CN108211118B - Implantable package, method of manufacturing the same, and implantable medical device - Google Patents
Implantable package, method of manufacturing the same, and implantable medical device Download PDFInfo
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- CN108211118B CN108211118B CN201711410701.2A CN201711410701A CN108211118B CN 108211118 B CN108211118 B CN 108211118B CN 201711410701 A CN201711410701 A CN 201711410701A CN 108211118 B CN108211118 B CN 108211118B
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- 238000004519 manufacturing process Methods 0.000 title claims abstract description 17
- 229910052751 metal Inorganic materials 0.000 claims abstract description 294
- 239000002184 metal Substances 0.000 claims abstract description 294
- 239000000758 substrate Substances 0.000 claims abstract description 111
- 230000008018 melting Effects 0.000 claims abstract description 48
- 238000002844 melting Methods 0.000 claims abstract description 48
- 238000004806 packaging method and process Methods 0.000 claims abstract description 44
- 238000003466 welding Methods 0.000 claims abstract description 30
- 239000000155 melt Substances 0.000 claims abstract description 13
- 230000001678 irradiating effect Effects 0.000 claims abstract description 8
- 238000000034 method Methods 0.000 claims description 17
- 238000005476 soldering Methods 0.000 claims description 8
- 230000000638 stimulation Effects 0.000 claims description 6
- 229910052734 helium Inorganic materials 0.000 claims description 4
- 239000001307 helium Substances 0.000 claims description 4
- SWQJXJOGLNCZEY-UHFFFAOYSA-N helium atom Chemical compound [He] SWQJXJOGLNCZEY-UHFFFAOYSA-N 0.000 claims description 4
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- 229910045601 alloy Inorganic materials 0.000 description 6
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- 229910052719 titanium Inorganic materials 0.000 description 6
- 239000010936 titanium Substances 0.000 description 6
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- 230000004936 stimulating effect Effects 0.000 description 2
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- PNEYBMLMFCGWSK-UHFFFAOYSA-N aluminium oxide Inorganic materials [O-2].[O-2].[O-2].[Al+3].[Al+3] PNEYBMLMFCGWSK-UHFFFAOYSA-N 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
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- HQVNEWCFYHHQES-UHFFFAOYSA-N silicon nitride Chemical compound N12[Si]34N5[Si]62N3[Si]51N64 HQVNEWCFYHHQES-UHFFFAOYSA-N 0.000 description 1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/372—Arrangements in connection with the implantation of stimulators
- A61N1/37205—Microstimulators, e.g. implantable through a cannula
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/372—Arrangements in connection with the implantation of stimulators
- A61N1/375—Constructional arrangements, e.g. casings
- A61N1/3758—Packaging of the components within the casing
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Radiology & Medical Imaging (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Laser Beam Processing (AREA)
Abstract
The invention provides an implantable packaging body, a manufacturing method thereof and an implantable medical device, and provides a packaging substrate with biocompatibility; preparing a biocompatible metal cover, the metal cover comprising a melt, the melt comprising a weld face; forming a metal connecting layer on the periphery of the surface of the packaging substrate; covering the metal cover on the surface of the packaging substrate, and attaching the welding surface to the surface of the metal connecting layer; and irradiating the melting part with laser to melt the melting part and connect the package substrate and the metal cover. The manufacturing method of the implantable packaging body can be used for preparing the implantable packaging body with high strength and strong stability.
Description
Technical Field
The invention relates to the technical field of implantable medical devices, in particular to an implantable packaging body, a manufacturing method and an implantable medical device.
Background
Nowadays, the normal living standard of a person is seriously affected because a disease occurs in a part of the organs of the person's body. The rapid development of implantable medical devices has made it possible to restore the function of a part of the patient's organs. The implantable medical device includes an implantable package and an implantable stimulation electrode. The implantable packaging body plays a key role in protecting chips, electronic components, integrated circuits and the like of implantable medical equipment, so that the preparation of the implantable packaging body with excellent performance is particularly important. However, problems still exist with current implantable packages: poor fastness and stability.
Disclosure of Invention
The invention aims to provide an implantable packaging body, a manufacturing method thereof and an implantable medical device.
A method of manufacturing an implantable package, comprising:
providing a packaging substrate with biocompatibility;
preparing a biocompatible metal cover, the metal cover comprising a melt, the melt comprising a weld face;
forming a metal connecting layer on the periphery of the surface of the packaging substrate;
covering the metal cover on the surface of the packaging substrate, and attaching the welding surface to the surface of the metal connecting layer;
and irradiating the melting part with laser to melt the melting part and connect the package substrate and the metal cover.
Wherein, in the step of preparing a biocompatible metal cap including a fusion melting portion including a welding surface, the step of:
preparing a metal cover body, wherein the metal cover body comprises a connecting surface and a fixing part convexly arranged on one side of the connecting surface;
preparing a metal ring, wherein the metal ring comprises a first ring surface and a second ring surface which are oppositely arranged, and the melting part is arranged on the second ring surface;
and welding the metal ring on the metal cover body so as to connect the first ring surface with the connecting surface.
Wherein, in the step of preparing a metal ring, the metal ring comprises a first ring surface and a second ring surface which are oppositely arranged, and the melting part is arranged on the second ring surface, the step of preparing the metal ring comprises the following steps:
and a positioning part is formed around the inner surface of the metal ring, and the positioning part and the fixing part of the metal cover are mutually abutted.
Wherein the step of forming a metal connection layer at the periphery of the surface of the package substrate includes:
a plurality of first grooves arranged at intervals are formed around the surface of the metal connecting layer, and the melting part is melted and filled in the first grooves.
Wherein the step of covering the metal cover on the surface of the package substrate and attaching the soldering surface to the surface of the metal connection layer further comprises:
and applying constant pressure to the metal cover along the direction of the packaging substrate so as to enable the metal connecting layer to be attached to the welding surface.
Wherein the step of "irradiating the melting portion with laser light to melt the melting portion and connect the package substrate and the metal cap" further includes:
placing the metal cover and the packaging substrate on a rotatable soldering station;
and rotating the welding table at a constant speed so that the laser beam melts the melting part along the periphery of the metal cover.
Wherein the air tightness of the packaging substrate and the metal cover meets the requirement that the helium leakage rate is less than 1 multiplied by 10-9Pa·m3/s。
The present invention provides an implantable package comprising: the packaging substrate with the biocompatibility and the metal cover with the biocompatibility are arranged, and a metal connecting layer is arranged on the periphery of the surface of the packaging substrate; the metal cover is fixedly connected to the metal connecting layer of the packaging substrate.
The present invention provides an implantable package comprising: a package substrate having biocompatibility and a metal cap having biocompatibility; the metal cover comprises a metal cover body and a metal ring which are connected with each other; the surface of the metal cover body is provided with a fixing part, the inner circumferential surface of the metal ring is provided with a positioning part, and the fixing part and the positioning part are abutted against each other; a metal connecting layer is arranged on the periphery of the surface of the packaging substrate; the metal ring is connected and fixed on the metal connecting layer of the packaging substrate.
The invention provides an implantable medical device, which comprises an implantable stimulating electrode and an implantable packaging body; the implantable package is electrically connected to the implantable stimulation electrode.
The invention has the following beneficial effects: the method includes forming a metal connection layer on a peripheral edge of a surface of a package substrate and irradiating the melting portion of the metal cap with laser light to melt the melting portion and connect the package substrate and the metal cap. Therefore, the manufacturing method of the implantable packaging body can prepare the implantable packaging body with strong stability and high strength and biocompatibility.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, it is obvious that the drawings in the following description are only some embodiments of the present invention, and for those skilled in the art, other drawings can be obtained according to the drawings without creative efforts.
Fig. 1 is a flow chart illustrating a method of manufacturing an implantable package of the present application.
Fig. 2 is a schematic top view of the package substrate of step S10 in fig. 1.
Fig. 3 is a schematic internal plan view of the package substrate of step S10 in fig. 1.
Fig. 4 is a schematic cross-sectional structure of the metal cap of step S20 in fig. 1.
Fig. 5 is a partial schematic flow chart of step S20 in fig. 1.
Fig. 6 is a schematic cross-sectional structure view of the metal shell body formed in step S21 shown in fig. 5.
Fig. 7 is a schematic structural diagram of the metal ring formed in step S22 shown in fig. 5.
Fig. 8 is a partial flowchart of step S22 in fig. 5.
Fig. 9 is a schematic structural diagram of the metal ring formed in step S22a shown in fig. 8.
Fig. 10 is a schematic plan view of the metal ring formed in step S22a shown in fig. 8.
Fig. 11 is a schematic structural view of the metal cap formed in step S23 shown in fig. 5.
Fig. 12 is a schematic plan view of the inner portion of the metal connection layer formed in step S30 in fig. 1.
Fig. 13 is a partial flowchart of step S30 in fig. 1.
Fig. 14 is a schematic diagram of the inner plane of the metal connection layer formed in step S31 in fig. 13.
Fig. 15 is a partial flowchart of step S40 in fig. 1.
Fig. 16-19 are schematic internal plan views of the resulting implantable package of step S50 in fig. 1.
Fig. 20 is a partial flowchart of step S50 in fig. 1.
Detailed Description
The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
Referring to fig. 1, a flow chart of a method for manufacturing an implantable package is provided in accordance with a preferred embodiment of the present application. The manufacturing method of the implantable package is mainly used for preparing the implantable package 100 with high stability and high strength, so as to prolong the service life of the implantable package 100.
In this embodiment, the manufacturing method of the implantable package includes, but is not limited to, step S10, step S20, step S30, step S40 and step S50, and each step is described in detail as follows:
step S10 provides the package substrate 10 with biocompatibility. Please refer to fig. 2 and fig. 3.
Here, the term "package substrate 10 having biocompatibility" means a package substrate 10 that satisfies the International standard requirements of ISO (International Organization for Standardization) 10993.5, ISO10993.10, ISO 10993.6, ISO 10993.6, and ISO 10993.3. The package substrate 10 is airtight and meets the requirement that the helium leakage rate is less than 1 multiplied by 10-9Pa·m3And/s, body fluid, blood, and the like in the human body are prevented from penetrating the package substrate 10 to damage the electronic components in the package substrate 10.
In this embodiment, the package substrate 10 is a cylinder, so that when the package substrate 10 is placed in a human body, the injury to organs in the human body due to the sharp points on the surface of the package substrate 10 can be avoided. The package substrate 10 includes a first surface 111 and a second surface 112 disposed oppositely. Please refer to fig. 2 and fig. 3. In this case, "opposite" means opposite to each other, and in this embodiment, means that the first surface 111 and the second surface 112 are two "faces" opposite to each other. The material of the package substrate 10 may be, but is not limited to, alumina, zirconia, silicon nitride, and bioglass material, and the purity thereof is greater than or equal to 99%. The package substrate 10 has a diameter of 6-15 mm, a thickness of 0.3-0.8 mm, and a number of channels of 1-1000. The surface of the package substrate 10 is embedded with a plurality of conductive pillars 11 arranged at intervals, the conductive pillars 11 are embedded in the package substrate 10 by a filling technique, which may be, but not limited to, an embedding technique, a magnetron sputtering technique, a thermal evaporation technique, or a screen printing technique. The material of the conductive post 11 may be, but is not limited to, titanium, platinum, iridium, palladium, niobium, tantalum, or an alloy of at least two of them. In other embodiments, the shape, diameter, thickness and number of channels of the package substrate 10 may be set according to practical situations, and the present application is not limited thereto.
Step S20 is to prepare a biocompatible metal cover 20, where the metal cover 20 includes a melting portion 21, and the melting portion 21 includes a welding surface 211. Please refer to fig. 4.
In the present embodiment, the meaning of the metal cover 20 having biocompatibility means the metal cover 20 satisfying the requirements of ISO 10993.5, ISO10993.10, ISO 10993.6, ISO 10993.6, ISO 10993.3. The metal cover 20 is gas-tight so that the helium leakage rate is less than 1 x 10-9Pa·m3And s. The material of the metal cap 20 may be, but is not limited to, titanium, platinum, iridium, palladium, niobium, tantalum, or an alloy of at least two thereof. The purity of the metal cap 20 is greater than or equal to 99%. For example, when the material of the metal cap 20 is platinum, the composition of the metal cap 20 is platinum with a purity of 99% or more. The metal cover 20 is formed integrally by bending an end portion of a metal plate. The end of the metal cap 20 is a melting portion 21 for providing a welding material for welding. The end face of the melting portion forms a soldering face 211 for connecting with the package substrate 10.
In other embodiments, the metal cover 20 may be formed by welding a plurality of metal plates. Specifically, in step S20 ″, a biocompatible metal cap 20 is prepared, where the metal cap 20 includes a melting portion 21, and the melting portion 21 includes a welding surface 211. "includes but is not limited to including step S21, step S22, step S23 and step S24, please refer to fig. 5, each step is described in detail as follows:
step S21 is to prepare a metal cover body 23, where the metal cover body 23 includes a connecting surface 232 and a fixing portion 231 protruding from one side of the connecting surface 232; please refer to fig. 6.
In the present embodiment, the material of the metal shell body 23 may be, but is not limited to, titanium, platinum, iridium, palladium, niobium, tantalum, or an alloy formed by at least two of these. The size of the metal cover body 23 is 6-15 mm. The metal shell body 23 is formed integrally by bending a metal plate. The end of the metal shell body 23 is stepped. The fixing portion 231 of the metal shell body 23 protrudes relative to the connecting surface 232. The fixing portion 231 is used for fixing when the metal cover body 23 is covered on the metal ring 24. When the side surface of the fixing portion 231 is attached to the inner circumferential surface of the metal ring 24, the metal cover body 23 can be tightly fixed to the metal ring 24, and the connection firmness and the air tightness between the metal cover body 23 and the metal ring 24 can be prevented from being reduced due to the movement of the metal cover body 23 and the metal ring 24 in the subsequent welding process. The outer surface of the metal cover body 23 is smooth and free of burrs, so that it is possible to prevent the metal cover body 23 from stabbing body organs due to the rough surface when placed in the human body. In other embodiments, the size and shape of the metal cover body 23 are not limited, and may be set according to actual conditions.
Step S22 is to prepare a metal ring 24, where the metal ring 24 includes a first ring surface 241 and a second ring surface 242 oppositely disposed, and the melting portion 21 is disposed on the second ring surface 242; please refer to fig. 7.
In the present embodiment, the material of the metal ring 24 may be, but is not limited to, titanium, platinum, iridium, palladium, niobium, tantalum, or an alloy formed by at least two of these. The metal ring 24 is machined. The machining process comprises turning, milling, planing, grinding, drilling, boring and the like. The outer diameter of the metal ring 24 is 6-15 mm, and the height is 0.3-3 mm. The metal ring 24 is provided with a melting portion 21 for supplying a welding material for welding. The first ring surface 241 of the metal ring 24 is used for connecting the metal cover 23. The second ring surface 242 is used to connect with the surface of the metal connection layer 30 to connect the metal cap 20 and the package substrate 10. The outer peripheral surface of the metal ring 24 is smooth and burr-free, so that the body organ can be prevented from being punctured. In other embodiments, the outer diameter and height of the metal ring 24 are not limited and can be set according to practical situations.
In step S22 ", preparing a metal ring 24, where the metal ring 24 includes a first ring surface 241 and a second ring surface 242 oppositely disposed, and the melting portion 21 is disposed on the second ring surface 242" includes:
step S22a forms a positioning portion 243 around the inner surface of the metal ring 24, and the positioning portion 243 and the fixing portion 231 of the metal cover 23 abut against each other. Please refer to fig. 8-10.
In this embodiment, the material of the positioning portion 243 may be, but not limited to, titanium, platinum, iridium, palladium, niobium, tantalum, or an alloy formed by at least two of these materials. The size of the positioning portion 243 is 0.1-2 mm. The positioning portion 243 is used for positioning when the metal cover body 23 covers the metal ring 24, and the positioning portion 243 and the fixing portion 231 abut against each other, so that the metal cover body 23 can be firmly fixed on the metal ring 24, and the connection firmness and the air tightness between the metal cover body 23 and the metal ring 24 are prevented from being reduced due to the movement of the metal cover body 23 and the metal ring 24 in the subsequent welding process.
Step S23 welds the metal ring 24 to the metal cover body 23 to connect the first annular surface 241 to the connecting surface 232.
In this embodiment, the metal ring 24 is fixed to the welding table by a clamp. The welding table can rotate at any angle, and the rotation angular speed and the rotation angle of the welding table can be accurately controlled. The metal cover body 23 is covered on the metal ring 24, so that the first ring surface 241 of the metal ring 24 is attached to the connecting surface 232 of the metal cover body 23. Since the outer diameter of the metal ring 24 and the outer diameter of the metal shell body 23 are equal, the metal shell body 23 and the metal ring 24 are aligned with each other. In addition, in order to further reduce the gap between the metal shell body 23 and the metal ring 24, a constant pressure is applied to the outer surface of the metal shell body 23 in the direction of the metal ring 24. In this way, the metal shell body 23 and the metal ring 24 can be welded more firmly, thereby increasing the stability and the air tightness of the metal shell body 23 and the metal ring 24.
In the present embodiment, as shown in fig. 11, the end portion of the metal shell body 23 close to the metal ring 24 is irradiated with a laser beam to melt the end portion of the metal shell body 23 and connect the connection surface 232 to the first ring surface 241. The wavelength of the laser beam may be, but is not limited to, 1060nm or 532 nm. The laser beam is emitted by a laser. The laser may be, but is not limited to, a light laser, a carbon dioxide laser, or a semiconductor laser. Specifically, the laser beam is irradiated to a first position of the end portion of the metal shell body 23, and the metal shell body 23 at the position starts to be melted and connects the metal shell body 23 at the position with the metal ring 24. The depth of the laser beam melting is not limited to the width of the weld in the exemplary metal shell as shown in fig. 11, but should be more than two-thirds the width of the metal shell body 24 in order to ensure the firmness of the connection of the metal shell body 23 and the metal ring 24. The specific setting can be according to the actual conditions. Further, the welding stage is again precisely rotated so that the laser beam melts the end of the metal shell body 23 along the periphery of the metal shell body 23. In this way, the metal shell body 23 is connected to the metal ring 24. Therefore, the metal cover body 23 and the metal ring 24 are welded by the laser beam, so that not only is the firmness of the connection between the metal cover body 23 and the metal ring 24 improved, but also the air tightness between the metal cover body 23 and the metal ring 24 is improved, and the situation that body fluid, blood and the like penetrate through the metal cover 20 and enter the metal cover 20 to damage electronic elements after the implantable packaging body is implanted into a human body is avoided, so that the service life of the implantable packaging body is prolonged. In addition, the metal cover body 23 and the metal ring 24 are welded by the laser beam, so that other impurities are prevented from being introduced into the implanted package 100. In other embodiments, the metal shell body 23 and the metal ring 24 may be connected by brazing or diffusion welding. The method is specifically set according to the actual situation.
Step S30 is to form a metal connection layer 30 on the periphery of the surface of the package substrate 10; please refer to fig. 12.
In this embodiment, the metal connection layer 30 is a ring-shaped structure formed around the periphery of the package substrate 10. The material of the metal connection layer 30 may be, but is not limited to, titanium, platinum, iridium, palladium, niobium, tantalum, or an alloy formed by at least two of the above. Preferably, the material of the metal connection layer 30 is the same as the material of the metal cover 20, which may help to improve the firmness of the connection between the metal cover 20 and the metal connection layer 30. The metal connection layer 30 is formed on the surface of the package substrate 10 by a damascene technique, a screen printing technique, magnetron sputtering, thermal evaporation, or the like. The thickness of the metal connection layer 30 is 100nm to 10 μm. The difference between the outer diameter and the inner diameter of the metal connecting layer 30 is 0.1-3 mm. By forming the metal connection layer on the periphery of the package substrate 10, the metal cover 20 and the package substrate 10 can be connected more firmly, thereby significantly increasing the stability and the air tightness of the metal cover 20 and the package substrate 10. In other embodiments, the thickness and size of the metal connection layer 30 are not limited.
The step S30 "forming the metal connection layer 30 at the periphery of the surface of the package substrate 10" further includes:
step S31 is to form a plurality of first recesses 31 arranged at intervals around the surface of the metal connection layer 30, and the melting portion melts and fills the plurality of first recesses 31. Please refer to fig. 13 and 14.
In this embodiment, the first groove 31 is formed by plasma etching the metal connection layer 30 or formed by multiple metal sputtering or thermal evaporation of a mask. On the surface of the package substrate 10. The shape of the first groove 31 may be, but is not limited to, a circular ring shape. When in a subsequent welding process, the melting part 21 is melted and fills the first recess 31. Thus, the metal cap 20 is firmly coupled to the package substrate 10. The connection area between the metal cap 20 and the package substrate 10 can be further increased by the plurality of first grooves 31 arranged at intervals, so that the firmness and the air tightness of the connection between the package substrate 10 and the metal cap 20 are increased. In addition, the melted melting part 21 is prevented from overflowing out of the metal cover 20, the surface roughness of the outer part of the metal cover 20 is increased, and the rough surface damages human organs.
Step S40 is to cover the metal cap 20 on the surface of the package substrate 10, and to bond the soldering surface 211 and the metal connection layer 30.
In this embodiment, the package substrate 10 is fixed to the bonding stage by a jig. The metal cap 20 is then covered on the first surface 111 of the package substrate 10, so that the soldering surface 211 of the metal cap 20 is attached to the surface of the metal connection layer 30. Since the outer diameter of the metal cap 20 and the outer diameter of the package substrate 10 are equal, the metal cap 20 and the package substrate 10 are aligned with each other. This makes the metal cap 20 more aesthetically pleasing after being soldered to the package substrate 10.
Further, the step S40 of covering the metal cover 20 on the surface of the package substrate 10 and bonding the bonding surface 211 to the surface of the metal connection layer 30 includes:
step S41 is to apply a constant pressure to the metal cover 20 along the direction of the package substrate 10 to make the metal connection layer 30 adhere to the soldering surface 211. Please refer to fig. 15.
In this embodiment, a constant pressure is applied to the outer surface of the metal cap 20 along the direction of the package substrate 10, so that the gap between the metal cap 20 and the package substrate 10 can be further reduced, and after subsequent soldering, the firmness of the connection between the metal cap 20 and the package substrate 10 can be significantly increased, and the air tightness of the soldered connection between the metal cap 20 and the package substrate 10 can be improved.
Step S50 is a step of irradiating the melting part 21 with a laser beam to melt the melting part 21 and connect the package substrate 10 and the metal cap 20. Please refer to fig. 16-19.
In this embodiment, the wavelength of the laser beam may be, but is not limited to, 1060nm or 532 nm. The laser beam is emitted by a laser. The laser may be, but is not limited to, a light laser, a carbon dioxide laser, or a semiconductor laser. The connection between the metal cap 20 and the package substrate 10 is achieved by melting the melting portion 21 and connecting the metal cap 20 to the metal connection layer 30 on the package substrate 10. Therefore, the firmness of the connection between the metal cover 20 and the package substrate 10 is improved, the air tightness between the metal cover 20 and the package substrate 10 is improved, and the damage to electronic components caused by the body fluid, blood and the like penetrating into the implantable package is avoided after the implantable package 100 is implanted into the human body, so that the service life of the implantable package 100 is prolonged. Furthermore, by laser welding, the introduction of other impurities can be avoided. Moreover, the metal cover 20 and the package substrate 10 are connected by laser, so that the operation is simple, the popularization is easy, and the mass production efficiency is high.
The step S50 "laser irradiates the melting part 21 to melt the melting part 21 and connect the package substrate 10 and the metal cap 20" includes, but is not limited to, the steps S51 and S52, and referring to fig. 20, the steps are described in detail as follows:
step S51 places the metal cap 20 and the package substrate 10 on a rotatable bonding stage.
Step S52 rotates the welding stage at a constant speed so that the laser beam melts the melting portion 21 along the peripheral edge of the metal cover 20.
In the present embodiment, the laser beam is irradiated to the first position of the melting portion 21, and the melting portion 21 at that position melts and connects the metal cap 20 at that position to the package substrate 10. The welding stage is then precisely rotated so that the laser beam melts the melting portion 21 along the periphery of the metal cap 20. Thus, the metal cap 20 is connected to the package substrate 10. The depth of the laser beam melting is not limited to the welding depth of the exemplary implantable package 100 shown in fig. 16-19, but the depth of the laser beam melting should be greater than two-thirds of the width of the metal cap body 24 in order to ensure the firmness of the connection between the metal cap 20 and the package substrate 10. In other embodiments, the depth of dissolution of the laser beam is not particularly limited. The metal cover 20 and the packaging substrate 10 are welded by the laser beam, so that the connection firmness of the metal cover 20 and the packaging substrate 10 is improved, the air tightness of the metal cover 20 and the packaging substrate 10 is improved, and the situation that body fluid, blood and the like penetrate into the implanted packaging body 100 to damage electronic elements after the implanted packaging body 100 is implanted into a human body is avoided, so that the service life of the implanted packaging body 100 is prolonged. In addition, the metal cover 20 is welded to the package substrate 10 by the laser beam, thereby preventing other impurities from being introduced into the implant package 100.
Since laser welding is performed between the metal cap 20 and the package substrate 10, a part of the molten metal is also solidified outside the metal cap 20 and the package substrate 10, and the surface of the molten metal is rough. This can seriously affect the appearance of the implantable package 100. Thus, when the implantable package 100 is implanted in a human organ, the organ may be damaged. Therefore, the welded metal ball needs to be ground and polished. Thereby, the surfaces of the metal cover 20 and the package substrate 10 are smooth, and the rough surface is prevented from stabbing human organs. In addition, the surface of the package substrate 10 and the metal cap 20 may be polished to enhance the appearance of the implantable package 100.
In this embodiment, the package substrate 10 and the metal cap 20 are connected by forming the metal connection layer 30 on the periphery of the surface of the package substrate 10 and irradiating the melting portion 21 of the metal cap 20 with laser light to melt the melting portion 21 and connect the package substrate 10 and the metal cap 20. Therefore, the manufacturing method of the implantable package can prepare the implantable package 100 with strong stability and high strength and biocompatibility.
Referring to fig. 16, in a preferred embodiment of the present application, an implantable package 100 is provided, which includes: the package substrate comprises a package substrate 10 with biocompatibility and a metal cover 20 with biocompatibility, wherein a metal connecting layer 30 is arranged on the periphery of the surface of the package substrate 10; the metal cap 20 is connected and fixed to the metal connection layer 30 of the package substrate 10.
In this embodiment, the metal connection layer 30 is disposed on the surface of the package substrate 10, and the metal cap 20 and the package substrate 10 are connected through the metal connection layer 30 to form the implantable package 100. The implantable package 100 has high stability, high strength and high air tightness, thereby significantly improving the lifetime of the implantable package 100.
Referring to fig. 18, in a preferred embodiment of the present application, an implantable package 100 is provided, which includes: a package substrate 10 having biocompatibility and a metal cap 20 having biocompatibility; the metal cover 20 comprises a metal cover body 23 and a metal ring 24 which are connected with each other; the surface of the metal cover body 23 is provided with a fixing part 231, the inner circumferential surface of the metal ring 24 is provided with a positioning part 243, and the fixing part 231 and the positioning part 233 are abutted against each other; a metal connecting layer 30 is arranged on the periphery of the surface of the packaging substrate 10; the metal ring 24 is connected and fixed to the metal connection layer 30 of the package substrate 10, so that the metal cap 20 is connected to the package substrate 10.
In this embodiment, the metal connection layer 30 is disposed on the surface of the package substrate 10, and the metal cap 20 and the package substrate 10 are connected through the metal connection layer 30 to form the implantable package 100. In addition, forming the fixing portion 231 on the metal cover body 23 and forming the positioning portion 233 on the metal ring 24 can not only enable the metal cover body 23 to be accurately welded on the metal ring 24, but also increase the firmness of the metal cover body 23 and the metal ring. The implantable package 100 has high stability, high strength and high air tightness, thereby significantly improving the lifetime of the implantable package 100.
In a preferred embodiment of the present application, an implantable medical device is provided. The implantable medical device is used for implantable medical devices, including cardiac pacemakers, brain pacemakers, artificial cochlea, artificial retina and the like. The implantable medical device comprises: an implantable package 100 having biocompatibility and an implantable stimulation electrode 200. The implantable package 100 is electrically connected to an implantable stimulation electrode 200. The implantable medical device can achieve long-term stability in a human body, prevent the implantable stimulating electrode 200 from falling off from the implantable packaging body 100, obviously enhance the air tightness of the implantable medical device, and prevent body fluid, blood and the like from permeating into the implantable packaging body to damage the electronic element after the implantable packaging body is implanted into the human body, thereby prolonging the service life of the implantable packaging body.
While the invention has been described with reference to a preferred embodiment, it will be understood by those skilled in the art that various changes in form and detail may be made therein without departing from the spirit and scope of the invention.
Claims (7)
1. A method of manufacturing an implantable package, comprising:
providing a packaging substrate with biocompatibility;
preparing a biocompatible metal cover, the metal cover comprising a melt, the melt comprising a weld face; the step of preparing the metal cover with biocompatibility comprises the steps of preparing a metal cover body, wherein the metal cover body comprises a connecting surface and a fixing part convexly arranged on one side of the connecting surface; preparing a metal ring, wherein the metal ring comprises a first ring surface and a second ring surface which are oppositely arranged, and the melting part is arranged on the second ring surface; welding the metal ring on the metal cover body so as to connect the first ring surface with the connecting surface; the step of preparing the metal ring comprises a first ring surface and a second ring surface which are oppositely arranged, the melting part is arranged on the second ring surface, and the step of forming the positioning part around the inner surface of the metal ring comprises the step of mutually abutting the positioning part and the fixing part of the metal cover body;
forming a metal connecting layer on the periphery of the surface of the packaging substrate;
covering the metal cover on the surface of the packaging substrate, and attaching the welding surface to the surface of the metal connecting layer;
and irradiating the melting part with laser to melt the melting part and connect the package substrate and the metal cover.
2. The method of claim 1, wherein the step of forming a metal connection layer at the periphery of the surface of the package substrate comprises:
a plurality of first grooves arranged at intervals are formed around the surface of the metal connecting layer, and the melting part is melted and filled in the first grooves.
3. The method for manufacturing an implantable package according to claim 1 or 2, wherein the step of "covering the metal cover on the surface of the package substrate and attaching the bonding surface to the surface of the metal connection layer" further comprises:
and applying constant pressure to the metal cover along the direction of the packaging substrate so as to enable the metal connecting layer to be attached to the welding surface.
4. The method for manufacturing an implantable package according to claim 3, wherein the step of "laser irradiating the melting portion to melt the melting portion and connect the package substrate and the metal cover" further comprises:
placing the metal cover and the packaging substrate on a rotatable soldering station;
and rotating the welding table at a constant speed so that the laser beam melts the melting part along the periphery of the metal cover.
5. The method of claim 4, wherein the package substrate and the metal cap are hermetically sealed such that a helium leakage rate is less than 1 x 10-9Pa·m3/s。
6. An implantable package, comprising: a package substrate having biocompatibility and a metal cap having biocompatibility; the metal cover comprises a metal cover body and a metal ring which are connected with each other; the surface of the metal cover body is provided with a fixing part, the inner circumferential surface of the metal ring is provided with a positioning part, and the fixing part and the positioning part are abutted against each other; a metal connecting layer is arranged on the periphery of the surface of the packaging substrate; the metal ring is connected and fixed on the metal connecting layer of the packaging substrate.
7. An implantable medical device comprising an implantable stimulation electrode and the implantable package of claim 6; the implantable package is electrically connected to the implantable stimulation electrode.
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