Implant delivery
Inventors
Diedering, Jason S. • Berndt, Jonathan • Khouengboua, Sounthara • Thompson, Paul • Byron, Shelby Jo
Assignees
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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 described invention relates to an implant-delivery system for delivering an implant through a delivery catheter to a heart chamber. The implant is delivered in constrained and relaxed configurations, and strut ends are captured by a titanium hub. The hub defines a reference angle associated with a swivel body, and the swivel body can rotate through the reference angle to allow orientation while advancing the implant.
A pusher catheter and a bushing are provided such that the bushing is fixed to an end of the pusher catheter and is moved along a delivery catheter lumen to guide the implant to a keyed position at the bushing. A delivery cable engages the implant and draws the implant into the keyed position, with an end of the delivery cable including a shaft configured to engage the implant. The keyed position is achieved using engagement of a protrusion with a recess and includes a hub/hinge-block swivel structure and hub engagement structures.
The system also includes a positioner catheter and a snare for maintaining depth and supporting cinching by circumscribing an internal implant section, including an inner valve support. A gauge handle with a force gauge measures differential force between the delivery cable and the pusher catheter, and threshold forces are used to indicate proximity to material failure. The delivery cable includes a neck and a predetermined failure region configured to fail under less tension than failure of the implant, at a location inside the implant, to reduce sharp-tissue contact. The hub engagement structures and engagement between the delivery cable shaft and implant are arranged to place the predetermined failure region in the hub.
Claims Coverage
The partial content identifies three independent claims: clm-00001, clm-00022, and clm-00044. Across these independent claims, the core inventive aspects include a bushing that moves along a delivery catheter lumen to guide the implant to a keyed position, a delivery cable that engages and draws the implant into the keyed position, and mechanisms for changing implant orientation and/or a cable failure region that fails under lower tension at a location inside the implant.
Bushing-guided keyed delivery with pusher catheter
A pusher catheter and a bushing fixed to an end of the pusher catheter are moved along a delivery catheter lumen to guide the implant to a keyed position at the bushing.
Delivery cable shaft engagement to draw implant into keyed position
A delivery cable engages the implant and draws the implant into the keyed position, wherein an end of the delivery cable includes a shaft configured to engage the implant.
Passageway with positioner catheter and snare for implant orientation
The bushing defines a passageway configured to receive a positioner catheter, wherein the positioner catheter is moved through the bushing to change an orientation of the implant relative to a central axis of the delivery catheter, and a snare is moved through the positioner catheter.
Tension-limited delivery cable failure at location inside implant
A delivery cable engages the implant and draws the implant into the keyed position, and when there is tension between the delivery cable and the implant, the delivery cable fails under a tension that is less than that at which the implant fails, at a location inside the implant.
The independent claims cover delivery through a delivery catheter using a pusher catheter with a bushing that moves along the lumen to guide the implant to a keyed position, a delivery cable with a shaft end that engages and draws the implant into the keyed position, a passageway for a positioner catheter and a snare to change implant orientation relative to a central axis, and a delivery cable failure mechanism where the cable fails under less tension than the implant at a location inside the implant.
Stated Advantages
Uses threshold forces to indicate proximity to material failure.
The delivery cable predetermined failure region is configured to fail under less tension than the implant, at a location inside the implant, to reduce sharp-tissue contact.
Documented Applications
Delivering an implant through a delivery catheter to a heart chamber.
Deployment, repositioning, and recapture workflows for the implant in a heart-chamber delivery context.
Maintaining depth and supporting cinching during deployment/recapture using a positioner catheter and snare circumscribing an internal implant section.
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