Apparatus and method for septal punch

Patent metadata

Field	Value
Publication number	US-2022249126-A1
Application number	US-202117526616-A
Country	US
Kind code	A1
Filing date	Nov 15, 2021
Priority date	Nov 1, 2017
Publication date	Aug 11, 2022
Grant date	—

Abstract

In some embodiments, a method includes a shaft having a side catheter guide attached thereto via a guide coupler into an inferior vena cava and a superior vena cava such that the guide coupler is disposed in a right atrium, and applying a distal force to a proximal portion of the side catheter guide such that a distal end of the side catheter guide deflects laterally about the guide coupler towards a septum. The method further includes extending a side catheter that is disposed within the side catheter guide distally from the side catheter guide towards and into contact with the septum. The method further includes, with the side catheter in contact with the septum, extending a septum penetrator that is slidably disposed within the side catheter distally from the side catheter such that the septum penetrator pierces the septum.

First claim

1 . A method, comprising:
inserting a shaft having a guide attached thereto via a guide coupler into a heart of a patient such that (1) the shaft spans an inferior vena cava (IVC) of the heart and a superior vena cava (SVC) of the heart, and (2) a distal end of the guide is disposed in the right atrium of the heart; with the shaft spanning the IVC and SVC and the distal end of the guide disposed in the right atrium, deflecting the distal end of the guide about the guide coupler such that the distal end of the guide points towards a septum of the heart; extending an elongate member that is disposed within the guide distally from the guide and towards the septum; and extending a septum penetrator that is slidably disposed within the elongate member distally from the elongate member such that the septum penetrator pierces the septum at a target puncture site.

2 . The method of claim 1 ,
wherein the inserting the shaft includes inserting the shaft into the IVC before the SVC.

3 . The method of claim 1 , wherein the target puncture site is within a perimeter of the fossa ovalis of the septum of the heart.

4 . The method of claim 1 , wherein the extending the septum penetrator such that the septum penetrator pierces the septum includes extending the septum penetrator into a left atrium of the heart, the method further comprising:
with the septum penetrator disposed in the left atrium, extending distally a guide wire from within a lumen defined by the septum penetrator from the septum penetrator and into the left atrium.

5 . The method of claim 1 , wherein:
the deflecting including causing a length of the guide that is proximal to the guide coupler and disposed within the heart to increase.

6 . The method of claim 1 , wherein:
the guide coupler is a hinge rotatably coupled to the shaft to allow rotational movement of the distal end of the guide relative to the shaft and limit relative linear movement between the hinge and the distal end of the guide.

7 . The method of claim 1 , wherein the deflecting includes protruding a portion of the guide that is disposed proximal to the guide coupler through a lateral opening defined by the shaft.

8 . The method of claim 1 , further comprising:
after the extending the septum penetrator, verifying that a distal end portion of the septum penetrator is disposed within the left atrium of a heart.

9 . The method of claim 8 , wherein the verifying includes at least one of (1) measuring a pressure representative of the left atrium from outside the patient and via the lumen defined by the septum penetrator, or (2) delivering a fluid to the left atrium via the lumen defined by the septum penetrator.

10 . The method of claim 9 , wherein the guide wire is disposed within the septum penetrator during the verifying.

11 . The method of claim 9 , wherein the lumen of the septum penetrator has a first internal diameter at a distal end portion thereof and a second internal diameter, greater than the first internal diameter, in a portion proximal to the distal end portion,
the guide wire being disposed within the portion having the second internal diameter and not the portion having the first internal diameter during the verifying.

12 . The method of claim 1 , wherein the elongate member is a side catheter, and guide is a side catheter guide.

13 . The method of claim 1 , wherein the guide coupler is spaced proximally from a distal end of the shaft.

14 . The method of claim 1 , wherein the shaft has an atraumatic distal end, the atraumatic distal end being disposed within the SVC during (1) the deflecting the distal end of the guide, and (2) the extending the elongate member.

15 . An apparatus, comprising:
a shaft; a guide coupled and angularly deflectable relative to the shaft via a guide coupler, the guide configured to be transitioned between a delivery configuration and a deployed configuration in which a distal end of the guide points away from a centerline of the shaft when transitioned from its delivery configuration to its deployed configuration, the guide defining a lumen; an elongate member slidably disposable within the lumen of the guide and configured to extend distally relative to the guide, the elongate member defining a lumen; and a puncture member slidably disposable within the lumen of the elongate member and configured to extend distally relative to the distal end of the elongate member, the puncture member being configured to puncture a target puncture site.

16 . The apparatus of claim 15 , wherein:
the puncture member defines a lumen configured to slidably receive a guide wire.

17 . The apparatus of claim 15 , wherein:
the guide coupler allows rotational movement of the guide relative to the shaft and limits relative linear movement between the guide coupler and the guide.

18 . The apparatus of claim 15 , wherein:
the guide extends proximally from its distal end across at least a portion of the shaft, and beyond a side of the shaft, and then turns and extends proximally towards a proximal end of the shaft, when the guide is in its deployed configuration and the elongate member is at least partially disposed within the lumen of the guide.

19 . The apparatus of claim 15 , further comprising:
a handle operably coupled to the shaft and the guide, the shaft and the guide extending distally from the handle, a length of the guide disposed between a distal end of the handle and the guide coupler increases in response to the guide being transitioned from its delivery configuration to its deployed configuration.

Assignees

• Univ Maryland
• Univ Of Maryland Medical System Llc
• Protaryx Medical Inc

Inventors

• Gammie James S
• Haarstad Philip J
• Blaeser David
• Bauer Ryan
• Roller Stephen
• Quinn Rachael
• Pasrija Chetan
• Hlavka Edwin

Classifications

• A61B2017/00247

  Making holes in the wall of the heart, e.g. laser Myocardial revascularization · CPC title

• A61B2017/003

  Steerable · CPC title

• A61B2090/08021

  of the patient or his organs · CPC title

• A61B2017/22069

  Immobilising; Stabilising · CPC title

• A61B2017/22038

  with a guide wire · CPC title