Implantable Multi-Axis Rotating Magnetic Device, Manufacturing Method and Sacrificial Layer Coating Device

Abstract

Implantable multi-axis rotating magnetic device, manufacturing method and sacrificial layer coating device. The method includes: providing a magnetizable sphere, coating a soluble sacrificial layer outside the magnetizable sphere; stacking a plurality of magnetizable spheres coated with the soluble sacrificial layer in a set manner to form a stacked body, and making two adjacent magnetizable spheres fix to each other through their respective soluble sacrificial layers; pouring a liquid potting material to form a support frame in the gap between the spheres in the stacked body and form a housing outside the stacked body; magnetizing the spheres in the housing; dissolving the soluble sacrificial layer in the housing and discharging the soluble sacrificial layer outside the housing to form a cavity at the position of the soluble sacrificial layer; injecting a lubricant into the cavity and performing overall encapsulation. The implantable multi-axis rotating magnetic device manufactured by this manufacturing method has relatively tight combination of each part, relatively accurate positioning of the magnetizable spheres, relatively simple manufacturing method and relatively high yield rate.

Description

Technical Field

[0001] The present invention relates to the technical field of medical auxiliary devices, and in particular to an implantable multi-axis rotating magnetic device, a manufacturing method and a sacrificial layer coating device. Background Art

[0002] At present, many patients usually adopt implantable medical auxiliary devices to assist their normal life. For example, an implantable cochlear stimulator is used to help patients hear the outside sounds clearly. Such implantable medical auxiliary devices generally include an implant part and an externally worn part, and the implant part usually has magnetism and is not easy to take out. The implant part usually cooperates with the externally worn part magnetically to achieve precise positioning and fixation of the two parts across the human body epidermis.

[0003] Although the above-mentioned implantable medical auxiliary devices are relatively convenient, when a patient wearing an implantable medical auxiliary device experiences a scenario such as magnetic resonance imaging that requires applying a magnetic field to the human body, since the implantable medical auxiliary device is fixed in the body, with the change of the external magnetic field, the implantable medical auxiliary device will bend, and in severe cases, there will also be risks such as breaking and flying out of the body. Summary of the Invention

[0004] In view of this, the present invention provides an implantable multi-axis rotating magnetic device, a manufacturing method and a sacrificial layer coating device. The implantable multi-axis rotating magnetic device manufactured by the manufacturing method of the implantable multi-axis rotating magnetic device has relatively tight combination of each part, relatively accurate positioning of magnetizable spheres, relatively simple manufacturing method and high yield.

[0005] The present invention provides a manufacturing method of an implantable multi-axis rotating magnetic device, including the following steps:.

[0006] S1: Provide a magnetizable sphere and coat a soluble sacrificial layer outside the magnetizable sphere;

[0007] S2: Stack a plurality of magnetizable spheres coated with the soluble sacrificial layer in a set manner to form a stacked body, and make two adjacent magnetizable spheres coated with the soluble sacrificial layer be fixed to each other through their respective soluble sacrificial layers;

[0008] S3: Pour a liquid potting material to form a support frame in the gap between the magnetizable spheres coated with the soluble sacrificial layer in the stacked body and form a shell outside the stacked body;

[0009] S4: Magnetize the magnetizable spheres in the shell;

[0010] S5: Dissolve the soluble sacrificial layer within the housing and discharge the soluble sacrificial layer outside the housing, forming a cavity at the position of the soluble sacrificial layer;

[0011] S6: Inject lubricant into the cavity and perform overall encapsulation.

[0012] Further, the melting point of the material of the soluble sacrificial layer is lower than 100 °C, and the density of the material of the soluble sacrificial layer in the liquid state is lower than 1 g / cm3.

[0013] Further, the material of the soluble sacrificial layer is paraffin wax, polyethylene wax, and / or ethylene-vinyl acetate copolymer.

[0014] Further, the stacking method of the plurality of magnetizable spheres coated with the soluble sacrificial layer in the stack is hexagonal closest packing or face-centered cubic closest packing.

[0015] Further, in step S2, by means of instantaneous high temperature and cooling and / or local heating, adjacent two of the magnetizable spheres are fixed to each other through their respective soluble sacrificial layers.

[0016] Further, the liquid potting material is silicone or polyurethane.

[0017] Further, when performing potting, an injection channel and an output channel are formed within the housing, and both the injection channel and the output channel communicate with the soluble sacrificial layer within the stack.

[0018] Further, when performing step S5, the method includes injecting a solution corresponding to the material of the soluble sacrificial layer into the housing through the injection channel to remove the soluble sacrificial layer, and flowing out from the output channel.

[0019] The present invention also provides an implantable multi-axis rotating magnetic device, and the implantable multi-axis rotating magnetic device is manufactured by the manufacturing method of the implantable multi-axis rotating magnetic device described above.

[0020] The present invention also provides a sacrificial layer coating device for coating the above-mentioned soluble sacrificial layer outside the magnetizable sphere. The sacrificial layer coating device includes a receiving groove for storing coolant, and a heater for heating the material of the soluble sacrificial layer to make it in a liquid state. The density of the coolant used in the sacrificial layer coating device is greater than the density of the material of the soluble sacrificial layer in the liquid state, and the heater is at least partially disposed above the liquid level of the coolant so that the interface of the heated liquid material of the soluble sacrificial layer contacts the interface of the coolant.

[0021] In summary, in the present invention, a sacrificial layer is first coated on the sphere, and then a plurality of spheres coated with the sacrificial layer are stacked. Subsequently, a housing and a support frame are formed outside and inside the stack, and finally the sacrificial layer is removed to fabricate the implantable multi-axis rotating magnetic device. The housing has an integral structure and there is no risk of interface separation, and each part is relatively tightly combined. Further, since the method of stacking first and then potting the support frame and the housing is adopted, the magnetizable spheres are directly formed in the cavities divided by the support frame when the sacrificial layer is removed, and the positioning of the magnetizable spheres is relatively accurate. Therefore, for the implantable multi-axis rotating magnetic device fabricated by the method for fabricating an implantable multi-axis rotating magnetic device, each part is relatively tightly combined, the positioning of the magnetizable spheres is relatively accurate, the fabrication method is relatively simple, and the yield is relatively high.

[0022] The above description is only an overview of the technical solution of the present invention. In order to be able to understand the technical means of the present invention more clearly, it can be implemented according to the content of the description. And in order to make the above and other objects, features and advantages of the present invention more obvious and understandable, the following specific preferred embodiments are given and described in detail in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figures 1 to 6 The structural schematic diagrams of the steps of the method for fabricating an implantable multi-axis rotating magnetic device provided by the embodiment of the present invention are shown.

[0024] Figure 7 The flow schematic diagrams of the steps in the method for fabricating an implantable multi-axis rotating magnetic device are shown.

[0025] Figure 8 The structural schematic diagram of the stacking manner of the spheres coated with the sacrificial layer provided by the first embodiment of the present invention is shown.

[0026] Figure 9 The structural schematic diagram of the stacking manner of the spheres coated with the sacrificial layer provided by the second embodiment of the present invention is shown.

[0027] Figure 10 The structural schematic diagram of the sacrificial layer coating device for coating the sacrificial layer outside the sphere provided by the present invention is shown. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0028] In order to further elaborate on the technical means and effects adopted by the present invention to achieve the predetermined invention purpose, the following is described in detail in conjunction with the accompanying drawings and preferred embodiments.

[0029] The present invention provides an implantable multi-axis rotating magnetic device, a manufacturing method thereof, and a sacrificial layer coating device. The implantable multi-axis rotating magnetic device manufactured by the manufacturing method of the implantable multi-axis rotating magnetic device has relatively tight combination of each part, relatively accurate positioning of the magnetizable sphere, relatively simple manufacturing method, and high yield rate.

[0030] As Figures 1 to 10 shown, the manufacturing method of the implantable multi-axis rotating magnetic device provided by the embodiment of the present invention includes the following steps:

[0031] S1: Provide a magnetizable sphere 10, and coat a soluble sacrificial layer 11 on the magnetizable sphere 10; (As Figures 1 to 2 shown)

[0032] In this step, the magnetizable sphere 10 only has the property of being magnetizable and does not have magnetism. It can be a rigid magnetic sphere that has magnetism permanently after magnetization or a flexible magnetic sphere that has magnetism temporarily after magnetization.

[0033] The above-mentioned soluble sacrificial layer 11 refers to a sacrificial layer 11 that can be dissolved by a solution corresponding to the material of the sacrificial layer 11. Preferably, the soluble sacrificial layer 11 is a low-density low-melting-point soluble solid organic matter with a melting point lower than 100°C and a density lower than 1 g / cm 3 so as to facilitate the relatively convenient and uniform coating of the soluble sacrificial layer 11 outside the magnetizable sphere 10.

[0034] The material of the low-density low-melting-point soluble sacrificial layer 11 can be one or more of materials such as paraffin, polyethylene wax, ethylene-vinyl acetate copolymer (EVA), etc. This organic matter can be dissolved by corresponding solvents such as dichloromethane, chloroform, xylene, heated acetone, ethanol, or water in subsequent steps.

[0035] Please refer to Figure 10 , in order to be able to coat the soluble sacrificial layer 11 on the outside of the magnetizable sphere relatively conveniently and uniformly, the present invention also provides a sacrificial layer coating device 20. The sacrificial layer coating device 20 includes a containing groove 21 for storing coolant, and a heater 22 for heating the material of the soluble sacrificial layer 11 and making it in a liquid state. Among them, the density of the coolant used in this device is greater than the density of the material of the soluble sacrificial layer 11 in the liquid state. The heater 22 is at least partially arranged above the liquid level of the coolant so that the interface of the liquid-soluble sacrificial layer 11 material contacts the interface of the coolant. More specifically, the heater can be a heating coil surrounded in a ring shape.

[0036] When coating the soluble sacrificial layer 11 outside the magnetizable sphere 10, the heater 22 can be started first, and the solid particles of the soluble sacrificial layer 11 can be placed in the ring surrounded by the heater 22, or the liquid soluble sacrificial layer 11 can be directly placed on the surface of the coolant; the heater 22 melts the solid soluble sacrificial layer 11 and maintains the liquid state of the soluble sacrificial layer 11.

[0037] The magnetizable sphere 10 is put in from above the liquid soluble sacrificial layer 11, and the sphere 10 falls by gravity. During the falling process, it first passes through the liquid soluble sacrificial layer 11 and then enters the coolant. At the junction of the liquid soluble sacrificial layer 11 and the coolant, the liquid soluble sacrificial layer 11 covering the outside of the sphere 10 will be carried into the coolant by the sphere 10. Under the action of the coolant, the liquid soluble sacrificial layer 11 cools and solidifies again into a solid state. When the sphere 10 completely enters the coolant, the soluble sacrificial layer 11 can be evenly coated on the sphere 10.

[0038] In the sacrificial layer coating device 20, the coolant used can be water. Understandably, in other embodiments, it can also be other materials. The material of the soluble sacrificial layer 11 is adapted to the material of the coolant, and the density of the material of the liquid soluble sacrificial layer 11 needs to be less than the density of the coolant so that the liquid soluble sacrificial layer 11 can float on the liquid surface of the coolant.

[0039] S2: Stack a plurality of magnetizable spheres 10 coated with the soluble sacrificial layer 11 in a set manner to form a stack 30, and fix adjacent two magnetizable spheres 10 to each other through their respective sacrificial layers 11; (such as Figure 3 and Figure 4 shown)

[0040] In this embodiment, a plurality of magnetizable spheres 10 coated with the soluble sacrificial layer 11 can be stacked in the hexagonal closest packing manner as shown in Figure 7 to Figure 8 the face-centered cubic closest packing shown or other packing manners.

[0041] In Figure 3 and Figure 4 , when stacking, a plurality of magnetizable spheres 10 coated with the soluble sacrificial layer 11 can be arranged in a plane first, and then a plurality of planes formed by the magnetizable spheres 10 coated with the soluble sacrificial layer 11 are stacked to complete the stacking.

[0042] When fixing two adjacent magnetizable spheres 10 to each other through their respective sacrificial layers 11, a method of instantaneously heating the magnetizable spheres 10 coated with the soluble sacrificial layer 11 to a high temperature and then cooling and / or locally heating them can be used, at least making the connection part of the two magnetizable spheres 10 in a slightly molten state, and then after re-solidification, the fixation between the two adjacent magnetizable spheres 10 coated with the soluble sacrificial layer 11 can be completed.

[0043] In this step, in the stack 30, a gap 31 is formed between the magnetizable spheres 10 coated with the soluble sacrificial layer 11, and the gaps 31 communicate with each other and are integrated within the stack 30.

[0044] S3: Pour the liquid potting material so that a support frame 41 is formed in the gap 31 between the magnetizable spheres 10 coated with the soluble sacrificial layer 11 in the stack 30, and a housing 42 is formed outside the stack 30; (as Figure 5 shown)

[0045] The liquid potting material can be a room-temperature curing potting material, such as elastic polymer materials like silicone rubber and polyurethane. When it is filled in a liquid state, it will not cause the soluble sacrificial layer 11 to melt.

[0046] Since gaps 31 communicating with each other are formed between the magnetizable spheres 10 coated with the soluble sacrificial layer 11 during stacking, the liquid potting material can enter into the gaps 31 and form a support frame 41 that connects the entire gap 31 after curing. At the same time, it can form a housing outside the entire stack 30.

[0047] It should be explained that Figure 5 only shows a schematic cross-sectional structure diagram of the stack 30 with the housing 42 coated. Actually, since the gaps 31 between the spheres 10 coated with the soluble sacrificial layer 11 in the stack 30 communicate with each other, the support frame 41 is actually a three-dimensional structure formed as a whole. Preferably, the housing can be cylindrical.

[0048] After this step, the magnetizable spheres 10 will be fixed by the housing and the support frame 41.

[0049] When performing potting, the stack 30 can be placed in a negative pressure chamber so that the potting material can more easily enter into the gap 31.

[0050] In order to facilitate the removal of the sacrificial layer 11 in subsequent steps, in this embodiment, when performing potting, an injection channel 43 and an output channel 44 also need to be formed in the housing 42, and both the injection channel 43 and the output channel 44 need to communicate with the soluble sacrificial layer 11 in the stack 30.

[0051] In this embodiment, during potting, a filling strip made of the same material as the soluble sacrificial layer 11 can be preset to replace the spaces of the injection channel 43 and the output channel 44.

[0052] Preferably, the injection channel 43 is connected to the sacrificial layer 11 at the bottom layer of the stack 30, and the output channel 44 is connected to the sacrificial layer 11 at the top layer of the stack 30. There can be multiple injection channels 43, and the multiple injection channels 43 are evenly connected to the sacrificial layer 11 at the bottom layer of the stack 30.

[0053] S4: Magnetize the magnetizable spheres inside the housing;

[0054] S5: Dissolve the soluble sacrificial layer 11 inside the housing 42 and discharge the soluble sacrificial layer 11 outside the housing 42 to form a cavity 45 at the position of the soluble sacrificial layer 11.

[0055] In this step, a solution corresponding to the material of the soluble sacrificial layer 11 can be injected into the housing 42 through the injection channel 43 to remove the soluble sacrificial layer 11, and then it flows out from the output channel 44. After dissolution, residues can also be removed by ultrasonic waves.

[0056] After removing the sacrificial layer 11, the space originally occupied by the sacrificial layer 11 forms a cavity 45, which is separated by the support frame 41, and adjacent cavities 45 can communicate with each other. The magnetizable spheres 10 can be placed in the cavity 45 and supported by the support frame 41.

[0057] S6: Inject lubricant into the cavity 45 and perform overall encapsulation to form an implantable multi-axis rotating magnetic device.

[0058] During encapsulation, the injection channel 43 and the output channel 44 can be blocked.

[0059] In the present invention, since it first coats the sacrificial layer 11 on the spheres 10, then stacks multiple spheres 10 coated with the sacrificial layer 11, and then forms the housing 42 and the support frame 41 outside and inside the stack 30, and finally removes the sacrificial layer 11 to manufacture the implantable multi-axis rotating magnetic device, its housing 42 is an integral structure without the hidden danger of interface separation, and each part is combined relatively tightly. Further, since it first performs stacking and then pots the support frame 41 and the housing 42, the magnetizable spheres 10 are directly formed in the cavity 45 separated by the support frame 41 when the sacrificial layer 11 is removed, and the positioning of the magnetizable spheres 10 is relatively accurate. Therefore, for the implantable multi-axis rotating magnetic device manufactured by this manufacturing method of the implantable multi-axis rotating magnetic device, each part is combined relatively tightly, the positioning of the magnetizable spheres 10 is relatively accurate, the manufacturing method is relatively simple, and the yield is relatively high.

[0060] The present invention also provides an implantable multi-axis rotating magnetic device, which is fabricated by the manufacturing method of the above-mentioned implantable multi-axis rotating magnetic device.

[0061] The present invention also provides a sacrificial layer coating device 20 for coating a soluble sacrificial layer 11 outside a magnetizable sphere 10. The coating device includes a containing groove 21 for storing a coolant 24, and a heater 22 for heating the material 23 of the soluble sacrificial layer 11 to make it in a liquid state. Among them, the density of the coolant 24 used in the device is greater than the density of the material 23 of the soluble sacrificial layer 11 in the liquid state. The heater 22 is at least partially disposed above the liquid level of the coolant 24 so that the interface of the heated liquid material 23 of the soluble sacrificial layer 11 is in contact with the interface of the coolant 24.

[0062] The above are only the preferred embodiments of the present invention, and do not impose any form of limitation on the present invention. Although the present invention has been disclosed above with the preferred embodiments, it is not intended to limit the present invention. Any person skilled in the art can make some changes or modifications to equivalent embodiments by using the above-disclosed technical content within the scope of the technical solution of the present invention. However, as long as it does not depart from the content of the technical solution of the present invention, any simple modification, equivalent change and modification made to the above embodiments according to the technical essence of the present invention still fall within the scope of the technical solution of the present invention.

Claims

1. A manufacturing method of an implantable multi-axis rotating magnetic device, characterized in that: It includes the following steps: S1: Provide a magnetizable sphere, and coat a soluble sacrificial layer outside the magnetizable sphere; S2: Stack a plurality of magnetizable spheres coated with the soluble sacrificial layer in a set manner to form a stack, and make two adjacent magnetizable spheres coated with the soluble sacrificial layer fix to each other through their respective soluble sacrificial layers; S3: Pour a liquid potting material so that a support frame is formed in the gap between the magnetizable spheres coated with the soluble sacrificial layer in the stack, and a shell is formed outside the stack; S4: Magnetize the magnetizable spheres in the shell; S5: Dissolve the soluble sacrificial layer in the shell, and discharge the soluble sacrificial layer outside the shell to form a cavity at the position of the soluble sacrificial layer; S6: Inject a lubricant into the cavity and perform overall encapsulation.

2. The manufacturing method of the implantable multi-axis rotating magnetic device according to claim 1, characterized in that: The melting point of the material of the soluble sacrificial layer is lower than 100 °C, and the density of the material of the soluble sacrificial layer in the liquid state is lower than 1 g / cm 3 .

3. The manufacturing method of the implantable multi-axis rotating magnetic device according to claim 2, characterized in that: The material of the soluble sacrificial layer is paraffin, polyethylene wax, and / or ethylene-vinyl acetate copolymer.

4. The manufacturing method of the implantable multi-axis rotating magnetic device according to claim 1, characterized in that: The stacking manner of the plurality of magnetizable spheres coated with the soluble sacrificial layer in the stack is hexagonal closest packing or face-centered cubic closest packing.

5. The manufacturing method of the implantable multi-axis rotating magnetic device according to claim 1, wherein: In step S2, adjacent two magnetizable spheres are fixed to each other through their respective soluble sacrificial layers by means of instantaneous high temperature and cooling and / or local heating.

6. The manufacturing method of the implantable multi-axis rotating magnetic device according to claim 1, wherein: The liquid potting material is silicone or polyurethane.

7. The manufacturing method of the implantable multi-axis rotating magnetic device according to claim 1, characterized in that: During potting, an injection channel and an output channel are formed in the shell, and both the injection channel and the output channel communicate with the soluble sacrificial layer in the stack.

8. The manufacturing method of the implantable multi-axis rotating magnetic device according to claim 7, characterized in that: When performing step S5, the method includes injecting a solution corresponding to the material of the soluble sacrificial layer into the shell through the injection channel to remove the soluble sacrificial layer, and flowing out from the output channel.

9. An implantable multi-axis rotating magnetic device, characterized in that: The implantable multi-axis rotating magnetic device is made by the manufacturing method of the implantable multi-axis rotating magnetic device according to any one of claims 1 to 8.

10. A sacrificial layer coating device for coating the soluble sacrificial layer according to any one of claims 1 to 9 on the outside of the magnetizable sphere, characterized in that: The sacrificial layer coating device includes a containing groove for storing coolant, and a heater for heating the material of the soluble sacrificial layer to make it in a liquid state. The density of the coolant used in the sacrificial layer coating device is greater than the density of the material of the soluble sacrificial layer in the liquid state. The heater is at least partially disposed above the liquid level of the coolant so that the interface of the heated liquid material of the soluble sacrificial layer contacts the interface of the coolant.

Images