ANTI-RESTENOSIS DRUG COVERED AND ELUTING BALLOONS FOR VALVULOPLASTY OF AORTIC VALVE STENOSIS FOR THE PREVENTION OF RESTENOSIS

• US 20110021985A1
• Filed: 05/13/2008
• Published: 01/27/2011
• Est. Priority Date: 05/14/2007
• Status: Active Grant

• Current Assignee: Eurocor GmbH (Opto Circuits (India) Ltd.)
• Original Assignee: Eurocor GmbH (Opto Circuits (India) Ltd.)
• Inventors: Spargias, Konstantinos
• Granted Patent: US 8,187,223 B2
• Time in Patent Office: Days
• US Class Current: 604/96.01
• CPC Class Codes: A61B 2017/22098 Decalcification of valves
• 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 29/08 Materials for coatings
• 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 2025/1072 having balloons with two or more compartments
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

In one embodiment, balloons are intended for use in valvuloplasty of stenosed aortic valves, with a potential use for valvuloplasty of other heart valves as well. Their common special feature is that the entire or part of their external surface is covered by a drug that is eluted at the valve tissues during the balloon brief contact with them at the time of dilatation. The drug acts against the process of restenosis, which almost uniformly occurs after some time. The shape of the balloon can be the classical cylindrical or an hour-glass shape that facilitates targeted delivery of the drug at the valve tissues. Additional balloon shapes are described for usage after valvuloplasty is carried out in order to achieve targeted drug delivery in the upper or both surfaces of the leaflets, and for prolonged contact with the valve tissues without interruption of blood circulation. An advantage of the balloons is that the local delivery of the drug will significantly reduce the likelihood of restenosis. As a result the procedural benefits for the patient are sustained in the long term, and the procedure from alleviating progresses into end-therapy.

Claims

1. A balloon for use in valvuloplasty comprising a catheter having two lumens running through its entire shaft and reaching to its external end that remains outside of the patient'"'"'s body:

wherein one lumen is used for the inflation of the balloon that is mounted to the other end of the catheter, and the other lumen is used for passing the guide-wire over which the balloon is advanced from the entry site to the application site;

wherein a drug against restenosis coats a portion of the external surface of the balloon; and

wherein the antirestenotic drug is delivered from the external surface of the balloon to the aortic valve tissues during the inflation of the balloon in performing valvuloplasty.

2. The balloon of claim 1, wherein the entire external balloon surface is coated with the antirestenotic drug.

3. The balloon of claim 1, wherein the external balloon surface is partially coated with the antirestenotic drug at the level of its middle segment that contacts the aortic valve tissues upon inflation;

and wherein the other balloon surfaces at its both ends remain uncoated with the antirestenotic drug.

4. The balloon of claim 1, wherein the balloon has a shape of an hour-glass shape when inflated with its waist having a smaller diameter than that of its ends;

and wherein only the surfaces of the middle segment of this balloon are coated with the antirestenotic drug.

5. The balloon of claim 4, wherein the waist has a crease shape.

6. The balloon of claim 4, wherein the waist has a concave shape.

7. The balloon of claim 1, wherein a distal end surface of the balloon has a shape that is the relief of the upper surfaces of the aortic valve leaflets;

and wherein the distal end is coated with the antirestenotic drug.

8. The balloon of claim 7, wherein the distal end surface that comes in contact with the upper surfaces of the aortic valve comprises tiny microholes/pores;

wherein the microholes/pores allow, during use, the exit of an inflating solution when the balloon is expanded; and

wherein the inflating solution comprises the antirestenotic drug that soaks the upper surfaces of the aortic leaflets.

9. The balloon of claim 5, wherein the waist is has a shape such that, when it is inflated, the waist forms an envelope in which the aortic valve leaflets are captured during use;

and wherein the surfaces of the envelope are coated with the antirestenotic drug that is delivered this way to both upper and lower surfaces of the aortic valve, which are inserted within.

10. The balloon of claim 9, wherein the surfaces that form the waist comprise microscopic holes/pores;

wherein the microholes/pores allow the exit of an inflating solution when the balloon is expanded; and

wherein the inflation solution comprises the antirestenotic drug that soaks both the upper and lower surfaces of the aortic leaflets.

11. The balloon of claim 9, wherein the waist reaches a central lumen of the system and separates completely the two spaces on its sides such that the two spaces do not communicate and the two spaces are inflated by two separate lumens.

12. The balloon of claim 9, comprising a hollow center along its long axis that, when the balloon is inflated, is expanded and creates a central cylindrical lumen.

13. The balloon of claim 1, wherein the balloon is designed for use in aortic valve stenosis.