INTEGRATED CROSSING BALLOON CATHETER

• US 20130096604A1
• Filed: 10/16/2012
• Published: 04/18/2013
• Est. Priority Date: 10/18/2011
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: QUILLIN, DANIEL T., HANSON, CASS A., GUPTA, AJAY, RUDMAN, BARRY E.
• Granted Patent: US 9,079,000 B2
• Time in Patent Office: Days
• US Class Current: 606/194
• CPC Class Codes: A61B 2017/22044 with a pointed tip
• CPC Class Codes: A61B 2017/22094 for crossing total occlusions, i.e. piercing
• CPC Class Codes: A61F 2002/9583 Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve
• CPC Class Codes: A61M 2025/0024 Expandable catheters or sheaths
• CPC Class Codes: A61M 2025/1061 having separate inflations tubes, e.g. coaxial tubes or tubes otherwise arranged apart from the catheter tube
• 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 25/104 used for angioplasty

Abstract

An integrated crossing balloon catheter. The catheter includes a hub assembly secured to the proximal end of the catheter shaft, an inflatable balloon secured to the distal end of the catheter shaft, and a stiffening tube positioned over the inflatable balloon and a distal end portion of the catheter shaft. The stiffening tube is configured to be advanced through a vasculature with the catheter shaft as a unit. The stiffening tube is translatable along the catheter shaft from a first position in which the inflatable balloon is within the stiffening tube to a second position in which the inflatable balloon is exposed from the stiffening tube.

Claims

1. An integrated crossing balloon catheter comprising:

a catheter shaft having a proximal end, a distal end, a proximal end portion proximate the proximal end, and a distal end portion proximate the distal end;

a hub assembly secured to the proximal end of the catheter shaft;

an inflatable balloon secured to the distal end of the catheter shaft; and

a stiffening tube positioned over the inflatable balloon and the distal end portion of the catheter shaft, the stiffening tube configured to be advanced through a vasculature with the catheter shaft as a unit;

wherein the stiffening tube is translatable along the catheter shaft from a first position in which the inflatable balloon is within the stiffening tube to a second position in which the inflatable balloon is exposed from the stiffening tube.

2. The integrated crossing balloon catheter of claim 1, wherein the catheter shaft has a length measured from the inflatable balloon to the hub assembly, and the stiffening tube has a length measured from a distal end of the stiffening tube to a proximal end of the stiffening tube, wherein the length of the stiffening tube is less than the length of the catheter shaft.

3. The integrated crossing balloon catheter of claim 2, wherein the stiffening tube extends along 70% or more of the length of the catheter shaft.

4. The integrated crossing balloon catheter of claim 2, wherein the stiffening tube is dimensioned such that the proximal end of the stiffening tube remains exterior of a patient while the balloon is positioned proximate a target site within a vessel lumen throughout a medical procedure.

5. The integrated crossing balloon catheter of claim 2, wherein the proximal end of the stiffening tube is flared outward to be grasped by a physician in order to manipulate the stiffening tube.

6. The integrated crossing balloon catheter of claim 2, wherein the inflatable balloon has a length, and the stiffening tube is translatable relative to the catheter shaft over a distance at least as long as the length of the inflatable balloon.

7. The integrated crossing balloon catheter of claim 1, wherein the stiffening tube frictionally engages the catheter shaft as the stiffening tube is translated along the catheter shaft.

8. The integrated crossing balloon catheter of claim 7, wherein the catheter shaft has an outer diameter and the stiffening tube has an inner diameter, wherein the difference between the outer diameter of the catheter shaft and the inner diameter of the stiffening tube is 0.002 inches or less.

9. The integrated crossing balloon catheter of claim 1, wherein the catheter shaft includes visual indicia located proximate a proximal end of the stiffening tube when the stiffening tube is at the first position to indicate the stiffening tube is positioned over the inflatable balloon.

10. An integrated crossing balloon catheter system comprising:

a catheter including an elongate shaft extending from a hub assembly at a proximal end of the catheter to an inflatable balloon at a distal end of the catheter, the catheter including an inflation lumen extending through the elongate shaft from the hub assembly to the inflatable balloon for delivering inflation fluid to the inflatable balloon; and

a stiffening tube having a proximal end, a distal end and a length measured from the proximal end to the distal end, the stiffening tube surrounding the elongate shaft and in intimate contact with an outer surface of the elongate shaft along a majority of the length of the elongate shaft, the stiffening tube configured to be advanced through a vasculature with the catheter as a unit;

wherein the stiffening tube is translatable along the elongate shaft from a first position in which a distal end of the stiffening tube is positioned distal of the inflatable balloon to a second position in which the distal end of the stiffening tube is positioned proximal of the inflatable balloon.

11. The system of claim 10, wherein the elongate shaft of the catheter has a length measured from the inflatable balloon to the hub assembly, wherein the length of the elongate shaft is greater than the length of the stiffening tube.

12. The system of claim 11, wherein the length of the stiffening tube is 70% or more of the length of the elongate shaft of the catheter.

13. The system of claim 10, wherein the stiffening tube has a tapered distal tip configured to expand from a first configuration to a second configuration, the first configuration being a low profile configuration for traversing an occlusion and the second configuration being sized to allow the inflatable balloon to be deployed through the tapered distal tip.

14. The system of claim 10, wherein the stiffening tube includes an expandable region surrounding the inflatable balloon.

15. The system of claim 14, wherein the expandable region includes a distensible material configured to expand radially outward when the inflatable balloon is inflated within the expandable region.

16. The system of claim 14, wherein the expandable region includes a plurality of slots.

17. A method of crossing an occlusion in a vessel lumen, the method comprising:

advancing a crossing balloon catheter over a guidewire intravascularly to a location proximal of the occlusion in a vessel lumen, the crossing balloon catheter including an elongate shaft extending between an inflatable balloon and a hub assembly, and a stiffening tube surrounding the balloon and extending proximal of the balloon over a majority of a length of the elongate shaft;

positioning the balloon across the occlusion;

retracting the stiffening tube from the balloon by translating the stiffening tube proximally relative to the elongate shaft; and

inflating the balloon within the occlusion to expand the occlusion by delivering inflation fluid through an inflation lumen of the elongate shaft from the hub assembly to the balloon.

18. The method of claim 17, wherein the balloon is positioned across the occlusion with the stiffening tube surrounding the balloon.

19. The method of claim 18, wherein the balloon is at least partially inflated within the stiffening tube while the balloon is positioned across the occlusion.

20. The method of claim 17, wherein the guidewire is advanced through the occlusion after the crossing balloon catheter has been advanced to the location proximal of the occlusion, yet before the balloon is positioned across the occlusion, the crossing balloon catheter acting to support the guidewire during advancement of the guidewire through the occlusion.