Devices, systems, and methods for performing atherectomy including delivery of a bioactive material

Abstract

Devices, systems, and methods are employed to perform an atherectomy in an identified region to restore patency to arterial lesions. A bioactive material is introduced into the identified region before, after or during performing the atherectomy. The bioactive material can be introduced, e.g., on a balloon coated with the bioactive material, which is expanded in contact with the identified region to deliver the bioactive material. The bioactive material can be, e.g., at least one of a restenosis-inhibiting agent, a thrombus-inhibiting agent, and an anti-inflammatory agent.

Description

RELATED APPLICATIONS[0001]This application is a divisional of co-pending U.S. patent application Ser. No. 12 / 215,752, filed Jun. 30, 2008 and entitled “Atherectomy Devices, Systems, and Methods,” which claims the benefit of U.S. Provisional Patent Application Ser. No. 61 / 013,998, filed Apr. 10, 2008, and entitled “Atherectomy Devices and Methods,” which is incorporated herein by reference.[0002]This application also claims the benefit of U.S. Provisional Patent Application Ser. No. 60 / 981,735, filed Oct. 22, 2007, and entitled “Atherectomy Devices and Methods,” which is incorporated herein by reference.[0003]This application is also a continuation-in-part of co-pending U.S. patent application Ser. No. 11 / 771,865, filed Jun. 29, 2007, and entitled “Atherectomy Devices and Methods,” which is a continuation-in-part of co-pending U.S. patent application Ser. No. 11 / 567,715, filed Dec. 6, 2006, and entitled “Atherectomy Devices and Methods,” which is a continuation of co-pending U.S. pat...

AI Technical Summary

Problems solved by technology

Plaque (the build-up of cholesterol, cells, and other fatty substances) is often friable and may dislodge naturally or during an endovascular procedure, possibly leading to embolization of a downstream vessel.

Unlike coronary artery disease, current treatment options for PAD, including PAD in the arteries of the leg, have significant limitations for at least three main reasons: A) large volumes of plaque build up in very long, diffuse lesions, B) low blood flow promotes thrombus formation and plaque buildup, and C) arteries of the leg are bent, twisted, stretched, and pinched shut during routine movement.

The SilverHawk has a number of limitations including the length of time the procedure takes to clear a lumen, it requires multiple devices and repeated catheter exchanges, it produces embolic debris, and it uses an unguarded cutter design that requires great patience and care to open the lumen while sparing the vessel wall.

The long receptacle at the tip of the catheter limits the use of the device to mainly straight lumens.

Balloon angioplasty is known to cause barotrauma to the vessel from the high pressures required to compress the plaque, and can also cause dissection of the vessel wall.

This trauma leads to an unacceptably high rate of restenosis.

Furthermore, this procedure may not be efficient for treatment of elastic-type plaque tissue, where such tissue can spring back to occlude the lumen.

Cryoplasty has been available for only a few years and has provided only limited positive results.

With cryoplasty, the main problem appears to be restenosis after an extended period, such as a year.

One main limitation of a laser system is that the laser can only be effectively used in a straight lumen, and is less effective in or around tortuous lumens.

Laser systems have been less effective for removing calcified legions because of the laser properties.

On their own, stents, including drug eluding stents, fail to perform well in the peripheral vasculature for a variety of reasons.

A stent with the necessary structural integrity to supply sufficient radial force to reopen the artery often does not perform well in the harsh mechanical environment of the peripheral vasculature.

Such an environment may lead to stent failure (strut fracture, stent crushing, etc.) that eventually compromises the ability of the stent to maintain lumen diameter over the long-term.

Stenting is also susceptible to in-stent restenosis, typically at a restenosis rate of 30 percent or higher.

Stent fracture or restenosis may require subsequent vascular bypass surgery, which is invasive and is limited in the types of lesions or artery obstructions that may produce acceptable results.

Stenting is not advisable in regions which would be candidates for proximal or distal anastomosis during surgical bypass procedures, because a stent in that region makes bypass difficult or impossible.

On the other hand, a stent that is able to withstand the harsh mechanical aspects of the periphery often will not supply enough radial force to open the vessel satisfactorily.

Accordingly, when such steering features are combined with tissue debulking systems, there remains a risk of injury if the tissue debulking system has an undesirable bend when the device is intended to be in a straight configuration.

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