Atrial septal aneurysm transseptal access system

Abstract

A transseptal access stability system (TASS) and method of use thereof is disclosed. The TASS includes a venous sheath for reducing the likelihood of complications that may arise when performing transseptal punctures. The TASS uses either suction force or cryo-based energy for securing the fossa ovale against the rim of the orifice of the venous sheath. A method of performing a transseptal puncture using the presently disclosed TASS also is disclosed.

1 . A transseptal access stability system comprising a cardiac catheter, wherein the cardiac catheter comprises:
 a venous sheath comprising an orifice defined by a rim at a distal end thereof, wherein the rim is configured to secure a fossa ovale thereto, and wherein the venous sheath is fluidly coupled to at least one of a vacuum source and a cryoenergy source at a proximal end thereof; and   a hollow dilator having a transseptal needle operationally positioned therein, wherein the dilator and needle are axially positioned through the venous sheath and wherein the dilator and the needle each have a distal end configured to protrude from the orifice at the distal end of the venous sheath and are adapted to be advanced and retracted to puncture a interatrial septum through the fossa ovale.   
     
     
         2 . The transseptal access stability system of  claim 1 , wherein the venous sheath is curved at the distal end by an angle α. 
     
     
         3 . The transseptal access stability system of  claim 2 , wherein angle α has a range from about 0 degrees to about 160 degrees. 
     
     
         4 . The transseptal access stability system of  claim 2 , wherein angle α is fixed. 
     
     
         5 . The transseptal access stability system of  claim 2 , wherein angle α is adjustable. 
     
     
         6 . The transseptal access stability system of  claim 5 , wherein angle α is adjustable by a steering mechanism coupled to the proximal end of the venous sheath. 
     
     
         7 . The transseptal access stability system of  claim 1 , wherein the proximal end of the venous sheath is coupled to a hemostatic valve in fluid communication with the venous sheath and the at least one of a vacuum source and a cryoenergy source. 
     
     
         8 . The transseptal access stability system of  claim 1 , wherein the proximal end of the venous sheath is coupled to a pressure gauge in fluid communication with the venous sheath and the at least one of a vacuum source and a cryoenergy source. 
     
     
         9 . The transseptal access stability system of  claim 1 , wherein the venous sheath is fluidly coupled to at least one of a vacuum source and a cryoenergy source via a side port at the proximal end thereof. 
     
     
         10 . The transseptal access stability system of  claim 1 , further comprising a regulator in fluid communication with at least one of the vacuum source and the cryoenergy source for controlling a pressure within the venous sheath or a flow of coolant from the cryoenergy source. 
     
     
         11 . The transseptal access stability system of  claim 1 , wherein the venous sheath comprises a plurality of channels and wherein the plurality of channels are fluidly coupled to at least one of a vacuum source and a cryoenergy source at a proximal end thereof. 
     
     
         12 . The transseptal access stability system of  claim 11 , further comprising a porous end cap coupled to the distal end of the venous sheath, and wherein the porous end cap has a plurality of pores in fluid communication with the plurality of channels. 
     
     
         13 . The transseptal access stability system of  claim 9 , wherein each pore comprising the plurality of pores has a geometry selected from the group consisting of a straight-walled hole, an idealized taper, a trumpet geometry, a wine glass geometry, and a champagne flute geometry, and wherein each port can be the same or different. 
     
     
         14 . The transseptal access stability system of  claim 1 , wherein the venous sheath comprises a 9.5 Fr sheath. 
     
     
         15 . The transseptal access stability system of  claim 1 , further comprising a J-wire. 
     
     
         16 . A method for performing a transseptal puncture on a subject in need of treatment thereof, the method comprising:
 (a) providing a transseptal access stability system (TASS) of  claim 1  including a J-wire;   (b) accessing the femoral venous of the subject and inserting a J-wire into the vein thereof;   (c) advancing the venous sheath with the assembled dilator of the TASS over the J-wire and into the vein;   (d) once positioned in the heart of the subject, removing the J-wire and leaving the venous sheath and the dilator in place;   (e) inserting the needle into the dilator;   (f) positioning the venous sheath/dilator/needle assembly against the septum of the fossa ovale;   (g) advancing the venous sheath over the dilator/needle until the venous sheath is in direct contact with the septal tissue;   (h) applying suction force to the venous sheath;   (i) performing the transseptal puncture by puncturing the interatrial septum with the needle; and   (j) releasing the suction force and advancing the venous sheath and the dilator across the punctured septum.   
     
     
         17 . A kit comprising:
 (a) a transseptal access stability system of  claim 1 ; and   (b) a J-wire.   
     
     
         18 . The kit of  claim 17 , further comprising instructions for use of the kit for performing a transseptal puncture on a subject in need of treatment thereof.