Method and catheter for creating an interatrial aperture
View Patent ↗A catheter device 10 with a cutting structure or means 16 on the distal portion 14 is disclosed, along with a medical procedure for using the device. The catheter 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 lumen and a distal end,
an RF cutter on the distal end, the RF cutter comprising an electrode and a cutter lumen,
the RF electrode configured to cut a 3 mm or larger durable aperture in an interatrial septum,
a proximal tissue retention device,
a second delivery catheter comprising:
a distal tissue retention device,
an actuator, the actuator configured to change a relative position between the proximal and distal tissue retention devices.
2 . The assembly of claim 1 further comprising a second electrode.
3 . The assembly of claim 2 , wherein the electrode is configured to cut the durable aperture and sense the orientation of the interatrial septum.
4 . The assembly of claim 1 , wherein the RF cutter comprises a ring.
5 . The assembly of claim 1 , wherein the RF cutter is configured to pass through the interatrial septum to a distal interatrial septum side.
6 . The assembly of claim 1 , wherein the distal tissue retention device comprises a tapered cone.
7 . The assembly of claim 6 , wherein the tapered cone is a dilator.
8 . The assembly of claim 1 , wherein the distal tissue retention device further comprises a barb.
9 . The assembly of claim 8 wherein the barb is configured to grab or hook a portion of the interatrial septum.
10 . The assembly of claim 9 wherein one of the barb or the distal tissue retention device is configured to tent a portion of the interatrial septum into the shaft lumen or the cutter lumen.
11 . The assembly of claim 1 , wherein the distal tissue retention device is configured to secure and withdraw the interatrial septum into the cutter lumen or the shaft lumen.
12 . The assembly of claim 1 , wherein the actuator is configured to reduce a gap between the proximal tissue retention device and the distal tissue retention device.
13 . The assembly of claim 12 , further comprising a locking mechanism adapted to retain a set distance between the proximal tissue retention device and the distal tissue retention device.
14 . A medical device assembly comprising:
a first delivery catheter comprising:
an elongated delivery catheter shaft having a shaft lumen 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 distal tissue retention system comprising a retention shaft and a distal tissue retention device,
an actuator, the actuator configured to change a relative position between the RF cutter and the distal tissue retention device to secure the interatrial septum between them.
15 . The assembly of claim 14 , wherein the RF cutter and the distal tissue retention device are configured to retain a cut tissue between them.
16 . The assembly of claim 15 , wherein the cut tissue is retained in a cutter lumen.
17 . The assembly of claim 15 , wherein the distal tissue retention device further comprises a barb.
18 . The assembly of claim 17 wherein the barb is configured to tent a portion of the interatrial septum into the shaft lumen or the cutter lumen.
19 . The assembly of claim 18 , further comprising a second electrode on the distal tissue retention device.
20 . The assembly of claim 18 , wherein the RF cutter is configured to cut a portion of the interatrial septum while the septum is tented into the shaft lumen or the cutter lumen.
21 . The assembly of claim 14 wherein the distal tissue retention device is an expandable nitinol basket.
22 . A medical device assembly comprising:
a delivery catheter comprising:
an elongated delivery catheter shaft having a lumen and a distal end,
an RF cutter on the distal end, the RF cutter comprising an electrode, and configured to cut a 3 mm or larger durable aperture in an interatrial septum,
a proximal tissue retention device,
a distal tissue retention device,
an actuator, the actuator configured to change a relative position between the proximal and distal tissue retention devices.
23 . The assembly of claim 22 , wherein the proximal and distal tissue retention devices are configured to retain the interatrial septum securely between them.
24 . The assembly of claim 22 , wherein one of the distal end, the RF cutter, or the proximal tissue retention device comprises a cavity, and wherein the distal tissue retention device is configured to tent the interatrial septum into the cavity.
25 . The assembly of claim 22 , wherein the proximal tissue retention device and the distal tissue retention device apply a force at an outer circumference of one of the proximal tissue retention device or the distal tissue retention device.