Catheter liner binding layer coating

Abstract

To provide an alternative tubular liner that can be adequately bonded to an overlying outer layer in a catheter structure, and a method for providing such a tubular liner. [Solution] This disclosure provides a coated tube material comprising a layer of PEBA (or other polymer) on an etched polymer tube material. The PEBA (or other polymer) layer can have a thin thickness, for example, less than 1 micron, and can provide efficient bonding to an overlay layer. This disclosure further provides a method for manufacturing and using such a coated tube material.

Description

Technical Field

[0001] Cross - reference to Related Applications This application claims the benefit of U.S. Provisional Application No. 63 / 395,057, filed on August 4, 2022, the disclosure of which is incorporated herein by reference in its entirety.

[0002] This application is directed to functional plastic tubing materials with applications in various fields and methods of manufacturing such functional plastic tubing materials.

Background Art

[0003] Polytetrafluoroethylene (PTFE) tubular liners are known in the art and are widely used, for example, in catheter manufacturing. In the context of catheter manufacturing, PTFE liners are commonly used as the first (innermost) layer of a catheter. Due to the chemical resistance, biocompatibility, and low coefficient of friction (COF) of PTFE, PTFE is an ideal material as an inner liner of a catheter. PTFE exhibits unique properties that are unsurpassed by other polymers in this field. Due to such a low COF, PTFE can provide an inner diameter that allows various catheter technologies, such as stents, balloons, atherectomy, or thrombus removal devices, to be easily pushed through a small - diameter catheter lumen. The effect of increased lubricity of the catheter inner diameter (ID) reduces the deployment force of the catheter device as it passes through the lumen of the catheter ID, increasing the likelihood of a successful procedure.

[0004] To facilitate adhesion between the outer surface of a PTFE liner and an adjacent outer / coating layer, such as polyether block amide (PEBA), the outer surface of the PTFE liner is typically etched. A well-known drawback of the etching process used to functionalize the surface of a PTFE liner is that the etched surface changes over time as it adsorbs reactive species from its surroundings. As a result of this reactive adsorption process, the proliferation of bonding sites on the PTFE liner for adhesion to the coating decreases as the surface ages. Known techniques utilize phenolic coatings to apply PEBA coatings. Similar products manufactured by casting are taught in Non-Patent Literature 1. Liu et al. dissolve very soft PEBA, Altofina 2533, in an n-butanol / isopropanol mixture to cast a film. The researchers have not reported any tests using harder grades of PEBA or applications using tube coatings. [Prior art documents] [Non-patent literature]

[0005] [Non-Patent Document 1] L. Liu, A. Chakman, X. Feng, “A Novel Method of Preparing Ultrathin Poly (Ether Block Amide) Membranes,” J. Membrane Sci., 235, 43-52, 2004 [Overview of the project] [Problems that the invention aims to solve]

[0006] It would be useful to provide an alternative tubular liner that can be adequately bonded to the overlying outer layer in a catheter structure, and a method for providing such a tubular liner. [Means for solving the problem]

[0007] This disclosure generally provides tubing materials comprising a thin layer (also referred to herein as a “tie layer”) of a tie-resin coated with PEBA, nylon, polyurethane, and / or polyester of various hardnesses on a functional plastic tubing material. The functional plastic tubing material may be, for example, an etched PTFE liner or plasma-treated polyethylene, which can be used for the shaft structure of a catheter. The tie-resin layer bonds to the functionalized outer surface of the functional plastic tubing material and provides adhesion to other materials applied thereon, including tubes made of PEBA, nylon, polyurethane, etc., which are then reflowed onto the liner / tie-resin and braided assembly during catheter construction.

[0008] Coating an etched surface with a thin binder resin layer, as provided herein, can help maintain adhesion by preventing further aging of the surface of the underlying functional plastic tubing material. If the binder resin layer is applied in a second step, some surface aging will nevertheless occur prior to that application step. In some embodiments, the disclosed binder layer application step can be performed inline immediately after a surface etching operation performed on the functional plastic tubing material, thereby minimizing / eliminating the aging effect on the etched surface.

[0009] This disclosure includes, but is not limited to, the following embodiments.

[0010] Embodiment 1: A coated tubing material comprising an etched PTFE tubing material having an inner surface and an outer surface, wherein the outer surface comprises a layer of PEBA having an average thickness of less than 1 micron.

[0011] Embodiment 2: The coating tube material according to Embodiment 1, wherein the PEBA has a durometer of 25 to 72.

[0012] Embodiment 3: A coating tube material according to Embodiment 1 or 2, prepared using a PEBA-containing solution.

[0013] Embodiment 4: The coating tube material according to Embodiment 3, wherein the PEBA-containing solution comprises a solvent selected from methanol, ethanol, 2-methyl-2-propanol, 1-butanol, 2-butanol, and mixtures thereof.

[0014] Embodiment 5: The coating tube material according to Embodiment 3, wherein the PEBA-containing solution contains 1-butanol.

[0015] Embodiment 6: The coating tube material according to any one of Embodiments 3 to 5, wherein the PEBA is present in the PEBA-containing solution at a weight / volume ratio of less than 0.10 g / mL.

[0016] Embodiment 7: A coating tube material according to any one of Embodiments 3 to 6, wherein the PEBA-containing solution is at a temperature of 20°C to 100°C during coating.

[0017] Embodiment 8: The coated tube material according to any one of Embodiments 1 to 7, wherein the average thickness of the coating is less than 0.9 μm.

[0018] Embodiment 9: The coated tube material according to Embodiment 8, wherein the average thickness of the coating is less than 0.8 μm.

[0019] Embodiment 10: The coated tube material according to any one of Embodiments 1 to 9, further comprising a jacket layer containing PEBA or a polyamide coated on a layer of PEBA.

[0020] Embodiment 11: The coating tube material according to any one of Embodiments 1 to 10, wherein the PEBA layer is essentially made of PEBA.

[0021] Embodiment 12: The coating tube material according to any one of Embodiments 1 to 10, wherein the layer of PEBA contains one or more additives.

[0022] Embodiment 13: The coating tube material according to any one of Embodiments 1 to 12, wherein the layer of PEBA substantially does not contain residual solvent.

[0023] Embodiment 14: The coating tube material according to any one of Embodiments 1 to 13, wherein the coating tube material is a catheter liner.

[0024] Embodiment 15: A catheter comprising the coating tube material according to any one of Embodiments 1 to 14.

[0025] Embodiment 16: A coating tube material comprising a tube material containing a fluoropolymer and having an inner surface and an outer surface, wherein the outer surface includes a bonding layer thereon, and the bonding layer has an average thickness of less than 1 micron.

[0026] Embodiment 17: A method of manufacturing a coating tube material having an inner surface and an outer surface, the method comprising: providing an etched PTFE tube material having an inner surface and an outer surface; dissolving PEBA in one or more solvents to provide a PEBA-containing solution; and applying the PEBA-containing solution to the outer surface of the etched PTFE tube material to form a PEBA layer having an average thickness of less than 1 micron thereon.

[0027] Embodiment 18: The method according to Embodiment 17, wherein the dissolving includes heating and / or stirring the PEBA in one or more solvents.

[0028] Embodiment 19: The method according to Embodiment 17 or 18, wherein the PEBA-containing solution includes a solvent selected from non-aromatic alcohols.

[0029] Embodiment 20: The method according to Embodiment 19, wherein the non-aromatic alcohol is selected from methanol, ethanol, 2-methyl-2-propanol, 1-butanol, 2-butanol, and mixtures thereof.

[0030] Embodiment 21: The method according to any one of Embodiments 17 to 20, wherein the PEBA-containing solution comprises a solvent selected from glycols, diols, and ketones.

[0031] Embodiment 22: The method according to any one of Embodiments 17 to 21, wherein the PEBA-containing solution does not contain an aromatic alcohol.

[0032] Embodiment 23: The method according to any one of Embodiments 17 to 21, wherein the method of application includes physically coating, chemically coating, dipping, or spraying the PEBA-containing solution onto an etched PTFE tube material.

[0033] These and other features, aspects, and advantages of this disclosure will become apparent upon reading the following detailed description together with the concisely described accompanying drawings below. The present invention includes any combination of two, three, four, or more of the embodiments described above, and any combination of any two, three, four, or more features or elements described herein, whether or not such features or elements are expressly combined in the description of a particular embodiment herein. This disclosure is intended to be read in whole so that, in any of its various aspects and embodiments, any separable features or elements of the disclosed invention are intended to be combined unless the context explicitly indicates otherwise.

[0034] The accompanying drawings are provided for understanding embodiments of the present invention; however, these drawings are not necessarily drawn to exact scale, and the reference numerals refer to components of exemplary embodiments of the present invention. The drawings are illustrative and should not be construed as limiting the present invention. [Brief explanation of the drawing]

[0035] [Figure 1] This is a general schematic diagram of a functional plastic tube material 10, which is a component of the tube material of this disclosure, having related parameters, and an enlarged schematic diagram of one cross-sectional end face of the tube material. [Figure 2] This is a schematic diagram of a tube material 15 provided according to one embodiment of the present disclosure, which includes a functional plastic tube material 10 and a bonding layer coating 12 thereon. [Modes for carrying out the invention]

[0036] The present invention will be described in more detail below with reference to the accompanying drawings, which illustrate some, though not all, embodiments of the invention. In fact, these inventions can be embodied in many different forms and should not be construed as being limited to the embodiments described herein; rather, these embodiments are provided to satisfy the legal requirements to which this disclosure is applicable. Similar numbers refer to similar elements throughout.

[0037] This disclosure provides a functional plastic tube material having a binding layer coating on its outer surface, the binding layer coating in direct contact with the outer polymer layer. This disclosure further provides a method for preparing and using such assemblies.

[0038] The underlying functional plastic tubing material referenced herein can be better understood by referring to Figure 1, where the functional plastic tubing material 10 is depicted in its longitudinal and cross-sectional shape. Because this disclosure is applicable to a wide range of plastic tubing materials, the size of the plastic tubing material (e.g., inner diameter (ID), outer diameter (OD), wall thickness, length L, etc.) is not particularly limited. In some embodiments, the plastic tubing material is thin-walled, but this disclosure is not limited thereto. In some embodiments, the plastic tubing material may have an average wall thickness of 0.1 mm or less, e.g., about 0.09 mm or less, about 0.08 mm or less, about 0.07 mm or less, about 0.06 mm or less, or about 0.05 mm or less, e.g., about 0.01 mm to about 0.1 mm. The ID (determining the diameter of the lumen) can be varied and, in some embodiments, is a size suitable for catheter applications such as liners. The outer diameter of the tube, indicated as "OD," is the average distance from one point on the outer wall of the tube through the lumen of the tube to the opposite / farthest point on the outer wall of the tube. Therefore, half of the value obtained by subtracting the ID value from the OD value is the average wall thickness of the tube.

[0039] The composition of the functional plastic tubing material is not particularly limited; in preferred embodiments, the plastic tubing material may include any material suitable for use as an inner layer / liner of a catheter assembly. Such materials include, but are not limited to, fluoropolymers such as poly(tetrafluoroethylene) (PTFE), fluorinated ethylene propylene (FEP), polyfluoroalkoxy (PFA), polyvinylidene fluoride (PVDF), and their derivatives, copolymers, and mixtures. In some embodiments, the functional plastic tubing material may consist essentially of a reference polymer. In other embodiments, the functional plastic tubing material may include one or more additives, which may be added intentionally and / or residues of resins used to manufacture the tubing (e.g., lubricants or other processing additives).

[0040] "Functionalized" means that the surface of the plastic tubing material is treated in some way to facilitate adhesion between the OD surface and the material to which it is applied. In some embodiments, functionalization includes etching. Methods for etching such plastic tubing materials and commercially available etched tubing materials are known. In some embodiments, etching is performed in-line during the manufacture of the plastic tubing material, for example, as will be described in more detail below. Other surface functionalization methods known to enhance the bond between two plastic surfaces (e.g., improving adhesive properties by activating the surface of the plastic tubing material) can also be used in various embodiments.

[0041] Figure 2 shows a tube material 15 comprising a functional plastic tube material 10, having a bonding layer 12 that covers and directly contacts the surface of the OD of the tube material 10. As used herein, “bonding layer” (12) is intended to mean a thin layer of polymer compound. In some embodiments, the bonding layer has an average thickness of about 10 microns or less, about 5 microns or less, about 4 microns or less, about 3 microns or less, about 2 microns or less, about 1 micron or less, about 0.9 microns or less, or about 0.8 microns or less, for example, about 0.1 to about 10 microns, about 0.5 to about 10 microns, about 0.1 to about 5 microns, about 0.5 to about 5 microns, about 0.8 to about 10 microns, about 0.8 to about 5 microns, about 0.1 to about 1 micron, about 0.1 to about 0.8 microns, or about 0.1 to about 0.5 microns. As such, the OD is slightly increased compared to the functional plastic tube material alone (hence indicated as OD' in Figure 2). In certain embodiments, the thickness is substantially uniform, i.e., it does not change significantly along the length of the tubing or around the circumference of the tubing. For example, for a bonding layer with an average thickness of 1 micron, the deviation may be less than 0.1 microns, less than 0.05 microns, less than 0.01 microns, less than 0.005 microns, or less than 0.001 microns. The bonding layer 12 is preferably substantially well uniform in coating as well, for example, containing few or no pinholes in the coating. Other types of coatings (prepared by other methods) may not exhibit such a high level of uniformity.

[0042] The composition of the binding layer is not particularly limited. In certain embodiments, the binding layer comprises polyether block amide (PEBA). Various grades of PEBA are known and can be used in accordance with this disclosure. In some embodiments, the tubes provided herein can be prepared with a wide range of PEBA grades, e.g., PEBA of various durometers. For example, in some embodiments, the binding layer can include PEBA with a high Shore hardness of about 72D to very soft grades of PEBA such as 25D. In some embodiments, the Shore hardness of the PEBA is about 50D to about 72D, and in some embodiments, the Shore hardness of the PEBA is about 25D to about 50D. In some embodiments, the binding layer can include one or more nylons, polyesters, polyethers, and / or copolymers, derivatives, and / or mixtures thereof.

[0043] In some embodiments, the binding layer consists essentially of a polymer compound (e.g., PEBA). For example, in certain embodiments, the binding layer does not contain anti-blocking or anti-slip additives. In some embodiments, the binding layer comprises a single polymer compound, and in other embodiments, the binding layer may include a mixture of one or more polymer compounds (e.g., multiple PEBA resins). In some embodiments, the binding layer may include one or more additives, including, but not limited to, lubricants or processing aids that may remain from the resin used to prepare the layer. In preferred embodiments, the binding layer is substantially solvent-free (i.e., contains little or no detectable solvent), and contains, for example, less than about 10% by weight, less than about 5% by weight, less than about 1% by weight, less than about 0.5% by weight, less than about 0.1% by weight, or less than about 0.05% by weight of solvent based on the total weight of the binding layer.

[0044] In preferred embodiments, this minimum solvent content provides a bonding layer that can be described as non-tacky. Tackiness can be quantified, for example, by calculating the tan(δ) / E' amount at low frequencies for the coating formulation in question using DMA (N. Akram, M. Saeed, M. Usman, Polymers, 14, p. 572, 2022). The larger this value, the higher the tackiness of the polymer. The tackiness of a material can also be measured by mechanically joining two tubular material fragments of the coated material at room temperature under constant pressure for a known time and measuring the force separating the samples using an Instron mechanical tester. Furthermore, other surface analysis instruments / methods such as AFM and SEM may be used to detect and / or measure the tackiness of the material. Polymers such as PEBA, nylon, polyester, polyethers, and their copolymers are susceptible to alcohol attack, especially when remaining in solution at high temperatures and for extended periods. The tubular materials provided herein have a lower tendency to decompose with alcohol because the solution dries faster at lower temperatures than commercially available solutions.

[0045] The tubular materials described in the various embodiments provided herein have several advantages over known tubular materials, including, but are not limited to, the following features:

[0046] • Low tackiness of the bonded layer relative to the given hardness. Residual solvents, such as those from high-boiling point solvent systems, tend to increase the tackiness of the bonded layer. In various embodiments, a low-boiling point solvent is poured to leave no residual solvent after in-line drying. • Compatible with low-durometer PEBA layers (e.g., 25D to 72D, e.g., 35D and 25D). • High peel strength after reflow. • It can be stretched further without compromising its adhesive strength. • The coating thickness range was kept wide, and the applied coating thickness was reduced. A coating thickness of 0.5 μm or less was achieved.

[0047] This disclosure also provides a method for preparing tubing materials as described herein. In certain embodiments, the binder layer material is provided in liquid form (e.g., in the form of a solution, suspension, dispersion, etc.), and the binder layer is applied to the functional plastic tubing material by coating the solution onto the functional plastic tubing material. In preferred embodiments, the binder layer material is provided in the form of a solution. Solutions, suspensions, dispersions, etc., can be formed by combining the binder layer material (e.g., a resin) with one or more solvents. The solvent can be modified. In certain embodiments, the solvent can include a single component or a multi-component mixture of solvents such as non-aromatic alcohols (e.g., methanol, ethanol, 2-methyl-2-propanol, 1-butanol, and 2-butanol), glycols, diols, ketones, etc. In certain embodiments, the solvent does not contain aromatic components, for example, aromatic alcohols. The solution can be modified to give a wide range of target binder layer thicknesses on functional polymer tubing material (e.g., etched PTFE tubing). Methods for adjusting the target thickness include slightly changing the concentration of the polymer in the solution, the viscosity of the solution during processing, the coating temperature, the line speed, the drying speed, the dimensions of the mold spacing, and the number of coating passes (e.g., one to many).

[0048] The concentration of the binder material in the solutions provided herein can be changed, and therefore the viscosity of the solution can be changed. In some embodiments, the binder material is present in the solution in a weight / volume ratio of less than 0.10, for example, from about 0.02 to about 0.10. The weight / volume ratios provided herein are given in grams of polymer per milliliter of solvent unless otherwise expressly indicated. In some embodiments, the viscosity of the solution can be, for example, 10 to 200 cP at 60°C (and can be within or higher within this range at temperatures below 60°C / within or lower within this range at temperatures above 60°C). The binder solutions used in the present invention have a significant temperature-viscosity relationship. Changing the solution temperature can have a dramatic effect on viscosity, etc., and the viscosity of the solution can be changed by changing the temperature of solvation / application to the functional plastic tubing material. For example, a 55D Pebax solution of a certain concentration has a much higher viscosity at 60°C than at 80°C. In one embodiment, the viscosity of a 10% (weight / volume) 1-butanol solution of 55D Pebax was less than 50 cP at 80°C, while the viscosity of a 5% (weight / volume) 1-butanol solution of 55D Pebax was 150 cP or greater at 50°C. The weight / volume ratio is defined as the weight / volume ratio of grams of PEBA (or other polymer material) divided by milliliters of solvent. According to this disclosure, a wide range of temperatures can be used for solvation and / or coating of binder materials, and a wide range of solution viscosities can be used.

[0049] The grades of binder resins that can be used with these solvent systems range from high Shore hardness grades such as 72D to very soft grades such as 25D. The solvation conditions of the resin can be varied and may optionally include heating and / or stirring. Solvation of harder grades of resin can be carried out, for example, in a sealed container with stirring at a temperature above ambient temperature (e.g., within a few hours).

[0050] Applications can be carried out by various means, including physical coating, chemical coating, immersion coating, or spraying of a liquid binder material (e.g., binder solution) onto functional plastic tubing materials, by conventional methods known in the art, for example. The solvent (e.g., alcohol) of the binder solution applied to the functional polymer tubing material is generally easily removed after application by drying, for example, with ambient air, heated air, convection, infrared heat, or radiant heat. The conditions for such drying (e.g., temperature) can be selected, for example, based on the solvent used in the coating process. Furthermore, the coated tubing material may be quenched with water or cold air before undergoing the drying step.

[0051] Various embodiments provide a stable process for manufacturing tubing materials as described herein. The pot life at the processing temperature is suitable for continuous application (e.g., more than 8-hour shifts) of functional polymer tubing materials (e.g., etched PTFE tubing).

[0052] The processes used to manufacture tubular materials according to the various embodiments provided herein also have several advantages over conventional processes.

[0053] • Solvent systems that take environmental health and safety (EH&S) into consideration can be used for bonding layer coatings (compared to current aromatic alcohol and co-solvent systems). • High-speed processing capability (due to the fast drying speed, higher processing capacity can be achieved). This process can be designed to produce a continuous length of coated PTFE liner. • The dried binding layer contains little to no detectable residual solvent. Compared to known tubes (for example, tubes made of the same material but prepared according to different methods), tubes according to various embodiments can be shown as follows: • To increase the peel strength of the reflowed catheter shaft. • Higher elongation without a decrease in peel strength. • Softer grades of Pebax (e.g., 25D and 35D) have low tackiness, eliminating the need for antiblocking or anti-slip agents. Low tackiness means easier handling during processing and packaging, as well as easier handling for the customer (e.g., in relation to the use of catheter-structured tubing). • Thinner coatings (e.g., less than 1 micron) to improve flexibility. Some embodiments provide coatings having a thickness of less than 1 micron, less than 0.9 μm, or less than 0.8 μm. • A softer grade of Pebax can be used to improve flexibility. The mechanism of poor adhesion means complete miscibility with the reflowed Pebax, which in turn means a lower risk of delamination in the finished catheter. While competing products are manufactured using manual batch processes, this invention describes an in-line continuous process. • Adopts a solvent system with a lower environmental impact. The tubes described in the various embodiments are dried at lower temperatures and for shorter periods of time, significantly reducing the possibility of alcohol decomposition of Pebax compared to the processes of related technologies, which generally require drying at higher temperatures (>120°C) and for longer periods (>1 minute). [Examples]

[0054] Examples of known bonded layer coated tubes, bonded layer coated tubes described in various embodiments of this disclosure, and uncoated etched PTFE tubes were tested to evaluate their physical, mechanical, and thermal properties, including tensile and burst tests, FTIR, DSC, DMA, contact angle, NMR, HPLC, GPC, tackiness, coating thickness, and coating uniformity (e.g., concentricity).

[0055] Example 1: A 5% (by weight / volume) solution of Pebax 5533 and 1-butanol was prepared in a 90°C water bath. This solution was used to dip-coat etched PTFE tubing with an OD of 0.081 inches at 70°C in a continuous in-line process. The coated tubing was then passed through a 120°C oven. The average coating thickness was measured to be approximately 0.5 microns by microscope.

[0056] Example 2: A 5% (by weight / volume) solution of Pebax 3533 and 1-butanol was prepared in a 90°C water bath. This solution was used to dip-coat etched PTFE tubing with an OD of 0.081 inches at room temperature (ambient temperature) in a continuous in-line process. The coated tubing was then passed through a 120°C oven. The average coating thickness was measured to approximately 0.5 microns by micrometer.

[0057] Example 3: A 10% (by weight / volume) solution of Pebax 5533 and 1-butanol was prepared in a 90°C water bath. This solution was used to dip-coat etched PTFE tubing with an OD of 0.081 inches at 80°C in a continuous in-line process. The coated tubing was then passed through a 120°C oven. The average coating thickness was measured to be approximately 2 microns by micronography.

[0058] Example 4: A 20% (by weight / volume) solution of Pebax 2533 and 1-butanol was prepared in a 90°C water bath. This solution was used to dip-coat etched PTFE tubing with an OD of 0.081 inches at room temperature (ambient temperature) in a continuous in-line process. The coated tubing was then passed through a 120°C oven. The average coating thickness was measured to approximately 4.5 microns by micrometer.

[0059] Comparative Example 1: For comparison, commercially available Pebax-coated tubes obtained from a manual immersion / drying process using an aromatic / hydrocarbon solvent mixture were acquired. The average coating thickness was measured to be approximately 1 micron by microscopy.

[0060] Comparative Example 2: For comparison, commercially available Pebax-coated tubes obtained from a manual immersion / drying process using an aromatic / hydrocarbon solvent mixture were acquired. The average coating thickness was measured to be approximately 2 microns by micron.

[0061] Those skilled in the art in which the present invention relates and who have an interest in the teachings set forth in the foregoing description will likely be able to conceive of many variations and other embodiments of the present invention. Therefore, it should be understood that the present invention should not be limited to the specific embodiments disclosed, and that variations and other embodiments are intended to be included within the scope of the appended claims. Certain terms are used herein, but they are used only in a general and descriptive sense and not for limiting purposes.

Claims

1. A coated tube material comprising an etched PTFE tube material having an inner surface and an outer surface, wherein the outer surface comprises a layer of PEBA having an average thickness of less than 1 micron.

2. The coating tube material according to claim 1, wherein the PEBA has a durometer of 25 to 72.

3. A coating tube material according to claim 1, prepared using a PEBA-containing solution.

4. The coating tube material according to claim 3, wherein the PEBA-containing solution comprises a solvent selected from methanol, ethanol, 2-methyl-2-propanol, 1-butanol, 2-butanol, and mixtures thereof.

5. The coating tube material according to claim 3, wherein the PEBA-containing solution contains 1-butanol.

6. The coating tube material according to claim 3, wherein the PEBA is present in the PEBA-containing solution in a weight / volume ratio of less than 0.10 g / mL.

7. The coating tube material according to claim 3, wherein the PEBA-containing solution is at a temperature of 20°C to 100°C during coating.

8. The coating tube material according to claim 1, wherein the average thickness of the PEBA layer is less than 0.9 μm.

9. The coating tube material according to claim 8, wherein the average thickness of the PEBA layer is less than 0.8 μm.

10. The coated tube material according to claim 1, further comprising an outer coating layer containing PEBA or a polyamide coated on a layer of PEBA.

11. The coating tube material according to claim 1, wherein the PEBA layer is essentially made of PEBA.

12. The coating tube material according to claim 1, wherein the PEBA layer comprises one or more additives.

13. The coating tube material according to claim 1, wherein the PEBA layer is substantially free of residual solvent.

14. The coating tube material according to claim 1, wherein the coating tube material is a catheter liner.

15. A catheter comprising the coated tube material according to claim 14.

16. A coated tube material comprising a tubular material containing a fluoropolymer, having an inner surface and an outer surface, wherein the outer surface includes a bonding layer thereon, and the bonding layer has an average thickness of less than 1 micron.

17. A method for manufacturing a coated tube material having an inner surface and an outer surface, To provide an etched PTFE tube material having an inner surface and an outer surface; To provide a PEBA-containing solution, dissolve PEBA in one or more solvents; and, A method comprising applying a PEBA-containing solution to the outer surface of an etched PTFE tube material to form a PEBA layer with an average thickness of less than 1 micron thereon.

18. The method according to claim 17, wherein the dissolution comprises heating and / or stirring the PEBA in one or more solvents.

19. The method according to claim 17, wherein the PEBA-containing solution comprises a solvent selected from non-aromatic alcohols.

20. The method according to claim 19, wherein the non-aromatic alcohol is selected from methanol, ethanol, 2-methyl-2-propanol, 1-butanol, 2-butanol, and mixtures thereof.

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