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Composition and method for preparing biocompatible surfaces

a biocompatible surface and composition technology, applied in the field of biocompatible surfaces, can solve the problems of surface induced thrombosis (clot formation), adverse reactions to medical devices, thinness of polymer coatings, etc., and achieve the effects of reducing throughput time, reducing the activity of each layer, and reducing the thickness of the polymer coating

Inactive Publication Date: 2006-09-28
STUCKE SEAN M +3
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

"The invention provides methods for creating a biocompatible coating on medical devices by using a polymeric material and a bioactive agent. The polymeric material is applied to the surface of the device and the bioactive agent is added to the polymer to create a biocompatible coating. The coating can be made by mixing the polymer and the bioactive agent together and applying it to the device surface. The coating can also be made by adding the polymer and the bioactive agent separately and then treating them to activate the polymer. The polymer can be an adherent polymer that sticks to the device surface without needing additional treatment. The coating can also contain a mixture of different polymers. Overall, the invention provides a way to create a biocompatible coating on medical devices that can control the release of the bioactive agent."

Problems solved by technology

However, the molecular weight, porosity of the polymer, a greater percentage of coating exposed on the medical device, and the thickness of the polymer coating can contribute to adverse reactions to the medical device.
The materials used for manufacture of medical devices are not inherently compatible with blood and its components, and the response of blood to a foreign material can be aggressive, resulting in surface induced thrombus (clot) formation.
This foreign body response can in turn impair or disable the function of the device and, most importantly, threaten patient health.
The preparation of biocompatible surfaces, however, can be challenging.
Materials that are used to form these coating may not be inherently compatible with each other, thereby making it difficult to form a coating that is both biocompatible and that has drug-releasing properties.
In addition, treatments that are used to form coatings can in some cases damage the bioactive agent and therefore reduce the overall effectiveness of the coated article.
Irradiation sources can be useful for activating components of a coating composition to form the coating, but can also lack the specificity and therefore cause degradation of the bioactive agent that is present in the coating.
Another problem relates to the release of bioactive agent, as some materials release the bioactive agent immediately upon contact with tissue; therefore the bioactive agent is not present for an amount of time sufficient to provide a beneficial effect.

Method used

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  • Composition and method for preparing biocompatible surfaces
  • Composition and method for preparing biocompatible surfaces
  • Composition and method for preparing biocompatible surfaces

Examples

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example 1

[0241] Coating composition premixtures containing pBMA (poly(butyl)methacrylate); and photo-heparin (Compound I) were prepared and coated on stainless steel stents, demonstrating that a medical article having a coating containing an adhesion polymer and having biocompatible properties can be prepared in a process that requires a minimum number of steps.

[0242] Solutions of pBMA at a concentration of 10 mg / ml in 90% THF, 10% H2O, and a solution of pBMA at a concentration of 10 mg / ml in 100% THF was prepared. Solutions of photo-heparin at concentrations of 5 mg / ml and 10 mg / ml in 90% THF 10% H2O, and a solution of photo-heparin at 50 mg / ml in H2O was prepared. For a control, a solution of heparin (non-photo) at 50 mg / ml in H2O was prepared. At these concentrations the pBMA and photo-heparin did not precipitate out of solution. The solutions of pBMA and photoheparin were mixed in order to prepare mixtures having the following concentrations of pBMA and photo-heparin:

[0243] (A) 5 mg / ml...

example 2

[0248] Coating composition premixtures containing pBMA, photo-heparin, and acetylated-photo-PVP (Compound III) were prepared and coated on stainless steel stents. The stents had coatings that demonstrated excellent biocompatibility properties.

[0249] A mixture of pBMA at a concentration of 5 mg / ml, photo-heparin at 2.5 mg / ml, and photo-polyvinylpyrrolidone at 0.25 mg / ml in 90% THF and 10% H20 was prepared (Table 2).

[0250] Stents were coated using the spray coating apparatus having a pair of rollers and an ultrasonic nozzle (as described herein) at rate of 0.03 ml / min, 20% speed, and 1 psi. 20-50 μg of mixture was coated onto each stent.

[0251] After the coating was performed the stents were: not subject to an irradiation step (2-A1 / A2), subject to UV irradiation for 45 seconds at 6-8 mW / cm2 using a 324 nm filter (2-A3 / A4), or subject to UV irradiation in addition to receiving a top coat of photo-heparin (2-A5 / A6). A heparin top coat was applied to the stents (50 mg / ml photo-heparin...

example 3

[0254] Coating composition premixtures containing photo-heparin and photo-PVP were prepared and subject to UV irradiation. The irradiated premixtures of photo-heparin and acetylated photo-PVP were then added to a solution of pBMA and the resulting mixtures were then coated on stents. Stents having surface heparin activity were able to be prepared without directly irradiating the stent surface.

[0255] In addition, the coating compositions were applied in an improved coating solution that included isopropanol alcohol.

[0256] A miscibility test was first performed to determine if isopropanol alcohol is suitable as a common liquid for preparing a mixture of pBMA, photo-heparin, and acetylated photo-PVP. pBMA was dissolved at a concentration of 10 mg / ml in 80% isopropanol (IPA), 20% THF. Photo-heparin was dissolved at a concentration of 10 mg / ml in 90% EPA, 10% H20. Acetylated photo-PVP was dissolved at a concentration of 10 mg / ml in 100% IPA. To 7 mls of IPA was added each 1 ml of the p...

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Abstract

The invention provides methods and compositions for providing biocompatible surfaces to medical articles. In particular the invention provides biocompatible coatings with heparin activity. In some aspects, the biocompatible coatings of the invention are able to release a bioactive agent. The coatings can be formed using biostable or biodegradable polymeric material and photoreactive groups. The invention also provides methods for improving the quality of bioactive agent-containing coatings by performing pre-irradiation of biocompatible coating compositions.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is a continuation of patent application Ser. No. 11 / 090,655, filed Mar. 25, 2005, now U.S. publication No. 2005 / 0244453A1 and entitled COMPOSITION AND METHOD FOR PREPARING BIOCOMPATIBLE SURFACES, which claims the benefit of U.S. Provisional Application No. 60 / 556,634, filed on Mar. 26, 2004, and entitled PROCESS AND SYSTEMS FOR BIOCOMPATIBLE SURFACES; U.S. Provisional Application No. 60 / 568,021, filed on May 3, 2004, and entitled COMPOSITION AND METHOD FOR PREPARING BIOCOMPATIBLE SURFACES; U.S. Provisional Application No. 60 / 640,602, filed on Dec. 31, 2004 and entitled COMPOSITION AND METHOD FOR PREPARING SURFACES WITH BIOCOMPATIBILITY; and U.S. Provisional Application No. 60 / 567,915, filed on May 3, 2004, and entitled DRUG RELEASE COATING WITH BLOOD COMPATIBLE POLYMERIC TOPCOAT, which Applications are incorporated herein by reference in their entirety.FIELD OF THE INVENTION [0002] The invention relates to preparation o...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K6/083A61F13/00A61F2/00A61F2/82A61L27/34A61L27/54A61L29/08A61L29/16A61L31/10A61L31/16A61L33/00
CPCA61L27/34A61L27/54A61L31/10A61L31/16A61L33/0011A61L2300/406A61L2300/416A61L2300/42A61L2300/608C08L33/10C08L29/04C08L39/06
Inventor STUCKE, SEAN M.CHAPPA, RALPH A.CHINN, JOSEPH A.ANDERSON, ARON B.
Owner STUCKE SEAN M
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