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, configured to be delivered to a septal location;   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, wherein the piercing element is configured to be advanced distally or proximally, wherein the piercing element incorporates radiofrequency energy to create a hole in the septum, and wherein the piercing element further incorporates a measurement device to measure a parameter associated with transseptal access, to provide real time feedback to an operator to define when transseptal access is achieved.   
     
     
         2 . The device of  claim 1 , wherein the parameter is pressure. 
     
     
         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 piercing element is an electrode. 
     
     
         11 . The device of  claim 10 , wherein the electrode is an annular or ring electrode. 
     
     
         12 . The device of  claim 11 , wherein the annular or ring electrode is operated in a unipolar or bipolar configuration. 
     
     
         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 to the distal end. 
     
     
         14 . The device of  claim 1 , wherein the distal end of the tubular member incorporates a fixed curve. 
     
     
         15 . The device of  claim 1 , wherein the tubular member incorporates a variation in diameter. 
     
     
         16 . A device for transseptal access, comprising:
 an elongated member having a proximal end and a distal end, configured to be delivered to a septal location;   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, wherein the piercing element is configured to be advanced distally or proximally, wherein the piercing element incorporates radiofrequency energy to create a hole in the septum, and wherein the piercing element further incorporates a measurement device to measure a parameter associated with transseptal access, to provide real time feedback to an operator to define when transseptal access is achieved;   wherein the piercing element includes an RF electrode, and   wherein the tubular member has a distal end that incorporates a fixed curve.   
     
     
         17 . The device of  claim 16 , further comprising a dilator, and wherein the electrode is an annular or ring electrode. 
     
     
         18 . The device of  claim 17 , wherein the annular or ring electrode is operated in a unipolar or bipolar configuration. 
     
     
         19 . A method for transseptal access, comprising:
 delivering a device to a transseptal location, the device including:
 an elongated member having a proximal end and a distal end, configured to be delivered to a septal location; 
 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, wherein the piercing element is configured to be advanced distally or proximally, wherein the piercing element incorporates radiofrequency energy to create a hole in the septum, and wherein the piercing element further incorporates a measurement device to measure a parameter associated with transseptal access, to provide real time feedback to an operator to define when transseptal access is achieved; 
 wherein the piercing element includes an RF electrode, and 
 wherein the tubular member has a distal end that incorporates a fixed curve; and 
   activating an RF source to cause the electrode to burn a hole in the septum; and   monitoring real time feedback of the parameter to define when transseptal access is achieved.