Oral MRI shielding device and processing method thereof

Abstract

The invention provides an oral MRI (Magnetic Resonance Imaging) shielding device and a processing method thereof, the oral MRI shielding device comprises a gradient porous titanium alloy layer, a shielding layer attached to the gradient porous titanium alloy layer, and an outer layer wrapping the gradient porous titanium alloy layer and the shielding layer, the gradient porous titanium alloy layer is made of a titanium alloy material and is further provided with a contact area and an edge area surrounding the contact area, the contact area has the porosity of 60-70%, the edge area has the porosity of 20-30%, the shielding layer comprises a PEEK base material and a gold plating layer covering the PEEK base material, and the outer layer is made of a medical silica gel material. The problem that in the prior art, due to the fact that a metal implant exists in the oral cavity, image distortion possibly occurs in MRI examination is solved.

Description

Technical Field

[0001] This invention relates to the field of oral MRI auxiliary equipment technology, and in particular to an oral MRI shielding device and its manufacturing method. Background Technology

[0002] During oral MRI examinations, a shielding device is required, typically positioned on the upper and lower rows of teeth using occlusion. However, some users may have metal implants, such as dental implants, orthodontic brackets, or fixed dentures. These implants can cause eddy current effects during MRI scans with a field strength of 1.5T or higher, leading to image distortion (artifact area >35%), especially when examining the maxillofacial region, where artifacts severely impact image quality. Therefore, there is an urgent need to improve existing shielding devices to avoid image distortion. Summary of the Invention

[0003] To address the shortcomings of existing technologies, this invention provides an oral MRI shielding device that solves the problem of image distortion during MRI examinations caused by metal implants in the oral cavity.

[0004] According to an embodiment of the present invention, an oral MRI shielding device includes a gradient porous titanium alloy layer, a shielding layer bonded to the gradient porous titanium alloy layer, and an outer layer surrounding the gradient porous titanium alloy layer and the shielding layer. The gradient porous titanium alloy layer is made of titanium alloy and includes a contact area and an edge area surrounding the contact area. The contact area has a porosity of 60-70%, and the edge area has a porosity of 20-30%. The shielding layer includes a PEEK substrate and a gold-plated layer covering the PEEK substrate. The outer layer is made of medical-grade silicone. The use of medical-grade silicone in the outer layer of this solution assists in precise positioning of the device through biting, improving wearing comfort. The high porosity (60%-70%) of the contact area of ​​the gradient porous titanium alloy layer reduces weight and adheres to the mucosa, while the low porosity (20%-30%) of the edge area maintains shielding effectiveness. Ultimately, this results in a better shielding effect, solving the problem in the prior art where metal implants in the oral cavity can cause image distortion during MRI examinations.

[0005] Furthermore, multiple titanium-plated magnets are also embedded in the outer layer.

[0006] Furthermore, an epoxy resin covering the titanium-plated magnet is cured and applied to the outer layer.

[0007] Furthermore, the outer surface of the outer layer has a hydrophobic contact angle >150°.

[0008] Furthermore, the sheet resistance of the shielding layer is ≤0.2Ω / sq.

[0009] Furthermore, the magnetic flux density of the outer layer is 50-80 mT.

[0010] According to the embodiments, a processing method for the above-mentioned device is also provided, wherein the gradient porous titanium alloy layer is formed by SLM: Ti-6Al-4V powder, laser power 180-220W, scanning speed 1000-1200mm / s, and the porosity of the contact area is 60-70% and the porosity of the edge area is 20-30% by adjusting the scanning spacing; electrolytic polishing, voltage 12V, time 5min, so that the surface roughness Ra≤1.0um.

[0011] According to the embodiments, a processing method for the above-mentioned device is also provided, wherein the shielding layer processing method includes: PEEK pretreatment: oxygen plasma activation, power 100W, time 5min; magnetron sputtering gold plating: Ar gas pressure 0.5Pa, sputtering power 250W, substrate temperature 60℃.

[0012] According to the embodiments, a processing method for the above-mentioned device is also provided, wherein the outer layer processing method includes: silicone coating: liquid silicone injection molding, pressure 0.8 MPa, ultraviolet curing, wavelength 385 nm, strength 60 mW / cm. 2 Magnet embedding: After laser drilling, a titanium-plated magnet is inserted and sealed with epoxy resin.

[0013] Compared with the prior art, the present invention has the following beneficial effects:

[0014] By setting the gradient porous titanium alloy layer of titanium alloy to have high porosity (60%-70%) in the contact area to reduce weight and fit the mucosa, and low porosity (20%-30%) in the edge area to maintain shielding effectiveness, the device ultimately has a better shielding effect, solving the problem of image distortion in MRI examinations caused by metal implants in the oral cavity in the existing technology; the provided device fills the gap in oral artifact elimination products and has broad market application prospects. Attached Figure Description

[0015] Figure 1 This is a schematic diagram of the external structure of an embodiment of the present invention;

[0016] Figure 2 This is a schematic diagram of the cross-sectional structure of an embodiment of the present invention;

[0017] In the above attached figures:

[0018] Gradient porous titanium alloy layer 1, shielding layer 2, outer layer 3. Detailed Implementation

[0019] The technical solutions of the present invention will be further described below with reference to the accompanying drawings and embodiments.

[0020] In the description of this invention, it should be understood that the terms "center," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," "counterclockwise," "axial," "radial," and "circumferential" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this invention.

[0021] In an exemplary implementation, such as Figure 1 , 2As shown, this embodiment provides an oral MRI shielding device, which includes a gradient porous titanium alloy layer 1, a shielding layer 2 attached to the gradient porous titanium alloy layer 1, and an outer layer 3 surrounding the gradient porous titanium alloy layer 1 and the shielding layer 2. The gradient porous titanium alloy layer 1 is made of titanium alloy and also has a contact area and an edge area surrounding the contact area. The contact area refers to the inner surface area that directly contacts the wearer's oral soft tissues (such as gums, buccal mucosa, lingual surface, etc.). The edge area is the area that does not directly contact the soft tissues over a large area, referring to the area near the occlusal surface of the teeth and the gradient porous titanium alloy layer 2. The outer edge of the gradient porous titanium alloy layer 1 has a porosity of 60-70% in the contact area and 20-30% in the edge area. The shielding layer 2 includes a PEEK substrate (polyetheretherketone, a polymer composed of repeating units containing one ketone bond and two ether bonds in the main chain structure) and a gold-plated layer covering the PEEK substrate. The outer layer 3 is made of medical-grade silicone. The gradient porous titanium alloy layer 1 is formed using SLM: Ti-6Al-4V powder, laser power 180-220W, scanning speed 1000-1200mm / s, and adjustable by the scanning spacing. The control process ensures that the porosity of the contact area is 60-70%, and the porosity of the edge area is 20-30%. Electropolishing (voltage 12V, time 5min) achieves a surface roughness Ra≤1.0um. By setting the gradient porous titanium alloy layer 1 to have high porosity (60%-70%) in the contact area to reduce weight and adhere to the mucosa, and low porosity (20%-30%) in the edge area to maintain shielding effectiveness, the device ultimately achieves better shielding performance. The artifact area is reduced from 5-10cm to 1-2cm, and the image diagnostic availability is 100%. This solves the problem of artifacts in existing technologies due to oral cavity... Metal implants may cause image distortion in MRI examinations; the provided device fills the gap in oral artifact elimination products and has broad market application prospects; in particular, the porosity of the contact area and the edge area are set differently, so that the deformation compensation mechanism is: when elastic deformation (bending radius ≥3mm), the compression of the high porosity area and the expansion of the low porosity area are dynamically balanced. It can also be designed based on the three-period minimal surface (Gyroid-Primitive hybrid unit), which ultimately makes the pore connectivity >95% and the shielding effectiveness fluctuation <1dB when the compressive strain ≤10%.

[0022] In a further embodiment, the processing method for the shielding layer 2 includes: PEEK pretreatment: oxygen plasma activation, power 100W, time 5min; magnetron sputtering gold plating: Ar gas pressure 0.5Pa, sputtering power 250W, substrate temperature 60℃.

[0023] In a further embodiment, the outer layer 3 processing method includes: silicone coating: liquid silicone injection molding, pressure 0.8MPa, UV curing, wavelength 385nm, strength 60mW / cm². 2Magnet embedding: After laser drilling, a titanium-plated magnet is inserted and sealed with epoxy resin.

[0024] The processing method provided in this solution yields an oral MRI shielding device that improves shielding effectiveness from less than 15dB (traditional conductive gel) to over 30dB (1.5T). It can be reused more than 50 times, and can be quickly disinfected by wiping with alcohol or irradiating with ultraviolet light (5 min). When worn, the pressure is lower than the mucosal pain threshold (20 kPa), reaching below 15 kPa. The artifact area is reduced from 5-10 cm to 1-2 cm, and the image diagnostic availability is 100%.

[0025] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention and are not intended to limit it. Although the present invention has been described in detail with reference to preferred embodiments, those skilled in the art should understand that modifications or equivalent substitutions can be made to the technical solutions of the present invention without departing from the spirit and scope of the technical solutions of the present invention, and all such modifications or substitutions should be covered within the scope of the claims of the present invention.

Claims

1. An oral MRI shielding device, characterized in that, It includes a gradient porous titanium alloy layer, a shielding layer bonded to the gradient porous titanium alloy layer, and an outer layer wrapped around the gradient porous titanium alloy layer and the shielding layer. The gradient porous titanium alloy layer is made of titanium alloy and has a contact area and an edge area surrounding the contact area. The contact area has a porosity of 60-70%, and the edge area has a porosity of 20-30%. The shielding layer includes a PEEK substrate and a gold-plated layer covering the PEEK substrate. The outer layer is made of medical-grade silicone.

2. The oral MRI shielding device as described in claim 1, characterized in that, Multiple titanium-plated magnets are also embedded in the outer layer.

3. The oral MRI shielding device as described in claim 2, characterized in that, An epoxy resin covering the titanium-plated magnet is also cured on the outer layer.

4. The oral MRI shielding device as described in claim 3, characterized in that, The outer surface of the outer layer has a hydrophobic contact angle >150°.

5. The oral MRI shielding device as described in claim 1, characterized in that, The sheet resistance of the shielding layer is ≤0.2Ω / sq.

6. The oral MRI shielding device as described in claim 2, characterized in that, The magnetic flux density of the outer layer is 50-80 mT.

7. A method for manufacturing an oral MRI shielding device as described in any one of claims 1-6, characterized in that, The gradient porous titanium alloy layer is formed by SLM: Ti-6Al-4V powder, laser power 180-220W, scanning speed 1000-1200mm / s, and the porosity of the contact area is 60-70% and the porosity of the edge area is 20-30% by adjusting the scanning spacing; electrolytic polishing, voltage 12V, time 5min, so that the surface roughness Ra≤1.0um.

8. A method for manufacturing an oral MRI shielding device as described in any one of claims 1-6, characterized in that, The shielding layer processing method includes: PEEK pretreatment: oxygen plasma activation, power 100W, time 5min; magnetron sputtering gold plating: Ar gas pressure 0.5Pa, sputtering power 250W, substrate temperature 60℃.

9. A method for manufacturing an oral MRI shielding device as described in any one of claims 1-6, characterized in that, The outer layer processing methods include: silicone coating: liquid silicone injection molding, pressure 0.8MPa, UV curing, wavelength 385nm, strength 60mW / cm². 2 Magnet embedding: After laser drilling, a titanium-plated magnet is inserted and sealed with epoxy resin.

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