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Coating for use with medical devices and method of making same

a technology of silicone and medical devices, applied in the field of silicone based medical devices, can solve the problems of system offering poor adhesion to silicone medical devices, additional manufacturing process steps, and inability to meet the requirements of patients, and achieve the effect of enhancing adhesion and facilitating drug delivery

Inactive Publication Date: 2005-03-24
COVIDIEN AG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0009] As is described in greater detail below, the present disclosure provides a coating composition including a combination of RTV silicone and urethane. The combination of RTV silicone and urethane produces an inventive coating that facilitates drug delivery and enhances adherence to a flexible silicone medical device. The inventive coating provides adherence over highly expanded surfaces such as, for example, catheter balloons, etc.

Problems solved by technology

Various medical devices that are inserted into body cavities of humans and animals can unfortunately introduce bacterial, viral and fungal infections into these body cavities.
While the above coatings are appropriate for application to urethane, polyvinylchloride (PVC), steel or polyesters, these systems offer poor adherence to silicone medical devices unless the silicone surface is subjected to corona or plasma treatment.
The need to pre-treat these silicone based medical devices limits coatings to surfaces that are pre-treated by the above methods, resulting in additional manufacturing process steps, additional costs and variability of the medical device.
Additionally, the above methods have not been adequate as performance of the coatings has been unsatisfactory over flexible or expandable segments of medical devices such as catheter balloons.
However, these methods do not overcome the inherently poor drug delivery properties of silicone.
These problematic silicone drug delivery properties include poor diffusion of the drug in a hydrophobic environment and surfaces that resist subsequent application of a hydrophilic bolus coating or lubricious coating.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

[0024] A drug delivery coating for silicone medical devices is prepared by blending at room temperature the following components in three separate containers. In a first container, THF, Pellethane® and an emulsifier are mixed for at least 2-3 hours until the Pellethane® is fully dissolved forming a first solution. In a second container, NMP and norfloxacin are mixed for approximately 20 minutes forming a second solution. In a third container, tolnaftate is mixed for approximately 10 minutes with THF until the tolnaftate is dissolved forming a third solution. The second solution is added to the first solution and mixed for approximately 5-10 minutes. The third solution is added to the combination of the first and second solutions and the combined solutions are mixed for approximately 15 minutes. Prior to coating the medical device, the RTV / Silane is added to the combined solutions and mixed for approximately one hour.

THF29.75 gFirst ContainerUrethane   3 gEmulsifier 0.25 gNMP  30 g...

example 2

[0025] A drug delivery coating for silicone medical devices is prepared by blending at room temperature the following components in three separate containers. In a first container, THF, Pellethane® and an emulsifier are mixed for at least 2-3 hours until the Pellethane® is fully dissolved forming a first solution. In a second container, NMP and norfloxacin are mixed for approximately 20 minutes forming a second solution. In a third container, clotrimazole is mixed for approximately 10 minutes with THF until the clotrimazole is dissolved forming a third solution. The second solution is added to the first solution and mixed for approximately 5-10 minutes. The third solution is added to the combination of the first and second solutions and the combined solutions are mixed for approximately 15 minutes. Prior to coating the medical device, the RTV / Silane is added to the combined solutions and mixed for approximately one hour.

THF29.75 gFirst ContainerUrethane   3 gEmulsifier 0.25 gNMP  ...

example 3

[0026] A drug delivery coating for silicone medical devices is prepared by blending at room temperature the following components in three separate containers. In a first container, THF, Pellethane® and an emulsifier are mixed for at least 2-3 hours until the Pellethane® is fully dissolved forming a first solution. In a second container, NMP and norfloxacin are mixed for approximately 20 minutes forming a second solution. In a third container, RTV / Silane is mixed for approximately one hour with THF until the RTV / Silane is dissolved forming a third solution. The second solution is added to the first solution and mixed for approximately 5-10 minutes. The third solution is added to the combination of the first and second solutions and the combined solutions are mixed for approximately one hour.

THF29.75 gFirst ContainerUrethane   3 gEmulsifier 0.25 gNMP  25 gSecond ContainerNorfloxacin   1 gTHF  40 gThird ContainerRTV / Silane   1 g

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PUM

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Abstract

The inventive coating may be employed to deliver a pharmaceutical agent to a selected body area that is involved within the insertion or application of a medical device. Such medical devices may include silicone based urinary catheters and other medical implants as well as other silicone based devices having deformable portions which could benefit from the release of a pharmaceutical agent from its surface. The coating allows the introduction of the pharmacological additive having a release rate that is within acceptable pharmacokinetic criteria. The release rate is adjusted by utilizing different salt forms of the additive and adjusting the concentration of urethane and RTV silicone. The coating incorporates additive compounds such as anti-microbial, anti-fungals and other organic compounds. Methods are also provided for the manufacture of the subject coating and for the application of the same to surfaces of medical devices.

Description

BACKGROUND [0001] 1. Technical Field [0002] The present disclosure relates to a coating for silicone based medical devices, and more particularly, to a coating which allows a pharmaceutical agent to be released from an internal and / or external surface of such medical devices. [0003] 2. Background of the Related Art [0004] Various medical devices that are inserted into body cavities of humans and animals can unfortunately introduce bacterial, viral and fungal infections into these body cavities. Numerous coatings are available for medical devices that employ polyurethane or urethane pre-polymers to act as lubricants, drug delivery systems and the like. Known coatings applied to surfaces of medical devices include coatings of polyvinylpyrrolidone, polyurethane, acrylic polyester, vinyl resin, fluorocarbons, silicone rubber, and combinations of these substances. For example, U.S. Pat. Nos. 4,100,309 and 4,119,094 to Micklus et al., relate to a hydrophilic coating of polyvinylpyrrolidon...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61L27/34A61L27/54A61L29/08A61L29/16A61L31/10A61L31/16
CPCA61L29/085A61L29/16A61L2300/606A61L2300/404A61L2300/30Y10T428/31663
Inventor MCGHEE, DIANEBRITTON, SCOTT M.LAGWINSKA, ELIZABETH
Owner COVIDIEN AG
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