Method and apparatus for coating medical invasive components

Abstract

The present invention relates to an apparatus (1) for coating a medical invasive component (100) having a longitudinal axis (101) and a side surface (102) that is rotationally symmetric with respect to the longitudinal axis (101) and extends linearly in the longitudinal direction, comprising: a rotating device (10) configured to clamp the invasive component (100) and to drive the invasive component (100) to rotate at a specified rotational speed (U) about its longitudinal axis (101); a coating device (20, 20a) that is immovable in the rotational direction with respect to the longitudinal axis (101) and configured to apply a specified amount (R) of a viscous coating solution (S) to the side surface (102) of the rotating invasive component (100); and the longitudinal axis (101 The system comprises a linear motion device (30) configured to move relatively linearly between a coating device (20, 20a) and a rotating device (10) at a predetermined forward speed (V) along the longitudinal axis (101) by a drive mechanism, and a control device (40) configured to control the rotational speed (U) of the rotating device (10), the coating amount (R) of the coating device (20, 20a), and the forward speed (V) of the linear motion device (30), wherein the control device (40) is configured to control the rotational speed (U), the coating amount (R), and the forward speed (V) in a cooperative manner according to the viscosity (C) of the viscous coating solution (S), so that the viscous coating solution (S) can be applied to the entire surface of the side surface (102) in the form of a spiral (H) that overlaps along the longitudinal axis (101).

Description

[Technical Field]

[0001] The present invention relates to a method and apparatus for coating medical invasive components. [Background technology]

[0002] Medical invasive components are often coated to improve their functional properties.

[0003] For example, catheter tubes are typically equipped with a hydrophilic coating that forms a sliding film when in contact with fluid. This sliding film is intended to improve the sliding properties of the catheter tube within the guide tube or inside the body.

[0004] Various methods for hydrophilic coating of catheter tubes are known from the prior art. [Overview of the project] [Problems that the invention aims to solve]

[0005] In known methods, a viscous coating solution is sprayed onto the sides of a catheter tube. The viscous coating solution contains volatile solution components, and after evaporation, the actual coating material remains on the sides in the form of a hydrophilic coating. Uncoated areas of the sides must be covered before spraying. Furthermore, such spraying methods require the use of a coating solution that is more viscous than the amount that ultimately reaches the sides.

[0006] Another known method involves immersing the catheter tube in a viscous coating solution to cover the uncoated areas. Even with this immersion method, a considerably larger volume of viscous coating solution must be supplied than is ultimately needed to reach the sides.

[0007] In another known method, the viscous coating solution is applied to the side using a tool, such as a sponge or brush. The amount of coating solution that can be applied is limited by the contact force of the tool. The thickness of the coating layer is not adjustable or is difficult to adjust. [Means for solving the problem]

[0008] The object of the present invention is to provide a method and apparatus that enables improvement of coating of medical invasive components having linearly extending rotationally symmetrical sides. In particular, the object is to ensure that a selected area is coated over the maximum possible surface area with an easily adjustable layer thickness while minimizing the consumption of viscous coating solution.

[0009] This objective is achieved by providing an apparatus having the features of claim 1 and a method having the features of claim 8. Advantageous embodiments are specified in the dependent claims.

[0010] The apparatus according to the present invention comprises a rotating device, a coating device, a linear motion device, and a control device. The rotating device is configured to clamp an invasive component and drive the invasive component around its longitudinal axis. The rotating device is configured to rotate the invasive component at a specified rotational speed. The rotational speed is a measure of the number of rotations of the rotating device, and thus of the number of rotations of the invasive component per unit time. The coating device is stationary in the rotational direction with respect to the longitudinal axis and is configured to apply a viscous coating solution to the side of the rotating invasive component. The coating device is configured to apply the viscous coating solution in a specified amount. The amount applied is a measure of the volume or weight of the viscous coating solution applied per unit time. In one embodiment, the coating device is positioned below the longitudinal axis with respect to gravity ("standing drop of viscous coating solution"). In a further embodiment, the coating device is instead positioned above the longitudinal axis ("hanging drop of viscous coating solution"). The linear motion device is configured for the driven linear motion of the coating device and / or rotating device along the longitudinal axis of a rotating invasive component. The linear motion device drives the coating device and the rotating device toward each other in linear motion. In one embodiment, the linear motion device is configured for the linear motion of the coating device, and the rotating device is linearly stationary. In further embodiments, the linear motion device is configured for the linear motion of the rotating device, and the coating device is linearly stationary. In further embodiments, the linear motion device is configured for the linear motion of both the coating device and the rotating device. The linear motion device is configured to move linearly at a specified rate of travel. The rate of travel is a measure of the distance traveled by the coating device and / or rotating device per unit time along the longitudinal axis. A control device is configured to control the rotational speed of the rotating device, the coating amount of the coating device, and the rate of travel of the linear motion device. The control is automatic. For this purpose, the control device can be connected wirelessly or wired to the rotating device, the coating device, and the linear motion device. To apply the coating, the invasive component is first clamped to the rotating device. To clamp the invasive components, the rotating device is configured in different ways in different embodiments.For example, the rotating device may have a clamping unit having movable clamping jaws, etc. The clamped invasive component is then rotated about its longitudinal axis. For this purpose, the rotating device preferably has a drive unit, in particular an electric drive. However, the drive unit is not part of the device in all embodiments. Furthermore, the coating device and / or rotating device is moved by a linear motion device during simultaneous coating of the coating solution along the longitudinal axis of the rotating invasive component. To coat a viscous coating solution in a specified amount, the coating device in one embodiment has at least a coating unit and a pump unit. An optional coating unit can be designed in the form of, for example, a hollow needle, tube, tapered hose, etc., with an outlet opening at one end, which helps to coat the viscous coating solution to the side. The coating device, in particular the coating unit, is preferably at a radial distance from the longitudinal axis such that the rotating side is, so to speak, pulling the viscous coating solution away from the coating device / coating unit. This distance is preferably 0.1 mm to 1.5 mm, and particularly preferably 0.2 mm to 1.0 mm. If the surface to be coated has an outer diameter that varies along the longitudinal axis, the distance is preferably kept constant by a radial linear motion device configured for relative radial displacement between the coating device and the rotating device. An optional pump unit helps to transport the viscous coating solution through the coating unit, and the coating amount may be influenced by changes in the pump output of the pump unit. The pumping output, and therefore the coating amount, is preferably controlled so that the coating device, in particular the coating unit, produces droplets that are pulled away (upright or hanging) upon contact with the rotating surface, resulting in the viscous coating solution wrapping around the invasive component. In a further embodiment, the pump unit is located away from the coating device and therefore in a stationary position relative to the coating device. For example, the pump unit may be located in the area of ​​a solution container that stores the viscous coating solution to be coated. Movement is performed by a linear motion device. The viscous coating solution is applied or wrapped in a spiral, i.e., helical manner, onto the surface that rotates relative to the coating device.The linear motion of the coating apparatus can be performed over the entire length of the side surface or only over a portion thereof, i.e., a selected area. The viscous coating solution thus applied to the side surface forms an actual coating after drying, evaporation, and / or crosslinking. Whether drying, evaporation, and / or crosslinking of the viscous coating solution is performed to form a coating depends on the properties of the coating solution / coating used and is not essential to the core of the present invention. The uniformity of the coating, the complete surface coverage, and / or the layer thickness can be easily adjusted by coordinated control of the rotation speed, application amount, and forward speed. Furthermore, multiple forward movements are conceivable and possible in the opposite direction of forward movement, so that the coating is formed by several layers of the viscous coating solution, so to speak. According to the present invention, the control device is configured to control the rotation speed, application amount, and forward speed according to the viscosity of the viscous coating solution. The viscosity of the viscous coating solution forms a control parameter for automatic control. In one embodiment of the present invention, the apparatus has an input device configured to manually input an input variable representing viscosity. In a further embodiment of the present invention, the apparatus has a storage device that stores data representing different viscosities of different coating solutions. The data can be retrieved from a storage device depending on the viscous coating solution actually used and can serve as the basis for control. Viscosity may and may be determined by a measuring device during the operation of the apparatus. If the side surface has an outer diameter that changes along the longitudinal axis, the control device is preferably configured to control the rotation speed, coating amount, and forward speed according to the viscosity and the changing outer diameter. In this case, an optional storage device can store data representing the outer diameter that changes along the longitudinal axis. Furthermore, according to the present invention, the control device is configured to coordinately control the rotation speed, coating amount, and forward speed so that the viscous coating solution can be applied to the entire side surface in the form of an overlapping spiral along the longitudinal axis. Thus, the rotation speed, coating amount, and forward speed are coordinated with each other so that the side surface is continuously covered with the viscous coating solution in the circumferential and axial directions.In one embodiment, the coordinated control is based on a predetermined rotational speed, and the coating amount and / or travel speed are adapted accordingly, for example, based on a corresponding determination formula based on a characteristic diagram. In a further embodiment, the coordinated control is based on a predetermined coating amount, and the rotational speed and travel speed are determined accordingly. In a further embodiment, the coordinated control is based on a predetermined travel speed, and the rotational speed and / or coating amount are adapted accordingly. It goes without saying that combinations of the aforementioned methods are also conceivable and possible. Within the scope of this specification, ranges of values ​​defined by explicit descriptions such as “value X to value Y” explicitly include their limit values ​​X and Y, where X and Y are described only as examples. Preferably, the surface to be coated has an outer diameter of 0.5 mm to 1.5 mm, preferably 0.7 mm to 1.0 mm, and particularly preferably 0.8 mm to 0.9 mm. The outer diameter is preferably constant along the longitudinal axis.

[0011] The solution according to the present invention is suitable for coating medical invasive components having a longitudinal axis and a linearly extending side surface that is rotationally symmetric with respect to the longitudinal axis. Particularly preferred is the solution according to the present invention, which is suitable for hydrophilic coating of catheter tubes.

[0012] In a further embodiment of the present invention, the viscous coating solution to be applied is formed from a plurality of separately stored solution components, and the application apparatus is configured to apply the plurality of solution components simultaneously, with an application unit for each of the plurality of solution components. This embodiment of the present invention enables the simple and efficient application of a multi-component coating solution. The application unit is preferably in the form of a hollow needle with an outlet opening at one end. It is not necessary to apply different solution components simultaneously. Rather, it is conceivable and possible for one of the solution components to be applied first along the direction of travel, and then another solution component to be applied along the opposite direction of travel. Alternatively, application can be carried out continuously in the same direction of travel, and as a result, it can be easily ensured that the coated areas on the sides undergo the same evaporation and / or drying time before further solution components are applied. In principle, it is also possible to apply a multi-component coating solution using only one application unit. However, in some cases this requires intermediate cleaning of the application unit. This can be omitted in this embodiment of the present invention.

[0013] In further embodiments of the present invention, an evaporator is present and configured to evaporate and / or accelerate the evaporation of volatile solution components of a viscous coating solution applied to a side surface. In particular, hydrophilic coating solutions often have volatile solution components that act as a solvent for the actual coating material. After the viscous coating solution is applied, evaporation of the volatile solution components occurs, resulting in the coating material remaining on the side surface and forming a hydrophilic coating. The evaporator causes and / or supports this evaporation process. In different embodiments, the evaporator is designed differently. In one embodiment, the evaporator has a heating unit for heating the side surface to which the viscous coating solution is applied. In further embodiments, the evaporator may, alternatively or additionally, have a fan unit configured to spray onto the side surface to which the viscous coating solution is applied. By heating and / or spraying the viscous coating solution located on the side surface, the evaporation process can be initiated, maintained and / or accelerated, depending on the specific properties of the viscous coating solution used and the ambient conditions.

[0014] In further embodiments of the present invention, a crosslinking device is present and configured to crosslink and / or accelerate the crosslinking of crosslinkable solution components of a viscous coating solution applied to a side surface. In particular, hydrophilic coatings are often formed by crosslinking of viscous solution components. The solution components used are preferably crosslinked individually and sequentially, and not together. The crosslinking device is configured to initiate, maintain, and / or accelerate the crosslinking process and is designed differently in different embodiments of the present invention. For example, coating solutions that can be crosslinked by light, particularly UV light, are known. In this case, the crosslinking device preferably has at least one light source, particularly a UV light source.

[0015] In a further embodiment of the present invention, the rotating device is configured for clamping and driving rotation of an invasive component, the invasive component having a diameter of 0.5 mm to 10 mm, preferably 0.7 mm to 0.9 mm, and a length of 40 mm to 500 mm, preferably 80 mm to 250 mm, and a rotational speed of 20 rpm to 900 rpm, preferably 250 rpm to 800 rpm, preferably 300 rpm to 600 rpm, preferably 600 rpm.

[0016] In a further embodiment of the present invention, the coating apparatus is 25 × 10 -3 kg / ms ~ 80 × 10 -3 kg / ms, preferably 35 × 10 -3 kg / ms ~ 55 × 10 -3 kg / ms, more preferably 43 × 10 -3 kg / ms ~ 48 × 10 -3 The viscous coating solution having a viscosity of kg / ms is configured to be applied in coating amounts of 0.5 μl / s to 10 μl / s, preferably 0.7 μl / s to 5 μl / s, more preferably 1 μl / s to 3 μl / s, and more preferably 0.9 μl / s to 2.5 μl / s. Therefore, the processable viscosity is in the range of 25 to 80 cP (centipoise).

[0017] In a further embodiment of the present invention, the linear motion device is configured for the driven linear motion of a coating device and / or a rotating device at a speed of 0.5 mm / s to 50 mm / s, preferably 4 mm / s to 40 mm / s, more preferably 5 mm / s to 10 mm / s, and more preferably 10 mm / s.

[0018] The method according to the invention serves to coat a medical invasive component having a longitudinal axis and a side surface that is rotationally symmetric about the longitudinal axis and extends linearly. In particular, this method serves for the hydrophilic coating of a catheter tube. The method according to the invention comprises the steps of clamping the invasive component in a rotating device, rotating the invasive component clamped by the rotating device at a defined rotational speed, applying a viscous coating solution to the side surface of the rotating invasive component, the viscous coating solution being applied in a defined application amount by an application device that is stationary in the rotational direction with respect to the longitudinal axis, linearly moving the application device and / or the rotating device along the longitudinal axis of the rotating invasive component, the application device being linearly moved relative to the rotating device at a defined advance speed by a linear motion device and / or vice versa, and controlling the rotational speed, the application amount and the advance speed by a control device, the rotational speed, the application amount and the advance speed being coordinatedly controlled in dependence on the viscosity of the viscous coating solution such that the viscous coating solution is applied over the entire side surface in the form of overlapping spirals along the longitudinal axis. What has already been said with respect to the device according to the invention applies to the method according to the invention with the necessary modifications. Therefore, for the sake of avoiding repetition, reference is made explicitly to the description of the device according to the invention. Embodiments of the method according to the invention are specified in the dependent method claims and are directly and unambiguously derivable from the disclosure of the embodiments of the device according to the invention. Therefore, embodiments of the method according to the invention can include, for example, application according to claim 2, evaporation according to claim 3, and / or crosslinking according to claim 4.

[0019] In a further embodiment of the invention, the rotational speed is from 20 rpm to 900 rpm, preferably from 250 rpm to 800 rpm, preferably from 300 rpm to 600 rpm, preferably 600 rpm.

[0020] In a further embodiment of the invention, the viscosity is 25×10 -3 kg / ms to 80×10-3 kg / ms, preferably 35×10 -3 kg / ms to 55×10 -3 kg / ms, more preferably 43×10 -3 kg / ms to 48×10 -3 kg / ms.

[0021] In a further embodiment of the present invention, the coating amount is 0.5 μl / s to 10 μl / s, preferably 0.7 μl / s to 5 μl / s, more preferably 1 μl / s to 3 μl / s, and even more preferably 0.9 μl / s to 2.5 μl / s.

[0022] In a further embodiment of the present invention, the traveling speed is 0.5 mm / s to 50 mm / s, more preferably 4 mm / s to 40 mm / s, preferably 5 mm / s to 10 mm / s, and more preferably 10 mm / s.

[0023] In a further embodiment of the present invention, the rotation speed is 300 rpm to 600 rpm, the viscosity is 35×10 -3 kg / ms to 55×10 -3 kg / ms, the coating amount is 1 μl / s to 3 μl / s, and the traveling speed is 5 mm / s to 10 mm / s. This is a particularly preferred embodiment. In a further embodiment of the present invention, the rotation speed is 600 rpm, and the viscosity is 43×10 -3 kg / ms to 48×10 -3The viscosity is kg / ms, the coating rate is 0.9 μl / s to 2.5 μl / s, and the progress rate is 10 mm / s. The above range of values ​​for the process parameters has proven particularly advantageous from the standpoint of solving the problem in question. This embodiment of the present invention ensures that, despite the relatively high viscosity and / or paste-like properties of the coating solution, no defects remain between adjacent windings of the helical / coating, and that a constant and / or uniform layer thickness of the coating is obtained along the longitudinal axis. Since relatively low viscosity coating liquids wet and / or flow along the sides and can therefore be applied in the form of a liquid film rather than, for example, a helical form, such coordinated control of process parameters is not necessary in the case of relatively low viscosity coating solutions.

[0024] In further embodiments of the present invention, a coating with a primer, which may also be called a base coat, is performed first, followed by a coating with a top coat.

[0025] In a further embodiment of the present invention, with respect to gravity, the viscous coating solution is discharged downward in the form of hanging droplets in the coating apparatus, and the hanging droplets come into contact with a rotating invasive component, resulting in the viscous coating solution spiraling around the side. The coating amount is coordinately controlled to discharge the hanging droplets.

[0026] In a further embodiment of the present invention, with respect to gravity, the viscous coating solution is discharged upward in the form of upright droplets in the coating apparatus, and the upright droplets come into contact with a rotating invasive component, resulting in the viscous coating solution spiraling around the side. The coating amount is coordinately controlled to discharge the drooping droplets.

[0027] Further advantages and features of the present invention will become apparent from the claims and from the following description of preferred exemplary embodiments of the invention illustrated with the drawings. [Brief explanation of the drawing]

[0028] [Figure 1] This is a schematic diagram of one embodiment of the apparatus according to the present invention for coating medical invasive components in the form of catheter tubes. [Figure 2] A section of the catheter tube is shown enlarged for more detail. [Figure 3] This is a simplified schematic diagram of a modified coating apparatus shown in Figure 1. [Figure 4] A flowchart illustrating one embodiment of the method according to the present invention is shown. [Modes for carrying out the invention]

[0029] According to Figure 1, an apparatus 1 for coating medical invasive components is provided.

[0030] In this case, the invasive component is a catheter tube 100 having a longitudinal axis 101 and a side surface 102. The side surface 102 extends straight along the longitudinal axis 101 and is rotationally symmetric. The coated catheter tube 100 extends between a first end 103 and a second end 104. The dimensions shown in Figure 1 should be understood as purely illustrative and not to scale.

[0031] The coating applied by the apparatus 1 (see Figure 2) is, in this case, a hydrophilic coating B that forms a sliding film when in contact with a liquid. The sliding film supports the mobility of the catheter tube 100 within the catheter system, thereby allowing the catheter tube 100 to advance as smoothly as possible within the guide tube and / or to its destination in the body. Coating B is formed on the side surface 102 from a viscous coating solution S (see Figure 1) in a manner that will be described in more detail.

[0032] Apparatus 1 comprises a rotating device 10, a coating device 20, a linear motion device 30, and a control device 40.

[0033] In the illustrated embodiment, the apparatus 1 also has an optional evaporator 50, which can alternatively be configured as a crosslinking apparatus 60. Furthermore, in this case the apparatus has an optional solution container 70.

[0034] The rotating device 10 is configured for clamping and driving the rotation of the catheter tube 100 around its longitudinal axis 101. The rotation is performed at a specified rotational speed U, i.e., the number of rotations per unit time.

[0035] The coating device 20 is fixed in the rotational direction with respect to the longitudinal axis 101 and is configured to apply a viscous coating solution S to the side surface 102 of the rotating catheter tube 100. The viscous coating solution S is applied in a specified application amount R, which represents a measure of the amount (volume and / or mass) of coating solution S applied per unit time.

[0036] In this case, the linear motion device 30 is configured for the driven linear motion of the coating device 20 along the longitudinal axis 101. The linear motion is performed at a specified rate of travel V, i.e., the distance along the longitudinal axis 101 per unit time. In embodiments not shown, the linear motion device is alternatively or additionally configured for the driven linear motion of a rotating device along the longitudinal axis.

[0037] The control device 40 is configured to control the rotational speed U of the rotating device 10, the dispensing amount R of the dispensing device 20, and the forward speed V of the linear motion device 30. The rotational speed U and / or forward speed V can also be controlled according to the outer diameter of the catheter tube 100 and / or side 102, which varies particularly along the longitudinal axis.

[0038] The viscous coating solution S is applied to the side surface 102 during the forward movement of the application device 20 and during the rotation of the rotating device 10 and, consequently, the catheter tube 100. Depending on how far the application device 20 advances along the longitudinal axis 101, the viscous coating solution S can be applied substantially completely to the side surface 102, except for the portion clamped to the rotating device 10. However, it is also possible to coat only the longitudinal section of the side surface 102. Furthermore, the forward movement can be repeated several times and / or performed in the opposite direction. This allows the viscous coating solution S to be applied in several layers.

[0039] In the illustrated embodiment, the rotational speed U, the coating amount R, and the advance rate V are controlled according to the viscosity C of the viscous coating solution S being applied. Viscosity C acts as a control parameter of the control device 40 in this regard, but of course, further or alternative control parameters can also be provided.

[0040] Viscosity C, or more precisely, the numerical value representing this physical parameter, can be manually entered into an input device not shown in Figure 1, for example. Alternatively or additionally, viscosity C can be retrieved based on data from a storage device or measured by a measuring device.

[0041] In the illustrated embodiment, the control device 40 is configured for coordinated control of the rotational speed U, the coating amount R, and the forward speed V, and is specifically configured to apply the viscous coating solution S to the side surface 102 in the form of a spiral H that overlaps along the longitudinal axis 101 (see Figure 2).

[0042] The helical H can also be called a coil or spiral wire, and in the schematic detail diagram shown in Figure 2, it has four exemplary windings or sections H1, H2, H3, and H4. Directly adjacent windings overlap along the longitudinal axis 101 by a dimension G, which can also be called an overlap. The overlap results in the entire surface being coated.

[0043] In the illustrated embodiment, the viscous coating solution S is discharged downward from the top of the coating device 20 in the form of a hanging droplet (not shown in detail in the figure) relative to gravity. The hanging droplet comes into contact with the rotating catheter tube 100 so that the viscous coating solution S spirally wraps around the side surface 102. As a result, the coating solution S is not dropped or sprayed onto the side surface 102, but rather "removed" from the coating device.

[0044] The actual coating B, in this case, is hydrophilic and is formed after the drying and / or crosslinking of the viscous coating solution S applied to the side surface 102.

[0045] In the embodiment shown in Figure 1, the viscous coating solution S comprises a volatile solution component SF and a coating material SB dissolved within the volatile solution component SF. After the evaporation of the volatile solution component SF, the coating material SB remains and forms a coating B on the side surface 102.

[0046] In the illustrated embodiment, the rotating device comprises a clamp unit 11 and a drive unit 12.

[0047] The clamp unit 11 is configured to clamp the end of the catheter tube 100 and for this purpose has, for example, a movable chuck, a clamping device, or a locking device.

[0048] The drive unit 12 is responsible for rotating the clamp unit 11 and is preferably designed as an electric motor.

[0049] Furthermore, at least one support unit may be present, which may be specifically assigned to a rotating device. The optional support unit provides radial support for the coated catheter tube and counteracts the bending of the catheter tube.

[0050] In this case, in order to control the rotational speed U, the control device 40 is connected to the rotating device 10, in particular to the drive unit 12, by a signal line 41.

[0051] In the illustrated embodiment, the coating apparatus 20 includes a coating unit 21 and a pump unit 22.

[0052] In this case, the coating unit 21 is in the form of a hollow needle and has an outlet opening (not reference numeral) through which the viscous coating solution S exits the coating device 20 onto the side surface 102. In this case, the (hanging) droplets are discharged at the outlet opening.

[0053] The pump unit 22 is responsible for pumping the viscous coating solution S through the coating unit 21 and its outlet opening. In the illustrated embodiment, the pump unit 22 is assigned to the coating apparatus 20, but this is not the case in all embodiments. The pump unit 22 is connected to the solution container 70 via a fluid line (not reference numeral). The viscous coating solution S to be applied is stored in the solution container 70. As already mentioned earlier, the solution container 70 is optional and is not present in all embodiments of the apparatus. The fluid line is designed and arranged to ensure the functional mobility of the coating apparatus 20 relative to the fixed solution container 70.

[0054] In this case, the control device 40 for controlling the coating amount R is connected to the coating device 20 by a signal line 42. The coating amount R in this case is controlled so that the (hanging) droplets described above are formed and continuously drawn away from the coating device 20 onto the side surface 102, and is particularly adapted to viscosity C and / or further process parameters.

[0055] In the illustrated embodiment, the linear motion device 30 has a guide shaft 31, which extends parallel to the longitudinal axis 101 and between a first end 32 and a second end 33. The coating unit 20 is guided and driven in linear motion on the guide shaft 31 between the first end 32 and the second end 33. The driving can be carried out by any suitable method. For example, the linear motion device 30 can interact with the coating device 20 via a moving spindle, a belt drive, a rack, or the like.

[0056] In order to control the forward speed V, the control device 40 in this case is connected to the linear motion device 30 via a signal line 43.

[0057] In the illustrated embodiment, the apparatus 1 also has the aforementioned optional evaporator 50. The evaporator 50 sustains the drying of the viscous coating solution S applied to the side surface 102 by initiating, maintaining, and / or accelerating the evaporation process of the volatile solution component SF. For this purpose, the evaporator 50 may have a heating unit (not shown in detail in the figure), in particular an infrared radiator, and alternatively or additionally, a fan unit may also be present. In the illustrated embodiment, the evaporator 50 extends over substantially the entire length of the possible forward path of the coating apparatus 20 and is positioned on the side of the longitudinal axis 101 of the catheter tube 100 opposite the coating apparatus 20 and the linear motion apparatus 30. Its position does not change. In an embodiment not shown, the evaporator may instead be relatively short and positioned movably with the coating apparatus and offset by a certain longitudinal distance from the coating apparatus. This results in a more compact design by comparison.

[0058] In the illustrated embodiment, the evaporator 50 is incorporated into the control device of the device 1 and, for this purpose, is connected to the control device 40 via a signal line 44.

[0059] In the illustrated embodiment, the rotating device 10 is configured for clamping and rotating invasive components having a diameter of 0.5 mm to 10 mm, particularly 0.7 mm to 0.9 mm. The length of the invasive components that can be coated is 40 mm to 500 mm, particularly 80 mm to 250 mm. The possible rotational speed U is 20 rpm to 900 rpm.

[0060] In the illustrated embodiment, the coating apparatus 20 is 25 × 10 -3 kg / ms ~ 80 × 10 -3 This enables the processing of viscous coating solutions with a viscosity V of 25 cP to 80 cP, corresponding to kg / ms. The possible application rate is in the range of 0.5 μl / s to 10 μl / s.

[0061] Furthermore, in the illustrated embodiment, a travel speed V of 0.5 mm / s to 50 mm / s is possible. The linear motion device 30 is configured accordingly.

[0062] In the specific coating of the catheter tube 100, a rotation speed U of 300 rpm to 600 rpm, a forward speed V of 5 mm / s to 10 mm / s, and a coating amount of 1 μl / s to 3 μl / s are provided, and the viscosity V of the viscous coating solution S used in this case is 35 × 10⁻⁶ -3 kg / ms ~ 55 × 10 -3 The density is kg / ms. The coating volume is 1 μl / cm to 4 μl / cm.

[0063] In embodiments not shown, the rotational speed U is 600 rpm, the forward speed V is 10 mm / s, the coating volume is 0.9 μl / s to 2.5 μl / s, and the viscosity V of the viscous coating solution S used in this case is 43 × 10⁻¹⁰ -3 kg / ms ~ 48 × 10 -3 It is kg / ms.

[0064] Figure 3 shows a different design of coating apparatus 20a that can be used in place of the coating apparatus 20 in apparatus 1 according to Figure 1.

[0065] The coating apparatus 20a shown in Figure 3 is provided for coating a viscous coating solution or a first solution component S1 and a second solution component S2 that together form a coating. Such multi-component coatings are generally known, particularly in hydrophilic coatings of catheter tubes.

[0066] The first solution component S1 is stored in the first solution container 70a. The second solution component S2 is stored in the second solution container 70a'. The two solution containers 70a and 70a' are connected to the coating device 20a via their respective fluid lines (not reference numerals). In addition, separate pump units 22a and 22a' are provided. Each fluid line, and thus each of the two solution containers 70a and 70a', is assigned one of the two pump units 22a and 22a'. In the illustrated modification, the two pump units 22a and 22a' are positioned away from the actual coating device 20a and are stationary relative to the coating device 20a.

[0067] The coating apparatus 20a has a first coating unit 21a and a second coating unit 21a'. Regarding the specific design of the two coating units 21a and 21a', what has already been stated with respect to Figure 1 and the coating unit 21 shown therein is applied with necessary modifications. The first coating unit 21a is provided for coating a first solution component S1 and is connected to a first solution container 70a via fluid lines not shown in detail. The second coating unit 21a' is connected to a second solution container 70a' via further fluid lines (not reference numerals).

[0068] In the modified example shown in Figure 3, the first solution component S1 can be applied in a first application amount R1. The second solution component S2 can be applied in a second application amount R2. The two application amounts R1 and R2 can be changed / controlled via the corresponding controls of the respective pump units 22a and 22a'.

[0069] To form a coating, two solution components S1 and S2 are crosslinked individually. For this purpose, apparatus 1 may have an optional crosslinking apparatus 60, which has already been described with reference to Figure 1 and is provided as an alternative to the evaporator 50. The crosslinking apparatus 60 is configured to crosslink the solution components S1 and S2 applied to the side surface and / or to facilitate the crosslinking. For this purpose, the crosslinking apparatus 60 may have, for example, a light source, particularly a UV light source.

[0070] Figure 4 schematically shows one embodiment of Method 1000 according to the present invention. Method 1000 can be performed using Apparatus 1 shown in Figure 1. Method 1000 includes step 1001 of clamping a catheter tube 100 in a rotating device 10. Method 1000 further includes step 1002 of rotating the clamped catheter tube 100 by the rotating device 10, the rotation being performed at a rotational speed U. Method 1000 further includes step 1003 of applying a viscous coating solution S to the side surface 102 of the rotating catheter tube 100. The viscous coating solution S is applied here by an application device 20. This is done in amount R. Method 1000 further includes step 1004 of linearly moving the application device 20 along the longitudinal axis 101 of the rotating catheter tube 100. The application device 20 is linearly moved along the longitudinal axis 101 at a specified rate of travel V by a linear motion device 30. Method 1000 further includes step 1005, in which the control device 40 controls the rotation speed U, the amount applied R, and the forward speed V. In this case, the rotation speed U, the amount applied R, and the forward speed V are coordinately controlled according to the viscosity C of the viscous coating solution S, so that the viscous coating solution S is applied over the entire surface of the side surface 102 in the form of a spiral H that overlaps along the longitudinal axis (101). [Explanation of Symbols]

[0071] 1 Apparatus, 10 Rotating apparatus, 11 Clamping unit, 12 Drive unit, 20 Coating apparatus, 20a Coating apparatus, 21 Coating unit, 21a First coating unit, 21a' Second coating unit, 22 Pump unit, 22a Pump unit, 22a' Pump unit, 30 Linear motion apparatus, 31 Guide shaft, 32 First end, 33 Second end, 40 Control device, 41 Signal line, 42 Signal line, 43 Signal line, 44 Signal line, 50 Evaporator, 60 Crosslinking apparatus, 70 Solution container, 70a First solution container, 70a' Second solution container, 100 Catheter tube, 101 Longitudinal axis, 102 Side, 103 First end, 104 Second end, 1000 Method, 1001 Clamping step, 1002 Rotating step, 1003 Steps: 1004 Application, 1005 Movement, 1005 Control, B Coating, C Viscosity, G Dimensions, H Helix, H1 Winding, H2 Winding, H3 Winding, H4 Winding, R Coating Amount, t First Coating Amount, R2 Second Coating Amount, S Viscous Coating Solution, S1 First Solution Component, S2 Second Solution Component, SB Coating Material, SF Volatile Solution Component, U Rotational Speed, V Progression Speed

Claims

1. An apparatus (1) for coating a medical invasive component (100) having a longitudinal axis (101) and a side surface (102), wherein the side surface is rotationally symmetric with respect to the longitudinal axis (101) and extends linearly in the longitudinal direction, A rotating device (10) is configured to clamp the invasive component (100) and drive the invasive component (100) around its longitudinal axis (101) at a specified rotational speed (U), A coating device (20, 20a) is configured to apply a viscous coating solution (S) in a specified amount (R) to the side surface (102) of the rotating invasive component (100), which is immovable in the rotational direction with respect to the longitudinal axis (101), A linear motion device (30) configured for driven relative linear motion between the coating device (20, 20a) and the rotating device (10) at a specified speed (V) along the longitudinal axis (101) of the rotating invasive component (100), A control device (40) configured to control the rotational speed (U) of the rotating device (10), the coating amount (R) of the coating device (20, 20a), and the forward speed (V) of the linear motion device (30), Equipped with, The apparatus (1) is characterized in that the control device (40) is configured to coordinately control the rotation speed (U), the coating amount (R), and the forward speed (V) according to the viscosity (C) of the viscous coating solution (S), and as a result, the viscous coating solution (S) can be applied over the entire surface of the side surface (102) in the form of a spiral (H) that overlaps along the longitudinal axis (101).

2. The apparatus (1) according to claim 1, characterized in that the viscous coating solution (S) to be applied is formed from a plurality of separately stored solution components (S1, S2), the coating apparatus (20a) is configured to apply the plurality of solution components (S1, S2) simultaneously, and each of the plurality of solution components (S1, S2) has a coating unit (21a, 21a').

3. The apparatus (1) according to claim 1 or 2, characterized in that an evaporation device (50) is present and configured to evaporate the volatile solution component (SF) of the viscous coating solution (S) applied to the side surface (102), and / or to accelerate its evaporation.

4. The apparatus (1) according to any one of claims 1 to 3, characterized in that a crosslinking device (60) is present and configured to crosslink and / or accelerate the crosslinking of the crosslinkable solution components (S1, S2) of the viscous coating solution (S) applied to the side surface (102).

5. The apparatus (1) according to any one of claims 1 to 4, wherein the rotating device (10) is configured for clamping and driving rotation of the invasive component, and the invasive component has a diameter of 0.5 mm to 10 mm and a length of 40 mm to 500 mm, and a rotational speed of 20 rpm to 900 rpm, preferably 300 rpm to 600 rpm.

6. The coating apparatus (20, 20a) is 25 × 10 －３ kg / ms~80×10 －３ kg / ms, preferably 35 × 10 －３ kg / ms~55×10 －３ The apparatus (1) according to any one of claims 1 to 5, characterized in that it is configured to apply a viscous coating solution having a viscosity (C) of kg / ms at a coating rate of 0.5 μl / s to 10 μl / s, preferably 1 μl / s to 3 μl / s.

7. The apparatus (1) according to any one of claims 1 to 6, characterized in that the linear motion device (30) is configured for the driven linear motion of the coating device (20, 20a) and / or the rotating device (10) at a forward speed (V) of 0.5 mm / s to 50 mm / s, preferably 5 mm / s to 10 mm / s.

8. A method (1000) for coating a medical invasive component (100) having a longitudinal axis (101) and a side surface (102) that is rotationally symmetric with respect to the longitudinal axis (101) and extends linearly in the longitudinal direction, Step (1001) clamps the invasive component (100) inside the rotating device (10), Step (1002) of rotating the clamped invasive component (100) by the rotating device (10), wherein the rotation is performed at a specified rotational speed (U), Step (1003) of applying a viscous coating solution (S) to the side surface (102) of the rotating invasive component (100), wherein the viscous coating solution (S) is applied in a specified amount (R) by a coating device (20, 20a) that is immovable in the rotational direction with respect to the longitudinal axis (101), Step (1004) of linearly moving the coating device (20, 20a) and / or the rotating device (10) along the longitudinal axis (101) of the rotating invasive component (100), wherein the coating device (20, 20a) is linearly moved relative to the rotating device (10) by a linear motion device (30) at a specified rate of travel (V), and / or the other way around. Step (1005) of controlling the rotation speed (U), the coating amount (R), and the forward speed (V) by a control device (40), Step (1005) is a step in which the rotational speed (U), the coating amount (R), and the forward speed (V) are coordinately controlled according to the viscosity (C) of the viscous coating solution (S), and as a result, the viscous coating solution (S) is applied over the entire surface of the side surface (102) in the form of overlapping spirals (H) along the longitudinal axis (101), A method (1000) including the following.

9. The method according to claim 8 (1000), characterized in that the rotational speed (U) is 20 rpm to 900 rpm, preferably 300 rpm to 600 rpm.

10. The viscosity (C) is 25 × 10 －３ kg / ms~80×10 －３ kg / ms, preferably 35 × 10 －３ kg / ms~55×10 －３ The method according to claim 8 or 9 (1000), characterized in that it is kg / ms.

11. The method according to any one of claims 8 to 10 (1000), characterized in that the coating amount (R) is 0.5 μl / s to 10 μl / s, preferably 1 μl / s to 3 μl / s.

12. The method according to any one of claims 8 to 11 (1000), characterized in that the advance speed (V) is 0.5 mm / s to 50 mm / s, preferably 5 mm / s to 10 mm / s.

13. The rotational speed (U) is 300 rpm to 600 rpm, and the viscosity (C) is 35×10 －３ kg / m·s to 55×10 －３ kg / m·s, the coating amount (R) is 1 μl / s to 3 μl / s, and the traveling speed (V) is 5 mm / s to 10 mm / s. The method (1000) according to any one of claims 8 to 12, characterized in that.

14. The method according to any one of claims 8 to 13 (1000), characterized in that, with respect to the direction of gravity, the viscous coating solution (S) is discharged downward in the form of hanging droplets from the coating apparatus (20, 20a), the hanging droplets come into contact with the rotating invasive component (100), and as a result, the viscous coating solution (S) spirally wraps around the side surface (102).

15. The method according to any one of claims 8 to 13 (1000), characterized in that, with respect to the direction of gravity, the viscous coating solution (S) is discharged upward in the form of upright droplets from the coating apparatus (20, 20a), the upright droplets come into contact with the rotating invasive component (100), and as a result, the viscous coating solution (S) spirally wraps around the side surface (102).

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