Intravascular hinge stent

• US 6,245,101 B1
• Filed: 05/03/1999
• Issued: 06/12/2001
• Est. Priority Date: 05/03/1999
• Status: Active Grant

• Current Assignee: Femoralis LLC
• Original Assignee: Joseph M. Thielen, William J. Drasler
• Inventors: Drasler, William J., Thielen, Joseph M.
• Primary Examiner(s): Milano, Michael J.
• Assistant Examiner(s): Phan, Hieu
• Application Number:
  US09/304,310
• Time in Patent Office: 771 Days
• Field of Search: 623/1.11, 623/1.12, 623/1.15, 623/1.16, 623/1.17, 623/1.18, 623/1.21, 623/1.22, 623/1.35, 606/195, 606/198
• US Class Current: 623/1.15
• 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 2002/91541 Adjacent bands are arranged out of phase
• CPC Class Codes: A61F 2002/9155 Adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0036 differing in thickness

Abstract

The hinge stent is a balloon-expandable or self-expandable intravascular endoprosthesis used for treatment of vascular injury. The hinge stent is formed of a single stent section or of multiple stent sections joined together. Each stent section has a node and strut structure extending throughout in order to uncouple expansion forces of the stent to hold a blood vessel outward from crush forces that resist the formation of an oval shape during a crush deformation. Each node includes a hinge which is joined via a transition region to a strut. The hinge can bend in the direction of a uniformly curved surface of the stent but not in the radial direction. The strut can bend in the radial direction but not in the uniformly curved surface of the stent. The widths, lengths, and radial dimensions of the hinges and struts provide a balloon-expandable hinge stent that is non-crushable. For a self-expandable stent the hinge and strut dimensions provide expansion forces that are controlled independently from crush forces. The hinge stent can be formed of a high modulus metal with expansion properties being determined by the hinge dimensions and crush properties being determined independently by the design of the strut dimensions. The node and strut structure of the hinge stent provides for flexibility in traversing along tortuous passages.

Claims

1. A tubular wall structure deliverable to the site of a lesion within a tubular vessel of the body, said tubular wall structure having a smaller nondeployed perimeter and capable of undergoing an expansion deformation to a larger deployed perimeter and being implanted within the tubular vessel in order to hold the wall of the tubular vessel outward, said tubular wall structure comprising;

A. nodes and struts with each of said struts extending between two of said nodes, said struts being able to flex elastically in a radial direction and pivot with respect to said nodes but not flex in a uniform curved surface of said tubular wall structure, said struts having a strut radial dimension that is less than a strut width and a strut length that is greater than the strut width,

B. each of said nodes having two or more hinges that are adapted to bend in the uniform curved surface of the tubular wall structure but not radially, said hinges having a hinge radial dimension that is greater than both a hinge width and the strut radial dimension, the hinge width being less than the strut width, and a hinge length being equal to or greater than the hinge width,

C. each node having a hub, said hub having hinges attached thereto, said hub having a hub radial dimension that is equal to or greater than the hinge radial dimension, and a hub width that is equal to or greater than the hinge width, said hub not undergoing significant deformation during an expansion deformation,

D. each of said hinges having a transition region that is unable to substantially flex in ether a radial direction or in the uniform curved surface of said tubular wall structure, said transition region having a transition region radial dimension that is greater than the strut radial dimension and a transition region width that is greater than the hinge width,

whereby upon application of an external applied force said hinges provide an outward force to the uniform curved surface of said tubular wall structure to retain the larger deployed perimeter and the struts bend elastically in the radial direction to allow the uniform curved surface to form an oval shape.

2. The tubular wall structure of claim 1 wherein the said hinges undergo a plastic deformation as they bend during the expansion deformation from the smaller nondeployed perimeter to the larger deployed perimeter.

3. The tubular wall structure of claim 1 wherein the said hinges undergo an elastic deformation as they bend during the expansion deformation from a smaller nondeployed perimeter to a larger deployed perimeter.

4. The tubular wall structure of claim 1 wherein said nodes are comprised of three of said hinges.

5. The tubular wall structure of claim 1 wherein said nodes at each end of said tubular wall structure are comprised of two of said hinges and said nodes in a mid portion of said tubular wall structure are comprised of four of said hinges.

6. The tubular wall structure of claim 4 wherein the said hinges at each end of said tubular wall structure have hinge widths that are less than the hinge widths of said hinges in a mid portion of said tubular wall structure thereby reducing the force applied by said tubular wall structure to the tubular vessel wall at each end of said tubular wall structure.

7. The tubular wall structure of claim 5 wherein the said hinges of said nodes at each end of said tubular wall structure have hinge widths that are less than the hinge widths of said hinges of said nodes in the mid portion of said tubular wall structure thereby reducing the force applied by said tubular wall structure to the tubular vessel wall at each end of said tubular wall structure.

8. The tubular wall structure of claim 5 wherein said nodes at one or both ends of said tubular wall structure ends are comprised of three of said hinges, said hinges connecting two or more of said tubular wall structures together to lengthen said tubular wall structure while providing for longitudinal flexibility.

9. The tubular wall structure of claim 8 wherein said hinges of said nodes at each end of said tubular wall structure and said hinges of said nodes that have three hinges all have hinge widths that are less than the hinge widths of said hinges of said nodes in the mid portion of said tubular wall structure.

10. The tubular wall structure of claim 1 wherein at least one of said nodes comprises a barb.

11. The tubular wall structure of claim 10 wherein said barb is held in a nonextended condition while said tubular wall structure has a smaller nondeployed perimeter and said barb is allowed to extend outward in a radial direction during an expansion deformation to a larger deployed perimeter.

12. The tubular wall structure of claim 1 formed from a metal taken from a list including:

nitinol, stainless steel, titanium, gold, platinum, and metal alloys.

13. The tubular wall structure of claim 1 forming an expandable stent that is attachable to an intravascular graft to hold the intravascular graft outwards against the tubular vessel wall, to reduce leakage of blood between a native blood lumen and the intravascular graft, and to prevent migration of the intravascular graft within the tubular blood vessel.

14. The tubular wall structure of claim 1 comprised of at least two node configurations, a first node configuration having a first hinge configuration for the purpose of providing expansion force for holding the tubular vessel outward, and a second node configuration having a second hinge configuration which provides said tubular wall structure with flexibility in a longitudinal direction.

15. The tubular wall structure of claim 1 wherein said nodes are comprised of two of said hinges.

16. A tubular wall structure that is deliverable to the site of a lesion within a tubular vessel of the body, said tubular wall structure having a smaller nondeployed perimeter and capable of undergoing an expansion deformation to a larger deployed perimeter and be implanted within the tubular vessel in order to hold the wall of the tubular vessel outward, said tubular wall structure comprising;

A. struts, hinges, and transition regions with each end of said struts being attached to a transition region, and each transition region being attached to a hinge, said struts being able to flex elastically in a radial direction and pivot with respect to said hinges but not flex in a uniform curved surface of said tubular wall structure, said struts having a strut radial dimension that is less than a strut width and a strut length that is greater than the strut width,

B. each of said hinges being adapted to bend in the uniform curved surface of said tubular wall structure but not radially, said hinges having a hinge radial dimension that is greater than both a hinge width and the strut radial dimension, the hinge width being less than the strut width, and a hinge length being equal to or greater than the hinge width,

C. said transition region being unable to substantially flex in ether a radial direction or in the uniform curved surface of said tubular wall structure, said transition region having a transition region radial dimension that is greater than the strut radial dimension and a transition region width that is greater than the hinge width.

17. A tubular wall structure deliverable to the site of a lesion within a tubular vessel of the body, said tubular wall structure having a smaller nondeployed perimeter and capable of undergoing an expansion deformation to a larger deployed perimeter and being implanted within the tubular vessel in order to hold the wall of the tubular vessel outward, said tubular wall structure comprising;

A. nodes and struts with each of said struts extending between two of said nodes, said struts being able to flex elastically in a radial direction and pivot with respect to said nodes but not flex in a uniform curved surface of said tubular wall structure, said struts having a strut radial dimension that is less than a strut width and a strut length ithat is greater than the strut width,

B. each of said nodes having two or more hinges that are adapted to bend in the uniform curved surface of the tubular wall structure but not radially, said hinges having a hinge radial dimension that is greater than both a hinge width and the strut radial dimension, the hinge width being less than the strut width, and a hinge length being equal to or greater than the hinge width,

C. each node having a hub, said hub having hinges attached thereto, said hub having a hub radial dimension that is equal to or greater than the hinge radial dimension, and a hub width that is equal to or greater than the hinge width, said hub not undergoing significant deformation during an expansion deformation.

18. A tubular wall structure deliverable to the site of a lesion within a tubular vessel of the body, said tubular wall structure having a smaller nondeployed perimeter and capable of undergoing an expansion deformation to a larger deployed perimeter and being implanted within the tubular vessel in order to hold the wall of the tubular vessel outward, said tubular wall structure comprising;

A. nodes and struts with each of said struts extending between two of said nodes, said struts being able to flex elastically in a radial direction and pivot with respect to said nodes but not flex in a uniform curved surface of said tubular wall structure, said struts having a strut radial dimension that is less than a strut width and a strut length that is greater than the strut width,

B. each of said nodes having two or more hinges that are adapted to bend in the uniform curved surface of the tubular wall structure but not radially, said hinges having a hinge radial dimension that is greater than both a hinge width and the strut radial dimension, the hinge width being less than the strut width, and a hinge length being equal to or greater than the hinge width,

C. each of said hinges having a transition region that is unable to substantially flex in ether a radial direction or in the uniform curved surface of said tubular wall structure, said transition region having a transition region radial dimension that is greater than the strut radial dimension and a transition region width that is greater than the hinge width.

19. A tubular wall structure deliverable to the site of a lesion within a blood vessel of the body, said tubular wall structure having a smaller nondeployed perimeter and capable of undergoing an expansion to a larger deployed perimeter and being implanted within the blood vessel in order to hold the wall of the blood vessel outward, said tubular wall structure comprising;

A. nodes and struts with each of said struts extending between two of said nodes, said struts being able to flex elastically in a radial direction and pivot with respect to said nodes but not flex in a uniform curved surface of said tubular wall structure, said struts having a strut radial dimension that is less than a strut width and a strut length that is greater than the strut width,

B. each of said nodes having two or more hinges that are adapted to bend in the uniform curved surface of the tubular wall structure but not radially, said hinges having a hinge radial dimension that is greater than both a hinge width and the strut radial dimension, the hinge width being less than the strut width, and a hinge length being equal to or greater than the hinge width,

C. each node having a hub that is attached to said hinges, said hub having a hub radial dimension that is equal to or greater than the hinge radial dimension, and a hub width that is equal to or greater than the hinge width, said hub being unable to substantially flex in either a radial direction or in the uniform curved surface of said tubular wall structure,

D. each of said hinges having a transition region that is unable to substantially flex in ether a radial direction or in the uniform curved surface of said tubular wall structure, said transition region having a transition region radial dimension that is greater than the strut radial dimension and a transition region width that is greater than the hinge width.