Implantable Medical Device with Drug Filled Holes

• US 20070219628A1
• Filed: 03/28/2007
• Published: 09/20/2007
• Est. Priority Date: 09/23/2002
• Status: Abandoned Application

• Current Assignee: Innovational Holdings, LLC (Johnson & Johnson)
• Original Assignee: Innovational Holdings, LLC (Johnson & Johnson)
• Inventors: Parker, Theodore, Shanley, John
• Application Number:
  US11/692,770
• Publication Number:
  US 20070219628A1
• Time in Patent Office: Days
• US Class Current: 623/1.420
• CPC Class Codes: A61F 2/2493 Transmyocardial revascularisation [TMR] devices
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/91541 Adjacent bands are arranged out of phase
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2250/003 differing in adsorbability or resorbability, i.e. in adsorption or resorption time
• CPC Class Codes: A61F 2250/0031 made from both resorbable and non-resorbable prosthetic parts, e.g. adjacent parts
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir
• 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 2300/604 Biodegradation
• CPC Class Codes: A61L 2300/608 having two or more layers
• 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

Abstract

The present invention relates to implantable medical devices for delivery of therapeutic agents, such as drugs, to a patient. More particularly, the invention relates to a device having therapeutic agents protected by a protective layer that prevents or retards processes that deactivate or degrade the active agents.

Claims

1. An implantable medical device comprising:

an implantable device body having a plurality of through holes therein;

a barrier formed in the plurality of through holes, the barrier formed of a biodegradable copolymer having a first copolymer ratio;

a drug filled portion formed in the plurality of through holes adjacent the barrier; and

a cap formed in the plurality of through holes adjacent the drug filled portion, the cap formed of the biodegradable copolymer having a second copolymer ratio wherein the second copolymer ratio is different from the first copolymer ratio.

2. The device of claim 1, wherein the implantable medical device is a stent.

3. The device of claim 2, wherein the drug filled portion comprises a drug for prevention of restenosis.

4. The device of claim 1, wherein the barrier, the drug filled portion, and the cap are formed by loading compositions dropwise into the through holes.

5. The device of claim 1, wherein the biodegradable copolymer is poly(lactide-co-glycolide).

6. The device of claim 5, wherein the first copolymer ratio is 85:

15.

7. The device of claim 5, wherein the second copolymer ratio is 50:

50.

8. The device of claim 1, wherein the first and second copolymer ratios are selected such that following implantation the cap degrades faster than the barrier.

9. The device of claim 2, wherein the barrier is formed adjacent a luminal surface of the stent and the cap degrades faster than the barrier.

10. The device of claim 1, wherein the drug filled portion includes a limus drug.

11. The device of claim 1, wherein the drug filled portion includes a water sensitive drug.

12. A method of forming an implantable medical device comprising:

forming an implantable device body having a plurality of through holes therein;

loading a mixture of a biodegradable copolymer having a first copolymer ratio and a first solvent into the holes and evaporating the first solvent to form a barrier;

loading a mixture of a drug, a polymer, and a second solvent into the holes and evaporating the second solvent to form a drug portion; and

loading a mixture of the biodegradable copolymer having a second copolymer ratio and a third solvent into the holes and evaporating the third solvent to form a cap wherein the second copolymer ratio is different from the first copolymer ratio.

13. The method of claim 12, wherein the first, second, and third solvents are the same.

14. The method of claim 12, wherein the implantable medical device is a stent.

15. The method of claim 12, wherein the drug comprises a drug for prevention of restenosis.

16. The method of claim 12, wherein the loading steps include loading the mixtures dropwise into the through holes.

17. The method of claim 12, wherein the biodegradable copolymer is poly(lactide-co-glycolide).

18. The method of claim 17, wherein the first copolymer ratio is 85:

15.

19. The method of claim 17, wherein the second copolymer ratio is 50:

50.

20. The method of claim 12, wherein the first and second copolymer ratios are selected such that following implantation the cap degrades faster than the barrier.

21. The method of claim 14, wherein the barrier is formed adjacent a luminal surface of the stent and the cap degrades faster than the barrier.

22. The method of claim 12, wherein the drug comprises a limus drug.

23. The method of claim 12, wherein the drug comprises a water sensitive drug.