CN106821569A - Neonate's auricle KAFO and its manufacture method - Google Patents
Neonate's auricle KAFO and its manufacture method Download PDFInfo
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- CN106821569A CN106821569A CN201710214861.3A CN201710214861A CN106821569A CN 106821569 A CN106821569 A CN 106821569A CN 201710214861 A CN201710214861 A CN 201710214861A CN 106821569 A CN106821569 A CN 106821569A
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- Prior art keywords
- auricle
- kafo
- neonate
- base
- upper lid
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- 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
-
- 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
- A61F5/0102—Orthopaedic devices, e.g. splints, casts or braces specially adapted for correcting deformities of the limbs or for supporting them; Ortheses, e.g. with articulations
- A61F5/0104—Orthopaedic devices, e.g. splints, casts or braces specially adapted for correcting deformities of the limbs or for supporting them; Ortheses, e.g. with articulations without articulation
-
- 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
- B33Y10/00—Processes of 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
- B33Y30/00—Apparatus for additive manufacturing; Details thereof or accessories therefor
-
- 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
- B33Y70/00—Materials specially adapted 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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- Engineering & Computer Science (AREA)
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Manufacturing & Machinery (AREA)
- Materials Engineering (AREA)
- Heart & Thoracic Surgery (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Biomedical Technology (AREA)
- Nursing (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
Abstract
Neonate's auricle KAFO of the invention, upper lid including base and with base engagement, base includes the auricle covering portion for coating outer auricle, auricle covering portion is connected with connection sheet near basal part of the ear side, the space for housing upper lid is left in the middle part of auricle covering portion, the rectifier can be used for the correction of all types auricle form deformity, and the manufacture method of neonate's auricle KAFO of the invention is comprised the following steps：Step one, data acquisition and reverse modeling：Step 2, the position for correcting lopsided auricle data needs are adjusted simultaneously reverse modeling according to normal auricle data：The air-vent of step 3, the catch, through hole and upper lid of drafting base：Step 4, auricle KAFO mould is printed using 3D printer：Step 5, medical silica-gel auricle KAFO moulding by casting, the actual conditions of the manufacture method combination neonates in China auricle form manufacture and design, according to different patient personalized customizations, accurate size, comfortable wearing.
Description
Technical field
The present invention relates to technical field of medical instruments, more particularly to neonate's auricle KAFO and its manufacture method.
Background technology
Deformity of ear is clinically very common, and Japanese neonate's statistics is 55.2%, often bends with first and second cheek and develops
It is bad to wait cranium face congenital malformation syndrome concurrent, it is to be caused by the change of developmental deformity or mechanical structure.Ear form is lopsided to be controlled
Treatment method is preschool operative treatment, there is cartilage deformation, high recurrence rate, invasive etc., and overall merit risk is higher.Day in 1984
This scholar Matsuo K and Hirose T et al. is proposed by new life first on U.S. reconstruction shaping surgery magazine PRS
The non-operative treatment of phase in childhood corrects ear form deformity, but due to complex operation, and antidote is lack of standardization and non-popularization and application.
Since 2010, foreign countries to be begun one's study and correct congenital ear form deformity using ear mold, and it is intervened in early days, achieved
More than 90% clinical effective rate, compares according to the nearly 10 years ears plastic operation data in the U.S. as can be seen that amount for surgical is from annual
36295 drop to 29828, and decreasing ratio is 18%, no matter from medical-risk or payment for medical care or even healthy from humanity
Analyzed with the angle of love, noninvasive ear shaping technique is the breakthrough of credulous biomechanics of bone correction, can be generalized to other cartilage diseases
In the treatment of trouble.
The auricle KAFO of prior art is not bound with the actual conditions design of neonates in China auricle form, wears not enough
Comfortably, and it is likely to cause local compression and makes auricle ulceration.
Therefore, in view of the shortcomings of the prior art, providing neonate's auricle KAFO and its manufacture method to overcome prior art
It is not enough very necessary.
The content of the invention
An object of the present invention is to avoid the deficiencies in the prior art part and provide neonate auricle KAFO, and this is new
Raw youngster's auricle KAFO can be used for the correction of all types auricle form deformity, meet the actual conditions of neonates in China, wear
Comfortably.
The second object of the present invention is to avoid the deficiencies in the prior art part and provide neonate the system of auricle KAFO
Method is made, the actual conditions of the manufacture method combination neonates in China auricle form manufacture and design, it is patient personalized according to difference
Customization, accurate size, comfortable wearing.
Above-mentioned purpose of the invention is realized by following technological means.
Neonate's auricle KAFO, including base and the upper lid with base engagement, base are included for coating outer auricle
Auricle covering portion, auricle covering portion is connected with connection sheet near basal part of the ear side, is left in the middle part of auricle covering portion for accommodating
The space of lid.
Further, some air-vents are above covered with, auricle covering portion is provided with some through holes.
Further, base is the base of silica gel material, and upper lid is the upper lid of silica gel material.
Further, base is provided with the fixing device for fixed cover, and fixing device is catch, upward by auricle covering portion
Extend catch in lid direction.
Preferably, catch is three, and three catch are uniformly distributed in auricle covering portion.
Preferably, connection sheet is integrally formed with auricle covering portion.
Further, the periphery of connection sheet is additionally provided with adhesive sheet, for connection sheet to be adhered into the ear portion.
Preferably, adhesive sheet for 3M exempt from stitch adhesive tape.
Base and upper lid meet the anatomic morphological of ear.
The manufacture method of neonate's auricle KAFO, comprises the following steps：
Step one, data acquisition and reverse modeling：
Step 2, by lopsided auricle data need correction position be adjusted according to normal auricle data and inversely built
Mould：
The air-vent of step 3, the catch, through hole and upper lid of drafting base：
Step 4, auricle KAFO mould is printed using 3D printer：
Step 5, medical silica-gel auricle KAFO moulding by casting.
Neonate's auricle KAFO of the invention, including base and the upper lid with base engagement, base are included for coating
The auricle covering portion of outer auricle, auricle covering portion is connected with connection sheet near basal part of the ear side, and use is left in the middle part of auricle covering portion
In the space of accommodating upper lid, the rectifier can be used for the correction of all types auricle form deformity, and indication is wide, can not only control
Treat existing aural deformity, can also prevent it may happen that auricle form deformity, comfortable wearing.
The manufacture method of neonate's auricle KAFO of the invention, comprises the following steps：Step one, data acquisition and reverse
Modeling：Step 2, the position for correcting lopsided auricle data needs are adjusted simultaneously reverse modeling according to normal auricle data：Step
Rapid three, the air-vent of the catch, through hole and upper lid of base is drawn：Step 4, auricle KAFO mould is printed using 3D printer
Tool：Step 5, medical silica-gel auricle KAFO moulding by casting, the actual feelings of the manufacture method combination neonates in China auricle form
Condition manufactures and designs, according to different patient personalized customizations, accurate size, comfortable wearing.
Brief description of the drawings
Using accompanying drawing, the present invention is further illustrated, but content in accompanying drawing is not constituted to any limit of the invention
System.
Fig. 1 is the structural representation of the upper lid of neonate's auricle KAFO of the present invention.
Fig. 2 is the structural representation of the upper lid of neonate's auricle KAFO of the present invention.
Fig. 3 is the base of neonate's auricle KAFO of the present invention and the assembly structure diagram of upper lid.
Fig. 4 is the structural representation in another direction of Fig. 3.
Fig. 5 is the use state schematic diagram of neonate's auricle KAFO of the present invention.
In Fig. 1 to Fig. 5, including：
10 --- base, 11 --- connection sheet, 12 --- auricle covering portion, 13 --- catch, 14 --- through hole, 15 ---
3M exempts to stitch adhesive tape；
20 --- upper lid, 21 --- air-vents.
Specific embodiment
The invention will be further described with the following Examples.
Embodiment 1.
As shown in Figures 1 to 4, neonate's auricle KAFO, including base 10 and the upper lid 20 coordinated with base 10, base
10 include the auricle covering portion 12 for coating outer auricle, and auricle covering portion 12 is connected with connection sheet 11, ear near basal part of the ear side
Leave the space for housing upper lid 20 in the middle part of wide covering portion 12.Upper lid 20 is provided with some air-vents 21, auricle covering portion 12
It is provided with some through holes 14.Good permeability, makes wearer comfort.Base 10 is the base 10 of silica gel material, and upper lid 20 is silica gel material
The upper lid 20 of matter.It is made up of silica gel, rigid compressing will not be formed to auricle, comfort level is good.Base 10 is provided with for fixed cover
20 fixing device, base 10 and upper lid 20 meet the anatomic morphological of ear.
The manufacture method of neonate's auricle KAFO is specifically：
Step one, data acquisition and reverse modeling：
The three-dimensional data of bilateral auricle is obtained using spatial digitizer, and model is entered using Geomagic Studio 11
The treatment such as row mesh uniform, noise reduction, surface smoothing, removal spike, eliminate local grid deformity, and left side is normal
Auricle three-dimensional data mirror image, finally obtains the STL form models of normal auricle after the lopsided auricle and mirror image of surface smoothing；
Step 2, by lopsided auricle data need correction position be adjusted according to normal auricle data and inversely built
Mould：
In Geomagic Studio 11, as shown in Fig. 3-3, by the normal ear after right side deformity auricle and left side mirror image
Wide manually registering functional aligns two auricle model combinations, normal auricle model is sized and is matched with lopsided auricle,
The position of adjustment is needed to mark in lopsided auricle by creating batten border, meanwhile, in normal auricle model same position subscript
Go out batten border.Adjustment position is needed to delete in lopsided auricle, normal auricle needs partly to be deleted outside adjustment position, by cloth
After your computing merges two parts, the generation bridge and filling function that hole is filled to model connect two parts, to generation
The treatment such as model row mesh uniform, noise reduction, surface smoothing, removal spike form it into an auricle model for smoothness,
Batten border is drawn on the inside of helix, auricle model is divided into upper lid 20 and the two parts of base 10, base 10 is amplified 1.05 times
Afterwards, 2.00mm and 1.00mm is stretched out on the inner ring of base 10 and the outer ring border of upper lid 20 laterally respectively, and by the extension of upper lid 20
Closing, base 10 thickeies 1.00mm；
The air-vent 21 of step 3, the catch 13, through hole 14 and upper lid 20 of drafting base 10：
According to the profile of design ear mold, 9.00x6.00x1.00mm baffle plates and a diameter of are drawn out in UG NX6.0
2.00mm, the cylinder of a length of 20mm merges baffle plate with auricle model base 10, and cylinder subtracts each other to be formed with auricle model to be engraved
Sky, boolean is carried out by the above-mentioned relevant position of auricle model base 10 is placed in three baffle plates importing Geomagic Studio 11
Computing merges, and cylinder is imported in Geomagic Studio 11 carries out Boolean calculation with lid 20 on auricle model and base 10
Subtract each other, reach hollow out effect；
Step 4, auricle KAFO mould is printed using 3D printer：
Carry out the moulding by casting of the mold design, 3D printing manufacture and silica gel ear of outer ear support.Due to human ear complex structure,
Time-consuming for traditional moulds processing method, high cost.Consider that the outer ear mold of human body needs normally to be picked up the ears according to different patients simultaneously
Piece shape separately designed, and mould will be corresponded with patient, be single-piece production, therefore go to expect processing side using traditional
Formula is simultaneously uneconomical.And 3D printing then can be higher precision rapid build complicated shape, reduce submodular amount, shorten Mold Making
Time simultaneously greatly reduces cost.Plan the outer ear mold of human body and be divided into upper and lower two mould, it is different to each the characteristics of for 3D printing
Model carries out mold design and carries out 3D printing manufacture.Use the photocuring 3D printer of Shanghai Lian Tai Science and Technology Co., Ltd.
Lite 450 carries out mould printing.The printer formed precision is ± 0.1mm (L≤100mm) or ± 0.1%x L (L>
100mm), relatively it is adapted to the printing of outer ear mold.Printing uses PLA material, prints thickness 0.1mm, and shell quantity is 6, filling
Density is 60%, and filling shape is hexagon, and print speed is 60mm/s, and nozzle temperature is 185 DEG C, and platform temperature is 55 DEG C；
Step 5, medical silica-gel auricle KAFO moulding by casting.
Medical silica-gel selects NuSil MED4765, and the silica gel is a kind of typical bi-component addition type silica gel, Shao after shaping
Family name's hardness is 65, and silica gel is at normal temperatures soft paste solid-state, and its performance parameter is shown in Table 3-1.Component A and B component 1:1 mixing
After refining glue, 90min is kept at a temperature of 1MPa pressure and 100 DEG C using vulcanizer (XLB-D 500X500), make the complete sulphur of silica gel
Change.The silica gel auricle KAFO of shaping is taken out after last forced demoulding, neonate's auricle KAFO quality is moderate, surface light
It is sliding, can play a supporting role but local compression will not be caused because hardness is too strong.
The use of auricle KAFO：
As shown in figure 5, ear is pulled through from base 10, and by base 10 close to skull.Base is passed through in ear
10 and after base 10 is against skull, lift ear, and ensure that base 10 falls in the posterior sulcus of auricle of the ear near baby.Check
To ensure ear cosily in the middle of base 10.After being properly positioned, using skin Closure Srips by auricle KAFO base 10 and head
It is fixed.After after the fixation of base 10, by upper lid 20 as relevant position, the problems such as observation will not be oppressed.Clinic is applied to, observation is new
Raw youngster's wearing effect, mechanical deformation of the adjustment soft durometer so as to fit neonate's deformity of ear.
When KAFO is removed, following steps should be followed：1st, skin Closure Srips are removed；2nd, base 10 is removed；3rd, covered in dismounting
20。
Specifically, first base 10 is placed on outside auricle when wearing, upper lid 20 is positioned over matched position after fixing, observes ear
Exterior feature is fixed auricle KAFO base 10 with head using skin Closure Srips without compressing, and skin Closure Srips exempt to stitch adhesive tape 15 using 3M, are
A kind of breathable adhesive tape, is made up of the backing and pressure sensitive adhesive of adhesive-bonded fabric, while can strengthen tension stress with elastic fibers.In follow-up
Whether observation auricle there is local compression, unbalance stress and form the problems such as correct not good, is suitably adjusted.
Table 1-1 NuSil MED4765 silica gel properties
Table.1-1 Properties of NuSil MED4765 silicone
Embodiment 2.
As shown in figure 3, neonate's auricle KAFO and its manufacture method, other structures are same as Example 1, difference
It is：Fixing device is catch 13, and catch 13 is extended by the upward direction of lid 20 of auricle covering portion 12.Catch 13 is three, three
Individual catch 13 is uniformly distributed in auricle covering portion 12.Connection sheet 11 is integrally formed with auricle covering portion 12.It is easy to fixed cover 20,
It is difficult to drop out base 10 when wearing.
Embodiment 3.
As shown in figure 5, neonate's auricle KAFO and its manufacture method, other structures are identical with embodiment 1 or 2, different
Part is：The periphery of connection sheet 11 is additionally provided with 3M and exempts to stitch adhesive tape 15.3M exempts to stitch adhesive tape 15, is a kind of breathable adhesive tape, by not knitting
The backing and pressure sensitive adhesive of cloth are constituted, while can strengthen tension stress with elastic fibers.Auricle KAFO and head are fixed.
Finally it should be noted that the above embodiments are merely illustrative of the technical solutions of the present invention rather than the present invention is protected
The limitation of scope, although being explained in detail to the present invention with reference to preferred embodiment, one of ordinary skill in the art should manage
Solution, technical scheme can be modified or equivalent, without deviating from technical solution of the present invention essence and
Scope.
Claims (10)
1. neonate's auricle KAFO, it is characterised in that：Upper lid including base and with the base engagement, the base includes
Auricle covering portion for coating outer auricle, the auricle covering portion is connected with connection sheet, the auricle bag near basal part of the ear side
Cover the space left in the middle part of portion for housing the upper lid.
2. neonate's auricle KAFO according to claim 1, it is characterised in that：Some air-vents are covered with described,
The auricle covering portion is provided with some through holes.
3. neonate's auricle KAFO according to claim 1, it is characterised in that：The base is the bottom of silica gel material
Seat, the upper lid is the upper lid of silica gel material.
4. neonate's auricle KAFO according to claim 1, it is characterised in that：The base is provided with for fixed described
The fixing device of upper lid, the fixing device is catch, and the gear is extended from the auricle covering portion to the upper lid direction
Piece.
5. neonate's auricle KAFO according to claim 4, it is characterised in that：The catch is three, described in three
Catch is uniformly distributed in the auricle covering portion.
6. neonate's auricle KAFO according to claim 1, it is characterised in that：The connection sheet is coated with the auricle
Portion is integrally formed.
7. neonate's auricle KAFO according to claim 6, it is characterised in that：The periphery of the connection sheet is additionally provided with viscous
Contact pin, for the connection sheet to be adhered into the ear portion.
8. neonate's auricle KAFO according to claim 7, it is characterised in that：The adhesive sheet is exempted to stitch adhesive tape for 3M.
9. neonate's auricle KAFO according to claim 1, it is characterised in that：The base and the upper lid meet
The anatomic morphological of ear.
10. the manufacture method of the neonate's auricle KAFO described in claim 1 to 9 any one, it is characterised in that including with
Lower step：
Step one, data acquisition and reverse modeling：
Step 2, the position for correcting lopsided auricle data needs are adjusted simultaneously reverse modeling according to normal auricle data：
The air-vent of step 3, the catch, through hole and upper lid of drafting base：
Step 4, auricle KAFO mould is printed using 3D printer：
Step 5, medical silica-gel auricle KAFO moulding by casting.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201710214861.3A CN106821569A (en) | 2017-04-01 | 2017-04-01 | Neonate's auricle KAFO and its manufacture method |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201710214861.3A CN106821569A (en) | 2017-04-01 | 2017-04-01 | Neonate's auricle KAFO and its manufacture method |
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Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107260375A (en) * | 2017-08-02 | 2017-10-20 | 傅兰轲 | A kind of moulding fixator of auricle |
| CN108734783A (en) * | 2018-05-22 | 2018-11-02 | 南方医科大学 | A method of judging reconstruction ear supporter ulceration risk |
| CN108743031A (en) * | 2018-04-03 | 2018-11-06 | 韩军宁 | The shaping methods of cavity of concha and duct deformity |
| CN109199698A (en) * | 2018-10-22 | 2019-01-15 | 南方医科大学 | A kind of anti-scar orthoses of 3D printing aural deformity and its preparation method |
| CN111067684A (en) * | 2020-03-04 | 2020-04-28 | 林向上 | Auricle shape orthosis and preparation method thereof |
| CN112006820A (en) * | 2020-09-10 | 2020-12-01 | 珠海赛纳三维科技有限公司 | Test model, test system and test method of ear orthosis |
| CN114533363A (en) * | 2022-03-23 | 2022-05-27 | 苏述平 | Postoperation auricle shaping device and preparation method thereof |
| CN115302777A (en) * | 2022-07-22 | 2022-11-08 | 安徽工程大学 | 3D printing manufacturing method for customized auricle orthotics |
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