ENDOLUMINAL COILED ENDOLUMINAL PROSTHESIS

• US 20010044621A1
• Filed: 09/22/1999
• Published: 11/22/2001
• Est. Priority Date: 02/26/1999
• Status: Active Grant

• Current Assignee: Thomas J. Fogarty
• Original Assignee: Vascular Architects Incorporated
• Inventors: KLUMB, KATHERINE J., KAMDAR, KIRTI P., HILL, BRADLEY B., FOGARTY, THOMAS J.
• Granted Patent: US 6,645,237 B2
• Time in Patent Office: Days
• US Class Current: 606/1
• 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 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• 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 2002/9511 the retaining means being filaments or wires
• 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 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

A coiled stent (196) has a coiled stent body with a main body portion (106) and end portions (108). The end portions may be substantially less stiff than the body portion to help prevent tissue trauma. A graft material (124) may be used to cover at least the main body portion to create a coiled stent graft (122) in which adjacent turns (128) have gaps defined therebetween to create a generally helical gap (130). The coiled stent may have side elements (10) separated by connector elements (112) and be placeable in a contracted, reduced diameter state and in a relaxed, expanded diameter state. The connector elements are preferably generally parallel to the stent axis when placed in the contracted, reduced-diameter state, typically tightly wrapped around a placement catheter (136).

Claims

1. A coiled endoluminal prosthesis comprising:

a coiled stent body having a main body portion and first and second end portions, said end portions having a substantially different stiffness than the main body portion.

2. A coiled endoluminal prosthesis according to

claim 1

wherein the end portions are substantially less stiff than the main body portion.

3. A coiled endoluminal prosthesis according to

claim 1

wherein the main body portion comprises a coiled ribbon of material with its width being much greater than its thickness.

4. A coiled endoluminal prosthesis according to

claim 3

wherein the main body portion comprises first and second edge elements separated by connector elements.

5. A coiled endoluminal prosthesis according to

claim 1

wherein said end portions each have an inwardly-tapering portion with a blunt tip.

6. A coiled endoluminal prosthesis according to

claim 1

wherein the main body portion comprises first, second and third longitudinal sections each having a different radial stiffness.

7. A coiled endoluminal prosthesis according to

claim 1

wherein the stiffness of the main body portion continuously varies along at least part of its length.

8. A coiled endoluminal prosthesis according to

claim 3

further comprising a graft material covering at least the main body portion to create a coiled stent graft in which adjacent turns thereof define a generally helical gap therebetween.

9. A coiled endoluminal prosthesis according to

claim 8

wherein the generally helical gap between the turns of the coiled stent grant has an average width equal to about 0% to 1200% of the average width of the turns of the coiled stent graft.

10. A coiled endoluminal prosthesis comprising:

a coiled stent body having a main body portion and first and second end portions, said end portions being substantially less stiff than the main body portion;

the main body portion comprising a coiled ribbon of material with its width much greater than its thickness;

the end portions having an inwardly-tapering portion with a blunt tip, a longitudinally-extending length and a laterally-extending width, said length greater than said width; and

a graft material covering at least part of the main body portion to create a coiled stent graft in which adjacent turns thereof define a generally helical gap therebetween.

11. The coiled endoluminal prosthesis according to

claim 10

wherein the gap between the turns of the coiled stent graft has an average width equal to about 0% to 1200% of the average width of the turns of the coiled stent graft.

12. An endoluminal prosthesis comprising:

a coiled body having first and second ends and a main portion between the first and second ends;

the main portion having an average cross-sectional dimension of x; and

at least one of the first and second ends has a maximum cross-sectional dimension of about 5x to 25x and a blunt tip to help avoid trauma to the patient'"'"'s tissue.

13. The endoluminal prosthesis according to

claim 12

wherein both said first and second ends have said maximum cross-sectional dimension.

14. The endoluminal prosthesis according to

claim 12

wherein the main portion has a circular cross-sectional shape and the ends have flattened, generally oval shapes.

15. The endoluminal prosthesis according to

claim 12

wherein the ends are less stiff than the main body.

16. A coiled endoluminal prosthesis comprising:

a coiled body comprising a main body portion and end portions;

a graft material covering at least a part of the main body portion to create a coiled stent graft in which adjacent turns thereof define a generally helical gap therebetween, whereby the coiled body and the generally helical gap help prevent restenosis.

17. The coiled endoluminal prosthesis according to

claim 16

wherein the graft material is two layers thick and completely surrounds said at least part of the main body.

18. The coiled endoluminal prosthesis according to

claim 16

wherein said generally helical gap has an average width equal to about 0% to 1200% of the average width of the coiled stent graft.

19. The coiled endoluminal prosthesis according to

claim 16

wherein said generally helical gap has an average width equal to about 50% to 800% of the average width of the coiled stent graft.

20. The coiled endoluminal prosthesis according to

claim 16

further comprising an orientation-specific marker carried by the stent graft so to aid proper rotary orientation and longitudinal placement of the stent graft.

21. A coiled endoluminal prosthesis comprising:

a body comprising a coiled ribbon of material with first and second edge elements separated by connector elements;

said body movable between a contracted, reduced diameter state, extending along a body axis, and a relaxed, expanded diameter state; and

said connector elements being generally parallel to the body axis when in the contracted, reduced diameter state so to provide a smoother appearance when in the contracted, reduced diameter state.

22. The coiled endoluminal prosthesis according to

claim 21

comprising a graft material covering at least a part of the body to create a coiled stent graft.

23. The coiled endoluminal prosthesis according to

claim 22

wherein the coiled stent graft has turns defining a generally helical gap therebetween.

24. A coiled endoluminal prosthesis comprising:

a body comprising a coiled ribbon of material with first and second edge elements separated by connector elements;

said body movable between a contracted, reduced diameter state, extending along a body axis, and a relaxed, expanded diameter state; and

said connector elements being generally helically-oriented so to extend both axially and circumferentially when in the relaxed, expanded diameter state.

25. A catheter system comprising:

a placement catheter having an outer surface extending along a catheter axis;

a body comprising a coiled ribbon of material with first and second edge elements separated by connector elements;

said body placeable against the outer surface of the placement catheter in a contracted, reduced diameter state, extending along the catheter axis, and a relaxed, expanded diameter state; and

said connector elements being generally parallel to the catheter axis when in the contracted, reduced diameter state so to provide a smoother appearance when in the contracted, reduced diameter state.

26. The catheter system according to

claim 25

comprising a graft material covering at least a part of the body to create a coiled stent graft, the coiled stent graft having turns defining a helical gap therebetween.

27. A method for enhancing the ease of placement of an endoluminal prosthesis within a hollow body organ comprising:

obtaining a placement catheter having an outside diameter and a catheter axis;

obtaining an endoluminal prosthesis comprising;

a body comprising a coiled ribbon of material with first and second edge elements separated by connector elements; and

said body movable between in a contracted, reduced diameter state, extending along a body axis, and a relaxed, expanded diameter state; and

at least one of the obtaining steps being carried out so that said connector elements are generally parallel to the catheter axis when in the contracted, reduced diameter state so to provide a smoother appearance for the endoluminal prosthesis when in the contracted, reduced-diameter state.

28. The method according to

claim 27

wherein the endoluminal prosthesis obtaining step is carried out so the body is covered at least in part by a graft material to create a coiled stent graft, the coiled stent graft having turns.

30. The method according to

claim 28

wherein the endoluminal prosthesis obtaining step is carried out so the body is covered at least in part by a graft material to create a coiled stent graft, the coiled stent graft having turns.

29. A method for placement of a coiled endoluminal prosthesis within a hollow body organ comprising:

obtaining a placement catheter having an outside diameter and a catheter axis;

obtaining an endoluminal prosthesis comprising;

a body comprising a coiled ribbon of material with first and second edge elements separated by connector elements; and

said body movable between in a contracted, reduced diameter state, extending along a body axis, and a relaxed, expanded diameter state;

placing the placement catheter, with the endoluminal prosthesis mounted thereto in the contracted, reduced diameter state with the connector elements generally parallel to the catheter axis, at a target site within a hollow body organ;

expanding the endoluminal prosthesis; and

removing the placement catheter from the target site leaving the expanded endoluminal prosthesis at the target site.

31. The method according to

claim 29

wherein the expanding step is carried out so the turns of the coiled stent graft define a generally helical gap therebetween.

32. The method according to

claim 29

wherein the placing step comprises remotely visualizing an orientation-specific marker on the endoluminal prosthesis.

33. A method for stabilizing a traumatic injury site within a tubular body region comprising:

positioning a coiled stent body, of the type releasably mounted to a shaft and having a main body portion and first and second end portions with said end portions having substantially different stiffnesses from the main body portion, at a traumatic injury site within a tubular body region of a patient;

releasing the coiled stent body from the shaft;

expanding the coiled stent body from a first, reduced-diameter state to a second, expanded-diameter state to stabilize the traumatic injury site; and

removing the shaft from the patient.

34. The method according to

claim 33

wherein the releasing step is begun prior to beginning the expanding step.

35. The method according to

claim 33

wherein the positioning step is carried out using a coiled stent body having end portions which are substantially less stiff than the main body portions.

36. The method according to

claim 33

wherein the positioning step is carried out with the traumatic injury site comprising at least one of an occlusion site, a severed vessel site and an endarterectomy site.

37. The method according to

claim 33

wherein the positioning step comprises remotely visualizing an orientation-specific marker on the stent body to help ensure proper rotary orientation and longitudinal placement of the stent body at the traumatic injury site.