DRUG ELUTING SCULPTING BALLOON

• US 20140058358A1
• Filed: 11/04/2013
• Published: 02/27/2014
• Est. Priority Date: 12/12/2011
• Status: Active Grant

• Current Assignee: Kassab Kughn Endovascular Devices, LLC
• Original Assignee: Kassab Kughn Endovascular Devices, LLC
• Inventors: KASSAB, Elias H.
• Granted Patent: US 8,882,790 B2
• Time in Patent Office: Days
• US Class Current: 604/509
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 2017/22061 for spreading elements apart
• CPC Class Codes: A61L 29/00 Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters shape or structure of catheters A61M25/00
• 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 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 2025/109 having balloons for removing solid matters, e.g. by grasping or scraping plaque, thrombus or other matters that obstruct the flow
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A plaque-modifying balloon and method for use in an endovascular procedure includes an elongated balloon that defines a longitudinal axis and is inflatable from a first deflated configuration to a second radially expanded configuration. One or more plaque-modifying elements are mounted on the outside of the inflatable balloon. Optionally, a compressible sheath made of a relatively low durometer, flexible material is mounted on the balloon to cover the elements during transit of the plaque-modifying balloon to and from the treatment site.

Claims

1. -23. (canceled)

24. A plaque-modifying catheter system comprising:

a catheter having a proximal end, a distal end and an intermediate section therebetween;

an inner lumen between the proximal and distal ends through which a medical device or fluid may pass without interruption or interference;

an expandable balloon located between the proximal and distal ends of the catheter and circumscribing at least the intermediate section of the catheter, the balloon receiving a pressurizing fluid between the catheter and the balloon which causes the balloon to inflate, the balloon having an outer surface;

an assembly of plaque-modifying elements mounted on at least a part of the outer surface of the balloon, wherein the plaque-modifying elements are separated from each other before, during, and after balloon expansion, thereby creating an array of weakened areas in a vessel wall when the plaque-modifying elements are urged into contact with the vessel wall by the pressurizing fluid inflating the balloon and the plaque-modifying elements impinging on the vessel wall, thereby fracturing hardened tissue and creating the weakened areas therein, at least some of the plaque-modifying elements having a tip situated atop a plaque-modifying element, the tip having a cross section geometry selected from the group consisting of an oval, a circle, a dome, an ellipse, an “

x”

shape, a star shape and a “

y”

shape; and

a drug bonded to the outer surface of the balloon that is by contiguity between the expandable balloon and the vessel wall eluted into the vessel wall.

25. The plaque-modifying catheter system of claim 24 wherein the drug is lipophilic.

26. The plaque-modifying catheter system of claim 24 wherein the drug reacts within 60 seconds with the vessel wall.

27. The plaque-modifying catheter system of claim 24 wherein some plaque-modifying elements include microchannels through which the drug is delivered to the vessel wall.

28. The plaque-modifying catheter system of claim 24 wherein drug delivery occurs before, during and/or after fracture of a stenosed region.

29. The plaque-modifying catheter system of claim 24, further including:

a retractable sheath that at least partially covers the plaque-modifying elements as the catheter system is maneuvered through a tortuous vasculature, the sheath being retracted to expose at least a part of the plaque-modifying assembly when the assembly is juxtaposed with a site to be treated, and is repositioned to cover the plaque-modifying assembly before the catheter system is withdrawn.

30. The plaque-modifying catheter system of claim 24, wherein:

the assembly of plaque-modifying elements is normally in a radially collapsed configuration and displaceable outwardly to a radially expanded configuration, the assembly returning to its radially collapsed configuration when the balloon is deflated;

the plaque-modifying elements bring adapted to crack hardened stenotic material when the balloon is expanded in a blood vessel lumen; and

at least some of the one or more plaque-modifying elements are disposed proximate a distal end region of the catheter, the balloon being at least partially covered by a sheath that extends over the elements as the balloon is inflated and deflated.

33. The plaque-modifying balloon of claim 24, further comprising mounting pads positioned between the outer surface of the balloon and the plaque-modifying elements for attaching the plaque-modifying elements to the balloon.

34. The plaque-modifying balloon of claim 24 wherein a tip of a plaque-modifying element extends a radial distance (X) from the outer surface of said balloon and said balloon inflates by a radial distance (x) where X>

x.

35. The plaque-modifying balloon as recited in claim 34 wherein the distance (X) that characterizes plaque-modifying elements closer to the distal end of the balloon is less than the distance (X) that characterizes plaque-modifying elements closer to the proximal end of the balloon to facilitate insertion of the catheter system into the vasculature.

36. The plaque-modifying balloon of claim 24 wherein the balloon covers approximately a distal third of the length of the catheter.

37. The plaque-modifying balloon of claim 24 further including means for delivering, maintaining and removing a pressurizing fluid to a chamber located between an inside surface of the balloon and an outside surface of the catheter.

38. The plaque-modifying balloon of claim 24 further including a radio-opaque tip located at the distal end of the balloon.

39. The plaque-modifying balloon of claim 24 further including a pressurizing fluid comprising a saline solution mixed with an x-ray contrast material.

40. The plaque-modifying balloon of claim 24 wherein the plaque-modifying elements are aligned in longitudinally oriented rows on an outside surface of the balloon.

41. The plaque-modifying balloon of claim 24 wherein the plaque-modifying elements are aligned in laterally oriented rows on an outside surface of the balloon.

42. The plaque-modifying balloon of claim 24 wherein the plaque-modifying elements are staggered so that an element in a row lies between adjacent elements in a neighboring lateral row.

31. A method for treating a stenosed region in a blood vessel, the method having steps including:

positioning and expanding an inflatable balloon that carries on its outside surface a drug and supports an assembly of plaque-modifying elements to radially outwardly displace the plaque-modifying elements within the stenosed region, the assembly extending from an outer surface of the balloon, the plaque-modifying elements being disposed between the balloon and the stenosed region,

imparting a modified pattern by the plaque-modifying elements in the stenotic material associated with an inner wall of the blood vessel as the balloon assumes an expanded state and elutes the drug to the inner wall of the blood vessel; and

radially contracting the balloon so that the plaque-modifying assembly lies in folds of the balloon as the balloon is withdrawn.

32. A method for dilating a stenosed region in a blood vessel, said method comprising:

expanding an assembly of plaque-modifying elements to radially displace the elements outwardly within a stenosed region of the blood vessel;

wherein the elements are disposed between an expansible balloon and the stenosed region and expanding the balloon causes the elements to modify the stenotic material to create an impression in or fracture the stenotic material about the inner wall of the blood vessel as the balloon is in an expanded state;

delivering a drug from the outside of the balloon to the stenosed region; and

radially contracting the balloon.