Manufacturing method of multi-lumen catheters
The method of supplying carbon plasma to multi-lumen catheters within a decompression chamber simplifies the formation of DLC films on both inner and outer surfaces, addressing the complexity of existing methods and enhancing catheter safety by reducing thrombosis and infection risks.
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- KAKE EDUCATIONAL INSTITUTION
- Filing Date
- 2022-06-27
- Publication Date
- 2026-07-03
AI Technical Summary
Existing methods for forming diamond-like carbon (DLC) films on the inner surfaces of multi-lumen catheters are complex and impractical due to the need for moving electrodes or tubes within narrow lumens, and assembling DLC-coated components increases manufacturing complexity.
A method involving supplying carbon plasma to each lumen of a multi-lumen catheter within a decompression chamber using a plasma generation unit with spaced electrodes, allowing simultaneous formation of DLC films on both inner and outer surfaces, facilitated by a plasma branching unit.
Enables easy and simplified manufacturing of multi-lumen catheters with DLC films, reducing the risk of thrombosis and infections by forming the films simultaneously within the lumens, thus simplifying the manufacturing process.
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Abstract
Description
Technical Field
[0001] The present disclosure relates to a method for manufacturing a multi-lumen catheter, and particularly to a method for manufacturing a multi-lumen catheter coated with a diamond-like carbon film, an apparatus for manufacturing the same, and a multi-lumen catheter.
Background Art
[0002] Various catheters are used for purposes such as blood access, infusion or drug administration into blood vessels, and monitoring of hemodynamics. Since a catheter is placed in a blood vessel, it has risks of causing various complications such as thrombosis and infectious diseases. The possibility of causing complications depends on the environment and technique, but also varies depending on the characteristics of the catheter. In order to reduce the risk of complications, various coatings for catheters have been studied. For example, hydrophilic coating or coating with an antithrombotic agent has been studied to reduce the occurrence of thrombosis. In addition, antibacterial coating has also been studied for preventing infectious diseases.
[0003] A diamond-like carbon (DLC) film is expected as a coating material that can achieve both effects of preventing thrombosis and infectious diseases. If a catheter is formed of a material coated with a DLC film, there is a possibility of reducing the risk of occurrence of thrombosis and infectious diseases.
[0004] As a method for coating a DLC film on the surface of a material, a plasma coating method using carbon plasma is known. In the case of a film-forming apparatus using ordinary parallel plate electrodes, it is practically impossible to form a DLC film on the inner surface of a long tube such as a catheter. As a method for forming a DLC film on the inner surface of a long tube, methods such as forming a film while moving an electrode along the tube or inserting an electrode into the tube to generate plasma in the tube have been studied (see, for example, Patent Documents 1 and 2).
Prior Art Documents
Patent Documents
[0005] [Patent Document 1] Japanese Patent Publication No. 2011-233345 [Patent Document 2] Japanese Patent Publication No. 2018-145478 [Overview of the Initiative] [Problems that the invention aims to solve]
[0006] However, a film deposition method that involves moving the electrode requires a mechanism to move the electrode within the chamber, making the apparatus extremely complex. It is also conceivable to move the tube instead of the electrode, but moving it while passing gas through a narrow tube is not easy.
[0007] Furthermore, most catheters placed in blood vessels are multi-lumen catheters, which have multiple lumens. In a multi-lumen catheter, the inside of the tubular cavity is divided into several independent lumens. Forming DLC (Diamond-Likely Carbon Fiber) films on the inner surfaces of multiple independent, thin lumens using conventional methods of inserting electrodes into a tube is extremely difficult, and practically impossible considering the inner diameter of the lumens.
[0008] Furthermore, a multi-lumen catheter is formed not only from the main body with multiple lumens, but also from multiple components such as branch tubes connected to each lumen, hubs connecting the lumens and branch tubes, and connectors provided on the branch tubes. While it is possible to form a DLC coating on all of these components before assembling the multi-lumen catheter, this is not practical due to the increased manufacturing process. Moreover, attempting to form a DLC coating on both the inner and outer surfaces of the multi-lumen catheter would further increase the number of steps involved.
[0009] The objective of this disclosure is to enable the easy manufacture of multi-lumen catheters coated with a diamond-like carbon film. [Means for solving the problem]
[0010] One embodiment of the method for manufacturing a multi-lumen catheter according to the present disclosure comprises the step of supplying carbon plasma to each of the multiple lumens of a multi-lumen catheter in a decompression chamber to form a diamond-like carbon film on the inner and outer surfaces of the multi-lumen catheter. The carbon plasma is generated in a plasma generation unit having a discharge electrode and a counter electrode arranged spaced apart from each other, a cylindrical generation unit body into which the discharge electrode is inserted from a first end, and a gas supply unit that supplies a raw material gas containing hydrocarbons into the generation unit body from the first end. The carbon plasma generated in the plasma generation unit is supplied to each of the multiple lumens via a plasma branching unit.
[0011] According to one embodiment of a method for manufacturing a multi-lumen catheter, carbon plasma is supplied to each of the multiple lumens of the multi-lumen catheter to form a diamond-like carbon film on the inner and outer surfaces of the multi-lumen catheter. Therefore, a multi-lumen catheter coated with a diamond-like carbon film can be manufactured much more easily than by forming the film on individual components and then assembling them. Furthermore, since the diamond-like carbon film can be formed simultaneously within the lumens of multiple thin catheters, the manufacturing process can be significantly simplified.
[0012] In one embodiment of a method for manufacturing a multi-lumen catheter, the multi-lumen catheter may have a catheter body having a plurality of lumens, a plurality of connecting tubes connected to each of the plurality of lumens, and a connecting hub that connects the plurality of connecting tubes to the catheter body.
[0013] In one embodiment of a method for manufacturing a multi-lumen catheter, an AC bias can be intermittently applied between the discharge electrode and the counter electrode.
[0014] One embodiment of a multi-lumen catheter manufacturing apparatus comprises a decompression chamber for housing a multi-lumen catheter having multiple lumens, a plasma generation unit disposed within the decompression chamber, and a plasma branching unit for branching the plasma generated in the plasma generation unit. The plasma generation unit includes a discharge electrode and a counter electrode spaced apart from each other, a cylindrical generation unit body into which the discharge electrode is inserted from a first end, and a gas supply unit for supplying a raw material gas containing hydrocarbons into the generation unit body from the first end. The plasma branching unit hermetically connects a second end of the generation unit body to each of the multiple lumens, and supplies carbon plasma generated in the plasma generation unit to each of the multiple lumens via the plasma branching unit to form a diamond-like carbon film on the inner and outer surfaces of the multi-lumen catheter.
[0015] According to one embodiment of a multi-lumen catheter manufacturing apparatus, carbon plasma generated in a plasma generation unit is supplied to each of the multiple lumens via a plasma branching unit. Therefore, a multi-lumen catheter in which each of the multiple lumens is coated with a diamond-like carbon film can be easily manufactured.
[0016] One embodiment of the multi-lumen catheter of the present disclosure comprises a catheter body having a plurality of lumens, a plurality of connecting tubes connected to each of the plurality of lumens, and a connecting hub connecting the plurality of connecting tubes to the catheter body, wherein at least one of the catheter body, connecting tubes and connecting hub has a portion fitted onto another member, and the inner surfaces of the catheter body, connecting tubes and connecting hub are formed of a diamond-like carbon film except for the portion fitted onto the other member. [Effects of the Invention]
[0017] According to the method for manufacturing a multi-lumen catheter of this disclosure, a multi-lumen catheter coated with a diamond-like carbon film can be easily manufactured. [Brief explanation of the drawing]
[0018] [Figure 1] It is a perspective view showing a multi-lumen catheter according to an embodiment. [Figure 2] It is a cross-sectional view taken along line II-II of FIG. 1. [Figure 3] It is a cross-sectional view showing a part of the connection hub. [Figure 4] It is a cross-sectional view showing an enlarged view of the first tube connection part. [Figure 5] It is a cross-sectional view showing an enlarged view of the base end part of the first connection tube. [Figure 6] It is a view showing an example of a film forming apparatus.
MODE FOR CARRYING OUT THE INVENTION
[0019] As shown in FIG. 1, the multi-lumen catheter 100 of the present embodiment includes a catheter body 101, a connection hub 102 attached to the proximal end of the catheter body 101, and a first connection tube 131 and a second connection tube 132 extending from the connection hub 102 toward the proximal end side. In the multi-lumen catheter 100 of the present embodiment, a diamond-like carbon (DLC) film is formed on the inner surface and the outer surface of the exposed portion. Here, the side inserted into the patient's body is the distal end side, and the opposite side is the proximal end side.
[0020] As shown in FIG. 2, the catheter body 101 has a first lumen 111 and a second lumen 112. A DLC film 151 is formed on the outer surface of the catheter body 101 and the inner surfaces of the first lumen 111 and the second lumen 112. Although an example is shown in which the cross-sectional shapes of both the first lumen 111 and the second lumen 112 are semi-circular, the cross-sectional shape of each lumen may be any shape such as circular, elliptical, crescent-shaped, etc. Also, the cross-sectional shape of the first lumen 111 and the cross-sectional shape of the second lumen 112 may be different. Although an example is shown in which the cross-sectional areas of the first lumen 111 and the second lumen 112 are substantially equal, the cross-sectional areas of the lumens may be different.
[0021] As shown in Figure 3, the tip end of the connecting hub 102 has a tip-side connecting portion 125 into which the catheter body 101 is inserted, and the proximal end has a first tube connecting portion 127 into which the first connecting tube 131 is inserted and a second tube connecting portion 128 into which the second connecting tube 132 is inserted. Inside the connecting hub 102, there is a first fluid passage 121 connecting the first tube connecting portion 127 and the tip-side connecting portion 125, and a second fluid passage 122 connecting the second tube connecting portion 128 and the tip-side connecting portion 125.
[0022] The tips of the first fluid passage 121 and the second fluid passage 122 are liquid-tightly connected to the first lumen 111 and the second lumen 112 of the catheter body 101 inserted into the tip-side connecting portion 125, respectively. Therefore, the first lumen 111 communicates with the first connecting tube 131 connected to the first tube connecting portion 127, and the second lumen 112 communicates with the second connecting tube 132 connected to the second tube connecting portion 128.
[0023] As shown in Figure 4, a DLC film 151 is formed on the outer surface of the connecting hub 102 and the inner surface of the first fluid passage 121. The same applies to the inner surface of the second fluid passage 122. The DLC film 151 is not formed on the inner surface of the first tube connecting portion 127 which is fitted onto the first connecting tube 131. The same applies to the inner surface of the tip-side connecting portion 125 which is fitted onto the catheter body 101 and the inner surface of the second tube connecting portion 128 which is fitted onto the second connecting tube 132.
[0024] Furthermore, the DLC film 151 is formed on the outer and inner surfaces of the portion of the first connecting tube 131 that is not fitted into the first tube connecting portion 127, but the DLC film 151 is not formed on the outer surface of the portion of the first connecting tube 131 that is fitted into the first tube connecting portion 127. The same applies to the catheter body 101 fitted into the tip-side connecting portion 125 and the second connecting tube 132 fitted into the second tube connecting portion 128.
[0025] A first connector 133 is connected to the base end of the first connecting tube 131, which is connected to the first tube connecting portion 127, and a second connector 134 is connected to the base end of the second connecting tube 132, which is connected to the second tube connecting portion 128. Clamps 135 are also attached to the first connecting tube 131 and the second connecting tube 132, respectively.
[0026] As shown in Figure 5, the tip of the first connector 133 is fitted into the base end of the first connecting tube 131, and the DLC film 151 is not formed on the portion of the inner surface of the first connecting tube 131 that is fitted onto the first connector 133. The same applies to the second connecting tube 132. It is also possible to configure the connector to be fitted onto the connecting tube. In this case, the DLC film is not formed on the portion of the outer surface of the connecting tube that is fitted onto the connector.
[0027] Figure 5 shows an example where the DLC film 151 is not formed on the base end side of the inner surface of the first connector 133. However, depending on the method of forming the DLC film 151, the DLC film 151 may be formed on the entire inner surface of the first connector 133, or there may be a portion on the base end side of the outer surface of the first connector 133 where the DLC film 151 is not formed. The same applies to the first connector 134.
[0028] Furthermore, the connection tube can be configured without a connector attached to its base end. Also, the connection tube can be configured without a clamp 135 attached.
[0029] In the multi-lumen catheter of this embodiment, the DLC film 151 is not formed on the inner surface of the portion fitted to another component or on the outer surface of the portion fitted to another component. On the other hand, the DLC film 151 is formed on the outer surface and inner surface that are exposed and not covered by other components. From the viewpoint of reducing the risk of thrombosis and infection, the film thickness of the DLC film 151 is preferably 10 nm or more, more preferably 30 nm or more. From the viewpoint of ease of film formation and prevention of peeling, the film thickness is preferably 300 nm or less, more preferably 100 nm or less. Furthermore, it is preferable that the film thickness on the inner surface, where thrombosis is more likely to occur, is thicker than the film thickness on the outer surface.
[0030] The multi-lumen catheter 100 with DLC films formed on its inner and outer surfaces according to this embodiment can be formed by assembling a catheter without a DLC film using a conventional method to create a catheter assembly, and then forming DLC films on its inner and outer surfaces. The formation of DLC films on the inner and outer surfaces of the catheter assembly can be carried out using a film deposition apparatus 200 as described below.
[0031] As shown in Figure 6, the film deposition apparatus 200 has a chamber 201 inside which a catheter assembly 100A, which is the object to be deposited, is housed. The chamber 201 has a vacuum exhaust unit 202 for reducing the pressure inside the chamber, a plasma generation unit 203, and a gas supply unit 205 for supplying gas.
[0032] In this embodiment, the vacuum exhaust unit 202 includes a vacuum pump 222 and a valve 223. The vacuum exhaust unit 202 may have any configuration as long as it can control the pressure inside the chamber to a predetermined value. In this embodiment, the gas supply unit 205 includes a plurality of cylinders 251, a flow path switching unit 252 for switching between the cylinders 251, and a mass flow controller 253. The gas supply unit 205 may have any configuration as long as it can supply the necessary gas to the plasma generation unit 203.
[0033] The plasma generation unit 203 comprises a cylindrical generation unit body 235, a discharge electrode 231 and a counter electrode, and a power supply unit 233. The discharge electrode 231 is inserted into the first end of the cylindrical generation unit body 235. A gas nozzle 236, connected to the gas supply unit 205, is connected to the first end of the generation unit body 235. The power supply unit 233 has a voltage generator 237 and an amplifier 238, and applies an AC voltage between the discharge electrode 231 and the counter electrode. The counter electrode is a ground electrode and is located on the inner wall of the chamber 201.
[0034] By applying a voltage to the electrodes while the chamber 201 is under reduced pressure, the gas supplied from the gas nozzle 236 can be converted into plasma within the generation unit body 235. The plasma generated within the generation unit body 235 moves to the second end of the generation unit body 235 by riding on the gas flow. A plasma branching section 204, which is a Y-shaped tube, is connected to the second end of the generation unit body 235. At the plasma branching section 204, the gas flow is distributed in two directions, so the plasma can be branched.
[0035] The plasma branched at the plasma branching section 204 passes through the first lumen and the second lumen of the catheter assembly 100A, respectively. This forms a DLC film on the inner surface of the catheter assembly 100A. The plasma-generated raw material gas that has passed through the catheter assembly 100A flows out from the tip and diffuses into the chamber 201. This also forms a DLC film on the outer surface of the catheter assembly 100A.
[0036] When forming a DLC film, it is preferable to first perform bombardment cleaning of the catheter assembly 100A using argon gas plasma. In bombardment cleaning, argon gas is supplied to the plasma generation unit 203 by the gas supply unit 205 to generate argon plasma. In bombardment cleaning, the flow rate of argon gas is adjusted to approximately 50 sccm to 200 sccm, and the pressure in the chamber 201 is approximately 5 Pa to 200 Pa. It is preferable to perform bombardment cleaning for approximately 1 second to 5 minutes. By performing bombardment cleaning, a DLC film can be formed more uniformly on the surface of the catheter assembly 100A. Note that bombardment cleaning may be performed as needed, but is not required.
[0037] After bombardment cleaning, the gas supplied by the gas supply unit 205 is switched to a raw material gas containing hydrocarbons to generate a carbon plasma and deposit a DLC film. When switching gases, the chamber 201 is temporarily emptied to 1 × 10⁻¹⁰⁻¹ -3 Pa~5×10 -3 It is preferable to reduce the pressure to approximately Pa.
[0038] The raw material gas can be a hydrocarbon gas such as methane, ethane, propane, butane, ethylene, acetylene, and benzene, which are commonly used in conventional CVD methods, with methane being preferred from a handling standpoint. Alternatively, the raw material gas can be a vaporized organosilicon compound such as tetramethylsilane or an oxygen-containing organosilicon compound such as hexamethyldisiloxane. The raw material gas can be supplied diluted with an inert gas such as argon, neon, and helium as needed, with argon being preferred from a handling standpoint. When diluting, the ratio of hydrocarbon to inert gas is preferably around 10:1 to 10:5.
[0039] When forming a DLC film, it is preferable to adjust the supply rate of the raw material gas to about 50 sccm to 200 sccm and the pressure in the chamber 201 to about 5 Pa to 200 Pa. From the viewpoint of avoiding damage to the discharge electrode 231 and temperature rise, it is preferable to set the applied voltage to the electrode to 10 kV or less. The voltage applied to the electrode is preferably an AC voltage with a frequency of about 1 kHz to 50 kHz. From the viewpoint of suppressing temperature rise, it is more preferable to apply the AC voltage as an intermittently pulsed voltage. If the AC is a burst wave, it is preferable to set the pulse repetition frequency to about 3 pps to 50 pps. If you want to increase the film deposition rate, you should increase the pulse repetition frequency, and if you want to suppress the temperature rise, you should decrease the pulse repetition frequency.
[0040] To stabilize the discharge and obtain good adhesion of the DLC film, it is preferable to apply an offset negative voltage to the discharge electrode 231. The offset voltage can be approximately 0kV to 3kV.
[0041] To coat the surface of the catheter assembly 100A with DLC, it is preferable to set the total deposition time to approximately 5 to 60 minutes. From the viewpoint of suppressing temperature rise, it is preferable to perform intermittent deposition separately from setting the pulse repetition frequency. In this case, it is preferable to adjust the total deposition time by repeating a cycle of deposition for about 10 minutes followed by a rest for about 5 minutes.
[0042] The length of the generation unit body 235 of the plasma generation unit 203 is not particularly limited, but from the viewpoint of inserting the discharge electrode 231 and generating plasma inside, it is preferably about 30 mm to 150 mm. The inner diameter of the generation unit body 235 is not particularly limited, but from the viewpoint of efficiently generating plasma, it is preferably about 4 mm to 12 mm. The material of the generation unit body 235 is not particularly limited, but a resin with a high heat resistance temperature, such as silicone resin, fluororesin, or polyimide resin, is preferred.
[0043] The outer diameter of the discharge electrode 231 should be such that it can be inserted into the generation unit body 235, but it is preferable that the outer diameter be about 1 mm to 5 mm smaller than the inner diameter of the generation unit body 235 in order to enable gas supply from the first end side. From the viewpoint of efficiently generating plasma inside the generation unit body 235, it is preferable that the discharge electrode 231 is inserted into the generation unit body 235 about 5 mm to 50 mm. The discharge electrode 231 can be conductive and can be made of metal, for example. In the case of metal, stainless steel is preferred from the viewpoint of corrosion resistance, etc. Even if the discharge electrode 231 is made of metal, metal contamination will hardly occur at a distance of about 5 cm or more from the discharge electrode. From the viewpoint of further avoiding the influence of metal, the discharge electrode 231 can also be made of carbon. In the case of the film deposition apparatus of this embodiment, carbon electrodes can also be easily formed.
[0044] In Figure 6, the counter electrode is the inner wall of the chamber 201, but the configuration is not limited to this. Anything that can generate plasma by applying a voltage between it and the discharge electrode 231 is acceptable. For example, the counter electrode can be a flat plate or a mesh-shaped electrode positioned at a distance from the discharge electrode 231.
[0045] The plasma branching section 204 can have any configuration as long as it can branch the gas flow. From the viewpoint of efficiently supplying the plasma-generated raw material gas to the catheter assembly 100A, it is preferable that the base end of the plasma branching section 204 is airtightly connected to the second end of the generation unit body 235 of the plasma generation unit 203. It is also preferable that the tip of the plasma branching section 204 is airtightly connected to the base end of the connecting tube of the catheter assembly 100A. If a connector is provided at the base end of the catheter assembly 100A, it is preferable to attach a connector that can be connected to it to the tip of the branch tube of the plasma branching section 204.
[0046] From the viewpoint of evenly distributing the plasma-generated raw material gas, it is preferable to make the inner diameter and length of the branched pipes equal. However, since the fluid flowing through the plasma branch section 204 is a gas and at low pressure, some non-uniformity between the branch pipes has almost no effect on the distribution of the plasma-generated raw material gas. Also, even if the inner diameters of the lumens of the catheter assembly 100A are not the same, it does not significantly affect the distribution of plasma in the plasma branch section 204. However, the inner diameter and ratio of the branch pipes can also be made to match the ratio of the inner diameters of the lumens.
[0047] The tip of the catheter assembly 100A is open, and the plasma-generated raw material gas that passes through the lumen of the catheter assembly 100A flows out into the chamber 201 and diffuses. As a result, a DLC film is deposited not only on the inner surface of the catheter assembly 100A but also on the outer surface. By exhausting the chamber 201 to prevent the raw material gas from diffusing into it, it is also possible to deposit a DLC film only on the inner surface of the catheter assembly 100A.
[0048] Depending on the type of catheter, side holes may be formed in at least one of the first lumen 111 and the second lumen 112. Branching and distribution of the plasma-generated raw material gas occurs at the side holes, but by adjusting the flow rate, the plasma-generated raw material gas can be distributed to the tip.
[0049] The materials of each part of the catheter assembly without the DLC film formed thereon are not particularly limited, and those of various materials can be combined and used. The catheter body can be made of various resins such as, for example, polyurethane, polyvinyl chloride, polyamide, polyolefin, polyester, fluororesin, silicone resin, etc., or a resin composition obtained by combining two or more of these. The connecting tube can be made of, for example, polyurethane, soft polyvinyl chloride, polyolefin, polycarbonate, fluororesin, silicone resin, etc. The connecting hub and the connector can be made of, for example, polyurethane, rigid polyvinyl chloride, polycarbonate, polyolefin, ABS resin, nylon, etc. According to the film-forming method of the present embodiment, even if the materials of each member constituting the catheter assembly 100A are different, the DLC film can be formed in one step on the exposed outer surface and inner surface of the entire catheter assembly 100A.
[0050] In the present embodiment, a double-lumen catheter having two lumens has been exemplified. However, the DLC film can be similarly deposited on a multi-lumen catheter having three or more lumens. In this case, a plasma branching portion having a number of branches corresponding to the number of lumens can be used. Also, a valve or the like can be provided so that the number of branches of the plasma branching portion 204 can be changed according to the number of lumens.
[0051] The type of the multi-lumen catheter is not limited. For example, the DLC film can be formed on various multi-lumen catheters such as a central venous catheter, a peripherally inserted central venous catheter, and a vascular catheter by the method shown in the present embodiment.
Examples
[0052] The multi-lumen catheter and its manufacturing method of the present disclosure will be described in more detail using examples. Note that the following examples are illustrative and are not intended to limit the present invention.
[0053] <Confirmation of DLC film> The confirmation of DLC film formation was performed using a Raman spectroscopy measurement device (RAMAN11 manufactured by nano photon). The measurement conditions were a light source wavelength of 532 nm, an objective lens magnification of 100 times, a numerical aperture of 0.9, and a diffraction grating of 1200 gr / mm.
[0054] <Formation of DLC film> A DLC film was formed on the inner and outer surfaces of a commercially available double-lumen central venous catheter (manufactured by Nihon Covidien Co., Ltd., SMAC Plus, double-lumen, Seldinger type, 15G×20 cm type). Before forming the DLC film, bombardment cleaning was first performed using argon gas.
[0055] <00,00206>As the film formation conditions, the source gas was CH4, the flow rate was 96.2 ccm (room temperature), and the pressure inside the chamber was 39 Pa. The bias voltage during film formation was 5 kV, and the frequency was 10 kHz. The application of the alternating voltage was intermittently performed for 20 minutes so that the pulse repetition frequency was 10 pps. In addition, an offset of 2 kV was applied by an amplifier during film formation.
[0056] Regarding the catheter after film formation, the presence or absence of DLC film formation on the inner and outer surfaces of the first connection tube and the inner and outer surfaces of the second connection tube was evaluated. For the first connection tube and the second connection tube, the evaluation was performed at a position 15 cm from the proximal end. At any position, the ratio (D / G ratio) of the D-band peak to the G-band peak in the Raman spectrum was 0.9 or less, and the presence of the DLC film was confirmed.
Industrial Applicability
[0057] The manufacturing method of the multi-lumen catheter of the present disclosure can easily manufacture a multi-lumen catheter coated with a diamond-like carbon film and is useful in the manufacturing field of medical devices and the like.
Explanation of Signs
[0058] 100 Multi-lumen catheter 100A Catheter Assembly 101 Catheter body 102 Linking Hub 111 First Lumen 112 Second Lumen 121 First liquid passage 122 Second liquid passage 125 Tip side connection part 127 First tube connection 128 Second tube connection 131 First connecting tube 132 Second connecting tube 133 First connector 134 Second connector 135 Clamp 151 DLC membrane 200 Film deposition equipment 201 Chamber 202 Vacuum Exhaust Section 203 Plasma generation unit 204 Plasma branching section 205 Gas Supply Department 222 Vacuum pump 223 Valve 231 Discharge electrode 233 Power supply section 235 Generating Unit Body 236 Gas Nozzle 237 Voltage Generator 238 Amplifier 251 cylinders 252 Flow path switching section 253 Mass Flow Controller
Claims
1. The process includes a step of supplying carbon plasma to each of the multiple lumens of a multi-lumen catheter within a decompression chamber to form a diamond-like carbon film on the inner and outer surfaces of the multi-lumen catheter. The carbon plasma is generated in a plasma generation unit having a discharge electrode and a counter electrode arranged spaced apart from each other, a cylindrical generation unit body into which the discharge electrode is inserted from a first end, and a gas supply unit that supplies a raw material gas containing hydrocarbons into the generation unit body from the first end. A method for manufacturing a multi-lumen catheter having a diamond-like carbon film formed on it, wherein carbon plasma generated in the plasma generation section is supplied to each of the multiple lumens via a plasma branching section.
2. The method for manufacturing a multi-lumen catheter according to claim 1, wherein the multi-lumen catheter comprises a catheter body having a plurality of lumens, a plurality of connecting tubes connected to each of the plurality of lumens, and a connecting hub that connects the plurality of connecting tubes to the catheter body.
3. A method for manufacturing a multi-lumen catheter according to claim 1 or 2, wherein an AC bias is intermittently applied between the discharge electrode and the counter electrode.
4. A decompression chamber for accommodating a multi-lumen catheter having multiple lumens, A plasma generating unit is located within the aforementioned depressurization chamber, The plasma generation unit comprises a plasma branching unit that branches the plasma generated in the plasma generation unit, The plasma generating unit comprises a discharge electrode and a counter electrode arranged spaced apart from each other, a cylindrical generating unit body into which the discharge electrode is inserted from a first end, and a gas supply unit that supplies a raw material gas containing hydrocarbons into the generating unit body from the first end. The plasma branching section hermetically connects the second end of the generation unit body to each of the plurality of lumens, A multi-lumen catheter manufacturing apparatus that supplies carbon plasma generated in the plasma generation unit to each of the multiple lumens via the plasma branching unit to form a diamond-like carbon film on the inner and outer surfaces of the multi-lumen catheter.
5. A catheter body having multiple lumens, Multiple connecting tubes connected to each of the multiple lumens, It has a connecting hub that connects a plurality of the connecting tubes and the catheter body, The connecting hub has a tip-side connecting portion into which the catheter body is inserted, a plurality of tube connecting portions into which the connecting tube is inserted, and a plurality of fluid passages connecting each of the tube connecting portions to the lumen of the catheter body inserted into the tip-side connecting portion. A multi-lumen catheter wherein the inner surface of the lumen, the inner surface of the connecting tube, and the inner surface of the fluid passage are formed with a diamond-like carbon film, except for the portion fitted onto another component, and the inner surface of the tip-side connecting portion and the tube connecting portion are not formed with a diamond-like carbon film.