Percutaneously retrievable stent assembly with fluid draining capability

• US 20060129223A1
• Filed: 07/27/2005
• Published: 06/15/2006
• Est. Priority Date: 07/27/2004
• Status: Active Grant

• Current Assignee: University of Southern California
• Original Assignee: University of Southern California
• Inventors: Shaolian, Samuel M., Jabbour, Nicolas
• Granted Patent: US 8,267,917 B2
• Time in Patent Office: Days
• US Class Current: 623/1.110
• 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: A61M 27/00 Drainage appliance for wounds or the like , i.e. wound drains, implanted drains negative pressure wound therapy devices A61M1/90; implements for holding wound open A61B17/02 ; middle ear drainage A61F11/202
• CPC Class Codes: A61M 27/008 pre-shaped, for use in the urethral or ureteral tract

Abstract

The present invention provides a stent assembly for expanding a bodily passage in a patient and draining a fluid therefrom. The assembly comprises at least one expandable stent and an elongated carrier for delivery or retrieval of the stent. The stent is circumferentially attached to a distal end of the carrier. The carrier defines at least two concentric lumens therethrough, a drainage lumen in fluid communication with the bodily passage for drainage of the fluid and an inflation lumen in fluid communication with the expandable stent. The invention also provides a method of expanding a bodily passage in a patient and draining a fluid therefrom. The method comprises providing a stent assembly of the present invention; inserting a guidewire into the bodily passage through the drainage lumen of the carrier; advancing the assembly along the guidewire until the assembly reaches a desired location; expanding the stent; and draining the fluid through drainage lumen of the carrier.

Claims

1. A stent assembly for expanding a bodily passage in a patient and draining a fluid therefrom, the assembly comprising:

at least one expandable stent having a first and a second end; and

an elongated carrier for delivery or retrieval of the stent, the carrier having a distal end and a proximal end, wherein the stent is circumferentially attached to the distal end of the carrier, the carrier defining at least two concentric lumens therethrough, a drainage lumen in fluid communication with the bodily passage and an inflation lumen in fluid communication with the expandable stent.

2. The assembly of claim 1, wherein the drainage lumen is sized to accommodate a removable guidewire.

3. The assembly of claim 1, wherein the carrier further comprises a separate guidewire lumen sized to accommodate a guidewire.

4. The assembly of claim 1, wherein the inflation lumen communicates with an internal cavity of the stent through inflation holes located within an orthogonal projection of the stent onto the inflation lumen of the carrier.

5. The assembly of claim 1, wherein the drainage lumen communicates with the bodily passage through a plurality of drainage holes connecting an outer surface of the carrier with the drainage lumen.

6. The assembly of claim 1, wherein the carrier is a catheter with an outer diameter from 8 to 18 French.

7. The assembly of claim 1, wherein the carrier comprises a plurality of drainage lumens.

8. The assembly of claim 1, wherein the carrier is made from a polymeric biocompatible material with hardness in the range of 80 A to 50 D.

9. The assembly of claim 1, wherein the stent is made from a resilient polymeric material.

10. The assembly of claim 1, wherein an outer diameter of the stent when expanded is larger than an internal diameter of the bodily passage to be treated.

11. The assembly of claim 1, wherein the passage is selected from a group consisting of biliary duct, kidney duct, sinus pathway, intracranial passages and voids, esophagus, urinary tract, gastrointestinal (GI) tract, and the tracheo-bronchial tree.

12. The assembly of claim 11, wherein the stent assembly is used for treatment of a biliary stricture and drainage of biliary tract.

13. The assembly of claim 12, wherein an outer diameter of the stent is from 4 to 12 mm when expanded.

14. The assembly of claim 12, wherein a length of the stent is from 20 to 100 mm when expanded.

15. The assembly of claim 11, wherein the stent assembly is used intracranially, wherein an outer diameter of the stent is from 3 to 5 French when expanded and the carrier is a catheter with an outer diameter from 2 to 3 French.

16. The assembly of claim 1, wherein an outer diameter of the stent when expanded is larger than an internal diameter of the bodily passage to be treated by from 1 to 2 mm.

17. The assembly of claim 1, wherein the assembly further comprises a connector attached to the proximal end of the carrier, the connector having a first side arm in a communication with the drainage lumen and a second side arm in a communication with the inflation lumen.

18. The assembly of claim 17, wherein the first side arm is further connected to a fluid collection container.

19. The assembly of claim 17, wherein the second side arm is further removably connected to an inflation device for inflation or diflation of the stent via a valve connector or a three-way stopcock.

20. The assembly of claim 19, wherein the valve connector allows injection of a solution into the expandable stent while preventing retrograde flow of the solution from the stent.

21. The assembly of claim 17, wherein the carrier further comprises a separate guidewire lumen sized to accommodate a guidewire and the connector further comprises a third side arm in a communication with the guidewire lumen of the carrier.

22. The assembly of claim 1, wherein the stent forms a spiral about the carrier.

23. The assembly of claim 22, wherein the stent is fused or glued to an outer surface of the carrier at multiple points of their junction.

24. The assembly of claim 1, wherein a plurality of expandable stents is circumferentially attached to the distal end of the carrier.

25. The assembly of claim 24, wherein the plurality of the stents are fused with or glued to the carrier.

26. The assembly of claim 1, wherein the stent is permanently affixed to the carrier.

27. The assembly of claim 1, wherein the stent is detachable from the catheter.

28. The assembly of claim 27, wherein the carrier comprises a combination of at least two movable concentric tubes, wherein a first tube forms a drainage lumen and an inflation lumen and a second tube is a movable member that houses the first tube and is movable over the stent in an expanded form.

29. The assembly of claim 28, wherein the drainage lumen is sized to accommodate a guidewire during insertion of the assembly into the bodily passage.

30. The assembly of claim 28, wherein the drainage lumen is structured to remain connected to the stent and act as a fluid discharge channel when other parts of the carrier are removed.

31. The assembly of claim 28, wherein the second tube has a perforated section to allow the tube to move over the expanded stent.

32. The assembly of claim 28, wherein the carrier further comprises a third concentric tube capable of moving over the second tube to seal the second tube over the expanded stent.

33. The assembly of claim 27, wherein the stent further comprises a valve assembly for inflation or deflation of the stent, the valve assembly is in a fluid communication with an internal cavity of the stent.

34. The assembly of claim 33, wherein the valve assembly allows injection of a solution into the cavity of the stent while preventing retrograde flow from the stent when the carrier is disengaged from the stent.

35. The assembly of claim 1, wherein the stent further comprises a cylindrical net-like structure.

36. The assembly of claim 35, wherein the net-like structure is connected to a plurality of barb elements located on its outer surface.

37. The assembly of claim 35, wherein the net-like structure is fused or connected to an outer surface of the stent.

38. A method of expanding a bodily passage in a patient and draining a fluid therefrom, the method comprising:

(a) providing a stent assembly comprising;

at least one first expandable stent having a first and a second end; and

an elongated carrier for delivery or retrieval of the stent, the carrier having a distal end and a proximal end, wherein the stent is circumferentially attached to the distal end of the carrier, the carrier defining at least two concentric lumens therethrough, a drainage lumen in fluid communication with the bodily passage for drainage of the fluid and an inflation lumen in fluid communication with the expandable stent;

(b) inserting a guidewire into the bodily passage through the drainage lumen of the carrier;

(c) advancing the assembly along the guidewire until the assembly reaches a desired location;

(d) expanding the stent; and

(e) draining the fluid through drainage lumen of the carrier.

39. The method of claim 38, wherein the carrier further comprises a separate guidewire lumen and wherein step (b) is carried out by inserting the guidewire into the bodily passage through the guidewire lumen.

40. The method of claim 38 further comprising a step of retrieving the stent percutaneously.

41. The method of claim 40 further comprising steps of replacing the retrieved stent with a new stent, wherein the new stent, when expanded, has a size that is larger than the size of the retrieved stent.

42. The method of claim 41, further comprises steps of sequentially replacing stents, wherein each subsequent stent has a size, when expanded, that is larger than a size of a previous stent.

43. The method of claim 40, wherein the guidewire has a proximal end, which remains accessible from an outside of the body, and wherein the guidewire remains in the passage after expansion of the stent.

44. The method of claim 43, wherein the stent is permanently affixed to the carrier, the method further comprising steps of deflating the stent, removing the assembly over the guidewire, inserting a new assembly over the guidewire, and expanding a new stent of the new assembly.

45. The method of claim 43, wherein the stent is detachable from the carrier, the method further comprising a step of disengaging the carrier from the stent after the stent is inflated and removing the carrier over the guidewire.

46. The method of claim 45, further comprising steps of moving the carrier over the guidewire into the passage;

attaching the carrier to the stent;

deflating the stent;

removing the carrier with the deflated balloon over the guidewire; and

using the carrier to deliver a new stent over the guidewire.

47. The method of claim 38, wherein the stent is continuously expanded until it reaches a desirable size.

48. The method of claim 38, wherein the stent is incrementally expanded until it reaches a desirable size.