Repositioning wires and methods for repositioning prosthetic heart valve devices within a heart chamber and related systems, devices and methods

Inventors

Diedering, Jason S. • Kumar, Saravana B.

Assignees

4C Medical Technologies Inc

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Publication Number

US-11000000-B2

Patent

Publication Date

2021-05-11

Expiration Date


Abstract

The invention provides methods, devices and systems for delivering, positioning and/or repositioning an expandable prosthetic heart valve in a patient's heart chamber. At least one non-looped wire and looped wire pair is operatively connected with an expanded prosthetic heart valve that is collapsed within a delivery catheter lumen having its distal end positioned in the subject heart chamber. The collapsed prosthetic heart valve is translated through the delivery catheter lumen to and out of its distal end where the prosthetic heart valve expands to a working configuration. The wire(s) of the non-looped and looped wire pair may be manipulated by pulling proximately or pushing distally to position or reposition the expanded prosthetic stent into position, then released from connection with the positioned stent and withdrawn from the patient.

Core Innovation

The invention provides a method for delivering, positioning and/or repositioning a collapsible and expandable stent having a stent frame within a patient's heart chamber. The method uses at least three non-looped wire and looped wire pairs whose distal ends are operatively and releasably connected with a corresponding junction between two struts of the stent, and proximal ends of each wire extend outside the patient.

A delivery catheter is provided having a lumen with a proximal end and a distal end, with positioning of the distal end within the heart chamber. The stent is advanced in an expanded configuration into the proximal end of the lumen of the delivery catheter, then collapsed to a collapsed configuration and translated distally through the lumen, delivered out of the distal end of the lumen, and expanded to an expanded working configuration.

After positioning, the method releases the non-looped wire from the looped wire to disconnect each of the at least three non-looped wire and looped wire pairs from the expanded and positioned stent. Finally, each non-looped wire and looped wire is withdrawn proximally through the delivery catheter lumen, supporting repositioning by unlocking and disconnecting the wire pairs from the expanded stent after manipulation.

Claims Coverage

The patent includes one independent method claim defining the delivery, positioning or repositioning, wire-pair connection, release or disconnection, and withdrawal sequence using at least three non-looped and looped wire pairs connected to stent strut junctions.

Non-looped and looped wire pairs connected at stent strut junctions

At least three non-looped wire and looped wire pairs have distal ends operatively and releasably connected with a corresponding junction between two struts of the stent, with the non-looped wire wrapping around the junction and extending through a loop formed on the distal end of the looped wire, and proximal ends of each wire extending outside the patient.

Catheter lumen translation for collapsed and expanded configurations

A delivery catheter comprises a lumen with a proximal end and a distal end, the distal end is positioned within the heart chamber, the stent is advanced in an expanded configuration into the proximal end, collapsed to a collapsed configuration, translated distally through the lumen, delivered out of the distal end, and expanded to an expanded working configuration.

Wire manipulation to position the expanded stent in the heart chamber

The proximal ends of each wire in the at least three non-looped wire and looped wire pairs are manipulated to position the expanded stent within the patient's heart chamber.

Releasing and disconnecting the non-looped wire from the looped wire

The non-looped wire is released from the looped wire to disconnect each of the at least three non-looped wire and looped wire pairs from the expanded and positioned stent, and each wire is withdrawn proximally through the delivery catheter lumen.

Overall, the independent claim centers on connecting at least three non-looped and looped wire pairs to stent strut junctions, translating a collapsed expandable stent through a delivery catheter lumen, manipulating proximal wire ends to position the stent, and then releasing the non-looped wire from the looped wire to disconnect and withdraw the wires through the catheter.

Stated Advantages

Documented Applications

No documented applications found

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