PREFORM FOR AND AN ENDOLUMINAL PROSTHESIS

• US 20100198333A1
• Filed: 01/28/2010
• Published: 08/05/2010
• Est. Priority Date: 01/31/2009
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: MACATANGAY, EDWIN E., Farag, Jacqueline, Melsheimer, Jeffry S., Frye, Mark R.
• Granted Patent: US 8,641,753 B2
• Time in Patent Office: Days
• US Class Current: 623/1.15
• CPC Class Codes: A61F 2/04 Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95
• CPC Class Codes: A61F 2/07 Stent-grafts
• 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 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• 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 2250/0007 for adjusting length
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

An endoluminal prosthesis may include a tubular graft extending in a longitudinal direction, where the graft has an inner surface forming a lumen extending a length of the graft. An elongate member may be attached to the graft in a circumferentially and longitudinally extending manner such that the elongate member forms a series of longitudinally spaced apart turns, each turn extending substantially around a circumference of the graft. The elongate member may torsion the graft in at least the circumferential direction and cause the graft to form circumferentially and longitudinally extending folds in the portions of the graft disposed between longitudinally adjacent turns of the elongate member.

Claims

1. An endoluminal prosthesis comprising:

a tubular graft extending in a longitudinal direction, the graft having an inner surface forming a lumen extending a length of the graft; and

an elongate member attached to the graft in a circumferentially and longitudinally extending manner and having a series of longitudinally spaced apart turns, each turn extending substantially around a circumference of the graft,

wherein the elongate member is attached to and torsions the graft in at least the circumferential direction, the graft having circumferentially and longitudinally extending folds in the portions of the graft disposed between longitudinally adjacent turns of the elongate member.

2. The prosthesis of claim 1, wherein the graft comprises a first section having a uniform diameter.

3. The prosthesis of claim 2, further comprising a second section having a first opening at a first end and a second opening at a second end with the second opening being larger than the first, the graft increasing in size moving from the first opening to the second opening, the first and second sections being in mechanical communication with each other.

4. The prosthesis of claim 1, wherein the elongate member comprises a plurality of discrete attachment members disposed at predetermined intervals along at least a portion of the elongate member.

5. The prosthesis of claim 3, wherein the elongate member comprises a plurality of first and second struts connected by bends at an angle, each of the first struts extending between adjacent bends disposed on the same turn in a first direction and each of the second struts extending between adjacent bends disposed on the same turn in a second direction, the second direction being different than the first direction.

6. The prosthesis of claim 5, wherein the elongate member comprises a first section corresponding to the first section of the graft and a second section corresponding to the second section of the graft, wherein the first struts are longer than the second struts in the first and second sections of the elongate member.

7. The prosthesis of claim 6, wherein in the first section of the elongate member, each angle between pairs of first and second struts is substantially the same.

8. The prosthesis of claim 7, wherein, in the second section, the length of the first strut and a length of the second strut progressively increases moving from the first end of the second section toward the second end, and the angle at each bend progressively increases for each successive bend moving in a direction from the first end toward the second end of the second section.

9. The prosthesis of claim 8, wherein at least one bend on a selected turn of the elongate member is circumferentially aligned with at least one bend on a longitudinally adjacent turn and wherein the elongate member is attached to the graft such that at least one of the angles of at least one of the bends is at least partially compressed from a first angle when the elongate body is in a relaxed and unattached state to a second angle when the elongate member is attached to the graft, the second angle being less than the first.

10. The prosthesis of claim 9, wherein each of the bends on each of the turns of the elongate member is circumferentially aligned with each other.

11. The prosthesis of claim 10, wherein the circumferentially and longitudinally extending folds extend between opposing bends of longitudinally adjacent turns of the elongate member.

12. The prosthesis of any of claim 4, wherein the circumferentially and longitudinally extending folds extend between opposing attachment members of longitudinally adjacent turns of the elongate member.

13. The prosthesis of claim 12, wherein the circumferentially and longitudinally extending folds create a plurality of cells, each cell having a boundary comprising a portion of the elongate member extending between first and second attachment members disposed on each of a first and a second turn, the first turn being longitudinally adjacent the second turn, and two tensioned folds extending longitudinally and circumferentially between the first and second turns, wherein each cell comprises a relaxed fold disposed within the boundary when the graft is in a first condition having a substantially straight shape.

14. The prosthesis of claim 11, wherein the circumferentially and longitudinally extending folds create a plurality of cells, each cell having a boundary comprising a pair of first and second struts of a first turn and a second turn, the second turn being longitudinally adjacent to the first turn, wherein each cell comprises and relaxed fold disposed within the boundary when the graft is in a first condition having a substantially straight shape.

15. The prosthesis of claim 14, wherein the graft is movable between the substantially straight first condition to a second condition in which the graft is curved, the graft having an interior radius and an exterior radius, the inner radius being less than the outer radius, and wherein when the graft is in the first condition, the lumen has a substantially circular open cross sectional area, and wherein when the graft is in the second condition the portion of the graft disposed in each of the plurality of cells disposed about at least the interior radius at least partially compress inwardly along the relaxed folds, thereby creating a plurality of discrete, localized folds in the graft that substantially maintain the patency of the lumen.

16. An endoluminal prosthesis preform, comprising:

an elongate member comprising a plurality of bends, each bend connecting a pair of first and second struts at an angle, each of the first struts extending between adjacent bends in a first direction and each of the second struts extending between adjacent bends in a second direction, the second direction being different than the first direction;

a first section of the elongate member having first and second ends, wherein a length of the first struts is shorter than a length of the second struts, and the angle between pairs of first and second struts in the relaxed state is progressively larger for each successive bend moving in a direction from the first end toward the second end.

17. The preform of claim 16, wherein the lengths of the first and second struts are progressively increased moving in a direction from the first end toward the second end. The preform wherein the lengths of the first and second struts are increased by a progressively smaller amount moving in a direction from the first end toward the second end.

18. The preform of claim 17, wherein every other bend of the first section is circumferentially aligned with longitudinally adjacent bends when the elongate member is in a helical shape.

19. A method of making an endoluminal prosthesis, the method comprising:

providing a tubular graft formed of biocompatible material having a proximal end, a distal end, and a lumen disposed therethrough;

providing an elongate member;

positioning the elongate member longitudinally and circumferentially about an outer surface of the graft to form a plurality of torqued turns; and

attaching the elongate member to the graft such that the elongate member torsions the graft in at least the circumferential direction, and causes the graft to form circumferentially and longitudinally extending folds in the portions of the graft disposed between longitudinally adjacent turns of the elongate member.

20. The method of claim 19, wherein the elongate member torsions the graft in the circumferential and longitudinal directions.

21. The method of claim 20, wherein at least a central portion of the elongate member is substantially formed in a single flat plane prior to being attached to the graft, and when the elongate member is attached circumferentially and longitudinally to the graft, the elongate member is constrained in an elastically torsioned state, wherein the graft is torsioned by a force exerted by the torsioned elongate member.

22. The method of claim 20, wherein the elongate member comprises a plurality of bends, each bend connecting a pair of first and second struts at a first angle prior to being attached to the graft, each of the first struts extending between adjacent bends in a first direction and each of the second struts extending between adjacent bends in a second direction, the second direction being different than the first direction,

wherein, when the elongate member is positioned longitudinally and circumferentially on the outer surface of the graft, every other bend of the elongate member is circumferentially aligned with longitudinally adjacent bends,

wherein, when the elongate member is attached to the graft, the first angle of the bends is compressed to a second angle, the second angle being less than the first angle, and

wherein, the graft is torsioned by a force exerted by the bends having the compressed second angle.

23. The method of claim 20, wherein at least a central portion of the elongate member is substantially formed in a single flat plane prior to being attached to the graft, and when the elongate member is attached circumferentially and longitudinally to the graft, the elongate member is constrained in an elastically torsioned state, wherein the graft is torsioned by a first force exerted by the torsioned elongate member,

wherein the elongate member comprises a plurality of bends, each bend connecting a pair of first and second struts at a first angle prior to being attached to the graft, each of the first struts extending between adjacent bends in a first direction and each of the second struts extending between adjacent bends in a second direction, the second direction being different than the first direction,

wherein, when the elongate member is positioned longitudinally and circumferentially on the outer surface of the graft, every other bend of the elongate member is circumferentially aligned with longitudinally adjacent bends,

wherein, when the elongate member is attached to the graft, the first angle of the bends is compressed to a second angle, the second angle being less than the first angle, and

wherein, the graft is also torsioned by a second force exerted by the bends having the compressed second angle.

24. A method of treating a diseased body lumen, the method comprising:

providing an endoluminal prosthesis comprising a tubular graft extending in a longitudinal direction, the graft having an inner surface forming a lumen extending a length of the graft; and

an elongate member attached to the graft in a circumferentially and longitudinally extending manner and having a series of longitudinally spaced apart turns, each turn extending substantially around a circumference of the graft, wherein the elongate member is attached to and torsions the graft in at least the circumferential direction, the graft having circumferentially and longitudinally extending folds in the portions of the graft disposed between longitudinally adjacent turns of the elongate member, wherein the endoluminal prosthesis is movable between a first condition in which the endoluminal prosthesis is substantially straight to a second condition in which the endoluminal prosthesis is curved to approximate the curved shape of a body lumen, the endoluminal prosthesis having an interior radius and an exterior radius in the second condition, the inner radius being less than the outer radius, and wherein, when the endoluminal prosthesis is in the first condition, the lumen has a substantially circular open cross sectional area, and wherein, when the graft is in the second condition the portion of the graft disposed about at least the interior radius at least partially compresses, thereby creating a plurality of discrete, localized folds in the graft that substantially maintain the patency of the lumen;

advancing the endoluminal prosthesis into the body lumen; and

implanting the endoluminal prosthesis in the body lumen.