CN115302757A - Novel bone fracture splint and design and manufacturing method of personalized lining thereof - Google Patents

Novel bone fracture splint and design and manufacturing method of personalized lining thereof Download PDF

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CN115302757A
CN115302757A CN202210993066.XA CN202210993066A CN115302757A CN 115302757 A CN115302757 A CN 115302757A CN 202210993066 A CN202210993066 A CN 202210993066A CN 115302757 A CN115302757 A CN 115302757A
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splint
standardized
lining
shell
affected limb
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奚小冰
周明东
刘宽
阮贝特
颜威
马泓泓
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Ruinjin Hospital Affiliated to Shanghai Jiaotong University School of Medicine Co Ltd
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    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C64/00—Additive manufacturing, i.e. manufacturing of three-dimensional [3D] objects by additive deposition, additive agglomeration or additive layering, e.g. by 3D printing, stereolithography or selective laser sintering
    • B29C64/10—Processes of additive manufacturing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/01—Orthopaedic devices, e.g. splints, casts or braces
    • A61F5/04—Devices for stretching or reducing fractured limbs; Devices for distractions; Splints
    • A61F5/05—Devices for stretching or reducing fractured limbs; Devices for distractions; Splints for immobilising
    • A61F5/058—Splints
    • A61F5/05841—Splints for the limbs
    • A61F5/0585—Splints for the limbs for the legs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/01—Orthopaedic devices, e.g. splints, casts or braces
    • A61F5/04—Devices for stretching or reducing fractured limbs; Devices for distractions; Splints
    • A61F5/05—Devices for stretching or reducing fractured limbs; Devices for distractions; Splints for immobilising
    • A61F5/058—Splints
    • A61F5/05841—Splints for the limbs
    • A61F5/05858—Splints for the limbs for the arms
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C64/00—Additive manufacturing, i.e. manufacturing of three-dimensional [3D] objects by additive deposition, additive agglomeration or additive layering, e.g. by 3D printing, stereolithography or selective laser sintering
    • B29C64/30—Auxiliary operations or equipment
    • B29C64/386—Data acquisition or data processing for additive manufacturing
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
    • B29C65/56—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor using mechanical means or mechanical connections, e.g. form-fits
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B33—ADDITIVE MANUFACTURING TECHNOLOGY
    • B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
    • B33Y50/00—Data acquisition or data processing for additive manufacturing
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B33—ADDITIVE MANUFACTURING TECHNOLOGY
    • B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
    • B33Y80/00—Products made by additive manufacturing

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Abstract

The invention discloses a novel bone fracture splint and a design and manufacturing method of a personalized lining thereof, comprising the following steps: designing and manufacturing standardized splint shells with different styles and specifications according to the sizes and the shapes of the affected limbs of different people by a three-dimensional scanning technology and by using a principal component analysis algorithm; generating a point cloud model of the affected limb through three-dimensional scanning, modeling a curved surface of the affected limb, and selecting a splint shell with the size closest to that of the affected limb; performing point cloud registration on the point cloud of the inner surface of the splint shell and the point cloud of the outer surface of the affected limb by using a point cloud registration algorithm; taking a gap between the registered splint shell model and the affected limb model as a basis, and relatively unfolding the two registered curved surfaces by using a relative curved surface unfolding algorithm; generating a personalized splint lining mold based on the two opposite unfolding curved surfaces, and finishing the design and manufacture of the personalized splint lining which is accurately matched with the splint shell and the affected limb; and (4) assembling and fixedly connecting the splint shell and the personalized splint lining to finish the manufacture of the novel bone fracture splint and the personalized splint lining.

Description

Novel bone fracture splint and design and manufacturing method of personalized lining thereof
Technical Field
The invention relates to the technical field of bone fracture splints, in particular to a novel bone fracture splint and a design and manufacturing method of a personalized lining of the novel bone fracture splint.
Background
After the fracture of a patient, the fracture part needs to be fixed by using a medical splint, the stability between the fracture ends is maintained, the contraction of muscles in the upper joint and the lower joint of the fracture is limited, and the fracture displacement caused by the muscle contraction is avoided. The current common bone fracture splints are mainly plaster and Chinese traditional small splints.
The plaster is prepared by spreading fine powder of anhydrous calcium sulfate on a special dilute pore gauze bandage, is soaked in water for crystallization, is wound on limbs, and is solidified into a firm hard shell so as to fix the limbs of the fracture. The traditional Chinese medicine small splint is fixed by using an elastic fir board or a plastic board, a pressing pad and a bone splitting pad are placed on the inner side of the board and bound on the outer side of the limb of the fracture part to fix the fracture and prevent the fracture end from angulating, rotating and laterally shifting.
The plaster fixing mode is thick, inelastic, and poor in air permeability and light transmittance in imaging examination, the tightness cannot be adjusted after the plaster is shaped, the plaster is not suitable for early functional exercise, and complications such as joint stiffness and skin pressure sore are easily caused after the plaster is worn for a long time. Although standardized bone fracture splints (such as traditional Chinese medicine splints) can be manufactured in batches quickly, individual differences of patients are not considered in the standardized splints, and the splints cannot be well attached to affected limbs, so that the fixation efficiency is insufficient and the splints are easy to loosen. And the small splint is rough in material, and the pressure pad and the bone separating pad for fixation are worn for a long time and rub with the skin of the affected limb to easily cause complications such as pressure sores.
The Chinese patent with the publication number of CN110215329B discloses a personalized light medical splint and a design method thereof: the method comprises the steps of constructing a model of an affected limb through three-dimensional scanning, determining a design domain of the splint, carrying out biomechanical analysis on the splint and the affected limb, constructing a biomechanical model, designing a porous light splint by adopting a creative design method, and manufacturing the splint by adopting a material adding mode.
The personalized bone fracture splint is only concerned with the design and manufacture of the splint shell, and the time to manufacture the splint shell is long (typically 2 to 4 days). During current 3D printed customization brace, must gather the three-dimensional shape information in affected part, nevertheless the patient ubiquitous swells in earlier stage, and the customization brace and splint that produce often have the difference with later stage dynamic swelling and detumescence process, then press in the brace to compel and the cavity appears, and the adjustment that can't pass through the shell comes quick adaptation, if change the shell again for the adaptation this moment, has economic cost and the too high problem of time cost. Simultaneously splint and brace after topology optimization at present constitute by thinner strip slice form material because of a large amount of fretworks, patient's skin directly contacts with stereoplasm splint shell, through clinical test, if wear for a long time, the swelling hand easily receives the oppression and leads to discomfort, pain, presses the sore even.
Therefore, those skilled in the art are dedicated to develop a novel bone fracture splint and a method for designing and manufacturing a personalized inner liner thereof, and a scheme of the personalized novel bone fracture splint which can be precisely attached to an affected limb, has good fixing efficiency, is breathable and comfortable to wear, can adjust the degree of tightness and can be rapidly manufactured can be provided.
Disclosure of Invention
In view of the above defects in the prior art, the technical problem to be solved by the invention is how to solve the problems in the prior art that the plaster structure is heavy, the tightness degree cannot be adjusted after shaping, and complications are easily caused after long-term wearing; the traditional Chinese medicine small splint is difficult to completely fit the affected limb, the fixing efficiency is poor, and the 3D printing brace has the problem of incapability of dynamic adjustment.
In order to achieve the above objects, the present invention provides a novel bone fracture splint and a method for designing and manufacturing a personalized lining thereof, the method comprising the steps of:
step 1, designing standardized splint shells with different styles and specifications according to the sizes and the shapes of affected limbs of different crowds by a three-dimensional scanning technology and a principal component analysis algorithm;
step 2, processing and manufacturing standardized splint shells of various styles and specifications by using a 3D printing technology;
step 3, generating a point cloud model of the affected limb through three-dimensional scanning, modeling a curved surface of the affected limb, and selecting a standardized splint shell closest to the size of the affected limb from standardized splint shells with different styles and specifications;
step 4, point cloud registration is carried out on the point cloud of the inner surface of the standardized splint shell and the point cloud of the outer surface of the affected limb by using a point cloud registration algorithm;
step 5, taking a gap between the registered splint shell model and the affected limb model as a basis, and relatively unfolding the two registered curved surfaces by using a relative curved surface unfolding algorithm, namely unfolding the inner surface of the standardized splint shell into a plane, and unfolding the outer surface of the affected limb relative to the inner surface of the standardized splint shell;
step 6, generating an individualized splint lining mold by using computer-aided design software based on the two relatively unfolded curved surfaces, and finishing the individualized splint lining design of accurately matching the standardized splint shell and the affected limb;
step 7, manufacturing a splint lining mold by using a 3D printing technology, and turning over the mold to obtain a personalized splint lining which is accurately matched with the splint shell and the affected limb;
and 8, assembling and fixedly connecting the standardized splint shell and the personalized splint lining to complete the manufacture of the novel bone fracture splint and the personalized splint lining.
Further, the step 1 specifically includes the following steps:
step 1.1, selecting a plurality of groups of clinical case samples with different sexes, ages and body states, extracting through three-dimensional scanning to obtain a diseased limb model and establishing a diseased limb model database;
step 1.2, classifying and averaging the data of the affected limb model in the affected limb model database by using a principal component analysis algorithm to obtain different affected limb surface standard models, and designing standardized splint shell models with different styles and specifications according to the different affected limb surface standard models;
and 1.3, carrying out lightweight improvement on the standardized splint shell model by using a creative optimization algorithm.
Further, the step 1.1 further includes the steps of:
and (3) collecting the mechanical distribution characteristics of the affected limb fracture organism under the fixation of the splint by using a film pressure sensor, and establishing a biomechanics model experiment database.
Further, the step 1.3 specifically includes the following steps:
and according to mechanical data in the biomechanics model experiment database, performing lightweight design on the standardized splint shell model by using a topological optimization algorithm to generate a porous lightweight structure splint model which accords with an optimal force transmission path.
Further, the step 1 further comprises:
and step 1.4, designing and configuring a stepless tightness adjusting module at least one position of the standardized splint shell.
Furthermore, standardized splint shell includes by two splint shell bodies that can part from top to bottom, electrodeless regulation elasticity module sets up on the splint shell body, be convenient for dress and adjust the elasticity.
Further, infinitely variable control elasticity module includes that the solid fixed ring of magic subsides and magic are pasted, the solid fixed ring fixed connection of magic subsides is in on the splint shell body, the magic is pasted and is passed solid fixed ring and encircleing are pasted to the magic splint shell body sets up.
Further, the point cloud registration algorithm in the step 4 uses a closest point iteration algorithm.
Further, the closest point iterative algorithm solves the optimal transformation of the standardized splint shell curved surface point cloud and the affected limb curved surface point cloud, so that the coincidence degree of the two curved surface point clouds is as high as possible, namely, the minimum cost function j is convenient for the subsequent curved surfaces to be relatively expanded, and the specific formula is as follows:
Figure BDA0003804354490000031
Figure BDA0003804354490000032
wherein x is i Representing a point cloud of an outer surface of the affected limb; y is j Representing a point cloud of an inner surface of a standardized splint shell; r represents an optimal rotation matrix; t represents an optimal translation matrix; e.g. of the type i (R, t) represents the ratio of x to i Per-point distance of (a); y is j* Is expressed relative to x i I.e. with respect to x i The distance is minimum; given the initial transformations R and t, the closest point iterative algorithm computes the optimal transformation in equation (1), and iteratively solves the minimized cost function in alternation between finding the closest point match in equation (2).
Further, in the step 5, the relative curved surface unfolding algorithm calculates distances of each point corresponding to the standardized splint shell curved surface and the affected limb curved surface by point approximation, and converts the distances of each point corresponding to the standardized splint shell curved surface into the affected limb unfolding curved surface corresponding to the standardized splint shell unfolding curved surface, that is, a spline curve is obtained by fitting projection points, and then the relative unfolding curved surface is obtained by fitting the spline curve, and the specific formula is as follows:
Figure BDA0003804354490000033
S(y)＝d(τ([y 1 ,y 2 ,...,y n ])) (4)
wherein x is i Representing a point cloud of an outer surface of the affected limb;
Figure BDA0003804354490000034
a projection function representing an outer surface of the affected limb relative to an inner surface of the standardized splint housing; c represents a fitting function of the spline curve; y is i Representing a spline curve obtained by fitting according to the projection points; τ denotes the standardized splint shell interior surfaceThe expansion function of (a); d represents a fitting function of the multi-section curved surface; s represents the resulting curved surface of the affected limb that is developed relative to the inner surface of the standardized splint shell by spline curve fitting.
The invention is different from other traditional treatment modes that only a splint shell is designed and a bandage is wound at the affected limb, the standardized splint shell and the personalized splint lining are fused, the manufacturing time is considered, meanwhile, the fixation efficiency and the treatment effect are improved through the personalized and accurate treatment mode, the discomfort of a patient in the treatment process is relieved, and the invention has the advantages of light weight, ventilation, the attachment to the affected limb, the promotion of healing and the like.
The conception, the specific structure and the technical effects of the present invention will be further described with reference to the accompanying drawings to fully understand the objects, the features and the effects of the present invention.
Drawings
FIG. 1 is a flow chart of the design and manufacture of a new bone fracture splint and its personalized liner according to a preferred embodiment of the present invention;
FIG. 2 is a schematic view of a standardized bone fracture splint housing according to a preferred embodiment of the present invention;
FIG. 3 is a schematic diagram of a point cloud registration algorithm for normalizing the point cloud of the inner surface of the splint shell and the point cloud of the outer surface of the affected limb according to a preferred embodiment of the present invention;
fig. 4 is a schematic view of a relative curve expansion algorithm of the outer surface of the affected limb relative to the inner surface of the standardized splint housing in accordance with a preferred embodiment of the present invention;
FIG. 5 is a schematic view of a mold structure of a customized bone fracture splint lining created by relatively unfolded curved surfaces according to a preferred embodiment of the present invention;
fig. 6 is a schematic view of a structure of a personalized bone fracture splint lining made by over-molding a splint lining mold according to a preferred embodiment of the present invention.
Wherein, 1-splint shell body, 2-magic tape fixing ring, 3-magic tape and 4-splint lining.
Detailed Description
The technical contents of the preferred embodiments of the present invention will be more clearly and easily understood by referring to the drawings attached to the specification. The present invention may be embodied in many different forms of embodiments and the scope of the invention is not limited to the embodiments set forth herein.
In the drawings, elements that are structurally identical are represented by like reference numerals, and elements that are structurally or functionally similar in each instance are represented by like reference numerals. The size and thickness of each component shown in the drawings are arbitrarily illustrated, and the present invention is not limited to the size and thickness of each component. The thickness of the components may be exaggerated where appropriate in the figures to improve clarity.
The novel bone fracture splint provided by the invention comprises two main components, namely a standardized splint shell and a personalized splint lining. The standardized splint shell can be well matched and attached to the affected limb, and rapid batch manufacturing can be realized; individualized splint inside lining can realize matcing with the accurate laminating of suffering limb, promotes the patient and wears experience to accelerate the fracture to resume, shorten treatment cycle.
Fig. 1 is a flow chart of the design and manufacturing method of the novel bone fracture splint and the personalized lining thereof according to a preferred embodiment of the invention. Taking a human arm as an example, the detailed design scheme is as follows:
1. design and manufacture of standardized splint shells
In order to accurately construct splint shells adapting to the sizes and the shapes of arms of different crowds, 100 groups of clinical case samples with different sexes, ages and body states are selected, a 3D scanner is used for quickly extracting an arm model of a patient and establishing an arm model database, a film pressure sensor is used for collecting mechanical distribution characteristics of a fracture organism of a diseased limb under splint fixation, and a biomechanics model experiment database is established; classifying and averaging arm model data in an arm model database by using a Principal Component Analysis (PCA) algorithm to obtain three types of standard models of the surfaces of the affected limbs, designing three types of standard splint shells A, B and C according to the three types of standard models of the surfaces of the affected limbs, dividing each type of splint shell into three sizes of L, M and S, making a splint shell specification table (such as table 1), and being clinically applicable to various types of hand models of patients. The standardized splint shell model is subjected to lightweight improvement by using a creative optimization algorithm: according to mechanical data in a biomechanics model experiment database, a lightweight design is carried out on the three standardized splint shell models by using a topological optimization algorithm, a porous lightweight structure splint model which accords with an optimal force transmission path is generated, and the weight of the splint is obviously reduced while topological holes are generated, so that the wearing air permeability and the comfort of a patient are improved; design and dispose electrodeless regulation elasticity module in splint palm, wrist, arm department, the patient can adjust splint by oneself according to suffering limb swelling degree and wear the elasticity degree, obtains best wearing experience and treatment.
After the design is completed, the 3D printing technology can be used for manufacturing the standardized splint shell quickly in batches, as shown in figure 2.
Table 1 standard specification table for splint shell for bone fracture
Figure BDA0003804354490000051
2. Design and manufacture of personalized splint liners
In order to fit the affected limb accurately in a matching manner, improve the fixing efficiency and improve the wearing comfort level, a 3D scanner is used for scanning the arm of a patient to quickly generate a point cloud model of the affected limb and model a curved surface of the affected limb, a standardized splint shell with the size closest to the affected limb is selected from three standardized splint shells, and point cloud registration is carried out on the point cloud of the inner surface of the standardized splint shell and the point cloud of the outer surface of the affected limb by using a point cloud registration algorithm, so that the point cloud of the model of the affected limb and the point cloud of the model of the standardized splint shell are superposed as much as possible (as shown in figure 3); based on the gap between the registered splint shell model and the affected limb model, using a relative curved surface unfolding algorithm to relatively unfold the two registered curved surfaces, namely unfolding the inner surface of the standardized splint shell into a plane, and unfolding the outer surface of the affected limb relative to the inner surface of the standardized splint shell (as shown in fig. 4); based on the two relatively expanded curved surfaces, a Computer Aided Design (CAD) software is used for quickly generating a precise and personalized splint lining mold model, and the personalized lining Design of precisely matching the splint shell and the affected limb is completed.
After the design is finished, a lining mold (as shown in figure 5) is rapidly manufactured by using a 3D printing technology, and after the mold is turned over, the personalized silica gel splint lining (as shown in figure 6) which is accurately matched with the splint shell and the affected limb is obtained.
Fig. 2 is a schematic diagram of a standardized bone fracture splint shell, wherein the splint shell body 1 is divided into an upper part and a lower part, which is convenient to wear and adjust the tightness; the solid fixed ring of magic subsides 2 and magic subsides 3 and constitutes electrodeless regulation elasticity module, thereby the patient can adjust magic subsides 3 by oneself according to affected limb swelling degree and adjust splint and wear the elasticity degree, obtains best wearing experience and treatment.
Fig. 3 is a point cloud registration algorithm that normalizes the point cloud of the inner surface of the splint shell and the point cloud of the outer surface of the affected limb. The algorithm uses an Iterative Closest Point (ICP) algorithm to solve the optimal transformation (as shown in formulas (1) and (2)) of the standardized splint shell curved surface Point cloud and the affected limb curved surface Point cloud, so that the coincidence degree of the two curved surface Point clouds is as high as possible, namely, a cost function is minimized, and the subsequent curved surfaces can be conveniently expanded relatively.
Figure BDA0003804354490000061
Figure BDA0003804354490000062
Wherein x is i Representing a point cloud of an outer surface of the affected limb; y is j Representing a point cloud of an inner surface of a standardized splint shell; r represents an optimal rotation matrix; t represents an optimal translation matrix; e.g. of the type i (R, t) is relative to x i Each point distance of (a); y is j* Relative to x i I.e. with respect to x i The distance is minimal. Given the initial transformations R and t, the ICP algorithm computes the optimal transformation in equation (1), and iteratively solves the minimized cost function alternately between finding the closest point match in equation (2).
Figure 4 is a relative curve deployment algorithm of the outer surface of the affected limb relative to the inner surface of the standardized splint shell. The algorithm calculates the distance between each point corresponding to the splint curved surface and the affected limb curved surface by taking points approximately, converts the distance between each point corresponding to the standardized splint shell curved surface into the affected limb unfolding curved surface relative to the standardized splint shell unfolding curved surface, namely obtains a spline curve (as formula (3)) through projection point fitting, and obtains a relative unfolding curved surface (as formula (4)) through spline curve fitting. The algorithm unfolds the inner surface of the standardized splint shell into a plane, unfolds the outer surface of the affected limb relative to the inner surface of the standardized splint shell, and can quickly generate a personalized lining mold through the unfolded curved surface of the affected limb and the unfolded curved surface of the splint shell (as shown in fig. 5).
Figure BDA0003804354490000063
S(y)＝d(τ([y 1 ,y 2 ,...,y n ])) (4)
Wherein x is i Representing an outer surface point cloud of the affected limb;
Figure BDA0003804354490000064
a projection function representing an outer surface of the limb relative to an inner surface of the standardized splint housing; c represents a fitting function of the spline curve; y is i Representing a spline curve obtained by fitting according to the projection points; τ represents the expansion function of the standardized splint shell interior surface; d represents a fitting function of the multi-section curved surface; s represents the resulting curved surface of the affected limb that is developed relative to the inner surface of the standardized splint shell by spline curve fitting.
Fig. 6 is a schematic view of a personalized bone fracture splint lining made by overmolding a splint lining mold. The splint lining mold is rapidly manufactured by using a 3D printing technology (as shown in figure 5), liquid silica gel is poured into the mold and heated after the mold is manufactured, and the individualized splint lining 4 which is accurately matched with the splint shell and the affected limb can be obtained by turning the mold after the heating is finished.
And finally, assembling and fixedly connecting the standardized splint shell and the personalized splint lining 4 in a gluing mode to complete the manufacture of the novel bone fracture splint and the personalized splint lining.
The foregoing detailed description of the preferred embodiments of the invention has been presented. It should be understood that numerous modifications and variations could be devised by those skilled in the art in light of the present teachings without departing from the inventive concepts. Therefore, the technical solutions that can be obtained by a person skilled in the art through logical analysis, reasoning or limited experiments based on the prior art according to the concepts of the present invention should be within the scope of protection determined by the claims.

Claims (10)

1. A novel bone fracture splint and a design and manufacturing method of a personalized lining thereof are characterized by comprising the following steps:
step 1, designing standardized splint shells with different styles and specifications according to the sizes and the shapes of affected limbs of different crowds by a three-dimensional scanning technology and a principal component analysis algorithm;
step 2, processing and manufacturing standardized splint shells with various styles and specifications by using a 3D printing technology;
step 3, generating a point cloud model of the affected limb through three-dimensional scanning, modeling a curved surface of the affected limb, and selecting a standardized splint shell closest to the size of the affected limb from standardized splint shells with different styles and specifications;
step 4, point cloud registration is carried out on the point cloud of the inner surface of the standardized splint shell and the point cloud of the outer surface of the affected limb by using a point cloud registration algorithm;
step 5, taking a gap between the registered splint shell model and the affected limb model as a basis, and relatively unfolding the two registered curved surfaces by using a relative curved surface unfolding algorithm, namely unfolding the inner surface of the standardized splint shell into a plane, and unfolding the outer surface of the affected limb relative to the inner surface of the standardized splint shell;
step 6, based on the two relatively unfolded curved surfaces, generating an individualized splint lining mold by using computer aided design software to finish the individualized splint lining design of accurately matching the standardized splint shell and the affected limb;
step 7, manufacturing a splint lining mold by using a 3D printing technology, and turning over the mold to obtain a personalized splint lining which is accurately matched with the splint shell and the affected limb;
and 8, assembling and fixedly connecting the standardized splint shell and the personalized splint lining to complete the manufacture of the novel bone fracture splint and the personalized splint lining.
2. The method for designing and manufacturing a novel bone fracture splint and personalized lining thereof according to claim 1, wherein the step 1 comprises the following steps:
step 1.1, selecting a plurality of groups of clinical case samples with different sexes, ages and body states, extracting to obtain a diseased limb model through three-dimensional scanning, and establishing a diseased limb model database;
step 1.2, classifying and averaging the data of the affected limb model in the affected limb model database by using a principal component analysis algorithm to obtain different affected limb surface standard models, and designing standardized splint shell models with different styles and specifications according to the different affected limb surface standard models;
and 1.3, carrying out lightweight improvement on the standardized splint shell model by using a creative optimization algorithm.
3. The new bone fracture splint and the method for designing and manufacturing the personalized lining thereof as claimed in claim 2, wherein the step 1.1 further comprises the steps of:
and (3) collecting the mechanical distribution characteristics of the affected limb fracture organism under the fixation of the splint by using a film pressure sensor, and establishing a biomechanics model experiment database.
4. The method for designing and manufacturing a new bone fracture splint and its personalized lining according to claim 3, wherein the step 1.3 comprises the following steps:
and (3) according to mechanical data in the experimental database of the biomechanics model, carrying out lightweight design on the standardized splint shell model by using a topological optimization algorithm to generate a porous lightweight structure splint model which accords with an optimal force transmission path.
5. The method for designing and manufacturing a novel bone fracture splint and its personalized lining according to claim 2, wherein the step 1 further comprises:
and step 1.4, designing and configuring a stepless tightness adjusting module at least one position of the standardized splint shell.
6. The novel bone fracture splint and the design and manufacturing method for the personalized lining thereof according to claim 5, wherein the standardized splint shell comprises two splint shell bodies which can be separated from each other up and down, and the stepless tightness adjusting module is arranged on the splint shell bodies for convenient wearing and tightness adjustment.
7. The novel bone fracture splint and the design and manufacturing method of the personalized lining thereof as claimed in claim 6, wherein the stepless adjusting tightness module comprises a magic tape fixing ring and a magic tape, the magic tape fixing ring is fixedly connected to the splint shell body, and the magic tape passes through the magic tape fixing ring and is arranged around the splint shell body.
8. The method for designing and manufacturing a novel bone fracture splint and personalized lining thereof according to claim 1, wherein the point cloud registration algorithm in the step 4 uses a closest point iteration algorithm.
9. The method for designing and manufacturing a novel bone fracture splint and personalized lining thereof according to claim 8, wherein the closest point iterative algorithm solves the optimal transformation of the standardized splint shell curved surface point cloud and the affected limb curved surface point cloud, so that the coincidence degree of the two curved surface point clouds is as high as possible, namely, the cost function j is minimized, and the subsequent curved surfaces can be conveniently expanded relatively, and the specific formula is as follows:
Figure FDA0003804354480000021
Figure FDA0003804354480000022
wherein x is i Representing a point cloud of an outer surface of the affected limb; y is j Representing a point cloud of an inner surface of a standardized splint shell; r represents an optimal rotation matrix; t represents an optimal translation matrix; e.g. of the type i (R, t) is relative to x i Per-point distance of (a); y is j * Relative to x i I.e. with respect to x i The distance is minimum; given the initial transformations R and t, the closest point iterative algorithm computes the optimal transformation in equation (1), and iteratively solves the minimized cost function in alternation between finding the closest point match in equation (2).
10. The method for designing and manufacturing a novel bone fracture splint and its personalized lining according to claim 1, wherein the relative surface unfolding algorithm in step 5 calculates the distances of each point corresponding to the standardized splint shell curved surface and the affected limb curved surface by point approximation, and converts the distances of each point corresponding to the standardized splint shell curved surface into the affected limb unfolding curved surface relative to the standardized splint shell unfolding curved surface, i.e. a spline curve is obtained by projection point fitting, and then the relative unfolding curved surface is obtained by spline curve fitting, and the specific formula is as follows:
Figure FDA0003804354480000023
S(y)＝d(τ([y 1 ,y 2 ,...,y n ])) (4)
wherein x is i Representing a point cloud of an outer surface of the affected limb;
Figure FDA0003804354480000024
a projection function representing an outer surface of the limb relative to an inner surface of the standardized splint housing; c represents a fitting function of the spline curve; y is i Representing a spline curve obtained by fitting according to the projection points; τ represents the expansion function of the standardized splint shell inner surface; d represents a fitting function of the multi-section curved surface; s represents the resulting curved surface of the affected limb that is developed relative to the inner surface of the standardized splint shell by spline curve fitting.
CN202210993066.XA 2022-08-18 2022-08-18 Novel bone fracture splint and design and manufacturing method of personalized lining thereof Pending CN115302757A (en)

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