Intravascular catheter having an expandable incising portion and medication delivery system

• US 10,610,255 B2
• Filed: 12/03/2016
• Issued: 04/07/2020
• Est. Priority Date: 09/13/2011
• Status: Active Grant

• Current Assignee: VentureMed Group, Inc.
• Original Assignee: VentureMed Group, Inc.
• Inventors: Pigott, John P.
• Primary Examiner(s): Ho, Tan-Uyen T
• Assistant Examiner(s): Igboko, Chima U
• Application Number:
  US15/368,604
• Publication Number:
  US 20170079679A1
• Time in Patent Office: 1,221 Days
• Field of Search: 606159
• 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
• CPC Class Codes: A61M 2025/0096 being laterally outward extensions or tools, e.g. hooks or fibres
• CPC Class Codes: A61M 25/0074 Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 25/0082 Catheter tip comprising a tool

Abstract

An intravascular device is provided having a catheter tube and an expandable portion including a plurality of struts capable of being moved between an open and a closed position. An incising element is provided on at least 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. A medication delivery device may be located on one or more of the struts and may be configured to deliver a substance to an area of interest.

Claims

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

a handle assembly;

a flexible catheter tube extending from said handle assembly;

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;

a tip member positioned at a distal end of said expandable portion;

an inner sleeve extending from said handle assembly, through the catheter tube, and connected to said tip member, wherein said inner sleeve is configured for sliding movement such that retraction of said inner sleeve is configured to cause retraction of said tip member;

an incising member provided on and extending from the outward facing surface of at least one of the struts, the incising member extending parallel with a longitudinal axis of the expandable portion when the expandable portion is in the closed position; and

a medication delivery mechanism configured to deliver a substance along the blood vessel when the expandable portion is axially retracted, wherein said medication delivery mechanism comprises a medication delivery tube extending through the at least one of the struts;

wherein each of said struts are connected to the tip member at a first end thereof and the catheter tube at a second end thereof such that said struts are configured to bow outwardly when said tip member is retracted by way of said inner sleeve;

wherein said handle member comprises a mechanism for retracting said inner sleeve.

2. The intravascular catheter device of claim 1 wherein:

the medication delivery tube terminates below the incising member.

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

an internal passageway connected to the medication delivery tube and extending through the incising member to an upper surface of the incising member.

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

an internal passageway connected to the medication delivery tube and extending through at least a portion of the incising member; and

a jet positioned at the distal end of the internal passageway, wherein said jet is configured to aerosolize a substance passing through said jet.

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

a pump in communication with the drug delivery tube, wherein said pump is configured to move a fluid containing a substance through said drug delivery tube.

6. The intravascular catheter device of claim 5 further comprising:

a reservoir configured to hold the substance.

7. The intravascular catheter device of claim 1 wherein:

the incising member comprises a sharpened edge extending along an upper edge of the incising member.

8. The intravascular catheter device of claim 1 wherein:

the incising member extends along a proximal half of the at least one of the struts.

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

a handle assembly;

a flexible catheter tube extending from the handle assembly;

an expandable portion secured to a distal end of said catheter tube comprising a plurality of struts each defining a flat, outer facing surface configured to ride along the atherosclerotic material, wherein said expandable portion is 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;

a tip member connected to said flexible inner sleeve and configured for sliding movement, wherein said tip member is configured to engage each of said plurality of struts to move the expandable portion between the collapsed position and the expanded position;

a medication delivery mechanism configured to deliver a substance along the blood vessel when the expandable portion is axially retracted, said medication delivery mechanism comprising a drug delivery tube extending through at least one of said plurality of struts; and

at least one incising element extending longitudinally along the midline of, and perpendicular from, at least a portion of the flat, outer facing surface of at least one of said plurality of struts, said at least one incising element comprising a sharpened edge positioned along an upper edge thereof;

wherein the struts are configured to extend parallel with a longitudinal axis of the expandable portion when the expandable portion is in the closed position;

wherein each of said struts are connected to the tip member at one end and to the catheter tube at the other end such that retraction of the tip member is configured to cause the struts to bow outwardly;

wherein said inner sleeve extends from said handle assembly, through said catheter tube, and is connected to said tip member such that retraction of said inner sleeve results in retraction of said tip member.

10. The intravascular catheter device of claim 9 wherein:

said drug delivery tube terminates at the at least one incising element.

11. The intravascular catheter device of claim 10 further comprising:

an internal passageway that is connected to the drug delivery tube and travels through the at least one incising element to the surface thereof.

12. The intravascular catheter device of claim 10 further comprising:

an internal passageway that is connected to the drug delivery tube and travels through at least a portion of the at least one incising element;

a jet positioned at the distal end of the internal passageway, wherein said jet is configured to aerosolize a substance passing therethrough.

13. The intravascular catheter device of claim 9 wherein:

the incising element extends along a proximal half of the at least one of the struts.

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

a handle assembly;

a flexible catheter tube extending from the handle assembly;

an expandable portion secured to a distal end of said catheter tube and comprising a plurality of struts each defining a flat, outer facing surface configured to ride along a surface of the atherosclerotic material, wherein said expandable portion is 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;

a control member located on the handle assembly, wherein said control member is associated with said flexible inner sleeve and said control member is configured to move said flexible inner sleeve;

a tip member connected to said flexible inner sleeve and configured for sliding movement, wherein said tip member is figure configured to engage each of said plurality of struts so as to move the expandable portion between the collapsed position and the expanded position;

at least one incising element extending longitudinally along the midline of, and perpendicular from, the distal half of the flat, outer facing surface of at least one of said plurality of struts, said at least one incising element comprising a sharpened edge positioned along an upper edge thereof;

a medication delivery mechanism configured to deliver a substance along the blood vessel when the expandable portion is axially retracted along the blood vessel, wherein said medication delivery mechanism comprises a drug delivery tube extending through the at least one of said plurality of struts;

wherein each of said plurality of struts are connected to the tip member at one end and the catheter tube at the other end such that retraction of the tip member is configured to cause the struts to bow outwardly;

wherein each of said plurality of struts extend parallel with a longitudinal axis of the expandable portion when the expandable portion is in the closed position;

wherein said inner sleeve extends from said handle assembly, through said catheter tube, and is connected to said tip member such that retraction of said inner sleeve results in retraction of said tip member.