COATINGS FOR IMPLANTABLE MEDICAL DEVICES

• US 20070212386A1
• Filed: 03/08/2007
• Published: 09/13/2007
• Est. Priority Date: 03/08/2006
• Status: Abandoned Application

• Current Assignee: Sahajanand Medical Technologies Pvt Ltd.
• Original Assignee: Sahajanand Medical Technologies Pvt Ltd.
• Inventors: Managoli, Nandkishore, Kotadia, Haresh D., Kotadia, Dhirajlal, Kothwala, Devesh M., Raval, Ankur J., Patravale, Vandana B., Doshi, Manish
• Application Number:
  US11/683,686
• Publication Number:
  US 20070212386A1
• Time in Patent Office: Days
• US Class Current: 424/422
• CPC Class Codes: A61K 31/337 having four-membered rings, e.g. taxol
• CPC Class Codes: A61K 31/352 condensed with carbocyclic rings, e.g. methantheline cannabinoids A61K31/658
• CPC Class Codes: A61K 31/353 3,4-Dihydrobenzopyrans, e.g. chroman, catechin
• CPC Class Codes: A61K 31/436 the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin
• CPC Class Codes: A61K 31/496 Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
• CPC Class Codes: A61K 31/7048 having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin , digitoxin or digoxin
• CPC Class Codes: A61K 31/727 Heparin; Heparan
• CPC Class Codes: A61K 47/6957 the form being a device or a kit, e.g. stents or microdevices
• 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 2300/604 Biodegradation
• CPC Class Codes: A61L 2300/608 having two or more layers
• CPC Class Codes: A61L 2300/61 containing two or more active agents in different layers
• CPC Class Codes: A61L 29/085 Macromolecular materials
• CPC Class Codes: A61L 29/126 having a macromolecular matrix
• CPC Class Codes: A61L 29/146 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 29/148 Materials at least partially resorbable by the body
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/129 containing macromolecular fillers
• CPC Class Codes: A61L 31/146 Porous materials, e.g. foams or sponges
• 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: A61L 33/08 : Polysaccharides
• CPC Class Codes: C08L 39/06 : Homopolymers or copolymers of N-vinyl-pyrrolidones
• CPC Class Codes: C08L 5/10 : Heparin; Derivatives thereof
• CPC Class Codes: C08L 67/04 : Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence

Abstract

An implantable medical device comprising an expandable balloon having an outer surface, a polymer coated on at least a portion of the outer surface of the balloon, and a pharmaceutically active agent dispersed within the polymer.

Claims

1. An implantable medical device, comprising:

an expandable balloon having an outer surface,

a polymer coated on at least a portion of the outer surface of the balloon,

a pharmaceutically active agent dispersed within the polymer.

2. The device of claim 1, wherein the polymer is biodegradable.

3. The device of claim 1, wherein the polymer is chosen from poly(l-lactide), racemic polylactide, poly(l-lactide-co-glycolide), racemic poly(l-lactide-co-glycolide), poly(l-lactide-co-caprolactone poly(d,l-lactide-co-caprolactone), poly(l-lactide-co-trimethylene carbonate) and poly(d,l-lactide-co-trimethylene carbonate).

4. The device of claim 1, wherein the at least one polymer is chosen from polylactides.

5. The device of claim 2, wherein the pharmaceutically active agent is chosen from heparin, flavonoids, paclitaxel and its analogs, rapamycin and its analogs and benzopyran-4-one compounds.

6. The device of claim 1, wherein the device is selected from catheters and intraluminal devices.

7. The device of claim 5, wherein the concentration of the pharmaceutically active agent based on the surface area of the stent ranges from 0.1 to about 5 μ

g/mm².

8. The device of claim 5, wherein the pharmaceutically active agent is a flavonoid selected from narigenin, naringin, eriodictyol, hesperetin, hesperidin (esperidine), kampferol, quercetin, rutin, cyanidol, meciadonol, catechin, epi-gallocatechin-gallate, taxifolin (dihydroquercetin), genistein, genistin, daidzein, biochanin, glycitein, chrysin, diosmin, luetolin, apigenin, tangeritin and nobiletin.

9. The device of claim 8 wherein the pharmaceutically active agent is genistein.

10. The device of claim 5 wherein the polymer is chosen from poly(l-lactide), racemic polylactide, poly(l-lactide-co-glycolide), racemic poly(l-lactide-co-glycolide), poly(l-lactide-co-caprolactone poly(d,l-lactide-co-caprolactone), poly(l-lactide-co-trimethylene carbonate) and poly(d,l-lactide-co-trimethylene carbonate).

11. The device of claim 10 wherein the polymer is a polylactide.

12. The device of claim 1 wherein the polymer contains an electrophilic group and the pharmaceutically active agent contains a nucleophilic group reactive with the electrophilic group to covalently bond the pharmaceutically active agent to the polymer.

13. Method of revascularizing a luminal passage in a subject comprising:

selecting a catheter having an expandable balloon,

coating the balloon with a selected polymer in which a selected pharmaceutically active agent is dispersed,

routing the catheter through a predetermined length of the luminal passage,

expanding the balloon at one or more selected positions along the predetermined length.

14. The method of claim 13 wherein the polymer is selected from poly(l-lactide), racemic polylactide, poly(l-lactide-co-glycolide), racemic poly(l-lactide-co-glycolide), poly(l-lactide-co-caprolactone poly(d,l-lactide-co-caprolactone), poly(l-lactide-co-trimethylene carbonate) and poly(d,l-lactide-co-trimethylene carbonate).

15. The method of claim 13 wherein the pharmaceutically active agent is selected from heparin, flavonoids, paclitaxel and its analogs, rapamycin and its analogs and benzopyran-4-one compounds.

16. The method of claim 15 wherein the pharmaceutically active agent is selected from heparin and genistein.

17. The method of claim 13 wherein the pharmaceutically active agent is covalently bonded to the polymer.