Systems and methods for transseptal delivery of therapeutic devices
Inventors
Stack, Richard S. • Athas, William L. • Johnson, Kevin
Assignees
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Publication Number
US-11890031-B2
Publication Date
2024-02-06
Expiration Date
Abstract
A system and method used to deliver a percutaneous ventricular assist device (pVAD) or other cardiac therapeutic device to a site within the heart, such as a site at the aortic valve. A flexible device is percutaneously introduced into a vasculature of a patient and positioned to run from a femoral vein, through the heart via a transseptal puncture, and to a femoral artery. The venous-side end of the flexible device is withdrawn out the venous vasculature superior to the heart, and a pVAD is secured to the flexible device. The pVAD is pushed in a distal direction while the arterial-side end of the flexible device is pulled in the proximal direction to advance the pVAD to the target site. A left ventricle redirector aids in orienting the pVAD and preventing migration of the flexible member towards delicate structures of the heart during advancement of the pVAD.
Core Innovation
The invention describes systems and methods for delivering a percutaneous ventricular assist device (pVAD) to a target site in a heart of a patient using a delivery assembly that includes an advancer on a distal end of the pVAD and a flexible member routed through the patient. The delivery assembly is configured to extend from the right subclavian vein, through the heart via a transseptal puncture, and to a femoral artery, with a first end of the flexible member external to the patient at the right subclavian vein and a second end external to the patient at the femoral artery.
The advancer comprises an elongate flexible element with a distal-end diameter and a tip element on the distal end of the elongate flexible element. The tip element has a diameter greater than the diameter of the distal end of the elongate flexible member, and the flexible member includes a first end releasably engageable with the tip element on the elongate flexible element of the pVAD. In the described implementation, the delivery path is routed to traverse the interatrial septum and reaches the left ventricle and a descending aorta target region for pVAD delivery.
The invention further includes redirecting and coupling features to support transseptal, superior-access delivery of the pVAD and other non-guidewire cardiac therapeutics. A left ventricle redirector (LVR) includes an articulated, pull-wire/return-wire steerable distal curve that is locked by an external pull wire to orient the pVAD toward the aortic valve and to prevent migration toward delicate cardiac tissues during advancement. Coupling is supported by a conveyor cable with engageable tip features that can be pulled or pushed and coupled to a pVAD advancer, including a shape-memory (nitinol) element and an engageable tip for secure grasper/snare coupling.
The background problem addressed is the need to deliver a percutaneous ventricular assist device via a transseptal route using superior access, while avoiding migration toward delicate cardiac tissues and supporting delivery to a target site including the aortic valve and mitral valve regions. The described systems and methods address this by routing a flexible conduit through the heart via a transseptal puncture, using an advancer with a larger tip diameter and releasable engagement, and employing an LVR to orient the pVAD while controlling the advancement path. A second embodiment is described in which a tracker balloon catheter carries the route prior to exchanging it for the conveyor cable.
Claims Coverage
The provided independent claim defines a delivery system for delivering a pVAD to a target site in a patient’s heart, with multiple structural limitations. Dependent claims further refine the advancer configuration and add specific end-effector features at the first end of the flexible member.
Subclavian-to-femoral transseptal pVAD delivery flexible member with external ends and releasable engagement
a flexible member proportioned for introduction into a vasculature and having a length to extend from the right subclavian vein, through the heart via a transseptal puncture, and to a femoral artery such that a first end of the cable is external to the patient at the right subclavian vein and a second end of the cable is external to the patient at the femoral artery, the flexible member having a first end releasably engageable with the tip element on the elongate flexible element of the pVAD.
Advancer with elongate flexible element and larger-diameter tip element
an advancer on its distal end, the advancer comprising an elongate flexible element with a diameter at a distal end of the elongate flexible member and a tip element on the distal end of the elongate flexible member, the tip element having a diameter that is greater than the diameter of the distal end of the elongate flexible member.
Resiliently biased two-position curved/straight advancer configuration
an advancer that resiliently biases an elongate flexible element in a first curved position and moves it to a second generally straight position.
Advancer includes flexible tubular element with lumen and shape-memory core member
an advancer with a flexible tubular element containing a lumen and a shape-memory core member positioned in the lumen.
Tapered core member diameter from proximal to distal ends
the core member’s diameter narrows from the proximal end to the distal end.
Freely moveable core member within the lumen
the core member can move freely within the lumen.
Grasper at the first end of the elongate flexible member
the elongate flexible member has a grasper at its first end.
Across the provided claim set, the main inventive aspects are a transseptal delivery flexible member routed from the right subclavian vein to a femoral artery with releasable engagement to a pVAD advancer, and an advancer whose tip element has a diameter greater than the distal end of an elongate flexible element. Dependent refinements specify a resiliently biased two-position configuration, a flexible tubular element with a lumen and a shape-memory core member, a tapered core member diameter, free movement of the core member within the lumen, and a grasper at the first end.
Stated Advantages
Supports delivering a percutaneous ventricular assist device (pVAD) via a transseptal puncture using superior access from the right subclavian vein to a femoral artery.
Helps orient the pVAD toward the aortic valve using a left ventricle redirector with an articulated, steerable distal curve.
Prevents migration toward delicate cardiac tissues during advancement.
Enables secure grasper/snare coupling using an engageable tip on the pVAD advancer and engageable tip features on a conveyor cable.
Documented Applications
Transseptal, superior-access delivery of a percutaneous ventricular assist device (pVAD) to a target site in a patient’s heart, including delivery involving mitral valve and aortic valve regions.
Delivery of other non-guidewire cardiac therapeutics (as described together with the transseptal pVAD delivery system).
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