Catheter system for stenting bifurcated vessels
Inventors
Hilaire, Pierre • Van Der Leest, Machiel
Assignees
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Publication Number
US-7713296-B2
Publication Date
2010-05-11
Expiration Date
Abstract
A stenting system includes a stent delivery catheter having a catheter shaft with a step balloon mounted thereon. The step balloon has a proximal portion and a distal portion, wherein the proximal portion is inflatable to a larger expanded diameter than the distal portion. A two-part stent has a proximal part that is mounted on the proximal portion of the step balloon and a distal part that is mounted on the distal portion of the step balloon and a non-link zone between the proximal part and the distal part of the two-part stent. The proximal part and the distal part of the two-part stent are each configured with stent struts that extend like interdigitating fingers into the non-link zone to provide improved strut coverage in the carina region of the bifurcated vessel. The non-link zone effectively eliminates any difficulties in alignment of the two parts relative to one another during placement of the two-part stent in a bifurcated vessel.
Core Innovation
A catheter-based bifurcation stenting system is provided with a stent delivery catheter that includes a step balloon mounted thereon. The step balloon has a stent-carrying proximal portion and a stent-carrying distal portion, and the proximal portion is inflatable to a larger expanded diameter than the distal portion with a step in the diameter of the step balloon.
The two-part stent includes a non-link zone with no links or physical connections between the proximal part and the distal part of the two-part stent. During deployment, stent struts extend across the non-link zone as interdigitating structures, in which distally-extending stent struts and proximally-extending stent struts extend toward one another.
The interdigitation of the struts across the non-linked region is described as improving carina strut coverage and mitigating alignment problems between the proximal and distal stent parts. In an unexpanded condition, the proximal part and the distal part have approximately the same unexpanded diameter and the opposed stent struts interdigitate within the non-link zone, while in an expanded condition the proximal part has an expanded diameter larger than the expanded diameter of the distal part and only a portion of the struts interdigitate.
Claims Coverage
The document includes two independent claim sets that define a stenting system with a step balloon and a corresponding two-part stent structure. Across these independent claims, four inventive features are specified: step-balloon diameter stepping for proximal versus distal expansion, a non-link zone with no physical connections between stent parts, interdigitating stent struts within the non-link zone, and condition-dependent interdigitation with a larger proximal expanded diameter.
Step balloon with proximal larger expanded diameter and diameter step
A stent delivery catheter having a catheter shaft with a step balloon mounted thereon, the step balloon having a stent-carrying proximal portion and a stent-carrying distal portion, wherein the proximal portion is inflatable to a larger expanded diameter than the distal portion with a step in the diameter of the step balloon between the stent-carrying proximal portion and the stent-carrying distal portion.
Two-part stent separated by non-link zone with no physical connections
A two-part stent having a proximal part mounted on the proximal portion of the step balloon and a distal part mounted on the distal portion of the step balloon, and a non-link zone with no links or physical connections between the proximal part and the distal part of the two-part stent.
Interdigitation of distally- and proximally-extending struts within the non-link zone
A plurality of distally-extending stent struts extending distally from a distal end of the proximal part of the two-part stent and a plurality of proximally-extending stent struts extending proximally from a proximal end of the distal part of the two-part stent, wherein the distally-extending stent struts interdigitate with the proximally-extending stent struts within the non-link zone.
Condition-dependent interdigitation and proximal expanded diameter larger than distal expanded diameter
The two-part stent has an unexpanded condition and an expanded condition, wherein in the unexpanded condition the proximal part and the distal part have approximately the same unexpanded diameter and the distally-extending stent struts interdigitate with the proximally-extending stent struts within the non-link zone, and wherein in the expanded condition the proximal part has an expanded diameter that is larger than an expanded diameter of the distal part and only a portion of the distally-extending stent struts interdigitate with a portion of the proximally-extending stent struts within the non-link zone.
Overall, the independent claims cover a stenting system and corresponding two-part stent in which proximal-versus-distal expansion is produced by a step balloon with a diameter step, stent parts are separated by a non-link zone with no physical connections, and interdigitating strut engagement within the non-link zone transitions between full interdigitation in an unexpanded condition and partial interdigitation in an expanded condition where the proximal part is larger in expanded diameter.
Stated Advantages
Improves carina strut coverage.
Mitigates alignment problems between the proximal and distal stent parts.
Documented Applications
Bifurcation stenting using a catheter-based step-balloon and two-part stent deployment in a bifurcated vessel/sidebranch, including provisional stenting technique and kissing balloon technique setups.
Catheter alignment using linking devices for side-by-side catheter alignment with releasability/auto-release, including split-tube peel-away sheath configurations.
Low-profile tandem or staggered bifurcation stenting configurations using flexible tubular extensions.
Use of bifurcation-optimized stent strut designs with region division for differential expansion, including carina and proximal/distal areas.
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