Devices, Methods, and Systems for Prosthetic Meniscus Selection, Trialing, and Implantation

Abstract

Methods of selecting and implanting prosthetic devices for use as a replacement meniscus are disclosed. The selection methods include a pre-implantation selection method and a during-implantation selection method. The pre-implantation selection method includes a direct geometrical matching process, a correlation parameters-based matching process, and a finite element-based matching process. The implant identified by the pre-implantation selection method is then confirmed to be a suitable implant in the during-implantation selection method. In some instances, the during-implantation selection method includes monitoring loads and/or pressures applied to the prosthetic device and/or the adjacent anatomy. In some instances, the loads and/or pressures are monitored by a trial prosthetic device comprising one or more sensors. Methods of implanting meniscus prosthetic devices are also disclosed.

1 . A method of selecting a meniscus prosthetic device for a patient from a library of available meniscus prosthetic devices, the method comprising:
 utilizing a pre-implantation matching process to identify two or more most suitable meniscus prosthetic devices from the library of available prosthetic devices for replacing the damaged meniscus of the patient;   obtaining two or more trial prosthetic devices corresponding to the two or more most suitable prosthetic devices identified by the pre-implantation matching process;   positioning a first trial prosthetic device of the two or more trial prosthetic devices within a knee joint of the patient;   loading the knee joint of the patient with the first trial prosthetic device positioned within the knee joint; and   measuring a contact pressure distribution between the first trial prosthetic device and a tibialis plateau of the knee joint during loading of the knee joint with the first trial prosthetic device positioned within the knee joint.   
     
     
         2 . The method of  claim 1 , further comprising comparing the measured contact pressure distribution to a desired contact pressure distribution. 
     
     
         3 . The method of  claim 2 , wherein comparing the measured contact pressure distribution to the desired contact pressure distribution comprises comparing a pressure map based on the measured contact pressure distribution to a desired pressure map based on the desired contact pressure distribution. 
     
     
         4 . The method of  claim 3 , wherein the pressure maps are compared on a region-by-region basis. 
     
     
         5 . The method of  claim 2 , further comprising evaluating the first trial prosthetic device based on the comparison of the measured contact pressure distribution to the desired contact pressure distribution. 
     
     
         6 . The method of  claim 1 , further comprising:
 positioning a second trial prosthetic device of the two or more trial prosthetic devices within a knee joint of the patient;   loading the knee joint of the patient with the second trial prosthetic device positioned within the knee joint; and   measuring a contact pressure distribution between the second trial prosthetic device and a tibialis plateau of the knee joint during loading of the knee joint with the second trial prosthetic device positioned within the knee joint.   
     
     
         7 . The method of  claim 6 , further comprising comparing the measured contact pressure distributions of the first and second trial prosthetic devices to a desired contact pressure distribution. 
     
     
         8 . The method of  claim 7 , wherein comparing the measured contact pressure distributions to the desired contact pressure distribution comprises comparing pressure maps based on the measured contact pressure distributions to a desired pressure map based on the desired contact pressure distribution. 
     
     
         9 . The method of  claim 7 , evaluating the first and second trial prosthetic devices based on the comparison of the measured contact pressure distributions to the desired contact pressure distribution to identify which of the first and second trial prosthetic devices is best suited for the patient. 
     
     
         10 . The method of  claim 1 , wherein measuring the contact pressure distribution between the first trial prosthetic device and a tibialis plateau comprises obtaining data from at least one pressure sensor associated with the first trial prosthetic device. 
     
     
         11 . The method of  claim 10 , wherein the at least one pressure sensor is positioned within the first trial prosthetic device. 
     
     
         12 . The method of  claim 10 , wherein loading the knee joint of the patient comprises imparting a load of between about 800 N and about 1600 N with the knee joint at a flexion angle of approximately 0°. 
     
     
         13 . The method of  claim 12 , wherein the load is imparted on the knee by a machine. 
     
     
         14 . The method of  claim 12 , wherein the load is imparted on the knee manually by medical personnel. 
     
     
         15 . A method for selecting a meniscus prosthetic device for a patient from a library of available meniscus prosthetic devices, the method comprising:
 obtaining a plurality of trial prosthetic devices, each trial prosthetic device having a profile corresponding to one of the available meniscus prosthetic devices of the library, and each trial prosthetic device comprising one or more pressure sensors for measuring a load imparted on the trial prosthetic device;   positioning a first trial prosthetic device selected from the plurality of trial prosthetic devices within a knee joint of the patient;   loading the knee joint of the patient with the first trial prosthetic device positioned within the knee joint;   obtaining a pressure distribution across the first trial prosthetic device based on measurements from the one or more pressure sensors during loading of the knee joint with the first trial prosthetic device positioned within the knee joint; and   evaluating the first trial prosthetic device based on the pressure distribution.   
     
     
         16 . The method of  claim 15 , further comprising:
 positioning a second trial prosthetic device selected from the plurality of trial prosthetic devices within a knee joint of the patient;   loading the knee joint of the patient with the second trial prosthetic device positioned within the knee joint;   obtaining a pressure distribution across the second trial prosthetic device based on measurements from the one or more pressure sensors during loading of the knee joint with the second trial prosthetic device positioned within the knee joint; and   evaluating the second trial prosthetic device based on the pressure distribution.   
     
     
         17 . The method of  claim 16 , further comprising comparing the evaluations of at least the first and second trial prosthetic devices to identify a most suitable prosthetic device for the patient. 
     
     
         18 . The method of  claim 15 , wherein evaluating the first trial prosthetic device comprises comparing the measured pressure distribution to a desired pressure distribution. 
     
     
         19 . The method of  claim 18 , wherein the comparing of the measured pressure distribution to the desired pressure distribution is performed on a regional basis. 
     
     
         20 . The method of  claim 19 , wherein each of the regions is weighted based on importance. 
     
     
         21 . The method of  claim 15 , wherein the first trial prosthetic device is positioned within the knee joint of the patient for less than 3 hours. 
     
     
         22 . The method of  claim 15 , wherein the first trial prosthetic device is positioned within the knee joint of the patient for at least 24 hours. 
     
     
         23 . The method of  claim 22 , wherein the first trial prosthetic device further comprises a processor and memory in communication with the one or more pressure sensors for processing and storing data regarding the measurements from the one or more pressure sensors during loading of the knee joint while the first trial prosthetic device is positioned within the knee joint. 
     
     
         24 . The method of  claim 23 , further comprising retrieving the data regarding the measurements from the one or more sensors from the memory of the first trial prosthetic device. 
     
     
         25 . A surgical method, comprising:
 utilizing a pre-implantation matching process to identify at least two suitable meniscus prosthetic devices from a library of available meniscus prosthetic devices for replacing a meniscus of a knee joint of a patient;   obtaining at least two trial prosthetic devices corresponding to the at least two suitable prosthetic devices identified by the pre-implantation matching process;   positioning a first trial prosthetic device of the at least two trial prosthetic devices within the knee joint of the patient;   loading the knee joint of the patient with the first trial prosthetic device positioned within the knee joint;   obtaining a first contact pressure across the first trial prosthetic device during loading of the knee joint with the first trial prosthetic device positioned within the knee joint;   evaluating the first trial prosthetic device based on the contact pressure distribution;   removing the first trial prosthetic device from the knee joint;   positioning a second trial prosthetic device of the at least two trial prosthetic devices within the knee joint of the patient;   loading the knee joint of the patient with the second trial prosthetic device positioned within the knee joint;   obtaining a second contact pressure across the second trial prosthetic device during loading of the knee joint with the second trial prosthetic device positioned within the knee joint;   evaluating the second trial prosthetic device based on the second contact pressure distribution;   identifying a best prosthetic device for the patient based on the evaluations of the at least two trial prosthetic devices; and   implanting the best prosthetic device for the patient into the knee joint of the patient.