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06/18/09 - USPTO Class 427 |  1 views | #20090155449 | Prev - Next | About this Page  427 rss/xml feed  monitor keywords

Medical device coating apparatus and methods of use

USPTO Application #: 20090155449
Title: Medical device coating apparatus and methods of use
Abstract: Apparatus and methods are configured to coat a medical device, such as a stent, with a beneficial medicinal agent using one or more liquid feeds and one or more micromist nozzles. In one implementation, an agent coating rig includes a vertical adjustment means, a rotation means, and a traverse adjustment means for moving a medical device along virtually any point on an x or y axis. In additional or alternative implementations, the agent coating rig can further include a secondary horizontal adjustment means that allows adjustment along virtually any point on a z axis. Furthermore, methods and apparatus are provided for distributing the beneficial agent on the medical device, including delivering the beneficial agent efficiently over time. (end of abstract)



Agent: Workman Nydegger - Salt Lake City, UT, US
Inventors: Isaac Plans, David O'Neill, Matthew Coates, Javier P. Moreno
USPTO Applicaton #: 20090155449 - Class: 427 21 (USPTO)

Medical device coating apparatus and methods of use description/claims


The Patent Description & Claims data below is from USPTO Patent Application 20090155449, Medical device coating apparatus and methods of use.

Brief Patent Description - Full Patent Description - Patent Application Claims
  monitor keywords BACKGROUND OF THE INVENTION

1. The Field of the Invention

The present invention relates to systems, methods, and apparatus for coating medical devices with beneficial agents, such as medicinal agents including immuno-neutral chemicals.

2. Background and Relevant Art

In the medical fields, there are a number of devices that may be used inside a patient, whether on a temporary or permanent basis. For example, a medical practitioner may use various instruments or implants for various internal operating procedures, as well as instruments used to introduce other instruments or implants inside a patient. One common medical implant used in internal operations is a stent, which may be placed inside a patient\'s blood vessel.

In general, the various devices or objects that are inserted or implanted within a patient\'s body, whether on a temporary or permanent basis, often need to be coated with one or more beneficial agents. For example, the practitioner may desire for an implant to be coated with one or more chemicals configured to release a beneficial agent over time. In other cases, the practitioner may desire the implant to be coated with one or more immuno-neutral chemicals to ensure that the body does not reject the implant or instrument for some determined period.

There are a number of different devices or assemblies that can be used to coat a medical device or apparatus, such as a stent, with a beneficial agent (or, simply “agent.”) Some apparatus and techniques, such as those described in U.S. Pat. No. 5,464,650, involve applying an agent to a medical device using one or more agent coating rigs and corresponding sprayers (micromist devices). The spray apparatus used are generally configured to provide a “micromist.” Creating the micromist generally involves receiving the beneficial agent (such as dissolved within a polymeric compound) and applying air and/or ultrasonic forces to the agent. The air and/or ultrasonic forces, in turn, atomize (create particles of) the agent into the mist.

In conventional operation, therefore, a technician might position the medical device of interest in a micromist spraying apparatus. The spray apparatus might then rotate the medical device while a micromist nozzle sprays the atomized agent in mist form. Rotating and spraying the medical device in this manner is generally thought to distribute the agent on the medical device fairly evenly.

Unfortunately, there remain a number of different problems with these types of spraying or misting apparatus when coating a medical device with a beneficial agent. For example, there is often some variability in agent distribution across the medical device, and thus corresponding variability in agent concentration from device to device. Other disadvantages include difficulties controlling and maintaining drug concentration, verifying drug distribution or drug loading on any given device, and varying drug distribution in a controlled and predetermined manner to effect a more desirable drug loading profile. These differences in variability can be complicated by the fact that many medical devices have a varied surface area along their length.

In general, the problems with variability in spray distribution can be due to a wide range of factors in the construction of the conventional spray apparatus, as well as in the actual spray. For example, conventional spray apparatus are typically configured to hold one specific type of micromist nozzle, which usually means that a holding portion (nozzle adaptor) of the spray apparatus is configured for a specific dimension, thereby limiting the opportunity to vary the spray characteristics through changing the micromist nozzle. If there is a different, preferred micromist nozzle with a better distribution, the technician may be required to replace the entire spray/coating rig. While a technician can sometimes position a different micromist nozzle (having a similar dimensions) into the micromist nozzle adaptor, conventional apparatus are not configured to accommodate the different micromist nozzle\'s delivery parameters. For example, while conventional spray apparatus are configured to move the medical device horizontally with respect to the micromist nozzle\'s nozzle, conventional spray apparatus usually provide no vertical variability, which could be useful to accommodate differences between micromist nozzles.

Positioning of micromist nozzles and micromist nozzle types, however, is only one aspect of conventional spray apparatus that can cause agent distribution variability. Other aspects that can negatively affect agent distribution deal with the time needed to apply the agent. For example, conventional spray apparatus are usually optimized for delivering agent at about 2 to 10 psi of pressure. At this spray pressure, it usually takes a number of repeat passes before a medical device is sufficiently covered with the agent of interest.

The more passes that are needed to coat each medical device, however, the more likely there will be downtime to remove agent build up in the liquid feed nozzles and/or micromist nozzles. In particular, longer than necessary rates of use, or more frequent than necessary numbers of passes, per medical device can mean that a technician may need to clean the micromist nozzles more frequently than necessary. Despite the obvious disadvantages of associated downtime, buildup of agent in a liquid feed nozzle and/or micromist nozzle can also vary the evenness by which the technician is able to coat a medical device with beneficial agent.

Accordingly, there are a number of disadvantages with current micromist/spray rigs and apparatus in the art that can be addressed.

BRIEF SUMMARY OF THE INVENTION

Implementations of the present invention solve one or more problems in the art with systems, methods, and apparatus configured to efficiently distribute a beneficial agent on a medical device. In one implementation, for example, an agent coating rig can be configured with one or more vertically adjustable stands, which are customizable for alternating, holding, and accommodating different types of micromist nozzles. In addition, the agent coating rig can be configured with a plurality of motors, at least one of which is used to move a medical device in a horizontal direction, and at least another of which is used to spin the medical device during agent application.

Implementations of the present invention can also include methods and apparatus for adjusting micromist nozzle pressures, and/or for using multiple micromist nozzles to enable coating a device in a single pass. Furthermore, implementations of the present invention can include methods and apparatus for cleaning the micromist nozzle(s) with efficiency, and without requiring significant down-time. Thus, the vertical adjustment mechanisms, replaceable micromist nozzle adaptors, plurality of carriage motors, and methods for spraying or cleaning the coating rig/apparatus in a single pass ensure that a medical device can be coated adequately and efficiently, with minimal downtime.

For example, an agent coating rig configured in accordance with an implementation of the present invention can include a base, as well as a vertical adjustment means positioned on the base, where the vertical adjustment means is configured to hold one or more micromist nozzles. The agent coating rig can also include rotation means configured to rotate one or more medical devices with respect to the one or more micromist nozzles, as well as traverse adjustment means positioned on the base. In at least one implementation, the traverse adjustment means and the vertical adjustment means are configured to move the one or more micromist nozzles in a corresponding x axis or y axis direction relative to the base.

In addition, a system configured in accordance with an implementation of the present invention configured to coat a beneficial agent on one or more medical devices in a single pass can include a base, as well as a vertical member slidably coupled to the base. In one implementation, the vertical member is detachably coupled to one or more micromist nozzle adaptors having corresponding one or more micromist nozzles inserted therein. The system can also include first and second threaded members configured to rotate a medical device relative to the one or more micromist nozzles. In at least one implementation, at least one of the first and second threaded members is coupled to a first motor. In addition, the system can include a traverse adjustment means coupled to a second motor.

By contrast, a method of coating a medical device with a beneficial agent in a single pass can involve receiving a medical device in a rotation means of an agent coating rig. The method can also include receiving a micromist nozzle about the medical device, as well as receiving a first liquid feed line about the micromist nozzle. In addition, the method can include rotating the medical device in the rotation means, and adjusting a y coordinate of the micromist nozzle and an x coordinate of the medical device. Furthermore, the method can include providing a beneficial agent through the first liquid feed line, where the beneficial agent is atomized upon encountering air from the micromist nozzle.

Additional features and advantages of exemplary implementations of the invention will be set forth in the description which follows, and in part will be obvious from the description, or may be learned by the practice of such exemplary implementations. The features and advantages of such implementations may be realized and obtained by means of the instruments and combinations particularly pointed out in the appended claims. These and other features will become more fully apparent from the following description and appended claims, or may be learned by the practice of such exemplary implementations as set forth hereinafter.



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