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-11998236-B2
Publication Date
2024-06-04
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 that forms an elongated outer delivery sheath with a sheath lumen and an outer member shaft extending between a proximal end and a distal end, the shaft having a tapered outer tip and at least one tear seam extending longitudinally along a cylindrically contoured wall.
The system further includes an inner member with an elongated body and an internal channel. The inner member is removably received in and extends internally along the sheath lumen of the splittable outer member in a controllable relationship, and the inner member includes a proximal end and a tapered distal tip displaceable along a guide wire beyond the distal end of the outer delivery sheath. An interconnection mechanism disposed in operative coupling with the inner member and the splittable outer member is controllably actuated to operate the system intermittently in an engaged and disengaged mode of operation, including common displacement in the engaged mode and relative displacement in the disengaged mode.
In the disengaged mode, the splittable outer member is split along the tear seam for removal from the blood vessel of interest. The outer member shaft includes a reinforcement structure extending along a length of the outer member shaft between the proximal and distal ends of the sheath lumen, and a flexible encapsulating sheath enveloping the outer member shaft. A tear wire is encapsulated in the flexible encapsulating sheath in alignment with the tear seam, and the reinforcement structure includes a plurality of C-shaped rings coupled to a spine structure with aligned openings coinciding with the tear seam so that the tear wire is positioned in the aligned openings.
Claims Coverage
The document describes one independent claim (clm-00001). The inventive coverage centers on a splittable outer delivery sheath with a tear seam and reinforcement/tear-wire alignment, combined with a removably received inner member and an interconnection mechanism that switches between an engaged mode and a disengaged mode for splitting and removal of the outer member.
Splittable outer member with tear seam and closed/split configurations
A splittable outer member formed as an elongated outer delivery sheath defining a sheath lumen and an outer member shaft with a tapered outer tip and at least one tear seam extending longitudinally, wherein the splittable outer member assumes a closed configuration when the tear seam is intact and a split configuration when the tear seam is opened.
Removably received inner member displaceable along a guide wire
An inner member having an elongated body with an internal channel, removably received in and extending internally along the sheath lumen of the splittable outer member in a controllable relationship, and having a proximal end and a tapered distal tip displaceable along a guide wire beyond the distal end of the outer delivery sheath.
Interconnection mechanism with engaged and disengaged modes
An interconnection mechanism disposed in operative coupling with the inner member and the splittable outer member and controllably actuated to operate the intravascular delivery system intermittently in an engaged and disengaged mode of operation, wherein the inner member and splittable outer member are engaged for controllable common displacement in the engaged mode and disengaged for displacement relative to one another in the disengaged mode.
Disengaged mode splitting of outer member along tear seam for removal
In the disengaged mode of operation, the splittable outer member is split along the at least one tear seam thereof for removal from the blood vessel of interest.
Reinforced outer member shaft with flexible encapsulating sheath and tear wire aligned to tear seam
The outer member shaft includes a reinforcement structure extending along a length of the outer member shaft between the proximal and distal ends of the sheath lumen, 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.
C-shaped rings reinforcement with aligned openings for positioning tear wire
The reinforcement structure includes a plurality of C-shaped rings coupled to a spine structure and disposed in spaced apart mutual relationship along the length of the outer shaft member, with openings aligned with one another and coinciding with the at least one tear seam so that the tear wire is positioned in the aligned openings.
Overall, the independent claim coverage ties together a tear-seamed splittable outer delivery sheath with reinforcement and tear-wire alignment, a removably received inner member, and an interconnection mechanism that enables switching between engaged and disengaged modes, culminating in splitting of the outer member along the tear seam for removal.
Stated Advantages
Efficient delivery of a therapeutic catheter to a target site in a blood vessel of interest.
Documented Applications
Delivery of a therapeutic catheter to a target site in a blood vessel of interest, including intravascular delivery of a pacemaker lead to a target site in a coronary sinus branch context as described.
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