Transseptal access device and method of uses

Abstract

Systems, devices, and methods are provided for transseptal access of septa within a patient. The device can be advanced to a septum, e.g., towards a fossa ovalis. Instead of applying positive pressure to “tent” the septum, a negative pressure is applied to a lumen within a sheath, e.g., within an elongated member slidable within the sheath, via a negative pressure source such as a syringe on the proximal end of the sheath. This results in the septum pulling inward. The sheath employs a stationary needle-like central core component contained within the lumen of the sheath that punctures the septum when the same is pulled passed it by the negative pressure. The stationary needle-like central core component may be hollow and may form a portion of the elongated member or may be coupled to a distal end thereof.

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         8 . A device for transseptal access, comprising:
 an elongated member having a proximal end and a distal end; and   a funnel coupled to the elongated member at the distal end, the funnel having a proximal end with a first radius and a distal end with a second radius, the second radius greater than the first radius, the funnel having a retracted configuration and an expanded configuration, the expanded configuration defining an interior;   such that the elongated member and the funnel are configured to be delivered to a septal location, and such that the funnel is configured to transition from the retracted configuration to the expanded configuration, and such that a pressure lumen is defined in the elongated member extending from the proximal end and into the interior of the funnel, and such that the funnel further includes a bellows for increased flexibility; and   a piercing element movable in a distal and proximal direction, the piercing element configured to pierce the septum when the funnel is in the expanded configuration and when the funnel is coupled to the septum by a negative pressure.   
     
     
         9 . The device of  claim 8 , wherein the first radius is between about 3 French to 10 French and the second radius is between about 2.5 mm and 15 mm. 
     
     
         10 . The device of  claim 9 , wherein the first radius is between about 5 French to 8 French and the second radius is between about 5 mm and 10 mm. 
     
     
         11 . The device of  claim 8 , further comprising a fitting attached to the pressure lumen at the proximal end of the elongated member, the fitting configured to attach a negative pressure source thereto. 
     
     
         12 . The device of  claim 11 , wherein the fitting is configured to attach a syringe thereto. 
     
     
         13 . The device of  claim 8 , wherein the funnel further comprises a lip formed at the distal end. 
     
     
         14 . The device of  claim 11 , wherein the negative pressure source is configured to draw a negative pressure of between about that drawn by a 5 cc syringe and that drawn by a 100 cc syringe. 
     
     
         15 . The device of  claim 14 , wherein the negative pressure source is configured to draw a negative pressure of between about that drawn by a 10 cc syringe and that drawn by a 20 cc syringe. 
     
     
         16 . The device of  claim 8 , wherein the funnel further comprises a rib, a spine member, or a pleat. 
     
     
         17 . The device of  claim 16 , wherein the spine member is attached to the funnel. 
     
     
         18 . The device of  claim 8 , wherein the funnel has a straight shape or a convoluted shape. 
     
     
         19 . The device of  claim 8 , wherein the elongated member has further defined a guidewire lumen therein, the guidewire lumen extending from the proximal end and into the interior of the funnel. 
     
     
         20 . The device of  claim 8 , wherein in the retracted configuration, the funnel substantially surrounds the stationary needle. 
     
     
         21 . The device of  claim 8 , wherein in the expanded configuration, the funnel distal end extends further in a distal direction than does the piercing element. 
     
     
         22 . The device of  claim 8 , wherein the piercing element is a stationary needle coupled to the elongated member at the distal end. 
     
     
         23 . The device of  claim 8 , wherein the piercing element is a dilator with a sharp tip. 
     
     
         24 . The device of  claim 8 , wherein the funnel is formed of a shape memory material or is formed of a polymer, and the rib or spine member is comprised of a shape memory metal. 
     
     
         25 . A device for transseptal access, comprising:
 an elongated member having a proximal end and a distal end; and   a funnel coupled to the elongated member at the distal end, the funnel having a proximal end with a first radius and a distal end with a second radius, the second radius greater than the first radius, the funnel having a retracted configuration and an expanded configuration, the expanded configuration defining an interior;   such that the elongated member and the funnel are configured to be delivered to a septal location, and such that the funnel is configured to transition from the retracted configuration to the expanded configuration and such that a pressure lumen is defined in the elongated member extending from the proximal end and into the interior of the funnel; and   a piercing element movable in a distal and proximal direction, the piercing element configured to pierce the septum when the funnel is in the expanded configuration and when the funnel is coupled to the septum by a negative pressure, the piercing element employing radio frequency to assist penetration of target tissue.