Multi-Layer Vascular Prosthesis

Abstract

A vascular prosthesis comprising a tubular support structure having an outer surface and an internal lumen therethrough, the support structure comprising a base material, which can comprise natural or synthetic materials, the internal lumen surface including an extracellular matrix (ECM) layer that includes at least one ECM material, wherein, when said vascular prosthesis is deployed proximate damaged cardiovascular tissue, the prosthesis induces modulated healing of the damaged tissue. In some embodiments, the support member outer surface also includes an ECM layer.

Description

CROSS-REFERENCES TO RELATED APPLICATIONS[0001]This application claims the benefit of U.S. Application Nos. 61 / 710,992, filed on Oct. 8, 2012.FIELD OF THE INVENTION[0002]The present invention relates to methods and apparatus for repairing damaged or diseased vessels. More particularly, the present invention relates to multi-layer vascular endografts or prostheses employing extracellular matrix materials to treat and / or repair damaged or diseased vessels.BACKGROUND OF THE INVENTION[0003]As is well known in the art, treatment of various medical conditions commonly involves implantation of medical devices and prostheses into a body. Illustrative is the implantation or deployment of a vascular prosthesis, e.g., endograft or stent device, into a cardiovascular vessel, e.g. vein or artery, to treat and / or repair a diseased or damaged region therein.[0004]As is also well known in the art, vascular prostheses, i.e. stents, are often employed to provide an artificial conduit proximate a disea...

AI Technical Summary

Benefits of technology

[0019]According to the invention, the support structure can comprise various conventional metals, and synthetic and natural materials, including, without limitation, tantalum gauze, stainless mesh, Dacron®, Orlon®, Fortisan®, nylon, knitted polypropylene (e.g., Marlex®), microporous expanded-polytetrafluoroethylene (e.g., Gore-Tex®), Dacron®reinforced silicone rubber (e.g., Silastic®), polyglactin 910 (e.g., Vicryl®), polyester (e.g., Mersilene®), polyglycolic acid (e.g., Dexon®), processed sheep dermal collagen, crosslinked bovine pericardium (e.g., Peri-Guard®), and preserved human dura (e.g., Lyodura®).

[0020]In a preferred embodiment of the invention, the ECM composition includes at least one ECM material. According to the invention, the ECM material can be derived from various mammalian tissue sources, including the small intestine, large intestine, stomach, lung, liver, kidney, pancreas, placenta, heart, bladder, prostate, tissue surrounding growing enamel, tissue surrounding growing bone, and any fetal tissue from any mammalian organ, and methods for preparing same.

[0021]In some embodiments of the invention, the ECM composition further includes one or more additional biologically active components to facilitate the treatment of damaged tissue and / or the tissue regenerative process.

Problems solved by technology

There are, however, several drawbacks and disadvantages associated with conventional vascular prostheses.

A common problem associated with implantable vascular prostheses is intimal hyperplasia after intervention in the vessel, such as a coronary artery.

Indeed, it has been found that a significant percentage of arterial bypass grafts and vein grafts fail due to intimal hyperplasia after coronary bypass surgery.

Such prostheses often cause irritation and undesirable biologic responses from the surrounding tissues in a vessel.

Although conventional vascular prostheses are designed to be implanted for an extended period of time, it is sometimes necessary to remove the device prematurely, for example, because of poor patency or harsh biological responses.

In such instances, the device generally must be removed through a secondary surgical procedure, which can, and in many instances will, result in undesirable pain and discomfort to the patient and possibly additional trauma to the vessel tissue.

In addition to the pain and discomfort, the patient must be subjected to an additional time consuming and complicated surgical procedure with the attendant risks of surgery.

There are, however, several known disadvantages associated with bioabsorbable and biodegradable prostheses.

One major disadvantage is that the bioabsorbable and biodegradable materials and, hence, prostheses often break down at a faster rate than is desirable for the application.

A further disadvantage is that the bioabsorbable and biodegradable materials can, and in many instances will, break down into large, rigid fragments that can cause obstructions in the interior of a vessel.

Images