Granted Patent B2

US 12,558,116 · App. 17/702,344 · Granted Feb 24, 2026

Inventors: John P. Pigott (Sylvania, OH); Jenny Zeroni (Plymouth, MN); Adam Tschida (Brooklyn Park, MN)

Assignee: VentureMed Group, Inc.

A61B17/320725A61B17/3209A61B2017/00292A61B2017/00986A61B2217/005A61B2217/007A61M25/0082

Abstract

Claims (89)

1 . An intravascular device for treating a fistula, said intravascular device comprising:

a handle assembly;

a catheter tube extending from said handle assembly;

an expandable portion connected to said catheter tube and selectively movable between a first position and an expanded position; and

one or more incising elements for creating axially extending incisions in material accumulated at the fistula upon axial retraction of the expandable portion while in the expanded position through at least some of the fistula, wherein said one or more incising elements are located at said expandable portion and extend along a longitudinal axis of said expandable portion, each of said one or more incising elements comprising a leading edge, an upper edge, and a trailing edge, where said leading edge, said upper edge, and said trailing edge are interconnected straight edges forming a tapered profile from a side view thereof such that a first end of the upper edge adjoining the leading edge is relatively further from an adjacent portion of an outer surface of said expandable portion compared to a second end of the upper edge adjoining the trailing edge;

wherein said leading edge of each of said one or more incising elements extends at an angle between 10 and 30 degrees from the adjacent portion of the outer surface of the expandable portion, said trailing edge of each of said one or more incising elements extends at a 30-50 degree angle from the outer surface of the adjacent portion of the expandable portion, and said upper edge extends at a non-zero angle relative to the outer surface of the adjacent portion of the expandable portion.

2 . The intravascular device of claim 1 wherein:

said expandable portion comprises a plurality of struts;

each of said struts extend along the longitudinal axis of the expandable portion;

each of the struts comprises one of the incising elements; and

each of said incising elements extend along an outer surface of an associated one of the struts.

3 . The intravascular device of claim 2 wherein:

each of said incising elements extend along a proximal half of the associated one of the struts.

4 . The intravascular device of claim 2 further comprising:

a control element located at said handle assembly; and

an inner sleeve attached to said control element at a first end and a distal end of said struts at a second end such that actuation of said control element causes sliding movement of said inner sleeve, which causes movement of said struts between said first position, where said struts extend along an outer surface of said inner sleeve, and said expanded position, where said struts bow outwardly away from said inner sleeve.

5 . The intravascular device of claim 1 wherein:

said leading edge of each of said one or more incising elements has a maximum height of between 0.005 and 0.02 inches; and

said trailing edge of each of said one or more incising elements has a maximum height of between 0.01 and 0.03 inches.

6 . The intravascular device of claim 1 wherein:

each of said one or more incising elements has an overall length of between 0.2 and 0.6 inches.

7 . The intravascular device of claim 1 further comprising:

one or more hypotubes provided at said expandable portion for providing irrigation or suction.

8 . The intravascular device of claim 7 wherein:

said expandable portion comprises a plurality of struts; and

one of said hypotubes is provided at an interior surface of one of said struts.

9 . The intravascular device of claim 4 further comprising:

one or more items of equipment configured to provide at least one of irrigation fluid and suction force when activated;

one or more ports provided at a portion of said inner sleeve residing within said expandable portion; and

one or more tubes extending from said equipment to each of said one or more ports to provide fluid communication with said one or more items of equipment to provide the at least one of irrigation fluid and suction force at said one or more ports when said one or more items of equipment are activated.

10 . The intravascular device of claim 4 further comprising:

one or more items of equipment configured to provide at least one of irrigation fluid and suction force when activated;

a gap provided between an outer surface of said inner sleeve and an inner surface of said catheter tube; and

one or more tubes extending from said one or more items of equipment to said gap to provide the at least one of the irrigation fluid and suction force at said gap when said one or more items of equipment is activated.

11 . The intravascular device of claim 1 further comprising:

one or more items of equipment configured to provide at least one of irrigation fluid and suction force when activated;

one or more tubes extending from said equipment to said expandable portion; and

one or more clips provided at said expandable portion and configured to secure a distal end of said tubes to provide the at least one of irrigation fluid and suction force at said expandable portion when said one or more items of equipment are activated.

12 . A method for treating a fistula using the intravascular device of claim 1 , said method comprising the steps of:

placing the expandable portion of the intravascular device in the first position;

navigating the expandable portion to a distal portion of the fistula;

placing the expandable portion in the expanded position such that the incising element having the tapered profile contacts tissue located along a wall of the fistula;

retracting the expandable portion along the fistula to create axially extending incisions in said tissue.

13 . The method of claim 12 further comprising the steps of:

providing irrigation at the fistula by activating equipment fluidly connected to apertures at said expandable portion; or

providing suction of the tissue and other material at the fistula by activating equipment fluidly connected to apertures at said expandable portion.

14 . The method of claim 12 further comprising the steps of:

removing said expandable portion from said fistula;

introducing a balloon in a deflated state to said fistula; and

inflating said balloon at said fistula to compress said incised tissue.

15 . An intravascular device comprising:

a handle assembly comprising a control element;

a catheter tube extending from said handle assembly;

an inner sleeve located within the catheter tube and having a first end attached to said control element;

an expandable portion connected to said catheter tube, said expandable portion comprising a plurality of struts, each extending along the longitudinal axis of the expandable portion and selectively moveable between a first position where said struts extend longitudinally along the inner sleeve, and an expanded position where a mid-portion of each of said struts is moved away from the inner sleeve, wherein a second end of the inner sleeve is attached to a distal end of said expandable portion such that actuation of said control element causes sliding movement of said inner sleeve, which causes movement of said struts between said first position and said expanded position;

incising elements for creating axially extending incisions in tissue upon axial retraction of the expandable portion while in the expanded position through at least some of an intravascular passageway, each located at one of said struts and extending longitudinally along an outer surface of, and a longitudinal axis of, an associated one of said struts, wherein each of said incising elements comprises a tapered profile;

at least one of: one or more hypotubes provided at said expandable portion, and one or more ports provided at a portion of said inner sleeve located within said expandable portion; and

one or more fluid passageways extending from the at least one of the one or more hypotubes and the one or more ports to provide fluid communication with one or more items of equipment configured to provide at least one of irrigation fluid and suction force at the at least one of the one or more hypotubes and the one or more ports when connected and activated.

16 . The intravascular device of claim 15 wherein:

said one or more fluid passageways comprising one or more tubes extending from:

the at least one of the one or more hypotubes and the one or more ports to the one or more items of equipment; or

said one or more items of equipment to a gap provided between an outer surface of said inner sleeve and an inner surface of said catheter tube.

17 . An intravascular device for treating a fistula, said intravascular device comprising:

a handle assembly;

a catheter tube extending from said handle assembly;

an expandable portion connected to said catheter tube and selectively movable between a first position and an expanded position;

one or more incising elements for creating axially extending incisions in material accumulated at the fistula upon axial retraction of the expandable portion while in the expanded position through at least some of the fistula, said one or more incising elements located at said expandable portion and extending along a longitudinal axis of said expandable portion, each of said one or more incising elements comprising a tapered profile from a side view thereof where a first end of an upper edge is relatively further from an adjacent portion of an outer surface of said expandable portion at a first end of the upper edge compared to a second end of the upper edge;

one or more items of equipment configured to provide at least one of irrigation fluid and suction force when activated;

one or more tubes extending from said equipment to said expandable portion; and

one or more clips provided at said expandable portion and configured to secure a distal end of said tubes to provide the at least one of irrigation fluid and suction force at said expandable portion when said one or more items of equipment are activated.

18 . An intravascular device for treating a fistula, said intravascular device comprising:

a handle assembly;

a catheter tube extending from said handle assembly;

an expandable portion connected to said catheter tube and selectively movable between a first position and an expanded position; and

one or more incising elements for creating axially extending incisions in material accumulated at the fistula upon axial retraction of the expandable portion while in the expanded position through at least some of the fistula, said one or more incising elements located at said expandable portion and extending along a longitudinal axis of said expandable portion, each of said one or more incising elements comprising a leading edge, an upper edge, and a trailing edge, where said leading edge, said upper edge, and said trailing edge are interconnected straight edges forming a tapered profile from a side view thereof where a first end of the upper edge adjoining the leading edge is relatively further from an adjacent portion of an outer surface of said expandable portion compared to a second end of the upper edge adjoining the trailing edge;

wherein said leading edge of each of said one or more incising elements has a maximum height of between 0.005 and 0.02 inches, and said trailing edge of each of said one or more incising elements has a maximum height of between 0.01 and 0.03 inches.

19 . The intravascular device of claim 18 wherein:

said leading edge of each of said one or more incising elements extends at an angle between 10 and 30 degrees from an adjacent portion of the outer surface of the adjacent portion of the expandable portion;

said trailing edge of each of said one or more incising elements extends at a 30-50 degree angle from the outer surface of the adjacent portion of the expandable portion; and

said upper edge extends at a non-zero angle relative to the outer surface of the adjacent portion of the expandable portion.

20 . An intravascular device for treating a fistula, said intravascular device comprising:

a handle assembly;

a catheter tube extending from said handle assembly;

an expandable portion connected to said catheter tube and selectively movable between a first position and an expanded position;

one or more hypotubes provided at said expandable portion for providing irrigation or suction; and

one or more incising elements for creating axially extending incisions in material accumulated at the fistula upon axial retraction of the expandable portion while in the expanded position through at least some of the fistula, said one or more incising elements located at said expandable portion and extending along a longitudinal axis of said expandable portion, each of said one or more incising elements comprising a tapered profile from a side view thereof where a first end of an upper edge is relatively further from an adjacent portion of an outer surface of said expandable portion compared to a second end of the upper edge.

21 . The intravascular device of claim 20 wherein:

said expandable portion comprises a plurality of struts; and

one of said hypotubes is provided at an interior surface of one of said struts.

Assignments (2)

Continuity (1)

References Cited (212)