CN109279180B - Medical implant component with an encapsulation layer and method for encapsulating a medical implant component - Google Patents
Medical implant component with an encapsulation layer and method for encapsulating a medical implant component Download PDFInfo
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- CN109279180B CN109279180B CN201710602315.7A CN201710602315A CN109279180B CN 109279180 B CN109279180 B CN 109279180B CN 201710602315 A CN201710602315 A CN 201710602315A CN 109279180 B CN109279180 B CN 109279180B
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D75/00—Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes, or webs of flexible sheet material, e.g. in folded wrappers
- B65D75/26—Articles or materials wholly enclosed in laminated sheets or wrapper blanks
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Abstract
The invention provides a medical implant device with an encapsulation layer, which comprises a device body and the encapsulation layer used for encapsulating the device body, wherein the encapsulation layer comprises at least one organic thin film layer and at least one inorganic thin film layer which are stacked, the innermost layer of the encapsulation layer is the organic thin film layer or the inorganic thin film layer, the outermost layer of the encapsulation layer is the organic thin film layer or the inorganic thin film layer, the organic thin film layer is a parylene film or a polyimide resin film, and the inorganic thin film layer is an inorganic thin film with biocompatibility. The packaging layer of the device has good biocompatibility, can well isolate the water-oxygen environment of body fluid in a human body, prolongs the service life of the device, and can effectively solve the problem of packaging of the traditional medical implant device. The invention also provides a packaging method of the medical implant device.
Description
Technical Field
The invention relates to the technical field of medical implant device packaging, in particular to a medical implant device with a packaging layer and a packaging method of the medical implant device.
Background
With the development of medical technology, the trend of miniaturization and intellectualization of medical instruments is very obvious, and medical implantation devices with information sensing, processing and other functions, such as cardiac pacemakers, cochlear implants, deep brain stimulators and other products, are seen in a full scale, and a brand new solution is provided for various diseases which are difficult to solve by conventional medicine. However, these medical implant devices are particularly sensitive to water vapor and oxygen in body fluids and therefore require good packaging to ensure device performance and longevity.
At present, a relatively mature hard packaging mode (a mode of directly packaging by adopting plastic, metal, ceramic or silicon substrate) in the market cannot ensure that an electronic device is in a waterless environment for a long time, and a closed cavity with mechanical support performance and biological compatibility is needed, so that the cost of implanted packaging is extremely high and accounts for more than 30% of the cost of a medical implanted device, and along with rapid development of the society and requirements of human beings on future technologies, the number of channels of the implanted packaging substrate is more and more required and more intensive, and the traditional hard packaging process and method are difficult to package a high-density electronic device under the implantation requirement of small volume, so that the function realization of the implanted device is limited to a great extent.
The flexible packaging mode mainly adopts high polymer packaging and thin film packaging, and is widely applied to the fields of light emitting diode liquid crystal display (LED) packaging and the like due to the advantages of light weight, high strength, high temperature resistance, small size and the like. In order to effectively reduce the packaging cost of medical implant devices, meet the requirements of small volume and high density packaging, and improve the implant lifetime of the devices, it is necessary to provide a feasible flexible packaging scheme for medical implant devices.
Disclosure of Invention
In view of the above, the present invention provides a medical implant device having an encapsulation layer and a method for encapsulating the medical implant device, wherein the encapsulation layer is formed by laminating organic and inorganic films, the encapsulation layer has good biocompatibility, and the permeation route of water and oxygen molecules in a complex in vivo environment is along the interface layer of the organic/inorganic films, thereby greatly extending the permeation route of water and oxygen molecules in vivo, well isolating the in vivo water and oxygen environment, greatly improving the service life of the implant device, and effectively solving the problem of the implantation life of the conventional medical implant device encapsulation.
Specifically, in a first aspect, the present invention provides a medical implant device with an encapsulation layer, including a device body, and an encapsulation layer for encapsulating the device body, where the encapsulation layer includes at least one organic thin film layer and at least one inorganic thin film layer, the innermost layer of the encapsulation layer is an organic thin film layer or an inorganic thin film layer, the outermost layer of the encapsulation layer is an organic thin film layer or an inorganic thin film layer, the organic thin film layer is a parylene film or a polyimide resin film with biocompatibility, and the inorganic thin film layer is an inorganic thin film with biocompatibility.
The medical implant device of the invention adopts the organic film and the inorganic film with biocompatibility as the packaging materials to form the packaging layer, and the packaging layer has good biocompatibility on one hand, so that the device can meet the requirements of years of implantation, and on the other hand, the medical implant device can well isolate the water and oxygen environments of body fluid in human body and protect the normal operation of the implant device. In addition, the thin film packaging mode can well reduce the volume of the implant, can be suitable for packaging high-density electronic devices (such as 1000-channel chip sensors), meets the requirements of functions and performances of implanted products to a great extent, and solves the requirement of product flexibility.
Wherein the inorganic thin film having biocompatibility comprises Al2O3Film, SiO2Film, SiC film, TiO2A thin film or a SiN thin film. The inorganic film has good biocompatibility and good water and oxygen isolation capability, and can be stacked with the organic film layer to form a multi-layer compact structure, so that the water and oxygen permeation path can be prolonged to a great extent, and the device main body is effectively protected.
The thickness of the organic thin film layer is 0.5-60 μm, and further, the thickness of the organic thin film layer can be 1-25 μm, 5-20 μm, or 30-55 μm; the thickness of the inorganic thin film layer is 20-100nm, and further, the thickness of the inorganic thin film layer can be 30-90nm, 50-70nm or 60-80 nm; the proper thickness setting can not only ensure that each layer has good combination, but also obtain better water and oxygen isolation capability.
The parylene film with biocompatibility of the organic thin film layer can be parylene with N type, C type, D type or HT type and other structures.
In the present invention, the organic thin film layers and the inorganic thin film layers are alternately stacked.
In the invention, the number of the arranged layers of the organic thin film layer and the inorganic thin film layer can be designed according to the requirement of the implantation age of the implantation device, the requirement time of the implantation age is long, and the number of the arranged layers of the organic thin film layer and the inorganic thin film layer is correspondingly increased, generally, the total number of the layers is more than or equal to 2, and specifically, for example, the organic thin film layer and the inorganic thin film layer are respectively provided with 2-10 layers. When the number of the organic thin film layer and the inorganic thin film layer is greater than 1, the organic thin film layer and the inorganic thin film layer can be numbered in sequence according to the first organic thin film layer … …, the first inorganic thin film layer and the second inorganic thin film layer … …. The organic thin film layers may be made of the same material or different materials. The material of each inorganic thin film layer may be the same or different.
In order to further improve the encapsulation effect of the encapsulation layer, the encapsulation layer further comprises one or more organic buffer layers, and the organic buffer layers are polytetrafluoroethylene films with biocompatibility or fluorocarbon polymer films with polytetrafluoroethylene structures. The polytetrafluoroethylene film and the fluorocarbon polymer film material with the polytetrafluoroethylene structure are pure inert, have very strong biocompatibility, can not cause the rejection of organisms, have no physiological side effect on human bodies, have a microporous structure, can play a good buffering role in a packaging layer, and further enhance the binding force between an organic film layer and an inorganic film layer.
The organic buffer layer is disposed on any of the organic thin film layer or the inorganic thin film layer. That is, the organic buffer layer may be sandwiched between any two adjacent organic thin film layers, or between any two adjacent inorganic thin film layers, or between any adjacent organic thin film layers and inorganic thin film layers, or disposed on the outermost layer of the encapsulation layer.
The thickness of the organic buffer layer is 0.5-60 μm. Further, the organic buffer layer may have a thickness of 1 to 25 μm, 5 to 20 μm, or 30 to 55 μm. The number of the layers of the organic buffer layer can also be designed according to the requirement of the implantation age of the implanted device, the required time of the implantation age is long, and the number of the layers is correspondingly increased, specifically, for example, 1-10 layers can be provided. When the number of the organic buffer layers is greater than 1, the organic buffer layers can be numbered in sequence according to the first organic buffer layer and the second organic buffer layer … …. The organic buffer layers may be made of the same material or different materials.
In the invention, the device body comprises one or more of a nerve electrode, a wireless transmission coil, an integrated circuit chip, a PCB (printed Circuit Board), a sensor, a biological chip board, a cardiac pacemaker, an artificial retina, a cochlear implant, a defibrillator and a stimulator. Wherein the stimulator includes vagus nerve stimulator, spinal cord stimulator, carotid sinus electrical stimulator, bladder stimulator, gastrointestinal stimulator, deep brain stimulator, etc. The packaging layer of the invention can be arranged outside an integral device, or can be arranged outside a certain component in the integral device, and can be specifically arranged according to actual needs.
The medical implant device with the packaging layer provided by the first aspect of the invention has the advantages that the packaging layer has good biocompatibility, and can well isolate water vapor and oxygen, so that the normal operation of the implant device can be protected, the service life of the device is prolonged, the device can reach the requirement of years of implantation, and the packaging layer can also meet the packaging requirement of high-density implanted electronic devices.
In a second aspect, the present invention provides a method of packaging a medical implant device, comprising the steps of:
providing a device body, and laminating at least one organic thin film layer and at least one inorganic thin film layer on the surface of the device body to obtain a packaging layer, wherein the organic thin film layer is a parylene film or a polyimide resin film with biocompatibility; the inorganic thin film layer is an inorganic thin film with biocompatibility; the innermost layer of the packaging layer is an organic thin film layer or an inorganic thin film layer, and the outermost layer of the packaging layer is an organic thin film layer or an inorganic thin film layer.
According to the packaging method, the device body comprises one or more of a nerve electrode, a wireless transmission coil, an integrated circuit chip, a PCB (printed circuit board), a sensor, a biochip board, a cardiac pacemaker, an artificial retina, a cochlear implant, a defibrillator and a stimulator. Wherein the stimulator includes vagus nerve stimulator, spinal cord stimulator, carotid sinus electrical stimulator, bladder stimulator, gastrointestinal stimulator, deep brain stimulator, etc.
The parylene film with biocompatibility of the organic thin film layer can be parylene with N type, C type, D type or HT type and other structures. The thickness of the organic thin film layer is 0.5-60 μm, and further, the thickness of the organic thin film layer may be 1-25 μm, 5-20 μm, or 30-55 μm. The organic thin film layer can be prepared by adopting a Chemical Vapor Deposition (CVD), spin coating or pulling method, and the prepared thin film can provide a very smooth, continuous and defect-free thin film on any shape and curved surface, so that the encapsulation possibility of a heterogeneous composite thin film is provided, and the encapsulation volume is remarkably reduced.
The packaging method of the invention, the inorganic film with biocompatibility comprises Al2O3Film, SiO2Film, SiC film, TiO2A thin film or a SiN thin film. The thickness of the inorganic thin film layer is 20-100nm, and further, the thickness of the inorganic thin film layer can be 30-90nm, 50-70nm, or 60-80 nm. The inorganic thin film layer can be prepared by adopting an Atomic Layer Deposition (ALD) or magnetron sputtering mode, and the prepared thin film can provide a very smooth, continuous and defect-free thin film on any shape and curved surface, so that the encapsulation possibility of the heterogeneous composite thin film is provided, and the encapsulation volume is reduced remarkably.
The packaging method can alternately stack the organic thin film layers and the inorganic thin film layers to form a plurality of layers, can be specifically designed according to the requirement of the implantation age of an implanted device, has long requirement time of the implantation age, and correspondingly increases the number of the arranged layers of the organic thin film layers and the inorganic thin film layers and the thickness of each layer of the film, generally speaking, the total number of the layers of the organic thin film layers and the inorganic thin film layers is more than or equal to 2, and specifically, for example, the organic thin film layers and the inorganic thin film layers are respectively arranged with 2-10 layers.
In the invention, the packaging method further comprises the step of preparing an organic buffer layer on the surface of the organic thin film layer or the inorganic thin film layer, wherein the organic buffer layer is a polytetrafluoroethylene thin film or a polytetrafluoroethylene structure fluorocarbon polymer thin film. The organic buffer layer can be clamped between any two adjacent organic thin film layers, or between any two adjacent inorganic thin film layers, or between any adjacent organic thin film layers and inorganic thin film layers, or arranged on the outermost layer of the packaging layer. The organic buffer layer can be prepared by adopting a stretching or spraying mode.
The thickness of the organic buffer layer is 0.5-60 μm. Further, the organic buffer layer may have a thickness of 1 to 25 μm, 5 to 20 μm, or 30 to 55 μm. The number of the layers of the organic buffer layer can also be designed according to the implantation age requirement of the implanted device, the implantation age requirement time is long, the number of the layers and the thickness of each layer of thin film are correspondingly increased, and specifically, the number of the layers and the thickness of each layer of thin film can be 1-10, for example.
In the packaging method, before the inorganic thin film layer is prepared, the organic thin film layer or the organic buffer layer is annealed at the temperature of 100-200 ℃ for 5-120 minutes. After annealing treatment, the binding force between the inorganic thin film layer and the organic thin film layer or the surface of the organic buffer layer can be effectively enhanced, and the problem of layering before an interface is avoided, so that a compact organic and inorganic combined thin film layer is obtained.
The packaging method of the medical implant device provided by the second aspect of the invention is applied to the field of active implant medical equipment, can effectively improve the packaging problem of the existing active implant, can greatly reduce the cost, and can meet the requirement of packaging high-density implant electronic devices.
Advantages of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of embodiments of the invention.
Drawings
FIG. 1 is a schematic structural view of a medical implant device with an encapsulation layer prepared in example 1 of the present invention;
FIG. 2 is a schematic structural view of a medical implant device with an encapsulating layer prepared in example 2 of the present invention;
FIG. 3 is a schematic structural view of a medical implant device with an encapsulating layer prepared in example 3 of the present invention;
FIG. 4 is a schematic structural view of a medical implant device with an encapsulating layer prepared in example 4 of the present invention;
FIG. 5 is a schematic structural view of a medical implant device with an encapsulating layer prepared in example 5 of the present invention;
fig. 6 is a schematic structural view of a medical implant device with an encapsulation layer prepared in example 6 of the present invention.
Detailed Description
While the following is a description of the preferred embodiments of the present invention, it should be noted that those skilled in the art can make various modifications and improvements without departing from the principle of the embodiments of the present invention, and such modifications and improvements are considered to be within the scope of the embodiments of the present invention.
Example 1
A method of packaging a medical implant device, comprising the steps of:
(1) providing an implanted device body, and preparing an organic thin film layer with the thickness of 60 mu m on the surface of the device by adopting a chemical vapor deposition mode, wherein the organic thin film layer is a parylene thin film; then annealing treatment is carried out for 2 hours at 150 ℃;
(2) then preparing an inorganic thin film layer with the thickness of 100nm on the organic thin film layer by adopting an atomic layer deposition mode to obtain a packaging layer, wherein the inorganic thin film layer is Al2O3The film, as shown in fig. 1, is a medical implant device with an encapsulation layer prepared in this embodiment, where the encapsulation layer has a two-layer structure and includes an organic film layer and an inorganic film layer sequentially disposed on the surface of the implant device.
Example 2
A method of packaging a medical implant device, comprising the steps of:
(1) providing an implanted device body, and preparing an organic thin film layer with the thickness of 20 micrometers on the surface of the device in a spin coating mode, wherein the organic thin film layer is a polyimide resin thin film;
(2) preparing an organic buffer layer with the thickness of 30 mu m on the surface of the organic thin film layer by adopting a spraying mode, and then carrying out annealing treatment for 1 hour at 150 ℃; the organic buffer layer is a fluorocarbon polymer film with a polytetrafluoroethylene structure;
(3) after annealing is finished, preparing an inorganic thin film layer with the thickness of 80nm on the organic buffer layer in an atomic layer deposition mode to obtain a packaging layer, wherein the inorganic thin film layer is Al2O3The film, as shown in fig. 2, is a medical implant device with an encapsulation layer prepared in this embodiment, where the encapsulation layer has a three-layer structure and includes an organic thin film layer, an organic buffer layer, and an inorganic thin film layer sequentially disposed on the surface of the implant device.
Example 3
A method of packaging a medical implant device, comprising the steps of:
(1) providing an implanted device body, preparing an organic thin film layer with the thickness of 30 mu m on the surface of the device by adopting a chemical vapor deposition mode, and then carrying out annealing treatment at 180 ℃ for 30 minutes; the organic film layer is a parylene film;
(2) after annealing is finished, preparing an inorganic thin film layer with the thickness of 70nm on the organic thin film layer in an atomic layer deposition mode to obtain a packaging layer, wherein the inorganic thin film layer is SiO2A film;
(3) preparing an organic buffer layer with the thickness of 25 mu m on the surface of the inorganic thin film layer by adopting a spraying mode; the organic buffer layer is a fluorocarbon polymer film with a polytetrafluoroethylene structure; as shown in fig. 3, for the medical implant device with an encapsulation layer prepared in this embodiment, the encapsulation layer has a three-layer structure, and includes an organic thin film layer, an inorganic thin film layer, and an organic buffer layer sequentially disposed on the surface of the implant device.
Example 4
A method of packaging a medical implant device, comprising the steps of:
(1) providing an implant device body, and preparing a first organic thin film layer with the thickness of 10 mu m on the surface of the device in a lifting mode, wherein the first organic thin film layer is a polyimide resin thin film;
(2) preparing a first organic buffer layer with the thickness of 20 mu m on the surface of the organic thin film layer by adopting a spraying mode, and then carrying out annealing treatment for 1.5 hours at 150 ℃; the first organic buffer layer is a fluorocarbon polymer film with a polytetrafluoroethylene structure;
(3) after annealing is finished, preparing an inorganic thin film layer with the thickness of 80nm on the first organic buffer layer in an atomic layer deposition mode, wherein the inorganic thin film layer is a SiC thin film;
(4) preparing a second organic buffer layer with the thickness of 10 mu m on the surface of the inorganic thin film layer by adopting a spraying mode, wherein the second organic buffer layer is a polytetrafluoroethylene structure fluorocarbon polymer thin film;
(5) preparing a second organic thin film layer with the thickness of 15 mu m on the second organic buffer layer by adopting a chemical vapor deposition mode to obtain a packaging layer, wherein the second organic thin film layer is a parylene film; as shown in fig. 4, the medical implant device with an encapsulation layer prepared in this embodiment has a five-layer structure, and includes a first organic thin film layer, a first organic buffer layer, an inorganic thin film layer, a second organic buffer layer, and a second organic thin film layer sequentially disposed on the surface of the implant device.
Example 5
A method of packaging a medical implant device, comprising the steps of:
(1) providing an implanted device body, preparing a first organic thin film layer with the thickness of 20 microns on the surface of the device by adopting a chemical vapor deposition mode, and then carrying out annealing treatment for 40 minutes at 150 ℃; the first organic thin film layer is a parylene thin film;
(2) after annealing is finished, preparing a first inorganic thin film layer with the thickness of 40nm on the first organic buffer layer in an atomic layer deposition mode, wherein the first inorganic thin film layer is Al2O3A film;
(3) preparing an organic buffer layer with the thickness of 10 mu m on the surface of the inorganic thin film layer by adopting a spraying mode, wherein the organic buffer layer is a fluorocarbon polymer thin film with a polytetrafluoroethylene structure;
(4) preparing a second organic thin film layer with the thickness of 15 mu m on the organic buffer layer by adopting a chemical vapor deposition mode, and then carrying out annealing treatment for 40 minutes at 150 ℃; the second organic film layer is a polyimide resin film;
(5) after annealing is finished, preparing a second inorganic thin film layer with the thickness of 30nm on the second organic thin film layer in an atomic layer deposition mode to obtain a packaging layer, wherein the second inorganic thin film layer is Al2O3A film; as shown in fig. 5, the medical implant device with an encapsulation layer prepared in this embodiment has a five-layer structure, and includes a first organic thin film layer, a first inorganic thin film layer, an organic buffer layer, a second organic thin film layer, and a second inorganic thin film layer sequentially disposed on the surface of the implant device.
Example 6
A method of packaging a medical implant device, comprising the steps of:
(1) providing an implanted device body, and preparing a first inorganic thin film layer with the thickness of 40nm on the surface of the device in an atomic layer deposition mode, wherein the first inorganic thin film layer is Al2O3A film;
(2) preparing a first organic thin film layer with the thickness of 20 mu m on the first inorganic thin film layer by adopting a chemical vapor deposition mode; the first organic thin film layer is a parylene thin film;
(3) preparing an organic buffer layer with the thickness of 10 mu m on the surface of the first organic thin film layer by adopting a spraying mode; the organic buffer layer is a fluorocarbon polymer film with a polytetrafluoroethylene structure;
(4) preparing a second organic thin film layer with the thickness of 15 mu m on the organic buffer layer by adopting a chemical vapor deposition mode, and then carrying out annealing treatment for 40 minutes at 150 ℃, wherein the second organic thin film layer is a polyimide resin thin film;
(5) after annealing is finished, preparing a second inorganic thin film layer with the thickness of 30nm on the second organic thin film layer in an atomic layer deposition mode to obtain a packaging layer, wherein the second inorganic thin film layer is Al2O3A film; as shown in fig. 6, for the medical implant device with an encapsulation layer prepared in this embodiment, the encapsulation layer has a five-layer structure, and includes a first inorganic thin film layer, a first organic thin film layer, an organic buffer layer, a second organic thin film layer, and a third organic thin film layer sequentially disposed on the surface of the medical implant deviceTwo inorganic thin film layers.
The above-described embodiments of the present invention are merely illustrative of some of the possible implementations, and in other embodiments, the structure of the encapsulation layer may be modified within the scope of the claims of the present invention.
In the above embodiments of the present invention, the implant device body may specifically include one or more of a nerve electrode, a wireless transmission coil, an integrated circuit chip, a PCB board, a sensor, a biochip board, a cardiac pacemaker, an artificial retina, a cochlear implant, a defibrillator, and a stimulator. Wherein the stimulator includes vagus nerve stimulator, spinal cord stimulator, carotid sinus electrical stimulator, bladder stimulator, gastrointestinal stimulator, deep brain stimulator, etc.
According to the medical implant device with the packaging layer, which is prepared by the embodiment of the invention, the packaging layer is formed by laminating organic and inorganic multilayer biocompatible compact films, has the characteristics of uniform thickness, compactness, no pinhole, transparency, no stress and the like, and has excellent water-oxygen insulation and protection properties. After the implantation device is implanted into a human body, the permeation route of water and oxygen molecules in a complex environment in the body is along the interface layer of the organic/inorganic film, so that the permeation route of the water and oxygen molecules in the complex environment in the body is greatly prolonged, and the service life of the implantation device is greatly prolonged.
Effects of the embodiment
In order to strongly support the beneficial effects brought by the technical scheme of the embodiment of the invention, the following performance tests are provided:
the medical implant device with the packaging layer prepared by the embodiment of the invention is subjected to a cell relative proliferation rate toxicity reaction test and a helium leak detection airtightness test. The test of relative cell proliferation rate toxicity reaction can effectively reflect the biocompatibility of the implanted device, and the helium leak detection airtightness test can well reflect the implantation age reliability of the device.
The cytotoxicity test is carried out according to national standard GB/T16886.5-2003 of the people's republic of China. Table 1 shows the results of the toxicity test of the relative proliferation rate of cells of the medical implant devices with encapsulation layers prepared in examples 1 to 6 of the present invention.
TABLE 1
As can be seen from the results in table 1, the medical implant devices with encapsulation layers prepared in examples 1 to 6 of the present invention all had a cell classification of 0 grade in the cytotoxicity test, had excellent biocompatibility, and could be implanted into the human body for a long time.
The helium leak tightness test results show that the medical implant devices with the encapsulation layers prepared in examples 1-6 of the invention can reach the 10-year implantation standard.
It should be noted that, according to the disclosure and the explanation of the above description, the person skilled in the art can make variations and modifications to the above embodiments. Therefore, the present invention is not limited to the specific embodiments disclosed and described above, and some equivalent modifications and variations of the present invention should be covered by the protection scope of the claims of the present invention. Furthermore, although specific terms are employed herein, they are used in a generic and descriptive sense only and not for purposes of limitation.
Claims (5)
1. The medical implant device with the packaging layer is characterized by comprising a device body and the packaging layer used for packaging the device body, wherein the packaging layer comprises at least one organic thin film layer, at least one inorganic thin film layer and one or more organic buffer layers which are arranged in a stacked mode, the innermost layer of the packaging layer is the organic thin film layer or the inorganic thin film layer, the outermost layer of the packaging layer is the organic thin film layer or the inorganic thin film layer or the organic buffer layer, the organic thin film layer is a parylene film or a polyimide resin film with biocompatibility, the inorganic thin film layer is an inorganic thin film with biocompatibility, and the inorganic thin film with biocompatibility comprises Al2O3Film, SiO2Film, SiC film, TiO2The thickness of the inorganic thin film layer is 20-100 nm; the organic buffer layer isThe thickness of the organic buffer layer is 0.5-60 mu m.
2. The medical implant device with encapsulating layer of claim 1, wherein said organic thin film layer has a thickness of 0.5-60 μm.
3. The medical implant device with encapsulation layer according to claim 1, wherein the organic buffer layer is disposed on any of the organic thin film layer or the inorganic thin film layer.
4. The medical implant device with encapsulation layer of claim 1, wherein the device body comprises one or more of a nerve electrode, a wireless transmission coil, an integrated circuit chip, a PCB board, a sensor, a biochip board, a cardiac pacemaker, an artificial retina, a cochlear implant, a defibrillator, and a stimulator.
5. A method of packaging a medical implant device, comprising the steps of:
providing a device body, and laminating at least one organic thin film layer, at least one inorganic thin film layer and one or more organic buffer layers on the surface of the device body to obtain a packaging layer, wherein the organic thin film layer is a parylene film or a polyimide resin film with biocompatibility; the inorganic thin film layer is an inorganic thin film with biocompatibility; the inorganic thin film with biocompatibility comprises Al2O3Film, SiO2Film, SiC film, TiO2The thickness of the inorganic thin film layer is 20-100 nm; the organic buffer layer is a polytetrafluoroethylene structure fluorocarbon polymer film with biocompatibility, the innermost layer of the packaging layer is an organic film layer or an inorganic film layer, the outermost layer of the packaging layer is an organic film layer or an inorganic film layer or an organic buffer layer, the thickness of the organic buffer layer is 0.5-60 mu m, and the organic buffer layer is firstly processed before the inorganic film layer is prepared each timeAnd annealing the organic thin film layer or the organic buffer layer at 100-200 ℃ for 5-120 minutes.
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| CN115414105A (en) * | 2022-11-04 | 2022-12-02 | 清华大学 | Stress and strain monitoring system and method for orthopedic intramedullary nail and human fracture end |
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