Drug releasing coatings for medical devices

• US 8,998,847 B2
• Filed: 03/18/2013
• Issued: 04/07/2015
• 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:
  US13/846,163
• Publication Number:
  US 20130197436A1
• Time in Patent Office: 750 Days
• Field of Search: None
• US Class Current: 604/103.02
• 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: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61L 2300/216 with other specific functional groups, e.g. aldehydes, ketones, phenols, quaternary phosphonium groups
• 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 2300/428 Vitamins, e.g. tocopherol, riboflavin
• CPC Class Codes: A61L 2300/608 having two or more layers
• CPC Class Codes: A61L 2300/802 Additives, excipients, e.g. cyclodextrins, fatty acids, surfactants
• CPC Class Codes: A61L 2420/06 Coatings containing a mixture of two or more compounds
• CPC Class Codes: A61L 2420/08 Coatings comprising two or more layers
• CPC Class Codes: A61L 29/08 Materials for coatings
• CPC Class Codes: A61L 29/085 Macromolecular materials
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61L 29/18 Materials at least partially X-ray or laser opaque
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61L 31/18 Materials at least partially X-ray or laser opaque
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2210/1025 Respiratory system A61M2210/0618 take precedence
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61P 11/00 : Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 11/06 : Antiasthmatics
• CPC Class Codes: A61P 29/00 : Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 3/02 : Nutrients, e.g. vitamins, minerals
• CPC Class Codes: A61P 35/00 : Antineoplastic agents
• CPC Class Codes: A61P 37/06 : Immunosuppressants, e.g. drugs for graft rejection
• CPC Class Codes: A61P 7/02 : Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
• CPC Class Codes: A61P 9/00 : Drugs for disorders of the cardiovascular system

Abstract

Medical devices 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. The additive has a hydrophilic part and a hydrophobic part and the therapeutic agent is not enclosed in micelles or encapsulated in particles or controlled release carriers.

Claims

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

the therapeutic agent is one of paclitaxel, rapamycin, and combinations thereof;

the additive is an amino acid selected from the group consisting of alanine, asparagine, aspartic acid, cysteine, cystine, glycine, histidine, proline, isoleucine, leucine, methionine, phenylalanine, serine, threonine, tryptophan, tyrosine, valine, and combinations thereof.

2. The balloon catheter according to claim 1, wherein the amino acid is a low-solubility amino acid having a solubility in unbuffered water of less than 40 mg/mL, the low-solubility amino acid being selected from the group consisting of arginine, asparagine, aspartic acid, cysteine, cystine, glutamic acid, isoleucine, leucine, methionine, phenylalanine, tryptophan, tyrosine, and combinations thereof.

3. The balloon catheter according to claim 1, wherein the amino acid is proline.

4. The balloon catheter according to claim 1, wherein the therapeutic agent is paclitaxel and the amino acid is proline.

5. The balloon catheter according to claim 1, further comprising an adherent layer between the exterior surface of the balloon and the coating layer.

6. The balloon catheter according to claim 1, further comprising a top layer overlying the coating layer, wherein the top layer prevents loss of the therapeutic agent during transit through a body to a blood vessel.

7. The balloon catheter according to claim 1, further comprising a dimethylsulfoxide solvent layer, wherein the dimethylsulfoxide solvent layer is overlying the surface of the coating layer.

8. The balloon catheter according to claim 1, wherein the concentration of the therapeutic agent in the coating layer is from 1 to 20 μ

g/mm².

9. The balloon catheter according to claim 1, wherein the ratio by weight of the additive to the therapeutic agent in the coating layer is from about 0.1 to 5.

10. The balloon catheter according to claim 1, wherein the ratio by weight of the additive to the therapeutic agent in the coating layer is from about 0.5 to 2.

11. The balloon catheter according to claim 1, wherein the ratio by weight of the additive to the therapeutic agent in the coating layer is from about 0.8 to 1.2.

12. The balloon catheter according to 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.

13. The balloon catheter according to claim 1, wherein the coating layer does not include a polymer.

14. The balloon catheter according to claim 1, wherein the coating layer does not include oil, a lipid, or a polymer.