WO2024229333A1 - Bioprinting workflows for healthcare professionals - Google Patents

Abstract

Systems and methods are disclosed for the creation of custom bio-resorbable implants. A method of producing a patient-specific implants comprises receiving a collection of images from a PACS system, selecting a target area on from an area displayed in the collection of images, the target area shown in a plurality of views within the collection of images, segmenting each image within the collection of images based on the target area, displaying a list of parameters associated with the target area, indicating an implant material associated with the target area, overlaying one or more markups to the target area, creating a model implant of the target area based on the one or more markups, and printing the implant model using a 3d printer under sterile conditions.

Description

BIOPRINTING WORKFLOWS FOR HEALTHCARE PROFESSIONALS

RELATED APPLICATION(S)

[0001] This application claims priority to U.S. Provisional Application No. 63/499,834, filed May 3, 2023, which is incorporated herein by reference in its entirety.

TECHNICAL FIELD

[0002] The invention relates generally to workflows for bioprinting, and, in particular, to systems and methods for making a bio-resorbable bone implant from a material composition.

BACKGROUND

[0003] The number of bone grafting operations is increasing dramatically. This growing demand presents a number of issues for physicians, hospitals, and patients. One such issue is how to provide customized implants for a wide range of patients and procedures.

[0004] Accordingly, a solution to the emerging need for bone structure recovery is needed. By printing patient-specific polymer implants for each particular operation, the need for customizable implants can be met. To benefit the individual patient, the implant product is thoroughly tailored to match the needs of the healthcare specialist and procedure.

SUMMARY

[0005] According to certain aspects of the present disclosure, systems and methods are disclosed for making a bio-resorbable bone implant from a material composition. In one embodiment, a method comprises receiving a collection of images from a PACS system, selecting a selecting a target area on from an area displayed in the collection of images, the target area shown in a plurality of views within the collection of images. Then, each image within the collection of images is segmented based on the target area, and a list of parameters associated with the target area is displayed. An implant material associated with the target area is indicated and one or more markups to the target area is overlayed. A model implant is created based on the one or more markups and printed using a 3d printer under sterile conditions.

BRIEF DESCRIPTION OF THE DRAWINGS

[0006] The accompanying drawings, which are incorporated into and constitute a part of this specification, illustrate various exemplary embodiments and together with the description, serve to explain the principles of the disclosed embodiments.

[0007] FIG. 1A depicts an exemplary Picture Archiving and Communication System. [0008] FIG. IB illustrates an exemplary clinical image search and retrieval method.

[0009] FIG. 2 is an exemplary flowchart of a method used to develop the implant, according to an exemplary embodiment of the present disclosure.

[0010] FIG. 3A illustrates two exemplary patient-specific sterile implants, according to an exemplary embodiment of the present disclosure.

[0011] FIG. 3B illustrates an exemplary printed implant, according to an exemplary embodiment of the present disclosure.

[0012] FIG. 4 illustrates a workflow of producing a patient specific implant, according to an exemplary embodiment of the present disclosure. [0013] FIG. 5 is a chart showing the personnel related to the method on both the hospital and manufacturing sides, according to an exemplary embodiment of the present disclosure.

[0014] FIG. 6 illustrates a schematic of a production facilities plan, according to an exemplary embodiment of the present disclosure.

[0015] FIG. 7A illustrates a target slice image highlighting a problem area to be addressed in a patient, according to an exemplary embodiment of the present disclosure. [0016] FIG. 7B illustrates a target slice image that is displayed to a surgeon, according to an exemplary embodiment of the present disclosure.

[0017] FIG. 7C illustrates a target area displayed to the modeler, according to an exemplary embodiment of the present disclosure.

[0018] FIG. 7D illustrates an Al-generated model displayed to the surgeon, according to an exemplary embodiment of the present disclosure.

[0019] FIG. 8A illustrates a model with surgeon edits indicating defects, according to an exemplary embodiment of the present disclosure.

[0020] FIG. 8B illustrates an alternative view of the model, according to an exemplary embodiment of the present disclosure.

[0021] FIG. 8C illustrates a model with surgeon edits indicating defects, according to an exemplary embodiment of the present disclosure.

[0022] FIG. 8D illustrates an alternative view of the model, according to an exemplary embodiment of the present disclosure.

[0023] FIG. 9A illustrates a highlighted target area on a medical image with a sketch overlay, a according to an exemplary embodiment of the present disclosure.

[0024] FIG. 9B illustrates a model implant, according to an exemplary embodiment of the present disclosure. [0025] FIG. 9C illustrates a model implant with edits from a reviewing surgeon, according to an exemplary embodiment of the present disclosure.

[0026] FIG. 9D illustrates an updated model implant with the incorporated edits, according to an exemplary embodiment of the present disclosure.

[0027] FIG. 10 illustrates a reconstructed view of the implant within the patient, according to an exemplary embodiment of the present disclosure.

[0028] FIG. 11A illustrates a sterile packaging containing the printed implant, according to an exemplary embodiment of the present disclosure.

[0029] FIG. 11B illustrates an alternative view of the sterile packaging, according to an exemplary embodiment of the present disclosure.

[0030] FIG. 12 is an exemplary computing node, according to an embodiment of the present disclosure.

DETAILED DESCRIPTION

[0031] Reference will now be made in detail to the exemplary embodiments of the present disclosure, examples of which are illustrated in the accompanying drawings.

Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts.

[0032] The systems, devices, and methods disclosed herein are described in detail by way of examples and with reference to the figures. The examples discussed herein are examples only and are provided to assist in the explanation of the apparatuses, devices, systems, and methods described herein. None of the features or components shown in the drawings or discussed below should be taken as mandatory for any specific implementation of any of these devices, systems, or methods unless specifically designated as mandatory. [0033] Also, for any methods described, regardless of whether the method is described in conjunction with a flow diagram, it should be understood that unless otherwise specified or required by context, any explicit or implicit ordering of steps performed in the execution of a method does not imply that those steps must be performed in the order presented but instead may be performed in a different order or in parallel.

[0034] As used herein, the term “exemplary” is used in the sense of “example,” rather than “ideal.” Moreover, the terms “a” and “an” herein do not denote a limitation of quantity, but rather denote the presence of one or more of the referenced items.

[0035] Patient specific implants are custom-made implants manufactured to each patient’s individual anatomical specifications. The advent of new manufacturing techniques and materials opens the opportunity for a closer integration into the clinical routine. This benefits both doctors and patients: for doctors, patient specific implants helps to simplify complex surgical procedures by providing a perfect fit, and for patients, there is a decrease in pain, surgery time, and a generally faster recovery after implantation.

[0036] The materials used for implants are specified for each implant created but fall within one of two categories. The first category is biocompatible non-resorbable polymers, which are the basic material for flat bones. These non-resorbable polymers provide high bioactivity, are neutral to body fluids, and offer good mechanical properties for implants. The second material category is a modified bioresorbable polymer, which is the basic material for tubular bones. Technology behind the bioresorbable polymer is based on imitating natural bone structure, and provides a high level of strength and recoverability for implants.

[0037] Users of the implant system may be defined by their function and can be grouped by teams, such as a clinic team and a support team. The functional user may be a client or patient or be a member of the clinic team (such as a surgeon, department head, or director). Members of the support team may subdivided into members of the production, logistics, finance, or quality control departments. The production department comprises a receptionist, modeler, and operator. The logistics department includes an inventor operator and a shipment operator. The finance department includes an account manager for invoicing purposes. The quality assurance department includes a field-based quality controller, an assurance manager, and a post marketing controller.

[0038] A Picture Archiving and Communication System (PACS) is a medical imaging system that provides storage and access to images from multiple modalities. In many heathcare environments, electronic images and reports are transmitted digitally via PACS, thus eliminating the need to manually file, retrieve, or transport film jackets. A standard format for PACS image storage and transfer is DICOM (Digital Imaging and Communications in Medicine). Non-image data, such as scanned documents, may be incorporated using various standard formats such as PDF (Portable Document Format) encapsulated in DICOM.

[0039] Referring to FIG. 1A, an exemplary PACS 100 consists of four major components. Various imaging modalities 101...109 such as computed tomography (CT) 101, magnetic resonance imaging (MRI) 102, or ultrasound (US) 103 provide imagery to the system. In some implementations, imagery is transmitted to a PACS Gateway 111, before being stored in archive 112. Archive 112 provides for the storage and retrieval of images and reports. Workstations 121...129 provide for interpreting and reviewing images in archive 112. In some embodiments, a secured network is used for the transmission of patient information between the components of the system. In some embodiments, workstations 121...129 may be web-based viewers. PACS delivers timely and efficient access to images, interpretations, and related data, eliminating the drawbacks of traditional film-based image retrieval, distribution, and display. [0040] A PACS may handle images from various medical imaging instruments, such as X-ray plain film (PF), ultrasound (US), magnetic resonance (MR), Nuclear Medicine imaging, positron emission tomography (PET), computed tomography (CT), endoscopy (ES), mammograms (MG), digital radiography (DR), computed radiography (CR), Histopathology, or ophthalmology. However, a PACS is not limited to a predetermined list of images, and supports clinical areas beyond conventional sources of imaging such as radiology, cardiology, oncology, or gastroenterology.

[0041] Different users may have a different view into the overall PACS system. For example, while a radiologist may typically access a viewing station, a technologist may typically access a QA workstation.

[0042] In some implementations, the PACS Gateway 111 comprises a quality assurance (QA) workstation. The QA workstation provides a checkpoint to make sure patient demographics are correct as well as other important attributes of a study. If the study information is correct the images are passed to the archive 112 for storage. The central storage device, archive 112, stores images and in some implementations, reports, measurements and other information that resides with the images.

[0043] Once images are stored to archive 112, they may be accessed from reading workstations 121...129. The reading workstation is where a radiologist reviews the patient's study and formulates their diagnosis. In some implementations, a reporting package is tied to the reading workstation to assist the radiologist with dictating a final report. A variety of reporting systems may be integrated with the PACS, including those that rely upon traditional dictation. In some implementations, CD or DVD authoring software is included in workstations 121...129 to burn patient studies for distribution to patients or referring physicians. [0044] In some implementations, a PACS includes web-based interfaces for workstations 121...129. Such web interfaces may be accessed via the internet or a Wide Area Network (WAN). In some implementations, connection security is provided by a VPN (Virtual Private Network) or SSL (Secure Sockets Layer). The clients side software may comprise ActiveX, JavaScript, or a Java Applet. PACS clients may also be full applications which utilize the full resources of the computer they are executing on outside of the web environment.

[0045] Communication within PACS is generally provided via Digital Imaging and Communications in Medicine (DICOM). DICOM provides a standard for handling, storing, printing, and transmitting information in medical imaging. It includes a file format definition and a network communications protocol. The communication protocol is an application protocol that uses TCP/IP to communicate between systems. DICOM files can be exchanged between two entities that are capable of receiving image and patient data in DICOM format. [0046] DICOM groups information into data sets. For example, a file containing a particular image, generally contains a patient ID within the file, so that the image can never be separated from this information by mistake. A DICOM data object consists of a number of attributes, including items such as name and patient ID, as well as a special attribute containing the image pixel data. Thus, the main object has no header as such, but instead comprises a list of attributes, including the pixel data. A DICOM object containing pixel data may correspond to a single image, or may contain multiple frames, allowing storage of cine loops or other multi-frame data. DICOM supports three- or four-dimensional data encapsulated in a single DICOM object. Pixel data may be compressed using a variety of standards, including JPEG, Lossless JPEG, JPEG 2000, and Run-length encoding (RLE). LZW (zip) compression may be used for the whole data set or just the pixel data. [0047] Referring to FIG. IB, an exemplary PACS image search and retrieval method

150 is depicted. Communication with a PACS server, such as archive 112, is done through

DICOM messages that that contain attributes tailored to each request. At 151, a client, such as workstation 121, establishes a network connection to a PACS server. At 152, the client prepares a DICOM message, which may be a C-FIND, C-MOVE, C-GET, or C-STORE request. At 153, the client fills in the DICOM message with the keys that should be matched. For example, to search by patient ID, a patient ID attribute is included. At 154, the client creates empty attributes for all the values that are being requested from the server. For example, if the client is requesting an image ID suitable for future retrieval of an image, it include an empty attribute for an image ID in the message. At 155, the client send the message to the server. At 156, the server sends back to the client a list of one or more response messages, each of which includes a list of DICOM attributes, populated with values for each match.

[0048] Once the doctor has created the modelling request in the program, the request is then sent to the production team. The program associates a Link3D Team and a Surgicase Team to the request. The Link3D message tab within the program window functions to track the ID and URL of the request and associated information to Mimics, and a user can manually open Mimics to create and save marked areas on DICOM images. The resulting new model request with a model, marked up areas, etc., is then received by the production department within the program. A Link3D order routing request is sent to the logistics department, which checks for availability of consumables. If consumable materials are not available, the logistics department sends an outgoing notification through the system detailing availability of all required materials. Concurrently, the Surgicase Team launches Mimics Viewer, a licensed software, to share 3-matics/Mimics files with surgeons and doctors, to ensure that any comments and annotations are saved with the file. Once the element is modeled, a cost estimate is provided for a number of options and payment types, using the progam’s Link3D quoting system. The model file and the estimates are sent for physician review within the program. Mimics and 3-Matic files can be sent to the physicians for additional comments and measurements, but the physicians cannot manipulate files with adjustments or changes to the model at this point. The physician is able to add questions, sketches, and/or annotations.

[0049] If no adjustments to the model is required, the physician certifies approval with a digital signature. If not, the physician submits the file with comments and the model file is received by the production department for additional modelling steps. Once the approved model is received along with a production date, a Link3D order management/scheduler processes the information within the program and the Surgicase production date management is confirmed. The production team indicates the suitability of the production date, and chooses a suitable date through the Link3D Scheduling window, and the Surgicase application plans production date, delivery date per surgery date, and provides any feedback on missing deadlines. If it is not possible for the system to reach an agreement between all parties for the production dates, the model request is cancelled. However, assuming the system finds a suitable date, a production date proposal is sent to the physician’s account. Once there is agreement on dates from all parties, material available is determined and printing of the implant begins. The Link3D Scheduling system conducts the implant printing process, with a Link3D AMWatch application monitoring the printing process in real time, when there is machine connectivity. If no machine connectivity exists, a manual operator is on site to oversee the printing process. Surgicase updates the status of the printing process within the program. After the printing process has completed, Quality Control (QC) begins. Link3D Work Plan tracks the QC and sterilization packing steps, and outputs a form to indicate whether QC has been passed. The sterile package is sent to the physician, along with the packing slip and shipping invoice generated by the Link3D Shipping System. The package is sent to the physician by an indicated type of delivery, with a configurable form input in the Link3D Order Entry System.

[0050] Upon receipt, the physician manually determines that the product corresponds to the order, and confirms receipt of and correspondence to the product as ordered by indicated as such within the system. This indication triggers an invoice to the physician in the name of the patient — while the invoice is generated offline, the Link3D application stores uploaded invoices to be sent when the indication is received. Unless otherwise specified, the system will wait for 14 days for payment.

[0051] Throughout the process of requesting, producing, and delivering the implant, any errors in the system are able to be flagged as reportable events by the Link3D Quality Management System (QMS). Any reported events are sent as messages to the QMS team within the program. If the physician wants to send any feedback to the system after receiving a feedback request, that feedback is drawn up within the program and send from the doctor’s account. Meanwhile, the internal Link3D QMS reviews the entire process for reportable events. If any comments are found, adjustments to the process are made.

[0052] FIG. 2 is an exemplary flowchart of a method used to develop the implant. For example, an exemplary method 200 (e.g., steps 201 to 215) may be performed by the image analysis tool 101 automatically or in response to a request from a user (e.g., physician, surgeon, etc.).

[0053] According to one embodiment, the exemplary method 200 for determining to order additional slides may include one or more of the following steps. In step 201, the method may include receiving a collection of images from a PACS system. [0054] In step 203, the method may include displaying a target area on from an area displayed in the collection of images, the target area shown in a plurality of views within the collection of images.

[0055] In step 205, the method may include segmenting each image within the collection of images based on the target area. In step 207, the method may include displaying a list of parameters associated with the target area. In step 209, the method may include indicating an implant material associated with the target area. In step 211, the method may include overlaying one or more markups to the target area. In step 213, the method may include creating a model implant of the target area based on the one or more markups. In step 215, the method may include printing the implant model using a 3D printer under sterile conditions.

[0056] The exemplary method 200 can also use an artificial intelligence (Al) algorithm to further automate the process, making it faster and more accurate. The Al algorithm can be used to automatically segment different tissues and structures in CT scan data (or data from other imaging modalities), such as bones, organs, or blood vessels. This can help create a more accurate 3D model by separating the different components of the scan. The Al algorithm can also be used to reconstruct a 3D model from CT scan data. This process can involve taking 2D slices of the scan and combining them into a 3D model. Al algorithms can also help to optimize 3D models based on predetermined parameters as defined by the user, surgeon, or modeler. Additionally, Al can also be used to create visualizations of the 3D to aid in diagnosis and treatment planning.

[0057] FIG. 3A illustrates two exemplary patient-specific sterile implants 301 and 302, resulting from the method as disclosed. [0058] FIG. 3B illustrates an exemplary printed implant. Here, the implant 303 is shown during the printing process. A 3D printer is used to create each implant, based on the specifications provided by a physician and further modified by a skilled technician.

[0059] FIG. 4 is an exemplary workflow of producing a patient specific implant. Here, each step of the procedure is shown as occurring on the “hospital” side, the “implant producer” side (z.e., the A.D.A.M. side), or at a mutual manufacturing site, such as an A.D.A.M. manufacturing location on hospital premises. This distinction clarifies which is the acting party and can in turn better define how actors on either side view their role. In step 401, images are taken during a CT or MRI scan of the patient. These images can be uploaded to network 120, PACS, a local network, or any other means suitable for review by a physician. In step 402, the images are received at an order intake workstation. The workstation can be connected to the hospital servers. Once processed by the order intake workstation, images are sent for modelling, in step 403.

[0060] Once modelling is completed, images are sent back to the hospital side for approval or change requests in step 404. In step 405, once final model parameters and images are approved, 3D manufacturing begins at the mutual manufacturing site. With the completed implant, produced under sterile circumstances and packaged accordingly, implant surgery occurs at step 406.

[0061] FIG. 5 shows the actors within the method on both the hospital and manufacturing sides. On the hospital side, there is a surgeon 501, assistant surgeon 502, and one or more hospital officials 503. The surgeon 501 is responsible for the choice and initial design of the implant, based on the reviewed digital images of the patient’s CT or MRI scans, as well as the choice of implant materials. The assistant surgeon 502 documents file turnover, scheduling, monitoring of updates and amendments to the production order of the implant. The assistant surgeon 502 can be a nurse, administrative assistant, or other hospital employee who fulfills this function. The assistant surgeon 502 also creates the case for the patient to file information about the patient, including internal patient code, patient age, sex/gender, diagnosis, other clinical data, estimated operation date, estimated operation duration, hospital ID, surgeon ID, assistant ID, surgeon and assistant contact information, estimated shipment date, delivery address and method. The assistant surgeon 502 uploads a DICOM file with images, and indicates the set of images to establish a segmentation area before saving the case. The hospital official 503 handles any disputes stemming from the order and production of the implant. The surgeon 501 opens and reviews the case as created by the assistant surgeon 502, performing any necessary edits before sending the case to the manufacturing side as a request.

[0062] On the manufacturing side (z.e., the A.D.A.M. side), personnel includes a modeler 504, an operator 505, a receptionist 506, and a quality control manager 507. The receptionist 506 handles the processing of the surgeon’s request for the implant, as well as document turnover, scheduling, and any other interactions with the hospital side. The receptionist 506 can be an administrative aide, a project manager assigned to a specific case, etc. The modeler 504 creates the 3D design of the implant to comply with the surgeon 501 ’s request and any applicable updates to the model. The modeler 504 is only responsible for the model files generated by the modelling software. The quality control manager 507 processes the quality control workflow to ensure the finalized implant meets quality standards prior to delivery to the surgeon 501.

[0063] After the updated model is provided to the surgeon 501, the surgeon 501 can sketch the implant over the provided model and choose the implant properties.

[0064] FIG. 6 is an exemplary schematic of a production facilities plan. The production facilities can be located within a hospital or clinic setting, or external to the hospital. The facilities plan highlights where working staff, raw materials, and end products can move throughout the facilities to ensure that the procedure results in a clean, sterile, product. Material gateways and transmission windows are shown to illustrate the difference in transitions between rooms. As indicated on FIG. 6, a route through the production facility starts and ends in hallway 601. Working staff, including operators, modelers, and other administrative workers, and raw materials enter into the raw materials warehouse 602, where working staff deposits the raw materials into a “dusty” procedures chamber 604. The “dusty” procedures chambers 604 are intended for mixing powdered raw materials in specific V- shape pharmaceutical mixers and producing the printing filament from this mixed composition. The GMP class “D” requirements are the same for this room as for other operation rooms in the premises. Alternatively, working staff can enter staff gateway 603 and proceed to deposit materials into the “dusty” procedures chamber 604. In another path, staff enter inventory preparation or cleaning room 601a and deposit raw materials into the staff gateway 603. From “dusty” procedures chamber 604, raw materials are transported through a material gateway into the “clean” procedures chamber 605. The “clean” procedures chamber 605 is intended as a space where no work with raw materials is permitted. Instead, subproducts such as printing filament are used within the “clean” procedure chambers. From both the “dusty” procedures chamber 604 and the “clean” procedures chamber 605, an end product can be transported through a material gateway in the respective room into the end product warehouse 606. The end product warehouse 606 stores each product within the sterile storage area, before being transported back into hallway 601. This production plan ensures sterility throughout the production process while still enabling mobility for working staff, raw materials, and end products.

[0065] FIG. 7A-FIG. 11 illustrate the changes made to each model image as the method progresses. FIG. 7A is a target slice image highlighting a problem area to be addressed in a patient. Along with the target slice image, information about the patient including internal patient code, age, sex/gender, diagnosis, other important clinical data, estimated operation date, estimated operation duration, hospital ID, surgeon ID, assistant or administrator ID, surgeon contact information, assistant contact information, estimated shipment date, delivery address, and deliver method options. The digital image is one slice of a set of DICOM files uploaded to a workstation server, upon which a user can view each slice. The user can be the surgeon requesting the implant, or the modeler creating the model of the implant, as both of these actors have need to view DICOM images side by side. After uploading the files, the user indicates the set of images to establish the segmentation area, and indicates the set of files using a naming convention such as Casel_image2. The set of DICOM files can comprise sets of CT scan images, MRI images, or any other suitable medical images. The window opens with slice 1 of the set of images. The user can select a target slice that clearly shows the area of interest by clicking or scrolling through the set and chooses the one that matches a set of internal parameters. The user then marks up the target skeleton area 701 using a simple drawing tool. Once the area is marked up, the user saves the case and submits the image for review by a surgeon through the program.

[0066] FIG. 7B is a target slice image that is displayed to a surgeon, authorized clinical personnel, or radiologist, such as surgeon 501. The surgeon enters the system under his user account and sees the case as created in his list. The surgeon opens and reviews the case, where all data on the patient and the images is visible and is editable. If needed, the surgeon edits the case. Upon opening the file where the user marked the target skeleton area 701, the surgeon can choose another slice to indicate a second target skeleton area 702 of his choosing. The surgeon then saves the changes as desired on the image slice itself and in the case in general. If necessary, the surgeon may refine the specified parameters of the model or implant by adding those parameters to the text description. Once finished, the surgeon sends the case by selecting a send button with a pop-up disclaimer. The surgeon 501 must accept the terms in order for the case to be sent, otherwise the case remains saved but is not sent.

[0067] A receptionist, such as receptionist 506, then enters the system under his own user account. The system window shows the receptionist the newly delivered case, and clearly indicates that the particular case has not been opened or reviewed yet. Receptionist also opens to case to check for data integrity; if data integrity is not suitable, an option to return the case to the surgeon is available. In cases of doubt or in an ambiguous/controversial situation, the receptionist 506 may contact the modeler 504 about the need to return the case to the surgeon 501. Upon return, the surgeon may update the case as needed.

[0068] Should the case be unsuitable for further processing, for example, if an incorrect area is highlighted, the receptionist returns the case back to the surgeon with appropriate commentary detailing why the case is not suitable. The surgeon is notified that the case has been returned and enters the system under his user account to see the newly delivered case that has not been opened or reviewed. The surgeon is then able to open the newly delivered case, read the comments, and edits the target slice that was previously marked. Once completed, the surgeon against saves the changes and sends the image, again scrolling through the disclaimer window before the image is sent.

[0069] The receptionist can then view the updated case as delivered and recheck the data integrity. It should be clear that the updated case has not been opened or reviewed prior to opening by the receptionist. If the data integrity is verified as suitable by the receptionist, the receptionist sends the marked up case to the modeler, such as modeler 504.

[0070] FIG. 7C is an exemplary figure displayed to the modeler 504. The system window shows the modeler the newly delivered case, indicating that the case has not been opened or reviewed yet. The modeler opens the case, as well as the data set associated with the case (z.e., Casel_Image2). Based on the surgeon choice and comments, the modeler chooses a target skeleton area for segmentation. The modeler marks the target skeleton area 703 and starts the Al function to model the target skeleton area 703. The Al function involves segmenting tissue images with a common density. Data is input from defining the density range in a series of images. The output of the Al function is a volumetric image of the area with a common density, which allows for differentiation of various tissues in the volumetric range. The modeler then reviews and edits the Al-made model 704, as shown in FIG. 7D, and enters any necessary changes. The modeler then saves any changes and uploads or exports the case before closing the editor window. Back in the main case window, the modeler sees the final version of the target skeleton area model 704 as an . stl file.

[0071] At this point, the receptionist may perform a pre-check for elementary errors in the model file. The receptionist opens the case in the editor/viewer program and checks the model parameters according to an established checklist to catch any elementary errors, such as model scaling, printability of the model, material matching (especially in cases where the patient has a heightened sensitivity or allergy concerns), compliance of the model with the specification, case number, and model properties, unit matching, visual check for artifacts, and a review of the latest comments/last edits. If no errors are detected, the model is cleared to be sent to the surgeon. If errors are detected, the model is returned to the modeler for revision, with error number, text descriptions, and comments as necessary.

[0072] The target skeleton area model 704 is then sent to the surgeon, who views the updated case delivery in the system window. To edit, the surgeon opens the .stl file in the editor window and checks it for appropriateness. Using a highlighting tool, the surgeon shows the image defects or areas that do not reflect the bone structure appropriately, as shown in image 801 and images 802 of FIGs. 8A and 8B. FIGs. 8C and 8D provide an alternative view of model 804. The surgeon then sends the marked-up version of the .stl file to the modeler, who is able to also see all previous versions of the .stl file. The modeler opens the final version of the . stl file and enters the appropriate changes based on the surgeon’s notes and edits, before sending the updated case back to the surgeon.

[0073] If the surgeon opens the updated case and does not find the .stl file appropriate, the surgeon can request for a previous version of the .stl, and may add additional comments or edits to the implant model, or can provide highlighted edits on another image, such as image 901 in FIG. 9A. The surgeon also chooses an appropriate material from a provided list of appropriate materials for implants. Implant material varies with implant form and function, and depending on selected parameters by either the surgeon or the modeler, may be preselected for the implant. Once the modeler opens the case from his account, the updated .stl file is displayed in the editor window, or possible in the editor program (such as Mimics). Here, the modeler can create the implant model manually, such as manually created model implant 902 in FIG. 9B. This model is then saved and sent back to the surgeon for review. The surgeon then marks any implant defects or implant areas that require attention and remodeling, for example the indicated areas in image 903 in FIG. 9C. The modeler, upon receipt of the most recent edits from the surgeon, can manually adjust the implant model to reflect the highlighted edits, as shown in model implant image 904 in FIG. 9D. The established timeframe for modeling the typical implant model of simple to moderate complexity may range from 2 to 16 working hours. The modelling of advanced and/or complex implant models may take up to 5 business days, depending on the complexity of the model. This final version of the model implant is then approved by the surgeon, who saved the latest version of the .stl file; the approval option is available only if there are no other changes of implant model or comments. This step represents approval of the entire case file. [0074] Upon approval of the case, the receptionist views the newly updated case in the system window. It should be clearly demonstrated that this particular case is awaiting appointment for printing site. The receptionist opens the case and appoints an appropriate printing site. At the selected appropriate printing site, the operator enters the system to see the newly delivered case, clearly indicated as awaiting an established print date. Should the operator find that a printer is not functional without any backup available, the operator immediately sends a notification to the receptionist describing the situation. Accordingly, the receptionist enters the system to find the newly updated case. It should be clearly demonstrated that the equipment malfunction issue is at the previously selected site without any operations possible at that site. The receptionist then decides regarding the repair work and establishes an estimated delay of operation. Based on this decision, the reception can transfer the print operation to another site. At the second site, a second operator is able to view the newly delivered case, which is indicated as awaiting a print date.

[0075] If the operator determines that there is not enough of the selected material to complete printing of the model, the operator immediately notifies the receptionist. The receptionist then sends a request to the logistics department stating the issue. A logistics inventory operator, upon receiving the request and estimated delivery date and time, determines from a vendor whether enough raw material is available and establishes an estimated delivery date to the printing site. If the estimated raw material delivery date is significantly later than the date originally indicated by the receptionist, the inventory operator then develops a delivery task for the particular printing site and sends it to a responsible person through the system at the site as a message awaiting confirmation. The delivery task should contain a list of materials, the amount of the materials, and a list of supporting documents for any material; boxes indicating expiry date and batch number to be filled by the operator; a box for amount delivered for every raw material; a field to describe the cause of possible change or deviation for every material to be filled by the inventory operator; a list of documents, with an option for an associated quality department to expand the list upon request; supplier quality system ISO certificate; a CoA; material safety data sheet (MSDS); total dissolved solids (TDS); waybill or consignment; and specification. The list of raw materials can include, but is not limited to: polycaprolactone (PCL); polylactide (PLA); bioglass (45S5 or other bioglass formula); polypropylene (PP); polyvinylacetate (PVA); Polyether ether ketone (PEEK) and co-polymers; FiberTuff polymer product; Agrius product; and secondary materials including but not limited to lysoformin and ethanol. Upon receipt of the documents and materials, the inventor operator sends a report to the receptionist indicating the new delivery date.

[0076] In response, the receptionist enters the system to view the newly updated case. It should be clearly demonstrated that the new delivery date for raw material for the particular site has been established and is significantly later. The receptionist enters the new data for the case and sends it to surgeon for approval of the new shipment date. The updated case should clearly demonstrate the need to approve the new shipment date. Using the alternative manual tools, the surgeon can send the updated case to an appropriate hospital officer for further approval of the new shipment date. Upon approval by all relevant parties, the receptionist sends the approved case with the new date to the operator.

[0077] When the operator receives the raw materials, the operator will indicate as such in the system under the delivery task option, filling in the appropriate box in the delivery task for every raw material. The operator also visually inspects the primary and secondary packaging for any defects, pollutants, labeling, and delivery conditions. The operator then marks the respective lines in the delivery task for every delivery item as compliant or non- compliant. If the operator enters the delivery as non-compliant, a cause indicating the non- compliant issue must be indicated.

[0078] An example non-compliant delivery occurs when the amount delivered is significantly different from the expected delivery. The system should clearly demonstrate to the operator that there is a discrepancy between the expected and delivered amounts of material. The operator then saves the delivery tasks; the system in response indicates that the delivery task is not completed. An associated logistics department and quality department should have constant access to the latest version of the delivery task at any time point until the task is closed. The operator can send a notification to both the logistics department and the quality department. From this notification, the inventory operator can see and open the newly updated delivery task, and the reason for the non-compliance indicator. In response to the indicator, the inventory operator can change the expected amount for a particular material by adding a new line containing the name of particular material and a negative value for correction of the discrepancy, and can choose a cause of correction action from a list of reasons. The inventory operator then concludes the action by saving the delivery task, which is clearly indicated as not requiring any more logistics-related actions.

[0079] The quality manager can also address issues of non-compliant delivery. The quality manager can see and open the newly updated delivery task, where the system clearly demonstrates the changes made by the logistics operator. For example, one particular delivery item, the quality manager sees the non-compliance indicator. After analyzing the cause, the quality manager can pass or reject the particular delivery item. The quality manager reviews the list of documents and each document uploaded for every particular raw material. If the document is compliant, the quality manager marks it as such. If the quality manager sees that a document is non-compliant, the quality manager can delete the incompliant version of the particular document and upload a corrected version of the document. The quality manager marks the newly uploaded version of the document as the compliant version of the document. For example, if the quality manager sees that different types of documents are missing for two particular materials, the quality manager can upload a missing document for the first material and marks that the document is compliant. If the quality manager considers the situation critical for raw material two, the quality manager can mark the field for the document as non-compliant (z.e., issue a reject flag). If the amount and the documents are compliant, the delivery task is then closed and the message is sent to the printing site clearly stating that particular batches of raw materials can be used for printing. The closed delivery task automatically indicates the compliant batches, and clearly indicates their expiry dates. If a reject flag is issued, the delivery task is closed and the reject task is automatically formed. The quality manager opens the reject task and uploads the newly formed rejection act for the particular batch raw material and the particular delivery item. The task may include a cause; full name of raw material; batch number; amount of raw material; manufacturer and shipper; signature of the person responsible for the rejection, etc. In some cases, the quality manager sends the reject task to the operator. The operator opens the delivery task for a particular delivery and sees that it is compliant and closed with one material rejected and one delivery item rejected. The operator can close the delivery task and opens the reject task. The reject task clearly indicates the particular raw material name, account, and batch number. Operator reacts accordingly to the reject task and marks any actions taken in the appropriate field. If all fields of the reject task are complete it goes to the inventory operator automatically. The inventory operator then acts accordingly to the reject task, saves it, and sends it to the operator. The operator opens the reject task and completes any appropriate actions indicated.

[0080] The operator then enters the supporting documents for the raw materials into the delivery tasks. The operator first collects all supporting documents for the party delivered and enters the expiration dates for all batches of raw materials. Several batches for the same raw materials can be present in the delivery task (and several expiration dates, respectively). Under the related user account, the operator uploads all copies of necessary types supporting documents for each raw material as outlined in the delivery task. As shown in the example above, the operator failed to upload one document type. If not all necessary documents are uploaded, the system clearly demonstrates that: not all documents are uploaded for a particular material and that the delivery task is not completed yet. The operator then checks certificates for the raw materials and verifies the following: conformity of the documents list; compliance of batch numbers; and expiration dates for raw materials. The operator then enters the results into the delivery task. If the available amount of raw materials is ok and the functionality of the equipment is ok, then the operator is ready to print. The printed implant is shown in transparent sterile packaging, which enables visual control with supporting documentation, in FIGs. 11A-B, and modelled as implanted in FIG. 10.

[0081] To sterilize the product, the operator checks the conformity of the printed and verified final version of the 3D model of the implementation. The operator performs a 3D scan of the printed implant, and opens the quality control software to upload the 3D scan of the printed implant and the model. Surface deviation between the scan of the printed implant and the model is determined; if an acceptable deviation level is observed, the operator proceeds to the sterilization process. If unacceptable levels of deviation are observed, the operator contacts the quality control department and the receptionist.

[0082] The operator may sterilize the implant using the ozone sterilization system. To sterilize the implant, the operator ensures that a sterilization box is clean and all airlock hatches are closed. The operator then turns on the air supply to the sterilization box, checking the pressure drop indicators on one or more Magneholic type indicators, with pressure parameters of A 15 Pa. Once the pressure indicator show that the box is stable, the operator places the implant in the box, allows for the implant to be blown by the clean air, and moves the implant directly into the chamber. Ozone sterilization then begins. Once the sterilization cycle is complete, the sterilizing gas mixture is removed and destroyed. Once the sterilized product is finished, then the operator affixes a label and checks the integrity of the packaging. [0083] Referring now to Fig. 12, a schematic of an example of a computing node is shown. Computing node 10 is only one example of a suitable computing node and is not intended to suggest any limitation as to the scope of use or functionality of embodiments described herein. Regardless, computing node 10 is capable of being implemented and/or performing any of the functionality set forth hereinabove.

[0084] In computing node 10 there is a computer system/server 12, which is operational with numerous other general purpose or special purpose computing system environments or configurations. Examples of well-known computing systems, environments, and/or configurations that may be suitable for use with computer system/server 12 include, but are not limited to, personal computer systems, server computer systems, thin clients, thick clients, handheld or laptop devices, multiprocessor systems, microprocessor-based systems, set top boxes, programmable consumer electronics, network PCs, minicomputer systems, mainframe computer systems, and distributed cloud computing environments that include any of the above systems or devices, and the like.

[0085] Computer system/server 12 may be described in the general context of computer system-executable instructions, such as program modules, being executed by a computer system. Generally, program modules may include routines, programs, objects, components, logic, data structures, and so on that perform particular tasks or implement particular abstract data types. Computer system/server 12 may be practiced in distributed cloud computing environments where tasks are performed by remote processing devices that are linked through a communications network. In a distributed cloud computing environment, program modules may be located in both local and remote computer system storage media including memory storage devices.

[0086] As shown in Fig. 12, computer system/server 12 in computing node 10 is shown in the form of a general-purpose computing device. The components of computer system/server 12 may include, but are not limited to, one or more processors or processing units 16, a system memory 28, and a bus 18 that couples various system components including system memory 28 to processor 16.

[0087] Bus 18 represents one or more of any of several types of bus structures, including a memory bus or memory controller, a peripheral bus, an accelerated graphics port, and a processor or local bus using any of a variety of bus architectures. By way of example, and not limitation, such architectures include Industry Standard Architecture (ISA) bus, Micro Channel Architecture (MCA) bus, Enhanced ISA (EISA) bus, Video Electronics Standards Association (VESA) local bus, Peripheral Component Interconnect (PCI) bus, Peripheral Component Interconnect Express (PCIe), and Advanced Microcontroller Bus Architecture (AMBA).

[0088] Computer system/server 12 typically includes a variety of computer system readable media. Such media may be any available media that is accessible by computer system/server 12, and it includes both volatile and non-volatile media, removable and nonremovable media.

[0089] System memory 28 can include computer system readable media in the form of volatile memory, such as random access memory (RAM) 30 and/or cache memory 32. Computer system/server 12 may further include other removable/non-removable, volatile/non-volatile computer system storage media. By way of example only, storage system 34 can be provided for reading from and writing to a non-removable, non-volatile magnetic media (not shown and typically called a "hard drive"). Although not shown, a magnetic disk drive for reading from and writing to a removable, non-volatile magnetic disk (e.g., a "floppy disk"), and an optical disk drive for reading from or writing to a removable, non-volatile optical disk such as a CD-ROM, DVD-ROM or other optical media can be provided. In such instances, each can be connected to bus 18 by one or more data media interfaces. As will be further depicted and described below, memory 28 may include at least one program product having a set (e.g., at least one) of program modules that are configured to carry out the functions of embodiments of the disclosure.

[0090] Program/utility 40, having a set (at least one) of program modules 42, may be stored in memory 28 by way of example, and not limitation, as well as an operating system, one or more application programs, other program modules, and program data. Each of the operating system, one or more application programs, other program modules, and program data or some combination thereof, may include an implementation of a networking environment. Program modules 42 generally carry out the functions and/or methodologies of embodiments as described herein.

[0091] Computer system/server 12 may also communicate with one or more external devices 14 such as a keyboard, a pointing device, a display 24, etc.; one or more devices that enable a user to interact with computer system/server 12; and/or any devices (e.g., network card, modem, etc.) that enable computer system/server 12 to communicate with one or more other computing devices. Such communication can occur via Input/Output (VO) interfaces 22. Still yet, computer system/server 12 can communicate with one or more networks such as a local area network (LAN), a general wide area network (WAN), and/or a public network (e.g., the Internet) via network adapter 20. As depicted, network adapter 20 communicates with the other components of computer system/server 12 via bus 18. It should be understood that although not shown, other hardware and/or software components could be used in conjunction with computer system/server 12. Examples, include, but are not limited to: microcode, device drivers, redundant processing units, external disk drive arrays, RAID systems, tape drives, and data archival storage systems, etc.

[0092] The present disclosure may be embodied as a system, a method, and/or a computer program product. The computer program product may include a computer readable storage medium (or media) having computer readable program instructions thereon for causing a processor to carry out aspects of the present disclosure.

[0093] The computer readable storage medium can be a tangible device that can retain and store instructions for use by an instruction execution device. The computer readable storage medium may be, for example, but is not limited to, an electronic storage device, a magnetic storage device, an optical storage device, an electromagnetic storage device, a semiconductor storage device, or any suitable combination of the foregoing. A non- exhaustive list of more specific examples of the computer readable storage medium includes the following: a portable computer diskette, a hard disk, a random access memory (RAM), a read-only memory (ROM), an erasable programmable read-only memory (EPROM or Flash memory), a static random access memory (SRAM), a portable compact disc read-only memory (CD-ROM), a digital versatile disk (DVD), a memory stick, a floppy disk, a mechanically encoded device such as punch-cards or raised structures in a groove having instructions recorded thereon, and any suitable combination of the foregoing. A computer readable storage medium, as used herein, is not to be construed as being transitory signals per se, such as radio waves or other freely propagating electromagnetic waves, electromagnetic waves propagating through a waveguide or other transmission media (e.g., light pulses passing through a fiber-optic cable), or electrical signals transmitted through a wire.

[0094] Computer readable program instructions described herein can be downloaded to respective computing/processing devices from a computer readable storage medium or to an external computer or external storage device via a network, for example, the Internet, a local area network, a wide area network and/or a wireless network. The network may comprise copper transmission cables, optical transmission fibers, wireless transmission, routers, firewalls, switches, gateway computers and/or edge servers. A network adapter card or network interface in each computing/processing device receives computer readable program instructions from the network and forwards the computer readable program instructions for storage in a computer readable storage medium within the respective computing/processing device.

[0095] Computer readable program instructions for carrying out operations of the present disclosure may be assembler instructions, instruction-set-architecture (ISA) instructions, machine instructions, machine dependent instructions, microcode, firmware instructions, state-setting data, or either source code or object code written in any combination of one or more programming languages, including an object oriented programming language such as Smalltalk, C++ or the like, and conventional procedural programming languages, such as the “C” programming language or similar programming languages. The computer readable program instructions may execute entirely on the user’s computer, partly on the user’s computer, as a stand-alone software package, partly on the user’ s computer and partly on a remote computer or entirely on the remote computer or server. In the latter scenario, the remote computer may be connected to the user’s computer through any type of network, including a local area network (LAN) or a wide area network (WAN), or the connection may be made to an external computer (for example, through the Internet using an Internet Service Provider). In some embodiments, electronic circuitry including, for example, programmable logic circuitry, field-programmable gate arrays (FPGA), or programmable logic arrays (PLA) may execute the computer readable program instructions by utilizing state information of the computer readable program instructions to personalize the electronic circuitry, in order to perform aspects of the present disclosure. [0096] Aspects of the present disclosure are described herein with reference to flowchart illustrations and/or block diagrams of methods, apparatus (systems), and computer program products according to embodiments of the disclosure. It will be understood that each block of the flowchart illustrations and/or block diagrams, and combinations of blocks in the flowchart illustrations and/or block diagrams, can be implemented by computer readable program instructions.

[0097] These computer readable program instructions may be provided to a processor of a general purpose computer, special purpose computer, or other programmable data processing apparatus to produce a machine, such that the instructions, which execute via the processor of the computer or other programmable data processing apparatus, create means for implementing the functions/acts specified in the flowchart and/or block diagram block or blocks. These computer readable program instructions may also be stored in a computer readable storage medium that can direct a computer, a programmable data processing apparatus, and/or other devices to function in a particular manner, such that the computer readable storage medium having instructions stored therein comprises an article of manufacture including instructions which implement aspects of the function/act specified in the flowchart and/or block diagram block or blocks.

[0098] The computer readable program instructions may also be loaded onto a computer, other programmable data processing apparatus, or other device to cause a series of operational steps to be performed on the computer, other programmable apparatus or other device to produce a computer implemented process, such that the instructions which execute on the computer, other programmable apparatus, or other device implement the functions/acts specified in the flowchart and/or block diagram block or blocks.

[0099] The flowchart and block diagrams in the Figures illustrate the architecture, functionality, and operation of possible implementations of systems, methods, and computer program products according to various embodiments of the present disclosure. In this regard, each block in the flowchart or block diagrams may represent a module, segment, or portion of instructions, which comprises one or more executable instructions for implementing the specified logical function(s). In some alternative implementations, the functions noted in the block may occur out of the order noted in the figures. For example, two blocks shown in succession may, in fact, be executed substantially concurrently, or the blocks may sometimes be executed in the reverse order, depending upon the functionality involved. It will also be noted that each block of the block diagrams and/or flowchart illustration, and combinations of blocks in the block diagrams and/or flowchart illustration, can be implemented by special purpose hardware-based systems that perform the specified functions or acts or carry out combinations of special purpose hardware and computer instructions.

Claims

What is claimed:

1. A method of producing a patient-specific implant, the method comprising: receiving a collection of images from a PACS system; selecting a target area on from an area displayed in the collection of images, the target area shown in a plurality of views within the collection of images; segmenting each image within the collection of images based on the target area; displaying a list of parameters associated with the target area; indicating an implant material associated with the target area; overlaying one or more markups to the target area; creating a model implant of the target area based on the one or more markups; and printing the implant model using a 3d printer under sterile conditions.

2. The method of claim 1, wherein receiving images comprises receiving a series of DICOM files from a storage server.

3. The method of claim 1, further comprising receiving patient data associated with the images.

4. The method of claim 1, wherein creating the model implant comprises running an artificial intelligence (Al) algorithm to create the model based on the overlayed markups to the target areas.

5. The method of claim 4, wherein the Al algorithm automatically segments one or more different tissues and structures in a CT scan data to create the model.

6. The method of claim 4, wherein the Al algorithm reconstructs a 3D model from a CT scan data to create the model.

7. The method of claim 6, wherein Al algorithm reconstructs a 3D model comprises: taking a series of 2D slices of the CT scan; and combining the series of 2D slices to create a 3D model.

8. The method of claim 4, wherein the Al algorithm optimizes the 3D model based on predetermined parameters to create the model.

9. The method of claim 4, wherein the Al algorithm creates a visualization of the 3D model for treatment and diagnosis planning.

10. The method of claim 1, wherein displaying the list of parameters associated with the target area comprises displaying measurements, material properties, and patient history associated with the target area.

11. The method of claim 1, wherein the implant material is a resorbable polymer.

12. The method of claim 1, wherein the implant material is a biocompatible non- resorbable polymer.

13. The method of claim 1, further comprising outputting the printed implant into a sterile packaging.

14. The method of claim 1, further comprising: displaying the overlayed markup on the target area; overlaying additional layers onto the target area; removing one or more of the additional layers; and receiving approval for the model implant image.

15. A computer program product for producing a patient-specific implant, the computer program product comprising a computer readable storage medium having program instructions embodied therewith, the program instructions executable by a processor to cause the processor to perform a method comprising the method of claim 1.

16. A system for producing a patient-specific implant, the system comprising: a computing node comprising a computer readable storage medium having program instructions embodied therewith, the program instructions executable by a processor of the computing node to cause the processor to perform a method comprising the method of claim 1.