Rotating balloon expandable sheath bifurcation delivery system

• US 7,686,841 B2
• Filed: 12/29/2003
• Issued: 03/30/2010
• Est. Priority Date: 12/29/2003
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Gregorich, Daniel, Eidenschink, Tracee, Jagger, Karl A.
• Primary Examiner(s): Nguyen; Anhtuan T
• Assistant Examiner(s): Houston; Elizabeth
• Application Number:
  US10/747,546
• Publication Number:
  US 20050149161A1
• Time in Patent Office: 2,283 Days
• Field of Search: 606/108, 606/194, 606/200, 623/1.11, 623/1.12, 623/1.13, 623/1.23, 623/1.35, 604/96.01, 60410303-10305, 604/171
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/856 Single tubular stent with a side portal passage
• 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 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures

Abstract

A catheter assembly comprises a catheter, a rotatable sheath, a guidewire housing and a stent. The rotatable sheath is disposed about at least a portion of the catheter shaft and is rotatable thereabout. The stent is disposed about a stent receiving region of the rotatable sheath and at least a portion of the guidewire housing. The first end of the rotatable sheath extends beyond a proximal end region of the stent and the second end region of the rotatable sheath extends beyond a distal end region of the stent.

Claims

1. A catheter assembly comprising:

a catheter, the catheter comprising a catheter shaft and a balloon disposed about a distal region of the catheter shaft, the balloon being expandable from and between a reduced diameter configuration and an expanded diameter configuration;

a rotatable sheath, the rotatable sheath being rotatably disposed about at least a portion of the balloon and rotatable relative to the balloon, the rotatable sheath having a length less than that of the balloon, the rotatable sheath comprising a first end region, a second end region and a stent receiving region therebetween;

a stent, the stent having a proximal opening and a distal opening, the stent being expandable from a reduced stent state to an expanded stent state, in the reduced stent state the stent being disposed about the stent receiving region of the rotatable sheath, the first end of the rotatable sheath extending beyond a proximal end region of the stent and the second end region of the rotatable sheath extending beyond a distal end region of the stent, the stent at least partially constructed from a plurality of interconnected members, the interconnected members defining a plurality of cell openings, the cell openings positioned between the proximal opening and distal opening; and

a guidewire housing, the guidewire housing defining a guidewire lumen for passage of a guidewire therethrough, at least a portion of the guidewire housing being fixed attached to at least a proximal portion of the rotatable sheath, at least a portion of the guidewire housing extending distally through one of the cell openings.

2. The catheter assembly of claim 1 wherein at least a portion of the first end region of the rotatable sheath comprises a proximal flap, in the reduced stent state the proximal flap being positioned over a portion of the proximal end region of the stent, in the expanded stent state the proximal flap being withdrawn from about proximal end region of the stent.

3. The catheter assembly of claim 2 wherein the proximal flap has a first length in a region most proximate to the guidewire housing and a second length in a region furthest from the guidewire housing, the first length being less than the second length, the length of the proximal flap tapering therebetween.

4. The catheter assembly of claim 2 wherein the proximal flap defines a slot, the proximal flap having a circumferential length extending from a first side of the slot to the other side of the slot, the proximal flap having a longitudinal length, the longitudinal length being substantially the same throughout the circumferential length.

5. The catheter assembly of claim 1 wherein at least a portion of the second end region of the rotatable sheath comprises a distal flap, in the reduced stent state the distal flap being positioned over a portion of the distal end region of the stent, in the expanded stent state the distal flap being withdrawn from about distal end region of the stent.

6. The catheter assembly of claim 1 wherein at least a portion of the first end region of the rotatable sheath comprises a proximal flap, and at least a portion of the second end region of the rotatable sheath comprises a distal flap, in the reduced stent state the proximal flap being positioned over a portion of the proximal end region of the stent, in the expanded stent state the proximal flap being withdrawn from about proximal end region of the stent, in the reduced stent state the distal flap being positioned over a portion of the distal end region of the stent, in the expanded stent state the distal flap being withdrawn from about distal end region of the stent.

7. The catheter assembly of claim 6 wherein at least one of the proximal flap and the distal flap comprise a lubricious coating.

8. The catheter assembly of claim 1 wherein the rotatable sheath has an outer diameter, the outer diameter of the stent receiving region being less than the outer diameter of the first end region and the outer diameter of the a second end region.

9. The catheter assembly of claim 8 wherein the stent has an outer diameter, in the reduced stent state the outer diameter of the distal end region of the stent being no greater than the outer diameter of the second end region of the rotatable sheath.

10. The catheter assembly of claim 8 wherein the stent has an outer diameter, in the reduced stent state the outer diameter of the proximal end region of the stent being no greater than the outer diameter of the first end region of the rotatable sheath.

11. The catheter assembly of claim 1 wherein the guidewire housing is comprised of an outer guidewire housing and an inner guidewire housing, in the reduced stent state the outer guidewire housing being proximally adjacent to the proximal end region of the stent, at least a portion of the outer guidewire housing being radially offset from the proximal end region of the stent, the inner guidewire housing extending from the outer guide wire housing through at least a portion of the stent.

12. The catheter assembly of claim 1 wherein the guidewire housing compnses a proximal portion and a distal portion, the proximal portion having a diameter greater than that of the distal portion, in the reduced stent state the proximal portion of the guidewire housing being proximally adjacent to and radially offset from the proximal end region of the stent, the distal portion of the guidewire housing extending through at least a portion of the stent.

13. The catheter assembly of claim 1 wherein the rotatable sheath is expandable from a reduced sheath diameter when the balloon is in the reduced diameter configuration to an expanded sheath diameter when the balloon is in the expanded diameter configuration.

14. The catheter assembly of claim 13 wherein the balloon compnses a proximal balloon cone, a distal balloon cone and a rotatable sheath receiving region therebetween, the rotatable sheath being positioned on the rotatable sheath receiving region, such that the first portion of the rotatable sheath is distally adjacent the proximal balloon cone and the second portion of the rotatable sheath is proximally adjacent the distal balloon cone.

15. The catheter assembly of claim 14 wherein when the balloon is in the reduced diameter configuration, at least a portion of at least one of the proximal balloon cone and the distal balloon cone has an outer diameter greater than that of the rotatable sheath.

16. The catheter assembly of claim 14, wherein when the balloon is in the reduced diameter configuration, at least a portion of the distal balloon cone has an outer diameter greater than that of the distal end region of the stent.

17. The catheter assembly of claim 14, wherein when the balloon is in the reduced diameter configuration, at least a portion of the proximal balloon cone is radially offset from a portion of the proximal end region of the stent.

18. The catheter assembly of claim 1 further comprising a distal sleeve, the distal sleeve comprising a first sleeve region and a second sleeve region, in the reduced stent state at least a portion of the first sleeve region being disposed about the second end region of the rotatable sheath and the distal end region of the stent, the second sleeve region being rotatably engaged to a portion of the catheter shaft distally adjacent to the second end region of the rotatable sheath.

19. The catheter assembly of claim 18 wherein the first sleeve region is constructed of at least one first material and the second sleeve region is constructed of at least one second material, the at least on second material having a higher durometer value than the at least one first material.

20. The catheter assembly of claim 19 wherein in the expanded stent configuration the distal sleeve is retracted from about the second end region of the rotatable sheath and the distal end region of the stent.

21. The catheter assembly of claim 18 further comprising a proximal sleeve, the proximal sleeve comprising a first sleeve, region and a second sleeve region, in the reduced stent state at least a portion of the first sleeve region of the proximal sleeve being disposed about the first end region of the rotatable sheath and the proximal end region of the stent, the second sleeve region of the proximal sleeve being rotatably engaged to a portion of the catheter shaft proximally adjacent to the first end region of the rotatable sheath.

22. The catheter assembly of claim 21 wherein the proximal sleeve defines an opening the guidewire housing passing through the opening.

23. The catheter assembly of claim 22 wherein in the expanded stent configuration the proximal sleeve is retracted from about the first end region of the rotatable sheath and the proximal end region of the stent, the proximal sleeve being drawn proximally along the guidewire housing.

24. The catheter assembly of claim 1 wherein the stent is selected from at least one member of the group consisting of:

a self-expanding stent, a balloon-expandable stent, a hybrid expandable stent and any combination thereof.

25. The catheter assembly of claim 24 wherein at least a portion of the stent is coated with at least one therapeutic agent.

26. The catheter assembly of claim 25 wherein the at least one therapeutic agent is at least one non-genetic therapeutic.

27. The catheter assembly of claim 25 wherein the at least one therapeutic agent is at least one genetic therapeutic agent.

28. The catheter assembly of claim 25 wherein the at least one therapeutic agent is at least one type of cellular material.

29. The catheter assembly of claim 25 wherein the at least one therapeutic agent comprises at least one polymer coating.

30. The catheter assembly of claim 1 further comprising a lubricious coating, the lubricious coating positioned between at least a portion of the rotatable sheath and the at least a portion of the catheter shaft.

31. The catheter assembly of claim 1 further comprising a rotatable collar, the rotatable collar rotatably disposed about a portion of the catheter shaft proximal of the rotatable sheath, at least a portion of the guidewire housing being engaged to at least a portion of the rotatable collar.

32. The catheter assembly of claim 1 wherein the rotatable sheath is at least partially constructed from a hydrophilic polymer material.

33. The catheter assembly of claim 1 wherein the rotatable sheath is at least partially constructed from a tecophilic material.

34. The catheter assembly of claim 1 wherein the rotatable sheath is at least partially constructed from a first material and a second material.

35. The catheter assembly of claim 34 wherein the rotatable sheath is at least partially constructed from at least one material of the group consisting of:

hydrophilic polyurethanes, aromatic polyurethanes, polycarbonate base aliphatic polyurethanes, engineering polyurethane, elastomeric polyamides, block polyamide/ethers, polyether block amide, silicones, polyether-ester, polyester, polyester elastomer, polyethylene, polyamide, high-density polyethylene, polyetheretherketone, polyimide, polyetherimide, liquid crystal polymers, acetal, and any combination thereof.

36. The catheter assembly of claim 34 wherein the first material is a polymer matrix and the second material is at least one distinct member of reinforcing material at least partially supported within the polymer matrix.

37. The catheter assembly of claim 36 wherein polymer matrix is selected from at least one material from the group consisting of:

hydrophilic polyurethanes, aromatic polyurethanes, polycarbonate base aliphatic polyurethanes, engineering polyurethane, elastomeric polyamides, block polyamide/ethers, polyether block amide, silicones, polyether-ester, polyester, polyester elastomer, polyethylene and any combination thereof.

38. The assembly of claim 36 wherein the reinforcing material is selected from at least one material of the group consisting of polyamide, polyethylene, high-density polyethylene, polyetheretherketone, polyimide, polyetherimide, liquid crystal polymers, acetal, and any combination thereof.

39. A catheter assembly comprising:

a catheter shaft having a proximal region and a distal region;

a balloon disposed about a portion of the distal region of the catheter shaft, the balloon being expandable between a reduced diameter configuration and an expanded diameter configuration;

a rotatable sheath, the rotatable sheath being rotatably disposed about at least a portion of the balloon and rotatable relative to the balloon, the rotatable sheath comprising a first end region, a second end region and a stent receiving region therebetween, the rotatable sheath having limited longitudinal movement relative to the balloon;

a stent, the stent having a proximal opening and a distal opening, the stent being expandable from a reduced stent state to an expanded stent state, in the reduced stent state the stent being disposed about the stent receiving region of the rotatable sheath, the stent at least partially constructed from a plurality of interconnected members, the interconnected members defining a plurality of cell openings, the cell openings positioned between the proximal opening and distal opening;

a guidewire housing, the guidewire housing defining a guidewire lumen for passage of a guidewire therethrough, at least a portion of the guidewire housing being fixed attached to at least an outer surface of the rotatable sheath; and

further comprising a collar rotatably disposed about a portion of the catheter shaft, wherein the collar is directly attached to the guide wire housing to limit longitudinal movement of the rotatable sheath relative to the balloon.

40. The catheter assembly of claim 39 wherein the rotatable sheath is fixed longitudinally relative to the balloon.