Catheter system with balloon-mounted plaque-modifying elements

• US 8,574,248 B2
• Filed: 12/12/2011
• Issued: 11/05/2013
• Est. Priority Date: 12/12/2011
• Status: Expired due to Fees

• Current Assignee: Kassab Kughn Endovascular Devices, LLC
• Original Assignee: Kassab Kaghn Endovascular Devices LLC
• Inventors: Kassab, Elias H.
• Primary Examiner(s): Nguyen, Victor
• Application Number:
  US13/323,156
• Publication Number:
  US 20130150874A1
• Time in Patent Office: 694 Days
• Field of Search: 606/159, 606/170, 606/194, 606/195, 606/192, 604/22, 604/96.01
• US Class Current: 606/159
• 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. 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; and

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 outer surface of 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.

2. The plaque-modifying catheter system of claim 1, 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.

3. The plaque-modifying catheter system of claim 1, wherein:

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

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

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