Drug releasing coatings for medical devices

• US 9,023,371 B2
• Filed: 03/18/2013
• Issued: 05/05/2015
• Est. Priority Date: 11/20/2006
• Status: Active Grant

• Current Assignee: Lutonix, Inc. (Becton, Dickinson & Co)
• Original Assignee: Lutonix, Inc. (Becton, Dickinson & Co)
• Inventors: Wang, Lixiao
• Primary Examiner(s): ZISKA, SUZANNE E
• Application Number:
  US13/846,089
• Publication Number:
  US 20130189329A1
• Time in Patent Office: 778 Days
• Field of Search: None
• US Class Current: 424/400
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/337 having four-membered rings, e.g. taxol
• 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: A61L 2300/416 Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
• CPC Class Codes: A61L 2300/80 characterised by a special chemical form
• CPC Class Codes: A61L 2300/802 Additives, excipients, e.g. cyclodextrins, fatty acids, surfactants
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61L 31/08 Materials for coatings
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence

Abstract

Medical device are provided for delivering a therapeutic agent to a tissue. The medical device has a layer overlying the exterior surface of the medical device. The layer contains a therapeutic agent and an additive. In certain embodiments, the additive has a hydrophilic part and a drug affinity part, wherein the drug affinity part is at least one of a hydrophobic part, a part that has an affinity to the therapeutic agent by hydrogen bonding, and a part that has an affinity to the therapeutic agent by van der Waals interactions. In embodiments, the additive is water-soluble. In further embodiments, the additive is at least one of a surfactant and a chemical compound, and the chemical compound has a molecular weight of from 80 to 750 or has more than four hydroxyl groups.

Claims

1. A medical device for delivering a therapeutic agent to a tissue, the medical device comprising a coating layer overlying an exterior surface of the medical device, the coating layer comprising a therapeutic agent and an additive, wherein:

the therapeutic agent is chosen from paclitaxel, rapamycin, and mixtures thereof; and

the additive is chosen from gluconolactone, glucoheptonolactone, glucooctanoic lactone, gulonic acid lactone, mannonic acid lactone, ribonic acid lactone, and combinations thereof.

2. The medical device of claim 1, wherein the tissue includes tissue of one of coronary vasculature, peripheral vasculature, cerebral vasculature, esophagus, airways, sinus, trachea, colon, biliary tract, urinary tract, prostate, and brain passages.

3. The medical device of claim 1, wherein the medical device is chosen from a balloon catheter, a perfusion balloon catheter, an infusion catheter, a cutting balloon catheter, a scoring balloon catheter, a laser catheter, an atherectomy device, a debulking catheter, a stent, a filter, a stent graft, a covered stent, a patch, a wire, and a valve.

4. The medical device of claim 1, wherein the therapeutic agent in the coating layer is in combination with a second therapeutic agent, and wherein the second therapeutic agent is chosen from beta-lapachone and biologically active vitamin D.

5. The medical device of claim 1, further comprising an adherent layer between the exterior surface of the medical device and the coating layer.

6. The medical device of claim 1, further comprising a top layer overlying the surface of the coating layer overlying the exterior surface of the medical device to reduce loss of drug during transit through a body to the tissue.

12. The medical device of claim 1, wherein the additive is gluconolactone.

13. The medical device of claim 1, wherein the additive is glucoheptonolactone.

14. The medical device of claim 1, wherein the additive is glucooctanoic lactone.

15. The medical device of claim 1, wherein the additive is gulonic acid lactone.

16. The medical device of claim 1, wherein the additive is mannonic acid lactone.

17. The medical device of claim 1, wherein the additive is ribonic acid lactone.

18. The medical device of claim 1, wherein the second additive is gluconolactone.

19. The medical device of claim 1, wherein:

the coating layer consists essentially of the therapeutic agent and the additive;

the therapeutic agent is paclitaxel;

the additive is gluconolactone.

20. The medical device of claim 1, wherein:

the coating layer consists of the therapeutic agent and the additive;

the therapeutic agent is paclitaxel;

the additive is gluconolactone.

7. A balloon catheter for delivering a therapeutic agent to a blood vessel, the catheter comprising:

an elongate member having a lumen and a distal end;

an expandable balloon attached to the distal end of the elongate member and in fluid communication with the lumen; and

a coating layer overlying an exterior surface of the balloon, the coating layer comprising a therapeutic agent and an additive,

wherein;

the therapeutic agent is chosen from paclitaxel, rapamycin, and mixtures thereof; and

the additive is chosen from gluconolactone, glucoheptonolactone, glucooctanoic lactone, gulonic acid lactone, mannonic acid lactone, ribonic acid lactone, and combinations thereof.

8. The balloon catheter of claim 7, wherein the additive comprises gluconolactone.

9. The balloon catheter of claim 7, wherein the additive is gluconolactone.

10. The balloon catheter of claim 7, wherein:

the coating layer consists essentially of the therapeutic agent and the additive;

the therapeutic agent is paclitaxel;

the additive is gluconolactone.

11. The balloon catheter of claim 7, wherein:

the coating layer consists of the therapeutic agent and the additive;

the therapeutic agent is paclitaxel;

the additive is gluconolactone.