DEVICES, SYSTEMS, AND METHODS FOR PERCUTANEOUS TRANS-SEPTAL PUNCTURE

• US 20140277054A1
• Filed: 03/12/2014
• Published: 09/18/2014
• Est. Priority Date: 03/15/2013
• Status: Abandoned Application

• Current Assignee: Corvia Medical, Inc.
• Original Assignee: DC Devices Inc.
• Inventors: McNamara, Edward I., Finch, Matthew J., Forcucci, Stephen J., Devellian, Carol A.
• Application Number:
  US14/207,494
• Publication Number:
  US 20140277054A1
• Time in Patent Office: Days
• US Class Current: 606/185
• CPC Class Codes: A61B 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/22068 Centering
• CPC Class Codes: A61B 2090/033 Abutting means, stops, e.g. abutting on tissue or skin
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension

Abstract

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.

Claims

1-11. -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.

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.

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.

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.

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.