Claims for Patent: 5,399,352

Summary for Patent: 5,399,352

Title:	Device for local drug delivery and methods for using the same
Abstract:	A device for the local delivery of a substance into a natural tissue conduit in the mammalian body, having a first clement capable of contacting the lumen of the conduit and a second element which overlays first element, a reservoir being formed between the first element and the second element, the interior of the reservoir being capable of fluid communication with the conduit such that a substance placed in the reservoir is delivered into the conduit. Also provided are methods of locally delivering a substance into a natural tissue conduit in the mammalian body utilizing the device of the present invention.
Inventor(s):	Hanson; Stephen R. (Stone Mountain, GA)
Assignee:	Emory University (Atlanta, GA)
Application Number:	08/046,622
Patent Claims:	1. A device for the local delivery of a substance into a natural tissue conduit in the mammalian body, comprising: a) a first element comprised of a biocompatible material which can be affixed to the conduit and having a first surface, an opposite second surface, and an intermediate porous portion which communicates the second surface with the first surface, wherein the first surface of the porous portion can be placed in fluid communication with the lumen of the conduit; and b) a second element comprised of a substantially non-porous biocompatible material which overlays the second surface of the first element, a reservoir being formed between the first element and the second element, the interior of the reservoir being capable of fluid communication with the conduit via the porous portion such that a substance in the reservoir is delivered into the conduit. 2. The device of claim 1, wherein the first element forms a patch which overlies a portion of the conduit. 3. The device of claim 1, wherein the conduit is a blood vessel and the first element is a vascular patch. 4. The device of claim 1, wherein the first element further comprises an elongated tubular segment having a substantially non-compliant, hollow body portion which is open at both ends wherein the first surface is the luminal surface of the tubular segment, and wherein the tubular segment is capable of being affixed to the natural tissue conduit at both of the ends of the tubular segment. 5. The device of claim 4, wherein the conduit is a blood vessel and the first element is a tubular prosthesis. 6. The device of claim 4, wherein the first element forms a tubular vascular prosthesis with a blood vessel. 7. The device of claim 1, further comprising a tube in communication at its first end with the reservoir and at its second end with a remote source of the substance. 8. The device of claim 7, further comprising a pump connected to the second end of the tube for delivering a substance to the reservoir and for creating pressure within the reservoir which exceeds the intraluminal pressure of the natural tissue conduit. 9. The device of claim 1, wherein the first element comprises material selected from the group consisting of biocompatible polymers, metals and ceramics. 10. The device of claim 9, wherein the polymer is selected from the group consisting of fluoropolymer, polyurethane, and polyester. 11. The device of claim 9, wherein the polymer is selected from the group consisting of polyethylene terephthalate and polytetrafluoroethylene. 12. The device of claim 1, further comprising a coating on a portion of the first surface in contact with the lumen of the conduit which improves the biocompatibility of the first surface. 13. The device of claim 8 wherein the coating is selected from the group consisting of silicone rubber, fluorocarbon, hydrocarbon, and polyurethane based polymers. 14. The device of claim 1, wherein the second element is comprised of material selected from the group consisting of biocompatible polymers, metals and ceramics. 15. The device of claim 14, wherein the polymer is selected from the group consisting of silicone rubber, polyurethane, polyfluorocarbon, polyethylene, polycarbonate and polyvinyl chloride. 16. The device of claim 1, wherein the substance is a drug. 17. The device of claim 1, wherein the substance is an anticoagulant. 18. The device of claim 17, wherein the anticoagulant is selected from the group consisting of heparin, hirudin, hirulog, hirugen, activated and non-activated protein C, antagonists of thrombin, Factor Xa and activated and non-activated coagulation factors. 19. The device of claim 1, wherein the substance antagonizes platelet deposition and thrombus formation. 20. The device of claim 19, wherein the substance is selected from the group consisting of plasmin, tissue plasminogen activator (tPA), urokinase (UK), single chain prourokinase (scuPA), streptokinase, prostaglandins, cyclooxygenase inhibitors, phosphodiesterase inhibitors, thromboxane synthetase inhibitors, antagonists of glycoprotein receptors including (GP) Ib,GP IIb/IIIa, antagonists of collagen receptors, and antagonists of platelet thrombin receptors. 21. The device of claim 1, wherein the substance affects platelet metabolic function. 22. The device of claim 21, wherein the substance is selected from the group consisting of prostaglandins, cyclooxygenase inhibitors, phosphodiesterase inhibitors, thromboxane inhibitors, inhibitors of calcium transport, and cyclic AMP agonists. 23. The device of claim 1, wherein the substance prevents restenosis of a blood vessel. 24. The device of claim 21, wherein the substance is selected from the group consisting of a growth factor, a growth factor inhibitor, growth factor receptor antagonist, transcriptional repressor, translational repressor, antisense. DNA, antisense RNA, replication inhibitor, inhibitory antibodies, antibodies directed against growth factors, bifunctional molecules comprising a growth factor and a cytotoxin, and bifunctional molecules comprising an antibody and a cytotoxin. 25. The device of claim 1, wherein the substance is a vasodilator. 26. The device of claim 23, wherein the substance is selected from the group consisting of prostaglandins, thromboxane antagonists, nitroglycerin, nitroprusside, agents which liberate nitric oxide, and agents which inhibit calcium transport.

Details for Patent 5,399,352

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Microbix Biosystems Inc.	KINLYTIC	urokinase	For Injection	021846	01/16/1978		2040-03-31