Duodenum stent and associated method

• US 20060259051A1
• Filed: 04/07/2006
• Published: 11/16/2006
• Est. Priority Date: 04/08/2005
• Status: Active Grant

• Current Assignee: Merit Medical Systems, Inc.
• Original Assignee: Alveolus, Inc. (Merit Medical Systems, Inc.)
• Inventors: Nissl, Thomas
• Granted Patent: US 8,323,350 B2
• Time in Patent Office: Days
• US Class Current: 606/153
• 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 implanting in the soft duodenum of a patient and maintaining the patency of a stricture in a wall of the duodenum, the stent comprising:

a stent region having a stiffness configured to hold the stricture open after implantation;

a first transition region extending radially outwardly and axially away from an end of the stent region and defining a first open end, the first transition region having a stiffness less than the stiffness of the stent region; and

a second transition region extending radially outwardly and axially away from an opposite end of the stent region and defining a second open end opposite the first open end, the second transition region having a stiffness less than the stiffness of the stent region;

wherein the stent region defines in cross-section at least one concave portion, the concave portion being adapted to receive the stricture when the stent is properly positioned in the duodenum and to maintain the stent in position after implantation so as to prevent migration of the stent along the duodenum.

2. The stent according to claim 1, wherein the stent region and each of the first and second transition regions comprise the same material.

3. The stent according to claim 1, wherein the stent region comprises a different material than each of the first and second transition regions.

4. The stent according to claim 1, wherein at least a portion of at least one of the first and second transition regions is configured in a helix comprising a plurality of turns.

5. The stent according to claim 1, wherein the stent is secured within the lumen using only the stent region and the first and second transition regions.

6. The stent according to claim 1, wherein the stiffness of each of the first and second transition regions gradually decreases from a respective end of the stent region and outwardly along a length of the first and second transition regions.

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

a stent region having proximal and distal ends and an aperture defined therethrough;

a first transition region extending outwardly from an 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 and having an aperture defined therethrough; and

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

wherein each of the apertures of the first and second transition regions and stent region are substantially collinear, 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.

8. The stent according to claim 7, 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 members is larger than the medial portion.

9. The stent according to claim 7, wherein the stent region comprises scaffolding.

10. The stent according to claim 7, wherein each of the turns of the helix comprises a different width.

11. The stent according to claim 7, wherein each of the turns comprises a substantially rectangular cross section.

12. The stent according to claim 7, wherein the helix comprises at least three turns.

13. The stent according to claim 7, wherein the helix defines a gap between each of the turns.

14. The stent according to claim 13, further comprising a plurality of connectors, wherein each connector extends across each gap and between respective turns of the helix.

15. The stent according to claim 7, wherein each of the turns of the helix increases in diameter as the turns extend further away from the stent region.

16. The stent according to claim 7, wherein the second transition region is configured in a helix comprising a plurality of turns.

17. The stent according to claim 7, wherein the second transition region comprises a plurality of leg members extending axially from the distal end of the stent region.

18. The stent according to claim 17, wherein each of the leg members are separated by a gap.

19. The stent according to claim 17, wherein each of the leg members comprises a substantially rectangular cross section.

20. The stent according to claim 17, wherein each of the leg members are substantially parallel to one another and to each of the apertures of the first and second transition regions and stent region.

21. The stent according to claim 17, wherein each of leg members angle outwardly from the distal end of the stent region.

22. The stent according to claim 17, wherein the second transition region further comprises a helix extending from at least one of the leg members.

23. The stent according to claim 17, wherein each of the leg members are a different length.

24. The stent according to claim 17, wherein the leg members are configured to define an angled opening.

25. The stent according to claim 7, wherein the first transition region is longer than the second transition region.

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

a stent region and a pair of transition regions extending from respective ends of the stent region, each of the transition and stent regions defining an aperture therethrough,

wherein at least a portion of at least one of the transition regions is configured in a helix comprising a plurality of turns, and 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.

27. The stent according to claim 26, wherein the stent region comprises scaffolding.

28. The stent according to claim 26, wherein each of the transition regions comprises a more flexible material then the stent region.

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

30. The stent according to claim 26, wherein each of the transition regions comprises a helix comprising a plurality of turns.

31. The stent according to claim 26, wherein the helix defines a gap between each of the turns.

32. The stent according to claim 26, wherein each of the transition regions comprises a larger diameter than at least a portion of the stent region.

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

providing a stent comprising a stent region and a pair of transition regions extending from respective ends of the stent region, at least a portion of at least one of the transition regions configured in a helix comprising a plurality of turns;

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 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.

34. The method according to claim 33, wherein providing comprises providing a pair of transition regions each configured in a helix comprising a plurality of turns.

35. The method according to claim 33, wherein providing comprises providing a transition region comprising a plurality of leg members extending axially from the stent region.

36. The method according to claim 33, wherein positioning comprises positioning the stent within the lumen with an endoscope.