Method and apparatus for coating medical invasive components
By combining rotation and linear motion control, the problems of viscous coating solution consumption and thickness during the coating process are solved, achieving uniform coating of conduit hoses and improving coating efficiency and quality.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- B BRAUN MELSUNGEN AG
- Filing Date
- 2024-04-26
- Publication Date
- 2026-06-26
AI Technical Summary
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.
By employing a rotating device, an application device, a linear motion device, and a control device, the application rate and feed speed of the coating solution are precisely controlled through the combination of rotation and linear motion, thereby achieving uniform coating deposition.
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 quality and effectiveness of the coating.
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Figure CN120897803B_ABST
Abstract
Description
Technical Field
[0001] This 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 performance.
[0003] Catheter tubing is typically provided with a hydrophilic coating that forms a sliding film upon contact with a liquid. This sliding film is designed to improve the sliding properties of the catheter tubing in the guide tube or within the body.
[0004] Different methods for hydrophilic coating of catheters and hoses are known from the prior art.
[0005] In one known method, a viscous coating solution is sprayed onto the peripheral surface of a conduit hose. The viscous coating solution includes volatile solution components; after these components evaporate, the actual coating material remains on the peripheral surface as a hydrophilic coating. Areas on the peripheral surface that should not be coated must be masked before spraying. Furthermore, this spraying method requires more viscous coating solution than is ultimately applied to the peripheral surface.
[0006] In another known method, the conduit tubing is immersed in a viscous coating solution, which again presupposes covering areas that do not need to be coated. Even in this immersion method, a significantly larger amount of viscous coating solution must be provided than what is ultimately reached on the peripheral surface.
[0007] In other known methods, a tool, such as a sponge or brush, is used to apply a viscous coating solution to the surrounding surface. The amount of coating solution that can be applied is limited by the pressure applied by the tool. The thickness of the coating layer cannot be set or can be set poorly at best. Summary of the Invention
[0008] The object of this invention is to provide a method and an apparatus that allow for improved coating of medical invasive components having rotationally symmetrical and longitudinally extending peripheral surfaces. In particular, it aims to achieve, with minimal consumption of viscous coating solution, the coating of selected areas as comprehensively as possible with a well-adjustable layer thickness.
[0009] Advantageous design options are described below.
[0010] The device according to the invention includes a rotating device, an applying device, a linear motion device, and a control device. The rotating device is configured to clamp the invasive component and drive it to rotate about its longitudinal axis. The rotating device is configured to rotate the invasive component at a defined rotational speed. The rotational speed is a measure of the number of rotations per unit time for the rotating device and therefore the invasive component. The applying device is non-rotatable relative to the longitudinal axis and is configured to apply a viscous coating solution to the peripheral surface of the rotating invasive component. The applying device is configured to apply the viscous coating solution at a defined application rate. The application rate is a measure of the volume or weight of the viscous coating solution applied per unit time. In one design, the applying device is arranged below the longitudinal axis with respect to the direction of gravity ("upright droplet of viscous coating solution"). In another design, the applying device is instead arranged above the longitudinal axis ("suspended droplet of viscous coating solution"). The linear motion device is configured to drive the applying device and / or the rotating device linearly along the longitudinal axis of the rotating invasive component. With the aid of a linear motion device, the application device and the rotary device can move linearly relative to each other. In one design, the linear motion device is configured to enable linear movement of the application device, wherein the rotary device cannot move linearly. In another design, the linear motion device is configured to enable linear movement of the rotary device, wherein the application device cannot move linearly. In yet another design, the linear motion device is configured to enable linear movement not only of the application device but also of the rotary device. The linear motion device is configured for linear movement at a defined feed rate. The feed rate is a measure of the distance traveled by the application device and / or the rotary device along the longitudinal axis per unit time. A control device is configured to control the rotational speed of the rotary device, the application rate of the application device, and the feed rate of the linear motion device. Control is performed automatically. For this purpose, the control device can be wirelessly or wiredly connected to the rotary device, the application device, and the linear motion device. To apply the coating, the invasive component is first clamped into the rotary device. In different designs, the rotary device is configured in different ways to clamp the invasive component. The rotary device, for example, can have a preload unit with movable grippers, etc. Subsequently, the clamped invasive component is driven to rotate about its longitudinal axis. For this purpose, the rotating device preferably has a drive unit, especially an electric drive. However, the aforementioned drive unit is not a component of the device in all designs. Furthermore, the application device and / or the rotating device move along the longitudinal axis of the rotating invasive component by means of a linear motion device while simultaneously applying the coating solution. In order to apply the viscous coating solution at a defined application rate, in one design, the application device has at least one application unit and a pump unit. Optional application units can be designed, for example, as hollow needles, tubes, tapering hoses, etc., with outlets at one end, and are used to apply the viscous coating solution to the peripheral surface.The application device, particularly the application unit, is preferably spaced radially from the longitudinal axis such that the rotating peripheral surface is said to draw away the viscous coating solution from the application device / unit. The aforementioned spacing is preferably between 0.1 mm and 1.5 mm, and particularly preferably between 0.2 mm and 1.0 mm. If the peripheral surface to be coated should have an outer diameter that varies with respect to the longitudinal axis, the spacing is preferably kept constant, for example, by means of a radial linear motion device that provides for the relative radial displacement between the application device and the rotating device. An optional pump unit is used to deliver the viscous coating solution through the application unit, wherein the application rate can be affected by changing the pump power of the pump unit. The pump power and therefore the application rate are preferably controlled such that the application device, particularly the application unit, produces (upright or suspended) droplets that are drawn away upon contact with the rotating peripheral surface, thereby enveloping the invasive component with the viscous coating solution. In another design, the aforementioned pump unit is arranged away from the application device and thus fixed relative to it. A pump unit can be arranged, for example, in the area of a solution container storing the viscous coating solution to be applied. Movement is achieved by means of a linear motion device. Here, the viscous coating solution is applied helically, i.e., coiled and / or spirally, or wound onto a circumferential surface that rotates relative to the application device. The linear motion of the application device can occur over the entire length of the circumferential surface or only over a portion of it, i.e., a selected area. The viscous coating solution applied to the circumferential surface in this manner forms an actual coating after drying, evaporation, and / or crosslinking. Whether drying, evaporation, and / or crosslinking of the viscous coating solution is performed for coating formation depends on the characteristics of the coating solution / coating used and is not critical to the core of the invention. The uniformity, overall shape, and / or layer thickness of the coating can be easily set by coordinating the rotational speed, application rate, and feed rate. Furthermore, it is conceivable and feasible to perform multiple feeds in opposite feed directions, so that the coating can be said to be formed from multiple layers of the viscous coating solution. According to the present invention, the control device is configured to control the rotational speed, application rate, and feed rate based on the viscosity of the viscous coating solution. The viscosity of the viscous coating solution forms the control parameters for automatic control. In one embodiment of the invention, the device has an input device configured to manually input an input parameter representing the viscosity. In another embodiment of the invention, the device has a storage device storing data representing different viscosities of different coating solutions. The data can be retrieved from the storage device according to the viscous coating solution actually used and used as the basis for control. Furthermore, it is conceivable and feasible to obtain the viscosity during the operation of the device by means of a measuring device. If the peripheral surface has an outer diameter that varies with respect to the longitudinal axis, the control device is preferably configured to control the rotational speed, application rate, and feed rate based on the viscosity and the variable outer diameter.In this case, data representing the variable outer diameter with respect to the longitudinal axis can be stored in an optional storage device. Furthermore, according to the invention, the control device is configured to control the rotational speed, application rate, and feed rate in such a coordinated manner that the viscous coating solution can be applied comprehensively to the circumferential surface in an overlapping spiral pattern along the longitudinal axis. Thus, the rotational speed, application rate, and feed rate are coordinated such that the circumferential surface is continuously covered by the viscous coating solution in both the circumferential and axial directions. In one design, coordinated control is performed based on a predetermined rotational speed, wherein the application rate and / or feed rate are adapted to it, for example, based on a corresponding determining equation, a family of characteristic curves, etc. In another design, coordinated control is performed based on a predetermined application rate, wherein the rotational speed and feed rate are correspondingly acquired. In yet another design, coordinated control is performed based on a predetermined feed rate, wherein the rotational speed and / or application rate are correspondingly acquired. It goes without saying that combinations of the aforementioned solutions are also conceivable and achievable. Within the framework of this description, the range of values defined by expressions such as "between value X and value Y" also explicitly includes the extreme values X and Y mentioned here only by way of example. Preferably, the peripheral surface to be coated has an outer diameter between 0.5 mm and 1.5 mm, more preferably between 0.7 mm and 1.0 mm, and particularly preferably between 0.8 mm and 0.9 mm. Preferably, the outer diameter is constant about the longitudinal axis.
[0011] The solution according to the invention is applicable to coating medical invasive components having a longitudinal axis and peripheral surfaces that are rotationally symmetrical about the longitudinal axis and extend straight longitudinally. The solution according to the invention is particularly preferred for hydrophilic coating of catheter tubing.
[0012] In another embodiment of the invention, the viscous coating solution to be applied is formed from multiple separately stored solution components, wherein the application device is configured for simultaneously applying multiple solution components and has an application unit for each of the multiple solution components. This embodiment of the invention allows for easy and efficient application of multi-component coating solutions. The application units are preferably designed in the form of hollow needles or the like, each with an outlet at one end. Different solution components do not necessarily have to be applied simultaneously. More precisely, it is conceivable and feasible to first apply one solution component along the feed direction, and then apply the other solution component along the opposite feed direction. Alternatively, applications are performed sequentially along the same feed direction, thereby easily ensuring that the coated area on the peripheral side receives the same evaporation time and / or drying time before the application of the other solution component. While it is theoretically feasible to apply a multi-component coating solution using only one application unit, this may require cleaning the application unit during this period. This can be eliminated in this embodiment of the invention.
[0013] In another embodiment of the invention, an evaporation device is provided, which is configured to evaporate and / or accelerate the evaporation of volatile solution components of the viscous coating solution applied to the peripheral surface. Specifically, the hydrophilic coating solution typically has volatile solution components that serve as solvents for the actual coating material. Evaporation of the volatile solution components is provided after the application of the viscous coating solution, so that the coating material remains on the peripheral surface in the case of forming a hydrophilic coating. The evaporation device initiates and / or supports the evaporation process. In different embodiments, the evaporation device is designed differently. In one embodiment, the evaporation device has a heating unit for heating the peripheral surface where the viscous coating solution is applied. In another embodiment, as an alternative or additional embodiment, the evaporation device has a fan unit configured to blow air onto the peripheral surface where the viscous coating solution is applied. By heating and / or blowing air onto the viscous coating solution located on the peripheral surface, the evaporation process can be started, maintained, and / or accelerated according to the specific characteristics of the viscous coating solution used and the surrounding environmental conditions.
[0014] In another embodiment of the invention, a crosslinking device is provided, which is configured to crosslink and / or accelerate the crosslinking of the solution components to be crosslinked in the viscous coating solution applied to the peripheral surface. Specifically, a hydrophilic coating is typically formed when the viscous solution components are crosslinked. Here, the solution components used are preferably crosslinked individually and sequentially, and not, for example, with each other. The crosslinking device is configured to initiate, maintain, and / or accelerate the crosslinking process and is designed differently in different embodiments of the invention. For example, coating solutions that can be crosslinked by means of light, especially ultraviolet light, are known. In this case, the crosslinking device preferably has at least one light source, especially an ultraviolet light source.
[0015] In another embodiment of the invention, the rotating device is provided for clamping and driving the rotation of 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 a rotational speed of 20 U / min to 900 U / min, preferably 250 U / min to 800 U / min, preferably 300 U / min to 600 U / min, preferably 600 U / min.
[0016] In another embodiment of the invention, the application device is configured to apply a 25×10⁻⁶ atomized material at an application rate 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. -3 kg / ms up to 80×10 -3 kg / ms, preferably 35×10 -3 kg / ms to 55×10 -3 kg / ms, further optimized 43×10 -3 kg / ms up to 48×10 -3 A viscous coating solution with a viscosity of kg / ms. Therefore, the processable viscosity fluctuates between 25 and 80 cP (centipoise).
[0017] In another embodiment of the invention, the linear motion device is configured to drive the application device and / or the rotary device to linear motion at a feed rate between 0.5 mm / s and 50 mm / s, preferably between 4 mm / s and 40 mm / s, more preferably between 5 mm / s and 10 mm / s, and even more preferably 10 mm / s.
[0018] The method according to the invention is used for coating medical invasive components having a longitudinal axis and circumferential surfaces that are rotationally symmetrical about the longitudinal axis and extend vertically in a straight line. In particular, the method is used for hydrophilic coating of catheter tubing. The method according to the invention comprises the following steps: clamping an invasive component into a rotating device; rotating the clamped invasive component by means of the rotating device, wherein the rotation is performed at a defined rotational speed; applying a viscous coating solution to the peripheral surface of the rotating invasive component, wherein the viscous coating solution is applied by means of an application device that cannot rotate relative to the longitudinal axis and at a defined application rate; linearly moving the application device and / or the rotating device along the longitudinal axis of the rotating invasive component, wherein the application device is linearly moved relative to the rotating device and / or the rotating device is linearly moved relative to the application device by means of a linear motion device and at a defined feed rate; controlling the rotational speed, application rate, and feed rate by means of a control device, wherein the rotational speed, application rate, and feed rate are controlled in such a coordinated manner according to the viscosity of the viscous coating solution that the viscous coating solution is applied uniformly to the peripheral surface in an overlapping spiral pattern along the longitudinal axis. The description of the device according to the invention, with necessary modifications, also applies to the method according to the invention. To avoid repetition, the description of the device according to the invention is explicitly referenced and invoked. In another design of the present invention, 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, and most preferably 600 U / min.
[0019] In another embodiment of the invention, the viscosity is 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, further preferably between 43 × 10 -3 kg / ms up to 48×10 -3 Between kg / ms.
[0020] In another embodiment of the invention, the application rate is between 0.5 µl / s and 10 µl / s, preferably between 0.7 µl / s and 5 µl / s, more preferably between 1 µl / s and 3 µl / s, and even more preferably between 0.9 µl / s and 2.5 µl / s.
[0021] In another embodiment of the invention, the feed rate is between 0.5 mm / s and 50 mm / s, more preferably between 4 mm / s and 40 mm / s, more preferably between 5 mm / s and 10 mm / s, and more preferably 10 mm / s.
[0022] In another design of the present invention, the rotational speed is between 300 U / min and 600 U / min, and the viscosity is 35 × 10⁻⁶. -3 kg / ms and 55×10 -3 The application rate is between 1 µl / s and 3 µl / s, and the feed rate is between 5 mm / s and 10 mm / s. This is a particularly preferred design. In another embodiment of the invention, the rotational speed is 600 U / min, and the viscosity is 43 × 10⁻⁶. -3 kg / ms and 48×10 -3 The application rate is between 0.9 µl / s and 2.5 µl / s, and the feed rate is 10 mm / s. The aforementioned range of process parameters has proven particularly advantageous in achieving the stated objectives. This design of the invention particularly ensures that, despite the relatively high viscosity and / or paste-like nature of the coating solution, no defective portions are left between adjacent spiral sections of the spiral / coating, and a constant and / or uniform layer thickness along the longitudinal axis is obtained. In the case of relatively low viscosity coating liquids, such control of process parameters is not required because the coating liquid is wet and / or flows on the circumferential surface and can therefore be applied in the form of a liquid film rather than, for example, in a spiral manner.
[0023] In another embodiment of the invention, a primer, also known as a base coat, is first applied, followed by a top coat.
[0024] In another embodiment of the invention, the viscous coating solution is discharged from the application device in the form of suspended droplets from top to bottom with respect to gravity. These suspended droplets are contacted by a rotating invasive component, whereby the peripheral surface of the invasive component is spirally wrapped with the viscous coating solution. The application rate is controlled to facilitate the discharge of the suspended droplets.
[0025] In another embodiment of the invention, the viscous coating solution is discharged from the application device in the form of upright droplets from bottom to top with respect to gravity. These upright droplets are contacted by a rotating invasive component, whereby the peripheral surface of the invasive component is spirally wrapped with the viscous coating solution. The application rate is controlled to discharge the suspended droplets. Attached Figure Description
[0026] Further advantages and features of the present invention will become apparent from the following description of preferred embodiments of the invention, illustrated with reference to the accompanying drawings. Wherein:
[0027] Figure 1 An embodiment of the device according to the invention for coating a medical invasive component in the form of a catheter tubing is illustrated in a schematic simplified diagram.
[0028] Figure 2 A section of the catheter tubing is shown in a magnified, detailed diagram.
[0029] Figure 3 A simplified schematic diagram illustrates the following based on Figure 1 A variant of the application device of the equipment, and
[0030] Figure 4 A flowchart illustrating an embodiment of the method according to the present invention is shown. Detailed Implementation
[0031] according to Figure 1 A device 1 for coating medical invasive components has been developed.
[0032] The invasive component herein is a catheter tubing 100 having a longitudinal axis 101 and a peripheral side surface 102. The peripheral side surface 102 extends longitudinally in a straight line along the longitudinal axis 101 and is rotationally symmetrical. The catheter tubing 100 to be coated extends longitudinally between a first end 103 and a second end 104, wherein, according to Figure 1 The obvious dimensional design should be understood in a purely illustrative and not proportional manner.
[0033] The coating to be applied is obtained by means of device 1 (see Figure 2 The coating described herein is a hydrophilic coating B, which forms a sliding film upon contact with a liquid. This sliding film supports the mobility of the catheter tubing 100 within the catheter system, allowing the tubing 100 to be advanced as smoothly as possible to its designated location within the guide tube and / or within the body. Coating B is formed in a manner to be described in further detail by a viscous coating solution S (see [link to documentation]). Figure 1 It is formed on the circumferential side 102.
[0034] The device 1 has a rotating device 10, an applying device 20, a linear motion device 30, and a control device 40.
[0035] In the illustrated embodiment, device 1 further includes an optional evaporation device 50, which can also be configured as a crosslinking device 60. Additionally, the device herein includes an optional solution container 70.
[0036] The rotating device 10 is configured to clamp the tubing 100 and drive it to rotate about its longitudinal axis 101. The rotation is performed by means of a defined rotational speed U, i.e., the number of rotations per unit time.
[0037] The application device 20 is non-rotatable relative to the longitudinal axis 101 and is configured to apply the viscous coating solution S to the peripheral side 102 of the rotating conduit hose 100. The application of the viscous coating solution S is carried out at a defined application rate R, which is a measure of the amount (volume and / or mass) of coating solution S applied per unit time.
[0038] The linear motion device 30 is configured herein to drive the application device 20 to linear motion along the longitudinal axis 101. The linear motion is performed at a defined feed rate V, i.e., the distance traveled along the longitudinal axis 101 per unit time. In an embodiment not shown in the accompanying drawings, as an alternative or additional embodiment, the linear motion device is configured to drive the rotating device to linear motion along the longitudinal axis.
[0039] The control device 40 is configured to control 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 motion device 30. Furthermore, the rotational speed U and / or feed speed V can also be controlled based on the variable outer diameter of the tubing / hose 100 and / or the circumferential surface 102, particularly with respect to the longitudinal axis.
[0040] During the feeding motion of the application device 20 and with the rotation of the rotating device 10 and thus the catheter hose 100, the viscous coating solution S is applied to the peripheral side surface 102 of the catheter hose. Depending on the extent to which the application device 20 feeds along the longitudinal axis 101, the peripheral side surface 102 can be substantially completely coated with the viscous coating solution S, except for the section clamped in the rotating device 10. However, it is also possible to coat only the longitudinal section of the peripheral side surface 102. Furthermore, it is conceivable and feasible to perform the feeding motion repeatedly and / or in the opposite direction. This allows the viscous coating solution S to be applied in multiple layers.
[0041] In the illustrated embodiment, the rotational speed U, application rate R, and feed rate V are controlled based on the viscosity C of the viscous coating solution S to be applied. In this regard, viscosity C serves as a control parameter for the control device 40, although other or alternative control parameters can, of course, also be set.
[0042] Viscosity C, or more precisely, the numerical value representing this physical characteristic parameter, for example, can be expressed as... Figure 1 The input can be manually entered at an input device not shown. Alternatively or as an additional option, the viscosity C can be measured by recalling data from a storage device or by means of a measuring device.
[0043] In the illustrated embodiment, the control device 40 is configured to control the rotational speed U, the application rate R, and the feed rate V in a coordinated manner, and more precisely, to control such that the viscous coating solution S can be applied to the peripheral surface 102 in the form of overlapping spirals H along the longitudinal axis 101 (see [link]). Figure 2 ).
[0044] The helix H mentioned can also be called a coil or spiral, and according to Figure 2 The schematic diagram shows four exemplary windings or helices H1, H2, H3, and H4. Directly adjacent helices overlap along the longitudinal axis 101, forming a measurement G that can also be called the overlap. A full-coverage coating is achieved through the overlap.
[0045] In the illustrated embodiment, the viscous coating solution S is discharged from the application device 20 in the form of suspended droplets (not shown in detail in the figures) from top to bottom with respect to gravity. The suspended droplets are contacted by the rotating conduit hose 100, thereby spirally winding the viscous coating solution S around the peripheral side 102 of the conduit hose. Therefore, the coating solution S is not, for example, dripped or sprayed onto the peripheral side 102, but rather more accurately described as being "drawn away" from the application device.
[0046] In this paper, the actual, in this case, hydrophilic coating B is formed after the viscous coating solution S applied to the peripheral side 102 dries and / or crosslinks.
[0047] exist Figure 1 In the illustrated embodiment, 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 evaporates, the coating material SB remains on the peripheral side surface 102 in the case of constructing coating B.
[0048] In the illustrated embodiment, the rotating device has a pre-tensioning unit 11 and a drive unit 12.
[0049] The pre-tightening unit 11 is provided for clamping the tubing 100 at the end and for this purpose has, for example, a movable chuck, clamping device or locking device.
[0050] The drive unit 12 is used to rotate the preload unit 11 and is preferably configured as an electric motor.
[0051] Furthermore, at least one support unit may be present, and this support unit is particularly associated with the rotating device. Optional support units are used to radially support the tubing to be coated and to inhibit deflection of the tubing.
[0052] In this document, the control device 40 is connected to the rotating device 10, and in particular the drive unit 12, by means of a signal line 41 to control the rotational speed U.
[0053] In the illustrated embodiment, the application device 20 has an application unit 21 and a pump unit 22.
[0054] The application unit 21 is designed in the form of a hollow needle and has an outlet (not shown in the figures) through which the viscous coating solution S flows from the application device 20 onto the peripheral side 102. In this document, the aforementioned (suspended) droplets are discharged at the outlet.
[0055] Pump unit 22 is used to pump the viscous coating solution S through application unit 21 and its outlet. In the illustrated embodiment, pump unit 22 is associated with application device 20; however, this is not the case in all embodiments. Pump unit 20 is connected to solution container 70 via fluid lines (not shown in the figures). The solution container 70 stores the viscous coating solution S to be applied. Solution container 70, as mentioned earlier, is optional and not present in all embodiments of the device. The fluid lines are constructed and arranged to ensure functional mobility of application device 20 relative to the stationary solution container 70.
[0056] In this document, the control device 40 is connected to the application device 20 via signal line 42 to control the application rate R. In this document, the application rate R is controlled in such a way, especially in conjunction with the viscosity C and / or other process parameters, so that the aforementioned (suspended) droplets are formed and continuously applied from the application device 20 to the peripheral surface 102.
[0057] In the illustrated embodiment, the linear motion device 30 has a guide axis 31 extending parallel to the longitudinal axis 101, which extends longitudinally between a first end 32 and a second end 33. The application unit 20 is linearly guided and driven between the first end 32 and the second end 33 along the guide axis 31. The drive can be performed in any suitable manner. The linear motion device 30 can, for example, work in conjunction with the application device 20 via a motion spindle, belt drive, rack, etc.
[0058] In order to control the feed speed V, the control device 40 is connected to the linear motion device 30 via signal line 43 in this document.
[0059] In the illustrated embodiment, the device 1 further includes the previously mentioned optional evaporation unit 50. The evaporation unit 50 supports the drying of the viscous coating solution S applied to the peripheral side 102 by initiating, maintaining, and / or accelerating the evaporation process of the volatile solution component SF. For this purpose, the evaporation unit 50 can have a heating unit, particularly an infrared radiator, not shown in more detail in the figures, wherein a fan unit can also be present as an alternative or additional option. In the illustrated embodiment, the evaporation unit 50 extends substantially over the entire length of the feasible feed stroke of the application device 20 and is arranged on the side of the conduit hose 100 opposite to the application device 20 and the linear motion device 30 along the longitudinal axis 101. The arrangement is fixed. In embodiments not shown in the figures, the evaporation unit can instead move relatively shortly with the application device and be arranged at a certain longitudinal spacing offset from it. This achieves a relatively more compact structural form.
[0060] In the illustrated embodiment, the evaporation device 50 is connected to the control of the device 1 and is connected to the control device 40 via signal line 44 for this purpose.
[0061] In the illustrated embodiment, the rotating device 10 is configured to clamp and rotate an invasive component having a diameter of 0.5 mm to 10 mm, particularly 0.7 mm to 0.9 mm. The length of the coatable invasive component is between 40 mm and 500 mm, particularly 80 mm to 250 mm. The feasible rotational speed U fluctuates between 20 U / min and 900 U / min herein.
[0062] In the illustrated embodiment, the application device 20 allows the processing of viscous coating solutions with a viscosity V of 25 cP to 80 cP, which corresponds to 25 × 10⁻⁶. -3 kg / ms up to 80×10 -3 kg / ms. Feasible application rates vary between 0.5 µl / s and 10 µl / s.
[0063] Furthermore, in the illustrated embodiment, a feed rate V between 0.5 mm / s and 50 mm / s is feasible. A linear motion device 30 is correspondingly provided.
[0064] During the coating of the catheter hose 100, as specifically shown, a rotational speed U is specified to be between 300 U / min and 600 U / min, a feed rate V is specified to be between 5 mm / s and 10 mm / s, and an application rate is specified to be between 1 µl / s and 3 µl / s, wherein the viscosity V of the viscous coating solution S used herein is 35 × 10⁻⁶. -3 kg / ms and 55×10-3 The coating volume is between 1 µl / cm and 4 µl / cm.
[0065] In an embodiment not shown in the accompanying drawings, the rotational speed U is 600 U / min, the feed rate 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 43 × 10⁻⁶. -3 kg / ms and 48×10 -3 Between kg / ms.
[0066] according to Figure 3 An application device 20a, implemented differently, is shown, which can be used in place of application device 20 according to Figure 1 In device 1.
[0067] according to Figure 3 The application device 20a is provided for applying a first solution component S1 and a second solution component S2, which together form a viscous coating solution or coating. Such multi-component coatings are known in principle, especially in the hydrophilic coating of conduit hoses.
[0068] 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'. These two solution containers 70a and 70a' are respectively connected to the application device 20a via fluid lines (not shown in the figures). Furthermore, separate pump units 22a and 22a' are provided herein. Here, each fluid line and therefore each solution container in the two solution containers 70a and 70a' is associated with one of the two pump units 22a and 22a'. In the illustrated variant, the two pump units 22a and 22a' are arranged separately from and fixed relative to the actual application device 20a.
[0069] The application device 20a has a first application unit 21a and a second application unit 21a'. Regarding specific design schemes for these two application units 21a and 21a', [further details have been provided]. Figure 1 The description of the application unit 21 therein applies 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 via a fluid conduit (not shown in more detail). The second application unit 21a' is connected to the second solution container 70a' via a separate fluid conduit (not shown in the figure).
[0070] exist Figure 3In the variant shown, 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 and R2 can be changed / controlled by correspondingly controlling the respective pump units 22a and 22a'.
[0071] To construct the coating, the two solution components S1 and S2 are crosslinked separately. For this purpose, apparatus 1 can have components that have been crosslinked according to… Figure 1 The crosslinking device 60 is an optional alternative to the evaporation device 50. The crosslinking device 60 is configured to crosslink and / or accelerate the crosslinking of the solution components S1 and S2 applied to the peripheral surface. For this purpose, the crosslinking device 60 can, for example, have a light source, particularly an ultraviolet light source.
[0072] according to Figure 4 An embodiment of the method 1000 according to the present invention is illustrated schematically. When using... Figure 1 Method 1000 can be performed using device 1. Method 1000 specifies clamping 1001 of the catheter tubing 100 into the rotating device 10. Furthermore, method 1000 specifies rotating 1002 of the clamped catheter tubing 100 by means of the rotating device 10, wherein the rotation is performed at a rotational speed U. Furthermore, method 1000 specifies applying 1003 of a viscous coating solution S to the peripheral side 102 of the rotating catheter tubing 100. Here, the viscous coating solution S is applied by means of an application device 20. This is performed at an application rate R. Furthermore, method 1000 specifies linearly moving 1004 of the application device 20 along the longitudinal axis 101 of the rotating catheter tubing 100. Here, the application device 20 is linearly moved along the longitudinal axis 101 at a defined feed rate V by means of a linear motion device 30. Furthermore, method 1000 specifies controlling 1005 the rotational speed U, application rate R, and feed rate V by means of a control device 40. Here, the rotational speed U, application rate R, and feed rate V are controlled in such a coordinated manner according to the viscosity C of the viscous coating solution S, so that the viscous coating solution S is applied to the peripheral side surface 102 in a spiral H that overlaps along the longitudinal axis 101 as mentioned above.
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). Its features are, 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 overlapping spirals (H) along the longitudinal axis (101). The viscous coating solution (S) is discharged from top to bottom in the direction of gravity as suspended droplets at the application device (20, 20a), wherein the suspended droplets are contacted by the rotating invasive component (100), thereby spirally winding the peripheral side (102) of the invasive component with the viscous coating solution (S), or 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).
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 claim 1 or 2, 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 claim 1 or 2, characterized in that, The rotating device (10) is configured to clamp and drive 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.
6. The device (1) according to claim 5, characterized in that, The rotating device (10) is configured to clamp and drive the invasive component to rotate at a speed of 300 U / min to 600 U / min.
7. The device (1) according to claim 1 or 2, characterized in that, The application device (20, 20a) is configured to apply a 25×10⁻⁶ electrode material at an application rate of 0.5 µl / s to 10 µl / s. -3 kg / ms up to 80×10 -3 A viscous coating solution with a viscosity (C) of kg / ms.
8. The device (1) according to claim 7, characterized in that, The application device (20, 20a) is configured to apply a 25×10⁻⁶ atomized material at an application rate of 1 µl / s to 3 µl / s. -3 kg / ms up to 80×10 -3 A viscous coating solution with a viscosity (C) of kg / ms.
9. The device (1) according to claim 7, characterized in that, The application device (20, 20a) is configured to apply a 35×10⁻⁶ atomized material at an application rate of 0.5 µl / s to 10 µl / s. -3 kg / ms to 55×10 -3 A viscous coating solution with a viscosity (C) of kg / ms.
10. The device (1) according to claim 1 or 2, 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.
11. The device (1) according to claim 10, 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 5 mm / s and 10 mm / s.
12. 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 vertically in a straight direction, 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 characteristic feature is that 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 fully oriented spiral (H) pattern overlapping along the longitudinal axis (101). The viscous coating solution (S) is discharged from top to bottom in the direction of gravity as suspended droplets at the application device (20, 20a), wherein the suspended droplets are contacted by the rotating invasive component (100), thereby spirally winding the peripheral side (102) of the invasive component with the viscous coating solution (S), or 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).
13. The method (1000) according to claim 12, characterized in that, The rotational speed (U) is between 20 U / min and 900 U / min.
14. The method (1000) according to claim 13, characterized in that, The rotational speed (U) is between 300 U / min and 600 U / min.
15. The method (1000) according to claim 12 or 13, characterized in that, The viscosity (C) is at 25 × 10⁻⁶. -3 kg / ms and 80×10 -3 Between kg / ms.
16. The method (1000) according to claim 12 or 13, characterized in that, The viscosity (C) is 35 × 10⁻⁶. -3 kg / ms and 55×10 -3 Between kg / ms.
17. The method (1000) according to claim 12 or 13, characterized in that, The application rate (R) is between 0.5 µl / s and 10 µl / s.
18. The method (1000) according to claim 17, characterized in that, The application rate (R) is between 1 µl / s and 3 µl / s.
19. The method (1000) according to claim 12 or 13, characterized in that, The feed rate (V) is between 0.5 mm / s and 50 mm / s.
20. The method (1000) according to claim 19, characterized in that, The feed rate (V) is between 5 mm / s and 10 mm / s.
21. The method (1000) according to claim 12 or 13, 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.