Drug-eluting medical device

a medical device and drug-eluting technology, applied in the direction of medical devices, dilators, catheters, etc., can solve the problems of incomplete intervention, obstruction, and restriction or obstruction

Inactive Publication Date: 2011-12-01
INVATEC TECH CENT
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Such lesions are most often localized at predetermined portions of the blood vessels, of which they

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1a

Coating of Catheter Balloons with Crystalline Hydrated or Crystalline Hydrated Solvated Paclitaxel

[0102]Paclitaxel solutions have been prepared at a 50 mg / mL concentration in the following solvents:

[0103](1) 9:1 THF / water

[0104](2) 9:1 THF / water with addition of 15 mg / mL urea

[0105](3) 6.5:3.5 THF / water

[0106](4) Acetone / ethanol / water

[0107](5) Acetic acid (comparative solution)

[0108](6) Dichloromethane (comparative solution)

[0109]It shall be noted that paclitaxel in a crystalline hydrated or solvated hydrated form according to the invention is not obtained by crystallization from acetic acid. Instead, amorphous paclitaxel is obtained by precipitation from dichloromethane.

[0110]Some balloons—made of a polyamide-12+polyether-polyamide block copolymer compound (70% UBESTA® XPA9063+30% UBESTA® 3030XA) and in a folded condition—have been coated with paclitaxel by wetting the surface thereof with equal volumes of the solutions (1)-(6) by means of a Hamilton syringe, according to the previous...

example 1b

Coating of Catheter Balloons with Crystalline Hydrated or Crystalline Hydrated Solvated Paclitaxel (Coating in an Unfolded Condition)

[0113]The procedure of example 1A has been repeated using coating solution (2), by inflating first the folded balloons at 7 bar, then removing the pressurised air source and coating the inflated balloons by means of a Hamilton syringe. The coated balloons have then been re-folded after about 1 minute after the coating step, while the surface thereof was still wet.

[0114]The appearance of the coating was white, substantially homogeneous.

example 2

Assessment of Paclitaxel Adhesion on the Surface of the Catheter Balloons

[0115]The balloons prepared according to the example 1 have been subjected to some assessments, in order to determine the drug adhesion under the various conditions.

[0116]Test A

[0117]First, the dry adhesion has been assessed, which is useful to determine the paclitaxel loss which can occur in the production or handling steps of the balloon. Such determination has been carried out by dry expanding the balloon and shaking the inflated balloon within a tube.

[0118]The paclitaxel content in the tube was determined by HPLC / UV. The drug was taken up with ethanol, the tubes were closed and vigorously vortexed for at least 30 seconds, followed by a treatment in an ultrasound bath for 30 minutes. At least 70 μl of extract were injected into the HPLC, together with a paclitaxel standard solution (concentration of about 20 μg / mL). The results are reported in Table I.

[0119]Test B

[0120]Release of paclitaxel at the site of in...

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Abstract

The present invention relates to a drug-eluting medical device, in particular a balloon for angioplasty catheters with drug elution to prevent the restenosis of the vessel subjected to angioplasty. More particularly, the present invention relates to a catheter balloon completely or partially coated with paclitaxel in hydrated crystalline form or in hydrated solvated crystalline form, having an immediate release and bioavailability of a therapeutically effective amount of paclitaxel at the site of intervention. The balloon can be made of a polyether-polyamide block copolymer, or a polyester amide, or polyamide-12.

Description

[0001]The present invention relates to a drug-eluting medical device, in particular a balloon for angioplasty catheters with drug elution to prevent restenosis of the vessel subjected to angioplasty.BACKGROUND OF THE INVENTION[0002]The treatment of vascular atherosclerotic lesions is a widespread therapy. Such lesions are most often localized at predetermined portions of the blood vessels, of which they cause constrictions or also obstructions. Vascular atherosclerotic lesions are typically treated in angioplasty procedures by means of catheters provided with a balloon.[0003]A catheter provided at the distal end thereof with a balloon is advanced, following a guidewire, to the ostium of the narrowed artery. Once the balloon has been arranged at the artery narrowing, it is repeatedly inflated and deflated. The insufflation, with successive deflation, of the balloon within the artery reduce the extent of the arterial luminal narrowing, and restore a suitable blood flow in the cardiac ...

Claims

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Application Information

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IPC IPC(8): A61M25/10B65B1/04B05C13/02A61M29/00B05C11/00
CPCA61L29/06A61L29/16A61L2300/416A61L2300/602A61M2025/105C08L77/00A61L2300/63A61L2300/216A61M25/1002A61M25/1029A61M2025/1004A61M2025/1031
Inventor SPECK, ULRICHSCHAFFNER, SILVIORENKE-GLUSZKO, MAGDALENA
Owner INVATEC TECH CENT
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