# US 11,439,514 B2 · Systems and methods for orthopedic implant fixation > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,439,514 B2 - Document ID: US11439514B2 - Status: Granted - Kind: B2 - Application number: 16/383,215 - Filed: 2019-04-12 - Published: 2019-10-24 - Granted: 2022-09-13 - Earliest claimed: 2018-04-16 - Assignees: Carlsmed, Inc. - Applicants: Carlsmed, Inc. - Inventors: Niall Patrick Casey; Michael J. Cordonnier - Web page: https://patentgrep.com/patent/US11439514B2 ## CPC - A61B 17/7001: {Screws or hooks combined with longitudinal elements which do not contact vertebrae (A61B17/7058 takes precedence)} - 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)} - A61B 17/7007: {Parts of the longitudinal elements, e.g. their ends, being specially adapted to fit around the screw or hook heads} - A61B 17/7035: {Screws or hooks, wherein a rod-clamping part and a bone-anchoring part can pivot relative to each other} - A61B 17/7052: {of variable angle or length} - A61B 17/7058: {Plates mounted on top of bone anchor heads or shoulders} - A61B 17/8033: {having indirect contact with screw heads, or having contact with screw heads maintained with the aid of additional components, e.g. nuts, wedges or head covers} - A61B 17/8038: {the additional component being inserted in the screw head} - A61B 17/8085: {with pliable or malleable elements or having a mesh-like structure, e.g. small strips (A61B17/8071, A61B17/8076 take precedence)} - A61B 34/10: Computer-aided planning, simulation or modelling of surgical operations - A61F 2/30749: {Fixation appliances for connecting prostheses to the body} - A61B 2017/568: {produced with shape and dimensions specific for an individual patient} - A61B 2034/102: {Modelling of surgical devices, implants or prosthesis} - A61B 2034/105: {Modelling of the patient, e.g. for ligaments or bones} - A61B 2034/108: {Computer aided selection or customisation of medical implants or cutting guides} - A61F 2/30965: {Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping} - A61F 2/442: {Intervertebral or spinal discs, e.g. resilient (non-disc-shaped intervertebral inflatable pockets A61F2/441; non-disc-shaped intervertebral fusion implants A61F2/4455)} - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - 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 A personalized fixation system includes a surgical planning software tool configured to adjust relationships of relevant anatomy of a subject, at least one bone anchor, a plate having a shape that does not conform to a single plane, the plate configured to accept the at least one bone anchor, wherein the shape of the plate is at least partially determined by the surgical planning software tool, and wherein the plate includes at least one node having a hole configured to receive the at least one bone anchor, and a locking element configured to connect the at least one bone anchor to the plate, wherein the plate is manufactured using additive manufacturing. ## Claims ### Claim 1 A personalized spinal fixation system comprising: a surgical planning software tool configured to (1) generate a three-dimensional virtual model of at least a portion of a subject's spinal anatomy, (2) measure the three-dimensional virtual model to obtain one or more measurements associated with at least one of a pelvic tilt, sagittal alignment, or lumbar lordosis of the subject's spinal anatomy, (3) based at least in part on the obtained one or more measurements, adjust relationships of the subject's spinal anatomy in the virtual model to provide a corrected spinal geometry that at least partially corrects one or more anatomical deformaties of the subject's spinal anatomy, (4) apply one or more predictive guidelines to the virtual model to determine if the corrected spinal anatomy conforms to the one or more predictive guidelines, wherein the predictive tilt, sagittal alignment, or lumbar lordosis, and (5) if the corrected spinal anatomy confroms to the one or more predictive guidelines, at least partially design a plate for achieving the corrected spinal geometry when implanted in the subject; at least one bone anchor; the plate designed for achieving the corrected spinal geometry, the plate having a shape that does not conform to a single plane and being configured to extend across at least one intervertebral gap when implanted in the subject, wherein the shape of the plate is at least partially determined by the surgical planning software tool, and wherein the plate comprises at least one node having a hole configured to receive the at least one bone anchor; and a locking element configured to connect the at least one bone anchor to the plate, wherein the plate is manufactured using additive manufacturing. ### Claim 2 (depends on 1) The fixation system of claim 1, wherein the additive manufacturing is guided by the surgical planning software tool. ### Claim 3 (depends on 1) The fixation system of claim 1, wherein the plate is configured to provide fixation to surgically adjusted spinal anatomy of the subject to achieve the corrected spinal geometry. ### Claim 4 (depends on 3) The fixation system of claim 3, wherein the corrected spinal geometry comprises a partial or complete correction of a deformation. ### Claim 5 (depends on 1) The fixation system of claim 1, wherein each of the bone anchor, the plate, and the locking element is configured to lock with at least one of the others of the bone anchor, the plate, and the locking element. ### Claim 6 (depends on 1) The fixation system of claim 1, wherein the plate contains one or more longitudinal elements configured to connect the at least one node to at least a second node. ### Claim 7 (depends on 1) The fixation system of claim 1, wherein the plate is configured to have a geometry that allows for iliac fixation. ### Claim 8 (depends on 1) The fixation system of claim 1, wherein the plate has a surface treatment to encourage biological response. ### Claim 9 (depends on 1) The fixation system of claim 1, wherein the plate has a variable density. ### Claim 10 (depends on 1) The fixation system of claim 1, wherein the plate has a variable porosity. ### Claim 11 (depends on 1) The fixation system of claim 1, wherein the surgical planning software tool comprises at least one computer memory that is not a transitory signal, the at least one computer memory comprising instructions executable by at least one processor. ### Claim 12 A personalized spinal fixation system comprising: a surgical planning software tool configured to (1) generate a three-dimensional virtual model of at least a portion of a subject's spinal anatomy, (2) measure the three-dimensional virtual model to obtain one or more measurements associated with at least one of a pelvic tilt, sagittal alignment, or lumbar lordosis of the subject'spinal anatomy, (3) based at least in part on the obtained one or more measurements, adjust relationships of the subject's spinal anatomy in the virtual model to provide a corrected spinal geometry that at least partially corrects one or more anatomical deformaties of the subject's spinal anatomy, (4) apply one or more predictive guidelines to the virtual model to determine if the corrected spinal anatomy conforms to the one or more predictive guidelines, wherein the predictive tilt, sagittal alignment, or lumbar lordosis, and (5) if the corrected spinal anatomy confroms to the one or more predictive guidelines, at least partially design a plate for achieving the corrected spinal geometry when implanted in the subject, wherein the implant includes a plate having a shape that does not conform to a single plane and being configured to extend across at least one intervertebral gap when implanted in the subject, wherein the shape of the plate is at least partially determined by the surgical planning software tool, and wherein the plate comprises at least one node having a hole configured to receive the at least one bone anchor, at least one bone anchor, and a locking element configured to connect the at least one bone anchor to the plate. ### Claim 13 (depends on 12) The fixation system of claim 12, wherein the surgical planning software tool is configured to determine a shape and topography of the plate, and wherein the shape and the topography of the plate are designed to mate with the patient's spinal anatomy. ### Claim 14 (depends on 12) The fixation system of claim 12, wherein the implant is configured to provide fixation to surgically adjusted spinal anatomy of the subject to achieve the corrected spinal geometry. ### Claim 15 (depends on 12) The fixation system of claim 12, wherein the surgical planning software tool comprises at least one computer memory that is not a transitory signal, the at least one computer memory comprising instructions executable by at least one processor. ### Claim 16 A personalized spinal fixation system comprising: a surgical planning software tool configured to (1) generate a three-dimensional virtual model of at least a portion of a subject's spinal anatomy, (2) measure the three-dimensional virtual model to obtain one or more measurements associated with at least one of a pelvic tilt, sagittal alignment, or lumbar lordosis of the subject's spinal anatomy, (3) based at least in part on the obtained one or more measurements, adjust relationships of the subject's spinal anatomy in the virtual model to provide a corrected spinal geometry that at least partially corrects one or more anatomical deformities of the subject's spinal anatomy, (4) apply one or more predictive guidelines to the virtual model to determine if the corrected spinal anatomy conforms to the one or more predictive guidelines, wherein the predictive guidelines include predetermined values for one or more of pelvic tilt, sagittal alignment, or lumbar lordosis, and (5) if the corrected spinal anatomy conforms to the one or more predictive guidelines, at least partially design an implant for achieving the corrected spinal geometry when implanted in the subject, wherein the implant includes a plate having a shape that does not conform to a single plane and being configured to extend across at least one intervertebral gap when implanted in the subject, wherein the shape of the plate is at least partially determined by the surgical planning software tool, and wherein the plate comprises at least one node having a hole configured to receive the at least one bone anchor, and at least one bone anchor. ### Claim 17 (depends on 16) The fixation system of claim 16, wherein the surgical planning software tool is configured to determine a shape and topography of the plate, and wherein the shape and the topography of the plate are designed to mate with the patient's spinal anatomy. ### Claim 18 (depends on 16) The fixation system of claim 16, wherein the surgical planning software tool comprises at least one computer memory that is not a transitory signal, the at least one computer memory comprising instructions executable by at least one processor. ### Claim 19 (depends on 16) The fixation system of claim 16, wherein the one or more measurements include a measurement associated with pelvic tilt, and wherein the one or more predictive guidelines include a pelvic tilt value of less than 20 degrees. ### Claim 20 (depends on 16) The fixation system of claim 16, wherein the one or more measurements include a measurement associated with sagittal alignment, and wherein the one or more predictive guidelines include a sagittal vertebral axis value of less than or equal to 5 cm. ### Claim 21 (depends on 16) The fixation system of claim 16, wherein the one or more measurements include a first measurement associated with lumbar lordosis and second measurement associated with pelvic incidence, and wherein the one or more predictive guidelines include a mathematical rule defined by an absolute value of the difference between pelvic incidence and lumbar lordosis being less than 10 degrees.