Biodegradable vascular device with buffering agent

• US 20050278015A1
• Filed: 05/28/2004
• Published: 12/15/2005
• Est. Priority Date: 05/28/2004
• Status: Active Grant

• Current Assignee: Cardinal Health Switzerland 515 GmbH (Cardinal Health, Inc.)
• Original Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Inventors: Dave, Vipul Bhupendra, Landau, George, Patel, Premal
• Granted Patent: US 7,803,182 B2
• Time in Patent Office: Days
• US Class Current: 623/1.380
• CPC Class Codes: A61L 2300/604 Biodegradation
• CPC Class Codes: A61L 31/129 containing macromolecular fillers
• 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

A vascular or cardiovascular medical device for placement at a site in a patient'"'"'s body and for controlling pH levels at the site in the patient'"'"'s body includes one or more structural components made of a biodegradable and/or bioabsorbable material, or alternatively, a coating thereon made of a biodegradable and/or bioabsorbable material. A buffering agent is provided on or in the biodegradable and/or bioabsorbable material and the buffering agent is dispersed from the biodegradable and/or bioabsorbable material in response to hydrolysis of the biodegradable and/or bioabsorbable material. Additionally, the vascular or cardiovascular medical device can include a drug that is included with the biodegradable and/or bioabsorbable material. The vascular or cardiovascular medical device can also be a stent or a valve.

Claims

1. A vascular or cardiovascular medical device for placement at a site in a patient'"'"'s body and for controlling pH levels at the site in the patient'"'"'s body, the device comprising:

one or more structural components made of a biodegradable and/or bioabsorbable material; and

a buffering agent on or in the biodegradable and/or bioabsorbable material, the buffering agent being dispersed from the biodegradable and/or bioabsorbable material in response to hydrolysis of the biodegradable and/or bioabsorbable material.

2. The vascular or cardiovascular medical device according to claim 1, wherein the biodegradable and/or bioabsorbable material is a bulk erodible polymer that is either a homopolymer, a copolymer or a blend of polymers.

3. The vascular or cardiovascular medical device according to claim 2, wherein the bulk erodible polymer is a polyester.

4. The vascular or cardiovascular medical device according to claim 3, wherein the polyester belongs to the poly(alpha-hydroxy acids) group.

5. The vascular or cardiovascular medical device according to claim 4, wherein the polyester is an aliphatic polyester.

6. The vascular or cardiovascular medical device according to claim 5, wherein the aliphatic polyester is selected from the group consisting of poly(lactic acid), poly(glycolic acid), poly(caprolactone), poly(p-dioxanone) and poly (trimethylene carbonate).

7. The vascular or cardiovascular medical device according to claim 2, wherein the bulk erodible polymer is an amino acid derived polymer selected from the group consisting of poly(iminocarbonates), phosphorous containing polymers, poly(phosphazenes), poly (phosphoesters) and poly (ester amide).

8. The vascular or cardiovascular medical device according to claim 1, further comprising a drug with the biodegradable and/or bioabsorbable material.

9. The vascular or cardiovascular medical device according to claim 1, wherein the buffering agent is selected from the group consisting of calcium hydroxyapatite, carbonated apatite, tricalcium phosphate, calcium carbonate, sodium bicarbonate, calcium phosphates, carbonated calcium phosphates, magnesium hydroxide, amine monomers, and lactate dehydrogenase.

10. The vascular or cardiovascular medical device according to claim 1, wherein the buffering agent is dispersed from the biodegradable and/or bioabsorbable material at pH<

7.4.

11. The vascular or cardiovascular medical device according to claim 10, wherein the buffering agent is dispersed from the biodegradable and/or bioabsorbable material at pH ranging from about 3 to about 6.

12. The vascular or cardiovascular medical device according to claim 11, wherein the buffering agent is dispersed from the biodegradable and/or bioabsorbable material at pH of about 5.

13. The vascular or cardiovascular medical device according to claim 10, wherein the buffering agent raises pH at the site after being dispersed from the biodegradable and/or bioabsorbable material.

14. The vascular or cardiovascular medical device according to claim 13, wherein the buffering agent raises pH to about 7.4 at the site after being dispersed from the biodegradable and/or bioabsorbable material.

15. The vascular or cardiovascular medical device according to claim 1, wherein the device is a stent.

16. The vascular or cardiovascular medical device according to claim 1, wherein the device is a valve.

17. A vascular or cardiovascular medical device for placement at a site in a patient'"'"'s body and for controlling pH levels at the site in the patient'"'"'s body, the device comprising:

one or more structural components having a coating thereon, the coating made of a biodegradable and/or bioabsorbable material; and

a buffering agent on or in the coating of the biodegradable and/or bioabsorbable material, the buffering agent being dispersed from the coating on the biodegradable and/or bioabsorbable material in response to hydrolysis of the biodegradable and/or bioabsorbable material.

18. The vascular or cardiovascular medical device according to claim 17, wherein the biodegradable and/or bioabsorbable material is a bulk erodible polymer that is either a homopolymer, a copolymer or a blend of polymers.

19. The vascular or cardiovascular medical device according to claim 18, wherein the bulk erodible polymer is a polyester.

20. The vascular or cardiovascular medical device according to claim 19, wherein the polyester belongs to the poly(alpha-hydroxy acids) group.

21. The vascular or cardiovascular medical device according to claim 20, wherein the polyester is an aliphatic polyester.

22. The vascular or cardiovascular medical device according to claim 21, wherein the aliphatic polyester is selected from the group consisting of poly (lactic acid), poly (glycolic acid), poly (caprolactone), poly (p-dioxanone) and poly (trimethylene carbonate).

23. The vascular or cardiovascular medical device according to claim 18, wherein the bulk erodible polymer is an amino acid derived polymer selected from the group consisting of poly(iminocarbonates), phosphorous containing polymers, poly(phosphazenes), poly (phosphoesters) and poly (ester amide).

24. The vascular or cardiovascular medical device according to claim 17, further comprising a drug with the biodegradable and/or bioabsorbable material.

25. The vascular or cardiovascular medical device according to claim 17, wherein the buffering agent is selected from the group consisting of calcium hydroxyapatite, carbonated apatite, tricalcium phosphate, calcium carbonate, sodium bicarbonate, calcium phosphates, carbonated calcium phosphates, magnesium hydroxide, amine monomers, and lactate dehydrogenase.

26. The vascular or cardiovascular medical device according to claim 17, wherein the buffering agent is dispersed from the biodegradable and/or bioabsorbable material at pH<

7.4.

27. The vascular or cardiovascular medical device according to claim 26, wherein the buffering agent is dispersed from the biodegradable and/or bioabsorbable material at pH ranging from about 3 to about 6.

28. The vascular or cardiovascular medical device according to claim 27, wherein the buffering agent is dispersed from the biodegradable and/or bioabsorbable material at pH of about 5.

29. The vascular or cardiovascular medical device according to claim 26, wherein the buffering agent raises pH at the site after being dispersed from the biodegradable and/or bioabsorbable material.

30. The vascular or cardiovascular medical device according to claim 29, wherein the buffering agent raises pH to about 7.4 at the site after being dispersed from the biodegradable and/or bioabsorbable material.

31. The vascular or cardiovascular medical device according to claim 17, wherein the device is a stent.

32. The vascular or cardiovascular medical device according to claim 17, wherein the device is a valve.