Method and septostomy device for creating an interatrial aperture
A septostomy device 10 with a cutting structure or means 140 and tissue capture mechanisms 240, 250 is disclosed, along with a medical procedure for using the device. The system 10 is configured in such a way as to create a permanent interatrial aperture in the heart, including creating a permanent interatrial hole and/or removing tissue.
1 . A medical device assembly comprising:
a first delivery catheter comprising:
an elongated delivery catheter shaft having a shaft and a distal end,
an RF cutter on the distal end, the RF cutter comprising an electrode, the RF electrode configured to cut a 3 mm or larger durable aperture in an interatrial septum,
a second delivery catheter comprising:
a distal tissue retention device.
2 . The assembly of claim 1 further comprising a return electrode, the return electrode on one of the second delivery catheter or the distal tissue retention device.
3 . The assembly of claim 2 , wherein the return electrode is on an outer edge of the distal capture mechanism.
4 . The assembly of claim 1 further comprising an RF cutter lumen.
5 . The assembly of claim 1 , wherein the electrode is configured to cut the durable aperture and sense the orientation of the interatrial septum.
6 . The assembly of claim 1 , wherein the RF cutter comprises a ring.
7 . The assembly of claim 1 , wherein the RF cutter is circular.
8 . The assembly of claim 7 , wherein a first portion of the circular RF cutter is coated with an insulator.
9 . The assembly of claim 1 , wherein the RF cutter further comprises a second electrode.
10 . The assembly of claim 9 , wherein the electrode and the second electrode are configured to rotate.
11 . The assembly of claim 1 , wherein the RF cutter is divided into a first electrically isolated portion and a second electrically isolated portion, and the RF cutter is configured to sequentially direct RF energy from one portion of the blade to target a specific portion of the interatrial septum.
12 . The assembly of claim 1 , wherein the distal tissue retention device comprises a tapered cone.
13 . The assembly of claim 12 , wherein the tapered cone is a dilator.
14 . The assembly of claim 12 , wherein the distal tissue retention device further comprises a barb.
15 . The assembly of claim 14 wherein the barb is configured to grab or hook a portion of the interatrial septum.
16 . The assembly of claim 14 wherein one of the barb or the distal tissue retention device is configured to tent a portion of the interatrial septum into a shaft lumen or a cutter lumen.
17 . The assembly of claim 14 wherein the barb is an electrode.
18 . The assembly of claim 1 , further comprising an actuator, the actuator configured to change a relative position between the RF cutter and the distal tissue retention device.