Weeping balloon catheter

• US 8,911,399 B2
• Filed: 08/30/2011
• Issued: 12/16/2014
• Est. Priority Date: 04/08/2008
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: Boatman, Scott E.
• Primary Examiner(s): Bosques, Edelmira
• Application Number:
  US13/221,384
• Publication Number:
  US 20110313400A1
• Time in Patent Office: 1,204 Days
• Field of Search: 604/96.01, 604/10.03, 60410305-10308, 60410101-10103, 604/509
• US Class Current: 604/101.01
• 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 first portion attached to the catheter shaft, a second portion disposed distal of the first portion and attached to the catheter shaft, and a middle working region disposed from the first portion to the second portion, the first portion having an increasingly larger cross-sectional area along the longitudinal axis in a distal direction, the second portion having an increasingly smaller cross-sectional area along the longitudinal axis in the distal direction, the first portion and the second portion joined to one another by the 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 of the middle working length, the plurality of holes consisting of all of the holes through the second balloon, 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 being 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 annular space being defined by a length extending between a first end disposed at a most proximal hole of the plurality of holes of the second balloon and a second end disposed at a most distal hole of the plurality of holes of the second balloon, wherein said annular space has an increasingly smaller cross-sectional area along the longitudinal axis in the distal direction along the length from the first end to the second end of the annular space.

2. The balloon catheter of claim 1, wherein the middle working length of the second balloon has a substantially uniform cross-sectional area along the longitudinal axis in the distal direction.

3. The balloon catheter of claim 1, wherein the portion of the middle working region of the first balloon corresponding to the perforated portion of the second balloon has an increasingly larger cross-sectional area along the longitudinal axis in the distal direction.

4. The balloon catheter of claim 1, wherein the portion of the middle working region of the first balloon corresponding to the perforated portion of the second balloon has a cross-sectional area that decreases along the longitudinal axis in the distal direction.

5. The balloon catheter of claim 4, wherein the perforated portion of the second balloon has a cross-sectional area that decreases along the longitudinal axis in the distal direction.

6. The balloon catheter of claim 5, wherein a rate of decrease of the cross-sectional area of the perforated portion of the second balloon is greater than a rate of decrease of the cross-sectional area of the portion of the middle working region of the first balloon corresponding to the perforated portion of the second balloon.

7. The balloon catheter of claim 1, wherein the middle working region of the first balloon has a taper that is generally uniform along the longitudinal axis from the first end of the annular space to the second end of the annular space.

8. The balloon catheter of claim 1, wherein the middle working region of the first balloon comprises a series of steps each having a different cross-sectional area.

9. The balloon catheter of claim 8, wherein the series of steps includes a first step having a first cross-sectional area and a second step having a second cross-sectional area and positioned distal to the first step, the second cross-sectional area of the second step being greater than the first cross-sectional area of the first step.

10. The balloon catheter of claim 1, wherein the second balloon comprises a first portion attached to the catheter shaft and a second portion disposed distal of the first portion and attached to the catheter shaft, the first portion having an increasingly larger cross-sectional area along the longitudinal axis in the distal direction, the second portion having an increasingly smaller cross-sectional area along the longitudinal axis in the distal direction, wherein the middle working length of the second balloon is positioned longitudinally between the first portion and the second portion thereof.

11. The balloon catheter of claim 1, wherein the annular space extends longitudinally along a majority of a length of the middle working length of the second balloon.

12. A balloon catheter comprising:

a catheter shaft extending along a longitudinal axis and configured to carry a first fluid and a second fluid;

a first balloon mounted on the catheter shaft and expandable with introduction of the first fluid therein, the first balloon having a first portion attached to the catheter shaft, a second portion disposed distal of the first portion and attached to the catheter shaft, and a middle region positioned from the first portion to the second portion of the first balloon, the first portion and the second portion of the first balloon joined to one another by the middle region, the first portion having an increasingly larger cross-sectional area along the longitudinal axis in a distal direction, the second portion having an increasingly smaller cross-sectional area along the longitudinal axis in the distal direction; and

a second balloon mounted around at least a portion of the first balloon, the second balloon having a middle portion, a plurality of holes formed in the middle portion to define a perforated portion of the middle portion, the plurality of holes consisting of all of the holes through the second balloon;

the first and second balloons in an expanded configuration structured and arranged to define an annular lumen therebetween, the annular lumen being in communication with the plurality of holes of the second balloon, the annular lumen configured to allow the second fluid to pass therethrough and out the holes,

the annular lumen having a tapered working region extending longitudinally adjacent the perforated portion of the middle portion of the second balloon and a corresponding portion of the middle region of the first balloon, the annular lumen being defined by a length extending between a first end disposed longitudinally between the first portion and the second portion of the first balloon and at a most proximal hole of the plurality of holes of the second balloon, and a second end disposed distal of the first end and longitudinally between the first portion and the second portion of the first balloon and at a most distal hole of the plurality of holes of the second balloon, wherein the tapered working region has a cross-sectional area that decreases along the longitudinal axis in the distal direction along the length from the first end to the second end of the annular lumen.

13. The balloon catheter of claim 12, wherein the middle portion of the second balloon has a substantially uniform cross-sectional area along the longitudinal axis in the distal direction.

14. The balloon catheter of claim 12, wherein the middle region of the first balloon has an increasingly larger cross-sectional area along the longitudinal axis in the distal direction.

15. The balloon catheter of claim 12, wherein the portion of the middle region of the first balloon corresponding to the perforated portion of the second balloon has a cross-sectional area that decreases along the longitudinal axis in the distal direction.

16. The balloon catheter of claim 15, wherein the perforated portion of the second balloon has a cross-sectional area that decreases along the longitudinal axis in the distal direction.

17. The balloon catheter of claim 16, wherein a rate of decrease of the cross-sectional area of the perforated portion of the second balloon is greater than a rate of decrease of the cross-sectional area of the portion of the middle region of the first balloon corresponding to the perforated portion of the second balloon.

18. The balloon catheter of claim 12, wherein the middle region of the first balloon has a generally uniform taper along the longitudinal axis from the first end of the annular lumen to the second end of the annular lumen.

19. The balloon catheter of claim 12, wherein the middle region of the first balloon comprises a series of steps each having a different cross-sectional area.

20. A method of delivering a fluid to a treatment site within a body vessel, the method comprising:

translating a balloon catheter to the treatment site within the body vessel, the balloon catheter comprising a first balloon coupled to a shaft and comprising a middle working region, a first portion contiguous with a first end of the middle working region, and a second portion positioned distal of the first portion and contiguous with a second end of the middle working region, the middle working region disposed from the first portion to the second portion, the first portion attached to the shaft and comprising an increasingly larger cross-sectional area along a longitudinal axis in a distal direction, the second portion attached to the shaft and comprising an increasingly smaller cross-sectional area along the longitudinal axis in the distal direction, a second balloon coupled to the shaft at least partially around the first balloon, the second balloon having a plurality of holes formed therein to define a perforated portion of the second balloon, the plurality of holes consisting of all of the holes through the second balloon, the first and second balloons structured and arranged in an expanded configuration to define an annular lumen therebetween, the annular lumen in communication with the plurality of holes and being disposed between the perforated portion of the second balloon and a corresponding portion of the first balloon, the annular lumen being defined by a length extending between a first end disposed at a most proximal hole of the plurality of holes of the second balloon and a second end disposed at a most distal hole of the plurality of holes of the second balloon, wherein said annular lumen has an increasingly smaller cross-sectional area along the longitudinal axis in the distal direction along the length from the first end to the second end of the annular lumen;

expanding the first balloon to the expanded configuration; and

introducing a fluid into the annular lumen between the first and second balloons to deliver the fluid through the plurality of holes of the second balloon to the treatment site of the body vessel.