Patent Application
20210213684
The present disclosure relates to a construction method for customization of modular bone plates based on additive manufacturing with which modularized medical bone plates are constructed and a construction system for customization of modular bone plates based on additive manufacturing through which the construction method is practically implemented.
Bone plates (also known as steel sheets) are common medical devices in treatment to fractures or osteomiosis. In the existing practice, a patient's injury part should be scanned in a hospital according to computed tomography (CT) through which CT images are produced; then, a technician has to create a separate skeleton module for the patient and prepare off-the-shelf bone plates with respect to the skeleton module for a surgery operation. The same procedure applicable to each patient without exception is time-consuming during the early stage to create the skeleton module.
However, for a specific bone position (for example, proximal or distal humerus, distal femur, proximal or distal tibia, or pelvis), a single or a few off-the-shelf bone plates with an identical shape but a longer or shorter length only are attainable.
Particularly, the length and/or the position of a bone plate to be used and each screw's length to be measured during hole-drilling are subject to a surgeon's decision in a surgery operation. Accordingly, a standard bone plate (which is a standardized 2-dimensional part not completely matching the shape of a dissected part at a patient and folded for better flexibility as required) should be bent during a surgery operation. However, bending a bone plate takes long time during which a bone plate hardly fits a bone position once.
Moreover, standardized bone plates possibly shorter in length and combined with each other are characteristic of inconsistent mechanical strengths. In particularly, a surgery operation for two bone plates mounted on a limited position is more difficult than expected.
Because a human skeleton is modified within a reasonable extent, a great number of bone plate modules should be created for a surgeon who can select appropriate bone plate modules for a patient directly without excessive time consumed during the early stage of creating the skeleton module. In the present disclosure, a construction method for customization of modular bone plates based on additive manufacturing and a construction system thereof are a solution with an additive manufacturing technology integrated for fast customized manufacturing of bone plates as required.
A construction method for customization of modular bone plates based on additive manufacturing and a construction system thereof in the present disclosure have the potential to develop a “Build to Oder (BTO)” model that features a design easily modified on a computer interface before manufacturing for no need to stock up spared bond plates in a traditional model.
A construction method for customization of modular bone plates based on additive manufacturing in the present disclosure for treatment to fractures or osteomiosis by bone plates comprises steps as follows: step A: a plurality of bone plate modules are separated and simulated in software based on positions, areas and frequency of uses for off-the-shelf bone plates mounted on the human skeleton such that a great quantity of bone plate modules referring to various categorized body types are classified and each of the bone plate modules is saved as a transmittable and readable file one by one; step B: a file for each of the bone plate modules is categorized and saved in a database in which files about the human skeleton for various body types matched by the bone plate modules and files about screws with different sizes fitting the bone plate modules are saved simultaneously; step C: medical images for patients' fractures or osteomiosis are collected for simulations of medical images in an analysis unit connected with the database and files for the human skeleton, which are most approximate to the medical images and extracted from the database, as well as the bone plate modules corresponding to the human skeleton are compared and analyzed in the analysis unit with which an injury part and extent is recognized through comparisons and bone plates for the injury part and extent are further estimated and displayed to a user who will evaluate a surgery operation by severity of injury through the medical images and determine bone plates for the injury part and extent as well as screw with different sizes for the bone plate modules; step D: a combination of the bone plate modules and the screws with different sizes corresponding to the bone plate modules for a surgery operation are determined by a user who has read analyzed results of the analysis unit on an operation interface, selected through the operation interface, and transmitted to a remote manufacturing center by a processing unit;
Specifically, the medical images for a patient's fractures or osteomiosis are CT, MRI or X-ray images.
Specifically, the analysis unit in step C, which is used to identify an injury part and extent by checking and comparing medical images of a patient's fractures or osteomiosis, design and preset a group of bone plate modules according to severity of fractures automatically through introduction of intelligence analysis, estimate screws with different sizes for the bone plate modules early, and collect all data selected on the operation interface for integrated analysis, contributes to more accurate bone plate modules preset automatically than expected.
Specifically, the analysis unit in step C provides a surgeon with analyzed results which consist of synthesized actual medical images, intelligible reorganized medical images, or files for the human skeleton extracted from the database, all of which are freely selected by a user.
Specifically, either a single bone plate module or a combination of at least two optional bone plate modules for large-area coverage is available in step D.
Specifically, all bone plate modules, files about the human skeleton for various body types, and screws with different sizes to match the bone plate modules in step B are numbered for easy recognition and check in following steps including step D and step E.
Specifically, files for all selected bone plate modules and screws with different sizes, both of which have been received by the manufacturing center, are transmitted to an additive manufacturing apparatus for production and output of finished bone plates with curved surfaces on a basis of an additive manufacturing technology in step E after step D such that both the bone plates and prepared screws are provided to a user.
A construction system for customization of modular bone plates based on additive manufacturing in practice of the construction method for customization of modular bone plates based on additive manufacturing comprises at least a configuration platform and a manufacturing center. The configuration platform is provided with a import data unit, a database, an analysis unit, a processing unit and an operation interface wherein: the import data unit is used to read a medical image; the database is used to save a plurality of files for bone plate modules, a plurality of files about the human skeleton for various body types matched by the bone plate modules, and a plurality of files about screws with different sizes fitting the bone plate modules; the analysis unit which is connected with the import data unit, the database, the processing unit and the operation interface is used to select data in the database and compare the data with medical images in the import data unit for analysis of an injury part and display of analyzed results on the operation interface from which all bone plate modules and corresponding screws for a surgery operation are selected by a user and sent to the processing unit. The manufacturing center connected with the processing unit is interiorly provided with an additive manufacturing apparatus with which each bone plate module is output based on an additive manufacturing technology and practically manufactured as a finished bone plate with a curved surface.
In a preferred embodiment, the analysis unit is interiorly provided with an intelligence analysis module through which a group of bone plate modules based on analyzed results of the analysis unit for status of fractures are preset automatically as required.
In a preferred embodiment, the intelligence analysis module is used to estimate screws with different sizes for the bone plate modules.
In a preferred embodiment, the medical images are CT, MRI or X-ray images.
The technical details, features and effects of a construction method for customization of modular bone plates based on additive manufacturing and a system thereof are clearly presented in preferred embodiments and accompanying drawings herein.
In the present disclosure, a construction method for customization of modular bone plates based on additive manufacturing in which a bone plate is prepared for treatment to fractures or osteomiosis comprises steps as follows:
Step A: a plurality of bone plate modules are separated and simulated in software based on positions, areas, frequency of uses and service efficiency for off-the-shelf bone plates mounted on the human skeleton such that a great quantity of bone plate modules referring to various categorized body types are classified and each of the bone plate modules is saved as a transmittable and readable file one by one;
Step B: a file for each of the bone plate modules is categorized and saved in a database in which files about the human skeleton for various body types matched by the bone plate modules and files about screws with different sizes fitting the bone plate modules are saved simultaneously;
Step C: medical images (for example, CT, MRI or X-ray images) for patients' fractures or osteomiosis are collected for simulations of medical images in an analysis unit connected with the database; files for the human skeleton, which are most approximate to the medical images and extracted from the database, and the bone plate modules corresponding to the human skeleton are compared and analyzed in the analysis unit with which an injury part and extent is recognized through comparisons and bone plates for the injury part and extent are further estimated and partially displayed to a surgeon who will evaluate a surgery operation by severity of injury through the medical images and determine bone plates for the injury part and extent as well as screw with different sizes for the bone plate modules;
Step D: a combination of the bone plate modules and the screws with different sizes corresponding to the bone plate modules for a surgery operation are determined by a surgeon who has read analyzed results of the analysis unit on an operation interface, selected through the operation interface, and transmitted to a remote manufacturing center by a processing unit; and
Step E: files for all bone plate modules and screws with different sizes, both of which have been received by the manufacturing center, are transmitted to an additive manufacturing apparatus from which bone plate products with curved surfaces are produced and the finished bone plates as well as prepared screws with different sizes are delivered to a surgeon who is ready to perform a surgery operation.
As shown below, a hypothetical example is presented for explanations and practices of the above steps:
A: A patient in an emergency case is first diagnosed with suspected osteomiosis;
B: The routine checks including computed tomography (CT) , Magnetic Resonance Imaging (MRI) or X-ray are conducted and scanned medical images are transmitted to an analysis unit and a surgeon for step C;
C: A surgery operation is evaluated by the surgeon who inspects severity of injury from medical images and determines bone plates for an injury part and extent as well as screws with different sizes for the bone plate modules;
D: An operation interface from which the analysis unit is accessed controllably and results in stage C are displayed is available to the surgeon, as shown in
E: The combination of bone plate modules as well as screws, configured and selected in stage D (
F: A surgery operation is performed forthwith.
In a construction method for customization of modular bone plates based on additive manufacturing in the present disclosure, the analysis unit in step C is used to identify an injury part and extent by checking and comparing medical images of a patient's fractures or osteomiosis, design and preset a group of bone plate modules according to severity of fractures automatically through introduction of intelligence analysis, and estimate screws with different sizes for the bone plate modules early. Accordingly, both a combination of bone plate modules and screws with different sizes are quickly selected by a surgeon who has reviewed analyzed results of the analysis unit on the operation interface.
Because all data for bone plate modules and screws are selected on the operation interface for integrated analysis by the analysis unit, the accuracy of the bone plate modules preset automatically will be promoted gradually for easy operation of the medical staff or ordinary operators in addition to surgeons in days to come.
In a construction method for customization of modular bone plates based on additive manufacturing in the present disclosure, the analysis unit in step C provides a surgeon with analyzed results which consist of synthesized actual medical images, intelligible reorganized medical images, or files for the human skeleton extracted from the database, all of which are freely selected by the surgeon.
In a construction method for customization of modular bone plates based on additive manufacturing in the present disclosure, the bone plate module for a pelvis in an embodiment as shown in
In a construction method for customization of modular bone plates based on additive manufacturing in the present disclosure, all bone plate modules, files about the human skeleton for various body types, and screws with different sizes to match the bone plate modules in step B are numbered for easy recognition and check in following steps including step D and step E.
Referring to
In the construction system for customization of modular bone plates based on additive manufacturing, the configuration platform 1 comprises a import data unit 11, a database 12, an analysis unit 13, a processing unit 14 and an operation interface 15: the import data unit 11 is used to read a medical image A (a CT, MRI or X-ray image in general); the database 12 is used to save a plurality of files for bone plate modules B, a plurality of files about the human skeleton C for various body types matched by the bone plate modules B, and a plurality of files about screws D with different sizes fitting the bone plate modules B; the analysis unit 13 which is connected with the import data unit 11, the database 12, the processing unit 14 and the operation interface 15 is used to select data in the database 12 and compare the data with images in the import data unit 11 for analysis of an injury part and display of analyzed results on the operation interface 15 from which all bone plate modules B and corresponding screws D for a surgery operation are selected by an operator and sent to the processing unit 14.
In the construction system for customization of modular bone plates based on additive manufacturing, the manufacturing center 2 connected with the processing unit 14 is used to receive instructions from the processing unit 14 for preparation of medical devices for a surgery and provided with an additive manufacturing apparatus with which each bone plate module B is output on the basis of an additive manufacturing technology and practically manufactured as a finished bone plate with a curved surface.
Referring to
Compared with prior arts, a construction method for customization of modular bone plates based on additive manufacturing and a construction system thereof provided in the present disclosure features advantages as follows:
The preferred embodiments hereof are not taken as examples to restrict the scope of a construction method for customization of modular bone plates based on additive manufacturing and a construction system thereof in the present disclosure. Any equivalent change and/or modification made by the skilled persons who familiarize themselves with the above technical features and embodiments without departing from the spirit and scope of the present disclosure should be covered in claims of the patent specification.
