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Publication Number
US-10610210-B2
Publication Date
2020-04-07
Expiration Date
Abstract
The present disclosure relates to devices and methods for implanting a prosthesis into a heart of a mammal, such as a person. The disclosure includes a prosthesis that acts as a pressure vent between the left and right atria of the heart. The disclosure also includes a mounting tool for mounting the prosthesis onto a loading tool, the loading tool useful for loading the prosthesis onto a device for delivering the prosthesis into the patient's heart. Control devices and methods for using these devices are also disclosed. The intracardiac pressure vents disclosed allow sufficient flow from the left atrium to the right atrium to relieve elevated left atrial pressure and resulting patient symptoms. The devices also limit the amount of flow from the right atrium to the left atrium to minimize the potential for thrombi or other embolic material from entering arterial circulation.
Core Innovation
The invention relates to a method of deploying an implantable prosthesis in a patient via a placement catheter, where the placement catheter comprises an inner control wire and an outer sheath slidably disposed over the inner control wire. The implantable prosthesis includes a left atrium flange and a right atrium flange with flange segments whose distal ends are aligned with a first position of the inner control wire. The deployment includes folding the left and right atrium flanges away from each other and stowing the outer sheath onto the folded implantable prosthesis.
The method advances both the inner control wire and the outer sheath to a desired location adjacent to the atrial septum such that the distal ends of both the inner control wire and the outer sheath are in the left atrium. The desired location is verified via a non-invasive imaging technique. The outer sheath is then retracted a first instance of a fixed length proximally by a first actuation of a slider of a control device while maintaining the distal end of the inner control wire within the left atrium, thereby exposing a left atrium flange and legs of the implantable prosthesis in the left atrium while the inner control wire distal alignment is maintained.
After the left atrium flange is exposed and brought into contact with a left atrial side of the atrial septum, the outer sheath is retracted a second instance of a fixed length proximally by a second actuation of the slider while maintaining the distal end of the inner control wire within the left atrium, thereby exposing the right atrium flange in the right atrium. The first and second fixed lengths are determined by fixed lengths of a track in the control device. This sequential exposing process is performed by retracting the placement catheter and partially exposed implantable prosthesis toward the right atrium between the first and second sheath retractions.
Claims Coverage
The relevant independent claim is a method claim, with main inventive structure based on catheter-based sequential flange exposure using an inner control wire, an outer sheath, and a slider-driven control device with fixed-length track actuation.
Sequential flange exposure with inner control wire alignment
Folding a left atrium flange and a right atrium flange away from each other, stowing the outer sheath onto the folded implantable prosthesis, advancing the inner control wire and outer sheath to a desired location adjacent the atrial septum such that the distal ends are in the left atrium, and exposing a left atrium flange and legs by a first fixed-length proximal retraction while maintaining the distal end of the inner control wire within the left atrium and keeping aligning between the distal ends of flange segments and a first position.
Non-invasive verification of desired location
Verifying the desired location via a non-invasive imaging technique prior to retracting the outer sheath to expose the atrial flanges.
Fixed-length track-driven sheath retractions
Retracting the outer sheath a first instance of a fixed length proximally by a first actuation of a slider of a control device while maintaining the distal end of the inner control wire within the left atrium and exposing the left atrium flange, then retracting the placement catheter toward a right atrium until the left atrium flange is in contact with the left atrial side of the atrial septum, and retracting the outer sheath a second instance of a fixed length proximally by a second actuation of the slider while maintaining the distal end of the inner control wire within the left atrium to expose the right atrium flange, wherein the first and second fixed lengths are determined by fixed lengths of a track in the control device.
Across the independent method claim, deployment is centered on catheter advancement and non-invasive verification adjacent the atrial septum, maintaining alignment of flange segments relative to a fixed inner control wire position while sequentially exposing left and then right atrium flanges, and producing the sequential exposures through fixed-length proximal retractions of the outer sheath driven by a slider with track-determined fixed lengths.
Stated Advantages
Documented Applications
No documented applications found
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