Method of implementing an orthotic brace

Abstract

A method (100) for designing an orthopedic brace for a part (A) of a patient's body; the method initially provides a step (110) of determining the part (A) of the body to which the orthopedic brace will be applied; then provides a step (120) for identifying a general 3D model (H1) relative to the part (A) of the patient's body to which the orthopedic brace will be applied; then provides a step (130) for acquiring a 3D image (K) of the part (A) of the patient's body and a step (140) for detecting biometric data (B) of the part (A); and finally provides a step (150) for modeling the general 3D model (H1) by merging the general 3D model (H1) with the 3D image (K), thereby obtaining a 3D model modeled based on the morphology of the part (A) of the patient's body.

Description

Technical Field

[0001] This patent application relates to a design method and implementation method of an orthopedic brace.

[0002] In particular, the application field of this industrial invention patent application is the medical field for realizing orthopedic braces for fixing limbs or anatomical sites after fractures or for realizing implantable internal prostheses. Background Technology

[0003] As is well known, limb fractures are usually treated with traditional plaster casts to immobilize the injured or fractured limb or anatomical location.

[0004] Such a solution is not ideal for patients because plaster casts applied to injured or fractured limbs are not waterproof and can cause excessive sweating, skin irritation, and unpleasant odors. Furthermore, plaster casts are very heavy and cumbersome, hindering patients' freedom of movement and preventing them from leading a normal lifestyle.

[0005] Inventors, doctors, and engineers have been working for years to find a better solution than plaster based on existing technology.

[0006] Another solution is to use universal braces that can be purchased at orthopedic medical supply stores. These universal braces are very expensive, and they are not always functional and suitable for all types of injuries or fractures.

[0007] Suppliers of the aforementioned traditional braces must maintain large stock to provide various sizes to meet the needs of users of different body types.

[0008] Another solution is to create a custom 3D-printed scaffold, which is extremely difficult to manufacture and requires a long production time. More precisely, this custom scaffold is used to scan the injured area of ​​the body to obtain a 3D image. Designers or professional users then use CAD software to modify such a 3D image to obtain a 3D prototype of the scaffold. Modifying the 3D image by the designer or professional user is an extremely lengthy and complex operation. Clearly, such a long processing time is incompatible with patients who urgently need such a scaffold.

[0009] WO2017127887A1 discloses a method and system for producing a digital model of a customized device, comprising the following steps: importing a first digital file of a base component; importing a second digital file of a target shape; determining a warping interpolation function based on the source point position associated with the base component and the target point position associated with the target shape; and applying the warping interpolation function to the points of the base component to generate a model of the customized device.

[0010] US2015328016A1 discloses a custom modular device and a method for manufacturing the custom device, the method comprising marking the body with reference points and / or other markers. Multiple images of the body are then obtained from multiple angles. These images are used to determine the body's contour, while other markers are positioned and used to design a scaffold having an inner surface corresponding to the body's contour. The custom modular scaffold is manufactured as multiple components that are detachably connected together and removed as the patient recovers. Summary of the Invention

[0011] The purpose of this invention is to overcome the shortcomings of the prior art and disclose a design method for orthopedic braces, which can be used to quickly and conveniently design orthopedic braces for patients.

[0012] Another object of the present invention is to disclose a method for implementing an orthopedic brace, which allows for the quick and easy implementation of a customized orthopedic brace for a patient.

[0013] These objectives are achieved according to the invention having the features of the appended independent claim 1.

[0014] Advantageous embodiments are revealed in the dependent claims.

[0015] The method according to the invention is defined by claim 1. Attached Figure Description

[0016] For clarity, please continue to refer to Figure 1 A description of the design and implementation methods of the orthopedic stent according to the present invention, Figure 1 This is for illustrative and not restrictive purposes only; the aforementioned Figure 1 This is a flowchart illustrating the implementation method of the orthopedic brace according to the present invention.

[0017] refer to Figure 1 The invention discloses a design method for an orthopedic brace according to the invention, denoted by reference numeral 100, and a method for implementing the orthopedic brace, denoted by reference numeral 200. Detailed Implementation

[0018] The orthopedic brace designed using the above design method 100 and implemented using the implementation method 200 is suitable for application on part A or limb of a patient's body to temporarily fix part A of the body and thus cure part A of the body.

[0019] The orthopedic brace design method 100 provides a determination step 110 in which a physician or professional determines part A of the patient's body where the orthopedic brace will be applied.

[0020] After identifying the part A of the patient's body, identification step 120 is performed, wherein a general 3D model H1 of the part A of the patient's body to which the stent is to be applied is determined in a 3D model database.

[0021] The database contains multiple generic 3D models H1, each corresponding to a given body part A and a specific type of injury or fracture.

[0022] The generic 3D model H1 stored in the database was previously implemented and loaded by doctors, biomedical engineers, 3D modeling designers, or professional operators.

[0023] Preferably, each generic 3D model H1 stored in the 3D model database comprises multiple basic units, which are connected to each other to define the generic 3D model H1. The basic units of the generic 3D model H1 are arranged such that they define dividing lines between adjacent basic units that coincide with the stress lines and fracture lines of the generic 3D model H1.

[0024] After identifying the general 3D model H1 corresponding to part A of the patient's body, the acquisition step 130 is performed by the 3D image acquisition device to acquire the 3D image K of part A of the patient's body to which the orthopedic brace is to be applied.

[0025] Preferably, the acquisition step 130 is performed using any imaging diagnostic process such as X-ray, CT, CAT, MRI equipment, 3D scanner, laser scanner, etc.

[0026] Alternatively, the acquisition step 130 can be performed by one or more cameras that generate 2D photographs of part A of the patient's body from different viewpoints and angles.

[0027] If the acquisition step is performed by taking multiple 2D photographs generated by one or more cameras, then a step of reconstructing a 3D image from the 2D photographs must be performed. In this step of reconstructing the 3D image, a photogrammetric technique called Structure for Motion (SFM) is preferably used. This is a computer vision technique for generating 3D models from 2D photographs, where objects are framed from multiple viewpoints and different rotation angles.

[0028] This photogrammetric technique for performing the step of reconstructing the 3D image K provides the following steps:

[0029] - Extract features (key points) from 2D photographic images; the features are points in other 2D photographic images of the same object that are likely to be identified; for example, the features may be angles, corner points, or sharp color variations in the 2D photographic images.

[0030] - Match features in each pair of 2D photographic images;

[0031] - Calculate the camera position and photographic parameters for each 2D photographic image to locate features in 3D space and generate a scattered cloud of points;

[0032] - Densification, in which the density of scattered clouds increases, producing dense clouds;

[0033] - Construct a continuous surface with dense cloud points to generate a "mesh", i.e., a 3D image K.

[0034] This photogrammetry technique, which allows the reconstruction of 3D images from 2D photographs, is cheaper than 3D scanning and does not require special equipment other than a regular digital camera.

[0035] The 3D image K of the injured part A of the body is stored as a 3D model in digital format.

[0036] After acquiring part A of the patient's body and generating a 3D image K, step 140 is performed to detect biometric data B of part A. In step 140, biometric data B, such as volume, length, perimeter, and curvature angle, is detected from part A of the patient's body.

[0037] To facilitate the detection step 140 of the biometric data B, an application step 135 is performed prior to the detection step 140 to apply a marker T to the skin of part A of the patient's body or to apply a visual digital marker T to the 3D image K acquired in the acquisition step 130.

[0038] If acquisition is performed using a 3D laser, laser scanner, or camera, a marker T is applied to the skin at site A prior to acquisition step 130.

[0039] For illustrative purposes, the marker T may be a PVC sticker (with different colors and shapes). The marker is coded with its color or shape to identify different parts of the body, the beginning or end of a limb, the direction of collection, the injury point, etc.

[0040] The mark T can also be used to identify the location of the holes that doctors or professionals want to have in the final orthopedic stent.

[0041] The markers can also be pre-generated and strictly stored in the database of the general 3D model H1 as known points that can be used for acquisition.

[0042] Conversely, if the 3D image comes from X-ray, CT, CAT, and / or MRI equipment, a professional operator will directly introduce a digital marker T (landmark) into the acquired 3D image K. In this case, the application step 135 will obviously be performed after the acquisition step 130.

[0043] Detection step 140 is used to calculate the relative distance and relative position between markers T, thereby determining the biometric data B (volume, length, curvature angle) of part A of the patient's body.

[0044] Modeling step 150 provides a general 3D model H1 after acquisition step 130 and detection step 140.

[0045] The modeling step 150 provides:

[0046] - Merging step, in which the general 3D model H1 is merged with the 3D image K to obtain a 3D model based on the morphology of part A of the patient's body;

[0047] -Sizing step, wherein the dimensions of the modeled 3D model are re-determined based on the biometric data B extracted in detection step 140, thereby obtaining a 3D digital prototype P of the orthopedic stent.

[0048] More precisely, during the modeling step 150, each basic unit of the general 3D model H1 is modeled and resized based on the biometric data B detected in the detection step 140.

[0049] The merging step adapts a general 3D model to a 3D image K using shape modeling algorithms combined with Active Shape Modeling (ASM), Meyer flooding, generative forest, or other suitable implementations of image recording algorithms. These algorithms are used to merge the general 3D model with the 3D image K.

[0050] Otherwise, the general 3D model H1 overlaps with the acquired or scanned 3D image K, and the general 3D model H1 is adjusted and modified based on the configuration of the acquired site and the biometric data B determined in detection step 140.

[0051] After realizing the 3D digital prototype P of the orthopedic brace, perform creation step 155 to realize the STL file or DWG file of the 3D digital prototype P that can be stored in the storage unit of a PC or smart device.

[0052] If the orthopedic brace is to be physically implemented, then after storing the 3D digital prototype P, the orthopedic brace implementation method 200 must be performed after the 3D digital prototype P is designed.

[0053] The orthopedic stent implementation method 200 provides for performing all the steps previously described in the design method and performing the following steps:

[0054] - Step 160: Importing the 3D digital prototype P into the 3D printer; In this step, the 3D digital prototype P is loaded onto software typically defined as SLICER, which sets up data and parameters for the 3D printer and saves the 3D digital prototype P in G-code format.

[0055] Step 170: Print a 3D model of the orthopedic brace using a 3D printer to obtain the orthopedic brace.

[0056] Considering that the initial universal 3D model H1 consists of multiple basic units, multiple elements are printed during printing step 170, each element corresponding to one basic unit of the initial universal 3D model H1. After printing, during assembly step 180, all elements are assembled around part A of the patient's body using adjustable fixation devices, thereby adjusting the relative positions of the elements printed in printing step 170. The ability to adjust the relative positions of the elements ensures the versatility and adjustability of the orthopedic brace to meet the patient's needs at various stages of injury.

[0057] Adjustable fasteners may include connecting screws or Archimedes screws to ensure precise adjustment.

[0058] Alternatively, the component can be secured using a single tooth, rear tooth, double tooth, dovetail, male-female coupling, or other suitable connection method.

[0059] The connection used for components may vary depending on the type of stress experienced during operation and the materials used. For illustrative purposes, if a conventional interlocking coupling is used, stress will be transmitted directly through compression after the contact surfaces are machined. If a mechanical connection is used, stress will be transmitted indirectly by inserting mechanical and / or plastic components to connect adjacent components.

[0060] Mechanical components used for indirect connection elements can be connectors (nails, pins, screws, and clips) with cylindrical rods or surface connectors (nails, rings, and toothed plates).

[0061] Preferably, the initial generic 3D model H1 stored in the database has holes.

[0062] After modeling the generic 3D model H1 in modeling step 150, the hole defines the opening of the 3D digital prototype P.

[0063] Therefore, the final orthopedic brace printed during printing step 170 also has an opening.

[0064] Such an opening can be used to approach the patient's skin, allowing the application of sensors that communicate with smartphones or other devices to detect biomedical signals and remotely monitor the patient.

[0065] Alternatively, the opening can be used to approach the patient's skin to apply a device for releasing anti-inflammatory substances, or to apply an electrode to stimulate part A of the patient's body, thereby accelerating and improving the patient's recovery.

[0066] Preferably, the final orthopedic brace printing step 170 is performed using a polymer material, such as polylactic acid (PLA), acrylonitrile butadiene styrene (ABS), allium ide, titanium (Ti Gr1), or other alloys.

[0067] Furthermore, depending on the structural, mechanical, and functional characteristics of the orthopedic stent, various polymer materials / alloys can be used to realize the orthopedic stent.

[0068] The advantages of the present invention will become apparent after the foregoing description.

[0069] In fact, the availability of a database of general 3D models H1 has greatly accelerated the design and implementation of orthopedic braces, allowing for greater diversity of orthopedic braces based on the morphology of body part A and the specific type of injury, fracture, or defect in body part A of the patient.

[0070] Furthermore, the advantages of the orthotic bracket obtained by the above-described method 200 include adjustability, perspiration wicking, rapid production and economical use, and recyclable materials.

[0071] Although this specification relates to methods for designing and implementing orthotic braces, if these methods are used to implement implantable internal prostheses that accurately reproduce lost or injured internal areas without altering joint movement, they can ensure faster and easier functional recovery. These internal prostheses can be applied to all areas of the skeleton, including facet joints and vertebrae.

[0072] Furthermore, the method can also be used to design or realize general wearable items, such as hats, bracelets, or rings, or to realize scaffolds in tissue engineering, or to realize 3D scaffolds in cell culture for the growth and proliferation of eukaryotic and / or prokaryotic cells.

[0073] Many equivalent changes and modifications can be made to the current embodiments of the invention, which are within the capabilities of those skilled in the art and in any case fall within the scope of the invention as disclosed in the appended claims.

Claims

1. A method (100) for designing an orthopedic brace suitable for a part (A) of a patient's body; the method comprising the following steps: - Step (110) of determining the part (A) of the body to which the orthopedic brace will be applied; - Step (120) to identify a generic 3D model (H1) of the patient’s body part (A) to which the orthopedic brace will be applied in a 3D model database; - Step (130) of acquiring a 3D image (K) of the part (A) of the patient's body to which the orthopedic brace will be applied using a 3D image acquisition device; - Step (140) to detect biometric data (B) of this part (A) of the patient's body to which the orthopedic brace will be applied; - A step (150) of modeling a general 3D model (H1); the modeling of the general 3D model (H1) provides a merging step, wherein the general 3D model (H1) is merged with the 3D image (K) to obtain a 3D model modeled according to the morphology of that part (A) of the patient's body; the modeling (150) also provides a sizing step, wherein the modeled 3D model is resized based on the biometric data (B) detected in the detection step (140) to obtain a 3D digital prototype (P) of the orthopedic brace. Each generic 3D model (H1) stored in the 3D model database comprises multiple interconnected basic units; wherein, in the sizing step of the modeling step (150), each basic unit of the 3D model is resized based on the biometric data (B) detected in the detection step (140); and The basic units of the general 3D model (H1) are arranged such that a dividing line is defined between adjacent basic units that coincides with the stress line and fracture line of the general 3D model.

2. The design method (100) of the orthopedic bracket according to claim 1, wherein, The generic 3D model (H1) stored in the 3D model database has holes; after the generic 3D model (H1) is modeled in the modeling step (150), the holes define the openings of the 3D digital prototype (P).

3. The method (100) for designing an orthopedic brace according to any one of the preceding claims, comprising an application step (135) prior to the detection step (140), wherein, The marker (T) is applied to the skin of the site (A) or directly to the 3D image (K) acquired in the acquisition step (130); the detection step (140) provides a calculation of the relative distance between the markers (T) to determine the biometric data (B) of the site (A) of the patient's body.

4. The design method (100) of the orthopedic brace according to any one of the preceding claims, wherein, The acquisition step (130) is performed using any imaging diagnostic process, such as X-ray, CT, CAT, MRI, 3D scanner, or laser scanner.

5. The design method (100) of the orthopedic bracket according to any one of claims 1 to 3, wherein, The acquisition step (130) is performed by one or more cameras that generate 2D photographs of the part (A) of the patient's body from different viewpoints and angles; the design method (100) provides a reconstruction step after the acquisition step (130), wherein the 3D image is reconstructed from the 2D photographs using photogrammetry.

6. The method (100) for designing an orthopedic brace according to any one of the preceding claims, comprising a creation step (155) following the modeling step (150), wherein an STL file, DWG file or similar file of the 3D digital prototype (P) is obtained.

7. A method (200) for implementing an orthopedic brace suitable for a part (A) of a patient's body; the method (200) is used to implement the steps of the design method (100) according to any one of claims 1 to 6, and to implement the following steps in sequence: - Step (160) of importing the 3D digital prototype (P) into the 3D printer; - Step (170) of printing a 3D orthopedic bracket model using the 3D model printer to obtain a 3D orthopedic bracket.

8. A method (200) for implementing an orthopedic brace suitable for a part (A) of a patient's body; the method (200) is used to implement the steps of the design method (100) according to any one of claims 2 to 6, and to implement the following steps in sequence: - Step (160) of importing the 3D digital prototype (P) into the 3D printer; - Step (170) of printing a 3D orthopedic brace using the 3D printer to obtain the 3D orthopedic brace; wherein during the printing step (170) a plurality of elements are printed, each element corresponding to a basic unit of the general 3D model (H1); - Assembly step (180), wherein the element printed during the printing step (170) is assembled around the part (A) of the patient's body by an adjustable fixing device, thereby adjusting the relative positions of the elements printed during the printing step (170).

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