Duodenum stent and associated method

• US 8,323,350 B2
• Filed: 04/07/2006
• Issued: 12/04/2012
• Est. Priority Date: 04/08/2005
• Status: Active Grant

• Current Assignee: Merit Medical Systems, Inc.
• Original Assignee: Merit Medical Systems, Inc.
• Inventors: Nissl, Thomas
• Primary Examiner(s): Isabella, David
• Assistant Examiner(s): IWAMAYE, ANDREW MICHAEL
• Application Number:
  US11/400,630
• Publication Number:
  US 20060259051A1
• Time in Patent Office: 2,433 Days
• Field of Search: 623/1.22, 623 115- 121, 623 13- 131, 623/1.37, 623 2364- 237, 604/8
• US Class Current: 623/23.7
• 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 2/88 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 2002/041 Bile ducts
• CPC Class Codes: A61F 2002/045 Stomach, intestines
• CPC Class Codes: A61F 2002/821 Ostial stents
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

A stent for positioning within a lumen is provided. The stent includes a stent region and a pair of transition regions extending from respective ends of the stent region, wherein each of the transition and stent regions define an aperture therethrough. At least a portion of at least one of the transition regions is configured in a helix including a plurality of turns, wherein the stent region is capable of expanding to conform to a stricture and each of the transition regions is capable of expanding to conform to the lumen proximally and distally of the stricture.

Claims

1. A flexible stent for positioning within a body lumen, the stent comprising:

a stent region having a proximal end and a distal end and a first aperture defined therethrough;

a first transition region extending outwardly from the proximal end of the stent region and at least a portion of the first transition region configured in a helix comprising a plurality of turns, the first transition region having a larger diameter than at least a portion of the stent region, the helix defining a second aperture therethrough; and

a second transition region extending outwardly from the distal end of the stent region, the second transition region having a larger diameter than at least a portion of the stent region and having a third aperture defined therethrough,

wherein the second transition region comprises a plurality of leg members extending axially from the distal end of the stent region and each of the leg members extends from near the distal end of the stent region to a distal end of the second transition region, wherein each of the leg members are a different length,

wherein at least one of the first transition region and the second transition region includes a gap extending from near the stent region to a free end of a respective transition region such that the gap does not extend within the stent region, and

wherein each of the first and second transition regions are capable of expanding from a first diameter prior to being deployed into the lumen to a larger second diameter after being deployed into the lumen,

wherein each of the first, second, and third apertures are collinear.

2. The stent according to claim 1, wherein the proximal and distal ends of the stent region flare outwardly from a medial portion of the stent region such that a diameter of each of the first and second transition regions is larger than the medial portion.

3. The stent according to claim 1, wherein each of the turns of the helix comprises a different width.

4. The stent according to claim 1, wherein each of the turns comprises a rectangular cross section.

5. The stent according to claim 1, wherein the helix comprises at least three turns.

6. The stent according to claim 1, wherein the first transition region includes a turn-gap extending from the proximal end of the stent region to a free end of the first transition region such that each of the turns is separated by the turn-gap, and wherein a width of the turn-gap is smaller than a width of each turn.

7. The stent according to claim 6, further comprising a plurality of connectors, wherein each connector extends across each turn-gap and between respective turns of the helix.

8. The stent according to claim 1, wherein each of the turns of the helix increases in diameter as the turns extend further away from the stent region.

9. The stent according to claim 1, wherein adjacent leg members are separated by a leg-gap, wherein each leg-gap extends from the distal end of the stent region to a free end of the second transition region, and wherein a width of each leg-gap is smaller than a width of each leg member.

10. The stent according to claim 1, wherein each of the leg members comprises a rectangular cross section.

11. The stent according to claim 1, wherein each of the leg members are parallel to one another and to each of the first, second, and third apertures.

12. The stent according to claim 1, wherein each of the leg members angle outwardly from the distal end of the stent region.

13. The stent according to claim 1, wherein the second transition region further comprises a second helix extending from at least one of the leg members.

14. The stent according to claim 1, wherein the leg members are configured to define an angled opening.

15. The stent according to claim 1, wherein the first transition region is longer than the second transition region.

16. The stent according to claim 1, wherein each of the transition regions comprises a more flexible material than the stent region.

17. The stent according to claim 1, wherein each of the first and second transition regions has the same diameter between its respective proximal and distal ends.

18. A method for deploying a stent within a body lumen comprising:

providing a stent comprising

a stent region having a proximal end and a distal end, the stent region defining a first aperture therethrough;

a first transition region extending from the proximal end of the stent region, wherein at least a portion of the first transition region is configured in a helix comprising a plurality of turns, the helix defining a second aperture,

a second transition region extending from the distal end of the stent region, the second transition region defining a third aperture, wherein the second transition region comprises a plurality of leg members extending axially from the distal end of the stent region and each of the leg members extending from near the distal end of the stent region to a distal end of the second transition region, wherein adjacent leg members are separated by a leg-gap, each leg-gap extending from the distal end of the stent region to the distal end of the second transition region, and a width of each leg-gap being smaller than a width of each leg member,

wherein each of the first, second, and third apertures are collinear;

compressing the stent to a diameter smaller than that of the lumen;

positioning the stent in a predetermined position within the lumen; and

deploying the stent within the lumen such that the stent region expands to conform to a stricture and each of the transition regions expands to conform to the lumen proximally and distally of the stricture.

19. The method according to claim 18, wherein positioning comprises positioning the stent within the lumen with an endoscope.

20. The method according to claim 18, wherein the first transition region includes a turn-gap extending from the proximal end of the stent region to a free end of the first transition region such that each of the turns is separated by the turn-gap, and wherein a width of the turn-gap is smaller than a width of each turn.

21. A flexible stent for positioning within a body lumen, the stent comprising:

a stent region having a proximal end and a distal end and a first aperture defined therethrough;

a first transition region configured as a helix comprising a plurality of turns, the helix defining a second aperture therethrough, the first transition region extending outwardly from the proximal end of the stent region; and

a second transition region defining a third aperture therethrough, the second transition region extending outwardly from the distal end of the stent region, wherein the second transition region comprises a plurality of leg members extending axially from the distal end of the stent region, adjacent leg members being separated by a leg-gap that extends from a distal end of the stent region to a distal end of the second transition region, and a width of each leg-gap being smaller than a width of each leg member

wherein each of the first, second, and third apertures are collinear.

22. The stent according to claim 21, wherein each of the first and second transition regions has a larger diameter than at least a portion of the stent region.

23. The stent according to claim 21, wherein each of the first and second transition regions has the same diameter between its respective proximal and distal ends.

24. A flexible stent for positioning within a body lumen, comprising:

a stent region having a proximal end and a distal end and a first aperture defined therethrough;

a first transition region extending outwardly from the proximal end of the stent region and at least a portion of the first transition region configured in a helix comprising a plurality of turns, the first transition region having a larger diameter than at least a portion of the stent region, the helix defining a second aperture therethrough; and

a second transition region extending outwardly from the distal end of the stent region, the second transition region having a larger diameter than at least a portion of the stent region and having a third aperture defined therethrough,

wherein the second transition region comprises a plurality of leg members extending axially from the distal end of the stent region, wherein each of the leg members extends from near the distal end of the stent region to a distal end of the second transition region, and wherein adjacent leg members are separated by a leg-gap, wherein each leg-gap extends from the distal end of the stent region to the distal end of the second transition region, and wherein a width of each leg-gap is smaller than a width of each leg member, wherein each of the first and second transition regions are capable of expanding from a first diameter prior to being deployed into the lumen to a larger second diameter after being deployed into the lumen; and

wherein each of the first, second, and third apertures are collinear.

25. The stent according to claim 24, wherein the proximal and distal ends of the stent region flare outwardly from a medial portion of the stent region such that a diameter of each of the first and second transition regions is larger than the medial portion.

26. The stent according to claim 24, wherein each of the turns of the helix comprises a different width.

27. The stent according to claim 24, wherein each of the turns comprises a rectangular cross section.

28. The stent according to claim 24, wherein the helix comprises at least three turns.

29. The stent according to claim 24, wherein the first transition region includes a turn-gap extending from the proximal end of the stent region to a free end of the first transition region such that each of the turns is separated by the turn-gap, and wherein a width of the turn-gap is smaller than a width of each turn.

30. The stent according to claim 29, further comprising a plurality of connectors, wherein each connector extends across each gap and between respective turns of the helix.

31. The stent according to claim 24, wherein each of the turns of the helix increases in diameter as the turns extend further away from the stent region.

32. The stent according to claim 24, wherein each of the leg members comprises a rectangular cross section.

33. The stent according to claim 24, wherein each of the leg members are parallel to one another and to each of the first, second, and third apertures.

34. The stent according to claim 24, wherein each of leg members angle outwardly from the distal end of the stent region.

35. The stent according to claim 24, wherein the second transition region further comprises a second helix extending from at least one of the leg members.

36. The stent according to claim 24, wherein each of the leg members are a different length.

37. The stent according to claim 24, wherein the leg members are configured to define an angled opening.

38. The stent according to claim 24, wherein the first transition region is longer than the second transition region.

39. The stent according to claim 24, wherein each of the transition regions comprises a more flexible material than the stent region.

40. The stent according to claim 24, wherein each of the first and second transition regions has the same diameter between its respective proximal and distal ends.