Two-piece transseptal cannula, delivery system, and method of delivery

A method of implanting a cannula assembly within a heart tissue, the cannula assembly including a flexible cannula body having distal and proximal ends with a lumen extending therebetween, the distal end including a receiving portion, a transseptal tip having distal and proximal ends, the proximal end including an engaging portion operable to connect to the receiving portion of the flexible cannula body in vivo, and first and second anchors coupled to the transseptal tip, the first and second anchors configured to be deployed from a contracted state to an expanded state and to engage opposite sides of the heart tissue, the method comprising:

• (a) introducing the transseptal tip into the heart tissue;
• (b) directing the flexible cannula body to the transseptal tip;
• and
• (c) in vivo connecting the receiving portion of the flexible cannula body to the engaging portion of the transseptal tip.

A method of introducing a surgical device into the vascular network of a patient with an introducer assembly, the introducer assembly including a removable dilator having an attachment mechanism for removably attaching an introducer set and an introducer including a hub and a sheath extending distally from the hub, the method comprising:

• attaching the introducer set to the attachment mechanism of the removable dilator, the introducer set including a sheath introducer, a vascular dilator, and a guide-wire;
• receiving the removable dilator and the introducer set into the introducer;
• creating a puncture in a vessel wall of a blood vessel with the guide-wire;
• advancing the introducer assembly over the guide-wire and into the blood vessel, thereby dilating the vessel wall until the hub of the introducer contacts an external surface of the blood vessel;
• removing the removable dilator and the introducer set;
• and
• directing the surgical device through the introducer and into the blood vessel.

A method of in vivo coupling a flexible cannula body to a transseptal tip, the flexible cannula body having distal and proximal ends with a lumen extending therebetweeen, the distal end including a receiving portion having a first marker, and the transseptal tip having distal and proximal ends, the proximal end including an engaging portion having a second marker, the method comprising:

• directing the flexible cannula body to the transseptal tip;
• in vivo localizing the first and second markers;
• coupling the receiving portion of the flexible cannula body to the engaging portion of the transseptal tip;
• and
• continuing the coupling until the first marker overlays the second marker.

A method of aligning a flexible cannula body to a transseptal tip, in vivo, the flexible cannula body having distal and proximal ends with a lumen extending therebetween, the distal end including a receiving portion, and the transseptal tip having distal and proximal ends, the proximal end including an engaging portion, the method comprising:

• directing a cannula guide to the transseptal tip, the cannula guide comprising an expandable member having distal and proximal tapers and an alignment section therebetween and a body extending proximally from the expandable member, the alignment section configured to engage an inner surface of the transseptal tip and to resist movement of the transseptal tip;
• inflating the expandable member such that the expandable member engages the inner surface of the transseptal tip;
• and
• advancing the flexible cannula body over the proximal taper to the engaging portion of the transseptal tip.

A method of removing a circulatory assist device, the circulatory assist device including a transseptal tip, a pump, and a flexible cannula body extending proximally from the transseptal tip to the pump, the method comprising:

• disengaging the flexible cannula body from the pump;
• uncoupling the flexible cannula body from the transseptal tip;
• retracting the flexible cannula body;
• and
• sealing the transseptal tip.