Prepackaged intra-aortic balloon assembly with holder, and method of using same

A holder and, within said holder, a prepackaged ready-for-insertion intra-aortic balloon assembly for assisting the pumping action of the heart, said balloon assembly comprising an elongated catheter tube, an elongated balloon having a proximal end joined to said catheter tube and having an opposite distal end terminating in a tip, and a slender, elongated balloon support having a distal end terminating in said tip and extending through said balloon and into said catheter tube, said balloon having tapered distal and proximal ends respectively joined to said tip and to said catheter tube, said balloon having an annular cross-section, when inflated, that is generally symmetric about a first longitudinal axis, and

• said tapered distal and proximal ends joining said balloon to said tip and to said catheter tube and aligning said elongated support so that said support is displaced from said first longitudinal axis of said balloon to facilitate tight wrapping of the balloon about said support, said elongated balloon being, as a result of manufacture, in a collapsed, wrapped condition about said balloon support thereby having reduced profile ready for insertion into a human body;
• and
• said holder comprising a set of separable elongated parts adapted to be assembled to form a holder body having an elongated cavity defined by opposed surfaces of said body parts, said opposed surfaces, with said intra-aortic balloon in collapsed, wrapped condition of reduced profile disposed within said cavity, lying in close contact with said balloon, thereby to restrict said balloon from unwrapping,
• said holder defining a first opening at a proximal, first end of said cavity and defining a second opening at a distal, second end of said cavity, said first opening and said second opening sized, relative to the reduced profile size of said balloon in said cavity, for passage of said balloon in a distal direction from within said cavity, out of said holder, in said collapsed, wrapped condition.

A method for introducing an intra-aortic balloon into an artery of the body via a tubular sheath having an entry outside the body, the method comprising the steps of:

• providing a holder and, within said holder, a prepackaged, ready-for-insertion, intra-aortic balloon assembly comprising an elongated catheter tube, an elongated balloon having a proximal end joined to said catheter tube and having an opposite distal end terminating in a tip, and a slender, elongated balloon support having a distal end terminating in said tip and extending through said balloon and into said catheter, said elongated balloon being, as a result of manufacture, in a collapsed condition wrapped about said balloon support providing a reduced profile ready for insertion via said tubular sheath into a human body, and said holder comprising a set of separable elongated parts adapted to be assembled to form a holder body having an elongated cavity defined by opposed surfaces of said body parts, said opposed surfaces, with said intra-aortic balloon in collapsed, wrapped condition of reduced profile disposed within said cavity, lying in close contact with said balloon, thereby to restrict said balloon from unwrapping, said holder defining a first opening at a proximal, first end of said cavity and defining a second opening at a distal, second end of said cavity, said first opening and said second opening sized, relative to the reduced profile size of said balloon in said cavity, for passage of said balloon in a distal direction from within said cavity, out of said holder, in said collapsed, wrapped condition,
• introducing a tubular sheath into a patient's body and advancing the distal end of the sheath to a position within an artery, with an entry at the proximal end of the sheath outside the body,
• positioning the intra-aortic balloon assembly with said tip of said balloon within said holder adjacent the entry to said tubular sheath, and
• sliding said wrapped balloon axially in the distal direction said cavity of said holder, through said distal opening, through said entry into said tubular sheath, and therethrough into said artery.