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US 8,986,387 B1Granted
Staged, bilaterally expandable trial
AssigneeOuroboros Medical, Inc.
InventorsJohn To, Praveen Gopal Rao
Life of this patent
Estimating the term…
Abstract
Systems and methods for distracting an intervertebral disc space are provided. The systems use a staged, bilaterally expandable trial. The systems and methods of distracting an intervertebral space are provided in a manner that addresses the problem of subsidence. The method includes inserting the trial into the intervertebral space in a collapsed state and, once inserted, the trial is then used for distracting the intervertebral space using an expansion that includes a first stage and a second stage. The first stage includes expanding the trial laterally toward the peripheral zones of the top vertebral plate and the bottom vertebral plate, and the second stage includes expanding the trial vertically to distract the intervertebral space.
Claims30
A staged, bilaterally-expandable trial for an intervertebral space, comprising:
- a bilaterally-expandable shell having a proximal region with an end, a mid-region, a distal region with an end, and a lumen;
- the proximal region having a slider-guide;
- the distal region having a bilaterally-expandable head with 4 subheads that include a first top beam, a second top beam, a first bottom beam, and a second bottom beam;
- and, the mid-region having 4 flex rods that include a first top flex rod, a second top flex rod, a first bottom flex rod, and a second bottom flex rod, each of which operably attaches the slider-guide to it's respective subhead, the shell having a collapsed state and an expanded state;
- and,
- a shim having a proximal region with an end;
- a mid-region;
- a distal region with an end;
- a central axis;
- a top surface with a first top-lateral surface and a second top-lateral surface;
- a bottom surface with a first bottom-lateral surface and a second bottom-lateral surface;
- a first side surface with a first top-side surface and a first bottom-side surface;
- and, a second side surface with a second top-side surface and a second bottom-side surface;
- the shim configured for a proximal-to-distal axial translation in the lumen of the shell that induces a lateral force on the 4 subheads followed by a vertical force on the 4 subheads for a staged, bilateral expansion in vivo that includes a lateral expansion of the head followed by a vertical expansion of the head in an intervertebral space having a top vertebral endplate, a bottom vertebral endplate, and an annulus;
- wherein, the head has a proximal portion having an end;
- a distal portion having an end;
- and, a central shell axis of the expanded state;
- the head configured for slidably-engaging with the shim in vivo following placement of the trial in the intervertebral space through the annular opening, the slidably-engaging including axially-translating the shim in the lumen of the shell from the proximal end of the lumen toward the distal end of the lumen in vivo;
- the translating including keeping the central shim axis at least substantially coincident with the central shell axis during the translating.
16 more elements
A system for distracting an intervertebral space, the system comprising
- a bilaterally-expandable shell having a proximal region with an end, a mid-region, a distal region with an end, and a lumen;
- the proximal region having a slider-guide;
- the distal region having a bilaterally-expandable head with 4 subheads that include a first top beam, a second top beam, a first bottom beam, and a second bottom beam;
- and, the mid-region having 4 flex rods that include a first top flex rod, a second top flex rod, a first bottom flex rod, and a second bottom flex rod, each of which operably attaches the slider-guide to it's respective subhead, the shell having a collapsed state and an expanded state;
- a shim having a proximal region with an end;
- a mid-region;
- a distal region with an end;
- a central axis;
- a top surface with a first top-lateral surface and a second top-lateral surface;
- a bottom surface with a first bottom-lateral surface and a second bottom-lateral surface;
- a first side surface with a first top-side surface and a first bottom-side surface;
- and, a second side surface with a second top-side surface and a second bottom-side surface;
- the shim configured for a proximal-to-distal axial translation in the lumen of the shell that induces a lateral force on the 4 subheads followed by a vertical force on the 4 subheads for a staged, bilateral expansion in vivo that includes a lateral expansion of the head followed by a vertical expansion of the head in an intervertebral space having a top vertebral endplate, a bottom vertebral endplate, and an annulus;
- an actuation bar, the actuation bar having a proximal portion with a proximal end, a distal portion with a distal end, and configured to transfer the axial proximal-to-distal force to the shim through the slider-guide;
- the shim configured to receive an axial proximal-to-distal force through the actuation bar for the axial translation;
- and,
- an actuation means operably attached to the proximal end of the actuation bar to transfer the axial proximal-to-distal force to the shim through the distal end of the actuation bar;
- wherein, the head has a proximal portion having an end;
- a distal portion having an end;
- and, a central shell axis of the expanded state;
- the head configured for slidably-engaging with the shim in vivo following placement of the trial in the intervertebral space through the annular opening, the slidably-engaging including axially-translating the shim in the lumen of the shell from the proximal end of the lumen toward the distal end of the lumen in vivo;
- the translating including keeping the central shim axis at least substantially coincident with the central shell axis during the translating.
19 more elements
Dependencies are inferred from the claim text.