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CN109732207A - A kind of manufacturing method of implantable medical device - Google Patents

A kind of manufacturing method of implantable medical device Download PDF

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Publication number
CN109732207A
CN109732207A CN201811551704.2A CN201811551704A CN109732207A CN 109732207 A CN109732207 A CN 109732207A CN 201811551704 A CN201811551704 A CN 201811551704A CN 109732207 A CN109732207 A CN 109732207A
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China
Prior art keywords
coil
pad
manufacturing
free end
diameter
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Pending
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CN201811551704.2A
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Chinese (zh)
Inventor
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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Application filed by Shenzhen Institute of Advanced Technology of CAS filed Critical Shenzhen Institute of Advanced Technology of CAS
Priority to CN201811551704.2A priority Critical patent/CN109732207A/en
Publication of CN109732207A publication Critical patent/CN109732207A/en
Priority to PCT/CN2019/123440 priority patent/WO2020125436A1/en
Pending legal-status Critical Current

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Classifications

    • BPERFORMING OPERATIONS; TRANSPORTING
    • B23MACHINE TOOLS; METAL-WORKING NOT OTHERWISE PROVIDED FOR
    • B23KSOLDERING OR UNSOLDERING; WELDING; CLADDING OR PLATING BY SOLDERING OR WELDING; CUTTING BY APPLYING HEAT LOCALLY, e.g. FLAME CUTTING; WORKING BY LASER BEAM
    • B23K26/00Working by laser beam, e.g. welding, cutting or boring
    • B23K26/20Bonding
    • B23K26/21Bonding by welding
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B23MACHINE TOOLS; METAL-WORKING NOT OTHERWISE PROVIDED FOR
    • B23KSOLDERING OR UNSOLDERING; WELDING; CLADDING OR PLATING BY SOLDERING OR WELDING; CUTTING BY APPLYING HEAT LOCALLY, e.g. FLAME CUTTING; WORKING BY LASER BEAM
    • B23K26/00Working by laser beam, e.g. welding, cutting or boring
    • B23K26/70Auxiliary operations or equipment

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

Abstract

The present invention provides a kind of manufacturing methods of implantable medical device, comprising: provides packaging body, packaging body includes package substrate, and the surface of package substrate includes coil area and electrode district, is equipped at least two first pads in coil area.At least one coil is provided, each coil includes two free ends, free end is directed at setting with the first pad one by one, the free end is made to be in contact with first pad, and falls into the orthographic projection of the free end on the package substrate in first pad.Using laser welding by free end together with the first pad solder, during laser welding, bonding power 50-1000w, weld interval 0.5-5s obtain implantable medical device.The manufacturing method of the present invention introduces lead material and other impurities substance due to not needing during welding manufacture, not will form potential difference at solder joint in implantation human body, avoids solder joint and is corroded the appearance of phenomenon, while improving weld strength.

Description

A kind of manufacturing method of implantable medical device
Technical field
The invention belongs to field of medical device technology, and in particular to a kind of manufacturing method of implantable medical device.
Background technique
With the continuous improvement of medical level, and since implantable medical device can effectively treat disease and extend patient Service life, be widely used.In the manufacturing process of implantable medical device, needing will be on coil and packaging body Package substrate links together, so as to the wireless transmission of data and/or energy.The methods of Reflow Soldering or soldering are generallyd use at present Coil and package substrate are welded.But the above method is haveed the shortcomings that many, such as weld strength is low;It is easily introduced discontented The impurity material of sufficient bio-compatibility;The presence of impurity material causes easily to form potential difference and solder joint is made to be corroded in body fluid. It solves the above problems accordingly, it is now desired to find the new manufacturing method of one kind.
Summary of the invention
In consideration of it, by using laser welding, can be kept away the present invention provides a kind of manufacturing method of implantable medical device Exempt from solder joint to be corroded the appearance of phenomenon, and improve weld strength, improves the quality of implantable medical device.
The present invention provides a kind of manufacturing methods of implantable medical device, comprising:
Packaging body is provided, the packaging body includes package substrate, and the surface of the package substrate includes coil area and electrode Area is equipped at least two first pads in the coil area;
At least one coil is provided, each coil includes two free ends, by the free end and first weldering Disk is directed at setting one by one, so that the free end is in contact with first pad, and make the free end in the package substrate On orthographic projection fall into first pad;
Using laser welding by the free end together with first pad solder, in the process of the laser welding In, bonding power 50-1000w, weld interval 0.5-5s obtain implantable medical device.
Manufacturing method provided by the invention, since laser welding does not need to introduce lead material and other impurities in the fabrication process Substance, therefore not will form potential difference at solder joint in body fluid avoids solder joint and is corroded the appearance of phenomenon.Laser welding simultaneously Compared to traditional welding methods such as Reflow Soldering or solderings, the solder joint of laser welding preparation, will not be right due to being formed in a short time Non-solder area impacts, and weld strength can also significantly improve.It, can be in addition, the specific choice of bonding power and weld interval The intensity for further increasing solder joint improves the quality of implantable medical device.
It wherein, further include by the free end before the free end is directed at setting with first pad one by one End sinter spherical end into, and the diameter of the spherical end is not more than the diameter of the first pad.
Wherein, the coil is formed by coil method coiling, and the diameter of the coil method is welded with no more than described first The diameter of disk.
Wherein, the diameter of the coil method is 50-500 μm, and the diameter of the spherical end is 100-500 μm, described The diameter of first pad is 120-500 μm.
Wherein, the shape of first pad is circle, triangle, quadrangle or polygon.
Wherein, the material of the coil and first pad is independently selected from gold, platinum, titanium, iridium, palladium, niobium, tantalum and its conjunction One of gold is a variety of.
Wherein, the coil includes energy coil and data coil, and the energy coil and the data coil are not led mutually It is logical.
Wherein, in addition to the free end, the surface of the coil method is additionally provided with the insulating layer with bio-compatibility.
Wherein, in addition to the free end, anti-corrosion layer is additionally provided with outside the coil.
Wherein, multiple second pads are equipped in the electrode district, second pad with electrode for being connected.
Detailed description of the invention
It to describe the technical solutions in the embodiments of the present invention more clearly, below will be to required in the embodiment of the present invention The attached drawing used is illustrated.
Fig. 1 is the process flow chart of manufacturing method in the embodiment of the present invention;
Fig. 2 is the structural schematic diagram of coil of the embodiment of the present invention;
Fig. 3 is the structural schematic diagram of package substrate in the embodiment of the present invention;
Fig. 4 is the structural schematic diagram of package substrate in another embodiment of the present invention.
Appended drawing reference:
Coil -1, free end -11, energy coil -12, data coil -13, package substrate -2, coil area 21, the first weldering Disk -211, electrode district -22, the second pad -221.
Specific embodiment
It is the preferred embodiment of the present invention below, it is noted that for those skilled in the art, Various improvements and modifications may be made without departing from the principle of the present invention, these improvements and modifications are also considered as this hair Bright protection scope.
Please refer to Fig. 1-Fig. 3, a kind of manufacturing method of implantable medical device provided in an embodiment of the present invention, comprising:
Step 1: providing packaging body, the packaging body includes package substrate 2, and the surface of the package substrate 2 includes coil Area 21 and electrode district 22, the coil area 21 is interior to be equipped at least two first pads 211.
Step 2: providing at least one coil 1, each coil 1 includes two free ends 11, by the free end 11 It is directed at setting one by one with first pad 211, the free end 11 is made to be in contact with first pad 211, and makes described Free end 11 is fallen into first pad 211 in the orthographic projection on the package substrate 2.
Step 3: the free end 11 and first pad 211 being welded together using laser welding, swashed described During photocoagulation, bonding power 50-1000w, weld interval 0.5-5s obtain implantable medical device.
Referring to FIG. 3, the surface of package substrate 2 of the invention is equipped with coil area 21 and electrode district 22, the coil area 21 It is inside equipped with the first pad 211, for being attached with coil 1, and the second pad 221 is equipped in electrode district 22, is used for and electrode It is attached.Referring to FIG. 2, a coil 1 of the invention is formed by single line loop material coiling, there are two free ends for tool 11。
In manufacturing process of the invention, need the free end 11 of the coil 1 and first pad 211 1 is a pair of Quasi- setting is below specifically described alignment setting: such as present invention provides a coil 1, including two free ends 11, and The surface of package substrate 2 is set there are two the first pad 211, therefore is needed in alignment setting one by one by a free end 11 and one A alignment of first pad 211 setting is placed in a free end 11 in first pad 211 and connects with the first pad 211 Touching.Another free end 11 is directed at setting with another first pad 211, another free end 11 is made to be placed in other one It is in contact in a first pad 211 and with the first pad 211.Each free end 11 for setting and every will be finally directed at one by one again A first pad 211 is welded together using laser welding, obtains implantable medical device.
Laser welding in a short time can be melted the end portion of 1 free end 11 of coil simultaneously by high laser pulse power Solder joint is combined together to form with the first pad 211.Therefore it is not needed as soldering processes in manufacturing process of the invention Introduce lead material and other impurities substance, it is only necessary to use coil 1 and the first pad 211;Therefore in body fluid at solder joint not It will form potential difference, avoid solder joint and be corroded the appearance of phenomenon.Simultaneously compared to traditional welding methods such as Reflow Soldering or solderings, The solder joint of laser welding preparation will not impact non-solder area due to being formed in a short time, therefore weld strength also can It significantly improves.
In addition, the specific selection of above-mentioned bonding power and weld interval, can be further improved the intensity of solder joint, improves and plant Enter the quality of formula medical device.The weld strength for the implantable medical device for using the manufacturing method of the present invention to obtain is 20- 200g.Preferably, the weld strength of implantable medical device is 50-150g.It is highly preferred that the welding of implantable medical device is strong Degree is 80-100g.
Preferably, during the laser welding, bonding power 100-800w, weld interval 0.5-3s.More Preferably, during the laser welding, bonding power 200-600w, weld interval 1-2s.
In the preferred embodiment for the present invention, multiple second pads 221, second pad are equipped in the electrode district 22 221 with electrode for being connected.First pad 211 and the second pad 221 of the invention are using high after printing slurry or contact pin It is formed after temperature sintering, or is formed again using modes such as plating or chemical platings after having prepared package substrate 2.
Referring to FIG. 4, the shape of first pad 211 is circle, triangle, four in the preferred embodiment for the present invention Side shape or polygon.First pad 211 of triangle, quadrangle or multilateral shape can make operator be easier to carry out alignment set It sets, greatly improves work efficiency.When the shape of the first pad 211 is round, the diameter of the first pad 211 is 100-500 μ m.When the shape of the first pad 211 is triangle, quadrangle or polygon, the length of the longest edge of the first pad 211 is 0.1-0.5mm, the length of the most short side of the first pad 211 are 0.1-0.5mm.Preferably, the shape of first pad 211 is Quadrangle.It is highly preferred that the shape of first pad 211 is square.
It is using alignment device that the free end 11 of coil 1 and the first pad 211 1 is a pair of in the preferred embodiment for the present invention Quasi- setting.One free end 11 and first pad 211 can be once aligned by alignment device, can also once will be all Free end 11 and the first all pads 211 are aligned one by one.
In the preferred embodiment for the present invention, the free end 11 is being directed at setting with first pad 211 one by one Before, it further include the end of the free end 11 being sintered to spherical end into, and the diameter of the spherical end is no more than the first weldering The diameter of disk 211.
Size due to preparing the coil method of coil 1 is smaller, quality is softer, by the free end 11 and described first When pad 211 is directed at setting one by one, free end 11 is not easy to be in contact with the first pad 211.And it is being directed at first certainly By end 11 and first after pad 211, when being directed at second free end 11 and the first pad 211, first free end 11 Position is easy to happen variation.Therefore due to weight after the present invention first uses the end sintering for burning ball machine for free end 11, end to melt The effect of power, can glomeration end.Sintered bulbous end area of bed becomes larger, and quality is hardened, thus easily with the first pad 211 1 One alignment setting falls in free end 11 in first pad 211 and is in contact with the first pad 211, while free end 11 is right Position is not susceptible to change when quasi- setting.
In addition, the present invention can make the diameter dimension of spherical end no more than the first pad by controlling the parameter of sintering process 211 size.Because needing operator to need using naked eyes when making free end 11 and the first pad 211 is directed at setting Or free end 11 is first placed in the surface of the first pad 211 by the multiplying arrangements such as microscope, makes free end 11 relative to encapsulation base The orthographic projection of plate 2 is fallen in the first pad 211, and then free end 11 falls again, and free end 11 is made to connect with the first pad 211 Touching.If the diameter dimension of spherical end is greater than the size of the first pad 211, operator is difficult for be adjusted to free end 11 the The surface of one pad 211.Therefore free end 11 and the first pad 211 also can not just be made to be directed at setting.
In the preferred embodiment for the present invention, during sintering the end of the free end 11 into spherical end, institute Stating sintering temperature is 600-2000 DEG C, sintering time 1-30s.Preferably, the sintering temperature is 800-1800 DEG C, when sintering Between be 5-25s.It is highly preferred that the sintering temperature is 1000-1500 DEG C, sintering time 10-20s.
In the preferred embodiment for the present invention, the coil 1 is formed by coil method coiling, the diameter of the coil method with No more than the diameter of first pad 211.The diameter of control coil material can preferably make the free end 11 and first of coil 1 Pad 211 aligns.If the diameter of the coil method and the diameter for being greater than first pad 211, operator are difficult Free end 11 is adjusted to the surface of the first pad 211, and after sintering spherical end into, the diameter dimension of spherical end will become Must be bigger, further increase the operation difficulty of operator.Preferably, the cross section of coil method of the present invention is circle
In the preferred embodiment for the present invention, the diameter of the coil method is 50-500 μm, the diameter of the spherical end It is 100-500 μm, the diameter of first pad 211 is 120-500 μm.Using the coil method of above-mentioned size, ball joint With the first pad 211, can be convenient for the free end 11 of coil method being directed at setting with the first pad 211.Preferably, the coil The diameter of material is 100-450 μm, and the diameter of the spherical end is 150-480 μm, and the diameter of first pad 211 is 180-500μm.It is highly preferred that the diameter of the coil method is 150-400 μm, the diameter of the spherical end is 200-450 μ M, the diameter of first pad 211 are 250-480 μm.
In the preferred embodiment for the present invention, the material of the coil 1 and first pad 211 independently selected from gold, platinum, One of titanium, iridium, palladium, niobium, tantalum and its alloy are a variety of.Wherein, the material of coil 1 and the material of the first pad 211 can phases With or it is not identical.For example, the material of coil 1 and the material of the first pad 211 be not identical, the material of coil 1 is gold, the first pad 211 material is platinum;Or the material of coil 1 is identical with the material of the first pad 211, the material of coil 1 and the first pad 211 It is titanium alloy.Preferably, the material of the coil 1 is identical as the material of first pad 211.The coil 1 of same material And the first pad 211 can further improve welding after weld strength.
In the preferred embodiment for the present invention, the quantity of coil 1 is two, and the coil 1 includes energy coil 12 and data Coil 13, the energy coil 12 and the data coil 13 are mutually not turned on.Coil 1 of the present invention may include energy datum line Circle 13 or energy coil 12, data coil 13.When coil 1 is energy datum coil 13, it is only necessary to which a coil 1 can be realized The transmission of energy and data.When coil 1 includes energy coil 12 and data coil 13, energy and data can be made to pass through energy respectively Amount coil 12 and data coil 13 are transmitted, and keep the laser propagation effect of energy and data more preferable.The present invention only needs data coil 13 It is mutually not turned on energy coil 12, prevents the generation of short circuit phenomenon.
In the preferred embodiment for the present invention, energy coil 12 mutually can be not in contact with each other or be in contact with data coil 13, work as energy When amount coil 12 and data coil 13 contact with each other, it is only necessary to be equipped with the insulating layer with bio-compatibility on coil method surface ?.It even if energy coil 12 and data coil 13 contact with each other, can also mutually be not turned on, avoid the generation of short circuit phenomenon.This hair In bright preferred embodiment, data coil 13 can be set up directly in the cavity of energy coil 12, and data coil 13 may also set up Outside energy coil 12, energy coil 12 and data coil is arranged side by side.The position of specific energy coil 12 and data coil 13 It sets the relationship present invention and is not specifically limited.Such as data coil 13 can be arranged in parallel with energy coil 12, can also be vertically arranged Or intersection setting.In addition, data coil 13 is placed in energy coil 12 by the present invention more one to improve energy and data progressively Laser propagation effect.
In the preferred embodiment for the present invention, the number of turns of energy coil 12 is 10-30 circle, and the number of turns of data coil 13 is 5-20 Circle.Preferably, the number of turns of energy coil 12 is 12-25 circle, and the number of turns of data coil 13 is 6-15 circle.It is highly preferred that energy line The number of turns of circle 12 is 14-20 circle, and the number of turns of data coil 13 is 8-15 circle.
In the preferred embodiment for the present invention, when coil 1 includes energy coil 12 and data coil 13, energy coil 12 A length of 5-20mm of outmost turns, the width of outmost turns are 3-12mm;A length of 4-18mm of 13 outmost turns of data coil, the width of outmost turns For 1-8mm.
In the preferred embodiment for the present invention, in addition to the free end 11, the surface of the coil method, which is additionally provided with, has life The insulating layer of object compatibility.In the preferred embodiment for the present invention, in addition to the free end 11, corrosion resistant is additionally provided with outside the coil 1 Lose layer.Coil 1 of the invention is formed by single line loop material coiling, before coiling in addition to free end 11, first by coil material The surface of material forms the insulating layer with bio-compatibility, and making coil method is not in showing for short circuit during coiling As, and the above-mentioned insulating layer with bio-compatibility can be directly placed in the body fluid of human body.After the completion of coiling, work as coil It when 1 quantity is one, can be molded directly outside the coil 1 in addition to free end 11 by silica gel, form anti-corrosion layer, and corrosion resistant Lose layer with a thickness of 0.1-2mm, the cladding of coil 1 is got up, avoids contact and then being corroded with the body fluid of human body.Work as line When the quantity of circle 1 is more than one, after the completion of coiling, also it can be used the insulating materials with stickiness by more than one coil 1 is fixed up, so as to the preparation of anti-corrosion layer.The material of insulating layer with bio-compatibility includes Parylene (Parylene) or Teflon.The material of anti-corrosion layer includes silica gel.
In the preferred embodiment for the present invention, the manufacturing method of the present invention need to carry out Laser Welding in the environment of protective atmosphere Connect, with guarantee welding when be not in oxidative phenomena generation, prevent weld to be oxidized.
Content provided by embodiment of the present invention is described in detail above, herein to the principle of the present invention and reality The mode of applying is expounded and illustrates, described above to be merely used to help understand method and its core concept of the invention;Meanwhile For those of ordinary skill in the art, according to the thought of the present invention, has change in specific embodiments and applications Become place, in conclusion the contents of this specification are not to be construed as limiting the invention.

Claims (10)

1.一种植入式医疗器件的制造方法,其特征在于,包括:1. a manufacturing method of an implantable medical device, is characterized in that, comprises: 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;A package body is provided, the package body includes a package substrate, a surface of the package substrate includes a coil area and an electrode area, and at least two first pads are arranged in the coil area; 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;at least one coil is provided, each of the coils includes two free ends, the free ends are arranged in a one-to-one alignment with the first pads, and the free ends are in contact with the first pads, and making the orthographic projection of the free end on the package substrate fall into the first pad; 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。The free end and the first pad are welded together by laser welding. During the laser welding process, the welding power is 50-1000w and the welding time is 0.5-5s to obtain an implantable medical device. 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。2 . The manufacturing method according to claim 1 , wherein before aligning the free ends with the first pads one by one, the method further comprises sintering the ends of the free ends into spherical ends. 3 . , and the diameter of the spherical end is not greater than the diameter of the first pad. 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。3 . The manufacturing method of claim 1 , wherein the coil is made of coil material, and the diameter of the coil material is not greater than the diameter of the first pad. 4 . 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。4 . The manufacturing method according to claim 2 , wherein the diameter of the coil material is 50-500 μm, the diameter of the spherical end is 100-500 μm, and the diameter of the first pad is 120-500 μm. 5 . 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。5 . The manufacturing method of claim 1 , wherein the shape of the first pad is a circle, a triangle, a quadrangle or a polygon. 6 . 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。6. The manufacturing method of claim 1, wherein the coil and the first pad are made of materials independently selected from gold, platinum, titanium, iridium, palladium, niobium, tantalum and alloys thereof. one or more. 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。7 . The manufacturing method of claim 1 , wherein the coil comprises an energy coil and a data coil, and the energy coil and the data coil are non-conductive with each other. 8 . 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。8 . The manufacturing method of claim 1 , wherein in addition to the free end, the surface of the coil material is further provided with a biocompatible insulating layer. 9 . 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。9 . The manufacturing method according to claim 1 , wherein in addition to the free end, the coil is provided with a corrosion-resistant layer. 10 . 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。10 . The manufacturing method of claim 1 , wherein a plurality of second pads are provided in the electrode region, and the second pads are used for connecting with the electrodes. 11 .
CN201811551704.2A 2018-12-18 2018-12-18 A kind of manufacturing method of implantable medical device Pending CN109732207A (en)

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PCT/CN2019/123440 WO2020125436A1 (en) 2018-12-18 2019-12-05 Method for manufacturing implantable medical device

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Application publication date: 20190510