Abstract: A method for inserting an intra-aortic balloon device into a patient without using an insertion sheath is provided. Additionally, a hemostasis sheath is described for use with the insertion method. The hemostasis sheath may be incorporated onto the balloon catheter during manufacture before attachment of the intra-aortic balloon bladder. The hemostasis sheath is tapered from a smaller outside diameter at the point closest to the balloon bladder gradually increasing in diameter towards a large outside diameter at the end opposite the balloon bladder. The hemostasis sheath may also have an extended tip of constant outside diameter at its proximal end to facilitate insertion through the skin. If bleeding occurs after insertion of the intra-aortic balloon according to the invention, the hemostasis sheath is slid into the insertion site to stop the bleeding.

Abstract: An apparatus for wrapping a balloon catheter such as an intra-aortic balloon catheter is disclosed. The wrapping apparatus comprises a housing having a channel which receives the balloon membrane of the intra-aortic balloon. The wrapping apparatus also includes a clutching means located in the channel for exerting a predetermined pressure on the balloon membrane to enable the balloon membrane to be wrapped as the wrapping apparatus is rotated relative to the balloon catheter. The clutching means also permits relatively free rotation of the balloon membrane within the wrapping apparatus after the balloon membrane has been wrapped.The clutching means can include a shoe and a biasing means for biasing the shoe towards the balloon membrane with a predetermined pressure while the balloon membrane is being wrapped, yet enable the balloon membrane to rotate relatively freely within the wrapping apparatus after the balloon membrane has been wrapped to a predetermined degree.

Abstract: A method for inserting an intra-aortic balloon device into a patient without using an insertion sheath is provided. Additionally, a hemostasis sheath is described for use with the insertion method. The hemostasis sheath may be incorporated onto the balloon catheter during manufacture before attachment of the intra-aortic balloon bladder. The hemostasis sheath is tapered from a smaller outside diameter at the point closest to the balloon bladder gradually increasing in diameter towards a large outside diameter at the end opposite the balloon bladder. The hemostasis sheath may also have an extended tip of constant outside diameter at its proximal end to facilitate insertion through the skin. If bleeding occurs after insertion of the intra-aortic balloon according to the invention, the hemostasis sheath is slid into the insertion site to stop the bleeding.