US 11,908,565 B2Granted

Force prediction for spinal implant optimization

AssigneeMazor Robotics Ltd.

InventorsShlomit Steinberg, Moshe Shoham

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Abstract

A method for optimizing orthopedic spinal implant survival using preoperative finite element analysis combined with intraoperative stress analysis. Based on clinically relevant data, finite element analysis, and corrected values of spinal parameters, an acceptable long-term stress score is determined for an appropriate implant, which is selected from a set of potential implants, such that the shape of the implant minimizes predicted stress values. From a preoperative medical image set, values of selected spinal alignment parameters are determined; finite element analysis is performed on potential implants to determine stress values; and a selected implant is digitally positioned in the medical image set to create a virtual bone/implant configuration. After the selected implant is inserted and bent to shape, actual stress values are measured intraoperatively. The process of bending and measuring stress values is repeated until the bone/implant configuration falls within the acceptable long-term stress score range.

Claims29

Dependent claims

A method of determining an optimal, long-term orthopedic implant configuration for a spinal alignment correction procedure in a subject, comprising:

(a) based on a set of preoperative medical images, determining initial values and a desired corrected set of values of selected spinal alignment parameters;
(b) selecting at least one potential implant for correcting the selected spinal alignment parameters;
(c) digitally positioning, in the set of preoperative medical images, the at least one potential implant for correcting the selected spinal alignment parameters, to create at least one virtual configuration of at least one potential bone-implant combination;
(d) determining an acceptable long-term stress score range for the at least one virtual configuration based on (i) clinically relevant data of the subject, and (ii) similarly characterized cases from a medical database;
(e) for the at least one virtual configuration, (i) performing finite element analysis on the at least one potential implant to determine stress scores along an extent of the at least one potential implant;
and (ii) calculating expected corrected values of the selected spinal alignment parameters;
(f) select an implant from the at least one potential implant, which minimizes the long-term stress score;
(g) intraoperatively, inserting the selected implant into a spine of the subject, the inserted implant being adapted to have at least one mode of stress detection;
(h) using the at least one mode of stress detection, intraoperatively measuring a stress score at each point along a length of the inserted implant;
and
(i) modifying the inserted implant and repeating steps (g) to (h) until an implant configuration falling within the acceptable long-term stress score range is achieved.

8 more elements

A surgical system for determining an optimal long-term orthopedic implant configuration for a spinal alignment correction in a subject, the system comprising:

a control unit, wherein the control unit comprises:
(i) a module for finite element analysis of orthopedic configurations;
(ii) an analytic engine for evaluating a long-term effect of implant configurations using previous cases documented in a large database;
(iii) a calculating unit for determining spinal alignment parameters from a virtual configuration of a spine corrected using a spinal implant arrangement;
(iv) a comparator unit for determining whether a predicted stress score of an implant configuration falls within a predetermined acceptable stress score for long term sustainability, the control unit being configured to determine an optimal implant configuration, by:
(a) based on a set of preoperative medical images, determining initial values and a desired corrected set of values of selected spinal alignment parameters;
(b) selecting at least one potential implant for correcting the selected spinal alignment parameters;
(c) digitally positioning, in the set of preoperative medical images, the at least one potential implant for correcting the selected spinal alignment parameters, to create at least one virtual configuration of at least one potential bone-implant combination;
(d) determining an acceptable long-term stress score range for the at least one virtual configuration based on (i) clinically relevant data of the subject, and (ii) similarly characterized cases from a medical database;
(e) for the at least one virtual configuration, (i) performing finite element analysis on the at least one potential implant to determine stress scores along an extent of the at least one potential implant;
and (ii) calculating expected corrected values of the selected spinal alignment parameters;
and
(f) selecting an implant from the at least one potential implant, which minimizes the long-term stress score;
and
a measurement system configured to measure the stress in an implant inserted onto the spine of a subject, the measurement system comprising a camera adapted to determine a stress pattern arising in the implant by analyzing an image of a photoelastic coating on the inserted implant,
the measurement system being thus configured to enable adjustment intraoperatively of the at least one potential implant to minimize its stress score, thereby providing an improved long term orthopedic implant configuration.

13 more elements

A method of modeling and predicting long-term success of a spinal implant configuration in a subject, comprising:

(a) for a plurality of potential implants, calculating a long-term stress score for at least one potential implant based on (i) stress within the at least one potential implant as determined using finite element analysis of a virtual configuration of the at least one potential implant virtually inserted into a preoperative image of a spine of a subject, (ii) calculated values of selected spinal parameters, and (iii) clinical data of the subject and from a database of similar cases;
(b) determining an acceptable long-term stress score range for the virtual configuration of the at least one potential implant based on (i) clinically relevant data of the subject, and (ii) similarly characterized cases from a medical database;
(c) when the long-term stress score for the for at least one potential implant does not fall within the acceptable long-term stress score range, selecting another potential implant from the plurality of potential implants, until the stress score of an optimal one of the potential implants falls within the acceptable long-term stress score range;
(d) intraoperatively inserting the optimal implant into the subject, the implant being adapted to have at least one mode of stress detection;
(e) using the at least one mode of stress detection to measure a stress at points along the inserted optimal implant to obtain a field pattern of stress of the inserted implant;
(f) inputting the field pattern of stress to a model to simulate an interaction between the spine and the inserted optimal implant over a given time period to determine expected changes in the field pattern of stress over the given time period;
(g) based on the expected changes in the field pattern of stress, calculating an optimal shape of the inserted optimal implant that causes the inserted optimal implant to have a minimum long term stress score over the given time period;
and
(h) based on the calculations of step (g), adjusting the inserted optimal implant to the calculated optimal shape.

6 more elements

A method for long-term follow-up of bone-implant success in a subject, comprising:

(a) selecting an optimal implant from a plurality of potential implants based on (i) stress within the plurality of potential implants detected using finite element analysis of a virtual configuration of each of the plurality of potential implants virtually inserted into a preoperative image of a spine of a subject, (ii) calculated values of selected spinal parameters, and (iii) clinical data of the subject and from a database of similar cases;
(b) determining an acceptable long-term stress score of the optimal implant for the subject;
(c) intraoperatively inserting the optimal implant into the subject to yield a bone-implant system, the optimal implant being equipped with at least one mode of stress detection able to provide remote, real time measurement of stress on the bone-implant system;
(d) determining, at regular intervals of time post-operatively, selected spinal parameters by analysis of medical images and by finite element analysis of a field pattern of stress detected with the at least one mode of stress detection;
(e) providing real-time feedback of the selected spinal parameters and of the field pattern of stress to at least one of the subject and a surgeon;
and
(f) measuring evolution of at least one of the spinal parameters and of the field pattern of stress of bone-implant system.

4 more elements

Dependencies are inferred from the claim text.

Facts

Application: 17/288,660Filed 15 Oct 2019 · us provisional application
Priority: 15 Oct 2018
Published: US 2022/0013211 A113 Jan 2022
Granted: 20 Feb 2024
Term ends: Not estimatedThe source records don’t support an estimate.

Classification22 codes

G16H 20/40
ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient…:…
G16H 50/30
ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or…: for…
A61B 34/10
Computer-aided surgery; Manipulators or robots specially adapted for use in surgery: computer-aided planning, simulation or modelling of surgical…
G16H 30/20
ICT specially adapted for the handling or processing of medical images: for handling medical images, e.g. DICOM, HL7 or PACS

Family

Application62/745,489Us provisional application · filed 15 Oct 2018
US 2022/0013211 A1Pre-grant publication · published 13 Jan 2022
US 11,908,565 B2This patent

From the US filing history. Foreign family members aren’t listed.

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