Method of operating an integrated balloon catheter inflation system
First Claim
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1. A method of storing and actuating a balloon catheter system, comprising:
- providing an integrated pre-assembled system packaged and sold as a single, unitary system in a unique sterile enclosure, the system including;
a manifold having internal passages;
a sealed pressurized vessel permanently attached to an inflation port in the manifold;
a balloon catheter having a balloon on a distal end in fluid communication with an inflation lumen extending through the catheter;
a balloon port in the manifold in fluid communication with the balloon catheter inflation lumen; and
a control valve on the manifold configured to selectively open and close fluid communication between the balloon port and the inflation port so that a positive pressure differential from the pressurized vessel inflates the balloon;
the method including;
opening the unique sterile enclosure and removing the system;
advancing the balloon catheter so that the balloon thereon is positioned at a procedure site within the body; and
operating the control valve on the manifold to open fluid communication between the balloon port and the inflation port and inflate the balloon.
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Abstract
An inflation system having two pressure vessels integrated into a balloon catheter. A pressurized chamber and a vacuum chamber are integrally attached to proximal end of the balloon catheter and activated by a common valve or switch. Pressure or vacuum is selectively transmitted to the balloon depending on the valve/switch position. The working fluid may be air, or a combination of air and saline with an intermediate piston/cylinder assembly. The balloon catheter may be a part of a heart valve delivery system with a balloon-expandable heart valve crimped onto the balloon.
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Citations
20 Claims
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1. A method of storing and actuating a balloon catheter system, comprising:
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providing an integrated pre-assembled system packaged and sold as a single, unitary system in a unique sterile enclosure, the system including; a manifold having internal passages; a sealed pressurized vessel permanently attached to an inflation port in the manifold; a balloon catheter having a balloon on a distal end in fluid communication with an inflation lumen extending through the catheter; a balloon port in the manifold in fluid communication with the balloon catheter inflation lumen; and a control valve on the manifold configured to selectively open and close fluid communication between the balloon port and the inflation port so that a positive pressure differential from the pressurized vessel inflates the balloon; the method including; opening the unique sterile enclosure and removing the system; advancing the balloon catheter so that the balloon thereon is positioned at a procedure site within the body; and operating the control valve on the manifold to open fluid communication between the balloon port and the inflation port and inflate the balloon. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10)
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11. A method of storing and actuating a balloon catheter system, comprising:
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providing an integrated pre-assembled system packaged and sold as a single, unitary system in a unique sterile enclosure, the system including; a balloon catheter having a balloon on a distal end in fluid communication with an inflation lumen extending through the catheter; an integrated inflation system having; a manifold having internal passages; a sealed pressurized vessel permanently attached to an inflation port in the manifold; a sealed vacuum vessel permanently attached to a vacuum port in the manifold; a balloon port in the manifold in fluid communication with the balloon catheter inflation lumen; and a control valve on the manifold configured to selectively open and close fluid communication between the manifold internal passages and one or the other of the pressurized vessel and vacuum vessel; the method including; opening the unique sterile enclosure and removing the system; advancing the balloon catheter so that the balloon thereon is positioned at a procedure site within the body; operating the control valve on the manifold to open fluid communication between the balloon port and the inflation port and inflate the balloon; operating the control valve on the manifold to close fluid communication between the balloon port and the inflation port and inflate the balloon; operating the control valve on the manifold to open fluid communication between the balloon port and the vacuum port and deflate the balloon after inflating the balloon; and withdrawing the balloon catheter from within the body. - View Dependent Claims (12, 13, 14, 15, 16, 17, 18, 19, 20)
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Specification