Expandable guide sheath and apparatus with distal protection and methods for use

• US 20050085842A1
• Filed: 09/02/2004
• Published: 04/21/2005
• Est. Priority Date: 04/24/2003
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Mourlas, Nicholas J., Eversull, Christian S., Leefiang, Stephen A.
• Granted Patent: US 7,591,832 B2
• Time in Patent Office: Days
• US Class Current: 606/191
• CPC Class Codes: A61B 17/1204 temporary occlusion
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/3431 being collapsible, e.g. made of thin flexible material A61B17/3423 takes precedence
• CPC Class Codes: A61F 2/013 Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61M 2025/0024 Expandable catheters or sheaths
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 25/0023 by the form of the lumen, e.g. cross-section, variable diameter
• CPC Class Codes: A61M 25/005 with embedded materials for reinforcement, e.g. wires, coils, braids
• CPC Class Codes: A61M 25/0102 Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00

Abstract

Apparatus and methods provide distal protection while accessing blood vessels within a patient'"'"'s vasculature. A flexible sheath and distal protection element, e.g., a balloon or filter, are carried by a stiffening member. The sheath is lubricious and has a relatively thin wall, thereby providing a collapsible/expandable guide for delivering fluids and/or instruments. The sheath is advanced into a blood vessel in a contracted condition, expanded to an enlarged condition to define a lumen, and the distal protection element is deployed within the vessel beyond the sheath. Fluids and/or instruments are introduced into the vessel via the sheath lumen, the distal protection element retaining the fluids and/or capturing emboli released by the instruments. Upon completing the procedure, the sheath, distal protection element, and stiffening member are removed from the vessel.

Claims

1. 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; and

a distal protection element carried on the distal end of the stiffening member beyond a distal end of the sheath.

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

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

4. 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.

5. The apparatus of claim 4, wherein the stiffening member comprises one or more strands extending along the sheath.

6. The apparatus of claim 5, wherein the one or more strands extend along the sheath at least one of axially, helically, and circumferentially.

7. The apparatus of claim 1, wherein the sheath comprises a sheet of material whose edges are attached to the stiffening member such that the sheet and the stiffening member together define the lumen.

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 substantially closed distal end comprising a break-away portion for creating an opening such that an instrument inserted through the lumen may be advanced from the opening into a body lumen.

10. The apparatus of claim 9, wherein the break-away portion comprises a weakened region of a material comprising the sheath.

11. The apparatus of claim 1, wherein the sheath comprises a substantially closed distal end attached to the distal end of the stiffening member, the distal end of the sheath being separable from the stiffening member to create an opening such that an instrument inserted through the lumen may be advanced from the opening into a body lumen.

12. The apparatus of claim 1, wherein the sheath is configured to split such that the sheath may be removed from around an instrument disposed within the lumen.

13. The apparatus of claim 12, wherein the sheath comprises a weakened region extending between proximal and distal ends of the sheath.

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

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

16. The apparatus of claim 1, wherein the stiffening member comprises an arcuate cross-section, thereby defining a groove extending between the proximal and distal ends within which the sheath may be at least partially disposed in the contracted condition to minimize a cross-sectional profile of the apparatus.

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

18. The apparatus of claim 1, wherein the sheath is attached to the stiffening member at one or more locations.

19. The apparatus of claim 18, wherein the sheath is attached to the stiffening member at the proximal and distal ends of the stiffening member.

20. The apparatus of claim 18, wherein the sheath is attached substantially continuously to the stiffening member between the proximal and distal ends of the stiffening member.

21. The apparatus of claim 18, wherein the sheath is detachably secured to the stiffening member.

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

23. The apparatus of claim 22, wherein the constraint comprises a tubular member comprising a lumen within which the stiffening member, distal protection element, and sheath may be disposed.

24. The apparatus of claim 22, wherein the constraint comprises an outer sheath that surrounds the sheath in the contracted condition, the outer sheath comprising one or more weakened regions that are separable to allow the sheath to expand to the enlarged condition.

25. The apparatus of claim 24, 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.

26. The apparatus of claim 24, 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.

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

28. The apparatus of claim 22, wherein the constraint comprises at least one of an adhesive and a bioabsorbable encapsulating material.

29. 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.

30. The apparatus of claim 1, wherein the distal protection element comprises an expandable occlusion member.

31. The apparatus of claim 30, wherein the stiffening member comprises an infusion lumen extending from the proximal end to one or more ports on the distal portion located distally relative to the occlusion member.

32. The apparatus of claim 30, wherein the stiffening member comprises an infusion lumen extending from the proximal end to one or more ports on the distal portion located proximally relative to the occlusion member.

33. The apparatus of claim 1, wherein the distal protection element comprises a filter.

34. A method for performing a procedure at a location within a body lumen of a patient, the method comprising:

advancing an expandable sheath from an entry site into the body lumen with the sheath in a contracted condition;

expanding the sheath to an enlarged condition, thereby defining a lumen within the sheath;

deploying a distal protection element beyond a distal end of the sheath adjacent the location;

performing at least one of diagnostic and therapeutic procedure within the body lumen via the lumen defined by the sheath, the distal protection element preventing embolic material from leaving the location; and

removing the sheath and the distal protection element from the body lumen.

35. The method of claim 34, wherein the distal protection element comprises an occlusion member, and wherein the occlusion member is expanded after being deployed to substantially seal the body lumen.

36. The method of claim 35, wherein the occlusion member is carried by a stiffening member extending from the sheath, and wherein fluid is delivered via the stiffening member to a location adjacent the occlusion member.

37. The method of claim 36, wherein the fluid is delivered distally beyond the occlusion member.

38. The method of claim 36, wherein the fluid is delivered between the occlusion member and the sheath.

39. The method of claim 35, further comprising aspirating fluid adjacent the occlusion member to aspirate particles retained at the location.

40. The method of claim 35, wherein the occlusion member is collapsed before the sheath is removed from the body lumen.

41. The method of claim 34, wherein the distal protection member comprises a filter.

42. The method of claim 41, wherein the filter is expanded across the body lumen to prevent embolic material from leaving the location.

43. The method of claim 34, wherein the sheath is advanced from the entry site until a distal end of the sheath is disposed within the body lumen while a proximal end of the sheath remains outside the entry site.

44. The method of claim 34, wherein the entry site comprises a percutaneous site communicating with the patient'"'"'s vasculature, and wherein the body lumen comprises a target blood vessel.

45. The method of claim 44, wherein the target blood vessel comprises a vessel within one of the patient'"'"'s coronary, peripheral, and neuro vasculature.

46. The method of claim 44, further comprising introducing an instrument through the lumen defined by the sheath into the target blood vessel.

47. The method of claim 46, wherein the instrument comprises at least one of a catheter, a guidewire, a balloon, a stent, a filter, a pacing lead, an atherectomy device, and a thrombectomy device.

48. The method of claim 44, wherein the target blood vessel comprises a coronary vein, and wherein the instrument comprises an electrical lead.

49. The method of claim 44, wherein the target blood vessel comprises an occlusion or stenosis, and wherein the instrument comprises at least one of a dilation balloon, a filter, and a stent.

50. The method of claim 44, wherein the sheath comprises lubricious material for facilitating advancing the instrument through narrow or tortuous regions of the patient'"'"'s vasculature.

51. The method of claim 34, further comprising advancing an elongate rail from the entry site to the body lumen, and wherein the sheath is advanced from the entry site to the body lumen over the rail.

52. The method of claim 34, wherein the sheath is expanded to the enlarged condition by introducing a fluid into the lumen defined by the sheath.

53. The method of claim 34, wherein the body lumen is part of the patient'"'"'s urogenital tract, respiratory tract, gastrointestinal tract, lymphatic system, or vascular system.

54. A method for delivering an instrument through an occlusion in a body lumen using a catheter comprising an expandable sheath extending along an outer surface of the catheter, the method comprising:

introducing a distal end of the catheter into the body lumen proximal to the occlusion with the sheath in a contracted condition;

advancing the distal end of the catheter through the occlusion until a distal end of the sheath at least partially enters the occlusion;

deploying a distal protection element distal to the occlusion;

advancing an elongate member through the sheath until a distal end of the elongate member is disposed at least partially within the occlusion, the distal protection element capturing embolic material released from the occlusion; and

withdrawing the catheter, distal protection element, and sheath from the body lumen.

55. The method of claim 54, wherein the elongate member is advanced through the occlusion.

56. The method of claim 55, wherein the elongate member comprises a guidewire, and wherein one or more instruments are advanced over the guidewire to treat the occlusion.

57. The method of claim 56, wherein the catheter and sheath are withdrawn from the body lumen before the one or more instruments are advanced over the guidewire.

58. The method of claim 54, wherein the distal end of the catheter comprises one or more elements for facilitating advancing the distal end through the occlusion.

59. The method of claim 58, wherein the one or more elements comprises at least one of an imaging element, a dissection element, and a steering element.

60. The method of claim 54, wherein the distal protection element comprises an occlusion member, and wherein the occlusion member is expanded after being deployed to substantially seal the body lumen distal to the occlusion.

61. The method of claim 60, further comprising delivering fluid via the catheter adjacent the occlusion member.

62. The method of claim 61, wherein the fluid is delivered between the occlusion member and the sheath.

63. The method of claim 60, further comprising aspirating fluid adjacent the occlusion member to aspirate particles retained by the occlusion member.

64. The method of claim 60, wherein the occlusion member is collapsed before the sheath is removed from the body lumen.

65. The method of claim 54, wherein the distal protection member comprises a filter.

66. The method of claim 65, wherein the filter is expanded across the body lumen to prevent embolic material from passing beyond the filter and away from the body lumen.