Balloon expandable platform with retaining features for a collapsible valve

• US 9,254,191 B2
• Filed: 05/19/2011
• Issued: 02/09/2016
• Est. Priority Date: 05/19/2010
• Status: Expired due to Fees

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Inventors: Chalekian, Aaron J., Klima, Daniel J., Knight, Cherry L., Korfe, Jane M., Knight, Trevor C.
• Primary Examiner(s): ALEMAN, SARAH WEBB
• Application Number:
  US13/698,162
• Publication Number:
  US 20130218266A1
• Time in Patent Office: 1,727 Days
• Field of Search: 623/1.11, 606/194
• US Class Current: 1/1
• 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, the delivery system comprising:

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;

a balloon extending in a longitudinal direction and having a first tapered end portion, a second tapered end portion and a middle portion between the first tapered end portion and the second tapered end portion, the middle portion having an outer surface with a first diameter in a fully 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 attached to an outer surface of only the middle portion, each of the first and second retainer structures 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,

wherein the raised edges allow for limited movement of the stent structure in the longitudinal direction relative to the balloon both when the stent structure is in the collapsed condition and the balloon is in the deflated condition and when the stent structure is in the expanded condition and the balloon is in the fully inflated condition, the raised edges being configured to maintain their shape when the balloon is inflated from the deflated condition to the fully inflated condition, and

wherein the raised edges are configured to no longer limit movement of the stent structure in the longitudinal direction relative to the balloon after the balloon is deflated from the fully inflated condition to the deflated condition and the stent structure is in the expanded condition, and the first retainer structure is of a first type and the second retainer structure is of a second type different from the first type.

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 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 configured to allow for rotational movement of the stent structure in the collapsed condition.

5. The delivery system 1, further comprising:

a first group of retainer structures of the first type defining raised edges at a first end of the receiving space, wherein the first retainer is included in the first group; and

a second group of retainer structures of the second type defining raised edges at a second end of the receiving space opposite of the first end of the receiving space, wherein the second retainer is included in the second group.

6. The delivery system of claim 5, wherein the first group of retainers are of a first type of node having a first size and a first shape, and the second group of retainers are of a second type of node having a second size different from the first size, the second type of node having a second shape different from the first shape.

7. The delivery system of claim 5, wherein the first group of retainers include nodes that are not all of a same size and shape.

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 a fully inflated condition and a deflated condition, the balloon extending in a longitudinal direction and having a first tapered end portion, a second tapered end portion and a middle portion between the first tapered end portion and the second tapered end portion, the balloon having an outer surface and first and second retainer structures attached to the outer surface of only the middle portion and each of the first and second retainer structures 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 between the first and second tapered end portions, the first retainer structure is of a first type to accommodate a first end of the stent and the second retainer structure is of a second type different from the first type to accommodate a second end of the stent, 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 allow for limited movement of the stent structure in the collapsed condition in the longitudinal direction relative to the balloon;

inflating the balloon to the fully inflated condition, whereby the stent structure of the valve is expanded to the expanded condition and the raised edges continue to limit movement of the stent structure in the longitudinal direction relative to the balloon, the raised edges being configured to maintain their shape while the balloon is inflated to the fully inflated condition;

after inflating the balloon to the inflated condition, deflating the balloon in order to release 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; and

removing the deflated balloon from the stent structure.

10. The method of claim 9, wherein removing the deflated balloon includes withdrawing the retainer structures through a lumen of the stent structure.

11. 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.

12. 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.

13. The method of claim 9, wherein the raised edges are configured to allow for rotational movement of the stent structure in the collapsed condition.