Drug Eluting Stent System with Controlled Self Expansion

• US 20080200974A1
• Filed: 02/15/2007
• Published: 08/21/2008
• Est. Priority Date: 02/15/2007
• Status: Abandoned Application

• Current Assignee: Cardiac Innovation, LLC
• Original Assignee: Cardiac Innovation, LLC
• Inventors: Trauthen, Brett A., Verheye, Stefan
• Application Number:
  US11/675,451
• Publication Number:
  US 20080200974A1
• Time in Patent Office: Days
• US Class Current: 623/1.2
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2250/0073 Force-limiting means

Abstract

A self-expanding stent providing a high compliance mismatch upon initial placement, to exert radially outward force over the course of several weeks or months until it reaches the limits of expansion as imposed by a limiting mechanism, and thereafter provide high resistance to inward radial forces exerted by the artery without exerting additional outward radial force on the artery. The stent is coated with a compound including an MMPI, in a formulation in which the MMPI is substantially exhausted over the course of several weeks or months, to be substantially coincident with expansion of the stent to its stop limited diameter.

Claims

1. A method of treating an occluded blood vessel in a patient comprising:

providing a self-expanding stent having a fully expanded diameter when completely unrestrained;

providing a restraining means on the stent, said restraining means adapted to restrain the stent from expanding to its fully expanded diameter

coating the stent with a metalloproteinase inhibitors in a formulation which is substantially exhausted within the blood vessel in one to three months;

implanting the stent in an occluded blood vessel of a patient; and

allowing the stent to expand elastically or pseudoelastically inside the blood vessel over the course of one to three months, until limited by the restraining means;

whereby the stent expansion becomes limited by the restraining means contemporaneously with exhaustion of the metalloproteinase inhibitors.

2. The method of claim 1, wherein the coating step comprises coating the stent with a drug eluting compound including one of the following metalloproteinase inhibitors:

collagen peptidomimetic and non-peptidomimetic inhibitors, tetracycline and tetracycline derivatives, batimastat, marimastat (BB-2516), prinomastat (AG3340), metastat (NSC

     683551) BMS-279251, BAY 12-9566, TAA211, MMI270B or AAJ996, trocade, CGS 27023, RS 130830 or AG3340.

3. The method of claim 1, further comprising the steps of training the stent to open to the fully expanded diameter exceeding the diameter of a target vessel, providing the restraining means to limit the expansion of the stent to a diameter matching a desired final vessel diameter smaller than the fully expanded diameter.

4. The method of claim 1, further comprising the steps of preparing the stent for implantation into a blood vessel of nominal inner diameter of about 2 mm, training the stent to open to the fully expanded diameter of about 4 mm, providing the restraining means to limit the expansion of the stent to a diameter of about 2 mm, and implanting the stent in an occluded vessel with a nominal inner diameter of 2 mm, and allowing the stent to expand within the blood vessel.

5. A device comprising:

a vascular stent comprising a wire mesh tube including a plurality of stent elements (struts, loops, mesh wires, etc.)), comprising a elastic or pseudoelastic material, said stent having an unrestrained diameter;

restraining means, disposed on the stent, for limiting expansion of the stent to a desired final diameter;

a drug eluting coating disposed on the device, said drug eluting coating comprising a therapeutic dose of an MMP inhibitor, wherein said therapeutic dose is chosen so as to be substantially depleted within the body within one to three months after implantation.

6. The device of claim 5 wherein:

the stent is self-expanding stent having generally longitudinally oriented struts trained to resiliently or pseudoelastically abduct from adjacent struts, and the restraining means comprises a stop disposed on one or more of said struts to impede abduction of the struts.

7. The device of claim 5 wherein:

the stent is a self expanding stent having generally longitudinally oriented struts trained to resiliently or pseudoelastically abduct from adjacent struts, and the restraining means comprises a strap secured to adjacent abducting struts so as to prevent full expansion of the stent to its unrestrained diameter.

8. The device of claim 5 wherein:

the restraining means comprises one or more inelastic hoops surrounding the stent so as to prevent full expansion of the stent to its unrestrained diameter.