Intravascular folded tubular endoprosthesis

• US 6,451,051 B2
• Filed: 07/02/2001
• Issued: 09/17/2002
• Est. Priority Date: 04/26/1999
• Status: Expired due to Fees

• Current Assignee: Femoralis LLC
• Original Assignee: Joseph M. Thielen, William J. Drasler
• Inventors: Drasler, William J., Thielen, Joseph M.
• Primary Examiner(s): Thaler, Michael H.
• Application Number:
  US09/897,879
• Publication Number:
  US 20010047198A1
• Time in Patent Office: 442 Days
• Field of Search: 623/1.14, 623/1.13, 623/1.36, 623/1.15, 606/155
• US Class Current: 623/1.15
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/844 folded prior to deployment
• 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 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/8483 Barbs
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0007 for adjusting length

Abstract

A bifurcated or straight intravascular folded tubular member is deliverable percutaneously or by small cutdown to the site of a vascular lesion. Its inserted state has a smaller nondeployed diameter and a shorter nondeployed length. The intravascular tubular member has a folded tubular section that is unfolded following insertion into the blood vessel. The length of the intravascular folded tubular member is sized in situ to the length of the vessel lesion without error associated with diagnostic estimation of lesion length. The folded tubular member is self-expandable or balloon-expandable to a larger deployed diameter following delivery to the lesion site. An attachment anchor can be positioned at the inlet or outlet ends of the intravascular folded tubular member to prevent leakage between the tubular member and the native vessel lumen and to prevent migration of the tubular member. The attachment anchor has a short axial length to provide a more focal line of attachment to the vessel wall. Such attachment is valuable in attaching to a short aortic neck in the treatment of abdominal aortic aneurysm. The attachment anchor can have barbs which are held in a protected conformation during insertion of the tubular member and are released upon deployment of the attachment anchor. The intravascular tubular member can be formed of woven multifilament polymeric strands with metallic strands interwoven along with them. Double weaving is incorporated to prevent leakage at crossover points.

Claims

1. An attachment anchor for holding an intravascular tubular member outward within a blood vessel, said attachment anchor being deliverable in the nondeployed state with a smaller nondeployed diameter and able to expand to a deployed state with a larger deployed diameter and a deployed perimeter, said attachment anchor having a curved surface, said attachment anchor comprising;

A nodes and struts connected to each other to form a ring structure, said nodes being comprised of at least one hinge,

B said hinge having a hinge width less than a hinge radial dimension which allows said hinge to bend only in a direction substantially along the curved surface of said attachment anchor,

C said strut having a strut radial dimension that is less than a strut width and providing said strut with an ability to deform only in substantially the radial direction with substantially an elastic deformation due to an external crush force that deforms said attachment anchor to an oval shape while retaining a deployed perimeter,

D said hinge having a hinge radial dimension of adequate magnitude such that the forces transmitted to said hinges by said struts are unable to cause said hinges to bend substantially in the radial direction while said attachment anchor forms an oval shape due to exposure to an externally applied crush force,

E each of said struts having a strut width of adequate magnitude such that the forces transmitted to said struts by said hinges are unable to cause said struts to bend in the curved surface during an expansion of said attachment anchor,

whereby said attachment anchor provides an uncoupling of the expansion force associated with said hinge from the elastic radial bending force of said strut generated from the crushing deformation of said attachment anchor to an oval shape such that these forces can be varied independently from one another by adjusting the radial dimensions and widths of said hinges and struts as described herein.

2. The attachment anchor of claim 1 wherein said hinge expands plastically as said attachment anchor expands from a smaller nondeployed diameter to a larger deployed diameter.

3. The attachment anchor of claim 1 wherein said hinge expands elastically as said attachment anchor expands from a smaller nondeployed diameter to a larger deployed diameter.

4. The attachment anchor of claim 1 wherein each of said nodes further comprises at least one transition region, said transition region extending between a hinge and a strut, said transition region having a portion with a larger radial dimension than said strut radial dimension and a portion with a larger width than said hinge width.

5. The attachment anchor of claim 4 wherein said node comprises a barb.

6. The attachment anchor of claim 5 wherein said barb is held in a nondeployed state by said transition regions.

7. The attachment anchor of claim 5 wherein said barb is released by said transition regions during the deployment of said attachment anchor to deployed state.

8. The attachment anchor of claim 1 wherein said attachment anchor has an axial length that is short in comparison to the deployed diameter of said attachment anchor.

9. The attachment anchor of claim 1 wherein said attachment anchor has an axial length that is short in comparison to the nondeployed diameter of said attachment anchor.

10. The attachment anchor of claim 1 wherein said attachment anchor is formed with a serial alignment of nodes and struts, each node being joined to two struts.

11. The attachment anchor of claim 1 wherein at least one of said nodes comprises a barb.

12. The attachment anchor of claim 11 wherein said barb is held in a folded conformation by said struts in a nondeployed state and is released by said struts upon achieving a specific strut deployment angle, said barb extending outward to substantially its fullest extent upon release.

13. The attachment anchor of claim 12 wherein said specific strut deployment angle is intermediate between a strut deployment angle in a deployed state and a nondeployed state.

14. The attachment anchor of claim 11 wherein said barb is attached contiguously to said node.

15. The attachment anchor of claim 1 wherein said hinges have a hinge length that provides a focused plastic deformation as said hinges deform during the expansion of said attachment anchor from the smaller nondeployed state to the larger deployed state.

16. The attachment anchor of claim 1 wherein said hinges have a hinge length that provides an unfocused elastic deformation as said hinges bend during the expansion of the attachment anchor from a smaller nondeployed state to a larger deployed state.

17. An attachment anchor for holding an intravascular tubular member outward within a blood vessel, said attachment anchor being deliverable in the nondeployed state with a smaller nondeployed diameter and able to expand to a deployed state with a larger deployed diameter and a deployed perimeter, said attachment anchor having a curved surface, said attachment anchor comprising;

A. hinges and struts connected to each other to form a ring structure,

B. a hinge width less than a hinge radial dimension which allows said hinge to bend substantially in a direction along the curved surface of said attachment anchor,

C. said strut having a strut radial dimension less than a strut width and providing said strut with an ability to deform substantially in the radial direction and with substantially elastic deformation due to an external crush force that deforms said attachment anchor to an oval shape with a deployed perimeter,

D. said hinge having a hinge radial dimension of sufficient dimension such that the forces transferred to said hinges by said struts are unable to cause said hinges to bend substantially in the radial direction while forming an oval shape due to exposure of said attachment anchor to an externally applied crush force,

E. each of said struts having a strut width of sufficient dimension such that said the forces transferred to said struts by said hinges are unable to cause said struts to bend substantially in the curved surface during an expansion of said attachment anchor,

whereby said attachment anchor provides an uncoupling of the expansion force of said hinge from the elastic radial bending force of said strut generated from a crushing deformation of said attachment anchor to an oval shape such that these forces can be varied independently from one another.

18. The method of use for an attachment anchor for holding an intravascular tubular member outward within a blood vessel, said attachment anchor being deliverable in the nondeployed state with a smaller nondeployed diameter and able to expand to a deployed state with a larger deployed diameter and a deployed perimeter for implantation, said method comprising;

A. providing an attachment anchor having nodes and struts connected to each other to form a ring structure, said nodes being comprised of at least one hinge,

said hinge having a hinge width less than a hinge radial dimension which allows said hinge to bend only in a direction along the curved surface of said attachment anchor,

said strut having a strut radial dimension that provides said strut with an ability to only deform in the radial direction with substantially an elastic deformation due to an external crush force that deforms said attachment anchor to an oval shape in a deployed state,

said hinge having a hinge radial dimension of adequate magnitude such that the forces transferred to said hinges by said struts is unable to cause said hinges to bend substantially in the radial direction while forming an oval shape due to exposure of said attachment anchor to an externally applied crush force,

each of said struts having a strut width of adequate magnitude such that the forces transferred to said struts by said hinges is unable to cause said struts to bend substantially in the curved surface during an expansion of said attachment anchor,

B. expanding the attachment anchor whereby said hinges provide an outward force to hold said intravascular tubular member outward in a deployed state and said struts pivot on said hinge during the expansion,

C. elastically deforming said struts in a radial direction as said attachment anchor is formed into an oval shape with a deployed perimeter due to exposure to external crush forces.

19. The method of claim 18 further comprising the steps of removing the external crush forces and allowing said attachment anchor to elastically return from an oval shape to its original shape prior to the application of the external crush force due to the elasticity of said struts in a radial direction.

20. The method of claim 18 further comprising the steps;

A. releasing at least one barb attached to at least one of said nodes as said attachment anchor undergoes an expansion, the release of said barb and extension of said barb to substantially its fullest extent occurring intermediate between the nondeployed state and the fully deployed state of said attachment anchor.