Seeding implantable medical devices with cells

• US 7,759,120 B2
• Filed: 09/01/2006
• Issued: 07/20/2010
• Est. Priority Date: 03/02/2005
• Status: Expired due to Fees

• Current Assignee: Kips Bay Medical, Inc.
• Original Assignee: KPS Bay Medical Incorporated
• Inventors: Wolf, Michael F., Trescony, Paul V., Yunker, Laurie A.
• Primary Examiner(s): Ford; Allison M
• Application Number:
  US11/515,344
• Publication Number:
  US 20070059335A1
• Time in Patent Office: 1,418 Days
• Field of Search: None
• US Class Current: 435/395
• 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 27/3616 Blood, e.g. platelet-rich plasma
• CPC Class Codes: A61L 27/38 containing added animal cells organs or tissue containing native cells A61L27/36
• 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 comprising:

inserting an implantable medical device having a lumen into a protective sleeve;

inserting the protective sleeve into a tube through an open end of the tube, wherein the tube defines a longitudinal axis;

sealing the open end of the tube with a self-sealable membrane fabricated from a self-sealable material, wherein the self-sealable membrane provides a selective liquid barrier at the open end of the tube;

delivering a preparation media comprising calcium to said lumen of the implantable medical device by penetrating said self-sealable membrane with a delivery device;

after a first application period, removing any residue preparation media from said lumen through said self-sealable membrane with a removal device;

subsequent to removing any residue preparation media, delivering a blood centrifugation product comprising blood plasma to said lumen of the implantable medical device by penetrating said self-sealable membrane with the delivery device;

after a second application period, removing any residue of the blood centrifugation product from said lumen through said self-sealable membrane with the removal device;

subsequent to removing any residue centrifugation product, delivering cells to said lumen of the implantable medical device by penetrating said self-sealable membrane with the delivery device;

withdrawing the delivery device to re-establish the liquid barrier at said self-sealable membrane; and

centrifuging the implantable medical device with the cells in the lumen by rotating the tube substantially around the longitudinal axis.

2. The method of claim 1, further comprising securing the self-sealable membrane over the open end with a tube cap.

3. The method of claim 1, further comprising:

removing the implantable medical device from the protective sleeve; and

implanting the implantable medical device after removing the implantable medical device from the protective sleeve.

4. The method of claim 1, further comprising:

removing the protective sleeve from the tube;

implanting the implantable medical device; and

removing the implantable medical device from the protective sleeve after implanting the implantable medical device.

5. The method of claim 4, further comprising attaching the protective sleeve to a tunneling device, wherein implanting the implantable medical device comprises drawing the protective sleeve and the implantable medical device through a tunnel formed through patient tissue by the tunneling device with the sleeve attached to the tunneling device.

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

7. The method of claim 1, further comprising centrifuging the implantable medical device with the cells in the lumen by rotating the tube substantially around the longitudinal axis at a rate sufficient to develop between 250-500 g for 1-10 minutes.

8. The method of claim 1, wherein the protective sleeve has an inner diameter that is sized to substantially conform to an outer diameter of the implantable medical device.