Bifurcated stent and delivery system

• US 8,932,340 B2
• Filed: 05/29/2008
• Issued: 01/13/2015
• Est. Priority Date: 05/29/2008
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Meyer, Michael P., Davis, Michael W., Arcand, Benjamin, Rassat, Jay, Anderson, James, Sutermeister, Derek
• Primary Examiner(s): FISHBACK, ASHLEY LAUREN
• Application Number:
  US12/129,372
• Publication Number:
  US 20090299460A1
• Time in Patent Office: 2,420 Days
• Field of Search: 604/96.01, 60410101-10105, 60410306-10308, 604/284, 606/108, 606/153, 606191-192, 606194-195, 606/198, 623 111- 112, 623/1.23, 623/1.35, 623/1.15
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/856 Single tubular stent with a side portal passage
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61M 2025/1013 with concentrically mounted balloons, e.g. being independently inflatable

Abstract

A delivery system has a stent and a balloon. The stent has a first section made of a plurality of interconnected framework members which define a plurality of potential side branches. The balloon is a dual lumen balloon that can inflate from the proximal end to the distal end with a plurality of protrusions and/or herniations.

Claims

1. A catheter assembly comprising:

a catheter, the catheter comprising;

an inner shaft, the inner shaft defining an inner inflation lumen;

an outer shaft, the outer shaft disposed about the inner shaft, the outer shaft defining an outer inflation lumen;

a dual lumen balloon, the dual lumen balloon comprising;

an inner balloon, the inner balloon being made of non-compliant polymeric material, the inner balloon being in fluid communication with the inner inflation lumen;

an outer balloon, the outer balloon being disposed about and coextensive with the inner balloon, the entire outer balloon being made of a compliant polymeric material so that the entire balloon is compliant, the outer balloon being in fluid communication with the outer inflation lumen,

the dual lumen balloon having an unexpanded state when both the inner balloon and the outer balloon are uninflated; and

a stent, the stent disposed about the dual lumen balloon, the stent having a unexpanded state with an unexpanded diameter for delivery to an implantation site, the stent being radially expandable from the unexpanded state, the stent being in the unexpanded state when the dual lumen balloon is in the unexpanded state.

2. The catheter assembly of claim 1, wherein the inner balloon is configured to inflate at a first pressure and the entire outer balloon is configured to inflate at a second pressure, the second pressure being less than the first pressure.

3. The catheter assembly of claim 1, wherein the non-compliant polymeric material is selected from the group consisting of polyethylene terephthalates, polyacrylenesulfides and copolyesters and the compliant polymeric material is selected from the group consisting of nylon and polyamines.

4. The stent of claim 1, each of the plurality of circumferential bands of struts having a zig-zag pathway about the circumference of the stent.

5. The stent of claim 1, the stent having a circumferential axis, the plurality of serpentine rings comprising a first portion of serpentine rings and a second portion of serpentine rings, the first portion of serpentine rings positioned about the circumference of the stent on a first circumferential axis, the second portion of serpentine rings positioned about the circumference of the stent on a second circumferential axis, the first circumferential axis longitudinally separated from the second circumferential axis, one of the plurality of circumferential bands of struts positioned between the first and second portions of serpentine rings.

6. The catheter assembly of claim 1, wherein the unexpanded diameter of the stent is less than a diameter of the inner balloon when inflated for deployment of the stent.

7. The catheter assembly of claim 1, the dual lumen balloon having a first expanded state wherein only the inner balloon is in the inflated state, the stent being radially expandable to a deployed state from the unexpanded state for deployment at an implantation site, wherein the stent is in the deployed state when the dual lumen balloon is in the first expanded state.

8. The catheter assembly of claim 7, the dual lumen balloon having a second expanded state for expanding a side branch of the stent into a side branch lumen of an implantation site, the side branch being expanded after the stent is in the deployed state, wherein the outer balloon is inflated when the dual lumen balloon is in the second expanded state.

9. A catheter assembly comprising:

a catheter, the catheter comprising;

an inner shaft, the inner shaft defining an inner inflation lumen;

an outer shaft, the outer shaft disposed about the inner shaft, the outer shaft defining an outer inflation lumen;

a dual lumen balloon, the dual lumen balloon comprising;

an inner balloon, the inner balloon being made of non-compliant material, the inner balloon being in fluid communication with the inner inflation lumen;

an outer balloon, the outer balloon being disposed about and coextensive with the inner balloon, the outer balloon having a longitudinal length and being made of a compliant material, the compliant material having a compliancy that is the same along the longitudinal length of the outer balloon, the outer balloon being in fluid communication with the outer inflation lumen;

a stent with a side branch, the side branch forming a part of a wall of the stent when undeployed and extending away from an outer surface of the wall when deployed, the stent disposed about the dual lumen balloon, the stent and the side branch being separately deployable with the stent being deployed by the inner balloon and the side branch being deployed by the outer balloon and the stent having a tubular body, the stent having an unexpanded state and an expanded state, the tubular body having a wall, the wall having a first section comprising;

a plurality of circumferential bands of struts;

a plurality of serpentine rings, each serpentine ring being a side branch, each serpentine ring defining a first cell and a plurality of petals extending toward a center of the first cell when the side branch is in the undeployed state, the plurality of petals of the serpentine ring being positioned at an angle to the wall of the stent when the side branch is in the deployed state; and

a plurality of connecting members engaging each serpentine ring to at least one of the plurality of circumferential bands so that each serpentine ring is engaged only to one or more circumferential bands.

10. A catheter assembly comprising:

a catheter, the catheter comprising;

an inner shaft, the inner shaft defining an inner inflation lumen;

an outer shaft, the outer shaft positioned around the inner shaft, the outer shaft defining an outer inflation lumen;

a dual lumen balloon, the dual lumen balloon comprising;

an inner balloon, the inner balloon inflatable at a first pressure, the inner balloon being in fluid communication with the inner inflation lumen;

an outer balloon, the outer balloon being disposed around and coextensive with the inner balloon, the outer balloon having a longitudinal length extending from a first end to a second end, the longitudinal length of the outer balloon inflatable at a second pressure less than the first pressure, the outer balloon being in fluid communication with the outer inflation lumen; and

a stent, the stent having an unexpanded diameter when positioned on the dual lumen balloon;

wherein inflation of the inner balloon radially expands the stent to an expanded diameter greater than the unexpanded diameter.

11. The catheter assembly of claim 10, wherein inflation of the outer balloon expands a portion of the stent outward relative to an outer surface of the stent in the expanded diameter.