Continuous 3D ultraviolet curing of urinary catheters

Abstract

A curing system 2 for curing hydrophilic coatings on urinary catheters 12. The curing system has a curing unit 14 with a curing compartment 22 wherein curing radiation is reflected within the curing compartment and the catheters pass through the curing compartment in a continuous or stepwise manner. Optionally, the curing may include heat curing in addition to radiation curing.

Description

PATENTAttorney Docket No. 3400-0326.01 (794PCT)Continuous 3D Ultraviolet Curing Of Urinary CathetersThe present application claims the benefit of and priority to U.S. Provisional Patent Application no. 63 / 701 ,718, filed October 1 , 2024, which is hereby incorporated herein by reference.FIELD OF DISCLOSURE

[0001] The present disclosure relates to devices and methods for curing coatings on the surface of urinary catheters. More particularly, the present disclosure generally relates to ultraviolet curing of hydrophilic coatings on the outer surface of urinary catheters in a 3D configuration.BACKGROUND

[0002] Hydrophilic urinary catheters include a hydrophilic coating on the outer surface of the insertable portion of a urinary catheter shaft. The hydrophilic coating becomes lubricious when hydrated with a hydration medium, such as water. The lubricious hydrophilic coating eases the advancing and withdrawing of the catheter shaft into and out of the urethra. The lubricious coating also provides comfort to the user as the catheter is advanced and withdrawn.

[0003] Typically, a hydrophilic coating formulation is applied to the insertable portion of the catheter shaft. The hydrophilic coating formulation may be in liquid or semi-liquid form, such as a solution or dispersion. The hydrophilic coating formulation may be applied to the insertable portion of the catheter shaft by dip coating, spraying, or painting. After the coating formulation is applied, the catheter having the coating formulation thereon is cured. In some instances, curing is achieved by exposure to ultraviolet radiation (UV) and or thermal or radiative heat.

[0004] The hydrophilic coated catheters are produced on an industrial scale. Therefore, there remains a need for a rapid and 3D curing of the coating in systems and methods of curing hydrophilic coatings without contact with other surfaces.PATENT Attorney Docket No. 3400-0326.01 (794PCT)SUMMARY

[0005] In one aspect, a system for curing hydrophilic coatings on a plurality of urinary catheters. The system includes at least one curing unit having a top wall, opposing side walls and an opening along the bottom of the curing unit. The top and side walls define a curing compartment with a receiving opening at a receiving end of the curing compartment and an opposed exit opening at an exit end of the curing compartment. At least one radiation source is positioned adjacent or within the opening along the bottom of the curing unit, wherein the at least one radiation source emits radiation into the curing compartment. The system includes at least one carrier supporting a plurality of urinary catheters having an uncured hydrophilic coating on them ready to go through the process of being at least partially cured. The at least one carrier is configured to enter the curing compartment of the curing unit through the receiving opening, move through the curing compartment in a continuous manner, and exit out of exit opening of the curing unit. The radiation emitted into the curing unit initiates curing of the hydrophilic coating formulation. The curing could be accompanied by heat from the radiation or other sources such heated air which may also help to remove solvents and any byproducts of the curing. Other heating sources may be used to assist curing process. Optionally, the process results in partial curing to thereby form a partially cured hydrophilic coating on the urinary that is ready for the next step, such as packaging.

[0006] In another aspect, a system for curing hydrophilic coatings on a plurality of urinary catheters. The system includes at least one curing unit with a top wall, a bottom wall, and opposing side walls defining a curing compartment. The curing compartment has a receiving opening at a receiving end of the curing compartment and an opposed exit opening at an exit end of the curing compartment. One of the top, bottom, and opposing side walls may be configured to allow radiation and or heat to pass from outside the curing unit and enter the curing compartment. One or more of the top, bottom, and opposing side walls has an inner radiative reflective surface configured to reflect the radiation within the curing compartment. There is at least one radiation source positioned outside the curing unit and adjacent to the one of the top, bottom, and opposing side wallsPATENTAttorney Docket No. 3400-0326.01 (794PCT) configured to allow passage of radiation into the curing compartment. The system includes a diffuser configured to scatter the radiation entering the curing compartment. The system includes at least one carrier supporting a plurality of urinary catheters having a hydrophilic coating formulation thereon. The at least one carrier is configured to enter the curing compartment of the curing unit through the receiving opening, move through the curing compartment, and exit out of the exit opening of the curing unit. The radiation diffused and reflected within the curing unit at least partially cures the hydrophilic coating formulation, thereby forming a hydrophilic coated substrate. As used herein, the terms “cure,” “curing” and “cured” means sufficiently cured by radiation and or heat as desired by the user. The coating can be ready made hydrated or hydrated at point of use for insertion into the urinary tract.

[0007] In another aspect, a method of curing hydrophilic coatings on a plurality of catheters. The method includes receiving into a curing compartment a plurality of urinary catheters having an uncured hydrophilic coating formulation thereon. The plurality of catheters is moved through the curing compartment. Radiation curing beams are reflected off the inner surfaces of the curing compartment, wherein the plurality of catheters is exposed to the radiation and or heat to cure the hydrophilic coating formulation and thereby form a hydrophilic coating on the substrate. The plurality of urinary catheters exits out of the curing compartment.

[0008] In yet another aspect, a continuous coating and curing system includes a coating system for coating urinary catheters with an uncured hydrophilic coating and a curing system for curing the hydrophilic coatings on the urinary catheter, wherein the urinary catheters continuously move through the curing system.BRIEF DESCRIPTION OF DRAWINGS

[0009] Fig. 1 A is a schematic view of a continuous coating and curing system in accordance with the present disclosure.

[0010] Fig. 1 B is a perspective view of a curing system that can be used with the continuous system of Fig. 1 A, the curing system is shown from the front or receiving end.

[0011] Fig. 1 C is a perspective view of another embodiment of a curing system that can be used with the continuous system of Fig. 1 A.PATENTAttorney Docket No. 3400-0326.01 (794PCT)

[0012] Fig. 1 D is schematic view of the curing system with an optional heating source associated with one or both sidewalls of the curing unit.

[0013] Fig. 2A is a perspective view of the curing unit shown in Fig. 1 B from the rear or exit end.

[0014] Fig. 2B is a perspective view of the curing unit shown in Fig. 1 C from the rear or exit end.

[0015] Fig. 3 is a side view elevational view of the system of Fig. 1 B.

[0016] Fig. 4 is a perspective view showing a schematic illustration of radiation emitted from the radiation sources and scattered inside the curing compartment by a diffuser.

[0017] Fig. 5 is a schematic view showing radiation emitted from a radiation source and scattered inside the curing compartment by a diffuser.

[0018] Fig. 6A is a cross-sectional view of the curing system of Fig. 1 B, showing a schematic illustration of the reflection of radiation.

[0019] Fig. 6B is a cross-sectional view of the curing system of Fig. 1 C, showing a schematic illustration of the reflection of radiation.

[0020] Fig. 7 is a schematic illustration of radiation being reflected off an inner surface of a wall.

[0021] Fig. 8 is a schematic illustration of radiation being reflected off an inner surface of a wall.

[0022] Fig. 9A is a cross-sectional view of the curing system of Fig. 1 B, showing a schematic illustration of the urinary catheters being exposed to reflected radiation.

[0023] Fig. 9B is a cross-sectional view of the curing system of Fig. 1 C, showing a schematic illustration of the urinary catheters being exposed to reflected radiation.

[0024] Fig. 10 is a side view of one embodiment of a carrier.

[0025] Fig. 11 is an exit end view of the curing unit of Fig. 1 .DETAILED DESCRIPTION

[0026] While the subject matter of the present disclosure is susceptible to embodiments in various forms, there will hereinafter be described presently preferred embodiments with the understanding that the present disclosure is to bePATENTAttorney Docket No. 3400-0326.01 (794PCT) considered an exemplification and is not intended to limit the disclosure to the specific embodiments illustrated. The words “a” or “an” are to be taken to include both the singular and the plural. Conversely, any reference to plural items shall, where appropriate, include the singular.

[0027] Fig. 1 A illustrates a continuous coating and curing system 2. System 2 includes a coating subsystem / system 4 and a curing subsystem / system 10 for coating and curing urinary catheters 12. The continuous system includes carriers 62 (shown in more detail in Figs. 10 and 1 1 ) that carry and move catheters 12 through system 2. Carriers 62 could be on tracks or belts that advance carriers 62, and thus catheters 12, through system 2. Catheters 12 are coated in the coating subsystem / system 4 and then cured in curing subsystem / system 10. During the manufacturing process, catheters 12 move continuously through at least through curing system 10. The curing system 2 may reduce the dwelling and dip speeds of the coating system 4 / process. For example, when the catheter is dipped into the coating formulation to apply the coating, the dwell time of the catheter within the formulation may be as short as 1 second. In one alternative, the dwell time is less than 5 seconds or from 1 to 5 seconds. Additionally, the dip speed may be as low as 40 mm / s. In one embodiment, the dip speed may be less than 60 mm / s or from 40 mm / s to 60 mm / s.

[0028] Figs. 1 B, 2A, and 3 illustrate one alternative of a curing system (subsystem) 10 that may be used to cure coatings on the surfaces of urinary catheters 12. For example, system 10 may be used to cure a hydrophilic coating formulation on the outer surfaces of a plurality of urinary catheter shafts to form a hydrophilic coating on the respective surface. A hydrophilic coating formulation is applied to a surface of the substrate of urinary catheter 12 (e.g., the outer surface of flexible polymeric tubing) in, for example, coating subsystem 4. The hydrophilic coating formulation may be a solution or dispersion that includes a water soluble polymers among other ingredients that form the formulation known to those skilled in the art, such as polyvinylpyrrolidone (PVP), polyvinyl alcohol (PVOH), polyacrylamide (PAM), polyoxyethylene (PEG), flexible polyurethane, etc., and mixtures and copolymers thereof. As urinary catheters 12 pass through curing system 10, the system cures the hydrophilic coating formulation to form a thinPATENT Attorney Docket No. 3400-0326.01 (794PCT) layer coating on curing that on the surfaces of the urinary catheters 12. The hydrophilic coating is a coating that becomes lubricious when wetted or hydrated with a hydration medium, such as water. Hydration medium may also include other ingredients such as water soluble polymers, glycerin, osmolality agents among other ingredients.

[0029] As indicated above with reference to Fig. 1 A, curing system 10 may be a sub-system of a urinary catheter manufacturing system. For instance, curing system 10 may be a sub-system in a manufacturing line that includes, for example, sub-systems that apply a hydrophilic formulation to the catheter shafts, place the urinary catheters in packaging, wet the hydrophilic coating, sterilize the catheters, perform quality control checks, etc.

[0030] In the embodiment illustrated in Fig. 1 B, curing system 10 includes a curing unit 14, for example a curing box, with a top wall 16, bottom wall 18 (optional), and opposed side walls 20a, 20b. The terms “top,” “bottom,” “side,” and other like terms are used to indicate relative positions to a given point or element and are used in this description to describe some embodiments more clearly. However, when applied to equipment and methods for use in environments that are deviated, such terms may refer to a left to right, right to left, or other relationship as appropriate. Top, bottom, and side walls 16, 18, 20a, and 20b define a curing compartment 22 in which urinary catheters 12 pass through during the curing of hydrophilic coatings. Curing compartment 22, and thus curing system 10 and curing unit 14, has a receiving opening 24 at a receiving end 26 of curing compartment 22 and an exit opening 28 at an exit end 30 of curing compartment 22. Receiving and exit openings 24, 28 may be coextensive with the receiving and exit ends of the system 10 and / or curing unit 14.

[0031] Curing compartment 22 may have a length “L,” extending between receiving and exit openings 24, 28. In one alternative, the length L is at least 2 meters. In other alternatives, the length may be shorter. Curing compartment 22 also has a width “W,” extending between side walls 20a, 20b. In one alternative, the width W is at least 0.5 meters. It will be understood that the length and width of curing compartment 22 may vary depending on the desired application.PATENT Attorney Docket No. 3400-0326.01 (794PCT)

[0032] One of the top, bottom, and opposing side walls 16, 18, 20a, and 20b is configured to allow radiation to pass from outside of curing unit 14 and into curing compartment 22. The radiation may be, for example, blue visible light, infrared or UV radiations. In one alternative the radiation is UV light with wavelength ranging from 190 to 500nm. For example, the wall allowing the passage of radiation may be transparent or translucent or include transparent or translucent portions or sections. Additionally, the wall allowing radiation to pass through may, optionally, allow directional passage. For example, it may allow radiation to pass from outside curing unit 14 into curing compartment 22 and prevent or substantially prevent radiation from passing from inside curing compartment 22 to outside curing unit 14. As will be set forth in more detail below, the inner surface of the walls of the curing unit may be radiative reflective surfaces that reflect radiation within curing compartment 22. In another alternative, the wall allowing the passage of radiation may have holes or openings allowing the passage of radiation from outside of curing unit 14 and into curing compartment 22. Referring to Figs. 1 B and 2A, optional holes or openings, or optional transparent or translucent sections may be in the area of 32 on bottom wall 18 or any other area suitable area. Also, the number of holes or sections may vary depending on the application and system configurations.

[0033] System 10 includes at least one radiation source 34 that produces radiation at a wavelength and intensity suitable for curing a selected coating. For example, the radiation source may produce or emit ultraviolet radiation. In one alternative, the radiation may be ultraviolet A, ultraviolet B, and ultraviolet C or a combination. The at least one radiation source may be located at any location suitable for emitting radiation into curing compartment 22. The at least one radiation source may be positioned outside the curing unit, where the system is configured to allow the radiation to pass from outside curing unit 14 into curing compartment 22. In other embodiments, the at least one radiation source may be positioned inside curing unit 14 and / or curing compartment 22. In one alternative, the at least one radiation source includes a plurality of radiation sources. In the illustrated embodiments, system 10 includes four radiation sources 34 (Figs. 3 and 4). Of course, there could be more than one radiation source. Furthermore,PATENT Attorney Docket No. 3400-0326.01 (794PCT) the radiation source may include a plurality of lamps. In one alternative, the radiation source may include a plurality of radiation emitting diodes (LEDs) that emit radiation at a selected intensity and wavelength. The radiation source could also be mercury lamps, microwave-assisted UV lamps, solid-state diode array UV generators, or any other suitable radiation source. The angle of the radiation source(s) or the direction(s) of emitted radiation may vary depending on the geometry and the arrangement of the samples to be cured. For example, the angle of a radiation source(s) or the direction(s) of emitted radiation may be at an angle “A,” (Fig, 2) which may be from 0 to 90 degrees relative to the surface of bottom wall 18 of the curing unit 14. In one alternative, the angle may be from 10 to 80 degrees relative to the surface of bottom wall 18.

[0034] As shown in Figs. 3 and 4, the illustrated embodiment of system 10 includes four radiation sources 34 outside of and adjacent to bottom wall 18, which allows the passage of radiation into curing compartment 22.

[0035] In one alternative, system 10 includes a radiation diffuser that diffuses the radiation emitted from the at least one radiation source 34. For example, referring to Fig. 4, bottom wall 18 may comprise or serve as a diffuser, radiation 36 emitted from radiation sources 34 passes through bottom wall 18, where bottom wall 18 diffuses radiation 36 into scattered radiation 36a. As mentioned above, bottom wall 18 may be transparent and / or translucent or include such sections. The transparent and / or translucent material of the bottom wall 18 may be made from suitable materials that reflect the radiation into the compartment. For example, specifically designed PTFE material that reflects from 50 to 99.9% of the UV radiation. Other materials such as reflective aluminum or glass can be used. In another alternative, referring to Fig. 5, system 10 may include a diffuser 40 placed over the radiation source 34 or between the radiation source and curing compartment. For example, optionally, the diffuser 40 may be a cover placed over the radiation source 34. Diffuser 40 may be made from UV resistant material or the same or similar materials and / or have the same or similar configurations as disclosed above. Optionally, system 10 may include emitted radiation reflectors 42 that reflect radiation in different angles or directions before the radiation passes through the diffuser. In another configuration where the bulk of radiationPATENT Attorney Docket No. 3400-0326.01 (794PCT) is directed upwards and used for curing of the coating, there maybe little or no radiation be reflected to the bottom base. In that case no or minimal radiation reflective materials will be needed to be employed on the bottom base.

[0036] Turning to Figs. 6A, 7, 8 and 9A, optionally, at least a portion of the inner surfaces 44, 46, 48, and 50 of top 16, bottom 18, and side walls 20a, 20b, respectively, include radiative reflective surfaces. The radiative reflect surfaces 44, 46, 48 and 50 may be configured for diffuse and / or specular reflection. The reflective surfaces may be made from porous PTFE, polished stainless steel, aluminum, or silver coated glass and / or have a surface configuration for reflecting the specific radiation. The radiative reflective material may be any suitable material. For example, Fig. 7 shows one embodiment wherein the reflective surface produces specular reflection, and Fig. 8 shows an embodiment wherein the reflective surfaces produce diffuse reflection. Fig. 7 shows a schematic illustration of incident radiation 52 reflecting off an inner surface 54 (which may be any of the reflective surfaces 44, 46, 48, 50) to produce specular reflected radiation 56 that reflects at substantially the same angle as the angle of incident radiation 52. Fig. 8 shows a schematic illustration of incident radiation 52 reflecting off an inner reflective 58 surface to produce a scattered radiation pattern 60. In some alternatives specular and diffuse reflective may be used produced. Fig. 6 is a cross-section of the curing unit 14 showing a schematic illustration of radiation reflected within the curing compartment 22. In one alternative, the curing compartment and reflective surfaces are configured such that at least 70% to 90% of the radiation received within curing compartment 22 is reflected back and within curing compartment 22. It should be understood that more or less of the radiation percentage may be reflected within the curing compartment.Additionally, the curing compartment and reflective surfaces may be configured so that the radiation homogenizes in the curing compartment to provide a consistent and uniform dose of radiation to the catheters passing through the compartment.

[0037] Figs. 1 C, 2B, 6B and 9B illustrate another embodiment of a curing system 10a which includes a curing unit 14a with a top wall 16a and opposed side walls 21 a, 21 b. Unlike curing system 10, the curing unit 14a of curing system 10a does not include a bottom wall. Instead, the curing unit 14a is generally U-shapedPATENT Attorney Docket No. 3400-0326.01 (794PCT) with an opening 19a in the bottom. Top wall 16a and side walls 21 a, and 21 b define a curing compartment 22a in which urinary catheters 12 pass through during the curing of hydrophilic coatings. Curing compartment 22a, and thus curing system 10a and curing unit 14a, has a receiving opening 24a at a receiving end 26a of curing compartment 22a and an exit opening 28a at an exit end 30a of curing compartment 22a. Receiving and exit openings 24a, 28a may be coextensive with the receiving and exit ends of the system 10a and / or curing unit 14a. Curing compartment 22a may have a length “L” and “W” the same or similar to curing compartment 22.

[0038] System 10a includes at least one radiation source 34a that produces radiation at a wavelength and intensity suitable for curing a selected coating. The radiation source 34a may be any the same or similar to the radiation source(s) described above. The at least one radiation source 34a is located below curing unit 14a and positioned adjacent or within opening 19a along the bottom of the curing unit 14a. radiation source 34a emits radiation into curing compartment 22a to cure the coating on the catheters as described above. As mentioned above, the number of radiation sources may vary depending on the configuration and desired use.

[0039] Referring now to Figs. 1 A-C, 10, and 1 1 , system 10 includes at least one carrier 62 configured to carry and move urinary catheters 12 with a hydrophilic coating formulation thereon through the curing compartment 22. Each carrier may support as many catheter as feasible for the system. In one alternative each carrier supports 24-34 catheters. The carriers may also support more or less catheters. The hydrophilic coating formulation may have been applied to the urinary catheter 12 in any sufficient manner, such as dip coating, spraying, brushing, etc. In one alternative, the at least one carrier 62 may be a plurality of carriers 62a, 62b, 62c, and 62d. In the illustrated embodiment, the at least one carrier 62 includes four carriers. It will be understood that more or less than four carriers 62 may be employed. Urinary catheters 12 are releasably attached to the carrier 62. Referring to Fig. 11 , in the illustrated embodiment, carriers 62 include attachment members 64 for releasably attaching the catheters 12 to carriers 62. For example, the carriers 62 may include attachment membersPATENT Attorney Docket No. 3400-0326.01 (794PCT)64 that are releasably attached to the drainage member 66 (funnel or connection member) of the urinary catheter 12. In this arrangement, the urinary catheters 12 hang and / or the shafts extend downward from the carrier 62.

[0040] Furthermore, urinary catheters 12 may be in a linear arrangement along carrier 62, wherein catheters 12 on a particular carrier are arranged one next to another in the linear arrangement so that the catheters are linearly spaced from an adjacent catheter. Catheters 12 may be arranged in other configurations as well. When a plurality of carriers 62a-d is used, the catheters 12a on one carrier 62a may be staggered from or misaligned relative to catheters 12b of an adjacent carrier 62b.

[0041] In the illustrated embodiment, the carriers 62a-d mover along the top wall 16 of the curing unit 14. In some alternatives, the carriers 62a-d may move along tracks associated with the top wall 16. In other embodiments, the carriers 62a-d may be suspended within the curing compartment 22. Catheters 12 may move through the curing compartment 22 in a continuous manner or a substantially continuous manner. In an alternative, catheters 12 pas s through curing compartment 22 in a stepwise manner, wherein catheters 12 alternately stop and go as they move through curing compartment 22.

[0042] In some alternatives, catheters 12 move through the curing compartment 22 at a rate or speed sufficient to cure the coating of the catheters with the radiation (reflected and / or scattered) within the curing compartment 22. The rate or speed may be at least 5 mm / s, or at least 10 mm / s, or at least 20 mm / s. In some embodiments, catheters 12 move through the curing compartment 22 at a rate or speed from about 5 mm / s to about 20 mm / s. In particular, whether the catheters 12 move continuously or stepwise, the rate is calculated by dividing the distance between the receiving opening 24 and the exit opening 28 by the time it takes for a catheter 12 to enter the curing compartment 22 through opening 24 and exit the compartment through opening 28. In some alternatives, the catheters move through the curing compartment in a time period sufficient to at least partially cure the coating of the catheters with the radiation (reflected and / or scattered) and or heat within the curing compartment 22. The time period may be from about 100 seconds to about 400 seconds. In one embodiment, the period ofPATENTAttorney Docket No. 3400-0326.01 (794PCT) time is about 200 seconds. That is, the catheters 12 enter the curing compartment 22 at the receiving opening 24 and exit the curing compartment 22 at the exit opening 28 in the time periods described above. In one embodiment, as the catheters move through curing compartment 22, the catheters receive the same or substantially the same dose of radiation and or heat to cure the hydrophilic coatings on the catheters.

[0043] Optionally, the temperature of the space within the curing compartment 22 may be at least 40qC. In one alternative, the temperature with the curing compartment 22 may be between 40 °C to 90qC. Optionally, the system may include running heated air or a heater or a heating element 68 (Fig. 2A-B) to heat the space within the curing compartment 22. Referring to Figs. 1 B and 2A, optionally, the curing compartment 22 may be heated by air stream 23, which may have air / gases at a temperature to at least partially cure or assist in curing the hydrophilic coating. Also, curing systems disclosed herein may include an optional heating element 68. In one alternative, the heating element 68 may be one or more flow paths 68a embedded or attached to the inner or outer surfaces of the opposed sidewalls of the curing unit. In the illustrated embodiment, flow path 68a is a serpentine flow path. Referring to Fig. 1 D, fluid, such as heated gas or liquid, may flow through the flow path 68a of the heating element 68 to raise and / or control the temperature within the curing compartment. The flow path may have an entrance 69a that received the fluid and an exit 69b for the fluid to exit.

[0044] Although systems 10 and 10a are shown with one curing unit 14, the systems may include one or a plurality of curing units 14. The plurality of curing units 14 may be modular and can be sequentially arranged so that the exit opening of a first curing unit is adjacent and aligned with the receiving opening of a second or subsequent curing unit 14. In other words, the curing units may be aligned one linearly adjacent to another. In other embodiments, the curing unitsl 4 can be arranged in parallel or any other suitable arrangement.

[0045] The curing unit 14 may also have a mechanism for removing any byproducts from the curing compartment 22. By-products may include solutions or liquids of the hydrophilic coating formulations that evaporate or otherwise separate from the urinary catheter 12. Other by-products could be fumes orPATENT Attorney Docket No. 3400-0326.01 (794PCT) gases coming off the hydrophilic coating during the curing process. The mechanism for removing by-products could include an air stream 23 (Figs. 1 B and 2A) that may flow through the curing compartment. The air stream 23 contacts and carry the by-products out of one of the receiving and exit openings of the curing compartment. The air / gases of the air stream 23 may also be at a temperature that heats the curing compartment 22. The temperature may be sufficient to at least partially cure or assist in curing the hydrophilic coating as the catheters pass through the curing compartment 22. In an alternative, the mechanism could include holes in the curing unit and, optionally, a suction source associated with the holes. The by-products may be suctioned or forced out of the holes.

[0046] In one method of curing a hydrophilic coating formulation to form a hydrophilic coating on a catheter, a plurality of urinary catheters with a hydrophilic coating formulation thereon are received into a curing compartment. The plurality of catheters is moved continuously or stepwise through the curing compartment. Radiation is reflected off the inner surfaces of the curing compartment, wherein the plurality of urinary catheters and the hydrophilic coating formulations are exposed to the radiation as the catheters move through the curing unit. The catheter exits out of the curing compartment.

[0047] The catheters may move through the curing compartment at any of the rates, speeds and time periods as described above. Furthermore, the radiation may be any of the radiation described above, such as ultraviolet radiation.

[0048] It should be understood that various changes and modifications to the presently preferred embodiments described herein will be apparent to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the invention disclosed herein.

[0049] It should be understood that assembly described here can be used for heat curing of hydrophilic coating when no radiation curing is necessary.

Claims

PATENT Attorney Docket No. 3400-0326.01 (794PCT)Claims1 . A continuous 3D system for curing hydrophilic coatings on a plurality of urinary catheters, comprising: at least one curing unit having a top wall, opposing side walls and an opening along a bottom of the curing unit, the top and side walls defining a curing compartment, the curing compartment having a receiving opening at a receiving end of the curing compartment and an opposed exit opening at an exit end of the curing compartment; at least one radiation source positioned adjacent or within the opening along the bottom of the curing unit, wherein the at least one radiation source emits radiation into the curing compartment; at least one carrier supporting a plurality of urinary catheters having an uncured hydrophilic coating formulation thereon, the at least one carrier configured to enter the curing compartment of the curing unit through the receiving opening, move through the curing compartment for the coating to be at least partially cured, and exit out of exit opening of the curing unit; and wherein the radiation emitted into the curing unit at least partially cures the hydrophilic coating formulation to thereby form a hydrophilic coating on the urinary.

2. The system of claim 1 , wherein the urinary catheters continuously move through the curing compartment.

3. The system of any one of claims 1-2, wherein the urinary catheters move stepwise through the curing compartment, wherein stepwise moment comprise moving and stopping a plurality of time as the urinary catheters move through the curing compartment.

4. The system of any one of claims 1-3, wherein the catheters move through the curing compartment at a speed required to at least partially cure the coating to a selected extent.

5. The system of claim 4, wherein the speed varies as the catheters move through the curing compartment.PATENTAttorney Docket No. 3400-0326.01 (794PCT)6. The system of any one of claims 1-5, wherein the catheters move through the curing compartment in a time period from about 100 seconds to about 400 seconds.

7. The system of any one of claims 1-6, wherein the radiation emitted from the radiation source is ultraviolet radiation.

8. The system of claim 7, wherein the ultraviolet radiation comprises one or more of ultraviolet A, ultraviolet B, and ultraviolet C.

9. The system of any one of claims 1-8, wherein a temperature within the curing compartment is at least 40 °C, preferably from 40°C to 90°C.

10. The system of claim 9, further including a heater that is configured to maintain the temperature in the curing compartment.11 . The system of claim 10, wherein the heater comprises a heating element.

12. The system of claim 11 , wherein the heating element comprises a fluid flow path associated with at least one of the opposed sidewalls of the curing unit.

13. The system of any one of the claims 1 -12, further including an air stream that flows through the curing compartment.

14. The system of claim 13, wherein the air stream heats the curing compartment.

15. The system of any one of claims 13 and 14, wherein the air stream removes byproducts, solvents and / or gases from the curing compartment.

16. The system of any one of claims 1-15, wherein the curing compartment is at least 2 meters long as measured from the receiving opening of the curing compartment to the exit opening of the curing compartment.

17. The system of any one of claims 1-16, wherein the at least one curing unit includes a plurality of modular curing units linearly adjacent to one another.

18. The system of any one of claims 1-17, wherein 70% to 100% of the radiation entering the curing unit is reflected by inner surfaces of the top, bottom and opposed walls.

19. The system of any one of claims 1-18, wherein the at least one carrier includes a plurality of carriers moving through the curing compartment.

20. A system for curing hydrophilic coatings on a plurality of urinary catheters, comprising:PATENTAttorney Docket No. 3400-0326.01 (794PCT) at least one curing unit having a top wall, a bottom wall and opposing side walls defining a curing compartment, the curing compartment having a receiving opening at a receiving end of the curing compartment and an opposed exit opening at an exit end of the curing compartment; one of the top, bottom and opposing side walls configured to allow radiation to pass from outside of the curing unit and entering into the curing compartment, and one or more of the top, bottom and opposing side walls having an inner reflective surface configured to reflect radiation within the curing compartment; at least one radiation source positioned outside of the curing unit and adjacent to the one of the top, bottom and opposing side walls configured to allow passage of radiation into the curing compartment; a diffuser configured to scatter the radiation entering the curing compartment; at least one carrier supporting a plurality of urinary catheters having a hydrophilic coating formulation thereon, the at least one carrier configured to enter into the curing compartment of the curing unit through the receiving opening, move through the curing compartment, and exit out of exit opening of the curing unit; and wherein the radiation diffused and reflected within the curing unit at least partially cures the hydrophilic coating formulation to thereby form a hydrophilic coating on the urinary.21 . The system of claim 20, wherein one of the top, bottom and opposing side walls comprises the diffuser.

22. The system of claim 20, wherein the diffuser comprises a cover over the radiation source.

23. The system of any one of claims 20-22, further comprising a radiation reflector adjacent to the at least one radiation source wherein the radiation reflector is configured to reflect radiation from the radiation source at different angles.

24. The system of any one of claims 20-23, wherein the urinary catheters continuously move through the curing compartment.PATENTAttorney Docket No. 3400-0326.01 (794PCT)25. The system of any one of claims 20-23, wherein the urinary catheters move stepwise through the curing compartment, wherein stepwise moment comprise moving and stopping a plurality of time as the urinary catheters move through the curing compartment.

26. The system of any one of claims 20-25, wherein the catheters move through the curing compartment at a speed of at least 5 mm / s or 10 mm / s or 20 mm / s, preferably at a speed from about 5 mm / s to about 20 mm / s.

27. The system of claim 26, wherein the speed varies as the catheters move through the curing compartment.

28. The system of any one of claims 20-27, wherein the catheters move through the curing compartment in a time period from about 100 seconds to about 400 seconds.

29. The system of any one of claims 20-28, wherein the radiation emitted from the radiation source is ultraviolet radiation.

30. The system of claim 29, wherein the ultraviolet radiation comprises one or more of ultraviolet A, ultraviolet B, and ultraviolet C.31 . The system of any one of claims 15-25, wherein a temperature within the curing compartment is at least 60 °C, preferably from 80°C to 90°C.

32. The system of claim 31 , further including a heater that is configured to maintain the temperature in the curing compartment.

33. The system of claim 32, wherein the heater comprises a heating element.

34. The system of claim 33, wherein the heating element comprises a fluid flow path associated with at least one of the opposed sidewalls of the curing unit.

35. The system of any one of the claims 20-34, further including an air stream that flows through the curing compartment.

36. The system of claim 35, wherein the air stream heats the curing compartment.

37. The system of any one of claims 35 and 36, wherein the air stream removes byproducts, solvents and / or gases from the curing compartment.

38. The system of any one of claims 20-37, wherein the curing compartment is at least 2 meters long as measured from the receiving opening of the curing compartment to the exit opening of the curing compartment.PATENTAttorney Docket No. 3400-0326.01 (794PCT)39. The system of any one of claims 20-38, wherein the at least one curing unit includes a plurality of modular curing units linearly adjacent to one another.

40. The system of any one of claims 20-39, wherein 90% to 100% of the radiation entering the curing unit is reflected by the inner surfaces of the top, bottom and opposed walls.41 . The system of any one of claims 20-40, wherein the at least one carrier includes a plurality of carriers moving through the curing compartment.

42. A method of curing hydrophilic coatings on a plurality of catheters, comprising: receiving into a curing compartment a plurality of urinary catheters having a hydrophilic coating formulation thereon; moving the plurality of catheters through the curing compartment; reflecting radiation off of inner surfaces of the curing compartment, wherein the plurality of catheters is exposed to the radiation to cure the hydrophilic coating formulation and thereby form a hydrophilic coating; and exiting the plurality of urinary catheters out of the curing compartment.

43. The method of claim 42, wherein the plurality of urinary catheters comprises catheters that are linearly spaced from an adjacent catheter.

44. The method of any one of claims 42 and 43, wherein the moving is continuous or stepwise with a plurality of stop and go movements.

45. A continuous coating and curing system, comprising: a coating system for coating urinary catheters with a hydrophilic coating; and a curing system for at least partially curing the hydrophilic coatings on the urinary catheter, wherein the urinary catheters continuously move through the curing system.

46. The system of claim 45, wherein the urinary catheters move stepwise through the curing system, wherein stepwise moment comprise moving and stopping a plurality of time as the urinary catheters move through the curing system.PATENT Attorney Docket No. 3400-0326.01 (794PCT)47. The system of any one of claims 45-46, wherein the catheters move through the curing system at a speed of at least 5 mm / s or 10 mm / s or 20 mm / s, preferably at a speed from about 5 mm / s to about 20 mm / s.

48. The system of claim 47, wherein the speed varies as the catheters move through the curing system.

49. The system of any one of claims 45-48, wherein the catheters move through the curing system in a time period from about 100 seconds to about 400 seconds.

50. A continuous 3D system for curing hydrophilic coatings on a plurality of urinary catheters, comprising: at least one curing unit having a top wall, opposing side walls and an opening along a bottom of the curing unit, the top and side walls defining a curing compartment, the curing compartment having a receiving opening at a receiving end of the curing compartment and an opposed exit opening at an exit end of the curing compartment; at least one heat source suitable positioned adjacent or within the opening along the bottom or inside the walls of the curing unit, wherein the at least one heat source emits radiation into the curing compartment; at least one carrier supporting a plurality of urinary catheters having an uncured hydrophilic coating formulation thereon, the at least one carrier configured to enter the curing compartment of the curing unit through the receiving opening, move through the curing compartment for the coating to be at least partially cured, and exit out of exit opening of the curing unit; and wherein the heat emitted into the curing unit at least partially cures the hydrophilic coating formulation to thereby form a hydrophilic coating on the urinary.

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