초록 ▼

The present invention provides a system, device, instruments and methods for inserting and/or improving the holding strength and purchase of a bone screw, bone pin, or bone dowel in bone. Embodiments include monolithic allograft tissue forms, multi-piece allograft tissue forms, distally expandable p

The present invention provides a system, device, instruments and methods for inserting and/or improving the holding strength and purchase of a bone screw, bone pin, or bone dowel in bone. Embodiments include monolithic allograft tissue forms, multi-piece allograft tissue forms, distally expandable portions, partially and fully demineralized portions, and flexible connecting portions. Advantages of the allograft tissue forms of the present invention include improved pedicle screw blackout strength and improved filling of bone voids. Methods for making and instruments and techniques for inserting the augmentation device, system and screws or pins are also disclosed.

대표청구항 ▼

1. An implant configured to be positioned into bone tissue, the implant comprising: a member, at least a portion of the member comprising allograft, the member adapted for insertion into the bone tissue, the member having a distal end, a proximal end spaced from the distal end along a central axis,

1. An implant configured to be positioned into bone tissue, the implant comprising: a member, at least a portion of the member comprising allograft, the member adapted for insertion into the bone tissue, the member having a distal end, a proximal end spaced from the distal end along a central axis, an intermediate portion extending between the distal end and the proximal end, the implant defining a hollow cavity extending into the member at the proximal end, the hollow cavity extending along the central axis from the proximal end into the intermediate portion and toward the distal end, the member further defining an outer surface that extends from the proximal end to the distal end and is monolithic with each of the proximal end and the distal end, the member defining a plurality of recesses that each: 1) is disposed at least partially within the intermediate portion, 2) extends from the outer surface toward the hollow cavity, and 3) is spaced from adjacent ones of the plurality of recesses, the outer surface defining a cross-sectional dimension measured along a direction perpendicular to the central axis from the outer surface to the central axis;wherein at least a portion of the member is at least partially demineralized, and at least a portion of the outer surface is expandable along the direction away from the central axis, such that the cross-sectional dimension of the member at the intermediate portion measured from a first location into the hollow cavity to the central axis is greater than the cross-sectional dimension at each of the proximal end and the distal end, the first location being located on the outer surface in the intermediate portion between adjacent ones of the plurality of recesses. 2. The implant of claim 1, comprising a proximal portion proximate the proximal end, and a distal portion proximate the distal end, wherein both the proximal and distal portions are configured to expand, and the distal portion is configured to expand more than the proximal portion. 3. The implant of claim 2, wherein the member is substantially cylindrically shaped having a substantially uniform outer diameter wherein the outer diameter is between about 2 mm and about 9 mm, the member length between about 10 mm and about 60 mm, with the distal portion between about 5 mm and about 50 mm in length, the proximal portion having a wall thickness between about 0.3 mm and about 1 mm, and the distal portion having a wall thickness between about 1 mm and about 2 mm. 4. The implant of claim 1, wherein the plurality of recesses include at least one of a slot, slit, cut, groove or perforation. 5. The implant of claim 4, wherein the plurality of recesses include at least three slots, wherein at least one of the slots is between about 10 mm and about 20 mm in length, and between about 1 mm and about 2 mm in width, wherein the width is measured perpendicular to the length. 6. The implant of claim 3, wherein the member is substantially cylindrically shaped, the distal portion defines a wall thickness, the proximal portion defines a wall thickness, and the wall thickness of the distal portion is greater than the wall thickness of the proximal portion. 7. The implant of claim 1 wherein the distal end is closed and defines a solid distal wall that has a depth, measured from the distal end toward the proximal end, of less than about 7 mm. 8. The implant of claim 7, wherein the closed distal end has a guide wire hole. 9. The implant of claim 7, wherein the solid distal wall of the closed distal end has a depth of about 3 mm. 10. The implant of claim 1 wherein the member is at least partially formed of freeze-dried allograft bone tissue. 11. The implant of claim 2, wherein the proximal portion is substantially cylindrically shaped and further comprises at least one of a slot, a slit, a cut, a groove, or a perforation. 12. The implant of claim 2, further comprising at least one of a slot, slit, groove or perforation that is configured to form a parting line in the distal portion that is configured to tear and form expandable fingers upon insertion of at least one of a bone screw, a bone pin, or a bone dowel into the hollow cavity. 13. The implant of claim 1, further comprising a continuous ring wall formed at the proximal end, and a plurality of strips extending from the continuous ring wall. 14. The implant of claim 2, wherein the distal portion has a plurality of strips connected by a continuous ring wall at the distal end, the plurality of strips having a thinned section that acts as a hinge and a preferential fold line, whereby the continuous ring wall is moveable to form an expanded distal portion having folded strips. 15. The implant of claim 2, wherein the distal portion has a continuous wall forming a distal ring section, and the member further includes a mid-section having at least one of slots, slits, grooves or perforations to facilitate expansion of the mid-section, the mid-section having a larger wall thickness than both the proximal portion and distal ring section. 16. The implant of claim 1, wherein at least a portion of the implant is formed from at least one of a thermoplastic elastomer, rubber, titanium, stainless steel, titanium alloy, metal alloys, or ceramic. 17. The implant of claim 16, wherein the thermoplastic elastomer is at least one of PEEK, PCU, PCL, and EVA. 18. The implant of claim 2, wherein the direction is a first direction, the implant, further including a protrusion extending from the proximal end of the member in a second direction away from the distal portion, the protrusion configured to restrict rotation or translation of the member relative to a fastener as the fastener is inserted into the hollow cavity. 19. The implant of claim 1, wherein as the outer surface expands a distance between the proximal end and the distal end decreases. 20. The implant of claim 1, wherein an entirety of the member is made from allograft. 21. The implant of claim 1, wherein the hollow cavity extends through the distal end. 22. The implant of claim 1, wherein the member further defines a second location on the outer surface that is disposed in the intermediate portion, the outer surface defines an outer dimension measured along the direction perpendicular to the central axis, and at least a portion of the outer surface is expandable along the direction away from the central axis, such that the outer dimension of the member at the intermediate portion measured from the first location through the hollow cavity and the central axis to the second location is greater than the outer dimension at each of the proximal end and the distal end. 23. The implant of claim 1, wherein the at least a portion of the outer surface is expandable along the direction away from the central axis such that the cross-sectional dimension of the outer surface at the intermediate portion before expansion is less than the cross-sectional dimension of the outer surface at the intermediate portion after expansion. 24. A bone implant comprising: a member, at least a portion of the member comprising allograft, the member configured to be inserted into bone tissue, the member having a distal end, a proximal end spaced from the distal end along a central axis that extends from the proximal end to the distal end such that the member is elongate along the central axis, the proximal end including a proximal opening, and the member defining a hollow cavity that extends from the proximal opening toward the distal end along the central axis, the proximal end including an inner surface facing the central axis, an outer surface opposite the inner surface, and a thickness measured from the inner surface to the outer surface in a first direction that is perpendicular to the central axis, the hollow cavity sized to receive a fastener that imparts a force onto the member as it is received in the hollow cavity; anda protrusion that extends from the proximal end in a second direction that is substantially parallel to the central axis, such that the proximal end is disposed between the distal end and at least a portion of the protrusion with respect to the second direction, the protrusion includes a protrusion inner surface facing the central axis, a protrusion outer surface opposite the protrusion inner surface, and a thickness measured from the protrusion inner surface to the protrusion outer surface in the first direction, the protrusion configured to be held by an insertion instrument such that the protrusion receives a counterforce to the force imparted onto the member by the fastener as the hollow cavity receives the fastener;wherein the thickness of the protrusion is substantially equal to the thickness of the proximal end, and the bone implant is devoid of a second protrusion that extends from the proximal end at a position opposite the protrusion with respect to the first direction. 25. The implant of claim 18, wherein the protrusion includes a tab having an inner surface facing the central axis and an outer surface opposite the inner surface. 26. The bone implant of claim 24, wherein the protrusion includes a tab, and the fastener includes one of a bone screw or a bone pin. 27. The bone implant of claim 24, wherein the protrusion is flexible, such that the protrusion is movable in a direction away from the central axis. 28. The bone implant of claim 27, the protrusion is flexible such that the protrusion is movable in a direction away from the central axis such that at least a portion of the protrusion is positioned farther from the central axis than the outer surface of the proximal end. 29. The bone implant of claim 24, wherein the protrusion extends away from the proximal end of the member such that when the implant is positioned within the hollow cavity and the fastener is inserted into the hollow cavity, the protrusion remains at least partially outside the hollow cavity. 30. The bone implant of claim 24, wherein the protrusion is monolithic with the member. 31. The bone implant of claim 24, wherein at least a portion of the protrusion is made of at least one of allograft bone tissue, a thermoplastic elastomer, rubber, titanium, stainless steel, titanium alloy, metal alloys, or ceramic. 32. The bone implant of claim 24, wherein at least a portion of the member is at least partially demineralized. 33. The bone implant of claim 24, wherein the protrusion presents a grip surface that extends from the proximal end such that the proximal end is disposed between the distal end and at least a portion of the grip surface. 34. A bone implant comprising: a member, at least a portion of the member comprising allograft, the member configured to be inserted into bone tissue, the member having a distal portion and a proximal portion that is spaced from the distal portion along a central axis that extends from the proximal portion to the distal portion such that the member is elongate along the central axis, the bone implant defining a proximal opening that extends into the proximal portion and a hollow cavity that extends from the proximal opening toward the distal portion along the central axis;wherein the member is expandable, and at least a portion of the member is at least partially demineralized such that the proximal portion is demineralized to a greater extent than the distal portion. 35. The implant of claim 34, wherein at least a portion of the distal portion is nondemineralized. 36. The implant of claim 34, wherein at least a portion of the proximal portion is at least 80% demineralized. 37. The implant of claim 36, wherein an entirety of the proximal portion is at least 80% demineralized. 38. The implant of claim 34, wherein the member is expandable in a direction perpendicular to the central axis. 39. The implant of claim 34, wherein the hollow cavity is configured to receive a fastener, and the member is configured to expand in a radial direction perpendicular to the central axis as the hollow cavity receives the fastener. 40. The implant of claim 34, wherein the proximal portion is expandable in the radial direction to a greater extent without breaking than the distal portion. 41. The implant of claim 34, wherein the distal portion is closed such that the distal portion defines a solid distal wall that has a depth, measured from a distal end of the implant toward a proximal end of the implant. 42. The implant of claim 34, further including a protrusion extending from the proximal portion of the member in a direction away from the distal portion. 43. A bone implant comprising: a member, at least a portion of the member comprising allograft, the member configured to be inserted into bone tissue, the member having a distal portion including a distal end, a proximal portion including a proximal end, the distal portion spaced from the proximal portion along a central axis that extends from the proximal end to the distal end such that the member is elongate along the central axis, the proximal end including a proximal opening, the bone implant defining a hollow cavity that extends from the proximal opening along the central axis toward the distal end, the member having an inner surface that at least partially defines the hollow cavity and an outer surface opposite the inner surface,wherein 1) the member defines a wall thickness measured between the inner surface and the outer surface in a first direction that is perpendicular to the central axis, such that the wall thickness at the distal portion is greater than the wall thickness at the proximal portion, 2) the outer surface of the member extends from the proximal end to the distal end along at least one straight line that extends from the proximal end to the distal end in a second direction that is parallel to the central axis, and the outer surface is substantially smooth such that the outer surface is devoid of any indentations, ridges, or gaps that intersect with the at least one straight line, and 3) at least a portion of the member is at least partially demineralized. 44. The implant of claim 43, wherein the outer surface defines an outer dimension measured along the first direction, and the member is expandable such that the outer dimension of the member in the distal portion is greater than the outer dimension at the proximal portion. 45. The implant of claim 43, wherein the distal end is closed and defines a solid distal wall that has a depth, measured from the distal end toward the proximal end. 46. The implant of claim 43, further including a protrusion extending from the proximal end of the member in a direction away from the distal portion, the protrusion configured to restrict rotation or translation of the member relative to a fastener as the fastener is inserted into the hollow cavity. 47. The implant of claim 46, wherein the protrusion includes a tab having an inner surface facing the central axis and an outer surface opposite the inner surface. 48. An implant configured to be positioned into bone tissue, the implant comprising: a member, at least a portion of the member comprising allograft, the member adapted for insertion into the bone tissue, the member having a distal end, a proximal end spaced from the distal end along a central axis, an intermediate portion extending between the distal end and the proximal end, the implant defining a hollow cavity extending into the member at the proximal end, the hollow cavity extending along the central axis from the proximal end into the intermediate portion and toward the distal end, the member further defining an outer surface that extends from the proximal end to the distal end and is monolithic with each of the proximal end and the distal end, the outer surface defining an outer dimension measured along a direction perpendicular to the central axis, the member defining at least one recess that extends from the outer surface toward the hollow cavity, such that the at least one recess interrupts the outer surface;wherein at least a portion of the member is at least partially demineralized, and at least a portion of the outer surface is expandable away from the central axis along an entirety of a circumferential line that 1) lies on the outer surface, 2) is spaced from the recess along the central axis, and 3) lies in a plane normal to the central axis, such that the outer dimension of the member at the intermediate portion is greater than the outer dimension at each of the proximal end and the distal end. 49. The implant of claim 48, wherein the at least one recess includes a plurality of recesses that each: 1) are disposed at least partially within the intermediate portion, and 2) are spaced from adjacent ones of the plurality of recesses, the member further defining a first location on the outer surface that is disposed in the intermediate portion between adjacent ones of the plurality of recesses, and a second location on the outer surface that is disposed in the intermediate portion, and the outer dimension of the intermediate portion is measured from the first location through the hollow cavity and the central axis to the second location. 50. The implant of claim 49, wherein the member is expandable such that the outer dimension of the member at the intermediate portion measured from the first location through the hollow cavity and the central axis to the second location is greater than the outer dimension at each of the proximal end and the distal end. 51. The implant of claim 48, wherein the direction is a first direction, the implant, further comprising a protrusion that extends from the proximal end in a second direction that is substantially parallel to the central axis, such that the proximal end is disposed between the distal end and at least a portion of the protrusion with respect to the direction that is substantially parallel to the central axis. 52. The implant of claim 48, wherein the at least one recess that extends from the outer surface into the hollow cavity. 53. The implant of claim 48, wherein the outer surface defines a cross-sectional dimension measured along the direction from the outer surface to the central axis, and at least a portion of the outer surface is expandable along the direction away from the central axis, such that the cross-sectional dimension of the member measured from a first location into the hollow cavity to the central axis is greater than the cross-sectional dimension at each of the proximal end and the distal end, the first location being located on the outer surface in the intermediate portion even with the at least one recess along the central axis.