Delivery systems for stents having protruding features
Inventors
Jimenez, Teodoro S. • Fulkerson, John • Rizk, Isa • Mustapha, Jihad Ali
Assignees
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Publication Number
US-12076257-B2
Publication Date
2024-09-03
Expiration Date
Abstract
Delivery systems for expandable elements, such as stents or scaffolds having spikes, flails, or other protruding features for delivering drugs and/or penetrating target tissue within a human patient and associated methods for using such systems. The delivery systems can be configured to deliver and position expandable structures within a body lumen (e.g., vessel). In addition, these delivery systems can also be configured to deploy and expand the expandable structures in the body lumen. The delivery systems can further be configured to engage with the expanded structure and collapse the structure for removal from the body lumen. The delivery systems can be configured to deliver another expandable structure or the same expandable structure to another body lumen, or the same body lumen, in a single procedure or during a plurality of procedures.
Core Innovation
The patent describes a delivery system for an expandable element, including a stent or scaffold, that is self-expanding to transform between a low-profile delivery state and an expanded deployed state for a temporary period upon delivery to a target location within a human patient. The expandable element includes barbs that extend radially outwardly in the deployed state to penetrate a portion of a body lumen for a temporary period. An elongated outer shaft sheaths at least a zone of the stent, while an elongated pusher shaft advances the stent, and an elongated inner shaft extends through a lumen of the stent.
The system further includes a stabilizing wire that is slidably disposed within a second pusher shaft lumen or within an outer shaft lumen, and that is fixedly coupled by a weld or a clamp to a proximal end of the stent or expandable element. The stabilizing wire and the stent are configured to remain coupled together as the stabilizing wire slides with respect to the elongated outer shaft. In one configuration, the proximal end of the expandable element is such that all of the struts of a radially self-expanding cylindrical frame are joined together and converge at the stabilizing wire.
The patent addresses deployment and recapturing by using shaft retraction/advancement relationships in which the outer shaft hub and pusher shaft hub are configured to retract and/or advance the outer shaft and pusher shaft such that the pusher shaft and the stent slide together with respect to the elongated outer shaft. A deployed state with barbs configured to penetrate a first portion of the body lumen is followed by a recapturing transformation in which barbs are drawn inward toward the struts and an outer shaft resheathes the stent to a low-profile removal state. Retrieval is described as being performed by a retrieval catheter that collapses and resheathes the expanded stent, enabling rescue/recapture and redeploying in one or multiple procedures.
Claims Coverage
The partial content includes three independent claims (clm-00001, clm-00007, and clm-00015). Across these claims, the inventive coverage centers on shaft-and-hub delivery architecture with an inner shaft extending through a stent lumen, a stabilizing wire fixedly coupled to a proximal end of the stent/expandable element while remaining coupled during relative sliding, and self-expanding barbs that penetrate a portion of a body lumen in the deployed state with temporary transformable delivery and recapturing behavior.
Self-expanding stent system with connector, outer and pusher shafts, and stabilized barbs
A stent system comprising a connector having a connector lumen; an elongated outer shaft fixedly coupled to an outer shaft hub, the outer shaft hub being fixedly coupled to the connector, the outer shaft having an outer shaft lumen; an elongated pusher shaft slidably disposed within the outer shaft lumen and the connector lumen and fixedly coupled to a pusher shaft hub, the pusher shaft having a first pusher shaft lumen and a second pusher shaft lumen; an elongated inner shaft slidably disposed within the first pusher shaft lumen and having an inner lumen; a stabilizing wire slidably disposed within the second pusher shaft lumen; and a stent comprising barbs, wherein the stabilizing wire is fixedly coupled by a weld or a clamp to a proximal end of the stent such that the stabilizing wire and the stent are configured remain coupled together as the stabilizing wire slides with respect to the elongated outer shaft and the stent self-expands to a deployed state with the barbs extending radially outwardly to penetrate a portion of a body lumen for a temporary period upon delivery to a target location within a human patient, the elongated inner shaft extending through a lumen of the stent.
Delivery, deployment, and recapturing system with stabilized self-expanding barbs
A system for delivering, deploying, and recapturing a stent within a body lumen of a patient, the system comprising the stent; an elongated outer shaft configured to sheath at least a zone of the stent; an outer shaft hub configured to proximally retract and/or distally advance the outer shaft; an elongated pusher shaft configured to distally advance the stent, the stent being fixedly coupled to the elongated pusher shaft, wherein the pusher shaft has a first pusher shaft lumen and a second pusher shaft lumen; a pusher shaft hub configured to proximally retract and/or distally advance the pusher shaft such that the pusher shaft and the stent are slidable together with respect to the elongated outer shaft; an elongated inner shaft slidably disposed within the first pusher shaft lumen and having an inner lumen, the elongated inner shaft extending through a lumen of the stent; and a stabilizing wire slidably disposed within the second pusher shaft lumen, wherein the stabilizing wire is fixedly coupled by a weld or a clamp to a proximal end of the stent such that the stabilizing wire and the stent are configured remain coupled together as the stabilizing wire slides with respect to the elongated outer shaft, wherein the stent is self-expanding to transform between a low-profile delivery state and an expanded deployed state for a temporary period, and wherein, in the deployed state, a plurality of barbs carried by one or more struts extend radially outwardly away from the struts and are configured to penetrate a first portion of the body lumen.
Expandable element delivery system with radially self-expanding cylindrical frame and converging struts at a stabilizing wire
A delivery system for an expandable element, the delivery system comprising a connector having a connector lumen; an outer shaft hub; an elongated outer shaft fixedly coupled to the outer shaft hub, the outer shaft hub being fixedly coupled to the connector, wherein the elongated outer shaft includes an outer shaft lumen; the expandable element carried within a distal portion of the elongated outer shaft and configured for delivery for a temporary period to a target location within a human patient, the expandable element comprising a radially self-expanding cylindrical frame having struts and barbs carried by the struts, the barbs being circumferentially spaced apart from each other along a circumference formed by the struts and extending radially in a deployed state of the expandable element to penetrate a portion of a body lumen, the barbs being distributed along a length of the frame between a proximal end and a distal end of the expandable element; a stabilizing wire slidably disposed within the outer shaft lumen and extending through an opening in the connector, wherein a distal portion of the stabilizing wire is fixedly coupled by a weld or a clamp to the proximal end of the expandable element at which all of the struts of the frame are joined together such that all of the struts converge at the stabilizing wire; and an elongated inner shaft slidably disposed within the outer shaft lumen and extending through the expandable element, wherein the stabilizing wire, the proximal end of the expandable element, and the distal end of the expandable element are slidable together with respect to the elongated outer shaft and the elongated inner shaft.
Across clm-00001, clm-00007, and clm-00015, the claims are directed to delivery architectures using an outer shaft and pusher shaft to sheath and advance a self-expanding stent/expandable element, an inner shaft extending through the stent lumen, and a stabilizing wire fixedly coupled by weld or clamp to a proximal end and configured to remain coupled during relative sliding. The expandable element is defined by radially self-expanding cylindrical frames with barbs that extend radially outwardly to penetrate a portion of a body lumen in a deployed state for a temporary period, and the system is further configured for deployment and recapturing with transformation between low-profile delivery/removal and expanded deployed states.
Stated Advantages
Enables barbs to extend radially outwardly to penetrate a portion of a body lumen for a temporary period upon delivery to a target location within a human patient.
Provides self-expanding transformable delivery from a low-profile delivery state to an expanded deployed state for a temporary period.
Supports delivery, deployment, and recapturing of a stent within a body lumen.
Allows barbs to penetrate a body lumen in the deployed state and enables resheathing/low-profile removal through recapturing transformations.
Documented Applications
Delivering, deploying, and recapturing a self-expanding stent within a body lumen of a patient.
Temporarily delivering an expandable element to a target location within a human patient, with barbs configured to penetrate a portion of a body lumen in a deployed state.
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