Apparatus and methods for controlled substance delivery from implanted prostheses

• US 6,939,375 B2
• Filed: 02/13/2001
• Issued: 09/06/2005
• Est. Priority Date: 12/22/2000
• Status: Expired due to Fees

• Current Assignee: Avantec Vascular Corporation (Nipro Corporation)
• Original Assignee: Avantec Vascular Corporation (Nipro Corporation)
• Inventors: Yan, John, Sirhan, Motasim
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): Phan, Hieu
• Application Number:
  US09/783,253
• Publication Number:
  US 20020082685A1
• Time in Patent Office: 1,666 Days
• Field of Search: 623 139- 148
• US Class Current: 623/1.42
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• 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 2300/602 Type of release, e.g. controlled, sustained, slow
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence

Abstract

The present invention provides improved devices and methods for inhibiting restenosis and hyperplasia after intravascular intervention. In particular, the present invention provides luminal prostheses which allow for programmed and controlled substance delivery with increased efficacy to selected locations within a patient'"'"'s vasculature to inhibit restenosis. The luminal delivery prosthesis comprises a scaffold which is implantable within a body lumen and means on the scaffold for releasing a substance from the scaffold. The substance is released over a predetermined time pattern comprising an initial phase wherein the substance delivery rate is below a threshold level and a subsequent phase wherein the substance delivery rate is above a threshold level.

Claims

1. A method for luminal substance delivery, said method comprising:

providing a luminal prosthesis incorporating and/or coupled to a substance, wherein the prosthesis comprises a rate limiting barrier; and

implanting the prosthesis in a body lumen so that the substance is released from the prosthesis at multiple rates including an initial rate and at least one subsequent rate which is substantially higher than the initial rate and begins after an appreciable preselected time period.

2. A method as in claim 1, wherein the barrier has a sufficient thickness to allow diffusion of the substance through the barrier.

3. A method as in any of claims 1-2, wherein the at least one subsequent rate begins within a time period ranging from 4 hours to 24 weeks in a vascular environment.

4. A method as in any of claim 3, wherein the at least one subsequent rate begins within a time period of 1 day to 12 weeks in a vascular environment.

5. A method as in any of claim 3, wherein the at least one subsequent rate begins within a time period of 2 days to 8 weeks in a vascular environment.

6. A method as in claim 3, wherein the at least one subsequent rate begins within a time period of 3 days to 50 days in a vascular environment.

7. A method as in any one of claims 1-2, wherein the substance comprises at least one agent selected from the group consisting of immunosuppressant agent, anti-inflammatory agent, anti-proliferative agent, anti-migratory agent, anti-fibrotic agent, anti-thrombotic agent, anti-platelet agent, and lIb/IIIa agent.

8. A method as in claim 1, further comprising directing energy at the prosthesis to effect release of the substance from the prosthesis.

9. A method as in claim 8, wherein the energy is at least one of ultrasound, magnetic resonance imaging, magnetic field, radio frequency, temperature change, electromagnetic, x-ray, radiation, heat, gamma, or microwave.

10. A method as in claim 1, wherein the prosthesis incorporates the substance by coating, spraying, dipping, deposition, or painting the substance on the prosthesis.

11. A method as in claim 1, wherein the substance is incorporated in a reservoir in or on a scaffold containing the substance.

12. A method as in claim 1, wherein the prosthesis incorporates magnetic particles coupled to the substance and further comprising the step of directing a magnetic field at the prosthesis to effect release of the substance from the prosthesis.

13. A method as in claim 1, wherein the initial rate is in a range between 0 μ

g/day to 50 μ

g/day.

14. A method as in claim 13, wherein the initial rate is in a range between 5 μ

g/day to 30 μ

g/day.

15. A method as in claim 1, wherein the at least one subsequent rate is in a range between 5 μ

g/day to 200 μ

g/day.

16. A method as in claim 15, wherein the at least one subsequent rate is in a range between 10 μ

g/day to 100 μ

g/day.