Removable biliary stent

• US 7,875,068 B2
• Filed: 09/30/2003
• Issued: 01/25/2011
• Est. Priority Date: 11/05/2002
• Status: Active Grant

• Current Assignee: Merit Medical Systems, Inc.
• Original Assignee: Merit Medical Systems, Inc.
• Inventors: Borg, Ulf R., Reynolds, Jason M., Mangiardi, Eric K., Alexander, Tony D.
• Primary Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US10/674,972
• Publication Number:
  US 20040127973A1
• Time in Patent Office: 2,674 Days
• Field of Search: 623/1.15, 623/1.16, 623/1.2, 623/1.44, 623/1.46, 606191-198, 128/898
• US Class Current: 623/1.15
• CPC Class Codes: A61F 2/07 Stent-grafts
• 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 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/041 Bile ducts
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/91525 within the whole structure different bands showing different meander characteristics, e.g. frequency or amplitude
• CPC Class Codes: A61F 2002/91533 characterised by the phase between adjacent bands
• CPC Class Codes: A61F 2002/91566 connected trough to trough
• CPC Class Codes: A61F 2002/91575 connected peak to trough
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0017 Angular shapes
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0051 differing in tissue ingrowth capacity, e.g. made from both ingrowth-promoting and ingrowth-preventing parts
• CPC Class Codes: A61L 31/08 Materials for coatings

Abstract

The present invention, in an exemplary embodiment, provides a stent, which combines many of the excellent characteristics of both silicone and metal stents while eliminating the undesirable ones. In particular, a principal objective in accordance with the present invention is to provide a family of stents generally and a biliary stent in particular where the relative hardness/softness of regions of the stent can differ from other regions of the stent to provide additional patient comfort and resistance to radial forces. An exemplary embodiment also provides a family of stents with novel interstice configurations that facilitate flexibility, durability and/or proper installation. Additionally, the biliary stent in accordance with the present invention provides enhanced flow mechanics to ensure the adequate clearance of viscid fluids such as bile.

Claims

1. A medical appliance for placement within a portion of anatomy of a patient, the appliance comprising:

a scaffolding defining a substantially cone-shaped member having a proximal end and a distal end, wherein the distal end has an internal diameter larger than that of the proximal end but less than the greatest internal diameter of the cone-shaped member, the cone-shaped member forming a lumen there through and configured to facilitate the flow of bile through the lumen, the scaffolding configured such that when pressure is exerted along varying points of the appliance, the appliance does not undesirably foreshorten or elongate.

2. The medical appliance of claim 1, wherein along the longitudinal extension of the appliance, the scaffolding forms geometrical patterns.

3. The medical appliance of claim 2, wherein the scaffolding further comprises a coating coupled with the scaffolding, the coating of sufficient thickness to prevent the medical appliance from becoming epithelialized when installed in the desired portion of the patient'"'"'s anatomy.

4. The medical appliance of claim 3, wherein the coating does not inhibit flexing or radial expansion of the medical appliance.

5. The medical appliance of claim 4, wherein the coating is coupled with the medical appliance.

6. The medical appliance of claim 2, wherein the dimensions of the scaffolding geometry determine torsionality of the medical appliance.

7. The medical appliance of claim 1, wherein the scaffolding is formed of a memory capable alloy.

8. The medical appliance of claim 7, wherein the scaffolding is electropolished.

9. The medical appliance of claim 1, wherein the scaffolding of the medical appliance further comprises a plurality of eyelets there through for receiving suture.

10. The medical appliance of claim 2, further comprising a connector coupled with portions of the geometrical patterns, the connector comprising a crossing member and a plurality of leg members extending from the crossing member.

11. The medical appliance of claim 10, wherein the connector further comprises a rectangular detent extending from a leg thereof.

12. The medical appliance of claim 10, wherein the length of the leg members and the degree of the angle at which the legs extend from the crossing member determines the relative flexibility of the medical appliance.

13. The medical appliance of claim 12, wherein the angle at which the leg members extend from the crossing member is greater than 90°

.

14. The medical appliance of claim 13, wherein the medical appliance is relatively rigid.

15. The medical appliance of claim 12, wherein the angle at which the leg members extend from the crossing member is 90°

or less.

16. The medical appliance of claim 15, wherein the medical appliance is relatively flexible.

17. The medical appliance of claim 2, wherein the geometrical patterns are substantially U-shaped.

18. The medical appliance of claim 2, wherein the geometrical patterns are substantially W-shaped.

19. The medical appliance of claim 2, wherein the geometrical patterns are substantially V-shaped.

20. The medical appliance of claim 2, wherein the geometrical patterns are substantially Z-shaped.

21. The medical appliance of claim 2, wherein the geometrical patterns are substantially S-shaped.

22. The medical appliance of claim 2, wherein the geometrical patterns are substantially X-shaped.

23. The medical appliance of claim 1, further comprising an additional distal end wherein the medical appliance forms a substantially Y-shape.

24. The medical appliance of claim 23, wherein along the longitudinal extension of the appliance, the scaffolding forms geometrical patterns.

25. The medical appliance of claim 24, wherein the scaffolding further comprises a coating coupled with the scaffolding, the coating of sufficient thickness to prevent the medical appliance from becoming epithelialized when installed in the desired portion of the patient'"'"'s anatomy.

26. The medical appliance of claim 25, wherein the dimensions of the scaffolding geometry determine torsionality of the medical appliance.

27. The medical appliance of claim 25, wherein the scaffolding is formed of a memory capable alloy.

28. The medical appliance of claim 25, wherein the scaffolding is electropolished.

29. The medical appliance of claim 25, wherein near the distal and proximal ends of the scaffolding the medical appliance further comprise a plurality of flanges that define apertures there through.

30. The medical appliance of claim 23, further comprising a connector member coupled with portions of the geometrical patterns, the connector comprising a crossing member and a plurality of leg members extending from the crossing member.

31. The medical appliance of claim 30, wherein the connector further comprises a rectangular detent extending from a leg thereof.

32. The medical appliance of claim 30, wherein the length of the leg members or the degree of the angle at which the legs extend from the crossing member positively contributes to the relative flexibility of the medical appliance.

33. The medical appliance of claim 32, wherein the angle at which the leg members extend from the crossing member is greater than 90°

.

34. The medical appliance of claim 33, wherein the medical appliance is relatively rigid.

35. The medical appliance of claim 32, wherein the angle at which the leg members extend from the crossing member is 90°

or less.

36. The medical appliance of claim 35, wherein the medical appliance is relatively flexible.

37. The medical appliance of claim 23, wherein the geometrical patterns are substantially U-shaped.

38. The medical appliance of claim 23, wherein the geometrical patterns are substantially W-shaped.

39. The medical appliance of claim 23, wherein the geometrical patterns are substantially V-shaped.

40. The medical appliance of claim 23, wherein the geometrical patterns are substantially Z-shaped.

41. The medical appliance of claim 23, wherein the geometrical patterns are substantially S-shaped.

42. The medical appliance of claim 23, wherein the geometrical patterns are substantially S-shaped.

43. A method of treating a patient suffering from luminal irregularities, comprising the steps of:

providing a medical appliance comprising a scaffolding defining a substantially cone-shaped member, wherein the distal end has an internal diameter larger than that of the proximal end but less than the greatest internal diameter of the cone-shaped member, the cone-shaped member forming a lumen there through and configured to facilitate the flow of bile through the lumen, the scaffolding configured such that when pressure is exerted along varying points of the appliance, the appliance does not undesirably foreshorten or elongate;

installing the medical appliance in a preferred location of the anatomy of the patient; and

activating the expansion of the medical appliance in the desired location.

44. The method of claim 43, wherein the preferred location is a non-vascular lumen.

45. The method of claim 44, further comprising the step of removing the medical appliance from the anatomy of the patient.

46. The method of claim 44, wherein the medical appliance further comprises anti-microbial agents coupled therewith.

47. The method of claim 44, wherein the medical appliance further comprises chemotherapeutic agents coupled therewith.

48. The medical appliance of claim 43, further comprising an additional distal end wherein the medical appliance forms a substantially Y-shape.

49. A method of removing a medical appliance from a patient, comprising the steps of:

locating the medical appliance comprising a scaffolding defining a substantially cone-shaped member, wherein the distal end has an internal diameter larger than that of the proximal end but less than the greatest internal diameter of the cone-shaped member, the medical appliance further comprising a plurality of eyelets and suture threaded there through, the cone-shaped member forming a lumen there through and configured to facilitate the flow of bile through the lumen, the scaffolding configured such that when pressure is exerted along varying points of the appliance, the appliance does not undesirably foreshorten or elongate;

grasping the suture threaded through the eyelets of the medical appliance;

pulling on the suture to reduce the outward radial force of the medical appliance; and

removing the medical appliance from the patient.