DEVICES, SYSTEMS, AND METHODS FOR PERCUTANEOUS TRANS-SEPTAL PUNCTURE
The present teachings provide devices for puncturing the atrial septum percutaneously. Specifically, one aspect of the present teachings provides a trans-septal puncturing device comprising one or more of a locating element, a stabilizing element, a puncturing element, a safety element, and optionally a monitoring element, each of which is disposed in a lumen of a sheath. The locating element and the stabilizing element locate a desired puncture site and stabilize the trans-septal puncturing device at or near the site. The puncturing element of the trans-septal puncturing device has a limited puncturing distance due in certain instances to the safety element. The present teachings provide methods of using such device for percutaneously locating a fossa ovalis, stabilizing such device at the fossa ovalis, and piercing tissue across the fossa ovalis.
1 - 11 . (canceled)
12 . A trans-septal puncturing device comprises
a locating element configured to locate a fossa ovalis on an atrial septum,
a monitoring element configured to visualize the locating element, and
a puncturing element configured to pierce the fossa ovalis.
13 . (canceled)
14 . A method of trans-septally puncturing an atrial septum at a fossa ovalis, comprising
locating a fossa ovalis by using a locating element,
engaging a stabilizing element with atrial septum near the fossa ovalis, and
advancing a puncturing element to pierce the fossa ovalis.
15 . A device configured to locate a fossa ovalis on an atrial septum, comprising
an elongated body extends from the inferior vena cava into the right atrium, and
a radially outward structure at a portion of the elongated body configured to conform to the contour of the atrial septum.
16 . The device of claim 15 , wherein the radially outward structure comprises a substantially flat surface having an edge configured to deflect upon contacting the atrial septum.
17 . The device of claim 15 , wherein the radially outward structure comprises a plurality of side arms extending radially outwardly from the elongated body, wherein at least one of the side arms is configured to extend into and locate the fossa ovalis.
18 . The device of claim 15 , wherein the radially outward structure comprises a pre-formed radially outward curve, wherein the greatest curvature of the pre-formed curve is configured to extend into and locate the fossa ovalis.
19 . The device of claim 18 comprising a tissue puncturing needle configured to pierce the fossa ovalis by tracking the elongated body until it reaches the greatest curvature of the elongated body.
20 . The device of claim 19 comprising a stabilizing element configured to engage the septal tissue near the fossa ovalis and to prevent the slippage of the tissue puncturing needle.
21 . The device of claim 19 comprising a safety element configured to limit the distal movement of the tissue puncturing needle.
22 . The device of claim 15 , wherein the elongated body having a distal end reaching inside the superior vena cava.
23 . The device of claim 12 comprising a stabilizing element configured to engage the atrial septum near the fossa ovalis and to prevent the slippage of the puncturing element.
24 . The device of claim 23 , wherein the stabilizing element is configured to limit the septum exposed to the puncturing element.
25 . The device of claim 24 , wherein the stabilizing element comprises radially expanded distal end is configured to apply vacuum to the atrial septum.
26 . The device of claim 24 , wherein the stabilizing element comprises a plurality of struts at a distal end, wherein the plurality of struts are configured to deflect when contacting the atrial septum.
27 . The device of claim 26 , wherein at least one of the plurality of struts comprises a securing element configured to securely engage the atrial septum when the struts are pressed on the atrial septum.
28 . The device of claim 23 , wherein the puncturing element comprises an incision stop element.
29 . The device of claim 28 , wherein the incision stop element comprises a radially expandable structures proximally to a distal tip of the puncturing element, wherein the radially expandable structure limits the distal movement of the puncturing element.
30 . The method of claim 14 comprising deploying an incision stop element to limit a distal movement of the puncturing element.
31 . The method of claim 14 comprising employing a monitoring element to visualize the locating element.