Patent Description:
Functional improvements to implantable or insertable medical devices can be achieved by coating the surface of the device. For example, a coating formed on the surface of the device can provide improved lubricity, improved biocompatibility, or drug delivery properties to the surface. In turn, this can improve movement of the device in the body, extend the functional life of the device, or treat a medical condition near the site of implantation. However, various challenges exist for the design and use of coating apparatus designed to provide coatings to medical devices.

Traditional coating methods, such as dip coating, are often undesirable as they may result in flawed coatings that could compromise the function of the device or present problems during use. These methods can also result in coating inaccuracies, which can be manifested in variable amounts of the coated material being deposited on the surface of the device. When a drug is included in the coating material, it is often necessary to deliver precise amounts of the agent to the surface of the device to ensure that a subject receiving the coated device receives a proper dose of the agent. It has been difficult to achieve a great degree of accuracy using traditional coating methods and machines.

One type of insertable medical device is a balloon catheter. Balloon catheter constructions are well known in the art and are described in various documents, for example, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, and <CIT>. Balloon catheters generally include four portions, the balloon, catheter shaft, guide wire, and manifold. A balloon catheter generally includes an elongated catheter shaft with an inflatable balloon attached to a distal section of the catheter shaft. At a proximal end of the catheter shaft, there is typically a manifold. At the manifold end, placement of the catheter can be facilitated using a guide wire. Guide wires are small and maneuverable when inserted into an artery. Once the guide wire is moved to the target location, the catheter with balloon portion is then fed over the guide wire until the balloon reaches the target location in the vessel. The balloon is typically inserted into the arterial lumen of a patient and advanced through the lumen in an unexpanded state. The balloon is then inflated when the catheter reaches target site resulting in application of mechanical force sufficient to cause vessel dilation. The balloon is typically inflated using a fluid, which is injected through an inflation port. The manifold can control the fluid introduction within shaft for expansion of the balloon. The mechanics of fluid transfer and introduction within balloons vary according to the specific design of the catheter, and are well known in the art.

<CIT> describes a system and method for coating an expandable member of a medical device which comprises providing a dispenser in fluid communication with a fluid source with the dispenser having at least one outlet to dispense fluid of the fluid source therefrom. The outlet(s) of the dispenser is positioned proximate a surface of an expandable member, with relative movement between the outlet(s) and the surface of the expandable member established along a coating path, and fluid is dispensed from the dispenser to form a substantially continuous bead of fluid between the at least one outlet and the surface of the expandable member along the coating path, and simultaneously drying the fluid while dispensing the fluid from the dispenser to control flow of fluid on the surface of the expandable member. The fluid source can include a variety of therapeutic agents.

<CIT> describes a method and apparatus for coating a medical device. In one embodiment, the method for preparing a substantially uniform coated medical device includes (<NUM>) preparing a coating solution comprising a solvent, a therapeutic agent, and an additive; (<NUM>) loading a metering dispenser with the coating solution; (<NUM>) rotating the medical device about the longitudinal axis of the device and/or moving the medical device along the longitudinal or transverse axis of the device; (<NUM>) dispensing the coating solution from the metering dispenser onto a surface of the medical device and flowing the coating solution on the surface of the medical device while the medical device is rotating and/or linearly moving; and (<NUM>) evaporating the solvent, forming a substantially uniform coating layer on the medical device.

The present invention comprises a coating apparatus and a method of coating a medical device as defined by the claims. Embodiments that do not fall within the scope of the claims are to be interpreted as examples useful for understanding the invention.

Embodiments include apparatus and methods for coating drug coated medical devices. An embodiment which is disclosed but not claimed includes a coating apparatus including a coating application unit comprising a movement restriction structure; a fluid applicator; and an air nozzle. The apparatus can further include a rotation mechanism and a axial motion mechanism, the axial motion mechanism configured to cause movement of at least one of the coating application unit and the rotation mechanism with respect to one another.

Another embodiment which is disclosed but not claimed includes a coating apparatus including a coating application unit comprising a fluid applicator; a fluid distribution bar; an air nozzle; and a rotation mechanism. The coating apparatus can further include an axial motion mechanism, the axial motion mechanism configured to cause movement of the coating application unit with respect to the rotator.

Another embodiment which is disclosed but not claimed includes a method of coating including rotating a balloon catheter with a rotation mechanism, the balloon catheter comprising a balloon, contacting the balloon with a movement restriction structure defining a channel; applying a coating solution onto the surface of the balloon with a fluid applicator, contacting the surface of the balloon with a fluid distribution bar, blowing a stream of a gas onto the surface of the balloon, wherein the channel limits lateral movement of the balloon.

Another embodiment includes a coating apparatus. The coating apparatus includes a coating application unit. The coating application unit includes a movement restriction structure, a fluid applicator having a lengthwise axis and a width. The fluid applicator includes a tip. The tip includes a face across the width of the fluid applicator. The face is oriented at an angle of from about <NUM> to about <NUM> degrees with respect to the lengthwise axis of the fluid applicator. The fluid applicator is configured to rotate around its lengthwise axis so as to change the orientation of the face with respect to the device being coated. The coating apparatus further includes a rotation mechanism and an axial motion mechanism. The axial motion mechanism is configured to cause movement of at least one of the coating application unit and the rotation mechanism with respect to one another. The fluid applicator is configured to rotate around its lengthwise axis by an amount from about <NUM> degrees to about <NUM> degrees.

Another embodiment includes a method of coating a medical device. The method includes engaging a medical device to be coated into a movement restriction structure and rotating a medical device to be coated with a rotation mechanism. The method further includes contacting the surface of the medical device with a fluid applicator having a lengthwise axis and a width. The fluid applicator includes a tip. The tip includes a face across the width of the fluid applicator. The face is oriented at an angle of from about <NUM> to about <NUM> degrees with respect to the lengthwise axis of the fluid applicator. The method includes applying a coating solution onto the surface of the balloon with the fluid applicator. The method further includes rotating the fluid applicator about its lengthwise axis by an amount from about <NUM> to about <NUM> degrees.

Another embodiment which is disclosed but not claimed includes a coated medical device including a shaft, an expandable portion having a surface, and a coating disposed on the expandable portion. The coating can include a continuous coverage segment and a discontinuous coverage segment.

This summary is an overview of some of the teachings of the present application and is not intended to be an exclusive or exhaustive treatment of the present subject matter. Further details are found in the detailed description and appended claims. Other aspects will be apparent to persons skilled in the art upon reading and understanding the following detailed description and viewing the drawings that form a part thereof, each of which is not to be taken in a limiting sense. The scope of the present invention is defined by the appended claims and their legal equivalents.

The invention may be more completely understood in connection with the following drawings, in which:.

While the invention is susceptible to various modifications and alternative forms, specifics thereof have been shown by way of example and drawings, and will be described in detail. It should be understood, however, that the invention is not limited to the particular embodiments described. On the contrary, the intention is to cover modifications, equivalents, and alternatives falling within the scope of the claims.

The embodiments described herein are not intended to be exhaustive or to limit the invention to the precise forms disclosed in the following detailed description. Rather, the embodiments are chosen and described so that others skilled in the art can appreciate and understand the principles and practices of the present invention.

The publications and patents disclosed herein are provided solely for their disclosure. Nothing herein is to be construed as an admission that the inventors are not entitled to antedate any publication and/or patent, including any publication and/or patent cited herein.

Embodiments herein can be used to apply visually uniform coatings, such as coatings including active agents, onto medical devices, such as onto the balloons of drug coated or drug eluting balloon catheters, that have substantially uniform active agent concentrations along the length of the medical device. For example, in some embodiments, coatings can be formed with apparatus and methods wherein each section of the device that has been coated contains an amount of the active agent that is within ten percent of the average amount of active agent across all sections coated.

Referring now to <FIG>, a schematic side view is shown of a coating apparatus <NUM> in accordance with various embodiments herein. The coating apparatus <NUM> is shown in conjunction with a drug coated balloon catheter <NUM>. The drug coated balloon catheter <NUM> can include a catheter shaft <NUM> and a balloon <NUM>. The balloon <NUM> can assume a deflated configuration and an inflated configuration. The drug coated balloon catheter <NUM> can include a distal end <NUM> and a proximal end <NUM>. The drug coated balloon catheter <NUM> can include a proximal end manifold (not shown). The coating apparatus <NUM> can include a coating application unit <NUM>. The coating apparatus <NUM> can further include, in some embodiments, an axial motion mechanism <NUM> (axial with respect to the axis of rotation of the balloon catheter and thus parallel to the lengthwise axis of the balloon catheter) that can function to move one or more components of the coating application unit <NUM>. In some embodiments, axial motion can be substantially horizontal. In other embodiments, axial motion can be substantially vertical. In some embodiments, axial motion can be somewhere in between horizontal and vertical, depending on the orientation of the lengthwise axis of the balloon catheter. However, it will be appreciated that in other embodiments, the coating application unit <NUM> can remain stationary.

Coating of the balloon <NUM> to make it drug coated can occur starting at the proximal end of the balloon and proceeding to the distal end. However, in other embodiments, coating of the drug coated balloon <NUM> can occur starting at the distal end of the balloon and proceeding to the proximal end. In many embodiments, coating can take place with a single pass of the coating application unit <NUM> with respect to the balloon. However, in other embodiments, multiple passes of the coating. application unit with respect to the balloon can be made.

The coating apparatus <NUM> can further include a fluid pump <NUM>. The fluid pump <NUM> can be, for example, a syringe pump. The fluid pump <NUM> can be in fluid communication with components of the coating application unit <NUM> (such as the fluid applicator) and with a fluid reservoir <NUM>. The fluid pump <NUM> can operate to pump a coating solution at a rate sufficient to apply about <NUM>µl to about <NUM>µl of the coating solution per millimeter of length of the balloon or other device to be coated. The coating apparatus <NUM> can further include a rotation mechanism <NUM> (or rotating balloon catheter fixture). The rotation mechanism <NUM> can be directly or indirectly coupled to the drug coated balloon catheter in order to rotate the drug coated balloon catheter <NUM> around its lengthwise (major) axis (about the central lumen of the catheter). In some embodiments, the drug coated balloon catheter can be rotated at a speed of between <NUM> and <NUM> rotations per minute. In some embodiments, the drug coated balloon catheter can be rotated at a speed of between <NUM> and <NUM> rotations per minute.

In some embodiments, a guide wire <NUM>, passing through the central lumen of the catheter, can extend from the distal tip of the catheter and be inserted into a distal tip support ring <NUM> or guide. In this manner, the guide wire <NUM> can be used to support the distal tip of the balloon catheter to be coated while allowing the balloon catheter to rotate freely.

The coating apparatus <NUM> can further include, in some embodiments, an axial motion mechanism <NUM> which can be configured to move the drug coated balloon catheter <NUM> in the direction of its lengthwise major axis. In some embodiments, axial motion can be substantially horizontal. In other embodiments, axial motion can be substantially vertical. In some embodiments, axial motion can be somewhere in between horizontal and vertical, depending on the orientation of the lengthwise axis of the balloon catheter. In some embodiments, the axial motion mechanism <NUM> can be a linear actuator. In some embodiments, the axial motion mechanism <NUM> can include an electric motor. The coating apparatus <NUM> can further include a frame member <NUM> (in some embodiments this can also be referred to as an axial motion support rail). The frame member <NUM> can support other components of the coating apparatus <NUM> such as one or more guides <NUM>. The frame member <NUM> can itself be support by a platform <NUM>. The coating apparatus <NUM> can further include a controller <NUM> that can serve to control operation of the coating apparatus <NUM> including, specifically, fluid pump <NUM>, axial motion mechanism <NUM>, rotation mechanism <NUM>, and axial motion mechanism <NUM>.

Referring now to <FIG>, a schematic view of a coating application unit <NUM> in accordance with various embodiments herein is shown. The coating application unit <NUM> can include a movement restriction structure <NUM> (or wobble control structure), an air nozzle <NUM>, a fluid distribution bar <NUM>, and a fluid applicator <NUM>. The movement restriction structure <NUM> can serve to limit the lateral motion (e.g., movement in a direction perpendicular to the lengthwise axis of the catheter) of the balloon during a coating operation.

The fluid applicator <NUM> can serve to apply a coating solution <NUM> to the surface of the balloon <NUM> on the drug coated balloon catheter. In some embodiments, the fluid applicator <NUM> is less than or equal to about <NUM> away from the movement restriction structure <NUM>. In some embodiments, the air nozzle <NUM> is less than or equal to about <NUM> away from the fluid applicator <NUM>. The air nozzle <NUM> can provide a stream of a gas in order to assist in drying the coating solution after it has been applied to the balloon or other medical device.

The fluid distribution bar <NUM> can serve to promote distribution of the applied coating solution. For example, the fluid distribution bar <NUM> can serve to prevent pooling of the applied coating solution. In some embodiments, the fluid distribution bar <NUM> can be at least about <NUM> away from the fluid applicator and less than <NUM> away. In some embodiments, the fluid distribution bar <NUM> can be at least about <NUM> away from the fluid applicator and less than <NUM> away.

In this embodiment, the coating application unit <NUM> can move, relative to the balloon <NUM> in the direction of arrow <NUM>. As such, during a coating operation, the movement restriction structure <NUM> can pass over the balloon first, followed by the fluid applicator <NUM>, followed by the fluid distribution bar <NUM>, with the air nozzle last. It should be emphasized, however, that this movement is relative in the sense that in some embodiments the coating application unit <NUM> is moving and the balloon <NUM> is rotating but otherwise stationary, in some embodiments the balloon <NUM> is rotating and moving in the direction of its lengthwise axis and the coating application unit <NUM> is stationary, in still other embodiments both the coating application unit <NUM> and the balloon <NUM> are moving. The speed of movement of the balloon <NUM> relative to the coating application unit <NUM> can vary depending on the amount of coating solution to be applied. In some embodiments the speed can be from about <NUM> centimeters per second to about <NUM> centimeters per second.

It will be appreciated that based on the rotation of the drug coated balloon catheter and the movement of the balloon relative to the coating application unit that the path of the deposition of the coating onto the balloon follows a roughly helical path. It will be appreciated that the combination of the rotation speed of the drug coated balloon catheter and the speed of the movement of the balloon relative to the coating application unit can influence the amount of coating solution that is deposited at any given point and the nature of the helical path. For example, the coating material can be deposited in helical layers that partially overlap one another at their edges, helical layers wherein the edge of one turn substantially meets the edge of a previous turn, and helical layers wherein there are gaps in between subsequent helical turns. In some embodiments, these helical patterns can be configured so as to maximize release of the active agent. For example, in some embodiments, the apparatus can be used to coat device so as to produce helical ridges of the coating material on the balloon surface.

In some embodiments, the coating application unit <NUM> can optionally include a manifold block <NUM>. The manifold block <NUM> can facilitate support of, and in some embodiments movement of, the components of the coating application unit <NUM>. In some embodiments, the components of the coating application unit can move together as a unit during a coating operation. However, in other embodiments the components of the coating application unit are substantially separate from one another and can move independently. In some embodiments, the components of the coating application unit are all substantially stationary during a coating operation.

While the components of the coating application unit <NUM> are shown in <FIG> as being within a particular plane and disposed at approximately the same angle with respect to the balloon <NUM> being coated, it will be appreciated that this is not the case with all embodiments herein. In some embodiments, the components of the coating application unit <NUM> lie in different planes with respect to the balloon <NUM> and/or the components of the coating application unit <NUM> are disposed at different angles (both with respect to the lengthwise axis of the balloon and radially) with respect to the balloon.

Referring now to <FIG>, a schematic end view is shown of a movement restriction structure <NUM> in accordance with various embodiments herein. The structure <NUM> can include a body member <NUM> defining a channel <NUM> or aperture. The body member <NUM> can be formed of various materials such as polymers, metals, ceramics, and the like. In a particular embodiment, the body member <NUM> is formed of polytetrafluoroethylene (PTFE). The channel <NUM> can have a diameter <NUM> that is sufficiently large so as to accommodate the balloon of a drug coated balloon catheter in an expanded state. In the example of <FIG>, the channel <NUM> is shown as being bounded in a radially continuous manner by the body member <NUM> (e.g., it is completely surrounded on all sides by the body member <NUM>). However, it will be appreciated that in some embodiments the channel <NUM> is not bounded in a radially continuous manner by the body member <NUM>.

In some embodiments the movement restriction structure can include multiple pieces that together define a channel or aperture. Referring now to <FIG>, a movement restriction structure <NUM> is shown including a body member that includes a first piece <NUM> and a second piece <NUM> that together define a channel <NUM> or aperture. The first piece <NUM> and second piece <NUM> are joined together by a hinge <NUM> in this embodiment, however it will be appreciated that there are many ways known to those of skill in the art by which to hold two structure pieces in association with one another.

It will be appreciated that body members of movement restriction structures can take on many different shapes. In addition, the shape of the channel defined by the body member(s) can take on many different shapes. Referring now to <FIG>, a movement restriction structure <NUM> is shown including a first side piece <NUM> and a second side piece <NUM> that together define a channel <NUM> or aperture. In this case, the first side piece <NUM> and the second side piece <NUM> are supported by a frame member <NUM>. However, it will be appreciated that there are many different ways of supporting the first side piece <NUM> and the second side piece <NUM>. In some embodiments, one or both of the first side piece <NUM> and the second side piece <NUM> can be spring loaded such that it is biased toward sliding inward toward the other piece. In other embodiments, one or both of the first side piece <NUM> and the second side piece <NUM> can be adjustable and then fixed in position so as to create a channel <NUM> of a desired size.

Referring now to <FIG> a schematic end view of a fluid distribution bar <NUM> in conjunction with the balloon <NUM> of a drug coated balloon catheter <NUM> is shown. In some embodiments, the fluid distribution bar <NUM> can include a support structure <NUM> and a shaft <NUM>. In some embodiments, the support structure <NUM> can be omitted. The shaft <NUM> can be formed of various materials such as polymers, metals, ceramics, and the like. In a particular embodiment, the shaft <NUM> is formed of polytetrafluoroethylene (PTFE). The shaft <NUM> can be of various lengths and diameters and can have various cross-sectional shapes. In some embodiments, the shaft <NUM> is from about <NUM> to about <NUM> and is substantially circular in cross-sectional shape. In some embodiments, the shaft is about <NUM>/<NUM> inch (<NUM>) in diameter. The shaft <NUM> is configured to rest against the balloon <NUM> of the balloon catheter <NUM>.

In yet other embodiments the fluid distribution bar <NUM> can include multiple rods or extensions from support structure <NUM>. Exemplary of these embodiments can include, but are not limited to, a comb-like structure or a brush.

The balloon <NUM> is supported by the catheter shaft <NUM>, but generally only at the ends of the balloon <NUM>. Because of the limited support of the balloon <NUM> by the catheter shaft <NUM>, the inherent flexibility of the balloon material and manufacturing variations, the balloon <NUM> may not be perfectly round. As such, when it is being rotated during a coating operation there may be variations in the distance of the outer surface of the balloon <NUM> from the catheter shaft <NUM> of the balloon catheter <NUM>. If unaccounted for, this could lead to circumstances where the fluid distribution bar <NUM> does not maintain contact with the surface of the balloon <NUM>. As such, the shaft <NUM> of the fluid distribution bar <NUM> can be configured to maintain contact with the surface of the balloon <NUM>. For example, the shaft <NUM> of the fluid distribution bar <NUM> can be positioned such that it exerts a small degree of pressure against the surface of the balloon <NUM> such that when an irregularity in the balloon is encountered the fluid distribution bar <NUM> can move slightly in order to maintain contact with the balloon surface. In some embodiments the shaft <NUM> of the fluid distribution bar <NUM> is flexible to accommodate movement to stay in contact with the balloon surface. In other embodiments, the fluid distribution bar <NUM> can be configured to pivot from where it is mounted in order to accommodate movement to stay in contact with the balloon surface.

While the shaft <NUM> of the fluid distribution bar <NUM> is shown in <FIG> as contacting the top of the balloon <NUM> and thus exerting a pressure downward in the direction of arrow <NUM>, it will be appreciated that in other embodiments the surface of the balloon <NUM> can be contacted at other points along its surface, such as on the sides or on the bottom.

Referring now to <FIG>, a schematic end view of a fluid applicator <NUM> in conjunction with the balloon <NUM> of a drug coated balloon catheter <NUM> is shown in accordance with an embodiment. The fluid applicator <NUM> can include a shaft <NUM> and an orifice <NUM>. In some embodiments, the fluid applicator <NUM> can be a pipette. Fluid, such as a coating solution, can travel through the shaft <NUM> of the fluid applicator <NUM> in order to be deposited on the surface of the balloon <NUM> of the drug coated balloon catheter <NUM>. The shaft <NUM> is configured to rest against the balloon <NUM> of the balloon catheter <NUM>. The balloon <NUM> is supported by the catheter shaft <NUM>, but generally only at the ends of the balloon <NUM>. Because of the limited support of the balloon <NUM> by the catheter shaft <NUM>, the inherent flexibility of the balloon material and manufacturing variations, the balloon <NUM> may not be perfectly round. As such, when it is being rotated during a coating operation there may be variations in the distance of the outer surface of the balloon <NUM> from the catheter shaft <NUM> of the balloon catheter <NUM>. If unaccounted for, this could lead to circumstances where the fluid applicator <NUM> does not maintain contact with the surface of the balloon <NUM>. As such, the shaft <NUM> of the fluid applicator <NUM> can be configured to maintain contact with the surface of the balloon <NUM>. For example, the shaft <NUM> of the fluid applicator <NUM> can be positioned such that it exerts a small degree of pressure against the surface of the balloon <NUM> such that when an irregularity in the balloon <NUM> is encountered the fluid applicator <NUM> can move slightly in order to maintain contact with the balloon surface. In some embodiments the shaft <NUM> of the fluid applicator <NUM> is flexible to accommodate movement to stay in contact with the balloon surface. In other embodiments, the fluid applicator <NUM> can be configured to pivot from where it is mounted in order to accommodate movement to stay in contact with the balloon surface. In other embodiments, the fluid applicator may not be in direct contact with the balloon surface but situated closely, for example within <NUM> millimeter.

While the shaft <NUM> of the fluid applicator <NUM> is shown in <FIG> as contacting the upper right side (approximately equivalent to an area between the <NUM> and <NUM> position of a clock face) of the balloon <NUM>, it will be appreciated that in other embodiments the surface of the balloon <NUM> can be contacted at other points along its surface. For example, in some embodiments, the very top of the balloon <NUM> can be contacted by the fluid applicator <NUM>.

In some embodiments the fluid distribution bar <NUM> and the fluid applicator <NUM> can be configured such that the shaft <NUM> of the fluid distribution bar <NUM> contacts the surface of the balloon at approximately the same point radially along the surface of the balloon as the shaft <NUM> of the fluid applicator <NUM>. In some embodiments, the fluid distribution bar <NUM> and the fluid applicator <NUM> can be configured such that the shaft <NUM> of the fluid distribution bar <NUM> contacts the surface of the balloon within at least <NUM> degrees radially along the surface of the balloon as the shaft <NUM> of the fluid applicator <NUM>.

Referring now to <FIG>, a schematic end view of an air nozzle <NUM> in conjunction with the balloon <NUM> of a drug coated balloon catheter <NUM> is shown. The air nozzle <NUM> can include an orifice <NUM>. A gas such nitrogen, ambient air or another gas can be directed to flow out of the orifice <NUM> and towards the balloon <NUM> of the drug coated balloon catheter <NUM>. In some embodiments, the gas can be heated. For example, in some embodiments the gas can be from about <NUM> to about <NUM> degrees Celsius. While the orifice <NUM> of the air nozzle <NUM> is shown in <FIG> as directing air to the top of the balloon <NUM>, it will be appreciated that in other embodiments the air nozzle <NUM> and orifice <NUM> can be configured to direct air at other parts of the balloon <NUM> such as, but not limited to, the sides or the bottom.

Referring now to <FIG>, a schematic view of a coating application unit in accordance with various embodiments herein is shown. The coating application unit <NUM> can include a movement restriction structure <NUM>, a first air nozzle <NUM>, a fluid applicator <NUM>, and a second air nozzle <NUM>. The first air nozzle <NUM> is disposed on one side of the fluid applicator <NUM> and the second air nozzle <NUM> is disposed on the other side of the fluid applicator <NUM>. In some embodiments the first air nozzle <NUM> can act to avoid pooling of the coating at the fluid applicator <NUM>. In some embodiments the second air nozzle <NUM> can act to avoid pooling of the coating fluid at the fluid applicator <NUM>. The fluid applicator <NUM> can serve to apply a coating solution <NUM> to the surface of the balloon on the drug coated balloon catheter. Other embodiments can include three or more air nozzles.

In this embodiment, the coating application unit <NUM> can move, relative to the balloon <NUM> in the direction of arrow <NUM>. As such, during a coating operation, the movement restriction structure <NUM> can pass over the balloon first. It should be emphasized, however, that this movement is relative in the sense that in some embodiments the coating application unit <NUM> is moving and the balloon <NUM> is rotating but otherwise stationary, in some embodiments the balloon <NUM> is rotating and moving in the direction of its lengthwise axis and the coating application unit <NUM> is stationary, in still other embodiments both the coating application unit <NUM> and the balloon <NUM> are moving.

It will be appreciated that the coating solution can be applied on to the balloon in various ways including, but not limited to, spraying (including both ultrasonic spraying and conventional spraying techniques), dribbling, blade coating, contact printing, drop coating, or the like. In some embodiments, the fluid applicator can include a fluid spray nozzle. Referring now to <FIG>, a schematic view of a coating application unit in accordance with various embodiments herein is shown. The coating application unit <NUM> can include a movement restriction structure <NUM>, an air nozzle <NUM>, a fluid distribution bar <NUM>, and a fluid spray nozzle <NUM>. The fluid spray nozzle <NUM> can serve to apply a coating solution <NUM> to the surface of the balloon <NUM> on the drug coated balloon catheter. In some embodiments there is a small gap between the fluid spray nozzle <NUM> and the balloon <NUM>. For example, the gap can be between <NUM> millimeter and <NUM> centimeters. In some embodiments, multiple fluid applicators and/or spray nozzles can be used.

<FIG> is a schematic top view of a movement restriction structure in accordance with various embodiments herein. The structure <NUM> can include a first body member <NUM> and a second body member <NUM>. The first and second body members <NUM>, <NUM> can be formed of various materials such as polymers, metals, ceramics, and the like. The first and second body members <NUM>, <NUM> can function together to restrict movement of a balloon <NUM> to be coated. The first and second body members <NUM>, <NUM> can be separated from one another by a distance <NUM> that is greater than or equal to the diameter of the balloon <NUM>. In some embodiments, the distance <NUM> is approximately equal to the balloon <NUM>. In some embodiments, the distance <NUM> is between about <NUM> millimeters and about <NUM> millimeters.

<FIG> is a schematic end view of the movement restriction structure <NUM>. The first body member <NUM> can include a curved segment <NUM> and an end <NUM>. The curved segment <NUM> can define a portion of a channel which can surround at least a portion of the balloon <NUM>, thereby restricting its movement. In some embodiments, the second body member <NUM> can be formed similarly but with a different orientation so that together the first body member <NUM> and the second body member <NUM> can effectively restrict movement of the balloon <NUM>. For example, the end <NUM> of the second body member <NUM> can be pointed upward instead of downward. <FIG> is a schematic front view of the movement restriction structure <NUM> that shows the differing orientations of the first body member <NUM> and the second body member <NUM>.

It will be appreciated that the balloon can be loaded into the movement restriction structure in various ways. For example, in some embodiments, the balloon catheter can simply be threaded through the movement restriction structure before or after being connected with other portions of the apparatus in preparation for coating. In other embodiments, the movement restriction structure itself can be manipulated in order to load the balloon. For example, in some embodiments, the movement restriction structure can be rotated into an open orientation in order to accommodate loading the balloon from the side. Then, in some embodiments, the movement restriction structure can be rotated from the open orientation to a closed orientation in order to lock the balloon in place. Referring now to <FIG>, a schematic front view of the movement restriction structure <NUM> is shown illustrating an open orientation. In this view, it can be seen that the first body member <NUM> and the second body member <NUM> are rotated approximately <NUM> degrees from their respective positions in <FIG>. The balloon <NUM> can be slid out from between the first and second body members <NUM>, <NUM> when the movement restriction structure <NUM> is in this orientation. In operation, then, a new balloon to be coated can be slid back in between the first and second body members <NUM>, <NUM> and then the body members can be rotated in the direction of arrows <NUM> and <NUM> to put the movement restriction structure <NUM> into the closed position (illustrated in <FIG>) where the balloon <NUM> is locked in place. In some embodiments, the first and second body members <NUM>, <NUM> can be rotated in either direction. The first and second body members <NUM>, <NUM> can be rotated together around a single axis or independently from one another around two separate axes.

It will be appreciated that body members of movement restrictions structures in accordance with embodiments herein can also include various other features. Referring now to <FIG>, a schematic end view of portions of a movement restriction structure <NUM> are shown in accordance with various embodiments herein. The movement restriction structure <NUM> can include a first body member <NUM>. The first body member <NUM> can include a curved segment <NUM> and an end <NUM>. The curved segment <NUM> can define a portion of a channel which can surround at least a portion of the balloon <NUM>, thereby restricting the balloon's <NUM> movement, in conjunction with a second body member (not shown in this view). The first body member <NUM> can also include an alignment lip <NUM> adjacent to the end <NUM>. The alignment lip <NUM> can include a surface <NUM> that is angled away from the channel defined by the curved segment <NUM>. The alignment lip <NUM> can aid in positioning the balloon <NUM> within the channel formed by the curved segment <NUM>. For example, when the first body member <NUM> is rotated starting from the open position, if the balloon <NUM> is slightly out of position by being too close to the end <NUM>, the surface <NUM> of the alignment lip <NUM> will contact the balloon <NUM> surface and cause the balloon <NUM> to move into alignment with the channel.

It will be appreciated that fluid applicators can take on various configurations in accordance with embodiments herein. <FIG> is a schematic end view of a fluid applicator <NUM> in accordance with various embodiments herein. The fluid applicator <NUM> can include a shaft <NUM> and an orifice <NUM>. The orifice <NUM> can be located along the shaft <NUM> at a position other than at the distal end <NUM> of the shaft <NUM>. Fluid <NUM>, such as a coating solution, can pass from the fluid applicator <NUM> through the orifice <NUM> in order to be deposited on the surface of the balloon. The segment <NUM> of the shaft <NUM> that extends beyond where the orifice <NUM> is located can be curved, in some embodiments, in order to form part of a channel which can serve to maintain the position of the balloon relative to the fluid applicator <NUM>. In some embodiments, segment <NUM> can be disposed between the orifice <NUM> and the distal end <NUM> of the shaft <NUM>.

Referring now to <FIG>, a schematic perspective view of a coating apparatus <NUM> is shown in accordance with various embodiments herein. The coating apparatus <NUM> can include a fluid applicator <NUM> and a movement restriction structure <NUM>. The movement restriction structure <NUM> can include an engagement surface <NUM> having a U-shaped contour. A device to be coated, such as a balloon catheter <NUM>, is shown as ready for insertion into the movement restriction structure <NUM>.

Referring now to <FIG>, a schematic perspective view is shown of a fluid applicator <NUM> interfacing with balloon catheter <NUM> as held by a movement restriction structure <NUM>. The movement restriction structure <NUM> can include an engagement surface <NUM> having a U-shaped contour. The fluid applicator <NUM> can include a contact surface <NUM> that is angled with respect to the lengthwise axis of the fluid applicator <NUM>. The contact surface <NUM> can fit against the balloon catheter during the coating operation so as to make contact and aid in holding the balloon catheter against the engagement surface <NUM> of the movement restriction structure. <NUM> is a schematic perspective view of a fluid applicator <NUM> interfacing with balloon catheter <NUM> as held by a movement restriction structure <NUM>. A fluid coating composition <NUM> is applied onto the surface of the balloon catheter <NUM>. The fluid coating composition <NUM> then passes past a drying nozzle <NUM> forming a dried coating <NUM>.

Referring now to <FIG>, a schematic perspective view of elements of a coating apparatus in accordance with various embodiments herein. In this view, a coating operation has been completed and the now coated balloon catheter <NUM> has been removed from contact with the fluid applicator <NUM> and has been moved out from within the engagement surface <NUM> of the movement restriction structure <NUM>.

Referring now to <FIG>, a schematic cross-sectional view through the middle of a fluid applicator <NUM> is shown in accordance with various embodiments herein. The fluid applicator <NUM> can be formed of various materials including polymers, metals, ceramics, glasses, and the like. The fluid applicator <NUM> can define a central channel <NUM> through which a fluid coating composition can be delivered. The fluid applicator <NUM> can further include a contact surface <NUM>. The contact surface <NUM> can be angled with respect to the lengthwise axis of the fluid applicator <NUM>. In some embodiments, the contact surface <NUM> can be angled from about <NUM> degrees to about <NUM> degrees with respect to the lengthwise axis of the fluid applicator <NUM>. In some embodiments, the contact surface <NUM> is angled such that its surface is substantially parallel with a line that is a tangent to the balloon catheter <NUM> at the point of contact between the fluid applicator <NUM> and the balloon catheter <NUM>. A fluid orifice <NUM> can be disposed as the distal end of the fluid applicator <NUM>.

<FIG> is a schematic cross-sectional view of a fluid applicator <NUM> interfacing with a balloon catheter <NUM> as held by a movement restriction structure <NUM>. The contact surface <NUM> of the fluid applicator <NUM> can contact the surface of the balloon catheter <NUM>. In some embodiments, the contact point between the fluid applicator <NUM> and the surface of the balloon catheter <NUM> can be at a position equivalent to between <NUM> and <NUM> on the face of a standard clock (or between <NUM> and <NUM> if the fluid applicator <NUM> is arranged on the other side of the balloon catheter). If the position of <NUM> on a clock face is taken as <NUM> degrees, then the contact point can be between <NUM> degrees and <NUM> degrees (or between <NUM> degrees and <NUM> degrees if the fluid applicator <NUM> is arranged on the other side of the balloon catheter). The surface of the balloon catheter <NUM> can contact the engagement surface <NUM> of the movement restriction structure <NUM>. In some embodiments, the leading and trailing edges of the engagement surface <NUM> can include curved edges. In some embodiments, the engagement surface <NUM> can include a radius of curvature extending from the leading edge to the trailing edge such that the point of contact with the surface of the balloon catheter is in the middle of the engagement surface between the leading edge and the trailing edge.

<FIG> is a schematic cross-sectional view of a fluid applicator <NUM> interfacing with a balloon catheter <NUM> as held by a movement restriction structure <NUM>. The contact surface <NUM> of the fluid applicator <NUM> can contact the surface of the balloon catheter <NUM>. In some embodiments, the contact point between the fluid applicator <NUM> and the surface of the balloon catheter <NUM> can be at a position equivalent to between <NUM> and <NUM> on the face of a standard clock (or between <NUM> and <NUM> if the fluid applicator <NUM> is arranged on the other side of the balloon catheter). If the position of <NUM> on a clock face is taken as <NUM> degrees, then the contact point can be between <NUM> degrees and <NUM> degrees (or between <NUM> degrees and <NUM> degrees if the fluid applicator <NUM> is arranged on the other side of the balloon catheter). Additionally, the fluid applicator <NUM> can be held at an angle θ<NUM> (with respect to a fully horizontal position) from the contact points described above. The angle θ<NUM> can vary between <NUM> (as shown in <FIG>) and as much as <NUM> degrees. The surface of the balloon catheter <NUM> can contact the engagement surface <NUM> of the movement restriction structure <NUM>. In some embodiments, the leading and trailing edges (e.g., oriented such that a line connecting the leading and trailing edges would be perpendicular to the cross-section of <FIG> and thus go into and out of the page) of the engagement surface <NUM> can include curved edges. In yet other embodiments the engagement surface can include an engagement ramp <NUM> to allow the balloon catheter <NUM> to more easily become engaged with the engagement surface <NUM>. In some embodiments, the engagement surface <NUM> can include a radius of curvature extending from the leading edge to the trailing edge such that the point of contact with the surface of the balloon catheter is in the middle of the engagement surface between the leading edge and the trailing edge.

In some embodiments the fluid distribution bar <NUM> can act to further restrict movement and keep the balloon catheter <NUM> engaged against the engagement surface <NUM>. In some exemplary embodiments, wherein the angle θ<NUM> exceeds <NUM> degrees, the fluid distribution bar <NUM> can further restrict movement and keep the balloon catheter <NUM> engaged against the engagement surface <NUM>.

Referring now to <FIG>, a schematic cross-sectional view is shown of a fluid applicator <NUM> interfacing with the surface <NUM> of a balloon catheter. The coating apparatus can further include a fluid distribution bar <NUM> (or wire) that is connected to the fluid applicator <NUM> and is arranged to contact the surface <NUM> of the balloon catheter.

In this view, the fluid distribution bar <NUM> is angled upward with respect to device to be coated such that it contacts the device to be coated at a higher point than the fluid applicator. In some embodiments, the fluid distribution bar is arranged such that it does not actually contact the surface of the device to be coated but is sufficiently close so as to contact any coating material that is deposited thereon. The angle (θ<NUM>) of the body of the fluid distribution bar <NUM> with respect to the lengthwise major axis of the fluid applicator <NUM> and/or the tip of the fluid applicator <NUM> can be from about <NUM> degrees to about <NUM> degrees. In some embodiments the angle (θ<NUM>) is from about <NUM> degrees to about <NUM> degrees. In some embodiments, the angle is sufficient such that the body of the fluid distribution bar <NUM> is tangent with respect to the surface of the device to be coated. In other embodiments, the fluid distribution bar is not be angled upward.

In this view, the fluid distribution bar <NUM> is shown connected to the top side of the fluid applicator <NUM>. However, it will be appreciated that the fluid distribution bar <NUM> can also be connected to the sides, bottom, or any other portion of the fluid applicator in other embodiments. In still other embodiments, the fluid distribution bar is not connected to the fluid applicator at all. <FIG> is a schematic top view of the fluid applicator <NUM> and fluid distribution bar <NUM> interfacing with the surface <NUM> balloon catheter.

While the embodiment shown in <NUM> illustrates an embodiment of a fluid distribution bar <NUM> that is substantially straight, it will be appreciated that in other embodiments the fluid distribution bar can be curved and/or have bent portions. <NUM> a schematic top view of a fluid applicator interfacing with a balloon catheter is shown in accordance with another embodiment. The coating apparatus includes a fluid distribution bar <NUM> that is connected to the fluid applicator <NUM> and is arranged to contact the surface <NUM> of the balloon catheter. The fluid distribution bar <NUM> also includes a portion <NUM> (or tail) that is angled with respect to the major axis of the fluid applicator. The portion <NUM> extends in a direction that is downstream of the fluid applicator (e.g. on the side of the fluid applicator where coating material has already been deposited based on how the fluid applicator and/or the device to be coated move with respect to one another). However, in other embodiments, the portion <NUM> could extend upstream of the fluid applicator.

In some embodiments the portion <NUM> can be substantially parallel with the lengthwise axis of the device to be coated, such as the balloon catheter. In other embodiments, the portion <NUM> can be angled with respect to the lengthwise axis of the device to be coated. <NUM>, a schematic top view is shown of a fluid applicator interfacing with a balloon catheter in accordance with various embodiments. The coating apparatus includes a fluid distribution bar <NUM> that is connected to the fluid applicator <NUM> and is arranged to contact the surface <NUM> of the balloon catheter. The fluid distribution bar <NUM> includes a portion <NUM> that is angled back toward the fluid applicator <NUM>. <FIG> shows another embodiment of the coating apparatus. In this view, the fluid distribution bar <NUM> includes a portion <NUM> that is angled away from the fluid applicator <NUM>.

<FIG> is a schematic top view of a fluid applicator interfacing with a balloon catheter in accordance with another embodiment The coating apparatus includes a fluid distribution bar <NUM> that is connected to the fluid applicator <NUM> and is arranged to contact the surface <NUM> of the balloon catheter. The fluid distribution bar <NUM> includes a portion <NUM> that is disposed upstream of the fluid applicator and a portion <NUM> that is disposed downstream of the fluid applicator.

It will be appreciated that the fluid distribution bar can be made of various materials. In some embodiments it can be formed of polymers, metals, composites, ceramics and the like. In some embodiments it is flexible. In other embodiments it is substantially rigid. In some embodiments it can have a diameter that is less than the diameter of the fluid applicator. In some embodiments it is circular in cross sectional. In other embodiments it can be polygonal, ovoid, or irregular in cross-section. In some embodiments it can have a flattened surface where it contacts the device to be coated.

It will be appreciated that coating solutions applied onto balloons can include various components including, but not limited to, one or more active agents, carrier agents and/or solvents, polymers (including degradable or non-degradable polymers), excipients, and the like. The relative amounts of the components of the coating solution will depend on various factors including the desired amount of active agent to be applied to the balloon and the desired release rate of the active agent.

Embodiments herein include methods of applying coatings onto balloon catheters. In an embodiment, the method can include rotating a balloon catheter with a rotation mechanism, the balloon catheter comprising a balloon, contacting the balloon with a movement restriction structure defining a channel, wherein the channel limits lateral movement of the balloon, applying a coating solution onto the surface of the balloon with a fluid applicator (such as through direct contact with a fluid applicator), contacting the surface of the balloon with a fluid distribution bar, and blowing a stream of a gas onto the surface of the balloon. In some embodiments, the balloon catheter can be rotated at a speed of between <NUM> and <NUM> rotations per minute.

In some embodiments, the method can include moving the fluid applicator relative to the lengthwise axis of the drug eluting balloon catheter. In some embodiments, the method can include moving the drug eluting balloon catheter along its lengthwise axis relative to the fluid applicator, fluid distribution bar, and movement restriction structure.

In <FIG> a schematic cross-sectional view is shown of a fluid applicator <NUM>. The fluid applicator <NUM> includes a tip <NUM> having a face <NUM> (or surface) that is angled with respect to the lengthwise axis of the fluid applicator <NUM>. The face <NUM> extends across the width of the tip <NUM>. As shown, a line that connects the top portion <NUM> of the tip <NUM> with the bottom portion <NUM> of the tip <NUM> (or the line is parallel to the face <NUM> of the tip <NUM>) has an angle Θ2 with respect to a line parallel to the lengthwise axis of the fluid applicator <NUM>. Angle Θ2 can be from about <NUM> to about <NUM> degrees.

<FIG> shows a view of the fluid applicator <NUM> interfacing with a surface <NUM> of a device to be coated, such as a balloon catheter. The fluid applicator <NUM> is configured to rotate around its lengthwise axis as indicated by arrow <NUM>, and is connected to a rotation mechanism to cause it to rotate.

Referring now to <FIG>, a schematic top view is shown of a fluid applicator <NUM> interfacing with a surface <NUM> of a device to be coated. In this view, the face of the fluid applicator <NUM> is oriented downward toward the surface <NUM> consistent with the orientation shown in <FIG>. It has been found that this orientation of the tip face <NUM> results in a coating <NUM> being applied that is substantially continuous in coverage. In <FIG>, a schematic top view is shown of a fluid applicator <NUM> interfacing with a surface <NUM> of a device to be coated wherein the face <NUM> of the tip <NUM> is oriented differently than as shown in <FIG>. In this view, the fluid applicator <NUM> has been rotated approximately <NUM> degrees such that the face <NUM> of the tip <NUM> is now facing approximately sideward with respect to the surface <NUM>. It has been found that this orientation of the tip face <NUM> results in a coating <NUM> being applied that is discontinuous in coverage and forms a spiral or helical shape.

The fluid applicator <NUM> can be rotated from about <NUM> degrees to about <NUM> degrees.

In various embodiments, the fluid applicator <NUM> can be rotated to a particular orientation in order to create either a continuous or discontinuous coating as desired. In some embodiments, the fluid applicator <NUM> can be rotated during a coating application process allowing for the creation of medical devices having segments of continuous coating coverage and segments with discontinuous coating coverage.

Referring now to <FIG>, a schematic top view is shown of a fluid applicator <NUM> interfacing with a surface <NUM> of a device to be coated. In this view, the lengthwise axis <NUM> of the fluid applicator <NUM> forms an angle Θ3 with respect to the lengthwise axis <NUM> of the device to be coated. In specific, angle Θ3 can be from about <NUM> to about <NUM> degrees. In some embodiments, angle Θ3 can be from about <NUM> to about <NUM> degrees. In some embodiments, angle Θ3 can be from about <NUM> to about <NUM> degrees. In some embodiments, angle Θ3 can be from about <NUM> to about <NUM> degrees. In some embodiments, angle Θ3 can be from about <NUM> to about <NUM> degrees. In some embodiments, angle Θ3 can be about <NUM> degrees. In some embodiments, angle Θ3 can be from about <NUM> degrees to about <NUM> degrees. In some embodiments, angle Θ3 can be from about <NUM> degrees to about <NUM> degrees.

Referring now to <FIG>, a schematic view is show of a portion of a medical device <NUM> having a surface <NUM>. The surface <NUM> includes a segment <NUM> with continuous coating coverage and segments <NUM> with discontinuous coating coverage. The segment with discontinuous coating coverage can have various shaped coating configurations such as spiral, helical, ring, and the like. In some embodiments, the surface <NUM> can also include a segment <NUM> with no coating coverage.

It will be appreciated that the segments can be aligned with various features of the device to be coated. By way of example, to decrease the amount of coating material in an area near the ends of a balloon on a balloon catheter, the fluid applicator can be rotated during the coating process to produce a discontinuous coating segment when approaching the ends of the balloon.

Referring now to <FIG>, a schematic view of a medical device <NUM> is shown. The medical device <NUM> can optionally include a connection manifold <NUM>, a shaft <NUM> having a surface, and an expandable portion <NUM> (such as a balloon) having a surface. The expandable portion <NUM> can include a proximal end <NUM> and a distal end <NUM>. Coating segments, such as those shown in <FIG>, can be disposed onto one or more of the shaft <NUM> and the expandable portion <NUM>. In some embodiments, the expandable portion <NUM> can include multiple coating segments thereon disposed adjacently to one another. By way of example, the expandable portion <NUM> can include both continuous coating coverage segments and discontinuous coating coverage segments.

In some embodiments, the medical device <NUM> can include at least one continuous coverage segment and at least two discontinuous coverage segments in some embodiments. In some embodiments, the discontinuous coverage segment can be disposed over at least one of the distal end and the proximal end. In some embodiments, a first discontinuous coverage segment can be disposed over the proximal end and a second discontinuous coverage segment can be disposed over the distal end. In some embodiments, the continuous coverage segment can be disposed over the expandable portion between the distal end and the proximal end.

In various embodiments, a method of coating a medical device is included. The method includes rotating a medical device to be coated with a rotation mechanism. In some embodiments, the medical device can be a balloon catheter comprising a balloon. The method further includes contacting the surface of the medical device with a fluid applicator, applying a coating solution onto the surface of the balloon with the fluid applicator, and rotating the fluid applicator axially about its lengthwise major axis.

It should be noted that, as used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. Thus, for example, reference to a composition containing "a compound" includes a mixture of two or more compounds. It should also be noted that the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise.

It should also be noted that, as used in this specification and the appended claims, the phrase "configured" describes a system, apparatus, or other structure that is constructed or configured to perform a particular task or adopt a particular configuration to.

All publications and patent applications in this specification are indicative of the level of ordinary skill in the art to which this invention pertains.

Claim 1:
A coating apparatus (<NUM>) comprising:
a coating application unit (<NUM>) comprising
a movement restriction structure (<NUM>); and
a fluid applicator (<NUM>) having a lengthwise axis (<NUM>) and a width, the fluid applicator (<NUM>) comprising a tip (<NUM>), the tip (<NUM>) comprising a face (<NUM>) across the width of the fluid applicator (<NUM>), the face (<NUM>) oriented at an angle (θ<NUM>) of from about <NUM> to about <NUM> degrees with respect to the lengthwise axis (<NUM>) of the fluid applicator (<NUM>), the fluid applicator (<NUM>) configured to rotate (<NUM>) around its lengthwise axis (<NUM>);
a rotation mechanism (<NUM>); and
an axial motion mechanism (<NUM>, <NUM>), the axial motion mechanism (<NUM>, <NUM>) configured to cause movement of at least one of the coating application unit (<NUM>) and the rotation mechanism (<NUM>) with respect to one another
characterised in that the fluid applicator (<NUM>) is configured to rotate (<NUM>) around its lengthwise axis (<NUM>) by an amount from about <NUM> degrees to about <NUM> degrees.