Extracellular Matrix Encasement Structures and Methods

Abstract

A bioremodelable encasement structure comprising a pouch formed from at least one sheet of bioremodelable material, the pouch including an internal region that is configured to receive a device therein, the bioremodelable material comprising mesothelial tissue.

Description

CROSS-REFERENCES TO RELATED APPLICATIONS[0001]This application is a division of U.S. application Ser. No. 13 / 896,424, which is a continuation-in-part of U.S. application Ser. No. 13 / 573,566, filed on Sep. 24, 2012, which is a continuation-in-part of U.S. application Ser. No. 13 / 033,102, filed on Feb. 23, 2011, now U.S. Pat. No. 8,758,448, which is a continuation of application Ser. No. 12 / 394,914, filed on Feb. 27, 2009, now abandoned, which is a continuation of application Ser. No. 11 / 747,004, filed on May 10, 2007, now abandoned.FIELD OF THE INVENTION[0002]The present invention relates to implantable devices. More particularly, the present invention relates to implantable structures and devices; particularly, medical devices, encased in extracellular matrix (ECM) based pouches and / or include ECM based coatings that effectuate modulated healing of damaged tissue and regeneration of new tissue structures with site-specific structural and functional properties.BACKGROUND OF THE INVEN...

AI Technical Summary

Benefits of technology

The present invention is directed to encasement structures and compositions for medical devices, particularly those that are implantable or insertable in the body. The encasement structures comprise a pocket or pouch that is designed to receive the device. The device can be a medical device, such as a pacemaker, defibrillator, or artificial heart, or a component thereof, such as electrical leads. The encasement structures can be made from an extracellular matrix (ECM) composition that includes at least one ECM material, such as small intestine submucosa, urinary bladder submucosa, or stomach submucosa. The ECM material can also include other biologically active agents or compositions, such as growth factors or cells, or pharmacological agents, such as anti-inflammatory agents or statins. The invention allows for modulated healing and regeneration of tissue structures with site-specific properties, resulting in improved outcomes for patients.

Problems solved by technology

The disclosed bioprostheses can, however, be affected by gradual calcification, which can, and in many instances will, lead to the eventual stiffening and tearing of the implant.

As is well known in the art, several major problems are often encountered when a medical device (or other device, e.g., tracking apparatus) fabricated from one of the aforementioned materials is implanted in the body.

A major problem that is often encountered after implantation of such a device in the body is inflammation of surrounding tissue.

Another major problem is the high incidence of infection.

A further problem that is often encountered after implantation of the medical device in the body is the formation of blood clots (thrombogenesis).

One additional problem that is also often encountered is the degradation, e.g., corrosion, of medical device leads and, thereby, premature failure of the device after implantation in the body.

However, when a harsh biological response (or premature failure of the device) is encountered after implantation, it is often necessary to remove the device 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 adjacent 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.

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