Emboli protection devices and related methods of use

• US 20030050600A1
• Filed: 08/09/2002
• Published: 03/13/2003
• Est. Priority Date: 05/01/2001
• Status: Active Grant

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Velocimed LLC (Abbott Laboratories Incorporated)
• Inventors: Ressemann, Thomas V., Wahr, Dennis W., Hackett, Steven S., Dusbabek, Andrew J.
• Granted Patent: US 7,604,612 B2
• Time in Patent Office: Days
• US Class Current: 604/101.01
• CPC Class Codes: A61B 17/12045 double occlusion, e.g. during anastomosis
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 17/22031 Gripping instruments, e.g. forceps, for removing or smashing calculi A61B17/221 takes precedence
• CPC Class Codes: A61B 17/22032 having inflatable gripping elements balloon catheters A61M25/10
• CPC Class Codes: A61B 2017/22054 with two balloons
• CPC Class Codes: A61B 2017/22069 Immobilising; Stabilising
• CPC Class Codes: A61B 2017/22082 after introduction of a substance
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube

Abstract

An evacuation sheath assembly and method of treating occluded vessels which reduces the risk of distal embolization during vascular interventions is provided. The evacuation sheath assembly includes an elongated tube defining an evacuation lumen having proximal and distal ends. A proximal sealing surface is provided on a proximal portion of the tube and is configured to form a seal with a lumen of a guided catheter. A distal sealing surface is provided on a distal portion of the tube and is configured to form a seal with a blood vessel. Obturator assemblies and infusion catheter assemblies are provided to be used with the evacuation sheath assembly. A method of treatment of a blood vessel using the evacuation sheath assembly includes advancing the evacuation sheath assembly into the blood vessel through a guide catheter. Normal antegrade blood flow in the blood vessel proximate to the stenosis is stopped and the stenosis is treated. Retrograde blood flow is induced within the blood vessel to carry embolic material dislodged during treating into the evacuation sheath assembly. If necessary to increase retrograde flow, the coronary sinus may be at least partially occluded. Alternatively, antegrade flow may be permitted while flow is occluded at the treatment site.

Claims

1. An evacuation sheath assembly, comprising:

a tube having three lumens and first and second sealing surfaces, wherein a first lumen is an evacuation lumen configured to be placed in fluid communication with a bloodstream, wherein a second lumen is an inflation lumen in fluid communication with at least one of the first and second sealing surfaces, and wherein a third lumen is a core wire lumen; and

a shaft in fluid communication with the inflation lumen and configured to connect to an inflation source.

2. The assembly of claim 1, wherein the first and second sealing surfaces are balloons.

3. The assembly of claim 1, wherein the first sealing surface is located on a proximal portion of the tube and the second sealing surface is located on a distal portion of the tube.

4. The assembly of claim 3, wherein the second sealing surface is expandable to a greater diameter than the first sealing surface.

5. The assembly of claim 4, wherein the second sealing surface includes a proximal cone portion and a distal cone portion.

6. The assembly of claim 5, wherein the proximal cone portion and the distal cone portion, when in expanded configurations, each form an angle with respect to a longitudinal axis of the tube, and wherein the angle formed by the proximal cone portion is different from the angle formed by the distal cone portion.

7. The assembly of claim 5, wherein the proximal cone portion and the distal cone portion, when in expanded configurations, each form an angle with respect to a longitudinal axis of the tube, and wherein the angle formed by the proximal cone portion is less steep than the angle formed by the distal cone portion.

8. The assembly of claim 5, wherein the proximal cone portion of the second sealing surface, when in an expanded configuration, forms an angle ranging between approximately 10 degrees and approximately 20 degrees with respect to a longitudinal axis of the tube.

9. The assembly of claim 8, wherein the proximal cone portion of the second sealing surface, when in an expanded configuration, forms an angle of approximately 15 degrees with respect to a longitudinal axis of the tube.

10. The assembly of claim 5, wherein the distal cone portion of the second sealing surface, when in an expanded configuration, forms an angle ranging between approximately 20 degrees and approximately 45 degrees with respect to a longitudinal axis of the tube.

11. The assembly of claim 10, wherein the distal cone portion of the second sealing surface, when in an expanded configuration, forms an angle of approximately 30 degrees with respect to a longitudinal axis of the tube.

12. The assembly of claim 3, wherein the distal sealing surface is adjacent a distal end of the tube.

13. The assembly of claim 12, wherein the distal sealing surface is attached to the distal portion of the tube by two waist portions, and wherein at least a distal waist portion is inverted.

14. The assembly of claim 1, further comprising a kink resistant coil surrounding the tube.

15. The assembly of claim 1, further comprising a support collar for supporting a proximal open end of the tube.

16. The assembly of claim 14, further comprising an encapsulation layer encapsulating the tube and kink resistant coil.

17. The assembly of claim 16, further comprising an encapsulation layer encapsulating the tube and support collar.

18. The assembly of claim 1, wherein the proximal end of the tube is formed at an angle and includes a reverse bevel portion.

19. The assembly of claim 18, wherein the reverse bevel portion forms an angle ranging between approximately 30 degees and approximately 60 degrees with respect to a longitudinal axis of the evacuation lumen.

20. The assembly of claim 14, further comprising at least one marker band adjacent at least one end of the coil.

21. The assembly of claim 20, further comprising a second, shorter coil positioned between the at least one marker band and a support collar supporting a proximal end of the tube.

22. The assembly of claim 20, further comprising an inflation port extending through the at least one marker band and through the tube to provide fluid communication between at least one of the sealing surfaces and the inflation lumen.

23. The assembly of claim 22, wherein the inflation port includes a first portion having a first diameter and a second portion having a second diameter, the first diameter being larger than the second diameter.

24. An evacuation sheath assembly comprising:

an elongated tube defining an evacuation lumen having proximal and distal ends; and

a distal sealing surface configured to form a seal with a blood vessel, the distal sealing surface including a proximal cone portion and a distal cone portion, wherein at least one of the proximal and distal cone portions, when in an expanded configuration, forms an angle with respect to a longitudinal axis of the elongated tube.

25. The evacuation sheath assembly of claim 24, wherein the proximal cone portion and the distal cone portion, when in expanded configurations, each form an angle with respect to a longitudinal axis of the tube, and wherein the angle formed by the proximal cone portion is different from the angle formed by the distal cone portion.

26. The evacuation sheath assembly of claim 24, wherein the proximal cone portion and the distal cone portion, when in expanded configurations, each form an angle with respect to a longitudinal axis of the tube, and wherein the angle formed by the proximal cone portion is less steep than the angle formed by the distal cone portion.

27. The evacuation sheath assembly of claim 24, wherein the proximal cone portion, when in an expanded configuration, forms an angle ranging between approximately 10 degrees and approximately 20 degrees with respect to a longitudinal axis of the tube.

28. The evacuation sheath assembly of claim 27, wherein the proximal cone portion, when in an expanded configuration, forms an angle of approximately 15 degrees with respect to a longitudinal axis of the evacuation lumen.

29. The evacuation sheath assembly of claim 24, wherein the distal cone portion, when in an expanded configuration, forms an angle ranging between approximately 20 degrees and approximately 45 degrees with respect to a longitudinal axis of the tube.

30. The evacuation sheath assembly of claim 29, wherein the distal cone portion, when in an expanded configuration, forms an angle of approximately 30 degrees with respect to a longitudinal axis of the evacuation lumen.

31. The evacuation sheath assembly of claim 24, wherein at least one of the ends of the lumen is formed at an angle.

32. The evacuation sheath assembly of claim 24, further comprising a proximal sealing surface at a proximal end of the tube configured to form a seal with a catheter.

33. The evacuation sheath assembly of claim 32, wherein the proximal sealing surface includes an inflatable balloon.

34. The evacuation sheath assembly of claim 24, wherein the distal sealing surface includes an inflatable balloon.

35. The evacuation sheath assembly of claim 32, wherein the proximal and distal sealing surfaces include inflatable balloons, and wherein the distal balloon is larger than the proximal balloon.

36. The evacuation sheath assembly of claim 24, further comprising a proximal shaft portion attached to a proximal end of the elongate tube.

37. The evacuation sheath assembly of claim 24, further comprising a flexible tip on a distal end of the assembly.

38. The evacuation sheath assembly of claim 37, wherein the flexible tip is formed by a portion of the distal sealing surface.

39. The evacuation sheath assembly of claim 24, wherein a proximal end of the evacuation lumen is formed at an angle.

40. The evacuation sheath assembly of claim 24, further comprising at least one marker band adjacent at least one of said proximal and distal ends of said evacuation lumen.

41. The evacuation assembly of claim 40, further comprising an inflation port extending through the at least one marker band.

42. The evacuation assembly of claim 41, wherein the inflation port includes a first portion having a first diameter and a second portion having a second diameter, wherein the first diameter is larger than the second diameter.

47. The evacuation sheath assembly of claim 36, wherein the support collar includes a cylindrical portion positioned about the proximal open end of the tube.

43. An evacuation sheath assembly comprising:

an elongated tube defining an evacuation lumen having open proximal and distal ends and an inflation lumen having an open proximal end and a closed distal end, wherein the proximal end of the evacuation lumen is angled and includes a reverse bevel portion; and

a first sealing region on a proximal portion of the evacuation lumen and a second sealing region on a distal portion of the evacuation lumen, wherein at least one of the first and second sealing regions is in fluid communication with the inflation lumen.

44. The evacuation sheath assembly of claim 43, wherein the first sealing region is expandable to a first diameter and the second sealing region is expandable to a second diameter different than the first diameter.

45. An evacuation sheath assembly, comprising:

an elongated tube defining an evacuation lumen having open proximal and distal ends and an inflation lumen having an open proximal end and a closed distal end; and

first and second sealing surfaces on the tube;

wherein the open proximal end of the evacuation lumen is angled and includes a structure to reinforce the proximal opening of the elongated tube.

46. The evacuation sheath assembly of claim 45, wherein the structure to reinforce the proximal opening of the tube is a support collar.

48. The evacuation sheath assembly of claim 46, wherein the support collar further includes a tab portion extending proximally from the cylindrical portion in a direction parallel to a longitudinal axis of the tube.

49. The evacuation sheath assembly of claim 46, further comprising an encapsulation layer encapsulating the tube and the support collar.

50. The evacuation sheath assembly of claim 46, wherein the support collar is formed of a metallic material.

51. The evacuation sheath assembly of claim 49, wherein the encapsulation layer is formed of polyurethane.

52. The evacuation sheath assembly of claim 49, wherein the support collar further includes a plurality of windows to promote adhesion of the encapsulation layer to the support collar.

53. The evacuation sheath assembly of claim 45, wherein the tube includes a third lumen.

54. The evacuation sheath assembly of claim 53, wherein the second and third lumens are positioned adjacent to one another.

55. The evacuation sheath assembly of claim 53, wherein both the second lumen and the third lumen are smaller in diameter than the first lumen.

56. The evacuation sheath assembly of claim 45, wherein the first and second sealing members are balloons.

57. The evacuation sheath assembly of claim 45, wherein the first and second sealing members are elastomeric.

58. The evacuation sheath assembly of claim 45, wherein the first sealing member is located on a proximal portion of the elongated tube and the second sealing member is located on a distal portion of the elongated tube.

59. An evacuation sheath assembly, comprising:

an elongated tube defining an evacuation lumen having open proximal and distal ends and an inflation lumen having an open proximal end and a closed distal end;

a kink resistant coil surrounding the elongated tube;

at least one marker band adjacent at least one end of the kink resistant coil; and

at least one inflatable sealing surface in fluid communication with the inflation lumen via an inflation port passing through the at least one marker band.

60. The evacuation sheath assembly of claim 59, further comprising an encapsulation layer encapsulating the kink resistant coil and elongated tube.

61. The evacuation sheath assembly of claim 59, wherein the inflation port includes a first portion having a first diameter and a second portion having a second diameter, wherein the first diameter is larger than the second diameter.

62. The evacuation sheath assembly of claim 60, wherein the inflation port includes a first portion extending through the marker band and having a first diameter.

63. The evacuation sheath assembly of claim 62, wherein the inflation port includes a second portion extending through the encapsulation layer and having a second diameter.

64. The evacuation sheath assembly of claim 63, wherein the first diameter is larger than the second diameter.

65. An evacuation sheath assembly, comprising:

an elongated tube defining an evacuation lumen having open proximal and distal ends and an inflation lumen having an open proximal end and a closed distal end; and

proximal and distal sealing surfaces in fluid communication with the inflation lumen;

wherein the distal sealing surface extends distally beyond the distal end of the evacuation lumen.

66. The evacuation sheath assembly of claim 65, wherein a waist portion connecting the balloon to the tube is inverted.

67. A combination for isolating fluid communication between a blood vessel and a catheter, comprising:

a catheter having a lumen;

an evacuation sheath assembly configured to move within the lumen of the catheter and having an evacuation lumen and first and second sealing members; and

a three-arm adaptor having a first arm for receiving a guide wire, a second arm for receiving the evacuation sheath assembly, and a third arm for connection to an evacuation means, wherein the third arm is spaced distally from the first and second arms.

68. The combination of claim 67, wherein the evacuation means includes a means for creating a vacuum.

69. The combination of claim 67, wherein the evacuation means includes an evacuation syringe.

70. The combination of claim 67, wherein the proximal end of the evacuation lumen includes means for preventing devices from hanging up on the evacuation lumen.

71. The combination of claim 70, wherein the means for preventing devices from hanging up on the evacuation lumen includes an angled proximal end of the evacuation lumen.

72. The combination of claim 71, wherein the means for preventing devices from hanging up on the evacuation lumen further includes a reverse beveled portion on the proximal end of the evacuation lumen.

73. The combination of claim 67, wherein the first sealing member includes a proximal portion of the evacuation sheath assembly configured to seal against the lumen of the catheter.

74. The combination of claim 67, wherein the second sealing member is located on a distal portion of the evacuation sheath assembly.

75. The combination of claim 67, wherein the first and second sealing members include expandable surfaces.

76. The combination of claim 67, wherein the second sealing member is configured to create a seal between the evacuation sheath assembly and the blood vessel.

77. The combination of claim 75, wherein a distal end of the evacuation lumen is perpendicular to a longitudinal axis of the evacuation lumen.

78. The combination of claim 77, wherein the second sealing member is adjacent the distal end of the evacuation lumen.

79. The combination of claim 78, wherein the second sealing member extends distally beyond the distal end of the evacuation lumen.

80. The combination of claim 79, wherein the second sealing member includes an inverted waist portion attaching the second sealing member to an outer surface of the evacuation lumen.

81. The combination of claim 80, wherein the expandable surfaces are inflatable balloons.

82. The combination of claim 81, wherein the second sealing member includes proximal and distal cone portions.

83. The combination of claim 82, wherein the proximal cone portion and the distal cone portion, when in expanded configurations, each form an angle with respect to a longitudinal axis of the tube, and wherein the angle formed by the proximal cone portion is different from the angle formed by the distal cone portion.

84. The combination of claim 82, wherein the proximal cone portion and the distal cone portion, when in expanded configurations, each form an angle with respect to a longitudinal axis of the tube, and wherein the angle formed by the proximal cone portion is less steep than the angle formed by the distal cone portion.

85. The combination of claim 82, wherein the proximal cone portion, when in an expanded configuration, forms an angle ranging between approximately 10 degrees and approximately 20 degrees with respect to a longitudinal axis of the tube.

86. The combination of claim 85, wherein the proximal cone portion, when in an expanded configuration, forms an angle of about 15 degrees with respect to a longitudinal axis of the evacuation lumen.

87. The combination of claim 82, wherein the distal cone portion, when in an expanded configuration, forms an angle ranging between approximately 20 degrees and approximately 45 degrees with respect to a longitudinal axis of the tube.

88. The combination of claim 87, wherein the distal cone portion, when in an expanded configuration, forms an angle of about 30 degrees with respect to a longitudinal axis of the evacuation lumen.