# US 7,611,536 B2 · Hemi-interbody spinal fusion implants manufactured from a major long bone ring > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 7,611,536 B2 - Document ID: US7611536B2 - Status: Granted - Kind: B2 - Application number: 11/338,395 - Filed: 2006-01-24 - Published: 2006-06-08 - Granted: 2009-11-03 - Earliest claimed: 2001-04-02 - Assignees: Warsaw Orthopedic, Inc. - Inventors: Gary K. Michelson - Web page: https://patentgrep.com/patent/US7611536B2 ## CPC - A61F 2/4455: {for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages (intervertebral discs A61F2/442)} - A61F 2/28: Bones - A61F 2/30767: {Special external or bone-contacting surface, e.g. coating for improving bone ingrowth} - A61F 2/3094: {Designing or manufacturing processes} - A61F 2/30965: {Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping} - A61F 2/4611: {of spinal prostheses} - A61F 2002/2817: {Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]} - A61F 2002/2835: {Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material} - A61F 2002/30062: {(bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive} - A61F 2002/30192: {J-shaped} - A61F 2002/30677: {Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body} - A61F 2002/30774: {internally-threaded} - A61F 2002/30836: {knurled} - A61F 2002/30904: {serrated profile, i.e. saw-toothed} - A61F 2002/448: {comprising multiple adjacent spinal implants within the same intervertebral space or within the same vertebra, e.g. comprising two adjacent spinal implants} - A61F 2210/0004: bioabsorbable - A61F 2230/0041: J-shaped - A61F 2310/00293: containing a phosphorus-containing compound, e.g. apatite - A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C) ## Abstract An interbody spinal implant comprising cortical bone having a width less than one-half the width of the disc space into which it is adapted to be inserted. The implant has a leading end that is asymmetrical from side to side and/or includes a straight portion adapted to be used in side-by-side pairs. ## Claims ### Claim 1 An interbody spinal implant made of cortical bone for insertion at least in part across the height of a disc space between adjacent vertebral bodies of a human spine, the vertebral bodies having an anterior aspect and a posterior aspect, said implant comprising: a leading end for insertion first into the disc space, a trailing end opposite said leading end, said implant having a length along a mid-longitudinal axis of said implant from said leading end to said trailing end; opposed upper and lower portions between said leading and trailing ends adapted to be placed at least in part within and across the height of the disc space to contact and support the adjacent vertebral bodies, said opposed upper and lower portions having a maximum height therebetween, said upper and lower portions being non-arcuate along at least a portion of the length of said implant; an interior side, an exterior side opposite said interior side, and a maximum width therebetween greater than said maximum height, said maximum width of said implant being less than one-half of the width of the adjacent vertebral bodies into which said implant is adapted to be inserted, said interior and exterior sides connecting said upper and lower portions and said leading and trailing ends, said interior side and said exterior side each being at least in part straight along at least a portion of the length of said implant, said leading end being asymmetrical from side to side, said leading end and said trailing end each being at least in part curved from side to side, said interior side adapted to be oriented toward an interior side of another implant when inserted within the disc space; said implant being manufactured from a bone ring obtained from a major long bone of a human having a medullary canal, said implant including at least 40 percent of the bone ring from which it is being formed, said interior side of said implant including at least a portion of the medullary canal so that when said implant is placed side by side another implant having an interior side including at least a portion of a medullary canal a passage is formed adapted to hold bone growth promoting material for permitting for the growth of bone from vertebral body to vertebral body through said passage. ### Claim 2 (depends on 1) The implant of claim 1, wherein said leading end includes a generally straight portion from side to side. ### Claim 3 (depends on 2) The implant of claim 2, wherein said straight portion of said leading end is generally oriented at 90 degrees to the mid-longitudinal axis of said implant. ### Claim 4 (depends on 1) The implant of claim 1, wherein at least a portion of said leading end has a reduced height to facilitate insertion of said implant between the two adjacent vertebral bodies. ### Claim 5 (depends on 1) The implant of claim 1, wherein said trailing end is at least in part straight from side to side. ### Claim 6 (depends on 1) The implant of claim 1, wherein said trailing end is configured in the shape of a half circle from side to side. ### Claim 7 (depends on 1) The implant of claim 1, wherein said trailing end is asymmetrical side to side. ### Claim 8 (depends on 1) The implant of claim 1, wherein the trailing end is adapted to conform from side to side to at least a portion of the peripheral contour of at least one of the anterior and posterior aspects of the vertebral bodies adjacent a disc space into which said implant is inserted. ### Claim 9 (depends on 1) The implant of claim 1, wherein at least one of said interior and exterior sides is at least in part oriented generally parallel to the mid-longitudinal axis of said implant. ### Claim 10 (depends on 1) The implant of claim 1, wherein said interior and exterior sides are at least in part generally parallel one another. ### Claim 11 (depends on 1) The implant of claim 1, wherein at least a portion of said upper and lower surfaces are in an angular relationship to each other from trailing end to leading end for allowing angulation of the adjacent vertebral bodies relative to each other. ### Claim 12 (depends on 1) The implant of claim 1, wherein said upper and lower surfaces include at feast one opening in communication with one another to permit for the growth of bone from vertebral body to vertebral body through said implant. ### Claim 13 (depends on 1) The implant of claim 1, wherein said implant has a maximum length less than and approximating the posterior to anterior depth of the vertebral bodies. ### Claim 14 (depends on 1) The implant of claim 1, further comprising a bone engaging surface formed on the exterior of at least said upper and lower portions for engaging the adjacent vertebral bodies, said bone engaging surface including at least one of a protrusion, a ratchet, a spike, a spline, surface roughenings, and knurling. ### Claim 15 (depends on 1) The implant of claim 1, wherein said implant comprises at least in part of a bone growth promoting material. ### Claim 16 (depends on 15) The implant of claim 15, wherein said bone growth promoting material is selected from one of bone, bone derived products, demineralized bone matrix, mineralizing proteins, ossifying proteins, bone morphogenetic protein, hydroxyapatite, and genes coding for the production of bone. ### Claim 17 (depends on 1) The implant of claim 1, in combination with a bone growth promoting material. ### Claim 18 (depends on 17) The implant of claim 17, wherein said bone growth promoting material is selected from one of bone, bone derived products, demineralized bone matrix, mineralizing proteins, ossifying proteins, bone morphogenetic protein, hydroxyapatite, and genes coding for the production of bone. ### Claim 19 (depends on 1) The implant of claim 1, wherein said implant is treated with a bone growth promoting substance. ### Claim 20 (depends on 1) The implant of claim 1, wherein said implant is at least in part resorbable. ### Claim 21 (depends on 1) The implant of claim 1, in combination with a chemical substance adapted to inhibit scar formation. ### Claim 22 (depends on 1) The implant of claim 1, in combination with an antimicrobial material. ### Claim 23 (depends on 1) The implant of claim 1, wherein at least a portion of said implant is treated to promote bone ingrowth between said implant and said adjacent vertebral bodies. ### Claim 24 (depends on 1) The implant of claim 1, further in combination with at least one spinal fixation implant. ### Claim 25 A pair of interbody spinal implants made of a bone composite material for insertion at least in part across the height of a disc space between adjacent vertebral bodies of a human spine, the vertebral bodies having an anterior aspect, a posterior aspect, and a depth therebetween, each of said implants comprising: a leading end for insertion first into the disc space, a trailing end opposite said leading end, said implant having a length along a mid-longitudinal axis of said implant from said leading end to said trailing end, said length of said implant being greater than one half the depth of the vertebral bodies adjacent the disc space into which said implant is adapted to be inserted; opposed upper and lower portions between said leading and trailing ends adapted to be placed at least in part within and across the height of the disc space to contact and support the adjacent vertebral bodies, said opposed upper and lower portions having a maximum height therebetween, said upper and lower portions being non-arcuate along at least a portion of the length of said implant; an interior side, an exterior side opposite said interior side, and a maximum width therebetween greater than said maximum height, said maximum width of said implant being less than approximately one-half of the width of the adjacent vertebral bodies into which said implant is adapted to be inserted, said interior and exterior sides connecting said upper and lower portions and said leading and trailing ends, said interior side and said exterior side each being at least in part straight along at least a portion of the length of said implant, said leading end being asymmetrical from side to side, said leading end and said trailing end each being at least in part curved from side to side, said interior side adapted to be oriented toward an interior side of another implant when inserted within the disc space; and said implant being manufactured from a bone composite material, said interior side of said implant including a recess, said interior side of said implant including a recess so that when said implant is placed side by side another implant having an interior side including a recess a passage is formed adapted to hold bone growth promoting material for permitting for the growth of bone from vertebral body to vertebral body through said passage; and the combined width of said pair of said implants being greater than one halt the width of the adjacent vertebral bodies into which said implants are adapted to be inserted. ### Claim 26 (depends on 25) The implant of claim 25, wherein said bone composite material includes at least one of cortical bone fibers, bone filaments, bone particles and bone dust. ### Claim 27 (depends on 25) The implant of claim 25, further comprising a binding material. ### Claim 28 (depends on 27) The implant of claim 27, wherein said binding material is at least one of bioactive and bioresorbable. ### Claim 29 (depends on 25) The implant of claim 25, wherein said leading end includes a generally straight portion from side to side. ### Claim 30 (depends on 29) The implant of claim 29, wherein said straight portion of said leading end is generally oriented at 90 degrees to the mid-longitudinal axis of said implant. ### Claim 31 (depends on 25) The implant of claim 25, wherein at least a portion of said leading end has a reduced height to facilitate insertion of said implant between the two adjacent vertebral bodies. ### Claim 32 (depends on 25) The implant of claim 25, wherein said trailing end is at least in part straight from side to side. ### Claim 33 (depends on 25) The implant of claim 25, wherein said trailing end is configured in the shape of a half circle from side to side. ### Claim 34 (depends on 25) The implant of claim 25, wherein said trailing end is asymmetrical side to side. ### Claim 35 (depends on 25) The implant of claim 25, wherein the trailing end is adapted to conform from side to side to at least a portion of the peripheral contour of at least one of the anterior and posterior aspects of the vertebral bodies adjacent a disc space into which said implant is inserted. ### Claim 36 (depends on 25) The implant of claim 25, wherein at least one of said interior and exterior sides is at least in part oriented generally parallel to the mid-longitudinal axis of said implant. ### Claim 37 (depends on 25) The implant of claim 25, wherein said interior and exterior sides are at least in part generally parallel one another. ### Claim 38 (depends on 25) The implant of claim 25, wherein at least a portion of said upper and lower surfaces are in an angular relationship to each other from trailing end to leading end for allowing angulation of the adjacent vertebral bodies relative to each other. ### Claim 39 (depends on 25) The implant of claim 25, wherein said upper and lower surfaces include at least one opening in communication with one another to permit for the growth of bone from vertebral body to vertebral body through said implant. ### Claim 40 (depends on 25) The implant of claim 25, wherein said implant has a maximum length less than and approximating the posterior to anterior depth of the vertebral bodies. ### Claim 41 (depends on 25) The implant of claim 25, further comprising a bone engaging surface formed on the exterior of at feast said upper and lower portions for engaging the adjacent vertebral bodies, said bone engaging surface including at least one of a protrusion, a ratchet, a spike, a spline, surface roughenings, and knurling. ### Claim 42 (depends on 25) The implant of claim 25, wherein said implant comprises at least in part of a bone growth promoting material. ### Claim 43 (depends on 42) The implant of claim 42, wherein said bone growth promoting material is selected from one of bone, bone derived products, demineralized bone matrix, mineralizing proteins, ossifying proteins, bone morphogenetic protein, hydroxyapatite, and genes coding for the production of bone. ### Claim 44 (depends on 25) The implant of claim 25, in combination with a bone growth promoting material. ### Claim 45 (depends on 44) The implant of claim 44, wherein said bone growth promoting material is selected from one of bone, bone derived products, demineralized bone matrix, mineralizing proteins, ossifying proteins, bone morphogenetic protein, hydroxyapatite, and genes coding for the production of bone. ### Claim 46 (depends on 25) The implant of claim 25, wherein said implant is treated with a bone growth promoting substance. ### Claim 47 (depends on 25) The implant of claim 25, wherein said implant is at least in part resorbable. ### Claim 48 (depends on 25) The implant of claim 25, in combination with a chemical substance adapted to inhibit scar formation. ### Claim 49 (depends on 25) The implant of claim 25, in combination with an antimicrobial material. ### Claim 50 (depends on 25) The implant of claim 25, wherein at least a portion of said implant is treated to promote bone ingrowth between said implant and said adjacent vertebral bodies. ### Claim 51 (depends on 25) The implant of claim 25, further in combination with at least one spinal fixation implant. ### Claim 52 A pair of interbody spinal implants made of cortical bane for insertion at least in part into the same implantation space formed across the height of a disc space between adjacent vertebral bodies of a human spine, the vertebral bodies having an anterior aspect and a posterior aspect and a depth therebetween, each of said implants comprising: a leading end for insertion first into the disc space, a trailing end opposite said leading end, and a length from said leading end to said trailing end; opposed upper and lower portions between said leading and trailing ends adapted to be placed at least in part within and across the height of the disc space to contact and support the adjacent vertebral bodies, said upper and lower portions defining a height of each of said implants, said upper and lower portions being non-arcuate along at least a portion of the length of each of said implants; and opposite sides between said upper portion and said lower portion, and between said leading and trailing ends, said opposite sides defining a width of each of said implants, said leading end being configured in the shape of a portion of a circle from one of said opposite sides to another one of said opposite sides, the circle having a radius greater than the width of each of said implants; each of said implants being manufactured from a bone ring obtained from a major long bone of a human being having a medullary canal, one of said opposite sides of each of said implants including at least a portion of the medullary canal so that when said pair of implants are placed side-by-side in the same disc space a passage is formed adapted to hold bone growth promoting material for permitting for the growth of bone from vertebral body to vertebral body through each of said implants; said leading ends of said implants forming part of the same circle when inserted into the same implantation space. ### Claim 53 (depends on 52) The pair of implants of claim 52, wherein each of said implants has a maximum width between said opposite sides that is less than one-half of the width of the adjacent vertebral bodies into which each of said implants is adapted to be inserted. ### Claim 54 (depends on 52) The pair of implants of claim 52, wherein at least a portion of said leading end of each of said implants has a reduced height to facilitate insertion of each of said implants between the two adjacent vertebral bodies. ### Claim 55 (depends on 52) The pair of implants of claim 52, wherein said trailing end of at least one of said implants has a radius of curvature of a second circle from side to side. ### Claim 56 (depends on 55) The pair of implants of claim 55, wherein the radius of curvature said trailing end is greater than the radius of curvature of the leading end of said at least one of said implants. ### Claim 57 (depends on 52) The pair of implants of claim 52, wherein each of said implants has a mid-longitudinal axis along the length, at least one of said opposite sides of at least one of said implants being at least in part oriented generally parallel to the mid-longitudinal axis of said at least one of said implants. ### Claim 58 (depends on 52) The pair of implants of claim 52, wherein said opposite sides of at least one of said implants are at least in part generally parallel one another. ### Claim 59 (depends on 52) The pair of implants of claim 52, wherein at least a portion of said upper and lower portions of at least one of said implants are in an angular relationship to each other from trailing end to leading end for allowing angulation of the adjacent vertebral bodies relative to each other. ### Claim 60 (depends on 52) The pair of implants of claim 52, wherein at least one of said implants has a maximum length less than and approximating the posterior to anterior depth of the vertebral bodies. ### Claim 61 (depends on 52) The pair of implants of claim 52, wherein at least one of said implants further comprises a bone engaging surface formed on the exterior of at least said upper and lower portions for engaging the adjacent vertebral bodies, said bone engaging surface including at least one of a protrusion, a ratchet, surface roughenings, and knurling. ### Claim 62 (depends on 52) The pair of implants of claim 52, in combination with a bone growth promoting material. ### Claim 63 (depends on 62) The pair of implants of claim 62, wherein said bane growth promoting material is selected from one of bone, bone derived products, demineralized bone matrix, mineralizing proteins, ossifying proteins, bone morphogenetic protein, hydroxyapatite, and genes coding for the production of bone. ### Claim 64 (depends on 52) The pair of implants of claim 52, wherein at least one of said implants is treated with a bone growth promoting substance. ### Claim 65 (depends on 52) The pair of implants of claim 52, wherein at least one of said implants is at least in part resorbable. ### Claim 66 (depends on 52) The pair of implants of claim 52, in combination with a chemical substance adapted to inhibit scar formation. ### Claim 67 (depends on 52) The pair of implants of claim 52, in combination with an antimicrobial material. ### Claim 68 (depends on 52) The pair of implants of claim 52, wherein at least a portion of at least one of said implants is treated to promote bone ingrowth between said at least one of said implants and said adjacent vertebral bodies. ### Claim 69 (depends on 52) The pair of implants of claim 52, wherein said first and second implants are mirror images of one another. ### Claim 70 An interbody spinal implant made of cortical bone for insertion at least in part into an implantation space formed across the height of a disc space between adjacent vertebral bodies of a human spine, the vertebral bodies having an anterior aspect and a posterior aspect and a depth therebetween, said implant comprising: a leading end for insertion first into the disc space and a trailing end opposite said leading end, said implant having a length from said leading end to said trailing end; opposed upper and lower portions between said leading and trailing ends adapted to be placed at least in part within and across the height of the disc space to contact and support the adjacent vertebral bodies, said upper and lower portions defining a height of said implant, said upper and lower portions being non-arcuate along at least a portion of the length of said implant; and opposite sides between said upper portion and said lower portion, and between said leading and trailing ends, said opposite sides defining a width of said implant, each of said sides being at least in part straight along at least a portion of the length of said implant, said leading end being configured in the shape of a portion of a circle from one of said opposite sides to another one of said opposite sides, the circle having a radius greater than the width of said implant, the width of said implant being less than one-half the width of the adjacent vertebral bodies into which said implant is adapted to be inserted; said implant being manufactured from a bone ring obtained from a major long bone of a human being having a medullary canal, one of said opposite sides of each of said implants including at least a portion of the medullary canal so that when said pair of implants are placed side-by-side in the same disc space a passage is formed adapted to hold bone growth promoting material for permitting for the growth of bone from vertebral body to vertebral body through said implant. ### Claim 71 (depends on 70) The implant of claim 70, wherein said implant is adapted to be inserted side by side a second implant into the disc space between the adjacent vertebral bodies, said second implant having a leading end configured in the shape of a portion of a circle from side to side, the circle having a radius greater than the width of said second implant. ### Claim 72 (depends on 70) The implant of claim 70, wherein at least a portion of said leading end has a reduced height to facilitate insertion of said implant between the two adjacent vertebral bodies. ### Claim 73 (depends on 70) The implant of claim 70, wherein said trailing end has a radius of curvature of a second circle from side to side. ### Claim 74 (depends on 73) The implant of claim 73, wherein the radius of curvature said trailing end is greater than the radius of curvature of the leading end of said implant. ### Claim 75 (depends on 70) The implant of claim 70, wherein said implant has a mid-longitudinal axis along the length, at least one of said opposite sides being at least in part oriented generally parallel to the mid-longitudinal axis of said implant. ### Claim 76 (depends on 70) The implant of claim 70, wherein said opposite sides are at least in part generally parallel one another. ### Claim 77 (depends on 70) The implant of claim 70, wherein at least a portion of said upper and lower portions are in an angular relationship to each other from trailing end to leading end for allowing angulation of the adjacent vertebral bodies relative to each other. ### Claim 78 (depends on 70) The implant of claim 70, wherein said implant has a maximum length less than and approximating the posterior to anterior depth of the vertebral bodies. ### Claim 79 (depends on 70) The implant of claim 70, further comprising a bone engaging surface formed on the exterior of at least said upper and lower portions for engaging the adjacent vertebral bodies, said bone engaging surface including at least one of a protrusion, a ratchet, surface roughenings, and knurling. ### Claim 80 (depends on 70) The implant of claim 70, in combination with a bone growth promoting material. ### Claim 81 (depends on 80) The implant of claim 80, wherein said bone growth promoting material is selected from one of bone, bone derived products, demineralized bone matrix, mineralizing proteins, ossifying proteins, bone morphogenetic protein, hydroxyapatite, and genes coding for the production of bone. ### Claim 82 (depends on 70) The implant of claim 70, wherein said implant is treated with a bone growth promoting substance. ### Claim 83 (depends on 70) The implant of claim 70, wherein said implant is at least in part resorbable. ### Claim 84 (depends on 70) The implant of claim 70, in combination with a chemical substance adapted to inhibit scar formation. ### Claim 85 (depends on 70) The implant of claim 70, in combination with an antimicrobial material. ### Claim 86 (depends on 70) The implant of claim 70, wherein at least a portion of said implant is treated to promote bone ingrowth between said implant and said adjacent vertebral bodies.