Abstract: An introducer sheath for the insertion of a medical device into a blood vessel having an expandable sheath. The sheath has a length, a thickness, and proximal and distal ends. The expandable sheath has a frame extending longitudinally between the proximal and the distal ends, and having an exterior surface and an interior surface that forms an interior lumen along the length of the frame. The frame is configured to achieve an expanded state and a contracted state, the expanded state forming an expanded cross-section in the lumen for passing a medical device therethrough. The frame has a smooth coating about the exterior surface and protrusions extending into the lumen along the interior surface. The introducer sheath can be introduced into a patient in the contracted state, with the distal end of the introducer sheath prevented from moving in the proximal direction by an abutment against a dilator end surface.

Abstract: Systems and methods for a multi-layered peel-away sheath assembly for insertion of a blood pump including a sheath hub and a sheath body having a proximal end that is connected to the sheath hub, and a distal end. The sheath body comprises multiple layers including a reinforcing layer. The reinforcing layer improves flexibility and kink resistance of the assembly The reinforcing layer can comprise LCP, PEBAX, stainless steel, Nitinol, or Kevlar. The reinforcing layer may be a laser-cut hypotube or a braided or coiled filament. The first layer material and the third layer material are thermoplastics, including PEBAX or TPU. The reinforcing layer has at least one discontinuity, which is aligned with peel-away lines in the sheath body to allow an operator to peel-away the assembly. The peel-away lines are formed of inner, outer notches, or both. The sheath hub also includes a discontinuity to allow the sheath hub to peel-away.

Abstract: An introducer sheath for the insertion of a medical device into a blood vessel having an expandable sheath. The sheath has a length, a thickness, and proximal and distal ends. The expandable sheath has a frame extending longitudinally between the proximal end and the distal end, and having an exterior surface and an interior surface that forms an interior lumen along the length of the frame. The frame is configured to achieve an expanded state and a contracted state, the expanded state forming an expanded cross-section in the lumen for passing a medical device therethrough. The frame has a smooth coating about the exterior surface and protrusions extending into the lumen along the interior surface. The introducer sheath can be introduced into a patient in the contracted state, with the distal end of the introducer sheath prevented from moving in the proximal direction by an abutment against a dilator end surface.

Abstract: A hemostasis valve body provides strong sealing around a medical device during insertion of the medical device into a blood vessel, low forces for tearing, and stability during insertion of the medical devices as well as during peel away. The valve body comprises a first surface, a second surface opposite the first surface, an edge, helical slits, and a pair of longitudinal cuts. The helical slits are positioned at a center of the valve body and traverse the first surface to the second surface. The helical slits provide a seal around the medical device. Each respective longitudinal cut extends from the first surface partially through the valve body to a depth short of the second surface for at least part of a length of the respective longitudinal cut. The longitudinal cuts facilitate a separation of the valve body into two parts during a peel away action.

Abstract: An access sleeve can be attached to a medical device having first and second ends, the first end being positioned inside of a patient and the second end being positioned external to a patient. The access sleeve can include a tubular sleeve body having first and second open ends that define a first lumen extending along a longitudinal axis of the sleeve body. An opening in the sleeve body can connect the first lumen to an outer surface of the sleeve body. The access sleeve can be selectively attached to the medical device (e.g. catheter of a heart pump) and inserted into the access site when the medical device is positioned in the patient. The access sleeve can maintain vascular access to a patient's access site such as an arteriotomy and can be removed without disturbing the position of the medical device.

Abstract: An expandable medical sheath can include a sheath body having a lumen that extends between proximal and distal ends of the sheath. The sheath can have first and second members where the first member has a different elastic modulus than the second member such that one provides elasticity to the sheath and the other provides column strength. The first and second members can be coupled together in alternating sections to form the tubular sheath or the stiffer members can be embedded in the elastic member along all or a portion of the longitudinal length of the sheath. The sheath can automatically move to an expanded state to allow a larger diameter medical device to pass through the lumen, and once through the sheath can automatically return to its initial diameter.