METHOD OF USING AND PRODUCING TROPOELASTIN AND TROPOELASTIN BIOMATERIALS
A device implantable within a human body, and a method for producing the device, are provided. The device comprises a biocompatible coating on at least a portion of an outer surface of a substrate. The biocompatible coating comprises tropoelastin. A biocompatible coating is formed in situ on the outer surface of the substrate.
1 . A method for producing a device implantable within a human body, comprising:
forming a biocompatible coating in situ on at least a portion of an outer surface of a substrate, wherein the biocompatible coating comprises tropoelastin.
2 . The method of claim 1 , wherein said biocompatible coating comprises a polymer consisting essentially of tropoelastin.
3 . The method of claim 1 , wherein said forming a biocompatible coating in situ on at least a portion of an outer surface of the substrate comprises cross-linking tropoelastin on the outer surface of the substrate.
4 . The method of claim 3 , wherein said cross-linking tropoelastin on the outer surface of the substrate comprises introducing the substrate into a cross-linking solution.
5 . The method of claim 4 , wherein the cross-linking solution comprises a solvent capable of substantially preventing redissolution of the tropoelastin.
6 . The method of claim 5 , wherein the cross-linking solution comprises a water immiscible solvent.
7 . The method of claim 4 , wherein the cross-linking solution comprises a suberate cross-linking agent.
8 . The method of claim 1 , wherein said forming a biocompatible coating in situ on at least a portion of an outer surface of the substrate comprises cross-linking tropoelastin monomers to form a polymer consisting essentially of tropoelastin.
9 . The method of claim 1 , wherein said forming a biocompatible coating in situ on at least a portion of an outer surface of the substrate comprises:
forming an intermediate bonding layer on at least a portion the outer surface of the substrate; and
adhering tropoelastin to an outer surface of the intermediate bonding layer.
10 . The method of claim 9 , wherein said adhering tropoelastin to an outer surface of the intermediate bonding layer comprises covalently bonding tropoelastin to the outer surface of the intermediate bonding layer.
11 . The method of claim 9 , wherein the intermediate bonding layer comprises amine groups for cross-linking tropoelastin to the outer surface of said substrate.
12 . The method of claim 9 , wherein the intermediate bonding layer comprises an aminosilane for cross-linking the tropoelastin monomer to the outer surface of said substrate.
13 . The method of claim 1 , further comprising pretreating the substrate prior to forming the biocompatible coating to form a pretreated substrate which facilitates adhering of the biocompatible coating thereto.
14 . The method of claim 12 , wherein said pretreating the substrate prior to forming the biocompatible coating comprises oxidizing the substrate.
15 . The method of claim 13 , wherein said oxidizing the substrate comprises electrochemical oxidation.
16 . The method of claim 12 , wherein the pretreated substrate has a contact angle which is not more than about 50% of the contact angle of the unpretreated substrate prior to pretreatment.
17 . The method of claim 2 , wherein the substrate coated with the tropelastin polymer has a contact angle which is at least about 150% of the contact angle of the unpretreated substrate prior to pretreatment.
18 . The method of claim 1 , which further includes the step of arranging the tropoelastin to form poly-tropoelastin aggregates prior to forming said biocompatible coating in situ on at least a portion of an outer surface of the substrate.
19 . The method of claim 1 , wherein the substrate is formed of a metallic material.
20 . The method of claim 1 , wherein the substrate is formed of a non-metallic material.
21 . The method of claim 1 , wherein the substrate is a prosthetic device.
22 . The method of claim 1 , wherein the substrate comprises a stent, a conduit or a scaffold.
23 . The method of claim 1 , wherein the biocompatible coating is formed in a substantially single layer onto the substrate.
24 . The method of claim 1 , wherein the biocompatible coating includes a drug for use in the human body.
25 . A device implantable within a human body, comprising:
a substrate having an outer surface;
an intermediate bonding layer coating at least a portion of said outer surface of the substrate; and
an outer biocompatible layer of tropoelastin adheringly joined to the intermediate bonding layer.
26 . The device of claim 25 wherein, the outer biocompatible layer of tropoelastin is cross-linked to an outer surface of the intermediate bonding layer.
27 . The device of claim 25 , wherein said outer biocompatible layer of tropoelastin is joined to the outer surface of the intermediate bonding layer by covalent bonding.
28 . The device of claim 25 , wherein said substrate comprises a pretreated substrate which facilitates adhering of the biocompatible coating thereto.
29 . The device of claim 28 , wherein said pretreated substrate comprises an oxidatively pretreated substrate
30 . The device of claim 28 , wherein said pretreated substrate is an oxidatively electrochemically pretreated substrate.
31 . The device of claim 28 , wherein the pretreated substrate has a contact angle which is not more than about 50% of the contact angle of an unpretreated substrate.
32 . The device of claim 28 , wherein the substrate adheringly coated with the tropoelastin polymer has a contact angle which is at least about 150% of the contact angle of an unpretreated substrate.
33 . The device of claim 25 , wherein said substrate is formed of a metallic material.
34 . The device of claim 25 , wherein said substrate is formed of a non-metallic material.
35 . The device of claim 25 , wherein said substrate is a prosthetic device.
36 . The device of claim 25 , wherein the intermediate bonding layer comprises cross-linkable amine groups.
37 . The device of claim 25 , wherein the intermediate bonding layer comprises an aminosilane.
38 . The device of claim 25 , wherein the tropoelastin is formed in a substantially single layer onto the bonding coating layer.
39 . The device of claim 25 , wherein the pretreated substrate comprises a stent, a conduit or a scaffold.
40 . The device of claim 25 , wherein the outer biocompatible layer of tropoelastin comprises a polymer consisting essentially of tropoelastin.
41 . The device of claim 1 , wherein the outer biocompatible layer of tropoelastin includes a drug for use in the human body.
42 . A device implantable within a human body, comprising:
a pretreated substrate, having a pretreated outer surface capable of being adheringly coated with a layer of tropoelastin; and
an outer in-situ biocompatible layer of tropoelastin polymer adheringly joined to the pretreated substrate.