US 7,537,782 B2
	Methods for governing bone growth
Christopher J. Calhoun, San Diego, Calif. (US); and G. Bryan Cornwall, San Diego, Calif. (US)
Assigned to Kensey Nash Corporation, Exton, Pa. (US)
Filed on Feb. 27, 2003, as Appl. No. 10/375,451.
Claims priority of provisional application 60/360462, filed on Feb. 28, 2002.
Claims priority of provisional application 60/409103, filed on Sep. 09, 2002.
Prior Publication US 2003/0185874 A1, Oct. 02, 2003
Int. Cl. A61F 2/28 (2006.01)

U.S. Cl. 424—426  [523/112; 523/115; 528/323; 528/324; 528/326; 623/16.11; 623/17.11; 623/23.58]

59 Claims

1. A method for governing bone growth, the method comprising providing a substantially planar barrier membrane of resorbable polymer base material having a bone-growing substantially-smooth side that comprises a bone-inductive factor and a non-bone growing substantially-smooth side, the substantially planar barrier membrane of resorbable polymer base material comprising a single layer of resorbable polymer base material between the bone-growing side and the non-bone growing side, the single layer of resorbable polymer base material having a substantially uniform composition, wherein a thickness of the single layer of resorbable polymer base material, measured between the bone-growing side and the non-bone growing side, is between about 10 microns and about 300 microns, wherein the single layer of resorbable polymer base material is non-porous, wherein the single layer of resorbable polymer base material consists essentially of a material selected from the group consisting of a poly-lactide polymer and a copolymer of two or more cyclic esters, and wherein the single layer of resorbable polymer base material is adapted to maintain a smooth-surfaced barrier between the bone growing side and the non-bone growing side, and is adapted to be resorbed into a mammalian body within a period of approximately 18 to 24 months from an initial implantation of the substantially planar barrier membrane of resorbable polymer base material into the mammalian body; and forming a spatial barrier with the substantially planar barrier membrane of resorbable polymer base material, the substantially planar barrier membrane of resorbable polymer base material separating a bone-growth area, which faces the bone-growing side having the bone-inductive factor, from a non-bone-growth area, which faces the non-bone growing side having a pre-implantation compositional characteristic different from a pre-implantation compositional characteristic of the bone growing side, wherein the compositional characteristic is defined by an amount or concentration of one or more of a tissue growth inhibitor or anti-tissue agent, an anti-bone agent or factor, an anti-angiogenic factor, a monoclonal or polyclonal antibody, an antibody fragment, a substance for cellular control, a chemotactic substance for influencing cell-migration, an inhibitory substance for influencing cell-migration, a mitogenic growth factor for influencing cell proliferation, a bone-inductive factor, a growth factor for influencing cell differentiation, and a factor which promotes angiogenesis.