Stents combined with paclitaxel derivatives

a technology of paclitaxel and stents, applied in the field of pharmaceutical compositions, can solve the problems of limiting the effectiveness of invasive treatments for a variety of diseases, stenosis (or narrowing), and many devices implanted in the body are subject to a “foreign body” response, so as to reduce fibrosis and inhibit scar developmen

Active Publication Date: 2011-07-05
ANGIOTECH INT AG (CH)
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0007]Briefly stated, in one aspect, the present invention provides medical devices (e.g., stents) that are coated or otherwise contain paclitaxel derivatives or compositions comprising paclitaxel derivatives, methods for making such devices, methods for inhibiting fibrosis comprising placing medical devices that are coated with, or otherwise contain, paclitaxel derivatives or compositions comprising paclitaxel derivatives, and methods for inhibiting fibrosis comprising separately placing a medical device and applying at least one of (i) a paclitaxel...

Problems solved by technology

Unfortunately, many devices implanted in the body are subject to a “foreign body” response from the surrounding host tissues.
In particular, injury to tubular anatomical structures (such as blood vessels, the gastrointestinal tract, the male and female reproductive tract, the urinary tract, sinuses, spinal nerve root canals, lacrimal ducts, Eustachian tubes, the auditory canal, and the respiratory tract) from surgery and/or injury created by the implantation of medical devices can lead to a well known clinical p...

Method used

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  • Stents combined with paclitaxel derivatives
  • Stents combined with paclitaxel derivatives
  • Stents combined with paclitaxel derivatives

Examples

Experimental program
Comparison scheme
Effect test

example 1

Parylene Coating

[0347]The metallic portion of a coronary stent is washed by dipping it into HPLC grade isopropanol. The cleaned device is then coated with a parylene coating using a parylene coater and either di-p-xylylene or dichloro-di-p-xylylene as the coating feed material. This procedure may be used to coat other types of stents that include a metallic portion (e.g., peripheral stents, covered stents).

example 2

Paclitaxel Coating—End Coating

[0348]Solutions are prepared by dissolving 9-deoxotaxol in 5 mL HPLC grade THF. The ends of a parylene coated coronary stent (prepared as in Example 1) are then dipped into the paclitaxel derivative / THF solution. After various incubation times, the devices are removed and dried in a forced air oven (50° C.). The device is then further dried in a vacuum oven overnight. The amount of 9-deoxotaxol used in each solution is varied such that the amount of 9-deoxotaxol coated onto the ends of the device is in the range of 0.06 mg / mm2 to 10 mg / mm2. This procedure may be used to coat other types of devices that include a metallic portion (e.g., peripheral stents, covered stents).

example 3

Paclitaxel Coating—Complete Coating

[0349]Paclitaxel derivative solutions are prepared by dissolving 9-deoxotaxol in 5 mL HPLC grade THF. A parylene coated coronary stent (as prepared in Example 1) is then dipped entirely into the paclitaxel / THF solution. After various incubation times, the device is removed and dried in a forced air oven (50° C.). The device is then further dried in a vacuum oven overnight. The amount of paclitaxel used in each solution is varied such that the amount of paclitaxel coated onto the ends of the device is in the range of 0.06 mg / mm2 to 10 mg / mm2. In addition to paclitaxel, the following are exemplary compounds that may be also used to coat the device: 7-deoxy-9-deoxotaxol and 10-desacetoxy-7-deoxy-9-deoxotaxol. This procedure may be used to coat other types of parylene coated devices that include a metallic portion (e.g., peripheral stents, covered stents).

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PUM

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Abstract

Stents are used in combination with a paclitaxel derivative in order to inhibit scarring that may otherwise occur when the implant is placed within an animal. Suitable implants include vascular stents, esophageal stents, tracheal or bronchial stents, gastrointestinal stents, genital-urinary stents, nasal and sinus stents, and ENT stents.

Description

CROSS-REFERENCE TO RELATED APPLICATION[0001]This application claims the benefit under 35 U.S.C. § 119(e) of U.S. Provisional Patent Application No. 60 / 653,844, filed Feb. 17, 2005, which application is incorporated herein by reference in its entirety.BACKGROUND OF THE INVENTION[0002]1. Field of the Invention[0003]The present invention relates generally to pharmaceutical compositions that include paclitaxel derivatives and methods for preparing and using stent devices to make them resistant to overgrowth by inflammatory and fibrous scar tissue.[0004]2. Description of the Related Art[0005]The clinical function of numerous medical implants and devices is dependent upon the device being able to effectively maintain an anatomical, or surgically created, space or passageway. Unfortunately, many devices implanted in the body are subject to a “foreign body” response from the surrounding host tissues. In particular, injury to tubular anatomical structures (such as blood vessels, the gastroin...

Claims

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Application Information

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IPC IPC(8): A61F2/00
CPCA61F2/82A61F2250/0067A61L31/16A61L2300/416
Inventor TOLEIKIS, PHILIP M.
Owner ANGIOTECH INT AG (CH)
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