Medical device for dispersing medicaments

• US 8,439,868 B2
• Filed: 05/19/2010
• Issued: 05/14/2013
• Est. Priority Date: 09/20/2002
• Status: Active Grant

• Current Assignee: Bayer Intellectual Property GmbH (Bayer AG)
• Original Assignee: Bayer Pharma AG (Bayer AG)
• Inventors: Speck, Ulrich, Scheller, Bruno
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US12/782,989
• Publication Number:
  US 20100228228A1
• Time in Patent Office: 1,091 Days
• Field of Search: 604/103.02, 623/1.11
• US Class Current: 604/103.02
• CPC Class Codes: A61L 2300/41 Anti-inflammatory agents, e.g. NSAIDs
• CPC Class Codes: A61L 2300/412 Tissue-regenerating or healing or proliferative agents
• 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 2300/43 Hormones, e.g. dexamethasone
• 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 31/08 Materials for coatings
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61M 2025/0057 Catheters delivering medicament other than through a conventional lumen, e.g. porous walls or hydrogel coatings
• CPC Class Codes: A61M 2025/1004 Balloons with folds, e.g. folded or multifolded
• CPC Class Codes: A61M 2025/1031 Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface
• 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 2025/1075 having a balloon composed of several layers, e.g. by coating or embedding
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• 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: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/1027 Making of balloon catheters
• CPC Class Codes: A61M 25/1038 Wrapping or folding devices for use with balloon catheters
• CPC Class Codes: A61M 25/104 : used for angioplasty
• 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 35/00 : Antineoplastic agents
• CPC Class Codes: A61P 39/06 : Free radical scavengers or antioxidants
• CPC Class Codes: A61P 9/00 : Drugs for disorders of the cardiovascular system

Abstract

The present disclosure relates to balloon catheter medical devices. Some balloon catheter medical devices may include a balloon surface having paclitaxel embedded in a low-molecular weight matrix substance adhered thereto and dried. The dried paclitaxel may be immediately releasable after coming into contact with tissue. Other balloon catheter medical devices may include a balloon surface having a lipophilic proliferation inhibitor, an inflammation inhibitor, or an antioxidant adhered thereto.

Claims

1. A balloon catheter medical device comprising:

a balloon surface having paclitaxel embedded in a low-molecular weight matrix substance adhered thereto and dried,

wherein the dried paclitaxel is immediately releasable after coming into contact with tissue.

2. The medical device according to claim 1, wherein said low-molecular weight matrix substance has a molecular weight of less than 5000 D and is selected from contrast agents and dyes used in vivo, sugars, sugar alcohols, low-molecular polyethylene glycols, and biocompatible organic and inorganic salts.

3. The medical device according to claim 1, wherein said low-molecular weight matrix substance is selected from iodinated X-ray contrast agents, paramagnetic chelates, indocyanine green, fluorescein, and methylene blue.

4. The medical device according to claim 1, wherein said low-molecular weight matrix substance is a readily water-soluble hydrophilic matrix substance.

5. The medical device according to claim 1, wherein the low-molecular weight matrix substance has a molecular weight of less than 5000 D.

6. The medical device according to claim 1, wherein the lowe-molecular weight matrix substance has a molecular weight of less than 2000 D.

7. The medical device according to claim 1, wherein said balloon catheter medical device further comprises a stent.

8. The medical device according to claim 1, wherein the balloon catheter medical device does not comprise a stent.

9. The medical device according to claim 1, wherein the balloon surface has preformed longitudinal folds maintaining an inclination to refold after inflation.

10. The medical device according to claim 9, wherein at least an area covered by the folds is covered with the paclitaxel.

11. The medical device according to claim 9, wherein only an area covered by the folds is covered with the paclitaxel.

12. The medical device according to claim 1, wherein the balloon surface consists of a very smooth material to which the paclitaxel embedded in the low-molecular weight matrix substance adheres sufficiently well to resist forces required for folding, essentially without damage.

13. The medical device according to claim 1, wherein the balloon surface is coated by immersion in a low-viscosity pacitaxel solution while in a fully folded condition.

14. The medical device according to claim 1, wherein the paclitaxel is present as a dry solid on the balloon surface.

15. The medical device according to claim 14, wherein an effective dose of the paclitaxel includes amorphous structures with particle sizes ranging from <

0.1 micron to 5 microns that dissolve quickly due to their large surface area and despite the poor water-solubility of the paclitaxel.

16. The medical device according to claim 1, wherein matrix the low-molecular weight matrix substance is hydrophilic.

17. The medical device according to claim 1, wherein the paclitaxel is applied to the balloon surface with said low-molecular weight matrix substance.

18. The medical device according to claim 1, wherein the balloon surface further comprises a substance that influences the gliding quality of the device or that prevents blood coagulation.

19. A balloon catheter medical device comprising:

a balloon surface having a lipophilic proliferation inhibitor, a lipophilic inflammation inhibitor, or a lipophilic antioxidant adhered thereto, wherein the lipophilic proliferation inhibitor, the lipophilic inflammation inhibitor, or the lipophilic antioxidant is embedded in a low-molecular weight matrix substance, applied thereon to the balloon surface and dried, and

wherein the dried lipophilic proliferation inhibitor, the dried lipophilic inflammation inhibitor, or the dried lipophilic antioxidant is immediately releasable after coming into contact with tissue.

20. The medical device according to claim 19, wherein said the lipophilic proliferation inhibitor, the lipophilic inflammation inhibitor, or the lipophilic antioxidant is selected from taxanes, Rapamycin, tacrolimus, corticoids, sexual hormones, statins, epothilones, probucol, prostacyclins, and angiogenesis inducers.