DRUG COATED INFLATABLE BALLOON HAVING A THERMAL DEPENDENT RELEASE LAYER

• US 20170312484A1
• Filed: 04/28/2016
• Published: 11/02/2017
• Est. Priority Date: 04/28/2016
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Shipley, Adam, Le, Tony, Radhakrishnan, Rajesh, Morgan, Terry
• Granted Patent: US 11,147,952 B2
• Time in Patent Office: Days
• 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 2420/02 Methods for coating medical devices
• 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 2025/1075 having a balloon composed of several layers, e.g. by coating or embedding
• CPC Class Codes: A61M 2205/0238 the material being a coating or protective layer
• CPC Class Codes: A61M 2205/36 related to heating or cooling
• CPC Class Codes: A61M 2207/00 Methods of manufacture, assembly or production
• 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 25/104 used for angioplasty

Abstract

A medical device includes an inflatable balloon defining an interior surface and an exterior surface, and a coating including a therapeutic agent disposed on the exterior surface of the inflatable balloon. The coating has a release transition temperature within a range from about 25° C. to about 50° C. When the temperature of the coating is below the release transition temperature, the coating retains at least a portion of the therapeutic agent on the exterior of the inflatable balloon. When the temperature of the coating is above the release transition temperature, the coating releases at least a portion of the therapeutic agent from the exterior of the inflatable balloon.

Claims

1. A medical device comprising:

an inflatable balloon defining an interior surface and an exterior surface, the interior surface defining an interior space; and

a coating disposed on the exterior surface of the inflatable balloon, the coating comprising a therapeutic agent,

wherein the coating has a release transition temperature within a range of about 25°

C. to about 50°

C.,

wherein, when the temperature of the coating is below the release transition temperature, at least a portion of the therapeutic agent is retained in the coating, and

wherein, when the temperature of the coating is above the release transition temperature, at least a portion of the therapeutic agent is released from the coating.

2. The medical device of claim 1, wherein the coating comprises a first layer disposed on the exterior surface of the inflatable balloon and a second layer disposed on the first layer, wherein the second layer comprises the therapeutic agent.

3. The medical device of claim 1, wherein the coating comprises a first layer disposed on the exterior surface of the inflatable balloon and a second layer disposed on the first layer, wherein the first layer comprises the therapeutic agent.

4. The medical device of claim 1, wherein the coating comprises a polymer, and wherein the therapeutic agent and the polymer are intermixed in a layer disposed on the exterior surface of the inflatable balloon.

5. The medical device of claim 1, wherein the coating has a release transition temperature for the therapeutic agent within a range of about 37°

C. to about 50°

C.

6. The medical device of claim 1, wherein the coating has a release transition temperature for the therapeutic agent within a range of about 39°

C. to about 50°

C.

7. The medical device of claim 1, wherein the coating comprises a temperature-responsive hydrogel.

8. The medical device of claim 1, wherein the coating comprises poly(N-isopropylacrylamide), poly(N′

N;

-diethylacrylamide), an N-isopropylacrylamide copolymer, an N′

N;

-diethylacrylamide copolymer, or combinations thereof.

9. The medical device of claim 1, wherein the therapeutic agent comprises paclitaxel.

10. The medical device of claim 9, wherein the coating further comprises urea.

11. The medical device of claim 1, further comprising a catheter comprising a lumen in fluid communication with the interior space of the inflatable balloon.

12. The medical device of claim 1, further comprising a heating element configured to actively heat the coating to a temperature above the release transition temperature.

13. A method comprising:

providing a medical device comprising;

an inflatable balloon defining an interior surface and an exterior surface, the interior surface defining an interior space; and

a coating disposed on the exterior surface of the inflatable balloon, the coating comprising a therapeutic agent,

wherein the coating has a release transition temperature within a range of about 25°

C. to about 50°

C.,

wherein, when the temperature of the coating is below the release transition temperature, at least a portion of the therapeutic agent is retained in the coating, and

wherein, when the temperature of the coating is above the release transition temperature, at least a portion of the therapeutic agent is released from the coating;

inserting the inflatable balloon to a target location of a patient;

inflating the inflatable balloon by introducing a fluid into the interior space of the inflatable balloon; and

heating the coating disposed on the inflatable balloon to a temperature above the release transition temperature,

wherein inflating the inflatable balloon causes the inflatable balloon to expand against tissue of the patient to transfer the therapeutic agent to the tissue.

14. The method of claim 13, wherein introducing the fluid into the interior space of the inflatable balloon comprises introducing fluid having a temperature at or greater than the release transition temperature of the coating, and wherein heating the coating comprises introducing the fluid into the interior space of the inflatable balloon.

15. The method of claim 14, wherein the fluid introduced into the interior space of the inflatable balloon has a temperature of 2°

C. or more above the release transition temperature of the coating.

16. The method of claim 13, wherein heating the coating comprises heating a heating element in thermal communication with the coating.

17. A method for coating an inflatable balloon of a medical device, comprising:

applying a coating to an exterior surface of the inflatable balloon, wherein the coating comprises a therapeutic agent and a temperature-responsive polymer and wherein the coating has a release transition temperature within a range of about 25°

C. to about 50°

C.

18. The method of claim 17, wherein applying the coating comprises applying a composition comprising the polymer on the exterior surface of the inflatable balloon to form a first layer and applying a composition comprising the therapeutic agent on the first layer to form a second layer disposed on the first layer.

19. The method of claim 17, wherein applying the coating comprises applying a composition comprising the therapeutic agent on the exterior surface of the inflatable balloon to form a first layer and applying a composition comprising the polymer on the first layer to form a second layer disposed on the first layer.

20. The method of claim 17, wherein applying the coating comprises applying to the exterior surface of the inflatable balloon a composition comprising the therapeutic agent and the polymer.