# US 2019/0167435 A1 · Systems and methods for multi-planar orthopedic alignment > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2019/0167435 A1 - Document ID: US20190167435A1 - Status: Published application - Kind: A1 - Application number: 16/207,116 - Filed: 2018-12-01 - Published: 2019-06-06 - Earliest claimed: 2017-12-04 - Assignees: Carlsmed, Inc. - Applicants: Carlsmed, Inc. - Inventors: MICHAEL J. CORDONNIER - Web page: https://patentgrep.com/patent/US20190167435A1 ## CPC - A61F 2/30942: {for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques} - 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 2017/568: {produced with shape and dimensions specific for an individual patient} - A61F 2/446: {having a circular or elliptical cross-section substantially parallel to the axis of the spine, e.g. cylinders or frustocones} - A61F 2/4465: {having a circular or kidney shaped cross-section substantially perpendicular to the axis of the spine} - A61F 2/447: {substantially parallelepipedal, e.g. having a rectangular or trapezoidal cross-section} - A61F 2002/30593: {hollow} - A61F 2002/30943: {using mathematical models} - A61F 2002/30948: {using computerized tomography, i.e. CT scans} - A61F 2002/30952: {using CAD-CAM techniques or NC-techniques} - A61F 2002/30953: {using a remote computer network, e.g. Internet} - A61F 2002/30985: {using three dimensional printing [3DP]} - 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) - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## Abstract A method for designing a patient-specific implant includes obtaining image data of a region of interest of the spine of a patient, measuring one or more geometric characteristic of the region of interest from the image data, comparing a measurement obtained for at least one of the one or more geometric characteristics to a mathematical rule associated with the particular geometric characteristic, and generating three-dimensional implant geometry data if the measurement of the at least one of the one or more geometric characteristics conforms with the associated mathematical rule, the implant geometry data configured to guide an additive manufacturing operation. ## Claims ### Claim 1 A method for designing a patient-specific implant, comprising: obtaining image data of a region of interest of the spine of a patient; measuring one or more geometric characteristic of the region of interest from the image data; comparing a measurement obtained for at least one of the one or more geometric characteristics to a mathematical rule associated with the particular geometric characteristic; and generating three-dimensional implant geometry data if the measurement of the at least one of the one or more geometric characteristics conforms with the associated mathematical rule, the implant geometry data configured to guide an additive manufacturing operation. ### Claim 2 (depends on 1) The method of claim 1, further comprising creating a corrected value for the at least one of the one or more geometric characteristics if the measurement of the at least one of the one of more geometric characteristics does not conform with the associated mathematical rule. ### Claim 3 (depends on 2) The method of claim 2, further comprising generating three-dimensional implant geometry data if each of a predetermined set or subset of measurements or corrected values of the one or more geometric characteristics conforms with the associated mathematical rule, the implant geometry data configured to guide an additive manufacturing operation. ### Claim 4 (depends on 1) The method of claim 1, wherein the one or more geometric characteristics comprises pelvic tilt. ### Claim 5 (depends on 4) The method of claim 4, wherein the mathematical rule associated with pelvic tilt is defined by a pelvic tilt angle (PT) between 0 degrees and 20 degrees. ### Claim 6 (depends on 1) The method of claim 1, wherein the one or more geometric characteristics comprises sagittal alignment. ### Claim 7 (depends on 6) The method of claim 6, wherein the mathematical rule associated with sagittal alignment is defined by a C7 sagittal vertebral axis (SVA) having an absolute value less than 5 cm. ### Claim 8 (depends on 1) The method of claim 1, wherein the one or more geometric characteristics comprises lumbar lordosis. ### Claim 9 (depends on 8) The method of claim 8, wherein the mathematical rule associated with lumbar lordosis is defined by an absolute value of the difference between pelvic incidence and lumbar lordosis less than 10 degrees. ### Claim 10 (depends on 1) The method of claim 1, wherein the image data comprises computed tomography (CT) data. ### Claim 11 (depends on 1) The method of claim 1, wherein the image data comprises magnetic resonance imaging (MRI) data. ### Claim 12 (depends on 1) The method of claim 1, wherein the image data comprises x-ray data. ### Claim 13 (depends on 1) The method of claim 1, further comprising forming a patient-specific implant in an additive manufacturing operation guided by the implant geometry data. ### Claim 14 (depends on 13) The method of claim 13, wherein the forming step if further guided by patient information. ### Claim 15 (depends on 14) The method of claim 14, wherein the patient information includes one or more of patient age, patient weight, or prior patient surgical history. ### Claim 16 (canceled) ### Claim 17 (depends on 13) The method of claim 13, wherein the patient-specific implant further comprises a biologic material. ### Claim at position 18 18-51. (canceled) ### Claim 52 A computer system for designing a patient-specific implant, comprising: 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 for: obtaining image data of a region of interest of the spine of a patient; measuring one or more geometric characteristic of the region of interest from the image data; comparing a measurement obtained for at least one of the one or more geometric characteristics to a mathematical rule associated with the particular geometric characteristic; and generating three-dimensional implant geometry data if the measurement of the at least one of the one or more geometric characteristics conforms with the associated mathematical rule, the implant geometry data configured to guide an additive manufacturing operation. ### Claim at position 20 53-55. (canceled) ### Claim 56 A patient-specific implant manufactured by a process comprising: obtaining image data of a region of interest of the spine of a patient; measuring one or more geometric characteristic of the region of interest from the image data; comparing a measurement obtained for at least one of the one or more geometric characteristics to a mathematical rule associated with the particular geometric characteristic; and generating three-dimensional implant geometry data if the measurement of the at least one of the one or more geometric characteristics conforms with the associated mathematical rule, the implant geometry data configured to guide an additive manufacturing operation. ### Claim at position 22 57-61. (canceled) ### Claim 62 (depends on 13) The method of claim 13, wherein the patient specific implant comprises an interbody device. ### Claim 63 (depends on 1) The method of claim 1, wherein the additive manufacturing operation is an automated manufacturing operation. ### Claim at position 25 64-66. (canceled)