Weeping balloon catheter

• US 8,591,461 B2
• Filed: 08/30/2011
• Issued: 11/26/2013
• Est. Priority Date: 04/08/2008
• Status: Active Grant

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Inventors: Boatman, Scott E.
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): Bosques, Edelmira
• Application Number:
  US13/221,403
• Publication Number:
  US 20110313355A1
• Time in Patent Office: 819 Days
• Field of Search: 60410101-10103, 604/102.01, 604/919, 604/917, 604/916, 604/96.01, 604/97.01
• US Class Current: 604/101.02
• CPC Class Codes: A61M 2025/1013 with concentrically mounted balloons, e.g. being independently inflatable
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2206/20 having means for promoting or enhancing the flow, actively or passively
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

Balloon catheters, and methods of treatment therewith, are provided including an inflatable first balloon at least partially enclosed by an expandable second balloon that has holes. The annular space between the first balloon and the second balloon is configured to promote delivery of the fluid evenly through holes in the second balloon to avoid problems of underloading and/or overloading. Preferably, the annular space is in communication with the holes, and the annular space is configured to receive and then to release and distribute the fluid via the holes in a substantially uniform manner such that even amounts of fluid are released in the distal and proximal holes. The first balloon may have various configurations including being tapered relative to the second balloon. The second balloon may also be tapered accordingly. The device may also include raised portions disposed in the annular space and configured to define channels having various configurations.

Claims

1. A balloon catheter comprising:

a catheter shaft extending along a longitudinal axis;

a first balloon mounted on the catheter shaft, the first balloon having a middle working region; and

a second balloon mounted around at least a portion of the first balloon, the second balloon having a middle working length, and a plurality of holes formed in the middle working length to define a perforated portion, each of the first and second balloons movable to an expanded configuration to define an annular space therebetween, the annular space being in communication with the plurality of holes of the second balloon,

the annular space comprising an annular working region disposed between the perforated portion of the middle working length of the second balloon and a corresponding portion of the middle working region of the first balloon, the corresponding portion comprising a series of longitudinal segments defining a plurality of steps each having a different cross-sectional area, the cross-sectional area of a first longitudinal segment being less than the cross-sectional area of a second longitudinal segment positioned distal to the first longitudinal segment, wherein the annular working region has an increasingly smaller cross-sectional area along the longitudinal axis in a distal direction.

2. The balloon catheter of claim 1, wherein each of the series of longitudinal segments defines a cross-sectional area that increases along the longitudinal axis in the distal direction.

3. The balloon catheter of claim 1, wherein the perforated portion of the second balloon has a substantially uniform cross-sectional area along the longitudinal axis in the distal direction.

4. The balloon catheter of claim 1, wherein the annular working region comprises a series of longitudinal annular segments, each longitudinal annular segment corresponding to a longitudinal segment of the first balloon and having a cross-sectional area, the cross-sectional area of a first longitudinal annular segment being greater than the cross-sectional area of a second longitudinal annular segment positioned distal to the first longitudinal annular segment.

5. The balloon catheter of claim 4, wherein the cross-sectional area of each longitudinal annular segment is substantially uniform along the longitudinal axis in the distal direction.

6. The balloon catheter of claim 1, wherein the catheter shaft comprises a first tubular member and a second tubular member, the first tubular member comprises a first lumen in fluid communication with the annular space between the first balloon and the second balloon, and the second tubular member comprises a second lumen in fluid communication with the first balloon.

7. The balloon catheter of claim 6, wherein the first tubular member and the second tubular member are adjacent to one another.

8. The balloon catheter of claim 6, wherein the catheter shaft comprises a third tubular member.

9. The balloon catheter of claim 8, wherein a first end of the first balloon is attached to at least one of the first tubular member or the second tubular member of the catheter shaft, and a second end of the first balloon is attached to the third tubular member of the catheter shaft.

10. The balloon catheter of claim 1, wherein the first balloon comprises a tapered first portion attached to the catheter shaft and a tapered second portion attached to the catheter shaft, the middle working region is disposed between the first portion and the second portion, and the first portion and the second portion are joined to one another by the middle working region;

and

wherein the annular working region is disposed radially between the first balloon and the second balloon and longitudinally between the first portion and the second portion of the first balloon.

11. The balloon catheter of claim 10, wherein the tapered first portion comprises an increasingly larger cross-sectional area in the distal direction, and the tapered second portion comprises an increasingly smaller cross-sectional area in the distal direction.

12. A balloon catheter comprising:

a catheter shaft extending along a longitudinal axis;

a first balloon mounted on the catheter shaft, the first balloon having a middle working region; and

a second balloon mounted around at least a portion of the first balloon, the second balloon having a middle working length and a plurality of holes formed in the middle working length to define a perforated portion, each of the first and second balloons movable to an expanded configuration to define an annular space therebetween, the annular space being in communication with the plurality of holes of the second balloon;

wherein the annular space comprises an annular working region disposed between the perforated portion of the middle working length of the second balloon and a corresponding portion of the middle working region of the first balloon, and the annular working region has an increasingly smaller cross-sectional area along the longitudinal axis in a distal direction; and

wherein the corresponding portion of the middle working region of the first balloon comprises a series of longitudinal segments defining a plurality of steps each having a different cross-sectional area, the cross-sectional areas of the steps becoming increasingly larger with each successive step in the distal direction.

13. The balloon catheter of claim 12, wherein each step of the plurality of steps has a substantially uniform cross-sectional area along the longitudinal axis in the distal direction.

14. A balloon catheter comprising:

a catheter shaft extending along a longitudinal axis;

a first balloon mounted on the catheter shaft, the first balloon having a middle working region; and

a second balloon mounted around at least a portion of the first balloon, the second balloon having a middle working length, and a plurality of holes formed in the middle working length to define a perforated portion, each of the first and second balloons movable to an expanded configuration to define an annular space therebetween, the annular space being in communication with the plurality of holes of the second balloon,

the annular space comprising an annular working region disposed between the perforated portion of the middle working length of the second balloon and a corresponding portion of the middle working region of the first balloon, the corresponding portion comprising a series of longitudinal segments defining a plurality of steps each having a different cross-sectional area, the annular working region comprising a series of longitudinal annular segments each having a different cross-sectional area, wherein the annular working region has an increasingly smaller cross-sectional area along the longitudinal axis in a distal direction,

wherein the series of longitudinal annular segments includes a first longitudinal annular segment having a first cross-sectional area and a second longitudinal annular segment having a second cross-sectional area and positioned distal to the first longitudinal annular segment, the second cross-sectional area of the second longitudinal annular segment being less than the first cross-sectional area of the first longitudinal annular segment.

15. The balloon catheter of claim 14, wherein each longitudinal segment of the corresponding portion of the middle working region of the first balloon corresponds to a longitudinal annular segment of the annular working region, and the cross-sectional area of a first longitudinal segment is less than the cross-sectional area of a second longitudinal segment positioned distal to the first longitudinal segment.

16. The balloon catheter of claim 14, wherein the perforated portion of the second balloon has a substantially uniform cross-sectional area along the longitudinal axis in the distal direction.

17. The balloon catheter of claim 14, wherein the first balloon comprises a first end portion attached to the catheter shaft and a second end portion attached to the catheter shaft, the middle working region is disposed between the first end portion and the second end portion, and the first end portion and the second end portion are joined to one another by the middle working region;

and

wherein the annular working region is disposed radially between the first balloon and the second balloon and longitudinally between the first end portion and the second end portion of the first balloon.

18. The balloon catheter of claim 17, wherein the first end portion comprises an increasingly larger cross-sectional area in the distal direction, and the second end portion comprises an increasingly smaller cross-sectional area in the distal direction.