Granted Patent B2

US 12,185,968 · App. 17/221,473 · Granted Jan 7, 2025

Inventor: John P. Pigott (Sylvania, OH)

Assignee: VentureMed Group, Inc.

A61B17/320725A61B17/3209A61B2017/00986A61B17/32075

Abstract

Claims (70)

1. An intravascular catheter device comprising:

a flexible catheter tube;

an expandable portion located at a distal end portion of said flexible catheter tube;

a sleeve extending, at least in part, within said expandable portion, said expandable portion comprising a proximal end connected to said flexible catheter tube, a distal tip spaced apart a distance from the proximal end and connected to said sleeve, and a plurality of struts, each comprising a first intermediate strut connected to said proximal end and a second intermediate strut connected to the first intermediate strut and the distal tip, wherein said first intermediate strut of each of said plurality of struts is capable of hinging movement relative to said proximal end and said second intermediate strut, wherein said second intermediate strut of each of said plurality of struts is capable of hinging movement relative to said distal tip and said first intermediate strut, and wherein each paired set of said first intermediate strut and said second intermediate strut of a given one of the plurality of struts collectively span the distance between, and connect, the proximal end and the distal tip; and

an incising element located at an outer surface of a first one of the plurality of struts;

wherein movement of said sleeve relative to said flexible catheter tube moves said plurality of struts between a collapsed position where each of the plurality of struts extend along an outer surface of the sleeve such that said first intermediate strut and said second intermediate strut of each of said plurality of struts are longitudinally aligned and an expanded position where said first intermediate strut and said second intermediate strut longitudinally form a non-zero angle such that the connection between the first intermediate strut and the second intermediate strut is elevated away from said outer surface of the sleeve and the distance between the proximal end and the distal tip is shortened;

wherein a sharpened edge of said incising element extends longitudinally along a longitudinal axis of the given one of said plurality of struts; and

wherein each of said plurality of struts, at least while in the collapsed position, extends longitudinally along a centerline of an underlying portion of the sleeve.

2. The intravascular catheter device of claim 1 wherein:

said sleeve and said distal tip member are configured to accommodate a guide wire.

3. The intravascular catheter device of claim 1 :

wherein the incising element is located on the outer surface of the first intermediate strut of the first one of the plurality of struts;

further comprising a second incising element located at an outer surface of the first intermediate strut of a second one of the plurality of struts.

4. The intravascular catheter device of claim 1 wherein:

said incising element extends along at least a majority of said first intermediate strut of said first one of said plurality of struts; and

the incising element is exclusively attached to the first intermediate strut.

5. The intravascular catheter device of claim 4 wherein:

the longitudinal axis of each of the plurality of struts extends parallel to the centerline of the underlying portion of the sleeve, at least while the plurality of struts are in the collapsed position;

said incising element extends parallel to the centerline of said underlying portion of the sleeve when said expandable portion is placed in said collapsed position; and

said incising element extends along a midline of the outer surface of said first intermediate strut of said first one of said plurality of struts.

6. The intravascular catheter device of claim 1 wherein:

said sharpened edge of said incising element extends along an upper surface of said incising element.

7. The intravascular catheter device of claim 6 wherein:

said incising element comprises an arcuate shape.

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

a handle assembly;

a control member located at said handle assembly and configured for sliding movement to control movement of said sleeve relative to said flexible catheter tube.

9. The intravascular catheter device of claim 8 wherein:

a first portion of said control member extends outside a body of said handle assembly and is configured for user actuation;

a second portion of said control member extends within said body of said handle assembly and is connected to said sleeve such that sliding movement of said first portion is configured to mechanically translate to sliding movement of said sleeve.

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

weakened regions located at the connection between said proximal end and each of said plurality of struts, the connection between each of the plurality of struts and the said distal tip, and the connection between the first intermediate strut and the second intermediate strut of each of the plurality of struts, wherein said weakened regions facilitate said hinging movement of each of said plurality of struts.

11. The intravascular catheter device of claim 10 wherein:

said first intermediate strut of each of said plurality of struts defines a first cross-sectional area;

said second intermediate strut of each of said plurality of struts has a second cross-sectional area; and

said first cross-sectional area is different in size and shape from said second cross-sectional area.

12. The intravascular catheter device of claim 1 wherein:

the first intermediate strut and the second intermediate strut of each of said plurality of struts comprises a respective linear segment such that the first intermediate strut and the second intermediate strut of each of said plurality of struts are unbent when the plurality of struts are moved between the collapsed position and the expanded position.

13. The intravascular catheter device of claim 1 wherein:

the first intermediate strut is directly connected to the proximal end and the second intermediate strut of the given one of the plurality of struts; and

the second intermediate strut is directly connected to the distal tip of the given one of the plurality of struts.

14. The intravascular catheter device of claim 1 wherein:

the first intermediate strut is directly adjacent to the proximal end and the second intermediate strut of the given one of the plurality of struts; and

the second intermediate strut is directly adjacent to the distal tip of the given one of the plurality of struts.

15. An intravascular catheter device comprising:

a handle assembly;

a flexible catheter tube having a proximal end reaching said handle assembly;

an expandable portion connected to a distal end portion of the flexible catheter tube and comprising a proximal end, a distal tip spaced apart from the proximal end a longitudinal distance, and a plurality of struts, wherein each of said plurality of struts comprise a first intermediate strut connected to the proximal end and a second intermediate strut connected to the first intermediate strut and the distal tip, wherein each set of said first intermediate strut and said second intermediate strut collectively span the longitudinal distance between the proximal end and the distal tip;

a sleeve extending within the expandable portion and the flexible catheter tube, wherein said proximal end connects each of the first intermediate struts of the plurality of struts to the flexible catheter tube, and wherein the distal tip comprises a conical shaped member which connects each of the second intermediate struts to the sleeve; and

an incising element located at an outer surface of the first intermediate strut of at least one of the plurality of struts;

wherein a proximal end of said first intermediate strut of each of said plurality of struts is configured for hinging movement relative to said flexible catheter tube, wherein a distal end of said second intermediate strut of each of said plurality of struts is configured for hinging movement relative to said distal tip, and wherein said first intermediate strut of each of said of plurality of struts is configured for hinging movement relative to said second intermediate strut of the respective one of said plurality of struts;

wherein said handle assembly is configured, when actuated, to cause movement of said sleeve and said distal tip relative to said flexible catheter tube so as to move each of said plurality of struts between a collapsed position where each of the plurality of struts extend longitudinally along an outer surface of the sleeve such that said first intermediate strut and said second intermediate strut of each respective one of said plurality of struts are longitudinally aligned with one another and a centerline of an underlying portion of the sleeve and an expanded position where said first intermediate strut and said second intermediate strut of each respective one of said plurality of struts such that the connection between the first intermediate strut and the second intermediate strut of each of said plurality of struts is elevated away from said outer surface of the sleeve and the longitudinal distance between said proximal end and said distal tip is decreased;

wherein an upper, sharpened edge of said incising element is oriented to extend along a longitudinal axis of said first intermediate strut of said one of said plurality of struts when said one of said plurality of struts is placed in either of said expanded position and said collapsed position.

16. A method for incising vascular tissue at a zone of treatment within a vascular system of a patient, said method comprising the steps of:

introducing an expandable portion having a proximal end connected to a distal end portion of a flexible catheter tube and comprising a plurality of struts into the vascular system of a patient such that a handle assembly connected to a proximal end portion of said flexible catheter tube remains outside the vascular system of the patient;

negotiating the expandable portion to the zone of treatment;

actuating a control member at the handle assembly so as to cause movement of a sleeve extending within at least a portion of the expandable portion and the flexible catheter tube and a distal tip member connected to said sleeve relative to said flexible catheter tube to shorten a distance the proximal end is spaced apart from the distal tip member to move said expandable portion from a collapsed position where each of the plurality of struts extend along an outer surface of the sleeve and a first intermediate strut and a second intermediate strut of each respective one of said plurality of struts are longitudinally aligned with one another and a centerline of an underlying portion of the sleeve into an expanded position where said first intermediate strut and said second intermediate strut extend longitudinally at a non-zero angle relative to one another such that a connection between said first intermediate strut and said second intermediate strut of each of said plurality of struts is elevated away from said outer surface of the sleeve so as to place an incising element located at the first intermediate strut of one of the plurality of struts in contact with, or closer to, vascular tissue located about said expandable portion at said zone of treatment, wherein each paired set of said first intermediate strut and said second intermediate strut of a given one of the plurality of struts collectively span the distance between, and connect, the proximal end and the distal tip member to form the given one of the plurality of struts, wherein a sharpened edge of said incising element extends longitudinally along a longitudinal axis of the given one of said plurality of struts, and wherein each of said plurality of struts, at least while in the collapsed position, has a longitudinal axis which extends along a centerline of an underlying portion of the sleeve;

retracting the expandable portion axially along at least a portion of the zone of attention so as to incise, or facilitate incision of, at least some of the vascular tissue contacting the incensing element;

moving the expandable portion from the expanded position into the collapsed position; and

removing the expandable portion from the vascular system of the patient;

wherein each of said plurality of struts has a proximal end configured for hinging movement relative to said flexible catheter tube and a distal end configured for hinging movement relative to said distal tip member, where the connection between the first intermediate strut and the second intermediate strut is configured to facilitate hinging movement between said first intermediate strut and said second intermediate strut of the respective one of the struts.

17. The method of claim 16 wherein:

said control member is configured for sliding movement;

said control member comprises a first portion located outside of a body of said handle assembly; and

said control member comprises a second portion located within the body of the handle assembly and connected to a proximal end of said sleeve.

18. The method of claim 17 further comprising the steps of:

introducing a guide wire into the vascular system of the patient;

negotiating a distal end of the guide wire to the zone of attention, wherein the step of negotiating the expandable portion to the zone of treatment comprises advancing the expandable portion along the guide wire, and wherein the step of retracting the expandable portion axially along the zone of attention and removing the expandable portion from the vascular system of the patient comprises retracting the expandable portion along the guide wire, wherein at least said sleeve, said distal tip member, and said handle assembly are configured to accommodate the guide wire.

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

deploying a balloon at the zone of attention.

Assignments (3)

Continuity (5)

References Cited (177)