IP Library › Granted Patent US 12,702,437
Granted Patent B2
US 12,702,437 · App. 17/851,260 · Granted Aug 11, 2026

Method and septostomy device for creating an interatrial aperture

Inventors: Gil M. Vardi (Town and country, MO); Chris Minar (Excelsior, MN)
A61B17/3205A61B17/320016A61B17/32053A61B17/3478A61B2017/00247A61B2017/22042A61B2017/22047A61B2017/22069A61B2017/306A61B2017/320064A61B2017/3458
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Quick Facts
Patent No.
US 12,702,437
App. No.
17/851,260
Filed
Jun 28, 2022
Granted
Aug 11, 2026
Kind
B2
Art Unit
3771
USPC
606/170
Abstract

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.

Claims (23)

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.

Continuity (8)
Continuation 16677455 · Nov 7, 2019
Continuation In Part 15900127 · Feb 20, 2018
Continuation In Part 15089547 · Apr 20, 2016
Continuation In Part 14738802 · Jun 12, 2015
Continuation In Part 15812815 · Nov 14, 2017
Continuation 14738802 · Jun 12, 2015
Provisional Application 62012212 · Jun 13, 2014
Related Publication 20220323094A1 · Oct 13, 2022
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