Articles and methods of treating vascular conditions

Abstract

The present invention relates to articles and methods of treating vascular conditions with a thixotropic, turbid, bioactive agent-containing gel material capable of being essentially removed from an implantation site upon re-establishment of fluid flow at the implantation site.

Description

FIELD OF THE INVENTION [0001]The present invention relates to articles and methods of vascular-based therapies to treat a variety of vascular conditions.BACKGROUND OF THE INVENTION [0002]Vascular conditions arise from a variety of causes, and in some cases, necessitate surgical or endovascular intervention. Trauma to the vascular system may also necessitate surgical intervention to treat the traumatized anatomy. The long-term implantation of vascular prostheses including vascular grafts, stent-grafts, and stents, and the application of treatment modalities, including balloon angioplasty are often undertaken to treat vascular conditions including vascular disease and vascular trauma.[0003]Consequences of surgical intervention have been observed following implantation of vascular prostheses including vascular grafts, stent-grafts, stents, and other prostheses, particularly when an anastomosis is formed. The consequences of surgical intervention include, but are not limited to, inflamm...

AI Technical Summary

Benefits of technology

[0017]The present invention relates to methods of treating or preventing a vascular condition with a thixotropic, turbid, bioactive agent-containing gel material. The method can also be used to treat or repair traumatized vascular structures. The gel material will readily deliver one or more bioactive agents contained by the gel material to a diseased or disease-prone vascular treatment site in need of treatment or repair. In the method, the gel material is capable of being directly injected into luminal spaces of blood vessels and other fluid-conducting anatomical structures with little or no mechanical or chemical trauma to vascular tissues of the vascular treatment site. After contact with the vascular tissues, the gel material will substantially dissolve in flowing blood without occluding vascular structures located distally (i.e., downstream) to the administration site. The method could be applied prophylactically, interventionally, surgically, or endovascularly. The method does not require a high degree of skill to perform. On the contrary, the method relies on simple injection of the gel material within a vascular structure for delivery of a pharmaceutical or other bioactive agent to vascular tissue in need of treatment.

[0018]The gel material used in the method is a thixotropic, turbid, gel material, having high viscosity at low shear, and therefore, coherently resides in luminal spaces of a blood vessel under conditions of low or no blood flow. Upon resumption of flowing blood in the treated blood vessel, the resultant fluid shear force converts the gel material to a low viscosity, blood-soluble composition that is substantially dissolved in flowing blood. Consequently, the gel material is readily and essentially removed from the vascular treatment site upon re-establishment of flowing blood without obstructing vascular structures located downstream of the treatment site.

Problems solved by technology

However, this approach often requires extensive dwell times at the vascular treatment site to ensure adequate delivery and retention of the bioactive agent at the vascular treatment site to treat the vascular condition.

Even with extensive dwell times, the delivery and retention of the bioactive agent at the vascular treatment site using this approach may be insufficient to treat the vascular condition.

The long term implantation of the vascular prosthesis may also result in mechanical trauma to the vascular treatment site due to a nonlubricious nature of the pharmaceutical-containing coating.

The long term implantation of the vascular prosthesis may also result in an unwanted tissue reaction at the vascular treatment site due to the components of the vascular prosthesis and / or the pharmaceutical-containing coating.

The implantation of the DEBs may also result in mechanical trauma to the vascular treatment site due to the components of the DEBs and / or the pharmaceutical-containing coating.

The methods can be challenging as they involve chemical reactions with the blood vessel lumen.

These chemical reactions may induce trauma to the vascular treatment site.

These methods usually require complex procedural techniques, often implemented through invasive surgical techniques.

In addition, these methods may require long term implantation of a vascular prosthesis, drug eluting wraps, matrices, and flowable drug delivery vehicles.

Long term implantation of the vascular prosthesis, drug eluting wraps, matrices, and flowable drug delivery vehicles may also result in an unwanted tissue reaction at the vascular treatment site due to the nature of their components.

However, Li et al. do not teach their composition can be injected into the vasculature or into flowing blood.

Indeed, as indicated by the literature, injection of particles in the form of hydrogel materials, turbid solutions, and precipitates into the vasculature or into flowing blood can have adverse consequences, including decreased drug effectiveness, phlebitis, embolism, and blockage of capillaries (Nemec, Am J Heath Syst Pharm, 65, 1648, 2008; Wong, Adv Drug Del Rev, 60, 939, 2008; Minton, Nutrition, 14, 251, 1998; Tian, Polym Int, 55, 405, 2006).

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