock 592 and gear assembly 580 are housed in a partial housing in upper portion 563, and a pair of drive shafts 510, 512 (not shown in FIG. 44 ) and The sleeves 520 , 522 are secured to the main body 562 in the lower portion 561 by a bearing lock assembly 630 . In Fig. 45, housing 560 is removed to more clearly illustrate the positional relationship between chassis 560 and bearing lock assembly 630, which will be described in more detail below.

33 and 34, the pair of drive shafts 510, 512 are operably coupled to the handle 502 for applying torque to a workpiece (not shown). The pair of drive shafts 510 , 512 may include a first drive shaft 510 and a second drive shaft 512 . The first drive shaft 510 may be operatively connected to the handle 502 , eg, via an adapter 504 . The second drive shaft 512 may be coupled to or decoupled from the first drive shaft 510 via a gear assembly 580 . When the second drive shaft 512 is operatively coupled with the first drive shaft 510 , a first mode of operation is provided in which the handle 502 can rotate both the first drive shaft 510 and the second drive shaft 512 . When the second drive shaft 512 is disengaged from the first drive shaft 510 , a second mode of operation is provided in which the handle 502 only rotates the first drive shaft 510 .

The pair of drive shafts 510, 512 may be rotatably secured to the chassis 560 in the housing 540 by a bearing lock assembly 630 which will be described in more detail below. The pair of drive shafts 510 , 512 may each include a first portion 510 a , 512 a received in a housing 540 when assembled and a second portion 510 b , 512 b extending from the housing 540 . The first portions 510 a , 512 a of the pair of drive shafts 510 , 512 may be configured to be received in the pair of elongated channels 566 of the chassis 560 and to be rotatably secured to the chassis 560 . For example, the first portions 510a, 512a of the pair of drive shafts 510, 512 may include increased diameter portions and grooves 510c, 512c that provide bearing recesses to fit within or flush against. space, thereby restricting the drive shafts 510, 512 from sliding out of the housing 540 while allowing the drive shafts 510, 512 to rotate freely. The first portions 510a, 512a of the pair of drive shafts 510, 512 may extend into a partial housing 565 of the chassis 560 to receive a gear member, dial or adapter. For example, the first portion 510a, 512a may include a flat surface at a proximal end configured to receive a gear member, adapter or dial that may be provided with a corresponding flat surface and a remaining cylindrical surface. and channels, cutouts or holes in cylindrical surfaces. When the gear member, adapter or dial is received on the first portion 510a, 512a, the flat surface prevents rotational movement of the gear member, adapter or dial relative to the drive shaft 510, 512 when secured with a set screw or the like. The pair of drive shafts 510, 512 may have approximately the same length and approximately the same cross-sectional geometry along the length. Alternatively, the pair of drive shafts 510, 512 may have different lengths and cross-sectional geometries. For example, the length of the first drive shaft 510 can be extended and connected directly to the handle 502 without the need for an adapter.

The second portion 510b, 512b of the drive shaft 510, 512 includes a tip portion 510d, 512d having features configured to engage a workpiece. The workpiece engaging tip may have a quincunx or six-lobed configuration, or a modified quincunx or six-lobed configuration. Other suitable configurations or features known in the art may also be used to join workpieces with corresponding joining features. The workpiece may be an interbody fusion implant as described in US Patent No. 9,889,019, the entire disclosure of which is incorporated herein by reference. The workpiece may also be other medical devices that can be manipulated to expand, contract, or tilt using manipulation instruments.

Referring to Figures 33-34, the pair of sleeves or tubular shafts 520, 522 are operative to couple the operating instrument 500 to a workpiece, such as an interbody fusion implant. The pair of sleeves 520, 522 may include: a first sleeve 520 that surrounds the second portion 510b of the first drive shaft 510 extending from the housing 540; and a second sleeve 522 that 522 surrounds the second portion 512b of the second drive shaft 512 extending from the housing 540 . The pair of sleeves 520, 522 may be rotatably secured to the chassis 560 via a bearing lock assembly 630 described below such that the sleeves 520, 522 may rotate freely independently of the rotation of the pair of drive shafts 510, 512 or Rotates and is restricted from sliding out of the housing 540 during operation, but the sleeves 520, 522 can be removed after operation for cleaning and disinfection purposes.

The pair of sleeves 520 , 522 may be generally cylindrical in shape with a larger inner diameter than the outer diameter of the second portion 510 b , 512 b of the drive shaft 510 , 512 . The sleeves 520, 522 can each include a first end portion 520a, 522a configured to be rotatably secured to a chassis 560 in the housing 540 and a second end portion 520b, 522b configured to be rotatably secured to a chassis 560 in the housing 540, a second end portion 520b, 522b configured to The end portions 520b, 522b have features configured to couple with a workpiece. A finger grip 520c, 522c may be provided on each of the sleeves 520, 522 to facilitate rotation or turning of the sleeve when coupled to a workpiece. The first end portions 520a, 522a of the pair of sleeves 520, 522 may be configured to be received in the elongated channel 566 of the chassis 560 and to be rotatably secured thereto. The first end portions 520a, 522a of the pair of sleeves 520, 522 may each include a groove 520d, 522d that provides space for a bearing notch to fit within or abut flush against, thereby allowing the sleeve to The sleeves 520 , 522 are restricted from sliding out of the housing 540 while the barrels 520 , 522 are free to rotate. The second end portions 520b, 522b of the sleeves 520, 522 may be provided with internal threads or other suitable features configured to interface with workpieces having corresponding connection features, such as external threads, such as spinal implants. input device connection.

Referring to FIGS. 33 and 34 , the gear assembly 580 is used to couple the second drive shaft 512 to the first drive shaft 510 or to decouple the second drive shaft 512 from the first drive shaft 510 to provide various modes of operation. In some embodiments, the gear assembly 580 can lock the first drive shaft 510 and the second drive shaft 512 to prevent the first drive shaft 510 and the second drive shaft 512 from rotating.

Gear assembly 580 may include a pair of spur gears having substantially parallel gear axes. The first gear member 581 can be received on the first drive shaft 510 and the second gear member 582 can be received on the second drive shaft 512 ( FIGS. 48-50 ). The first gear member 581 may be fixedly fastened to the first drive shaft 510 via screws, keys, pins or the like. The second gear member 582 may be slidably received on the second drive shaft 512 but not rotate relative to the second drive shaft via a set screw, key, pin, or the like. A toggle shifter 610, described in more detail below, is receivable and slidably movable on the second drive shaft 512 to position the second gear member 582 in relation to the second drive shaft 512. A gear member 581 engages and disengages.

FIG. 46 schematically illustrates an exemplary gear member 586 that may be used in a gear assembly 580 according to embodiments of the present disclosure. As shown, the gear member 586 includes a plurality of teeth 587 each having two opposing side surfaces 588a, 588b extending between two end surfaces 590a, 590b. The side surfaces 588a, 588b of the teeth may be generally parallel to the axis of the gear member 586 configured to engage the teeth of a mating gear member. At least at one end of the gear member 586, or preferably at both ends of the gear member 586, the end surfaces 590a, 590b of the teeth 587 are chamfered or chamfered. The surfaces between adjacent teeth at the end surfaces may also be chamfered. A chamfered or lofted cut feature along the end or ends of the gear member's teeth allows the gears to smoothly shift and mesh back into each other with a seamless transition as the user operates the shifter 610 .

33 and 34, the toggle assembly 610 allows the user to operate the instrument 500 smoothly and seamlessly via an intuitive interface. As an example, the user may place the toggle assembly 610 in a first position provided in the toggle guide 556 (FIG. 41), such as an "expanded mode" position, to allow the second gear 582 to engage the first gear 581, the user Toggle assembly 610 may be placed in a second position, such as a "lordotic mode" position to allow disengagement of second gear 512 from first gear 510, or may be placed in a third position, such as a "locked mode" position. mode” position to allow the second gear member 512 to engage both the first gear member 510 and the gear lock 592.

Fig. 47 schematically illustrates a toggle switch 610 that may be used in the manipulation instrument 500 according to an embodiment of the present disclosure. As shown, the toggle 610 may include a first ring structure 612 and a second ring structure 614 spaced apart, for example, by a generally U-shaped structure 616, the generally U-shaped structure 616 may be coupled to a shroud member 618 having a toggle knob 620 . Each of the first ring structure 612 and the second ring structure 614 may have an open end. During assembly, the toggle 610 may snap onto the second drive shaft 512 through the open end, or the toggle 610 may be allowed to slide from the top of the drive shaft 512 through the top opening of the housing 540 . The toggle 610 can retain the second gear member 582 between the first ring structure 612 and the second ring structure 614 and slidably move the second gear member 582 on the second drive shaft 512 . The snap feature allows the toggle 610 to be easily attached and detached from the assembly, enabling more efficient cleaning and disinfection of the instrument and reuse for another procedure. The shield 618 on the toggle switch 610 can more effectively prevent biological material from entering the inner portion of the operating instrument through the toggle switch.

48-50 illustrate the operation of the switch assembly 610 and the gear assembly 580 more clearly. In FIG. 48, the toggle 610 is disposed in a first or "expanded mode" position, which allows the second gear member 582 to engage the first gear member 510, thereby coupling the second drive shaft 512 to the first drive shaft. Shaft 510 is operably coupled. 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, thereby providing, for example, an expandable spinal implant device. A first mode of operation that can expand or contract. In FIG. 49, the toggle switch 610 is placed in the second position or "lordosis mode" position, which allows the second gear member 582 to be disengaged from the first gear member 581, thereby allowing the second drive shaft 512 Separated from the first drive shaft 510 . When the second drive shaft 512 is disengaged from the first drive shaft 510, the handle 502 only rotates the first drive shaft 510 and the second drive shaft 512 becomes inactive, thereby providing a possibility in which, for example, the spinal implant device can be tilted or lordotic. Regulated second mode of operation. In FIG. 50 , toggle 610 is disposed in a third or “lock mode” position, which allows second gear member 582 to engage with both first gear member 581 and gear lock 592 . Because the second gear member 582 is engaged with the gear lock 592 , the rotation of the second gear member 582 is restricted, and thus, the rotation of the first gear member 581 is also restricted due to the engagement with the second gear member 582 . When the toggle 610 is disposed in the third or "lock mode" position, the instrument 500 is locked, wherein rotation of the first drive shaft 510 and the second drive shaft 512 is prevented.

FIG. 51 is a perspective view of an exemplary gear lock 592 according to an embodiment of the disclosure. As shown, gear lock 592 may include a tubular member 594 having an inner profile, such as a channel or groove, that may receive first gear member 581 and second gear member 582 . On the side receiving the second gear member 582 , the inner surface of the gear lock 592 may be provided with tooth formations 596 configured to cooperate with the teeth of the second gear member 582 . The sides of the gear lock 592 may be open to allow the toggle 610 to slidably seat or displace the second gear member 582, thereby allowing the teeth on the second gear member 582 to interact with each other. Teeth 596 on gear lock 592 engage or disengage. Opening 598 may also allow gear lock 592 to flex when seated inside portion of housing 565 of chassis 560 . The outer surface of the gear lock 592 may have a contour configured to mate with the contour of the inner surface of the chassis arm 564 such that the gear lock 592 may fit or mate with the chassis arm 564 and not when torque is applied. turn.

Referring to FIGS. 33-34 , the bearing lock assembly 630 operates to lock and unlock the drive shafts 510 , 512 and sleeves 520 , 522 to and from the chassis 560 in the housing 540 . The bearing lock assembly 630 is designed such that the drive shafts 510, 512 and sleeves 520, 522 are not free to move in the axial direction, but are still free to rotate or turn when the bearing lock assembly 630 is in the locked mode. With the bearing lock assembly 630 in the unlocked mode, the sleeves 520 , 522 and the drive shafts 510 , 512 can be slid out of the housing 540 while the components of the bearing lock assembly 630 can remain in the housing 540 . An exemplary bearing lock assembly 630 may include bearings 632, 634, 642, 644, fasteners 633, and retaining plates 652, 654 (FIG. 52).

FIG. 52 is a partial perspective view illustrating an exemplary bearing lock assembly 630 and other components of an instrument 500 according to an embodiment of the disclosure. In Fig. 52, the housing 540 and chassis 560 have been removed to more clearly illustrate the relationship of the bearing lock assembly 630 to the other components of the instrument. As shown, bearing lock assembly 630 may include a pair of drive shaft bearings 632, 634 configured to lock drive shafts 510, 512, respectively, to chassis 560 or to lock drive shafts 510, 512 from The chassis 560 is unlocked. As an example, drive shaft bearings 632, 634 may be in the form of curved plates having a generally arcuate inner surface 635 (FIG. 53). The drive shaft bearings 632, 634 can each be configured to be flush with the chassis body 562 when assembled and tightened, thereby forming a pair of channels between the pair of drive shaft bearings 632, 634 and the chassis body 562 to allow the pair of drive shafts to 510 and 512 are assembled therein. Drive shaft bearings 632 , 634 may each include a notch 636 ( FIG. 53 ) on inner surface 635 configured to fit into a groove of each drive shaft of pair of drive shafts 510 , 512 . When the bearing lock assembly 630 is in the locked mode, the notches 636 on the drive shaft bearings 632, 634 prevent the drive shafts 510, 512 from sliding away from the housing 540 while allowing the drive shafts 510, 512 to spin or turn freely. 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, thereby preventing the drive shafts 510, 512 from moving along. Free movement in the axial direction.

The drive shaft bearings 632, 634 may each be provided with a bore 639 having an internal thread. Fasteners 633 , which may be in the form of shoulder bolts or the like, may have external threads to be received in bores 639 of drive shaft bearings 632 , 634 . When twisted, the fastener 633 can turn in the threaded hole 639 , thereby pushing the drive shaft bearings 632 , 634 against the chassis 560 , thereby tightening the drive shafts 510 , 512 to the chassis 560 . Turning 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 .

The bearing lock assembly 630 may include a pair of sleeve bearings 642, 644 configured to lock the sleeves 520, 522 to the chassis 560 or to unlock the sleeves 520, 522 from the chassis 560, respectively. . Similar to drive shaft bearings 632 , 634 , sleeve bearings 642 , 644 may be in the form of curved plates having a generally arcuate inner surface 635 . The sleeve bearings 642, 644 can each be configured to be flush with the chassis body 562 when assembled and tightened, thereby forming a pair of channels between the pair of sleeve bearings 642, 644 and the chassis body 562 to allow the pair of sleeves to 520 and 522 are assembled therein.

Each of the sleeve bearings 642 , 644 may include a notch 636 on the inner surface 635 configured to fit into a groove of each of the pair of sleeves 520 , 522 . The notches 636 on the sleeve bearings 642, 644 prevent the sleeves 520, 522 from sliding away from the housing 540 while allowing the sleeves 520, 522 to rotate when the bearing lock assembly 630 is in the locked mode. In some embodiments, the grooves 520d, 522d in the sleeves 520, 522 can be machined slightly wider than the notches on the sleeve bearings 642, 644 to allow for slight axial movement of the sleeves 520, 522, which This may be required where the manipulation instrument 500 is connected to, for example, an interbody fusion device. The 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, thereby preventing the sleeves 520, 522 from moving along. Free movement in the axial direction. This dynamic locking system eases assembly and disassembly for cleaning and disinfection activities, allowing the instrument 500 to be reused for multiple procedures while providing a secure assembly connection during operation.

Similar to drive shaft bearings 632 , 634 , sleeve bearings 642 , 644 may be provided with holes 639 having internal threads for connection with fasteners 633 . The fastener 633, which may be a shoulder bolt or the like, may have external threads to be received in the bore of the sleeve bearing. When twisted, the fastener 633 can turn in the threaded hole, thereby pushing the sleeve bearing flush with the chassis 560 . Turning the fasteners in the opposite direction will loosen the sleeve bearings 642, 644 from the chassis 560, thereby unlocking the sleeves 520, 522.

The bearing lock assembly 630 may include a pair of retaining plates 652, 654 for retaining the fastener 633 within the housing. The retaining plates 652, 654 include holes 656 that allow a torque application tool to access the fastener 633 (Fig. 54) when tightening or loosening the bearing. 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 loosening from the overall assembly when the bearing is loosened after being twisted. The retaining plates 652, 654 allow the sleeves 520, 522 and drive shafts 510, 512 to be removed from the assembly for cleaning, disinfection or replacement without having to completely remove the fastener 633 from the assembly. This provides added convenience for healthcare workers when disassembly is required for replacement, cleaning and disinfection. The retaining plate may contain o-rings of medical grade silicone to ensure that biological material or water does not enter the crevices of the bearing lock assembly.

Retention plates 652, 654 may be configured to snap into sub-housings 554a, 554b by press fit or other suitable means (FIG. 54). A groove may be provided in the area adjacent to the aperture 656 for a sealing gasket, O-ring, etc. to prevent water, debris or biological material from entering the housing through the aperture. The retaining plates 652, 654 can be easily removed for further cleaning and disinfection when desired. 54 is a partial cross-sectional view of the operating instrument showing retaining plates 652, 654 that can be snapped into and removed from sub-housings 554a, 554b.

Returning to FIGS. 33-34 , the operating instrument 500 may include a first dial 506 and a second dial 508 configured to provide a user with information regarding the operation of the instrument. The first dial 506 can be coupled to the first drive shaft 510 . Second dial 508 may be coupled to second drive shaft 512 . As an example, the first dial 506 may be provided with an aperture configured to allow the first drive shaft 510 or the adapter 504 to fit therein. The second dial 508 may be provided with a channel configured to receive or be coupled with the second drive shaft 512 .

In use, the first dial 506 rotates with the first drive shaft 510 , and markings on the first dial 506 provide the user with information about the rotation of the first drive shaft 510 . The 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 mentioned above, when the second drive shaft 512 is coupled with the first drive shaft 510 through the gear assembly 580, the handle 502 rotates both the first drive shaft 510 and the second drive shaft 512, and thus, the first dial Both 506 and second dial 508 rotate, thereby providing an indication to the user of the first mode of operation of instrument 500 or an indication of the level of the expanded height. When the second drive shaft 512 is decoupled from the first drive shaft 510 by the gear assembly 580, the handle 502 only rotates the first drive shaft 510, and thus, only the first dial 506 coupled to the first drive shaft 510 revolves , thereby providing an indication of the second mode of operation of the instrument 500 to the user. When the first and second drive shafts are not driven equally, the indications of the first and second dials when separated are considered to be an increasing angle of lordosis or kyphosis.

In an embodiment of the present disclosure, the instrument 500 operates the interbody fusion implant device during surgery, and the markings provided on the first scale 506 and the second scale 508 may be configured to allow the user to measure the patient's intervertebral disc The amount of expansion, contraction, and/or lordotic adjustment that the space increases. For example, markings may be provided on the first scale 506 to indicate or allow the user to measure increased lordosis. As an example, four (4) degrees may be equivalent to one full turn of the dial 506 , or two (2) degrees may be equivalent to a half turn of the dial 506 . Indicia may also be provided on the first scale 506 and/or the second scale 508 to indicate or allow the user to measure the added height or dilation. As an example, 2.2 mm may correspond to one full revolution of the first dial 506 and second dial 508 , or 1.1 mm may correspond to half a revolution of the dials 506 , 508 .

Referring to FIGS. 33-34 , in use, the instrument 500 may be coupled via sleeves 520 , 522 to a workpiece, such as a spinal implant. A user may, for example, turn or rotate the sleeves 520, 522 inwardly to thread the instrument 500 onto the implant device. Before the instrument 500 is connected to the implant device, the user may first set the instrument 500 in a locked mode ( FIG. 50 ), such as by placing the switch 610 in an intermediate position in the switch guide ( FIG. 50 ), so that the first gear member and The second gear member is locked and rotation of the drive shafts 510, 512 is prevented. In placing the implant device into the spinal space of the patient, forward force may be required in some cases. The handle 502 of the instrument 500 can be temporarily removed and replaced with the impact cap 503 or the hammer 670 if desired. A forward force can then be applied through the instrument 500 by striking the impact cap 503 using, for example, a mallet. Once the implant device is properly positioned in the patient's spinal space, impact cap 503 may be removed and replaced with handle 502 for manipulation of the implant device. In some embodiments, the handle 502 or impact cap 503 can be removed, and the hammer 670 can be attached to the instrument, such as to the adapter 504 or the top of the housing 540 . Should the surgeon need to move the implant out of the disc space after insertion, the hammer 670 serves as an attachment to provide removal or pulling force on the implant.

To achieve expansion of the implant device, the user can place the toggle 610 in a proximal position, allowing the first and second gear members to disengage from the locked position and engage to couple the first drive shaft 510 and the second drive shaft 512 . The user may then rotate the handle 502 in, for example, a clockwise direction to apply torque to the 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 small increments. If desired, the user may rotate the handle 502 in the opposite direction, eg, counterclockwise, to retract or fine-tune the level of expansion of the implant device. Gear assembly 580 may be configured such that rotation of first drive shaft 510 in a first direction, eg, clockwise, causes rotation of second drive shaft 512 in a second direction opposite the first direction, eg, counterclockwise. 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.

To achieve lordosis, the user may place the shift member 610 in a distal position, allowing the first and second gear members to disengage, thereby disengaging the second drive shaft 512 from the first drive shaft 510 . The user may then rotate the handle 502 in, for example, a clockwise direction, applying torque only to the first drive shaft 510 as the second drive shaft 512 becomes inactive. Only rotation of the first drive shaft 510 causes the implant device to tilt, thereby achieving lordosis. If desired, the user may rotate the handle 502 in the opposite direction, eg, counterclockwise, to adjust or remove the level of lordosis while keeping the first drive shaft 510 and the second drive shaft 512 restricted from rotating. This restriction ensures that the drive shaft cannot retract the implant when the instrument is disconnected from the implant.

To disconnect the surgical instrument 500 from the implanted device, the user can place the switch 610 in the neutral position to set the instrument in the locked mode, and then rotate the sleeves 520, 522, for example, outwardly to remove the instrument 500 from the implanted device. The device unscrews out.

Various embodiments of the operating instrument have been described. It should be understood that the present disclosure is not limited to particular embodiments described. An aspect described in connection with a particular embodiment is not necessarily limited to that embodiment and may be practiced in any other embodiment.

Various embodiments have been described with reference to the figures. It should be emphasized that some of the figures are not necessarily drawn to scale. The drawings are intended only to facilitate the description of specific embodiments and are not intended to be exhaustive or as a limitation to the scope of the present disclosure. Furthermore, in the drawings and description, specific details may be set forth in order to provide a thorough understanding of the present disclosure. It will be apparent to one of ordinary skill in the art that some of these specific details may not be used in practicing the disclosed embodiments. In other instances, well known components may not have been shown or described in detail to avoid unnecessarily obscuring embodiments of the disclosure.

Unless otherwise specifically defined, technical terms and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. As used in the specification and the appended claims, the singular forms "a", "an" and "the" include plural referents unless the context clearly dictates otherwise. The term "or" means a non-exclusive "or" unless the context clearly dictates otherwise.

It will be understood by those skilled in the art that various other modifications may be made. All these and other variations and modifications are contemplated by the inventors and are within the scope of the invention.

Claims (39)

1. An operating instrument, comprising:

a handle;

a first drive shaft operably connected to the handle;

a second drive shaft;

a gear assembly including 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 operable to position the second gear member in engagement with the first gear member to couple the second drive shaft with the first drive shaft to provide a first mode of operation in which the handle is operated to rotate both the first drive shaft and the second drive shaft, or to position the second gear member out of engagement with the first gear member to decouple the second drive shaft from the first drive shaft to provide a second mode of operation in which the handle is operated to rotate only the first drive shaft;

a housing provided with a cavity configured to receive the gear assembly and the first portions of the first and second drive shafts, wherein the second portions of the first and second drive shafts extend out from the housing; and

a first tubular shaft surrounding the second portion of the first drive shaft and a second tubular shaft surrounding the second portion of the second drive shaft,

wherein the first and second tubular shafts each include a first end portion rotatably fixed to the housing to prevent axial movement of the first and second tubular shafts away from the housing while allowing the first and second tubular shafts to rotate independently of rotation of the first and second drive shafts, respectively.

2. The operating device of claim 1, wherein the first and second drive shafts are each rotatably secured to the housing such that the first and second drive shafts are prevented from moving axially away from the housing while allowing rotation thereof.

3. The operating instrument of claim 1, wherein the first and second tubular shafts each include a workpiece connecting end provided with an internal thread configured to connect with a workpiece having a corresponding external thread.

4. The operating instrument of claim 1, wherein at least one of the first tubular shaft and the second tubular shaft includes a finger grip.

5. The operating device of claim 1, wherein the lever member is further operable to dispose the second gear member in the housing in a locked position in which rotation of the second drive shaft and the first drive shaft by the handle is prevented.

6. The operating instrument of claim 5, wherein an inner surface of the housing is provided with a tooth configuration configured to mate with at least a portion of the second gear member in the locked position.

7. The operating instrument of claim 1, further comprising a first dial operably coupled to the first drive shaft indicating rotation of the first drive shaft.

8. The operating instrument of claim 7, further comprising a second dial operably coupled to the second drive shaft indicating rotation of the second drive shaft.

9. The operating device of claim 1, further comprising an adapter connecting the first drive shaft and the handle.

10. The operating device of claim 9, wherein the first and second drive shafts have substantially the same length and substantially the same cross-sectional geometry along the length.

11. The operating instrument of claim 1, wherein the first and second gear members are configured such that: when the first and second gear members are operatively engaged, rotation of the first drive shaft in a first direction by the handle causes rotation of the second drive shaft in a second direction opposite the first direction.

12. An operating instrument, comprising:

a handle;

a housing;

a first drive shaft operatively connected with the handle, the first drive shaft rotatably secured to the housing and including a first portion received in the housing and a second portion extending from the housing;

a second drive shaft rotatably secured to the housing and including a first portion received in 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 fixed to the housing;

a second tubular shaft surrounding the second portion of the second drive shaft and rotatably fixed to the housing; and

a gear assembly received in the housing, the gear assembly operable to couple the second drive shaft with the first drive shaft to provide a first operating mode in which the handle is operated to rotate both the first drive shaft and the second drive shaft, or the gear assembly operable to decouple the second drive shaft from the first drive shaft to provide a second operating mode in which the handle is operated to rotate only the first drive shaft.

13. The operating device of claim 12, further comprising an adapter connecting the first drive shaft and the handle.

14. The operating device of claim 13, wherein the first and second drive shafts have substantially the same length and substantially the same cross-sectional geometry along the length.

15. The operating instrument of claim 12, further comprising a first dial operably coupled to the first drive shaft indicating rotation of the first drive shaft.

16. The operating instrument of claim 15, further comprising a second dial operably coupled to the second drive shaft indicating rotation of the second drive shaft.

17. The operating device of claim 12, wherein the gear assembly is further operable to lock the second drive shaft and the first drive shaft, thereby preventing rotation of the second drive shaft and the first drive shaft.

18. The operating instrument of claim 17, wherein an inner surface of the housing is provided with a tooth configuration configured to cooperate with a portion of the gear assembly to lock the second drive shaft and the first drive shaft.

19. The operating device of claim 18, wherein the gear assembly is configured such that in the first operating mode, rotation of the first drive shaft in a first direction by the handle causes rotation of the second drive shaft in a second direction opposite the first direction.

20. An operating instrument, comprising:

a housing;

a chassis;

a first drive shaft and a second drive shaft each having a first portion supported by the chassis in 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, and a second tubular shaft surrounding the second portion of the second drive shaft and rotatably secured to the housing;

a gear assembly including a first gear member fixedly received on the first portion of the first drive shaft and a second gear member slidably received on the first portion of the second drive shaft;

a switching assembly operable to place the second gear member in engagement with the first gear member to couple the second drive shaft with the first drive shaft to provide a first mode of operation in which the second drive shaft is rotatable with the first drive shaft or to displace the second drive shaft out of engagement with the first gear member to disengage the second drive shaft from the first drive shaft to provide a second mode of operation in which the second drive shaft is not rotatable with the first drive shaft; and

a bearing locking assembly operable to lock the first and second drive shafts to the chassis whereby the first and second drive shafts are restricted from sliding away from the housing and are free to rotate, or operable to unlock the first and second drive shafts from the chassis to allow the first and second drive shafts to slide away from the housing.

21. The operating device of claim 20, further comprising a handle connectable to the first drive shaft for applying torque.

22. The operative instrument of claim 20 further comprising an impact cap configured to be disposed on the housing for receiving an impact force.

23. The operating instrument according to claim 20, further comprising a clapper connectable to the operating instrument for applying a pulling force thereto.

24. The operating device of claim 20, further comprising a gear lock disposed in the chassis, wherein the switching assembly is further operable to place the second gear member in engagement with both the gear lock and the first gear member, thereby providing a third operating mode in which rotation of the second and first drive shafts is restricted.

25. The operating device of claim 24, wherein the shift assembly includes a pair of open ring structures that snap over or slide over the second drive shaft, thereby disposing the second gear member between the pair of open ring structures.

26. The operating instrument of claim 25, wherein the switching assembly further comprises a shield member configured to prevent debris or biological material from entering the housing.

27. The operating instrument of claim 20, wherein each of the first and second gear members includes a plurality of teeth each having two end surfaces and two side surfaces extending therebetween, wherein the two end surfaces are chamfered to allow the first and second gear members to be smoothly engaged or disengaged.

28. The operating device of claim 27, wherein the gear assembly is configured such that in the first operating mode rotation of the first drive shaft in a first direction causes rotation of the second drive shaft in a second direction opposite the first direction.

29. The operating device of claim 20, wherein the chassis includes a first portion including a body supporting the first and second drive shafts and a second portion including spaced apart arms defining a partial housing for the gear assembly and the shift assembly, wherein the body is provided with a pair of elongated channels along opposite sides of the body configured to receive the first and second drive shafts.

30. The operating device of claim 29, wherein the body of the chassis further comprises a base at an end of the body, the base being provided with a pair of openings allowing the first and second drive shafts to pass through the pair of openings in the base, be received in the pair of elongated channels, and enter the partial enclosure defined by the spaced apart arms.

31. The operating instrument of claim 30, wherein the body of the chassis further includes a divider that bifurcates the elongate channel, the divider being provided with a pair of openings that align with the pair of openings in the base of the body.

32. The operating instrument of claim 31, wherein the chassis is constructed of stainless steel or aluminum.

33. The operating device of claim 31, wherein the bearing locking assembly includes a pair of bearings configured to lock or secure the first and second drive shafts to the body of the chassis.

34. The operating device of claim 33, wherein the pair of bearings includes a circumferential notch on an inner surface of each of the pair of bearings, the circumferential notches configured to mate with grooves provided in each of the first and second drive shafts to limit the first and second drive shafts from sliding out of the housing when locked or secured.

35. The operative device of claim 34, wherein each of the first and second pairs of bearings further comprises one or more circumferential ridges on an inner surface of the pair of bearings, the body of the chassis further comprising a plurality of ridges on an inner surface of each of the pair of elongated channels, wherein the ridges of the pair of bearings and the ridges of the body of the chassis are configured to limit free axial movement of the first and second drive shafts when locked or secured.

36. The operating instrument of claim 33, wherein the bearing lock assembly further comprises:

a first pair of fasteners configured to drive the pair of bearings, wherein rotation of the pair of fasteners allows the pair of bearings to tighten or loosen the first drive shaft and the second drive shaft in the pair of elongated channels of the chassis; and

a pair of retaining plates coupled to the housing, the pair of retaining plates configured to limit axial movement of the pair of fasteners.

37. The operating instrument of claim 20, wherein the housing includes a first end portion enclosing at least the gear assembly and a second end portion enclosing at least the bearing lock assembly, wherein the first end portion of the housing includes a pair of housing covers removably attached to the chassis, each housing cover of the pair of housing covers including a shoulder configured to support an impact cap.

38. The operating instrument of claim 37, wherein the housing comprises: a guide track providing guidance in operating the switching assembly in at least the first and second modes of operation; and a flag indicating at least the first and second modes of operation.

39. The operative instrument of claim 38, further comprising a guide washer constructed of silicone configured to smooth operation of said switching assembly in said guide track to help ensure that said switching assembly remains stationary in a selected mode of operation and/or to prevent debris or biological material from entering said housing.

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