KR102039693B1 - Body implantable device and manufacturing method thereof - Google Patents

Abstract

The present disclosure includes a substrate portion made of a polymer, a conductive portion formed on one surface of the substrate portion, a cover portion formed of a polymer bonded to one surface on which the conductive portion is formed on the substrate portion to protect the conductive portion and exposing at least one end of the conductive portion to form a pad portion. The package body made of a polymer comprising a fine wire array and a sidewall formed integrally with the fine wire array and having a pad portion penetrating the sidewall therein, and a functional portion electrically connected to the pad portion and positioned inside the package body. And a package cover made of a polymer coupled to the package body to seal the package body and comprising one or more packages connected to one end of the corresponding fine lead array and a method of manufacturing the same.

Description

Implantable device and method of manufacturing the same {BODY IMPLANTABLE DEVICE AND MANUFACTURING METHOD THEREOF}

The present disclosure relates to a living implantable device, and more particularly, to a living implantable device using a polymer and a method of manufacturing the same.

The structure that is attached to or implanted into a living body to collect and collect biochemical reactions and biological signals into electrical signals or to apply electrical signals for biological stimulation to neural tissues is called a living implantable device. The implantable device is also referred to as a microelectrode array package.

In a living implantable device such as a living implantable stimulator, a living implantable detector, a heart pacemaker, a neural prosthesis, and a neuromodulator, a sealed state of the device is very important because at least a part of the device is implanted or inserted into a living body. If the device is not sealed properly, body fluids may leak into the electronic circuitry present inside the device, which may cause various problems such as device failure, malfunction, and shortened life.

Republic of Korea Patent No. 10-1088806 (corresponding US Patent US 8,886,277 B2) describes a conventional technique for connecting the package and the microelectrode using feed-through, while living implantable type according to such a conventional technique The instrument points out the problem of poor sealing due to heterogeneous bonding.

In addition, there is a conventional technique for forming a package and a fine electrode using a liquid crystal polymer to solve the problem of poor sealing due to heterogeneous bonding, but pointed out that there is a problem in such a prior art, more stable and Disclosed are a microelectrode array package using a liquid crystal polymer having a shorter process period, and a method of manufacturing the same.

However, there is still a need for a technology that can increase the durability and stability of the bio-injectable device using the polymer and improve the convenience of the manufacturing process.

In response to the above needs, the present disclosure provides a living implantable device and a method of manufacturing the same, which have high durability and stability and excellent convenience of a manufacturing process.

The living implantable device of the present disclosure includes a substrate portion made of a polymer, a lead portion formed on one surface of the substrate portion, a cover made of a polymer bonded to one surface on which the conductive portion is formed on the substrate portion to protect the conductive portion, and exposing at least one end of the conductive portion to form a pad portion. One or more fine lead arrays comprising portions and one or more packages connected to one end of the corresponding fine lead array, each package comprising a sidewall formed integrally with the fine lead array, wherein the pad portion penetrates the sidewall and is located therein. That is, it comprises a package body made of a polymer, a functional part located in the interior of the package body electrically connected to the pad portion, and a package cover made of a polymer, coupled to the package body to seal the package body.

In the method of manufacturing a living implantable device of the present disclosure, (a) at least one fine wire array having a lead portion disposed between a substrate portion and a cover portion formed of a polymer, and at least one pad portion at which a portion of the lead portion is exposed to the outside of the cover portion is formed. B) forming sidewalls of polymer integrally with the corresponding fine lead array to obtain at least one package body having a pad portion of the fine lead array penetrating through the side wall and positioned therein; (c) Electrically connecting a corresponding functional part to the pad part to position the inside of the package body, and (d) sealing the package body by engaging the package cover made of polymer with the corresponding package body.

The implantable device of the present disclosure has high durability and stability, and excellent convenience of a manufacturing process.

1 is a longitudinal cross-sectional view of a living implantable device according to one embodiment of the present disclosure.
2 is a plan view of a living implantable device according to one embodiment of the present disclosure.
3 is a top view of a living implantable device according to another embodiment of the present disclosure.
4 to 7 are views sequentially showing a process of a method for manufacturing a living implantable device according to an embodiment of the present disclosure.

Advantages and features and methods of achieving them according to the present disclosure will become apparent with reference to the embodiments described below in detail in conjunction with the accompanying drawings. However, the present invention is not limited to the embodiments disclosed below, but will be implemented in various forms, and only the present embodiments are intended to complete the disclosure of the present invention, and the general knowledge in the art to which the present invention pertains. It is provided to fully convey the scope of the invention to those skilled in the art, and the present invention is defined only by the scope of the claims. Meanwhile, the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. In this specification, the singular also includes the plural unless specifically stated otherwise in the phrase.

In adding reference numerals to the elements of each drawing, it should be noted that the same elements are denoted by the same reference numerals as much as possible even if displayed on different drawings. In describing the embodiments, when it is determined that a detailed description of a related well-known configuration or function may obscure the subject matter of the present disclosure, the detailed description thereof will be omitted.

In the present disclosure, terms such as 'end', 'other', 'end' and the like do not necessarily mean the end, but should be understood to mean the part near the end rather than the middle.

1 is a longitudinal cross-sectional view of a living implantable device according to an embodiment of the present disclosure, and FIG. 2 is a plan view of a living implantable device according to an embodiment of the present disclosure.

As shown in FIGS. 1 and 2, the implantable device 100 of the present disclosure includes a fine lead array 110 and a package 120. The fine wire array 110 includes a substrate portion 112 made of a polymer, a lead portion 114 formed on one surface of the substrate portion 112, and a cover portion 116 made of a polymer covering and protecting the conductive portion 114. In addition, signals, currents, powers, etc. are transmitted through the conductive lines 114 of the fine conductive wire array 110 when the living implantable device 100 is operated.

The cover part 116 covers and protects the conductive part 114, but at least one end of the conductive part 114 is exposed from the cover part 116 to be the pad part 115. 1 and 2 illustrate that one end of the conductive line 114 is exposed to form the pad 115. In this embodiment, the electrode hole 117 is formed at the other end of the end where the pad part 115 of the cover part 116 is formed so that the electrode part 113 is exposed. The electrode unit 113 is an inlet of the collected biosignal when the bio implantable device 100 collects the biosignal, and the biostimulation signal when the bio implantable device 100 transmits the biostimulation signal to the living body. Is the exit of. The fine wire array 100 in which the electrode portion 113 is formed may be referred to as a fine electrode array.

The fine wire array 110 is coupled to the package 120. The package 120 includes a functional unit 122, a package body 124, and package covers 125a and 125b. The functional unit 122 performs various functions necessary for the normal operation of the living implantable device 100, such as signal processing and communication, and is generally composed of one or more functional modules. For example, a battery module that is responsible for power supply for the living implantable device 100 may be included as a function module. The functional unit 122 includes a terminal unit 123 that is electrically connected to the pad unit 115 of the fine wire array 110, and thus provides a signal, current, Power may flow.

The functional unit 122 and the pad unit 115 are protected from the external environment by the package body 124 and the package covers 125a and 125b made of a polymer. The package body 124 includes a sidewall 124a formed integrally with the fine wire array 110, and the pad portion 115 of the fine wire array 110 penetrates the sidewall 124a to form an interior of the package body 124. Located in The side wall 124a of the package body 124 is illustrated as being perpendicular to the longitudinal direction of the fine wire array 110, but is not limited thereto. The functional part 122 may be electrically connected to the pad part 115. ) Should have a suitable height and angle to accommodate the inside.

Since the package body 124 is made of a polymer that is the same material as the substrate portion 112 and the cover portion 116 of the fine lead array 110, the sidewalls 124a of the package main body 124 may be formed of the fine lead array 110. After being formed integrally with the substrate 112 and the cover 116, there is no problem of inferior sealing due to heterogeneous bonding. In the illustrated embodiment, the package body 124 is open at both the top and bottom, the open top of the package body 124 by the upper package cover 125a made of polymer, the open bottom is made of polymer The package body 124 is sealed by being sealed by the package cover 125b. Although not shown, the package main body may be sealed by forming the package main body so that only one of the upper and lower parts is opened, and the opened portion of the package main body is sealed by one package cover. Since the package covers 125a and 125b are made of a polymer that is the same material as the package body 124, after the package covers 125a and 125b are bonded to the package body 124, the sealing properties of the bonding sites are inferior due to heterogeneous bonding. No problem.

As will be described later, the package body 124 has a corresponding fine lead array, for example, using a double injection method in which the fine lead array 110 is placed in a mold, the polymer is injected into the mold and then cooled. It may be formed by a process of forming the side wall 124a integrally with the polymer (110).

3 is a top view of a living implantable device according to another embodiment of the present disclosure.

As shown in FIG. 3, the implantable device 200 may include two or more fine wire arrays 210, 220, and 230 and two or more packages 240 and 250. Each of the fine wire arrays 210, 220, and 230 is the same as the fine wire array 110 described above, and each of the packages 240 and 250 is also the same as the structure of the package 120 described above. Since one end of the first fine wire array 210 is connected to the first package 240, a pad part 211 is formed at one end thereof. Since one end of the second fine wire array 220 is connected to the first package 240 and the other end is connected to the second package 250, pads 221 and 222 are formed at both ends. Since one end of the third fine wire array 230 is connected to the second package 250, a pad part 231 is formed at one end, and the other end is not connected to the package, but is connected to the coil 260. Pad portion (not shown) may be formed. The coil 260 may be regarded as a kind of functional part but is not formed as a package. This may be the case in the case of a functional part existing outside the living body, but is not limited to a functional part existing outside the living body.

4 to 7 are views sequentially showing a process of a method for manufacturing a living implantable device according to an embodiment of the present disclosure, and a plan view is shown on the left side and on the right side of the cross section. Hereinafter, the processes will be described in the order shown in the drawings.

As shown in FIG. 4A, a step of forming the conductive part 114 on one surface of the substrate part 112 made of a polymer is performed. Forming the conductive portion 114 on one surface of the substrate portion 112 may be accomplished by applying a variety of known polymer-based microcircuit patterning methods, including semiconductor processing, the present disclosure is specific to this It is not limited to that.

As shown in FIG. 4B, the cover part 116 made of polymer is attached to one surface of the substrate part 112 on which the conductive part 114 is formed. Attaching the cover portion 116 may be performed by various known methods, including thermocompression, and the present disclosure is not limited thereto.

As shown in FIG. 4C, one end of the cover part 116 is processed to form a pad part 115 in which a part of the conductive part 114 is exposed. Processing of the cover portion 116 may be performed by various known methods including laser etching, and the present disclosure is not limited thereto.

As shown in FIG. 4D, an alignment hole 118 penetrating the substrate portion 112 and the cover portion 116 is formed in an area where the conductive portion 114 does not exist, mainly at an edge portion. The order in which the alignment holes 118 and the pad unit 115 are formed may be reversed, and may be simultaneously processed. The alignment hole 118 is used to align the position by being aligned with the alignment pins of the mold when it is disposed in the mold in the following process, and does not form the alignment hole 118 when there is another method for the alignment. It is also possible not to.

In this way, one fine wire array 100 is completed, and a larger number of fine wire arrays 100 are manufactured as necessary.

However, the process and the sequence shown in FIG. 4 are just one example, and the conductive wire part 114 is disposed between the substrate part 112 made of a polymer and the cover part 116, and a part of the conductive wire part 114 is covered. (116) It is a matter of course that any step of providing a fine wire array in which the pad portion 115 exposed to the outside is formed at least at one end is possible. For example, it is also possible to adhere the cover portion 116 to the substrate portion 114 in a state where the processing for the pad portion 115 is completed on the cover portion 116.

Next, as shown in FIG. 5A, the fine wire array 110 is seated on the lower plate 310 of the mold 300 (see FIG. 5B). At this time, the alignment pin 312 formed in the lower plate 310 of the mold 300 is inserted into the alignment hole 118 formed at the edge of the fine wire array 110 so that the position of the fine wire array 110 is aligned. .

As shown in FIG. 5B, the upper plate 320 of the mold 300 is coupled to the lower plate 310. A receiving hole 322 into which the alignment pin 312 is inserted may be formed in the upper plate of the mold 300 to maintain a firm coupling between the upper plate 320 and the lower plate 310. In addition, a polymer inlet 324 is formed on the upper plate of the mold 300, and an inner empty space of the mold 300 which is continued from the polymer inlet 324 forms a package body 124 including sidewalls 124a. It is formed to fit.

As shown in FIG. 5C, after injecting and cooling a liquid polymer into the mold 300 through the polymer inlet 324, and removing the package, the package body 124 may be formed in the fine wire array 110 as shown in FIG. 5D. It becomes an integrated state. The temperature of the mold 300 is high enough (eg 200 degrees Celsius or more) so that the polymer injected into the mold 300 does not harden until it fills the interior space of the mold 300 tightly, but the melting of the injected polymer It is lower than the point, allowing the polymer to harden over time. In this way, the hardened polymer forms the package body 124. The package body 124 formed as described above has a pad portion 115 positioned inside the sidewall 124a and integrated with the fine wire array 110. As a result, a portion of the portion penetrated by the pad portion 115 is formed. Sealing is made. If the melting point of the polymer forming the package body 124 is higher than the melting point of the substrate portion 112 and the cover portion 116 of the fine wire array 110, the substrate portion 112 is in contact with the package body 124 that is not yet hardened. And while the cover portion 116 is partially melted and hardened together with the package body 124, the adhesive force of the package body 124 with the fine wire array 110 is improved and the sealing property is more excellent.

After the package body 124 is integrated into the fine wire array 110 as shown in FIG. 5D, the electrode holes 117 are processed by any known method such as laser etching, as shown in FIG. 5E. Thus, the electrode portion 113 is formed.

Then, as shown in FIG. 5F, the outline of the fine wire array 110 is cut out by any known method such as laser cutting.

Next, as shown in FIG. 6, the fine wire array 110 and the functional unit 122 are electrically connected to each other. That is, the function unit 122 corresponding thereto is electrically connected to the pad unit 115 of the fine wire array 110. For this purpose, the terminal unit 123 and the fine wire array 110 formed in advance in the functional unit 122 are formed. Pad portion 115 may be bonded with silver epoxy or high temperature lead. However, any known technique for electrically connecting the fine wire array 110 and the functional unit 122 may be used, and these should be considered to be included in the present disclosure.

Next, as shown in FIG. 7, the package covers 125a and 125b made of a polymer prepared in advance are coupled to the package main body 124 to seal the upper and lower portions of the package main body 124.

 The package covers 125a and 125b and the package body 124 may be coupled by, for example, ultrasonic welding. When the package covers 125a and 125b are coupled by ultrasonic welding, the package covers 125a and 125b may be aligned with each other. It will be appreciated by those skilled in the art that there may be an ultrasonic fusion acid for smooth ultrasonic fusion in the corresponding mating structure and / or package body 124 or package covers 125a and 125b.

According to the method of the present disclosure, the functional unit 122 is electrically connected to the pad unit 115 after the step of forming the package body 124 requiring relatively high heat and high pressure, and the functional unit 122 is connected to the pad unit 115. In the step of coupling the package cover (125a, 125b) to the package body 124 after being located in the package body 124 is not applied to the function unit 122, high heat or high pressure. Thus, the method or apparatus of the present disclosure may be used even when the functional portion 122 includes a functional module such as a battery module that is vulnerable to high temperature or high pressure.

4 to 7 is a method of manufacturing a living implantable device 100 having one fine wire array 110 and one package 120 as shown in FIGS. 1 to 2. . If the bio implantable device 200 composed of one or more fine wire arrays 210, 220, 230 and one or more packages 240, 250, as shown in FIG. 3, two methods are possible.

First, the array of fine wires is placed on the bottom plate of the mold having an inner space shape in which a plurality of package bodies spaced apart from each other can be formed, the top plate of the mold is covered, the liquid polymer is injected, cooled, and demolded. It combines the necessary functions and the corresponding package cover to the package body. That is, this can be seen as a method of obtaining a plurality of package bodies at once.

Second, for example, after completing the living implantable device including the package 240 and the fine wire arrays 210 and 220 in FIG. 3, an internal space form in which a package body for the package 250 is formed may be formed. The micro lead array 220 and the micro lead array 230 are disposed on the lower plate of the mold, the top plate of the mold is covered, the liquid polymer is injected, cooled, demolded, and then removed in the package body for the package 250. The functional unit and the package cover are combined to complete the living implantable device 200 as shown in FIG. 3.

That is, in the latter case, in the state in which one or more packages are completed, forming a sidewall with a polymer integrally with a corresponding fine lead array to obtain an additional package body in which the pad portion of the fine lead array penetrates the side wall and is located therein; And electrically connecting a functional part corresponding thereto to the pad part of the fine wire array corresponding to the added package body, and positioning the inside of the added package body, and a package cover made of a polymer corresponding thereto. There is a step of sealing the added package body in combination. According to this method, a living body implantable device having the characteristics of a component or a module used to configure various bio implantable devices is made in advance, and a package body is formed and packaged using a mold according to the present disclosure when interconnecting such modules or components. By applying a cover coupling method, productivity can be improved and workability can be improved.

Although a living implantable device and a method of manufacturing the same according to the present disclosure have been described according to related embodiments, the invention to be protected, that is, the scope of the present invention is not limited to the specific embodiments, and the general knowledge in relation to the present disclosure Many alternatives, modifications, and changes may be made to the extent it is obvious to those who have it. Accordingly, the embodiments described in the present disclosure and the accompanying drawings are not intended to limit the technical spirit of the present invention but to describe the present invention, and the scope of the technical spirit of the present invention is not limited by the embodiments and the accompanying drawings. . The scope of protection of the present invention should be interpreted by the claims, and all technical ideas within the scope equivalent thereto should be construed as being included in the scope of the present invention.

100: living implantable device
110: fine wire array
112: substrate portion
113: electrode portion
114: lead portion
115: pad portion
116: cover part
117: electrode hole
118: alignment hole
120: Package
122: function
123: terminal portion
124: package body
125a: top package cover
125b: bottom package cover
200: living implantable device
210, 220, 230: fine wire array
211, 221, 222, 231: pad portion
240, 250: package
260: coil
300: mold
310: bottom plate
312: alignment pin
320: tops
322: reception hall
324: polymer inlet

Claims (11)

One or more arrays of fine leads and one or more packages,

Each fine wire array
A substrate portion made of a polymer;
A lead portion formed on one surface of the substrate portion; And
A cover part made of a polymer, which is adhered to one surface of the substrate part on which the conductive part is formed and protects the conductive part and exposes at least one end of the conductive part to form a pad part; Including;

Each package is connected to one end of the corresponding fine lead array,
Each package is
One side is penetrated by the fine wire array and includes a side wall integrally formed in the fine wire array so as to laterally surround the pad portion in the pad portion, wherein at least one of the upper and lower portions not surrounded by the side wall is opened with a polymer. A package body made up of;
A functional part electrically connected to the pad part and positioned inside the package body; And
A package cover made of a polymer, wherein the side wall and the edge of the package body are coupled to seal the open package body; Including,

In vivo Implantable Devices.
The method according to claim 1,
The package body is open at both the top and bottom, the package cover is composed of a top cover for sealing the open top of the package body and a bottom cover for sealing the open bottom of the package body,
In vivo Implantable Devices.
The method according to claim 1,
The package body is open only one of the top and bottom, the package cover is composed of one cover to seal the open portion of the package body,
In vivo Implantable Devices.
The method according to claim 1,
At least one of the fine wire array having a pad portion at both ends is connected to each of the different packages at both ends,
In vivo Implantable Devices.
The method according to claim 1,
At least one of the packages is connected to each other the different fine array of wires on both sides,
In vivo Implantable Devices.
The method according to claim 1,
Melting point of the package body is higher than the melting point of the substrate portion and the melting point of the cover portion,
In vivo Implantable Devices.
(a) providing one or more fine arrays of wires formed with at least one pad portion having a conductive portion disposed between the substrate portion and the cover portion formed of a polymer, and a portion of the conductive portion exposed to the outside of the cover portion;
(b) a sidewall integrally formed with the fine lead array so that one side is penetrated by the corresponding fine lead array and laterally surrounds the pad portion so as to be positioned in the pad portion, wherein at least one of the upper and lower portions not surrounded by the sidewall is Obtaining one or more open, package bodies of polymer;
(c) electrically connecting a functional unit corresponding to the pad unit located in the package main body to position the inside of the package main body; And
(d) combining the edge of the package cover made of polymer with the sidewall of the corresponding package body to seal the open package body;
Method of manufacturing a living implantable device comprising a.
The method of claim 7, wherein
In the step (a), each of the one or more fine wire array,
(a1) forming the lead portion on one surface of the substrate portion made of a polymer;
(a2) attaching the cover part made of a polymer to one surface of the substrate part on which the conductive part is formed; And
(a3) forming the pad part by processing one end of the cover part;
Method of manufacturing a living implantable device comprising a.
The method of claim 8,
before or after step (a3),
(a4) forming an alignment hole penetrating the substrate portion and the cover portion in an area where the conductive portion does not exist;
Method of manufacturing a living implantable device further comprising.
The method of claim 7, wherein
In the step (c), electrically connecting the corresponding functional part to the pad part may be achieved by bonding the terminal part and the pad part previously formed with the functional part to silver epoxy or high temperature lead.
Method of manufacturing a living implantable device.
The method of claim 7, wherein
(e) forming one sidewall with a polymer integrally with the corresponding fine lead array with one or more packages formed to further obtain at least one package body having a pad portion of the fine lead array penetrating through the sidewall and positioned therein;
(f) electrically connecting a function unit corresponding to the pad unit of the fine wire array corresponding to the added package body and placing the inside of the added package body; And
(g) sealing the added package body by combining a package cover made of a corresponding polymer with the added package body;
Method of manufacturing a living implantable device further comprising.

Images