Devices and methods for treating heart failure
Inventors
Finch, Matthew J. • McNamara, Edward I.
Assignees
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Publication Number
US-11135410-B2
Publication Date
2021-10-05
Expiration Date
Abstract
The present teachings provide a device to change the pressure in a chamber of a heart and methods of making and using thereof. One aspect of the present teachings provides a device comprising a frame (for example, a metallic frame) and a scaffold. The frame of the device has a distal flange portion, a shunt portion, and a proximal flange portion. The distal and proximal flange portions can align with the shunt portion and form an elongated first profile. At least one of the distal and proximal flange portions can bend radially away from the shunt portion to form a flange like profile. The scaffold includes one or more than covering layers and encloses parts of the frame or the entire frame. The covering layer provides a barrier between the biological matter and the frame of the device. The scaffold is designed to control and direct tissue growth, for example, by stimulating an irritation response and inducing cell proliferation around the retention flange and/or discouraging cell proliferation inside the shunt portion.
Core Innovation
The invention relates to a device for treating heart failure that includes a frame and a scaffold and is transformable between a first elongated profile and a second radially expanded profile. The frame comprises a first flange portion, a second flange portion, and a shunt portion having a generally tubular shape with a first end and a second end, and the flange portions each comprise a plurality of flange segments made of two adjacent struts joining at their ends, with the flange segments joining the shunt portion along an entire circumference of the respective end.
The device further includes a scaffold configured as a first layer and a second layer, where the first layer disposes against a first surface of the frame and the second layer disposes against a second surface of the frame. The first and second layers are bonded to each other sealing around every strut forming the frame, and the sealing between the first and second layers is biased toward one of the layers such that one exterior surface of the device is even and an opposing exterior surface is uneven.
The scaffold is configured to allow the device to transform from the first elongated profile to the second radially expanded profile without introducing any stress to the frame. In the radially expanded profile, flange segments bend radially outward from the longitudinal axis of the shunt portion and adjacent struts bow apart from each other with portions of the first and second layers of the scaffold bonded between the adjacent struts.
In one configuration, scaffold between adjacent struts is folded inward along the longitudinal axis of the shunt portion when the device is in the first radially expanded profile, and the scaffold includes pore characteristics configured to maintain substantially the same pore size when the device transitions between the first elongated profile and the second radially expanded profile.
Claims Coverage
The provided content includes two independent claims. Across these claims, the inventive features focus on a scaffolded frame with dual flange portions joined to a tubular shunt, a bonded two-layer scaffold with biased sealing to create an even exterior surface on one side and an uneven exterior surface on the other, and stress-free transformation between an elongated delivery profile and a radially expanded deployed profile with specified bending and strut/scaffold behavior, including maintaining substantially the same scaffold pore size across configurations.
Two-layer bonded scaffold sealing around frame struts with biased sealing exterior surface control
The scaffold comprises a first layer and a second layer disposed against first and second surfaces of the frame, wherein the first and second layers are bonded to each other sealing around every strut that forms the frame, and wherein the sealing between the first and second layers of the scaffold is biased toward one of the first or second layer leaving one exterior surface of the device even and an opposing exterior surface of the device uneven.
Stress-free transformation between elongated and radially expanded profiles
The scaffold is configured to allow the device to transform from the first elongated profile to the second radially expanded profile without introducing any stress to the frame.
Frame geometry with flange segments of two adjacent struts joining shunt ends along entire circumference
The frame comprises a first flange portion, a second flange portion, and a shunt portion having a generally tubular shape with a first end and a second end, wherein each flange segment of the first and second flange portions is made of two adjacent struts joining each other at their ends, and the flange segments join the first end and the second end of the shunt portion along their entire circumference.
Radial outward bending and bowing apart of adjacent struts with scaffold bonded between struts in the radially expanded profile
When the device is in the second radially expanded profile, flange segments bend radially outward from the longitudinal axis of the shunt portion and adjacent struts bow apart from each other, with portions of the first and second layers of the scaffold bonded between the adjacent struts.
Folded inward scaffold between adjacent struts and substantially same pore size
When the device is in the first radially expanded profile, the scaffold between adjacent struts is folded inward along the longitudinal axis of the shunt portion, and a pore size of the scaffold maintains substantially the same when the device is in the first elongated profile and the second radially expanded profile.
Across the independent claims, the core coverage combines a frame with two flange portions formed from flange segments of two adjacent struts that join opposite ends of a tubular shunt, a two-layer scaffold bonded and sealed around every strut with biased sealing to create an even exterior surface on one side, and a scaffolded transformation mechanism that produces a radially expanded deployed configuration while maintaining stress-free frame transformation and substantially the same scaffold pore size.
Stated Advantages
Allows transformation from the first elongated profile to the second radially expanded profile without introducing any stress to the frame.
Maintains substantially the same scaffold pore size when the device is in the first elongated profile and the second radially expanded profile.
Provides an even exterior surface on one side and an opposing exterior surface that is uneven via biased sealing between scaffold layers.
Documented Applications
A device for treating heart failure, including congestive heart failure (CHF) and/or diastolic heart failure (DHF), using a pressure-relief shunt associated with a heart chamber.
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