Seeding implantable medical devices with cells

• US 7,759,099 B2
• Filed: 03/02/2006
• Issued: 07/20/2010
• Est. Priority Date: 03/02/2005
• Status: Expired due to Fees

• Current Assignee: Kips Bay Medical, Inc.
• Original Assignee: Kips Bay Medical, Inc.
• Inventors: Trescony, Paul V., Yunker, Laurie A., Wolf, Michael F.
• Primary Examiner(s): Ford; Allison M
• Application Number:
  US11/367,006
• Publication Number:
  US 20060210596A1
• Time in Patent Office: 1,601 Days
• Field of Search: None
• US Class Current: 435/180
• CPC Class Codes: A61F 2/062 Apparatus for the production of blood vessels made from natural tissue or with layers of living cells prostheses made from natural tissue or living cells A61L27/507
• CPC Class Codes: A61L 27/16 obtained by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/3808 Endothelial cells
• CPC Class Codes: A61L 27/507 for artificial blood vessels apparatus for applying cells on a blood vessel prosthesis A61F2/062
• CPC Class Codes: C08L 27/18 Homopolymers or copolymers or tetrafluoroethene
• CPC Class Codes: Y10S 623/915 Method or apparatus for preparing biological material
• CPC Class Codes: Y10S 623/916 Blood vessel

Abstract

Apparatus and methods for seeding an implantable medical device, such as a vascular prosthesis, with cells, such as endothelial cells, are described. 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. The introduction of the cells may occur after a blood centrifugation product, such as platelet-poor plasma, is applied to the luminal surface. After the cells are introduced, the device is then subjected to centrifugation around a longitudinal axis defined by the lumen. Axial centrifugation causes the cells to concentrate toward and adhere to the luminal surface. Shortly after axial centrifugation, the seeded device can be presented for implantation in a patient. The implantable medical device may be inserted into a protective sleeve prior to seeding the device with cells, and the sleeve may or may not be removed prior to implantation.

Claims

1. A method for seeding cells on a luminal surface of an implantable medical device, the method comprising:

providing an implantable medical device having a lumen and a luminal surface, and wherein the lumen defines a longitudinal axis;

centrifuging blood to obtain a blood centrifugation product comprising blood plasma;

applying a preparation media comprising calcium to the luminal surface of the implantable medical device;

subsequent to applying the preparation media, applying the blood centrifugation product to the luminal surface of the implantable medical device;

subsequent to applying the blood centrifugation product, introducing cells into the lumen of the implantable medical device; and

axially centrifuging the implantable medical device by rotating the implantable medical device substantially around the longitudinal axis at a rate sufficient to generate between 1 g and 1000 g of centripetal acceleration on the cells, thereby seeding the cells on the luminal surface of the implantable medical device.

2. The method of claim 1, wherein the blood centrifugation product comprising blood plasma is a platelet poor plasma.

3. The method of claim 2, further comprising incubating the platelet-poor plasma following application of the platelet poor plasma to the luminal surface.

4. The method of claim 1, further comprising rubbing the luminal surface of the implantable medical device to lift nodes from the luminal surface and create recesses on the luminal surface.

5. The method of claim 1, wherein the luminal surface comprises expanded polytetrafluoroethylene.

6. The method of claim 1, further comprising inserting the implantable medical device into a protective sleeve prior to applying the blood centrifugation product.

7. The method of claim 1, wherein introducing cells comprises introducing endothelial cells.

8. The method of claim 1, wherein the implantable medical device comprises a vascular prosthesis.

9. The method of claim 1, further comprising:

injecting a blood sample into a device that separates the blood sample;

spinning the blood sample in the device in a soft spin to separate red blood cells;

spinning the blood sample in a hard spin to form a pellet of platelets, wherein the remaining solution is the blood centrifugation product.

10. The method of claim 1 wherein the axial centrifugation generates about 250 g of centripetal acceleration on the cells.