Steerable assembly for delivering a prosthetic heart valve

A delivery system for implanting a prosthetic valve within a native aortic valve in a patient, comprising:

• an outer sleeve comprising a proximal portion and a selectively steerable distal portion, the steerable distal portion having an open distal end;
• a handle portion connected to the proximal portion of the outer sleeve, the handle portion comprising a rotatable knob;
• a pull wire having a distal end portion fixedly connected to the steerable distal portion and a proximal end portion operatively connected to the rotatable knob such that rotating the knob in a first rotational direction increases tension in the pull wire to increase a curvature of the steerable distal portion and rotating the knob is a second rotational direction, opposite the first rotational direction, decreases tension in the pull wire to decrease the curvature of the steerable distal portion;
• a balloon catheter comprising a shaft extending through the outer sleeve and out of the open distal end of the steerable distal portion and an inflatable balloon along a distal end portion of the shaft;
• and
• a prosthetic valve disposed over the balloon in a radially crimped state, the prosthetic valve comprising an expandable stent portion and a valve structure mounted on the stent portion;
• wherein the balloon and the prosthetic valve are positioned distal to the open distal end of the steerable distal portion, wherein the open distal end is a free end;
• wherein the prosthetic valve has an outer diameter larger than a diameter of the open distal end such that the prosthetic valve is prevented from moving proximally into the lumen of the steerable distal portion when the balloon is deflated and the prosthetic valve is in a radially compressed state on the deflated balloon;
• wherein the outer sleeve, the balloon catheter and the prosthetic valve are configured for advancement as a single unit through a vasculature of the patient.

A delivery system for implanting a prosthetic valve within a native aortic valve in a patient, comprising:

• a tubular sleeve comprising a proximal portion and a selectively steerable distal portion, the steerable distal portion having a lumen with an inner diameter, the lumen communicating with an open distal end, and the steerable distal portion having a greater flexibility than the proximal portion;
• a pull wire fixed to the steerable distal portion for selectively controlling a curvature of the steerable distal portion, the steerable distal portion being capable of achieving sufficient curvature to navigate around an aortic arch of the patient;
• a balloon catheter extending through the tubular sleeve and out of the open distal end of the steerable distal portion, wherein the open distal end is a free end;
• a prosthetic valve disposed over an expandable balloon along a distal end portion of the balloon catheter, the prosthetic valve comprising an expandable stent portion and a valve structure mounted on the stent portion, wherein the prosthetic valve has an outer diameter larger than a diameter of the open distal end such that the prosthetic valve is prevented from moving proximally into the lumen of the steerable distal portion when the balloon is deflated and the prosthetic valve is in a radially compressed state on the deflated balloon, and wherein the pull wire has a distal end portion fixedly connected to the steerable distal portion at a location proximal to the prosthetic valve such that the prosthetic valve remains straight when the pull wire is actuated to change the curvature of the steerable distal portion;
• an introducer configured to be inserted into a blood vessel of the patient, the introducer having a proximal opening, a distal opening, an inner passageway between the proximal opening and the distal opening, and one or more valves configured to control blood flow inside the inner passageway, wherein the balloon catheter and the prosthetic valve are configured to be advanced through the introducer and into the blood vessel after the introducer is inserted into the blood vessel;
• and
• a loader assembly having a tube portion configured to be inserted through the proximal opening of the introducer, wherein the prosthetic valve and the distal end portion of the balloon catheter are configured to be inserted into the tube portion, and wherein the tube portion is configured to be inserted through the one or more valves of the introducer so that the prosthetic valve and the balloon catheter can be advanced outwardly through a distal opening of the tube portion into the inner passageway of the introducer and then outwardly through the distal opening of the introducer into the blood vessel.