Method and apparatus for coating medically invasive components

By controlling the coating parameters through a combination of rotation and linear motion devices, the problems of excessive coating solution consumption and uneven coating were solved, achieving efficient and uniform coating of conduit hoses.

CN120897803AActive Publication Date: 2025-11-04B BRAUN MELSUNGEN AG
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Patent Information

Application Number
CN202480024026.1
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Priority Date
2023-04-28
Filing Date
2024-04-26
Publication Date
2025-11-04
Estimated Expiration
2044-04-26

AI Technical Summary

Technical Problem

Existing technologies for coating medical invasive components, especially catheters and tubing, suffer from problems such as excessive consumption of viscous coating solution, difficulty in controlling layer thickness, and uneven coating.

Method used

By employing a rotating device, an application device, a linear motion device, and a control device, uniform coating of medical invasive components can be achieved by controlling the rotational speed, application rate, and feed speed.

Benefits of technology

This technology enables the coating of medical invasive components, particularly catheter tubing, with controlled layer thickness and uniformity while reducing the consumption of viscous coating solution, thus improving the overall coverage and uniformity of the coating.

✦ Generated by Eureka AI based on patent content.

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Abstract

The invention relates to a device (1) for coating a medical invasive component (100) having a longitudinal axis (101) and a circumferential side (102) which is rotationally symmetrical about the longitudinal axis (101) and which extends straightly longitudinally, comprising a rotating device (10), the rotating device is used for clamping the intrusive component (100) and enabling the intrusive component (100) to rotate around the longitudinal axis (101) of the intrusive component (100) in a driving manner at a defined rotating speed (U); an application device (20, 20a) which is non-rotatably movable with respect to the longitudinal axis (101) and which is designed to apply the viscous coating solution (S) at a defined application rate (R) to the circumferential side (102) of the rotating intrusive component (100); a linear movement device (30), which is designed to drive a relative linear movement between the application device (20, 20a) and the rotating device (10) at a defined feed speed (V) along the longitudinal axis (101) of the rotating intrusive assembly (100); a control device (40), which is designed to control the rotational speed (U) of the rotary device (10), the application rate (R) of the application device (20, 20a) and the feed speed (V) of the linear movement device (30), the control device (40) being designed to control the rotational speed (U), the application rate (R) and the feed speed (V) in accordance with the viscosity (C) of the viscous coating solution (S) in such a way that the viscous coating solution (S) can be applied to the rotary device (10), the application rate (R) and the feed speed (V). In this way, the viscous coating solution (S) can be applied to the circumferential side surface (102) in the form of a spiral (H) overlapping along the longitudinal axis (101) in all directions.
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Description

TECHNICAL FIELD

[0001] The present invention relates to a method and a device for coating a medical invasive component. BACKGROUND

[0002] Medical invasive components are usually provided with a coating to improve their functional properties.

[0003] Catheter hoses, for example, are usually provided with a hydrophilic coating which, on contact with a liquid, forms a sliding film which is intended to improve the sliding properties of the catheter hose in a guide hose or in the body.

[0004] Different methods for hydrophilic coating of catheter hoses are known from the prior art.

[0005] In one known method, a viscous coating solution is sprayed onto the peripheral side of the catheter hose. The viscous coating solution comprises volatile solution components, after evaporation of which the actual coating material remains on the peripheral side in the form of a hydrophilic coating. Areas of the peripheral side which should not be coated have to be covered before spraying. Furthermore, in this spraying method, more viscous coating solution has to be consumed than finally reaches the peripheral side.

[0006] In a further known method, the catheter hose is immersed in a viscous coating solution, which in turn presupposes covering of the areas which are not to be coated. Even in this immersion method, a significantly greater amount of viscous coating solution has to be provided than finally reaches the peripheral side.

[0007] In a further known method, a tool, for example a sponge or a brush, is used to apply the viscous coating solution to the peripheral side. The amount of coating solution which can be applied is limited by the pressing force of the tool. The layer thickness of the coating cannot be set or at best is set poorly. SUMMARY

[0008] It is an object of the present invention to provide a method and a device which allow an improved coating of a medical invasive component having a rotationally symmetrical and straight, longitudinally extending peripheral side. In particular, it is intended to achieve a coating of the selected areas as completely as possible with a well-settable layer thickness with a minimised consumption of viscous coating solution.

[0009] This object is achieved by providing a device having the features of claim 1 and a method having the features of claim 8. Advantageous design solutions are specified in the dependent claims.

[0010] The device according to the application has a rotating device, an application device, a linear movement device and a control device. The rotating device is designed to clamp the invasive component and to drive it in rotation about its longitudinal axis. The rotating device is designed to rotate the invasive component at a defined rotational speed. The rotational speed is a measure for the number of revolutions per unit of time of the rotating device and thus also of the invasive component. The application device is not rotatable relative to the longitudinal axis and is designed to apply the adhesive coating solution to the peripheral surface of the rotating invasive component. The application device is designed to apply the adhesive coating solution at a defined application rate. The application rate is a measure for the volume or weight of adhesive coating solution applied per unit of time. In one design variant, the application device is arranged below the longitudinal axis with respect to the direction of gravity ("upright drop of adhesive coating solution"). In a further design variant, the application device is instead arranged above the longitudinal axis ("suspended drop of adhesive coating solution"). The linear movement device is designed to drive the application device and / or the rotating device in linear movement along the longitudinal axis of the rotating invasive component. By means of the linear movement device, the application device and the rotating device can be driven in linear movement relative to one another. In one design variant, the linear movement device is designed to move the application device in linear movement, wherein the rotating device cannot be moved linearly. In a further design variant, the linear movement device is designed to move the rotating device in linear movement, wherein the application device cannot be moved linearly. In a further design variant, the linear movement device is designed to move not only the application device but also the rotating device in linear movement. The linear movement device is designed for linear movement at a defined feed speed. The feed speed is a measure for the distance along the longitudinal axis covered per unit of time by the application device and / or the rotating device. The control device is designed to control the rotational speed of the rotating device, the application rate of the application device and the feed speed of the linear movement device. The control takes place automatically. To this end, the control device can be connected wirelessly or by wire to the rotating device, the application device and the linear movement device. In order to apply the coating, the invasive component is first clamped into the rotating device. In different design variants, the rotating device is designed in different ways to clamp the invasive component. The rotating device can for example have a pre-tensioning unit with movable clamping jaws etc. Thereafter, the clamped invasive component is driven in rotation about its longitudinal axis. To this end, the rotating device preferably has a drive unit, in particular an electric drive. However, the mentioned drive unit is not a component part of the device in all design variants. Furthermore, the application device and / or the rotating device are moved along the longitudinal axis of the rotating invasive component by means of the linear movement device with simultaneous application of the coating solution. In order to apply the adhesive coating solution at a defined application rate, the application device has in one design variant at least one application unit and a pump unit. The optional application unit can for example be designed in the form of a hollow needle, a small tube, a gradually narrowing hose etc. with a flow outlet at one end and serves to apply the adhesive coating solution to the peripheral surface.The application device, in particular the application unit, is preferably spaced apart from the longitudinal axis in the radial direction such that the rotating peripheral surface can be said to draw off the adhesive coating solution from the application device / application unit. The mentioned spacing is preferably between 0.1 mm and 1.5 mm, particularly preferably between 0.2 mm and 1.0 mm. If the peripheral surface to be coated is to have a variable outer diameter with respect to the longitudinal axis, the spacing is preferably kept constant correspondingly, for example by means of a linear movement device in the radial direction, which is provided for the relative radial displacement between the application device and the rotating device. An optional pump unit is used to deliver the adhesive coating solution through the application unit, wherein the application rate can be influenced by varying the pump power of the pump unit. The pump power and thus the application rate are preferably controlled such that the application device, in particular the application unit, produces (upright or hanging) droplets which, when coming into contact with the rotating peripheral surface, are drawn off, whereby the invasive assembly is wrapped with adhesive coating solution. In a further design, the mentioned pump unit is arranged away from the application device and is thereby fixed with respect to the application device. The pump unit can be arranged, for example, in the region of a solution container which stores the adhesive coating solution to be applied. The movement takes place by means of a linear movement device. Here, the adhesive coating solution is applied helically, i.e. coiled and / or solenoid-shaped, onto the periphery which is moved in rotation with respect to the application device. The linear movement of the application device can take place over the entire length of the peripheral surface or only over a part, i.e. a selected region, of the peripheral surface. The adhesive coating solution applied in this way to the peripheral surface forms the actual coating after drying, evaporation and / or cross-linking. Whether the drying, evaporation and / or cross-linking of the adhesive coating solution takes place in order to form the coating depends on the properties of the coating solution / coating used and is not essential to the core of the invention. The uniformity, fullness and / or layer thickness of the coating can be set in an easy way by controlling the rotational speed, the application rate and the feed speed in coordination with one another. It is furthermore conceivable and feasible to carry out the feed in the opposite feed direction several times, so that the coating can be said to be formed from several layers of adhesive coating solution. According to the invention, the control device is provided for controlling the rotational speed, the application rate and the feed speed as a function of the viscosity of the adhesive coating solution. The viscosity of the adhesive coating solution forms the control parameter for the automatic control. In a design of the invention, the device has an input device which is provided for manually inputting an input variable which represents the viscosity. In a further design of the invention, the device has a storage device in which data are stored which represent different viscosities of different coating solutions. The data can be called up from the storage device as a basis for the control, depending on the adhesive coating solution actually used. It is furthermore conceivable and feasible to acquire the viscosity during the operation of the device by means of a measuring device. If the peripheral surface has a variable outer diameter with respect to the longitudinal axis, the control device is preferably provided for controlling the rotational speed, the application rate and the feed speed as a function of the viscosity and the variable outer diameter.In this case, data representative of the variable outer diameter with respect to the longitudinal axis can be stored in an optional storage device. Furthermore, according to the application, the control device is designed to control the rotational speed, the application rate and the feed speed in such a way that they cooperate with one another such that the viscous coating solution can be applied to the peripheral surface in the form of a helix that is overlaid along the longitudinal axis in an overall shape. Thus, the rotational speed, the application rate and the feed speed are coordinated with one another in such a way that the peripheral surface is continuously covered by the viscous coating solution in the circumferential direction and in the axial direction. In one design variant, the coordinated control in this regard is carried out on the basis of a predefined rotational speed, wherein the application rate and / or the feed speed are / is obtained in adaptation thereto, for example on the basis of a corresponding determination equation, from a characteristic map, etc. In a further design variant, the coordinated control is carried out on the basis of a predefined application rate, wherein the rotational speed and the feed speed are obtained in adaptation thereto. In a further design variant, the coordinated control is carried out on the basis of a predefined feed speed, wherein the rotational speed and / or the application rate are / is obtained in adaptation thereto. It goes without saying that combinations of the aforementioned variants can also be envisaged and realized. In the framework of the present description, a value range defined by an expression such as "between the value X and the value Y" also explicitly includes the here merely exemplarily mentioned limit values X and Y of the value range. It is preferred that the peripheral surface to be coated has an outer diameter that lies between 0.5 mm and 1.5 mm, preferably between 0.7 mm and 1.0 mm, particularly preferably between 0.8 mm and 0.9 mm. It is preferred that the outer diameter is constant with respect to the longitudinal axis.

[0011] The solution according to the application is suitable for coating medical invasive components having a longitudinal axis and a peripheral surface that is rotationally symmetrical about the longitudinal axis and extends straight and longitudinally. It is particularly preferred that the solution according to the application is suitable for the hydrophilic coating of catheter hoses.

[0012] In a further design of the application, the adhesive coating solution to be applied is formed from a plurality of solution components which are stored separately, wherein the application device is designed for simultaneous application of the plurality of solution components and has an application unit for each of the plurality of solution components. This design of the application allows easy and efficient application of a multi-component coating solution. The application units are preferably designed in the form of hollow needles or the like which are each provided with a flow outlet at one end. The different solution components do not necessarily have to be applied simultaneously. Rather, it is conceivable and possible to first apply one of the solution components along the feed direction and thereafter to apply the further solution components along the opposite feed direction. As an alternative, the application takes place one after the other in the same directed feed direction, whereby it is possible in an easy manner to ensure that the coated region of the peripheral surface obtains the same evaporation time and / or drying time before the further solution components are applied. Although it is possible in principle to apply a multi-component coating solution using only one application unit. This can require cleaning of the application unit in the meantime. This can be dispensed with in this design of the application.

[0013] In a further design of the application, an evaporation device is present and is designed for evaporation and / or acceleration of the evaporation of volatile solution components of the adhesive coating solution applied to the peripheral surface. In particular, a hydrophilic coating solution usually has volatile solution components which serve as a solvent for the actual coating material. The evaporation of the volatile solution components is provided after the application of the adhesive coating solution, so that the coating material remains on the peripheral surface in the case of a hydrophilic coating. The evaporation device causes and / or supports the evaporation process. In different designs, the evaporation device is designed differently. In one design, the evaporation device has a heating unit for heating the peripheral surface provided with the adhesive coating solution. In a further design, as an alternative or in addition, the evaporation device has a fan unit which is designed for blowing air onto the peripheral surface provided with the adhesive coating solution. By heating and / or blowing air onto the adhesive coating solution located on the peripheral surface, it is possible to initiate, maintain and / or accelerate the evaporation process depending on the specific properties of the adhesive coating solution used and the ambient conditions.

[0014] In a further design of the application, a crosslinking device is present and is designed for crosslinking and / or for accelerating the crosslinking of the solution components of the adhesive coating solution applied to the peripheral side which are to be crosslinked. In particular, a hydrophilic coating is formed in the case of crosslinking of the adhesive solution components. Here, the solution components used are preferably crosslinked individually and after one another and not, for example, with one another. The crosslinking device is designed for initiating, maintaining and / or accelerating the crosslinking process and is designed differently in the different designs of the application. For example, coating solutions are known which can be crosslinked by means of light, in particular ultraviolet light. In this case, the crosslinking device preferably has at least one light source, in particular an ultraviolet light source.

[0015] In a further design of the application, the rotating device is designed for clamping and drivingly rotating the invasive component, which has 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 has a rotational speed of 20 U / min to 900 U / min, preferably 250 U / min to 800 U / min, preferably a rotational speed of 300 U / min to 600 U / min, preferably 600 U / min.

[0016] In a further design of the application, the application device is designed for applying an adhesive coating solution having a viscosity of 25 x 10 -3 kg / ms to 80 x 10 -3 kg / ms, preferably 35 x 10 -3 kg / ms to 55 x 10 -3 kg / ms, further preferably 43 x 10 -3 kg / ms to 48 x 10 -3 kg / ms, at an application rate of 0.5 μΙ / s to 10 μΙ / s, preferably 0.7 μΙ / s to 5 μΙ / s, further preferably 1 μΙ / s to 3 μΙ / s, further preferably 0.9 μΙ / s to 2.5 μΙ / s. The processable viscosity thus fluctuates between 25 and 80 cP (centipoise).

[0017] In a further design of the application, the linear movement device is designed for drivingly linearly moving the application device and / or the rotating device at a feed speed of between 0.5 mm / s and 50 mm / s, preferably between 4 mm / s and 40 mm / s, further preferably between 5 mm / s and 10 mm / s, further preferably 10 mm / s.

[0018] The method according to the application is used for coating a medical invasive component having a longitudinal axis and a circumferential side which is rotationally symmetrical around the longitudinal axis and extends straight and longitudinally. In particular, the method is used for the hydrophilic coating of a catheter tube. The method according to the application has the following steps: clamping the invasive component into a rotating device; rotating the clamped invasive component by means of the rotating device, wherein the rotation takes place at a defined rotational speed; applying a viscous coating solution to the circumferential side of the rotating invasive component, wherein the viscous coating solution is applied by means of an application device which is not rotationally movable relative to the longitudinal axis and at a defined application rate; moving the application device and / or the rotating device linearly along the longitudinal axis of the rotating invasive component, wherein the application device is moved linearly relative to the rotating device and / or the rotating device is moved linearly relative to the application device by means of a linear movement device and at a defined feed speed; controlling the rotational speed, the application rate and the feed speed by means of a control device, wherein the rotational speed, the application rate and the feed speed are controlled in coordination with one another depending on the viscosity of the viscous coating solution such that the viscous coating solution is applied overall in the form of a spiral which overlaps along the longitudinal axis. What has been described with regard to the device according to the application applies mutatis mutandis also to the method according to the application. In order to avoid repetitions, explicit reference is therefore made and the description of the device according to the application is hereby incorporated by reference. The design options of the method according to the application are specified in the dependent method claims and are furthermore directly and clearly derived from the disclosure of the design options of the device according to the application. The design options of the method according to the application can then, for example, have the application according to claim 2, the evaporation according to claim 3 and / or the crosslinking according to claim 4.

[0019] In a further design option of the application, the rotational speed is between 20 U / min and 900 U / min, preferably between 250 U / min and 800 U / min, preferably between 300 U / min and 600 U / min, preferably 600 U / min.

[0020] In a further design option of the application, the viscosity is between 25 x 10 -3 kg / ms and 80 x 10 -3 kg / ms, preferably between 35 x 10 -3 kg / ms and 55 x 10 -3 kg / ms, further preferably between 43 x 10 -3 kg / ms and 48 x 10 -3 kg / ms.

[0021] In a further design of the application, the application rate is between 0.5 and 10 μl / s, preferably between 0.7 and 5 μl / s, further preferably between 1 and 3 μl / s, further preferably between 0.9 and 2.5 μl / s.

[0022] In a further design of the application, the feed speed is between 0.5 and 50 mm / s, further preferably between 4 and 40 mm / s, preferably between 5 and 10 mm / s, further preferably 10 mm / s.

[0023] In a further design of the application, the rotational speed is between 300 and 600 U / min, the viscosity is between 35 x 10 -3 kg / ms and 55 x 10 -3 kg / ms, the application rate is between 1 and 3 μl / s, and the feed speed is between 5 and 10 mm / s. This is a particularly preferred design. In a further design of the application, the rotational speed is 600 U / min, the viscosity is between 43 x 10 -3 kg / ms and 48 x 10 -3 kg / ms, the application rate is between 0.9 and 2.5 μl / s, and the feed speed is 10 mm / s. The mentioned value ranges of the process parameters prove to be particularly advantageous in the achievement of the object in question. This design of the application ensures, inter alia, that, despite the relatively high viscous and / or pasty nature of the coating solution, no defect sites remain between adjacent spirals of the spiral / coating, and a constant and / or uniform layer thickness of the coating along the longitudinal axis is obtained. In the case of a relatively low viscous coating liquid, no control of this coordination of the process parameters would be required, since the coating liquid is wet and / or flows on the peripheral side and thus can be applied in the form of a liquid film and not, for example, in the form of a spiral.

[0024] In a further design of the application, the coating is first carried out with a primer, which can also be referred to as a basecoat, and thereafter with a topcoat.

[0025] In a further design of the application, the viscous coating solution is discharged at the application device in the form of a pendant droplet with respect to the direction of gravity from above to below, wherein the pendant droplet is contacted by the rotating invasive component, whereby the peripheral side of the invasive component is helically wound by the viscous coating solution. The application rate is coordinatedly controlled to discharge the pendant droplet.

[0026] In a further design of the application, the adhesive coating solution is discharged at the application device in the form of an upright drop from below to above with respect to the direction of gravity, wherein the upright drop is contacted by the rotating invasive component, whereby the peripheral side of the invasive component is spirally wound by the adhesive coating solution. The application rate is controlled in coordination to discharge a hanging drop. BRIEF DESCRIPTION OF DRAWINGS

[0027] Further advantages and features of the application result from the claims and from the following description of preferred embodiments of the application, which are illustrated in the attached drawings. Therein: Figure 1 An embodiment of a device for coating a medical invasive component in the form of a catheter tube according to the application is shown in a schematic simplified illustration, Figure 2 A section of the catheter tube is shown in an enlarged detail illustration, Figure 3 A variant of the application device according to Figure 1 is shown in a schematic simplified illustration, and Figure 4 A flow chart for illustrating an embodiment of the method according to the application is shown. DETAILED DESCRIPTION

[0028] According to Figure 1 A device 1 for coating a medical invasive component is provided.

[0029] The invasive component is herein a catheter tube 100 having a longitudinal axis 101 and a peripheral side 102. The peripheral side 102 extends straight and longitudinally along the longitudinal axis 101 and is rotationally symmetrical. The catheter tube 100 to be coated extends longitudinally between a first end 103 and a second end 104, wherein according to Figure 1 The apparent dimensions are to be understood in a purely exemplary and not to scale manner.

[0030] The coating to be applied by means of the device 1 (see Figure 2 ) is herein a hydrophilic coating B, which forms a sliding film upon contact with a liquid. The sliding film supports the movability of the catheter tube 100 in a catheter system, so that the catheter tube 100 can be fed as smoothly as possible to its determined place in the guiding tube and / or in the body. The coating B is formed on the peripheral side 102 in a manner to be described in more detail yet by an adhesive coating solution S (see Figure 1 ).

[0031] The device 1 has a rotating device 10, an application device 20, a linear movement device 30 and a control device 40.

[0032] In the embodiment shown, the apparatus 1 furthermore has an optional evaporation device 50, which can also be configured as a cross-linking device 60 as an alternative. Furthermore, the apparatus also has an optional solution container 70 in this case.

[0033] The rotating device 10 is provided for clamping the conduit hose 100 and drivingly rotating it about its longitudinal axis 101. The rotation takes place with a defined rotational speed U, i.e. the number of revolutions per unit of time.

[0034] The application device 20 is not capable of rotational movement relative to the longitudinal axis 101 and is provided for applying the adhesive coating solution S to the peripheral side 102 of the rotating conduit hose 100. The application of the adhesive coating solution S takes place with a defined application rate R, which represents a measure for the amount of coating solution S (volume and / or mass) applied per unit of time.

[0035] The linear movement device 30 is provided herein for drivingly linearly moving the application device 20 along the longitudinal axis 101. The linear movement takes place with a defined feed speed V, i.e. the distance along the longitudinal axis 101 per unit of time. In an embodiment not shown in the drawing, the linear movement device is provided for drivingly linearly moving the rotating device along the longitudinal axis as an alternative or in addition.

[0036] The control device 40 is provided for controlling the rotational speed U of the rotating device 100, the application rate R of the application device 20 and the feed speed V of the linear movement device 30. The rotational speed U and / or the feed speed V can also be controlled in accordance with the outer diameter of the conduit hose 100 and / or the peripheral side 102, which can be variable in particular with respect to the longitudinal axis.

[0037] During the feed movement of the application device 20 and with the rotation of the rotating device 10 and thus of the conduit hose 100, the adhesive coating solution S is applied to the peripheral side 102 of the conduit hose. Depending on the extent to which the application device 20 is fed along the longitudinal axis 101, the peripheral side 102 can be provided substantially completely with the adhesive coating solution S, apart from the section clamped in the rotating device 10. However, it is also possible to coat only longitudinal sections of the peripheral side 102. It is furthermore conceivable and possible to perform the feed movement repeatedly and / or in the opposite direction. In this way, the adhesive coating solution S can be applied in a plurality of layers.

[0038] In the embodiment shown, the rotational speed U, the application rate R and the feed speed V are controlled in accordance with the viscosity C of the adhesive coating solution S to be applied. In this regard, the viscosity C serves as a control parameter for the control device 40, wherein further or alternative control parameters can of course also be provided.

[0039] The viscosity C, more precisely the value representing this physical characteristic variable, can for example be determined in Figure 1are manually input at an input device not shown. As an alternative or in addition, the viscosity C can be called up from a storage device on the basis of data or measured by means of a measuring device.

[0040] In the embodiment shown, the control device 40 is provided for controlling the rotational speed U, the application rate R and the feed speed V in coordination with one another and more precisely in such a way that the viscous coating solution S can be applied to the peripheral surface 102 in the form of a helix H which overlaps along the longitudinal axis 101 (see Figure 2 ).

[0041] The helix H mentioned can also be referred to as a coil or a spiral and has four exemplary windings or helix portions H1, H2, H3, H4 in the schematic detail view according to Figure 2 . The helix portions which directly adjoin one another overlap along the longitudinal axis 101 by a measure G which can also be referred to as an overlap. A comprehensive coating is obtained by the overlap.

[0042] In the embodiment shown, the viscous coating solution S is discharged at the application device 20 in the form of a hanging droplet which is not shown in detail in the drawing with respect to the direction of gravity from above to below. The hanging droplet is contacted by the rotating conduit hose 100 so that the peripheral surface 102 of the conduit hose is helically wound with the viscous coating solution S. The coating solution S is thus not, for example, dripped or sprayed onto the peripheral surface 102, but rather more precisely can be said to be "sucked off" from the application device.

[0043] In this context, the actual, in this case hydrophilic, coating B is formed after the viscous coating solution S applied to the peripheral surface 102 has dried and / or cross-linked.

[0044] In the embodiment shown in Figure 1 , the viscous coating solution S comprises a volatile solution component SF and a coating material SB dissolved in the solution component. After the volatile solution component SF has evaporated, the coating material SB remains on the peripheral surface 102 in the case of the construction of the coating B.

[0045] In the embodiment shown, the rotating device has a pretensioning unit 11 and a drive unit 12.

[0046] The pretensioning unit 11 is provided for clamping the conduit hose 100 at the end side and for this purpose has, for example, a movable chuck, a clamping device or a latching device.

[0047] The drive unit 12 serves for rotating the pretensioning unit 11 and is preferably constructed as an electric motor.

[0048] Furthermore, at least one support unit can be present, and this support unit is assigned, inter alia, to the rotary device. The optional support unit serves to support the catheter tube to be coated in the radial direction and to suppress a deflection of the catheter tube.

[0049] In the present case, the control device 40 is connected to the rotary device 10, in particular to the drive unit 12, by means of a signal line 41 in order to control the rotational speed U.

[0050] In the embodiment shown, the application device 20 has an application unit 21 and a pump unit 22.

[0051] The application unit 21 is designed in the present case in the form of a hollow needle and has a flow outlet (no reference numeral) through which the adhesive coating solution S flows out of the application device 20 onto the peripheral side 102. In the present case, the mentioned (pendent) droplets are discharged at the flow outlet.

[0052] The pump unit 22 serves to pump the adhesive coating solution S through the application unit 21 and its flow outlet. In the embodiment shown, the pump unit 22 is assigned to the application device 20, although this is not the case in all embodiments. The pump unit 20 is connected to a solution container 70 by means of a fluid line (no reference numeral). The adhesive coating solution S to be applied is stored in the solution container 70. The solution container 70 is optional, as already mentioned at the outset, and is not present in all embodiments of the apparatus. The mentioned fluid line is constructed and arranged in such a way that a functionally compliant movability of the application device 20 relative to the stationary solution container 70 is ensured.

[0053] In the present case, the control device 40 is connected to the application device 20 by means of a signal line 42 in order to control the application rate R. In the present case, the application rate R is controlled in such a way, in particular in coordination with the viscosity C and / or further process parameters, that the mentioned (pendent) droplets are formed and continuously applied from the application device 20 onto the peripheral side 102.

[0054] In the embodiment shown, the linear movement device 30 has a guide axis 31 which extends parallel to the longitudinal axis 101 and which extends longitudinally between a first end 32 and a second end 33. The application unit 20 is linearly movably guided and driven at the guide axis 31 between the first end 32 and the second end 33. The driving can take place in any suitable way. The linear movement device 30 can interact with the application device 20, for example, by means of a movement spindle, a belt drive, a rack, etc.

[0055] In order to control the feed speed V, the control device 40 is connected to the linear movement device 30 in the present case by means of a signal line 43.

[0056] In the embodiment shown, the device 1 furthermore has the already mentioned optional evaporation apparatus 50. The evaporation apparatus 50 supports the drying of the adhesive coating solution S applied to the peripheral side 102 in such a way that the evaporation process of the volatile solution components SF is initiated, maintained and / or accelerated. To this end, the evaporation apparatus 50 can have a heating unit, in particular an infrared radiator, which is not shown in more detail in the drawing, wherein, as an alternative or in addition, a fan unit can also be present. In the embodiment shown, the evaporation apparatus 50 extends essentially over the entire length of the possible feed stroke of the application apparatus 20 and is arranged on the side of the longitudinal axis 101 of the catheter tube 100 which is opposite the application apparatus 20 and the linear movement apparatus 30. The arrangement is fixed. In an embodiment not shown in the drawing, the evaporation apparatus can instead be relatively short and co-movable with the application apparatus and arranged at a certain longitudinal distance from this application apparatus. A relatively more compact design is thereby achieved.

[0057] In the embodiment shown, the evaporation apparatus 50 is integrated into the control of the device 1 and for this purpose is connected to the control apparatus 40 by means of a signal line 44.

[0058] In the embodiment shown, the rotation apparatus 10 is designed for clamping and rotating an invasive component having a diameter of 0.5 mm to 10 mm, in particular a diameter of 0.7 mm to 0.9 mm. The length of the coatable invasive component lies between 40 mm and 500 mm, in particular 80 mm to 250 mm. A possible rotational speed U fluctuates here between 20 U / min and 900 U / min.

[0059] In the embodiment shown, the application apparatus 20 allows the processing of adhesive coating solutions having a viscosity V of 25 cP to 80 cP, which corresponds to 25 x 10 -3 kg / ms to 80 x 10 -3 kg / ms. A possible application rate fluctuates between 0.5 μΙ / s and 10 μΙ / s.

[0060] Furthermore in the embodiment shown, a feed speed V of 0.5 mm / s to 50 mm / s is possible. The linear movement apparatus 30 is correspondingly designed.

[0061] In the particularly shown coating of the catheter tube 100, a rotational speed U of 300 U / min to 600 U / min, a feed speed V of 5 mm / s to 10 mm / s and an application rate of 1 μΙ / s to 3 μΙ / s are specified, wherein the viscosity V of the adhesive coating solution S used here lies between 35 x 10 -3 kg / ms and 55 x 10-3 kg / ms between. Here, the coating volume is between 1 µl / cm and 4 µl / cm.

[0062] In an embodiment not shown in the drawing, the rotational speed U is 600 U / min, the feed speed V is 10 mm / s, and the application rate is between 0.9 µl / s and 2.5 µl / s, wherein the viscosity V of the viscous coating solution S used is between 43 x 10 -3 kg / ms and 48 x 10 -3 kg / ms.

[0063] According to Figure 3 An application device 20a is shown, which is embodied differently and can be used instead of the application device 20 in the apparatus 1 according to Figure 1 .

[0064] According to Figure 3 The application device 20a according to the application is provided for applying a first solution component S1 and a second solution component S2, which together form a viscous coating solution or else a coating. Such a multi-component coating is generally known, inter alia, in the hydrophilic coating of catheter hoses.

[0065] The first solution component S1 is stored in a first solution container 70a. The second solution component S2 is stored in a second solution container 70a'. Both solution containers 70a, 70a' are connected to the application device 20a by means of fluid lines (no reference signs) respectively. Furthermore, separate pump units 22a, 22a' are provided in this case. Here, each fluid line and thus each of the two solution containers 70a, 70a' is assigned to one of the two pump units 22a, 22a' respectively. In the variant shown, the two pump units 22a, 22a' are arranged away from the actual application device 20a and are fixed relative thereto.

[0066] The application device 20a has a first application unit 21a and a second application unit 21a'. In terms of the specific design of these two application units 21a, 21a', the content described with regard to Figure 1 and the application unit 21 there is applicable in spirit. The first application unit 21a is provided for applying the first solution component S1 and is connected to the first solution container 70a by means of a fluid line not represented in more detail. The second application unit 21a' is connected to the second solution container 70a' by means of a further fluid line (no reference signs).

[0067] In Figure 3In the variant shown in the middle, the first solution component S1 can be applied at a first application rate R1. The second solution component S2 can be applied at a second application rate R2. These two application rates R1, R2 can be varied / controlled by correspondingly controlling the respective pump units 22a, 22a'.

[0068] For the construction of the coating, the two solution components S1, S2 are crosslinked individually. For this purpose, the apparatus 1 can have a crosslinking device 60 which has already been described above according to Figure 1 The crosslinking device 60 is explained as an alternative to the evaporation device 50. The crosslinking device 60 is provided for crosslinking and / or accelerating the crosslinking of the solution components S1, S2 applied to the peripheral side. For this purpose, the crosslinking device 60 can have, for example, a light source, in particular an ultraviolet light source.

[0069] According to Figure 4 Embodiments of the method 1000 according to the application are illustrated schematically. The method 1000 can be carried out in the case of use of the apparatus 1 according to Figure 1 The method 1000 provides for clamping 1001 the catheter hose 100 into the rotating device 10. Furthermore, the method 1000 provides for rotating 1002 the clamped catheter hose 100 by means of the rotating device 10, wherein the rotation takes place at a rotational speed U. Furthermore, the method 1000 provides for applying 1003 the adhesive coating solution S to the peripheral side 102 of the rotating catheter hose 100. Here, the adhesive coating solution S is applied by means of the application device 20. This takes place at an application rate R. Furthermore, the method 1000 provides for moving 1004 the application device 20 linearly along the longitudinal axis 101 of the rotating catheter hose 100. Here, the application device 20 is moved linearly along the longitudinal axis 101 by means of the linear movement device 30 at a defined feed speed V. Furthermore, the method 1000 provides for controlling 1005 the rotational speed U, the application rate R and the feed speed V by means of the control device 40. Here, the rotational speed U, the application rate R and the feed speed V are controlled in coordination with one another in such a way that the adhesive coating solution S is applied to the peripheral side 102 in the form of the mentioned overlapping helix H along the longitudinal axis 101 in an overall shape, in dependence on the viscosity C of the adhesive coating solution S.

Claims

1. An apparatus (1) for coating a medical invasive component (100), the medical invasive component having a longitudinal axis (101) and a peripheral side surface (102) that is rotationally symmetrical about the longitudinal axis (101) and extends longitudinally in a straight line, the apparatus having: A rotating device (10) is provided for clamping the invasive component (100) and driving it to rotate about its longitudinal axis (101) at a defined rotational speed (U); An application device (20, 20a) is non-rotatable relative to the longitudinal axis (101) and is configured to apply a viscous coating solution (S) to the peripheral side (102) of a rotating invasive component (100) at a defined application rate (R). A linear motion device (30) is provided for relative linear motion between the application device (20, 20a) and the rotating device (10) at a defined feed rate (V) along the longitudinal axis (101) of the rotating invasive component (100). A control device (40) is provided for controlling the rotational speed (U) of the rotating device (10), the application rate (R) of the applying device (20, 20a) and the feed speed (V) of the linear motion device (30). in, The control device (40) is configured to control the rotational speed (U), the application rate (R), and the feed rate (V) in such a coordinated manner according to the viscosity (C) of the viscous coating solution (S) that the viscous coating solution (S) can be applied to the peripheral surface (102) in a fully oriented manner in the form of an overlapping spiral (H) along the longitudinal axis (101).

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

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

4. The device (1) according to any one of the preceding claims, characterized in that, A crosslinking device (60) is present, and the crosslinking device establishes the crosslinking of the solution components (S1, S2) of the viscous coating solution (S) applied to the peripheral side surface (102) for crosslinking and / or accelerating the crosslinking of the solution components (S1, S2) to be crosslinked.

5. The device (1) according to any one of the preceding claims, characterized in that, The rotating device (10) is provided for clamping and driving the rotation of an invasive component having a diameter of 0.5 mm to 10 mm and a length of 40 mm to 500 mm and a rotational speed of 20 U / min to 900 U / min, preferably 300 U / min to 600 U / min.

6. The device (1) according to any one of the preceding claims, characterized in that, The application device (20, 20a) is configured to apply a 25×10⁻⁶ atomized material at an application rate of 0.5 µl / s to 10 µl / s, preferably 1 µl / s to 3 µl / s. -3 kg / ms up to 80×10 -3 kg / ms, preferably 35×10 -3 kg / ms to 55×10 -3 A viscous coating solution with a viscosity (C) of kg / ms.

7. The device (1) according to any one of the preceding claims, characterized in that, The linear motion device (30) is configured to drive the application device (20, 20a) and / or the rotation device (10) to linear motion at a feed rate (V) between 0.5 mm / s and 50 mm / s, preferably between 5 mm / s and 10 mm / s.

8. A method (1000) for coating a medical invasive component (100), the medical invasive component having a longitudinal axis (101) and a peripheral side surface (102) that is rotationally symmetrical about the longitudinal axis (101) and extends straight longitudinally, the method comprising the steps of: The invasive component (100) is clamped (1001) into the rotating device (10); The clamped invasive component (100) is rotated (1002) by means of a rotating device (10), wherein, The rotation is performed at a defined rotational speed (U); A viscous coating solution (S) is applied (1003) to the peripheral side (102) of a rotating invasive component (100), wherein the viscous coating solution (S) is applied by means of an application device (20, 20a) that cannot rotate relative to the longitudinal axis (101) and at a defined application rate (R). The applying device (20, 20a) and / or the rotating device (10) are moved linearly (1004) along the longitudinal axis (101) of the rotating invasive assembly (100), wherein the applying device (20, 20a) is moved linearly relative to the rotating device (10) and / or the rotating device is moved linearly relative to the applying device by means of a linear motion device (30) and at a defined feed rate (V); The rotational speed (U), the applied rate (R), and the feed rate (V) are controlled (1005) by means of a control device (40). The rotational speed (U), the application rate (R), and the feed rate (V) are controlled in such a coordinated manner according to the viscosity (C) of the viscous coating solution (S) that the viscous coating solution (S) is applied to the peripheral surface (102) in a spiral (H) that overlaps along the longitudinal axis (101).

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

10. The method (1000) according to claim 8 or 9, characterized in that, The viscosity (C) is at 25 × 10⁻⁶. -3 kg / ms and 80×10 -3 Between kg / ms, preferably between 35 × 10 -3 kg / ms and 55×10 -3 Between kg / ms.

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

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

13. The method (1000) according to any one of claims 8 to 12, characterized in that, The rotational speed (U) is between 300 U / min and 600 U / min, and the viscosity (C) is 35 × 10⁻⁶. -3 kg / ms and 55×10 -3 The application rate (R) is between 1 µl / s and 3 µl / s, and the feed rate (V) is between 5 mm / s and 10 mm / s.

14. The method (1000) according to any one of claims 8 to 13, characterized in that, The viscous coating solution (S) is discharged from top to bottom in the form of suspended droplets about the direction of gravity at the application device (20, 20a), wherein the suspended droplets are contacted by the rotating invasive component (100), thereby the peripheral side (102) of the invasive component is spirally wrapped with the viscous coating solution (S).

15. The method (1000) according to any one of claims 8 to 13, characterized in that, The viscous coating solution (S) is discharged from the bottom up in the direction of gravity in the form of upright droplets at the application device (20, 20a), wherein the upright droplets are contacted by the rotating invasive component (100), thereby the peripheral side (102) of the invasive component is spirally wrapped with the viscous coating solution (S).

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