Implantable medical device having package and method for packaging implantable medical device

Abstract

An implantable medical device having a package, including: a device body, and a package configured for packaging the device body. The package includes at least one organic film layer and at least one inorganic film layer that are stacked on one another. An innermost layer of the package is an organic film layer or an inorganic film layer, and an outermost layer of the package is an organic film layer or an inorganic film layer. Each organic film layer is a parylene film or polyimide resin film with biocompatibility, and each inorganic film layer is an inorganic film with biocompatibility. A method for packaging an implantable medical device is also provided.

Claims

1. An implantable medical device having a package, comprising: a device body, and a package configured for packaging the device body, the package comprising a plurality of film layers, the plurality of film layers comprising at least one organic film layer and at least one inorganic film layer that are stacked on one another; wherein an innermost layer of the package is an organic film layer or an inorganic film layer, and an outermost layer of the package is an organic film layer or an inorganic film layer; and each organic film layer is a polyimide resin film with biocompatibility, and each inorganic film layer is an inorganic film with biocompatibility; the package further comprises one or more organic buffer layers, and each organic buffer layer is a polytetrafluoroethylene-like fluorocarbon polymer film with biocompatibility; and each organic buffer layer is sandwiched between two adjacent film layers, and at least one of the two adjacent film layers is the organic film layer.

2. The implantable medical device having a package according to claim 1, wherein the inorganic film with biocompatibility comprises: an Al.sub.2O.sub.3 film, a SiO.sub.2 film, a SiC film, a TiO.sub.2 film, or a SiN film.

3. The implantable medical device having a package according to claim 1, wherein the organic film layer has a thickness of 0.5-60 μm, and the inorganic film layer has a thickness of 20-100 nm.

4. The implantable medical device having a package according to claim 1, wherein each organic buffer layer has a thickness of 0.5-60 μm.

5. The implantable medical device having a package according to claim 1, wherein the device body comprises one or more selected from a neural electrode, a wireless transmission coil, an integrated circuit chip, a printed circuit board, a sensor, a biochip board, a cardiac pacemaker, an artificial retina, a cochlear implant, a defibrillator, and a stimulator.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) FIG. 1 is a structural diagram of an implantable medical device having a package prepared by Embodiment 1 of the present application;

(2) FIG. 2 is a structural diagram of an implantable medical device having a package prepared by Embodiment 2 of the present application;

(3) FIG. 3 is a structural diagram of an implantable medical device having a package prepared by Embodiment 3 of the present application;

(4) FIG. 4 is a structural diagram of an implantable medical device having a package prepared by Embodiment 4 of the present application;

(5) FIG. 5 is a structural diagram of an implantable medical device having a package prepared by Embodiment 5 of the present application; and

(6) FIG. 6 is a structural diagram of an implantable medical device having a package prepared by Embodiment 6 of the present application.

DETAILED DESCRIPTION OF THE EMBODIMENTS

(7) Preferred embodiments of the present application are described hereinbelow. It should be understood that for those skilled in the art, some improvements and modifications may be made without departing from the principles of the embodiments of the present application, and such improvements and modifications may be considered to be within the protection scope of the embodiments of the present application.

Embodiment 1

(8) A method for packaging an implantable medical device, included the following steps:

(9) 1) an implantable device body was provided, an organic film layer having a thickness of 60 μm was prepared on a surface of the device body by chemical vapor deposition, in which, the organic film layer was a parylene film; thereafter, an annealing treatment was performed at 150° C. for 2 hrs; and

(10) 2) an inorganic film layer having a thickness of 100 nm was prepared on the organic film layer by atomic layer deposition, thus obtaining a package. The inorganic film layer was an Al.sub.2O.sub.3 film The implantable medical device having a package obtained by the present embodiment was shown in FIG. 1. The package was in a double-layered structure, which included the organic film layer and the inorganic film layer sequentially arranged on the surface of the implantable device body.

Embodiment 2

(11) A method for packaging an implantable medical device, included the following steps:

(12) 1) an implantable device body was provided, an organic film layer having a thickness of 20 μm was prepared on a surface of the device body by spin coating, of which, the organic film layer was a polyimide resin film;

(13) 2) an organic buffer layer having a thickness of 30 μm was prepared on a surface of the organic film layer by spray coating and annealed at 150° C. for 1 hr; the organic buffer layer was a polytetrafluoroethylene-like fluorocarbon polymer film; and

(14) 3) after the annealing, an inorganic film layer having a thickness of 80 nm was prepared on the organic buffer layer by atomic layer deposition, thus obtaining a package. The inorganic film layer was an Al.sub.2O.sub.3 film. The implantable medical device having a package prepared by the present embodiment was shown in FIG. 2. The package was in a three-layered structure which included: the organic film layer, the organic buffer layer, and the inorganic film layer sequentially arranged on the surface of the device body.

Embodiment 3

(15) A method for packaging an implantable medical device, included the following steps:

(16) 1) an implantable device body was provided, an organic film layer having a thickness of 30 μm was prepared on a surface of the device body by chemical vapor deposition, and annealed at 180° C. for 30 mins; the organic film layer was a parylene film;

(17) 2) after annealing, an inorganic film layer having a thickness of 70 nm was prepared on the organic film layer by atomic layer deposition, thus obtaining the package. The inorganic film layer was a SiO.sub.2 film; and

(18) 3) an organic buffer layer having a thickness of 25 μm was prepared on a surface of the inorganic film layer by spray coating. The organic buffer layer was a polytetrafluoroethylene-like fluorocarbon polymer film. The implantable medical device having a package prepared by the present embodiment was shown in FIG. 3, the package was a three-layered structure which included: the organic film layer, the inorganic film layer, and the organic buffer layer sequentially arranged on the surface of the device body.

Embodiment 4

(19) A method for packaging an implantable medical device, included the following steps:

(20) 1) an implantable device body was provided, a first organic film layer having a thickness of 10 μm was prepared on a surface of the device body by dip-coating, and the first organic film layer was a polyimide resin film;

(21) 2) a first organic buffer layer having a thickness of 20 μm was prepared on a surface of the first organic film layer by spray coating and annealed at 150° C. for 1.5 hrs; the first organic buffer layer was a polytetrafluoroethylene-like fluorocarbon polymer film;

(22) 3) after annealing, an inorganic film layer having a thickness of 80 nm was prepared on the first organic buffer layer by atomic layer deposition, in which, the inorganic film layer was a SiC film;

(23) 4) a second organic buffer layer having a thickness of 10 μm was prepared on a surface of the inorganic film layer by spray coating, in which, the second organic buffer layer was a polytetrafluoroethylene-like fluorocarbon polymer film; and

(24) 5) a second organic film layer with a thickness of 15 μm was prepared on the second organic buffer layer by chemical vapor deposition, thus obtaining a package. The second organic film layer was a parylene film. The implantable medical device having a package prepared by the present embodiment was shown in FIG. 4. The package has a five-layered structure, which included: the first organic film layer, the first organic buffer layer, the inorganic film layer, the second organic buffer layer, and the second organic film layer sequentially arranged on the surface of the implantable device body.

Embodiment 5

(25) A method for packaging an implantable medical device, included the following steps:

(26) 1) an implantable device body was provided, a first organic film layer having a thickness of 20 μm was prepared on a surface of the device body by chemical vapor deposition, and annealed at 150° C. for 40 mins, in which, the first organic film layer was a parylene film;

(27) 2) after annealing, a first inorganic film layer having a thickness of 40 nm was prepared on the first organic buffer layer by atomic layer deposition, where the inorganic film layer was an Al.sub.2O.sub.3 film;

(28) 3) an organic buffer layer having a thickness of 10 μm was prepared on a surface of the inorganic film layer by spray coating, the organic buffer layer was a polytetrafluoroethylene-like fluorocarbon polymer film.

(29) 4) a second organic film layer having a thickness of 15 μm was prepared on the organic buffer layer by chemical vapor deposition, and annealed at 150° C. for 40 mins, in which, the second organic film layer was a polyimide resin film; and

(30) 5) after annealing, a second inorganic film layer having a thickness of 30 nm was prepared on the second organic film layer by atomic layer deposition, thus obtaining a package, and the second inorganic film layer was an Al.sub.2O.sub.3 film The implantable medical device having a package prepared by the present embodiment was shown in FIG. 5. The package had a five-layered structure, which included: the first organic film layer, the first inorganic film layer, the organic buffer layer, the second organic film layer, and the second inorganic film layer sequentially arranged on the surface of the implantable device body.

Embodiment 6

(31) A method for packaging an implantable medical device, included the following steps:

(32) 1) an implantable device body was provided, a first inorganic film layer having a thickness of 40 μm was prepared on a surface of the device body by atomic layer deposition, and the first organic film layer was an Al.sub.2O.sub.3 film;

(33) 2) a first organic film layer having a thickness of 20 μm was prepared on the first inorganic film layer by chemical vapor deposition; the first organic film layer was a parylene film;

(34) 3) an organic buffer layer having a thickness of 10 μm was prepared on the first organic film layer by spray coating; the organic buffer layer was a polytetrafluoroethylene-like fluorocarbon polymer film;

(35) 4) a second organic film layer having a thickness of 15 μm was prepared on the organic buffer layer by chemical vapor deposition, and annealed at 150° C. for 40 mins, in which, the second organic film layer was a polyimide resin film; and

(36) 5) after annealing, a second inorganic film layer having a thickness of 30 nm was prepared on the second organic film layer by atomic layer deposition, thus obtaining a package. The second inorganic film layer was an Al.sub.2O.sub.3 film The implantable medical device having a package prepared by the present embodiment was shown in FIG. 6. The package had a five-layered structure, which included: the first inorganic film layer, the first organic film layer, the organic buffer layer, the second organic film layer, and the second inorganic film layer sequentially arranged on the surface of the implantable device body.

(37) Only some of embodiments are described in the above embodiments of the present application, in other embodiments, the structure of the package may be modified with the protection scope of the claims of the present application.

(38) In the above embodiments of the present application, the device body comprises one or more selected from a neural electrode, a wireless transmission coil, an integrated circuit chip, a printed circuit board, a sensor, a biochip board, a cardiac pacemaker, an artificial retina, a cochlear implant, a defibrillator, and a stimulator. The stimulator includes: a vagus nerve stimulator, a spinal cord stimulator, a carotid sinus electrical stimulator, a bladder stimulator, a gastrointestinal stimulator, and a deep brain stimulator.

(39) In the implantable medical devices having a package prepared by the above embodiments of the present application, the package is formed by stacking a plurality of organic and inorganic dense films with biocompatibility, thereby having a uniform thickness and being dense, pinhole-free, transparent, and stress-free, and having excellent water and oxygen insulation and proof. After implanting the implanted device into the human body, the permeation paths of water and oxygen molecules in the complex environment of the body will extend along the interfaces of the organic/the inorganic films, thus, the water and oxygen permeation paths are greatly extended, the water and oxygen environment can be well isolated, which greatly improves the service life of the implantable device.

Effect Embodiment

(40) In order to strongly support the beneficial effects brought by the technical solutions of the embodiments of the present application, the following performance tests were performed:

(41) The implantable medical devices having a package prepared by the above embodiments of the present application were performed with a relative growth rate toxicity test and a helium leak test. The relative growth rate toxicity test can effectively reflect the biocompatibility of the implantable device, while the helium leak test can well reflect the reliability of implantation life of the device.

(42) Cytotoxicity test refers to the national standard GB/T 16886.5-2003 of the People's Republic of China. Table 1 shows results of the relative growth rate toxicity test of the implantable medical device having a package prepared in Embodiments 1-6 of the present application.

(43) TABLE-US-00001 TABLE 1 Absorbance Absorbance Absorbance Absorbance Absorbance Absorbance value of value of value of value of value of value of Groups Embodiment 1 Embodiment 2 Embodiment 3 Embodiment 4 Embodiment 5 Embodiment 6 1 0.247 0.252 0.256 0.265 0.251 0.254 2 0.284 0.267 0.223 0.233 0.229 0.265 3 0.254 0.262 0.298 0.283 0.273 0.275 4 0.282 0.275 0.244 0.259 0.247 0.248 5 0262 0.257 0.264 0.268 0.256 0.273 6 0.246 0.259 0.266 0.265 0.254 0.258 Average absorbance value 0.261833 0.262 0.257833 0.251667 0.253785 0.257455 Relative growth rate 1.033554 1.034212 1.023827 1.028757 1.027335 1.032454 Grading 0 0 0 0 0 0

(44) It can be seen from the results of Table 1 that the cytotoxicity test of the implantable medical devices having a package prepared in Embodiments 1-6 of the present application had a cell grading of 0, good biocompatibility, and were able to be implanted inside the body for a long period.

(45) The helium leak test showed that the implantable medical devices having the package prepared in Embodiments 1-6 of the present application were able to satisfy a 10-year implantation life standard.

(46) It should be noted that those skilled in the art to which the present application pertains may also make modifications and changes to the embodiments described in the above. Thus, the present application is not limited to the specific embodiments disclosed and described in the above, and equivalents of the present application are intended to be included within the protection scope of the appended claims. In addition, although specific terms are used in the specification, these terms are merely for convenience of description and do not limit the application.