Variable lordotic interbody spacer

{
  "publication_number": "US11123200B2",
  "country": "US",
  "kind": "B2",
  "title": "Variable lordotic interbody spacer",
  "abstract": "A variable lordotic interbody spacer including a face plate, superior and inferior endplates coupled to the face plate via a hinge, an actuation frame between the endplates, and an actuation screw. The face plate includes actuation and stabilizer channels. Each of the endplates has endplate arms coupled by an endplate base, and includes actuation ramp recesses. The actuation frame includes frame arms coupled by a frame base in a generally U-shaped configuration, each actuation frame arm having a stabilizer feature passing through a corresponding stabilizer channel and having actuation ramp pins fitted to a corresponding ramp recesses. The actuation screw passes through the actuation channel, with a head retained at the front surface and a threaded end coupled to the actuation frame. When operated, the actuation screw moves the actuation frame between the superior endplate and the inferior endplate to adjust an angle therebetween.",
  "claims": [
    "1. A method of implanting a variable lordotic interbody spacer in a disc space between two adjacent vertebrae, the method comprising: inserting the spacer in the disc space, the spacer comprising: a face plate having a front surface and a rear surface, the face plate further having at least one actuation channel; superior and inferior endplates, each of the endplates having proximal and distal ends and having first and second endplate arms coupled by an endplate base, each endplate arm coupled to the rear surface of the face plate opposite from the base, and each endplate arm having a ramp recess on a top surface and a bottom surface; an actuation frame positioned between the superior endplate and the inferior endplate, the actuation frame having first and second frame arms coupled by a frame base, each frame arm having an actuation ramp pin on a top surface and on a bottom surface fitted to a corresponding ramp recess, the actuation frame further including a receptacle formed at the inside of the frame base between each frame arm; and an actuation screw having a head, body and threaded end, the actuation screw body passing through one of the at least one actuation channel, the head retained at the front surface and the threaded end threadably coupled to the receptacle of the actuation frame, wherein, when operated, the actuation screw moves the actuation frame between the superior endplate and the inferior endplate causing the superior and inferior endplates to pivot with respect to each other such that the distance between the distal end of the superior and inferior endplates increases and the distance between the proximal ends of superior and inferior endplates remains the same, adjusting an angle formed between the superior and inferior endplates, and wherein the actuation screw is configured to be retained in the face plate by a screw plate retainer fastened to the front surface of the face plate, wherein the screw plate retainer is configured to allow rotation of the actuation screw within the face plate while otherwise preventing the actuation screw from changing position relative to the face plate.",
    "2. The method of claim 1, wherein at least two stabilizer channels are formed in the face plate and configured to receive the first and second frame arms, respectively.",
    "3. The method of claim 1, wherein, when rotated, the actuation screw moves the actuation frame toward the face plate to adjust the angle formed between the superior and inferior endplates.",
    "4. The method of claim 1, further comprising at least one blocking assembly formed on the front surface of the face plate, each blocking assembly comprising a blocking screw and a blocking screw channel, wherein the blocking assembly allows for threaded insertion of the blocking screw into the corresponding blocking screw channel.",
    "5. The method of claim 4, wherein one blocking assembly is located adjacent to the head of the actuation screw, wherein, when tightened, the blocking screw of the one blocking assembly prevents the operation of the actuation screw.",
    "6. The method of claim 4, further comprising at least one bone screw channel formed through the face plate between the front and rear surfaces, wherein one blocking assembly is located adjacent to a corresponding bone screw channel, and wherein, when tightened, the blocking screw of the one blocking assembly retains a bone screw in the corresponding bone screw channel.",
    "7. The method of claim 1, wherein each of the superior endplate and the inferior endplate further includes a center housing formed between and in parallel with each corresponding endplate arm and coupled at one end to the corresponding endplate base, the superior endplate and the inferior endplate center housings forming a receptacle channel in between, wherein the receptacle of the actuation frame is guided by the receptacle channel when the actuation frame moves with respect to the face plate.",
    "8. The method of claim 1, further comprising at least one tool keying recess and at least one tapped recess formed on the front surface of the face plate, wherein the at least one tool keying recess and the at least one tapped recess are formed so as to lock the spacer to a corresponding tool.",
    "9. The method of claim 1, wherein the rear surface of the face plate includes a protrusion having the actuation channel passing through and guiding the body of the actuation screw, wherein the protrusion is further coupled to a hinge.",
    "10. The method of claim 9, wherein the hinge comprises tabs located on an end of each endplate arm coupled to the rear surface of the face plate via pins, wherein the tabs are fastened, via the pins, to the rear surface of the face plate at corresponding pin recesses.",
    "11. The method of claim 10, wherein the rear surface of the face plate is formed with a tapered wall to provide clearance for the hinge.",
    "12. The method of claim 1, wherein each of the superior endplate and the inferior endplate have a recess formed in the endplate base to receive a knob formed on the frame base of the actuation frame.",
    "13. The method of claim 1, wherein the superior endplate, the inferior endplate, and the actuation frame have generally U-shaped configurations with an area inside that form graft window regions, the graft window regions allowing for insertion of graft material within the variable lordotic interbody spacer.",
    "14. A method of implanting a variable lordotic interbody spacer in a disc space between two adjacent vertebrae, the method comprising: inserting the spacer in the disc space, the spacer comprising: a face plate having a front surface and a rear surface, the face plate further having at least one actuation channel and at least two stabilizer channels formed through a portion of the face plate; superior and inferior endplates, each of the endplates having proximal and distal ends and having first and second endplate arms coupled by an endplate base in a generally U-shaped configuration, each endplate arm coupled to the rear surface of the face plate via a hinge opposite from the base, and each endplate arm having a ramp recess on a top surface and a bottom surface; an actuation frame positioned between the superior endplate and the inferior endplate, the actuation frame having first and second frame arms coupled by a frame base in a generally U-shaped configuration, each frame arm having a stabilizer opposite from the frame base and configured to pass through a corresponding stabilizer channel, each frame arm having an actuation ramp pin on a top surface and on a bottom surface fitted to a corresponding ramp recess, the actuation frame further including a receptacle formed at the inside of the frame base between each frame arm; and an actuation screw having a head, body and threaded end, the actuation screw body passing through one of the at least one actuation channel, the head retained at the front surface and the threaded end threadably coupled to the receptacle of the actuation frame, and wherein the actuation screw is configured to be retained in the face plate by a screw plate retainer fastened to the front surface of the face plate, wherein the screw plate retainer is configured to allow rotation of the actuation screw within the face plate while otherwise preventing the actuation screw from changing position relative to the face plate; and adjusting an angle between the superior endplate and the inferior endplate by rotating the actuation screw such that the distance between the distal ends of the superior and inferior endplates increases while the distance between the proximal ends of the superior and inferior endplates remains the same.",
    "15. The method of claim 14, further comprising securing the face plate to at least one of the adjacent vertebrae with one or more bone screws."
  ],
  "description_excerpt": "The present invention relates to intervertebral disc prostheses, and more particularly to a lordotic interbody spacer that is adjusted or expanded in situ to occupy desired space between vertebral bodies.\n\nSpinal fusion is a surgical technique used to facilitate the growth of bone between two vertebrae. The procedure involves implanting a spacer, such as an interbody device, for example, packed with grafting material into the disc space to stabilize the spine while bone grows in between two vertebrae. As the bone graft material heals, one long bone is formed with the adjacent vertebrae. The purpose is to eliminate movement between the vertebrae to reduce pain and nerve irritation.\n\nAn interbody fusion may involve removing the intervertebral disk. When the disk space has been cleared, the interbody device is implanted between the two adjoining vertebrae. These devices may contain the bone graft material that promotes bone healing and facilitates the fusion. After insertion, surgeons may use (e.g., bone) screws, plates, and rods to further stabilize the spine. Interbody fusion can be performed using a variety of different approaches, and, in an anterior lumbar interbody fusion, the procedure is performed from the front of the patient.\n\nLordotic angle is the angle between the top (superior surface) of the second lumbar vertebra and the bottom (inferior surface) of the fifth lumbar vertebra, used as a measurement of the curve of the lumbar spine. In some instances, it might be desirable to adjust or otherwise set the lordotic angle during the spinal fusion operation to adjust lordosis of the spine.",
  "cpc": [
    "A61F 2/447",
    "A61F 2/4455",
    "A61F 2002/30182",
    "A61F 2002/30471",
    "A61F 2002/30507",
    "A61F 2002/30538",
    "A61F 2002/30579",
    "A61F 2002/30593",
    "A61F 2002/30787",
    "A61F 2002/3093"
  ],
  "ipc": [
    "A61F 2/44"
  ],
  "assignees": [
    "Globus Medical Inc"
  ],
  "inventors": [
    "Kurt Faulhaber"
  ],
  "filing_date": "2019-07-17",
  "publication_date": "2021-09-21",
  "grant_date": "2021-09-21",
  "priority_date": "2015-06-17",
  "application_number": "US-201916513913-A",
  "family_id": "57546362",
  "cited_by_count": 25,
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