EP4536152A2 - Implantatsystem und verfahren zur verwendung - Google Patents

Implantatsystem und verfahren zur verwendung

Info

Publication number
EP4536152A2
EP4536152A2 EP23820547.0A EP23820547A EP4536152A2 EP 4536152 A2 EP4536152 A2 EP 4536152A2 EP 23820547 A EP23820547 A EP 23820547A EP 4536152 A2 EP4536152 A2 EP 4536152A2
Authority
EP
European Patent Office
Prior art keywords
staple
cage
implant device
orthopedic implant
shaft
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
EP23820547.0A
Other languages
English (en)
French (fr)
Inventor
Randal R. Betz
Dale E. Whipple
Charlie Barfield
Dimitri K. Protopsaltis
Michael Sherman
Marc Burel
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Foundation Surgical Group Inc
Original Assignee
Foundation Surgical Group 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 US18/051,732 external-priority patent/US11883300B2/en
Application filed by Foundation Surgical Group Inc filed Critical Foundation Surgical Group Inc
Publication of EP4536152A2 publication Critical patent/EP4536152A2/de
Pending legal-status Critical Current

Links

Classifications

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    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8875—Screwdrivers, spanners or wrenches
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    • A61B17/0642—Surgical staples, i.e. penetrating the tissue for bones, e.g. for osteosynthesis or connecting tendon to bone
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    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/683—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin comprising bone transfixation elements, e.g. bolt with a distal cooperating element such as a nut
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    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
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    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70—Spinal positioners or stabilisers, e.g. stabilisers comprising fluid filler in an implant
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    • 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
    • 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
    • A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30576—Special structural features of bone or joint prostheses not otherwise provided for with extending fixation tabs
    • A61F2002/30578—Special structural features of bone or joint prostheses not otherwise provided for with extending fixation tabs having apertures, e.g. for receiving fixation screws
    • 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
    • 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
    • A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30579—Special structural features of bone or joint prostheses not otherwise provided for with mechanically expandable devices, e.g. fixation devices
    • 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
    • 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
    • A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30593—Special structural features of bone or joint prostheses not otherwise provided for hollow
    • 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
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30772—Apertures or holes, e.g. of circular cross section
    • A61F2002/30784—Plurality of holes
    • 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
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30841—Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes
    • 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
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/3085—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves with a threaded, e.g. self-tapping, bone-engaging surface, e.g. external surface
    • 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
    • A61F2/3094—Designing or manufacturing processes
    • A61F2002/30985—Designing or manufacturing processes using three dimensional printing [3DP]
    • 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
    • A61F2/46—Special tools for implanting artificial joints
    • A61F2/4603—Special tools for implanting artificial joints for insertion or extraction of endoprosthetic joints or of accessories thereof
    • A61F2002/4625—Special tools for implanting artificial joints for insertion or extraction of endoprosthetic joints or of accessories thereof with relative movement between parts of the instrument during use
    • A61F2002/4627—Special tools for implanting artificial joints 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

Definitions

  • This invention relates to orthopedic implants.
  • the implants may be used as spinal implants configured to augment the vertebral body or fuse multiple vertebral bodies to decompress neural elements and alter the alignment of the spine.
  • the implants may also be configured for use within other bones or other joints.
  • Compression fractures account for more than 60 percent of thoracolumbar fractures.
  • the specific types of injuries associated with vertebral compression fractures may include: endplate impaction, wedge impaction fractures, vertebral body collapse, split fractures and coronal split fractures.
  • Extended reconstruction (>3 levels) of the lumbar spine has been a foundation of correction for adult degenerative scoliosis.
  • fusions of this scope also start a cascade of events by transferring the spine motion of the fused to the unfused segments of the spine resulting in the eventual deterioration of the adjacent levels requiring further treatment which is usually additional fusion.
  • Clinical presentation of adjacent segment deterioration, with coronal, sagittal or both deformities above or below the existing fusion causing severe back and/or leg pain often occur, necessitating further treatment and may result in additional levels requiring fusion.
  • Another means of addressing leg pain is a more traditional decompression and fusion by implanting a device between two vertebral bodies and fusing them together.
  • two or more vertebrae may be fused, or joined, together with the implant device to stabilize the spine and permanently stop the movement between bones that is causing pain and ensure appropriate space for exiting nerve roots.
  • the stabilization may also be used to correct alignment of the spine in multiple planes.
  • the staple head comprises one or more staple tine on one end of the staple head and one or more staple tine on an other end of the staple head, and the staple head is a unitary staple head from the one end to the other end.
  • the orthopedic implant device is configured to alter an angle between a superior endplate surface plane and an inferior endplate surface plane of a vertebral body.
  • the orthopedic implant device is configured to alter an angle between an endplate surface plane of one vertebral body and an endplate surface plane of another vertebral body.
  • the staple and the cage are configured to secure the cage to adjacent bones of a joint.
  • the staple and the cage are configured to secure the cage to adjacent bone portions.
  • the bone comprises a vertebral body of a vertebrae
  • the anchoring element is configured to secure the anchor frame and the cage to a sidewall of the vertebral body.
  • the orthopedic implant device further comprises a securing element configured to secure the cage and the anchor frame to the bone.
  • the securing element comprises a staple.
  • the securing element comprises a staple
  • the bone comprises a vertebral body of a vertebrae
  • the staple is slidably coupled to the cage and configured to engage a distal lateral sidewall of the vertebral body
  • the anchoring element is configured to engage a proximal lateral sidewall of the vertebral body whereby the anchor frame and the staple secure the cage to the vertebral body.
  • the staple shaft is received in a through bore of the cage, and the staple shaft is rotatable within the through bore of the cage whereby the staple shaft is configured to move the staple head from the first position to the second position.
  • the staple shaft is longitudinally slidable within the through bore of the cage whereby the staple shaft is configured to slidably move the staple head from the first position to the second position.
  • the staple shaft is configured to retract the staple head relative to the cage.
  • the cage further comprising a cage stop, the staple shaft having a key, and the cage stop configured to engage the key to limit a rotational movement of the staple head relative to the cage.
  • the orthopedic implant device further comprises a threaded nut, the staple shaft having a threaded portion, and the threaded nut configured to mate with the threaded portion of the staple shaft whereby when the threaded nut is rotated, the threaded nut engages the threaded portion of the staple shaft and the staple head is moved away from the cage.
  • the orthopedic implant device further comprises a threaded nut, the staple shaft having a threaded portion, and the threaded nut is configured to mate with the threaded portion of the staple shaft whereby when the threaded nut is rotated, the threaded nut engages the threaded portion of the staple shaft and the staple head is retracted towards the cage.
  • the present disclosure provides a method to secure a first bone portion to a second bone portion, the method comprising, providing an orthopedic implant device comprising a cage, a staple and an anchor frame, the cage coupled to the anchor frame and the staple, inserting the cage and the staple into an opening between the first bone portion and the second bone portion, and securing the anchor frame to the first bone and the second bone by retracting the staple towards the cage and/or anchor frame.
  • the method further comprises positioning the staple in a stabilized position to secure the staple to the first bone and the second bone whereby the staple further secures the cage to the first and the second bone portions.
  • the present disclosure provides a method to secure an orthopedic implant device to a vertebral body, the method comprising, providing an orthopedic implant device comprising a cage and a staple, performing an osteotomy procedure through a vertebral body, inserting the cage and the staple into an opening created by the osteotomy procedure, and positioning the staple whereby one or more staple tines secure the cage and the staple to the vertebral body.
  • the step of positioning the staple comprises moving the staple from a first to a second position.
  • the first position is a deployed position
  • the second position is a stabilized position.
  • the step of positioning the staple comprises extending the staple from a position relative to the cage to an extended position, rotating the staple relative to the cage to a deployed position, and retracting the staple relative to the cage to a stabilized position whereby one or more staple tines secure the cage and the staple to the vertebral body.
  • the orthopedic implant device further comprises an anchor frame coupled to the cage and the method further comprises anchoring the anchor frame to the vertebral body by implanting one or more anchoring element through the anchor frame and into the vertebral body.
  • the orthopedic implant device further comprises an anchor frame coupled to the cage and the method further comprises anchoring the anchor frame to the vertebral body by retracting the staple towards the anchor frame.
  • This technology will bridge the gap between a minimally invasive decompression without fusion and more extensive decompressions requiring a fusion procedure and lead to an improved quality of life when compared to current standard surgical techniques and technology.
  • the patient will have relief from back and/or leg pain without a loss of spine mobility, which can significantly reduce or eliminate the risk of adjacent level accelerated degeneration in the other levels of the spine.
  • the custom alignment created with the implant device can prevent the clinical outcomes of spinal misalignment.
  • FIGS. 3C-3E show examples of a locking sleeve where FIG. 3C shows a perspective view showing the distal end, FIG. 3D shows a perspective view from the proximal end and FIG. 3E shows a perspective view from the proximal end and a key;
  • FIGS. 12A and 12B show different view of the distal end of an example of implant insertion channel guide where FIG. 12A shows an example for use with an implant device in an intervertebral application and FIG. 12B shows an example for use with an implant device in an intravertebral application;
  • FIG. 14 shows an example of a threaded locking rod
  • FIG. 15 shows a view of a threaded locking rod received in the insertion handle assembly and coupled to an implant device
  • FIGS. 18A and 18B show elements of an example of the staple drive handle assembly where FIG. 18A shows the engagement of the staple drive handle with the staple shaft and nut and FIG. 18B shows the distal end of the staple drive handle assembly;
  • FIGS. 19A and 19B show different views of an example of an insertion handle assembly with a threaded locking rod, staple drive handle assembly and implant device positioned for use in anterior to psoas (ATP) implant procedure where FIG. 19A shows a top perspective view and FIG. 19B shows a perspective view from the proximal end;
  • ATP anterior to psoas
  • FIG. 20 shows an example of an insertion handle assembly for use in a lateral implant procedure
  • FIG. 21 shows examples of footprint sizer tools
  • FIGS. 25A-25C show different views of an example of the implant system
  • FIGS. 26A-26E show different views of an example of the anchor frame
  • FIGS. 34A and 34B show different views of components of an example of the implant system
  • FIGS. 36A and 36 B show exploded perspective views of an example implant system where FIG. 36A shows a view from a proximal end and FIG. 36B shows a view from the distal end;
  • FIGS. 37A and 37B show views of an example implant system assembled where FIG. 37 A shows the implant system from a proximal end view and FIG. 37B shows an example implant system from a side view;
  • FIGS. 41A-41F show different views of an example implant system where 41A shows a top perspective view of an example implant system with the staple in a partially deployed position, FIG. 4 IB shows a side perspective view, FIG. 41C shows a top view, FIG. 41D shows a side view, FIG. 41E shows a distal end view and FIG. 41F shows a proximal end view;
  • FIG. 45 shows an example of a misaligned spine to be corrected for scoliosis
  • FIG. 47 shows an example of a spine corrected using an embodiment of the implant system using the implant system as intervertebral implants
  • FIGS. 52A-52D illustrate an example of a lock driver with FIG. 52A showing the lock driver engaged with a tipped bone screw, FIG. 52B showing a cross section of the lock driver engaged with the tipped bone screw in a vertebral body, FIG. 52C showing an exploded view of the lock driver and securing element and FIG. 52D showing details of the lock driver and the securing element.
  • Foraminal narrowing is a specific type of spinal stenosis, a spinal condition that occurs when the open spaces between the vertebra (the foramina) narrow.
  • the foramina are bony passageways located between the vertebrae on either side of the spine. Their primary purpose is to provide an exit path for nerves leaving the spinal cord and traveling to other parts of the body.
  • the implant system may be a modular system including a self-stabilizing cage which includes deployable and fixed securing elements, an anchor frame fixable to the cage, anchoring elements such as bone fixation screws attachable to the anchor frame and any one of many anti-backout features known in the art to prevent the bone fixation screws from projecting out of the anchor frame.
  • a self-stabilizing cage which includes deployable and fixed securing elements, an anchor frame fixable to the cage, anchoring elements such as bone fixation screws attachable to the anchor frame and any one of many anti-backout features known in the art to prevent the bone fixation screws from projecting out of the anchor frame.
  • the staple of the implant system may have extension, deployment and retracting features that allow the staple to be moved through multiple positions to secure the implant device to the bone.
  • the movement features may allow the distal staple to be easily moved between an insertion position, an extended position, a deployed position and a stabilized position. These different positions of the staple describe both the rotational alignment of the staple head and the location of the staple head relative to other elements of the implant device.
  • Insertion position In the insertion position, alignment of the length of the staple head is in a neutral alignment, generally the orientation of the length of the staple head being coplanar or parallel to a plane extending along the transverse axis of the cage. In this position, the longitudinal location of the staple head relative to the longitudinal axis of the cage is the location as the implant device is being positioned for implanting. In some embodiments, the longitudinal location of the staple head is generally positioned in a non-extended/insertion location close to the distal end of the cage. In some embodiments, the insertion location of the staple head position may have the staple head in an extended location extended away from the cage. In some embodiments, portions of the staple head may be received in a protective recess on the cage.
  • Extended position In the extended position, the alignment of the staple head is in the neutral alignment, generally parallel to the transverse axis of the cage. In this position, the longitudinal location of the staple head relative to the cage longitudinal axis is in an extended location extended away from the cage. The extended position generally extends the location of the distal staple head from the cage longitudinally so that the staple head and the staple tines extend beyond the sidewalls of the bone.
  • Deployed position In the deployed position, the staple head is rotated to a non-neutral alignment that is other than parallel to the transverse axis of the cage. In this position, the non-neutral alignment of the staple head may be at any angle relative to the insertion and extended position sufficient to allow the staple tines of the staple to be positioned to engage the sidewalls of the bone.
  • the longitudinal location of the staple head relative to the longitudinal axis of the cage is in an extended location extended away from the cage sufficient to allow the staple tines of the staple head to extend beyond the bone.
  • the nonneutral alignment in the deployed position is about 90 degrees from the neutral alignment to maximize engagement with the bone.
  • the staple is positioned on the distal side of the implant to be secured to the distal sidewall of the vertebral body yet control of the positioning of the staple is done by manipulating system elements and features accessible on the proximal side of the implant.
  • These features are particularly beneficial for vertebral procedures where the implants are inserted and secured from a lateral or an oblique approach angle and the implant is implanted across the vertebral body and secured to both lateral sidewalls of the vertebrae. These procedures include the ATP approach to access the vertebral body and implant the implant device.
  • components of the implant device may be 3D printed as one unit.
  • the cage and anchor frame of the embodiments shown in FIGS. 40A-42C may be 3D printed as one unit.
  • the Implant System The Implant System:
  • the vertebral implant system generally comprises an intravertebral implant device 200 comprising a cage 260 and one or more securing element configured to secure the cage 260 to the vertebral body.
  • the securing element may be any suitable element or combination of elements to secure the cage 260 and the implant device 200 to a superior and inferior portion of the vertebral body.
  • the securing element may comprise one or more staple 240 received in, and rotationally and longitudinally adjustable relative to the cage 260. From a proximal end to a distal end, the example shown comprises an anchor frame 280, the cage 260 and a distal staple 240.
  • FIGS. 6A-9C further illustrate examples of a vertebral implant device.
  • FIGS. 6A and 6B show additional partially exploded views of the example of the vertebral implant device consistent with the example shown in FIG. 2.
  • FIG. 7 illustrates a partially exploded view of the cage and anchor frame components of a vertebral implant device alongside an example vertebral body with an osteotomy as may be used in an intravertebral application.
  • FIG. 7 shows the distal staple 740 prior to being deployed.
  • FIG. 8 shows the example of FIG. 7 assembled and implanted in a vertebral body with the staple 840 deployed.
  • Engagement portion 347 may comprise any type of profile that can be engaged by a tool to rotate the staple shaft 346.
  • one example of the engagement portion 347 may be an off-round profile such as a profile with a flat surface (flat) to allow a mating engagement with a tool having a mating recess with a flat to rotate the engagement portion 347 and the staple shaft 346.
  • the distal staple shaft 346 may further include elements to adjustably couple the distal staple 340 to the cage.
  • the distal staple shaft 346 includes a coupling portion 349 configured to mate with a coupling element.
  • the coupling portion 349 of the staple shaft 346 may be a threaded portion configured to mate with a threaded coupling element such as a nut.
  • the coupling portion 349 of the staple shaft 346 and the coupling element engage each other to function as a coupling device to adjust the longitudinal position of the staple head 342 relative to the cage.
  • the threaded portion and the threaded coupling element are configured to cause the distal staple head 342 to retract towards the cage as the staple shaft 346 is rotated in one direction and extend away from the cage as the staple shaft is rotated in the other direction.
  • the threaded portion mates with a threaded coupling element, such as a nut (for example only, see example in FIG. 18 A), positioned on the staple shaft and engaging the cage.
  • FIGS. 3C-3E illustrate different views of an example of a locking sleeve 330.
  • the locking sleeve 330 is generally a cylindrical sleeve configured to receive one or more staple shaft through a central bore 335.
  • the locking sleeve 330 has a through hole 333 to receive a mating element like a pin to couple the locking sleeve 330 to the one or more staple shaft.
  • the locking sleeve 330 may have one or more staple stop feature to limit the rotation of the sleeve through desired positions.
  • staple stop 337 on the exterior surface of the locking sleeve 330 is configured to function as a limit to the rotation of the sleeve by having the staple stop 337 physically engage other implant elements to stop the rotation of the locking sleeve 330 and staple shaft at certain positions.
  • the staple stop 337 shown may engage a mated protrusion on the cage, a cage stop, to stop the locking sleeve 330 and the coupled staple shaft in a particular position.
  • the locking sleeve 330 may also have a key configured to keep the locking sleeve 330 in a certain position.
  • the distal staple shaft may be received in and through the inner staple shaft bore and the pin may be inserted through both pin holes to couple the two staple shafts. With the shafts coupled, they rotate together such that when the distal staple shaft 346 is rotated through the use of the engagement portion, the inner staple shaft and the inner staple 322 are also rotated.
  • the configuration of the cage 460 with a cavity 463 or other gaps within the cage body 462 is to allow for placement of ample bone graft (autogenous, allogenic or synthetic) to reach the osteotomized vertebral body both superior and inferior when the cage 460 is positioned within the vertebral body and facilitate fusion (healing).
  • the dimensions of the cage surface planes define an offset dimension that is used to alter the planes of the endplates of the vertebral body.
  • the dimensions of the cage define a cage surface angle between the cage upper surface plane and the cage lower surface plane to alter the endplate surface planes of a vertebral body when the cage is implanted in the vertebral body.
  • the dimensions of the cage may also define a distance between the cage upper surface plane and the cage lower surface plane to alter the height defined by the distance between the endplate surface planes of a vertebral body when the cage is implanted in the vertebral body.
  • the cage 460 may have a cage stop 469 to function as a rotational stop with the staple stop 437 on the locking sleeve 430.
  • the cage stop 469 is a generally a protrusion within the cavity 463 of the cage 460 to stop rotation of the locking sleeve at a position that properly positions the staple head.
  • the cage stop 469 may be an elongated protrusion that in cooperation with the stop 437 and/or key 438 keeps the locking sleeve properly positioned as it and the staple shaft are extended, deployed and retracted into the through bore 468 of the cage 460.
  • This example shows cage screw recesses 467 extending through the walls of the cage body.
  • the one or more staple head 442 is configured in an undeployed or horizontal position with staple tines 444 positioned generally parallel with the transverse surface planes of the cage 460 to allow it to fit through the osteotomy (or intervertebral space) during insertion.
  • the engagement portion of the staple shaft 436 such as a hex, flat, D shaped or other non-round profile on the proximal end of the staple shaft 436, is rotated by a mating engagement tool such as a staple drive handle assembly.
  • the staple tines 444 of the staple head 442 are rotated into a deployed position to engage and secure the staple tines 444 and the implant device in the vertebral body.
  • the staple tines 444 may engage the spongy cancellous bone of the vertebral body, or they may engage the compact bone on the distal wall of the vertebral body.
  • the anchor frame 580 generally provides the structural elements to anchor and further secure the implant device to the vertebral body.
  • the anchor frame may be any type of structural element having any position or angle relative to the cage to help secure implant device components to bone.
  • the anchor frame may be any a structural element having any shape and having any relative position or angle relative to the cage that helps secure the implant device to the vertebral body.
  • the anchoring element may be any element to anchor the anchor frame 580 to the vertebral body.
  • the anchoring element may be a bone screw 590 (see FIG. 5C).
  • the anchoring element may be an expandable anchor akin to a dry wall screw or molly bolt.
  • the anchor frame 580 may also have elements to secure the implant device to other system components.
  • one example element to secure the implant device to other system components may comprise one or more through hole 582 that may receive a coupling element like a cage screw 587 (see FIG. 5B) to secure an element such as the cage (see FIG. 4) to the anchor frame 580.
  • the features of the anchor frame coupling the cage and the anchoring elements may be provided by other types of anchor frames or multiple anchor frames or a divided element coupled by one or more anchor frame.
  • the anchor frame may be a fixed or adjustable anchor frame and they may be used in combination.
  • the vertebral implant device 600 comprises a cage 660, an anchor frame 680 a staple 640 and anchoring elements 690.
  • the distal staple 640 has a convex shape.
  • the engagement portion 647 of the distal staple shaft is shown in and blocked in the locking channel of the anchor frame 680.
  • the anchor frame has one or more through hole 684 to accept an anchoring element such as a one screw.
  • the bone screw anti-backout feature 695 is shown to be positioned within the anchor posts 689 to block the proximal end of the anchoring elements 690, here bone screws, thus to provide anti-backout features for the bone screws.
  • the vertebral body is too small to safely accommodate bone screws as a method to secure the implant.
  • the implant may have other anchoring elements to secure the implant device to the vertebral body.
  • the anchoring element may be any element to secure a component of the implant device to the bone.
  • the anchoring element may comprise one or more teeth extending from the anchor frame to penetrate into the wall of the vertebral body and secure the anchor frame and the implant device.
  • FIGS. 25A-25C show different views of an example of the implant system having teeth as anchoring elements. As shown, this example of the implant device 2500 has a cage 2560, a distal staple 2540 and anchor frame 2580 similar to the example described above.
  • FIGS. 29A and 29B show different views of an example of the vertebral implant system 2900 that use bone screws as anchoring elements 2990. Illustrated are distal staple 2940, cage 2960, anchor frame 2980, anchoring elements 2990 and cage screws 2987.
  • FIGS. 30A and 30B show different views of this example of components of the vertebral implant system 3000 showing the distal staple 3040, the cage 3060, the anchor frame 3080 and the proximal tab 2970.
  • FIGS. 33A and 33B show different detailed views of components of an example of the vertebral implant system in a configuration to be deployed for implanting.
  • FIG. 33A shows an example of the vertebral implant system 3300 having a proximal tab 3370, a cage 3360, a distal staple 3340 and locking sleeve 3330.
  • FIG. 33B shows a detailed view of the locking sleeve 3330.
  • the implant system may be sized and configured so that the distal staple and the bone screws (in FIG. 29 A) or the teeth (in FIG. 31 A) secure the implant device cage between two bones of a finger or foot/ankle joint.
  • FIGS. 11A-24E, 42D-42I, 44-48 and 50A-52D show examples of tools to be used to insert examples of the implant system. These tools may be used for the implant system whether configured for use as part of an intravertebral body implant system or as part of an intervertebral body implant system. Similar- tools may be modified for use with implant systems configured to be used in arthrodesis procedures for other joints throughout the body.
  • FIG. 12A shows an example with these features configured for an interbody implant procedure
  • FIG. 12B shows an example with the guide features configured for an intrabody implant procedure.
  • FIG. 17 shows the staple drive handle assembly 1795 and locking rod positioned 1793 in the insertion handle assembly 1792.
  • This example shows a staple drive handle assembly 1795 having multiple handles coupled to multiple engagement elements.
  • one handle 1797 may be coupled to an inner rod to engage the engagement portion of the staple shaft and another handle 1796 may be coupled to an outer rod to engage the coupling element, or nut.
  • one handle may turn the inner rod and the staple and the other handle may turn the coupling element, such as the nut, to extend and retract the staple from the cage.
  • the inner drive rod 1872 and outer drive rod 1874 may be frictionally engaged to allow a turn of the staple drive handle to turn both drive rods until the staple shaft 1846 positions the staple in the “deployed” position. This positioning may be assisted by the stops and keys on the staple shaft and/or locking sleeve and/or the cage that can be configured to stop rotation of the staple shaft 1846 when the staple is in the deployed position. Once the staple is in the deployed position, the outer drive rod 1874 may still be turned by the staple drive handle to turn the nut 1841 and retract the shaft 1846 and staple.
  • FIG. 18B shows an example of the end of the staple drive handle assembly with the inner drive rod with an engagement portion 1873 shaped to mate with the coupling portion 1849 of the staple shaft 1846 and the outer drive rod having an engagement portion 1875 shaped to mate with the exterior surface of the nut 1841.
  • the distal end of the outer drive rod 1874 may be physically limited to move only a certain distance by hitting a physical stop such as the proximal end of the sleeve or other component.
  • the rotation and the threading of the staple shaft 1846 and nut 1841 allows the staple shaft 1846 to be extended in a distal direction away from the cage.
  • FTGS. 19A and 19B show different views of an example of an insertion handle assembly 1992 with a threaded locking rod 1993, staple drive handle assembly 1995 and implant device 1900 positioned for use in anterior to psoas (ATP) implant procedure.
  • FIG. 19A shows a top perspective view
  • FIG. 19B shows a perspective view from the proximal end.
  • the inner rod may be coupled to a handle 1997 to move the engagement portion of the staple shaft and the outer rod may be coupled to a knob 1996 to engage the coupling element.
  • FIGS. 23A and 23B show different views of an example of a far-side elevator tool 2370.
  • the far-side elevator tool 2370 generally is used to prepare the insertion site for the implant device.
  • the far-side elevator tool 2370 comprises a shell 2372, a paddle 2374, an outer sleeve 2371, and inner shaft 2373 and a paddle assembly 2376.
  • the outer sleeve is coupled to the shell 2372 to control its position.
  • a paddle shaft (not shown) is coupled to the paddle 2374 and the paddle handle 2376 to allow the paddle handle 2376 to control the rotational position of the paddle 2374 (see FIG. 23B).
  • the paddle handle 2476 is configured to lock relative to the outer sleeve 2471 and the inner shaft 2473 with a shaft lock 2478.
  • the shaft lock 2478 may be disengaged by pulling the handle portion of the paddle handle 2476 away from the inner shaft 2473, opening a lock gap 2479 to allow the handle portion to rotate and rotate the paddle.
  • the tip portion 5092 of the bone screw is configured to have a surface 5091 that can be frictionally or mechanically engaged by the securing element.
  • the tip portion 5092 may be configured to have features that facilitate this frictional engagement with other screw plate alignment system components.
  • the tip portion 5092 may have a frictional surface, roughened surface or a radially ribbed surface.
  • the bone screw 5090 may have an engagement portion 5094 to mate with a tool, such as a screw driver, to turn and insert the bone screw 5090 into the vertebral body.
  • the engagement portion 5094 of the tipped bone screw 5090 may comprise teeth 5093 to mate with teeth on the screw driver tool.
  • FIGS. 51A-51F illustrate an example of a screw driver.
  • FIG. 51A shows the screw driver 5180 engaged with a tipped bone screw in a vertebral body.
  • FIG. 5 IB illustrates a cut away profile B-B of FIG. 51A showing an upper staple with tipped bone screw 5190 functioning as a staple tine.
  • the bone screw is a tipped bone screw 5190 with the tip portion of the tipped bone screw configured to engage a hollow tip of the bone screw driver 5180.
  • the tip portion 5192 is configured to extend beyond the engagement portion 5194 of the tipped bone screw 5190 and be received in a hollow tip 5183 of the bone screw driver 5180.
  • the tip portion 5192 is also configured to secure the tipped bone screw 5190 to a staple plate or directly to an anchor frame 5150 through a screw plate alignment system.
  • FIG. 51B also shows the forward portion of the screw driver 5180 also has a drive stop 5184 that limits the driving of the tipped bone screw 5190.
  • FIG. 51C shows the screw driver positioned to be engaged with a tipped bone screw.
  • FIG. 5 ID shows details of the screw driver and the tipped bone screw 5190 showing its threaded portion 5196, the engagement portion 5194, the tip portion 5192 and the engagement portion 5182 of the screw driver.
  • the tip of the tipped bone screw driver 5180 is configured to receive the tip portion of the tipped bone screw 5190 and engage the engagement portion 5194 so that the tipped bone screw 5190 may be turned and driven into the bone.
  • FIG. 5 IE shows another view of the screw driver 5180 positioned to be engaged with a tipped bone screw 5190 and FIG. 51F showing another view of details of the screw driver engagement portion 5182 and the tipped bone screw 5190.
  • FIG. 52A shows a lock driver 5270 engaged with a tipped bone screw in a vertebral body.
  • FIG. 52B shows a cut-away portion A-A of FIG. 52A showing a screw plate alignment system comprising the tip portion 5292 of the bone screw 5290, the interior surface of the through hole through the plate 5250, a locking element 5272, and a securing element 5279.
  • the tip of the lock driver 5270 is configured with the locking element 5272.
  • the locking element 5272 functions to frictionally lock the securing element 5279 around the tip portion 5292 of the bone screw 5290 and hold the securing element 5279 and tip portion 5292 in the through hole of the plate 5250.
  • the securing element 5279 positioned within the locking element 5272 so that the securing element 5279 and the locking element 5272 can be positioned over and around the tip portion of the bone screw.
  • the tip of the lock driver 5270 allows the locking element 5272 to be “screwed” or otherwise inserted into the plate 5250 through hole so that the exterior surface of the locking element 5272 engages the interior surface of the plate 5250 through hole.
  • the lock driver 5270 may also be configured to have a “break away” ability to allow the locking element 5272 to break off of the lock driver 5270 and secure the locking element 5272 with the implant system.
  • a thin portion 5276 of the lock driver at the end of a tapered portion 5275 can be configured to break when a pre-determined amount of torque is applied with the lock driver 5270.
  • the securing element 5279 generally comprises a shaped malleable element configured to frictionally engage the outer surface of the tipped bone screw and the interior surface of the locking element bore 5271.
  • the securing element 5279 may be a hollow cylindrical sphere-shaped element with a through bore 5279B configured to engage the interior surface of the locking element bore 5271 and engage the exterior surface of the tip portion of the tipped bone screw.
  • the securing element 5279 is a malleable element to deform and mold around the tip portion and deform and mold within the locking element bore 5271 of the locking element 5272.
  • the securing element 5279 may include a lengthwise slit 5279S to allow the securing element 5279 to reduce its circumference and provide more compressive force on the surface of the tip portion of the bone screw.
  • FIGS. 35A-35G illustrate an example of an implant system.
  • Implant systems consistent with this example may be used as intervertebral implant systems, intravertebral implant systems and implant systems configured for use in arthrodesis procedures.
  • this example will be described as used as a vertebral implant system.
  • an example of the implant system used in an intervertebral application will be described and referred to as a vertebral implant system, an intervertebral implant system, a vertebral implant device and an intervertebral implant device.
  • FIGS. 35A - 35C show an example of a vertebral implant system comprising a vertebral implant device with FIG. 35A showing a perspective view of the vertebral implant device 3500.
  • FIG. 35A shows the staple in an insertion position 35421 with the staple in the insertion location and in an insertion alignment.
  • FIG. 35B shows an assembled view with anchoring elements with the staple in an example of a stabilized position 3542S where the staple is retracted relative to the cage and in a deployed alignment.
  • FIG. 35C an exploded perspective view of the vertebral implant device 3500.
  • the vertebral implant device generally comprises a staple 3540, a cage 3560, an anchor frame 3580 and a coupling element 3541.
  • the cage 3560 generally functions as a spacer between bones or between portions of a bone.
  • the staple 3540 generally extends through a longitudinal bore of the cage to mechanically engage a sidewall of the bone to secure it and the cage 3560 to the bone.
  • the anchor frame 3580 also provides features to receive the staple 3540 and secure itself and the cage 3560 to the bone. Together with the staple 3540, the anchor frame 3580 provides a compressive force to secure the cage 3560 to the bone.
  • the engagement portion 3547 is a proximal portion of the staple shaft 3546 having flats on its outer profile whereby the engagement portion 3547 can mate with a tool, such as a driver with a recess having mating flats, whereby the staple shaft 3546 can be engaged, pushed and rotated with the tool.
  • the engagement portion 3547 may also provide a means to mate with a key 3538 to engage a cage stop to influence the movement of the staple shaft 3546 and the staple head 3542 relative to the cage 3560.
  • the key 3538 may be configured with any surface features such as for example, teeth to mechanically engage a similarly configured mating surface the cage 3560.
  • the cage may further comprise a pivot coupler 3581 to pivotally couple the cage 3560 to the anchor frame 3580.
  • the pivot coupler 3581 may be any type of coupling that allows the anchor frame 3580 to move in relation to the cage 3560.
  • the pivot coupler 3581 comprises a cylindrical protrusion received in a through hole on the proximal end of the cage 3560 whereby the anchor frame 3580 pivots about an axis about ninety degrees to a longitudinal axis of the cage.
  • the anchor frame pivots about an axis having a range of about 45 degrees to 90 degrees to the longitudinal axis of the cage.
  • FIG. 35D shows an exploded perspective view of an example of a vertebral implant device showing the staple 3540, the cage 3560, the nut 3541 and the washer 3538.
  • FIG. 35E details callout B of the nut 3541 showing the nut flange 3541W and the retaining channel 3541 C. Also shown is the washer 3538 and the radial grooves 3538G and the recess 3538R with the flats to engage the engagement portion 3547 of the staple shaft 3546.
  • FIGS. 37A and 37B show views of an example vertebral implant device 3700 consistent with FIGS. 36A and 36B.
  • FIG. 37A shows an assembled proximal perspective view and
  • FIG. 37B shows a side view.
  • the key 4238 is a recess channel extending along the longitudinal surface of the staple shaft 4246.
  • FIGS. 42D-42F show an example of an outer drive rod 4274 of a staple drive handle assembly having a recess 4274R for an inner drive rod (see FIG. 42G).
  • the end of the outer drive rod 4274 has an inner surface defining a nut engagement portion 4275 configured to engage the shape of the nut 4241 so that the turning of the nut, when the threaded portion of the staple shaft 4246 is engaged with the threads of the nut 4241 and the nut is retained in the cage by the nut flange 4241W and the retaining channel 4241C, the staple shaft 4246 can be extended away from and retracted towards the cage.
  • FIG. 42G-42I show an example of an inner drive rod 4272 having an inner surface shape defining a shaft engagement portion 4273 to engage the engagement portion 4247 of the staple shaft 4246. With this engagement, by rotating the inner drive rod 4272, the staple shaft 4246 and the staple head are rotated without turning the nut 4241 to put the staple head in the deployed position.
  • the implant device generally uses the exterior surface planes of the cage to alter the alignment of skeletal components of a mammalian body.
  • the disclosed implant device primarily provides adjustment of the spine in the sagittal (110) and coronal (100) planes and combinations of these two planes.
  • the implant device when used as a vertebral implant, is intended to be used on the vertebra and may be inserted from different orientations. As shown, the implant device may be inserted from a lateral/side position, from an anterior/front position or from an oblique position.
  • the implant system may also be applied to different portions of the spine (thoracic or lumbar).
  • FIG. 9A shows an example of an implanted implant device with an inner staple 920 and a distal staple 940.
  • FIG. 9C shows an example of an implanted implant device with a single distal staple 940 with the staple tines defining a concave shape.
  • the distal forked end of the implant insertion channel guide (for example only, see example at FIGS. 11A-1 IB) is positioned with its distal tip in the osteotomy.
  • the insertion stop, the anterior stop and the cleat are used to engage the bone and properly maintain the position of the distal forked end of the implant insertion channel guide.
  • the staple drive handle assembly is positioned in the insertion handle assembly (for example only, see example at FIG. 17) and the distal end of the staple drive handle assembly is positioned over the engagement portion of the staple shaft and nut (for example only, see example at FIG. 18A) so that it can engage and rotate the staple shaft and the nut independently. If needed, the staple shaft and staple may be moved to an extended position further away from the distal end of the cage so that the staple is positioned outside of the osteotomy and beyond the opposite side boarder of the vertebral walls.
  • the cage screws 1087 may be inserted through the anchor frame through holes 1082 and tightened in the threaded holes in the cage (see FIGS. 10F and 10G) using a tool such as but not limited to a screwdriver. With the anchor frame guide still coupled to the anchor frame, only the cage screw on the unobstructed side can be inserted.
  • the cage screws may incorporate an antibackout thread design (e.g., spiral-lock) or other anti-backout elements 1095 to prevent loosening or disengagement of the cage from the anchor frame once it is implanted.
  • the locking rod may be removed and the additional bone graft material may be delivered into the cage cavity through the threaded cage screw recess/hole.
  • FIG. 49A shows a sagittal view of a spine to be corrected for kyphosis.
  • the processes and devices used are similar to those used to correct for scoliosis.
  • the difference from a coronal correction for scoliosis being the orientation of the surface plane angles of the cage are angled sufficient to provide the sagittal correction when implanted.
  • osteotomies would be performed on vertebrae to receive the vertebral implant devices.
  • FIG. 49B shows sagittal view of the corrected spine with implant devices 4900A and 4900D used as an intravertebral implant devices and implant devices 4900B and 4900C used as an intervertebral implant devices.

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  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
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EP23820547.0A 2022-06-05 2023-06-05 Implantatsystem und verfahren zur verwendung Pending EP4536152A2 (de)

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US202263349136P 2022-06-05 2022-06-05
US202263369330P 2022-07-25 2022-07-25
US18/051,732 US11883300B2 (en) 2020-06-15 2022-11-01 Orthopedic implant system and methods of use
US202363478620P 2023-01-05 2023-01-05
PCT/US2023/067912 WO2023240032A2 (en) 2022-06-05 2023-06-05 Implant system and methods of use

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US8142479B2 (en) * 2007-05-01 2012-03-27 Spinal Simplicity Llc Interspinous process implants having deployable engagement arms
FR2934147B1 (fr) * 2008-07-24 2012-08-24 Medicrea International Implant d'osteosynthese vertebrale
US9861399B2 (en) * 2009-03-13 2018-01-09 Spinal Simplicity, Llc Interspinous process implant having a body with a removable end portion
US8852278B2 (en) * 2011-12-22 2014-10-07 DePuy Synthes Products, LLC Lateral cage with integrated plate
US20160331544A1 (en) * 2015-05-12 2016-11-17 Warsaw Orthopedic, Inc. Spinal implant system and method
US11259936B2 (en) * 2020-06-15 2022-03-01 Nofusco Corporation Intravertebral implant system and methods of use

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