Methods of implanting a prosthesis

• US 8,636,788 B2
• Filed: 08/03/2012
• Issued: 01/28/2014
• Est. Priority Date: 09/03/2003
• Status: Active Grant

• Current Assignee: Bolton Medical, Inc. (Terumo Corporation)
• Original Assignee: Bolton Medical, Inc. (Terumo Corporation)
• Inventors: Arbefeuille, Samuel, Berra, Humberto, Barbre, Carol, Moore, Michael
• Primary Examiner(s): Jackson, Gary
• Assistant Examiner(s): YABUT, DIANE D
• Application Number:
  US13/566,412
• Publication Number:
  US 20120296413A1
• Time in Patent Office: 543 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 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• 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 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2002/9528 for retrieval of stents
• 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 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61M 25/0105 Steering means as part of the catheter or advancing means; Markers for positioning systems for detection of markers A61B
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers
• CPC Class Codes: Y10T 29/49799 Providing transitory integral holding or handling portion
• CPC Class Codes: Y10T 74/18392 Crank, pitman, and crank

Abstract

A method of implanting a prosthesis in a patient at a treatment site includes advancing an outer catheter of a prosthesis delivery system in the patient and advancing an inner sheath and a guidewire lumen of the delivery system from the outer catheter to the treatment site along a guidewire while the outer catheter remains stationary relative to the patient. The method also includes locking an apex release lumen, a sheath lumen and a guidewire lumen within the apex release lumen, with respect to an outer catheter and rotationally locking the apex release lumen, the sheath lumen and the guidewire lumen. The apex release lumen, the sheath lumen and the guidewire lumen are threaded onto a guidewire and directed into a patient and the apex release lumen and the sheath lumen are unlocked with respect to the outer catheter.

Claims

1. A method of implanting a prosthesis in a patient at a treatment site within a blood vessel, comprising the steps of:

a) locking an apex release lumen, a sheath lumen and a guidewire lumen within the apex release lumen, with respect to an outer catheter, wherein an inner sheath extends from a distal end of the sheath lumen and radially about the prosthesis, at least one of the apex release lumen and the sheath lumen constraining a proximal stent of the prosthesis and wherein the apex release lumen is within the sheath lumen and the sheath lumen is within the outer catheter;

b) rotationally locking the apex release lumen, the sheath lumen and the guidewire lumen, whereby they rotate together and independently of the outer catheter;

c) threading the apex release lumen, the sheath lumen and the guidewire lumen onto a guidewire and directing the apex release lumen, the sheath lumen and the guidewire lumen into a patient to place the outer catheter in an aorta of the patient at a point distal to the treatment site;

d) unlocking the apex release lumen and the sheath lumen with respect to the outer catheter;

e) advancing the apex release lumen, the sheath lumen and the guidewire lumen distally out of the outer catheter in the aorta, whereby the advancement of the apex release lumen, the sheath lumen and the guidewire lumen positions the prosthesis at the treatment site; and

f) locking the apex release lumen and the outer catheter relative to the sheath lumen, whereby the sheath lumen can move axially relative to the apex release lumen and the outer catheter; and

g) retracting the inner sheath in a proximal direction to at least partially implant the prosthesis in the vessel.

2. The method of claim 1, wherein a proximal portion of the prosthesis is fixed at an apex capture device at proximal apices of a stent component of the prosthesis, the apex capture device including a distal apex head fixedly connected to a distal end of the guidewire lumen, the distal apex head having,

i) a distal portion with a proximal end;

and

ii) a proximal portion having an exposed side facing distally that is disposed in a plane substantially perpendicular to a longitudinal axis of the apex release lumen and defining stopping surface portions,

a proximal apex body fixedly connected to a distal end of the apex release lumen and having fingers extending toward the distal apex head in a distal direction, the fingers defining at least in part an interior cavity shaped to receive the proximal portion of the distal apex head therein, and

the proximal apex body and the distal apex head being formed to hold at least one apex of the stent component of the prosthesis therebetween and, together, defining a stent captured state in which the proximal portion of the distal apex head is received in the interior cavity of the apex capture device.

3. The method of claim 1, wherein curvature of the guidewire lumen in response to resistance to advancement of the guidewire lumen within the blood vessel is biased.

4. The method of claim 1, wherein the prosthesis is asymmetric about a major longitundinal axis and advancing the inner sheath causes rotational alignment of the prosthesis at the treatment site.