WO2020125436A1 - 一种植入式医疗器件的制造方法 - Google Patents

一种植入式医疗器件的制造方法 Download PDF

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Publication number
WO2020125436A1
WO2020125436A1 PCT/CN2019/123440 CN2019123440W WO2020125436A1 WO 2020125436 A1 WO2020125436 A1 WO 2020125436A1 CN 2019123440 W CN2019123440 W CN 2019123440W WO 2020125436 A1 WO2020125436 A1 WO 2020125436A1
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Prior art keywords
coil
pad
manufacturing
welding
free end
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English (en)
French (fr)
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杨汉高
吴天准
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Shenzhen Institute of Advanced Technology of CAS
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Shenzhen Institute of Advanced Technology of CAS
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    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B23—MACHINE TOOLS; METAL-WORKING NOT OTHERWISE PROVIDED FOR
    • B23K—SOLDERING OR UNSOLDERING; WELDING; CLADDING OR PLATING BY SOLDERING OR WELDING; CUTTING BY APPLYING HEAT LOCALLY, e.g. FLAME CUTTING; WORKING BY LASER BEAM
    • B23K26/00—Working by laser beam, e.g. welding, cutting or boring
    • B23K26/20—Bonding
    • B23K26/21—Bonding by welding
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B23—MACHINE TOOLS; METAL-WORKING NOT OTHERWISE PROVIDED FOR
    • B23K—SOLDERING OR UNSOLDERING; WELDING; CLADDING OR PLATING BY SOLDERING OR WELDING; CUTTING BY APPLYING HEAT LOCALLY, e.g. FLAME CUTTING; WORKING BY LASER BEAM
    • B23K26/00—Working by laser beam, e.g. welding, cutting or boring
    • B23K26/70—Auxiliary operations or equipment

Definitions

  • This application belongs to the technical field of medical devices, and specifically relates to a method for manufacturing an implantable medical device.
  • the implantable medical device can effectively treat diseases and extend the life of patients, it has now been widely used.
  • the coil and the packaging substrate are usually soldered by reflow soldering or soldering.
  • the above method has many shortcomings, such as low welding strength; easy introduction of impurity materials that do not meet biocompatibility; the presence of impurity materials in body fluids leads to easy formation of potential differences and corrosion of solder joints. Therefore, it is now necessary to find a new manufacturing method to solve the above problems.
  • the present application provides a method for manufacturing an implantable medical device.
  • laser welding the occurrence of corrosion of solder joints can be avoided, welding strength can be improved, and the quality of the implantable medical device can be improved.
  • This application provides a method for manufacturing an implantable medical device, including:
  • a package body includes a package substrate, and a surface of the package substrate includes a coil area and an electrode area, and at least two first pads are provided in the coil area;
  • each of the coils including two free ends, aligning the free ends and the first pads one by one so that the free ends are in contact with the first pads, and Making the orthographic projection of the free end on the packaging substrate fall into the first pad;
  • Laser welding is used to weld the free end and the first pad together.
  • the welding power is 50-1000w and the welding time is 0.5-5s to obtain an implanted medical device.
  • the laser welding does not need to introduce other impurities such as lead material during the manufacturing process, no potential difference will be formed at the solder joints in the body fluid, thus avoiding the occurrence of corrosion of the solder joints.
  • laser welding produces solder joints that are formed in a short time and will not affect the non-welded area, and the welding strength will be significantly improved.
  • the specific selection of welding power and welding time can further improve the strength of the solder joints and improve the quality of the implanted medical device.
  • the free end and the first pad before aligning the free end and the first pad one by one, it also includes sintering the end of the free end into a spherical end, and the diameter of the spherical end is not larger than the first welding The diameter of the disc.
  • the coil is formed by winding a coil material, and the diameter of the coil material is not greater than the diameter of the first pad.
  • the diameter of the coil material is 50-500 ⁇ m
  • the diameter of the spherical tip is 100-500 ⁇ m
  • the diameter of the first pad is 120-500 ⁇ m.
  • the shape of the first pad is circular, triangular, quadrangular or polygonal.
  • the material of the coil and the first pad is independently selected from one or more of gold, platinum, titanium, iridium, palladium, niobium, tantalum and their alloys.
  • the coil includes an energy coil and a data coil, and the energy coil and the data coil are not conductive to each other.
  • the surface of the coil material is also provided with an insulating layer having biocompatibility.
  • a corrosion-resistant layer is also provided outside the coil.
  • the electrode area There are a plurality of second pads in the electrode area, and the second pads are used to connect with the electrodes.
  • FIG. 1 is a process flowchart of a manufacturing method in an embodiment of this application
  • FIG. 2 is a schematic structural diagram of a coil in an embodiment of the present application.
  • FIG. 3 is a schematic structural diagram of a packaging substrate in an embodiment of this application.
  • FIG. 4 is a schematic structural diagram of a packaging substrate in another embodiment of the present application.
  • Coil-1 free end-11, energy coil-12, data coil-13, package substrate-2, coil area 21, first pad-211, electrode area-22, second pad-221.
  • a method for manufacturing an implantable medical device provided by an embodiment of the present application includes:
  • Step 1 A package body is provided.
  • the package body includes a package substrate 2.
  • the surface of the package substrate 2 includes a coil area 21 and an electrode area 22. At least two first pads 211 are provided in the coil area 21.
  • Step 2 Provide at least one coil 1, each of the coils 1 includes two free ends 11, align the free ends 11 and the first pads 211 one by one, so that the free ends 11 and all The first pad 211 is in contact, and the orthographic projection of the free end 11 on the packaging substrate 2 falls into the first pad 211.
  • Step 3 Use laser welding to weld the free end 11 and the first pad 211 together.
  • the welding power is 50-1000w
  • the welding time is 0.5-5s to get implanted. Medical device.
  • the surface of the package substrate 2 of the present application is provided with a coil area 21 and an electrode area 22, the coil area 21 is provided with a first pad 211 for connecting with the coil 1, and the electrode area 22 The second pad 221 is provided for connection with the electrode.
  • a coil 1 of the present application is made of a coil material, and has two free ends 11.
  • the free end 11 of the coil 1 and the first pad 211 need to be aligned one by one, and the alignment setting will be specifically described below:
  • this application provides a coil 1,
  • the two free ends 11 are included, and the surface of the package substrate 2 is provided with two first pads 211. Therefore, one free end 11 and one first pad 211 need to be aligned for one-to-one alignment so that one The free end 11 is placed in a first pad 211 and is in contact with the first pad 211.
  • the other free end 11 is aligned with the other first pad 211, so that the other free end 11 is placed in the other first pad 211 and is in contact with the first pad 211.
  • each free end 11 and each first pad 211 which are aligned one by one are laser welded together to obtain an implantable medical device.
  • Laser welding can melt the end of the free end 11 of the coil 1 in a short time by high laser pulse power and combine with the first pad 211 to form a welding spot. Therefore, in the manufacturing process of this application, there is no need to introduce other impurities such as lead material like the brazing process, only the coil 1 and the first pad 211 need be used; therefore, no potential difference will be formed at the solder joint in the body fluid, Avoid the occurrence of corrosion of solder joints. At the same time, compared with the traditional welding methods such as reflow soldering or brazing, the solder joints prepared by laser welding will be formed in a short time and will not affect the non-welded area, so the welding strength will be significantly improved.
  • the above-mentioned specific selection of welding power and welding time can further increase the strength of the solder joint and improve the quality of the implantable medical device.
  • the welding strength of the implantable medical device obtained by the manufacturing method of the present application is 20-200g.
  • the welding strength of the implantable medical device is 50-150 g. More preferably, the welding strength of the implantable medical device is 80-100g.
  • the welding power is 100-800w and the welding time is 0.5-3s. More preferably, in the laser welding process, the welding power is 200-600w and the welding time is 1-2s.
  • a plurality of second pads 221 are provided in the electrode area 22, and the second pads 221 are used to connect with the electrodes.
  • the first pad 211 and the second pad 221 are formed by printing paste or pin after high-temperature sintering, or after the package substrate 2 is prepared and then formed by electroplating or electroless plating.
  • the shape of the first pad 211 is circular, triangular, quadrangular or polygonal.
  • the triangular, quadrangular or polygonal first pad 211 can make it easier for the operator to perform the alignment setting, which greatly improves the work efficiency.
  • the diameter of the first pad 211 is 100-500 ⁇ m.
  • the shape of the first pad 211 is triangular, quadrangular, or polygonal, the length of the longest side of the first pad 211 is 0.1-0.5 mm, and the length of the shortest side of the first pad 211 is 0.1-0.5 mm.
  • the shape of the first pad 211 is a quadrangle. More preferably, the shape of the first pad 211 is square.
  • an alignment device is used to align the free end 11 of the coil 1 and the first pad 211 one by one.
  • the alignment device may align one free end 11 and one first pad 211 at a time, or may align all the free ends 11 and all first pads 211 one at a time.
  • the free ends 11 and the first pads 211 before aligning the free ends 11 and the first pads 211 one by one, it further includes sintering the ends of the free ends 11 into spherical ends, and the spherical The diameter of the tip is not larger than the diameter of the first pad 211.
  • the coil material for preparing the coil 1 has a small size and a soft texture
  • the free end 11 is not easy to be in contact with the first pad 211 contact.
  • the position of the first free end 11 is likely to change. Therefore, in this application, a ball burner is used to sinter the end of the free end 11. After the end is melted, it will form a spherical end due to the action of gravity.
  • the sintered spherical tip becomes larger in size and harder in texture, so it is easy to align with the first pad 211 one by one, so that the free end 11 falls within the first pad 211 and contacts the first pad 211, At the same time, the position of the free end 11 is not likely to change when aligned.
  • the present application can control the parameters of the sintering process so that the diameter of the spherical tip is not greater than the size of the 211 of the first pad. Because when aligning the free end 11 and the first pad 211, the operator needs to use a magnifying device such as the naked eye or a microscope to first place the free end 11 directly above the first pad 211, so that the free end 11 is opposite to the The orthographic projection of the package substrate 2 falls within the first pad 211, and then the free end 11 is dropped to make the free end 11 contact the first pad 211. If the diameter of the spherical tip is larger than the size of the first pad 211, it is difficult for the operator to adjust the free end 11 directly above the first pad 211. Therefore, the free end 11 and the first pad 211 cannot be aligned.
  • a magnifying device such as the naked eye or a microscope
  • the sintering temperature in the process of sintering the end of the free end 11 into a spherical end, is 600-2000°C and the sintering time is 1-30s.
  • the sintering temperature is 800-1800°C, and the sintering time is 5-25s. More preferably, the sintering temperature is 1000-1500°C, and the sintering time is 10-20s.
  • the coil 1 is formed by winding a coil material, and the diameter of the coil material is not greater than the diameter of the first pad 211. Controlling the diameter of the coil material can better align the free end 11 of the coil 1 with the first pad 211. If the diameter of the coil material is greater than the diameter of the first pad 211, it is difficult for the operator to adjust the free end 11 directly above the first pad 211, and after sintering into a spherical end, the spherical end The diameter size will become larger, further increasing the operator's difficulty of operation.
  • the cross-section of the coil material of the present application is circular
  • the diameter of the coil material is 50-500 ⁇ m
  • the diameter of the spherical tip is 100-500 ⁇ m
  • the diameter of the first pad 211 is 120-500 ⁇ m.
  • the ball joint and the first pad 211 can facilitate the alignment of the free end 11 of the coil material and the first pad 211.
  • the diameter of the coil material is 100-450 ⁇ m
  • the diameter of the spherical tip is 150-480 ⁇ m
  • the diameter of the first pad 211 is 180-500 ⁇ m. More preferably, the diameter of the coil material is 150-400 ⁇ m
  • the diameter of the spherical tip is 200-450 ⁇ m
  • the diameter of the first pad 211 is 250-480 ⁇ m.
  • materials of the coil 1 and the first pad 211 are independently selected from one or more of gold, platinum, titanium, iridium, palladium, niobium, tantalum, and alloys thereof.
  • the material of the coil 1 and the material of the first pad 211 may be the same or different.
  • the material of the coil 1 and the first pad 211 are different, the material of the coil 1 is gold, and the material of the first pad 211 is platinum; or the material of the coil 1 and the first pad 211 are the same, the coil 1 and the material of the first pad 211 are both titanium alloys.
  • the material of the coil 1 is the same as the material of the first pad 211.
  • the coil 1 of the same material and the first pad 211 can further improve the welding strength after welding.
  • the number of the coil 1 is two, the coil 1 includes an energy coil 12 and a data coil 13, and the energy coil 12 and the data coil 13 are not conductive to each other.
  • the coil 1 may include an energy data coil 13 or an energy coil 12 and a data coil 13.
  • the coil 1 is the energy data coil 13
  • only one coil 1 is needed to realize the transmission of energy and data.
  • the coil 1 includes an energy coil 12 and a data coil 13
  • energy and data can be transmitted through the energy coil 12 and the data coil 13, respectively, so that the transmission effect of energy and data is better.
  • only the data coil 13 and the energy coil 12 need not be connected to each other to prevent the occurrence of a short circuit.
  • the energy coil 12 and the data coil 13 may not be in contact with or in contact with each other.
  • the energy coil 12 and the data coil 13 are in contact with each other, it is only necessary to provide a biocompatible insulating layer on the surface of the coil material. can. Even if the energy coil 12 and the data coil 13 are in contact with each other, they may not conduct to each other to avoid the occurrence of a short circuit phenomenon.
  • the data coil 13 may be directly arranged in the cavity of the energy coil 12, or the data coil 13 may be arranged outside the energy coil 12, so that the energy coil 12 and the data coil are arranged side by side.
  • the specific positional relationship between the energy coil 12 and the data coil 13 is not specifically limited in this application.
  • the data coil 13 may be arranged in parallel with the energy coil 12, or may be arranged vertically or intersectingly.
  • the application of the data coil 13 in the energy coil 12 can further improve the transmission effect of energy and data.
  • the number of turns of the energy coil 12 is 10-30 turns, and the number of turns of the data coil 13 is 5-20 turns.
  • the number of turns of the energy coil 12 is 12-25 turns, and the number of turns of the data coil 13 is 6-15 turns. More preferably, the energy coil 12 has 14-20 turns, and the data coil 13 has 8-15 turns.
  • the coil 1 when the coil 1 includes an energy coil 12 and a data coil 13, the length of the outermost circle of the energy coil 12 is 5-20 mm, and the width of the outermost circle is 3-12 mm; the outermost circle of the data coil 13 The length is 4-18mm, and the width of the outermost ring is 1-8mm.
  • the surface of the coil material in addition to the free end 11, is also provided with an insulating layer having biocompatibility.
  • a corrosion-resistant layer is also provided outside the coil 1.
  • the coil 1 of the present application is formed by winding a coil material. Before winding, in addition to the free end 11, a biocompatible insulating layer is formed on the surface of the coil material, so that the coil material is in the process of winding There will be no short circuit, and the above-mentioned biocompatible insulating layer can be placed directly in the body fluids of the human body.
  • the corrosion-resistant layer can be formed by directly injecting silicone rubber outside the coil 1 except the free end 11, and the thickness of the corrosion-resistant layer is 0.1-2mm, so that the coil 1 Wrapped up to avoid contact with body fluids and corrosion.
  • the number of the coils 1 is more than one, after the winding is completed, more than one coils 1 can also be fixed using an adhesive insulating material, so as to prepare a corrosion-resistant layer.
  • the material of the biocompatible insulating layer includes Parylene or Teflon.
  • the material of the corrosion-resistant layer includes silicone.
  • the manufacturing method of the present application requires laser welding in a protective atmosphere to ensure that no oxidation occurs during welding and to prevent oxidation of the weld.

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  • Engineering & Computer Science (AREA)
  • Physics & Mathematics (AREA)
  • Optics & Photonics (AREA)
  • Plasma & Fusion (AREA)
  • Mechanical Engineering (AREA)
  • Laser Beam Processing (AREA)
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  • Electrotherapy Devices (AREA)

Abstract

一种植入式医疗器件的制造方法，包括：提供封装体，封装体包括封装基板（2），封装基板（2）的表面包括线圈区（21）和电极区（22），线圈区（21）内设有至少两个第一焊盘（211）。提供至少一个线圈（1），每个线圈（1）包括两个自由端（11），将自由端（11）与第一焊盘（211）一一对准设置，使所述自由端（11）与所述第一焊盘（211）相接触，且使所述自由端（11）在所述封装基板（2）上的正投影落入所述第一焊盘（211）内。采用激光焊接将自由端（11）与第一焊盘（211）焊接在一起，在激光焊接的过程中，焊接功率为50-1000w，焊接时间为0.5-5s，得到植入式医疗器件。由于该制造方法在焊接制造过程中不需要引入铅料等其他杂质物质，因此植入人体内在焊点处不会形成电位差，避免了焊点被腐蚀现象的出现，同时提高了焊接强度。

Description

一种植入式医疗器件的制造方法 技术领域
本申请属于医疗器件技术领域，具体涉及一种植入式医疗器件的制造方法。
背景技术
随着医疗水平的不断提高，且由于植入式医疗器件可有效地治疗疾病和延长患者的寿命，现已得到广泛的应用。在植入式医疗器件的制造过程中，需要将线圈和封装体上的封装基板连接在一起，以便数据和/或能量的无线传输。目前通常采用回流焊或钎焊等方法将线圈和封装基板焊接起来。但上述方法存在着诸多的缺点，例如焊接强度低；易引入不满足生物兼容性的杂质材料；在体液中杂质材料的存在导致易形成电位差并使焊点被腐蚀。因此，现在需要寻找一种新的制造方法解决上述问题。
申请内容
鉴于此，本申请提供了一种植入式医疗器件的制造方法，通过采用激光焊接，可避免焊点被腐蚀现象的出现，并且提高焊接强度，提高植入式医疗器件的质量。
本申请提供了一种植入式医疗器件的制造方法，包括：
提供封装体，所述封装体包括封装基板，所述封装基板的表面包括线圈区和电极区，所述线圈区内设有至少两个第一焊盘；
提供至少一个线圈，每个所述线圈包括两个自由端，将所述自由端与所述 第一焊盘一一对准设置，使所述自由端与所述第一焊盘相接触，且使所述自由端在所述封装基板上的正投影落入所述第一焊盘内；
采用激光焊接将所述自由端与所述第一焊盘焊接在一起，在所述激光焊接的过程中，焊接功率为50-1000w，焊接时间为0.5-5s，得到植入式医疗器件。
本申请提供的制造方法，由于激光焊接在制造过程中不需要引入铅料等其他杂质物质，因此在体液中焊点处不会形成电位差，避免了焊点被腐蚀现象的出现。同时激光焊接相比于回流焊或钎焊等传统焊接方法，激光焊接制备的焊点由于在短时间内形成，不会对非焊接区造成影响，焊接强度也会显著提高。另外，焊接功率和焊接时间的具体选择，可以进一步提高焊点的强度，提高植入式医疗器件的质量。
其中，在将所述自由端与所述第一焊盘一一对准设置之前，还包括将所述自由端的端头烧结成球状端头，且所述球状端头的直径不大于第一焊盘的直径。
其中，所述线圈由线圈材料绕制而成，所述线圈材料的直径与不大于所述第一焊盘的直径。
其中，所述线圈材料的直径为50-500μm，所述球状端头的直径为100-500μm，所述第一焊盘的直径为120-500μm。
其中，所述第一焊盘的形状为圆形、三角形、四边形或多边形。
其中，所述线圈和所述第一焊盘的材质独立地选自金、铂、钛、铱、钯、铌、钽及其合金中的一种或多种。
其中，所述线圈包括能量线圈和数据线圈，所述能量线圈和所述数据线圈互不导通。
其中，除所述自由端外，所述线圈材料的表面还设有具有生物兼容性的绝缘层。
其中，除所述自由端外，所述线圈外还设有耐腐蚀层。
其中，所述电极区内设有多个第二焊盘，所述第二焊盘用于与电极相连接。
附图说明
为了更清楚地说明本申请实施例中的技术方案，下面将对本申请实施例中所需要使用的附图进行说明。
图1为本申请实施例中制造方法的工艺流程图；
图2为本申请实施例中线圈的结构示意图；
图3为本申请实施例中封装基板的结构示意图；
图4为本申请另一实施例中封装基板的结构示意图。
附图标记：
线圈-1，自由端-11，能量线圈-12，数据线圈-13，封装基板-2，线圈区21，第一焊盘-211，电极区-22，第二焊盘-221。
具体实施方式
以下是本申请的优选实施方式，应当指出，对于本技术领域的普通技术人员来说，在不脱离本申请原理的前提下，还可以做出若干改进和润饰，这些改进和润饰也视为本申请的保护范围。
请参考图1-图3，本申请实施例提供的一种植入式医疗器件的制造方法，包括：
步骤1：提供封装体，所述封装体包括封装基板2，所述封装基板2的表面包括线圈区21和电极区22，所述线圈区21内设有至少两个第一焊盘211。
步骤2：提供至少一个线圈1，每个所述线圈1包括两个自由端11，将所述自由端11与所述第一焊盘211一一对准设置，使所述自由端11与所述第一焊盘211相接触，且使所述自由端11在所述封装基板2上的正投影落入所述第一焊盘211内。
步骤3：采用激光焊接将所述自由端11与所述第一焊盘211焊接在一起，在所述激光焊接的过程中，焊接功率为50-1000w，焊接时间为0.5-5s，得到植入式医疗器件。
请参考图3，本申请的封装基板2的表面设有线圈区21和电极区22，所述线圈区21内设有第一焊盘211，用于与线圈1进行连接，而电极区22内设有第二焊盘221，用于与电极进行连接。请参考图2，本申请的一个线圈1是由一根线圈材料绕制而成，其具有两个自由端11。
在本申请的制造过程中，需要将所述线圈1的自由端11与所述第一焊盘211一一对准设置，下面对对准设置进行具体说明：例如本申请提供一个线圈1，包括两个自由端11，而封装基板2的表面设有两个第一焊盘211，因此在一一对准设置时需要将一个自由端11与一个第一焊盘211对准设置，使一个自由端11置于一个第一焊盘211内并与第一焊盘211相接触。另外一个自由端11与另外一个第一焊盘211对准设置，使另外一个自由端11置于另外一个第一焊盘211内并与第一焊盘211相接触。最后再将一一对准设置好的每个自由端11与每个第一焊盘211采用激光焊接焊接在一起，得到植入式医疗器件。
激光焊接可通过高激光脉冲功率在短时间内将线圈1自由端11的端头部 分融化并与第一焊盘211结合在一起形成焊点。因此在本申请的制造过程中不需要像钎焊工艺那样引入铅料等其他杂质物质，只需要使用线圈1和第一焊盘211即可；因此在体液中焊点处不会形成电位差，避免了焊点被腐蚀现象的出现。同时相比于回流焊或钎焊等传统焊接方法，激光焊接制备的焊点由于在短时间内形成，不会对非焊接区造成影响，因此焊接强度也会显著提高。
另外，上述焊接功率和焊接时间的特定选择，可以进一步提高焊点的强度，提高植入式医疗器件的质量。采用本申请的制造方法得到的植入式医疗器件的焊接强度为20-200g。优选地，植入式医疗器件的焊接强度为50-150g。更优选地，植入式医疗器件的焊接强度为80-100g。
优选地，在所述激光焊接的过程中，焊接功率为100-800w，焊接时间为0.5-3s。更优选地，在所述激光焊接的过程中，焊接功率为200-600w，焊接时间为1-2s。
本申请优选实施方式中，所述电极区22内设有多个第二焊盘221，所述第二焊盘221用于与电极相连接。本申请第一焊盘211和第二焊盘221是采用印刷料浆或者插针后高温烧结后形成，或者是制备完封装基板2后再采用电镀或化学镀等方式形成。
请参考图4，本申请优选实施方式中，所述第一焊盘211的形状为圆形、三角形、四边形或多边形。三角形、四边形或多边形状的第一焊盘211可使操作人员更容易进行对准设置，大大提高了工作效率。当第一焊盘211的形状为圆形时，第一焊盘211的直径为100-500μm。当第一焊盘211的形状为三角形、四边形或多边形时，第一焊盘211的最长边的长度为0.1-0.5mm，第一焊盘211的最短边的长度为0.1-0.5mm。优选地，所述第一焊盘211的形状为四边形。 更优选地，所述第一焊盘211的形状为正方形。
本申请优选实施方式中，采用对准装置将线圈1的自由端11与第一焊盘211一一对准设置。对准装置可一次将一个自由端11和一个第一焊盘211进行对准，也可一次将所有的自由端11和所有的第一焊盘211进行一一对准。
本申请优选实施方式中，在将所述自由端11与所述第一焊盘211一一对准设置之前，还包括将所述自由端11的端头烧结成球状端头，且所述球状端头的直径不大于第一焊盘211的直径。
由于制备线圈1的线圈材料的尺寸较小、质地较软，在将所述自由端11与所述第一焊盘211一一对准设置时，自由端11不容易与第一焊盘211相接触。并且在对准好第一个自由端11和第一焊盘211之后，在对准第二个自由端11和第一焊盘211时，第一个自由端11的位置容易发生变化。因此本申请先使用烧球机将自由端11的端头烧结，端头融化后由于重力的作用，会成球状端头。烧结后的球状端头尺寸变大，质地变硬，因此易与第一焊盘211一一对准设置，使自由端11落在第一焊盘211内并与第一焊盘211相接触，同时自由端11在对准设置时位置不易发生变动。
另外，本申请可通过控制烧结工艺的参数使球状端头的直径尺寸不大于第一焊盘的211的尺寸。因为在使自由端11和第一焊盘211对准设置时，需要操作人员需要采用肉眼或显微镜等放大设备先将自由端11置于第一焊盘211的正上方，使自由端11相对于封装基板2的正投影落在第一焊盘211内，然后再将自由端11下落，使自由端11与第一焊盘211相接触。若球状端头的直径尺寸大于第一焊盘211的尺寸，则操作人员很难将自由端11调整到第一焊盘211的正上方。因此也就无法使自由端11和第一焊盘211对准设置。
本申请优选实施方式中，在将所述自由端11的端头烧结成球状端头的过程中，所述烧结温度为600-2000℃，烧结时间为1-30s。优选地，所述烧结温度为800-1800℃，烧结时间为5-25s。更优选地，所述烧结温度为1000-1500℃，烧结时间为10-20s。
本申请优选实施方式中，所述线圈1由线圈材料绕制而成，所述线圈材料的直径与不大于所述第一焊盘211的直径。控制线圈材料的直径可更好地使线圈1的自由端11与第一焊盘211相对准。若所述线圈材料的直径与大于所述第一焊盘211的直径，则操作人员很难将自由端11调整到第一焊盘211的正上方，而烧结成球状端头后，球状端头的直径尺寸将变得更大，进一步增加了操作人员的操作难度。优选地，本申请线圈材料的横截面为圆形
本申请优选实施方式中，所述线圈材料的直径为50-500μm，所述球状端头的直径为100-500μm，所述第一焊盘211的直径为120-500μm。采用上述尺寸的线圈材料，球状接头和第一焊盘211，可便于将线圈材料的自由端11与第一焊盘211对准设置。优选地，所述线圈材料的直径为100-450μm，所述球状端头的直径为150-480μm，所述第一焊盘211的直径为180-500μm。更优选地，所述线圈材料的直径为150-400μm，所述球状端头的直径为200-450μm，所述第一焊盘211的直径为250-480μm。
本申请优选实施方式中，所述线圈1和所述第一焊盘211的材质独立地选自金、铂、钛、铱、钯、铌、钽及其合金中的一种或多种。其中，线圈1的材质和第一焊盘211的材质可相同或不相同。例如，线圈1的材质和第一焊盘211的材质不相同，线圈1的材质为金，第一焊盘211的材质为铂；或者线圈1的材质和第一焊盘211的材质相同，线圈1和第一焊盘211的材质均为钛合 金。优选地，所述线圈1的材质与所述第一焊盘211的材质相同。相同材质的线圈1的和第一焊盘211可进一步提高焊接后的焊接强度。
本申请优选实施方式中，线圈1的数量为两个，所述线圈1包括能量线圈12和数据线圈13，所述能量线圈12和所述数据线圈13互不导通。本申请中线圈1可以包括能量数据线圈13或能量线圈12、数据线圈13。当线圈1为能量数据线圈13时，只需要一个线圈1即可实现能量和数据的传输。当线圈1包括能量线圈12和数据线圈13时，可使能量和数据分别通过能量线圈12和数据线圈13进行传输，使能量和数据的传输效果更好。本申请只需数据线圈13与能量线圈12互不导通即可，防止短路现象的发生。
本申请优选实施方式中，能量线圈12和数据线圈13可相互不接触或相接触，当能量线圈12和数据线圈13相互接触时，只需要在线圈材料表面设有具有生物兼容性的绝缘层即可。即使能量线圈12和数据线圈13相互接触，也可互不导通，避免短路现象的发生。本申请优选实施方式中，数据线圈13可直接设置在能量线圈12的空腔内，数据线圈13也可设置在能量线圈12外，使能量线圈12与数据线圈并排设置。具体能量线圈12和数据线圈13的位置关系本申请并不做具体限定。例如数据线圈13可与能量线圈12平行设置，也可垂直设置或相交设置。另外，本申请将数据线圈13置于能量线圈12内可更一进步地提高能量和数据的传输效果。
本申请优选实施方式中，能量线圈12的匝数为10-30匝，数据线圈13的匝数是5-20匝。优选地，能量线圈12的匝数为12-25匝，数据线圈13的匝数是6-15匝。更优选地，能量线圈12的匝数为14-20匝，数据线圈13的匝数是8-15匝。
本申请优选实施方式中，当线圈1包括能量线圈12和数据线圈13时，能量线圈12的最外圈的长为5-20mm，最外圈的宽为3-12mm；数据线圈13最外圈的长为4-18mm，最外圈的宽为1-8mm。
本申请优选实施方式中，除所述自由端11外，所述线圈材料的表面还设有具有生物兼容性的绝缘层。本申请优选实施方式中，除所述自由端11外，所述线圈1外还设有耐腐蚀层。本申请的线圈1是由一根线圈材料绕制而成，在绕制之前除自由端11外，先将线圈材料的表面形成具有生物兼容性的绝缘层，使线圈材料在绕制的过程中不会出现短路的现象，并且上述具有生物兼容性的绝缘层可直接放置在人体的体液中。在绕制完成后，当线圈1的数量为一个时，可直接在除自由端11外的线圈1外通过硅胶注塑，形成耐腐蚀层，且耐腐蚀层的厚度为0.1-2mm，以将线圈1包覆起来，避免与人体的体液进行接触进而被腐蚀。当线圈1的数量为一个以上时，在绕制完成后，还可使用具有黏性的绝缘材料将一个以上的线圈1固定起来，以便耐腐蚀层的制备。具有生物兼容性的绝缘层的材质包括聚对二甲苯(Parylene)或特氟龙。耐腐蚀层的材质包括硅胶。
本申请优选实施方式中，本申请的制造方法需在保护性气氛的环境下进行激光焊接，以保证在焊接时不会出现氧化现象的产生，防止焊接处被氧化。
以上对本申请实施方式所提供的内容进行了详细介绍，本文对本申请的原理及实施方式进行了阐述与说明，以上说明只是用于帮助理解本申请的方法及其核心思想；同时，对于本领域的一般技术人员，依据本申请的思想，在具体实施方式及应用范围上均会有改变之处，综上所述，本说明书内容不应理解为对本申请的限制。

Claims (10)

  1. 一种植入式医疗器件的制造方法，其特征在于，包括：
    提供封装体，所述封装体包括封装基板，所述封装基板的表面包括线圈区和电极区，所述线圈区内设有至少两个第一焊盘；
    提供至少一个线圈，每个所述线圈包括两个自由端，将所述自由端与所述第一焊盘一一对准设置，使所述自由端与所述第一焊盘相接触，且使所述自由端在所述封装基板上的正投影落入所述第一焊盘内；
    采用激光焊接将所述自由端与所述第一焊盘焊接在一起，在所述激光焊接的过程中，焊接功率为50-1000w，焊接时间为0.5-5s，得到植入式医疗器件。
  2. 如权利要求1所述的制造方法，其特征在于，在将所述自由端与所述第一焊盘一一对准设置之前，还包括将所述自由端的端头烧结成球状端头，且所述球状端头的直径不大于第一焊盘的直径。
  3. 如权利要求1所述的制造方法，其特征在于，所述线圈由线圈材料绕制而成，所述线圈材料的直径与不大于所述第一焊盘的直径。
  4. 如权利要求2所述的制造方法，其特征在于，所述线圈材料的直径为50-500μm，所述球状端头的直径为100-500μm，所述第一焊盘的直径为120-500μm。
  5. 如权利要求1所述的制造方法，其特征在于，所述第一焊盘的形状为圆形、三角形、四边形或多边形。
  6. 如权利要求1所述的制造方法，其特征在于，所述线圈和所述第一焊盘的材质独立地选自金、铂、钛、铱、钯、铌、钽及其合金中的一种或多种。
  7. 如权利要求1所述的制造方法，其特征在于，所述线圈包括能量线圈和数据线圈，所述能量线圈和所述数据线圈互不导通。
  8. 如权利要求1所述的制造方法，其特征在于，除所述自由端外，所述线圈材料的表面还设有具有生物兼容性的绝缘层。
  9. 如权利要求1所述的制造方法，其特征在于，除所述自由端外，所述线圈外还设有耐腐蚀层。
  10. 如权利要求1所述的制造方法，其特征在于，所述电极区内设有多个第二焊盘，所述第二焊盘用于与电极相连接。
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