Methods of implanting a prosthesis and treating an aneurysm

A method of implanting a prosthesis in a patient at a treatment site, comprising the steps of:

• a) axially locking an apex release lumen, a sheath lumen and a curved guidewire lumen located 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, the inner sheath constraining 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 curved guidewire lumen, whereby they rotate together and independently of the outer catheter;
• c) threading the apex release lumen, the sheath lumen and the curved guidewire onto a guidewire and directing the apex release lumen and the sheath lumen into a patient to place the outer catheter into an aorta of the patient;
• d) axially unlocking the apex release lumen, the sheath lumen and the curved guidewire lumen with respect to the outer catheter;
• e) advancing the apex release lumen, the sheath lumen and the curved guidewire lumen distally out of the outer catheter in the aorta toward the patient's heart, whereby the advancement of the apex release lumen, the sheath lumen and the curved guidewire lumen causes rotation of the prosthesis to thereby rotationally align the prosthesis at the treatment site, thereby delivering the prosthesis to the treatment site in proper rotational alignment;
• f) axially locking the apex release catheter and the curved guidewire lumen relative to the outer catheter, whereby the sheath lumen can move axially relative to the apex release lumen and the outer catheter;
• and
• g) retracting the sheath lumen and the inner sheath to release the prosthesis from the inner sheath.

A method for treating an aneurysm of a patient by deploying a prosthesis from a delivery device, comprising the steps of:

• a) advancing an outer catheter locked in a neutral position of the delivery device with respect to an apex release lumen, a sheath lumen and a curved guidewire lumen located within the apex release lumen, wherein an inner sheath extends from a distal end of the sheath lumen and radially about a prosthesis within the outer catheter, wherein the apex release lumen is within the sheath lumen and the sheath lumen is within the outer catheter, the outer catheter, the apex release lumen, the sheath lumen and the curved guidewire lumen moving along a guidewire through an arterial access to a treatment site in an aorta of the patient;
• b) rotationally locking the apex release lumen, the sheath lumen and the curved guidewire lumen, whereby they rotate together and independently of the outer catheter;
• c) axially unlocking the apex release lumen, the sheath lumen and the curved guidewire lumen relative to the outer catheter, thereby shifting the delivery device from the neutral position to an advancement position;
• d) advancing the apex release lumen, the sheath lumen and the curved guidewire lumen distally out of the outer catheter in the aorta toward the patient's heart to thereby deliver the prosthesis to the treatment site, whereby advancing the inner sheath, the apex release lumen and the curved guidewire lumen causes rotation of the prosthesis to thereby rotationally align the prosthesis at the treatment site;
• e) axially unlocking the sheath lumen from the apex release lumen and locking the apex release lumen and the curved guidewire lumen relative to the outer catheter, whereby the sheath lumen can move axially relative to the apex release lumen and the outer catheter to thereby shift from the advancement position to a deployment position of the delivery device;
• f) partially retracting the sheath lumen, thereby partially retracting the inner sheath from the prosthesis to partially deploy the prosthesis, the prosthesis being fixed at an apex capture device of the delivery device at proximal apices of a stent component of the prosthesis, the apex capture device including,
• 1) a distal apex head fixedly connected to a distal end of the curved guidewire lumen of the delivery device within the apex release lumen, the apex head having
• i) a distal portion with a proximal end, and
• ii) a proximal portion having an exposed side facing distally that is in a plane approximately perpendicular to a longitudinal axis of the apex release lumen, and defining stopping surface portions, and
• 2) 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 an interior cavity shaped to receive the proximal portion of the distal apex head therein,
• 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 an interior cavity of the apex capture device and the distal apex head approximately closes off the interior cavity along the longitudinal axis of the apex release lumen to capture at least one apex of the stent component of the prosthesis;
• g) positioning the proximal end of the prosthesis within the aorta while the prosthesis is partially deployed;
• h) retracting the sheath lumen and the inner sheath to fully expose the prosthesis within the aorta;
• i) retracting the apex release lumen relative to the curved guidewire lumen, thereby releasing at least one apex of the stent from the stent captured state, whereby the stent expands to fix the proximal portion of the prosthesis and is released from the delivery device within the aorta;
• and
• j) retracting the device from the aorta and the arterial access of the patient.