Dual capture device for stent graft delivery system and method for capturing a stent graft

• US 9,220,617 B2
• Filed: 06/10/2014
• Issued: 12/29/2015
• 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
• Primary Examiner(s): Shi, Katherine M
• Assistant Examiner(s): Mendoza, Michael
• Application Number:
  US14/300,647
• Publication Number:
  US 20140316510A1
• Time in Patent Office: 567 Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• 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 2002/828 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 2230/0054 V-shaped

Abstract

A delivery system for delivering and deploying stents with proximal and distal apices includes a guidewire catheter, a nose cone assembly, a proximal capture portion and a stent graft with proximal and distal stents. The nose cone assembly is at the distal end of the guidewire catheter and includes a nose cone and a distal capture portion. The proximal capture portion is proximal to the distal capture portion of the nose cone assembly. The proximal stent is releasably secured to the distal capture portion and the distal stent is releasably secured to the proximal capture portion. The stent graft can be deployed by releasing the proximal stent and the distal stent from proximal and distal capture portions of the delivery system.

Claims

1. A delivery system for delivering and deploying a stent graft having distal and proximal stents, comprising:

a) a guidewire catheter having a proximal end, a distal end and defining an interior extending along a longitudinal axis;

b) a nose cone assembly at the distal end of the guidewire catheter, the nose cone assembly including a nose cone and a distal capture portion proximal to the nose cone;

c) a proximal capture portion along the longitudinal axis and proximal to the distal capture portion of the nose cone assembly; and

d) a stent graft including a graft component having a proximal end and a distal end, a proximal stent at the proximal end of the graft component and a distal stent at the distal end of the graft component, wherein the proximal stent is radially constrained from within the stent graft by the distal capture portion and the distal stent is releasably secured to the proximal capture portion.

2. The delivery system of claim 1, wherein the proximal stent and the distal stent extend beyond the respective proximal and distal ends of the graft component.

3. The delivery system of claim 2, further including an outer catheter that extends about the guidewire catheter and the stent graft, wherein the outer catheter is retractable from the stent graft.

4. The delivery system of claim 3, further including a sheath that is flexible relative to the outer catheter and that extends about the stent graft and the guidewire catheter, wherein the sheath is retractable from the stent graft.

5. The delivery system of claim 4, wherein the sheath extends between the stent graft and the outer catheter.

6. The delivery system of claim 5, wherein the proximal end of the stent graft is releasably secured to the distal apex capture portion at the proximal apices of the proximal stent, and the distal end of the stent graft is releasably secured to the proximal capture portion at the distal apices of the distal stent.

7. The delivery system of claim 2, wherein the proximal stent and the distal stent each include struts that define distal and proximal apices, whereby the proximal apices of the proximal stent extend beyond the proximal end of the graft component, and the distal apices of the distal stent extend beyond the distal end of the graft component.

8. The delivery system of claim 1, wherein the guidewire catheter is curved.

9. The delivery system of claim 1, wherein the proximal capture portion and the distal capture portion actuate independently.

10. The delivery system of claim 1, wherein the proximal stent is releasable from the distal capture portion by proximal movement of the distal capture portion from a capture position to a release position.

11. The delivery system of claim 1, wherein the distal stent is releasable from the proximal capture portion by proximal movement of the proximal capture portion from a capture position to a release position.

12. A method of deploying a stent graft from a stent graft delivery system to thereby implant the stent graft intravascularly within a patient, comprising the steps of:

a) releasing a proximal stent at a proximal end of a stent graft from a distal capture portion of a nose cone assembly fixed to a distal end of a guidewire catheter of a delivery system, while the stent graft is positioned at a treatment site within a blood vessel of a patient, the distal capture portion being moveable by proximal movement of the distal capture portion from a capture position to a release position; and

b) releasing a distal stent at a distal end of the stent graft from a proximal capture portion of the delivery system, thereby deploying the stent graft from the delivery system and implanting the stent graft intravascularly within the patient.

13. The method of claim 12, further including the step of retracting an outer catheter from around the stent graft before releasing the proximal stent from the distal capture portion.

14. The method of claim 13, further including the step of retracting a sheath that is flexible relative to the outer catheter from around the stent graft before releasing the proximal stent from the distal capture portion.

15. The method of claim 14, wherein the sheath is retracted after the step of retracting the outer catheter.

16. The method of claim 12, wherein each of the proximal stent and the distal stent include struts that define respective proximal and distal apices.

17. The method of claim 16, wherein the proximal apices of the proximal stent extend beyond a proximal end of a graft component of the stent graft to which the proximal stent is attached, and wherein the proximal stent is released by releasing the proximal apices from the distal apex capture portion.

18. The method of claim 17, wherein the distal apices of the distal stent extend beyond a distal end of the graft component of the stent graft to which the distal stent is attached and wherein the distal stent is released by releasing the distal apices from the proximal apex capture portion.

19. The method of claim 12, wherein releasing the proximal stent at the proximal end of the stent graft is from the distal capture portion of the nose cone assembly fixed to the distal end of the guidewire catheter, and the guidewire catheter is curved.

20. The method of claim 12, wherein the distal stent is released from the proximal capture portion by proximal movement of the proximal capture portion from a capture position to a release position.

21. A delivery system for delivering and deploying a stent graft having distal and proximal stents, comprising:

a) a guidewire catheter having a proximal end and a distal end, and defining an interior extending along a longitudinal axis;

b) a nose cone assembly at the distal end of the guidewire catheter, the nose cone assembly including a nose cone and a distal capture portion proximal to the nose cone, the distal capture portion being movable from a capture position to a release position by proximal movement of the distal capture portion;

c) a proximal capture portion along the longitudinal axis and proximal to the distal capture portion of the nose cone assembly, wherein the proximal capture portion and the distal capture portion arcuate independently; and

d) a stent graft including,

i) a graft component having a proximal end and a distal end,

ii) a proximal stent having proximal apices at the proximal end of the graft component, and

iii) a distal stent having distal apices at the distal end of the graft component, wherein the proximal stent is secured to the distal capture portion and releasable by proximal movement of the distal capture portion from the capture position to the release position, and wherein the distal stent is releasably secured to the proximal capture portion and is releasable from the proximal capture portion by proximal movement of the proximal capture portion from the capture position to the release position.

22. A method of deploying a stent graft from a stent graft delivery system to thereby implant the stent graft intravascularly within a patient, comprising the steps of:

a) releasing a proximal stent at a proximal end of a stent graft from a distal capture portion of a nose cone assembly fixed to a distal end of a guidewire catheter of a delivery system, while the stent graft is positioned at a treatment site within a blood vessel of a patient, the proximal stent being radially constrained from within the stent graft by the distal capture portion; and

b) releasing a distal stent at a distal end of the stent graft from a proximal capture portion of the delivery system, thereby deploying the stent graft from the delivery system and implanting the stent graft intravascularly within the patient.

23. The method of claim 22, further including the step of retracting an outer catheter from around the stent graft before releasing the proximal stent from the distal capture portion.

24. The method of claim 23, further including the step of retracting a sheath that is flexible relative to the outer catheter from around the stent graft before releasing the proximal stent from the distal capture portion.

25. The method of claim 24, wherein the sheath is retracted after the step of retracting the outer catheter.

26. The method of claim 22, wherein each of the proximal stent and the distal stent include struts that define respective proximal and distal apices.

27. The method of claim 26, wherein the proximal apices of the proximal stent extend beyond a proximal end of a graft component of the stent graft to which the proximal stent is attached, and wherein the proximal stent is released by releasing the proximal apices from the distal apex capture portion.

28. The method of claim 27, wherein the distal apices of the distal stent extend beyond a distal end of the graft component of the stent graft to which the distal stent is attached and wherein the distal stent is released by releasing the distal apices from the proximal apex capture portion.

29. The method of claim 22, wherein releasing the proximal stent at the proximal end of the stent graft is from the distal capture portion of the nose cone assembly fixed to the distal end of the guidewire catheter, and the guidewire catheter is curved.