The present disclosure relates generally to a bio-implantable device and, more particularly, to a bio-implantable device using a polymer and a method of manufacturing the same.
Bio-adhesive or bio-implantable structures for collecting biochemical responses and bio-signals by conversion into electrical signals and delivering electrical signals for neural stimulation to neural tissues are implantable devices respectively including a microelectrode array and a package are also referred to as microelectrode array packages.
In a bio-implantable device, such as a bio-implantable stimulator, a bio-implantable detector, a cardiac pacemaker, a neural prosthesis, or a neuromodulator, the encapsulated state thereof is critical, since the bio-implantable device operates, with at least a portion thereof being implanted or inserted into a living body. When the encapsulated state of the device is inadequate, a body fluid may leak into an electronic circuit present within the device, thereby causing a variety of problems, such as a breakdown, malfunction, and shortened longevity, to the device.
Korean Patent No. 10-1088806 (corresponding U.S. Pat. No. 8,886,277 B2) describes a related-art approach in which a package and microelectrodes are connected using feed-throughs, and indicates that a bio-implantable device of the related-art approach disadvantageously has low encapsulation property due to heterogeneous binding.
In addition, although there is another related-art approach of forming a package and microelectrodes using a liquid crystal polymer (LCP) in order to overcome the disadvantageous low encapsulation property due to heterogeneous binding, this related-art approach is also indicated as having a problem. The above-stated document discloses a microelectrode array package using a liquid polymer and a method of manufacturing the same, in which the microelectrode array package is more reliable, and the processing period thereof is reduced.
However, a technical solution able to improve the endurance and reliability of a bio-implantable using a polymer and improve the convenience of a manufacturing process is still demanded.
Accordingly, the present disclosure has been made keeping in mind the above problems occurring in the prior art, and an object of the present disclosure is to provide a bio-implantable device and a method of manufacturing the same, the device and method having superior endurance and reliability and excellent convenience in a manufacturing process.
A bio-implantable device according to the present disclosure includes one or more microwire arrays and one or more packages connected to one end of a corresponding microwire array among the microwire arrays. Each of the one or more microwire arrays includes: a substrate section made of a polymer; a wire section provided on one surface of the substrate section; and a cover section made of a polymer, the cover section being adhered to the one surface of the substrate section on which the wire section is provided to protect the wire section and expose at least one end of the wire section, thereby providing a pad section. Each of the one or more packages includes: a functioning section electrically connected to the pad section via a terminal section; and an encapsulating section made of a polymer, the encapsulating section being in contact with the functioning section and the pad section without gaps to protect the functioning section and the pad section, and extending to and being adhered to portions of the substrate section and the cover section adjacent to the pad section. The encapsulating section is provided by curing of the polymer, an initial state of which is liquid.
A method of manufacturing a bio-implantable device according to the present disclosure includes: (a) a step of preparing one or more microwire arrays respectively including a wire section disposed between a substrate section and a cover section made of polymers, with a portion of the wire section being exposed from the cover section to provide a pad section on at least one end thereof; (b) a step of electrically connecting the one or more microwire arrays and one or more functioning sections by electrically connecting terminal sections of the one or more functioning sections to the pad sections of the one or more microwire arrays; and (c) a step of providing an encapsulating section in contact with the one or more functioning sections and the pad sections without gaps to protect the one or more functioning sections and the pad sections by placing the electrically-connected one or more microwire arrays and functioning sections in a mold, injecting a liquid polymer into the mold, and cooling the injected polymer, the encapsulating section extending and being adhered to portions of the substrate sections and the cover sections adjacent to the pad sections.
The bio-implantable device according to the present disclosure has superior endurance and reliability, as well as excellent convenience in a manufacturing process.
Advantages and features of the present disclosure, as well as implementation methods thereof, will be clarified through following embodiments described with reference to the accompanying drawings. The present invention may, however, be embodied in different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the present invention to those skilled in the art. Further, the present invention is only defined by scopes of claims. The terms used herein shall be interpreted as being illustrative of the following embodiments, while not being limitative of the present invention. In addition, the terms of a singular form used herein may include plural forms unless referred to the contrary.
It should be understood that, throughout different drawings, the same reference numerals and symbols will be used to designate the same or like components. In the following description of the embodiments, detailed descriptions of known functions and components incorporated herein will be omitted in the case that the subject matter of the present disclosure may be rendered unclear thereby.
It should be understood that the terms, such as “one end”, “the other end”, and “end”, used herein do not necessarily indicate a most distal end but indicate a portion more adjacent to a distal portion rather than to a central portion.
As illustrated in
The cover section 116 cover sections and protects the wire section 114, such that at least one end of the wire section 114 is exposed from the cover section 116 to provide a pad section 115.
The microwire array 110 is coupled to the package 120. The package 120 includes a functioning section 122 and an encapsulating section 124. The functioning section 122 performs a variety of functions necessary for the bio-implantable device 100 to perform ordinary operations, such as signal processing, communication, and the like, and is typically comprised of one or more functional modules. The functioning section 122 is provided with a terminal section 123 electrically connected to the pad section 115 of the microwire array 110, such that signals, current, electric power, and the like may flow to the pad section 115 through the terminal section 123 and vice versa.
The functioning section 122 and pad section 115 are protected from the external environment by the encapsulating section 124 made of a polymer. The encapsulating section 124 is in contact with the functioning section 122 and the pad section 115 without gaps therebetween to protect the functioning section 122 and the pad section 115. In addition, the encapsulating section 124 extends to reach and is adhered to portions of the substrate section 112 and the cover section 116. That is, the encapsulating section 124 extends and is adhered to the portions of the substrate section 112 and the cover section 116 adjacent to the pad section 115.
Since the encapsulating section 124 is made of a polymer, i.e. the same material as those of the substrate section 112 and the cover section 116, the problem of low encapsulation property due to heterogeneous binding does not occur after the encapsulating section 124 is adhered to the substrate section 112 and the cover section 116. Since the encapsulating section 124 is in contact with and supports the functioning section 122 and the pad section 115 without gaps therebetween, the endurance and reliability of the bio-implantable device 100 are improved.
The encapsulating section 124 is formed by curing of the polymer, the initial state of which is liquid. The term “initial state” used herein refers to a state at a point in time at which the encapsulating section 124 initially occupied the space that the encapsulating section 124 is occupying. This means that the polymer has occupied the space of the encapsulating section 124 from the initial stage, in which the polymer is liquid instead of being, for example, powder or a film, and the liquid polymer is cured to form the encapsulating section 124. When the initial state is powder or a film, the powder or film must be subjected to, for example, high-temperature and high-pressure processing for 30 minutes or more to form the encapsulating section 124. Consequently, the functioning section 122 is subjected to a high-pressure and high-temperature atmosphere for a long time, thereby causing a breakdown in an electronic component of the functioning section 122. However, in the case in which the encapsulating section 124 is formed by curing the polymer having the liquid initial state, for example, when the method illustrated in
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As described above, a single microwire array 100 is completed, and a larger number of microwire arrays 100 is manufactured as required.
However, the processes and the sequence thereof illustrated in
Afterwards, as illustrated in
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According to the present embodiment, the first mold 300 and the second mold 400 are configured such that the upper encapsulating section 124a is formed first before the lower encapsulating section 124b is formed. However, in contrast, the molds may be configured such that the lower encapsulating section 124b is formed first before the upper encapsulating section 124a is formed. It should be understood that this configuration shall be within the scope of the present disclosure, and the scope of this configuration shall be defined by at least one claim of the Claims appended herein and all of its equivalents.
According to the present embodiment, the upper encapsulating section 124a and the lower encapsulating section 124b are formed using the separate molds 300 and 400 with a time difference. However, for example, forming both the upper encapsulating section 124a and the lower encapsulating section 124b using a single mold is within the scope of the present disclosure. That is, any process of forming the encapsulating section 124, which is in contact with the functioning section 122 and the pad section 115 without gaps therebetween to protect the functioning section 122 and the pad section 115 and extends and is adhered to portions of the substrate section 112 and the cover section 116 adjacent to the pad section 115, by placing the microwire array 110 and the functioning section 120 within the mold, injecting a liquid polymer into the mold, and cooling the injected polymer, is included within the scope of the present disclosure and the appended Claims.
Afterwards, as illustrated in
Afterwards, as illustrated in
The embodiment illustrated in
According to the first method, after electrical connections for the bio-implantable device 200 are completed, a half-finished product, the electrical connections of which are completed, is disposed in a mold having an inner space configuration in which a plurality of packages spaced apart from each other can be formed. A liquid polymer for forming an encapsulating section is injected into the mold, is cooled, and removed from the mold. Accordingly, a plurality of packages is manufactured in a single time.
According to the second method, after electrical connections to elements designated with, for example, reference numerals 21, 240, and 220 in
That is, in the latter case, a step of additionally forming one or more encapsulating sections is present. Specifically, in a state in which one or more encapsulating sections are formed, one or more functioning sections are added via microwire arrays, and the resultant structures are disposed in the mold. A liquid polymer is injected into the mold and then is cooled, thereby forming the one or more encapsulating sections. The encapsulating sections are in contact with the added functioning sections and pad sections connected to the functioning sections without gaps to protect the functioning sections and the pad sections, and extend and are adhered to portions of the substrate sections and the cover sections of the mediating microwire arrays adjacent to the pad sections. According to this method, bio-implantable device components and modules used for construction of a variety of bio-implantable devices may be previously manufactured, and the encapsulating section-forming method using the mold according to the present disclosure may be applied to connect the modules and components, thereby improving productivity and workability.
Although the functioning section 122 generally includes a circuit board 122a and electronic components 122e (see
The method of manufacturing the functioning section 122 according to the present embodiment will be described with reference to
A circuit board 122a, as illustrated in
Polymer films 122c are laminated on the top surface and the bottom surface of the circuit board 122a, as illustrated in
Since the electronic component 122e (see
As illustrated in
Although not shown, the lamination process may be performed after portions corresponding to the mounting section 122b and the terminal section 123 of the circuit board 122a are removed from the polymer films 122c, which has not yet been subjected to lamination. It should be understood that this configuration shall also belong the equivalent range of the invention defined by the Claims.
The portions corresponding to the mounting section 122b and the terminal section 123 of the circuit board 122a may be removed by a variety of methods, such as laser engraving, and this feature according to the present disclosure is not specifically limited.
As illustrated in
Since the above-described adhesion-improving layer 122d is additionally provided on the functioning section 122, the adhesion of the encapsulating section 124 to the functioning section 122 is increased. That is, when the surface of the circuit board 122a is made of a different material from the polymer of the encapsulating section 124 or, in the case that the surface is made of a polymer material the same as the polymer of the encapsulating section 124, has a high melting temperature equal to the melting temperature of the polymer of the encapsulating section 124, the adhesion-improving layer 122d made of a lower melting temperature may be additionally provided on an outer portion of the functioning section 122. The adhesion-improving layer 122d may be injected in a liquid state to be cured later, thereby further increasing the adhesion between the polymer of the encapsulating section 124 and the functioning section 122,
Although the a bio-implantable device and the method of manufacturing the same according to the present disclosure have been described with respect to the embodiments thereof, the scope of the present invention to be protected is not limited to specific embodiments, and those skilled in the art will appreciate that various substitutions, modifications, and alterations are possible without departing from the scope of the present disclosure. The foregoing embodiments disclosed herein and the accompanying drawings are provided for illustrative purposes rather than limiting the principle of the present invention. The scope of the principle of the present invention is not limited by the foregoing embodiments or the accompanying drawings. It should be understood that the scope of the present invention shall be defined by the appended Claims and all of their equivalents fall within the scope of the present invention.
Number | Date | Country | Kind |
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10-2016-0065292 | May 2016 | KR | national |
10-2017-0066027 | May 2017 | KR | national |
This Application is a Section 371 National Stage Application of International Application No. PCT/KR2017/005598, filed May 29, 2017, the contents of which is hereby incorporated by reference in its entirety.
Filing Document | Filing Date | Country | Kind |
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PCT/KR2017/005598 | 5/29/2017 | WO | 00 |