Rational drug therapy device and methods

• US 20030083739A1
• Filed: 09/24/2002
• Published: 05/01/2003
• Est. Priority Date: 09/24/2001
• Status: Abandoned Application

• Current Assignee: Medtronic Ave Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Ave Incorporated (Medtronic Plc)
• Inventors: Cafferata, Robert
• Application Number:
  US10/254,832
• Publication Number:
  US 20030083739A1
• Time in Patent Office: Days
• US Class Current: 623/1.42
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61L 2300/114 Nitric oxide, i.e. NO
• CPC Class Codes: A61L 2300/45 Mixtures of two or more drugs, e.g. synergistic mixtures
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 39/06 Free radical scavengers or antioxidants
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 9/10 for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

Abstract

A method and a system for treating vascular in-stent restenosis that combines two disparate drug delivery systems wherein the two drug systems act in a synergistic fashion to produce maximal therapeutic benefit at a targeted site. Controlled delivery of non-toxic, subthreshold doses of a systemic drug is combined with the localized delivery of a second drug via catheter-mediated stent placement to provide therapeutic benefit. Because each drug acts independently via distinct yet related molecular pathways, full therapeutic benefit can be designed as additives and occurs only at the targeted site.

Claims

1. A drug delivery system for delivering drugs to a localized site comprising:

a first drug; and

a second drug, wherein said first drug and said second drug act synergistically at said localized site.

2. The drug delivery system of claim 1 wherein said first drug is a systemically delivered drug.

3. The drug delivery system of claim 2 wherein said systemically delivered drug is administered orally, sublingually, intravenously, intraocularly, intramuscularly, intracranially, peritoneally, transdermally, vaginally, rectally, by insufflation, by inhalation, or by catheterization.

4. The drug delivery system of claim 2 wherein said first drug is selected from the group consisting of a phosphodiesterase inhibitor, a superoxide dismutase, an anti-inflammatory compound, or an anti-oxidant.

5. The drug delivery system of claim 1 wherein said second drug is a locally delivered drug.

6. The drug delivery system of claim 5 wherein said second drug is nitric oxide or a gene encoding nitric oxide synthase.

7. The drug delivery system of claim 5 wherein said second drug is locally delivered by a stent.

8. A drug delivery system for delivering drugs to a localized site comprising:

a systemically delivered drug; and

a locally delivered drug, wherein said systemically delivered drug and said locally delivered drug act synergistically at a site of local delivery.

9. The drug delivery system of claim 8 wherein said systemically delivered drug is administered orally, sublingually, intravenously, intraocularly, intramuscularly, intracranially, peritoneally, transdermally, vaginally, rectally, by insufflation, by inhalation, or by catheterization.

10. The drug delivery system of claim 8, wherein said systemically delivered drug is selected from the group consisting of a phosphodiesterase inhibitor, a superoxide dismutase, an anti-inflammatory compound, or an anti-oxidant.

11. The drug delivery system of claim 10, wherein said locally delivered drug is delivered by a stent.

12. The drug delivery system of claim 11, wherein said locally delivered drug is nitric oxide, a gene encoding nitric oxide synthase, superoxide dismutase, an anti-inflammatory compound, or an anti-oxidant.

13. A method of delivering a drug to an affected site comprising:

delivering a first drug to an affected site; and

administering a second drug, wherein said first drug and said second drug act synergistically at said affected site.

14. The method of claim 13 wherein said first drug is delivered to said affected site by a stent.

15. The method of claim 14 wherein said first drug is nitric oxide or a gene encoding nitric oxide synthase.

16. The method of claim 13 wherein said second drug is administered orally, sublingually, intravenously, intraocularly, intramuscularly, intracranially, peritoneally, transdermally, vaginally, rectally, by insufflation, by inhalation, or by catheterization.

17. The method of claim 13 wherein said second drug is selected from the group consisting of a phosphodiesterase inhibitor, a superoxide dismutase, an anti-inflammatory compound, or an anti-oxidant.

18. A drug delivery system for delivering drugs to a localized site comprising:

a medical device having a metallic surface, said metallic surface having nitric oxide releasably bound thereto; and

a systemically delivered drug.

19. The drug delivery system of 18 wherein said medical device is selected from the group consisting of stents, guide wires, catheters, trocar needles, bone anchors, bone screws, protective platings, hip and joint implants, electrical leads, biosensors and probes.

20. The drug delivery system of 18 wherein said systemically delivered drug is administered orally, sublingually, intravenously, intraocularly, intramuscularly, intracranially, peritoneally, transdermally, vaginally, rectally, by insufflation, by inhalation, or by catheterization.

21. The drug delivery system of 18, wherein said systemically delivered drug is selected from the group consisting of a phosphodiesterase inhibitor, a superoxide dismutase, an anti-inflammatory compound, or an anti-oxidant.