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

• US 5,486,193 A
• Filed: 05/01/1995
• Issued: 01/23/1996
• Est. Priority Date: 01/22/1992
• Status: Expired due to Fees

• Current Assignee: Medtronic Ave Incorporated (Medtronic Plc)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Whittaker, Gregory R., Bourne, George, Ouellette, Gerry, Lock, James E., Davis, Randall W., Perry, Stanton B., Duval, George, Wagner, Maria, Goodine, Dennis
• Primary Examiner(s): Green, Randall L.
• Assistant Examiner(s): CLARKE, ROBERT A
• Application Number:
  US08/432,971
• Time in Patent Office: 267 Days
• Field of Search: 606/191-194, 604/93, 604/96, 604/103, 604/264, 604/280, 623/1, 623/2
• 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 of a collapsible prosthetic occluder includes a front-end loading portion, a control assembly and an introducer. 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. A control assembly advances the occluder through the front-end loading portion, the introducer and into the defect site.

Claims

1. A front-end loading delivery device for transluminal delivery of a collapsible prosthetic occluder, 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; 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;

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.

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

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

4. The front-end loading delivery 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 an introducer sheath lumen.

5. The front-end loading delivery 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 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 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 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 device according to claim 1 wherein said value 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 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 device according to claim 10 wherein said cap is internally threaded.

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

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

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

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

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

25. The front-end loading delivery 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 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 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 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 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. A percutaneous transluminal front-end loading delivery assembly, for delivery of a collapsible prosthetic occluder 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 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.

31. The percutaneous transluminal introducer assembly according to claim 30 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.

32. The percutaneous transluminal front-end delivery system according to claim 30, wherein said elongated shaft further comprises a hypodermic tube.

33. The percutaneous transluminal front-end delivery system according to claim 32 wherein said hypodermic tube is encapsulated in a non-thrombogenic jacket.

34. The percutaneous transluminal front-end delivery system according to claim 30 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.

35. The percutaneous transluminal front-end delivery system according to claim 30 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.

36. The percutaneous transluminal front-end delivery system according to claim 30 wherein said front-end loading portion lumen has a uniform diameter.

37. The percutaneous transluminal front-end delivery system according to claim 30 wherein said front-end loading portion main body is transparent.

38. The percutaneous transluminal front-end delivery system according to claim 30 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.

39. The percutaneous transluminal front-end delivery system according to claim 38 wherein said compressible gland further includes a cylindrical portion proximally of said tapered portion.

40. The percutaneous transluminal front-end delivery system according to claim 30 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.

41. The percutaneous transluminal front-end delivery system according to claim 40 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.

42. The percutaneous transluminal front-end delivery system according to claim 40 wherein said cap is internally threaded.

43. The percutaneous transluminal front-end delivery system according to claim 42 wherein said cap includes a locking step projection distally of said internal threads.

44. The percutaneous transluminal front-end delivery system according to claim 40 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.

45. The percutaneous transluminal front-end delivery system according to claim 30 wherein said tapered portion of said front-end loading portion lumen is conically shaped.

46. The percutaneous transluminal front-end delivery system recited in claim 30 wherein said front-end loading portion distal end is rigid.

47. The percutaneous transluminal front-end delivery system according to claim 30 wherein said portion of said control assembly flexible distal end includes a tip of said elongated shaft.

48. The percutaneous transluminal front-end delivery system according to claim 47 wherein said flexible distal end is formed of a plastic material and said tip is made of a metallic material.

49. The percutaneous transluminal front-end delivery system according to claim 48 wherein said tip a metal sleeve.

50. The percutaneous transluminal front-end delivery system according to claim 49 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.

51. The percutaneous transluminal front-end delivery system according to claim 30 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.

52. The percutaneous transluminal front-end delivery system according to claim 30 wherein said portion of said flexible distal end of said elongated shaft is less flexible than an adjacent portion of said flexible distal end.

53. The percutaneous transluminal front-end delivery system according to claim 30 wherein said locking members include an enlarged spherical portion of said distal end.

54. The percutaneous transluminal front-end delivery system according to claim 30 wherein said locking members are bulbous shaped.

55. The percutaneous transluminal front-end delivery system according to claim 30 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.

56. The percutaneous transluminal front-end delivery system according to claim 55 wherein said handle includes telescoping distal and proximal portions and a stop for limiting the displacement of said telescoping distal and proximal portions.

57. The percutaneous transluminal front-end delivery system according to claim 56 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.

58. The percutaneous transluminal front-end delivery system according to claim 55 wherein said handle further includes means for releasably locking said telescoping distal and proximal portions relative to one another.

59. The percutaneous transluminal front-end delivery system according to claim 30 wherein said control assembly flexible distal end is bendable to conform to a shape of a body lumen abject to a defect site.