US2014303990A1PendingUtilityA1

Integrated orthopedic planning and management process

Assignee: BIOMET MFG CORPPriority: Apr 5, 2013Filed: Oct 14, 2013Published: Oct 9, 2014
Est. expiryApr 5, 2033(~6.7 yrs left)· nominal 20-yr term from priority
A61B 2034/105G16H 30/40G16H 15/00G16H 20/40A61B 34/10A61B 2034/102G16H 50/50G06F 19/321A61B 19/50
53
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Claims

Abstract

A method can include receiving, at a server, preoperative image data of a patient's bone, and accessing, at the server, a database of three-dimensional model data. A patient specific three-dimensional model of the patient's bone can be generated, at the server. A preoperative surgical plan can be generated at the server, which can include comparing aspects of the preoperative surgical plan with predetermined reliability criteria. An interactive user interface for use by a surgeon to review the preoperative surgical plan can be provided, from the server, to a user device. Approval of the preoperative surgical plan can be received, at the server, via the interactive user interface. Postoperative image data of the patient's bone can be received at the server. A postoperative outcome study report can be generated, at the server, and can include a comparison of the preoperative surgical plan with the postoperative image data.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A method for orthopedic planning and management, the method, comprising:
 receiving, at a server, preoperative image data of a patient's bone;   generating, at the server, a patient specific three-dimensional model of the patient's bone based at least on the preoperative image data;   generating, at the server, a preoperative surgical plan based at least on the patient specific three-dimensional model, including comparing aspects of the preoperative surgical plan with predetermined reliability criteria;   providing, from the server, an interactive user interface for use by a surgeon or delegated team member to a user device, the interactive user interface displaying the preoperative surgical plan;   receiving, at the server, approval of the preoperative surgical plan via the interactive user interface;   receiving, at the server, postoperative image data of the patient's bone, the postoperative image data including an image of an implant associated with the patient's bone; and   generating, at the server, a postoperative outcome study report including a comparison of the preoperative surgical plan with the postoperative image data.   
     
     
         2 . The method of  claim 1 , further comprising accessing, at the server, a database of three-dimensional model data of one or more bones of a type associated with the patient's bone;
 wherein generating, at the server, the patient specific three-dimensional model of the patient's bone includes automatically generating, at the server and without any user input, the patient specific three-dimensional model of the patient's bone including identification of anatomical landmarks based at least on the preoperative image data and the database three-dimensional model data.   
     
     
         3 . The method of  claim 2 , wherein generating, at the server, the patient specific three-dimensional model of the patient's bone includes accessing, at the server, statistical shape modeling software, the statistical shape modeling software generating the three-dimensional model of the patient's bone based at least on the preoperative image data and an analysis of the database of three-dimensional model data. 
     
     
         4 . The method of  claim 3 , wherein the database of three-dimensional model data includes defined anatomical landmarks for surgical planning; and
 wherein generating, at the server, the patient specific three-dimensional model of the patient's bone includes automatically identifying anatomical landmarks on the generated patient specific three-dimensional model based at least on the preoperative image data and the defined anatomical landmarks in the database of three-dimensional bone model data.   
     
     
         5 . The method of  claim 1 , further comprising determining, at the server, whether the preoperative surgical plan meets the predetermined reliability criteria. 
     
     
         6 . The method of  claim 5 , further comprising providing, from the server upon determining that the preoperative plan does not meet the predetermined reliability criteria, a notification to a predetermined user device indicating the preoperative surgical plan does not meet the predetermined reliability criteria. 
     
     
         7 . The method of  claim 6 , wherein the notification to the predetermined user device indicating the preoperative surgical plan does not meet the predetermined reliability criteria includes a requirement for input, to the server, of one of the following: i) authorization to proceed with the preoperative surgical plan without revising the preoperative surgical plan; and ii) a revision to the preoperative surgical plan and authorization to proceed with a revised version of the preoperative surgical plan. 
     
     
         8 . The method of  claim 7 , wherein the input is required before the preoperative surgical plan can be provided, via the interactive user interface, to the user device of the surgeon or delegated team member. 
     
     
         9 . The method of  claim 1 , further comprising:
 receiving, at the server, a request for a physical model of the patient's bone; and   providing, from the server, a notification to a predetermined user device to generate a physical model of the patient's bone.   
     
     
         10 . The method of  claim 9 , wherein the predetermined user device includes a user device associated with the manufacturer, a user device associated with a predetermined fabricator, a user device associated with a medical facility or a combination thereof; and
 wherein the notification includes data in the form of the patient specific three-dimensional model of the patient's bone.   
     
     
         11 . The method of  claim 9 , further comprising providing the physical model of the patient's bone along with the preoperative plan to the surgeon or delegated team member. 
     
     
         12 . The method of  claim 1 , wherein receiving, at the server, approval of the preoperative surgical plan via the interactive user interface includes receiving, at the server, edits to the preoperative surgical plan, the edits being provided via user interaction with the interactive user interface displayed at the user device. 
     
     
         13 . The method of  claim 12 , wherein receiving, at the server, approval of the preoperative surgical plan via the interactive user interface includes receiving, at the server, input regarding contents of a patient specific kit to be delivered to an operating room at a medical facility. 
     
     
         14 . The method of  claim 13 , further comprising providing, from the server, data files for instrumentation to be used in the operating room, the data files including three-dimensional models of the instrumentation to used in the operating room. 
     
     
         15 . The method of  claim 14 , further comprising manufacturing disposable instrumentation based on the data files, wherein the disposable instrumentation is to be used in the operating room, included in the patient specific kit, or a combination thereof. 
     
     
         16 . The method of  claim 13 , wherein providing, from the server, the interactive user interface for use by the surgeon or delegated team member includes providing the interactive user interface including (i) an implant selection portion, (ii) an instrument selection portion, and (iii) a guide selection portion. 
     
     
         17 . The method of  claim 13 , further comprising, after receiving approval of the preoperative surgical plan including contents of an order for a patient specific kit, providing, from the server to a manufacturing planning system of a manufacturer associated with the server, information regarding the contents of the ordered patient specific kit. 
     
     
         18 . The method of  claim 13 , further comprising after receiving approval of the preoperative surgical plan including contents of an order for a patient specific kit, providing, from the server to a user device associated with a third party different from the manufacturer, information regarding the contents of the ordered patient specific kit and instructions for assembling the patient specific kit and delivering the patient specific kit to the operating room at the medical facility. 
     
     
         19 . The method of  claim 1 , further comprising receiving, at the server, a request for an interactive user interface displaying selection options for patient specific recovery and education materials from a patient user interacting with a patient user device. 
     
     
         20 . The method of  claim 19 , further comprising determining, at the server, whether the patient's master data file or surgeon's preferences stored in a database associated with the server specifies material information regarding the patient specific recovery and education materials and, if so, generating the patient specific user interface with selection options in compliance with the material information. 
     
     
         21 . The method of  claim 20 , further comprising:
 generating, at the server, a patient specific user interface including selection options for one or more of the following: (i) information about the patient's bone; (ii) information about the implants associated with the preoperative plan; (iii) information about the surgical procedure; and (iv) information about recovery; and   providing, from the server, the patient specific user interface to the patient user device.   
     
     
         22 . The method of  claim 1 , further comprising receiving, at the server, a request to display the preoperative surgical plan at a user device in an operating room. 
     
     
         23 . The method of  claim 22 , further comprising scanning an information tag associated with a patient specific kit intended for use with the patient in the operating room;
 wherein receiving, at the server, the request to display the preoperative surgical plan at the user device in the operating room occurs automatically upon scanning the information tag.   
     
     
         24 . The method of  claim 23 , further comprising:
 generating, at the server, an operating room interactive user interface for displaying the preoperative surgical plan at the operating room user device; and   providing, from the server, the operating room interactive user interface to the operating room user device.   
     
     
         25 . The method of  claim 24 , further comprising:
 receiving, at the server, input identifying information regarding implants planned for use with the patient, the input being transmitted via the operating room interactive user interface;   comparing, at the server, the transmitted information regarding the implants planned for use with stored information, at the server, regarding implants identified for use with the patient in the preoperative surgical plan; and   providing, from the server to the operating room interactive user interface, output indicative of the transmitted implant information and the stored implant information either (i) matching, or (ii) not matching.   
     
     
         26 . The method of  claim 24 , further comprising:
 receiving, at the server, intraoperative data via the operating room interactive user interface; and   storing the intraoperative data at a patient master data file at the server.   
     
     
         27 . The method of  claim 26 , wherein the intraoperative data includes force data, motion data, audible data, time data, or a combination thereof. 
     
     
         28 . The method of  claim 1 , further comprising providing, from the server, the postoperative outcome report to the user device associated with the surgeon. 
     
     
         29 . The method of  claim 1 , further comprising, receiving, at the server, via the interactive user interface, input to a patient satisfaction survey; and
 wherein generating the postoperative outcome study report comprises including the input to the patient satisfaction survey in the postoperative outcome study report.   
     
     
         30 . The method of  claim 1 , further comprising providing, from the server, the postoperative outcome report to a regulatory body. 
     
     
         31 . The method of  claim 1 , wherein the preoperative image data includes two-dimensional X-ray data, MRI data, CT data, ultrasound data, digital photograph data, point cloud data, or a combination thereof. 
     
     
         32 . A method for orthopedic planning and management, the method, comprising:
 receiving, at a server, preoperative two-dimensional image data of a patient's bone joint;   accessing, at the server, a database of three-dimensional model data of one or more bones of a type associated with the patient's bone joint, the three-dimensional bone data including defined anatomical landmarks for use for surgical planning;   generating automatically, at the server, a patient specific three-dimensional model of the patient's bone joint including identification of anatomical landmarks based at least on the preoperative image data and the database three-dimensional model data;   generating, at the server, a preoperative surgical plan based at least on the patient specific three-dimensional model, including:
 comparing aspects of the preoperative surgical plan with predetermined reliability criteria and determining whether the preoperative surgical plan meets the predetermined reliability criteria; 
 providing, from the server upon determining that the preoperative plan does not meet the predetermined reliability criteria, a notification to a predetermined user device; and 
 receiving, at the server, input responsive to the notification; 
   providing, from the server, an interactive user interface for use by a surgeon or delegated team member to a user device, the interactive user interface displaying the preoperative surgical plan;   receiving, at the server, input from the interactive user interface indicating contents of a patient specific surgical kit order for use with the patient, the kit order including one or more of (i) an implant, (ii) instrumentation, (iii) one or more guides, and (iv) a trial;   receiving, at the server, approval of the preoperative surgical plan via the interactive user interface;   providing, from the server, information regarding the contents of the ordered patient specific kit to a system or user device of an assembler of the ordered patient specific kit;   receiving, at the server, postoperative image data of the patient's bone joint, the postoperative image data including images of implants associated with the patient's bone joint;   generating, at the server, a postoperative outcome study report including a comparison of the preoperative surgical plan with the postoperative image data; and   providing, from the server, the postoperative outcome study report to a user device associated with one or more of the surgeon, a medical facility and a regulatory body.   
     
     
         33 . The method of  claim 32 , further comprising:
 receiving, at the server, a request for a user interface displaying selection options for patient specific recovery and education materials from a patient user interacting with a patient user device;   generating, at the server, a patient specific user interface including selection options for one or more of the following: (i) information about the patient's bone joint; (ii) information about the implants associated with the preoperative plan; (iii) information about the surgical procedure; and (iv) information about recovery; and   providing the patient specific user interface to the patient user device.   
     
     
         34 . The method of  claim 32 , further comprising:
 receiving, at the server, a request to display the preoperative surgical plan at a user device in an operating room;   generating, at the server, an operating room interactive user interface for displaying the preoperative surgical plan at the operating room user device; and   providing, from the server, the operating room interactive user interface to the operating room user device.   
     
     
         35 . The method of  claim 34 , further comprising:
 receiving, at the server, input identifying information regarding implants planned for use with the patient, the input being transmitted via the operating room interactive user interface;   comparing, at the server, the transmitted information regarding the implants planned for use with stored information, at the server, regarding implants identified for use with the patient in the preoperative surgical plan; and   providing, from the server to the operating room interactive user interface, output indicative of the transmitted implant information and the stored implant information either (i) matching, or (ii) not matching.   
     
     
         36 . The method of  claim 34 , further comprising scanning an information tag associated with the patient specific kit or the contents thereof intended for use with the patient in the operating room;
 wherein receiving, at the server, the request to display the preoperative surgical plan at the user device in the operating room occurs automatically upon scanning the information tag.   
     
     
         37 . The method of  claim 34 , further comprising:
 receiving, at the server, intraoperative data via the operating room interactive user interface; and   storing the intraoperative data at a patient master data file at the server.   
     
     
         38 . The method of  claim 37 , wherein the intraoperative data includes force data, motion data, audible data, time data, or a combination thereof. 
     
     
         39 . The method of  claim 32 , further comprising, receiving, at the server, via the interactive user interface, input to a patient satisfaction survey;
 wherein generating the postoperative outcome study report further comprises including the input to the patient satisfaction survey in the postoperative outcome study report.

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