WO2023229106A1

WO2023229106A1 - Surface treatment device and surface treatment method for bioimplant medical device

Info

Publication number: WO2023229106A1
Application number: PCT/KR2022/013388
Authority: WO
Inventors: 이원오
Original assignee: 주식회사 큐브인스트루먼트
Priority date: 2022-05-27
Filing date: 2022-09-06
Publication date: 2023-11-30
Also published as: KR20230165615A

Abstract

The present invention relates to a surface treatment device and a surface treatment method for removing foreign substances from the surface of a bioimplant medical device and, more specifically, to a surface treatment device and a surface treatment method for a bioimplant medical device, in which traces of viruses and germs remaining after the sterilization or disinfection of the bioimplant medical device are removed using plasma, and carbonized layers are removed from the surface.

Description

Surface treatment device and treatment method for medical devices for bioimplantation

The present invention relates to a surface treatment device and method for removing surface foreign substances from medical devices for biological implantation, and more specifically, to removing traces of viruses and bacteria remaining after sterilization or sterilization of medical devices for biological transplantation using plasma. It relates to a surface treatment device and treatment method for medical devices for bioimplantation, which removes other organic substances including carbonized layers on the surface.

High-energy particles in the plasma state collide with the surface of various materials and transfer energy to the material surface. This plasma has the characteristic of enabling various surface treatments because various physical/chemical reactions occur when it interacts with the material surface.

For example, self-purifying surface treatment technology with antifouling function that prevents various contaminants from attaching to the surface or easily removing them, surface treatment technology that increases the bonding strength between implants and bone tissue, and miniaturization of semiconductor surface patterns for biosensors or conductive inks. Plasma surface treatment technology is being used in a variety of places, including micro-patterning technology and anti-fingerprint surface treatment technology for polymer films.

In particular, bioimplantable medical devices such as fixtures take a long time for bone fusion when implanted in the human body, so technology is needed to reduce biostabilization time or speed up treatment by removing surface impurities through a plasma treatment process during the production stage. It has been announced.

However, as time passes during production, transportation, distribution, and storage, impurities are formed on the surface of bioimplantable medical devices, making the surface change to hydrophobic over time, making it difficult to maintain biocompatibility.

To solve this problem, technology is being developed to secure biocompatibility by treating the surface of the fixture before implant surgery. Representative technologies include plasma surface treatment and ultraviolet ray irradiation to improve hydrophilicity and bone fusion efficiency.

However, in the case of medical devices inserted into the human body, a guarantee of sterility is required, but in the case of removing the sterile packaging of the fixture for plasma surface treatment or ultraviolet irradiation, and processing it externally or separating the fixture from the packaging, sterility is required. Performance is not guaranteed, and additional problems such as fixture contamination may occur.

As another example, a technology has been known to irradiate ultraviolet rays without removing the packaging by using quartz glass, which has a high ultraviolet transmittance, as a case, but the use of quartz glass causes an increase in cost.

The present invention was created to solve the above problems, and the purpose of the present invention is to remove traces of viruses and bacteria (dead viruses or bacteria) remaining after sterilization or sterilization of bioimplantable medical devices through plasma surface treatment. ) and remove other organic substances, including carbonized layers on the surface, to provide a surface treatment device and treatment method for medical devices for bioimplantation.

In addition, to protect the surface of the medical device, the present invention provides a surface treatment device and method for medical devices for bioimplantation that enable plasma surface treatment while the product is packaged.

In addition, a surface treatment device and treatment method for medical devices for bioimplants that enable plasma surface treatment at a desired location and with a desired intensity by varying the position of the electrode or controlling the position of the magnetic field through an external magnetic field generation means and control means, or by combining the two processes. In providing.

An apparatus for treating the surface of a medical device for biological implantation according to an embodiment of the present invention includes a case in which a medical device for plasma surface treatment is accommodated; a chamber portion in which the case is accommodated; an electrode unit provided in the chamber unit to charge the inside of the chamber unit by applying power; a vacuum passage formed in the case to form a vacuum inside the case, and a vacuum line provided in the chamber, one end of which is connected to a vacuum pressure forming means, and the other end of which communicates with the vacuum passage; and a gas passage formed in the case for injecting a process gas into the case, and a gas line provided in the chamber, one end of which is connected to a gas supply means, and the other end of which communicates with the gas passage.

In addition, the chamber unit includes a chamber cylinder 210 having an open upper and lower sides with a space formed therein to accommodate the inner packaging container 100; A first cover 220 that seals one side of the chamber cylinder 210 and is provided with a vacuum line 225 for forming a vacuum inside the chamber cylinder 210; and a second cover 230 that seals the other side of the chamber cylinder 210 and is provided with a gas line 235 for supplying process gas into the chamber cylinder 210.

In addition, the first cover 220 is configured to fix and support the upper side of the inner packaging container 100 through the bottom when coupled to the chamber cylinder 210, and the second cover 230 is coupled to the chamber cylinder 210. It is configured to fix and support the lower side of the inner packaging container 100 through the upper end.

In addition, the electrode unit may be a first electrode provided in a ring shape along the circumference of the first cover, or a second electrode provided in a ring shape along the circumference of the chamber cylinder 210, or the first electrode. It includes both an electrode and a second electrode.

In addition, a plurality of second electrodes are arranged to be spaced apart along the vertical direction of the chamber cylinder 210, and each second electrode 320 is configured to enable power on/off switching individually.

In addition, the case includes a case cylinder 110 with an open upper and lower side and a space formed therein to accommodate and fix the medical device S; A first case cover 120 that seals one side of the case cylinder 110 and has a vacuum passage 125 for forming a vacuum inside the case cylinder 110; It includes a second case cover 130 that seals the other side of the case cylinder 110 and has a gas passage 135 for supplying process gas into the case cylinder 110, and the vacuum passage 125 is The lower end of the first cover 220 is in close contact with the upper side of the inner packaging container 100 and communicates with the vacuum line 225 when the upper side of the inner packaging container 100 is fixed, and the gas flow path 135 is connected to the second cover. The lower end of 220 is in close contact with the lower side of the inner packaging container 100 and communicates with the gas line 235 when the lower side of the inner packaging container 100 is fixed.

In addition, the surface treatment device includes a magnetic field generator 500 for generating a magnetic field around the chamber 200 and controlling the magnetic flux around the chamber 200 to vary the plasma density at a specific location inside the chamber 200. ) includes.

In addition, the magnetic field generator 500 is formed in a ring shape with a predetermined thickness, and has an inner diameter larger than the outer diameter of the chamber 200, so that it forms a radial direction between the chamber 200 and the magnetic field generator 500. It is configured to form a separation space along the magnetic field generator 500, and is provided with a first moving means to be able to move along the longitudinal direction of the chamber 200 to increase the plasma density in the vertical direction of the inner packaging container 100. It is configured to be variable.

In addition, the magnetic field generator 500 is configured to rotate through a second moving means that rotates along the circumferential direction with respect to the center of the chamber 200, and the center of the magnetic field generator 500 and the The centers of the second moving means are configured to be spaced apart so that the magnetic field generator 500 rotates eccentrically.

The surface treatment method using a surface treatment device for medical device for biological implantation according to an embodiment of the present invention includes the medical device installation step of installing the inner packaging container 100 in which the medical device (S) is packaged in the chamber 200 ( S10); The chamber 200 is sealed through the first or

second covers

220 and 230, and a vacuum is applied inside the chamber 200 and the inner packaging container 100 through the vacuum line 225 and the vacuum passage 125. forming a vacuum (S20); A gas injection step (S30) of injecting a process gas into the chamber 200 and the inner packaging container 100 through the gas line 235 and the gas flow path 135; A surface treatment step (S40) of generating plasma by applying power to the first electrode and the second electrode; Turning off the power to stop plasma generation (S50); releasing the vacuum inside the chamber 200 (S60); and a step (S70) of opening the chamber portion 200 to retrieve the medical device S accommodated in the inner packaging container 100.

In addition, the surface treatment step (S40) changes the process pressure or type by varying the vacuum level inside the chamber 400 and adjusting the input amount of process gas, adjusting the power supply voltage for plasma generation, and adjusting the power frequency and shape of the electrode. It further includes a plasma density variable step (S45) of controlling the plasma density by adjusting and varying the magnetic flux around the chamber 400.

The surface treatment device and treatment method for a medical device for biological implantation of the present invention according to the above configuration have the effect of reducing the biostabilization time and speeding up the treatment speed when implanting a medical device into a living body according to plasma treatment of the medical device for biological implantation. There is.

In addition, plasma surface treatment is possible while the product is packaged, which has the effect of preventing direct contact with external contamination or damage to the specially treated implant surface.

In addition, it is effective in preventing inflammation of the skin, blood, or bone tissue when implanting a medical device into a living body by removing dead bodies of viruses or bacteria remaining on the surface during the pretreatment and sterilization process of medical devices, or entotoxins and other organic substances generated during the process. .

In addition, plasma surface treatment can be performed at a desired intensity at a desired location on the product, which has the effect of improving surface treatment quality as the surface treatment uniformity of products with various shapes is improved.

1 is a front view of a surface treatment device for medical devices for biological implantation according to an embodiment of the present invention.

Figure 2 is a projected cross-sectional view of a surface treatment device for medical devices for living implants according to an embodiment of the present invention.

3 is a power connection diagram of an electrode according to an embodiment of the present invention.

Figure 4 is a cross-sectional view of a packaging case according to an embodiment of the present invention.

Figure 5 is a plan view of the magnetic field generator according to an embodiment of the present invention.

Figures 6 and 7 are plan schematic diagrams showing the operating principle of the magnetic field generator according to an embodiment of the present invention.

1000: Medical device surface treatment device for bioimplantation

100: case

110: case cylinder

120: 1st case cover

125: Vacuum passage

130: 2nd case cover

135: Gas flow path

200: Chamber part

210: Chamber cylinder

220: first cover

225: Vacuum line

230: second cover

235: gas line

310: first electrode

320: second electrode

500: Magnetic field generator

S: Medical device

Hereinafter, an embodiment of the present invention described above will be described in detail with reference to the drawings.

Figure 1 shows a front view of a surface treatment apparatus 1000 (hereinafter referred to as “processing apparatus”) for a medical device for biological implantation according to an embodiment of the present invention. As shown, the processing device 1000 accommodates a medical device for plasma processing and includes an inner packaging container 100 to prevent external contamination or surface damage to the medical device during transportation, distribution, and storage of the medical device, and an inner packaging container 100 A chamber unit 200 for accommodating the packaging container 100 and forming a vacuum inside the packaging container 100, supplying process gas, and generating plasma by charging the interior of the packaging container 100, and a chamber. It is provided on the outside of the unit 200 and includes a magnetic field generator 500 that generates a magnetic field and adjusts the plasma density by controlling the magnetic flux. The inner packaging container 100 may have ventilation holes formed at both ends so that process gas is introduced, organic matter and impurities on the surface of the medical device are separated in a plasma state, and discharged through an exhaust or vacuum line.

Figure 2 shows a projected cross-sectional view of a processing device 1000 according to an embodiment of the present invention. As shown, the chamber part 200 has a space formed inside to accommodate the inner packaging container 100, a chamber cylinder 210 with open upper and lower sides, and one side of the chamber cylinder 210 is sealed to form a chamber. A first cover 220 equipped with a vacuum line 225 for forming a vacuum inside the cylinder 210, sealing the other side of the chamber cylinder 210, and supplying process gas into the chamber cylinder 210. It is configured to include a second cover 230 provided with a gas line 235. In the drawing, the vacuum line 225 is shown as being provided on the first cover 220, and the gas line 235 is shown as being provided on the second cover 230. However, the vacuum line 225 is provided on the second cover 230. and the gas line 235 may be provided on the second cover 230. The first cover 220 is configured to fix and support the upper side of the inner packaging container 100 through the bottom when coupled to the chamber cylinder 210, and the second cover 230 is configured to secure and support the upper side of the inner packaging container 100 when coupled to the chamber cylinder 210. It is configured to fix and support the lower side of the inner packaging container 100.

In addition, the processing device 1000 includes a first electrode 310 provided along the circumference of the first cover 220 to charge the inside of the inner packaging container 100, and an electrode 310 formed along the circumference of the chamber cylinder 210. Includes 2 electrodes 320. At this time, the second electrode 320 is formed in a ring shape surrounding the circumferential circumference of the chamber cylinder 210, and a plurality of second electrodes 320 may be spaced apart along the vertical direction of the chamber cylinder 210. Additionally, each second electrode 320 is configured to enable power on/off switching individually, so that the plasma surface treatment range can be determined according to the size or shape of the medical device.

Figure 3 shows a power connection diagram of a plurality of

second electrodes

321, 322, 323, and 324 according to an embodiment of the present invention.

As shown, a plurality of

second electrodes

321, 322, 323, and 324 are connected in parallel, and each of the

second electrodes

321, 322, 323, and 324 has a switch S1, S2, S3, and S4, respectively. It can be provided. Therefore, it is configured to independently control the on and off of each switch (S1, S2, S3, and S4) to determine the plasma surface treatment range according to the size or shape of the medical device.

Figure 4 shows a cross-sectional view of an inner packaging container 100 for packaging according to an embodiment of the present invention. As shown, the inner packaging container 100 has a space formed inside to accommodate and fix the medical device (S), a case cylinder 110 with the upper and lower sides open, and one side of the case cylinder 110 sealed. The first case cover 120, which has a vacuum passage 125 for forming a vacuum inside the case cylinder 110, and the other side of the case cylinder 110 are sealed, and process gas is supplied into the case cylinder 110. It is configured to include a second case cover 130 on which a gas flow path 135 is formed. In the drawing, the vacuum passage 125 is shown as being provided in the first case cover 120, and the gas passage 135 is shown as being provided in the second case cover 130. However, the vacuum line 225 and the gas line 235 ) Depending on the arrangement, the vacuum passage 125 may be provided in the second case cover 130, and the gas passage 135 may be provided in the second case cover 130. The vacuum passage 125 is in close contact with the upper side of the inner packaging container 100 at the lower end of the first cover 220 and communicates with the vacuum line 225 when the upper side of the inner packaging container 100 is fixed, and the gas passage 135 is The lower end of the second cover 220 is configured to be in close contact with the lower side of the inner packaging container 100 and communicate with the gas line 235 when the lower side of the inner packaging container 100 is fixed.

The first case cover 120 is configured to fix and support the upper side of the medical device (S) through the bottom when coupled to the case cylinder 110, and the second case cover 130 is configured to secure and support the upper side of the medical device (S) when coupled to the case cylinder 110. It is configured to fix and support the lower side of the medical device (S) through the top.

Figure 5 shows a plan view of the magnetic field generator 500 according to an embodiment of the present invention, and Figures 6 and 7 show the operating principle of the magnetic field generator 500 according to an embodiment of the present invention. A plan schematic diagram is shown.

The magnetic field generator 500 is provided to generate a magnetic field around the chamber 200 and control the magnetic flux around the chamber 200 to vary the plasma density at a specific location inside the chamber 200. Therefore, the magnetic field generator 500 may be a magnet or a solenoid. In addition, the magnetic field generator 500 is formed in a ring shape with a predetermined thickness, and the inner diameter is formed to be larger than the outer diameter of the chamber 200, so that a space is formed along the radial direction between the chamber 200 and the magnetic field generator 500. It is configured to form this. In addition, the magnetic field generator 500 is provided with a first moving means (not shown) so as to be movable along the longitudinal direction of the chamber 200, and is configured to vary the plasma density in the vertical direction of the inner packaging container 100. . In addition, the magnetic field generator 500 is configured to rotate through the second moving means 550 so as to be able to rotate along the circumferential direction with respect to the center of the chamber 200.

At this time, the second moving means 550 is formed in a ring shape, accommodates the chamber 200 in the center, and is configured to rotate around the center (X1), which is the same as the center of the chamber 200. The magnetic field generator 500 may be fixed to the second moving means 550, and its center (X2) may be arranged at a predetermined distance from the center (X1) of the second moving means (550).

That is, the center (X2) of the magnetic field generator 500 and the center (X1) of the second moving means 550 are configured to be spaced apart so that the magnetic field generator 500 rotates eccentrically. Accordingly, when the magnetic field generator 500 rotates eccentrically, the point at which the inner diameter of the magnetic field generator 500 and the outer diameter of the chamber 200 are closest are configured to vary along the circumferential direction of the chamber 200. That is, as shown in FIG. 6, point A of the chamber 200 approaches the magnetic field generator 500 due to the eccentric rotation of the magnetic field generator 500, thereby increasing the plasma density at point A, and as shown in FIG. 7 As shown, point B of the chamber 200 may be configured to be close to the magnetic field generator 500 to increase the plasma density at point B.

As it is configured to increase the plasma density at a specific location inside the inner packaging container 100 through the magnetic field generator 500 and the first and second moving means as described above, the surface treatment uniformity of medical devices having various shapes is improved. This has the effect of improving the quality of plasma surface treatment of medical devices.

Hereinafter, a method of treating the surface of a medical device for biological implantation using the processing device 1000 according to an embodiment of the present invention configured as described above will be described.

First, a medical device installation step (S10) is performed in which the inner packaging container 100 in which the medical device (S) is packaged is installed in the chamber 200.

Next, the chamber 200 is sealed through the first or

second covers

220 and 230, and a vacuum is applied inside the chamber 200 and the inner packaging container 100 through the vacuum line 225 and the vacuum passage 125. A vacuum forming step (S20) is performed to form a .

Next, after confirming that the set vacuum degree is reached, a gas injection step (S30) is performed in which process gas is injected into the chamber 200 and the inner packaging container 100 through the gas line 235 and the gas flow path 135. .

Next, a surface treatment step (S40) is performed in which plasma is generated by applying power to the first electrode and the second electrode while maintaining the process gas vacuum. The surface treatment step (S40) is a process of removing impurities such as hydrocarbons and other organic substances from the surface of the medical device, a process of making the surface of the medical device hydrophilic by cleaning the surface so that bone bonding can proceed quickly when transplanting a living body, and a process of making the surface of the medical device hydrophilic when transplanting a living body. A process can be performed to remove entotoxins that can cause exothermic reactions.

During the surface treatment step (S40), the vacuum level inside the chamber 400 is changed, the process pressure or type is changed by adjusting the input amount of process gas, the power supply voltage for plasma generation is adjusted, the power frequency and the shape of the electrode are adjusted, and the chamber 400 is adjusted. (400) A plasma density variable step (S45) of controlling the plasma density by varying the surrounding magnetic flux, etc. may be performed.

Next, turn off the power to stop plasma generation (S50), release the vacuum inside the chamber 200 (S60), and open the chamber 200 (70) to remove the inner packaging container 100. ) and complete the process by recovering the medical device (S) contained in it.

The technical idea of the present invention should not be interpreted as limited to the above-described embodiments. Not only is the scope of application diverse, but various modifications can be made at the level of those skilled in the art without departing from the gist of the present invention as claimed in the claims. Therefore, such improvements and changes fall within the scope of protection of the present invention as long as they are obvious to those skilled in the art.

Claims

Case housing medical devices for plasma surface treatment;

a chamber portion in which the case is accommodated;

an electrode unit provided in the chamber unit to charge the inside of the chamber unit by applying power;

a vacuum passage formed in the case to form a vacuum inside the case, and a vacuum line provided in the chamber, one end of which is connected to a vacuum pressure forming means, and the other end of which communicates with the vacuum passage; and

a gas passage formed in the case for injecting a process gas into the case, and a gas line provided in the chamber, one end of which is connected to a gas supply means, and the other end of which communicates with the gas passage;

A medical device surface treatment device for bioimplantation, including a.
According to clause 1,

The chamber part,

A chamber cylinder 210 having a space inside to accommodate the inner packaging container 100 and having open upper and lower sides;

A first cover 220 that seals one side of the chamber cylinder 210 and is provided with a vacuum line 225 for forming a vacuum inside the chamber cylinder 210; and

A second cover 230 that seals the other side of the chamber cylinder 210 and is provided with a gas line 235 for supplying process gas into the chamber cylinder 210;

A medical device surface treatment device for bioimplantation, including a.
According to clause 2,

The first cover 220 is configured to fix and support the upper side of the inner packaging container 100 through the bottom when coupled to the chamber cylinder 210, and the second cover 230 is configured to secure and support the upper side of the inner packaging container 100 when coupled to the chamber cylinder 210. A surface treatment device for a medical device for bioimplantation, configured to fix and support the lower side of the inner packaging container 100 through.
According to clause 2,

The electrode part,

A first electrode provided in a ring shape along the circumference of the first cover,

Alternatively, a second electrode provided in a ring shape along the circumferential circumference of the chamber cylinder 210,

Or a surface treatment device for a medical device for biological implantation, comprising both the first electrode and the second electrode.
According to clause 4,

The second electrode is,

A plurality of pieces are spaced apart along the vertical direction of the chamber cylinder 210,

Each second electrode 320 is configured to individually switch power on and off. A medical device surface treatment device for biological implantation.
According to clause 2,

In the above case,

A case cylinder (110) with an open upper and lower side and a space formed therein to accommodate and fix the medical device (S);

A first case cover 120 that seals one side of the case cylinder 110 and has a vacuum passage 125 for forming a vacuum inside the case cylinder 110;

It seals the other side of the case cylinder 110 and includes a second case cover 130 with a gas flow path 135 for supplying process gas into the case cylinder 110,

The vacuum flow path 125 is in close contact with the upper side of the inner packaging container 100 at the lower end of the first cover 220 and communicates with the vacuum line 225 when the upper side of the inner packaging container 100 is fixed, and the gas flow path ( 135) is a surface treatment device for medical devices for living implants, wherein the lower end of the second cover 220 is in close contact with the lower side of the inner packaging container 100 and communicates with the gas line 235 when the lower side of the inner packaging container 100 is fixed. .
According to clause 1,

The surface treatment device,

For bioimplantation, including a magnetic field generator 500 for generating a magnetic field around the chamber 200 and controlling the magnetic flux around the chamber 200 to vary the plasma density at a specific location inside the chamber 200. Medical device surface treatment device.
According to clause 7,

The magnetic field generator 500,

It is formed in a ring shape with a predetermined thickness, and the inner diameter is formed to be larger than the outer diameter of the chamber 200 so that a separation space is formed along the radial direction between the chamber 200 and the magnetic field generator 500,

The magnetic field generator 500,

A surface treatment device for a medical device for bioimplantation, comprising a first moving means capable of moving along the longitudinal direction of the chamber 200 and configured to vary the plasma density in the vertical direction of the inner packaging container 100.
According to clause 8,

The magnetic field generator 500,

It is configured to rotate through a second moving means that rotates along the circumferential direction based on the center of the chamber 200, and is configured so that the center of the magnetic field generator 500 and the center of the second moving means are spaced apart. A surface treatment device for a medical device for bioimplantation, wherein the magnetic field generator 500 is configured to rotate eccentrically.
In the surface treatment method using the surface treatment device for bioimplantable medical devices according to claims 1 to 9,

A medical device installation step (S10) of installing the inner packaging container 100 in which the medical device (S) is packaged into the chamber 200;

The chamber 200 is sealed through the first or second covers 220 and 230, and a vacuum is applied inside the chamber 200 and the inner packaging container 100 through the vacuum line 225 and the vacuum passage 125. Vacuum forming step (S20);

A gas injection step (S30) of injecting a process gas into the chamber 200 and the inner packaging container 100 through the gas line 235 and the gas flow path 135;

A surface treatment step (S40) of generating plasma by applying power to the first electrode and the second electrode;

Turning off the power to stop plasma generation (S50);

releasing the vacuum inside the chamber 200 (S60); and

Retrieving the medical device (S) accommodated in the inner packaging container (100) by opening the chamber portion (200) (S70);

Including, a surface treatment method.
According to clause 10,

The surface treatment step (S40) is,

Change the vacuum level inside the chamber 400, change the process pressure or type by adjusting the input amount of process gas, adjust the power supply voltage for plasma generation, adjust the power frequency and shape of the electrode, and change the magnetic flux around the chamber 400. A surface treatment method further comprising a plasma density variable step (S45) of controlling the plasma density through, etc.