BALLOON EXPANDABLE PLATFORM WITH RETAINING FEATURES FOR A COLLAPSIBLE VALVE

• US 20130218266A1
• Filed: 05/19/2011
• Published: 08/22/2013
• Est. Priority Date: 05/19/2010
• Status: Active Grant

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: St Jude Medical Incorporated (Abbott Laboratories Incorporated)
• Inventors: Chalekian, Aaron J., Klima, Daniel J., Knight, Cherry L., Korfe, Jane M., Knight, Trevor C.
• Granted Patent: US 9,254,191 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• 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: A61F 2002/9586 the means being inside the balloon
• CPC Class Codes: A61M 2025/1031 Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves

Abstract

Retainer structures (150) maintain stented valves (800) on the balloon (130) of a balloon catheter during delivery of the valve to an implantation node and subsequent expansion of the valve. The retainer structures define a raised edge relative to the outer surface of the balloon and limit movement of the valve longitudinally relative to the balloon. Deflation of the balloon following expansion of the valve stent releases the valve.

Claims

1. A delivery system for a prosthetic valve having a valve structure mounted to a stent structure, the stent structure having a collapsed condition, an expanded condition, and a length in the collapsed condition between a first end and a second end, the delivery system comprising:

a balloon extending in a longitudinal direction and having a first end portion, a second end portion and a middle portion between the first end portion and the second end portion, the middle portion having an outer surface with a first diameter in an inflated condition and a second diameter in a deflated condition;

an inflation lumen connected in fluid communication to an interior of the balloon for supplying an inflation fluid to the balloon; and

,

first and second retainer structures each defining a raised edge relative to the outer surface of the middle portion, the raised edges being spaced apart in the longitudinal direction to define a receiving space around the middle portion of the balloon, the receiving space having a length in the longitudinal direction which is greater than the length of the stent structure in the collapsed condition so that the entire length of the stent structure in the collapsed condition is receivable in the receiving space and the raised edges limit movement of the stent structure in the longitudinal direction relative to the balloon.

2. The delivery system of claim 1, wherein the first retainer structure is of a type selected from the group consisting of a node, a ring, a skirt, and a fan skirt.

3. The delivery system of claim 2, wherein the second retainer structure is of a type selected from the group consisting of a node, a ring, a skirt, and a fan skirt.

4. The delivery system of claim 1, wherein the first retainer structure is of a first type and the second retainer structure is of a type different from the first type.

5. The delivery system of claim 1, wherein the first retainer structure is of a first type and the second retainer structure is of the first type.

6. The delivery system of claim 1, wherein the raised edges are positioned relative to the middle portion to limit movement of the stent structure in the longitudinal direction relative to the balloon when the balloon is in the inflated condition and the stent is in the expanded condition.

7. The delivery system of claim 1, wherein the raised edges are positioned relative to the middle portion to limit movement of the stent structure in the longitudinal direction relative to the balloon during inflation of the balloon from the deflated condition to the inflated condition.

8. The delivery system of claim 1, wherein the raised edges are sized and shaped to release the valve structure upon deflation of the balloon from the inflated condition.

9. A method of delivering a prosthetic valve to an implantation site, the prosthetic valve having a valve structure mounted to a stent structure, the stent structure having a collapsed condition, an expanded condition, and a length in the collapsed condition between a first end and a second end, the method comprising:

assembling the valve around a balloon having an inflated condition and a deflated condition, the balloon extending in a longitudinal direction and having an outer surface and first and second retainer structures each defining a raised edge relative to the outer surface, the raised edges being spaced apart in the longitudinal direction to define a receiving space around the outer surface of the balloon, the receiving space having a length in the longitudinal direction which is greater than the length of the stent structure in the collapsed condition, the valve being assembled in the receiving space so that the stent structure is in the collapsed condition and the balloon is in the deflated condition;

covering the valve in the collapsed condition and the balloon in the deflated condition with a sheath;

moving the covered valve and balloon to an implantation site;

removing the sheath from over the valve and the balloon to expose the valve and the balloon, whereby the valve is held in the receiving space and the raised edges limit movement of the stent structure in the longitudinal direction relative to the balloon;

inflating the balloon to the inflated condition, whereby the stent structure of the valve is expanded to the expanded condition;

deflating the balloon to the deflated condition; and

removing the deflated balloon from the stent structure.

10. The method of claim 9, wherein the raised edges limit movement of the stent structure in the longitudinal direction relative to the balloon when the balloon is in the inflated condition.

11. The method of claim 9, wherein the deflating step releases the stent structure from the receiving space so that the raised edges no longer limit movement of the stent structure in the longitudinal direction relative to the balloon.

12. The method of claim 9, wherein the removing step includes withdrawing the retainer structures through a lumen of the stent structure.

13. The method of claim 9, wherein the first retainer structure is of a type selected from the group consisting of a node, a ring, a skirt, and a fan skirt.

14. The method of claim 9, wherein the second retainer structure is of a type selected from the group consisting of a node, a ring, a skirt, and a fan skirt.

15. The method of claim 9, wherein the first retainer structure is of a first type and the second retainer structure is of a type different from the first type.

16. The method of claim 9, wherein the first retainer structure is of a first type and the second retainer structure is of the first type.