Drug delivery medical device

• US 9,510,856 B2
• Filed: 07/16/2010
• Issued: 12/06/2016
• Est. Priority Date: 07/17/2008
• Status: Active Grant

• Current Assignee: Micell Medtech Incorporated
• Original Assignee: Micell Technologies Inc.
• Inventors: McClain, James B., Taylor, Charles Douglas, Neet, John, Zani, Brett G.
• Primary Examiner(s): FLICK, JASON E
• Application Number:
  US13/384,216
• Publication Number:
  US 20120172787A1
• Time in Patent Office: 2,335 Days
• Field of Search: 604/103.02, 604/103.1, 604 9601-109
• US Class Current: 1/1
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 2017/00893 pharmaceutically effective
• CPC Class Codes: A61B 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61B 2017/22061 for spreading elements apart
• CPC Class Codes: A61B 2017/22065 Functions of balloons dilating A61M29/02
• 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 2300/606 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: 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 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

Abstract

Provided is a coated implantable medical device, comprising: a substrate; and a coating disposed on the substrate, wherein the coating comprises at least one polymer and at least one pharmaceutical agent in a therapeutically desirable morphology and/or at least one active biological agent and optionally, one or more pharmaceutical carrying agents; wherein substantially all of pharmaceutical agent and/or active biological agent remains within the coating and on the substrate until the implantable device is deployed at an intervention site inside the body of a subject and wherein upon deployment of the medical device in the body of the subject a portion of the pharmaceutical agent and/or active biological agent is delivered at the intervention site along with at least a portion of the polymer and/or a at least a portion of the pharmaceutical carrying agents.

Claims

1. A medical device comprising:

a balloon comprising a tacking element formed on a balloon surface; and

a coating attached to at least the tacking element in a manner that allows the coating to detach from the tacking element upon inflation of the balloon in vivo,

the coating comprising an active agent and a polymer such that the active agent and polymer detach from the tacking element upon inflation of the balloon in vivo,

wherein the tacking element remains on the balloon surface when the balloon is inflated in vivo.

2. The medical device of claim 1 wherein the device releases at least 5% of the active agent in vivo.

3. The medical device of claim 1 wherein the device releases at least 10% of the active agent in vivo.

4. The medical device of claim 1 wherein in vivo measurement involves inflating the balloon inside the artery of a rabbit for about 1 minute and wherein the amount of active agent transferred to the artery is measured by UV-Vis.

5. The medical device of claim 1 wherein the device is adapted to free greater than 35% of the coating from the balloon upon a single stimulation of the coating.

6. The medical device of claim 1 wherein the device is adapted to dissociate greater than 35% of the coating from the balloon upon a single stimulation of the coating.

7. The medical device of claim 1 wherein the device is adapted to transfer greater than 35% of the coating from the balloon to an intervention site upon a single stimulation of the coating.

8. The medical device of claim 1 wherein the device is adapted to transfer greater than 35% of the coating from the balloon to an intervention site upon a single stimulation of the coating, wherein at least a portion of the coating is adapted to free from the balloon upon stimulation of the coating.

9. The medical device of claim 1 wherein at least a portion of the coating is adapted to dissociate from the balloon upon stimulation of the coating.

10. The medical device of claim 1 wherein at least a portion of the coating is adapted to transfer from the balloon to an intervention site upon stimulation of the coating.

11. The device of claim 1, wherein the balloon is a compliant balloon.

12. The device of claim 1, wherein the balloon is a semi-compliant balloon.

13. The device of claim 1, wherein the balloon is a non-compliant balloon.

14. The device of claim 1, wherein the balloon comprises a cylindrical portion.

15. The device of claim 1, wherein the balloon comprises a substantially spherical portion.

16. The device of claim 1, wherein the balloon comprises a complex shape.

17. The device of claim 16, wherein the complex shape comprises at least one of a double noded shape, a triple noded shape, a waisted shape, an hourglass shape, and a ribbed shape.

18. The device of claim 1, wherein the balloon conforms to a shape of the intervention site.

19. The device of claim 1, wherein the balloon comprises a cutting balloon.

20. The device of claim 1, wherein the tacking element comprises a wire.

21. The device of claim 20, wherein the wire is shaped in the form of an outward pointing wedge.

22. The device of claim 20, wherein the tacking element does not cut tissue at the intervention site.

23. The device of any of claim 1, wherein the device comprises at least a portion of a tool for performing a medical procedure.