Capture device for stent graft delivery

• US 8,070,790 B2
• Filed: 02/13/2006
• Issued: 12/06/2011
• Est. Priority Date: 09/03/2003
• Status: Active Grant

• Current Assignee: Bolton Medical, Inc. (Terumo Corporation)
• Original Assignee: Bolton Medical, Inc. (Terumo Corporation)
• Inventors: Berra, Humberto A., Arbefeuille, Samuel, Ouellette, Gerry
• Primary Examiner(s): Jackson, Gary
• Assistant Examiner(s): YABUT, DIANE D
• Application Number:
  US11/353,927
• Publication Number:
  US 20060188408A1
• Time in Patent Office: 2,122 Days
• Field of Search: 623/1.11, 623/1.12
• US Class Current: 623/1.12
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/844 folded prior to deployment
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/825 having longitudinal struts
• CPC Class Codes: A61F 2002/828 Means for connecting a plurality of stents allowing flexibility of the whole structure
• CPC Class Codes: A61F 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
• CPC Class Codes: A61F 2002/9528 for retrieval of stents
• CPC Class Codes: A61F 2002/9665 with additional retaining means
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

An apex capture device for holding proximal apices of a stent to be implanted includes a distal capture portion to be fixedly connected to a distal end of a first hollow lumen and a proximal capture portion fixedly connected to a distal end of a second hollow lumen. The distal capture portion has a longitudinal axis, a distal portion with a proximal end, and a proximal stopper having a distal side and a proximal side. At least a portion of the proximal side of the proximal stopper extends along a line that intersects a hollow first lumen. The proximal capture portion has fingers that define an interior cavity shaped to receive the proximal stopper.

Claims

1. A delivery system for delivering and deploying stents having proximal apices that join struts of the stents, comprising:

a) a hollow first lumen having a distal end and an interior extending along a longitudinal axis;

b) a hollow second lumen having a distal end and being slidably disposed about said first lumen; and

c) an apex capture device, comprising

i) a distal capture portion fixedly connected to said distal end of said first lumen, said distal capture portion having

a distal portion with a proximal end, and

a proximal stopper having an exposed side facing distally that is disposed in a plane approximately perpendicular to said longitudinal axis, and defining stopping surface portions, and a proximal side extending along a line that intersects with the hollow first lumen proximal to the exposed side of the proximal stopper, and

ii) a proximal capture portion fixedly connected to said distal end of said second lumen and having fingers extending toward said distal capture portion in a distal direction, said fingers defining an interior cavity shaped to receive said proximal stopper therein,

said proximal and distal capture portions being formed to hold the proximal apices therebetween and, together, defining a stent captured state in which said proximal stopper and proximal apices of the stent are received in said interior cavity to thereby constrain the proximal apices while the struts emanate radially from between the fingers of the proximal capture portion, and said distal capture portion approximately closes off said interior cavity along said longitudinal axis.

2. The delivery system according to claim 1, wherein:

said proximal end of said distal portion and said proximal stopper define a stent apex cavity; and

said proximal and distal capture portions are formed to hold the proximal apices in said stent apex cavity.

3. The delivery system according to claim 1, further comprising:

a hollow third lumen having a distal end and an inner diameter, said second lumen being slidably disposed inside said third lumen; and

said proximal stopper having a greatest outer diameter smaller than said inner diameter of said third lumen to fit said proximal stopper slidably within said third lumen.

4. The delivery system according to claim 3, wherein said distal portion has a greatest outer diameter smaller than said inner diameter of said third lumen to fit said distal portion slidably within said third lumen.

5. The delivery system according to claim 3, wherein said distal portion has a greatest outer diameter greater than said inner diameter of said third lumen to prevent at least a part of said distal portion from being slidably disposed within said third lumen.

6. The delivery system according to claim 3, wherein said distal portion has a greatest outer diameter portion wider than said inner diameter of said third lumen to stop proximal retraction of said greatest outer diameter portion of said distal portion proximally past said distal end of said third lumen.

7. The delivery system according to claim 3, wherein:

said distal portion;

has a greatest outer diameter portion, and a distal end; and

tapers radially inwards towards said distal end from said greatest outer diameter portion and tapers radially inwards towards said proximal end from said greatest outer diameter portion; and

said third lumen fits over at least a portion of said proximal end of said distal portion.

8. The delivery system according to claim 3, wherein said third lumen is relatively stiff and at least one of said first lumen and said second lumen are relatively flexible.

9. The delivery system according to claim 3, wherein:

said third lumen is relatively stiff;

a hollow fourth lumen has a distal end and is slidably disposed between said third lumen and said second lumen; and

a hollow and relatively flexible stent holding sheath is fixedly connected to said distal end of said fourth lumen for holding therein a stent to be deployed.

10. The delivery system according to claim 9, wherein said sheath has a tapered proximal end fixedly connected to said distal end of said fourth lumen for transitioning entry of said sheath into said third lumen.

11. The delivery system according to claim 9, wherein said first, second, third, and fourth lumens are rotationally and slidably connected.

12. The delivery system according to claim 3, wherein:

said third lumen has an inner wall surface;

said proximal and distal capture portions have a greatest outer diameter smaller than said inner diameter of said third lumen to fit said proximal and distal capture portions within said third lumen and to space said proximal and distal capture portions at a positive radial distance from said inner wall surface of said third lumen.

13. The delivery system of claim 3, wherein the distal portion includes a nose cone at a distal end of said distal portion.

14. The delivery system of claim 13, wherein a greatest outer diameter of the distal portion is at the nose cone.

15. The delivery system of claim 13, wherein the distal portion has a greatest outer diameter wider than the inner diameter of the third lumen.

16. The delivery system according to claim 1, wherein:

said first and second lumens each have distal ends; and

said captured state exists when said distal ends of said first and second lumens are moved adjacent one another.

17. The delivery system according to claim 1, wherein:

said proximal end of said distal portion and said proximal stopper define a stent apex cavity;

said proximal and distal capture portions are formed to hold the proximal apices in said stent apex cavity; and

relative movement of said first and second lumens moves said proximal and distal capture portions with respect to one another to substantially close said stent apex cavity and, thereby, place said proximal and distal capture portions in said captured state.

18. The delivery system according to claim 1, wherein:

said first lumen has a proximal end;

said second lumen has a proximal end; and

an apex release assembly operatively connects said proximal end of said first lumen to said proximal end of said second lumen.

19. The delivery system according to claim 18, wherein said apex release assembly has:

a first release part connected to said first lumen;

a second release part connected to said second lumen; and

a locking part that selectively locks said first release part with respect to said second release part to, thereby, selectively secure said first lumen to said second lumen along said longitudinal axis.

20. The delivery system according to claim 19, wherein said locking part secures said first and second lumens in a form-locking connection.

21. The delivery system according to claim 19, wherein movement of said first and second release parts with respect to one another causes a corresponding movement of said proximal and distal capture portions with respect to one another to, thereby, release or capture the proximal apices inside said apex capture device.

22. The delivery system according to claim 21, wherein:

a separating movement of said first and second release parts causes a corresponding movement of said proximal and distal capture portions with respect to one another to, thereby, substantially close said interior cavity of said fingers;

an adjoining movement of said first and second release parts causes a corresponding movement of said proximal and distal capture portions with respect to one another to, thereby, open said interior cavity of said fingers.

23. The delivery system according to claim 21, wherein:

a separating movement of said first and second release parts causes a corresponding movement of said proximal and distal capture portions with respect to one another to, thereby, capture the proximal apices; and

an adjoining movement of said first and second release parts causes a corresponding movement of said proximal and distal capture portions with respect to one another to, thereby, release the proximal apices.

24. The delivery system according to claim 19, wherein said locking part is one of a lever and a clip.

25. The delivery system according to claim 19, wherein said locking part selectively axially locks said first release part with respect to said second release part and, thereby, selectively secures first lumen to said second lumen along said longitudinal axis.

26. The delivery system according to claim 1, further including a stent having proximal apices, the stent extending about the hollow second lumen, and wherein

the stent has a given number of the proximal apices;

and

the number of said fingers is equal to the number of the proximal apices.

27. The delivery system according to claim 26, wherein a number of said stopping surface portions is equal to a number of said fingers.

28. The delivery system according to claim 27, wherein:

said proximal stopper has extensions extending in a radial direction away from said longitudinal axis;

a number of said extensions is equal to said number of said stopping surface portions; and

each of said extensions includes one of said stopping surface portions.

29. The delivery system according to claim 28, wherein said extensions are distributed spokes about a circumference of said proximal stopper.

30. The delivery system according to claim 1, wherein:

a corresponding pair of one of said fingers and one of said stopping surface portions is formed to pass through one of the proximal apices; and

said one stopping surface portion limits proximal movement of the one stent proximal apex when in said captured state.

31. The delivery system according to claim 1, wherein, in said captured state:

said fingers are formed to radially restrain the proximal apices in said interior cavity; and

said stopping surface portions are formed to axially restrain the proximal apices in said interior cavity.

32. The delivery system according to claim 1, wherein said first lumen is of a metal and said second lumen is of a polymer.

33. The delivery system according to claim 1, wherein said distal portion has at least one radiopaque portion.

34. The delivery system of claim 1, further including an intermediate portion connecting said distal portion of said distal capture portion to said proximal stopper at a proximal distance from said proximal end of said distal portion of said distal capture portion.

35. The delivery system of claim 34, wherein the distal portion of the distal capture portion defines a distal end and a proximal side of the distal capture portion, wherein the proximal side is along a line that intersects the longitudinal axis at an acute angle proximal to the distal end of the distal portion.

36. The delivery system of claim 34, wherein the distal portion includes a nose cone at a distal end of the distal portion.

37. The delivery system of claim 36, further comprising a hollow third lumen having a distal end and an inner diameter, said second lumen being slidably disposed inside said third lumen;

and

said proximal stopper having a greatest outer diameter smaller than said inner diameter of said third lumen to fit said proximal stopper slidably within said third lumen.

38. The delivery system of claim 1, wherein the proximal stopper is disposed at a distance proximal to the proximal end of the distal portion of the distal capture portion of the apex capture device.

39. The delivery system of claim 1, wherein the distal portion of the distal capture portion defines a distal end and a proximal side of the distal capture portion, wherein the proximal side is along a line that intersects the longitudinal axis at an acute angle proximal to the distal end of the distal portion.

40. The delivery system of claim 39, wherein the exposed side of the proximal stopper is disposed at a proximal distance from the proximal side of the distal portion that is along the line that intersects the longitudinal axis at the acute angle proximal to the distal end of the distal portion.

41. The delivery system of claim 1, further including a hollow third lumen being slidably disposed about said hollow second lumen.

42. An apex capture device for holding proximal apices that join struts of a stent to be implanted, comprising:

a) a distal capture portion to be fixedly connected to a distal end of a first hollow lumen, said distal capture portion having

i) a longitudinal axis,

ii) a distal portion with a proximal end, and

iii) a proximal stopper having an exposed side facing distally that is disposed in a plane approximately perpendicular to said longitudinal axis and defining stopping surface portions, and a proximal side extending along a line that intersects with the hollow first lumen proximal to the exposed side of the proximal stopper; and

b) a proximal capture portion to be fixedly connected to a distal end of a second lumen and having fingers extending toward said distal capture portion in a distal direction, said fingers defining an interior cavity shaped to receive said proximal stopper therein, wherein

said proximal and distal capture portions are formed to hold the proximal apices therebetween and, together, defining a stent captured state in which said proximal stopper and proximal apices of the stent are received in said interior cavity to thereby constrain the proximal apices while the struts emanate radially from between the fingers of the proximal capture portion, and said distal capture portion closes off said interior cavity along said longitudinal axis.

43. The apex capture device of claim 42, wherein the distal portion includes a nose cone at a distal end of the distal portion.

44. The apex capture device of claim 43, further comprising a hollow third lumen having a distal end and an inner diameter, said second lumen being slidably disposed inside said third lumen;

and

said proximal stopper having a greatest outer diameter smaller than said inner diameter of said third lumen to fit said proximal stopper slidably within said third lumen.

45. The apex capture device of claim 44, wherein the distal portion has a greatest outer diameter wider than the inner diameter of the third lumen.

46. The apex capture device of claim 42, wherein the distal portion of the distal capture portion defines a distal end and a proximal side of the distal capture portion, wherein the proximal side is along a line that intersects the longitudinal axis at an acute angle proximal to the distal end of the distal portion.

47. The apex capture device of claim 46, wherein the exposed side of the proximal stopper is disposed at a proximal distance from the proximal side of the distal portion that is along the line that intersects the longitudinal axis at the acute angle proximal to the distal end of the distal portion.

48. The apex capture device of claim 42, wherein the proximal stopper is disposed at a distance proximal to the proximal end of the distal portion of the distal capture portion of the apex capture device.