Prosthesis, delivery system and method for neurovascular aneurysm repair

• US 20060004438A1
• Filed: 06/15/2005
• Published: 01/05/2006
• Est. Priority Date: 04/30/2004
• Status: Abandoned Application

• Current Assignee: NovoStent Corp.
• Original Assignee: NovoStent Corp.
• Inventors: Leopold, Eric, Chi, David, Alexander, Miles
• Application Number:
  US11/154,056
• Publication Number:
  US 20060004438A1
• Time in Patent Office: Days
• US Class Current: 623/1.220
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• 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 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/91525 within the whole structure different bands showing different meander characteristics, e.g. frequency or amplitude
• CPC Class Codes: A61F 2002/91533 characterised by the phase between adjacent bands
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2230/0054 V-shaped

Abstract

The present invention is directed to a prosthesis for treating an aneurysm, and delivery systems and methods therefor. The prosthesis includes a radially expanding distal section coupled to a helical section, the helical section including a localized feature configured to exclude or retard blood flow into an aneurysm. Methods of loading the prosthesis onto a specially-designed delivery system that facilitates proper orientation of the prosthesis within a target vessel, and methods of using the delivery system to deliver the prosthesis, also are provided.

Claims

1. A prosthesis for treating a vascular aneurysm, the prosthesis comprising:

a distal section;

a helical section coupled to the distal section at a junction, the helical section comprising a plurality of turns; and

a feature disposed on the helical section, the feature configured to retard or exclude blood flow into the aneurysm,

wherein the prosthesis has a contracted delivery configuration and an expanded deployed configuration, and adjacent turns of the helical section overlap one another in the contracted delivery configuration.

2. The prosthesis of claim 1, wherein the feature comprises an area of the helical section having a locally denser concentration of material than adjacent regions of the helical section, wherein the area is configured to span the neck of the aneurysm.

3. The prosthesis of claim 2, wherein the feature comprises a multiplicity of struts.

4. The prosthesis of claim 1, wherein the feature comprises graft material disposed on a predetermined area of the helical section.

5. The prosthesis of claim 1, wherein the feature is disposed at a predetermined axial and angular position on the helical body during manufacture.

6. The prosthesis of claim 1, further comprising a radio-opaque mark disposed on the helical section that indicates the location of the feature.

7. The prosthesis of claim 5, wherein the angular position of the feature is determined by the equation:

r=360*x/Π

*D*tan(θ

),

wherein r is an angular distance from a predefined reference point,

x is an axial distance from the reference point,

θ

is an angle of the helical section in the expanded deployed configuration and

D is a diameter of the helical section in the expanded deployed configuration.

8. The prosthesis of claim 1, wherein the angular location of the feature may be determined at different diameters from the equation:

r₂=D₁*r₁/D₂,

wherein r₁ is the initial angular location,

D₁ is a diameter of the helical section in the contracted delivery configuration, and

D₂ is a diameter of the helical section in the expanded deployed configuration.

9. A method of marking a location of a feature on a prosthesis to be placed adjacent to an aneurysm using a delivery catheter, the prosthesis having a contracted delivery configuration and an expanded deployed configuration, the delivery catheter comprising a helical ledge affixed to its outer surface, the method comprising steps of:

selecting a reference point on the delivery catheter;

determining an axial location of the reference point;

determining an angular location of the feature; and

placing a radio-opaque mark on the prosthesis to indicate the expected location of the feature.

10. The method of claim 9, wherein a distal end of the helical ledge is used as the reference point.

11. The method of claim 9, wherein the axial location of the feature is predetermined, and the angular location of the feature is determined using the formula:

r=360*x/Π

*D*tan(θ

),

wherein r is angular distance from the reference point,

x is an axial distance from the reference point,

θ

is an angle of the helical section in the expanded deployed configuration and

D is a diameter of the helical section in the expanded deployed configuration.

12. The method of claim 9, further comprising placing the prosthesis adjacent to the aneurysm using the radio-opaque mark disposed on the prosthesis.

13. Apparatus for treating an aneurysm, the apparatus comprising:

a prosthesis comprising a self-expanding helical section having a contracted delivery configuration and a deployed configuration; and

a delivery catheter comprising;

a sheath having proximal and distal ends and a lumen extending therethrough; and

an inner member configured to be slidably received within the lumen of the sheath, the inner member having an outer surface defining a helical ledge and a non-circular cross-section, wherein the non-circular cross-section facilitates angular orientation of the prosthesis within a body vessel.

14. The apparatus of claim 13, wherein the inner member has an elliptical cross-section.

15. The apparatus of claim 13, wherein the inner member includes major and minor axes, the major axis configured to place the prosthesis in apposition to an aneurysm.

16. The apparatus of claim 13, wherein the prosthesis includes a feature disposed on the helical section, the feature configured to exclude or retard blood flow into the aneurysm.

17. The apparatus of claim 15, wherein the feature comprises an area of locally higher strut density.

18. The apparatus of claim 15, wherein the feature comprises an area of graft material.

19. The apparatus of claim 13, wherein the non-circular cross-section of the inner member causes the delivery catheter to enter tortuous anatomy with a known orientation.

20. The apparatus of claim 13, wherein the delivery catheter automatically orients itself within a vessel so that a feature of the prosthesis is disposed in apposition to the aneurysm.