Seeding Implantable Medical Devices with Cells

Abstract

The invention is directed to apparatus and methods for seeding an implantable medical device, such as a vascular prosthesis, with cells, such as endothelial cells. The invention supports techniques for seeding a luminal surface of the device with axial centrifugation. Cells are introduced in suspension into the lumen of the device, and the device is subjected to centrifugation around a longitudinal axis defined by the lumen. Axial centrifugation causes the cells to concentrate toward the luminal surface. Shortly after axial centrifugation, the seeded device can be presented for implantation in a patient.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application is a divisional of U.S. patent application Ser. No. 11 / 071,597 filed on Mar. 2, 2005, and entitled “Seeding Implantable Medical Devices with Cells”, the content of which is hereby incorporated herein in its entirety.FIELD OF THE INVENTION[0002]The field of the invention relates to materials and devices implantable in a living human or animal body, such as materials and devices used in vascular prostheses.BACKGROUND OF THE INVENTION[0003]Some patients develop conditions that can be corrected with implantable medical devices such as mechanical and bioprosthetic heart valves, coronary stents, stent grafts, abdominal aortic aneurysm (AAA) grafts and other devices. Conditions that affect blood flow through the vessels of the body, for example, may be treated with vascular grafts, in which a surgeon applies the graft to supplant the damaged vascular tissue. Coronary artery disease, peripheral vascular disease and venipuncture f...

AI Technical Summary

Benefits of technology

[0008]Various methods for preparation of an implantable medical device to enhance endothelial cell seeding are described. Some of the methods involve creation of recesses in the luminal surface of implantable medical device, such as a vascular prosthesis, that can receive endothelial cells. When the implantable medical device is constructed of a material such as expanded polytetrafluoroethylene (ePTFE), the recesses may be created by physical processing of the microstructures of the material. The recesses support and shelter endothelial cells deposited on the lumen and reduce the risk of the cells being washed away. When the endothelial cells wash away, the vessel is less likely to endothelialize, and is at greater risk of developing complications, such as thrombosis and stenosis.

[0010]The methods described herein for cell seeding of an implantable medical device can be performed directly in the operating room. While the patient is undergoing surgery, the cells may be introduced into the lumen of the prosthesis, and the prosthesis seeded by subjection to axial centrifugation. Also described are methods to prepare the implantable medical device to receive the cells, as well as to protect of the implantable medical device from hazards associated with handling.

[0015]In the case of an implantable medical device, such as a vascular prosthesis, manufactured and seeded as described, fewer endothelial cells will be washed away when the prosthesis is implanted, thereby benefiting the patient. Also, various embodiments of the invention take advantage of physical properties of ePTFE, a material that has a proven track record in implantable medical devices. The invention improves ePTFE without adversely affecting the favorable features of ePTFE, such as biocompatibility, physical properties and ease of handling and suturing.

[0016]In addition, the invention also makes a “one-stage procedure” feasible, in which endothelial cells can be harvested, a prosthesis can be seeded with the harvested cells, and the seeded device can be presented for implantation in a single surgical operation. Seeding with axial centrifugation can be an efficient way to deploy cells rapidly and evenly on the luminal surface.

Problems solved by technology

When the endothelial cells wash away, the vessel is less likely to endothelialize, and is at greater risk of developing complications, such as thrombosis and stenosis.

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