Catheter assembly with plaque cutting balloon

• US 20060149308A1
• Filed: 12/28/2005
• Published: 07/06/2006
• Est. Priority Date: 12/30/2004
• Status: Active Grant

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated)
• Inventors: Melsheimer, Jeffry S., Burton, David G.
• Granted Patent: US 7,303,572 B2
• Time in Patent Office: Days
• US Class Current: 606/192
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• 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: A61M 2025/1031 Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface
• 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 25/1027 Making of balloon catheters
• CPC Class Codes: A61M 25/1038 Wrapping or folding devices for use with balloon catheters
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A balloon catheter assembly comprises an elongate catheter shaft having a proximal portion and a distal portion, and an inflatable balloon secured to the shaft distal portion. A plurality of cutters are arranged along an outer surface of the balloon. The cutters are shielded by folds of the balloon when the balloon is uninflated, and are arranged and configured to facilitate breakdown of a vascular restriction when said balloon is inflated. Preferably, the cutters are arranged in at least three generally parallel longitudinal rows along the balloon outer surface, and there are at least three longitudinally-aligned cutters in each row. Preferably, the cutters are formed of the same or a similar base composition as the balloon, and are bonded to the balloon outer surface.

Claims

1. A balloon catheter assembly, comprising:

an elongate catheter shaft having a proximal portion and a distal portion;

an inflatable balloon secured to said distal portion of said catheter shaft; and

a plurality of cutters disposed along an outer surface of the balloon, said cutters being shielded by folds of the balloon when said balloon is in an uninflated condition, and being arranged and configured to facilitate breakdown of a vascular restriction when said balloon is in an inflated condition, said cutters being fixedly engaged with said outer surface of said balloon.

2. The balloon catheter assembly of claim 1, wherein at least some of said cutters are disposed in respective generally parallel longitudinal rows along said balloon outer surface.

3. The balloon catheter assembly of claim 2, wherein said cutters are disposed in at least three generally parallel longitudinal rows along said balloon outer surface.

4. The balloon catheter assembly of claim 2, wherein said cutters are disposed in four generally parallel longitudinal rows along said balloon outer surface, said rows being spaced at substantially 90 degree intervals along said outer surface.

5. The balloon catheter assembly of claim 3, wherein each row includes at least three longitudinally-aligned cutters.

6. The balloon catheter assembly of claim 5, wherein said cutters are substantially equally spaced along said row.

7. The balloon catheter assembly of claim 3, wherein said cutters include a base portion in fixed engagement with said balloon outer surface.

8. The balloon catheter assembly of claim 7, wherein said base portion comprises two base segments engaged with said balloon outer surface, said cutters further comprising a respective converging body portion extending radially from each of said base segments, said respective converging body portions configured and aligned to meet to define a cutting edge.

9. The balloon catheter assembly of claim 8, wherein said cutting edges have an elongated cutting surface and have a curved surface at an axial edge of said cutting surface.

10. The balloon catheter assembly of claim 3, wherein said balloon comprises a polymer, said polymer selected from the group consisting of polyamides, polyethylene terephthalate, polyether block amides, and blends of the foregoing.

11. The balloon catheter assembly of claim 1, wherein said elongate catheter has a lumen longitudinally extending therein, an interior space of said balloon being in fluid communication with said lumen for receiving an inflation fluid therefrom.

12. The balloon catheter assembly of claim 3, wherein said cutters are formed from the same polymer as the balloon, and said cutters are heat bonded to said balloon outer surface.

13. The balloon catheter assembly of claim 4, wherein said balloon comprises a polymer selected from the group consisting of polyamides, polyethylene terephthalate, polyether block amides, and blends of the foregoing, and said cutter comprises a polymer capable of fixed engagement with the outer surface of said balloon by heat bonding, each of said cutter rows including at least three longitudinally-aligned cutters substantially equally spaced along said row.

14. The balloon catheter assembly of claim 3, wherein said balloon comprises a noncompliant balloon having a generally cylindrical configuration upon inflation.

15. A method for breaking down a restriction in a blood vessel of a patient, comprising:

providing a balloon catheter assembly for insertion into said vessel, said balloon catheter assembly comprising an elongate catheter shaft and an inflatable balloon secured to a distal portion of said catheter shaft, said balloon having a plurality of cutters fixedly disposed in respective generally parallel longitudinal rows along an outer surface of said balloon, said cutters being shielded by folds of the balloon when said balloon is in an uninflated condition, and being arranged and configured to facilitate a breakdown of said restriction when said balloon is in an inflated condition;

inserting the distal end of the balloon catheter assembly into said vessel, and advancing the assembly in the vessel with the balloon in an uninflated condition until said uninflated balloon reaches said restriction;

inflating the balloon such that said cutters penetrate said restriction;

deflating said balloon; and

withdrawing said balloon catheter assembly from said vessel.

16. The method of claim 15, wherein said cutters are disposed in at least three generally parallel longitudinal rows along said balloon outer surface, each of said rows comprising at least three cutters, said rows being spaced at substantially equal intervals along said outer surface.

17. The method of claim 15, wherein said inflating and deflating steps are repeated at least one additional time prior to withdrawing the balloon catheter assembly from the vessel.

18. The method of claim 17, wherein said assembly is rotated prior to said at least one additional step of inflating and deflating.

19. The method of claim 15, wherein said assembly is inserted into the vessel utilizing the Seldinger technique.

20. The method of claim 15, wherein said balloon and said cutters are formed from a polymer, and said cutters are heat bonded to said balloon outer surface.