System for the percutaneous transluminal front-end loading delivery and retrieval of a prosthetic occluder

• US 5,649,950 A
• Filed: 05/01/1995
• Issued: 07/22/1997
• Est. Priority Date: 01/22/1992
• Status: Expired due to Term

• Current Assignee: Medtronic Ave Incorporated (Medtronic Plc)
• Original Assignee: C. R. Bard
• Inventors: Whittaker, Gregory R., Davis, Randall W., Wagner, Maria, Bourne, George, Ouellette, Gerry, Lock, James E., Perry, Stanton B., Duval, George, Goodine, Dennis
• Primary Examiner(s): Clarke, Robert A.
• Application Number:
  US08/431,451
• Time in Patent Office: 813 Days
• Field of Search: 606/191-194, 604/93, 604/96, 604/103, 604/264, 604/280, 623/1, 623/2, 623/11
• US Class Current: 606/194
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00606 Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
• CPC Class Codes: A61B 2017/00619 Locking means for locking the implement in expanded state
• CPC Class Codes: A61B 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/00902 transparent or translucent

Abstract

A system for percutaneous transluminal front-end delivery and retrieval of a collapsible prosthetic occluder includes a front-end loading portion, a control assembly and an introducer and retrieval sheath assembly. The front-end loading portion includes a tapering lumen portion and a smaller diameter distal lumen portion. An infusion port communicates with the distal lumen portion immediately adjacent the distal end of the tapering lumen portion. A valve assembly seals the front-end loading portion lumen proximally of the collapsed occluder. The distal end of the front-end loading portion lumen is inserted into the proximal end of an introducer and retrieval sheath assembly. A control assembly advances the occluder through the front-end loading portion, the introducer and retrieval sheath assembly and into the defect site. The retrieval sheath assembly is less flexible than the introducer sheath and is sufficiently rigid to evert the deployed occluder when retracted thereagainst.

Claims

1. A front-end loading delivery device for transluminal delivery of a collapsible prosthetic occluder and retrieval sheath assembly, comprising:

a front-end loading portion comprising a main body having a distal end, a proximal end and a lumen extending therethrough, a portion of said lumen being tapered inwardly toward a smaller diameter distal portion;

an infusion port extending through said main body and in direct communication with said distal portion of said lumen;

a valve for sealing said lumen proximally of said small diameter distal portion;

a control assembly comprising;

an elongated shaft having a proximal end, a flexible distal end and a lumen extending therethrough;

a locking wire extending through said lumen of said elongated shaft having a proximal end and a locking member at a distal end which is extendable beyond said flexible distal end of said elongated shaft; and

a portion of said flexible distal end of said elongated shaft being adapted to lockingly hold said locking member and a locking member of a collapsible prosthetic occluder;

an introducer sheath having a proximal end, a flexible distal end which is bendable to conform to a shape of a body lumen adjacent a defect site and a lumen extending therethrough; and

a retrieval sheath removeably mounted about said introducer sheath and having a lumen extending therethrough adapted to slidably receive said introducer sheath, a distal end of said retrieval sheath being less flexible than said flexible distal end of said introducer sheath.

2. The front-end loading delivery and retrieval device according to claim 1 wherein said elongated shaft further comprises a hypodermic tube.

3. The front-end loading delivery and retrieval device according to claim 2 wherein said hypodermic tube is encapsulated in a non-thrombogenic jacket.

4. The front-end loading delivery and retrieval device according to claim 1 wherein said front-end loading portion distal end is constructed and arranged for insertion into a hub at a proximal end of said introducer sheath lumen.

5. The front-end loading delivery and retrieval device according to claim 1 wherein said infusion port opens into said front-end loading portion lumen distal portion immediately adjacent said inwardly tapered portion of said front-end loading portion lumen.

6. The front-end loading delivery and retrieval device according to claim 1 wherein said distal portion of said front-end loading portion lumen has a uniform diameter.

7. The front-end loading delivery device according to claim 1 wherein said front-end portion main body is transparent.

8. The front-end loading delivery and retrieval device according to claim 1 wherein said valve includes a compressible gland having a tapered outer portion constructed and arranged to closely fit in a non-compressed state within a proximal end of said tapered portion of said lumen.

9. The front-end loading delivery and retrieval device according to claim 8 wherein said compressible gland further includes a cylindrical portion proximally of said tapered portion.

10. The front-end loading delivery and retrieval device according to claim 1 wherein said valve includes a cap threadably mounted to said proximal end of said main body and having a lumen extending therethrough and a compressible gland having a lumen in alignment with said cap lumen.

11. The front-end loading delivery and retrieval device according to claim 10 wherein one of said cap and said gland has an annular groove and the other of said cap and said gland has an annular projection fitted within said groove.

12. The front-end loading delivery and retrieval device according to claim 10 wherein said cap is internally threaded.

13. The front-end loading delivery and retrieval device according to claim 12 wherein said cap includes a locking step projection distally of said internal threads.

14. The front-end loading delivery and retrieval device according to claim 10 wherein a perimeter of said cap lumen and said gland lumen in a non-compressed state are smaller than a perimeter of said collapsible prosthetic occluder in a collapsed state.

15. The front-end loading delivery and retrieval device according to claim 1 wherein said tapered portion of said front-end loading portion lumen is conically shaped.

16. The front-end loading delivery and retrieval device according to claim 1 wherein said front-end loading portion distal end is rigid.

17. The front-end loading delivery and retrieval device according to claim 1 wherein said portion of said control assembly flexible distal end includes a tip of said elongated shaft.

18. The front-end loading delivery and retrieval device according to claim 17 wherein said flexible distal end is formed of a plastic material and said tip is made of a metallic material.

19. The front-end loading delivery and retrieval device according to claim 18 wherein said tip is a metal sleeve.

20. The front-end loading delivery and retrieval device according to claim 19 wherein said locking member includes an enlarged spherical portion and said locking wire distal end and said metal sleeve has an inner diameter greater than the diameter of said enlarged spherical portion but less than twice the diameter of said enlarged spherical portion.

21. The front-end loading delivery and retrieval device according to claim 1 wherein an inner perimeter of a portion of said control assembly flexible distal end is adapted to lockingly hold said locking member and said locking member of the collapsible prosthetic occluder.

22. The front-end loading delivery and retrieval device according to claim 1 wherein said portion of said flexible distal end of said elongated shaft is less flexible than an adjacent portion of said flexible distal end.

23. The front-end loading delivery and retrieval device according to claim 1 wherein said locking members include an enlarged spherical portion of said distal end.

24. The front-end loading delivery and retrieval device according to claim 1 wherein said locking members are bulbous shaped.

25. The front-end loading delivery and retrieval device according to claim 1 wherein said control assembly comprises a handle connected to said proximal end of said elongated shaft and including a moveable member connected to said proximal end of said locking wire for reciprocally advancing and retracting said locking member relative to said portion of said flexible distal end of said shaft.

26. The front-end loading delivery and retrieval device according to claim 25 wherein said handle includes telescoping distal and proximal portions and a stop for limiting the displacement of said telescoping distal and proximal portions.

27. The front-end loading delivery and retrieval device according to claim 26 wherein said stop includes a groove extending through the surface of one of said telescoping distal and proximal portions and a projection extending into said groove from said other of said telescoping distal and proximal portions.

28. The front-end loading delivery and retrieval device according to claim 25 wherein said handle further includes means for releasably locking said telescoping distal and proximal portions relative to one another.

29. The front-end loading delivery and retrieval device according to claim 1 wherein said control assembly flexible distal end is bendable to conform to a shape of a body lumen adjacent to a defect site.

30. The front-end loading delivery and retrieval device according to claim 1, wherein a positioning wire is extendable through and beyond said introducer sheath lumen, having a distal tip connected to an article to be retrieved having a configuration larger than said introducer sheath lumen.

31. The front-end loading delivery and retrieval device according to claim 30 wherein said distal end of said removeably mounted retrieval sheath is positioned proximally of said flexible distal end of said introducer sheath.

32. The front-end loading delivery and retrieval device according to claim 30 wherein said removeably mounted retrieval sheath is moveable from a first position wherein said less flexible distal end of said removeably mounted retrieval sheath is proximal of said flexible distal end of said introducer sheath and said distal tip of said positioning wire to a second position wherein said less flexible distal end of said removeably mounted retrieval sheath is distal of said flexible distal end of said introducer sheath and said distal tip of said positioning wire.

33. The front-end loading delivery and retrieval device according to claim 30 further comprising a valve for sealing said proximal end of said lumen of said introducer sheath about said positioning wire.

34. The front-end loading delivery and retrieval device according to claim 30 further comprising a flange fixed to a proximal end of said removeably mounted retrieval sheath and having a lumen therethrough adapted to slidably receive said introducer sheath.

35. The front-end loading delivery and retrieval device according to claim 34 wherein said flange is tapered inwardly towards a distal tip thereof.

36. The front-end loading delivery and retrieval device according to claim 35 wherein said tapering flange is cone-shaped.

37. The front-end loading delivery and retrieval device according to claim 34 wherein said flange is releasably connected to a projection supported by a proximal end of said introducer sheath.

38. The front-end loading delivery and retrieval device according to claim 37 wherein said projection is tapered inwardly towards a distal tip thereof.

39. The front-end loading delivery and retrieval device according to claim 38 wherein said flange includes a proximal end adapted to receive said tapered projection in a releasable tight-fitting relationship.

40. The front-end loading delivery and retrieval device according to claim 39 wherein said proximal end of said flange is more flexible than said projection.

41. A percutaneous transluminal front-end loading delivery assembly, for delivery of a collapsible prosthetic occluder, and retrieval sheath assembly comprising:

a front-end loading portion comprising a main body having a distal end, a proximal end and a lumen extending therethrough, a portion of said lumen being tapered inwardly toward a smaller diameter distal portion;

an infusion port extending through said main body and in direct communication with said distal portion of said lumen, and a valve for sealing said lumen proximally of said small diameter distal portion;

an introducer sheath having a flexible distal end, a proximal end and a lumen extending therethrough, said distal end of said front-end loading portion being removeably mountable to a hub at a proximal end of said introducer sheath;

a retrieval sheath removeably mounted about said introducer sheath and having a lumen extending therethrough adapted to slidably receive said introducer sheath, a distal end of said retrieval sheath being less flexible than said flexible distal end of said introducer sheath; and

a control assembly moveable through said lumen of said front-end loading portion and said lumen of said introducer sheath;

said control assembly comprising;

an elongated shaft having a proximal end, a flexible distal end and a lumen extending therethrough;

a locking wire extending through said lumen of said elongated shaft having a proximal end and a locking member at a distal end which is extendable beyond said flexible distal end of said elongated shaft;

a portion of said flexible distal end of said elongated shaft being adapted to lockingly hold said locking member and a locking member of the collapsible prosthetic occluder and a valve for sealing said proximal end of said introducer lumen about said distal end of said front-end loading portion.

42. The percutaneous transluminal front-end loading delivery and retrieval assembly according to claim 41 wherein said valve for sealing said introducer sheath lumen includes a cap threadably mounted to said introducer sheath, a compressible gland and a washer disposed between said cap and said compressible gland.

43. The percutaneous transluminal front-end loading delivery and retrieval system according to claim 41, wherein said elongated shaft further comprises a hypodermic tube.

44. The percutaneous transluminal front-end loading delivery and retrieval system according to claim 43 wherein said hypodermic tube is encapsulated in a non-thrombogenic jacket.

45. The percutaneous transluminal front-end loading delivery and retrieval system according to claim 41 wherein said front-end loading portion distal end is constructed and arranged for insertion into a hub at a proximal end of an introducer sheath lumen.

46. The percutaneous transluminal front-end loading delivery and retrieval system according to claim 41 wherein said infusion port opens into said front-end loading portion lumen distal portion immediately adjacent said inwardly tapered portion of said front-end loading portion lumen.

47. The percutaneous transluminal front-end loading delivery and retrieval system according to claim 41 wherein said front-end loading portion lumen has a uniform diameter.

48. The percutaneous transluminal front-end loading delivery and retrieval system according to claim 41 wherein said front-end loading portion main body is transparent.

49. The percutaneous transluminal front-end loading delivery and retrieval system according to claim 41 wherein said valve includes a compressible gland having a tapered outer portion constructed and arranged to closely fit in a non-compressed state within a proximal end of said tapered portion of said lumen.

50. The percutaneous transluminal front-end loading delivery and retrieval system according to claim 49 wherein said compressible gland further includes a cylindrical portion proximally of said tapered portion.

51. The percutaneous transluminal front-end loading delivery and retrieval system according to claim 41 wherein said valve includes a cap threadably mounted to said proximal end of said main body and having a lumen extending therethrough and a compressible gland having a lumen in alignment with said cap lumen.

52. The percutaneous transluminal front-end loading delivery and retrieval system according to claim 51 wherein one of said cap and said gland has an annular groove and the other of said cap and said gland has an annular projection fitted within said groove.

53. The percutaneous transluminal front-end loading delivery and retrieval system according to claim 51 wherein said cap is internally threaded.

54. The percutaneous transluminal front-end loading delivery and retrieval system according to claim 53 wherein said cap includes a locking step projection distally of said internal threads.

55. The percutaneous transluminal front-end loading delivery and retrieval system according to claim 51 wherein a perimeter of said cap lumen and said gland lumen in a non-compressed state are smaller than a perimeter of said collapsible prosthetic occluder in a collapsed state.

56. The percutaneous transluminal front-end loading delivery and retrieval system according to claim 41 wherein said tapered portion of said front-end loading portion lumen is conically shaped.

57. The percutaneous transluminal front-end loading delivery and retrieval system recited in claim 41 wherein said front-end loading portion distal end is rigid.

58. The percutaneous transluminal front-end loading delivery and retrieval system according to claim 41 wherein said portion of said control assembly flexible distal end includes a tip of said elongated shaft.

59. The percutaneous transluminal front-end loading delivery and retrieval system according to claim 41 wherein an inner perimeter of a portion of said control assembly flexible distal end is adapted to lockingly hold said locking member and said locking member of the collapsible prosthetic occluder.

60. The percutaneous transluminal front-end loading delivery and retrieval system according to claim 41 wherein said portion of said flexible distal end of said elongated shaft is less flexible than an adjacent portion of said flexible distal end.

61. The percutaneous transluminal front-end loading delivery and retrieval system according to claim 58 wherein said flexible distal end is formed of a plastic material and said tip is made of a metallic material.

62. The percutaneous transluminal front-end loading delivery and retrieval system according to claim 61 wherein said tip is a metal sleeve.

63. The percutaneous transluminal front-end loading delivery and retrieval system according to claim 62 wherein said locking member includes an enlarged spherical portion of said locking wire distal end and said metal sleeve has an inner diameter greater than the diameter of said enlarged spherical portion but less than twice the diameter of said enlarged spherical portion.

64. The percutaneous transluminal front-end loading delivery and retrieval system according to claim 41 wherein said locking members include an enlarged spherical portion of said distal end.

65. The percutaneous transluminal front-end loading delivery and retrieval system according to claim 41 wherein said locking members are bulbous shaped.

66. The percutaneous transluminal front-end loading delivery and retrieval system according to claim 41 wherein said control assembly comprises a handle connected to said proximal end of said elongated shaft and including a moveable member connected to said proximal end of said locking wire for reciprocally advancing and retracting said locking member relative to said portion of said flexible distal end of said shaft.

67. The percutaneous transluminal front-end loading delivery and retrieval system according to claim 66 wherein said handle includes telescoping distal and proximal portions and a stop for limiting the displacement of said telescoping distal and proximal portions.

68. The percutaneous transluminal front-end loading delivery and retrieval system according to claim 67 wherein said stop includes a groove extending through the surface of one of said telescoping distal and proximal portions and a projection extending into said groove from said other of said telescoping distal and proximal portions.

69. The percutaneous transluminal front-end loading delivery and retrieval system according to claim 66 wherein said handle further includes means for releasably locking said telescoping distal and proximal portions relative to one another.

70. The percutaneous transluminal front-end loading delivery and retrieval system according to claim 41 wherein said control assembly flexible distal end is bendable to conform to a shape of a body lumen adjacent to a defect site.

71. The percutaneous transluminal front-end loading delivery and retrieval system according to claim 41 wherein a positioning wire is extendable through and beyond said introducer sheath lumen, having a distal tip connected to an article to be retrieved having a configuration larger than said introducer sheath lumen.

72. The percutaneous transluminal front-end loading delivery and retrieval system according to claim 71 wherein said distal end of said removeably mounted retrieval sheath is positioned proximally of said flexible distal end of said introducer sheath.

73. The percutaneous transluminal front-end loading delivery and retrieval system according to claim 71 wherein said removeably mounted retrieval sheath is moveable from a first position wherein said less flexible distal end of said removeably mounted retrieval sheath is proximal of said flexible distal end of said introducer sheath and said distal tip of said positioning wire to a second position wherein said less flexible distal end of said removeably mounted retrieval sheath is distal of said flexible distal end of said introducer sheath and said distal tip of said positioning wire.

74. The percutaneous transluminal front-end loading delivery and retrieval system according to claim 71 further comprising a valve for sealing said proximal end of said lumen of said introducer sheath about said positioning wire.

75. The percutaneous transluminal front-end loading delivery and retrieval system according to claim 71 further comprising a flange fixed to a proximal end of said removeably mounted retrieval sheath and having a lumen therethrough adapted to slidably receive said introducer sheath.

76. The percutaneous transluminal front-end loading delivery and retrieval system according to claim 75 wherein said flange is tapered inwardly towards a distal tip thereof.

77. The percutaneous transluminal front-end loading delivery and retrieval system according to claim 76 wherein said tapering flange is cone-shaped.

78. The percutaneous transluminal front-end loading delivery and retrieval system according to claim 75 wherein said flange is releasably connected to a projection supported by a proximal end of said introducer sheath.

79. The percutaneous transluminal front-end loading delivery and retrieval system according to claim 78 wherein said projection is tapered inwardly towards a distal tip thereof.

80. The percutaneous transluminal front-end loading delivery and retrieval system according to claim 79 wherein said flange includes a proximal end adapted to receive said tapered projection in a releasable tight-fitting relationship.

81. The percutaneous transluminal front-end loading delivery and retrieval system according to claim 80 wherein said proximal end of said flange is more flexible than said projection.

82. A percutaneous transluminal introducer and retrieval sheath assembly, comprising:

an introducer sheath having a proximal end, a flexible distal end which is bendable to conform to a shape of a body lumen adjacent a defect site and a lumen extending therethrough;

a retrieval sheath removeably mounted about said introducer sheath and having a lumen extending therethrough adapted to slidably receive said introducer sheath, a distal end of said retrieval sheath being less flexible than said flexible distal end of said introducer sheath; and

a control assembly comprising;

an elongated shaft having a proximal end, a flexible distal end and a lumen extending therethrough;

a locking wire extending through said lumen of said elongated shaft having a proximal end and a locking member at a distal end which is extendable beyond said flexible distal end of said elongated shaft;

said locking wire extending through and beyond said introducer sheath lumen, and having said distal locking member connected to an article to be retrieved having a configuration larger than said introducer sheath lumen.

83. The percutaneous transluminal introducer and retrieval assembly according to claim 82 wherein said distal end of said removeably mounted retrieval sheath is positioned proximally of said flexible distal end of said introducer sheath.

84. The percutaneous transluminal introducer and retrieval assembly according to claim 82 wherein said removeably mounted retrieval sheath is moveable from a first position wherein said less flexible distal end of said removeably mounted retrieval sheath is proximal of said flexible distal end of said introducer sheath and said distal locking member of said locking wire to a second position wherein said less flexible distal end of said removeably mounted retrieval sheath is distal of said flexible distal end of said introducer sheath and said distal locking member of said locking wire.

85. The percutaneous transluminal introducer and retrieval assembly according to claim 82 further comprising a valve for sealing said proximal end of said lumen of said introducer sheath about said locking wire.

86. The percutaneous transluminal introducer and retrieval assembly according to claim 82 further comprising a flange fixed to a proximal end of said removeably mounted retrieval sheath and having a lumen therethrough adapted to slidably receive said introducer sheath.

87. The percutaneous transluminal introducer and retrieval assembly according to claim 86 wherein said flange is tapered inwardly towards a distal tip thereof.

88. The percutaneous transluminal introducer and retrieval assembly according to claim 87 wherein said tapering flange is cone-shaped.

89. The percutaneous transluminal introducer and retrieval assembly according to claim 86 wherein said flange is releasably connected to a projection supported by a proximal end of said introducer sheath.

90. The percutaneous transluminal introducer and retrieval assembly according to claim 89 wherein said projection is tapered inwardly towards a distal tip thereof.

91. The percutaneous transluminal introducer and retrieval assembly according to claim 90 wherein said flange includes a proximal end adapted to receive said tapered projection in a releasable tight-fitting relationship.

92. The percutaneous transluminal introducer and retrieval assembly according to claim 91 wherein said proximal end of said flange is more flexible than said projection.