Post Dilation Balloon With Marker Bands For Use With Stented Valves
AssigneeInterValve, Inc.
InventorsWilliam J. Drasler, Mark Ungs, Wesley R. Pedersen, Scott R. Schewe, Richard C. Kravik, Michael Scott Allen
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Abstract
A bulbous valvuloplasty balloon is described that maintains its bulbous shape in its final deployed configuration along with the method of use for post dilation of a TAVR device. The bulbous balloon has two larger diameter bulb segments located on each side of a smaller diameter waist and can be used to post dilate a TAVR device that has been implanted at the site of a stenotic aortic valve. The post dilation causes deformation of the underlying tissues residing outside of the TARV stent structure.
Claims32
A method for dilating a stent valve structure that is implanted across an annulus, native leaflets of a heart valve, blood-flow tract upstream of the annulus, and other surrounding tissues of the heart valve comprising the steps:
- A. introducing a bulbous balloon having a fully inflated distal bulb section that is at least 3 mm larger in diameter than a fully inflated smaller diameter proximal section of the balloon;
- B. positioning said balloon into a stent valve structure while in a deflated configuration, a portion of said distal bulb section being located adjacent an inflow end of the stent valve structure and adjacent the blood-flow tract;
- C. inflating said distal bulb section to provide an outward bulb force against the stent valve and against the blood-flow tract and deforming tissues of the blood-flow tract, said smaller diameter proximal section providing a smaller annular outward force than said outward bulb force against the stent valve and against the annulus to protect the annulus from rupture.
A bulbous balloon for post dilating a stent valve that extends across a valve of the heart, said balloon comprising:
- A. a fully inflated distal bulb section that is at least 3 mm larger in diameter than a fully inflated diameter of a proximal balloon section;
- B. said distal bulb section having a fully expanded diameter that is larger than a heart valve annulus, said proximal balloon section having a fully inflated diameter that is smaller than a heart valve annulus;
- C. said balloon having a stent located along a perimeter of said distal bulb section that is adjacent the proximal balloon section, said stent being expandable from a small diameter configuration to a larger diameter configuration;
- D. said balloon configured to position said distal bulb section upstream of the annulus and deliver said stent to a location just upstream of the annulus;
- E. said balloon configured to place said proximal balloon section adjacent the valve annulus;
- F. said balloon being configured such that said proximal balloon section applies a smaller force outwards against the annulus than a force applied by said distal bulb section against the surrounding tissues of the heart valve.
A bulbous balloon for performing valvuloplasty on a valve of the heart, said balloon comprising:
- A. a fully inflated distal balloon portion that is at least 3 mm larger in diameter than a fully inflated diameter of a proximal balloon portion;
- B. said distal bulb portion having a fully inflated diameter that is larger than a heart valve annulus, said proximal balloon portion having a fully inflated diameter that is smaller than a heart valve annulus;
- C. said balloon having a marker band located along a perimeter of said proximal balloon portion;
- D. said balloon configured to position said distal bulb section upstream of the annulus;
- E. said balloon configured to place said proximal balloon section adjacent the valve annulus;
- F. said balloon being configured such that said proximal balloon portion applies a smaller force outwards against the annulus than a force applied by said distal bulb section against the surrounding tissues of the heart valve.
Dependencies are inferred from the claim text.