Drainage stent and associated method

• US 20070100437A1
• Filed: 05/12/2006
• Published: 05/03/2007
• Est. Priority Date: 05/13/2005
• Status: Active Grant

• Current Assignee: Merit Medical Systems, Inc.
• Original Assignee: Alveolus, Inc. (Merit Medical Systems, Inc.)
• Inventors: Nissl, Thomas, Welborn, Kristin
• Granted Patent: US 8,262,721 B2
• Time in Patent Office: Days
• US Class Current: 623/1.440
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/856 Single tubular stent with a side portal passage
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• CPC Class Codes: A61F 2002/91508 the meander having a difference in amplitude along the band
• CPC Class Codes: A61F 2002/91533 characterised by the phase between adjacent bands
• CPC Class Codes: A61F 2002/91575 connected peak to trough
• CPC Class Codes: A61F 2002/91583 by a bridge, whereby at least one of its ends is connected along the length of a strut between two consecutive apices within a band
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

A stent for facilitating flow between a branch of a bifurcated lumen and an interior region of the stent is provided. The stent includes proximal and distal ends and an interior region defined therethrough. The stent typically includes scaffolding having a cover applied thereto. The stent also includes at least one drainage region having at least one drainage hole defined between the scaffolding and through the cover such that fluid is capable of flowing through the drainage holes. The drainage region is typically offset from the proximal and/or distal end to facilitate fluid flow between the branch of the bifurcated lumen and the interior region of the stent.

Claims

1. An implantable device for facilitating fluid flow between a branch of a bifurcated lumen and an interior region of the implantable device, the implantable device comprising:

a scaffolding of struts formed from a tube of memory material and having a proximal end and a distal end;

a cover applied to and between the scaffolding of struts to define an interior region within the scaffolding; and

at least one drainage region having a proximal end, a distal end, and at least one drainage hole defined between the scaffolding and through the cover such that fluid is capable of flowing through the drainage hole, wherein the drainage region is offset from the proximal and distal ends of the scaffolding to facilitate fluid flow between the branch of the bifurcated lumen and the interior region of the scaffolding.

2. The implantable device according to claim 1, wherein the drainage region comprises a plurality of holes located at least partially about the circumference of the scaffolding.

3. The implantable device according to claim 1, wherein the scaffolding comprises a plurality of interconnected legs and connectors, and wherein the legs extend in circumferential rows about the implantable device, and the connectors extend longitudinally between adjacent rows.

4. The implantable device according to claim 3, wherein the distal end of the drainage region is offset at least one row of legs from the distal end of the scaffolding.

5. The implantable device according to claim 3, wherein the at least one drainage hole is defined through the cover and between the legs and connectors.

6. The implantable device according to claim 3, wherein the at least one drainage hole is defined to substantially conform to one or more adjacent legs and connectors.

7. The implantable device according to claim 1, wherein the distal end of the at least one drainage region is offset at least about 2 cm from the distal end of the scaffolding.

8. The implantable device according to claim 1, wherein the at least one drainage hole is circular or oval.

9. The implantable device according to claim 1, further comprising a plurality of drainage regions, wherein each drainage region is configured to be positioned proximate to a respective branch of a bifurcated lumen.

10. The implantable device according to claim 9, wherein the plurality of drainage regions are configured to be positioned proximate to at least one of a hepatic duct and a cystic duct of the biliary tract.

11. The implantable device according to claim 1, wherein at least a portion of the implantable device between the proximal end of the scaffolding and the proximal end of the at least one drainage region is configured to be positioned adjacent to a target area located within a second branch of the bifurcated lumen.

12. The implantable device according to claim 1, wherein the scaffolding comprises at least one radiopaque marker located proximate to at least one of the proximal and distal ends of the drainage region.

13. The implantable device according to claim 12, wherein each radiopaque marker comprises an eyelet defined in the scaffolding.

14. The implantable device according to claim 1, wherein the cover comprises a polymeric material.

15. A method for manufacturing an implantable device for facilitating fluid flow between a branch of a bifurcated lumen and an interior region of the implantable device, the method comprising:

forming a scaffolding from a tube of memory material having a proximal end and a distal end;

applying a cover to and between the scaffolding of struts to define an interior region within the scaffolding; and

defining at least one drainage region having at least one drainage hole between the scaffolding and through the cover such that fluid is capable of flowing through the drainage hole, wherein the drainage region is offset from the proximal and distal ends of the scaffolding to facilitate fluid flow between the branch of the bifurcated lumen and the interior region of the implantable device.

16. The method according to claim 15, wherein forming comprises etching a plurality of interconnected legs and connectors, and wherein the legs extend in circumferential rows about the implantable device, and the connectors extend longitudinally between adjacent rows.

17. The method according to claim 16, wherein defining comprises defining a distal end of the drainage region at least one row of legs from the distal end of the scaffolding.

18. The method according to claim 16, wherein defining comprises defining the at least one drainage hole through the cover and between the legs and connectors.

19. The method according to claim 16, wherein defining comprises defining the at least one drainage hole to substantially conform to one or more adjacent legs and connectors.

20. The method according to claim 15, wherein defining comprises defining a plurality of holes at least partially about the circumference of the implantable device.

21. The method according to claim 15, wherein defining comprises defining a plurality of drainage regions.

22. The method according to claim 15, wherein forming comprises forming at least one radiopaque marker proximate to at least one of a proximal end and a distal end of the drainage region.

23. The method according to claim 15, wherein applying comprising dipping the scaffolding within a polymeric material.

24. The method according to claim 15, wherein defining comprises penetrating the cover after applying the cover to the scaffolding to define the at least one drainage hole.

25. The method according to claim 15, wherein defining comprises masking at least a portion of the scaffolding during the applying step to define the at least one drainage hole.

26. An implantable device for facilitating fluid flow between a branch of a bifurcated lumen and an interior region of the implantable device, the implantable device comprising:

a scaffolding of struts formed from a tube of memory material and having a proximal end and a distal end;

a cover applied to and between the scaffolding of struts to define an interior region within the scaffolding; and

a plurality of drainage holes defined between the scaffolding and through the cover such that fluid is capable of flowing through each of the drainage holes, wherein each of the drainage holes is offset from the distal end of the scaffolding to define a gap therebetween and to facilitate fluid flow between the branch of the bifurcated lumen and the interior region of the scaffolding.

27. The implantable device according to claim 26, wherein the plurality of drainage holes are located at least partially about the circumference of the scaffolding.

28. The implantable device according to claim 26, wherein the scaffolding comprises a plurality of interconnected legs and connectors, and wherein the legs extend in rows circumferentially about the implantable device, and the connectors extend longitudinally between adjacent rows.

29. The implantable device according to claim 28, wherein the plurality of drainage holes are offset at least one row of legs from the distal end of the scaffolding.

30. The implantable device according to claim 28, wherein the plurality of drainage holes are defined through the cover and between the legs and connectors.

31. The implantable device according to claim 28, wherein the plurality of drainage holes are defined to substantially conform to one or more adjacent legs and connectors.

32. The implantable device according to claim 26, wherein each of the plurality of drainage holes are offset from the proximal end of the scaffolding to define a gap therebetween.