Expandable guide sheath and apparatus and methods using such sheaths

• US 7,762,995 B2
• Filed: 04/24/2003
• Issued: 07/27/2010
• Est. Priority Date: 04/25/2002
• Status: Active Grant

• Current Assignee: Board of Trustees of the Leland Stanford Junior University (Stanford University)
• Original Assignee: Board of Trustees of the Leland Stanford Junior University (Stanford University)
• Inventors: Mourlas, Nicholas J., Miller, David John, Leeflang, Stephen Arie, Nayak, Asha Shrinivas, Eversull, Christian Scott
• Primary Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US10/423,321
• Publication Number:
  US 20030233115A1
• Time in Patent Office: 2,651 Days
• Field of Search: 606/101, 606/103, 606/508, 606/509, 606/523
• US Class Current: 604/264
• CPC Class Codes: A61B 17/3431 being collapsible, e.g. made of thin flexible material A61B17/3423 takes precedence
• CPC Class Codes: A61B 17/3439 with means for changing the inner diameter of the cannula, e.g. expandable A61B17/3423, A61B17/3431 take precedence; catheters A61M25/0662
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61M 2025/0177 having external means for receiving guide wires, wires or stiffening members, e.g. loops, clamps or lateral tubes
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2025/1004 Balloons with folds, e.g. folded or multifolded
• CPC Class Codes: A61M 2025/1088 having special surface characteristics depending on material properties or added substances, e.g. for reducing friction
• CPC Class Codes: A61M 2029/025 characterised by the guiding element
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 25/0668 splittable, tear apart
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/1027 Making of balloon catheters
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

Apparatus and methods are provided for accessing body lumens and/or for delivering instruments into body lumens, e.g., vessels within a patient'"'"'s vasculature. A flexible sheath is provided that is expandable from a contracted condition to an enlarged condition wherein the sheath at least partially defines a lumen therein. The sheath is lubricious and has a relatively thin wall, thereby providing a collapsible/expandable guide for delivering fluids and/or instruments through tortuous anatomy and/or into relatively narrow passages. The sheath is advanced from an entry site to a body lumen in the contracted condition. Once the sheath reaches a target body lumen, the sheath is expanded to the enlarged condition, thereby defining a lumen within the sheath, and fluids and/or instruments are introduced into the body lumen via the sheath lumen. Upon completing the procedure, the sheath is removed from the body lumen.

Claims

1. An apparatus for providing access to a body lumen of a patient, comprising:

a flexible stiffening member having a proximal end, a distal end having a size and shape for insertion into a body lumen, and a substantially atraumatic distal tip; and

an expandable sheath extending between the proximal and distal ends of the stiffening member, the sheath being expandable from a contracted condition to minimize a profile of the sheath to allow insertion along with the stiffening member into a body lumen, and an enlarged condition wherein the sheath at least partially defines a lumen extending between the proximal and distal ends of the stiffening member,

wherein the sheath is attached to the stiffening member at one or more locations and wherein the sheath may be split into one or more pieces such that the sheath may be removed from around an instrument disposed within the lumen.

2. The apparatus of claim 1, wherein the sheath comprises a lubricious material.

3. The apparatus of claim 1, wherein the sheath comprises a polymer.

4. The apparatus of claim 3, wherein the polymer comprises at least one of PTFE, EPTFE, FEP, PET, urethane, olefin, and PE.

5. The apparatus of claim 1, wherein the sheath comprises an elastomeric material.

6. The apparatus of claim 5, wherein the elastomeric material comprises at least one of silicone, latex, isoprene, and chronoprene.

7. The apparatus of claim 1, wherein the sheath comprises a tubular member that is attached to the stiffening member at one or more locations between the proximal and distal ends of the stiffening member.

8. The apparatus of claim 1, wherein the sheath comprises a distal end having an opening communicating with the lumen such that an instrument inserted through the lumen may be advanced from the opening into a body lumen.

9. The apparatus of claim 1, wherein the sheath comprises a weakened region extending between proximal and distal ends of the sheath to accommodate splitting the sheath into one or more pieces.

10. The apparatus of claim 1, wherein the sheath comprises a wall thickness not more than about 0.01 inch (0.25 mm).

11. The apparatus of claim 1, wherein the stiffening member has sufficient column strength that the distal end may be advanced through a body lumen by pushing the proximal end without substantial risk of kinking or buckling.

12. The apparatus of claim 1, wherein the stiffening member comprises a guidewire.

13. The apparatus of claim 1, wherein the stiffening member comprises an elongate member extending substantially parallel to a longitudinal axis of the sheath.

14. The apparatus of claim 13, wherein the sheath is attached to the stiffening member at the proximal and distal ends of the stiffening member.

15. The apparatus of claim 13, wherein the sheath is attached substantially continuously to the stiffening member between the proximal and distal ends of the stiffening member.

16. The apparatus of claim 13, wherein the sheath is detachably secured to the stiffening member.

17. The apparatus of claim 1, further comprising a constraint for selectively maintaining the sheath in the contracted condition.

18. The apparatus of claim 17, wherein the constraint comprises a tubular member comprising a lumen within which the stiffening member and sheath may be disposed.

19. The apparatus of claim 17, wherein the constraint comprises an outer sheath that surrounds the sheath in the contracted condition, the outer sheath comprises one or more weakened regions that are separable to allow the sheath to expand to the enlarged condition.

20. The apparatus of claim 19, wherein the outer sheath is attached to the stiffening member at one or more locations between the proximal and distal ends of the stiffening member.

21. The apparatus of claim 19, wherein the outer sheath comprises a lumen within which the sheath may be disposed in the contracted condition, the lumen configured for receiving a fluid therein such that fluid pressure may cause the one or more weakened regions to separate.

22. The apparatus of claim 17, wherein the constraint comprises one or more strands disposed around the expandable member.

23. The apparatus of claim 17, wherein the constraint comprises at least one of an adhesive and a bioabsorbable encapsulating material.

24. The apparatus of claim 1, wherein the sheath comprises a plurality of lumens that extend between the proximal and distal ends in the enlarged condition.

25. The apparatus of claim 24, wherein each of the plurality of lumens is configured for at least one of the following:

infusion, aspiration, perfusion, and agitation.

54. The apparatus of claim 1, the stiffening member further comprising one or more lumens extending between the proximal and distal ends.

55. The apparatus of claim 1, further comprising an electrical lead advanceable through the lumen of the sheath after the sheath has been advanced along with the stiffening member into a desired body lumen of a patient.

56. The apparatus of claim 1, wherein the sheath comprises a coating for facilitating inserting one or more instruments through the lumen.

26. An apparatus for providing access to a body lumen of a patient, comprising:

a flexible stiffening member having a proximal end, a distal end having a size and shape for insertion into a body lumen, a substantially atraumatic distal tip, and having sufficient length to be advanced from a location outside a patient'"'"'s body through any intervening body passages into a site to be accessed; and

an expandable sheath expandable from a contracted condition to minimize a profile of the sheath and an enlarged condition, the expandable sheath being flimsy and extending between the proximal and distal ends of the stiffening member, the sheath being expandable from the contracted condition to allow insertion along with the stiffening member into a body lumen, and the enlarged condition wherein the sheath at least partially defines a lumen extending between the proximal and distal ends of the stiffening member,

wherein the sheath is attached to the stiffening member at one or more locations.

27. The apparatus of claim 26, wherein the sheath may be split into one or more pieces to allow the sheath to be removed easily from around an electrical lead advanced through the lumen of the sheath.

28. The apparatus of claim 26, further comprising an electrical lead that may be advanced through the lumen of the sheath after the sheath has been advanced along with the stiffening member to the site to be accessed.

29. The apparatus of claim 26, wherein the sheath has a wall thickness between about 0.005-0.06 millimeter.

30. The apparatus of claim 26, wherein the apparatus attains a relatively low profile when the sheath is in the contracted condition.

31. The apparatus of claim 26, wherein the apparatus attains a profile between about 0.1 and about ten millimeters (0.1-10 mm) in the contracted condition.

32. The apparatus of claim 26, wherein the lumen has a cross-section between about 0.3 and about one hundred millimeters (0.3-100 mm) when the sheath is expanded to the enlarged condition.

33. The apparatus of claim 26, wherein the stiffening member has a length between about twenty and one hundred fifty centimeters (20-150 cm).

34. The apparatus of claim 26, wherein the stiffening member extends axially along the sheath.

35. The apparatus of claim 26, wherein the sheath comprises a lubricious material.

36. The apparatus of claim 26, wherein the sheath comprises a coating for facilitating inserting one or more instruments through the lumen.

37. The apparatus of claim 26, wherein the stiffening member is received in a separate pocket or lumen of the sheath that extends between proximal and distal ends of the sheath.

38. The apparatus of claim 37, wherein the stiffening member is attached to the sheath within the lumen.

39. The apparatus of claim 26, wherein the sheath comprises a tubular member that is attached to the stiffening member at one or more locations between the proximal and distal ends of the stiffening member.

40. The apparatus of claim 26, wherein the sheath comprises a distal end having an opening communicating with the lumen such that an instrument inserted through the lumen may be advanced from the opening into a body lumen.

41. The apparatus of claim 26, wherein the sheath comprises a weakened region extending between proximal and distal ends of the sheath.

42. The apparatus of claim 26, wherein the sheath comprises a wall thickness not more than about 0.01 inch (0.25 mm).

43. The apparatus of claim 26, wherein the stiffening member has sufficient colunm strength that the distal end may be advanced through a body lumen by pushing the proximal end without substantial risk of kinking or buckling.

44. The apparatus of claim 26, wherein the stiffening member comprises a guidewire.

45. The apparatus of claim 26, wherein the stiffening member extends substantially parallel to a longitudinal axis of the sheath.

46. The apparatus of claim 26, wherein the sheath is attached to the stiffening member at the proximal and distal ends of the stiffening member.

47. The apparatus of claim 26, wherein the sheath is attached continuously to the stiffening member between the proximal and distal ends of the stiffening member.

48. The apparatus of claim 26, wherein the sheath is detachably secured to the stiffening member.

49. The apparatus of claim 26, further comprising a constraint for selectively maintaining the sheath in the contracted condition.

50. The apparatus of claim 49, wherein the constraint comprises a tubular member comprising a lumen within which the stiffening member and sheath may be disposed.

51. The apparatus of claim 49, wherein the constraint comprises an outer sheath that surrounds the sheath in the contracted condition, the outer sheath comprises one or more weakened regions that are separable to allow the sheath to expand to the enlarged condition.

52. The apparatus of claim 26, wherein the sheath comprises a plurality of lumens that extend between the proximal and distal ends in the enlarged condition.

53. The apparatus of claim 26, the stiffening member further comprising one or more lumens extending between the proximal and distal ends.

57. An apparatus for providing access to a body lumen of a patient, comprising:

a flexible stiffening member having a proximal end, a distal end having a size and shape for insertion into a body lumen, and one or more lumens extending between the proximal and distal ends; and

an expandable sheath extending between the proximal and distal ends of the stiffening member, the sheath being expandable from a contracted condition to minimize a profile of the sheath to allow insertion along with the stiffening member into a body lumen, and an enlarged condition wherein the sheath at least partially defines a lumen extending between the proximal and distal ends of the stiffening member, the sheath comprising a lubricious coating for facilitating inserting one or more instruments through the lumen,

wherein the sheath is attached to the stiffening member at one or more locations.

58. The apparatus of claim 57, further comprising an electrical lead advanceable through the lumen of the sheath after the sheath has been advanced along with the stiffening member into a desired body lumen of a patient.

59. An apparatus for providing access to a body lumen of a patient, comprising:

a flexible stiffening member having a proximal end, and a distal end having a size and shape for insertion into a body lumen;

an expandable sheath extending between the proximal and distal ends of the stiffening member, the sheath being expandable from a contracted condition to minimize a profile of the sheath to allow insertion along with the stiffening member into a body lumen, and an enlarged condition wherein the sheath at least partially defines a lumen extending between the proximal and distal ends of the stiffening member, wherein the sheath is attached to the stiffening member at one or more locations; and

an electrical lead advanceable through the lumen of the sheath after the sheath has been advanced along with the stiffening member into a desired body lumen of a patient,

wherein the sheath comprises a lubricious coating for facilitating inserting the lead through the lumen.