WO 2021/041889
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`PCT/US2020/048516
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`What is claimed is:
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`CLAIMS
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`1.
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`A decorticating screw device, comprising:
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`a substantially cylindrical body, the body having a distal threaded
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`section, a proximal threaded section, a central ring having one or more decorticating
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`elements.
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`2.
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`The device of claim 1, wherein the screw device further comprises
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`a lumen running between a proximal opening and a distal opening.
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`3.
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`The device of claim 2, wherein the screw device further comprises
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`a cap having a threaded lumensizedto fit over the proximal threaded section of the body
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`and a proximal lip having a diameter greater than a diameterof the cap.
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`4.
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`The device of claim 3, wherein the central ring is independently
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`rotatable from the threaded distal section.
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`5.
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`The device of claim 4, wherein the screw device further comprises
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`one or more lateral openingsfluidly connected to the lumen.
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`6.
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`The device of claim 1, wherein the screw device comprises one or
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`more cutting flutes at a distal end.
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`7.
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`The device of claim 1, wherein the screw device comprises one or
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`more pointed tips at a distal end.
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`8.
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`The device of claim 1, wherein the proximal threaded section
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`comprises a threading selected from the group consisting of: knuckle threads, trapezoidal
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`threads, square threads, and buttress threads.
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`WO 2021/041889
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`PCT/US2020/048516
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`9.
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`The device of claim 1, wherein the proximal threaded section
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`comprises a rounded or tapered proximal end.
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`10.
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`The device of claim 1, wherein the central ring is attached to the
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`proximal section, such that the central ring and proximal section are independently
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`rotatable from the threaded distal section.
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`11.
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`The device of claim 1, wherein the central ring is movable in
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`proximal and distal directions to increase the reach of the one or more decorticating
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`elements.
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`12.
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`The device of claim 1, wherein the screw device comprises two or
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`more external slots formed betweenthe distal threaded section, the central ring, and the
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`one or more decorticating elements, such that each external slot is sized to receive a pin
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`of a screw driving device.
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`13.
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`The device of claim 1, wherein the one or more decorticating
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`elements each comprise one or more surface voids configured to accept graft material or
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`tissue ingrowth.
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`14.
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`The device of claim 1, wherein the cap comprises one or more
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`surface voids configured to accept graft material or tissue ingrowth.
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`15.
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`The device of claim 1, wherein the cap comprises a thread-locking
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`insert positioned at a proximal end of the threaded lumen.
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`16.
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`The device of claim 1, wherein the cap lip comprisesa distal-
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`facing surface having a rounded convex shape.
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`17.
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`The device of claim 1, wherein the cap comprises a locking nut in
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`alignment with the threaded lumen of the cap, the locking nut being connected to the cap
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`by one or more connecting bridges configured to break with an application of a torque on
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`the locking nut.
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`WO 2021/041889
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`PCT/US2020/048516
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`18.
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`The device of claim 1, wherein the one or more decorticating
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`elements are moveable between a closed position and an open position.
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`19.
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`The device of claim 18, wherein the closed position positions the
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`decorticating elements adjacent to the central ring such that they have a diameter
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`substantially equal to a diameter of the threaded distal section, and wherein the open
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`position positions the decorticating elements away from the central ring such that the
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`decorticating elements extend beyond the diameter of the threaded distal section.
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`20.
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`The device of claim 18, wherein the one or more decorticating
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`elements are hingedly connected to the central ring along an axis that is in parallel with a
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`long axis of the body and are laterally swung from the closed position to the open
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`position.
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`21.
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`The device of claim 18, wherein the one or more decorticating
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`elements are hingedly connected to the central ring along an axis that is perpendicular to
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`a long axis of the body and splay outwards from the closed position to the open position.
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`22.
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`The device of claim 18, wherein the one or more decorticating
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`elements are flexible wire blades retracted into the central ring in a closed position and
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`are pushable outwards from the central ring to the open position.
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`23.
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`The device of claim 18, wherein the one or more decorticating
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`elements are sheathed within the central ring in a closed position and are slideable
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`outwards from the closed position to the open position.
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`24.
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`The device of claim 18, wherein the one or more decorticating
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`elements are at least partially pliable and are bendable from a closed position to an open
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`position.
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`25.
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`The device of claim 18, wherein the one or more decorticating
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`elements comprises at least one serration.
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`-31-
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`WO 2021/041889
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`PCT/US2020/048516
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`26.
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`The device of claim 1, wherein the threaded proximal section has
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`diameter that is less than a diameter of the threaded distal section.
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`27.
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`The device of claim 1, wherein the diameter of the cap is
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`substantially equal to a diameter of the threaded distal section.
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`28.
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`The device of claim 1, further comprising a lock screw having a
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`diameter larger than a diameter of the screw device lumen, the lock screw being drivable
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`into the proximal opening of the screw device to expand a proximal endofthe screw
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`device.
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`29.
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`The device of claim 1, wherein the screw device has a length
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`between about 10 mm and about 150 mm.
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`30.
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`The device of claim 1, wherein the screw device has an outer
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`diameter between about 5 mm and about 50 mm.
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`31.
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`A method of fusing a joint betweena first bone and a second bone,
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`comprising the steps of:
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`providing a decorticating screw having a threaded distal section, a
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`threaded proximal section, a rotatable central ring having one or more decorticating
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`elements, a lumen running between a proximal opening and a distal opening, and one or
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`morelateral openings fluidly connected to the lumen;
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`inserting the screw into a joint in need offixation, such that the
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`distal section is positioned in a first bone, the proximal section is positioned in a second
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`bone, and the central ring is positioned in a joint space betweenthe first bone and the
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`second bone;
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`rotating the central ring, such that the one or more decorticating
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`elements decorticate the joint space betweenthe first bone and the second bone;
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`packing at least one graft material into the proximal opening of the
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`screw, such that the at least one graft material enters the lumen and exits the one or more
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`WO 2021/041889
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`PCT/US2020/048516
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`lateral openingsof the screw;
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`placing a cap onto the proximal section of the screw; and
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`screwing a lock screw into the proximal opening ofthe screw.
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`32.
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`The method of claim 31, wherein the graft material is selected
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`from the group consisting of: autologous bone grafts, allogeneic bone grafts, xenogeneic
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`bonegrafts, hydroxyapatite, calctum phosphate, calcium sulphate, bioactive glass,
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`polymers, cements, and combinations thereof,
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