Endovascular graft system

• US 20030135261A1
• Filed: 01/14/2003
• Published: 07/17/2003
• Est. Priority Date: 12/03/1999
• Status: Active Grant

• Current Assignee: Cardinal Health Switzerland 515 GmbH (Cardinal Health, Inc.)
• Original Assignee: Chad J. Kugler, John R. Drontle, Matthew J. Olson, Peter T. Keith, Thomas K. Heiland
• Inventors: Kugler, Chad J., Drontle, John R., Olson, Matthew J., Keith, Peter T, Heiland, Thomas K.
• Granted Patent: US 6,884,260 B2
• Time in Patent Office: Days
• US Class Current: 623/1.13
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• 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 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2002/067 modular
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2220/0033 made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/008 paraboloidal

Abstract

The invention provides an endovascular graft system for repair of aneurysms. The graft system includes a trunk component and first and second leg components. The graft components include graft material supported by a plurality of stents which are spaced apart and affixed to the graft material in a manner that allows articulation of the graft system without excessive wear of the graft material. The stents are formed by intersecting struts which may be tapered to relieve stress. A stabilizing mechanism is provided to stabilize the position of the legs with respect to the trunk when the graft system is deployed.

Claims

1. An endovascular graft system capable of being deployed at a desired location within a vessel, the endovascular graft system comprising:

an aortic stent, having first and second ends;

a trunk formed of a graft material having an interior surface defining a lumen, the trunk being affixed to the second end of the aortic stent; and

a plurality of stents affixed to and supporting the interior surface of the trunk, the plurality of stents being spaced apart such that fully unsupported regions of the trunk lie between adjacent stents;

the graft material of the trunk being affixed to the aortic stent and to the plurality of stents in a manner which limits movement of the graft material with respect to the aortic stent and the plurality of stents.

2. The endovascular graft system of claim 1 wherein the graft material of the trunk is crimped toward the lumen in the unsupported regions between stents.

3. The endovascular graft system of claim 1 wherein the trunk has first and second branches configured such that the lumen comprises a main lumen and first and second branch lumens and wherein the plurality of stents includes a first stent located in the main lumen between the aortic stent and the first and second branch lumens and a plurality of second stents located in the first and second lumens.

4. A stent for placement in a vessel of a patient'"'"'s vascular system comprising:

a substantially tubular body portion having a plurality of struts, each strut having first and second ends and a midpoint located midway there between, each end of the plurality of struts intersecting with an end of at least one adjacent strut to form a plurality of strut intersections, at least one strut being configured to taper between the midpoint and the first and second ends in a manner that is gradual and substantially continuous.

5. The stent of claim 4 wherein the tubular body portion defines a longitudinal axis and has a first end and a second end and wherein a plurality of intersecting struts adjacent the first end form a substantially diamond shape pattern at the first end of the stent and a plurality of intersecting struts adjacent the second end form a substantially zigzag pattern at the second end of the stent, the diamond shape pattern and zigzag pattern being connected by a plurality of longitudinal struts, the longitudinal struts being substantially parallel to the longitudinal axis of the tubular body, and wherein the at least one strut being configured to taper is a strut adjacent the first end of the stent.

6. The stent of claim 4 wherein the at least one strut being configured to taper includes the plurality of struts adjacent the first end of the stent.

7. The stent of claim 4 wherein the at least one strut configured to taper is configured to taper from a larger dimension at the midpoint to smaller dimensions at the first and second ends.

8. The stent of claim 4 wherein the at least one stent configured to taper is configured to taper from a smaller dimension at the midpoint to larger dimensions at the first and second ends.

9. A delivery catheter for delivering and deploying an endovascular graft system at a desired location within a vessel of a patient'"'"'s vascular system comprising:

a handle;

a shaft having a distal end and a proximal end, the proximal end being connected to the handle, the shaft having an outer surface and defining an inflation lumen and a guidewire lumen;

a balloon attached at a location spaced from a distal end of the catheter, the balloon having an interior in fluid communication with the inflation lumen;

a transition element affixed to the balloon, the transition element having a distal portion between the balloon and distal end of the catheter, the distal portion being configured to provide increasing stiffness from the distal end of the catheter to the balloon, the shaft, balloon and transition element together forming a portion of an inner catheter;

an outer sheath defining a lumen containing the inner catheter, the outer sheath configured to move from an unretracted position to a retracted position, the outer sheath having a distal end positioned about the balloon when in the unretracted position.

10. The delivery catheter of claim 9 wherein the distal portion of the transition element tapers outwardly from the distal end of the catheter to the balloon.

11. The delivery catheter of claim 9 wherein the lumen of the outer sheath has a first diameter at the distal end of the outer sheath and wherein the balloon when inflated has a second diameter and wherein the second diameter is greater than the first diameter.

12. A delivery catheter for delivering an endovascular graft system at a desired location within a vessel of a patient'"'"'s vascular system comprising:

a shaft;

a first graft component positioned about the shaft;

a second graft component positioned about the shaft, the first graft component being positioned distally of the second graft component, the first graft component being configured to be deployed in the vessel prior to deployment of the second graft component, the first and second graft components each having proximal and distal portions, the distal portion of the second graft component being configured to be deployed within the proximal portion of the first graft component;

a retractable sheath defining a lumen containing the shaft and first and second graft components, the sheath being configured to deploy the first graft component when the outer sheath is withdrawn a first distance and to deploy the second graft component when the outer sheath is withdrawn a second distance; and

means for stabilizing the position of the distal portion of the second graft component with respect to the proximal portion of the first graft component when the sheath is being withdrawn the second distance.

13. A delivery catheter for delivering an endovascular graft system at a desired location within a vessel of a patient'"'"'s vascular system comprising:

a handle;

a shaft connected to the handle;

a first graft component positioned about the shaft;

a second graft component positioned about the shaft, the first graft component being positioned distally of the second graft component, the first graft component being configured to be deployed in the vessel prior to deployment of the second graft component, the first and second graft components each having proximal and distal portions, the distal portion of the second graft component being configured to be deployed within the proximal portion of the first graft component, the distal portion of the second graft component having a fastening element;

a retractable sheath defining a lumen containing the shaft and first and second graft components, the handle being configured to retract the sheath to deploy the first graft component when the outer sheath is retracted a first distance and to deploy the second graft component when the outer sheath is retracted a second distance; and

a stabilizing element connected at one end to the handle and at another end to the fastening element of the second graft component, the handle stabilizing element and fastening element being configured such that the stabilizing element is retracted in a manner that disconnects the stabilizing element from the fastening element when the second graft component is deployed.

14. The delivery catheter of claim 13 wherein the distal portion of the second graft component includes a stent and wherein the fastening element is an eyelet fixed to the stent and the stabilizing element is a wire.