Catheter delivery system for stent valve
Inventors
Essinger, Jacques • Delaloye, Stephane • Hefti, Jean-Luc • Mantanus, Luc
Assignees
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Publication Number
US-12268603-B2
Publication Date
2025-04-08
Expiration Date
Abstract
A delivery catheter for a stent. The delivery catheter may comprise a distal end and a proximal end. The distal end includes a stent attachment region adapted to receive a stent. The stent may be of the self-expanding type. The catheter further comprises a handle at its proximal end and at least one sheath which may at least partially circumferentially cover said stent such as to retain it in a collapsed configuration. The sheath is coupled at its proximal end to an actuator located on said handle portion.
Core Innovation
The invention relates to a delivery catheter configured to deliver a stent. The delivery catheter includes a distal end and a proximal end, where the distal end has a stent attachment region adapted to receive a stent. At least one sheath is provided to at least partially circumferentially cover the stent to retain the stent in a collapsed configuration, with the sheath coupled at a proximal end to an actuator located in or on the handle to move the sheath along the stent.
The actuator includes a manual rotary control associated with a helical threaded element that causes linear translation of the manual rotary control relative to the handle as the manual rotary control is turned. The helical threaded element is configured to present a first level of resistance to movement of the actuator relative to the handle when the distal end of the sheath has reached a first defined position on the stent, and a second level of resistance when the distal end of the sheath has reached a second defined position, with the first and second levels of resistance being different.
The disclosure further includes optional features supporting controlled positioning and operator feedback. These features include position and/or braking and tactile feedback means such as a removable stop and tactile indicators, indicia arranged for staged deployment phases, and a rotatable manually set stent-orientation indicator for commissure alignment. Additional structural features include a stem having a flexure characteristic quantified by a three-point bending test range balancing flexibility and support, gear means with different ratios along stent portions, and a distal-tip sheath partial-displacement concept configured to enhance distal flexibility without deploying the stent prematurely.
Claims Coverage
Independent claim clm-00001 is directed to a delivery catheter for delivering a stent using a sheath-retained collapsed configuration moved by a manual rotary control and a helical threaded element. The inventive coverage includes a resistance profile provided at first and second defined sheath positions, and additional inventive refinements are described across dependent claims that further specify actuation limits, mechanical characteristics, and operator feedback and positioning features. The remaining independent claims are not explicitly provided in the partial content.
Manual rotary control with helical threaded element for translating a sheath along a stent
A delivery catheter in which the actuator comprises a manual rotary control associated with a helical threaded element that causes linear translation of the manual rotary control relative to the handle as the manual rotary control is turned, with the at least one sheath coupled to the actuator and configured to move along the stent.
Different resistance levels at first and second defined sheath positions
The threaded element configured and adapted to present a first level of resistance to movement of the actuator relative to the handle when the distal end of the at least one sheath has reached a first defined position on the stent, and to present a second level of resistance when the distal end has reached a second defined position on the stent, wherein the first and second levels of resistance are different.
Limited rotation for sheath movement within an operative range
The delivery catheter arranged so that rotation of the manual rotary control moves the sheath in distal and/or proximal directions within an operative range by rotation through three turns or less around the longitudinal axis.
Actuator longitudinal length constraint
The manual rotary control is rotatable around the longitudinal axis and arranged to move the sheath in distal and/or proximal directions, the manual rotary control having a longitudinal length of at least 4 cm.
Flexure characteristic defined by a three-point bending test and applied force range
The stem portion has a flexure characteristic such that producing a flexure displacement of 10 mm using a three-point bending test requires an applied force between 2.5 and 7.5 N.
Tactile feedback guide warning operator of imminent sheath movement
A valve stent and a tactile feedback guide configured to warn an operator that the distal end of the sheath is about to move over the proximal end of the stent.
Valve stent with portions engaging opposite sides of a native aortic valve annulus
A valve stent in which the valve stent comprises first and second portions configured to engage opposite sides of a native aortic valve annulus.
Overall claim coverage centers on a delivery catheter with a sheath retaining a collapsed stent configuration, where sheath movement is driven by a manual rotary control and a helical threaded element that provides linear translation. The key inventive distinction is the threaded element presenting different levels of resistance at first and second defined sheath positions, supplemented by dependent refinements that specify rotation limits, actuator dimensions, flexure performance, and operator feedback and positioning features, including a tactile warning guide and a rotatable/manual orientation indicator as described in the partial content.
Stated Advantages
Documented Applications
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