Multilayered biodegradable stent and method of manufacture

• US 5,443,458 A
• Filed: 12/03/1993
• Issued: 08/22/1995
• Est. Priority Date: 12/22/1992
• Status: Expired due to Term

• Current Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Eury, Robert P.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): ELGART, VANITHA M
• Application Number:
  US08/162,670
• Time in Patent Office: 627 Days
• Field of Search: 604/97, 604/104, 604/132, 604/133, 604/285, 604/288, 604/891.1, 604/265, 606/191, 606/194, 606/195, 606/198.7, 606/8, 606/151, 606/153, 606/155, 606/108, 623/1, 623/11, 623/12, 623/13
• US Class Current: 604/891.1
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/92 Stents in the form of a rolled-up sheet expanding after insertion into the vessel , e.g. with a spiral shape in cross-section
• CPC Class Codes: A61F 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• 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 2300/42 Anti-thrombotic agents, anticoagulants, anti-platelet agents
• CPC Class Codes: A61L 2300/45 Mixtures of two or more drugs, e.g. synergistic mixtures
• CPC Class Codes: A61L 2300/602 Type of release, e.g. controlled, sustained, slow
• CPC Class Codes: A61L 2300/608 having two or more layers
• CPC Class Codes: A61L 2420/08 Coatings comprising two or more layers
• CPC Class Codes: A61L 31/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence

Abstract

A stent of multilayered laminated construction wherein one layer addresses the structural requirements of the stent and additional layers release drugs at predictable rates. Both the structural layer as well as the drug releasing layers are eventually completely resorbed by the body.

Claims

1. A method of fabricating a biodegradable, drug releasing stent for implantation within a lumen, comprising the steps of:

forming a first layer of biodegradable material having physical properties necessary to enable a stent to maintain patency of said lumen;

forming a second layer of biodegradable material which releases a selected drug upon exposure to an environment such as is encountered within said lumen; and

superposing said second layer on said first layer to provide a laminated structure that is biodegradable, drug releasing and has the physical properties necessary for said stent to perform its structural function within said lumen.

2. The method of claim 1 further comprising the steps of:

forming a third layer of biodegradable material which releases a selected drug upon exposure to an environment such as is encountered within said lumen; and

superposing said third layer to said first layer.

3. The method of claim 2, wherein said second and third layers are joined to said first layer with the application of heat.

4. The method of claim 2 wherein said second and third layers are joined to said first layer with the use of solvents.

5. The method of claim 1, wherein said first layer is formed by extrusion and orientation of a polymeric material.

6. The method of claim 5, wherein said polymeric material comprises poly-L-lactic acid.

7. The method of claim 5 wherein said polymeric material comprises polyglycolic acid.

8. The method of claim 1, wherein said second layer comprises a mixture of said drug and a polymeric material.

9. The method of claim 8 wherein said polymeric material comprises poly-DL-lactic acid.

10. The method of claim 8 wherein a polymeric material comprises a polycaprolactone.

11. The method of claim 1, wherein said second layer is joined to said first layer with the application of heat.

12. The method of claim 1, wherein said second layer is joined to said first layer with the use of solvents.

13. An expandable stent for implantation in a vessel, comprising:

a first layer formed of a first resorbable material selected to impart structural rigidity to said stent for maintaining patency of the vessel; and

second layer formed of a second resorbable material, superposed on and laminated to said first layer and selected to release a therapeutic drug at a predictable rate upon implantation;

said first layer and said second layer rolled up to form a cylinder for delivery to the site at which the stent is to be implanted; and

said stent providing a desired degree of structural support to said vessel, and releasing said drug at said predictable rate.

14. The stent of claim 13, wherein said material of said first layer further is selected to impart high tensile strength to said stent.

15. The stent of claim 13, wherein said first layer comprises poly-L-lactic acid.

16. The stent of claim 13, wherein said first layer comprises polyglycolic acid.

17. The stent of claim 13, wherein said second layer comprises poly-DL-lactic acid.

18. The stent of claim 13, wherein said second layer comprises polycaprolactone.

19. The stent of claim 13, wherein said stent is implantable in a lumen upstream from a cancerous growth and said second layer is selected to release a chemotherapeutic drug.

20. The stent of claim 13, wherein said second layer is selected to release heparin.

21. The stent of claim 20, wherein said second layer is selected to release angiopeptin, and said third layer is selected to release heparin.

22. The stent of claim 13, wherein a third layer of resorbable material is superposed on and laminated to said first layer and selected to release a therapeutic drug at a predictable rate therefrom, whereby upon implantation, said stent initially provides a desired degree of structural support to said vessel, releases said drugs at the predictable rates, and eventually is completely resorbed.

23. The stent of claim 22, wherein the drugs released by said second and said third layer are identical.

24. The stent of claim 22, wherein the drugs released by said second and said third layer are different.

25. The stent of claim 24, wherein said stent is implantable within a coronary artery, said second layer is superposed on and laminated to the outer side of said stent'"'"'s first layer and releases a drug that addresses restenosis, and said third layer is superposed on and laminated to the inner side of said stent'"'"'s first layer and releases a drug that addresses thrombosis.