BALLOON CATHETER WITH CENTRALIZED VENT HOLE

• US 20090312827A1
• Filed: 12/18/2006
• Published: 12/17/2009
• Est. Priority Date: 12/23/2005
• Status: Abandoned Application

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Stapleton, Corey E.
• Application Number:
  US12/096,773
• Publication Number:
  US 20090312827A1
• Time in Patent Office: Days
• US Class Current: 623/1.110
• CPC Class Codes: A61M 2025/1077 having a system for expelling the air out of the balloon before inflation and use
• CPC Class Codes: A61M 2025/1079 having radio-opaque markers in the region of the balloon
• CPC Class Codes: A61M 2025/1081 having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths
• CPC Class Codes: A61M 2205/32 with radio-opaque indicia
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A system and method providing a catheter assembly for engaging a stenosis. The assembly includes a catheter defining a first lumen and a second lumen spaced apart and disposed about a longitudinal axis. The catheter includes an opening in communication with the first lumen to define a flow path having an angle incident to the longitudinal axis. A first marker; and a second marker disposed on the catheter are spaced equidistantly from the opening. The assembly includes a balloon having a first end and a second end each sealed about the catheter and equidistantly from the opening to define a holding volume therebetween. The opening is disposed within the holding volume thereby placing the first lumen in sealed fluid communication with the holding volume. In a preferred embodiment, the catheter assembly includes a stent disposed about the balloon, and the balloon is configured to engage the stent with a stenosis.

Claims

1. A catheter assembly for engaging a stenosis, the assembly comprising:

a catheter including a wall having a proximal end and a distal end disposed along a longitudinal axis, the wall having an interior surface and an exterior surface, the interior surface defining a first lumen and a second lumen spaced apart and disposed about the longitudinal axis, the wall defining an opening extending between the inner surface and the exterior surface, the opening being in communication with the first lumen so as to define a flow path having an angle incident to the longitudinal axis;

a first marker disposed about the exterior surface along the longitudinal axis; and

a second marker disposed about the exterior surface along the longitudinal axis, the first and second markers being spaced from one another along the longitudinal axis so as to be substantially equidistant from the opening; and

a balloon having a first end and a second end defining a holding volume therebetween, the first end and the second ends being sealed about the exterior surface, the opening is disposed within the holding volume so as to place the first lumen in sealed fluid communication with the holding volume, the first and second ends being spaced substantially equidistantly about the opening along the longitudinal axis.

2. The catheter assembly of claim 1, wherein the holding volume defines a first volume and a second volume larger than the first volume, the opening being configured so as to alter the holding volume between the first and the second volumes substantially radially about the opening.

3. The catheter assembly of claim 2, wherein the balloon has an operational pressure of about 8 atm. so as to define a fluid delivery pressure at the opening to alter the holding volume between the first and the second volumes.

4. The catheter assembly of claim 1, wherein the balloon has a width ranging from about 1 millimeter to about 40 millimeters.

5. The catheter-assembly of claim 1, wherein the balloon has a width ranging from about 1 millimeter to about 26 millimeters.

6. The catheter-assembly of claim 1, wherein the balloon has a width ranging from about 3 millimeter to about 20 millimeters.

7. The catheter-assembly of claim 1, wherein the balloon has a length ranging from about 10 millimeters to about 120 millimeters.

8. The catheter-assembly of claim 1, further comprising a connector disposed about the exterior surface proximate the balloon, the connector having a first port and a second port in communication with the second lumen, the first port being in fluid communication with the first and the second lumen.

9. The catheter assembly of claim 8, wherein the first port defines an angle incident to the first lumen and the second port is substantially coaxial with the second lumen.

10. The catheter-assembly of claim 1, wherein the first marker and the second marker are disposed within the holding volume.

11. The catheter-assembly of claim 1, wherein at least one of the first marker and the second marker comprises at least one of a radiopaque and radiographic material.

12. The catheter-assembly of claim 1, wherein the exterior surface of the wall defines a first diameter outside the holding volume, the exterior surface defining a second diameter inside the holding volume, the second diameter being smaller than the first diameter, the exterior surface including a taper portion between the first and second diameter.

13. The catheter-assembly of claim 1, further comprising a deflator disposed about the exterior surface, the deflator having a first position proximate the balloon and a second position distal the balloon, the deflator being configured to translate along the longitudinal axis from the first position to the second position so as to alter the holding volume.

14. The catheter-assembly of claim 1, further comprising a cap engaged with the catheter such that the balloon is disposed inside the cap.

15. The catheter-assembly of claim 1, further comprising a stent disposed about the balloon, the balloon being configured to engage the stent with a stenosis.

16. A fluid delivery device comprising:

an elongated member having a proximal end and a distal end defining a first lumen and a second lumen spaced apart from the first lumen along a longitudinal axis, the first lumen being configured to convey a fluid, the member having an opening disposed between the proximal and distal ends, the opening being in fluid communication with the first lumen; and

a first marker and a second marker, the first marker and second marker being disposed about the member and spaced from one another so as to be substantially equidistant from the opening.

17. The fluid delivery device of claim 16, wherein the first lumen defines a substantially crescent shaped cross-sectional area perpendicular to the longitudinal axis.

18. The fluid delivery device of claim 16, wherein the first lumen defines a substantially rectangular cross-sectional area perpendicular to the longitudinal axis.

19. The fluid delivery device of claim 16, wherein the opening comprises a substantially rectangular opening.

20. The fluid delivery device of claim 16, wherein the first marker and the second marker are a radiopaque and radiographic material.

21. The fluid delivery device of claim 16, wherein the second lumen is disposed about the guidewire.

22. The fluid delivery device of claim 16, further comprising a connector disposed about the exterior, the connector having a first port in communication with the first lumen and a second port in communication with the second lumen.

23. The fluid delivery device of claim 16, wherein the elongated member includes a proximal portion and a distal portion, the proximal portion having a first diameter and the distal portion having a second diameter, the second diameter being smaller than the first.

24. The fluid delivery device of claim 23 wherein the proximal portion tapers down to the distal portion.

25. A method of expanding a stenosis, the method comprising:

locating a first marker of a catheter assembly to one side of a portion of a stenosis and locating a second marker on the opposite side of the portion such that the first and second markers are equidistant from the portion of the stenosis so as to align a substantially central region of an inflatable member with the portion; and

introducing a sufficient amount of the fluid into the inflatable member to expand the inflatable member substantially equally and radially about the central region to engage and apply an expansion force to the portion.

26. The method of claim 25, wherein the introducing comprises interposing a stent between the inflatable member and the portion.

27. A method of dilating a stenosis, the method comprising:

locating a first marker of a catheter assembly to one side of a portion of a stenosis and locating a second marker on the opposite side of the portion such that the first and second markers are generally equidistant from the portion of the stenosis;

disposing a fluid fill opening of an inflatable member generally equidistant between the first and second markers; and

expanding the inflatable member via the fluid fill opening substantially equally longitudinally and radially about the central region to engage and apply an expansion force to the portion.