초록 ▼

A system for distributing bone graft material in an intervertebral disc space is provided having a central beam having a proximal portion having an end, a grafting portion having a top and a bottom, a distal portion having a end, a central beam axis, a graft distribution channel having an entry port

A system for distributing bone graft material in an intervertebral disc space is provided having a central beam having a proximal portion having an end, a grafting portion having a top and a bottom, a distal portion having a end, a central beam axis, a graft distribution channel having an entry port at the end of the proximal portion, a top exit port at the top of the grafting portion, and a bottom exit port at the bottom of the grafting portion. These systems can also include a laterovertically-expanding frame operable for a reversible collapse from an expanded state into a collapsed state. The expanded state, for example, can be configured to have an open graft distribution window that at least substantially closes upon the reversible collapse.

대표청구항 ▼

1. A graft distribution system, comprising; a central beam having a central beam axis;a graft distribution channel with an entry port in fluid communication with a top exit port and a bottom exit port;a proximal portion having and end with the entry port, a grafting portion having the top exit port

1. A graft distribution system, comprising; a central beam having a central beam axis;a graft distribution channel with an entry port in fluid communication with a top exit port and a bottom exit port;a proximal portion having and end with the entry port, a grafting portion having the top exit port and the bottom exit port, and a distal portion;a transverse cross-section having a maximum dimension ranging from 5 mm to 15 mm for placing the central beam into an intervertebral space through an annular opening having a maximum lateral dimension ranging from 5 mm to 15 mm, the intervertebral space having a top vertebral plate and a bottom vertebral plate;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;and,a laterovertically-expanding frame configured for operably contacting the central beam to create a graft distribution system in vivo, the frame having a collapsed state with a transverse cross section having a maximum dimension ranging from 5 mm to 15 mm for placing the frame in the intervertebral space through the annular opening for expansion, an expanded state with a transverse cross section having a maximum dimension ranging from 6.5 mm to 18 mm for retaining the frame in the intervertebral space, the expanded state operably contacting with the central beam in the intervertebral space;a proximal portion having an end, a grafting portion, a distal portion having an end, and a central frame axis of the expanded state;a first top beam including a proximal portion having an end, a grafting portion, and a distal portion having an end, the first top beam configured for contacting the first top-lateral surface of the central beam and the first top-side surface of the central beam in the expanded state, a 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 a central axis of a second top beam and (ii) a first side plane containing the central axis of the first top beam and a central axis of a first bottom beam;the second top beam including a proximal portion having an end, a grafting portion having an end, and a distal portion having an end, the second top beam configured for contacting the second top-lateral surface of the central beam and the second top-side surface of the central beam 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 a central axis of a second bottom beam;the first bottom beam including a proximal portion having an end, a grafting portion, and a distal portion having an end, the first bottom beam configured for contacting the first bottom-lateral surface of the central beam and the first bottom-side surface of the central beam 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 the second top beam and (ii) the first side plane;the second bottom beam including a proximal portion having an end, a grafting portion having an end, and a distal region having an end, the second bottom beam configured for contacting the second bottom-lateral surface of the central beam and the second bottom-side surface of the central beam 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 central axis of the second top beam;a plurality of proximal top connector elements configured to expandably connect the proximal portion of the first top beam to the proximal portion of the second top beam, the expanding consisting of a flexing at least substantially on the top plane;a plurality of distal top connector elements configured to expandably connect the distal portion of the first top beam to the distal portion of the second top beam, the expanding consisting of a flexing at least substantially on the top plane;a plurality of proximal bottom connector elements configured to expandably connect the proximal portion of the first bottom beam to the proximal portion of the second bottom beam, the expanding consisting of a flexing at least substantially on the bottom plane;a plurality of distal bottom connector elements configured to expandably connect the distal portion of the first bottom beam to the distal portion of the second bottom beam, the expanding consisting of a flexing at least substantially on the bottom plane;a plurality of proximal first side connector elements configured to expandably connect the proximal portion of the first top beam to the proximal portion of the first bottom beam, the expanding consisting of a flexing at least substantially on the first side plane;a plurality of distal first side connector elements configured to expandably connect the distal portion of the first top beam to the distal portion of the first bottom beam, the expanding consisting of a flexing at least substantially on the first side plane;a plurality of proximal second side connector elements configured to expandably connect the proximal portion of the second top beam to the proximal portion of the second bottom beam, the expanding consisting of a flexing at least substantially on the second side plane;a plurality of distal second side connector elements configured to expandably connect the distal portion of the second top beam to the distal portion of the second bottom beam, the expanding consisting of a flexing at least substantially on the second side plane;wherein,the framing is configured for slidably engaging with the central beam in vivo to expand the framing following placement of the central beam in the intervertebral space through the annular opening, the slidably engaging including translating the central beam into the frame from the proximal end of the frame toward the distal end of the frame in vivo; the translating including keeping the central beam axis at least substantially coincident with the central frame axis during the translating to create the graft distribution system in vivo through the annular opening;the connector elements are struts configured to have a cross-sectional aspect ratio of longitudinal thickness to transverse thickness ranging from 1:2 to 1:8, adapted to maintain structural stiffness in the laterovertically expanding frame in a direction perpendicular to the central frame axis of the expanded state of the frame;the graft distribution system frames a top graft-slab depth between the top surface of the central beam and the top vertebral endplate; and, a bottom graft-slab depth between the bottom surface of the central beam and the bottom vertebral endplate in vivo; and,the transverse cross-section of the graft distribution system in the expanded state in vivo is greater than the maximum lateral dimension of the annular opening to avoid backout. 2. The graft distribution system of claim 1, the distal end of the frame having a slidably translational connection with a guide plate that restricts the first top beam, the first bottom beam, the second top beam, and the second bottom beam to laterovertical movement relative to the guide plate when converting the frame from the collapsed state to the expanded state in vivo. 3. The graft distribution system of claim 1, the central beam comprising an I-beam. 4. The graft distribution system of claim 1, the central beam further comprising a side graft port. 5. The graft distribution system of claim 1, wherein each of the plurality of proximal connector elements are proximal struts configured in an at least substantially parallel alignment in the expanded state; and, each of the distal connector elements are distal struts configured in an at least substantially parallel alignment in the expanded state. 6. The graft distribution system of claim 1, wherein each of the plurality of proximal connector elements are proximal struts configured in an at least substantially parallel alignment in the collapsed state; and, each of the distal connector elements are distal struts configured in an at least substantially parallel alignment in the collapsed state. 7. The graft distribution system of claim 1, wherein each of the plurality of proximal connector elements are proximal struts configured in an at least substantially parallel alignment in the expanded state and the collapsed state; and, each of the distal connector elements are distal struts configured in an at least substantially parallel alignment in the expanded state and the collapsed state. 8. The graft distribution system of claim 1, wherein each plurality of proximal top connector elements and proximal bottom connector elements are proximal struts configured in an at least substantially parallel alignment in the expanded state and the collapsed state; and, each plurality of distal top connector elements and distal bottom connector elements are distal struts configured in an at least substantially parallel alignment in the expanded state and the collapsed state; wherein, the proximal top struts are configured monolithically integral to the first top beam and the second top beam and adapted to flex toward the distal top struts during collapse; and, the distal top struts are configured monolithically integral to the first top beam and the second top beam and adapted to flex toward the proximal top struts during collapse; and,the proximal bottom struts are configured monolithically integral to the first bottom beam and the second bottom beam and adapted to flex toward the distal bottom struts during collapse; and, the distal bottom struts are configured monolithically integral to the first bottom beam and the second bottom beam and adapted to flex toward the proximal bottom struts during collapse;wherein, the top and bottom of the laterovertically-expanding frame are each configured to open a graft distribution window upon expansion to facilitate graft distribution within the intervertebral space, the graft window upon expansion expanding from the first top beam to the second top beam, the first top beam to the first bottom beam, the second top beam to the second bottom beam, or the first bottom beam to the second bottom beam. 9. The graft distribution system of claim 1, the central beam further comprising a first side graft port and a second side graft port, each plurality of proximal connector elements configured as proximal struts in an at least substantially parallel alignment in the expanded state and the collapsed state; and, each plurality distal connector elements are distal struts configured in an at least substantially parallel alignment in the expanded state and the collapsed state; wherein, the proximal top struts are configured monolithically integral to the first top beam and the second top beam and adapted to flex toward the distal top struts during collapse; and, the distal top struts are configured monolithically integral to the first top beam and the second top beam and adapted to flex toward the proximal top struts during collapse; and,the proximal bottom struts are configured monolithically integral to the first bottom beam and the second bottom beam and adapted to flex toward the distal bottom struts during collapse; and, the distal bottom struts are configured monolithically integral to the first bottom beam and the second bottom beam and adapted to flex toward the proximal bottom struts during collapse;the proximal first side struts are configured monolithically integral to the first top beam and the first bottom beam and adapted to flex toward the distal first side struts during collapse; and, the distal first side struts are configured monolithically integral to the first top beam and the first bottom beam and adapted to flex toward the proximal first side struts during collapse; and,the proximal second side struts are configured monolithically integral to the second top beam and the second bottom beam and adapted to flex toward the distal second side struts during collapse; and, the distal second side struts are configured monolithically integral to the second top beam and the second bottom beam and adapted to flex toward the proximal second side struts during collapse;wherein, the top, bottom, first side, and second side of the laterovertically-expanding frame form a monolithically integral frame, each adapted to open a graft distribution window upon expansion to facilitate graft distribution within the intervertebral space. 10. A method of fusing an intervertebral space using the graft distribution system of claim 1, the method comprising: creating a single point of entry into an intervertebral disc, the intervertebral disc having a nucleus pulposus surrounded by an annulus fibrosis, and the single point of entry having the maximum lateral dimension created through the annulus fibrosis;removing the nucleus pulposus from within the intervertebral disc through the single point of entry, leaving the intervertebral space for expansion of the graft distribution system of claim 1 within the annulus fibrosis, the intervertebral space having the top vertebral plate and the bottom vertebral plate;inserting the laterovertically expanding frame in the collapsed state through the single point of entry into the intervertebral space;inserting the central beam into the frame to form the graft distribution system;and,adding a grafting material to the intervertebral space through the entry port. 11. The method of claim 10, further comprising opening a bone graft window, wherein the connector elements include v-shaped struts that (i) stack either proximally or distally in a closed-complementary configuration in the collapsed state to minimize void space for a low profile entry of the system both vertically and laterally into the intervertebral space, and (ii) deflect upon expansion to open the bone graft window. 12. The method of claim 10, wherein the expanding includes selecting an amount of lateral expansion independent of an amount of vertical expansion. 13. The method of claim 10, wherein the lateral dimension of the single point of entry ranges from about 5 mm to about 15 mm. 14. The method of claim 10, wherein the expanding includes expanding the laterovertically expanding frame laterally to a width that exceeds the width of the single point of entry; and,inserting the central beam to expand the laterovertically expanding frame vertically to create the graft distribution system. 15. The method of claim 10, wherein the inserting of the central beam into the laterovertically expanding frame includes engaging a ratchet mechanism comprising a protuberance on the central beam that engages with the laterovertically-expanding frame to prevent the central beam from backing out of the laterovertically-expanding frame after the expanding. 16. A kit, comprising: the graft distribution system of claim 1;a cannula for inserting the graft distribution system into the intervertebral space;a guidewire adapted for guiding the central beam into the laterovertically expanding frame; and,an expansion handle for inserting the central beam into the laterovertically expanding frame to form the graft distribution system. 17. The kit of claim 16, the distal end of the frame having a slidably translational connection with a guide plate that restricts the first top beam, the first bottom beam, the second top beam, and the second bottom beam to laterovertical movement relative to the guide plate when converting the frame from the collapsed state to the expanded state in vivo. 18. The kit of claim 16, wherein each plurality of proximal top connector elements and proximal bottom connector elements are proximal struts configured in an at least substantially parallel alignment in the expanded state and the collapsed state; and, each plurality of distal top connector elements and distal bottom connector elements are distal struts configured in an at least substantially parallel alignment in the expanded state and the collapsed state; wherein, the proximal top struts are configured monolithically integral to the first top beam and the second top beam and adapted to flex toward the distal top struts during collapse; and, the distal top struts are configured monolithically integral to the first top beam and the second top beam and adapted to flex toward the proximal top struts during collapse; and,the proximal bottom struts are configured monolithically integral to the first bottom beam and the second bottom beam and adapted to flex toward the distal bottom struts during collapse; and, the distal bottom struts are configured monolithically integral to the first bottom beam and the second bottom beam and adapted to flex toward the proximal bottom struts during collapse;wherein, the top and bottom of the laterovertically-expanding frame are each configured to open a graft distribution window upon expansion to facilitate graft distribution within the intervertebral space. 19. The kit of claim 16, the central beam further comprising a first side graft port and a second side graft port, each plurality of proximal connector elements configured as proximal struts in an at least substantially parallel alignment in the expanded state and the collapsed state; and, each plurality distal connector elements are distal struts configured in an at least substantially parallel alignment in the expanded state and the collapsed state; wherein, the proximal top struts are configured monolithically integral to the first top beam and the second top beam and adapted to flex toward the distal top struts during collapse; and, the distal top struts are configured monolithically integral to the first top beam and the second top beam and adapted to flex toward the proximal top struts during collapse; and,the proximal bottom struts are configured monolithically integral to the first bottom beam and the second bottom beam and adapted to flex toward the distal bottom struts during collapse; and, the distal bottom struts are configured monolithically integral to the first bottom beam and the second bottom beam and adapted to flex toward the proximal bottom struts during collapse;the proximal first side struts are configured monolithically integral to the first top beam and the first bottom beam and adapted to flex toward the distal first side struts during collapse; and, the distal first side struts are configured monolithically integral to the first top beam and the first bottom beam and adapted to flex toward the proximal first side struts during collapse; and,the proximal second side struts are configured monolithically integral to the second top beam and the second bottom beam and adapted to flex toward the distal second side struts during collapse; and, the distal second side struts are configured monolithically integral to the second top beam and the second bottom beam and adapted to flex toward the proximal second side struts during collapse;wherein, the top, bottom, first side, and second side of the laterovertically-expanding frame form a monolithically integral frame, each adapted to open a graft distribution window upon expansion to facilitate graft distribution within the intervertebral space. 20. A graft distribution system, comprising: a central beam having a proximal portion having an end, a grafting portion having a top and a bottom, a distal portion having a end, a central beam axis, a graft distribution channel having an entry port at the end of the proximal portion, a top exit port at the top of the grafting portion, and a bottom exit port at the bottom of the grafting portion;a laterovertically-expanding frame having a lumen, a first top beam, a second top beam, a first bottom beam, and a second bottom beam, each having a proximal portion and a distal portion, and each operably connected to each other at their respective proximal portions and distal portions with connector elements to form the laterovertically-expanding frame that is operable for a reversible collapse from an expanded state into a collapsed state, the expanded state having an open graft distribution window that at least substantially closes upon the reversible collapse, the open graft window in the expanded state expanding from the first top beam to the second top beam, the first top beam to the first bottom beam, the second top beam to the second bottom beam, or the first bottom beam to the second bottom beam;wherein the laterovertically-expanding frame is adapted for receiving an insertion of the central beam to expand the frame and form the graft distribution system; and,the connector elements are configured to have a cross-sectional aspect ratio of longitudinal thickness to transverse thickness ranging from 1:2 to 1:8 to maintain structural stiffness in the laterovertically expanding frame in a direction perpendicular to the central frame axis of the expanded state of the frame. 21. The graft distribution system of claim 20, wherein the operable connection between the beams comprises proximal top struts, distal top struts, proximal bottom struts, and distal bottom struts, the proximal struts configured in an at least substantially parallel alignment in the expanded state and the collapsed state; and, the distal struts configured in an at least substantially parallel alignment in the expanded state and the collapsed state; wherein, the proximal top struts are configured monolithically integral to the first top beam and the second top beam and adapted to flex toward the distal top struts during collapse; and, the distal top struts are configured monolithically integral to the first top beam and the second top beam and adapted to flex toward the proximal top struts during collapse; and,the proximal bottom struts are configured monolithically integral to the first bottom beam and the second bottom beam and adapted to flex toward the distal bottom struts during collapse; and, the distal bottom struts are configured monolithically integral to the first bottom beam and the second bottom beam and adapted to flex toward the proximal bottom struts during collapse;wherein, the top and bottom of the laterovertically-expanding frame are each configured to open the graft distribution window upon expansion of the frame to facilitate graft distribution within the intervertebral space with the graft distribution system. 22. The graft distribution system of claim 20, wherein the operable connection between the beams comprises proximal top struts, distal top struts, proximal bottom struts, and distal bottom struts, proximal first side struts, distal first side struts, proximal second side struts, and distal second side struts, the proximal struts configured in an at least substantially parallel alignment in the expanded state and the collapsed state; and, the distal struts configured in an at least substantially parallel alignment in the expanded state and the collapsed state; wherein, the proximal top struts are configured monolithically integral to the first top beam and the second top beam and adapted to flex toward the distal top struts during collapse; and, the distal top struts are configured monolithically integral to the first top beam and the second top beam and adapted to flex toward the proximal top struts during collapse; and,the proximal bottom struts are configured monolithically integral to the first bottom beam and the second bottom beam and adapted to flex toward the distal bottom struts during collapse; and, the distal bottom struts are configured monolithically integral to the first bottom beam and the second bottom beam and adapted to flex toward the proximal bottom struts during collapse;the proximal first side struts are configured monolithically integral to the first top beam and the first bottom beam and adapted to flex toward the distal first side struts during collapse; and, the distal first side struts are configured monolithically integral to the first top beam and the first bottom beam and adapted to flex toward the proximal first side struts during collapse; and,the proximal second side struts are configured monolithically integral to the second top beam and the second bottom beam and adapted to flex toward the distal second side struts during collapse; and, the distal second side struts are configured monolithically integral to the second top beam and the second bottom beam and adapted to flex toward the proximal second side struts during collapse;wherein, the beams and struts are monolithically integral in the frame, each adapted to open the graft distribution window upon expansion of the frame to facilitate graft distribution within the intervertebral space with the graft distribution system. 23. The graft distribution system of claim 20, the distal end of the frame having a slidably translational connection with a guide plate that restricts the first top beam, the first bottom beam, the second top beam, and the second bottom beam to laterovertical movement relative to the guide plate when converting the frame from the collapsed state to the expanded state in vivo. 24. The graft distribution system of claim 23, wherein the laterovertically-expandable frame has a lumen, and the guide plate has a luminal side with connector for reversibly receiving a guide wire for inserting the laterovertically-expandable frame into the intervertebral space. 25. The graft distribution system of claim 20, the central beam comprising an I-beam. 26. The graft distribution system of claim 20, the central beam further comprising a side graft port. 27. A kit, comprising: the graft distribution system of claim 20;a cannula for inserting the graft distribution system into the intervertebral space;a guidewire adapted for guiding the central beam into the laterovertically expanding frame; and,an expansion handle for inserting the central beam into the laterovertically expanding frame to form the graft distribution system. 28. The kit of claim 27, the distal end of the frame having a slidably translational connection with a guide plate that restricts the first top beam, the first bottom beam, the second top beam, and the second bottom beam to laterovertical movement relative to the guide plate when converting the frame from the collapsed state to the expanded state in vivo. 29. A laterovertically-expanding frame, the frame configured for operably contacting a central beam to expand the frame and create a graft distribution system in vivo and having a collapsed state with a transverse cross section having a maximum dimension ranging from 5 mm to 15 mm for placing the frame in the intervertebral space through an annular opening for expansion, an expanded state with a transverse cross section having a maximum dimension ranging from 6.5 mm to 18 mm for retaining the frame in the intervertebral space, the expanded state operably contacting with the central beam in the intervertebral space;a proximal portion having an end, a grafting portion, a distal portion having an end, and a central frame axis of the expanded state;a first top beam including a proximal portion having an end, a grafting portion, and a distal portion having an end, the first top beam configured for contacting a first top-lateral surface of the central beam and a first top-side surface of the central beam in the expanded state, a 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 a central axis of a second top beam and (ii) a first side plane containing the central axis of the first top beam and a central axis of a first bottom beam;the second top beam including a proximal portion having an end, a grafting portion having an end, and a distal portion having an end, the second top beam configured for contacting a second top-lateral surface of the central beam and a second top-side surface of the central beam 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 a central axis of a second bottom beam;the first bottom beam including a proximal portion having an end, a grafting portion, and a distal portion having an end, the first bottom beam configured for contacting a first bottom-lateral surface of the central beam and a first bottom-side surface of the central beam 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 the second top beam and (ii) the first side plane;the second bottom beam including a proximal portion having an end, a grafting portion having an end, and a distal region having an end, the second bottom beam configured for contacting a second bottom-lateral surface of the central beam and a second bottom-side surface of the central beam 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 central axis of the second top beam;a plurality of proximal top connector elements configured to expandably connect the proximal portion of the first top beam to the proximal portion of the second top beam, the expanding consisting of a flexing at least substantially on the top plane;a plurality of distal top connector elements configured to expandably connect the distal portion of the first top beam to the distal portion of the second top beam, the expanding consisting of a flexing at least substantially on the top plane;a plurality of proximal bottom connector elements configured to expandably connect the proximal portion of the first bottom beam to the proximal portion of the second bottom beam, the expanding consisting of a flexing at least substantially on the bottom plane;a plurality of distal bottom connector elements configured to expandably connect the distal portion of the first bottom beam to the distal portion of the second bottom beam, the expanding consisting of a flexing at least substantially on the bottom plane;a plurality of proximal first side connector elements configured to expandably connect the proximal portion of the first top beam to the proximal portion of the first bottom beam, the expanding consisting of a flexing at least substantially on the first side plane;a plurality of distal first side connector elements configured to expandably connect the distal portion of the first top beam to the distal portion of the first bottom beam, the expanding consisting of a flexing at least substantially on the first side plane;a plurality of proximal second side connector elements configured to expandably connect the proximal portion of the second top beam to the proximal portion of the second bottom beam, the expanding consisting of a flexing at least substantially on the second side plane;a plurality of distal second side connector elements configured to expandably connect the distal portion of the second top beam to the distal portion of the second bottom beam, the expanding consisting of a flexing at least substantially on the second side plane;wherein,the laterovertically-expandable frame is configured for collapsing into a collapsed state having the transverse cross-section in vivo with the maximum dimension that is greater than the maximum lateral dimension of the annular opening to avoid backout; and,the connector elements are struts extending between their respective beams and have a cross-sectional aspect ratio of longitudinal thickness to transverse thickness ranging from 1:2 to 1:8, adapted to maintain structural stiffness in the laterovertically expanding frame in a direction perpendicular to the central frame axis of the expanded state of the frame. 30. The laterovertically-expandable frame of claim 29, wherein the plurality of proximal to connector elements and the plurality of distal to connector elements are configured to create a to graft distribution window, the to graft distribution window expanding from the first to beam to the second to beam;the plurality of proximal first side connector elements and the plurality of distal first side connector elements are configured to create a first side graft distribution window, the first side graft distribution window expanding from the first to beam to the first bottom beam;the plurality of proximal second side connector elements and the plurality of distal second side connector elements are configured to create a second side graft distribution window, the second side graft distribution window expanding from the second to beam to the second bottom beam; and,the plurality of proximal bottom connector elements and the plurality of distal bottom connector elements are configured to create a bottom graft distribution window, the bottom graft distribution window expanding from the first bottom beam to the second bottom beam.