Intralumenal drug eluting prosthesis

• US 5,545,208 A
• Filed: 12/21/1993
• Issued: 08/13/1996
• Est. Priority Date: 02/28/1990
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Wolff, Rodney G., Hull, Vincent W.
• Primary Examiner(s): BRITTINGHAM, DEBRA
• Application Number:
  US08/171,361
• Time in Patent Office: 966 Days
• Field of Search: 623/1, 623/11, 623/12, 606/191-200, 600/36, 604/891.1
• US Class Current: 623/1.22
• CPC Class Codes: A61F 2/852 Two or more distinct overlapping stents
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2250/0048 differing in mechanical expandability, e.g. in mechanical, self- or balloon expandability
• CPC Class Codes: A61F 2250/0063 Nested prosthetic parts
• 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 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50
• CPC Class Codes: D04C 1/02 made from particular materials
• CPC Class Codes: D10B 2509/06 Vascular grafts; stents

Abstract

A prosthesis for insertion into a lumen to limit restenosis of the lumen. The prosthesis carries restenosis-limiting drugs which elute after the device is positioned in the lumen.

Claims

1. A device for local intralumenal administration of drugs comprising:

(a) a catheter having proximal and distal ends;

(b) a body including a plurality of support elements forming a open-ended, radially expandable, self-supporting tubular structure having an interior surface and an exterior surface;

(c) at least one flexible, polymeric filament attached to the support elements of the body, at least a portion of the filament exposed at the exterior surface of the tubular body, said body mounted on the catheter at the distal end thereof;

(d) means at the proximal end of the catheter to provide sufficient radial expansion of the tubular body to bring the tubular body and polymeric filament into contact with a body lumen at an interior portion of the body lumen to be treated and for releasing the tubular body from the catheter; and

(e) a drug compounded into the polymeric filament such that the drug is delivered to the body lumen when the tubular body is radially expanded into contact with the portion of the body lumen to be treated.

2. The device of claim 1 wherein the support elements of the tubular body are arranged in a helically wound structure.

3. The device of claim 2 wherein the helically wound structure includes a plurality of helical elements, each of which is wound in a helix configuration along a center line of the tubular body as a common axis, said elements wound in opposing helical directions such that the tubular body is variable in radial diameter under axial movement of opposite ends of the body relative to each other.

4. The device of claim 3 wherein the helical elements are made from a bioabsorbable polymer.

5. The device of claim 2 wherein the support elements are made from a deformable metal.

6. The device of claim 1 wherein the polymeric filament is made from a bioabsorbable polymer.

7. The device of claim 1 also comprising a second polymeric filament having the drug compounded therein such that the drug is delivered to the body lumen more rapidly from the second polymeric filament than from the polymeric filament.

8. The device of claim 1 also comprising a barrier coating of polymeric material on the drug-containing filament to limit the rate of drug elution.

9. The device of claim 1 wherein the drug is selected from the group consisting of antiplatelet drugs, anticoagulant drugs, anti-inflammatory drugs, antireplicate drugs and combinations of said drugs.

10. The device of claim 9 wherein the polymeric filament includes a drug selected from the group consisting of anticoagulant drugs and antiplatelet drugs and wherein the device also comprises a second polymeric filament having a drug compounded therein selected from the group consisting of antiinflammatory drugs and antireplicate drugs such that the drug in the polymeric filament is delivered to the body lumen more rapidly than from the second polymeric filament.