DRUG COATED BALLOON

• US 20170281912A1
• Filed: 03/22/2017
• Published: 10/05/2017
• Est. Priority Date: 04/04/2016
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Melder, Robert, Kantor, John
• Granted Patent: US 10,695,542 B2
• Time in Patent Office: Days
• CPC Class Codes: A61K 31/17 having the group >N—C(O)—N< or >N—C(S)—N<, e.g. urea, thiourea, carmustine isoureas, isothioureas A61K31/155; sulfonylureas A61K31/64
• CPC Class Codes: A61K 31/337 having four-membered rings, e.g. taxol
• 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 2300/608 having two or more layers
• CPC Class Codes: A61L 2300/802 Additives, excipients, e.g. cyclodextrins, fatty acids, surfactants
• CPC Class Codes: A61L 2420/08 Coatings comprising two or more layers
• 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: 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 2025/1081 having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths
• 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 25/1027 Making of balloon catheters
• CPC Class Codes: B05D 7/52 Two layers
• CPC Class Codes: C08L 5/08 Chitin; Chondroitin sulfate; Hyaluronic acid; Derivatives thereof

Abstract

A balloon catheter includes an inflatable balloon defining an inner and an outer surface. A first biocompatible layer that includes hyaluronic acid is releasably disposed on the outer surface of the balloon. A second drug containing layer is disposed on the first biocompatible layer. The second drug containing layer includes paclitaxel and urea.

Claims

1. :

A balloon catheter comprising;

an inflatable balloon defining an inner surface and an outer surface;

a first biocompatible layer comprising hyaluronic acid releasably disposed on the exterior surface of the balloon; and

a second drug containing layer disposed on the first biocompatible layer, the second drug containing layer comprising paclitaxel and urea.

2. :

A balloon catheter according to claim 1, wherein the paclitaxel and the urea together comprise 90% or more of the weight of the second drug containing layer.

3. :

A balloon catheter according to claim 1, wherein the second drug containing layer consists essentially of urea and paclitaxel.

4. :

A balloon catheter according to claim 1, wherein the first biocompatible layer comprises a sheet wrapped around the balloon.

5. :

A balloon catheter according to claim 4, wherein the sheet has a width substantially equal to the outer diameter of the balloon when the balloon is inflated.

6. :

A balloon catheter according claim 4, wherein the sheet defines a first edge and a second opposing edge along the width of the sheet, wherein the second edge extends beyond the first edge when the sheet is wrapped around the balloon when the balloon is uninflated.

7. :

A balloon catheter according to claim 4, further comprising a sheath disposed over the balloon to retain the sheet on the balloon.

8. :

A method comprising;

inserting a balloon of a balloon catheter into a vessel of a patient, the vessel comprising a vessel wall defining a vessel lumen, the balloon catheter comprising a first biocompatible layer comprising hyaluronic acid releasably disposed on the balloon, and a second drug containing layer disposed on the first biocompatible layer, the second drug containing layer comprising paclitaxel and urea;

inflating the balloon within the vessel to cause the second drug containing layer to contact tissue of the patient; and

deflating the balloon leaving the second drug containing layer and the first biocompatible layer in the vessel, wherein the second drug containing layer is in contact with the vessel wall and the first biocompatible layer and is disposed between the vessel wall and the first biocompatible layer.

9. :

A method according to claim 8, wherein the paclitaxel and the urea together comprise 90% or more of the weight of the second drug containing layer.

10. :

A method according to claim 8, wherein the second drug containing layer consists essentially of urea and paclitaxel.

11. :

A method according to claim 8, further comprising

advancing the balloon with a sheath disposed over the balloon to a target location within the vessel before inflating the balloon, and

retracting the sheath to expose the balloon after the balloon is advanced to the target location, wherein the sheath is retracted prior to inflating the balloon.

12. :

A method according to claim 11, wherein the first biocompatible layer comprises a sheet wrapped around the balloon prior to inflating the balloon and wherein the sheath retains the sheet on the balloon while the balloon is advanced to the target location of the vessel.

13. :

A method for coating a medical balloon, comprising;

disposing a layer comprising hyaluronic acid on an outer surface of the balloon; and

disposing a layer comprising paclitaxel and urea onto the layer comprising hyaluronic acid.

14. :

A method according to claim 13, wherein the layer comprising hyaluronic acid consists essentially of hyaluronic acid.

15. :

A method according to claim 13, wherein the paclitaxel and the urea together comprise 90% or more of the weight of the layer comprising paclitaxel and urea.

16. :

A method according to claim 13, wherein the layer comprising paclitaxel and urea consists essentially of paclitaxel and urea.

17. :

A method according to any one of claim 13, where the layer comprising paclitaxel and urea is disposed on the layer comprising hyaluronic acid prior to the layer comprising hyaluronic acid being disposed on the balloon.

18. :

A method according to any one of claim 13, wherein disposing the layer comprising hyaluronic acid on the balloon comprises wrapping a sheet comprising hyaluronic acid around the balloon in an uninflated state.

19. :

A method according to claim 18, wherein the sheet defines a first edge and a second opposing edge along the width of the sheet, wherein wrapping the sheet around the balloon comprises overlapping at least a portion of the sheet such that the second edge extends beyond the first edge.

20. :

A method according to claim 19, wherein the sheet has a width substantially equal to the outer diameter of the balloon when the balloon is inflated.