A variety of extracellular matrix materials have been proposed for use in medical grafting, cell culture, and other related applications. For instance, medical grafts and cell culture materials containing submucosa derived from small intestine, stomach or urinary bladder tissues, have been proposed. See, e.g., U.S. Pat. Nos. 4,902,508, 4,956,178, 5,281,422, 5,554,389, 6,099,567 and 6,206,931. In addition, Cook Biotech Incorporated, West Lafayette, Ind., currently manufactures a variety of medical products based upon small intestinal submucosa under the trademarks SURGISIS®, STRATASIS® and OASIS®.
Medical materials derived from liver basement membrane have also been proposed, for example in U.S. Pat. No. 6,379,710. As well, ECM materials derived from amnion (see e.g. U.S. Pat. Nos. 4,361,552 and 6,576,618) and from renal capsule membrane (see WO 03/002165 published Jan. 9, 2003) have been proposed for medical and/or cell culture applications.
In addition to the above, there have been attempts to alter the surface properties of an ECM to improve its characteristics. For example, Woods et al. disclose a SIS material having improved biocompatibility by virtue of it being conditioned with human umbilical vein endothelial cells (HUVECs) (Biomaterials, (25)515-525 (2004)). To produce the conditioned SIS, HUVECs were grown for 2 weeks on SIS and then removed, leaving behind an intact basement membrane. Woods et al. suggest that the above approach could be a useful step in preparing a conditioned SIS that has certain biological advantages over a native SIS.
Similarly, Lindberg et al. teach that human epidermal cells, fibroblasts (human and mouse 3T3/J2), or a combination thereof, deposit several basement membrane proteins including fibronectin, collagen types IV and VII, and laminin when seeded onto a SIS matrix (Burns, (27)254-266 (2001)). In this regard, Lindberg et al. teach that SIS can support attachment, migration and/or proliferation and differentiation of both epidermal cells and fibroblasts, and that these cells can alter the SIS matrix by depositing basement membrane components onto SIS.
International PCT Patent Application No. WO 02/40630 (Amiel) provides a matrix which is decellularized and then reseeded with any of a variety of cells, most notably endothelial cells and fibroblasts. Amiel maintains that acellular matrices seeded with human saphenous vein endothelial cells (HSVECs) are able to withstand a hydrostatic pressure up to 900 mmHg without breaking or leaking and that a confluent layer of HSVECs on the luminal side of the acellular matrix is achieved. Moreover, Amiel suggest that the HSVECs are able to deposit VEGF, prostaglandin F1α, and nitric oxide onto the matrix. Such proteins are thought to contribute to the improvement of biological properties of the scaffold.
Despite work in these areas, there remain needs for alternative and improved medical materials, as well as methods and devices related to these materials. The present invention addresses these needs.
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USPTO Backgrounds