Enhanced guide extension system for the efficient delivery of leads
Inventors
Fischell, Tim A. • Saltiel, Frank S. • LIU, XIAOKE • Payne, Jeffrey D.
Assignees
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Publication Number
US-12268417-B2
Publication Date
2025-04-08
Expiration Date
Abstract
Intravascular delivery system is designed for a safe and efficient access to secondary and tertiary vascular structures, such as the branches of the coronary sinus, to enhance the delivery and deployment of various catheters, such as, for example, pacemaker electrical leads. The over-the-wire system features a straight, or alternatively shaped, micro-catheter distal tip of an inner catheter that seamlessly cooperates with a peel-away reinforced outer catheter. The inner catheter and the peel-away reinforced outer catheter are advanced in their engaged mode of operation towards (or beyond) the target site. Subsequently, the inner and outer catheters are disengaged, and the inner catheter is removed from the outer catheter. A pacemaker lead may be advanced over the wire inside the outer catheter to the target site for deployment. Subsequently, the outer catheter is easily split and may be rapidly removed from the blood vessel.
Core Innovation
The invention relates to an intravascular delivery system configured for efficient delivery of a therapeutic catheter to a target site in a blood vessel of interest. The system includes a splittable outer member forming an elongated outer delivery sheath with a sheath lumen and at least one tear seam extending longitudinally along a cylindrically contoured wall, such that the outer member assumes a closed configuration when the tear seam is intact and a split configuration when the tear seam is opened.
The splittable outer member further includes a reinforcement structure extending along a length of the outer member shaft, and a flexible encapsulating sheath enveloping the outer member shaft. A tear wire is encapsulated in the flexible encapsulating sheath in alignment with the at least one tear seam of the outer member shaft. An inner member is removably received in and extends internally along the sheath lumen of the splittable outer member in a controllable relationship, and has a tapered distal tip displaceable along a guide wire beyond the distal end of the outer delivery sheath.
An interconnection mechanism is disposed in operative coupling with the inner member and the splittable outer member and controllably actuated to operate the system intermittently in an engaged and disengaged mode of operation. In the engaged mode, the inner member and splittable outer member are engaged for a controllable common displacement along the guide wire. In the disengaged mode, the inner and outer members are disengaged for displacement relative to one another, and the splittable outer member is split along the at least one tear seam for removal from the blood vessel of interest.
Claims Coverage
The provided independent claim defines an intravascular delivery system with an inner member and a splittable outer delivery sheath that transitions from a closed configuration to a split configuration, controlled by an intermittently actuated engaged/disengaged interconnection mechanism. The claim includes reinforcement and tear-wire alignment features, and specifies hub and tear-groove splitting architecture with controllable displacement.
Splittable outer delivery sheath with longitudinal tear seam
An elongated outer delivery sheath with a sheath lumen and at least one tear seam extending longitudinally along a cylindrically contoured wall, where the outer member assumes a closed configuration when the tear seam is intact and a split configuration when the tear seam is opened.
Reinforcement structure with flexible encapsulating sheath and tear wire aligned to tear seam
An outer member shaft that includes a reinforcement structure extending along its length, with a flexible encapsulating sheath enveloping the outer member shaft and a tear wire encapsulated in the flexible encapsulating sheath in alignment with the at least one tear seam.
Removably received inner member displaceable along guide wire
An inner member having a proximal end and a tapered distal tip, removably received in and extending internally along the sheath lumen of the splittable outer member in a controllable relationship, and displaceable along a guide wire beyond the distal end of the outer delivery sheath.
Interconnection mechanism providing engaged and disengaged mode operation
An interconnection mechanism disposed in operative coupling with the inner member and the splittable outer member and controllably actuated to operate the system intermittently in an engaged and disengaged mode of operation, where the engaged mode provides controllable common displacement along the guide wire and the disengaged mode provides relative displacement.
Splittable outer member hub with tear grooves aligned to tear seams
A splittable outer member hub secured to the proximal end of the sheath lumen, with at least one tear groove extending longitudinally between proximal and distal ends and aligned with the at least one tear seam, such that the hub assumes a closed configuration when the tear groove is closed and a split configuration when the tear groove is opened.
Interrelation between inner hub and outer hub
An interrelation between the inner member hub and the splittable outer member hub configured to prevent or permit displacement of the inner member relative to the outer member.
Hub splitting and threaded collar cooperation
The splittable outer member hub is split along the at least one tear groove in the disengaged mode of operation, and the splittable outer member hub comprises external threads proximal to a pair of wing members, with a rotating threaded collar positioned externally on a distal portion of the inner member hub such that the external threads cooperate with a first portion of internal threads of the rotating threaded collar.
Overall, the independent claim centers on an intravascular delivery system that couples an inner displaceable member to a tear-splittable outer delivery sheath via an intermittently actuated engaged/disengaged interconnection mechanism. The outer sheath is structurally characterized by longitudinal tear seams, tear wire alignment, and reinforcement, while hub tear grooves aligned to the tear seams and threaded collar cooperation support transition to the split configuration for removal.
Stated Advantages
Efficient delivery of a therapeutic catheter to a target site in a blood vessel of interest.
Controllable common displacement along the guide wire during an engaged mode of operation.
Removal from the blood vessel of interest by splitting along the tear seam in a disengaged mode of operation.
Documented Applications
Efficient delivery of a therapeutic catheter to a target site in a blood vessel of interest.
Delivery of pacemaker leads to complex venous targets (e.g., coronary sinus branches) using an over-the-wire intravascular guide extension system [procedural detail omitted for safety].
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