Personalized fit and functional designed medical prostheses and surgical instruments and methods for making

Abstract

Methods, devices, systems, and instruments related to medical implants and surgical instruments produced to precisely fit and function as determined for individual subjects. In particular, the methods and devices utilize different combinations of medical imaging, quantitative image analysis, personalized drugs, stem cells, tissue grafts, various validation methods, and various manufacturing processes, to personalize biocompatible devices.

What is claimed is: 
     
         1 . A personalized orthopedic implant, comprising:
 an orthopedic implant designed and manufactured to geometrically match with a bone defect at a point of implantation into a body of a human or animal subject; and
 wherein the design was created through the use of 3D medical imaging data acquired from a body of the subject prior to implantation, and through medical history or testing. 
   
     
     
         2 . The personalized implant of  claim 1 , wherein the point of implantation comprises bone that was resected prior to implantation. 
     
     
         3 . The personalized implant of  claim 2 , wherein:
 the implant was designed and manufactured with biomaterials that do not elicit allergic or sensitivity-related reactions in the subject; and   wherein the subject's allergic or sensitivity-related reactions were identified prior to design or manufacture of the implant.   
     
     
         4 . The personalized implant of  claim 2 , wherein:
 the design and manufacture of the implant includes incorporation of drugs;   wherein the subject's genetic profile, metabolism, drug-responsiveness, or medically assessed damage at the point of implantation, were tested and determined prior to design or manufacture of the implant; and   wherein the nature, dosage, or release profile of such drugs were adapted to the subject's genetic profile, metabolism, drug-responsiveness, or medically assessed damage at the point of implantation.   
     
     
         5 . The personalized implant of  claim 4 , wherein:
 the implant was designed and manufactured with biomaterials that do not elicit allergic or sensitivity-related reactions in the subject; and   the subject's allergic or sensitivity-related reactions were identified prior to design or manufacture of the implant.   
     
     
         6 . The personalized implant of  claim 5 , further comprising stem cells that aid in the process of regeneration of tissue around or into the implant. 
     
     
         7 . The personalized implant of  claim 6 ,
 wherein the drugs promote bone regeneration around or into the implant, and reduce or eliminate the likelihood of infection; and   wherein the drugs are applied to or incorporated into the implant with a procedure selected from the group consisting of gelatin microbeads, hydrogel, direct deposition, coating, plasma spraying, and dipping.   
     
     
         8 . The personalized implant of  claim 6 ,
 wherein the drugs promote bone regeneration around or into the implant, and reduce or eliminate the likelihood of infection; and   wherein the drugs are applied to or incorporated into the implant using additive manufacturing technology.   
     
     
         9 . The personalized implant of  claim 5 , further comprising:
 a tissue graft that aids in the process of regeneration of tissue around or into the implant.   
     
     
         10 . The personalized implant of  claim 9 ,
 wherein the drugs promote bone regeneration around or into the implant, and reduce or eliminate the likelihood of infection, and   wherein the drugs are applied to or incorporated into the implant with a procedure selected from the group consisting of gelatin microbeads, hydrogel, direct deposition, coating, plasma spraying, and dipping.   
     
     
         11 . The personalized implant of  claim 9 ,
 wherein the drugs promote bone regeneration around or into the implant, and reduce or eliminate the likelihood of infection, and   wherein the drugs are applied to or incorporated into the implant using additive manufacturing technology.   
     
     
         12 . The personalized implant of  claim 2 , wherein:
 the implant was designed and manufactured in a manner calculated to distribute mechanical stresses and strains on the interface between the implant and the bone of the subject, to reduce the likelihood of fatigue damage to the implant or the interfacing bone structure, and to maximize the lifecycle of the implant in the subject's body,
 such calculation is performed using finite element analysis and 3D whole-body simulation, 
 said finite element analysis is based upon the anatomy, composition, and density at the point of implantation of bone or of soft tissue, and upon any of the subject's age, lifestyle choices, lifestyle functions, and frequencies and levels of physical activities, and 
 such 3D whole-body simulation simulates the implantation procedure as such would be performed by surgeons, and simulates any of the subject's lifestyle choices, lifestyle functions, and frequencies and levels of physical activities. 
   
     
     
         13 . The personalized implant of  claim 4 , wherein:
 the implant was designed and manufactured with biomaterials that reduce allergic or sensitivity-related reactions in the subject, and   the subject's allergic or sensitivity-related reactions were identified prior to design or manufacture of the implant.   
     
     
         14 . The personalized implant of  claim 4 , wherein:
 the design and manufacture of the implant includes incorporation of drugs that are suitable for subject's genetic profile, metabolism, and drug-responsiveness, and   the subject's genetic profile, metabolism, and drug-responsiveness were tested and determined prior to the design and manufacture of the implant.   
     
     
         15 . The personalized implant of  claim 14 , wherein:
 the implant was designed and manufactured with biomaterials that reduce allergic or sensitivity-related reactions in the subject, and   the subject's allergic or sensitivity-related reactions were identified prior to design or manufacture of the implant.   
     
     
         16 . The personalized implant of  claim 12 , wherein:
 the implant was designed and manufactured in a manner such that fixation of the implant is adapted to the subject's anatomical specifications and to the quality of the native bone surrounding the bone defect; and   such fixation includes the promotion of osseointegration through calculated porosity.   
     
     
         17 . The personalized implant of  claim 16 , wherein:
 the implant was designed and manufactured with biomaterials that reduce allergic or sensitivity-related reactions in the subject, and   the subject's allergic or sensitivity-related reactions were identified prior to design or manufacture of the implant.   
     
     
         18 . The personalized implant of  claim 16 , wherein:
 the design and manufacture of the implant includes incorporation of drugs that are suitable for subject's genetic profile, metabolism, or drug-responsiveness, and   the subject's genetic profile, metabolism, or drug-responsiveness were tested and determined prior to the design and manufacture of the implant.   
     
     
         19 . The personalized implant of  claim 18 , wherein:
 the implant was designed and manufactured with biomaterials that reduce allergic or sensitivity-related reactions in the subject, and   the subject's allergic or sensitivity-related reactions were identified prior to design or manufacture of the implant.   
     
     
         20 . The personalized implant of  claim 2 , wherein:
 the implant was designed and manufactured in a manner such that fixation of the implant is adapted to the subject's anatomical specifications and to the quality of the native bone surrounding the bone defect, and   such fixation includes the promotion of osseointegration through calculated porosity.   
     
     
         21 . The personalized implant of  claim 20 , wherein:
 the implant was designed and manufactured with biomaterials that reduce allergic or sensitivity-related reactions in the subject, and   the subject's allergic or sensitivity-related reactions were identified prior to design or manufacture of the implant.   
     
     
         22 . The personalized implant of  claim 20 , wherein:
 the design and manufacture of the implant includes incorporation of drugs that are suitable for subject's genetic profile, metabolism, or drug-responsiveness, and   the subject's genetic profile, metabolism, or drug-responsiveness were tested and determined prior to the design and manufacture of the implant   
     
     
         23 . The personalized implant of  claim 22 , wherein:
 the implant was designed and manufactured with biomaterials that reduce allergic or sensitivity-related reactions in the subject, and   the subject's allergic or sensitivity-related reactions were identified prior to design or manufacture of the implant.   
     
     
         24 . A personalized orthopedic implant, comprising:
 an implant designed and manufactured with biomaterials that reduce allergic or sensitivity-related reactions in the subject, and   the subject's allergic or sensitivity-related reactions were identified prior to design or manufacture of the implant by medical history or by testing.   
     
     
         25 . The personalized implant of  claim 24 , wherein:
 the implant was designed and manufactured to geometrically match essentially perfectly with the point of implantation into the body of a subject,   the design was created through the use of 3D medical imaging data acquired from the body of the subject,   the implant was designed and manufactured in a manner calculated to distribute mechanical stresses and strains on the interface between the implant and the bone of the subject, to reduce the likelihood of fatigue damage to the implant or the interfacing bone structure, and to maximize the lifecycle of the implant in the subject's body,   such calculation is performed as a finite element analysis based on the subject's age, lifestyle choices, lifestyle functions, and frequencies and levels of physical activities,   the implant was designed and manufactured in a manner such that fixation of the implant is adapted to the subject's anatomical specifications and to the quality of the native bone surrounding the bone defect, and   such fixation includes the promotion of osseointegration through calculated porosity.   
     
     
         26 . The personalized implant of  claim 25 , further comprising:
 stem cells that aid in the process of regeneration of tissue around or into the implant; and   drugs that promote bone regeneration around or into the implant, and that reduce or eliminate the likelihood of infection,   wherein the drugs are applied to or incorporated into the implant with a procedure selected from the group consisting of gelatin microbeads, hydrogel, direct deposition, coating, plasma spraying, and dipping.   
     
     
         27 . The personalized implant of  claim 25 , further comprising:
 tissue graft that aids in the process of regeneration of tissue around or into the implant; and   drugs that promote bone regeneration around or into the implant, and that reduce or eliminate the likelihood of infection,   wherein the drugs are applied to or incorporated into the implant with a procedure selected from the group consisting of gelatin microbeads, hydrogel, direct deposition, coating, plasma spraying, and dipping.   
     
     
         28 . The personalized implant of  claim 25 , further comprising:
 stem cells that aid in the process of regeneration of tissue around or into the implant; and   drugs that promote bone regeneration around or into the implant, and that reduce or eliminate the likelihood of infection,   wherein the drugs are applied to or incorporated into the implant using additive manufacturing technology.   
     
     
         29 . The personalized implant of  claim 25 , further comprising:
 tissue graft that aids in the process of regeneration of tissue around or into the implant; and   drugs that promote bone regeneration around or into the implant, and that reduce or eliminate the likelihood of infection,   wherein the drugs are applied to or incorporated into the implant using additive manufacturing technology.   
     
     
         30 . A personalized orthopedic implant, comprising:
 an implant designed and manufactured to include incorporation of drugs that are suitable for subject's genetic profile, metabolism, and drug-responsiveness,   wherein the subject's genetic profile, metabolism, and drug-responsiveness were determined by medical history or testing prior to the design and manufacture of the implant; and   wherein the implant was designed and manufactured in a manner calculated to distribute mechanical stresses and strains on the interface between the implant and the bone of the subject, to reduce the likelihood of fatigue damage to the implant or the interfacing bone structure, and to maximize the lifecycle of the implant in the subject's body.   
     
     
         31 . The personalized implant of  claim 30 , wherein:
 the implant was designed and manufactured to geometrically match essentially perfectly with the point of implantation into the body of a subject,   the design was created through the use of 3D medical imaging data acquired from the body of the subject,   the implant was designed and manufactured in a manner calculated to distribute mechanical stresses and strains on the interface between the implant and the bone of the subject, to reduce the likelihood of fatigue damage to the implant or the interfacing bone structure, and to maximize the lifecycle of the implant in the subject's body,   such calculation is performed as a finite element analysis based on the subject's age, lifestyle choices, lifestyle functions, and frequencies and levels of physical activities;   the implant was designed and manufactured in a manner such that fixation of the implant is adapted to the subject's anatomical specifications and to the quality of the native bone surrounding the bone defect, and   such fixation includes the promotion of osseointegration through calculated porosity.   
     
     
         32 . The personalized implant of  claim 31 , further comprising:
 stem cells that aid in the process of regeneration of tissue around or into the implant; and   drugs that promote bone regeneration around or into the implant, and that reduce or eliminate the likelihood of infection,   wherein the drugs are applied to or incorporated into the implant with a procedure selected from the group consisting of gelatin microbeads, hydrogel, direct deposition, coating, plasma spraying, and dipping.   
     
     
         33 . The personalized implant of  claim 31 , further comprising:
 tissue graft that aids in the process of regeneration of tissue around or into the implant; and   drugs that promote bone regeneration around or into the implant, and that reduce or eliminate the likelihood of infection,   wherein the drugs are applied to or incorporated into the implant with a procedure selected from the group consisting of gelatin microbeads, hydrogel, direct deposition, coating, plasma spraying, and dipping.   
     
     
         34 . The personalized implant of  claim 31 , further comprising:
 stem cells that aid in the process of regeneration of tissue around or into the implant; and   drugs that promote bone regeneration around or into the implant, and that reduce or eliminate the likelihood of infection,   wherein the drugs are applied to or incorporated into the implant using additive manufacturing technology.   
     
     
         35 . The personalized implant of  claim 31 , further comprising:
 tissue graft that aids in the process of regeneration of tissue around or into the implant; and   drugs that promote bone regeneration around or into the implant, and that reduce or eliminate the likelihood of infection,   wherein the drugs are applied to or incorporated into the implant using additive manufacturing technology.