Post dilation balloon with marker bands for use with stented valves
First Claim
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1. A bulbous balloon for post dilating a stent structure that has been implanted in a human body, 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. a waist portion located between the distal bulb section and the proximal balloon section, and the waist portion retaining a smaller fully inflated diameter than a fully inflated diameter of said proximal balloon section;
C. said balloon having a stent located over said waist portion and over said distal bulb section that is adjacent to the proximal balloon section, said stent being expandable from a small diameter configuration to a larger diameter configuration and is configured for generating an outward force against the stent structure during expanding to cause the stent structure to move outwards;
D. said balloon being configured such that said proximal balloon section applies a smaller force outwards against surrounding tissues than a force applied by said distal bulb section against surrounding tissues.
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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.
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Citations
26 Claims
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1. A bulbous balloon for post dilating a stent structure that has been implanted in a human body, said balloon comprising:
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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. a waist portion located between the distal bulb section and the proximal balloon section, and the waist portion retaining a smaller fully inflated diameter than a fully inflated diameter of said proximal balloon section; C. said balloon having a stent located over said waist portion and over said distal bulb section that is adjacent to the proximal balloon section, said stent being expandable from a small diameter configuration to a larger diameter configuration and is configured for generating an outward force against the stent structure during expanding to cause the stent structure to move outwards; D. said balloon being configured such that said proximal balloon section applies a smaller force outwards against surrounding tissues than a force applied by said distal bulb section against surrounding tissues. - View Dependent Claims (2, 3, 4, 5, 6)
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7. A bulbous balloon for performing valvuloplasty on a valve of the heart, said balloon comprising:
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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;
a waist portion located between the distal balloon portion and the proximal balloon portion, and the waist portion retaining a smaller fully inflated diameter than a fully inflated diameter of said proximal balloon portion;B. said balloon having a marker band in the form of stretchable wire located along a perimeter of said proximal balloon portion; C. said balloon configured to position said distal balloon portion upstream of the annulus; D. said balloon configured to place said proximal balloon section adjacent the valve annulus; E. 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 balloon portion against the surrounding tissues of the heart valve; and
,F. a stent disposed over said waist portion and one of said proximal balloon portion or said distal balloon portion. - View Dependent Claims (8, 9, 10, 11, 12, 13, 14, 15, 16, 17)
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18. A bulbous balloon for performing valvuloplasty, the bulbous balloon comprising:
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A. a proximal balloon portion; B. a distal balloon portion has a fully inflated diameter that is at least 3 mm larger than a fully inflated diameter of the proximal balloon portion; C. a waist portion located between the distal balloon portion and the proximal balloon portion, and the waist portion retaining a smaller fully inflated diameter than a fully inflated diameter of said proximal balloon portion; D. a marker band located along a perimeter of the balloon, the marker band being a discontinuous band comprised of a series of dots or dashes that extend around a circumference of the balloon; E. a stent disposed over said waist portion and over said distal balloon portion and/or said proximal balloon portion. - View Dependent Claims (19, 20, 21, 22, 23, 24, 25, 26)
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Specification