Retrievable devices for treating heart failure
Inventors
Forcucci, Stephen J. • Finch, Matthew J.
Assignees
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Publication Number
US-10463477-B2
Publication Date
2019-11-05
Expiration Date
Abstract
The present teachings provide devices 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 distal portion, a middle portion, and a proximal portion. The distal portion and proximal portion of the device are configured to be deployed inside the left and right atrium respectively with a minimum contact with the septal tissue. The middle portion of the device is configured to secure the device across an aperture on the atrial septum. The device further includes at least one retrieval portion with a plurality of struts. The distal end of the struts is connected with a proximal end of the proximal portions. The proximal end of the struts come together at a location near the axial center of the device. The radial expansion of the proximal portion will lead to the radially outward movement of the struts. And a radially inward movement of the struts will cause the proximal portion of the device to collapse radially. The device includes a delivery profile and a deployment profile.
Core Innovation
The patent describes a retrievable atrial septum pressure-regulating and shunt device configured to be positioned across an aperture in an atrial septum. The device includes a distal portion and a proximal portion joined by a middle portion spanning the atrial septal aperture, with an internal opening for blood flow in the radially expanded state. In the deployed geometry, the distal and proximal portions have first elongated configurations and second radially expanded configurations, with relative size differences between ends in the expanded configuration.
The device further includes a first retrieval portion joining the proximal end of the proximal portion, and a second retrieval portion joining the distal end of the distal portion. The retrieval portions include pluralities of struts that enable radial collapse, allowing the proximal and/or distal portions to be radially collapsed for catheter-based repositioning or removal. The retrieval struts maintain minimal septal tissue contact while enabling retrieval.
In additional embodiments, the device employs self-centering and controllable geometry, including a middle portion that spans the aperture and a narrowest middle portion arrangement. Deployment geometries include frusto-conical shapes for the distal and/or proximal portions, and the device may use flexible and/or stiffer regions via varying thickness or rigidity. The patent also describes embodiments using a lattice/frame architecture with lengthwise supports joined by perimeter supports, and first and second retrieval struts connected to proximal and distal ends, with lengthwise supports transitioning from a generally straight configuration to a second configuration in which both ends bend radially outward while at least one place between ends remains unchanged.
Claims Coverage
The independent claims define a retrievable device configured to be positioned across an atrial septum aperture with distinct distal, middle, and proximal portions, including retrieval portions/struts. The claim set centers on two inventive feature clusters: a multi-portion radially expandable device with retrieval portions and strut geometry, and a frame-like structure with lengthwise and perimeter supports plus first and second retrieval struts and a specific straight-to-bent geometric transition.
Retrievable atrial septum spanning device with distal, middle, and proximal portions and radially expanded configuration
A device configured to be positioned across an aperture in an atrial septum comprising a distal portion with first elongated configuration and second radially expanded configuration, a proximal portion with first elongated configuration and second radially expanded configuration, and a middle portion joining the distal end of the proximal portion to the proximal end of the distal portion.
First retrieval portion with plural struts that are straightened and kept close proximally while transitioning radially outward
A first retrieval portion joining the proximal end of the proximal portion, wherein the first retrieval portion has a plurality of struts, and the retrieval portion has a first elongated configuration wherein the plurality of struts are straightened and kept close to one another and proximal to the elongated proximal portion, and a second radially expanded configuration wherein one end of at least one of the plurality of struts is positioned radially outwardly from the other end of the strut.
Second retrieval portion with a plurality of struts at the distal end portion
A second retrieval portion joining the distal end of the distal portion, wherein the second retrieval portion also has a plurality of struts.
Frame with lengthwise supports joined by perimeter supports plus first and second retrieval struts
A device configured to be positioned across an aperture in an atrial septum comprising a plurality of lengthwise supports joining together with a plurality of perimeter supports, at least one perimeter support joining a distal end of the plurality of lengthwise supports, at least one perimeter support joining the proximal end of the plurality of lengthwise supports, and at least one perimeter support joining the plurality of lengthwise supports between the distal and proximal ends, plus a plurality of first retrieval struts and a plurality of second retrieval struts joined to the proximal and distal ends of the lengthwise supports.
Lengthwise support geometry transition with radially outward bending at both ends while an intermediate place remains unchanged
The lengthwise supports have a first generally straight configuration, and a second configuration wherein both ends of the lengthwise supports bend radially outwardly while at least one place between the two ends remains unchanged.
Across the independent claims, the inventive coverage is directed to atrial septum aperture spanning devices that transition between elongated and radially expanded configurations and that include retrieval structures connected to proximal and distal ends. One claim family focuses on distal, proximal, and middle portions joined across the aperture with retrieval portion struts, while the other claim family specifies a perimeter/lengthwise support frame with first and second retrieval struts and a defined geometry transition of the lengthwise supports.
Stated Advantages
Reduces elevated left-sided chamber pressure.
Avoids embolization.
Maintains minimal septal tissue contact during radial collapse for retrieval, repositioning, and removal.
Enables catheter-based repositioning and removal through radially collapsing proximal and/or distal portions.
Documented Applications
Used for diastolic heart failure (DHF) and congestive heart failure (CHF) through an atrial septum pressure-regulating/shunt device positioned across an atrial septal aperture.
Described in contexts involving patent foramen ovale (PFO) and atrial septal defect (ASD) with an atrial septal aperture.
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