WO2019022976A1 - SURGICAL OPERATING INSTRUMENT FOR EXPANDABLE AND ADJUSTABLE LYSOSE INTERSOMATIC MELTING SYSTEMS - Google Patents

SURGICAL OPERATING INSTRUMENT FOR EXPANDABLE AND ADJUSTABLE LYSOSE INTERSOMATIC MELTING SYSTEMS Download PDF

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Publication number
WO2019022976A1
WO2019022976A1 PCT/US2018/042199 US2018042199W WO2019022976A1 WO 2019022976 A1 WO2019022976 A1 WO 2019022976A1 US 2018042199 W US2018042199 W US 2018042199W WO 2019022976 A1 WO2019022976 A1 WO 2019022976A1
Authority
WO
WIPO (PCT)
Prior art keywords
housing
shafts
operating instrument
driving shaft
gear
Prior art date
Application number
PCT/US2018/042199
Other languages
English (en)
French (fr)
Inventor
Andrew Rogers
Robyn BURROWS-OWNBEY
Original Assignee
Spineex, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US15/661,435 external-priority patent/US10702396B2/en
Application filed by Spineex, Inc. filed Critical Spineex, Inc.
Priority to CN201880049470.3A priority Critical patent/CN110996858B/zh
Priority to JP2020503813A priority patent/JP7227218B2/ja
Priority to SG11202000543YA priority patent/SG11202000543YA/en
Priority to EP18838048.9A priority patent/EP3658079A4/de
Publication of WO2019022976A1 publication Critical patent/WO2019022976A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/4455—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/4455—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages
    • A61F2/447—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages substantially parallelepipedal, e.g. having a rectangular or trapezoidal cross-section
    • A—HUMAN NECESSITIES
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/4603—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
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    • A61F2/4603—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof
    • A61F2/4611—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof of spinal prostheses
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B25—HAND TOOLS; PORTABLE POWER-DRIVEN TOOLS; MANIPULATORS
    • B25B—TOOLS OR BENCH DEVICES NOT OTHERWISE PROVIDED FOR, FOR FASTENING, CONNECTING, DISENGAGING OR HOLDING
    • B25B17/00—Hand-driven gear-operated wrenches or screwdrivers
    • B25B17/02—Hand-driven gear-operated wrenches or screwdrivers providing for torque amplification
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B25—HAND TOOLS; PORTABLE POWER-DRIVEN TOOLS; MANIPULATORS
    • B25B—TOOLS OR BENCH DEVICES NOT OTHERWISE PROVIDED FOR, FOR FASTENING, CONNECTING, DISENGAGING OR HOLDING
    • B25B19/00—Impact wrenches or screwdrivers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B25—HAND TOOLS; PORTABLE POWER-DRIVEN TOOLS; MANIPULATORS
    • B25B—TOOLS OR BENCH DEVICES NOT OTHERWISE PROVIDED FOR, FOR FASTENING, CONNECTING, DISENGAGING OR HOLDING
    • B25B23/00—Details of, or accessories for, spanners, wrenches, screwdrivers
    • B25B23/0007—Connections or joints between tool parts
    • B25B23/0042—Connection means between screwdriver handle and screwdriver shaft
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    • A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30405—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by screwing complementary threads machined on the parts themselves
    • A61F2002/30411—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by screwing complementary threads machined on the parts themselves having two threaded end parts connected by a threaded central part with opposite threads at its opposite ends, i.e. for adjusting the distance between both end parts by rotating the central part
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
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    • A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30476—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements locked by an additional locking mechanism
    • A61F2002/30507—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements locked by an additional locking mechanism using a threaded locking member, e.g. a locking screw or a set screw
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
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    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30476—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements locked by an additional locking mechanism
    • A61F2002/30515—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements locked by an additional locking mechanism using a locking wedge or block
    • A—HUMAN NECESSITIES
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
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    • A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30518—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements with possibility of relative movement between the prosthetic parts
    • A61F2002/30523—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements with possibility of relative movement between the prosthetic parts by means of meshing gear teeth
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
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    • A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30537—Special structural features of bone or joint prostheses not otherwise provided for adjustable
    • A—HUMAN NECESSITIES
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    • A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30537—Special structural features of bone or joint prostheses not otherwise provided for adjustable
    • A61F2002/30538—Special structural features of bone or joint prostheses not otherwise provided for adjustable for adjusting angular orientation
    • A—HUMAN NECESSITIES
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    • A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30537—Special structural features of bone or joint prostheses not otherwise provided for adjustable
    • A61F2002/30556—Special structural features of bone or joint prostheses not otherwise provided for adjustable for adjusting thickness
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    • A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
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    • A61F2002/4627—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for insertion or extraction of endoprosthetic joints or of accessories thereof with relative movement between parts of the instrument during use with linear motion along or rotating motion about the instrument axis or the implantation direction, e.g. telescopic, along a guiding rod, screwing inside the instrument
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T74/00—Machine element or mechanism
    • Y10T74/19—Gearing
    • Y10T74/1956—Adjustable
    • Y10T74/19565—Relative movable axes
    • Y10T74/1957—Parallel shafts

Definitions

  • the invention relates to surgical procedures and apparatus for treating lumbar back pain.
  • Lumbar spinal fusion is a surgical procedure to correct problems relating to the human spine. It generally involves removing damaged disc and bone from between two vertebrae and inserting bone graft material that promotes bone growth. As the bone grows, the two vertebrae join, or fuse, together. Fusing the bones together can help make that particular area of the back more stable and help reduce problems related to nerve irritation at the site of the fusion. Fusions can be done at one or more segments of the spine.
  • Interbody fusion is a common procedure to remove the nucleus pulposus and or the annulus fibrosus that compose the intervertebral disc at the point of the back problem and replace it with a cage configured in shape and dimension to restore the distance between adjacent vertebrae to that of a proper condition.
  • Surgical approaches to implement interbody fusion vary, and access to the patient's vertebral column can be made through the abdomen or back.
  • One other surgical method for accomplishing lumbar spinal fusion in a less invasive way involves accessing the vertebral column through a small incision on the side of the body. This procedure is known as lateral lumbar interbody fusion.
  • An embodiment of the device comprises an expandable housing comprised of opposing shell members. Movable tapered screw-like elements having an external helical thread are disposed in the housing and operably engage against the top and bottom shell members, urging them apart to cause expansion in the height of the housing. This function permits adjustment of the distance (height) between adjacent vertebrae when in place.
  • the tapered members are disposed in a dual arrangement such that independent engagement of the tapered members along lateral portions of the top and bottom shells cause an angular tilt to the exterior surface of the housing when the wedge members are moved to different degrees. This function permits adjustment in the angular relationship between adjacent vertebrae and assists the lordotic adjustment of the patient's spine.
  • the device provides an effective tool for in situ adjustment when performing lateral lumbar interbody fusion.
  • An embodiment of the device further comprises a track configuration within the housing for guiding the tapered external helical threaded members in their engagement with the top and bottom shell members.
  • the track comprises raised elements on each of the interior surfaces of the top and bottom shell members that permit an interlocking engagement for lateral stability of the housing when in a contracted position. As the housing expands, the track area provides space for storage of bone graft material.
  • One embodiment may provide for an elastic membrane to be positioned around the housing to prevent bone graft material from seeping out of the cage and to provide a compressive force around the cage to provide structural stability to the housing
  • An embodiment of the device further comprises drive shafts for operating the tapered external helical threaded members.
  • the drive shafts permit the surgeon, through the use of a supplemental tool, to manipulate the shafts which operatively move the tapered external helical threaded members in controlling the expansion of the housing and angular adjustment of the top and bottom shell members for in situ fitting of the interbody fusion device.
  • a locking mechanism is provided for preventing rotation of the shafts when the tool is not engaged and after manipulation by the tool is completed. The tool also facilitates insertion of bone graft material into the fusion body during in situ adjustment.
  • An embodiment of the present invention provides a surgeon with the ability to both expand the fusion cage and adjust the lordotic angle of the fusion cage in situ during operation on a patient and to introduce bone graft material at the operation site while the device is in place.
  • This embodiment of the present invention therefore provides a fusion cage having geometric variability to accommodate the spinal condition unique to each patient.
  • Embodiments of the present invention therefore provide an interbody cage device for use in lateral lumbar interbody fusion procedures that combines the functions of height expansion for adjusting the distance between adjacent vertebrae with lordotic adjustment to control the angular relationship between the vertebrae.
  • Embodiments of the inventive interbody cage device further provide a storage capacity for containing bone graft material in the interbody cage device as disc height and lordotic adjustment takes place in situ.
  • the present invention also provides a device that may be used in environments other than in interbody fusion applications. It may generally be used to impart a separating effect between adjacent elements and to impart a variable angular relationship between the elements to which it is applied.
  • An embodiment of an operating instrument comprises a handle, a first driving shaft, a second driving shaft, and a gear assembly.
  • the first driving shaft is operably connected with the handle.
  • the gear assembly comprises a first gear member received on the first driving shaft, a second gear member slidably received on the second driving shaft, and a lever member.
  • the lever member is operable to place the second gear member into engagement with the first gear member thereby coupling the second driving shaft with the first driving shaft to provide a first operating mode wherein the handle operates to rotate both the first and second driving shafts, or place the second gear member out of engagement with the first gear member thereby decoupling the second driving shaft from the first driving shaft to provide a second operating mode wherein the handle operates to rotate solely the first driving shaft.
  • An embodiment of an operating instrument comprises a handle, a housing, a first and a second driving shaft, a first and a second tubular shaft, and a gear assembly.
  • the first driving shaft is operably connected with the handle, rotatably secured to the housing, and comprise a first portion received in the housing and a second portion extending out of the housing.
  • the second driving shaft is rotatably secured to the housing and comprises a first portion received in the housing and a second portion extending out of the housing.
  • the first tubular shaft surrounds the second portion of the first driving shaft and is rotatably secured to the housing.
  • the second tubular shaft surrounds the second portion of the second driving shaft and is rotatably secured to the housing.
  • the gear assembly is received in the housing operable to couple the second driving shaft with the first driving shaft to provide a first operating mode wherein the handle operates to rotate both the first and second driving shafts, or decouple the second driving shaft from the first driving shaft to provide a second operating mode wherein the handle operates to rotate solely the first driving shaft.
  • Embodiments of the disclosure provide a surgical operating instrument for expandable and adjustable lordosis interbody fusion systems.
  • the instrument provides for an improved and more efficient way to connect an interbody fusion implant device and physically implant it into the patient and further expand and lordotically adjust the implant in- situ.
  • the instrument allows for a smoother, more efficient, and more robust operation of an interbody fusion implant once the implant is inserted into the patient.
  • the instrument enables surgeons to expand, lordotically adjust, and position the implant in the patient's intervertebral disc space with a smoother instrument operating interface, while also being able to deliver more force to the instrument if needed without damaging it.
  • the instrument when connected to the implant can be operable and serve as a distraction system where two vertebral bodies can be forced or distracted away from each other. This allows for restoration of the normal intervertebral disc height anatomy for patients with degenerative disc disease (DDD), deformities, and tumors. This allows for a more streamlined and efficient means for distracting the intervertebral disc space.
  • the instrument's human interface aspects are more intuitive, allowing for a more seamless interaction between the surgeon and the instrument during surgery, ultimately making surgery easier and quicker.
  • the instrument provides for greater ease of assembly and disassembly after surgery to allow the instrument to be cleaned and sterilized so that it can be reused for more surgeries.
  • An embodiment of a surgical operating instrument includes a housing, a chassis, a first and second drive shaft, a gear assembly, a switch assembly, and a lock or bearing lock assembly.
  • the first and second drive shafts each has a first portion supported by the chassis in the housing and a second portion extending out of 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 switch 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 operating mode wherein the second drive shaft is rotatable with the first drive shaft, or displace the second gear member out of engagement with the first gear member thereby decoupling the second drive shaft from the first drive shaft to provide a second operating mode wherein the second drive shaft is non-rotatable with the first drive shaft.
  • the bearing lock assembly is operable to lock the first and second drive shafts to the chassis whereby the first and second drive shafts are restricted from sliding out of the housing and are capable of freely rotating or unlock the first and second drive shafts from the chassis to allow the first and second drive shafts to slide out of the housing.
  • FIG. 1 is a view in side elevation from the side of the expandable shell device.
  • FIG. 2 is a perspective view of a bottom section of the expandable shell.
  • FIG. 3 is a top plan view of the bottom section of the expandable shell.
  • FIG. 4 is a top plan view of the expandable shell device.
  • FIG. 5 is a perspective view of a tapered external helical threaded member.
  • FIG. 5A is a view in side elevation from the side of the tapered external helical threaded member.
  • FIG. 5B is a view in side elevation from the front of the tapered external helical threaded member.
  • FIG. 6 is a cross-sectional view of the device taken along lines 6-6 in FIG. 1.
  • FIGS. 7A-7C are a series of views in side elevation of the device as it undergoes expansion.
  • FIG. 8 is a view in side elevation of the device showing an expansion of the device to accommodate a lordotic effect.
  • FIG. 9A is a perspective expanded view of thrust bearing for the drive shaft.
  • FIG. 9B is a perspective view of the drive shafts and thrust bearings.
  • FIG. 9C is a top plan view in cross section of the area of engagement of the drive shafts with the thrust bearings.
  • FIG. 10 is a side elevation view of the housing as expanded.
  • FIG. 11 A is a top plan view of another embodiment of the device.
  • FIG. 11 B is a top plan view of yet another embodiment of the device.
  • FIG. 12A is a top plan view of the drive shafts disengaged by the locking mechanism.
  • FIG. 12B is a top plan view of the drive shafts engaged by the locking mechanism.
  • FIG. 13A is a perspective view of the locking mechanism.
  • FIG. 13B is a top plan cross sectional view of the drive shafts disengaged by the locking mechanism.
  • FIG. 13C is a top plan cross sectional view of the drive shafts engaged by the locking mechanism.
  • FIG. 14 is a view taken along lines 14-14 in FIG. 11A.
  • FIGS. 15A-C are a series of views in side elevation taken from the end of the device as it undergoes expansion showing the lordotic effect.
  • FIG. 16 is a perspective view of the operating tool.
  • FIG. 17 is a view showing a manner of attachment of the operating tool to the drive shafts of the device.
  • FIG. 18 is a breakaway perspective view of the handle of the operating tool.
  • FIG. 19 is a perspective view of gears in the handle engaged for operation of both drive shafts.
  • FIG. 20 is a perspective view of gears in the handle disengaged for operation of a single drive shaft.
  • FIG. 21A is a cutaway perspective view of an exemplary operating instrument according to embodiments of the disclosure.
  • FIG. 21 B is an exploded perspective view of the operating instrument shown in FIG. 21A.
  • FIG. 22A is a perspective view of a driving shaft according to embodiments of the disclosure
  • FIG. 22B is an enlarged perspective view of the tip portion of the driving shaft shown in FIG. 22A.
  • FIG. 22C is an enlarge plan view of a portion of the driving shaft shown in
  • FIG. 22A is a diagrammatic representation of FIG. 22A.
  • FIG. 23 is a perspective view of an exemplary lever member according to embodiments of the disclosure.
  • FIG. 24 is a perspective view of a portion of the operating instrument shown in
  • FIG. 21A illustrating a lever member in an expanded position with greater clarity.
  • FIG. 25 is a perspective view of a portion of the operating instrument shown in
  • FIG. 21A illustrating a lever member in a lordosis position with greater clarity.
  • FIG. 26 is a perspective view of a portion of the operating instrument shown in
  • FIG. 21A illustrating a lever member in a locked position with greater clarity.
  • FIG. 27A is a perspective view of an exemplary outer connection shaft according to embodiments of the disclosure.
  • FIG. 27B is a plan view of the outer connection shaft shown in FIG. 27A.
  • FIG. 27C is a plan view of an end portion of the outer connection shaft shown in FIG. 27B.
  • FIG. 28A is a perspective view of an exemplary handle according to embodiments of the disclosure.
  • FIG. 28B is a side view of the handle shown in FIG. 28A.
  • FIG. 28C is a cross-sectional view of the handle along line A-A in FIG. 28B.
  • FIG. 28D is an end view from a first end of the handle shown in FIG. 28A.
  • FIG. 28E is an end view from a second end of the handle shown in FIG. 28A.
  • FIG. 29 is a perspective view of a portion of the operating instrument shown in
  • FIG. 21A illustrating the housing, the outer connection shafts, and the driving shafts with greater clarity.
  • FIG. 30 is a perspective view of an exemplary adapter according to embodiments of the disclosure.
  • FIG. 31 is a perspective view of an exemplary dial according to embodiments of the disclosure.
  • FIG. 32 is a perspective view of an exemplary dial according to embodiments of the disclosure.
  • FIG. 33 is an exploded view of an exemplary surgical operating instrument according to embodiments of the disclosure.
  • FIG. 34 is a partial, cross-sectional view of an exemplary surgical operating instrument according to embodiments of the disclosure.
  • FIG. 35 is a perspective view of an exemplary surgical operating instrument according to embodiments of the disclosure.
  • FIG. 36 is a perspective view of an exemplary surgical operating instrument according to embodiments of the disclosure.
  • FIG. 37 is an exploded view of a housing including housing covers according to embodiments of the disclosure.
  • FIG. 38 schematically shows a housing enclosing a chassis according to embodiments of the disclosure.
  • FIG. 39 is a perspective end view of a housing according to embodiments of the disclosure.
  • FIG. 40 is a perspective front view of a housing according to embodiments of the disclosure.
  • FIG. 41 is a perspective side view of a housing showing switch guide features according to embodiments of the disclosure.
  • FIG. 42 is a perspective view of a switch gasket according to embodiments of the disclosure.
  • FIG. 43 is a perspective view of an exemplary chassis according to embodiments of the disclosure.
  • FIG. 44 is a perspective view of an exemplary chassis with sleeve and drive shaft bearings and other components being placed on the chassis according to embodiments of the disclosure.
  • FIG. 45 is a partial perspective view showing an exemplary chassis, a lock assembly, and other components according to embodiments of the disclosure.
  • FIG. 46 is a perspective view of an exemplary gear member according to embodiments of the disclosure.
  • FIG. 47 is a perspective view of an exemplary toggle switch according to embodiments of the disclosure.
  • FIG. 48 is a partial perspective view showing a gear assembly and a switch assembly in a first operating setting according to embodiments of the disclosure.
  • FIG. 49 is a partial perspective view showing a gear assembly and a switch assembly in a second operating setting according to embodiments of the disclosure.
  • FIG. 50 is a partial perspective view showing a gear assembly and a switch assembly in a third operating setting according to embodiments of the disclosure.
  • FIG. 51 is a perspective view of an exemplary gear lock according to embodiments of the disclosure.
  • FIG. 52 is a partial perspective view showing a bearing lock assembly and other components of an exemplary surgical operating instrument according to embodiments of the disclosure.
  • FIG. 53 schematically shows a bearing member which can be used as a drive shaft bearing or sleeve bearing according to embodiments of the disclosure.
  • FIG. 54 is a partial, cutaway view of an exemplary surgical operating instrument showing a lock assembly including retaining plates and other components according to embodiments of the disclosure.
  • FIG. 55 is an isometric view of an exemplary surgical operating instrument including a slap hammer according to embodiments of the disclosure.
  • FIG. 56 is an isometric exploded view of the exemplary surgical operating instrument shown in FIG. 55 according to embodiments of the disclosure.
  • FIG. 57 is an isometric view of an exemplary slap hammer according to embodiments of the disclosure.
  • the interbody fusion device 10 is shown generally in FIG. 1. It is comprised of a housing 12 having a top shell 14 and a bottom shell 16.
  • the overall housing may have a length of 50 mm and a width of 20 mm, as an example.
  • the shell material may be comprised of a suitable material, such as titanium alloy (Ti-6AL-4V), cobalt chromium, or polyether ether ketone (PEEK). Other materials may be suitable that can provide sufficient compositional integrity and that have suitable biocompatible qualities.
  • step tracking 18 begins towards the midpoint of an inner surface of bottom shell 16 with successive track steps increasing in height as the tracking extends to a first end of bottom shell 16.
  • step-tracking 20 begins towards the midpoint of the inner surface of bottom shell 16 with successive track steps increasing in height as that portion of the tracking extends to a second opposite end of bottom shell 16.
  • Step tracking 18 comprises dual track runs 22 and 24 while step tracking 20 comprises dual track runs 26 and 28 as shown in FIG. 3.
  • Corresponding step tracking 30 and 32 is provided on top shell 14 as shown in FIG. 4.
  • the respective track runs comprise a series of risers, or track steps, which are spaced apart to receive the threads of tapered external helical threaded members.
  • the tapered external helical threaded members provide a wedging action for separating the top and bottom shell thereby increasing the height of the housing to effect expansion between the vertebral bodies in which the device is placed.
  • track run 22 receives tapered external helical threaded member 34
  • track run 24 receives tapered external helical threaded member 36
  • track run 26 receives tapered external helical threaded member 38
  • track run 28 receives tapered external helical threaded member 40.
  • Track run 22 aligns collinearly with track run 26 such that the travel of tapered external helical threaded members 34 and 38 within the respective track runs occurs within that collinear alignment.
  • the thread orientation of tapered external helical threaded members 34 and 38 are opposite of each other such that their rotation will result in opposite directional movement with respect to each other.
  • a drive shaft 42 runs along the collinear span of track runs 22 and 26 and passes through tapered external helical threaded members 34 and 38.
  • Shaft 42 has a square cross sectional configuration for engaging and turning the tapered external helical threaded members.
  • the central axial opening 44 of the tapered external helical threaded members are configured to receive and engage the shaft 42.
  • Shaft 42 may alternatively comprise any shape for effectively creating a spline, such as a hexagonal shape, and central axial openings 44 may comprise a corresponding configuration for receiving that shape.
  • tapered external helical threaded members 34 and 38 are rotated and their respective thread orientations cause the screws to travel apart from each other along track run 22 and track run 26, respectively.
  • tapered external helical threaded members 34 and 38 are caused to travel towards each other along track run 22 and track run 26, respectively.
  • track run 24 aligns collinearly with track run 28 such that the travel of tapered external helical threaded members 36 and 40 within the respective track runs occurs within that collinear alignment.
  • the thread orientation of tapered external helical threaded members 36 and 40 are opposite of each other such that their rotation will result in opposite directional movement with respect to each other.
  • shaft 46 passes through and engages tapered external helical threaded members 36 and 40.
  • the orientation of tapered external helical threaded members 36 and 40 is reversed from the orientation of tapered external helical threaded members 34 and 38.
  • tapered external helical threaded members 36 and 40 are rotated and their respective thread orientations cause the screws to travel apart from each other along track run 24 and track run 28, respectively.
  • tapered external helical threaded members 36 and 40 are caused to travel towards each other along track run 24 and track run 28, respectively.
  • the step tracking is configured with a cascading series of risers of increasing height.
  • each track run has risers 52-60 as shown for step tracking 18 in FIG. 2.
  • the positional height of the tapered external helical threaded member body, as supported on risers 52 and 54 increases within the housing 12.
  • the tapered external helical threaded member continues to travel along the track run, its thread passes from the gap between risers 52 and 54 and enters the gap between risers 54 and 56 which raises the tapered external helical threaded member body further within housing 12 as it is supported on risers 54 and 56.
  • the combined effect of rotating the tapered external helical threaded members to cause their movement towards the outer ends of the respective track runs causes an expansion of the housing 12 as shown in FIG. 7.
  • the fully expanded shell is shown in FIG. 10.
  • the housing 12 may be contracted by reversing the movement of the tapered external helical threaded members such that they travel back along their respective track runs towards the midpoint of the housing.
  • the housing will optimally provide expansion and contraction to give the implant device a height over a range of around approximately 7.8 mm to 16.15 mm in the present embodiment.
  • the device of this embodiment of the invention can be adapted to provide different expansion dimensions.
  • the pairs of tapered external helical threaded members in each collinear dual track run may be rotated independently of the pair of tapered external helical threaded members in the parallel track run.
  • the degree of expansion of that portion of the housing over each collinear track run may be varied to adjust the lordotic effect of the device.
  • tapered external helical threaded members 36 and 40 have been extended to a particular distance along track run 24 and track run 28, respectively, causing the top shell 14 to separate from bottom shell 16 thereby expanding housing 12.
  • Tapered external helical threaded members 34 and 38 have been extended to a lesser distance along parallel track run 22 and 26, respectively, causing that portion of the top shell over track runs 22 and 26 to separate from bottom shell to a lesser degree.
  • the series of FIGS. 15A-15C show this effect where tapered external helical threaded members 36 and 40 are extended apart from each other in further increasing increments where the tapered external helical threaded members 34 and 38 maintain the same relative distance to each other.
  • FIG. 15A the respective positioning of the set of tapered external helical threaded members 36-40 is approximately the same as the set of tapered external helical threaded members 34-38 in their respective tracking.
  • the top shell 14 is essentially parallel with bottom shell 16.
  • the set of tapered external helical threaded members 36-40 move further distally apart along their tracking as the set of tapered external helical threaded members 34-38 remains at their same position in FIG. 15A.
  • the device can achieve a lordotic effect of between 0° and 35° in the present embodiment.
  • the device of this embodiment of the invention can be adapted to provide different lordotic tilt dimensions.
  • the tapered external helical threaded members have a configuration comprising a body profile that has an increasing minor diameter from D r i to D r 2 as shown in FIG. 5.
  • the threads 33 have a pitch to match the spacing between the riser elements 52-60 in the tracking runs as shown in FIG. 4.
  • Threads 33 can have a square profile to match the configuration between the risers, but other thread shapes can be used as appropriate.
  • the increasing diameter and tapering aspect of the helical threaded members cause top shell 14 and bottom shell 16 to move apart as described above. The contact at the tops of the risers 52-60 is made at the minor diameter of the helical threaded member.
  • Thrust bearings are provided to limit the axial direction motion of the drive shafts within shell 12.
  • thrust bearing 62 comprises a two-piece yoke configuration that mate together and press-fit around ends of the shafts.
  • the top part 64 of the thrust bearing yoke defines openings for receiving a round portion 66 of the shaft ends.
  • square shaft 42 has a rounded portion 66 of lesser diameter than the square portion of the shaft.
  • a mating piece 65 of the thrust bearing engages with top part 64 to encircle the rounded portion 66 of drive shaft 42.
  • Journal grooves 67 can also be provided in thrust bearing 62.
  • Shaft 42 can have an annular ridge 63 around its rounded portion 66 which is received in journal groove 67 as shown in FIG. 9C.
  • a thrust bearing is provided at each end of the drive shafts as shown in FIG. 9B. As shown in FIG. 6, the thrust bearings restrict the axial movement of the drive shafts in the housing.
  • a safety lock is provided at the proximal end of the device for preventing unintended rotation of the shafts.
  • safety lock member 70 is provided for engagement with the proximal ends of drive shafts 42 and 46.
  • the openings 73 in safety lock member 70 are configured with the shape of the cross-sectional configuration of the drive shafts (see FIG. 13A).
  • a portion of the drive shafts has a narrowed, rounded configuration 71 such that the drive shaft can rotate freely while the rounded portion of the shaft is in alignment with the safety lock member openings 73 (see FIG. 13C).
  • FIG. 12B shows this relationship among the safety lock member 70, thrust bearing 62 and drive shafts 42 and 46.
  • FIG. 12A shows this relationship among the safety lock member 70, thrust bearing 62 and drive shafts 42 and 46.
  • a compression spring 77 can be placed between thrust bearing 62 and safety lock member 70 to urge safety lock member back over the square portion 75 of the drive shafts.
  • FIG. 12B shows a lock disengagement when the safety lock member 70 is pushed forward out of alignment with the square portions 75 and placed in alignment with the rounded portions 71 of shafts 42 and 46.
  • Post 79 can be disposed between safety lock member 70 and thrust bearing 62 on which compression spring 77 can be positioned.
  • Post 79 can be fixedly connected to safety lock member 70 and an opening can be provided in thrust bearing 62 through which post 79 can slide.
  • Post 79 is provided with head 81 to limit the backward movement of safety lock member 70 from the compressive force of spring 77.
  • the above equation determines the torque necessary to apply to the drive shafts engaging the tapered external helical threaded members for expanding the shell members.
  • This torque is dependent upon the mean diameter of the tapered external helical threaded members, the load (F) applied by the adjacent vertebral bodies, the coefficient of friction (f) of the working material, and the lead (I) or, in this embodiment, the pitch of the helical threading. All of these factors determine the required operating torque to transform rotational motion into a linear lift to separate the shell members in accomplishing expansion and lordosis.
  • the torque required to lower the tapered external helical threaded members (T L ) must be a positive value.
  • the value of (Ti_) is zero or positive, self-locking of the tapered external helical threaded members within the step tracking is achieved. If the value of (Ti_) falls to a negative value, the tapered external helical threaded members are no longer self-locking within the step tracking.
  • the factors that can contribute to a failure to self-lock include the compressive load from the vertebral bodies, the pitch and mean diameter of the helical thread not being adequately great, and an insufficient coefficient of friction of the material. The condition for self-locking is shown below:
  • the operating torque to expand shell housing 12 between L4-L5 of the vertebral column is around 1.312 Ib-in (0.148 N-m), and the operating torque to contract shell housing 12 between L4-L5 of the vertebral column is around 0.264 Ib-in (0.029 N-m).
  • FIG. 11A shows housing 100 for use where a surgeon approaches the lumbar area from an anterior aspect of the patient.
  • the general configuration of the tracking runs for this embodiment is similar to that for device 10, but the drive shafts for moving the tapered external helical threaded members are applied with a torque delivered from a perpendicular approach.
  • a dual set of worm gears 102 and 104 respectively transfer torque to drive shafts 106 and 108 as shown in FIG. 14.
  • FIG. 11 B shows housing 200 for use where a surgeon approaches the lumbar area from a transforaminal aspect of the patient.
  • the general configuration of the tracking runs for this embodiment is also similar to that for device 10, but the torque is applied to the drive shafts from an offset approach.
  • a dual set of bevel gears may be used to transfer torque to drive shafts 206 and 208.
  • Housing 12 is provided with numerous niches and open areas in its surface and interior regions to accommodate the storage of bone grafting material.
  • the interstitial spaces between the risers of the cascading step tracking also offers areas for receiving bone-grafting material.
  • a membrane can be provided as a supplement around housing 12 to help maintain compression on the top and bottom shells and to hold in bone grafting material.
  • Tension spring elements 78 can be provided to hold together top member 14 and bottom member 16 as shown in FIG. 10. These elements may also serve to provide an initial tension force in the direction opposite of the expansion against the interbody fusion device. This allows the tapered external helical threaded members to climb the risers in the event that contact between the outer shells and the vertebral bodies is not yet made.
  • this embodiment of the interbody fusion device of the instant invention is capable of expansion to provide support between vertebral bodies and accommodate the load placed on that region. Furthermore, the inventive interbody fusion device is capable of achieving a configuration that can provide an appropriate lordotic tilt to the affected region. The device, therefore, provides a significant improvement with regards to patient-specific disc height adjustment.
  • the device is provided with a tool for operating the interbody fusion device as it is adjusted in situ in a patient's spine.
  • the operating tool 300 is shown generally in FIG. 16 and comprises a handle member 302, a gear housing 304 and torque rod members 306 and 308.
  • the torque rod members connect to the drive shafts of expandable shell 12.
  • One embodiment for connecting the torque rod members to the drive shafts of expandable shell 12 is shown in FIG. 17.
  • ends 48 and 50 of drive shafts 42 and 46 can be provided with a hex-shaped head.
  • the ends of torque rod members 306 and 308 can be provided with correspondingly shaped receivers for clamping around ends 48 and 50.
  • handle member 302 directly drives torque rod member 308.
  • Torque rod member 308 is provided with spur gear member 310 and torque rod member 306 is provided with spur gear member 312.
  • Spur gear 312 is slidably received on torque rod member 306 and can move in and out of engagement with spur gear 310.
  • Spur gear lever 314 engages with spur gear 312 for moving spur gear 312 into and out of engagement with spur gear 310.
  • Spur gear 312 can be moved out of engagement with spur gear 310 by retracting spur gear lever 314 as shown in FIG. 20. Wth spur gear 312 out of engagement with spur gear 310, rotation of handle 302 only turns torque rod member 308. In this condition, torque rod member 308 rotates drive shaft 46 solely and drive shaft 42 remains inactive to effect the tilt to the top member of shell 12 as shown in FIG. 8 and FIGS. 15A-15C to achieve lordosis.
  • the operator will turn handle member 302 clockwise to engage torqueing.
  • This applied torque will then engage the compound reverted spur gear train composed of spur gear members 310 and 312.
  • This series of gears will then spin torque rod members 306 and 308 in opposite directions of each other.
  • Torque rod member 308 (in alignment with handle member 302) will spin clockwise (to the right) and torque rod member 306 will spin counterclockwise (to the left).
  • the torque rod members will then rotate the drive shafts of interbody fusion device 12 expanding it to the desired height.
  • FIGS. 21-32 various embodiments of a surgical operating tool or instrument according to the disclosure will now be described.
  • FIG. 21 A is a cutaway perspective view of an exemplary operating tool or instrument according to embodiments of the disclosure.
  • FIG. 21 B is an exploded perspective view of the operating tool or instrument shown in FIG. 21A.
  • the exemplary operating tool 400 in general comprises a handle 402, driving shafts 404, 406, a gear assembly 408, and optionally outer connection or tubular shafts 414, 416.
  • the gear assembly 408 may be received in a housing 410.
  • the driving shafts 404, 406 and optionally the outer tubular shafts 414, 416 may be rotatably secured to the housing 410.
  • the handle 402 may be any suitable handle that a user can apply torque to the driving shafts 404, 406.
  • the handle 402 can be shaped in various configurations including l-shaped or T-shaped configurations.
  • the handle 402 may be a bi-directional ratchet handle which can apply torque by rotating both clockwise and counterclockwise.
  • the handle 402 may be a torque limiting ratchet handle which can limit the torque applied by the user so that damage to a workpiece (not shown) does not take place.
  • the workpiece is an expandable and adjustable spinal implant device described above in conjunction with FIGS. 1-15, and the handle 402 is a bi-directional torque limiting ratchet handle to effect expansion, contraction, and/or tilt of the spinal implant device.
  • Torque limiting ratchet handles are commercially available for example from Bradshaw Medical, Inc. in Kenosha, Wisconsin.
  • the driving shafts 404, 406 may include a first driving shaft 404 and a second driving shaft 406.
  • the first driving shaft 404 may be operably connected with and rotated by the handle 402.
  • the second driving shaft 406 may be operably coupled with the first driving shaft 404 or decoupled from the first driving shaft 404 via the gear assembly 408 to be described in greater detail below.
  • a first operating mode is provided wherein the handle 402 can rotate both the first driving shaft 404 and the second driving shaft 406.
  • a second operating mode is provided wherein the handle 402 rotates solely the first driving shaft 404.
  • the first and second driving shafts 404, 406 may each include a first portion 404a, 406a received in the housing 410 when assembled and a second portion 404b, 406b extending out of the housing 410.
  • the first and second driving shafts 404, 406 may be rotatably secured to the housing 410 via screws 418, or keys, pins or the like to be described in greater detail below.
  • the first and second driving shafts 404, 406 may have a substantially same length and cross-sectional geometry along the length. Alternatively, the first and second driving shafts 404, 406 may have different lengths and cross-sectional geometries.
  • the first driving shaft 404 may be connected with the handle 402 via an adapter 420 to be described in greater detail below. Alternatively, the first driving shaft 404 may extend its length out of the housing 410 to connect with the handle 402.
  • FIGS. 22A-22C illustrate an exemplary driving shaft which can be used as the first and/or the second driving shaft 404, 406.
  • the exemplary driving shaft 404 may include a first portion 404a and a second portion 404b.
  • the first portion 404a may be received in the housing 410 and the second portion 404b may extend out of the housing 410.
  • the first portion 404a and the second portion 404b may be integrally machined as a single component, or alternatively, separately machined and then assembled.
  • the first and second portions 404a, 404b may be generally cylindri cally shaped and have a diameter same as or different from each other.
  • the first portion 404a of the driving shaft 404 may include a potion 404d at the proximal end configured to receive a gear member, an adapter, or a dial to be described in greater detail below.
  • the portion 404d at the proximal end of the first portion 404a may include a flattened surface and a remaining cylindrical surface configured to receive a gear member, an adapter, or a dial having a channel, cutout, or aperture having a corresponding flattened surface and cylindrical surface.
  • the first portion 404a of the driving shaft 404 may include an undercut or groove forming a rounded portion 404e with a reduced diameter.
  • the undercut or groove provides space for crews, keys, pins, or the like to fit in or flush against the rounded portion 404e, thereby restricting the driving shaft 404 from axially moving or slipping out of the housing 410 while allowing the driving shaft 404 to freely rotate.
  • the second portion 404b extends from the first portion 404a and includes a workpiece-engaging tip 404c having features configured to engage a workpiece.
  • the workpiece-engaging tip 404c has a torx or hexalobular configuration.
  • Other suitable configurations or features known in the art may also be used to engage a workpiece having corresponding engaging features.
  • the workpiece may be a spinal implant device described above in conjunction with FIGS. 1-15.
  • the workpiece may also be other medical devices operable to expand, contract, or tilt by use of an operating tool.
  • the gear assembly 408 serves to couple the second driving shaft 406 with the first driving shaft 404 or decouple the second driving shaft 406 from the first driving shaft 404.
  • the gear assembly 408 may also lock the second and first driving shafts 406, 404 so that rotation of the first and second driving shafts 404, 406 are prohibited.
  • the gear assembly 408 may include a first gear member 408a received on the first driving shaft 404, a second gear member 408b received on the second driving shaft 406, and a lever member 408c operable to place the second gear member 408b into and out of engagement with the first gear member 408a.
  • the first gear member 408a may be fixedly secured to the first driving shaft 404 via screws, keys, pins or the like.
  • the second gear member 408b may be slidably received on the second driving shaft 406.
  • the lever member 408c may be coupled to the second driving shaft 406 configured to move the second gear member 408b along the second driving shaft 406, thereby allowing the second gear member 408b to engage the first gear member 408a, to disengage the first gear member 408a, or to be locked in a locked position to be described in greater detail below.
  • FIG. 23 depicts an exemplary lever member 408c which can be used in the operating tool 400.
  • the lever member 408c may include a first annular ring 422a and a second annular ring 422b spaced apart e.g. by a generally U-shaped structure 424 coupled with a bar member 426.
  • first and second rings 422a, 422b of the lever member 408c are slidably received on the second driving shaft 406 and the bar member 426 protrudes out of the housing 410.
  • the second gear member 408b which may be slidably received on the second driving shaft 406, is retained between the first and second annular rings 422a, 422b, and moved by the bar member 426.
  • FIGS. 24, 25, and 26 illustrate with greater clarity the gear assembly 408 in the housing 410.
  • the lever member 408c is placed in a proximal or first position, which allows the second gear member 408b to engage with the first gear member 408a, thereby operably coupling the second driving shaft 406 with the first driving shaft 404.
  • a rotation of the first driving shaft 404 by the handle 402 causes a rotation of the second driving shaft 406, providing a first operating mode wherein e.g. an expandable spinal implant device can be expanded or contracted.
  • the lever member 408c is placed in a distal or second position, which allows the second gear member 408b to disengage the first gear member 408a, thereby decoupling the second driving shaft 406 from the first driving shaft 404.
  • the handle 402 rotates solely the first driving shaft 404 whereas the second driving shaft 406 becomes inactive, providing a second operating mode wherein e.g. a spinal implant device can be tilted.
  • the lever member 408c may be placed in a third position where the second and first gear members 406, 404 are locked in the housing 410 and rotation of the first and second driving shafts 404, 406 are prohibited.
  • the lever member 408c is placed in the middle between the proximal and distal positions, allowing the second gear member 408b to engage both the first gear member 408a and a teeth-like configuration 428 built in the housing 410, to be described in greater detail below.
  • the lever member 408c is placed in the third position, the operating tool 400 is locked wherein rotation of the first and second driving shafts 404, 406 is prohibited.
  • the operating tool 400 may include outer connection or tubular shafts 414, 416 configured to connect the operating tool 400 to a workpiece such as a spinal implant device.
  • the outer connection shafts 414, 416 may include a first tubular shaft 414 surrounding the second portion 404b of the first driving shaft 404 extending out of the housing 410, and a second tubular shaft 416 surrounding the second portion 406b of the second driving shaft 406 extending out of the housing 410.
  • the first and second tubular shafts 414, 416 may be rotatably secured to the housing 410, to be described in greater detail below, so that the first and second tubular shafts 414, 416 are prevented from sliding out of the housing 410 while freely spinning or rotating independently of the rotation of the first and second driving shafts 404, 406 respectively.
  • FIGS. 27A-27C illustrate an exemplary tubular shaft which can be used as the outer connection shafts 414, 416.
  • the exemplary tubular shaft 414 may be generally cylindrically shaped having an internal diameter greater than the outer diameter of the second portion of the driving shaft 404.
  • the tubular shaft 414 may include a first end portion 414a configured to be rotatably secured to the housing 410 and a second end portion 414b having features configured to connect with a workpiece.
  • a finger grip 414c which may be machined as an integral part of the tubular shaft, may be provided to facilitate rotating or spinning of the tubular shaft in connecting with a workpiece. As detailed in FIG.
  • the first end portion 414a of the tubular shaft 414 may include an undercut or groove forming a rounded portion 414d with a reduced diameter.
  • screws 419 FIG. 21 B
  • keys, pins, or the like may fit into the space in the undercut or groove or flush against the rounded portion 414d, thereby preventing the tubular shafts 414 from axially moving or sliding out of the housing while allowing the tubular shaft 414 to freely rotate.
  • the second end portion 414b of the tubular shaft 414 may be provided with internal threads or other suitable features configured to connect with a workpiece such as a spinal implant device having corresponding connecting features such as external threads.
  • the operating tool 400 may include a housing 410 configured to receive or enclose the gear assembly 408, rotatably secure the driving shafts 404, 406 and optionally the outer connection shafts 414, 416.
  • FIGS. 28A-28E illustrate an exemplary housing according to embodiments of the disclosure. As shown, the housing 410 may be economically shaped for ease of holding by the user. The housing 410 can also be designed in any other suitable shapes or configurations.
  • the housing 410 may include a first end portion 410a proximal to the handle 402 and a second end portion 410b distal to the handle 402. In the first end portion 410a, a cavity 430 may be provided for receiving the gear assembly 408.
  • a teeth-like configuration 428 may be built in the internal surface of the housing for receiving or locking the second gear member 408b. Opening 432 may be provided in the side of the housing 410 for receiving a rubber slide 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 and second driving shafts 404, 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 and second tubular shafts 414, 416.
  • apertures or passages 438 may be provided for receiving screws 418, pins, keys or the like (FIG. 21 B) to rotatably secure the driving shafts 404, 406 to the housing 410.
  • apertures or passages 440 may be provided for receiving screws 419, pins, keys or the like (FIG. 21 B), to rotatably secure the outer connection shafts 414, 416 to the housing 410.
  • FIG. 29 shows with greater clarity the driving shafts 404, 406 and outer connection shafts 414, 416 rotatably secured to the second end 410b of the housing 410.
  • screws 418, keys, pins or the like may flush against the rounded portion with a reduced diameter of the first and second driving shafts 404, 406, preventing the driving shafts 404, 406 from sliding out of the housing 410 in the axial direction while allowing the driving shafts 404, 406 to freely spin or rotate.
  • screws 419, keys, pins or the like may flush against the rounded portion with a reduced diameter of the first and second tubular shafts 414, 416, preventing the tubular shafts 414, 416 from sliding out of the housing 410 in the axial direction while allowing the tubular shafts 414, 416 to freely spin or rotate.
  • the operating tool 400 may include an adapter 420 configured to connect the first driving shaft 404 with the handle 402.
  • FIG. 30 illustrates an exemplary adapter 420 according to embodiments of the disclosure.
  • the 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 sized to be received by the handle 402.
  • the second end portion 420b may be provided with a channel 442 configured to receive the first driving shaft 404.
  • the channel 442 may be shaped or configured to allow the end portion 404d (FIG.
  • first driving shaft 404 to freely sliding into or out of the channel 442 during assembly or disassembly and prevent the driving shaft 404 from rotating relative to the adapter 420 once the end portion 404d is received in the channel 442.
  • An aperture or passage 444 on the side of the second end portion 420b may be provided for receiving a screw, key, pin or the like to secure the first driving shaft 404 to the adapter 420.
  • the use of an adapter allows the first and second driving shafts 404, 406 to be made in the same length and/or geometry. As such, the cost of the operating tool 400 can be significantly reduced since the first and second driving shafts 404, 406 may be manufactured in a same style and the number of parts needed in the manufacturing is reduced.
  • the operating tool 400 may include a first dial 446 for providing the user with information about revolution(s) of the first driving shaft 404.
  • the first dial 446 may be operably coupled to and rotated with the first driving shaft 404 when in operation.
  • FIG. 31 illustrates an exemplary dial which can be used as the first dial of the operating tool.
  • the first dial 446 may include indicia 448 indicating revolution(s) of the dial and an aperture 450 configured to allow the first driving shaft 404 or the adapter 420 coupled to the first driving shaft 404 to fit in.
  • the first dial 446 rotates with the first driving shaft 404 and the indicia 448 on the first dial 446 provide the user with information about revolution(s) of first driving shaft 404.
  • the operating tool 400 may also include a second dial 452 for providing the user with information about revolution(s) of the second driving shaft 406.
  • the second dial 452 may be operably coupled to and rotated with the second driving shaft 406 when in operation.
  • FIG. 32 illustrates an exemplary dial 452 which can be used as the second dial of the operating tool.
  • the second dial 452 may include indicia 454 indicating revolution(s) of the dial and a portion having a channel 456 configured to receive the second driving shaft 406. In use, the second dial 452 rotates with the second driving shaft 406 and the indicia 454 on the second dial 452 provide the user with information about revolution(s) of the second driving shaft 406.
  • both the first dial 446 and second dial 452 revolve, providing an indication to the user of a first operating mode of the operating tool.
  • the second driving shaft 406 is decoupled from the first driving shaft 404 by the gear assembly 408 wherein the handle 402 rotates solely the first driving shaft 404, only the first dial 446 coupled to the first driving shaft 404 revolves, providing an indication to the user of a second operating mode of the operating tool.
  • the operating tool 400 may be connected with a workpiece such as a spinal implant device (not shown) via outer connection or tubular shafts 414, 416.
  • the user may spin or rotate the outer connection shafts 414, 416, for example, inwards to thread the operating tool 400 onto the implant device.
  • the user may first place the lever member 408c in the locked position (e.g. the middle position in FIG. 26) so that the gear members 408a, 408b are locked in the housing 410 and rotations of the driving shafts 404, 406 by the handle 402 are prohibited.
  • the user may place the lever member 408c to the expansion position (e.g. the proximal position in FIG. 24) so that the first and second gear members 408a, 408b are free from the locked position and engaged to couple the first and second driving shafts 404, 406.
  • the user may then rotate the handle 402 in a direction e.g. clockwise to apply torque to the first driving shaft 404.
  • the rotation of the first driving shaft 404 simultaneously causes rotation of the second driving shaft 406, thereby effecting expansion of the implant device in fine increments.
  • the user may rotate the handle 402 in an opposite direction e.g. counterclockwise, to contract or finely adjust the expansion level of the implant device.
  • the gear members 408a, 408b may be configured such that a rotation of the first driving shaft 404 in a first direction, e.g. clockwise, causes a rotation of the second driving shaft 406 in a second direction opposite to the first direction, e.g. counterclockwise.
  • the gear members 408a, 408b may be configured such that rotating the handle 402 causes the first and second driving shafts 404, 406 to rotate in the same direction.
  • the user may place the lever 408c to the lordosis position (e.g. the distal position in FIG. 25) so that the first and second gear members 408a, 408b are disengaged thereby decoupling the second driving shaft 406 from the first driving shaft 404.
  • the user may then rotate the handle 402 in a direction e.g. clockwise, applying torque solely to the first driving shaft 404 since the second driving shaft 406 becomes inactive.
  • the rotation of only the first driving shaft 404 causes the implant device to tilt, thereby achieving lordosis.
  • the user may rotate the handle 402 in an opposite direction, e.g. counterclockwise, to adjust or remove the levels of the lordosis.
  • the user may place the lever member 408c to the locked position and then spin the outer connection or tubular shaft 414, 416 e.g. outwards to unthread the operating tool 400 from the implant device.
  • the drive shafts, and optionally the outer connection shafts may include a portion that is angled with respect to a straight portion of the driving and outer connection shafts, e.g., ranging from 0 to 90 degrees.
  • the angled driving shafts allow a surgeon to reach lumbar disc space segments in certain patients who are not accessible from straight on.
  • the angled and straight portions may be machined as a single driving or outer connection shaft component, or alternatively, separately machined and then assembled as a driving or outer connection shaft.
  • the angled portion may be an adapter-type piece that can be inserted or connected onto an existing set of straight drive shafts or outer connection shafts.
  • the outer connection shafts can be angled through a variation of a ball joint which allows for perpendicular torqueing.
  • the driving shafts can be angled through some variation of a ball joint, worm gear, or bevel gear configuration which allows for perpendicular torqueing.
  • FIGS. 33-57 various embodiments of a surgical operating instrument will now be described.
  • FIG. 33 is an exploded view of an exemplary surgical operating instrument 500 according to embodiments of the disclosure.
  • FIG. 34 is a partial, cross-sectional view of the instrument 500.
  • the instrument 500 in general may 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 lock or bearing lock assembly 630.
  • the handle 502 may be operatively coupled to the pair of drive shafts 510, 512, allowing torque to be applied through the drive shafts to a workpiece such as an interbody fusion device (not shown) to effect expansion, contraction, and/or lordosis adjustment of the fusion device.
  • the pair of sleeves 520, 522 which would surround a portion of the pair of drive shafts 510, 512 outside the housing 540, serve to connect the instrument 500 to a workpiece such as an interbody fusion device.
  • the housing 540 encloses and protects the gear assembly 580, the bearing lock assembly 630, a portion of the drive shafts 510, 512 and sleeves 520, 522, and other components supported by the chassis 560.
  • the chassis 560 serves as a foundation of the instrument 500, providing support for the drive shafts 510, 512, the sleeves 520, 522, and the housing 540.
  • the chassis 560 may also serve as a partial housing for the gear assembly 580 and other components.
  • the switch assembly 610 in conjunction with the gear assembly 580, operates to provide various operating modes of the instrument 500.
  • the bearing lock assembly 630 operates to lock or unlock the drive shafts 510, 512 and sleeves 520, 522 to or from the chassis 560 inside the housing 540.
  • FIG. 35 is a perspective view of the instrument 500 assembled according to embodiments of the disclosure. [00146] Referring to FIGS. 33 and 34, the handle 502 may be any suitable handle that the user can apply torque to the drive shafts 510, 512.
  • the handle 502 can be driven manually or by a motor or robotics.
  • the handle 502 can be shaped in various configurations including l-shaped or T-shaped configurations.
  • the handle 502 may be a bi-directional ratchet handle which can apply torque by rotating both clockwise and counterclockwise.
  • the handle 502 may be a torque limiting ratchet handle which can limit the torque applied by the user so that damage to a workpiece does not take place.
  • the workpiece is an interbody fusion device and the handle 502 is a bi-directional torque limiting ratchet handle to effect expansion, contraction, lordosis, kyphosis, and/or coronal adjustment of the device.
  • Torque limiting ratchet handles are commercially available for example from Bradshaw Medical, Inc. in Kenosha, Wisconsin.
  • FIG. 36 is a perspective view of an exemplary operating instrument 500 including an impact cap 503 according to embodiments of the disclosure.
  • the impact cap 503 can be made of stainless steel, allowing the user to exert a forward force through the instrument by striking the impact cap with e.g. a mallet. This feature of the instrument can help push or wedge e.g. an interbody fusion device into the patient's vertebral space with more ease.
  • the impact cap 503 can avoid or reduce damages to the instrument when a hammering force is applied during the surgery.
  • the handle 502 or the impact cap 503 may be removed and replaced with a slap hammer.
  • a slap hammer can aid in providing a pull or removal force to the instrument 500 and the interbody fusion device if the surgeon desires to remove the implant following expansion and adjustment of the device or potentially even partial fusion of the device in a secondary removal surgery.
  • FIG. 55 is an isometric view of an exemplary surgical operating instrument including a slap hammer 670 according to embodiments 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 slap hammer according to embodiments of the disclosure.
  • the slap hammer 670 may include an elongate bar 672 and a hammer weight 674.
  • the hammer weight 674 is configured to be gripped by the user and can slide along the elongate bar 672 when a force is applied.
  • a stopper 676 may be provided to prevent the hammer weight 674 from coming off the elongate bar 672.
  • the stopper 676 may be removably coupled to the bar 672 via e.g. a threaded connection.
  • a connection site 678 may be provided to couple the slap hammer 670 with the instrument 500.
  • connection site 678 may be configured such that the slap hammer 670 can be coupled to the adapter 504 of the instrument 500 via a threaded connection, a clip-on connection, slotted "key-like” connection, or the like.
  • 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 sleeves 520, 522 etc., protects the components from contamination by biomaterials, and/or prevents outside objects from obstructing or interfering with the component operation.
  • the housing 540 may be constructed of a material that can withstand high sterilization steam temperatures at many cycles and/or of a material that provides mechanical strength to the instrument. Suitable materials for constructing the housing 540 include stainless steel, medical grade plastics such as Radel® R5500 Polyphenylsulfone (PPSU), which is commercially available from Solvay Advanced Polymers of Brussels, Belgium.
  • the housing 540 can be shaped to give an aesthetic appeal, and/or shaped ergonomically for the user to grip the instrument.
  • the housing 540 may include a first end portion 542 proximal to the handle 502 and a second end portion 544 distal to the handle 502.
  • the housing 540 may include two housing covers 546a, 546b.
  • the housing covers 546a, 546b may be separate pieces secured to the chassis 560 with e.g. screws 548, bolts, or the like.
  • the housing covers 546a, 546b can be dis-attached from the chassis 560 during cleaning and sterilization to help clean the instrument more efficiently and allow for the inside of the instrument to dry quicker following the sterilization.
  • the removable housing covers 546a, 546b allow for exposure of the gear assembly, the gear lock and other components inside of the chassis or housing, which in turn allows for quick and more efficient drying following sterilization.
  • the housing covers 546a, 546b can be constructed of a medical grade plastic or a metal such as stainless steel to add mechanical strength to the instrument.
  • the housing covers 546a, 546b each may be configured to provide a shoulder 550a, 550b for an impact cap 503 to sit on (FIGS. 33 and 36). As described above, in some situations it would be desirable to exert a forward force through the instrument to help push or wedge e.g. an interbody fusion device into the patient's vertebral space.
  • FIG. 38 shows the housing 540 enclosing the chassis 560, with the housing covers 546a, 546b attached to the chassis 560 providing shoulders 550a, 550b to allow an impact cap to sit on.
  • the housing 540 is provided with an opening 552 configured to allow a main portion of the chassis 560 to be placed inside.
  • the housing 540 may sit on the bottom base 567 of the chassis 560, which may include a raised rim 571 to surround the distal end of the housing 560 (FIG. 43). Threading may be provided on the distal end of the housing 560 for connecting to the chassis 560. Gaskets may be used to provide tight fit and sealing to prevent biomaterials and water from entering into the housing.
  • Two sub-housings or chambers 554a, 554b may be provided at the second end portion for housing the bearing lock assembly 630 to be described in greater detail below.
  • the sub-housings 554a, 554b may be integrally formed with the main body of the housing and arranged opposite to one another.
  • the sub-housings 554a, 554b may be configured to allow retaining plates 652, 654 of the bearing lock assembly 630 (FIG. 54), to be described below, to be inserted inside through a press fit and taken out easily for cleaning and sterilization.
  • Apertures may be provided in the side walls of the sub-housings 554a, 554b to allow access of a torque-applying tool to fasteners and connection of the fasteners to bearings of the bearing lock assembly 630, to be described in greater detail below.
  • FIG. 39 is a perspective end view of the housing 540 showing an opening 552 configured to receive the chassis and sub-housings 554a, 554b for a bearing lock assembly 630.
  • FIG. 40 is a perspective front view of the housing 540.
  • the housing 540 may include a switch guide track 556 for guiding the user in operating the instrument with the switch or switch assembly 610.
  • the guide track 556 may include slots corresponding to different operating modes or settings when the switch is placed in.
  • Indicia 558 may be provided next to the guide track 556 to indicate the various operating settings.
  • a gasket 559 (FIG. 42) may be coupled to the guide track 556 to allow the user to more smoothly and seamlessly operate the switch.
  • the gasket 559 may also help to keep biomaterials out of the inside of the housing through the switch site.
  • FIG. 42 schematically shows an exemplary gasket 559.
  • the gasket 559 may fit over hooks in the guide track 556 by tension or by other suitable means.
  • the gasket 559 may be made of an elastic material such as silicone rubber. A silicone rubber material allows the gasket to withstand high sterilization temperatures without melting or deforming.
  • the chassis 560 serves as a main foundation of the operating instrument 500.
  • the chassis 560 provides support for the drive shafts 510, 512, the sleeves 520, 522, and the housing 540.
  • the upper part of the chassis 560 may also serve as a partial housing for the gear assembly 580 and other components and provide a secure point for the housing covers 546a, 546b.
  • the chassis 560 may be constructed of a metal such as stainless steel or a medical grade plastic such as Radel® R5500 Polyphenylsulfone (PPSU), providing for a rugged operating instrument so that in case the instrument is dropped on the floor it does not break.
  • PPSU Polyphenylsulfone
  • the chassis 560 in conjunction with the housing 540 and the impact cap 503, allows for the user to apply a hammering force to the instrument without damaging it. Inclusion of the chassis 560 in the instrument 500 simplifies assembling, disassembling, and cleaning of the instrument.
  • FIG. 43 schematically shows an exemplary chassis 560 according to embodiments of the disclosure.
  • the chassis 560 may in general include a first or lower portion 561 and a second or upper portion 563.
  • the lower portion 561 may include a main body 562 providing support for the drive shafts 510, 512 and sleeves 520, 522.
  • the upper portion 563 may include spaced-apart arms 564 defining a partial housing 565 for the gear assembly 580, gear lock 592, and switch assembly 610, to be described in greater detail below.
  • the main body 562 may be provided with a pair of elongate channels 566 extending between a bottom base 567 and an upper base 568.
  • the pair of elongate channels 566 may be provided in parallel to one another along the opposite sides of the main body 562.
  • the channels 566 may be configured e.g. to have a generally arcuate surface to allow the generally cylindrical drive shafts or sleeves to fit in and spin.
  • a plurality of ridges 569 may be provided on the channel surfaces to keep the drive shafts and sleeves tight against the chassis when fastened by a bearing lock assembly 630, to be described in greater detail below.
  • a divider 570 may be provided to divide the channels 566 into two sections.
  • the divider 570 allows for separate bearings to lock the draft shafts and sleeves to the chassis independently each other.
  • drive shaft bearings 632, 634 may lock the drive shafts 510, 512 to the chassis 560 at the upper section of the channels 566 whereas sleeve bearings 642, 644 may secure the sleeves 520, 522 to the chassis 560 at the lower section of the channels 566 (FIGS. 44 and 45).
  • the divider 570 can keep the drive shaft bearings 632, 634 and sleeve bearings 642, 644 separate from each other and allow the bearings to rest on the chassis 560 as a support structure during assembly and operation.
  • the bottom base 567 has a raised rim 571 to allow the housing 540 to rest on the chassis 560. Openings 572 provided in the bottom base 567 allow the drive shafts 510, 512 and sleeves 520, 522 to pass through and fit into the channels 566 on the chassis 560 respectively.
  • the upper base 568 is provided with openings 573, allowing the drive shafts 510, 512 to pass through and extend into the partial housing 565 defined by the spaced- apart arms 564.
  • the upper base 568 may also provide support for the gear assembly 580 and the gear lock 592 while adding strength to the chassis or the operating instrument.
  • the spaced-apart arms 564 define a partial housing 565 for the gear assembly 580, the gear lock 592, and the switch assembly 610.
  • the arms 564 may also be configured to secure the gear lock 592, to be described in greater detail below.
  • the arms 564 may be configured to have an internal surface contour that mates with an outer surface contour of the gear lock 592.
  • the arms 564 may have convex inner surface portions that mate with concave outer surface portions of the gear lock 592 so that when the gear lock 592 is flexed and/or slid into the partial housing 565 and sits on the upper base 568, the gear lock 592 is secured and would not turn when torque is applied.
  • the arms 564 may have concave inner surface portions that mate with convex outer surface portions of the gear lock 592.
  • the arms 564 may be provided with features such as holes 574 with internal threads for securing housing covers 546a, 546b to the chassis 560 (FIGS. 37 and 38).
  • FIG. 44 a is perspective view showing a chassis 560 with drive shaft bearings 632, 634 and sleeve bearings 642, 644 being placed on the main body 562 in the lower portion 561 , and with the gear lock 592 and gear assembly 580 being accommodated in the partial housing 565 in the upper portion 563.
  • FIG. 45 is a partial perspective view showing a chassis 560 with a gear lock 592 and gear assembly 580 being accommodated in partial housing in the upper portion 563 and a pair of drive shafts 510, 512 (not shown in FIG. 44) and sleeves 520, 522 being secured by a bearing lock assembly 630 on the main body 562 in the lower portion 561.
  • the housing 560 is removed to more clearly show the positional relationship between the chassis 560 and the bearing lock assembly 630, to be described in greater detail below.
  • the pair of drive shafts 510, 512 are operably coupled to the handle 502 to apply 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 operably connected with the handle 502 e.g. via an adapter 504.
  • the second drive shaft 512 may be coupled with the first drive shaft 510 or decoupled from the first drive shaft 510 via the gear assembly 580.
  • a first operating mode is provided wherein the handle 502 can rotate both the first drive shaft 510 and the second drive shaft 512.
  • a second operating mode is provided wherein the handle 502 rotates solely 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 to be described in greater detail below.
  • the pair of drive shafts 510, 512 may each include a first portion 510a, 512a received in the housing 540 when assembled, and a second portion 510b, 512b extending out of the housing 540.
  • the first portions 510a, 512a of the pair of drive shafts 510, 512 may be configured to be received in the pair of elongate channels 566 of the chassis 560 and rotatably secured to the chassis 560.
  • the first portions 510a, 512a of the pair of drive shafts 510, 512 may include a section of increased diameter and a groove 510c, 512c providing space for a bearing notch to fit in or flush against, thereby restricting the drive shafts 510, 512 from sliding out of the housing 540 while allowing them to freely rotate.
  • the first portions 510a, 512a of the pair of drive shafts 510, 512 may extend into the partial housing 565 of the chassis 560 to receive a gear member, a dial, or an adapter.
  • the first portions 510a, 512a may include a flattened surface and a remaining cylindrical surface at the proximal end configured to receive a gear member, an adapter, or a dial, which may be provided with a channel, cutout, or aperture having a corresponding flattened surface and cylindrical surface.
  • a gear member, an adapter, or a dial is received on the first portions 510a, 512a, the flattened surfaces prevent rotational movement of the gear member, adapter, or dial relative to the drive shafts 510, 512 when secured with a set screw or the like.
  • the pair of drive shafts 510, 512 may have a substantially same length and cross-sectional geometry along the length. Alternatively, the pair of drive shafts 510, 512 may have different lengths and cross-sectional geometries.
  • the first drive shaft 510 may extend its length and connect with the handle 502 directly without the need for an adaptor.
  • the second portions 510b, 512b of the drive shafts 510, 512 include a tip 51 Od, 512d having features configured to engage a workpiece.
  • the workpiece-engaging tip may have a torx or hexalobular, or modified torx or hexalobular configuration. Other suitable configurations or features known in the art may also be used to engage a workpiece having corresponding engaging features.
  • the workpiece may be an interbody fusion implant device described U.S. Pat. No. 9,889,019, the disclosure of all of which is incorporated herein by reference in its entirety.
  • the workpiece may also be other medical devices operable to expand, contract, or tilt by use of an operating instrument.
  • the pair of sleeves or tubular shafts 520, 522 operate to connect the operating instrument 500 to a workpiece such as an interbody fusion implant device.
  • the pair of sleeves 520, 522 may include a first sleeve 520 surrounding the second portion 510b of the first drive shaft 510 extending out of the housing 540, and a second sleeve 522 surrounding the second portion 512b of the second drive shaft 512 extending out of the housing 540.
  • the pair of sleeves 520, 522 may be rotatably secured to the chassis 560 via the bearing lock assembly 630, to be described below, so that the sleeves 520, 522 can freely spin or rotate independently of the rotation of the pair of drive shafts 510, 512, and are restricted from sliding out of the housing 540 during operation but may be removed following operation for cleaning and sterilization purposes.
  • the pair of sleeves 520, 522 may be generally cylindrically shaped having an inner diameter greater than an outer diameter of the second portions 510b, 512b of the drive shafts 510, 512.
  • the sleeves 520, 522 may each include a first end portion 520a, 522a configured to be rotatably secured to the chassis 560 in the housing 540 and a second end portion 520b, 522b having features configured to connect with a workpiece.
  • a finger grip 520c, 522c may be provided on each of the sleeves 520, 522 to facilitate rotating or spinning of the sleeves in connecting with a workpiece.
  • the first end portions 520a, 522a of the pair of sleeves 520, 522 may be configured to be received in the elongate channels 566 of the chassis 560 and rotatably secured to the chassis.
  • the first end portions 520a, 522a of the pair of sleeves 520, 522 may each include a groove 520d, 522d providing space for a bearing notch to fit in or flush against, thereby restricting the sleeves 520, 522 from sliding out of the housing 540 while allowing the sleeves 520, 522 to freely rotate.
  • the second end portion 520b, 522b of the sleeves 520, 522 may be provided with internal threads or other suitable features configured to connect with a workpiece such as a spinal implant device having corresponding connecting features such as external threads.
  • the gear assembly 580 serves to couple the second drive shaft 512 with the first drive shaft 510 or decouple the second drive shaft 512 from the first drive shaft 510, providing various operating modes.
  • the gear assembly 580 may lock the second and first drive shafts 510, 512 so that rotation of the first and second drive shafts 510, 512 are prohibited.
  • the gear assembly 580 may include a pair of spur gears having substantially parallel gear axes.
  • a first gear member 581 may be received on the first drive shaft 510 and a second gear member 582 may be received on the second drive shaft 512 (FIGS. 48-50).
  • the first gear member 581 may be fixedly secured to the first drive shaft 510 via screws, keys, pins or the like.
  • the second gear member 582 may be slidably received on the second driving shaft 512 but secured from rotating relative to the second drive shaft via set screws, keys, pins, or the like.
  • a toggle switch 610 to be described in greater detail below, may be received and slidably move on the second driving shaft 512, placing the second gear member 582 into and out of engagement with the first gear member 581.
  • FIG. 46 schematically shows an exemplary gear member 586 which can be used in the gear assembly 580 according to embodiments of the disclosure.
  • the gear member 586 includes a plurality of teeth 587 each of which has two opposing side surfaces 588a, 588b extending between two end surfaces 590a, 590b.
  • the side surfaces 588a, 588b of the teeth may be generally in parallel with the axis of the gear member 586 configured to engage with the teeth of the mating gear member.
  • the end surfaces 590a, 590b of the teeth 587 are beveled or chamfered.
  • the surface between adjacent teeth at the end surfaces may also be beveled.
  • the beveled or lofted cut feature along the end or ends of the teeth of the gear members allow the gears to smoothly displace from one another and mesh back up to have a seamless transition when the user operates the switch 610.
  • the switch assembly 610 allows the user to operate the instrument 500 smoothly and seamlessly via an intuitive interface.
  • the user may place the switch assembly 610 in a first position e.g. an "expansion mode" position provided in the switch guide 556 (FIG. 41) to allow the second gear 582 and first gear 581 engaged, to a second position e.g. a "lordosis mode” position to allow the second gear 512 and first gear 510 disengaged, or to a third position e.g. a "lock mode” position to allow the second gear member 512 to engage both the first gear member 510 and a gear lock 592.
  • FIG. 47 schematically shows a toggle switch 610 which can be used in the operating instrument 500 according to embodiments of the disclosure.
  • the toggle switch 610 may include a first ring structure 612 and a second ring structure 614 spaced apart e.g. by a generally U-shaped structure 616, which may be coupled to a shield member 618 having a switch nob 620.
  • the first and second ring structures 612, 614 may each have an open end.
  • the toggle switch 610 can be snapped on the second drive shaft 512 through the open ends or allowed to slide on from the top of the drive shaft 512 through the top opening of the housing 540.
  • the toggle switch 610 may retain the second gear member 582 between the first and second ring structures 612, 614 and slidably move the second gear member 582 on the second drive shaft 512.
  • the snap on feature allows the toggle switch 610 to be easily attached to or dis-attached from the assembly, enabling more affective cleaning and sterilization of the instrument and reuse for another surgery.
  • the shield 618 on the toggle switch 610 may more effectively prevent bio-materials from passing through the toggle switch into the inner part of the operating instrument.
  • FIGS. 48-50 illustrate with greater clarity the operation of the switch assembly 610 and the gear assembly 580.
  • the toggle switch 610 is placed in a first or "expansion mode" position, which allows the second gear member 582 to engage with the first gear member 510, thereby operably coupling the second drive shaft 512 with the first drive shaft 510.
  • a rotation of the first drive shaft 510 by the handle 502 causes a rotation of the second drive shaft 512, providing a first operating mode wherein e.g. an expandable spinal implant device can be expanded or contracted.
  • the toggle switch 610 is placed in a second or "lordosis mode” position, which allows the second gear member 582 to disengage from the first gear member 581 , thereby decoupling the second drive shaft 512 from the first drive shaft 510.
  • the handle 502 rotates solely the first drive shaft 510 whereas the second driving shaft 512 becomes inactive, providing a second operating mode wherein e.g. a spinal implant device can be tilted or lordotically adjusted.
  • the toggle switch 610 is placed in a third or "lock mode” position, which allows the second gear member 582 to engage with both the first gear member 581 and the gear lock 592.
  • FIG. 51 is a perspective view of an exemplary gear lock 592 according to embodiments of the disclosure.
  • the gear lock 592 may include a tubular member 594 having an internal contour such as channels or slots that can accommodate the first and second gear members 581 , 582.
  • the internal surface of the gear lock 592 may be provided with a teeth configuration 596 configured to mate with the teeth of the second gear member 582.
  • the side of the gear lock 592 may be opened to allow the toggle switch 610 to slidably place or displace the second gear member 582, allowing the teeth on the second gear member 582 to engage or disengage with the teeth 596 on the gear lock 592.
  • the opening 598 may also allow gear lock 592 to flex when being placed inside the partial 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 arms 564 so that the gear lock 592 may fit in or mate with the chassis arms 564 and would not turn when torque applies.
  • the bearing lock assembly 630 operates to lock or unlock the drive shafts 510, 512 and sleeves 520, 522 to or from the chassis 560 in the housing 540.
  • the bearing lock assembly 630 is designed such that when the bearing lock assembly 630 is in a lock mode, the drive shafts 510, 512 and sleeves 520, 522 cannot freely move in the axial direction but may still freely rotate or spin.
  • the bearing lock assembly 630 is in an unlock mode, the sleeves 520, 522 and drive shafts 510, 512 may slide out of the housing 540 whereas components of the bearing lock assembly 630 may 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 showing an exemplary bearing lock assembly 630 and other components of the instrument 500 according to embodiments of the disclosure.
  • the housing 540 and chassis 560 are removed to show the bearing lock assembly 630 with greater clarity in relationship to other components of the instrument.
  • the bearing lock assembly 630 may include a pair of drive shaft bearings 632, 634 configured to lock the drive shafts 510, 512 to the chassis 560 respectively or unlock the drive shafts 510, 512 from the chassis 560.
  • the drive shaft bearings 632, 634 may be in the form of a curved plate having a generally arcuate inner surface 635 (FIG. 53).
  • the drive shaft bearings 632, 634 may each be configured to be flush with the chassis main body 562 when assembled and tightened, forming a pair of passages between the pair of drive shaft bearings 632, 634 and the chassis main body 562 to allow the pair of drive shafts 510, 512 to fit in.
  • the drive shaft bearings 632, 634 may each include a notch 636 on the inner surface 635 (FIG. 53) configured to fit into the grooves in each of the pair of drive shafts 510, 512.
  • the notches 636 on the drive shaft bearings 632, 634 prevent the drive shafts 510, 512 from sliding out the housing 540 while allowing them to freely rotate or spin when the bearing lock assembly 630 is the lock mode.
  • the drive shaft bearings 632, 634 may each include one or more ridges 638 on the inner surface 635.
  • 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, preventing the drive shafts 510, 512 from freely moving in the axial direction.
  • the drive shaft bearings 632, 634 may each be provided with a hole 639 having an internal thread.
  • the fasteners 633 which can be in the form of shoulder bolts or the like, may have an external thread to be received in the hole 639 of the drive shaft bearings 632, 634.
  • the fasteners 633 may turn in the threaded holes 639, pushing the drive shaft bearings 632, 634 against the chassis 560, thereby tightening the drive shafts 510, 512 to the chassis 560.
  • Turning the fasteners 633 in an opposite direction would 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 sleeves 520, 522 to the chassis 560 respectively or unlock the sleeve 520, 522 from the chassis 560. Similar to the drive shaft bearings 632, 634, the sleeve bearings 642, 644 may be in the form of a curved plate having a generally arcuate inner surface 635. The sleeve bearings 642, 644 may each be configured to be flush with the chassis main body 562 when assembled and tightened, forming a pair of passages between the pair of sleeve bearings 642, 644 and the chassis main body 562 to allow the pair of sleeves 520, 522 to fit in.
  • the sleeve bearings 642, 644 may each include a notch 636 on the inner surface 635 configured to fit into the grooves in each of the pair of sleeves 520, 522.
  • the notches 636 on the sleeve bearings 642, 644 prevent the sleeves 520, 522 from sliding out the housing 540 while allowing them to spin when the bearing lock assembly 630 is in a lock mode.
  • the grooves 520d, 522d in the sleeves 520, 522 may be machined slightly wider than the notch on the sleeve bearing 642, 644 to allow slight axial movement of the sleeves 520, 522, which may be needed when the operating instrument 500 is connected with e.g. an interbody fusion device.
  • the sleeve bearings 642, 644 may also include one or more ridges on the internal surface.
  • 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, preventing the sleeves 520, 522 from freely moving in the axial direction.
  • This dynamic lock system allows for ease of assembly and disassembly for cleaning and sterilization activities so that the instrument 500 may be reused for multiple surgeries while providing a strong assembly connection during operation.
  • the sleeve bearings 642, 644, similar to the drive shaft bearings 632, 634, may be provided with a hole 639 having an internal thread for connection with a fastener 633.
  • the fasteners 633 which can be a shoulder bolt or the like, may have an external thread to be received in the hole of the sleeve bearings. When torqued, the fasteners 633 may turn in the threaded hole, pushing the sleeve bearings to flush with the chassis 560. Turning the fasteners in an opposite direction would loosen the sleeve bearings 642, 644 from the chassis 560, unlocking the sleeves 520, 522.
  • the bearing lock assembly 630 may include a pair of retaining plates 652, 654 for retaining the fasteners 633 within the housing.
  • the retaining plates 652, 654 include apertures 656 allowing a torque applying tool to access the fasteners 633 in tightening or loosening the bearings (FIG. 54).
  • the retaining plates 652, 654 restrict the fasteners 633 from moving outwardly or in an axial direction of the fasteners, thereby preventing the fasteners 633 from coming loose from the entire assembly after being torqued in loosening the bearings.
  • the retaining plates 652, 654 allow the sleeves 520, 522 and drive shafts 510, 512 to be taken out from the assembly for cleaning, sterilization, or replacement without having to take the fasteners 633 all the way out of the assembly. This provides more ease for hospital personnel when they need to disassemble for replacement, cleaning, and sterilization.
  • the retaining plates may contain O-rings of a medical grade silicone to assure that biomaterial or water not make its way into the crevices of the bearing lock assembly.
  • the retaining plates 652, 654 may be configured to snap into the sub- housings 554a, 554b through a press fit or other suitable means (FIG. 54). Grooves may be provided in the areas adjacent to the apertures 656 for sealing gaskets, O-rings, or of the like, thus preventing water, debris or biomaterials from entering into the housing via the apertures. When needed, the retaining plates 652, 654 may be easily taken out for further cleaning and sterilization.
  • FIG. 54 is a partial, cutaway view of the operating instrument showing the retaining plates 652, 654 which can be snapped in and taken out of the sub- housings 554a, 554b.
  • the operating instrument 500 may include a first dial 506 and a second dial 508 configured to provide the user with information about operation of the instrument.
  • the first dial 506 may be coupled to the first drive shaft 510.
  • the second dial 508 may be coupled to the second drive shaft 512.
  • the first dial 506 may be provided with an aperture configured to allow the first drive shaft 510 or the adapter 504 to fit in.
  • the second dial 508 may be provided with a channel configured to receive or couple with the second drive shaft 512.
  • the first dial 506 rotates with the first drive shaft 510 and the indicia on the first dial 506 provide the user with information about revolution(s) of first drive shaft 510.
  • the second dial 508 rotates with the second drive shaft 512 and the indicia on the second dial 508 provide the user with information about revolution(s) of the second drive shaft 512.
  • the handle 502 rotates both the first and second driving shafts 510, 512, and as such, both the first dial 506 and second dial 508 revolve, providing an indication to the user of the first operating mode of the instrument 500 or an indication of the level of height expansion.
  • the handle 502 rotates solely the first drive shaft 510, and as such, only the first dial 506 coupled to the first drive shaft 510 revolves, providing an indication to the user of a second operating mode of the instrument 500.
  • the indication of the first dial and second dial when decoupled equates to an added angle of lordosis or kyphosis when the first drive shaft is driven unequally with the second drive shaft.
  • the instrument 500 operates an interbody infusion implant device in surgical procedures and the indicia provided on the first and second dials 506, 508 may be configured to allow the user to measure the amount of expansion, contraction, and/or lordosis adjustment added to the intervertebral disc space of the patient.
  • indicia may be provided on the first dial 506 to indicate or allow the user to measure added lordosis.
  • four (4) degrees may be an equivalent to one full turn of the dial 506 or two (2) degrees equivalent to a half turn of the dial 506.
  • Indicia may also be provided on the first and/or second dials 506, 508 to indicate or allow the user to measure the added height or expansion.
  • 2.2 mm may be an equivalent to one full turn of the first and second dials 506, 508 or 1.1 mm equivalent to a half turn of the dials 506, 508.
  • the instrument 500 may be connected with a workpiece such as a spinal implant device via sleeves 520, 522.
  • the user may spin or rotate the sleeves 520, 522, for example, inwards to thread the instrument 500 onto the implant device.
  • the user may first set the instrument 500 in the lock mode e.g. by placing the switch 610 in the middle position in the switch guide (FIG. 50) so that the first and second gear members are locked and rotation of the drive shafts 510, 512 is prohibited.
  • a forward force may be needed in some situations.
  • the handle 502 of the instrument 500 may be temporarily removed and replaced with the impact cap 503 or slap hammer 670.
  • a forward force may be then exerted through the instrument 500 by striking the impact cap 503 using e.g. a mallet.
  • the impact cap 503 may be removed and replaced with the handle 502 for operation of the implant device.
  • the handle 502 or impact cap 503 may be removed and a slap hammer 670 can be connected to the instrument e.g. to the adapter 504 or the top of the housing 540.
  • the slap hammer 670 acts as an attachment to provide a removal or pull force to the implant if the surgeon needs to remove the implant back out of the disc space after insertion.
  • the user may place the switch 610 to the proximal position, allowing the first and second gear members to be free from the locked position and engaged to couple the first and second drive shafts 510, 512.
  • the user may then rotate the handle 502 in a direction e.g. clockwise to apply torque to the first drive shaft 502.
  • the rotation of the first drive shaft 512 simultaneously causes rotation of the second drive shaft 51 , thereby effecting expansion of the implant device in fine increments.
  • the user may rotate the handle 502 in an opposite direction e.g. counterclockwise, to contract or finely adjust the expansion level of the implant device.
  • the gear assembly 580 may be configured such that a rotation of the first drive shaft 510 in a first direction, e.g.
  • the gear assembly 580 may be configured such that rotating the handle 502 causes the first and second drive shafts 510, 512 to rotate in the same direction.
  • the user may place the switch 610 to the distal position, allowing the first and second gear members to be disengaged thereby decoupling the second drive shaft 512 from the first drive shaft 510.
  • the user may then rotate the handle 502 in a direction e.g. clockwise, applying torque solely to the first drive shaft 510 since the second drive shaft 512 becomes inactive.
  • the rotation of only the first drive shaft 510 causes the implant device to tilt, thereby achieving lordosis.
  • the user may rotate the handle 502 in an opposite direction, e.g. counterclockwise, to adjust or remove the levels of the lordosis while keeping the first drive shaft 510 and second drive shaft 512 constrained from rotation. This constraint assures that the drive shafts are unable to contract the implant back down while the instrument is being disconnected from the implant.
  • the user may place the switch 610 to the middle position to set the instrument in a lock mode and then spin the sleeves 520, 522 e.g. outwards to unthread the instrument 500 from the implant device.
PCT/US2018/042199 2017-07-27 2018-07-15 SURGICAL OPERATING INSTRUMENT FOR EXPANDABLE AND ADJUSTABLE LYSOSE INTERSOMATIC MELTING SYSTEMS WO2019022976A1 (en)

Priority Applications (4)

Application Number Priority Date Filing Date Title
CN201880049470.3A CN110996858B (zh) 2017-07-27 2018-07-15 用于可扩张和可调节的脊柱前凸椎体间融合系统的外科操作器械
JP2020503813A JP7227218B2 (ja) 2017-07-27 2018-07-15 拡張可能かつ調整可能な脊柱前弯椎体間癒合システムのための外科的手術器械
SG11202000543YA SG11202000543YA (en) 2017-07-27 2018-07-15 Surgical operating instrument for expandable and adjustable lordosis interbody fusion systems
EP18838048.9A EP3658079A4 (de) 2017-07-27 2018-07-15 Chirurgisches operationsinstrument für erweiterbare und einstellbare lordosezwischenwirbelfusionssysteme

Applications Claiming Priority (2)

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US15/661,435 2017-07-27
US15/661,435 US10702396B2 (en) 2013-08-29 2017-07-27 Surgical operating instrument for expandable and adjustable lordosis interbody fusion systems

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WO2019022976A1 true WO2019022976A1 (en) 2019-01-31

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JP (1) JP7227218B2 (de)
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WO2021165455A1 (de) * 2020-02-19 2021-08-26 Nicolas Klaus Sebastian Lenzmann Handbetätigbarer schraubendreher
US11273046B2 (en) 2020-05-05 2022-03-15 Warsaw Orthopedic, Inc. Spinal implant system and method
US11344429B2 (en) 2020-05-05 2022-05-31 Warsaw Orthopedic, Inc. Spinal implant system and method
US20220183854A1 (en) * 2020-12-10 2022-06-16 Neurostructures, Inc. Expandable interbody spacer
EP4272709A1 (de) * 2022-05-04 2023-11-08 Globus Medical, Inc. Expandierbare fusionsvorrichtung und installationsvorrichtung dafür

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US20210085486A1 (en) * 2019-09-24 2021-03-25 Spineex, Inc. Surgical instrument for operating spinal implant system with dual axis adjustability and method of operating same
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EP4272709A1 (de) * 2022-05-04 2023-11-08 Globus Medical, Inc. Expandierbare fusionsvorrichtung und installationsvorrichtung dafür

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Publication number Publication date
JP2020528785A (ja) 2020-10-01
EP3658079A1 (de) 2020-06-03
CN110996858B (zh) 2023-04-04
EP3658079A4 (de) 2021-05-19
JP7227218B2 (ja) 2023-02-21
CN110996858A (zh) 2020-04-10
SG11202000543YA (en) 2020-02-27

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