KR101939468B1 - Packing material for coil embolization, apparatus and method for manufacturing the same - Google Patents

Abstract

The present invention provides a novel filling material for coil embolization, which can exhibit a high blood flow blocking effect even in a small amount due to its excellent filling density, an apparatus for manufacturing the same, and a manufacturing method thereof. The filling material for coil embolization according to the present invention is a filling material for coil embolization used in coil embolization. The filling material for coil embolization comprises a metal wire of a size that can be inserted into an artery of a human body and a metal wire which is composed of a plurality of polymer nanofibers, Polymer nanofiber mat. The filling material for coil embolization according to the present invention can attain a high filling density in a small amount when injecting and filling into the cerebral aneurysm. Therefore, the filling density is superior to that of the conventional metal coil, and a high blood flow blocking effect can be exhibited even in a small amount.

Description

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a packing material for coil embolization,

The present invention relates to a filling material for coil embolization, and more particularly, to a filling material for coil embolization which can be inserted into a cerebral aneurysm to block blood flow to the cerebral aneurysm, an apparatus for manufacturing the same, and a manufacturing method thereof.

The cause of the aneurysm has not been clarified to date, but it seems to be caused by multiple factors rather than one cause. It is the most widely accepted theory that an aneurysm is formed congenitally and a cerebral aneurysm arises from arteriosclerosis or hypertension.

The cerebral hemorrhage may occur due to the development and growth of the cerebral aneurysm. The blood is spread first in the subarachnoid space, which is the space between the soft membrane and the arachnoid membrane surrounding the brain. This is called subarachnoid haemorrhage. In the moment of bleeding, severe headache develops, one third of the patients die instantly on the spot, one third of them die in transit to hospital or in hospital, and only the remaining patients Is known to be able to receive.

Cerebral aneurysm ligation and cerebral aneurysm coil embolization are the treatment methods of the aneurysm. Cerebral aneurysm ligation is a traditional surgical procedure, in which the cranium is opened to ligate the aneurysm of the cerebral aneurysms with clips. However, because of the various side effects caused by the direct opening of the skull and the severe pain experienced by the patient, more intensive aneurysm coil embolization has been attempted in recent years. Coil embolization is a surgical procedure in which microcoils made of metal through the femoral artery are inserted into the aneurysm to block blood flow to the aneurysm. Coil embolization is advantageous because it does not require craniotomy and it has a simple operation and short operation time.

However, such aneurysm of the cerebral aneurysm has many problems. The number and amount of metal coils that can be moved at one time are limited to deliver metal coils to the aneurysm through the femoral artery. Therefore, in order to treat a relatively large cerebral aneurysm, it is necessary to repeatedly deliver metal coils during surgery. These repetitive implant surgery methods increase the cost of operation and increase the risk of coil leakage or damage to normal blood vessels if repeated surgery is performed through narrow and curved blood vessels.

Therefore, in order to minimize the risk, it is necessary to develop a new type of metal coil that can effectively fill the aneurysm of the cerebral artery through only a small number of metal coils, or to develop a new procedure related therewith.

Patent Registration No. 1480514 (Feb. 2015)

SUMMARY OF THE INVENTION The present invention has been conceived in view of the above-described problems, and it is an object of the present invention to provide a novel coil embolization filler material capable of exerting a high blood flow shielding effect even in a small amount as compared with a metal coil for coil embolization, And a manufacturing apparatus and a manufacturing method thereof.

In order to achieve the above object, the present invention provides a filling material for coil embolization, which is used for coil embolization, comprising: a metal wire having a size that can be inserted into the artery of a human body; And a polymer nanofiber mat composed of a plurality of polymer nanofibers and surrounding the metal wires.

The metal wire may have a coiled structure.

The metal wire may be made of a metal containing platinum.

The polymer nanofibers constituting the polymer nanofiber mat may be formed of a polymer material including polycaprolactone.

According to another aspect of the present invention, there is provided an apparatus for manufacturing a filling material for a coil embolization, the apparatus including: a metal wire support having a metal wire mounting portion on which a metal wire of a size that can be inserted into an artery of a human body is mounted; A gas supplier for supplying a radiant gas; A pump for supplying the polymer solution; And a flow path connecting the gas inlet and the injection port; and a flow path connecting the gas inlet and the injection port, wherein the flow path is connected to the gas supply port of the metal wire support, And a polymer solution injection port connected to the middle of the flow path for supplying the polymer solution to the flow path, wherein the spinning gas and the polymer solution mixed in the flow path are injected at a high speed through the injection port, And a spinneret for spinning the polymer nanofibers to the metal wire side mounted on the wire mounting portion.

Wherein the flow path of the spinning nozzle includes a high pressure fluid portion connected to the gas inlet, a low pressure fluid portion connected to the injection port, and a throttling portion disposed between the high pressure fluid portion and the low pressure fluid portion, The diameter of the flow portion gradually decreases from the gas inlet side toward the throttle portion side and the diameter of the low pressure flow portion gradually increases from the throttle portion toward the injection port side and the polymer solution injection port is connected to the middle of the low pressure flow portion .

An apparatus for manufacturing a filling material for a coil embolization according to the present invention includes an ultraviolet lamp for generating ultraviolet rays and is disposed between the metal wire support and the spinneret so as to irradiate ultraviolet rays to polymer nanofibers emitted from the injection port And a polymer nanofiber sterilizing device.

An apparatus for manufacturing a filling material for coil embolization according to the present invention comprises: a light-transmissive supply pipe connecting the pump and the spinneret so that a polymer solution can be supplied from the pump to the spinneret; And a polymer solution sterilizing device including an ultraviolet lamp generating ultraviolet rays and installed between the pump and the spinneret so as to irradiate ultraviolet rays to the polymer solution flowing along the light transmissive supply pipe.

The apparatus for manufacturing a filling material for coil embolization according to the present invention comprises a gas supply pipe connecting the gas supply unit and the spinning nozzle so that the gas supply unit can supply the spinning nozzle with the spinning nozzle; And a gas filtration filter disposed in the gas supply pipe to filter foreign substances in the radiant gas flowing along the gas supply pipe.

According to another aspect of the present invention, there is provided a method of manufacturing a filling material for a coil embolization comprising the steps of: (a) providing a gas inlet, an injection port, a flow path connecting the gas inlet and the injection port, Preparing a radio-frequency nanofiber spinning apparatus including a spinneret having a polymer solution injection port connected to the polymer solution inlet, a gas feeder for supplying a spinning gas to the gas inlet, and a pump for supplying a polymer solution to the polymer solution inlet step; (b) mounting a metal wire of a size that can be inserted into an artery of a human body in a metal wire support arranged to face an injection opening of the spinning nozzle; And (c) supplying a radiant gas to the flow path of the spinning nozzle through the gas feeder, supplying a polymer solution to the flow path through the pump, and supplying the spinning gas and the polymer solution mixed in the flow path through the injection port at a high speed And radiating the polymer nanofibers to the metal wire side mounted on the metal wire support.

In the step (c), the polymer nanofibers emitted from the injection port may be irradiated with ultraviolet rays to sterilize the polymer nanofibers.

In the step (c), the polymer solution supplied from the pump is flowed to the spinning nozzle through the light-permeable supply pipe, and ultraviolet rays are irradiated to the light-transmitting supply pipe to sterilize the polymer solution flowing along the light- have.

In the step (c), the polymer solution may be prepared by mixing a polycarboxylate with a formic acid and an acetic acid.

In the step (b), the metal wire may be twisted in a coil shape.

According to another aspect of the present invention, there is provided a fill material for coil embolization, which is used in coil embolization, comprising a plurality of fine metal wires twisted into a single strand .

The fine metal wire may be formed by plating metal on the polymer nanofiber.

The metal plated on the polymer nanofibers may include platinum.

The polymer nanofiber may be formed of a polymer material including polycaprolactone.

According to another aspect of the present invention, there is provided a method of manufacturing a filling material for coil embolization, comprising the steps of: (a) forming a polymer nanofiber mat comprising a plurality of polymer nanofibers stacked in a mat form; (b) forming a fine metal wire mat by plating the polymer nanofiber mat with a metal; And (c) finishing the fine metal wire mat in a wire form.

A method of manufacturing a filling material for a coil embolization according to another aspect of the present invention includes the steps of: (a) after the step (b), (d) sputtering the polymer nanofiber mat, And applying metal particles to the surface of the mat.

In the step (a), the polymer nanofibers are formed by spinning a polymer solution prepared by mixing polycaprolactone with formic acid and acetic acid. At the same time.

The filling material for coil embolization according to the present invention can attain a high filling density in a small amount when injecting and filling into the cerebral aneurysm. Therefore, the filling density is superior to that of the conventional metal coil, and a high blood flow blocking effect can be exhibited even in a small amount.

In addition, the manufacturing and disposing method and manufacturing method according to the present invention can efficiently manufacture a filling material for coil embolization having an excellent filling density.

1 schematically shows a filling material for coil embolization according to an embodiment of the present invention.
FIG. 2 illustrates a state in which a filling substance for coil embolization is filled in the cerebral aneurysm according to an embodiment of the present invention.
3 is a schematic view showing an apparatus for manufacturing a filling material for coil embolization according to an embodiment of the present invention.
FIG. 4 is a front view showing a device for sterilizing a polymer solution in an apparatus for producing a filling material for coil embolization according to an embodiment of the present invention. FIG.
5 is a computer simulation result for confirming the gas injection performance of the spinning nozzle of the apparatus for manufacturing a filling material for a coil embolization according to an embodiment of the present invention.
FIG. 6 is a front view showing a polymer nanofiber sterilizing apparatus of an apparatus for manufacturing a filling material for coil embolization according to an embodiment of the present invention. FIG.
7 is a view for explaining a process of spinning polymer nanofibers into a metal wire support of an apparatus for manufacturing a filling material for coil embolization according to an embodiment of the present invention.
8 is a schematic view of a filling material for coil embolization according to another embodiment of the present invention.
9 is a process flow diagram illustrating a method of manufacturing a filling material for coil embolization according to another embodiment of the present invention.
FIG. 10 shows a step-by-step process for preparing a filling material for coil embolization according to another embodiment of the present invention.
11 is a view showing a polymer nanofiber mat formed in the process of manufacturing a filling material for coil embolization according to another embodiment of the present invention.
12 shows an experimental apparatus for confirming the flow inhibiting effect of the filling material for coil embolization according to another embodiment of the present invention.
13 shows the results of the experiment using the experimental apparatus shown in Fig.
FIG. 14 shows another experimental apparatus for confirming the flow inhibition effect of the filling material for coil embolization according to another embodiment of the present invention.
15 and 16 are graphs showing experimental results using the experimental apparatus shown in Fig.

Hereinafter, a filling material for coil embolization according to the present invention, an apparatus for manufacturing the same, and a manufacturing method thereof will be described in detail with reference to the drawings.

FIG. 1 is a schematic view of a filling material for coil embolization according to an embodiment of the present invention, and FIG. 2 is a view showing a filling material for coil embolization filling a cerebral aneurysm according to an embodiment of the present invention.

As shown in the figure, the filling material 10 for coil embolization according to an embodiment of the present invention comprises metal wires 11 of a size that can be inserted into arteries of a human body, and a plurality of polymer nanofibers 14 And a polymeric nanofiber mat (13) surrounding the metal wire (11). The filling material 10 for coil embolization is used in coil embolization to fill the cerebral aneurysm C to effectively block blood flow to the cerebral aneurysm (C).

The metal wire 11 has a coiled structure. In order for coil embolization filling material (10) to be used for embolization of the aneurysm coil, there should be no side effects even if injected into the human body. For this purpose, the metal wire 11 is preferably made of a biocompatible metal such as platinum, tungsten, gold, iridium or an alloy thereof. The metal wire 11 may be in the form of another wire having a size that can be inserted into the artery of the human body in addition to the coil wire form.

The polymer nanofiber mat (13) covers the inside and outside of the metal wire (11). As the polymer nanofiber 14 constituting the polymer nanofiber mat 13, a biocompatible polymer material such as polycaprolactone may be used. As is known, polycaprolactone is an environmentally friendly and biocompatible material and is widely used as a cosmetic industry or molding. The polymer nanofiber mat (13) can be formed by stacking a plurality of polymer nanofibers (14) made by nanofiber spinning on a metal wire (11). The polymeric nanofiber 14 constituting the polymeric nanofiber mat 13 may be made of various other biocompatible polymeric materials other than polycaprolactone.

The filling material 10 for coil embolization according to an embodiment of the present invention can be used for coil embolization. That is, as shown in FIG. 2, the filling material for coil embolization 10 is filled in the cerebral aneurysm C through a femoral artery or the like by a medical device such as a catheter, thereby blocking blood flow to the cerebral artery C . The filling material 10 for coil embolization has a structure in which the polymer nanofibers 14 are coated with a high density on the metal wires 11 so that the filling density and the filling density are small in injection and filling into the cerebral aneurysm C Can be achieved. Therefore, the filling density is superior to that of the conventional metal coil, and a high blood flow blocking effect can be exhibited even in a small amount.

Hereinafter, a manufacturing apparatus for manufacturing the filling material 10 for a coil embolization according to an embodiment of the present invention as described above and a manufacturing method using the same will be described.

3 is a schematic view showing an apparatus for manufacturing a filling material for coil embolization according to an embodiment of the present invention.

As shown in the figure, an apparatus 100 for manufacturing a filling material for a coil embolization according to an embodiment of the present invention includes a metal wire support 110, a polymer wire 120, And a polymer nanofiber sterilizer 150 for ultraviolet sterilizing polymer nanofibers 14 radiated from the transponder nanofiber spinning device 120. The polymer nanofiber sterilizer 150 is a device for sterilizing polymer nanofibers 14, The apparatus 100 for manufacturing a filling material for coil embolization comprises a packing material 10 for filling a coil embolization having a high filling density by spinning polymer nanofibers 14 on a metal wire 11 of a size that can be inserted into a human artery, Can be effectively produced.

The metal wire support 110 is disposed to face the spinning nozzle 125 of the spinneret nanofiber spinner device 120 so that the metal wire 11 can be fixed. The metal wire support 110 is provided with a metal wire mount 111 on which the metal wire 11 is mounted. Although the metal wire attaching portion 111 is shown as being formed in a groove shape in which the metal wire attaching portion 111 receives the metal wire 11 therein, the metal wire attaching portion 111 may have various other structures capable of supporting the metal wire 11 can be changed.

The radio-frequency nanofiber spinning apparatus 120 includes a gas feeder 121 for supplying a spinning gas, a pump 123 for feeding a polymer solution, and a polymer nanofiber 14 And a spinning nozzle 125 connected to the gas feeder 121 and the pump 123 so as to be able to feed the gas. The radio-frequency nanofiber spinning apparatus 120 radiates the polymer solution supplied through the pump 123 at a high speed by using the spinning gas supplied from the gas feeder 121, The polymer nanofiber 14 may be spun into the polymer nanofibers.

The gas supply unit 121 supplies the spinning nozzle 125 with a spinning gas capable of spinning the polymer solution at a high speed. As the gas supplier 121, various devices capable of supplying various kinds of gases that can be used for polymer nanofiber emission such as a compressor capable of injecting high-pressure air can be used. The gas supply 121 is fluidly connected to the spinneret 125 via a gas supply pipe 137. A gas filtration filter 139 is connected in the middle of the gas supply pipe 137 and a polymer solution sterilizing device 146 is connected in the middle of the light transmission supply pipe 144.

The radiant gas flowing along the gas supply pipe 137 from the gas supply 121 is supplied to the spinning nozzle 125 after passing through the gas filtering filter 139. The gas filtration filter 139 is for filtering foreign matters in the radiant gas. The gas filtration filter 139 includes a moisture filter 141 for filtering moisture and an antibacterial filter 142 for filtering out mistake such as fine dust. Moisture contained in the spinning gas is removed while passing through the moisture filter 141, and contaminants such as fine dust, fungus, and bacteria contained in the spinning gas can be removed while passing through the antibacterial filter 142. As described above, the foreign matter contained in the spinning gas is filtered by the gas filtration filter 139, thereby reducing the problem of contamination of the polymer nanofibers 14 emitted from the spinning nozzle 125. As the gas filtration filter 139, various kinds of filters capable of removing foreign matter in the radiant gas may be used in addition to the moisture filter 141 and the antibacterial filter 142.

 The pump 123 supplies the polymer solution to the spinning nozzle 125. The pump 123 may be connected to a polymer solution reservoir (not shown) for storing the polymer solution, and may pump the polymer solution stored in the polymer solution reservoir to the spinneret 125. The polymer solution storage part may store a liquid polymer solution containing a biocompatible polymer. For example, a polymer solution containing polycaprolactone, which is an environmentally friendly and biocompatible polymer, in a formic acid and an acetic acid is stored in a polymer solution storage part, And may be supplied to the spinning nozzle 125. The pump 123 is fluidly connected to the spinneret 125 via a light transmissive supply tube 144. The polymer solution sterilizing device 146 is connected in the middle of the light transmitting supply pipe 144. The light-transmissive supply tube 144 is made of a material through which transparent or semitransparent light can pass.

The polymer solution flowing along the light-transmissive supply pipe 144 in the pump 123 is supplied to the spinneret 125 after passing through the polymer solution sterilizing device 146. The polymer solution sterilizing device 146 is for ultraviolet sterilizing the polymer solution passing through the light transmitting supply pipe 144. 4, the polymer solution sterilizing device 146 includes a support frame 147 having an open inside so that the light-transmissive supply pipe 144 can pass therethrough, an ultraviolet lamp (not shown) disposed inside the support frame 147, 148 and a heater 149. The polymer solution sterilizing device 146 is configured to sterilize the polymer solution flowing along the light transmissive supply pipe 144 by irradiating ultraviolet rays to the light transmissive supply pipe 144 and generating heat by the heater 149, It can be sterilized by heat.

For example, the polymer solution sterilizer 146 can sterilize the polymer solution by heating the polymer solution to about 120 degrees while irradiating ultraviolet rays of 200 to 300 nm wavelength band to the polymer solution passing through the light transmissive supply pipe 144. The polymer solution sterilizing device 146 sterilizes the polymer solution to reduce the problem of contamination of the polymer nanofibers 14 that become fibrous as the polymer solution is injected through the spinneret 125. [ The polymer solution sterilizing device 146 may take various structures to sterilize the polymer solution passing through the light transmitting supply pipe 144 in addition to the structure shown in the figure.

The spinning nozzle 125 can spin the polymer nanofibers toward the metal wire support 110 by injecting the polymer solution supplied through the pump 123 at a high speed using the spinning gas supplied from the gas supplier 121. The spinning nozzle 125 has a gas inlet 127 through which the gas supplied from the gas supplier 121 flows, a jetting port 128 which is disposed toward the metal wire mounting portion 111 of the metal wire support 110, And a polymer solution injecting unit 134 connected to the light transmissive supply pipe 144 and guiding the polymer solution to the flow path 130. [ One end of the polymer solution injection part 134 is disposed inside the flow path 130 and a polymer solution injection port 135 through which the polymer solution flows into the flow path 130 is provided.

The flow path 130 includes a high pressure fluid part 131 connected to the gas inlet 127, a low pressure fluid part 132 connected to the injection port 128, a high pressure fluid part 131 and a low pressure fluid part 132, (Not shown). The high pressure fluid portion 131 is provided in such a manner that the diameter gradually decreases from the gas inlet 127 side toward the diaphragm portion 133 side and the low pressure fluid portion 132 is provided in the diaphragm portion 133 side And gradually increases in diameter. The polymer solution injection port 135 is connected to the middle of the low-pressure fluid chamber 132. The radial gas supplied to the spinning nozzle 125 shows a high pressure supersonic flow in the high pressure fluid portion 131 and then changes from the low pressure fluid portion 132 to the low pressure supersonic flow after passing through the throttling portion 133. Therefore, the polymer solution discharged through the polymer solution injection port 135 can be rapidly diffused from the low-pressure flow portion 132 into the low-pressure spinning gas, uniformly mixed with the spinning gas, and then injected at a high speed through the injection port 128.

The spinning nozzle 125 injects the spinning gas and the polymer solution mixed in the flow path 130 at a high speed through the injection port 128 so that the metal wire 11 mounted on the metal wire mounting portion 111 of the metal wire support 110 The polymer nanofibers can be radiated to the side of the polymer nanofiber. That is, the spinning nozzle 125 can produce the polymer nanofibers by inducing the polymer solution to elongate aerodynamically through the supersonic spinning gas of high energy.

5 is a computer simulation result for confirming the gas injection performance of the spinning nozzle of the apparatus for manufacturing a filling material for a coil embolization according to an embodiment of the present invention.

In order to produce the polymer fibers by inducing the spinning nozzle 125 to stretch the polymer solution aerodynamically, the spinning nozzle 125 must inject the spinning gas at a predetermined speed or more. 5, the diameter D1 of the gas inlet 127 is 4 mm, the diameter D2 of the injection port 128 is 4.5 mm, the diameter D3 of the throttling portion 133, The diameter D4 of the polymer solution injection port 135 is 0.25 mm and the length L1 of the high pressure fluid portion 131 is 40 mm and the length L2 of the low pressure fluid portion 132 is 90 mm, The results are shown in FIG. 5 by simulation using a Navier-Stokes equation. 5, supersonic gas having a velocity of 700 m / s or more is injected when spinning a high-temperature and high-pressure spinning gas having a pressure of 500 ° C. and a pressure of 6 bar through the spinning nozzle 125. By injecting the supersonic gas having such a high energy through the spinning nozzle 125, it is possible to manufacture the polymer fiber by inducing the polymer solution to be elongated aerodynamically. It is also possible to emit nanofibers having a diameter of less than 1 [mu] m, without the need to supply electricity, such as nanofibers produced by conventional electrospinning processes.

3 and 6, the polymer nanofiber sterilizer 150 includes a metal wire support 110 for irradiating ultraviolet rays to the polymer nanofiber 14 emitted from the injection port 128 of the spinning nozzle 125, And the spinning nozzle 125. The polymer nanofiber sterilizing apparatus 150 includes a support frame 151 having an inner opening for allowing the polymer solution stream S injected at a high speed from the spinning nozzle 125 to pass therethrough and a support frame 151 disposed inside the support frame 151 And an ultraviolet lamp 152 that emits ultraviolet light. The polymer nanofiber sterilizer 150 can sterilize the polymer solution stream S by irradiating ultraviolet rays to the polymer solution stream S by the ultraviolet lamp 152. For example, when the polymer nanofiber sterilizer 150 irradiates the polymer solution stream S with ultraviolet light having a wavelength range of 200 to 300 nm, the polymer nanofiber 14, which is radiated toward the metal wire support 110, . The polymeric nanofiber sterilizer 150 may have various structures capable of sterilizing ultraviolet rays of the polymer solution stream S emitted to the metal wire support 110 side in addition to the structure shown in the drawing, have.

Hereinafter, a method for manufacturing a filling material 10 for a coil embolization using an apparatus 100 for manufacturing a filling material for coil embolization according to an embodiment of the present invention will be described.

First, the metal wire support 110, the radiofrequency nanofiber radiator 120 and the polymer nanofiber sterilizer 150 are aligned at appropriate positions and the metal wire 11 and the metal wire 11, which are the raw materials of the filling material 10 for coil embolization, Prepare a polymer solution. The metal wire 11 may be made of a biocompatible metal such as platinum, tungsten, gold, iridium or an alloy thereof. Also, the metal wire 11 may be of a structure that is twisted in a coil shape as shown in Fig. 7 (a). And the polymer solution can be made by mixing polycarbactolactone, an environmentally friendly, biocompatible polymer, with a formic acid and an acetic acid. For example, 8.5 g of a solution of 1.5 g of polycaprolactone mixed with a 1: 3 mass ratio of a formic acid and acetic acid solution is mixed to prepare a 15 wt% polycaprolactone polymer solution. The prepared metal wire 11 is mounted on the metal wire mount 111 of the metal wire support 110 as shown in Fig. 7 (a).

Next, the gas supplier 121 and the pump 123 of the radio-frequency nanofiber spinning apparatus 120 are operated to simultaneously supply the spinning gas and the prepared polymer solution to the spinning nozzle 125. The radiant gas supplied through the gas feeder 121 passes through the water filter 141 and the antibacterial filter 142 to remove foreign substances such as moisture, fine dust, fungi, bacteria, etc. from the gas inlet 121 of the spinning nozzle 125, And flows into the flow path 130 through the passage 127. The polymer solution pumped by the pump 123 is sterilized by ultraviolet rays and heat while passing through the polymer solution sterilizing device 146 and then injected into the flow path 130 through the polymer solution injection port 135 of the polymer solution injection unit 134. [ .

The polymer solution supplied to the inside of the spinning nozzle 125 through the polymer solution injecting unit 134 is diffused into the spinning gas flowing in the supersonic flow in the flow path 130 and injected at a high speed through the injection port 128 together with the spinning gas . In this process, the polymer solution is aerodynamically elongated to form a thin fiber-like polymer nanofiber (14).

The polymer solution stream S formed by ejecting the spinning gas and the polymer solution from the injection port 128 is sterilized while passing through the polymer nanofiber sterilizer 150. 7 (b), the polymer nanofibers 14 formed while the polymer solution is elongated adhere to the inside and outside of the metal wire 11 mounted on the metal wire support 110. Therefore, a filling material 10 for a coil embolization having a structure in which a twisted metal wire 11 is covered with a polymer nanofiber mat 13 in the form of a coil is produced. For example, the filling material for coil embolization 10 may have a structure in which a metal wire 11 having a width of 250 m made by twisting a metal wire having an average diameter of 47 m in the form of a coil is covered with polymer fibers having an average diameter of 390 nm.

The filling material 10 for coil embolization according to the present invention has a structure in which the polymer nanofibers 14 made by nanofiber spinning are coated on the metal wires 11 at a high density, A high filling density can be achieved with a small amount upon injection and filling. Therefore, the filling density is superior to that of the conventional metal coil, and a high blood flow blocking effect can be exhibited even in a small amount.

In addition, the packing material 10 for a coil embolization according to the present invention can be manufactured in a variety of customized shapes in which the distribution density of the polymer nanofibers 14 coated on the metal wires 11 is varied. And, according to the distribution density of the polymer nanofibers (14), appropriate use of coil embolization is possible to selectively control the blood flow according to the type of the aneurysm or the physical characteristics of the operation patient.

Meanwhile, FIG. 8 schematically shows a filling material for coil embolization according to another embodiment of the present invention.

As shown in the drawing, the filling material 20 for coil embolization according to another embodiment of the present invention is formed by twisting a plurality of fine metal wires 25 into one strand. The filling material 20 for coil embolization is formed in the form of a wire that can be inserted into the artery of a human body and is used for coil embolization to fill the cerebral aneurysm C The blood flow can be blocked.

The fine metal wires 25 may have a structure in which the polymer nanofibers 22 are plated with metal. As the metal constituting the fine metal wire 25, a biocompatible metal such as platinum, tungsten, gold, iridium or an alloy thereof may be used. As the polymer nanofiber 22, a biocompatible polymer material such as polycaprolactone may be used

Hereinafter, a method of manufacturing the filling material 20 for coil embolization according to another embodiment of the present invention will be described.

FIG. 9 is a flowchart illustrating a method of manufacturing a filling material for coil embolization according to another embodiment of the present invention. FIG. 10 is a step-by-step illustrating a method of manufacturing a filling material for coil embolization according to another embodiment of the present invention.

A method of manufacturing a filling material 20 for a coil embolization according to another embodiment of the present invention includes the steps of forming a polymer nanofiber mat 21 (S10), coating the metal nanofiber mat 21 with a metal particle A step S30 of forming a fine metal wire mat 24 by electroplating the polymer nanofiber mat 21 and a step S30 of forming a fine metal wire mat 24 on the coil embolization filling material 20, (S40).

First, in the polymer nanofiber mat 21 forming step S10, a plurality of polymer nanofibers 22 are laminated in a mat form to form a polymer nanofiber mat 21. [ In this step, a plurality of polymer nanofibers 22 may be formed by spinning a polymer solution containing a polymer substance, and laminated. The polymer solution used to form the polymer nanofibers (22) can be made by mixing polycarbactolactone, which is an environmentally friendly, biocompatible polymer, with a formic acid and an acetic acid.

As an experimental example, 8.5 g of a solution of 1.5 g of polycaprolactone mixed with a 1: 3 mass ratio of a formic acid and acetic acid solution was mixed to prepare a 15 wt% polycaprolactone polymer solution. The polymer nanofibers 22 can be formed from the polymer solution by an electrospinning method.

10, a syringe 200 equipped with a needle 210 (Nordson EFD) of 18-gauge size is used for discharging a polymer solution for electrospinning a polymer solution. In order to supply a constant flow rate Syringe pumps (Legato 100, KD Scientific) are available. At this time, the flow rate is 250 μl / h, and electrospinning can be performed while supplying a high voltage of 6 to 6.5 kV using a DC voltage supplier (EP20P2, Glassman High Voltage). Polymer nanofiber mat 21 made of polymer nanofibers 22 having diameters of about 200 to 300 nm as shown in Figs. 10 and 11 can be produced through electrospinning of such a polymer solution. In this process, the polymer nanofibers 22 can be electrospun with a square frame 300 of 3 x 3 cm ² in order to fabricate the polymer nanofibers 22 as a free-standing mat. At this time, the distance between the needle 210 and the square frame 300 can be maintained at 13 cm.

Next, the metal nanofiber mat 21 is coated with metal particles on the surface of the polymer nanofiber mat 21 (S20) of coating metal particles on the polymer nanofiber mat 21. The metal coated on the surface of the polymer nanofiber mat 21 may be a biocompatible metal such as platinum, tungsten, gold, iridium or an alloy thereof. The metal may be sputtered to form a polymer nano- The surface of the fiber mat 21 can be slightly coated.

As an experimental example, a rectangular frame 300 having a polymer nanofiber mat 21 formed in an electrospinning step may be inserted into a sputtering apparatus and the platinum may be slightly coated on the surface of the polymer nanofiber mat 21 to a thickness of several nanometers . In this process, the non-conductive polymer nanofibers 22 are coated with platinum particles in a seeding form. These platinum particle coatings facilitate the subsequent electroplating process. Since the platinum particles are very thinly coated on the surface of the polymer nanofibers (22) to a thickness of a few nanometers, the polymer nanofibers (22) remain nonconductive after this process.

Next, in the electroplating step (S30), the surface of the polymer nanofiber mat (21) coated with metal particles is plated with metal to form a fine metal wire mat (24). In this step, a biocompatible metal such as platinum, tungsten, gold, iridium or an alloy thereof such as a metal coated on the surface of the polymer nanofiber mat 21 can be plated in the previous step.

As an experimental example, the rectangular frame 300 having the polymer nanofiber mat 21 formed therein may be immersed in the platinum plating solution L to perform electroplating. Specifically, the platinum plating solution (L) can be prepared by mixing 80 mL of 5% H ₂ PtCl ₆ solution with 420 mL of distilled water and magnetically stirring at room temperature for about one day. The platinum plating solution (L) can be adjusted to a constant pH of 1.5 using H ₂ SO ₄ and NaOH. The rectangular frame 300 and the platinum plate 400 in which the polymer nanofiber mat 21 is formed are immersed in the prepared platinum plating solution L. The cathode electrode is connected to the square frame 300, Connect the electrodes. When the current 1 A is applied for 60 seconds, the surface of the polymer nanofibers 22 of the polymer nanofiber mat 21 supported on the square frame 300 is plated with platinum. Through this process, the polymer nanofiber 22 is plated with platinum to become a fine metal wire 25 having an average diameter of about 640 nm, and a fine metal wire mat 24 in which a plurality of fine metal wires 25 are laminated is produced .

Next, in step S40 of finishing the fine metal wire mat 24, the fine metal wire mat 24 is rolled so that a plurality of fine metal wires 25 are wound into a single stranded coil embolization filler material 20, .

As an experimental example, an end portion of the prepared fine metal wire mat 24 was fixed, and a fine metal wire mat 24 was twisted with a rotary drill to form a coil embolization filler material having an average diameter of 200 mu m as shown in Fig. (20) can be formed.

The filling material 20 for the coil embolization according to the experimental example made by the method as described above is formed in the form of closely packed with fine metal wires 25 having an average diameter of about 640 nm and has a surface- Of the platinum coil. Therefore, it is possible to fill the cerebral aneurysm (C) with a higher filling density even in a small amount, and it can be effectively used for embolization procedures.

The effect of such filling material 20 for coil embolization has been demonstrated through flow inhibition experiments through the experimental apparatus shown in Figs.

12 shows an experimental apparatus 500 for confirming the effect of suppressing the flow of fluid depending on the number of the coil embolization filler materials 20 through the Y-type channel 510. FIG. In order to confirm the effect of suppressing the fluid flow using the experimental apparatus 500, the fluid was flown at a constant flow rate of 1 ml per minute using a syringe pump (Legato 100, KD scientific Inc.) channel (510). Specifically, 10 ml of the fluid is flowed into the Y-type channel 510 for 10 minutes, and the two outlet channel w fibers 520 of the Y-type channel 510, depending on the number of the coil embolization filler materials 20, And the amount of fluid in the w / o fiber 530 was confirmed. Here, the outlet side channel w fiber 520 of the Y-type channel 510 is the outlet where the filling material 20 for coil embolization is placed, and the other outlet side channel w / o fiber 530 is the outlet tube for the coil embolization The outlet where the filling material 20 is not disposed.

FIG. 13 shows an experimental result using the experimental apparatus 500 shown in FIG.

The results of FIG. 13 can be summarized in the following table.

13 and the above table, it can be seen that as the number of filler materials 20 for coil embolization increases, the amount of fluid exiting the outlet channel W fiber 520 of the Y-type channel 510 decreases When the number of the coil embolization filler materials 20 is 5, the outlet channel W fiber 520 of the Y-type channel 510 is completely closed to prevent the fluid from escaping to the outlet channel W fiber 520 .

14 shows an experimental apparatus 600 for confirming the effect of suppressing the flow of fluid depending on the number of the coil embolization filler materials 20 through the L-type channel 610. As shown in FIG. In order to confirm the effect of suppressing the flow of fluid using the experimental apparatus 600 having the L-type channel 610, the effect of impeding fluid movement of the filling material 20 for the coil embolization according to different pressures was confirmed . Specifically, the filling material 20 for coil embolization was placed in the L-type channel 610, pressure was applied to the piston of the syringe using a copper plate (89.5 g / EA), and the pressure of the syringe piston (kPa) was changed while measuring the flow time of a certain amount (10 ml) of fluid flowing into the L-type channel 610. In the experiment, a coil embolization filling material 20 having various diameters was used. After the fluid discharge time according to the diameter of the filling material 20 for coil embolization was measured and the flow rate was calculated for each coil, The effects of the number of substances 20 and the diameter of the filling material 20 for coil embolization were examined.

 15 and 16 are graphs showing experimental results using the experimental apparatus shown in Fig.

15, as the diameter d _F of the coil embolization filler 20 is reduced to 500, 250 and 150 μm, the flow rate discharged through the L-type channel 610 decreases, It can be seen that the flow rate decreases as the number N of materials 20 increases. This is because as the diameter (d _F ) of the coil embolization filler material 20 is smaller, a larger amount can be filled in the L-type channel 610.

Meanwhile, FIG. 16 shows the results of comparing the effect of suppressing the fluid flow of the coil used in the conventional coil embolization and the filling material 20 for coil embolization according to the present experimental example. In this experiment, we compared the conventional coil with the filling material (20) for coil embolization with a diameter of 500 μm, which had the least effect of suppressing fluid flow in the previous experiment. 16 shows that the conventional coil (denoted by "Coil") passes about twice as much flow rate as the filling material for coil embolization according to this experimental example (denoted by "Fiber"), The excellent effect of the filling material for coil embolization 20 was confirmed.

While the present invention has been particularly shown and described with reference to exemplary embodiments thereof, it is to be understood that the invention is not limited to the disclosed exemplary embodiments. Those skilled in the art will appreciate that numerous modifications and variations can be made in the present invention without departing from the spirit and scope of the appended claims.

10, 20: filling material for coil embolization 11: metal wire
13, 21: Polymer nanofiber mat 14, 22: Polymer nanofiber
24: fine metal wire mat 25: fine metal wire
100: Manufacturing apparatus for filling substance for coil embolization
110: metal wire support 111: metal wire mount
120: radio-nano fiber spinning device 121: gas feeder
123: Pump 125: Spinning nozzle
127: gas inlet 128:
130: Flow path 131: High pressure fluid flow
132: low-pressure flow portion 133:
134: Polymer solution injection part 135: Polymer solution injection port
137: gas supply pipe 139: gas filtration filter
141: Moisture filter 142: Antibacterial filter
144: light transmitting pipe 146: polymer solution sterilizing device
147, 151: Support frame 148, 152: Ultraviolet lamp
149: Heater 150: Polymer nanofiber disinfection device
200: syringe 210: needle
300: square frame 400: platinum plate
500, 600: Experimental apparatus

Claims (21)

In a filling material for coil embolization used in coil embolization,
A metal wire of a size that can be inserted into an artery of a human body; And
And a polymer nanofiber mat comprising a plurality of polymer nanofibers and surrounding the metal wire.
The method according to claim 1,
Characterized in that the metal wire has a twisted structure in the form of a coil.
The method according to claim 1,
Wherein the metal wire is made of a metal containing platinum.
The method according to claim 1,
Wherein the polymer nanofiber composing the polymer nanofiber mat is made of a polymer material including polycaprolactone.
A metal wire support having a metal wire mount to which a metal wire of a size that can be inserted into an artery of a human body is mounted;
A gas supplier for supplying a radiant gas;
A pump for supplying the polymer solution; And
A gas inlet port through which the radiant gas supplied from the gas supplier flows, an injection port disposed toward the metal wire mounting section of the metal wire support, a flow path connecting the gas inlet port and the injection port, And a polymer solution injection port connected to an intermediate portion of the flow path for supplying a solution to the flow path, wherein the spinning gas mixed with the flow path and the polymer solution are sprayed at a high speed through the injection port, And a spinneret for spinning the polymer nanofibers toward the metal wire mounted on the mounting portion.
6. The method of claim 5,
The flow path of the spinning nozzle includes:
A high pressure fluid passage connected to the gas inlet,
A low pressure fluid passage connected to the injection port,
And a throttling portion disposed between the high-pressure flow portion and the low-pressure flow portion,
Wherein the diameter of the high-pressure flow portion gradually decreases from the gas inlet side toward the throttle portion side, and the diameter of the low-pressure flow portion gradually increases from the throttle portion toward the injection port side,
And the polymer solution injection port is connected to the middle of the low-pressure flow portion.
6. The method of claim 5,
And a polymer nanofiber sterilizer disposed between the metal wire support and the spinneret so as to irradiate ultraviolet rays onto the polymer nanofibers emitted from the injection port, characterized by further comprising an ultraviolet lamp generating ultraviolet light, Wherein the filling material for the coil embolization is made by a method comprising:
6. The method of claim 5,
A light transmissive supply pipe connecting the pump and the spinneret to supply the polymer solution from the pump to the spinneret; And
And a polymer solution sterilizing device which is disposed between the pump and the spinneret so as to irradiate ultraviolet light onto the polymer solution flowing along the light permeable supply pipe, comprising an ultraviolet lamp generating ultraviolet light, A device for manufacturing a filling material for embolization.
6. The method of claim 5,
A gas supply pipe connecting the gas supply unit and the spinning nozzle to supply a spinning gas to the spinning nozzle from the gas supply unit; And
And a gas filtration filter disposed in the middle of the gas supply pipe to filter foreign substances in the radiant gas flowing along the gas supply pipe.
(a) a spinning nozzle having a gas inlet, an injection port, a flow path connecting the gas inlet and the injection port, and a polymer solution injection port connected to the middle of the flow path, Preparing a radiofrequency nanofiber spinning device including a gas supplier for supplying a polymer solution to the polymer solution inlet and a pump for supplying a polymer solution to the polymer solution injection port;
(b) mounting a metal wire of a size that can be inserted into an artery of a human body in a metal wire support arranged to face an injection opening of the spinning nozzle; And
(c) supplying a radiant gas to the flow path of the spinning nozzle through the gas feeder, supplying a polymer solution to the flow path through the pump, and supplying the spinning gas and the polymer solution mixed in the flow path through the injection port at a high speed And spraying the polymer nanofibers to the metal wire side mounted on the metal wire support. ≪ Desc / Clms Page number 19 >
11. The method of claim 10,
In the step (c)
And irradiating ultraviolet rays to the polymer nanofibers emitted from the injection port to sterilize the polymer nanofibers by ultraviolet rays.
11. The method of claim 10,
In the step (c)
Characterized in that the polymer solution supplied from the pump is ultraviolet sterilized by irradiating ultraviolet rays to the light transmissive supply pipe while flowing the polymer solution supplied to the spinning nozzle through the light transmissive supply pipe to flow the polymer solution flowing along the light transmissive supply pipe. ≪ / RTI >
11. The method of claim 10,
In the step (c)
Wherein the polymer solution is a mixture of polycarboxylic acid and polycarboxylic acid, wherein the polymeric solution is prepared by mixing polycarboxylic acid with formalic acid and acetic acid.
11. The method of claim 10,
In the step (b)
Wherein the metal wire is twisted in a coil shape.
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