Computerized process for making a patient-specific implant

A computerized system for manufacturing a patient-specific spinal implant, the method comprising the steps of:

• a) generating one or more three-dimensional digital models of a current patient's target zone and surrounding tissues by computer processing scan data from one or more scanners selected from the group consisting of X-rays, ultrasound, computerized tomography (CT), magnetic resonance imaging (MRI), and dual-energy X-ray absorptiometry (DEXA);
• b) encrypting communications from the one or more medical scanners to communication devices, computers and manufacturing apparatus and decrypting communications received by the communications devices, computers and manufacturing apparatus;
• c) tagging, sending, and securely storing patient information in a non-transitory memory regarding:
• i) one or more three-dimensional digital models;
• ii) patient-specific digitized medical scans of a target zone;
• and
• iii) medical history, current medical conditions, clinical observations and/or medical test results;
• d) executing a processor and a software to process the patient's information and access an aggregate of prior patients' information to generate:
• i) a first set of patient-specific metrics relative to a center of the patient's spinal canal proximate to the target zone and a patient-specific coordinate correlating the one or more patient-specific digitized medical scans and a location of the target zone with X, Y and Z axes associated with the patient-specific coordinate;
• ii) three-dimensional geometric representations and measurements of prior patients' target zones;
• iii) metric outputs for:
• patient-specific implants previously manufactured and implanted into the prior patients;
• and previously submitted surgical options and accompanying probabilities of successful outcomes;
• iv) post-operative medical histories and clinical observations associated with the previously implanted patient-specific implants;
• and
• v) correlating previous metric outputs associated with a specific surgeon's use of the specific surgeon's previously implanted patient-specific implants;
• e) using the computer executing the processor to compare and correlate the first set of patient-specific metrics from the current patient with the aggregate to generate a second set of optimized metric outputs, wherein the second set of optimized metric outputs is specifically tailored to the current patient based on successful outcomes in prior patients;
• f) connecting a visual display to the computer system, the visual display configured to present the first set of metrics from the current patient and the aggregate to generate the second set of optimized metrics and physician options for the patient-specific spinal implant;
• g) transferring a physician-approved metric output, selected from the first set of metrics and the second set of optimized metric outputs, to a manufacturing apparatus;
• and
• h) controlling the manufacturing apparatus with the physician-approved metric output to physically fabricate the patient-specific spinal implant from one or more biocompatible materials.

A process for manufacturing an optimal patient-specific three-dimensional implant for a target zone in a current patient, the process comprising the steps of:

• a) using one or more medical scanners selected from the group consisting of X-rays, ultrasound, computerized tomography (CT), magnetic resonance imaging (MRI), dual-energy X-ray absorptiometry (DEXA) to generate one or more patient-specific digitized medical scans of a target zone;
• b) encrypting communications from the one or more medical scanners to communication devices, computers and manufacturing apparatus and decrypting communications received by the communications devices, computers and manufacturing apparatus;
• c) tagging, sending, and securely storing patient information in a non-transitory memory regarding:
• i) one or more patient-specific digitized medical scans of a target zone relative to X, Y, and Z axes of the target zone;
• and
• ii) medical history, current medical conditions, clinical observations, and/or medical test results;
• d) executing a software causing a processor to:
• i) process the medical scans to generate a patient-specific three-dimensional model of the target zone in the current patient and thereafter adding the patient-specific three-dimensional model to an aggregate of historical implant and outcome data from prior patients;
• ii) compare the patient-specific three-dimensional model with the aggregate of historical implant and outcome data from prior patients, wherein the aggregate includes three-dimensional geometric representations of prior patients' target zones and associated measurements;
• iii) calculate a first set of patient-specific metric outputs for designing the optimal patient-specific three-dimensional implant based solely on the patient-specific three-dimensional model of the target zone in the current patient;
• iv) to calculate a second set of optimized metric outputs by analyzing the first set of patient-specific metric outputs in view of the aggregate of historical implant and outcome data to improve the fit and performance of the optimal patient-specific three-dimensional implant;
• e) transmitting a metric selected from the first and second sets to a manufacturing apparatus, wherein the manufacturing apparatus is a three-dimensional printer, for the fabrication of the optimal patient-specific three-dimensional implant;
• and
• f) controlling the manufacturing apparatus to physically fabricate the optimal patient-specific three-dimensional implant from one or more biocompatible materials.