Abdominal aortic aneurysms: systems and methods of use

• US 9,364,314 B2
• Filed: 06/30/2009
• Issued: 06/14/2016
• Est. Priority Date: 06/30/2008
• Status: Active Grant

• Current Assignee: Bolton Medical, Inc. (Terumo Corporation)
• Original Assignee: Bolton Medical, Inc. (Terumo Corporation)
• Inventors: Berra, Humberto, White, Bryan, Lostetter, Timothy, Rush, Scott Lyle, Canning, John C.
• Primary Examiner(s): WEISBERG, AMY REGINA
• Application Number:
  US12/459,387
• Publication Number:
  US 20100030255A1
• Time in Patent Office: 2,541 Days
• Field of Search: 623 111- 113, 623/1.23, 623/1.35, 623/2.11, 623/6.12, 623/6.11, 606/107, 606/200, 606/108
• US Class Current: 1/1
• CPC Class Codes: A61F 2/064 with special features to facilitate anastomotic coupling anastomosis of natural blood vessels A61B17/11
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• 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 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• 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 2002/8483 Barbs
• 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 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2002/9665 with additional retaining means
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• 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 2220/0041 using additional screws, bolts, dowels or rivets, e.g. connecting screws
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61M 39/06 : Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof

Abstract

A stent graft delivery system includes an internal lead screw assembly within a track of a handle. The internal lead screw assembly is moveable along a major axis of the handle by rotation of a lead screw nut that extends about the handle and is threadably engaged with the threaded portion of the internal lead screw assembly. The lead screw nut is also slidable along the handle while engaged with the internal lead screw assembly. A stent graft system includes a proximal stent adjacent to a bare stent of angled struts joined by proximal and distal apices, wherein the proximal stent is nested within the bare stent.

Claims

1. A stent graft delivery system, comprising:

a) a handle that includes

i. a distal grip, and

ii. a handle body extending from one end of the distal grip, the handle defining a conduit and a track along a portion of the length of the distal grip and the handle body;

b) an outer sheath defining a lumen and extending through the conduit and moveable relative to the handle;

c) an internal lead screw assembly within the track, the internal lead screw assembly linked to the outer sheath and being moveable along a major axis of the conduit, and including a threaded portion that extends through the track;

d) a lead screw nut that extends externally around the handle body and is threadably engaged with the threaded portion of the internal lead screw assembly, whereby rotation of the lead screw nut while abutting the distal grip causes retraction of the internal lead screw assembly and the outer sheath relative to the handle, and wherein the lead screw nut simultaneously is slidable along the handle body while engaged with the internal lead screw assembly and the outer sheath without requiring rotation of the lead screw nut, thereby providing at least two mechanisms for causing retraction of the internal lead screw assembly and the outer sheath relative to the handle.

2. The stent graft delivery system of claim 1, further including a support member fixed to the handle body, and a sheath extending about a portion of the support member and fixed to the internal lead screw assembly, whereby relative movement of the handle body and the lead screw assembly causes relative movement of the support member and the sheath.

3. The stent graft delivery system of claim 2, wherein the internal lead screw assembly defines an opening essentially coaxial with the handle, wherein the support member extends through the internal lead screw assembly.

4. The stent graft delivery system of claim 3, wherein the support member includes a hypo-tube and a support tube within the hypo-tube, wherein the hypo-tube is fixed to the handle body.

5. The stent graft delivery system of claim 1, further including a slider, the slider comprising:

a) a slider body defining a central orifice through which a support member extends and a flush valve orifice extending substantially normal to the central orifice, the slider body being detachably fixable to the internal lead screw assembly, and wherein the outer sheath extends from a distal end of the slider body, the lumen being substantially aligned with the central opening of the slider body through which the support member extends;

b) a slider cap coupled to a distal end of the slider body, the slider cap defining a central orifice that is substantially aligned with the central orifice of the slider body and through which the support member extends;

c) a sheath valve knob coupled to a proximal end of the slider body;

d) a wiper valve at the central opening of the slider body proximal to the flush valve orifice, the wiper valve forming a seal about the support member;

e) an x-valve at the central opening of the slider body proximal to the wiper valve, the x-valve forming a seal about a guidewire upon withdrawal of the support member from the slider body; and

f) a sheath valve at the central opening of the slider body and proximal to the x-valve, the sheath valve being operable by activation of the sheath valve knob to seal the central opening.

6. The stent graft delivery system of claim 5, further including a gasket at the x-valve, the x-valve including a nitinol gasket.

7. The stent graft delivery system of claim 1, further including a slider, the slider comprising:

a) a slider body defining a central orifice through which a support member extends and a flush valve orifice extending substantially normal to the central orifice, the slider body being detachably fixable to an internal lead screw assembly;

b) a slider cap coupled to a proximal end of the slider body, the slider cap defining a central orifice that is substantially aligned with the central orifice of the slider body and through which the support member extends;

c) a sheath extending from a distal end of the slider cap, the sheath defining a lumen that is substantially aligned with the central opening of the slider body and through which the support member extends; and

d) a valve at the central orifice that provides hemostasis to the sheath.

8. The slider of claim 7, further including a lead screw, by which the slider is detachably fixable to the internal lead screw assembly.

9. A stent graft delivery system, comprising,

a) an apex capture device assembly, including:

1) a proximal apex capture portion, including

i. a nose, wherein the nose defines at least one radial restraint that is substantially parallel to a major axis of the proximal capture portion; and

ii. a plurality of tines extending distally from the nose, the tines radially distributed about the major axis radial to a most proximal radial restraint and substantially parallel to the major axis,

2) a distal apex capture portion defining recesses distributed radially about the major axis, the recesses mateable with the tines by relative movement of the proximal and distal apex capture portions along the major axis,

3) a plurality of bosses extending radially from the major axis between the nose and the distal apex capture portion and longitudinally and radially aligned with the recesses along the major axis in overlying relation with movement of the tines into mating relation with the recesses,

4) an elongate member to which the distal apex capture portion is fixed, the elongate member extending through the proximal apex capture portion,

5) a catheter component to which the proximal apex capture portion is fixed, through which the elongate member extends, whereby movement of the catheter component causes movement of the proximal apex portion along the major axis between a first position, in which the tines are mated with the recesses and overlie the bosses, and a second position, in which the tines are not mated with the recesses and do not overlie the bosses,

b) a stent graft extending around the catheter component, the stent graft including;

1) a graft component extending around the catheter component,

2) a bare stent at a proximal end of the graft component, the bare stent including struts linked by apices, the struts extending between the tines, a portion of the apices extending between the bosses and the distal apex capture portion when the tines are mated to the recesses, and

3) at least one suprarenal barb extending from the bare stent into the radial restraint;

c) a handle extending around the elongate member and the catheter component, and proximal to the proximal apex capture portion, the handle having a proximal end and a distal end;

d) a leg clasp distal to the handle through which the elongate member and catheter component extend, the leg clasp including,

1) a barrel,

2) a spool extending from the barrel along a major longitudinal axis of the barrel,

3) a rim aligned along the major longitudinal axis of the barrel and at an end of the spool opposite that of the barrel, the rim extending about the entire circumference of the barrel and having a diameter greater than that of the spool but less than that of the barrel; and

d) a support member fixed to the distal end of the handle body and extending proximally from the barrel, the support member extending externally around the elongate member and the catheter component.

10. The stent graft delivery system of claim 9, wherein the radial restraint is a pilot hole.

11. The stent graft delivery system of claim 10, wherein the stent further includes at least one bridge between a pair of the struts to define an eyelet through which a boss extends when a tine is mated to a slot, and wherein the barb extends from the bridge.

12. The stent graft delivery system of claim 11, wherein the suprarenal barb is angled from a major plane of the eyelet sufficient to distend the struts to which the eyelet is attached toward the major axis.

13. The stent graft delivery system of claim 12, further including an infrarenal barb extending from a distal apex of the stent.

14. The stent graft delivery system of claim 13, further including a luminal graft component fixed to a distal portion of the bare stent, and an infrarenal stent adjacent and distal to the bare stent, the infrarenal stent including struts linked by proximal and distal apices, the distal apices being substantially aligned with distal apices of the bare stent.

15. The stent graft delivery system of claim 14, wherein the infrarenal stent is fixed within the luminal graft component.

16. The stent graft delivery system of claim 15, wherein distention of the bare stent struts consequent to retention of the suprarenal barb within the pilot hole causes the infrarenal barb of the bare stent to be recessed between struts of the infrarenal stent.

17. The stent graft delivery system of claim 15, wherein the proximal apices of the infrarenal stent are proximal to the distal apices of the bare stent.

18. The stent graft delivery system of claim 10, further including:

f) a bare stent that includes struts linked by apices, the struts extending between the tines, a portion of the apices extending between the bosses and the distal apex capture portion when the tines are mated to the slots; and

g) at least one suprarenal barb extending from the stent into the pilot hole.

19. The stent graft delivery system of claim 10, wherein the nose defines grooves between the tines, wherein the grooves are aligned with spaces between the bosses.

20. The stent graft delivery system of claim 19, wherein the plurality of bosses are fixed relative to the distal apex capture portion.

21. The stent graft delivery system of claim 20, wherein the nose, the elongate member and each of the tines define a space.