Stents modified with material comprising amnion tissue and corresponding processes

Abstract

A stent scaffold combined with amniotic tissue provides for a biocompatible stent that has improved biocompatibility and hemocompatibility. The amnion tissue can be variously modified or unmodified form of amnion tissue such as non-cryo amnion tissue, solubilized amnion tissue, amnion tissue fabric, chemically modified amnion tissue, amnion tissue treated with radiation, amnion tissue treated with heat, or a combination thereof. Materials such as polymer, placental tissue, pericardium tissue, small intestine submucosa can be used in combination with the amnion tissue. The amnion tissue can be attached to the inside, the outside, both inside and outside, or complete encapsulation of the stent scaffold. In some embodiments, at least part of the covering or lining comprises a plurality of layers of amnion tissue. The method of making the biocompatible stent and its delivery and deployment are also discussed.

Description

CROSS REFERENCE TO RELATED APPLICATIONS[0001]This application is a continuation of copending patent application Ser. No. 12 / 713,666 filed Feb. 26, 2010 to Schorgl et al., entitled “Stents Modified with Material Comprising Amnion Tissue and Corresponding Processes,” which claims benefit of provisional patent application Ser. No. 61 / 157,462 filed on Mar. 4, 2009 to Schorgl et al., entitled “Stents Covered or Coated With Amnion Tissue and Methods,” incorporated herein by reference.FIELD OF THE INVENTION[0002]The inventions in general are related to using material comprising amnion tissue to modify stents. The inventions are further related to methods of using amnion tissue to modify stents.BACKGROUND[0003]Stents are widely used in interventional cardiology, interventional radiology, gastrointestinal medicine, and pulmonary medicine. Stents in general can be used to open constricted lumens. The implantation of stents however is known to risk restenosis. For example, bare metal coronary ...

AI Technical Summary

Benefits of technology

The invention is about a biocompatible stent for placement in a vessel of a living subject. The stent scaffold is made of metal, alloy, polymer, or a combination thereof and is coated or lined with a biocompatible material made of reconstitutable amnion tissue, which is a type of tissue that is not cryo-preserved. The amnion tissue can be solubilized, fabricated, or associated with the stent scaffold in various ways. The stent scaffold can also be encapsulated with a covering or lining made of amnion tissue. The invention provides a stent that is more biocompatible and can help reduce the risk of complications such as thrombosis, restenosis, and cellular material reaction.

Problems solved by technology

The implantation of stents however is known to risk restenosis.

Drug eluting stents have however poses new clinical risks such as delayed re-endothelization.

Subacute thrombosis of drug eluting coronary stents can be fatal in a significant number of the patients in whom it occurs.

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