Transseptal access device and method of use

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.

1 . 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 of the elongated member, the funnel having a retracted configuration and an expanded configuration;   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, the expanded configuration being a use configuration, and such that the funnel is configured to stabilize the elongated member when the funnel is placed against the septum of the heart; and   further comprising a piercing element attached to a tubular member that moves within the elongated member, the piercing element configured to pierce the septum of the heart when the funnel is stabilizing the elongated member against the septum of the heart, wherein the piercing element is configured to be advanced distally or proximally, and wherein the piercing element incorporates radiofrequency, resistive, or inductive heating, to create a hole in the septum.   
     
     
         2 . The device of  claim 1 , wherein the funnel is comprised of a soft durometer polymer. 
     
     
         3 . The device of  claim 1 , wherein the piercing element is configured to be advanced distally or proximally by a mechanical slide located at a handle of the device, the mechanical slide attached at least in part to the tubular member. 
     
     
         4 . The device of  claim 1 , wherein the piercing element is advanced distally or proximally by a knob located at a handle of the device, the knob coupled to the tubular member. 
     
     
         5 . The device of  claim 1 , further comprising a governor coupled to the piercing element, to inhibit movement of the piercing element past a pre-specified point. 
     
     
         6 . The device of  claim 1 , further comprising a guidewire. 
     
     
         7 . The device of  claim 1 , further comprising an ultrasound element at a distal portion of the elongated member to visualize transseptal access locations prior to puncture. 
     
     
         8 . The device of  claim 1 , further comprising a dilator. 
     
     
         9 . The device of  claim 1 , further comprising a steerable sheath. 
     
     
         10 . The device of  claim 1 , wherein the funnel has a proximal end with a first radius and a distal end with a second radius, and 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. 
     
     
         11 . The device of  claim 10 , wherein the first radius is between about 5 French to 8 French and the second radius is between about 5 mm and 10 mm. 
     
     
         12 . The device of  claim 1 , further comprising a side port tube to provide fluid exchange with the inner lumens of the device. 
     
     
         13 . The device of  claim 1 , 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. 
     
     
         14 . The device of  claim 1 , wherein the funnel is coupled to the elongated member by way of a bond. 
     
     
         15 . The device of  claim 1 , further comprising a hemostasis valve situated at the proximal end of the elongated member. 
     
     
         16 . The device of  claim 1 , further comprising a device to deliver contrast to perform venograms. 
     
     
         17 . The device of  claim 1 , wherein the piercing element is off axis. 
     
     
         18 . The device of  claim 1 , wherein the funnel is made of a polymer and has an inherent geometric shape to help the funnel deploy into the funnel shape. 
     
     
         19 . 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 of the elongated member, the funnel being made of a polymer, the polymer having an inherent geometric shape to help the funnel deploy into the funnel shape, the funnel having a retracted configuration and an expanded configuration;   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, the expanded configuration being a use configuration, and such that the funnel is configured to stabilize the elongated member when the funnel is placed against the septum of the heart; and   further comprising a piercing element attached to a tubular member that moves within the elongated member, the piercing element configured to pierce the septum of the heart when the funnel is stabilizing the elongated member against the septum of the heart, the piercing element incorporating radiofrequency, resistive, or inductive heating, to help create a hole in the septum.   
     
     
         20 . The device of  claim 19 , further comprising a governor coupled to the piercing element, to inhibit movement of the piercing element past a pre-specified point.