Intravascular catheter having an expandable incising portion

• US 10,485,572 B2
• Filed: 04/07/2017
• Issued: 11/26/2019
• Est. Priority Date: 09/13/2011
• Status: Active Grant

• Current Assignee: VentureMed Group, Inc.
• Original Assignee: John P. Pigott
• Inventors: Pigott, John P.
• Primary Examiner(s): Templeton, Christopher L
• Assistant Examiner(s): Igboko, Chima U
• Application Number:
  US15/481,552
• Publication Number:
  US 20170209169A1
• Time in Patent Office: 963 Days
• Field of Search: 606159, 606167, 606170
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 17/32075 Pullback cutting; combined forward and pullback cutting, e.g. with cutters at both sides of the plaque
• CPC Class Codes: A61B 17/3209 Incision instruments
• CPC Class Codes: A61B 2017/00986 Malecots, e.g. slotted tubes, of which the distal end is pulled to deflect side struts

Abstract

An intravascular device is provided having a catheter tube with an expandable portion located on an end thereof. The expandable portion includes a plurality of struts capable of being moved between an open and a closed position. An incising element is provided along at least a portion of one of the struts and has a sharpened edge for creating an incision in atherosclerotic material located within a blood vessel when the expandable portion is in the opened position.

Claims

1. An intravascular catheter device for the treatment of atherosclerotic material located within a blood vessel comprising:

a flexible catheter tube;

an expandable portion secured to a distal end of said catheter tube and comprising a plurality of struts each defining an outward facing surface, the expandable portion being operable between a closed position, wherein the expandable portion has a first diameter, and an opened position, wherein the expandable portion has a second diameter that is larger than the first diameter;

an inner sleeve disposed within the catheter tube wherein said inner sleeve is supported for sliding movement within the catheter tube and is configured to accommodate a guide wire;

an incising member provided on, and extending from, at least a portion of the outward facing surface of at least one of the struts, the incising member having a sharpened edge located along an upper edge thereof, wherein said sharpened edge extends in parallel with a longitudinal axis of the expandable portion when the expandable portion is in the closed position; and

a tip member attached to the inner sleeve and the expandable portion so as to move the struts between the closed position and the opened position when the tip member is extended or retracted relative to the catheter tube;

wherein each of said plurality of struts are connected at a proximal end to the catheter tube and are connected at a distal end to the tip member such that each of said plurality of struts are configured to bow outwardly when the tip member is retracted.

2. The intravascular catheter device of claim 1 wherein:

the sharpened edge extends in parallel with the outer surface of the strut along the entire length of the sharpened edge.

3. The intravascular catheter device of claim 1 further comprising:

a handle assembly secured to a proximal end of the catheter tube; and

a control member moveably supported on the handle assembly and in communication with the inner sleeve, wherein said control member is configured to selectively control movement of the expandable portion between the closed and the opened position.

4. The intravascular catheter device of claim 1 further comprising:

a protective sheath supported for sliding movement along an outer surface of the catheter tube and capable of covering said expandable portion when said expandable portion is in the closed position.

5. The intravascular catheter device of claim 1 wherein:

the incising member extends along only a proximal half of the at least one strut relative to the catheter tube.

6. The intravascular catheter device of claim 1 wherein:

the incising member is configured to extend parallel to a longitudinal axis of the blood vessel when the intravascular catheter device is deployed within the blood vessel.

7. The intravascular catheter device of claim 1 wherein:

the incising member is a slender member which extends along a midline of the strut and perpendicular from the outward facing surface of the strut.

8. An intravascular catheter device for the treatment of atherosclerotic material located within a blood vessel comprising:

a handle assembly;

a flexible catheter tube having a proximal end secured to said handle assembly;

an expandable portion secured to a distal end of said catheter tube comprising a plurality of struts each defining an outer facing surface and being operable between a collapsed position, wherein the expandable portion has a first diameter, and an expanded position, wherein the expandable portion has a second diameter that is larger than the first diameter;

a flexible inner sleeve disposed within the catheter tube, wherein said inner sleeve is supported for sliding movement within the catheter tube and is configured to accommodate a guide wire;

an incising element extending along the midline of only a proximal half of the outer facing surface of at least one of the struts, relative to the catheter tube, wherein the incising element extends perpendicular from the outer facing surface of the at least one strut;

a sharpened edge positioned along an upper edge of said incising element, wherein said sharpened edge extends in parallel with a longitudinal axis of the expandable portion when the expandable portion is in the collapsed position; and

a tip member attached to the inner sleeve and the expandable portion so as to move the struts between the collapsed position and the expanded position when the tip member is extended or retracted relative to the catheter tube, wherein said tip member is configured to accommodate the guide wire;

wherein each of said plurality of struts are connected at a proximal end to the catheter tube and are connected at a distal end to the tip member such that each of said plurality of struts are configured to bow outwardly when the tip member is retracted.

9. The intravascular catheter device of claim 8 wherein:

the incising element is configured to extend parallel to a longitudinal axis of the blood vessel when the intravascular catheter device is deployed within the blood vessel.

10. The intravascular catheter device of claim 8 wherein:

said sharpened edge extends perpendicular to the outer surface of the strut.

11. The intravascular catheter device of claim 8 further comprising:

a protective sheath capable of being disposed about the expandable portion when the expandable portion is in the collapsed position and wherein said protective sheath is supported for sliding movement along an outer surface of the catheter tube.

12. The intravascular catheter device of claim 11 wherein:

the struts are biased to the expanded position.

13. The intravascular catheter device of claim 8 wherein:

the sharpened edge of the incising element is configured to create an incision in atherosclerotic material located within the blood vessel when the expandable portion is deployed within the blood vessel, placed in the expanded position, and retracted through the blood vessel.

14. The intravascular catheter device of claim 8 wherein:

said catheter tube, inner tube, and expandable portion are sized and configured to fit within and negotiate the blood vessel.

15. A method for the treatment of atherosclerotic material at a zone of attention located within a blood vessel comprising the steps of:

providing an intravascular device comprising a flexible catheter tube, an expandable portion secured to a distal end of said catheter tube comprising a plurality of struts each defining an outer facing surface and being operable between a collapsed position wherein the expandable portion has a first diameter and an expanded position wherein the expandable portion has a second diameter that is larger than the first diameter, a flexible tube-shaped inner sleeve disposed within the catheter tube wherein said inner sleeve is supported for sliding movement within the catheter tube and is configured to fit atop a guide wire, an incising element provided on and extending perpendicular from the outer facing surface of at least one of the struts and extending longitudinally along at least a portion thereof, wherein the incising element comprises a sharpened edge located along an upper edge thereof such that the sharpened edge extends in parallel with a longitudinal axis of the expandable portion when the expandable portion is in the closed position, and a tip member attached to the inner sleeve and the expandable portion, wherein each of said struts are connected at a proximal end to the catheter tube and at a distal end to the tip member;

locating the intravascular device at a distal end of, or beyond, the zone of attention;

retracting the inner sleeve so as to force the struts to bow outwardly, thereby placing the expandable portion in the expanded position; and

retracting the intravascular device along the zone of attention to incise the atherosclerotic material.

16. The method of claim 15 further comprising the steps of:

providing a protective sheath disposed about the expandable portion;

removing the protective sheath; and

replacing the protective sheath.