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 t
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.
대표청구항▼
1. 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
1. 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. 2. The trial of claim 1, wherein the head has a transverse cross-section in the collapsed state having a maximum dimension ranging from 5 mm to 18 mm for placing the frame in an intervertebral space through an annular opening for expansion in the intervertebral space; and,a transverse cross-section in the expanded state having a maximum dimension ranging from 6.5 to 28 mm in the intervertebral space;and,the shim has a transverse cross-section with a maximum dimension ranging from 5 mm to 18 mm for translating the shim in the lumen of the shell. 3. The trial of claim 1, wherein the shim has a horizontal wedge configured to laterally-expand the trial, and a vertical wedge configured to vertically-expand the trial. 4. The trial of claim 1, wherein the shim has a top wedge configured to laterally-expand the first top beam away from the second top beam, a bottom wedge configured to laterally-expand the first bottom beam away from the second bottom beam, a first side wedge configured to vertically-expand the first top beam away from the first bottom beam, and a second side wedge configured to vertically-expand the second top beam away from the second bottom beam;the proximal portion of the first top beam and the proximal portion of the second top beam are configured to complement the top wedge at the onset of the lateral expansion during the proximal-to-distal axial translation;the proximal portion of the first bottom beam and the proximal portion of the second bottom beam are configured to complement the bottom wedge at the onset of the lateral expansion during the proximal-to-distal axial translation; and,the distance, DSTAGING, between the onset of the lateral expansion and the onset of the vertical translation ranges from 2 mm to 10 mm. 5. The trial of claim 4, wherein the proximal portion of the first top beam and the proximal portion of the first bottom beam are configured to complement the first side wedge during the proximal-to-distal axial translation for the vertical expansion; and,the proximal portion of the second top beam and the proximal portion of the second bottom beam are configured to complement the second side wedge during the proximal-to-distal axial translation for the vertical expansion. 6. The trial of claim 1, wherein, the first top beam includes a proximal portion having an end, a distal portion having an end, and a central axis; the first top beam configured for contacting a first top chamfer of the shim in the expanded state, the central axis of the first top beam at least substantially on (i) a top plane containing the central axis of the first top beam and the central axis of a second top beam and (ii) a first side plane containing the central axis of the first top beam and the central axis of a first bottom beam;the second top beam includes a proximal portion having an end, a distal portion having an end, and a central axis; the second top beam configured for contacting a second top chamfer of the shim in the expanded state, the central axis of the second top beam at least substantially on (i) the top plane and (ii) a second side plane containing the central axis of the second top beam and the central axis of a second bottom beam;the first bottom beam includes a proximal portion having an end, a distal portion having an end, and a central axis; the first bottom beam configured for contacting a first bottom chamfer of the shim in the expanded state, the central axis of the first bottom beam at least substantially on (i) a bottom plane containing the central axis of the first bottom beam and the central axis of a second top beam and (ii) the first side plane; and,the second bottom beam includes a proximal portion having an end, a distal portion having an end, and a central axis; the second bottom beam configured for contacting a second bottom chamfer of the shim in the expanded state, the central axis of the second bottom beam being at least substantially on (i) the bottom plane and (ii) a second side plane containing the central axis of the second bottom beam and the second top beam. 7. The trial of claim 1, wherein, the first top beam includes a proximal portion having an end, a distal portion having an end, and a central axis; the first top beam configured for contacting a first top-lateral surface of the shim and a first top-side surface of the shim in the expanded state, the central axis of the first top beam at least substantially on (i) a top plane containing the central axis of the first top beam and the central axis of a second top beam and (ii) a first side plane containing the central axis of the first top beam and the central axis of a first bottom beam;the second top beam includes a proximal portion having an end, a distal portion having an end, and a central axis; the second top beam configured for contacting the second top-lateral surface of the shim and the second top-side surface of the shim in the expanded state, the central axis of the second top beam at least substantially on (i) the top plane and (ii) a second side plane containing the central axis of the second top beam and the central axis of a second bottom beam;the first bottom beam includes a proximal portion having an end, a distal portion having an end, and a central axis; the first bottom beam configured for contacting the first bottom-lateral surface of the shim and the first bottom-side surface of the shim in the expanded state, the central axis of the first bottom beam at least substantially on (i) a bottom plane containing the central axis of the first bottom beam and the central axis of a second top beam and (ii) the first side plane; and,the second bottom beam includes a proximal portion having an end, a distal portion having an end, and a central axis; the second bottom beam configured for contacting the second bottom-lateral surface of the shim and the second bottom-side surface of the shim in the expanded state, the central axis of the second bottom beam being at least substantially on (i) the bottom plane and (ii) a second side plane containing the central axis of the second bottom beam and the second top beam. 8. The trial of claim 1, wherein the shim comprises a lateral-expansion wedge with angle θL ranging from 10° to 30° and a vertical-expansion wedge with angle θV ranging from 30° to 50°, the apex of the lateral-expansion wedge and the apex of the vertical-expansion wedge each at least substantially on a single plane that is orthogonal to the central axis of the shim, and the ratio of θV:θL ranges from 1:1.25 to 1:4 to stage the bilateral expansion of the head. 9. The trial of claim 1, wherein the wherein the shim comprises a lateral-expansion wedge with angle θL ranging from 10° to 90° and a vertical-expansion wedge with angle θV ranging from 10° to 90°, the apex of the lateral-expansion wedge on a first plane and the apex of the vertical expansion wedge on a second plane, both the first plane and the second plane being orthogonal to the central axis of the shim and separated on the central axis at a distance ranging from 2 mm to 10 mm to stage the bilateral expansion of the head. 10. The trial of claim 1, wherein the shell is a single-unit formed from a single body of material, and the slider-guide, head, and flex rods are monolithically integral. 11. The trial of claim 1, wherein the proximal end of the shim is configured to receive an axial proximal-to-distal force through an actuation bar for the axial translation, 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. 12. The trial of claim 1, wherein the first top beam is operably connected to the second top beam with a top telescopic beam stabilizer, the first top beam is operably connected to the first bottom beam with a first side telescopic beam stabilizer, the second top beam is operably connected to the second bottom beam with a second side telescopic beam stabilizer, the first bottom beam is operably connected to the second bottom beam with a bottom telescopic beam stabilizer. 13. 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. 14. The system of claim 13 further comprising a retractable retention plunger configured for retaining the trial in the collapsed state and releasing the trial for expansion into the expanded state. 15. The system of claim 13, wherein the first top beam is operably connected to the second top beam with a top telescopic beam stabilizer; wherein, the first top beam is operably connected to the first bottom beam with a first side telescopic beam stabilizer, the second top beam is operably connected to the second bottom beam with a second side telescopic beam stabilizer, the first bottom beam is operably connected to the second bottom beam with a bottom telescopic beam stabilizer. 16. The system of claim 13, wherein the actuation bar receives the axial proximal-to-distal force from an actuation screw that is operably attached to the proximal end of the actuation bar and transfers the force to the shim through the distal end of the actuation bar. 17. The system of claim 13, wherein the head has a transverse cross-section in the collapsed state having a maximum dimension ranging from 5 mm to 18 mm for placing the frame in an intervertebral space through an annular opening for expansion in the intervertebral space; and,a transverse cross-section in the expanded state having a maximum dimension ranging from 6.5 to 28 mm in the intervertebral space;and,the shim has a transverse cross-section with a maximum dimension ranging from 5 mm to 18 mm for translating the shim in the lumen of the shell. 18. The system of claim 13, wherein the shim has a horizontal wedge configured to laterally-expand the trial, and a vertical wedge configured to vertically-expand the trial. 19. The system of claim 13, wherein the shim has a top wedge configured to laterally-expand the first top beam away from the second top beam, a bottom wedge configured to laterally-expand the first bottom beam away from the second bottom beam, a first side wedge configured to vertically-expand the first top beam away from the first bottom beam, and a second side wedge configured to vertically-expand the second top beam away from the second bottom beam;the proximal portion of the first top beam and the proximal portion of the second top beam are configured to complement the top wedge at the onset of the lateral expansion during the proximal-to-distal axial translation;the proximal portion of the first bottom beam and the proximal portion of the second bottom beam are configured to complement the bottom wedge at the onset of the lateral expansion during the proximal-to-distal axial translation; and,the distance, DSTAGING, between the onset of the lateral expansion and the onset of the vertical translation ranges from 2 mm to 10 mm. 20. The system of claim 19, wherein the proximal portion of the first top beam and the proximal portion of the first bottom beam are configured to complement the first side wedge during the proximal-to-distal axial translation for the vertical expansion; and,the proximal portion of the second top beam and the proximal portion of the second bottom beam are configured to complement the second side wedge during the proximal-to-distal axial translation for the vertical expansion. 21. The system of claim 13, wherein, the first top beam includes a proximal portion having an end, a distal portion having an end, and a central axis; the first top beam configured for contacting a first top chamfer of the shim in the expanded state, the central axis of the first top beam at least substantially on (i) a top plane containing the central axis of the first top beam and the central axis of a second top beam and (ii) a first side plane containing the central axis of the first top beam and the central axis of a first bottom beam;the second top beam includes a proximal portion having an end, a distal portion having an end, and a central axis; the second top beam configured for contacting a second top chamfer of the shim in the expanded state, the central axis of the second top beam at least substantially on (i) the top plane and (ii) a second side plane containing the central axis of the second top beam and the central axis of a second bottom beam;the first bottom beam includes a proximal portion having an end, a distal portion having an end, and a central axis; the first bottom beam configured for contacting a first bottom chamfer of the shim in the expanded state, the central axis of the first bottom beam at least substantially on (i) a bottom plane containing the central axis of the first bottom beam and the central axis of a second top beam and (ii) the first side plane; and,the second bottom beam includes a proximal portion having an end, a distal portion having an end, and a central axis; the second bottom beam configured for contacting a second bottom chamfer of the shim in the expanded state, the central axis of the second bottom beam being at least substantially on (i) the bottom plane and (ii) a second side plane containing the central axis of the second bottom beam and the second top beam. 22. The system of claim 13, wherein, the first top beam includes a proximal portion having an end, a distal portion having an end, and a central axis; the first top beam configured for contacting a first top-lateral surface of the shim and a first top-side surface of the shim in the expanded state, the central axis of the first top beam at least substantially on (i) a top plane containing the central axis of the first top beam and the central axis of a second top beam and (ii) a first side plane containing the central axis of the first top beam and the central axis of a first bottom beam;the second top beam includes a proximal portion having an end, a distal portion having an end, and a central axis; the second top beam configured for contacting the second top-lateral surface of the shim and the second top-side surface of the shim in the expanded state, the central axis of the second top beam at least substantially on (i) the top plane and (ii) a second side plane containing the central axis of the second top beam and the central axis of a second bottom beam;the first bottom beam includes a proximal portion having an end, a distal portion having an end, and a central axis; the first bottom beam configured for contacting the first bottom-lateral surface of the shim and the first bottom-side surface of the shim in the expanded state, the central axis of the first bottom beam at least substantially on (i) a bottom plane containing the central axis of the first bottom beam and the central axis of a second top beam and (ii) the first side plane; and,the second bottom beam includes a proximal portion having an end, a distal portion having an end, and a central axis; the second bottom beam configured for contacting the second bottom-lateral surface of the shim and the second bottom-side surface of the shim in the expanded state, the central axis of the second bottom beam being at least substantially on (i) the bottom plane and (ii) a second side plane containing the central axis of the second bottom beam and the second top beam. 23. The system of claim 13, wherein the shim comprises a lateral-expansion wedge with angle θL ranging from 10° to 30° and a vertical-expansion wedge with angle θV ranging from 30° to 50°, the apex of the lateral-expansion wedge and the apex of the vertical-expansion wedge each at least substantially on a single plane that is orthogonal to the central axis of the shim, and the ratio of θV:θL ranges from 1:1.25 to 1:4 to stage the bilateral expansion of the head. 24. The system of claim 13, wherein the shim comprises a lateral-expansion wedge with angle θL ranging from 10° to 90° and a vertical-expansion wedge with angle θV ranging from 10° to 90°, the apex of the lateral-expansion wedge on a first plane and the apex of the vertical expansion wedge on a second plane, both the first plane and the second plane being orthogonal to the central axis of the shim and separated on the central axis at a distance ranging from 2 mm to 10 mm to stage the bilateral expansion of the head. 25. The system of claim 13, wherein the shell is a single-unit formed from a single body of material, and the slider-guide, head, and flex rods are monolithically integral. 26. A method of distracting an intervertebral space using the trial of claim 1, the method comprising: creating a point of entry into an intervertebral disc, the intervertebral disc having a nucleus pulposus surrounded by an annulus fibrosis, and the point of entry having the maximum lateral dimension created through the annulus fibrosis;removing the nucleus pulposus from within the intervertebral disc through the point of entry, leaving the intervertebral space for expansion of the head of the trial of claim 1 within the annulus fibrosis, the intervertebral space having the top vertebral plate and the bottom vertebral plate;inserting the head in the collapsed state through the point of entry into the intervertebral space; and,distracting the intervertebral space using a staged, bilateral expansion that includes a first stage and a second stage, the first stage including expanding the head laterally toward the peripheral zones of the top vertebral plate and the bottom vertebral plate; and,the second stage including expanding the head vertically to distract the intervertebral space. 27. The method of claim 26 further comprising retaining the trial with a retractable retention plunger and retracting the plunger to expand the trial. 28. The method of claim 26, wherein the lateral dimension of the point of entry ranges from about 5 mm to about 18 mm. 29. The method of claim 26, wherein the distracting includes selecting an amount of lateral expansion independent of an amount of vertical expansion. 30. The method of claim 26, wherein the distracting includes measuring the amount of lateral expansion independent of the amount of vertical expansion.
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