Device for local drug delivery and methods for using the same

• US 5,399,352 A
• Filed: 04/14/1993
• Issued: 03/21/1995
• Est. Priority Date: 04/14/1993
• Status: Expired due to Term

• Current Assignee: Emory University
• Original Assignee: Emory University
• Inventors: Hanson, Stephen R.
• Primary Examiner(s): Kishore, G. S.
• Assistant Examiner(s): AZPURU, CARLOS A
• Application Number:
  US08/046,622
• Time in Patent Office: 706 Days
• Field of Search: 424/423, 623/1, 623/12
• US Class Current: 424/423
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/064 with special features to facilitate anastomotic coupling anastomosis of natural blood vessels A61B17/11
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61M 2025/0063 having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body
• CPC Class Codes: A61M 25/0021 characterised by the form of the tubing A61M25/0054 takes precedence
• CPC Class Codes: A61M 25/0041 pre-formed, e.g. specially adapted to fit with the anatomy of body channels urethral catheters A61F2/04
• CPC Class Codes: A61M 37/00 Other apparatus for introducing media into the body for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30; Percutany, i.e. introducing medicines into the body by diffusion through the skin salt baths A61H33/04

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.

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.