CN106821569A - Neonate's auricle KAFO and its manufacture method - Google Patents

Abstract

The neonatal auricle orthosis of the present invention comprises a base and an upper cover matched with the base, the base includes an auricle covering part for covering the outer auricle, and the side of the auricle covering part close to the root of the ear is connected with a connecting piece, and the ear There is a space for accommodating the upper cover in the middle part of the cladding part of the pinna. The orthotic can be used for correction of all types of auricle deformities. The manufacturing method of the newborn auricle orthosis of the present invention comprises the following steps: Step 1, Data acquisition and reverse modeling: Step 2. Adjust the parts of the deformed auricle data that need to be corrected according to the normal auricle data and reverse modeling: Step 3. Draw the baffles of the base, the through holes and the ventilation holes of the upper cover: Steps 4. Use a 3D printer to print out the mold of the auricle orthosis: Step 5. The medical silicone auricle orthosis is poured into shape. This manufacturing method is designed and manufactured in combination with the actual situation of the auricle shape of newborns in China. It is customized according to different patients, and the size is accurate , comfortable to wear.

Description

Neonatal ear orthosis and manufacturing method thereof

technical field

The invention relates to the technical field of medical devices, in particular to a newborn auricle orthosis and a manufacturing method thereof.

Background technique

Ear deformities are very common in clinical practice. According to the statistical data of Japanese newborns, it is 55.2%. It is often complicated with craniofacial congenital malformation syndromes such as dysplasia of the first and second cheek arches, and is caused by developmental deformities or changes in mechanical structures. The treatment of ear deformity is preschool surgery, which has cartilage deformation, high recurrence rate, and invasiveness, and the comprehensive evaluation risk is high. In 1984, Japanese scholars Matsuo K and Hirose T first proposed in the American Journal of Prosthetic and Reconstructive Plastic Surgery PRS to correct ear deformities through non-surgical treatment in the neonatal period. However, due to the complicated operation and irregular correction methods, it has not been widely used. Since 2010, foreign countries have begun to study the application of ear molds to correct congenital ear deformities. Early intervention has achieved a clinical effective rate of more than 90%. According to the comparison of the data of ear plastic surgery in the United States in the past 10 years, it can be seen that the number of operations ranges from Every year, 36,295 cases dropped to 29,828 cases, a drop rate of 18%. No matter from the perspective of medical risks, medical expenses, or even from the perspective of human health and care, non-invasive ear plastic surgery is a breakthrough in mechanical correction of ear cartilage and can be extended to other cartilage on disease treatment.

The auricle orthosis of the prior art is not designed in combination with the actual situation of the auricle shape of Chinese newborns, and is not comfortable enough to wear, and may cause local pressure to cause the auricle to rupture.

Therefore, aiming at the deficiencies of the prior art, it is very necessary to provide a newborn auricle orthosis and a manufacturing method thereof to overcome the deficiencies of the prior art.

Contents of the invention

One of the purposes of the present invention is to avoid the deficiencies of the prior art and provide a newborn auricle orthosis, which can be used for the correction of all types of auricle deformities, and conforms to the actual situation of Chinese newborns. Comfortable to wear.

The second object of the present invention is to avoid the deficiencies of the prior art and provide a manufacturing method for neonatal auricular orthoses. The manufacturing method is designed and manufactured in conjunction with the actual situation of Chinese neonatal auricle shape, and is customized according to different patients. Precise size and comfortable to wear.

The above object of the present invention is achieved through the following technical means.

The neonatal auricle orthosis includes a base and an upper cover matched with the base. The base includes an auricle covering part for covering the outer auricle. There is a space for accommodating the upper cover in the middle of the part.

Furthermore, the upper cover is provided with a number of ventilation holes, and the covering part of the auricle is provided with a number of through holes.

Further, the base is made of silicone material, and the upper cover is made of silicone material.

Furthermore, the base is provided with a fixing device for fixing the upper cover, and the fixing device is a blocking piece, and the blocking piece extends from the auricle covering part toward the upper cover.

Preferably, there are three baffles, and the three baffles are evenly distributed on the covering part of the auricle.

Preferably, the connecting piece is integrally formed with the covering part of the auricle.

Furthermore, an adhesive sheet is provided on the periphery of the connecting sheet for bonding the connecting sheet to the base of the ear.

Preferably, the adhesive sheet is 3M seam-free adhesive tape.

Both the base and the cap follow the anatomy of the ear.

The manufacture method of neonatal ear orthosis, comprises the following steps:

Step 1. Data collection and reverse modeling:

Step 2. Adjust the parts of the deformed auricle data that need to be corrected according to the normal auricle data and perform reverse modeling:

Step 3. Draw the baffles of the base, the through holes and the ventilation holes of the upper cover:

Step 4. Use a 3D printer to print out the mold of the auricle orthosis:

Step 5: The medical silicone auricle orthosis is poured into shape.

The neonatal auricle orthosis of the present invention comprises a base and an upper cover matched with the base, the base includes an auricle covering part for covering the outer auricle, and the side of the auricle covering part close to the base of the ear is connected with a connecting piece, and the ear The middle part of the covering part of the pinna leaves a space for accommodating the upper cover. The corrector can be used for the correction of all types of deformities of the pinna and has a wide range of indications. It can not only treat the existing pinna deformities, but also prevent possible The shape of the auricle is deformed, and it is comfortable to wear.

The manufacturing method of the neonatal auricle orthosis of the present invention comprises the following steps: Step 1, data collection and reverse modeling: Step 2, adjusting the part of the deformed auricle data to be corrected according to the normal auricle data and performing reverse modeling : Step 3, drawing the base plate, the through hole and the air hole of the upper cover: Step 4, using a 3D printer to print out the mold of the auricle orthosis: Step 5, pouring the medical silicone auricle orthosis into shape, this manufacturing method combines Chinese Designed and manufactured according to the actual shape of the newborn's auricle, customized according to different patients, with accurate size and comfortable wearing.

Description of drawings

The present invention will be further described by using the accompanying drawings, but the content in the accompanying drawings does not constitute any limitation to the present invention.

Fig. 1 is a schematic structural view of the upper cover of the newborn auricle orthosis of the present invention.

Fig. 2 is a schematic structural view of the upper cover of the newborn auricle orthosis of the present invention.

Fig. 3 is a schematic diagram of the assembly structure of the base and the upper cover of the newborn auricle orthosis of the present invention.

FIG. 4 is a schematic view of the structure in another direction of FIG. 3 .

Fig. 5 is a schematic diagram of the use state of the newborn auricle orthosis of the present invention.

In Figures 1 to 5, including:

10—base, 11—connecting piece, 12—ear cover, 13—block, 14—through hole, 15—3M seam-free tape;

20—loam cake, 21—air vent.

detailed description

The present invention is further described in conjunction with the following examples.

Example 1.

As shown in Figures 1 to 4, the neonatal auricle orthosis includes a base 10 and an upper cover 20 matched with the base 10, the base 10 includes an auricle covering part 12 for covering the outer auricle, and the auricle covering The connecting piece 11 is connected to the side of the part 12 close to the root of the ear, and a space for accommodating the upper cover 20 is left in the middle part of the auricle covering part 12 . The upper cover 20 is provided with a plurality of ventilation holes 21 , and the auricle covering part 12 is provided with a plurality of through holes 14 . It is breathable and makes the wearer comfortable. The base 10 is the base 10 made of silica gel, and the upper cover 20 is the upper cover 20 made of silica gel. Made of silicone, it will not form hard pressure on the auricle and is comfortable. The base 10 is provided with a fixing device for fixing the upper cover 20, and both the base 10 and the upper cover 20 conform to the anatomical shape of the ear.

The manufacturing method of neonatal ear orthosis is specifically:

Step 1. Data collection and reverse modeling:

A 3D scanner was used to obtain the 3D data of the bilateral auricles, and Geomagic Studio 11 was used to perform mesh homogenization, noise reduction, surface smoothing, and nail removal on the model to eliminate local mesh deformities and transform the left The three-dimensional data of the normal auricle is mirrored, and finally the STL format model of the deformed auricle with a smooth surface and the mirrored normal auricle is obtained;

Step 2. Adjust the parts of the deformed auricle data that need to be corrected according to the normal auricle data and perform reverse modeling:

In Geomagic Studio 11, as shown in Figure 3-3, after mirroring the right deformed auricle and the left normal auricle, use the manual registration function to merge and align the two auricle models, and resize the normal auricle model to match the deformity Auricle matching, by creating a spline boundary to mark the parts of the deformed auricle that need to be adjusted, and at the same time, mark the spline boundary on the same position of the normal auricle model. Delete the part of the deformed auricle that needs to be adjusted, and delete the part of the normal auricle that needs to be adjusted. After the two parts are combined through Boolean operations, the bridge and filling functions are used to fill the holes in the model. Mesh homogenization, noise reduction, surface smoothing, nail removal and other treatments make it form a smooth auricle model, draw the spline boundary on the inner side of the helix, and divide the auricle model into two parts: the upper cover 20 and the base 10. part, after the base 10 is enlarged by 1.05 times, the inner circle of the base 10 and the outer circle of the upper cover 20 protrude outward by 2.00 mm and 1.00 mm respectively, and the protruding part of the upper cover 20 is closed, and the base 10 is thickened by 1.00 mm;

Step 3, draw the baffle 13 of the base 10, the through hole 14 and the vent hole 21 of the upper cover 20:

According to the shape of the designed ear mold, a 9.00x6.00x1.00mm baffle and a cylinder with a diameter of 2.00mm and a length of 20mm are drawn in UG NX6.0, and the baffle is combined with the base 10 of the auricle model. The contour model is subtracted to form a hollow, and the three baffles are imported into Geomagic Studio 11 and placed on the corresponding position of the above-mentioned pinna model base 10 to perform Boolean operations and merged, and the cylinder is imported into Geomagic Studio 11 and the upper cover 20 of the pinna model and the base 10 Carry out Boolean operation subtraction to achieve the hollow effect;

Step 4. Use a 3D printer to print out the mold of the auricle orthosis:

Carry out mold design, 3D printing and casting of silicone ears for outer ear brackets. Due to the complex structure of the human ear, traditional mold processing methods are time-consuming and costly. At the same time, considering that the human outer ear mold needs to be designed separately according to the shape of the normal ear of different patients, and the mold will correspond to the patient one by one, and it will be produced as a single piece, so it is not economical to adopt the traditional material removal processing method. 3D printing can quickly build complex shapes with high precision, reduce the number of mold parts, shorten mold making time and greatly reduce costs. It is planned to divide the human outer ear mold into upper and lower molds. According to the characteristics of 3D printing, mold design and 3D printing will be carried out for each different model. The mold was printed with the light-curing 3D printer Lite 450 of Shanghai Union Tech Co., Ltd. The printing accuracy of this printer is ±0.1mm (L≤100mm) or ±0.1% x L (L>100mm), which is more suitable for printing the outer ear mold. PLA material is used for printing, the thickness of the printing layer is 0.1mm, the number of shells is 6, the filling density is 60%, the filling shape is hexagonal, the printing speed is 60mm/s, the nozzle temperature is 185°C, and the platform temperature is 55°C;

Step 5: The medical silicone auricle orthosis is poured into shape.

NuSil MED4765 is used for medical silica gel. This silica gel is a typical two-component addition type silica gel. After molding, the Shore hardness is 65. The silica gel is a low-hardness paste-like solid at room temperature. Its performance parameters are shown in Table 3-1. After 1:1 mixing and mixing of component A and component B, use a vulcanizer (XLB-D 500X500) to maintain the pressure of 1MPa and temperature of 100°C for 90min to fully vulcanize the silica gel. Finally, after forced demoulding, the formed silicone auricle orthosis is taken out. The newborn auricle orthosis has a moderate texture and a smooth surface, which can play a supporting role but will not cause local compression due to excessive hardness.

Use of ear orthoses:

As shown in Figure 5, the ear is pulled through the base 10 and the base 10 is placed against the skull. After the ear passes through the base 10 and the base 10 rests behind the skull, lift the ear and make sure that the base 10 rests close to the retroauricular groove of the baby's ear. Check to make sure the ear is comfortably in the base 10. After correct positioning, the base 10 of the auricle orthosis and the head are fixed with a joint-free adhesive tape. After the base 10 is fixed, put the upper cover 20 in the corresponding position, and observe whether there will be pressure or other problems. It is used clinically to observe the wearing effect of newborns, adjust the softness and hardness, and make it suitable for the mechanical deformation of newborns' ear deformities.

When removing the orthosis, the following steps should be followed: 1. Remove the seam-free adhesive tape; 2. Remove the base 10; 3. Remove the upper cover 20.

Specifically, when wearing, put the base 10 on the outside of the auricle first, and then place the upper cover 20 in the matching position after being fixed, observe that there is no pressure on the auricle, and fix the base 10 of the auricle orthosis to the head with seam-free adhesive tape, without seams The adhesive tape uses 3M seam-free adhesive tape 15, which is a breathable adhesive tape, which is composed of a non-woven backing and pressure-sensitive adhesive. At the same time, it is attached with elastic fibers to strengthen the tension resistance. During the follow-up, observe whether there are problems such as local compression, uneven force, and poor shape correction of the auricle, and make appropriate adjustments.

Table 1-1 Properties of NuSil MED4765 silica gel

Table.1-1 Properties of NuSil MED4765 silicone

Example 2.

As shown in Figure 3, the neonatal auricle orthosis and its manufacturing method, other structures are the same as in Embodiment 1, the difference is that the fixing device is a blocking piece 13, which extends from the auricle covering part 12 to the upper cover 20. Block 13. There are three blocking pieces 13 , and the three blocking pieces 13 are evenly distributed on the auricle covering portion 12 . The connecting piece 11 is integrally formed with the auricle covering part 12 . It is convenient to fix the upper cover 20, and it is not easy to fall out of the base 10 when wearing it.

Example 3.

As shown in Figure 5, the neonatal auricle orthosis and its manufacturing method are the same as in Embodiment 1 or 2 in other structures, the difference is that: the periphery of the connecting piece 11 is also provided with a 3M seam-free tape 15. 3M seam-free tape 15. It is a kind of air-permeable adhesive tape, which is composed of non-woven backing and pressure-sensitive adhesive, and is attached with elastic fiber to strengthen the tension resistance. Secure the auricle to the head.

Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention rather than limit the protection scope of the present invention. Although the present invention has been described in detail with reference to the preferred embodiments, those of ordinary skill in the art should understand that Modifications or equivalent replacements are made to the technical solutions of the present invention without departing from the spirit and scope of the technical solutions of the present invention.

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.