Implant delivery
Inventors
Diedering, Jason S. • Berndt, Jonathan • Khouengboua, Sounthara • Thompson, Paul • Byron, Shelby Jo
Assignees
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Publication Number
US-12588989-B2
Publication Date
2026-03-31
Expiration Date
Abstract
Apparatus and methods for an implant are provided. The implant may have a constrained configuration and a relaxed configuration. The implant may include a strut having an end that may be captured by a hub and may define a reference angle in the relaxed configuration. The implant may include a swivel body that may engage a shaft of a delivery cable and may be rotated through the reference angle. The apparatus may include a pusher catheter to push the implant. The delivery cable may engage the implant. The apparatus may include gauge handle that may include a force gauge to indicate the presence of a force acting on the implant. The apparatus may include a bushing that may be fixed to an end of a pusher catheter. The bushing may move along a delivery catheter lumen and may guide the implant to a keyed position at the bushing.
Core Innovation
The invention describes a transcatheter implant-delivery system that manipulates an implant in a heart chamber. The system includes a pusher catheter configured to push the implant into the heart chamber and a delivery cable configured to be engaged with the implant. The delivery system uses a constrained configuration and a relaxed configuration for the implant, and a swivel body rotatable through a reference angle to orient the implant during deployment and retraction.
The delivery system includes a main handle and a gauge handle that includes a force gauge. The force gauge is configured to indicate a presence of a force acting on the implant other than that of the delivery cable, and indicates a threshold force that is a predetermined amount less than a failure strength of a predetermined failure region included in the delivery cable.
A keyed seating arrangement is provided using a fixed bushing on the pusher catheter with a protrusion/recess and a positioner catheter with a snare to maintain implant depth and adjust orientation. The delivery cable includes a predetermined failure region and threshold force marking, such that forces above a threshold indicate material failure risk and trigger pausing or assessment during loading and recapture.
Claims Coverage
The partial claim set includes three independent claims covering an implant-manipulating apparatus with a force gauge indicating forces other than the delivery-cable force with a threshold tied to a failure strength, a gauge handle coupled to first and second bases that define cannulas for routing the delivery cable and pusher catheter, and a pin preventing rotation between the first and second bases while mounting the force gauge across a spaced arrangement.
Force gauge indicating a non-delivery-cable force with a threshold below delivery-cable failure strength
A pusher catheter configured to push the implant into a heart chamber; a delivery cable configured to be engaged with the implant; a main handle; and a gauge handle that includes a force gauge configured to indicate a presence of a force acting on the implant other than that of the delivery cable; wherein the force gauge is further configured to indicate a threshold force that is a predetermined amount less than a failure strength of a predetermined failure region included in the delivery cable.
Gauge handle coupled to spaced bases defining cannulas and unison motion when locked
A pusher catheter configured to push the implant into a heart chamber; a delivery cable configured to be engaged with the implant; a main handle; and a gauge handle that includes a force gauge configured to indicate a presence of a force acting on the implant other than that of the delivery cable and is coupled to a first base and a second base; wherein the first base is spaced apart from the second base, configured to be coupled to the delivery cable, and defines a first cannula, and wherein the second base is configured to be coupled to the pusher catheter and defines a second cannula; wherein the delivery cable is positioned within and terminates inside the first cannula and extends through the second cannula, and the pusher catheter is positioned within and terminates inside the second cannula; and wherein the main handle is configured to advance and withdraw the pusher catheter; and when the pusher catheter and the delivery cable are locked to the first and second bases, respectively, the gauge handle, the pusher catheter and the delivery cable move in unison relative to the main handle.
Pin preventing rotation between spaced bases coupled to cable and catheter
A pusher catheter configured to push the implant into a heart chamber; a delivery cable configured to be engaged with the implant; a main handle; and a gauge handle that includes a force gauge configured to indicate a presence of a force acting on the implant other than that of the delivery cable; and is coupled to a first base and a second base; wherein the first base is spaced apart from the second base and configured to be coupled to the delivery cable, and the second base is configured to be coupled to the pusher catheter; and a pin that includes a first end disposed in the first base, includes a second end disposed in the second base, and prevents the first base from rotating relative to the second base.
Across the independent claims, the patent claims an implant-manipulating apparatus that integrates a force gauge on a gauge handle to indicate a force other than that of the delivery cable, with an explicit threshold relative to a predetermined failure region in the delivery cable. Additional claim coverage specifies a gauge handle structure using first and second spaced bases with cannulas for routing the delivery cable and pusher catheter, and further constrains relative base movement using a pin that prevents rotation.
Stated Advantages
Provides indication of a presence of a force acting on the implant other than that of the delivery cable.
Provides indication of a threshold force that is a predetermined amount less than a failure strength of a predetermined failure region included in the delivery cable.
When the pusher catheter and the delivery cable are locked to the first and second bases, the gauge handle, the pusher catheter and the delivery cable move in unison relative to the main handle.
The pin prevents the first base from rotating relative to the second base.
Documented Applications
Transcatheter implant delivery in a heart chamber, including deployment and retraction with implant orientation using a swivel body rotatable through a reference angle.
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