Systems, devices and methods for delivery systems
Inventors
Wallace, Daniel T. • Gregg, Peter W. • Boyette, Jeremy J. • Haynes, Evelyn N. • Noe, Spencer C.
Assignees
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Publication Number
US-12048639-B2
Publication Date
2024-07-30
Expiration Date
Abstract
Delivery systems for expandable and stented implants include adjustable tensioning members that control the expansion of the implant along the length of the implant. The tensioning members are wound onto one or more rotors located on the distal segment of the delivery system, which are rotated to unwind the tensioning members and incrementally expand the implant. Positioning mechanisms are also provided to adjust the position and orientation of the implant during delivery.
Core Innovation
The invention relates to a delivery system for self-expanding/stented implants that uses a rotatable drive shaft and a distal stator housing with an internal opening and an external opening to support a rotor disc. The rotor disc includes a plurality of tension line attachment sites, enabling wound tensioning members to be incrementally unwound and an implant to be extended or expanded while a movable sheath retracts to expose a distal section of the catheter body.
The system supports controlled expansion across multiple rotors and stators, including simultaneous equal-rate, sequential expansion, or differential-rate expansion. Differential-rate behavior is described as resulting from rotor geometry and diameter and from the number of tension members, and in double-wall stent embodiments the invention describes a controlled release sequence between an outer wall and an inner wall during expansion.
The invention further includes distal catheter construction and rotor/stator configurations in which tension lines are routed through openings in the stator housing to manage friction and release behavior during rotor actuation. In addition, the delivery system includes steering and positioning mechanisms using segmented two-way and four-way steering assemblies with non-planar segment interfaces having hyperbolic paraboloid configurations and bumpers to guide bending and pose, a catheter extension assembly using a worm/lead screw to reversibly adjust longitudinal spacing, and user controls including actuator knobs, dials, and a rotor lock with a handle lever.
Claims Coverage
The provided independent claim coverage centers on one independent claim, with four inventive features. It combines a proximal actuator-controlled rotatable drive shaft, a distal stator housing with defined openings, a rotor disc carrying multiple tension line attachment sites, and a movable retractable sheath that exposes the distal section during delivery.
Proximal handle and rotatable drive shaft in catheter body
A proximal handle comprising a handle housing and a first actuator, and a rotatable drive shaft coupled to the first actuator and located in the catheter body.
Catheter body with distal, middle, and proximal sections and retractable sheath
A catheter body having a distal section, a proximal section coupled to the proximal handle, and a middle section therebetween, with a movable sheath configured to retract and expose the distal section.
Distal stator housing with internal and external openings
A first stator housing attached to the distal section of the catheter body and distal from the proximal handle, the first stator housing comprising an internal opening and an external opening.
Rotor disc with tension line attachment sites coupled to drive shaft
A first rotor disc attached to the rotatable drive shaft and located in the first stator housing, the first rotor disc comprising a plurality of tension line attachment sites.
The claim coverage is directed to a delivery system architecture combining a proximal actuator-controlled rotatable drive shaft, a distal stator housing with internal and external openings, a rotor disc with multiple tension line attachment sites, and a movable retractable sheath that exposes the distal section during delivery.
Stated Advantages
Reduces stretching and slippage effects during expansion while enabling controlled incremental unwinding and expansion of the implant.
Documented Applications
Mitral valve replacement procedure [procedural detail omitted for safety].
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