Rationally designed therapeutic intravascular implant coating

• US 20040137066A1
• Filed: 10/29/2003
• Published: 07/15/2004
• Est. Priority Date: 11/26/2001
• Status: Abandoned Application

• Current Assignee: Vascular Concepts Holdings Limited
• Original Assignee: Vascular Concepts Holdings Limited
• Inventors: Jayaraman, Swaminathan
• Application Number:
  US10/696,174
• Publication Number:
  US 20040137066A1
• Time in Patent Office: Days
• US Class Current: 424/486
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/436 the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin
• CPC Class Codes: A61K 38/13 Cyclosporins
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61L 2300/416 Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
• CPC Class Codes: A61L 2300/426 Immunomodulating agents, i.e. cytokines, interleukins, interferons
• CPC Class Codes: A61L 2300/61 containing two or more active agents in different layers
• CPC Class Codes: A61L 27/34 Macromolecular materials
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 29/085 Macromolecular materials
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence

Abstract

The invention relates to a method for treating a vascular disease of a patient. The method includes identifying a disease process in the pathology of a vascular disease, selecting a therapeutic agent to treat or prevent the vascular disease, coating an intravascular implant with a therapeutically effective amount of the agent, and implanting the intravascular implant in the patient. The invention also relates to a coating for an intravascular implant to treat or prevent a vascular disease of a patient. The coating includes a therapeutically effective amount of rapamycin and a therapeutically effective amount of a second agent. The second agent is selected based on the vascular disease of the patient.

Claims

1. A method for treating a vascular disease of a patient with an intravascular implant, the method comprising:

identifying a disease process in the pathology of the vascular disease;

selecting a first agent to treat or prevent the vascular disease;

coating at least a portion of the intravascular implant with a therapeutically effective amount of the first agent; and

implanting the intravascular implant in the patient.

2. A method as defined in claim 1 wherein the disease process is identified using a technique selected from the group consisting of an angiogram, fluoroscopy, CT scan, MRI, intravascular MRI, lesion temperature determination, genetic determination and a combination thereof.

3. A method as defined in claim 2 wherein the disease process is selected from the group consisting of acute myocardial infarction, thrombotic lesions, unstable angina, fibrotic disease, total occlusion, hyperproliferative vascular disease, vulnerable plaque, diabetic vascular diffused disease and a combination thereof.

4. A method as defined in claim 3 wherein the first agent acts on a calcium independent cellular pathway.

5. A method as defined in claim 4 wherein the first agent is a macrolide immunosuppressant.

6. A method as defined in claim 5 further including selecting a second agent to treat or prevent the vascular disease, and wherein coating at least a portion of the intravascular implant with a therapeutically effective amount of the first agent includes coating at least a portion of the intravascular implant with a therapeutically effective amount of the second agent.

7. A method as defined in claim 6 wherein the second agent is selected from the group consisting of an anti-inflammatory agent, non-proliferative agent, anti-coagulant, anti-platelet agent, Tyrosine Kinase inhibitor, anti-infective agent, anti-tumor agent, anti-leukemic agent and a combination thereof.

8. A method as defined in claim 1 wherein coating at least a portion of the intravascular implant includes coating at least a portion of the intravascular implant with a polymer matrix.

9. A method as defined in claim 8 wherein the polymer matrix includes a bioabsorbable polymer.

10. A method as defined in claim 9 wherein the bioabsorbable polymer is selected from the group consisting of poly-α

hydroxy acids, polyglycols, polytyrosine carbonates, starch, gelatins, cellulose and combinations thereof.

11. A method as defined in claim 10 wherein the therapeutically effective amount of the first agent is dispersed within the bioabsorbable polymer.

12. A method as defined in claim 1 wherein the intravascular implant is selected from the group consisting of a balloon catheter, stent, stent graft, drug delivery catheter, atherectomy device, filter, scaffolding device, anastomotic clip, anastomotic bridge, suture material, wire, embolic coil and a combination thereof.

13. A method as defined in claim 12 wherein the intravascular implant includes a primer layer upon which the coating is applied.

14. A method as defined in claim 13 wherein the primer layer is made of a bioabsorbable polymer.

15. A method as defined in claim 13 wherein the primer layer is made of a biostable polymer.

16. A method as defined in claim 13 further including a top coat applied over the coating.

17. A method of making a therapeutically coated intravascular implant for treating a vascular disease, the method comprising:

identifying a disease process in the pathology of a vascular disease of a patient;

selecting a first agent to treat or prevent the vascular disease; and

coating at least a portion of the intravascular implant with a therapeutically effective amount of the first agent.

18. A method as defined in claim 17 wherein the disease process is identified using a technique selected from the group consisting of an angiogram, fluoroscopy, CT scan, MRI, intravascular MRI, lesion temperature determination, genetic determination and a combination thereof.

19. A method as defined in claim 18 wherein the disease process is selected from the group consisting of acute myocardial infarction, thrombotic lesions, unstable angina, fibrotic disease, total occlusion, hyperproliferative vascular disease, vulnerable plaque, diabetic vascular diffused disease and a combination thereof.

20. A method as defined in claim 19 further including selecting a second agent to treat or prevent the vascular disease, and wherein coating at least a portion of the intravascular implant with a therapeutically effective amount of the first agent includes coating at least a portion of the intravascular implant with a therapeutically effective amount of the second agent.

21. A method as defined in claim 20 wherein the first agent is rapamycin.

22. A method as defined in claim 21 wherein the second agent is selected from the group consisting of an anti-inflammatory agent, non-proliferative agent, anti-coagulant, anti-platelet agent, Tyrosine Kinase inhibitor, anti-infective agent, anti-tumor agent, anti-leukemic agent and a combination thereof.

23. A therapeutic intravascular implant coating for coating at least a portion of an intravascular implant to treat or prevent a vascular disease of a patient, the coating comprising:

a therapeutically effective amount of rapamycin; and

a therapeutically effective amount of a second agent,

wherein the second agent is selected based on the vascular disease of the patient.

24. A coating as defined in claim 23 wherein the second agent is selected from the group consisting of an anti-inflammatory agent, non-proliferative agent, anti-coagulant, anti-platelet agent, Tyrosine Kinase inhibitor, anti-infective agent, anti-tumor agent, anti-leukemic agent and a combination thereof.

25. A coating as defined in claim 24 wherein the intravascular implant is selected from the group consisting of a balloon catheter, stent, stent graft, drug delivery catheter, atherectomy device, filter, scaffolding device, anastomotic clip, anastomotic bridge, suture material, wire, embolic coil and a combination thereof.