BALLOON-STENT COMBINATION

• US 20070293931A1
• Filed: 06/18/2007
• Published: 12/20/2007
• Est. Priority Date: 06/20/2006
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated)
• Inventors: Parker, Fred
• Granted Patent: US 8,057,528 B2
• Time in Patent Office: Days
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61M 2025/1093 having particular tip characteristics
• CPC Class Codes: A61M 25/1006 Balloons formed between concentric tubes

Abstract

The present invention provides apparatus and methods for treating a vascular condition formed within a vessel by providing a balloon having proximal and distal regions and a stent configured to be disposed within the balloon. When the balloon is partially or fully inflated, the stent may be advanced within the confines of the balloon and then expanded to engage an inner surface of the balloon. The stent urges the balloon against the vessel wall, and the proximal and distal regions of the balloon then are cut to leave the balloon and stent within the vessel. The balloon may comprise a collagenous extracellular matrix material to facilitate fusion of the balloon with the vessel wall.

Claims

1. Apparatus suitable for treating a vascular condition, the apparatus comprising:

a balloon comprising proximal and distal regions, and further having uninflated and inflated states, wherein the balloon is configured to expand and contact at least a portion of the vessel wall in the inflated state;

a stent configured to be disposed within the balloon, the stent having contracted and expanded states, wherein the stent is configured to engage an inner surface of the balloon in the expanded state; and

means for detaching at least a portion of the balloon after the stent expands from the uninflated state to leave the portion of the balloon inside the vessel between the stent and an inner wall of the vessel.

2. The apparatus of claim 1 further comprising:

a balloon shaft having proximal and distal ends; and

a core wire having proximal and distal ends, wherein the proximal region of the balloon is attached to the balloon shaft and the distal region of the balloon is attached to the core wire.

3. The apparatus of claim 2 wherein the stent is self-expanding, the apparatus further comprising a stent introducer disposed between the balloon shaft and the core wire, wherein the stent introducer is configured to radially restrain the stent prior to deployment from the contracted to the expanded state.

4. The apparatus of claim 2 wherein the means for detaching comprises a distal cutting cannula having proximal and distal ends and a piercing element disposed at the distal end, the distal cutting cannula disposed annularly between the balloon shaft and the core wire.

5. The apparatus of claim 2 wherein the means for detaching comprises a proximal cutting cannula having proximal and distal ends and a piercing element disposed at the distal end, the proximal cutting cannula disposed for longitudinal movement over the balloon shaft.

6. The apparatus of claim 1 wherein the means for detaching comprises at least one perforation disposed in the distal region of the balloon.

7. The apparatus of claim I wherein at least a portion of the balloon comprises a collagenous extracellular matrix material to facilitate adhesion of the portion of the balloon with an intima of the vessel.

8. The apparatus of claim 7 wherein the collagenous extracellular matrix material comprises small intestinal submucosa.

9. A method suitable for treating a vascular condition, the method comprising:

providing a balloon comprising proximal and distal regions;

inflating the balloon to at least partially dilate a vessel wall;

expanding a stent inside the balloon to cause the stent to contact an inner portion of the balloon; and

detaching at least a portion of the balloon to leave the portion of the balloon between the stent and the vessel wall.

10. The method of claim 9 further comprising:

providing a balloon shaft having proximal and distal ends; and

providing a core wire having proximal and distal ends, wherein the core wire is disposed substantially within the balloon shaft, the distal end of the core wire extending past the distal end of the balloon shaft,

wherein the proximal region of the balloon is attached to the balloon shaft and the distal region of the balloon is attached to the core wire.

11. The method of claim 10 further comprising:

providing a stent introducer disposed between the balloon shaft and the core wire;

radially constraining the stent between the stent introducer and the core wire in a delivery configuration;

positioning the stent introducer and the stent within at least a portion of the balloon; and

proximally retracting the stent introducer with respect to the balloon to cause the stent to radially expand against the portion of the balloon.

12. The method of claim 10 further comprising:

providing a distal cutting cannula having proximal and distal ends and a piercing element disposed at the distal end;

disposing the distal cutting cannula annularly between the balloon shaft and the core wire; and

distally advancing the distal cutting cannula to cause the piercing element to pierce through a distal portion of the balloon.

13. The method of claim 10 farther comprising:

providing a proximal cutting cannula having proximal and distal ends and a piercing element disposed at the distal end;

disposing the proximal cutting cannula over the balloon shaft; and

distally advancing the proximal cutting cannula with respect to the balloon shaft to cause the piercing element to pierce through a proximal portion of the balloon.

14. The method of claim 9 wherein detaching at least a portion of the balloon comprises applying an internal pressure to tear apart at least one pre-formed perforation disposed in a distal region of the balloon.

15. The method of claim 9 further comprising providing a collagenous extracellular matrix on at least a portion of the balloon to facilitate adhesion of the portion of the balloon with an intima of the vessel.

16. Apparatus suitable for treating a vascular condition, the apparatus comprising:

a balloon shaft having proximal and distal ends;

a core wire comprising proximal and distal ends, wherein the core wire is disposed substantially within the balloon shaft, the distal end of the core wire extending past the distal end of the balloon shaft;

a balloon having proximal and distal regions, and further having inflated and uninflated states, wherein the proximal region of the balloon is attached to the balloon shaft and the distal region of the balloon is attached to the core wire; and

a stent configured to be disposed within the balloon, the stent having contracted and expanded states, wherein the stent is configured to engage an inner surface of the balloon in the expanded state,

wherein at least a portion of the balloon comprises a collagenous extracellular matrix material to facilitate adhesion of the portion of the balloon with an intima of the vessel.

17. The apparatus of claim 16 further comprising means for detaching at least a portion of the balloon to leave the portion of the balloon inside the vessel.

18. The apparatus of claim 17 wherein the means for detaching comprises at least one perforation disposed in a distal region of the balloon.

19. The apparatus of claim 17 wherein the means for detaching comprises a distal cutting cannula having proximal and distal ends and a piercing element disposed at the distal end, the distal cutting cannula disposed annularly between the balloon shaft and the core wire.

20. The apparatus of claim 17 wherein the means for detaching comprises a proximal cutting cannula having proximal and distal ends and a piercing element disposed at the distal end, the proximal cutting cannula disposed for longitudinal movement over the balloon shaft.